Implantable device with bionic micro-thorn attachment structure

Abstract

The present invention relates to an implantable device with a bionic microthorn attachment structure, comprising at least an attachment frame, which is a self-expanding stent or a ball-expanding stent. The attachment frame comprises multiple skeletons and multiple bionic microthorn attachment structures. The bionic microthorn attachment structures are arranged on the outer surface of the skeleton. The bionic microthorn attachment structures are shaped like sparse microthorns on the surface of plants. The bionic microthorn attachment structures include thorn roots and microthorns. The microthorns are composed of thorn bodies and thorn tips. The microthorns are linear, J-shaped, or a combination of the two. The thorn bodies and / or thorn tips can contact cavity tissue to achieve an attached anchoring function. The present invention has a wide range of applications, provides damage-free and secure anchoring, and is highly safe.

Description

Technical Field

[0001] The present invention relates to a medical device, in particular to an implant device with a bionic micro-thorn attachment structure. Background Art

[0002] With the rise of interventional surgery, venous filter implantation for pulmonary embolism and intravascular stent implantation for human aortic diseases (such as aortic aneurysm, aortic dissection, etc.) have received more and more social attention.

[0003] Venous filter implantation is an interventional surgical procedure that involves implanting a temporary filter in a blood vessel to intercept larger blood clots, preventing them from blocking blood vessels in vital organs and causing hypoxia and damage to the patient's organs. The filter is then removed after the lesion has resolved or resolved. Common problems with common filters currently on the market include the following: The support structure has a large contact area with the vessel wall, making it easy for the filter to be covered by the endothelium due to intimal hyperplasia or adhesion, which can easily cause tearing of the vessel wall during retrieval and shorten the retrieval cycle; The filter has poor stability and lacks self-centering, making it prone to displacement or tilting under the impact of blood flow, which makes retrieval difficult; and the barbed structure can easily cause puncture of the vessel wall, leading to other complications.

[0004] Among endovascular stent implantation procedures, aortic stent graft endoluminal exclusion has been widely used for aneurysms and dissections of the descending and abdominal aorta, becoming a first-line treatment. However, several issues remain: insufficient anchoring strength allows the stent to slip relative to the vessel, posing a potential risk to the body; barbs in the anchoring structure can easily puncture the vessel wall, posing a risk; and, to enhance anchoring, bare stent designs have been introduced, but these are not widely adaptable to tortuous vessels.

[0005] In summary, whether it's a filter or an intravascular stent, preventing the device from sliding within the blood vessel is a primary safety concern. To achieve effective anchoring, existing devices incorporate barbs that penetrate the vessel wall. However, these barbs are often rigid, straight, and long. While they improve anchoring to a certain extent, they carry the potential risk of puncturing the vessel wall, causing complications or even implant failure. Therefore, there is an urgent need for an implantable device with improved safety and a wider range of applications. Summary of the Invention

[0006] The purpose of the present invention is to overcome the deficiencies of the prior art and to provide an implant device with a bionic micro-thorn attachment structure, which can achieve damage-free anchoring and ensure firm fixation.

[0007] The object of the present invention is achieved through the following technical solutions:

[0008] An implant device with a bionic microthorn attachment structure, the implant device at least comprising an attachment frame, the attachment frame being a self-expanding stent or a ball-expanding stent, the attachment frame comprising multiple skeletons and multiple bionic microthorn attachment structures, the bionic microthorn attachment structures being arranged on the outer surface of the skeleton, the morphology of the bionic microthorn attachment structures being sparse microthorns imitating those on the surface of plants, the bionic microthorn attachment structures comprising thorn roots and microthorns, the microthorns consisting of a thorn body and a thorn tip, the microthorns being linear or J-shaped or a combination of the two, the thorn body and / or the thorn tip of the microthorn being able to touch cavity tissue, thereby achieving an attached anchoring function.

[0009] The purpose of this application can be further achieved through the following technical solutions:

[0010] In one embodiment, the micro-needles can undergo adaptive bending deformation when contacting the cavity tissue, which helps the micro-needles to adhere to the cavity tissue without damage and enhance their attachment anchoring function.

[0011] In one embodiment, the plants include but are not limited to Xanthium sibiricum, Humulus japonicus, Caesalpinia scoparia, Ellipticum ternata, Euryale ferox, Lepidium membranaceus, Rubus chinensis, Cirsium japonicum, Polygonum aviculare, and Acanthopanax spp.

[0012] In one embodiment, it is defined that: the length of the sashimi body is L1, the curved length of the thorn tip is L2, the angle between the outward extension direction of the sashimi body and the outward extension direction of the distal end of the thorn tip is β, the sashimi body length L1, the thorn tip curved length L2 and the angle β satisfy the following mathematical relationship: 0.2mm≤L1≤5mm, 0<L2≤3mm, 0≤β≤150°, and the length of the straight micro-thorn is less than the length of the J-shaped micro-thorn.

[0013] In a preferred embodiment, the total number of the bionic micro-thorn attachment structures is between 3 and 100. By adjusting the parameters L1, L2 and β, the thorn tips can be facilitated to touch the cavity tissue, thereby increasing the effectiveness of the attachment anchoring.

[0014] In a preferred embodiment, the stab body length L1, the stab tip curve length L2 and the angle β satisfy the following mathematical relationship: 0.5≤L1≤2mm, 0≤L2≤1mm, 90°≤β≤150°.

[0015] In a preferred embodiment, the number of the bionic micro-thorn attachment structures provided on each of the skeletons is between 1 and 10.

[0016] In a preferred embodiment, the distance between the tip of the spike and the stab body is ≤0.5 mm, so that the J-shaped spike is in the shape of a micron-sized folded hook or an arc-shaped hook.

[0017] In a preferred embodiment, when the micro-thorn is linear in shape, the body of the micro-thorn is the thorn tip.

[0018] In a preferred embodiment, the linear micro-thorn body length L1 is ≤ 1 mm.

[0019] In a preferred embodiment, among all the micro-punctures, the number of the linear micro-punctures accounts for between 50% and 99%.

[0020] In a preferred embodiment, among all the micro-thorns, multiple groups of straight micro-thorns and J-shaped micro-thorns are designed with intermittent repetition. When the J-shaped micro-thorns and straight micro-thorns in each group adaptively contact the cavity tissue, they cooperate with each other and form a "self-locking" structure, so that each of the skeletons cannot move toward the distal end or the proximal end along the axis of the skeleton, thereby increasing the constraint and strengthening the firmness of the attachment to the cavity tissue.

[0021] In one embodiment, the bionic micro-thorn attachment structure further includes a limiting mechanism, which is a hole groove provided on the skeleton. The bionic micro-thorn attachment structure corresponds to the hole groove in position, and at least a part of the thorn root is located in the hole groove. The thorn root and the hole groove cooperate with each other to limit the relative position of the micro-thorn on the skeleton.

[0022] In one embodiment, each of the bionic micro-thorn attachment structures comprises at least one thorn root and two micro-thorns, the micro-thorns and the holes and grooves correspond one to one in position and number, at least a portion of the thorn root is in contact with the skeleton, the thorn root is U-shaped or a circular structure, and the thorn root passes through the two holes and grooves, and each of the bionic micro-thorn attachment structures is formed by a wire material with elasticity and shape memory passing through the corresponding two holes and grooves in sequence, and the cross-sectional area of ​​the wire material is ≤0.3mm 2 The aspect ratio of the wire is between 2 and 40, making the micro-thorns thin and soft.

[0023] In a preferred embodiment, each of the microthorns is coplanar.

[0024] In a preferred embodiment, the thorn root passes through two adjacent holes.

[0025] In a preferred embodiment, the cross-sectional area of ​​the wire is 0.002 mm 2 and 0.015mm 2 between.

[0026] In a preferred embodiment, the bionic microthorn attachment structure is both flexible and elastic, and has villi-like properties, and is used to achieve attached anchoring with cavity tissue. When subjected to external force, the microthorns can be centered on the thorn root to achieve free rotation and deformation in the direction of the outer surface of each skeleton. When implanted in the human cavity tissue, because the inner wall of the cavity tissue has more local protrusions, when the microthorns contact the local protrusions, the orientation of some of the microthorns can be adaptively changed, thereby enhancing the attached anchoring of the microthorns, and they will not penetrate the tissue rigidly and straightly, and will not damage the cavity tissue. Therefore, the entire bionic microthorn attachment structure is adaptive, and the attached anchoring function to the cavity tissue is enhanced.

[0027] In one embodiment, the limiting mechanism is one or more of a local necking structure, a local protruding structure, and a keyway structure provided on the frame, or the limiting mechanism is fixedly connected to the frame and the thorn root by gluing, welding, or mechanical fitting.

[0028] In one embodiment, on any cross-section of the skeleton in the long diameter direction, the thickness of the skeleton is defined as P1, the length of the hole groove itself is P2, the spacing between any two adjacent hole grooves is P3, and the angle between the outward extension direction of the thorn body and the direction of the skeleton away from the central axis m of the attachment frame is ω, wherein the parameters P1, P2, P3 and ω respectively satisfy the following mathematical relationships: 0.05mm≤P1≤0.5mm, 0.05mm≤P2≤4mm, 0.5mm≤P3≤10mm, 30°≤ω<180°. Adjusting the specific parameters of P1 and P2 can achieve the adjustment of the angle ω, ensuring that each of the thorn tips is facing the cavity tissue or fluid flow direction in a natural state, thereby enhancing the effectiveness of the attached anchoring. At the same time, the total number of the micro-thorns can be adjusted by adjusting the parameter P3.

[0029] In a preferred embodiment, the thickness P1 of the skeleton, the outer diameter P2 of the hole, and the angle ω respectively satisfy the following mathematical relationships: 0.1mm≤P1≤0.3mm, 0.1mm≤P2≤2mm, 0.5mm≤P3≤2mm, 60°≤ω≤150°.

