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WO2022022332A1 - Implanted instrument having bionic spinule attachment structures - Google Patents

Implanted instrument having bionic spinule attachment structures Download PDF

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Publication number
WO2022022332A1
WO2022022332A1 PCT/CN2021/107357 CN2021107357W WO2022022332A1 WO 2022022332 A1 WO2022022332 A1 WO 2022022332A1 CN 2021107357 W CN2021107357 W CN 2021107357W WO 2022022332 A1 WO2022022332 A1 WO 2022022332A1
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WO
WIPO (PCT)
Prior art keywords
thorn
micro
attachment
skeleton
stent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/107357
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French (fr)
Chinese (zh)
Inventor
李彪
邵烨
吕世文
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ningbo Diochange Medical Technology Co Ltd
Original Assignee
Ningbo Diochange Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202021519994.5U external-priority patent/CN212879437U/en
Priority claimed from CN202010740896.2A external-priority patent/CN112022260B/en
Application filed by Ningbo Diochange Medical Technology Co Ltd filed Critical Ningbo Diochange Medical Technology Co Ltd
Publication of WO2022022332A1 publication Critical patent/WO2022022332A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01Filters implantable into blood vessels

Definitions

  • the present application relates to a medical device, in particular to an implanted device with a bionic micro-thorn attachment structure.
  • venous filter implantation for pulmonary embolism and endovascular stent implantation for human aortic diseases such as aortic aneurysm, aortic dissection, etc.
  • Intravenous filter implantation is to implant a temporary filter in the blood vessel, and use the filter to intercept large thrombus, prevent it from blocking the blood vessel in important organs and other positions, and avoid hypoxia damage to the patient's organs. After the disease is relieved or relieved An interventional method of removing the filter.
  • the common problems of common filters on the market at present are as follows: the contact area between the support structure and the blood vessel wall is large, the filter is easily covered by the blood vessel intima due to the proliferation or adhesion of the intima of the blood vessel, and the blood vessel wall is easily torn during recovery.
  • the recovery period is short; the stability is poor, the self-centering is insufficient, and it is easy to shift or skew under the impact of blood flow, which causes certain difficulties in the recovery work; the barbed structure can easily cause puncture of the blood vessel wall and cause other complications.
  • endovascular isolation of aortic stent-graft has been widely used in descending and abdominal aortic aneurysms and arterial dissection and other diseases, and has become a first-line treatment method.
  • insufficient anchoring strength the stent is easy to slide relative to the blood vessel, causing potential danger to human body; designed, but not widely adaptable to tortuous diseased vessels.
  • the purpose of the present application is to overcome the deficiencies of the prior art, and to provide an implanted device with a bionic micro-thorn attachment structure, which can achieve non-destructive anchoring and ensure firm fixation.
  • An implant device with a bionic micro-thorn attachment structure at least includes an attachment frame, the attachment frame is a self-expanding stent or a ball-expanding stent, and the attachment frame includes a plurality of skeletons and a plurality of bionic Micro-thorn attachment structure, the biomimetic micro-thorn attachment structure is arranged on the outer surface of the skeleton, and the shape of the biomimetic micro-thorn attachment structure is the sparse microthorn on the surface of the imitation plant, and the biomimetic micro-thorn attachment structure includes Thorn roots and microthorns, the microthorns are composed of a thorn body and a thorn tip, the microthorns are straight or J-shaped or a combination of the two, and the thorn body and/or the thorn tips of the microthorns can touch To the cavity tissue, to achieve the attached anchoring function.
  • microstabs when they are in contact with the cavity tissue, they can undergo adaptive bending deformation, which facilitates the microthorns to adhere to the cavity tissue without damage, and enhances its attached anchoring function.
  • the plants include, but are not limited to, Xanthium, Humulus japonicus, Yunshi, Gangbangui, Gorgon, sagebrush, Rubus, thistle, Polygonum spinosa, Acanthopanax senticosus.
  • the length of the sashimi is L1
  • the length of the curve of the thorn is L2
  • the direction of the outward extension of the sashimi and the direction of the outward extension of the distal end of the thorn is between
  • the included angle is ⁇
  • the length L1 of the sashimi, the length L2 of the thorn point curve and the included angle ⁇ satisfy the following mathematical relationships: 0.2mm ⁇ L1 ⁇ 5mm, 0 ⁇ L2 ⁇ 3mm, 0 ⁇ 150°
  • the length of the linear microspurs is smaller than the length of the J-shaped microspurs.
  • the total number of the bionic micro-thorn attachment structures is between 3 and 100.
  • the sashimi length L1, the thorn point curve length L2 and the included angle ⁇ satisfy the following mathematical relationships: 0.5 ⁇ L1 ⁇ 2mm, 0 ⁇ L2 ⁇ 1mm, 90° ⁇ 150 °.
  • the number of the biomimetic micro-thorn attachment structures disposed on each skeleton is between 1 and 10.
  • the distance between the tip point of the thorn and the thorn body is ⁇ 0.5 mm, so that the J-shaped thorn is in the shape of a micron folded hook or an arc hook.
  • the thorns of the microthorns are the thorn tips.
  • the sashimi length L1 of the linear microthorns is less than or equal to 1 mm.
  • the number of linear microthorns accounts for between 50% and 99%.
  • multiple groups of linear microspurs and J-shaped microspurs are designed with spaced repetition, and the J-shaped microspurs and the linear microspurs in each group are in adaptive contact with the cavity
  • the J-shaped microspurs and the linear microspurs in each group are in adaptive contact with the cavity
  • 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, which increases constraints and strengthens the attachment to the cavity tissue. firmness.
  • the biomimetic microthorn attachment structure further includes a limiting mechanism, the limiting mechanism is a hole and groove provided on the skeleton, and the biomimetic microthorn attachment structure is in position with the hole and slot Correspondingly, at least a part of the thorn root is located in the hole groove, and the thorn root and the hole groove cooperate with each other to define the relative position of the micro thorn on the skeleton.
  • each of the biomimetic micro-thorn attachment structures includes at least one of the thorn roots and two of the micro-thorns, and the micro-thorns correspond to the holes and grooves in one-to-one position and number, so At least part of the thorn root is attached to the skeleton, the thorn root is in a U-shaped or back-shaped structure, and the thorn root runs through the two holes and grooves, and each of the bionic microthorn attachment structures is composed of a
  • the elastic and shape-memory wire is formed by passing through the corresponding two holes in sequence, the cross-sectional area of the wire is ⁇ 0.3mm 2 , and the length-diameter ratio of the wire is in the range of 2 and 40.
  • the micro-thorns are made to have the characteristics of slenderness and softness.
  • each of the microspines are coplanar.
  • the thorns penetrate through two adjacent holes.
  • the cross-sectional area of the wire is between 0.002 mm 2 and 0.015 mm 2 .
  • the bionic microthorn attachment structure has both flexibility and elasticity, and has villi-like properties, so as to realize the attachment anchoring with the cavity tissue. With the thorn as the center, it can freely rotate and deform in the direction of the outer surface of each skeleton.
  • the microscopic When the thorn contacts the local protrusion the orientation of some of the micro thorns can be adaptively changed, which enhances the attachment and anchoring of the micro thorns, and does not penetrate the tissue rigidly and straightly, and has no effect on the cavity tissue. Therefore, the entire bionic micro-thorn attachment structure has self-adaptation, and enhances the attachment anchoring function to the cavity tissue.
  • the limiting mechanism is one or more of a partial constriction structure, a partial convex structure, and a keyway structure provided on the skeleton, or the limiting mechanism is glued or welded by gluing or welding. Or mechanically cooperate to realize the fixed connection between the skeleton and the thorn.
  • the thickness of the skeleton is respectively defined as P1, the length of the hole slot itself is P2, and the thickness of any two adjacent holes and slots is defined as P2.
  • the distance is P3
  • the angle between the direction of the extension line of the sashimi facing outward and the direction of the skeleton away from the central axis m of the attachment frame is ⁇
  • the parameters P1, P2, P3 and ⁇ respectively satisfy the following mathematical relationships : 0.05mm ⁇ P1 ⁇ 0.5mm, 0.05mm ⁇ P2 ⁇ 4mm, 0.5mm ⁇ P3 ⁇ 10mm, 30° ⁇ 180°
  • adjusting the specific parameters of P1 and P2 can realize the adjustment of the included angle ⁇ , ensuring that every In a natural state, each of the thorn tips is directed towards the direction of the cavity tissue or fluid flow, which enhances the effectiveness of the adherent anchoring, and at the same time, the total number of the microthorns can be adjusted by adjusting the parameter P3.
  • the thickness P1 of the skeleton, the outer diameter P2 of the hole and the angle ⁇ respectively satisfy the following mathematical relationships: 0.1mm ⁇ P1 ⁇ 0.3mm, 0.1mm ⁇ P2 ⁇ 2mm, 0.5mm ⁇ P3 ⁇ 2mm, 60° ⁇ 150°.
  • the implantation device is a filter
  • the cavity tissue is a blood vessel wall
  • the attachment frame is a self-expanding stent
  • the frame is elastic
  • the attachment frame further includes a center piece, a plurality of The skeleton radiates outward from the central piece and surrounds a three-dimensional structure, which has the function of blocking thrombus, and the three-dimensional structure presents one or more of lantern, gourd, mushroom, umbrella, bowl, and cone shapes. combination;
  • the implantation device is a hollow tubular intraluminal stent
  • the intravascular stent is a self-expanding stent or a ball-expanding stent
  • the cavity tissue is a blood vessel wall
  • the intravascular stent is composed of a plurality of The skeletons are interconnected to form one or more layers of wavy or net-like structures, which play the role of opening blood vessels or blocking diseased tissue.
  • the implanted device is a filter
  • the central piece is provided with a grabbing mechanism, and the grabbing mechanism is convenient for grabbing the filter from the target position and taking it out of the body.
  • the implanted device when the implanted device is a filter, a plurality of the biomimetic micro-thorn attachment structures are provided on the inner surface of the skeleton, and the thorns and/or thorn tips of the biomimetic micro-thorn attachment structures face the cavity
  • the body fluid flows in the direction or radial direction toward the cavity tissue wall to prevent the thrombus captured in the implanted device from being dislodged during the recovery and release adjustment process.
  • the attachment frame includes a micro-thorn protection structure
  • the micro-thorn protection structure is arranged on the skeleton, and the distance between the tip of the micro-thorn and the skeleton is defined as L3, the The height of the micro-thorn protection structure protruding from the skeleton is L4, then L3 and L4 satisfy the following relationship: L3 ⁇ L4, and the micro-thorn protection structure is one or more of a hemisphere shape, an ellipsoid shape, a curve shape, and a broken line shape.
  • the combination is such that the micro-stab attachment structure does not contact the inner wall of the delivery sheath during the process of the implantation device moving in and out of the delivery sheath.
  • the attachment frame is provided with a self-center structure
  • the self-center structure is a curled structure formed by the end of the skeleton further extending toward the end, and the curled structure is elliptical, circular or One or more of two-dimensional helical structures, and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame;
  • the self-center structure is a coil-like structure formed by a plurality of skeletons emanating from the center of the center piece to the surrounding, and the coil-shaped structure is one or more of an ellipse, a circle, or a two-dimensional helical structure. and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame.
  • the biomimetic microthorn attachment structure is provided on the outer surface of the self-center structure.
  • the curling direction of the curling structure is inward curling
  • the included angle ⁇ between the direction of the extension line of the end of the curling structure and the direction of the central axis m of the attachment frame toward the distal end satisfies : 0° ⁇ 90°
  • the number of turns n of the curled structure satisfies: 0.25 ⁇ n ⁇ 1.5.
  • the attachment frame includes a surrounding body, the surrounding body is wound on the skeleton, and at least wraps the thorns attached to the skeleton, so as to strengthen the skeleton and the bionic
  • the connection strength of the micro-thorn attachment structure avoids direct contact between part or all of the skeleton and the cavity tissue, reduces the amount of metal ion precipitation, and improves biocompatibility; reduces the friction coefficient and reduces the attachment frame in the delivery sheath.
  • the retraction and release resistance in the tube increase the smoothness, and experience a better feel; enhance the anti-fatigue durability of the attachment frame, play the role of "secondary protection" for the attachment frame, and avoid the attachment frame in the cavity Risk of fracture within the tissue due to long-term corrosion or fatigue failure.
  • one or more fixing structures are provided on each of the skeletons, and the proximal end and/or the distal end of the surrounding body and the skeleton are effectively connected through the fixing structures or location constraints.
  • the surrounding body is a flexible medical wire/wire/tape
  • the cross-sectional shape of the surrounding body includes one or a combination of a circle, an ellipse, and a rectangle.
  • the surrounding body is wound with suture
  • the material of the suture includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high Molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxetone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide (PGLA) ), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metal and/or medical polymer materials with developing effect.
  • PET polyethylene terephthalate
  • PTFE polytetrafluoroethylene
  • UHMWPE ultra-high Molecular weight polyethylene
  • PP polypropylene
  • PA polyamide
  • PDO polydioxetone
  • PGA polyglycolic acid
  • PLA polylactic acid
  • PGLA polyglycolide
  • PCL polycaprolactone
  • one or more local protrusions are provided on the outer surface of the surrounding body itself, and the local protrusions themselves form barb structures, and the barb structures face the vessel wall to further strengthen the anchor Certainly.
  • the outermost peripheral 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, so as to prevent the skeleton from interacting with The cavity tissue is in direct contact.
  • the implantation device is a hollow tubular intraluminal stent
  • the intravascular stent is a balloon-expandable stent
  • a balloon can be passed through the balloon-expanded stent, and the balloon is passed through the balloon. After expanding to a certain diameter, when the skeleton is abutted against the cavity tissue wall, the balloon makes the microspins adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue.
  • the implantation device is a hollow tubular intraluminal stent
  • the intravascular stent is a grid-like dense mesh stent formed by weaving a wire material, and the area of each grid is ⁇ 2.5mm 2 , one or more grids of the dense mesh stent have deformation adaptability, and when the grid is used as a channel interface of a small branch stent, the grid can expand and fit on the small branch stent.
  • the small branch stent is a thinned hollow tubular intraluminal stent with a diameter at least half smaller than that of the dense mesh stent.
  • the partial metal wires of the dense mesh stent are processed to form a flat structure with a certain thickness, and the bionic microthorn attachment structure is provided on the surface of the flat structure.
  • the implant device surface includes a flexible membrane on the surface of the attachment frame.
  • the implanted device is a filter
  • the surface of the attachment frame of the filter is provided with a flexible membrane
  • the membrane is soft and has micropores
  • the micropores can filter blood, but can block thrombus, It can effectively capture the thrombus in the blood vessel.