[0030] In one embodiment, the implantable device is a filter, the cavity tissue is a blood vessel wall, the attachment frame is a self-expanding stent, the skeleton is elastic, and the attachment frame further comprises a central piece, a plurality of skeletons radiate outward from the central piece and enclose a three-dimensional structure having the function of blocking thrombus, and the three-dimensional structure is in the shape of a lantern, a gourd, a mushroom, an umbrella, a bowl, or a cone, or a combination thereof;

[0031] Alternatively, the implantable device is a hollow tubular intravascular stent, the intravascular stent is a self-expanding stent or a balloon-expandable stent, the cavity tissue is the blood vessel wall, and the intravascular stent is composed of multiple skeletons interconnected to form one or more layers of wavy or mesh structures, which play the role of supporting blood vessels or blocking diseased tissues.

[0032] In a preferred embodiment, the implantable device is a filter, and the central piece is provided with a grasping mechanism, which facilitates grasping the filter from a target location and removing it from the body.

[0033] In one embodiment, when the implant device is a filter, a plurality of bionic micro-thorn attachment structures are provided on the inner surface of the skeleton, and the thorn bodies and / or thorn tips of the bionic micro-thorn attachment structures are oriented toward the direction of fluid flow in the cavity or radially toward the cavity tissue wall, thereby preventing the thrombus captured in the implant device from falling out during the recovery and release adjustment process.

[0034] In one embodiment, the attachment frame includes a micro-thorn protection structure, which is arranged on the skeleton. The distance between the tip of the micro-thorn and the skeleton is defined as L3, and the height of the micro-thorn protection structure protruding from the skeleton is L4. Then L3 and L4 satisfy the following relationship: L3<L4. The micro-thorn protection structure is one or more combinations of hemispherical, ellipsoidal, curved, and broken line shapes, so that when the implant device enters and exits the delivery sheath, the micro-thorn attachment structure does not contact the inner wall of the delivery sheath.

[0035] In one embodiment, the attachment frame is provided with a self-centering structure, wherein the self-centering structure is a curled structure formed by extending the end of the skeleton further toward the end, and the curled structure is one or more of an elliptical, circular or two-dimensional spiral structure, and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame;

[0036] Alternatively, the self-centered structure is a curled structure formed by multiple skeletons radiating from the center of the central piece to the surrounding areas, and the curled structure is one or more of an elliptical, circular or two-dimensional spiral structure, and the plane where each curled structure is located is coplanar with the central axis m of the attachment frame.

[0037] In a preferred embodiment, the bionic micro-thorn attachment structure is provided on the outer surface of the self-centering structure.

[0038] In a preferred embodiment, the curling direction of the curled structure is inward curling, the angle σ between the extension line direction of the end of the curled structure and the direction of the central axis m of the attachment frame toward the distal end satisfies: 0°≤σ≤90°, and the number of turns n of the curled structure satisfies: 0.25≤n≤1.5.

[0039] In one embodiment, the attachment frame includes a surrounding body, which is wrapped around the skeleton and at least wraps the thorn root that is in contact with the skeleton, and is used to enhance the connection strength between the skeleton and the bionic micro-thorn attachment structure, avoid direct contact between part or all of the skeleton and the cavity tissue, reduce the amount of metal ion precipitation, and improve biocompatibility; reduce the friction coefficient, reduce the contraction and release resistance of the attachment frame in the delivery sheath; increase smoothness, and experience a better feel; enhance the fatigue resistance and durability of the attachment frame, and play a "secondary protection" role for the attachment frame, avoiding the risk of fracture of the attachment frame due to long-term corrosion or fatigue failure in the cavity tissue.

[0040] In a preferred embodiment, one or more fixing structures are provided on each of the skeletons, and the proximal end and / or distal end of the surrounding body are effectively connected to or positionally defined by the skeleton via the fixing structures.

[0041] In a preferred embodiment, the surrounding body is a flexible medical wire / filament / belt, and the cross-sectional shape of the surrounding body includes one or a combination of circular, elliptical, and rectangular shapes.

[0042] In a preferred embodiment, the surrounding body is formed by winding sutures, and the material of the sutures includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxetane (PDO), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactide-co-glycolide) (PGLA), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metals and / or medical polymer materials with development effects.

[0043] In a preferred embodiment, one or more local protrusions are provided on the outer surface of the surrounding body itself, and the local protrusions themselves form barb structures. The barb structures face the blood vessel wall to further enhance anchoring.

[0044] In one embodiment, when the implant device is a filter, the outermost area of ​​the skeleton is provided with a flange structure, and the outer surface of the flange structure is provided with the bionic micro-thorn attachment structure to prevent the skeleton from directly contacting the cavity tissue.

[0045] In one embodiment, the implant device is a hollow tubular intravascular stent, which is a balloon-expandable stent. A balloon can pass through the balloon-expandable stent and expand to a certain diameter by the balloon. When the skeleton is attached to the wall of the cavity tissue, the balloon allows the micro-needles to adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue.

[0046] In one embodiment, the implantable device is a hollow tubular intravascular stent, which is a dense mesh stent woven from wires and has a mesh shape, and the area of ​​each mesh is ≤2.5mm. 2 One or more grids of the dense mesh stent have deformation adaptability. When the grid serves as a channel interface of a small branch stent, the grid can expand and fit onto the outer surface of the small branch stent. The small branch stent is a thinned hollow tubular intravascular stent with a diameter at least half that of the dense mesh stent.

[0047] In a preferred embodiment, the local metal wires of the dense mesh stent are processed to form a flat structure with a certain thickness, and the bionic micro-thorn attachment structure is provided on the surface of the flat structure.

[0048] In one embodiment, the implant device surface comprises a flexible film, and the film is located on the surface of the attachment frame.

[0049] In a preferred embodiment, the implantable device is a filter, and a flexible film is provided on the surface of the attachment frame of the filter. The film is soft and has micropores. The micropores can filter blood but can block blood clots, and can effectively capture blood clots in blood vessels.

[0050] In a preferred embodiment, the implant device is an intravascular stent, and the film is wrapped around the skeleton surface of the coated stent. It is soft and dense, and can isolate blood and prevent blood from seeping from the surface of the coated stent and flowing to the diseased part of the blood vessel.

[0051] Compared with the existing technology, this patent has the following outstanding advantages:

[0052] 1. The bionic microthorn attachment structure provided by the present invention has a sparse microthorn morphology that imitates the surface of plants. The bionic microthorn attachment structure includes a thorn root and microthorns. The microthorns can touch the cavity tissue and form an effective anchor. The microthorns are slender, shallow, short and soft, so that the microthorns have villi-like characteristics, realizing the attachment anchoring function and avoiding the trauma caused by deep and direct penetration into the cavity tissue; when the microthorns contact the cavity tissue, they can undergo adaptive bending deformation, which is conducive to the microthorns to adhere to the cavity tissue without damage, thereby enhancing their attachment anchoring function.

[0053] 2. The micro-thorns provided by the present invention are linear, J-shaped, or a combination of the two. The micro-thorns consist of a thorn body and a thorn tip, which has the following advantages: a) The J-shaped micro-thorns have micron-sized thorn tips that can hook the cavity tissue, avoiding trauma caused by deep and direct penetration into the cavity tissue; b) The numerous micro-thorns are like the uneven pattern on the outer surface of a tire, and thus also play a role in increasing the roughness. In particular, for the linear micro-thorns, the static friction between the micro-thorns and the cavity tissue is significantly increased, and the adhesion to the cavity tissue is enhanced, thereby achieving effective anchoring; c) In particular, the J-shaped micro-thorns and the linear micro-thorns cooperate with each other to form a "self-locking" structure, so that each skeleton cannot move toward the distal end or the proximal end along the axis of the skeleton, thereby increasing the constraint and strengthening the firmness of the attachment to the cavity tissue.

[0054] 3. The bionic micro-thorn attachment structure provided by the present invention includes a thorn root and a thorn tip, and adopts a combined structure with the skeleton, wherein the thorn root and the limiting mechanism on the skeleton cooperate with each other to limit the relative position of the micro-thorn on the skeleton. This design makes it possible: a) the length of the micro-thorn body and the thorn tip can be adjusted, which can effectively ensure that the thorn body and the thorn tip of the straight micro-thorn and the J-shaped micro-thorn contact the cavity tissue without damage, thereby avoiding piercing the cavity tissue and causing potential risks to the patient; b) the bionic micro-thorn attachment structure has both high flexibility and high elasticity, so that the micro-thorn can be centered on the thorn root under the action of external force, and can effectively prevent the micro-thorn from piercing the cavity tissue and causing potential risks to the patient; Now, each skeleton can rotate and deform freely in the direction of the outer surface. Due to the curvature of the cavity tissue itself or the different release positions of the instrument, the orientation and angle ω of some micro-thorns can be adaptively changed, thereby enhancing the attachment anchoring property of the micro-thorns. Instead of rigidly and straightly penetrating deep into the cavity tissue, the cavity tissue is not damaged or only slightly damaged. Therefore, the entire bionic micro-thorn attachment structure is adaptive, enhancing the attachment anchoring function to the cavity tissue; c) The skeleton of the attachment frame and the micro-thorns are connected through the cooperation of the thorn roots and the limiting mechanism. The thorn roots can effectively prevent the micro-thorns from breaking due to fatigue failure.