  • the implanted device is an intraluminal stent
  • the film is wrapped on the surface of the skeleton of the covered stent, has the characteristics of softness and density, and can play the role of isolating blood, The blood is prevented from leaking out from the surface of the stent-graft and flowing to the diseased part of the blood vessel.
  • the biomimetic micro-thorn attachment structure provided by the application has the sparse micro-thorn shape on the surface of the imitation plant, the biomimetic micro-thorn attachment structure includes thorn roots and micro-thorns, and the micro-thorn can touch the cavity tissue and form an effective anchor,
  • the microthorns are slender, shallow and soft, which makes the microthorns have villi-like characteristics, realizes the attachment anchoring function, and avoids the trauma caused by deep and direct penetration into the cavity tissue; when the microthorn contacts the cavity tissue, it can adapt sexual bending deformation is beneficial for the microthorn to attach to the cavity tissue without damage, and enhance its attached anchoring function.
  • the microthorns provided in this application are straight, J-shaped or a combination of the two.
  • the microthorns are composed of a thorn body and a thorn tip. , to avoid the trauma caused by deep and direct penetration into the cavity tissue;
  • Many micro-thorns are like uneven patterns on the outer surface of the tire, so they also play a role in increasing the roughness, especially for linear micro-thorns, significantly increase The static friction between the microspine and the cavity tissue enhances the attachment force to the cavity tissue, thereby achieving effective anchoring;
  • the J-shaped microspurs and the linear microspurs cooperate with each other to form a "self-locking" structure , so that each skeleton cannot move toward the distal end or toward the proximal end along the axis of the skeleton, which increases the restraint and strengthens the firmness of the attachment to the cavity tissue.
  • the bionic microthorn attachment structure provided by this application 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 microthorn on the skeleton.
  • This design makes: a) The length of the micro-thorn body and the thorn tip can be adjusted, which can effectively ensure that the straight-shaped micro-thorn and J-shaped micro-thorn and the thorn tip contact the cavity tissue without damage, so as to avoid piercing the cavity.
  • the bionic microthorn attachment structure has both high flexibility and high elasticity, so that under the action of external force, the microthorns can center on the thorn root and achieve freedom in the direction of the outer surface of each skeleton Rotation and deformation, due to the curvature of the cavity tissue itself or the release position of the device, the orientation and angle ⁇ of some microspurs can be adaptively changed, which enhances the attachment anchoring of the microspurs without being rigid and straight.
  • the skeleton of the attachment frame and the micro-thorns The thorn is connected through the cooperation of the thorn root and the limiting mechanism, and the thorn root can effectively prevent the micro-thorn from breaking due to fatigue failure.
  • the skeleton and the microspurs are covered or wrapped by a large amount of neo-endothelial tissue on the blood vessel wall, and the micro-spurs of the implanted device can also be easily prolapsed from the blood vessel wall, or extracted from a large number of neo-endothelial tissues, thereby realizing the implantation of the device. recycling and removal.
  • bionic microthorn attachment structures provided in this application can be adjusted, and can be densely distributed on the outer surface of the skeleton of the attachment frame according to actual clinical needs, increasing the contact probability between the attachment frame and the cavity tissue, and ensuring that the attachment frame is in contact with the cavity during implantation. All surfaces in contact with the inner wall of the cavity tissue can achieve effective attachment anchoring, which further increases the anchoring strength and avoids the risk of instrument falling off due to insufficient anchoring strength.
  • the protective structure prevents the micro-thorns from directly contacting the inner wall of the sheath tube, and prevents the micro-thorns from being pushed smoothly or other hidden dangers caused by scraping the sheath.
  • the implanted device with the bionic micro-thorn attachment structure provided in this application can adjust the design of the bionic micro-thorn attachment structure according to the different anatomical forms of the cavity tissue, that is, by reasonably setting the thickness of the skeleton, the holes and the holes.
  • the spacing of the grooves, the length of the hole and the groove itself, the inclination angle and the number of micro-thorns ensure that most of the micro-thorns can anchor the cavity tissue adaptively, and exert the greatest advantage of the micro-thorn-attached anchoring function.
  • the implanted device with the bionic micro-thorn attachment structure provided by this application is provided with a surrounding body, which has the following advantages: a) The surrounding body avoids direct contact between part or all of the skeleton and the cavity tissue, reduces the amount of metal ion precipitation, and improves the biological phase.
  • Capacitance b) reduce the friction coefficient, reduce the retraction and release resistance of the attachment frame in the delivery sheath; c) increase the smoothness and experience a better feel; d) enhance the anti-fatigue durability of the attachment frame
  • the function of "secondary protection" avoids the risk of fracture of the attachment frame caused by long-term corrosion or fatigue failure in the blood vessel; e) increases the force transmission, ensuring that the force of each frame is uniform when the filter is unsheathed, and there is no obvious stuck feeling; f ) Enhance the fit and position limitation of the thorn root and the skeleton; g) Micro-adjust the angle of the micro-thorn to ensure that the damage of the micro-thorn to the vessel wall is minimized; h) In the embodiment of the attachment frame setting the film, surrounding The body can pre-embed or hide the suture connecting the membrane and the attachment frame, which avoids the wear and tear caused by the suture directly contacting the inner surface of the delivery system sheath during the repeated retraction
  • the skeleton together with the surrounding body is covered by a large amount of neo-endothelial tissue, so that the implanted device is firmly fixed to the blood vessel wall. It is not convenient for the two to be directly detached.
  • the surrounding body can be separated from the skeleton and the micro-thorns, so that the skeleton and the micro-thorns can be pulled out from the surrounding body, and finally the implanted device can be recovered and taken out of the body, thus realizing the reproducibility of the implanted device. Take out function.
  • the proximal end of the bionic microthorn attachment structure is provided with a protective structure, and this design has the following advantages: a) when the filter is received in the delivery sheath, the protective structure directly contacts the inner wall of the delivery sheath, Therefore, it is avoided that the micro-thorns directly contact the inner wall of the delivery sheath, and the sheath or sheath is not smooth; 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 is helpful to achieve Removable function after filter implantation.
  • the implanted device with the bionic micro-thorn attachment structure provided by this application is provided with a flange structure in the outermost peripheral area of the skeleton, which minimizes the contact area between the outer surface of the filter and the blood vessel wall and reduces vascular intimal hyperplasia or adhesion.
  • the filter is easily covered by the intima of the blood vessel, which avoids the tearing damage caused by the filter to the blood vessel wall during recovery; in addition, the bionic micro-thorn attachment structure densely covered on the outer surface of the flange structure makes the contact between the filter and the blood vessel wall. For point contact, the recycling cycle is extended to a certain extent.
  • the bionic micro-thorn attachment structure can improve the anti-displacement performance of the stent in the aortic stent, prevent the stent from being displaced due to the impact of blood flow after implantation, and prevent the sealing strength of the proximal end of the stent from being caused by the stent displacement. Attenuates endoleak, or completely deviates from the predetermined release position, which leads to the failure of the stent treatment effect.
  • the micro-stab can undergo adaptive changes, not only without damage to the blood vessel wall, not only without damage to the blood vessel wall, Moreover, it will not be displaced by the impact of blood flow, which has the effect of precise positioning.
  • the micro-thorns of the bionic micro-thorn attachment structure have slender, shallow and short The characteristics of the micro-thorn make it possible to penetrate into the intima or media of the blood vessel in a tiny and shallow way, and realize the extremely minimally invasive anchoring function.
  • This anchoring is extremely minimally invasive and effective, avoiding the existing rigid and straight And various design drawbacks caused by the thick and long barb anchoring technology.
  • the implanted device of the bionic micro-thorn attachment structure provided by this application is a dense mesh stent, which has the following advantages: a) It can effectively block the diseased part on the blood vessel, including the rupture of arterial dissection and false lumen, true arterial or false artery b) It has outstanding bending deformation ability and can adapt to blood vessels of various anatomical forms, especially curved vessels and lesions; c) The existence of meshes will not affect the branches that supply blood to important organs in the body The blood flow of blood vessels has long-term patency maintenance; d) Small branch stents can be flexibly inserted into the wall of the dense mesh stent, so that the blood flow in the dense mesh stent can be shunted to the small branch stents, thereby forming a vascular stent.
  • FIG. 1 is a schematic diagram of an implanted device with a bionic microthorn attachment structure in the application
  • FIG. 2 is a partial schematic diagram of the bionic microthorn attachment structure provided by the application.
  • FIG. 3 is a schematic diagram of the biomimetic microthorn attachment structure provided by the application after the skeleton is matched;
  • Fig. 4 is the schematic diagram of the partial skeleton with hole groove in the application.
  • Fig. 5a is the U-shaped fixing form of the bionic microthorn attachment structure in the skeleton in the application;
  • Fig. 5b is the shape fixing form of the bionic microthorn attachment structure in the skeleton of the application
  • FIG. 6 is a dimensioning diagram related to the morphological control of the bionic microthorn attachment structure in the application.
  • FIG. 7a is a schematic diagram of the micro-thorns in the implanted device with the biomimetic micro-thorn attachment structure provided by the application under the action of external force to achieve a certain degree of free rotation and deformation with the thorn root as the center;
  • Fig. 7b is a schematic diagram of the J-shaped micro-thorns cooperating with the straight-line micro-thorns to form a "self-locking" structure when the J-shaped micro-thorns in the implanted device with the bionic micro-thorn attachment structure provided by the application are adaptively bent and deformed;
  • Figure 8a is a schematic diagram showing only the rigid, straight, thick and long straight barb structure in a conventional implant device
  • Fig. 8b is a schematic diagram showing only the rigid, thick and long barbed barb structure in a conventional implant device
  • Figure 8c is a schematic diagram showing only the J-shaped micro-thorns with soft, slender, shallow and short sashimi and thorn tips in the present application, and the thorn tips are tiny and in the shape of an arc hook;
  • Fig. 8d is a schematic diagram showing only the J-shaped micro-thorns with soft and slender sashimi and thorn tips in the present application, and the thorn tips are tiny and in the shape of a folded hook;
  • FIG. 8e is a schematic diagram showing only the soft, slender linear microthorns in the present application.
  • FIG. 9 is a partial view of a filter provided with a biomimetic microthorn attachment structure at the proximal end of the application;
  • 10a is a schematic diagram of the biomimetic micro-thorn attachment structure in the implant device with the biomimetic micro-thorn attachment structure provided by the application before being wound around the body;
  • Fig. 10b is a schematic diagram of the biomimetic micro-thorn attachment structure in the implant device with the biomimetic micro-thorn attachment structure provided by the application after being wound around the body;
  • FIG. 11 is a schematic diagram of the surrounding body fixing structure arranged on the partial skeleton in the application.
  • Figure 12a is a schematic diagram of a straight-wound surrounding body in the application.
  • Figure 12b is a schematic diagram of an obliquely wound surrounding body in the application.
  • Figure 12c is a schematic diagram of a cross-wound surrounding body in the application.
  • FIG. 13 is a schematic diagram of a surrounding body in a partial barb structure in the application.
  • FIG. 14 is a schematic diagram of a filter having a self-center structure in the application.
  • Figure 15a is a schematic diagram of a curled structure having an elliptical structure in the application.
  • Figure 15b is a schematic diagram of a curled structure with a circular structure in the application.
  • Fig. 15c is a schematic diagram of a curled structure having a two-dimensional spiral structure in the present application.
  • Figures 16a to 16c are three forms of three-dimensional wave-like and/or net-like structures formed by interconnecting skeletons in the present application;
  • Figure 17 is a three-dimensional view of the filter in the application in a "mushroom-shaped" state in its natural unconstrained state;
  • Figures 18a to 18c are enlarged views of the partial view I of Figure 1, showing several diagrams of the protective structure at the proximal end of the bionic microthorn attachment structure, wherein Figure 18a is a hemisphere-shaped protective structure, and Figure 18b is an ellipsoid-shaped protective structure Protection structure, Figure 18c is a broken line protection structure;
  • Figure 19 is a partial view of the filter provided with the protective structure in the application in the delivery sheath;
  • Fig. 20 is an enlarged view of the partial view I of Fig. 1, showing a protective structure formed by adding additional accessories and the like;
  • Figure 21 is a three-dimensional view of a filter provided with a flange structure in the application.
  • FIG. 22 is a schematic diagram of the bionic micro-thorn attachment structure provided on the outer surface of the flange structure in the application in contact with the blood vessel wall;
  • FIG. 23 is a schematic diagram of a filter provided with a flexible membrane on the surface of the attachment frame in the application;
  • Figure 24a is a schematic diagram of the pre-embedded winding method used for the suture in the application.
  • Figure 24b is a schematic diagram of a hidden winding method used for the suture in the application.
  • 25 is a schematic diagram of the sutures of conventional implantation devices on the market being sutured after using an exposed winding method
  • Figure 26 is a schematic diagram of a partial skeleton after being covered in the implant device with the biomimetic micro-thorn attachment structure provided by the application;
  • Figure 27 is a three-dimensional view of a stent-graft with a bare stent in the application
  • Figure 28 is a three-dimensional view of a covered stent without bare stent in the application.
  • Figure 29 is a schematic diagram of a ball-expandable stent in the application.
  • Figure 30 is a schematic diagram of a dense mesh support in the application.
  • Fig. 31 is an enlarged view of partial view II in Fig. 30, showing a mesh with deformation adaptability in a dense mesh support;
  • Fig. 32 is an enlarged view of the partial view II of Fig. 30, showing the branched stent established in the dense mesh stent grid;
  • Fig. 33 is an enlarged view of the partial view III in Fig. 30, showing a flat structure formed by processing the partial wire of the dense mesh stent.
  • Implantation device Part number: 1- Implantation device, 2- Delivery sheath, 11- Attachment frame, 12- Bionic micro-thorn attachment structure, 13- Center piece, 14- Balloon, 15- Grab mechanism, 111- Skeleton, 112 -Flange structure, 121-Thorn root, 122-Micro-thorn, 123-Limiting mechanism, 124-Self-center structure, 125-Surrounding body, 126-Film, 127-Suture, 1221-Sashimi, 1222-Thorn tip, 1223-protection structure, 1231-hole groove, 1251-fixed structure.
  • distal end refers to the end of the instrument near the heart
  • distal end refers to the end of the instrument remote from the heart.
  • an implant device 1 with a biomimetic micro-thorn attachment structure at least includes an attachment frame 11, and the attachment frame 11 includes a plurality of elastic skeletons 111 and a plurality of biomimetic micro-thorn attachment structures 12.
  • a plurality of skeletons 111 enclose a three-dimensional structure
  • the attachment frame 11 has anatomical shape adaptability
  • the bionic micro-thorn attachment structure 12 is arranged on the outer surface of the skeleton 111
  • the bionic micro-thorn attachment structure 12 is shaped like a plant
  • the sparse microthorns on the surface, the bionic microthorn attachment structure 12 includes thorn roots 121 and microthorns 122
  • the microthorns 122 are composed of a thorn body 1221 and a thorn tip 1222
  • the microthorns 122 are linear or J-shaped or a combination of the two
  • the thorn body 1221 and/or the thorn tip 1222 of the thorn 122 can touch the cavity tissue to realize the attached anchoring function.
  • the implanted device 1 provided by the present application with the bionic microthorn attachment structure is a filter, as shown in FIG. 1 , the cavity tissue is a blood vessel wall, the attachment frame 11 is a self-expanding stent, and the frame 111 has elasticity , the attachment frame 11 also includes a central piece 13 fixedly connected with the attachment frame 11, a plurality of skeletons 111 diverge outward from the central piece 13 and enclose a three-dimensional structure, and the three-dimensional structure presents a lantern-shaped, gourd-shaped, mushroom-shaped, umbrella-shaped, One or more combinations of bowl shape and cone shape, and the cavity tissue is the blood vessel wall.
  • the central piece 13 is provided with a grabbing mechanism 15, which facilitates grabbing the filter from the target position and taking it out of the body.
  • the microthorns 122 in the biomimetic microthorn attachment structure 12 are sparse microthorns 122 on the outer surface of the fruit, leaf or stem of some plants imitating in nature, with soft, The characteristics of slenderness, such plants include but are not limited to cocklebur, humulus japonicus, yunshi, gangbangui, gorgonian, gourd, rubus, thistle, polygonum thorn, and Acanthopanax thorn, so that the bionic microthorn attachment structure 12 has Villi-like properties for adherent anchoring to the vessel wall.
  • a single microthorn 122 is linear or J-shaped in shape.
  • the thorn body 1221 of the microthorn 122 is equivalent to the vertical segment of the "letter J”
  • the thorn tip 1222 is equivalent to 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 a good anchoring property, avoiding the trauma caused by deep and direct penetration into the blood vessel wall
  • the linear microthorns 122 can play a role in increasing the roughness, which can significantly increase the static friction between the microthorns 122 and the blood vessel wall, and enhance the adhesion to the blood vessel wall; preferably, when the thorn tips 1222 of the micro thorns 122 are extremely small, for example, the distance between the tip point of the thorn tips 1222 and the thorn body 1221 is less than or equal to 0.5 mm, so that the J-shaped thorn tips 1222 are in the shape of a micron folded hook (as shown in FIG.
  • the length of the sashimi 1221 is L1
  • the length of the curve of the thorn tip 1222 is L2
  • the angle between the direction of the outward extension line of the sashimi 1221 and the direction of the outward extension line of the distal end of the thorn tip 1222 is ⁇
  • the length L1 of the sashimi, the length L2 of the curve of the thorn, and the angle ⁇ satisfy the following mathematical relationships: 0.2mm ⁇ L1 ⁇ 5mm, 0 ⁇ L2 ⁇ 3mm, 0 ⁇ 150°
  • the optimal relationship is as follows: 0.5 ⁇ L1 ⁇ 2mm, 0 ⁇ L2 ⁇ 1mm, 90° ⁇ 150°, so that the microthorns 122 have the characteristics of being shallow and short like the sparse microthorns on the surface of plants, and the length of the straight microthorns 122 is shorter than the J-shaped microthorns 122 Length, as shown in Fig.
  • the total number of the bionic microthorn attachment structures 12 is between 3 and 100.
  • the linear The proportion of the number of thorns should be between 50% and 99%; in another preferred embodiment, the number of biomimetic microthorn attachment structures 12 arranged on each skeleton 111 is between 1 and 10, so designed
  • the bionic micro-thorn attachment structure 12 is densely covered on the outer surface of the skeleton 111 of the attachment frame 11, which increases the contact probability between the attachment frame 11 and the blood vessel wall, and ensures that the attachment frame 11 can be in contact with the blood vessel wall at each position during implantation.
  • Effective attachment anchoring further increases the anchoring strength and avoids the risk of filter shedding caused by insufficient anchoring strength.
  • the thorns 1221 of the microthorns 122 are the thorn tips 1222.
  • the length L1 of the thorns 1221 of the linear microthorns 122 is less than or equal to 1 mm, which can give full play to the The attached anchorage of the micro-thorn 122 avoids the trauma caused by deep and direct penetration into the vessel wall.
  • the bionic micro-thorn attachment structure 12 further includes a limiting mechanism 123, and the thorn roots 121 cooperate with the limiting mechanism 123 to limit the relative position of the micro-thorns 122 on the skeleton 111, which can effectively prevent microthorns.
  • the thorn 122 acts as a fracture due to fatigue failure.
  • the limiting mechanism 123 is a hole and groove provided on the skeleton 111 for fixing the bionic microthorn attachment structure 12 on the skeleton 111 .
  • the bionic microthorn attachment structure 12 and the hole slot The positions correspond to each other, and at least part of the thorns 121 are located in the holes and grooves.
  • each bionic microthorn attachment structure 12 includes at least one thorn root 121 and two microthorns 122, and the microthorns 122 and the holes are one in position and number
  • at least a part of the thorn root 121 is attached to the frame 111 , and the thorn root 121 is in a U-shaped or return-shaped structure, and runs through the two holes and grooves.
  • the bionic microthorn 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 microthorns 122 are adjustable, while the barbs of most filters on the market are The same tube as the attachment frame 11 is formed by laser engraving in one piece. Due to the design limitations of raw materials, such barbs are often hard and thick, which increases the risk of barb breakage; b) During the manufacturing process, once the manufacturer finds If the length of one or some of the microthorns 122 is too long or too short, and the size is too thick or too thin, the microthorns 122 with better length or thickness can be temporarily replaced to realize the personalized customized "seed thorns" according to the clinical needs of patients ( Sowing micro-thorns) function to ensure that each micro-thorn 122 can maximize the attached anchoring function.
  • each micro-thorn 122 is coplanar, and on this basis, the thorn roots 121 run through two adjacent holes, so as to avoid the possible overlapping of multiple thorn roots 121, which may lead to the use of the delivery sheath.
  • the sheath diameter of the The cross-sectional area is less than or equal to 0.3mm 2 , and the length-diameter ratio of the wire is in the range of 2 and 40, so that the microthorns 122 have the characteristics of slenderness and softness.
  • the length of some linear micro-thorns 122 is too long, and there is a high risk of piercing the blood vessel wall, so it can be flexibly cut into micro-thorns 122 with a more suitable length, so as to realize the "adjustment of the needles" according to the individual clinical needs of patients ( Adjusting the thorn length) function, thus ensuring the non-invasive advantages and characteristics of the attachment anchoring, avoiding the trauma caused by deep and direct piercing into the blood vessel wall;
  • 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, its cross-sectional area is between 0.002mm 2 and 0.015mm 2 , which can maximize the above-mentioned bionic microthorn attachment structure 12.
  • the skeleton and microspurs of the implanted device are covered or wrapped by a large amount of neo-endothelial tissue on the blood vessel wall, and the micro-spurs of the implanted device can also be easily prolapsed from the blood vessel wall, or extracted from a large number of neo-endothelial tissues, thereby realizing Recovery and removal of implanted devices.
  • the thickness of the skeleton 111 is respectively defined as P1
  • the length of the hole slot itself is P2
  • the length of any two adjacent holes and slots is defined as P2.
  • the distance is P3, the central axis of the attachment frame 11 is m, the angle between the direction of the outward extension of the sashimi 1221 and the direction of the skeleton 111 away from the central axis m is ⁇ , then the parameters P1, P2 and ⁇ respectively satisfy the following mathematical relationships : 0.05mm ⁇ P1 ⁇ 0.5mm, 0.05mm ⁇ P2 ⁇ 4mm, 0.5mm ⁇ P3 ⁇ 10mm, 30° ⁇ 180°, adjusting the specific parameters of P1 and P2 can realize the included angle ⁇ and the total number of microthorns 122 The adjustment of , ensures that each thorn tip 1222 in contact with the vessel wall can face the vessel wall, enhancing the effectiveness of the attached anchoring, and at the same time, the total number of microthorns 122 can be adjusted by adjusting the parameter P3.
  • the above mathematical relationship is as follows: 0.1mm ⁇ P1 ⁇ 0.3mm, 0.1mm ⁇ P2 ⁇ 2mm, 0.5mm ⁇ P3 ⁇ 2mm, 60° ⁇ 150°
  • the biomimetic microthorn attachment structure 12 has both flexibility and elasticity, and has villi-like characteristics, and is used to realize the attachment anchoring with the blood vessel wall.
  • the microspine 122 adheres to the vessel wall non-destructively, enhancing its adherent anchoring function. Further, under the action of external force, 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, as shown in FIG.
  • the orientation and angle ⁇ of some of the microspurs 122 can be adaptively changed, which enhances the attachment and anchoring of the microspurs 122 without penetrating the inner wall of the blood vessel rigidly and straightly.
  • the J-shaped micro-thorns adaptively contact the vascular tissue, it can cooperate with the linear micro-thorns to form a "self-locking" structure, which increases the restraint and strengthens the firmness of the vessel wall.
  • the entire bionic micro-thorn attachment structure 122 has self-adaptation and enhances the attached anchoring function to the blood vessel wall.
  • the length of the sashimi 1221 of the thorns 122 should be smaller than the length of the sashimi 1221 of the J-shaped micro-thorns 122, so that the thorn tips 1222 of both can contact the blood vessel wall.
  • the attachment firmness enhancement function of the bionic microthorn should be designed with multiple groups of linear microthorns 122 and J-shaped microthorns 122 at intervals, as shown in Figure 7b. Therefore, the entire bionic microthorn attachment structure 12 is self-adaptive and enhances the adhesion to the blood vessel wall. Dependent anchoring feature.
  • the barb of a conventional filter is usually a straight barb or a large barb whose shape is completely fixed with the skeleton 111, and The whole is rigid, straight, thick and long, and cannot be deformed adaptively at all. In the blood vessel, it can only be inserted into the blood vessel wall too deeply at a fixed angle, which is easy to cause the risk of damage to the blood vessel wall.
  • the sashimi 1221 and the thorn tip 1222 are slender, short, and soft in shape and performance, and the thorn tip 12221 is tiny and has a micron-level hook shape, so both in terms of morphological structure and function, it has the traditional barb structure.
  • a bionic micro-thorn attachment structure 12 is provided at the proximal end of the attachment frame 11 , and the thorn bodies 1221 and/or the thorn tips 1222 of these bionic micro-thorn attachment structures 12 face the proximal end. It can effectively prevent the captured thrombus in the device from being reversely dislodged during the recovery process, and play the role of preventing the thrombus from dislodging.
  • the attachment frame 11 of the present application is made of a medical metal tube with elasticity and shape memory that is integrally laser-cut and shaped by heat treatment, or is made of a medical metal or polymer wire with elasticity and shape memory that is integrally woven and formed. It is formed by heat treatment, or directly made from a medical polymer material with elasticity and shape memory through integral thermal processing.
  • the medical metals mentioned here include but are not limited to cobalt-chromium alloy and nickel-titanium alloy.
  • the attachment frame 11 includes a surrounding body 125, the surrounding body 125 is wrapped around the frame 111, and at least wraps the thorns that fit with the frame 111 121, for enhancing the connection strength between the skeleton 111 and the bionic microthorn attachment structure 12.
  • the design of the surrounding body 125 also has the following advantages: a) the surrounding body 125 avoids direct contact of part or all of the skeleton 111 with the blood vessel wall, which reduces the amount of metal ion precipitation and improves biocompatibility; b) reduces the friction coefficient and reduces attachment The retraction and release resistance of the rack 11 in the delivery sheath 2; c) increase the smoothness, and experience a better hand feeling; d) enhance the anti-fatigue durability of the attachment rack 11, and play the role of "secondary protection" for the attachment rack 11 to avoid To avoid the risk of fracture of the attachment frame 11 caused by long-term corrosion or fatigue failure in the blood vessel; e) increase the force transmission, to ensure that each frame 111 is uniformly stressed when the filter is unsheathed, and there is no obvious stuck feeling; f) strengthen the thorn root 121 and The fit and position of the skeleton 111 are limited, as shown in Figures 10a and 10b, by adjusting the wrapping strength of the surrounding body 125,
  • the inner surface of the tube contacts and causes wear and tear; i) by changing the thickness of the single layer and the number of winding turns of the surrounding body 125, the overall thickness of the surrounding body 125 in the radial direction is adjusted, and then the length of the micro-thorns 122 exposed on the skeleton 111 can be adjusted. Tonality, for example, when the surgeon finds that the blood vessel wall of some patients is very thin according to clinical needs, the length of the microspurs 122 exposed on the skeleton 111 needs to be reduced to the greatest extent. The number of winding turns around the body 125 is increased to achieve the intended purpose, and to a certain extent, the personalized customization of clinical needs can be achieved.
  • each skeleton 111 is provided with one or more fixing structures 1251, and the proximal and/or distal ends of the surrounding body 125 and the skeleton 111 are effectively connected or defined by the fixing structures 1251, as shown in FIG. 11 . shown.
  • the proximal end and the distal end of each skeleton 111 are respectively provided with fixing structures 1251, the fixing structures 1251 are through holes passing through the skeleton 111, and the surrounding body 125 passes through the holes on the proximal end. After the through-holes are connected, the skeleton 111 and all the thorns 121 between the through-holes are tightly wrapped and wrapped, and finally pass through the through-holes on the distal end to realize the connection.
  • Connecting the surrounding body 125 to the fixed structure 1251 by knotting or the like can further constrain the position of the surrounding body 125 on the skeleton 111, strengthen the strength of the surrounding body 125 on the skeleton 111, and avoid loosening.
  • the surrounding body 125 is wound by a single flexible round wire or flat wire and wraps most or all of the skeleton 111, all the thorns 121, and passes through all the through holes, and finally forms a closed loop,
  • the advantage of this method of winding by a single surrounding body 125 is that the number of knots between the surrounding body 125 and the fixing structure 1251 is minimized, the number of knotted heads is reduced, and the increase in the number of knotted heads is avoided.
  • the retraction and release resistance of the entire attachment frame 11 also simplifies the manufacturing process and improves the production efficiency of the product. At the same time, through the mutual cooperation with the through holes, the effectiveness and firmness of the connection are enhanced to ensure that the following surrounding body 125 is in the frame 111. In order to prevent 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, the surrounding body 125 can be prevented from being reduced or unable to exert the function of the surrounding body 125 mentioned above.