[0055] 4. The bionic micro-thorn attachment structure provided by the present invention can effectively achieve an attached anchoring function with the blood vessel wall due to the characteristics of the micro-thorns being slender, shallow, and soft, rather than deeply piercing the tissue to anchor, making it easy for the surgeon to recover and remove the implanted device as needed at any time during or after the operation. Even when the implanted device, such as a filter, has been implanted for a certain period of time (for example, 6 months) and has exerted its established effect of thrombus filtration, the skeleton and micro-thorns of the implanted device are covered or wrapped by a large amount of new endothelial tissue on the blood vessel wall. The micro-thorns of the implanted device can also be easily detached from the blood vessel wall or extracted from the large amount of new endothelial tissue, thereby achieving the recovery and removal of the implanted device.

[0056] 5. The number of bionic micro-needle attachment structures provided by the present invention is adjustable. According to actual clinical needs, they can be densely distributed on the outer surface of the skeleton of the attachment frame, thereby increasing the contact probability between the attachment frame and the cavity tissue, ensuring that all surfaces of the attachment frame in contact with the inner wall of the cavity tissue during implantation can achieve effective attachment anchoring, further increasing the anchoring strength, and avoiding the risk of device falling off due to insufficient anchoring strength; for the filter, the micro-needle is provided with a micro-needle protection structure to prevent the micro-needle from directly contacting the inner wall of the sheath, thereby eliminating the poor pushing of the micro-needle due to scraping the sheath or other safety hazards.

[0057] 6. The implant device of the bionic micro-thorn attachment structure provided by the present invention can make corresponding adjustments to the design of the bionic micro-thorn attachment structure according to the different anatomical morphologies of the cavity tissue. That is, by reasonably setting the thickness of the skeleton, the spacing of the holes and grooves, the length of the holes and grooves themselves, the inclination angle and number of the micro-thorns, it is ensured that most of the micro-thorns can adaptively anchor the cavity tissue, thereby giving full play to the maximum advantage of the micro-thorn attachment anchoring function.

[0058] 7. The implant device of the bionic micro-thorn attachment structure provided by the present invention is provided with a surrounding body, which has the following advantages: a) the surrounding body prevents part or all of the skeleton from direct contact with the cavity tissue, reduces the amount of metal ion precipitation, and improves biocompatibility; b) reduces the friction coefficient and reduces the contraction and release resistance of the attachment frame in the delivery sheath; c) increases smoothness and provides a better hand feel; d) enhances the fatigue resistance and durability of the attachment frame, plays a "secondary protection" role for the attachment frame, and avoids the risk of fracture of the attachment frame due to long-term corrosion or fatigue failure in the blood vessel; e) increases the force transmission to ensure that each skeleton is evenly stressed when the filter is unsheathed and there is no obvious sense of jamming; f) enhances the fit and position limitation between the thorn root and the skeleton; g) fine-tunes the micro-thorn angle to ensure that the damage to the blood vessel wall by the micro-thorn is minimized; h) in the embodiment where a thin film is provided on the attachment frame, the surrounding body can be pre-buried or hidden The sutures connecting the thin film and the attachment frame avoid wear and breakage caused by direct contact of the sutures with the inner surface of the sheath of the delivery system during repeated retraction and release of conventional filters; i) by changing the single-layer thickness of the surrounding body and the number of winding turns, the overall thickness of the surrounding body in the radial direction is adjusted, thereby achieving the adjustability of the length of the micro-thorns exposed from the skeleton, thereby avoiding deep penetration or even piercing the blood vessel wall; j) in one embodiment, the surrounding body is a structure that can be detached from the skeleton and / or micro-thorns. When the implant device is implanted in the blood vessel for a certain period of time, the skeleton and the surrounding body are covered by a large amount of new endothelial tissue, so that the implant device and the blood vessel wall are firmly fixed and it is not convenient for the two to be directly detached. At this time, the surrounding body can be detached from the skeleton and the micro-thorns, so that the skeleton and the micro-thorns are pulled out of the surrounding body, and finally the implant device can be recovered and taken out of the body, thereby realizing the removable function of the implant device.

[0059] 8. The proximal end of the bionic micro-thorn attachment structure of the present invention is provided with a protective structure. This design has the following advantages: a) when the filter is received in the delivery sheath, the protective structure is in direct contact with the inner wall of the delivery sheath, thereby avoiding scraping of the delivery sheath or poor entry and exit caused by direct contact of the micro-thorn with the inner wall of the delivery sheath; b) when the filter is placed in the target blood vessel, the protective structure reduces the contact area between the skeleton and the blood vessel wall to a certain extent, which helps to achieve the removable function of the filter after implantation.

[0060] 9. The implant device of the bionic micro-thorn attachment structure provided by the present invention is provided with a flange structure in the outermost area of ​​the skeleton, which minimizes the contact area between the outer surface of the filter and the blood vessel wall, reduces the occurrence of endothelial hyperplasia or adhesion that causes the filter to be easily covered by the endothelial membrane, and avoids the tearing damage to the blood vessel wall caused by the filter during recovery; in addition, the bionic micro-thorn attachment structure densely distributed on the outer surface of the flange structure makes the contact between the filter and the blood vessel wall point contact, which extends the recovery period to a certain extent.

[0061] 10. The bionic micro-thorn attachment structure in the present invention can improve the anti-displacement performance of the aortic stent, prevent the stent from being displaced by the impact of blood flow after implantation, and prevent the sealing strength of the proximal end of the stent from being weakened due to stent displacement, resulting in internal leakage, or completely deviating from the predetermined release position, resulting in the failure of the stent treatment effect. Especially in some blood vessels with complex curvature characteristics, the micro-thorns can undergo adaptive changes, not only without damaging the blood vessel wall, but also without being displaced by the impact of blood flow, thereby achieving the effect of precise positioning; in the field of balloon-expandable stents, when the stent penetrates into the cavity tissue, due to the slender, shallow and short characteristics of the micro-thorns of the bionic micro-thorn attachment structure, the micro-thorns can penetrate into the endothelium or media of the blood vessel in a small and shallow manner, realizing an extremely minimally invasive anchoring function. This anchoring is extremely minimally invasive and effective, avoiding the various design drawbacks caused by the existing rigid, straight and thick barbed anchoring technology.

[0062] 11. The implantable device of the bionic micro-thorn attachment structure provided by the present invention is a dense mesh stent, which has the following advantages: a) it can effectively block the diseased parts on the blood vessels, including arterial dissection ruptures and false lumens, true or false arterial aneurysms, and achieve a therapeutic effect; b) it has outstanding bending and deformation capabilities and can adapt to blood vessels of various anatomical forms, especially curved blood vessels and diseased parts; c) the presence of the mesh will not affect the blood flow of the branch blood vessels that supply blood to important organs in the body, and has long-term patency; d) small branch stents can also be flexibly inserted into the wall of the dense mesh stent, thereby diverting the blood flow in the dense mesh stent to the small branch stent, thereby forming blood flow in the branch blood vessels that supply blood to important organs; e) a bionic micro-thorn attachment structure is provided on the outer surface of the dense mesh stent and the branch stent, which facilitates the dense mesh stent to be non-destructively and firmly attached to the blood vessel wall, and enhances the stable connection between the main stent and the small branch stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Figure 1 A schematic diagram of an implantable device with a bionic micro-thorn attachment structure according to the present invention;

[0064] Figure 2 A partial schematic diagram of the bionic micro-thorn attachment structure provided by the present invention;

[0065] Figure 3 This is a schematic diagram of the bionic micro-thorn attachment structure provided by the present invention after being matched with the skeleton;

[0066] Figure 4 Schematic diagram of a partial skeleton with holes and grooves in the present invention;

[0067] Figure 5a The bionic micro-thorn attachment structure of the present invention is fixed in a U-shaped manner in the skeleton;

[0068] Figure 5b The bionic micro-thorn attachment structure of the present invention is fixed in a circular shape in the skeleton;

[0069] Figure 6 This is a dimension diagram related to the morphological control of the bionic micro-thorn attachment structure in the present invention;

[0070] Figure 7a A schematic diagram of the micro-thorns in the implant device with the bionic micro-thorn attachment structure provided by the present invention achieving a certain degree of free rotation and deformation around the thorn base under the action of external force;

[0071] Figure 7b A schematic diagram of the J-shaped micro-thorns in the implant device with the bionic micro-thorn attachment structure provided by the present invention forming a "self-locking" structure when they undergo adaptive bending deformation and cooperate with the straight micro-thorns;

[0072] Figure 8 a is a schematic diagram showing only the rigid, straight, thick and long straight barb structure in a conventional implant device;

[0073] Figure 8 b is a schematic diagram showing only the rigid, thick and long barb structure in a conventional implant device;

[0074] Figure 8 c is a schematic diagram showing only the J-shaped micro-thorn of the present invention having a soft, slender, shallow and short thorn body and a thorn tip, wherein the thorn tip is tiny and has an arc-shaped hook shape;

[0075] Figure 8 d is a schematic diagram showing only the J-shaped micro-thorn of the present invention having a soft and slender thorn body and a thorn tip, wherein the thorn tip is tiny and has a folded hook shape;

[0076] Figure 8e is a schematic diagram showing only the soft, slender, linear microthorns of the present invention;

[0077] Figure 9 This is a partial view of a filter provided with a bionic micro-thorn attachment structure at the proximal end in the present invention;

[0078] Figure 10a A schematic diagram of the bionic micro-thorn attachment structure of the implant device with the bionic micro-thorn attachment structure provided by the present invention before being wound around the body;

[0079] Figure 10b A schematic diagram of the bionic micro-thorn attachment structure of the implant device with the bionic micro-thorn attachment structure provided by the present invention after being wound around a body;

[0080] Figure 11 A schematic diagram of a fixing structure of a surrounding body provided on a local frame in the present invention;

[0081] Figure 12a Schematic diagram of the straight-wound surrounding body in the present invention;

[0082] Figure 12b Schematic diagram of the oblique winding body in the present invention;

[0083] Figure 12c Schematic diagram of the cross-winding surrounding body in the present invention;

[0084] Figure 13 Schematic diagram of a surrounding body with a local barbed structure in the present invention;