  • the winding methods of the surrounding body 125 include one or more combinations of straight winding, oblique winding, and cross winding.
  • the winding type has simple operation and high efficiency; the oblique winding type skeleton 111 has better smoothness in retracting and releasing the sheath; the cross winding type winding is more firm, and the manufacturer can choose the best winding method according to different needs.
  • the number of winding layers of the surrounding body 125 is between 1 layer and 5 layers. If the number of layers is too large, although the winding firmness will increase, the overall volume will increase, which increases the retraction and release resistance of the attachment frame 11 in the delivery sheath 2 , the experience of the operator is reduced.
  • the surrounding body 125 is a flexible medical wire/wire/strip, and its cross-sectional shape includes one or a combination of a circle, an ellipse, and a rectangle.
  • 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), polydioxetone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide (PGLA) ), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metal and/or medical polymer materials with developing effect.
  • PET polyethylene terephthalate
  • PTFE polytetrafluoroethylene
  • UHMWPE ultra-high Molecular weight polyethylene
  • PP polypropylene
  • PA polyamide
  • PDO polyd
  • one or more partial protrusions may be provided on the outer surface of the surrounding body 125 itself, and the partial protrusions themselves form a barb structure, and the barb structure faces the blood vessel wall and can lift the to further enhance the anchoring effect.
  • the surrounding body 125 is a structure that can be separated from the skeleton 111 and/or the microspurs 122.
  • the implant device 1 When the implant device 1 is implanted into the blood vessel for a certain period of time, the skeleton 111 and the surrounding body 125 are surrounded by a large amount of new endothelial tissue. covered, so that the implantation device and the blood vessel wall are firmly fixed and not convenient for the two to be directly detached.
  • the surrounding body 125 can be separated from the skeleton 111 and the micro-thorns 122, so that the skeleton and the micro-thorns can be pulled out from the surrounding body 125.
  • the implanted device 1 can be recovered and taken out of the body, thus realizing the removable function of the implanted device 1 .
  • 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 implantation device 1 is implanted into the blood vessel for a predetermined time, the surrounding body 125 has been degraded.
  • the skeleton 111 and the microthorns 122 can be easily detached from the blood vessel wall, thereby realizing the removable function of the implanted device 1.
  • PDO polydioxanone
  • PGA polyglycolic acid
  • PLA polylactic acid
  • PGLA polyglycolide
  • PCL polycaprolactone
  • Embodiment 3 is different from Embodiment 1 and Embodiment 2 in that the attachment frame 11 is provided with a self-centering structure 124 .
  • the self-centering structure 124 It is located at the proximal end and/or the distal end of the skeleton 111, and is a coil-like structure formed by the outward divergence of the center of the skeleton 111.
  • the curled structure has elasticity and shape memory; in a preferred embodiment, the curling direction of the curled structure is inward curling, and the direction of the extension line of the end of the curled structure
  • the included angle ⁇ with the direction of the central axis m toward the distal end satisfies: 0° ⁇ 90°, and the number of turns n of the curled structure satisfies: 0.25 ⁇ n ⁇ 1.5.
  • the self-center structure 124 is a three-dimensional wave-like and/or network-like structure formed by interconnecting the skeletons 111 , as shown in FIGS. 16 a to 16 c .
  • the advantages of the self-center structure 124 are: a) The curled structure with elasticity and shape memory directly contacts the periphery of the blood vessel wall, providing sufficient and stable radial support force to the blood vessel wall, so the filter can make the entire attachment during use.
  • the frame 11 maintains excellent self-centering, which prevents the filter from being displaced and offset due to long-term impact of blood flow; b) The surface of the curled structure is provided with a bionic micro-thorn attachment structure 12, which further enhances the gap between the curled structure and the blood vessel wall. The supporting force of 11 enhances the stability of the attachment frame 11; c) the curled structure adopts a curve design, so that the contact between the curled structure and the blood vessel wall is point contact, which reduces the vascular intima crawling, prolongs the service life of the filter, and facilitates Removal after filter implantation.
  • the crimp-like structure is formed by the end of the skeleton 111 extending further toward the end, so that the filter has a "mushroom shape" in a natural unconstrained state, as shown in Figure 17, this "mushroom” It has flexibility and resilience, not only has sufficient radial support, but also enables the entire attachment frame 11 to automatically adjust its position in the axial direction under the blood flushing, which has the effect of shock absorption and buffering, ensuring that the filter can be firmly attached to the on the walls of blood vessels.
  • Example 4 is different from Example 1 in that, in one embodiment, a protection structure 1223 is provided at the proximal end of the bionic microthorn attachment structure 12 on the outer surface of the skeleton 111 .
  • the protection structure 1223 is a hemisphere shape, ellipsoid shape, curve shape, polyline shape or a combination of multiple shapes.
  • Figures 18a to 18c are illustrations of several protective structures 1223, defined in a natural unconstrained state, the microthorns 122 and the skeleton
  • the vertical height between 111 is L3, and the farthest distance between the micro-thorn protection 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 of the protection structure 1223 and the skeleton 111 or
  • the connection area and the skeleton provided with the bionic micro-thorn attachment structure 12 are inclined designs that converge toward the proximal end, so that the thorn tips 1222 of the micro-thorns 122 or the most pointed ends of the micro-thorns 122 are located outside the protection structure 1223, so the micro-thorns 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, thus avoiding the scraping or in-out of the sheath caused by the micro
  • the protective structure 1223 reduces the contact area between the skeleton 111 and the blood vessel wall to a certain extent, which is helpful for realizing the removable function of the filter after implantation.
  • the protective structure 1223 can be integrally processed by the attachment frame 11, or can be joined by adding welding material for welding, adding glue for bonding, adding additional accessories, etc., friction fitting, interlacing, meshing, interlocking, or a combination of the above. together, as shown in Figure 20.
  • the fourth embodiment is different from the first embodiment in that, in one embodiment, the outermost peripheral area of the skeleton 111 is provided with a flange structure 112 , and the flange structure 112 The outer surface is provided with a bionic micro-thorn attachment structure 12.
  • the advantage of this design is that it minimizes the contact area between the outer surface of the filter and the blood vessel wall, and reduces the proliferation or adhesion of the intima of the blood vessel, which causes the filter to be easily covered by the intima of the blood vessel.
  • the bionic micro-thorn attachment structure 12 densely covered on the outer surface of the flange structure 112 makes the contact between the filter and the blood vessel wall a point contact, to a certain extent The payback period has been extended.
  • Embodiment 6 is different from the previous embodiments in that the surface of the attachment frame 11 is provided with a flexible film 126 , the film 126 is attached and connected to the skeleton 111 , and the film 126 is soft And it has micropores, which can filter blood, but can block thrombus, and can effectively capture thrombus in blood vessels.
  • the film 126 and the distal end face of the attachment frame 11 can be sutured and connected together with the suture 127 (referred to as the suture film).
  • the suture film On the frame 111 of the frame 11, a plurality of reserved holes can be designed on the frame 111 to facilitate threading and sewing.
  • Figures 24a and 24b show two winding forms of the suture 127 on the frame 111.
  • Figure 24a is a pre-buried type, that is, by passing the suture 127 through the surrounding body 125 on the distal surface of the frame 111, part of the suture 127 is buried Inside the surrounding body 125, the effect of pre-embedding is achieved, or the suture 127 is wound on the skeleton 111 in advance, and then the surrounding body 125 is wound, so that the suture 127 is buried between the surrounding body 125 and the proximal end surface of the skeleton 111; Fig.
  • FIG. 24b is a concealed type, and the suture 127 is wound inside the groove between the surrounding bodies 125, so that the suture 127 does not protrude.
  • the advantage of these two wrapping forms is that the suture 127 is pre-buried or hidden in the surrounding body 125, so that when the attachment frame 11 retracts the sheath, the suture 127 does not directly contact the inner wall of the delivery sheath 22, thus avoiding multiple retractions.
  • the release operation causes the sutures 127 to be worn and broken.
  • Figure 25 shows the winding method of the conventional filter sutures 127 on the market.
  • the sutures 127 on the proximal surface of the attachment frame 11 are directly exposed on the outer surface, and the sutures 127 in this area are bound to be Contacting the inner wall of the delivery sheath 2, when the filter is repeatedly retracted and released, it will cause the risk of wear and tear of the suture 127, resulting in the film 126 and the attachment frame 11 being not firmly fixed, and even causing the film 126 to fall off, which ultimately affects the blocking function of the film 126. .
  • Suitable flexible materials for the film 126 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomers, polyamides, silicones, polyolefins, degradable materials such as polylactic acid, polyethylene Alcohol, animal tissue, etc.
  • the suture 127 can be made of polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene and other non-absorbable materials, and can also be sheep intestine tissue, polylactic acid, polyglycolic acid Class and other absorbable materials.
  • the far and near end faces of the attachment frame 11 can be integrally coated by heating, glue bonding, coupling agent connection, etc., and the material used can be polytetrafluoroethylene (PTFE) with a porous structure.
  • PTFE polytetrafluoroethylene
  • PP polypropylene
  • PET polyethylene terephthalate
  • 26 is a partial view of the attachment frame 11 after being covered with film. At this time, both the far and near ends of the attachment frame 11 are covered by the film 126 , and part of the skeleton 111 of the attachment frame 11 is wrapped inside the film 126 .
  • the advantage of the film coating method is 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.
  • the film 126 can be integrally formed with the surrounding body 125 by lamination.
  • the implant device 1 with the bionic micro-thorn attachment structure provided by the present application is a hollow tubular intravascular stent, and the intravascular stent is a self-expanding stent with a plurality of The skeletons 111 are connected to each other to form one or more layers of wavy or mesh structure, which constitute the main body of the intravascular stent, and play the role of radially supporting the blood vessel or blocking the diseased tissue; preferably, the intravascular stent is a covered stent,
  • the surface is provided with a flexible film 126, the film 126 is wrapped on the surface of the skeleton 111 of the stent-graft, and has the characteristics of being soft and dense, and can play the role of isolating blood, preventing blood from seeping out of the surface of the stent-graft and flowing to the blood vessels.
  • the current stents on the market are equipped with bare stents or barbed bare stents at the proximal end to increase the anchoring area at the proximal end and improve the anti-displacement performance of the stents.
  • the barbs are usually rigid, straight and thick, as shown in Figure 8a and Figure 8b.
  • such barbed structures cannot adapt to changes and can only be inserted into the blood vessel wall at a fixed angle, which can easily lead to the risk of damage to the blood vessel wall.
  • Figure 27 shows a stent-graft with a bare stent structure according to the present embodiment.
  • the band of the bare stent is provided with multiple sets of bionic micro-thorn attachment structures 12. After release, the stent-graft can be firmly attached to the blood vessel wall, not only There is no damage to the blood vessel wall, and it will not be displaced by the impact of blood flow, which has the effect of precise positioning.
  • a plurality of bionic micro-thorn attachment structures 12 are arranged on the skeleton 111 of the stent body.
  • the advantage of this design is that the design of the bare stent in the covered stent is eliminated, so that the covered stent can be covered.
  • the stent-graft itself realizes the attached anchoring function to the vessel wall, making the stent-graft suitable for a wider range of applications, especially for vessels with complex curved shapes, such as the aortic arch.
  • the direct contact area is reduced, the precipitation of metal ions is reduced, and the biocompatibility is enhanced.
  • Embodiment 8 is different from Embodiment 7 in that the implant device 1 with the bionic micro-thorn attachment structure provided by the present application in Embodiment 8 is a hollow tubular intravascular stent,
  • the intravascular stent is a balloon-expandable stent.
  • the surface of the balloon-expandable stent is provided with a bionic micro-thorn attachment structure 12.
  • the balloon-expandable stent can pass through a balloon 14 and is expanded to a certain diameter through the balloon 14.
  • the balloon 14 makes the microthorns 122 adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue, and when pierced into the cavity tissue, Because the micro-thorns 122 of the bionic micro-thorn attachment structure 12 have the characteristics of slenderness and shortness, the micro-thorns 122 can penetrate into the intima or media of the blood vessel in a tiny and shallow way, so as to realize the extremely minimally invasive anchoring function.
  • This kind of anchoring is extremely minimally invasive and effective, and avoids various design drawbacks caused by the above-mentioned existing rigid, straight and thick barb anchoring technology.
  • the implant device 1 with the bionic micro-thorn attachment structure provided by the present application in the ninth embodiment is a hollow tubular intravascular cavity
  • the stent, the hollow tubular intravascular stent is a grid-like dense mesh stent formed by weaving metal wires, and the area of each grid is less than or equal to 2.5mm 2 .
  • the dense mesh stent has the following advantages: a) Effectively block the upper blood vessels
  • the diseased parts of the disease including the rupture of arterial dissection and false lumen, true or false aneurysm of the artery, have a therapeutic effect; b) The bending deformation ability is outstanding, and it can adapt to the blood vessels of various anatomical shapes, especially the curved blood vessels and lesions site; c) the existence of the mesh will not affect the blood flow of the branch blood vessels supplying blood to the important organs in the body, and has long-term patency maintenance.
  • the mesh of the dense mesh stent is used as the channel interface of the small branch stent.
  • the dense mesh stent is first placed at the target position, and then the guide wire is passed from the branch blood vessel. And pass through one of the meshes of the dense mesh stent, thereby establishing the channel interface of the small branch stent, as shown in Figure 31, when the dense mesh stent is made of elastic and shape memory wire woven to make the dense mesh stent.
  • the meshes in the selected mesh and its nearby areas can be adaptively deformed, so that the mesh expansion of the dense mesh stent wraps around the periphery of the small branch stent.
  • the small branch stent is a thinned hollow tubular intravascular stent with a diameter at least half smaller than that of the dense mesh stent, and a biomimetic micro-thorn attachment structure 12 is provided on the outer surface of the small branch stent to
  • the stable connection between the main body support and the small branch support is enhanced; in a preferred embodiment, the local metal wires of the dense mesh support are processed to form a flat structure with a certain thickness, and the bionic microthorns are arranged on the surface of the flat structure
  • the attachment structure 12 is convenient for the dense mesh stent to be attached to the blood vessel wall without damage, as shown in FIG. 33 .