[0085] Figure 14 Schematic diagram of a filter having a self-centered structure according to the present invention;

[0086] Figure 15 a is a schematic diagram of a curled structure having an elliptical structure in the present invention;

[0087] Figure 15 b is a schematic diagram of a curled structure having a circular structure in the present invention;

[0088] Figure 15 c is a schematic diagram of the curled structure having a two-dimensional spiral structure in the present invention;

[0089] Figure 16 a~ Figure 16 c represents three forms of three-dimensional wavy and / or network structures formed by interconnecting the skeletons in the present invention;

[0090] Figure 17 A three-dimensional view of a "mushroom-shaped" filter in a natural, unconstrained state according to the present invention;

[0091] Figures 18a to 18c for Figure 1 Local view Figure I The enlarged view shows several diagrams of the protective structure of the proximal end of the bionic micro-thorn attachment structure, in which Figure 18a It is a hemispherical protective structure. Figure 18b It is an ellipsoidal protective structure. Figure 18c It is a broken line protection structure;

[0092] Figure 19 This is a partial view of the filter provided with a protective structure in the present invention being placed in a delivery sheath;

[0093] Figure 20 for Figure 1 Local view Figure I An enlarged view of a protective structure is shown, which is formed by adding additional accessories;

[0094] Figure 21 A three-dimensional view of a filter provided with a flange structure according to the present invention;

[0095] Figure 22 Schematic diagram of the bionic micro-thorn attachment structure provided on the outer surface of the flange structure of the present invention in contact with the blood vessel wall;

[0096] Figure 23 Schematic diagram of a filter with a flexible film provided on the surface of an attachment frame according to the present invention;

[0097] Figure 24a Schematic diagram of the suture in the present invention using a pre-embedded winding method;

[0098] Figure 24b Schematic diagram of the suture in the present invention using a hidden winding method;

[0099] Figure 25 This is a schematic diagram of the exposed winding method used for sutures of conventional implantable devices currently on the market;

[0100] Figure 26 A schematic diagram of a partial skeleton after coating in an implant device with a bionic micro-thorn attachment structure provided by the present invention;

[0101] Figure 27 A three-dimensional view of a stent graft with a bare stent in the present invention;

[0102] Figure 28 A three-dimensional view of a stent graft without a bare stent in the present invention;

[0103] Figure 29 is a schematic diagram of a ball-expandable stent in the present invention;

[0104] Figure 30 This is a schematic diagram of a dense mesh bracket in the present invention;

[0105] Figure 31 for Figure 30 Central local view Figure II The enlarged image shows the mesh with deformation adaptability in the dense mesh support;

[0106] Figure 32 for Figure 30 Central local view Figure II A magnified view of the structure showing branch scaffolds established in a dense scaffold grid;

[0107] Figure 33 for Figure 30 Central local view Figure III The enlarged view shows the flat structure of the dense mesh stent formed by local metal wire processing.

[0108] Among them, 1 is the implant device, 2 is the delivery sheath, 11 is the attachment frame, 12 is the bionic micro-thorn attachment structure, 13 is the center piece, 14 is the balloon, 15 is the grasping mechanism, 111 is the skeleton, 112 is the flange structure, 121 is the thorn root, 122 is the micro-thorn, 123 is the limiting mechanism, 124 is the self-centering structure, 125 is the surrounding body, 126 is the film, 127 is the suture, 1221 is the thorn body, 1222 is the thorn tip, 1223 is the protective structure, 1231 is the hole groove, and 1251 is the fixing structure. DETAILED DESCRIPTION

[0109] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0110] To more clearly describe the implantable device with a biomimetic micro-thorn attachment structure provided by the present invention, the terms "distal end" and "proximal end" are defined here. These terms are commonly used in the field of interventional medical devices. Specifically, the "proximal end" refers to the end of the device closest to the heart, and the "distal end" refers to the end of the device farther from the heart.

[0111] Example 1:

[0112] like Figure 1As shown, the implant device 1 with a bionic microthorn attachment structure provided by the present invention at least includes an attachment frame 11, and the attachment frame 11 includes multiple elastic skeletons 111 and multiple bionic microthorn attachment structures 12. In a natural and unconstrained state, the multiple skeletons 111 surround a three-dimensional structure. The attachment frame 11 has anatomical morphological adaptability. The bionic microthorn attachment structure 12 is arranged on the outer surface of the skeleton 111. The morphology of the bionic microthorn attachment structure 12 is sparse microthorns imitating the surface of a plant. The bionic microthorn attachment structure 12 includes a thorn root 121 and a microthorn 122. The microthorn 122 consists of a thorn body 1221 and a thorn tip 1222. The microthorn 122 is a straight microthorn or a J-shaped microthorn or a combination of the two. The thorn body 1221 and / or the thorn tip 1222 of the microthorn 122 can touch the cavity tissue to achieve an attached non-destructive anchoring function.

[0113] In one embodiment, the implant device 1 with a bionic micro-thorn attachment structure provided by the present invention is a filter, such as Figure 1 As shown, the cavity tissue is a blood vessel wall, the attachment frame 11 is a self-expanding stent, and the skeleton 111 is elastic. The attachment frame 11 also includes a central member 13 fixedly connected to the attachment frame 11. Multiple skeletons 111 radiate outward from the central member 13 and form a three-dimensional structure. The three-dimensional structure exhibits one or more combinations of the shapes of a lantern, gourd, mushroom, umbrella, bowl, and cone. In a preferred embodiment, the cavity tissue is a blood vessel wall. The central member 13 is provided with a gripping mechanism 15 that facilitates gripping the filter from a target location and removing it from the body.

[0114] Figure 2This is a partial schematic diagram of the bionic micro-thorn attachment structure 12. The micro-thorns 122 in the bionic micro-thorn attachment structure 12 are sparsely distributed micro-thorns 122 on the outer surface of fruits, leaves or stems of some plants in nature, and are soft and slender. Such plants include but are not limited to Xanthium sibiricum, Humulus striata, Cloudberry, Coleus chinensis, Euryale ferox, Lepidium membranaceus, Rubus chinensis, Cirsium japonicum, Polygonum aviculare, and Tripterygium wilfordii. This makes the bionic micro-thorn attachment structure 12 have villus-like properties, which is used to achieve attached and lossless anchoring with the blood vessel wall. In the present invention, a single micro-thorn 122 is morphologically a straight micro-thorn or a J-shaped micro-thorn. When it is J-shaped, the body 1221 of the micro-thorn 122 is equivalent to the vertical section of the "letter J", and the thorn tip 1222 is equivalent to the hook section of the "letter J". The thorn tip 1222 of the J-shaped micro-thorn 122 can be hung on the blood vessel wall, so that the J-shaped micro-thorn 122 has good attachment-type non-destructive anchoring, avoiding trauma caused by deep and direct puncture of the blood vessel wall; when the micro-thorn 122 is straight, the straight micro-thorn 122 can increase the roughness, significantly increase the static friction between the micro-thorn 122 and the blood vessel wall, and enhance the adhesion to the blood vessel wall; preferably, when the thorn tip 1222 of the micro-thorn 122 is extremely small, for example, the distance between the tip of the thorn tip 1222 and the body 1221 is ≤0.5 mm, so that the J-shaped thorn tip 1222 is a micron-sized folded hook (such as Figure 8 d) or arc-shaped hook (as shown Figure 8 c), which not only gives the micro-needle 122 the advantages of both J-shape and straight line, but also enables the micro-needle 122 to perform the function of non-destructive anchoring of the blood vessel.

[0115] In one embodiment, it is defined that: the length of the thorn body 1221 is L1, the curved length of the thorn tip 1222 is L2, the angle between the outward extension direction of the thorn body 1221 and the outward extension direction of the distal end of the thorn tip 1222 is β, the length L1 of the thorn body 1221, the curved length L2 of the thorn tip 1222 and the angle β satisfy the following mathematical relationship: 0.2mm≤L1≤5mm, 0≤L2≤3mm, 0≤β≤150°, and the preferred relationship is as follows: 0.5≤L1≤2mm, 0≤L2≤1mm, 90°≤β≤150°, so that the micro-thorns 122 have the shallow and short characteristics of sparse micro-thorns on the surface of plants, and the length of the straight micro-thorns 122 is less than the length of the J-shaped micro-thorns 122. Figure 3 As shown, by adjusting the parameters L1, L2 and β, the needle tip 1222 can be easily touched to the blood vessel wall, thereby increasing the effectiveness of the attached non-destructive anchoring. At the same time, it can effectively ensure non-destructive contact with the blood vessel wall, thereby avoiding the traditional filter anchoring device from penetrating too deeply and causing damage to the blood vessel wall.

[0116] In a preferred embodiment, the total number of bionic micro-thorn attachment structures 12 is between 3 and 100. In order to give full play to the respective advantages of the linear and J-shaped micro-thorns 122 mentioned above and subsequently, the number of linear micro-thorns should be between 50% and 99%; in another preferred embodiment, the number of bionic micro-thorn attachment structures 12 set on each skeleton 111 is between 1 and 10. This design makes the bionic micro-thorn attachment structures 12 densely distributed on the outer surface of the skeleton 111 of the attachment frame 11, increasing the contact probability between the attachment frame 11 and the blood vessel wall, ensuring that the attachment frame 11 can achieve effective attachment-type non-destructive anchoring at all positions where it contacts the blood vessel wall during implantation, further increasing the anchoring strength, and avoiding the risk of filter falling off due to insufficient anchoring strength. In a preferred embodiment, when the micro-needle 122 is linear in shape, the body 1221 of the micro-needle 122 is the thorn tip 1222. Preferably, the length L1 of the body 1221 of the linear micro-needle 122 is ≤1 mm, which can give full play to the dependent non-destructive anchoring property of the micro-needle 122 and avoid trauma caused by deep and direct penetration into the blood vessel wall.

[0117] In one embodiment, the bionic micro-thorn attachment structure 12 further includes a limiting mechanism 123, and the thorn root 121 cooperates with the limiting mechanism 123 to limit the relative position of the micro-thorn 122 on the skeleton 111, which can effectively prevent the micro-thorn 122 from breaking due to fatigue failure. Figure 4 As shown, in this embodiment, the limiting mechanism 123 is a hole groove provided on the skeleton 111, which is used to fix the bionic micro-thorn attachment structure 12 on the skeleton 111. The bionic micro-thorn attachment structure 12 corresponds to the hole groove in position, and at least part of its thorn root 121 is located in the hole groove. The thorn root 121 cooperates with the hole groove to limit the relative position of the micro-thorn 122 on the skeleton 111. Figure 5a and Figure 5bAs shown, in one embodiment, each bionic micro-thorn attachment structure 12 includes at least one thorn root 121 and two micro-thorns 122. The micro-thorns 122 correspond to the holes in position and number. At least a part of the thorn root 121 is in contact with the skeleton 111. The thorn root 121 has a U-shaped or a circular structure and passes through the two holes. In this embodiment, the bionic micro-thorn attachment structure 12 and the skeleton 111 of the attachment frame 11 adopt a combined structure. The advantages of this design are: a) the length and thickness of the micro-thorns 122 are adjustable, while the barbs of most filters on the market are laser-engraved as a whole from the same tube as the attachment frame 11. Due to the design limitations of the raw materials, such barbs are often hard and thick, which increases the risk of barb breakage; b) during the production process, once the manufacturer finds that one or some micro-thorns 122 are too long or too short, too thick or too thin, they can temporarily replace them with micro-thorns 122 with better length or thickness, thereby realizing a personalized customized "thorn seeding" (sowing micro-thorns) function based on the patient's clinical needs, ensuring that each micro-thorn 122 can maximize the attached non-destructive anchoring function. Of course, for defective micro-thorns 122, performance can be reworked without loss of performance, avoiding the prior art where the entire device is scrapped due to defective barbs, ultimately leading to an increase in the manufacturer's production costs. As a preferred embodiment, each micro-thorn 122 is coplanar. On this basis, the thorn root 121 passes through two adjacent holes, thereby avoiding the possible overlap of multiple thorn roots 121, which may increase the sheath diameter of the delivery sheath 2 used. As a more preferred embodiment, each bionic micro-thorn attachment structure 12 is made of a wire with elasticity and shape memory that passes through two adjacent holes in sequence. The cross-sectional area of ​​the selected wire is ≤0.3mm 2 The aspect ratio of the wire is within the range of 2 and 40, so that the micro-needle 122 has the characteristics of being slender and soft. Under this premise, once the surgeon finds that the length of one or some linear micro-needles 122 is too long and there is a high risk of puncturing the blood vessel wall during the operation, the surgeon can flexibly cut the micro-needles 122 into a more suitable length, thereby realizing the "needle adjustment" (needle length adjustment) function based on the patient's personalized clinical needs, thereby ensuring the non-destructive advantages and characteristics of the attached non-destructive anchoring, and avoiding trauma caused by deep and direct puncture of the blood vessel wall; further, the material of the wire includes but is not limited to cobalt-chromium alloy, nickel-titanium alloy, 316L stainless steel, pure tantalum, titanium alloy, gold, platinum-iridium alloy, and its cross-sectional area is 0.002mm 2 and 0.015mm 2The aforementioned biomimetic micro-thorn attachment structure 12 can maximize its villus-like characteristics and effectively achieve an attached non-destructive anchoring function with the blood vessel wall. It is worth noting that, precisely because the micro-thorns 122 are slender, shallow, short, and soft, they can effectively achieve an attached non-destructive anchoring function with the blood vessel wall, rather than deeply piercing the tissue to anchor, making it easy for the surgeon to recover and remove the device as needed at any time during or after the operation. Even when the implanted device, such as the filter of this embodiment, has been implanted for a certain period of time (e.g., 6 months) and has exerted its established effect of thrombus filtration, the skeleton and micro-thorns of the implanted device are covered or wrapped by a large amount of newly formed endothelial tissue on the blood vessel wall. The micro-thorns of the implanted device can also be easily removed from the blood vessel wall, or extracted from the large amount of newly formed endothelial tissue, thereby achieving the recovery and removal of the implanted device.

[0118] like Figure 6 As shown, in one embodiment, on a cross section of any skeleton 111 in the long diameter direction, the thickness of the skeleton 111 is defined as P1, the length of the hole slot itself is P2, the spacing between any two adjacent hole slots is P3, the central axis of the attachment frame 11 is m, and the angle between the outward extension direction of the thorn body 1221 and the direction of the skeleton 111 away from the central axis m is ω. Then the parameters P1, P2 and ω respectively satisfy the following mathematical relationships: 0.05mm≤P1≤0.5mm, 0.05mm≤P2≤4mm, 0.5mm≤P3≤10mm, 30°≤ω<180°. Adjusting the specific parameters of P1 and P2 can adjust the angle ω and the total number of micro-needles 122, ensuring that each thorn tip 1222 in contact with the blood vessel wall can face the blood vessel wall, enhancing the effectiveness of the attached non-destructive positioning, and at the same time, the total number of micro-needles 122 can be adjusted by adjusting the parameter P3. In a preferred embodiment, the above mathematical relationship is as follows: 0.1 mm ≤ P1 ≤ 0.3 mm, 0.1 mm ≤ P2 ≤ 2 mm, 0.5 mm ≤ P3 ≤ 2 mm, 60° ≤ ω ≤ 150°.

[0119] The bionic micro-thorn attachment structure 12 of the present invention is both flexible and elastic, with villi-like properties, and is used to achieve non-destructive anchoring with the blood vessel wall. When the micro-thorns 122 contact the blood vessel wall tissue, they can undergo adaptive bending deformation, which facilitates the non-destructive attachment of the micro-thorns 122 to the blood vessel wall and enhances its non-destructive anchoring function. Furthermore, under the action of external forces, the micro-thorns 122 can freely rotate and deform in the direction of the outer surface of each skeleton 111 with the thorn root 121 as the center, such as Figure 7aAs shown, when implanted into a blood vessel, the orientation and angle ω of some micro-thorns 122 can be adaptively changed due to the curvature of the blood vessel or the different release positions of the device, thereby enhancing the dependent and non-destructive anchoring of the micro-thorns 122, and not rigidly and straightly penetrating deeply into the inner wall tissue of the blood vessel without damaging the blood vessel wall. At the same time, when the J-shaped micro-thorns adaptively contact the blood vessel tissue, they can cooperate with the straight micro-thorns to form a "self-locking" structure, thereby increasing the constraint and strengthening the firmness of the attachment to the blood vessel wall. Figure 7b As shown, the entire bionic micro-thorn attachment structure 122 has adaptability and enhances the non-destructive anchoring function of the attachment to the blood vessel wall. It is worth noting that in order to achieve this function, the length of the thorn body 1221 of the straight micro-thorn 122 should be shorter than the length of the thorn body 1221 of the J-shaped micro-thorn 122, so that the thorn tips 1222 of both can contact the blood vessel wall. In addition, in order to maximize the attachment firmness enhancement function brought by the "self-locking" structure, multiple groups of straight micro-thorns 122 and J-shaped micro-thorns 122 should be designed to be repeated at intervals, such as Figure 7b As shown, the entire bionic micro-thorn attachment structure 12 has self-adaptability, thereby enhancing the non-destructive anchoring function attached to the blood vessel wall. Figure 8 a to Figure 8 e are comparison diagrams of a single barb structure of a conventional filter and a single micro-thorn 122 structure of the present invention. The barbs of a conventional filter are usually straight barbs or large hooks with a shape completely fixed to the skeleton 111, and are rigid, straight, thick and long as a whole. They are completely unable to deform adaptively and can only penetrate too deeply into the blood vessel wall at a fixed angle in the blood vessel, which easily causes the risk of damaging the blood vessel wall. The thorn body 1221 and thorn tip 1222 of the micro-thorn 122 of the present invention have morphological and performance characteristics such as being slender, shallow, short and soft, and the thorn tip 12221 is tiny and hook-shaped at the micron level. Therefore, both in terms of morphological structure and function, it has advantages that cannot be matched by traditional barb structures.

[0120] like Figure 9 As shown, in one embodiment, a bionic micro-thorn attachment structure 12 is provided at the proximal end of the attachment frame 11. The thorn body 1221 and / or the thorn tip 1222 of these bionic micro-thorn attachment structures 12 are facing the proximal end side, which can effectively prevent the thrombus captured in the device from falling out in the reverse direction during the recovery process, thereby playing a role in preventing the thrombus from falling out.

[0121] The attachment frame 11 of the present invention is made of a medical metal tube with elasticity and shape memory through integrated laser cutting and heat treatment, or is made of a medical metal or polymer wire with elasticity and shape memory through integrated weaving and heat treatment, or is directly made of a medical polymer material with elasticity and shape memory through integrated hot processing. The medical metals mentioned here include but are not limited to cobalt-chromium alloys and nickel-titanium alloys.