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Abstract

An implanted instrument (1) having bionic spinule attachment structures, at least comprising an attachment stent (11); the attachment stent (11) is a self-expandable stent or a balloon-expandable stent, the attachment stent (11) comprises a plurality of frames (111) and a plurality of bionic spinule attachment structures (12), the bionic spinule attachment structures (12) are provided on the outer surface of the frames (111), the shape of the bionic spinule attachment structures (12) imitates spinules sparsely formed on a plant surface, each bionic spinule attachment structure (12) comprises a root (121) and spinules (122), the spinules (122) are each composed of a body (1221) and a tip (1222), the spinules (122) are linear or J-shaped or have a shape of a combination of both, and the bodies (1221) and/or the tips (1222) of the spinules (122) are able to touch lumen tissue, so as to achieve an attachment anchoring function.

Description

一种具有仿生微刺依附结构的植入器械An implanted device with a bionic microthorn attachment structure 技术领域technical field

本申请涉及一种医疗器械,具体涉及一种具有仿生微刺依附结构的植入器械。The present application relates to a medical device, in particular to an implanted device with a bionic micro-thorn attachment structure.

背景技术Background technique

随着介入手术的兴起,应用于肺栓塞疾病的静脉滤器植入术以及应用于人体主动脉疾病(如主动脉瘤、主动脉夹层等)的血管腔内支架植入术受到越来越广泛的社会关注。With the rise of interventional surgery, venous filter implantation for pulmonary embolism and endovascular stent implantation for human aortic diseases (such as aortic aneurysm, aortic dissection, etc.) Social concerns.

静脉滤器植入术是通过在血管中植入临时滤器,利用该滤器拦截较大的血栓,防止其在重要脏器等位置堵塞血管,避免造成患者脏器缺氧损坏,待病变缓解或解除后再撤掉该滤器的一种介入手术方法。目前市场上常见滤器的普遍问题有以下几个方面:支撑结构与血管壁接触面积大,由于血管内膜增生或粘结导致滤器容易被血管内膜包覆,回收时易造成血管壁撕裂,回收周期短;稳定性较差,自中心性不足,在血流冲击下容易发生移位或歪斜,给回收工作造成一定困难;倒刺结构极易造成血管壁穿刺,引起其他并发症。Intravenous filter implantation is to implant a temporary filter in the blood vessel, and use the filter to intercept large thrombus, prevent it from blocking the blood vessel in important organs and other positions, and avoid hypoxia damage to the patient's organs. After the disease is relieved or relieved An interventional method of removing the filter. The common problems of common filters on the market at present are as follows: the contact area between the support structure and the blood vessel wall is large, the filter is easily covered by the blood vessel intima due to the proliferation or adhesion of the intima of the blood vessel, and the blood vessel wall is easily torn during recovery. The recovery period is short; the stability is poor, the self-centering is insufficient, and it is easy to shift or skew under the impact of blood flow, which causes certain difficulties in the recovery work; the barbed structure can easily cause puncture of the blood vessel wall and cause other complications.

在血管腔内支架植入术中,主动脉覆膜支架腔内隔绝术已经广泛应用于降、腹主动脉的动脉瘤和动脉夹层等病变,已成为一线的治疗方法。但目前仍有以下问题:锚定强度不足,支架易与血管发生相对滑动,对人体造成潜在危险;锚定结构中的倒刺易刺破血管壁而造成风险;为增强锚定,增加裸支架设计,但不能广泛的适应与弯曲的病变血管。In endovascular stent implantation, endovascular isolation of aortic stent-graft has been widely used in descending and abdominal aortic aneurysms and arterial dissection and other diseases, and has become a first-line treatment method. However, there are still the following problems: insufficient anchoring strength, the stent is easy to slide relative to the blood vessel, causing potential danger to human body; designed, but not widely adaptable to tortuous diseased vessels.

综上所述,无论是滤器还是血管腔内支架,防止器械在血管内的位移滑动是首要的安全问题,现有器械的结构中,为了实现有效锚定,均增加了倒刺结构,以便通过扎入血管壁实现锚定,但这种倒刺结构往往刚硬、笔直且粗长,虽然在一定程度上增加了锚定性,但具有扎穿血管壁,引起并发症或导致植入失败等潜在风险。因此,目前市场上急需一种安全性更高、应用范围更广的植入器械。To sum up, whether it is a filter or an intravascular stent, preventing the displacement and sliding of the device in the blood vessel is the primary safety issue. It can be anchored by tying into the vessel wall, but this barb structure is often rigid, straight, and long. Although it increases the anchorage to a certain extent, it has the potential to penetrate the vessel wall, cause complications or lead to implantation failure. risk. Therefore, there is an urgent need for an implantable device with higher safety and wider application range on the market.

发明内容SUMMARY OF THE INVENTION

本申请的目的是为了克服现有技术的不足,提供一种具有仿生微刺依附结构的植入器械,能实现无损伤锚定,并确保实现牢固固定。The purpose of the present application is to overcome the deficiencies of the prior art, and to provide an implanted device with a bionic micro-thorn attachment structure, which can achieve non-destructive anchoring and ensure firm fixation.

本申请目的是通过以下技术方案实现的:The purpose of this application is to achieve through the following technical solutions:

一种具有仿生微刺依附结构的植入器械,所述植入器械至少包括依附架,所述依附架为自膨式支架或球扩式支架,所述依附架包括多根骨架和多个仿生微刺依附结构,所述仿生微刺依附结构设置在所述骨架的外表面上,所述仿生微刺依附结构的形态为仿植物表面上的疏生微刺,所述仿生微刺依附结构包括刺根和微刺,所述微刺由刺身和刺尖组成,所述微刺呈直线形或J形或两者组合,所述微刺的所述刺身和/或所述刺尖能够触碰到腔体组织,实现依附式锚定功能。An implant device with a bionic micro-thorn attachment structure, the implant device at least includes an attachment frame, the attachment frame is a self-expanding stent or a ball-expanding stent, and the attachment frame includes a plurality of skeletons and a plurality of bionic Micro-thorn attachment structure, the biomimetic micro-thorn attachment structure is arranged on the outer surface of the skeleton, and the shape of the biomimetic micro-thorn attachment structure is the sparse microthorn on the surface of the imitation plant, and the biomimetic micro-thorn attachment structure includes Thorn roots and microthorns, the microthorns are composed of a thorn body and a thorn tip, the microthorns are straight or J-shaped or a combination of the two, and the thorn body and/or the thorn tips of the microthorns can touch To the cavity tissue, to achieve the attached anchoring function.

本申请的目的还可以通过以下技术方案来进一步实现:The purpose of this application can also be further achieved through the following technical solutions:

在一个实施方式中,所述微刺在接触腔体组织时,能够发生适应性弯曲形变,利于所述微刺无损地依附在腔体组织上,增强其依附式锚定功能。In one embodiment, when the microstabs are in contact with the cavity tissue, they can undergo adaptive bending deformation, which facilitates the microthorns to adhere to the cavity tissue without damage, and enhances its attached anchoring function.

在一个实施方式中,所述植物包括但不限于苍耳、葎草、云实、杠板归、芡实、簕菜、悬钩子、大蓟、刺蓼、刺三加。In one embodiment, the plants include, but are not limited to, Xanthium, Humulus japonicus, Yunshi, Gangbangui, Gorgon, sagebrush, Rubus, thistle, Polygonum spinosa, Acanthopanax senticosus.

在一个实施方式中,定义:所述刺身的长度为L1,所述刺尖的曲线长度为L2,所述刺身朝外的延长线方向与所述刺尖远端朝外的延长线方向之间的夹角为β,所述刺身长度L1、所述刺尖曲线长度L2以及所述夹角β满足如下数学关系:0.2mm≤L1≤5mm,0<L2≤3mm,0≤β≤150°,所述直线形微刺长度小于所述J形微刺长度。In one embodiment, it is defined that the length of the sashimi is L1, the length of the curve of the thorn is L2, and the direction of the outward extension of the sashimi and the direction of the outward extension of the distal end of the thorn is between The included angle is β, the length L1 of the sashimi, the length L2 of the thorn point curve and the included angle β satisfy the following mathematical relationships: 0.2mm≤L1≤5mm, 0<L2≤3mm, 0≤β≤150°, The length of the linear microspurs is smaller than the length of the J-shaped microspurs.

在一个优选的实施方式中,所述仿生微刺依附结构的总数量在3个至100个之间,通过调节参数L1、L2以及β,能够便于所述刺尖触碰到腔体组织,增加依附式锚定的有效性。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, it is convenient for the thorn tips to touch the cavity tissue, increasing the Effectiveness of Dependent Anchoring.

在一个优选的实施方式中,所述刺身长度L1、所述刺尖曲线长度L2以及所述夹角β满足如下数学关系:0.5≤L1≤2mm,0≤L2≤1mm,90°≤β≤150°。In a preferred embodiment, the sashimi length L1, the thorn point curve length L2 and the included angle β satisfy the following mathematical relationships: 0.5≤L1≤2mm, 0≤L2≤1mm, 90°≤β≤150 °.

在一个优选的实施方式中,每根所述骨架上设置的所述仿生微刺依附结构的数量在1个至10个之间。In a preferred embodiment, the number of the biomimetic micro-thorn attachment structures disposed on each skeleton is between 1 and 10.

在一个优选的实施方式中,所述刺尖的尖端点与所述刺身的距离≤0.5mm,使得J形的所述 刺尖呈微米级的折形钩状或弧形钩状。In a preferred embodiment, the distance between the tip point of the thorn and the thorn body is ≤ 0.5 mm, so that the J-shaped thorn is in the shape of a micron folded hook or an arc hook.

在一个优选的实施方式中,当所述微刺形状为直线形时,所述微刺的所述刺身即为所述刺尖。In a preferred embodiment, when the shape of the microthorns is straight, the thorns of the microthorns are the thorn tips.

在一个优选的实施方式中,直线形的所述微刺的刺身长度L1≤1mm。In a preferred embodiment, the sashimi length L1 of the linear microthorns is less than or equal to 1 mm.

在一个优选的实施方式中,所有所述微刺中,直线形的所述微刺的数量占比在50%和99%之间。In a preferred embodiment, among all the microthorns, the number of linear microthorns accounts for between 50% and 99%.

在一个优选的实施方式中,所有所述微刺中,多组直线形微刺和J形微刺采用间隔性重复设计,每组中J形微刺和直线形微刺在适应性地接触腔体组织时,相互配合并形成“自锁”结构,使得每根所述骨架在沿骨架轴向上无法进行朝远心端或朝近心端移动,增加了约束,加强对腔体组织依附的牢固性。In a preferred embodiment, among all the microspurs, multiple groups of linear microspurs and J-shaped microspurs are designed with spaced repetition, and the J-shaped microspurs and the linear microspurs in each group are in adaptive contact with the cavity When the body tissue is used, 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, which increases constraints and strengthens the attachment to the cavity tissue. firmness.

在一个实施方式中,所述仿生微刺依附结构还包括限位机构,所述限位机构为设置在所述骨架上的孔槽,所述仿生微刺依附结构与所述孔槽在位置上形成对应,所述刺根至少部分区域位于所述孔槽内,所述刺根与所述孔槽相互配合,用于限定所述微刺在所述骨架上的相对位置。In one embodiment, the biomimetic microthorn attachment structure further includes a limiting mechanism, the limiting mechanism is a hole and groove provided on the skeleton, and the biomimetic microthorn attachment structure is in position with the hole and slot Correspondingly, at least a part of the thorn root is located in the hole groove, and the thorn root and the hole groove cooperate with each other to define the relative position of the micro thorn on the skeleton.

在一个实施方式中,每个所述仿生微刺依附结构至少包含1个所述刺根与2个所述微刺,所述微刺与所述孔槽在位置和数量上一一对应,所述刺根至少部分区域与所述骨架贴合,所述刺根呈U形或回形结构,且所述刺根贯穿于两个所述孔槽,每个所述仿生微刺依附结构由具有弹性及形状记忆性的丝材依次穿过对应的两个所述孔槽而成,所述丝材的横截面积≤0.3mm 2,所述丝材的长径比在2和40范围内,使得所述微刺具有纤细、柔软的特点。 In one embodiment, each of the biomimetic micro-thorn attachment structures includes at least one of the thorn roots and two of the micro-thorns, and the micro-thorns correspond to the holes and grooves in one-to-one position and number, so At least part of the thorn root is attached to the skeleton, the thorn root is in a U-shaped or back-shaped structure, and the thorn root runs through the two holes and grooves, and each of the bionic microthorn attachment structures is composed of a The elastic and shape-memory wire is formed by passing through the corresponding two holes in sequence, the cross-sectional area of the wire is ≤0.3mm 2 , and the length-diameter ratio of the wire is in the range of 2 and 40. The micro-thorns are made to have the characteristics of slenderness and softness.

在一个优选的实施方式中,每个所述微刺均共面。In a preferred embodiment, each of the microspines are coplanar.

在一个优选的实施方式中,所述刺根贯穿于两个相邻的所述孔槽。In a preferred embodiment, the thorns penetrate through two adjacent holes.

在一个优选的实施方式中,所述丝材的横截面积在0.002mm 2和0.015mm 2之间。 In a preferred embodiment, the cross-sectional area of the wire is between 0.002 mm 2 and 0.015 mm 2 .

在一个优选的实施方式中,所述仿生微刺依附结构兼具柔性和弹性,具有类绒毛特性,用于实现与腔体组织的依附式锚定,所述微刺在受到外力作用下,能够以所述刺根为中心,实现在每根所述骨架外表面方向上自由转动和变形,当植入人体腔体组织内时,因腔体组织内壁具有较多的局部凸起,所述微刺在接触所述局部凸起时,部分所述微刺的朝向能够发生适应性改变,增强了微刺的依附式锚定性,而不会刚硬且笔直地刺入组织,对腔体组织无损伤,因此整个所述仿生微刺依附结构具有自适应性,增强对腔体组织的依附式锚定功能。In a preferred embodiment, the bionic microthorn attachment structure has both flexibility and elasticity, and has villi-like properties, so as to realize the attachment anchoring with the cavity tissue. With the thorn as the center, it can freely rotate and deform in the direction of the outer surface of each skeleton. When implanted in the human body cavity tissue, because the inner wall of the cavity tissue has many local protrusions, the microscopic When the thorn contacts the local protrusion, the orientation of some of the micro thorns can be adaptively changed, which enhances the attachment and anchoring of the micro thorns, and does not penetrate the tissue rigidly and straightly, and has no effect on the cavity tissue. Therefore, the entire bionic micro-thorn attachment structure has self-adaptation, and enhances the attachment anchoring function to the cavity tissue.

在一个实施方式中,所述限位机构为设置在所述骨架上的局部缩颈结构、局部凸起结构、键槽结构的一种或多种,或者所述限位机构通过胶粘接、焊接或机械配合,实现所述骨架与所述刺根的固定连接。In one embodiment, the limiting mechanism is one or more of a partial constriction structure, a partial convex structure, and a keyway structure provided on the skeleton, or the limiting mechanism is glued or welded by gluing or welding. Or mechanically cooperate to realize the fixed connection between the skeleton and the thorn.

在一个实施方式中,在任意一个所述骨架长径方向的截面上,分别定义所述骨架的厚度为P1,所述孔槽自身的长度为P2,任意两个相邻的所述孔槽的间距为P3,所述刺身朝外的延长线方向与所述骨架远离所述依附架的中轴线m的方向之间的夹角为ω,其中参数P1、P2、P3以及ω分别满足如下数学关系:0.05mm≤P1≤0.5mm,0.05mm≤P2≤4mm,0.5mm≤P3≤10mm,30°≤ω<180°,调节P1、P2的具体参数能够实现所述夹角ω的调整,确保每个所述刺尖在自然状态下都朝向腔体组织或流体流动方向,增强依附式锚定的有效性,同时通过调节参数P3能够对所述微刺的总数量进行调整。In one embodiment, on any cross section in the longitudinal direction of the skeleton, the thickness of the skeleton is respectively defined as P1, the length of the hole slot itself is P2, and the thickness of any two adjacent holes and slots is defined as P2. The distance is P3, the angle between the direction of the extension line of the sashimi facing outward and the direction of the skeleton away from the central axis m of the attachment frame is ω, and 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 realize the adjustment of the included angle ω, ensuring that every In a natural state, each of the thorn tips is directed towards the direction of the cavity tissue or fluid flow, which enhances the effectiveness of the adherent anchoring, and at the same time, the total number of the microthorns can be adjusted by adjusting the parameter P3.

在一个优选的实施方式中,所述骨架的厚度P1、所述孔槽的外径P2以及所述夹角ω分别满足如下数学关系:0.1mm≤P1≤0.3mm,0.1mm≤P2≤2mm,0.5mm≤P3≤2mm,60°≤ω≤150°。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°.

在一个实施方式中,所述植入器械为滤器,所述腔体组织为血管壁,所述依附架为自膨式支架,所述骨架具有弹性,所述依附架还包括中心件,多根所述骨架由中心件朝外发散并围成立体结构,具有阻挡血栓的功能,所述立体结构呈现为灯笼形、葫芦形、蘑菇形、伞形、碗形、锥形的一种或多种组合;In one embodiment, the implantation device is a filter, the cavity tissue is a blood vessel wall, the attachment frame is a self-expanding stent, the frame is elastic, the attachment frame further includes a center piece, a plurality of The skeleton radiates outward from the central piece and surrounds a three-dimensional structure, which has the function of blocking thrombus, and the three-dimensional structure presents one or more of lantern, gourd, mushroom, umbrella, bowl, and cone shapes. combination;

或者,所述植入器械为空心管状的血管腔内支架,所述血管腔内支架为自膨式支架或球扩支架,所述腔体组织为血管壁,所述血管腔内支架由多根所述骨架相互连接形成一层或多层的波状或网状结构,起撑开血管或阻隔病变组织的作用。Alternatively, the implantation device is a hollow tubular intraluminal stent, the intravascular stent is a self-expanding stent or a ball-expanding stent, the cavity tissue is a blood vessel wall, and the intravascular stent is composed of a plurality of The skeletons are interconnected to form one or more layers of wavy or net-like structures, which play the role of opening blood vessels or blocking diseased tissue.

在一个优选的实施方式中,所述植入器械为滤器,所述中心件设置有抓取机构,所述抓取机构便于将所述滤器从目标位置抓取并取出到体外。In a preferred embodiment, the implanted device is a filter, and the central piece is provided with a grabbing mechanism, and the grabbing mechanism is convenient for grabbing the filter from the target position and taking it out of the body.

在一个实施方式中,所述植入器械为滤器时,在所述骨架的内表面设有多个所述仿生微刺依附结构,所述仿生微刺依附结构的刺身和/或刺尖朝向腔体内流体流动方向或径向朝向腔体组织 壁,防止植入器械内已捕获的血栓在回收和释放调整过程中脱出。In one embodiment, when the implanted device is a filter, a plurality of the biomimetic micro-thorn attachment structures are provided on the inner surface of the skeleton, and the thorns and/or thorn tips of the biomimetic micro-thorn attachment structures face the cavity The body fluid flows in the direction or radial direction toward the cavity tissue wall to prevent the thrombus captured in the implanted device from being dislodged during the recovery and release adjustment process.

在一个实施方式中,所述依附架包括微刺保护结构,所述微刺保护结构设置在所述骨架上,定义所述微刺的最尖端与所述骨架之间的距离为L3,所述微刺保护结构凸出所述骨架的高度为L4,则L3与L4满足如下关系:L3<L4,所述微刺保护结构为半球体状、椭球体状、曲线状、折线状的一个或多个组合,使得所述植入器械进出输送鞘管的过程中,所述微刺依附结构不接触到所述输送鞘管内壁。In one embodiment, the attachment frame includes a micro-thorn protection structure, the micro-thorn protection structure is arranged on the skeleton, and the distance between the tip of the micro-thorn and the skeleton is defined as L3, the The height of the micro-thorn protection structure protruding from the skeleton is L4, then L3 and L4 satisfy the following relationship: L3 < L4, and the micro-thorn protection structure is one or more of a hemisphere shape, an ellipsoid shape, a curve shape, and a broken line shape. The combination is such that the micro-stab attachment structure does not contact the inner wall of the delivery sheath during the process of the implantation device moving in and out of the delivery sheath.

在一个实施方式中,所述依附架设有自中心结构,所述自中心结构由所述骨架的末端进一步朝末端方向延伸所形成的卷曲状结构,所述卷曲状结构为椭圆形、圆形或二维螺旋线结构的一种或多种,且每个所述的卷曲状结构所在的平面均与所述依附架的中轴线m共面;In one embodiment, the attachment frame is provided with a self-center structure, and the self-center structure is a curled structure formed by the end of the skeleton further extending toward the end, and the curled structure is elliptical, circular or One or more of two-dimensional helical structures, and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame;

或者,所述自中心结构是由所述中心件中心向四周发散的多根骨架所形成的卷曲状结构,所述卷曲状结构为椭圆形、圆形或二维螺旋线结构的一种或多种,且每个所述卷曲状结构所在的平面均与所述依附架的中轴线m共面。Alternatively, the self-center structure is a coil-like structure formed by a plurality of skeletons emanating from the center of the center piece to the surrounding, and the coil-shaped structure is one or more of an ellipse, a circle, or a two-dimensional helical structure. and the plane where each of the curled structures is located is coplanar with the central axis m of the attachment frame.

在一个优选的实施方式中,所述自中心结构外表面设有所述仿生微刺依附结构。In a preferred embodiment, the biomimetic microthorn attachment structure is provided on the outer surface of the self-center structure.

在一个优选的实施方式中,所述卷曲状结构的卷曲方向为向内卷曲,所述卷曲状结构末端延长线方向与所述依附架中轴线m朝向远端的方向之间的夹角σ满足:0°≤σ≤90°,所述卷曲状结构的圈数n满足:0.25≤n≤1.5。In a preferred embodiment, the curling direction of the curling structure is inward curling, and the included angle σ between the direction of the extension line of the end of the curling structure and the direction of the central axis m of the attachment frame toward the distal end satisfies : 0°≤σ≤90°, the number of turns n of the curled structure satisfies: 0.25≤n≤1.5.

在一个实施方式中,所述依附架包括围绕体,所述围绕体缠绕在所述骨架上,并至少包裹与所述骨架贴合的所述刺根,用于增强所述骨架与所述仿生微刺依附结构的连接强度,避免部分或全部所述骨架与腔体组织直接接触,降低了金属离子的析出量,提高生物相容性;降低摩擦系数,减少所述依附架在所述输送鞘管中的收释放阻力;增加平滑性,体验手感更加;增强所述依附架的抗疲劳耐久性,对所述依附架起到“二次保护”的作用,避免了所述依附架在腔体组织内因长期腐蚀或疲劳失效引发的断裂风险。In one embodiment, the attachment frame includes a surrounding body, the surrounding body is wound on the skeleton, and at least wraps the thorns attached to the skeleton, so as to strengthen the skeleton and the bionic The connection strength of the micro-thorn attachment structure avoids direct contact between part or all of the skeleton and the cavity tissue, reduces the amount of metal ion precipitation, and improves biocompatibility; reduces the friction coefficient and reduces the attachment frame in the delivery sheath. The retraction and release resistance in the tube; increase the smoothness, and experience a better feel; enhance the anti-fatigue durability of the attachment frame, play the role of "secondary protection" for the attachment frame, and avoid the attachment frame in the cavity Risk of fracture within the tissue due to long-term corrosion or fatigue failure.

在一个优选的实施方式中,在每根所述骨架上设置有一个或多个固定结构,所述围绕体的近心端和/或远心端与所述骨架通过所述固定结构实现有效连接或位置限定。In a preferred embodiment, one or more fixing structures are provided on each of the skeletons, and the proximal end and/or the distal end of the surrounding body and the skeleton are effectively connected through the fixing structures or location constraints.

在一个优选的实施方式中,所述围绕体为具有柔性的医用线材/丝材/带材,所述围绕体的横截面形状包括圆形、椭圆形、矩形的一种和多种的组合。In a preferred embodiment, the surrounding body is a flexible medical wire/wire/tape, and the cross-sectional shape of the surrounding body includes one or a combination of a circle, an ellipse, and a rectangle.

在一个优选的实施方式中,所述围绕体是由缝线缠绕而成,所述缝线的材质包括聚对苯二甲酸乙二醇酯(PET)、聚四氟乙烯(PTFE)、超高分子量聚乙烯(UHMWPE)、聚丙烯(PP)、聚酰胺(PA)、聚对二氧环乙酮(PDO)、聚乙醇酸(PGA)、聚乳酸(PLA)、聚乙丙交酯(PGLA)、聚己内酯(PCL)、蚕丝、羊肠、动物肌腱组织,或具有显影效果的医用金属和/或医用高分子材料。In a preferred embodiment, the surrounding body is wound with suture, and the material of the suture includes polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ultra-high Molecular weight polyethylene (UHMWPE), polypropylene (PP), polyamide (PA), polydioxetone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide (PGLA) ), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metal and/or medical polymer materials with developing effect.

在一个优选的实施方式中,所述围绕体自身的外表面上设置有一个或多个局部凸起,所述局部凸起自身形成倒刺结构,所述倒刺结构朝向血管壁,进一步增强锚定。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, and the barb structures face the vessel wall to further strengthen the anchor Certainly.

在一个实施方式中,所述植入器械为滤器时,所述骨架的最外围区域设有凸缘结构,所述凸缘结构外表面设有所述仿生微刺依附结构,避免所述骨架与所述腔体组织直接接触。In one embodiment, when the implanted device is a filter, the outermost peripheral 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, so as to prevent the skeleton from interacting with The cavity tissue is in direct contact.

在一个实施方式中,所述植入器械为空心管状的血管腔内支架,所述血管腔内支架为球扩式支架,所述球扩式支架内可通球囊,并经所述球囊扩张至一定直径,当所述骨架贴靠在所述腔体组织壁时,所述球囊使得所述微刺最大程度依附在腔体组织上,或者刺入到腔体组织内。In one embodiment, the implantation device is a hollow tubular intraluminal stent, the intravascular stent is a balloon-expandable stent, and a balloon can be passed through the balloon-expanded stent, and the balloon is passed through the balloon. After expanding to a certain diameter, when the skeleton is abutted against the cavity tissue wall, the balloon makes the microspins adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue.

在一个实施方式中,所述植入器械为空心管状的血管腔内支架,所述血管腔内支架为由丝材编织形成的具有网格状的密网支架,每个所述网格的面积≤2.5mm 2,所述密网支架的一个或多个网格具有形变自适应性,当所述网格作为小分支支架的通道接口时,所述网格可扩张并贴合在所述小分支支架的外表面上,所述小分支支架为直径至少比密网支架小一半的细径化的空心管状的血管腔内支架。 In one embodiment, the implantation device is a hollow tubular intraluminal stent, and the intravascular stent is a grid-like dense mesh stent formed by weaving a wire material, and the area of each grid is ≤2.5mm 2 , one or more grids of the dense mesh stent have deformation adaptability, and when the grid is used as a channel interface of a small branch stent, the grid can expand and fit on the small branch stent. On the outer surface of the branch stent, the small branch stent is a thinned hollow tubular intraluminal stent with a diameter at least half smaller than that of the dense mesh stent.

在一个优选的实施方式中,所述密网支架的所述局部金属丝通过加工,形成具有一定厚度的扁平结构,所述扁平结构表面上设有所述仿生微刺依附结构。In a preferred embodiment, the partial metal wires of the dense mesh stent are processed to form a flat structure with a certain thickness, and the bionic microthorn attachment structure is provided on the surface of the flat structure.

在一个实施方式中,所述植入器械表面包括柔性薄膜,所述薄膜位于所述依附架的表面上。In one embodiment, the implant device surface includes a flexible membrane on the surface of the attachment frame.

在一个优选的实施方式中,所述植入器械为滤器,所述滤器的依附架表面设有柔性薄膜,所述薄膜柔软并具有微孔,所述微孔可过滤血液,但能阻挡血栓,能够起到有效抓捕血管内血栓的作用。In a preferred embodiment, the implanted device is a filter, and the surface of the attachment frame of the filter is provided with a flexible membrane, the membrane is soft and has micropores, and the micropores can filter blood, but can block thrombus, It can effectively capture the thrombus in the blood vessel.

在一个优选的实施方式中,所述植入器械为血管腔内支架,所述薄膜包裹在所述覆膜支架的 所述骨架表面,具有柔软且致密的特点,能起到隔离血液的作用,防止血液从所述覆膜支架表面渗出而流向血管的病变部位。In a preferred embodiment, the implanted device is an intraluminal stent, the film is wrapped on the surface of the skeleton of the covered stent, has the characteristics of softness and density, and can play the role of isolating blood, The blood is prevented from leaking out from the surface of the stent-graft and flowing to the diseased part of the blood vessel.