[0122] Example 2:

[0123] refer to Figure 10a and Figure 10b Based on the first embodiment, in the second embodiment, the attachment frame 11 includes a surrounding body 125, which is wrapped around the skeleton 111 and at least wraps the thorn roots 121 that are in contact with the skeleton 111, so as to enhance the connection strength between the skeleton 111 and the bionic micro-thorn attachment structure 12. The design of the surrounding body 125 also has the following advantages: a) the surrounding body 125 prevents part or all of the skeleton 111 from directly contacting the blood vessel wall, reducing the amount of metal ion precipitation and improving biocompatibility; b) reducing the friction coefficient and reducing the resistance of the attachment frame 11 to retraction and release in the delivery sheath 2; c) increasing smoothness and providing a better hand feel; d) enhancing the fatigue resistance of the attachment frame 11 and providing "secondary protection" for the attachment frame 11, thereby avoiding the risk of fracture of the attachment frame 11 due to long-term corrosion or fatigue failure in the blood vessel; e) increasing the force transmission and ensuring that each skeleton 111 is evenly stressed and has no obvious sense of jamming when the filter is unsheathed; f) enhancing the fit and position limitation between the thorn root 121 and the skeleton 111, such as Figure 10a and Figure 10b As shown, by adjusting the wrapping force of the surrounding body 125, it is beneficial to ensure that the thorn root 121 fits the skeleton 111 to the greatest extent, minimize the sheath diameter of the required delivery sheath 2, expand the range of suitable people, and especially suit people with small vascular access; g) the angle of the micro-puncture 122 can be fine-tuned to ensure that the damage of the micro-puncture 122 to the blood vessel wall is minimized; h) in the sixth embodiment of setting a film on the attachment frame 11, the surrounding body 125 can pre-embed or hide the suture 127 that sutures the film to the attachment frame 11, avoiding the suture 127 directly touching the filter during repeated retraction and release. Contact with the inner surface of the sheath of the delivery system causes wear and fracture; i) by changing the single-layer thickness and the number of windings of the surrounding body 125, the overall thickness of the surrounding body 125 in the radial direction is adjusted, thereby achieving the adjustability of the length of the micro-thorns 122 exposed on the skeleton 111. For example, when the surgeon finds that the blood vessel walls of some patients are very thin according to clinical needs and it is necessary to minimize the length of the micro-thorns 122 exposed on the skeleton 111, the surgeon can flexibly and immediately increase the number of windings of the surrounding body 125 to achieve the predetermined purpose, thereby realizing personalized customization of clinical needs to a certain extent.

[0124] In one embodiment, one or more fixing structures 1251 are provided on each skeleton 111, and the proximal end and / or distal end of the surrounding body 125 is effectively connected or positionally limited to the skeleton 111 through the fixing structures 1251, such as Figure 11In a preferred embodiment, a fixing structure 1251 is provided at the proximal and distal ends of each skeleton 111. The fixing structure 1251 is a through hole extending through the skeleton 111. After the surrounding body 125 passes through the through hole at the proximal end to achieve connection, it tightly wraps around and envelops the skeleton 111 and all thorn roots 121 between the through holes, ultimately passing through the through hole at the distal end to achieve connection. Connecting the surrounding body 125 to the fixing structure 1251 by tying a knot or other means can further constrain the position of the surrounding body 125 on the skeleton 111, strengthen the surrounding body 125 on the skeleton 111, and prevent it from loosening. In another preferred embodiment, the surrounding body 125 is made of a single flexible round wire or flat wire that wraps around and covers most or all of the skeleton 111 and all the thorn roots 121, and passes through all the through holes to finally form a closed loop. The advantage of winding with a single surrounding body 125 is that the number of knots between the surrounding body 125 and the fixed structure 1251 is minimized, the number of knots is reduced, and the increase in the retraction and release resistance of the entire attachment frame 11 due to too many knots is avoided. At the same time, it also simplifies the manufacturing process and improves the production efficiency of the product. At the same time, through mutual cooperation with the through holes, the effectiveness and firmness of the connection are enhanced, ensuring that the following surrounding body 125 maintains a predetermined winding shape on the skeleton 111, avoiding the surrounding body 125 from sliding relative to the skeleton 111 along the skeleton 111 during the process of entering and exiting the delivery sheath 2, resulting in weakening or failure of the above-mentioned surrounding body 125.

[0125] Figures 12a to 12c This diagram illustrates different winding methods for the surrounding body 125 on the local skeleton 111. These methods include straight winding, diagonal winding, and cross winding, or a combination thereof. Straight winding offers ease of operation and high efficiency; diagonal winding allows for smoother retraction and release of the skeleton 111; and cross winding provides greater security. Manufacturers can select the optimal winding method based on specific needs. The number of winding layers for the surrounding body 125 ranges from one to five. Excessive layers, while increasing winding strength, also increases overall volume, increasing resistance to retraction and release of the attachment frame 11 within the delivery sheath 2, and reducing the operator's experience.

[0126] In a preferred embodiment, the surrounding body 125 is a flexible medical wire / filament / ribbon, and its cross-sectional shape includes one or a combination of circular, elliptical, and rectangular shapes. In another preferred embodiment, the surrounding body 125 is formed by winding a suture 127, and the material of the suture 127 includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxetane (PDO), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactide-co-glycolide) (PGLA), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metals and / or medical polymers with imaging effects.

[0127] like Figure 13 As shown, in one embodiment, one or more local protrusions may be provided on the outer surface of the surrounding body 125 itself, and the local protrusions themselves form barb structures. The barb structures face the blood vessel wall, which can further enhance the anchoring effect.

[0128] In another embodiment, the surrounding body 125 is a structure that can be separated from the skeleton 111 and / or the micro-thorns 122. When the implant device 1 is implanted in the blood vessel for a certain period of time, the skeleton 111 and the surrounding body 125 are covered by a large amount of new endothelial tissue, so that the implant device and the blood vessel wall are firmly fixed and it is not convenient for the two to be directly separated. At this time, the surrounding body 125 can be separated from the skeleton 111 and the micro-thorns 122, so that the skeleton and the micro-thorns are pulled out of the surrounding body 125, and finally the implant device 1 can be recovered and removed from the body, thereby realizing the removable function of the implant device 1. Furthermore, the surrounding body 125 is made of a degradable material, and the degradation period of the material is shorter than the implantation time, so that after the implant device 1 is implanted into the blood vessel for a predetermined time, the surrounding body 125 has been degraded. In this case, the skeleton 111 and the micro-thorns 122 can be easily separated from the blood vessel wall, thereby realizing the removable function of the implant device 1. Materials that meet this performance include but are not limited to polydioxanone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polylactide-1-ol (PGLA), polycaprolactone (PCL), chitosan, etc.

[0129] Example 3:

[0130] refer to Figure 14 Compared with the first and second embodiments, the third embodiment is different from the first and second embodiments in that the attachment frame 11 is provided with a self-centering structure 124. In one embodiment, the self-centering structure 124 is located at the proximal end and / or the distal end of the skeleton 111 and is a curled structure radiating outward from the center of the skeleton 111. The curled structure is one or more of an elliptical, circular or two-dimensional spiral structure, such as Figure 15 a~ Figure 15 As shown in c, the plane where each curled structure is located is coplanar with the central axis m, and a bionic micro-thorn attachment structure 12 is provided on the outer surface of the curled structure. The thorn body 1221 and / or the thorn tip 1222 of the bionic micro-thorn attachment structure 12 point to only one side of the proximal end, and the curled structure has elasticity and shape memory. In a preferred embodiment, the curling direction of the curled structure is inward curling, and the angle σ between the extension line direction of the end of the curled structure and the direction of the central axis m toward the distal end satisfies: 0°≤σ≤90°, and the number of coils n of the curled structure satisfies: 0.25≤n≤1.5. In another preferred embodiment, the self-centering structure 124 is a three-dimensional wavy and / or mesh structure formed by interconnecting each skeleton 111, such as Figure 16 a~ Figure 16 c. The advantages of the self-centering structure 124 are: a) The elastic and shape-memory coiled structure directly contacts the vessel wall on all sides, providing sufficient and stable radial support to the vessel wall. Therefore, during use, the entire attachment frame 11 maintains excellent self-centering, preventing displacement of the filter due to long-term blood flow impact; b) The biomimetic micro-puncture attachment structure 12 is provided on the surface of the coiled structure, further enhancing the support force between the coiled structure and the vessel wall and the stability of the attachment frame 11; c) The coiled structure adopts a curved design, which ensures point contact between the coiled structure and the vessel wall, reducing intimal creep, extending the filter's lifespan, and facilitating removal after filter implantation.

[0131] In a preferred embodiment, the curled structure is formed by the end of the skeleton 111 further extending toward the end, so that the filter is in a "mushroom shape" in a natural unconstrained state, such as Figure 17 As shown, this "mushroom shape" is flexible and resilient, providing sufficient radial support. At the same time, under the flushing of blood, the entire attachment frame 11 can automatically adjust its position in the axial direction, which has a shock-absorbing and buffering effect, ensuring that the filter can be firmly attached to the blood vessel wall.

[0132] Example 4:

[0133] Compared with the first embodiment, the fourth embodiment is different from the first embodiment in that, in one embodiment, a protective structure 1223 is provided at the proximal end of the bionic micro-thorn attachment structure 12 on the outer surface of the skeleton 111. The protective structure 1223 is in the shape of a hemisphere, an ellipsoid, a curve, a broken line, or a combination of multiple shapes. Figures 18a to 18cThe figure shows several kinds of protective structures 1223. It is defined that in a natural unconstrained state, the vertical height between the micro-thorn 122 and the skeleton 111 is L3, and the farthest distance between the micro-thorn protective structure 1223 and the skeleton 111 is L4. Then L3 and L4 satisfy the following relationship: L3<L4. At the same time, the connection point or connection area between the protective structure 1223 and the skeleton 111 and the skeleton provided with the bionic micro-thorn attachment structure 12 are designed to be inclined and converge toward the proximal end, so that the thorn tip 1222 of the micro-thorn 122 or the tip of the micro-thorn 122 is located outside the protective structure 1223, so that the micro-thorn 122 can touch the blood vessel wall. When the filter is received in the delivery sheath 2, the protective structure 1223 directly contacts the inner wall of the delivery sheath 2, thereby avoiding scraping the sheath or poor entry and exit of the sheath caused by the micro-thorn 122 directly contacting the inner wall of the delivery sheath 2. Figure 19 As shown, after the filter is placed in the target blood vessel, the protective structure 1223 reduces the contact area between the frame 111 and the blood vessel wall to a certain extent, which helps to achieve the removable function after the filter is implanted. The protective structure 1223 can be processed as a whole with the attachment frame 11, or it can be welded by adding welding materials, bonded by adding glue, combined with additional accessories, friction fit, interweaving, meshing, interlocking, or a combination of the above methods, as shown in FIG. Figure 20 shown.

[0134] Example 5

[0135] like Figure 21 and Figure 22 As shown, compared with Example 1, Example 4 differs from Example 1 in that, in one embodiment, a flange structure 112 is provided in the outermost area of ​​the skeleton 111, and a bionic micro-thorn attachment structure 12 is provided on the outer surface of the flange structure 112. The advantage of this design is that it minimizes the contact area between the outer surface of the filter and the blood vessel wall, reduces the occurrence of endothelial hyperplasia or adhesion that causes the filter to be easily covered by the endothelial membrane, and avoids the tearing damage caused by the filter to the blood vessel wall during recovery; in addition, the bionic micro-thorn attachment structure 12 densely distributed on the outer surface of the flange structure 112 makes the contact between the filter and the blood vessel wall point contact, which extends the recovery cycle to a certain extent.

[0136] Example 6

[0137] refer to Figure 23Compared to Examples 1 to 5, Example 6 differs from the aforementioned examples in that a flexible film 126 is provided on the surface of the attachment frame 11. Film 126 is attached to and connected to the frame 111. Film 126 is soft and has micropores. The micropores can filter blood but block blood clots, effectively capturing intravascular clots. In one embodiment, sutures 127 can be used to suture the film 126 to the distal end of the attachment frame 11 (referred to as suture film). Sutures 127 are secured to the frame 111 of the attachment frame 11 by wrapping, bundling, or knotting. The frame 111 can be designed with multiple pre-reserved holes to facilitate threading and suturing. Figure 24a and Figure 24b There are two winding forms of the suture 127 on the skeleton 111. Figure 24a The suture 127 is pre-buried, that is, the suture 127 is passed through the surrounding body 125 on the distal end of the frame 111, so that part of the suture 127 is buried inside the surrounding body 125, thereby achieving a pre-buried effect; or the suture 127 is pre-wound around the frame 111, and then the surrounding body 125 is wound around the frame 111, so that the suture 127 is buried between the surrounding body 125 and the proximal end of the frame 111; Figure 24b The suture 127 is hidden, and is wound inside the groove between the surrounding body 125, so that the suture 127 does not protrude. The advantages of these two winding forms are that the suture 127 is pre-buried or hidden in the surrounding body 125, so that when the attachment frame 11 is retracted and released, the suture 127 will not directly contact the inner wall of the delivery sheath tube 22, avoiding the suture 127 from being worn and broken due to multiple retraction and release operations. Figure 25 This is the conventional winding method of filter sutures 127 currently on the market. In this case, the sutures 127 on the proximal end of the attachment frame 11 are directly exposed to the outer surface. The sutures 127 in this area will inevitably contact the inner wall of the delivery sheath 2. When the filter is repeatedly retracted and released, there is a risk of sutures 127 being worn and broken, resulting in a loose fixation between the film 126 and the attachment frame 11, or even causing the film 126 to fall off, ultimately affecting the sealing function of the film 126. Flexible materials suitable for making the film 126 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomer, polyamide, silicone, polyolefin, degradable materials such as polylactic acid, polyvinyl alcohol, and animal tissue. The sutures 127 can be made of non-absorbable materials such as polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene, or absorbable materials such as goat intestine tissue, polylactic acid, and polyglycolic acid.

[0138] In another embodiment, the distal and proximal end surfaces of the attachment frame 11 can be integrated into a single body and coated by heating, gluing, coupling agent connection, etc. The material used can be polytetrafluoroethylene (PTFE), polypropylene (PP), polyethylene terephthalate (PET), etc. having a porous structure. Figure 26This is a partial view of the attachment frame 11 after lamination. Both the distal and proximal end faces of the attachment frame 11 are covered with a film 126, and part of the skeleton 111 of the attachment frame 11 is wrapped within the film 126. The advantages of the lamination method are that the film 126 and the attachment frame 11 have excellent fit and flatness, and the deformation of the film 126 and the attachment frame 11 are consistent. During the retraction and release of the attachment frame 11, the lamination of the film 126 will not form local wrinkles or depressions, resulting in excellent retraction and release properties for the filter. In a preferred embodiment, when the surrounding body 125 on the attachment frame 11 is made of the same material as polytetrafluoroethylene, the film 126 can be integrally laminated with the surrounding body 125.

[0139] Example 7

[0140] like Figures 27 and 28 As shown, the implant device 1 with a bionic micro-thorn attachment structure provided by the present invention in Example 7 is a hollow tubular intravascular stent, which is a self-expanding stent. Multiple skeletons 111 are interconnected to form one or more layers of wavy or mesh structures, which constitute the main body of the intravascular stent and play a role in radially supporting blood vessels or blocking diseased tissues; preferably, the intravascular stent is a coated stent, and a flexible film 126 is provided on the surface. The film 126 is wrapped around the surface of the skeleton 111 of the coated stent, has the characteristics of being soft and dense, and can isolate blood, preventing blood from seeping from the surface of the coated stent and flowing to the diseased part of the blood vessel, such as the rupture of arterial dissection and false lumen, true or false arterial aneurysm. In the field of aorta, especially abdominal aortic stents, the proximal end of the stents currently on the market are all equipped with bare stents or bare stents with barbs to increase the proximal anchoring area, improve the stent's anti-displacement performance, prevent the stent from being displaced by blood flow impact after implantation, and prevent the proximal end of the stent from weakening due to stent displacement, resulting in internal leakage, or completely deviating from the predetermined release position, resulting in the failure of the stent treatment effect. To ensure the anchoring strength, the barbs are usually also hard, straight and thick, such as Figure 8 a and Figure 8 As shown in b, this barb structure can easily puncture the blood vessel wall, especially in some blood vessels with complex curvature characteristics. Since this type of barb structure cannot undergo adaptive changes, it can only penetrate the blood vessel wall at a fixed angle, which can easily cause the risk of damaging the blood vessel wall. Figure 27 This embodiment is a coated stent with a bare stent structure. A plurality of groups of bionic micro-thorn attachment structures 12 are provided on the band of the bare stent. After release, the coated stent can be firmly attached to the blood vessel wall, which not only does not damage the blood vessel wall but also will not be displaced by the impact of blood flow, thereby achieving the effect of precise positioning.

[0141] like Figure 28As shown, in a preferred embodiment, a number of bionic micro-thorn attachment structures 12 are provided on the skeleton 111 of the stent body. The advantage of this design is that the bare stent design in the coated stent is eliminated, so that the coated stent itself can achieve an attached anchoring function to the blood vessel wall, making the coated stent more applicable, especially for blood vessels with complex curved shapes, such as the aortic arch, with excellent adaptability. At the same time, the direct contact area between the metal material and the blood vessel wall is reduced, the precipitation of metal ions is reduced, and the biocompatibility is enhanced.

[0142] Example 8

[0143] refer to Figure 29 Based on the seventh embodiment, the eighth embodiment differs from the seventh embodiment in that the implant device 1 with a bionic micro-thorn attachment structure provided by the present invention in the eighth embodiment is a hollow tubular intravascular stent, which is a balloon-expandable stent. A bionic micro-thorn attachment structure 12 is provided on the surface of the balloon-expandable stent. A balloon 14 can pass through the balloon-expandable stent and is expanded to a certain diameter by the balloon 14. When the skeleton 111 is abutted against the cavity tissue wall, the balloon 14 allows the micro-thorns 122 to attach to the cavity tissue to the greatest extent, or penetrate into the cavity tissue. When penetrating into the cavity tissue, due to the slender, shallow and short characteristics of the micro-thorns 122 of the bionic micro-thorn attachment structure 12, the micro-thorns 122 can penetrate into the vascular intima or media in a small and shallow manner, thereby realizing an extremely minimally invasive anchoring function. This anchoring is extremely minimally invasive and effective, avoiding the various design drawbacks caused by the above-mentioned existing rigid, straight and thick barbed anchoring technology.

[0144] Example 9

[0145] like Figure 30 As shown, based on the eighth embodiment, the ninth embodiment differs from the eighth embodiment in that the implant device 1 with a bionic micro-thorn attachment structure provided by the present invention in the ninth embodiment is a hollow tubular intravascular stent, which is a dense mesh stent with a grid shape formed by weaving metal wires, and the area of ​​each grid is ≤2.5mm 2 , the dense mesh stent has the following advantages: a) It effectively blocks the diseased parts on the blood vessels, including the rupture of arterial dissection and false lumen, true or false arterial aneurysms, and achieves a therapeutic effect; b) It has outstanding bending and deformation capabilities and can adapt to blood vessels of various anatomical forms, especially curved blood vessels and diseased parts; c) The presence of the mesh will not affect the blood flow of the branch vessels that supply blood to important organs in the body, and has long-term patency. In one embodiment, specifically, the mesh of the dense mesh stent is used as a channel interface of the small branch stent. In this case, after the dense mesh stent is first placed at the target position, a guide wire is passed from the branch blood vessel and through one of the meshes of the dense mesh stent, thereby establishing a channel interface of the small branch stent, such as Figure 31As shown, when the dense mesh stent is made of woven silk materials with elasticity and shape memory so that one or more grids of the dense mesh stent have deformation adaptability, the selected grid and the grids in the surrounding area can undergo adaptive deformation, so that the grids of the dense mesh stent expand in a surrounding manner to wrap around the periphery of the small branch stent, and fit the outer surface of the small branch stent to the greatest extent, as shown in FIG. Figure 32 As shown, not only the dense mesh stent and the small branch stent fully adapt to the anatomical morphology of the target placement area and form a "straddling" anatomical fixation, thereby ensuring the effective connection between the two, but also avoid the inability of the small branch stent and the main stent in the existing technology to effectively seal at the connection point, resulting in the occurrence of type III internal leakage. Preferably, the small branch stent is a thinned hollow tubular intravascular stent with a diameter at least half that of the dense mesh stent, and a bionic micro-thorn attachment structure 12 is provided on the outer surface of the small branch stent to enhance the stability of the connection between the main stent and the small branch stent; in a preferred embodiment, the local metal wire of the dense mesh stent is processed to form a flat structure with a certain thickness, and the bionic micro-thorn attachment structure 12 is provided on the surface of the flat structure to facilitate the dense mesh stent to be non-destructively and firmly attached to the blood vessel wall, as shown in FIG. Figure 33 shown.