与现有技术相比,本专利具有以下突出优点:Compared with the prior art, this patent has the following outstanding advantages:

1、本申请提供的仿生微刺依附结构具有仿植物表面上的疏生微刺形态,仿生微刺依附结构包括刺根和微刺,微刺能够触碰到腔体组织并形成有效锚定,微刺纤细、浅短且柔软,使该微刺具有类绒毛特性,实现依附式锚定功能,避免深度且直接刺入腔体组织造成的创伤;当微刺接触腔体组织时,能够发生适应性弯曲形变,利于微刺无损地依附在腔体内腔组织上,增强其依附式锚定功能。1. The biomimetic micro-thorn attachment structure provided by the application has the sparse micro-thorn shape on the surface of the imitation plant, the biomimetic micro-thorn attachment structure includes thorn roots and micro-thorns, and the micro-thorn can touch the cavity tissue and form an effective anchor, The microthorns are slender, shallow and soft, which makes the microthorns have villi-like characteristics, realizes the attachment anchoring function, and avoids the trauma caused by deep and direct penetration into the cavity tissue; when the microthorn contacts the cavity tissue, it can adapt Sexual bending deformation is beneficial for the microthorn to attach to the cavity tissue without damage, and enhance its attached anchoring function.

2、本申请提供的微刺呈直线形、J形或两种组合,微刺由刺身和刺尖组成,具有如下优点:a)J形微刺具有微米级的刺尖可挂住腔体组织,避免深度且直接刺入腔体组织而造成的创伤;b)诸多微刺犹如轮胎外表面的凹凸不平的花纹,因此还起到增加粗糙度的作用,特别地对于直线形微刺,显著增加微刺和腔体组织之间的静摩擦力,增强对腔体组织的依附力,从而实现有效锚定;c)特别地,J形微刺和直线形微刺相互配合,形成“自锁”结构,使得每根骨架在沿骨架轴向上无法朝远心端或朝近心端移动,增加了约束,加强了对腔体组织依附的牢固性。2. The microthorns provided in this application are straight, J-shaped or a combination of the two. The microthorns are composed of a thorn body and a thorn tip. , to avoid the trauma caused by deep and direct penetration into the cavity tissue; b) Many micro-thorns are like uneven patterns on the outer surface of the tire, so they also play a role in increasing the roughness, especially for linear micro-thorns, significantly increase The static friction between the microspine and the cavity tissue enhances the attachment force to the cavity tissue, thereby achieving effective anchoring; c) In particular, the J-shaped microspurs and the linear microspurs cooperate with each other to form a "self-locking" structure , so that each skeleton cannot move toward the distal end or toward the proximal end along the axis of the skeleton, which increases the restraint and strengthens the firmness of the attachment to the cavity tissue.

3、本申请提供的仿生微刺依附结构包括刺根和刺尖,且与骨架采用组合式结构,其中刺根和骨架上的限位机构相互配合,用于限定微刺在骨架上的相对位置,这种设计使得:a)微刺刺身和刺尖的长度可调,能够有效保证直线形微刺和J形微刺的刺身以及刺尖无损伤地接触腔体组织,从而避免刺穿腔体组织,给患者造成潜在风险;b)仿生微刺依附结构兼具高柔韧性和高弹性,使得微刺在受到外力作用下,能够以刺根为中心,实现在每根骨架外表面方向上自由转动和变形,因腔体组织自身弯曲或者器械释放位置的不同,部分微刺的朝向以及夹角ω能够适应性地发生改变,增强了微刺的依附式锚定性,而不会刚硬且笔直地深度刺入腔体组织,对腔体组织无损伤或微损伤,因此整个仿生微刺依附结构具有自适应性,增强对腔体组织的依附式锚定功能;c)依附架的骨架与微刺通过刺根与限位机构的配合实现连接,刺根能够有效防止微刺因疲劳失效发生断裂。3. The bionic microthorn attachment structure provided by this application 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 microthorn on the skeleton. , This design makes: a) The length of the micro-thorn body and the thorn tip can be adjusted, which can effectively ensure that the straight-shaped micro-thorn and J-shaped micro-thorn and the thorn tip contact the cavity tissue without damage, so as to avoid piercing the cavity. tissue, causing potential risks to patients; b) The bionic microthorn attachment structure has both high flexibility and high elasticity, so that under the action of external force, the microthorns can center on the thorn root and achieve freedom in the direction of the outer surface of each skeleton Rotation and deformation, due to the curvature of the cavity tissue itself or the release position of the device, the orientation and angle ω of some microspurs can be adaptively changed, which enhances the attachment anchoring of the microspurs without being rigid and straight. It penetrates deeply into the cavity tissue without damage or micro-damage to the cavity tissue, so the entire bionic micro-thorn attachment structure is adaptive and enhances the attachment anchoring function to the cavity tissue; c) The skeleton of the attachment frame and the micro-thorns The thorn is connected through the cooperation of the thorn root and the limiting mechanism, and the thorn root can effectively prevent the micro-thorn from breaking due to fatigue failure.

4、本申请提供的仿生微刺依附结构中由于微刺纤细、浅短、柔软的特点,能有效实现与血管壁的依附式锚定功能,而非深度刺入组织锚定,使得术者便于在手术中或手术后的任何时刻视需要进行回收、取出,即便是当植入器械,如滤器植入一定时间(例如6个月),已发挥出血栓过滤的既定功效后,植入器械的骨架与微刺在血管壁上被大量的新生内皮组织所覆盖或包裹,植入器械的微刺也能轻易地从血管壁上脱出,或者从大量的新生内皮组织中抽出,进而实现植入器械的回收和取出。4. In the bionic micro-thorn attachment structure provided by this application, due to the characteristics of slender, shallow and soft micro-thorns, it can effectively realize the attachment anchoring function with the blood vessel wall, instead of deeply penetrating the tissue anchoring, which makes it convenient for the operator. Recover and remove as needed at any time during or after surgery, even when implanted devices, such as filters, have been implanted for a certain period of time (eg, 6 months) and have exerted their intended effect of thrombus filtering. The skeleton and the microspurs are covered or wrapped by a large amount of neo-endothelial tissue on the blood vessel wall, and the micro-spurs of the implanted device can also be easily prolapsed from the blood vessel wall, or extracted from a large number of neo-endothelial tissues, thereby realizing the implantation of the device. recycling and removal.

5、本申请提供的仿生微刺依附结构的数量可调,根据临床实际需求可密布于依附架的骨架的外表面,增加依附架与腔体组织的接触概率,保证依附架在植入时与腔体组织内壁接触的各个面均能实现有效的依附式锚定,进一步增加了锚定强度,避免了因锚定强度不足而引起的器械脱落风险;对于滤器而言,微刺设有微刺保护结构,避免微刺直接与鞘管内壁接触,杜绝了微刺因刮鞘所产生的推送不畅或其他安全隐患。5. The number of bionic microthorn attachment structures provided in this application can be adjusted, and can be densely distributed on the outer surface of the skeleton of the attachment frame according to actual clinical needs, increasing the contact probability between the attachment frame and the cavity tissue, and ensuring that the attachment frame is in contact with the cavity during implantation. All surfaces in contact with the inner wall of the cavity tissue can achieve effective attachment anchoring, which further increases the anchoring strength and avoids the risk of instrument falling off due to insufficient anchoring strength. The protective structure prevents the micro-thorns from directly contacting the inner wall of the sheath tube, and prevents the micro-thorns from being pushed smoothly or other hidden dangers caused by scraping the sheath.

6、本申请提供的仿生微刺依附结构的植入器械,可依据腔体组织解剖学形态的不同,对仿生微刺依附结构的设计做出相应地调整,即通过合理设置骨架的厚度、孔槽的间距、孔槽自身的长度、微刺倾角和数量,确保绝大部分的微刺均能适应性地锚住腔体组织,发挥出微刺依附式锚定功能的最大优势。6. The implanted device with the bionic micro-thorn attachment structure provided in this application can adjust the design of the bionic micro-thorn attachment structure according to the different anatomical forms of the cavity tissue, that is, by reasonably setting the thickness of the skeleton, the holes and the holes. The spacing of the grooves, the length of the hole and the groove itself, the inclination angle and the number of micro-thorns ensure that most of the micro-thorns can anchor the cavity tissue adaptively, and exert the greatest advantage of the micro-thorn-attached anchoring function.

7、本申请提供的仿生微刺依附结构的植入器械设有围绕体,具有以下优点:a)围绕体避免部分或全部骨架与腔体组织直接接触,降低金属离子的析出量,提高生物相容性;b)降低摩擦系数,减少依附架在输送鞘管中的收释放阻力;c)增加平滑性,体验手感更佳;d)增强依附架的抗疲劳耐久性,对依附架起到“二次保护”的作用,避免了依附架在血管内因长期腐蚀或疲劳失效引发的断裂风险;e)增加力的传递性,确保滤器出鞘时各骨架受力均匀、无明显卡顿感;f)增强刺根与骨架的贴合度及位置限定性;g)对微刺角度进行微调节,确保微刺对血管壁的损伤降至最低;h)在依附架设置薄膜的实施方式中,围绕体可预埋或隐藏薄膜与依附架缝合连接的缝线,避免了常规滤器在重复收释放过程中缝线直接与输送系统鞘管内表面接触而造成磨损断裂;i)通过改变围绕体的单层厚度和缠绕圈数,来调整围绕体在径向方向上的整体厚度,进而实现微刺外露于骨架的长度可调性,避免深度刺入甚至刺穿血管壁;j)在一个实施方式中,围绕体为能够与骨架和 /或微刺相互脱离的结构,当植入器械植入到血管内一定时间,骨架连同围绕体被大量新生内皮组织所覆盖,使得植入器械与血管壁牢牢固定住而不便于二者直接脱离,此时围绕体便可与骨架和微刺相互脱离,使得骨架和微刺从围绕体中抽出,最终植入器械得以回收、取出体外,因而实现植入器械的可取出功能。7. The implanted device with the bionic micro-thorn attachment structure provided by this application is provided with a surrounding body, which has the following advantages: a) The surrounding body avoids direct contact between part or all of the skeleton and the cavity tissue, reduces the amount of metal ion precipitation, and improves the biological phase. Capacitance; b) reduce the friction coefficient, reduce the retraction and release resistance of the attachment frame in the delivery sheath; c) increase the smoothness and experience a better feel; d) enhance the anti-fatigue durability of the attachment frame The function of "secondary protection" avoids the risk of fracture of the attachment frame caused by long-term corrosion or fatigue failure in the blood vessel; e) increases the force transmission, ensuring that the force of each frame is uniform when the filter is unsheathed, and there is no obvious stuck feeling; f ) Enhance the fit and position limitation of the thorn root and the skeleton; g) Micro-adjust the angle of the micro-thorn to ensure that the damage of the micro-thorn to the vessel wall is minimized; h) In the embodiment of the attachment frame setting the film, surrounding The body can pre-embed or hide the suture connecting the membrane and the attachment frame, which avoids the wear and tear caused by the suture directly contacting the inner surface of the delivery system sheath during the repeated retraction and release of the conventional filter; i) By changing the monolayer surrounding the body The thickness and the number of winding turns are used to adjust the overall thickness of the surrounding body in the radial direction, so as to realize the adjustable length of the micro-thorns exposed to the skeleton, 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 the microspurs. When the implanted device is implanted into the blood vessel for a certain period of time, the skeleton together with the surrounding body is covered by a large amount of neo-endothelial tissue, so that the implanted device is firmly fixed to the blood vessel wall. It is not convenient for the two to be directly detached. At this time, the surrounding body can be separated from the skeleton and the micro-thorns, so that the skeleton and the micro-thorns can be pulled out from the surrounding body, and finally the implanted device can be recovered and taken out of the body, thus realizing the reproducibility of the implanted device. Take out function.

8、本申请中仿生微刺依附结构的近心端设有保护结构,这种设计具有以下几方面的优点:a)当滤器收入输送鞘管中时,保护结构直接与输送鞘管内壁接触,因此避免了微刺直接接触输送鞘管内壁引起的刮鞘或出入鞘不畅;b)当滤器放置到目标血管后,保护结构在一定程度上减少骨架与血管壁的接触面积,有助于实现滤器植入后的可取出功能。8. In this application, the proximal end of the bionic microthorn attachment structure is provided with a protective structure, and this design has the following advantages: a) when the filter is received in the delivery sheath, the protective structure directly contacts the inner wall of the delivery sheath, Therefore, it is avoided that the micro-thorns directly contact the inner wall of the delivery sheath, and the sheath or sheath is not smooth; 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 is helpful to achieve Removable function after filter implantation.

9、本申请提供的仿生微刺依附结构的植入器械,在骨架最外围区域设有凸缘结构,最大程度地降低滤器外表面与血管壁的接触面积,减少血管内膜增生或粘结导致滤器容易被血管内膜包覆的情况发生,避免了回收时滤器对血管壁造成的撕裂损伤;此外,凸缘结构外表面密布的仿生微刺依附结构使得滤器与血管壁之间的接触方式为点接触,在一定程度上延长了回收周期。9. The implanted device with the bionic micro-thorn attachment structure provided by this application is provided with a flange structure in the outermost peripheral area of the skeleton, which minimizes the contact area between the outer surface of the filter and the blood vessel wall and reduces vascular intimal hyperplasia or adhesion. The filter is easily covered by the intima of the blood vessel, which avoids the tearing damage caused by the filter to the blood vessel wall during recovery; in addition, the bionic micro-thorn attachment structure densely covered on the outer surface of the flange structure makes the contact between the filter and the blood vessel wall. For point contact, the recycling cycle is extended to a certain extent.

10、本申请中仿生微刺依附结构在主动脉支架中能提高支架的抗移位性能,防止支架植入后受血流冲击而产生移位,防止由于支架移位造成支架近心端密封强度减弱产生内漏、或完全偏离预定释放位置导致支架治疗效果失效,尤其在一些具有复杂弯曲特性的血管中,微刺能够发生适应性变化,不仅对血管壁无损伤,不仅对血管壁无损伤,而且不会受血流冲击产生移位,起到了精准定位的效果;在球扩式支架领域,当支架刺入到腔体组织时,由于仿生微刺依附结构的微刺具有纤细、浅短的特性,使得微刺能够微小且较浅的刺入到血管内膜或中膜内,实现极微创化的锚定功能,这种锚定极为微创化且有效,避免现有刚硬、笔直且粗长的倒刺锚定技术而造成的种种设计弊端。10. In this application, the bionic micro-thorn attachment structure can improve the anti-displacement performance of the stent in the aortic stent, prevent the stent from being displaced due to the impact of blood flow after implantation, and prevent the sealing strength of the proximal end of the stent from being caused by the stent displacement. Attenuates endoleak, or completely deviates from the predetermined release position, which leads to the failure of the stent treatment effect. Especially in some blood vessels with complex bending characteristics, the micro-stab can undergo adaptive changes, not only without damage to the blood vessel wall, not only without damage to the blood vessel wall, Moreover, it will not be displaced by the impact of blood flow, which has the effect of precise positioning. In the field of ball-expandable stents, when the stent penetrates into the cavity tissue, the micro-thorns of the bionic micro-thorn attachment structure have slender, shallow and short The characteristics of the micro-thorn make it possible to penetrate into the intima or media of the blood vessel in a tiny and shallow way, and realize the extremely minimally invasive anchoring function. This anchoring is extremely minimally invasive and effective, avoiding the existing rigid and straight And various design drawbacks caused by the thick and long barb anchoring technology.