[0146] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. An implant device (1) having a bionic micro-thorn attachment structure, the implant device (1) comprising at least an attachment frame (11), the attachment frame (11) being a self-expanding stent or a ball-expanding stent, characterized in that: The attachment frame (11) comprises a plurality of skeletons (111) and a plurality of bionic micro-thorn attachment structures (12). The bionic micro-thorn attachment structures (12) are arranged on the outer surface of the skeleton (111). The bionic micro-thorn attachment structures (12) are in the form of sparse micro-thorns imitating the surface of plants. The bionic micro-thorn attachment structures (12) comprise thorn roots (121) and micro-thorns (122). The micro-thorns (122) are composed of thorn bodies (1221) and thorn tips (1222). The micro-thorns (122) are linear micro-thorns or J-shaped micro-thorns or a combination of the two. The thorn bodies (1221) and / or the thorn tips (1222) of the micro-thorns (122) can touch the cavity tissue, thereby realizing an attached non-destructive anchoring function. Wherein, when the micro-thorn (1221) contacts the cavity tissue, it can undergo adaptive bending deformation, which is beneficial for the micro-thorn (1221) to be attached to the cavity tissue without loss, thereby enhancing its attachment-type lossless anchoring function; Each of the bionic micro-thorn attachment structures (12) is formed of a wire material having elasticity and shape memory, and the aspect ratio of the wire material is within the range of 2 and 40, so that the micro-thorn (122) has the characteristics of being slender and soft; Wherein, the cross-sectional area of ​​the wire is 0.002mm 2 and 0.015mm 2 between.

2. The implant device (1) having a bionic micro-thorn attachment structure according to claim 1 is characterized in that: the length of the thorn body (1221) is L1, the curved length of the thorn tip (1222) is L2, the angle between the outward extension direction of the thorn body (1221) and the outward extension direction of the distal end of the thorn tip (1222) is β, the length L1 of the thorn body (1221), the curved length L2 of the thorn tip (1222) and the angle β satisfy the following mathematical relationship: 0.2mm≤L1≤5mm, 0<L2≤3mm, 0≤β≤150°, and the length of the straight-line micro-thorn (122) is less than the length of the J-shaped micro-thorn (122).

3. The implant device (1) having a bionic micro-thorn attachment structure according to claim 2, characterized in that: The implant device (1) further includes a limiting mechanism (123), wherein the limiting mechanism (123) is a hole groove (1231) provided on the skeleton (111); the bionic microthorn attachment structure (12) corresponds to the hole groove (1231) in position, and at least a part of the thorn root (121) is located in the hole groove (1231); the thorn root (121) and the hole groove (1231) cooperate with each other to limit the relative position of the microthorn (122) on the skeleton (111); or, the limiting mechanism (123) is one or more of a local necking structure, a local protruding structure, and a key groove structure provided on the skeleton (111); or, the limiting mechanism (123) realizes a fixed connection between the skeleton (111) and the thorn root (121) by gluing, welding or mechanical matching.

4. The implant device (1) having a bionic micro-thorn attachment structure according to claim 3, characterized in that: Each of the bionic micro-thorn attachment structures (12) comprises at least one thorn root (121) and two micro-thorns (122), the micro-thorns (122) and the hole grooves (1231) correspond one to one in terms of position and number, at least a portion of the thorn root (121) is in contact with the skeleton (111), the thorn root (121) is in a U-shaped or circular structure, and the thorn root (121) passes through the two hole grooves (1231).

5. The implant device (1) having a bionic micro-thorn attachment structure according to claim 3 or 4, characterized in that: On any cross section of the skeleton (111) in the long diameter direction, the thickness of the skeleton (111) is defined as P1, the length of the hole groove (1231) itself is defined as P2, the spacing between any two adjacent hole grooves (1231) is defined as P3, and the angle between the outward extension direction of the sashimi body (1221) and the direction of the skeleton (111) away from the central axis m of the attachment frame (11) is defined as ω, wherein the parameters P1, P2, P3 and ω respectively satisfy the following mathematical relationships: 0.05mm≤P1≤0.5mm, 0.05mm≤P2≤4mm, 0.5mm≤P3≤10mm, 30°≤ω<180°.

6. The implant device (1) having a bionic micro-thorn attachment structure according to claim 5, characterized in that: The implantable device (1) is a filter, the cavity tissue is a blood vessel wall, the attachment frame (11) is a self-expanding stent, the skeleton (111) is elastic, and the attachment frame (11) further includes a center piece (13), and a plurality of skeletons (111) diverge outward from the center piece (13) and enclose a three-dimensional structure, which has the function of blocking thrombus, and the three-dimensional structure is in the shape of a lantern, a gourd, a mushroom, an umbrella, a bowl, a cone, or a combination thereof; Alternatively, the implantable device (1) is a hollow tubular intravascular stent, the intravascular stent is a self-expanding stent or a balloon-expandable stent, the cavity tissue is a blood vessel wall, and the intravascular stent is composed of multiple skeletons (111) interconnected to form a one-layer or multi-layer wavy or mesh structure, which plays the role of supporting the blood vessel or blocking the diseased tissue.

7. The implant device (1) having a bionic micro-thorn attachment structure according to claim 6, characterized in that: When the implant device (1) is a filter, a plurality of the bionic micro-thorn attachment structures (12) are provided on the inner surface of the skeleton (111), and the thorn bodies (1221) and / or thorn tips (1222) of the bionic micro-thorn attachment structures face the direction of fluid flow in the cavity or radially face the cavity tissue wall, thereby preventing the thrombus captured in the implant device (1) from falling out during the recovery and release adjustment process.

8. The implant device (1) with a bionic micro-thorn attachment structure according to claim 6 or 7, characterized in that: The attachment frame (11) includes a micro-thorn protection structure (1223), and the micro-thorn protection structure (1223) is arranged on the skeleton (111). The distance between the tip of the micro-thorn (122) and the skeleton (111) is defined as L3. The height of the micro-thorn protection structure (1223) protruding from the skeleton (111) is L4. Then, L3 and L4 satisfy the following relationship: L3<L4. The micro-thorn protection structure (1223) is one or more combinations of hemispherical, ellipsoidal, curved, and broken line shapes, so that when the implant device (1) enters and exits the delivery sheath (2), the micro-thorn attachment structure (12) does not contact the inner wall of the delivery sheath (2).

9. The implant device (1) having a bionic micro-thorn attachment structure according to claim 6 or 7, characterized in that: The attachment frame (11) is provided with a self-centering structure (124), wherein the self-centering structure (124) is a curled structure formed by extending the end of the skeleton (111) further toward the end, wherein the curled structure is one or more of an elliptical, circular or two-dimensional spiral structure, and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame (11); Alternatively, the self-centering structure (124) is a curled structure formed by multiple skeletons (111) radiating from the center of the center piece (13) to the surrounding areas, and the curled structure is one or more of an elliptical, circular or two-dimensional spiral structure, and the plane where each curled structure is located is coplanar with the central axis m of the attachment frame (11).

10. The implant device (1) having a bionic micro-thorn attachment structure according to claim 7, characterized in that: The attachment frame (11) includes a surrounding body (125), which is wound around the frame (111) and at least wraps the thorn roots (121) that are in contact with the frame (111), so as to enhance the connection strength between the frame (111) and the bionic microthorn attachment structure (12); alternatively, the surrounding body (125) is a structure that can be separated from the frame (111) and / or the microthorns (122).

11. The implant device (1) having a bionic micro-thorn attachment structure according to claim 6, characterized in that: When the implant device (1) is a filter, the outermost area of ​​the skeleton (111) is provided with a flange structure (112), and the outer surface of the flange structure (112) is provided with the bionic micro-thorn attachment structure (12), so that the skeleton (111) does not directly contact the cavity tissue or contacts it to a minimum extent.

12. The implant device (1) having a bionic micro-thorn attachment structure according to claim 6, characterized in that: The implant device (1) is a hollow tubular intravascular stent, which is a balloon-expandable stent. A balloon (14) can pass through the balloon-expandable stent and expand to a certain diameter through the balloon (14). When the skeleton (111) is attached to the wall of the cavity tissue, the balloon (14) allows the micro-thorns (122) to adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue.

13. The implant device (1) having a bionic micro-thorn attachment structure according to claim 6, characterized in that: The implantable device (1) is a hollow tubular intravascular stent, which is a dense mesh stent woven from wires and has a grid shape, and the area of ​​each grid is ≤2.5 mm. 2 One or more grids of the dense mesh stent have deformation adaptability. When the grid serves as a channel interface of a small branch stent, the grid can expand and fit onto the outer surface of the small branch stent. The small branch stent is a thinned hollow tubular intravascular stent with a diameter at least half that of the dense mesh stent.

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