11、本申请提供的仿生微刺依附结构的植入器械为密网支架,具有如下优点:a)能有效阻隔血管上的病变部位,包括动脉夹层破口及假腔、动脉真性或假性动脉瘤,起到治疗效果;b)弯曲形变能力突出,能够适应各种解剖学形态的血管,特别是弯曲的血管和病变部位;c)网格的存在不会影响给体内重要脏器供血的分支血管的血流,具有长期的通畅保持性;d)密网支架的壁上还可机动性地插入小分支支架,从而将密网支架内的血流分流到小分支支架内,以此形成给重要脏器供血的分支血管的血流;e)在密网支架及分支支架的外表面设有仿生微刺依附结构,便于密网支架无损且牢固地依附在血管壁上,并增强主体支架与小分支支架的稳固性连接。11. The implanted device of the bionic micro-thorn attachment structure provided by this application is a dense mesh stent, which has the following advantages: a) It can effectively block the diseased part on the blood vessel, including the rupture of arterial dissection and false lumen, true arterial or false artery b) It has outstanding bending deformation ability and can adapt to blood vessels of various anatomical forms, especially curved vessels and lesions; c) The existence of meshes will not affect the branches that supply blood to important organs in the body The blood flow of blood vessels has long-term patency maintenance; d) Small branch stents can be flexibly inserted into the wall of the dense mesh stent, so that the blood flow in the dense mesh stent can be shunted to the small branch stents, thereby forming a vascular stent. The blood flow of the branch blood vessels supplying blood to important organs; e) the outer surface of the dense mesh stent and the branch stent is provided with a bionic micro-thorn attachment structure, so that the dense mesh stent can be attached to the blood vessel wall without damage and firmly, and enhance the adhesion of the main stent to the outer surface of the branch stent. Stable connection of small branch supports.

附图说明Description of drawings

图1为本申请中一种具有仿生微刺依附结构的植入器械示意图;1 is a schematic diagram of an implanted device with a bionic microthorn attachment structure in the application;

图2为本申请提供的仿生微刺依附结构的局部示意图;2 is a partial schematic diagram of the bionic microthorn attachment structure provided by the application;

图3为本申请提供的仿生微刺依附结构与骨架配合后的示意图;3 is a schematic diagram of the biomimetic microthorn attachment structure provided by the application after the skeleton is matched;

图4为本申请中带有孔槽的局部骨架的示意图;Fig. 4 is the schematic diagram of the partial skeleton with hole groove in the application;

图5a为本申请中仿生微刺依附结构在骨架中的U形固定形式;Fig. 5a is the U-shaped fixing form of the bionic microthorn attachment structure in the skeleton in the application;

图5b为本申请中仿生微刺依附结构在骨架中的回形固定形式;Fig. 5b is the shape fixing form of the bionic microthorn attachment structure in the skeleton of the application;

图6为本申请中仿生微刺依附结构形态控制相关的尺寸标注图;FIG. 6 is a dimensioning diagram related to the morphological control of the bionic microthorn attachment structure in the application;

图7a为本申请提供的具有仿生微刺依附结构的植入器械中微刺在受到外力作用下以刺根为中心实现一定程度地自由转动和变形的示意图;7a is a schematic diagram of the micro-thorns in the implanted device with the biomimetic micro-thorn attachment structure provided by the application under the action of external force to achieve a certain degree of free rotation and deformation with the thorn root as the center;

图7b为本申请提供的具有仿生微刺依附结构的植入器械中J形微刺发生适应性弯曲形变时和直线形微刺相互配合,形成“自锁”结构的示意图;Fig. 7b is a schematic diagram of the J-shaped micro-thorns cooperating with the straight-line micro-thorns to form a "self-locking" structure when the J-shaped micro-thorns in the implanted device with the bionic micro-thorn attachment structure provided by the application are adaptively bent and deformed;

图8a为仅显示常规植入器械中刚硬、笔直、粗长的直倒刺结构示意图;Figure 8a is a schematic diagram showing only the rigid, straight, thick and long straight barb structure in a conventional implant device;

图8b为仅显示常规植入器械中刚硬、粗长的大钩刺结构示意图;Fig. 8b is a schematic diagram showing only the rigid, thick and long barbed barb structure in a conventional implant device;

图8c为仅显示本申请中具有柔软、纤细、浅短的刺身和刺尖,且刺尖微小并呈弧形钩状的J形微刺的示意图;Figure 8c is a schematic diagram showing only the J-shaped micro-thorns with soft, slender, shallow and short sashimi and thorn tips in the present application, and the thorn tips are tiny and in the shape of an arc hook;

图8d为仅显示本申请中具有柔软、纤细的刺身和刺尖,且刺尖微小并呈折形钩状的J形微刺的示意图;Fig. 8d is a schematic diagram showing only the J-shaped micro-thorns with soft and slender sashimi and thorn tips in the present application, and the thorn tips are tiny and in the shape of a folded hook;

图8e为仅显示本申请中具有柔软、纤细的直线形微刺的示意图;FIG. 8e is a schematic diagram showing only the soft, slender linear microthorns in the present application;

图9为本申请中在近心端设有仿生微刺依附结构的滤器的局部视图;9 is a partial view of a filter provided with a biomimetic microthorn attachment structure at the proximal end of the application;

图10a为本申请提供的具有仿生微刺依附结构的植入器械中仿生微刺依附结构在围绕体绕制前的示意图;10a is a schematic diagram of the biomimetic micro-thorn attachment structure in the implant device with the biomimetic micro-thorn attachment structure provided by the application before being wound around the body;

图10b为本申请提供的具有仿生微刺依附结构的植入器械中仿生微刺依附结构经围绕体绕制后的示意图;Fig. 10b is a schematic diagram of the biomimetic micro-thorn attachment structure in the implant device with the biomimetic micro-thorn attachment structure provided by the application after being wound around the body;

图11为本申请中局部骨架上设置的围绕体固定结构示意图;11 is a schematic diagram of the surrounding body fixing structure arranged on the partial skeleton in the application;

图12a为本申请中直绕式围绕体示意图;Figure 12a is a schematic diagram of a straight-wound surrounding body in the application;

图12b为本申请中斜绕式围绕体示意图;Figure 12b is a schematic diagram of an obliquely wound surrounding body in the application;

图12c为本申请中交叉绕式围绕体示意图;Figure 12c is a schematic diagram of a cross-wound surrounding body in the application;

图13为本申请中呈局部倒刺结构的围绕体示意图;13 is a schematic diagram of a surrounding body in a partial barb structure in the application;

图14为本申请中具有自中心结构的滤器的示意图;14 is a schematic diagram of a filter having a self-center structure in the application;

图15a为本申请中具有椭圆形结构的卷曲结构示意图;Figure 15a is a schematic diagram of a curled structure having an elliptical structure in the application;

图15b为本申请中具有圆形结构的卷曲结构示意图;Figure 15b is a schematic diagram of a curled structure with a circular structure in the application;

图15c为本申请中具有二维螺线结构的卷曲结构示意图;Fig. 15c is a schematic diagram of a curled structure having a two-dimensional spiral structure in the present application;

图16a~图16c为本申请中由各个骨架相互连接形成的三维波状和/或网状结构的三种形式;Figures 16a to 16c are three forms of three-dimensional wave-like and/or net-like structures formed by interconnecting skeletons in the present application;

图17为本申请中在自然无约束状态下呈“蘑菇形”的滤器的三维视图;Figure 17 is a three-dimensional view of the filter in the application in a "mushroom-shaped" state in its natural unconstrained state;

图18a至图18c为图1的局部视图Ⅰ的放大图,示出了仿生微刺依附结构近心端的保护结构的几种图示,其中图18a为半球体形保护结构,图18b为椭球体形保护结构,图18c为折线状保护结构;Figures 18a to 18c are enlarged views of the partial view I of Figure 1, showing several diagrams of the protective structure at the proximal end of the bionic microthorn attachment structure, wherein Figure 18a is a hemisphere-shaped protective structure, and Figure 18b is an ellipsoid-shaped protective structure Protection structure, Figure 18c is a broken line protection structure;

图19为本申请中设有保护结构的滤器在收入输送鞘管中的局部视图;Figure 19 is a partial view of the filter provided with the protective structure in the application in the delivery sheath;

图20为图1的局部视图Ⅰ的放大图,示出了通过添加额外配件等形式组合成的一种保护结构;Fig. 20 is an enlarged view of the partial view I of Fig. 1, showing a protective structure formed by adding additional accessories and the like;

图21为本申请中设有凸缘结构的一种滤器的三维视图;Figure 21 is a three-dimensional view of a filter provided with a flange structure in the application;

图22为本申请中凸缘结构外表面设有的仿生微刺依附结构与血管壁接触的示意图;22 is a schematic diagram of the bionic micro-thorn attachment structure provided on the outer surface of the flange structure in the application in contact with the blood vessel wall;

图23为本申请中在依附架表面设有柔性薄膜的滤器的示意图;23 is a schematic diagram of a filter provided with a flexible membrane on the surface of the attachment frame in the application;

图24a为本申请中缝线采用预埋式缠绕方式的示意图;Figure 24a is a schematic diagram of the pre-embedded winding method used for the suture in the application;

图24b为本申请中缝线采用隐藏式缠绕方式的示意图;Figure 24b is a schematic diagram of a hidden winding method used for the suture in the application;

图25为目前市场上常规植入器械的缝线采用暴露式缠绕方式后缝合的示意图;25 is a schematic diagram of the sutures of conventional implantation devices on the market being sutured after using an exposed winding method;

图26为本申请提供的具有仿生微刺依附结构的植入器械中经过覆膜后的局部骨架示意图;Figure 26 is a schematic diagram of a partial skeleton after being covered in the implant device with the biomimetic micro-thorn attachment structure provided by the application;

图27为本申请中带有裸支架的一种覆膜支架的三维视图;Figure 27 is a three-dimensional view of a stent-graft with a bare stent in the application;

图28为本申请中不带裸支架的一种覆膜支架的三维视图;Figure 28 is a three-dimensional view of a covered stent without bare stent in the application;

图29为本申请中一种球扩式支架的示意图;Figure 29 is a schematic diagram of a ball-expandable stent in the application;

图30为本申请中一种密网支架示意图;Figure 30 is a schematic diagram of a dense mesh support in the application;

图31为图30中局部视图Ⅱ的放大图,示出了密网支架中具有形变自适应性的网格;Fig. 31 is an enlarged view of partial view II in Fig. 30, showing a mesh with deformation adaptability in a dense mesh support;

图32为图30中局部视图Ⅱ的放大图,示出了在密网支架网格中建立的分支支架;Fig. 32 is an enlarged view of the partial view II of Fig. 30, showing the branched stent established in the dense mesh stent grid;

图33为图30中局部视图Ⅲ的放大图,示出了密网支架局部金属丝通过加工形成的扁平结构。Fig. 33 is an enlarged view of the partial view III in Fig. 30, showing a flat structure formed by processing the partial wire of the dense mesh stent.

零部件标号:1-植入器械,2-输送鞘管,11-依附架,12-仿生微刺依附结构,13-中心件,14-球囊,15-抓取机构,111-骨架,112-凸缘结构,121-刺根,122-微刺,123-限位机构,124-自中心结构,125-围绕体,126-薄膜,127-缝线,1221-刺身,1222-刺尖,1223-保护结构,1231-孔槽,1251-固定结构。Part number: 1- Implantation device, 2- Delivery sheath, 11- Attachment frame, 12- Bionic micro-thorn attachment structure, 13- Center piece, 14- Balloon, 15- Grab mechanism, 111- Skeleton, 112 -Flange structure, 121-Thorn root, 122-Micro-thorn, 123-Limiting mechanism, 124-Self-center structure, 125-Surrounding body, 126-Film, 127-Suture, 1221-Sashimi, 1222-Thorn tip, 1223-protection structure, 1231-hole groove, 1251-fixed structure.

具体实施方式detailed description

为了使本申请的目的、技术方案及优点更加清楚明白,以下结合附图及具体实施例,对本申请进行详细说明。应当理解,此处所描述的具体实施例仅仅用于解释本申请,并不用于限定本申请。In order to make the objectives, technical solutions and advantages of the present application more clear, the present application will be described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application.

为了更加清楚地描述本申请提供的具有仿生微刺依附结构的植入器械,此处限定术语“远心端”和“近心端”,上述术语为介入医疗器械领域的惯用术语。具体而言,“近心端”表示器械靠近心脏的一端,“远心端”表示器械远离心脏的一端。In order to more clearly describe the implanted device provided by the present application with the biomimetic microstab attachment structure, the terms "distal end" and "proximal end" are defined herein, which are common terms in the field of interventional medical devices. Specifically, "proximal end" refers to the end of the instrument near the heart, and "distal end" refers to the end of the instrument remote from the heart.

实施例一Example 1

如图1所示,本申请提供的具有仿生微刺依附结构的植入器械1,至少包括依附架11,依附架11包括多根弹性骨架111和多个仿生微刺依附结构12,在自然无约束状态下,多根骨架111围成立体结构,依附架11具有解剖学形态自适应性,仿生微刺依附结构12设置在骨架111的外表面上,仿生微刺依附结构12的形态为仿植物表面上的疏生微刺,仿生微刺依附结构12包括刺根121和微刺122,微刺122由刺身1221和刺尖1222组成,微刺122呈直线形或J形或两者组合,微刺122的刺身1221和/或刺尖1222能够触碰到腔体组织,实现依附式锚定功能。As shown in FIG. 1 , an implant device 1 with a biomimetic micro-thorn attachment structure provided by the present application at least includes an attachment frame 11, and the attachment frame 11 includes a plurality of elastic skeletons 111 and a plurality of biomimetic micro-thorn attachment structures 12. In a restrained state, a plurality of skeletons 111 enclose a three-dimensional structure, the attachment frame 11 has anatomical shape adaptability, the bionic micro-thorn attachment structure 12 is arranged on the outer surface of the skeleton 111, and the bionic micro-thorn attachment structure 12 is shaped like a plant The sparse microthorns on the surface, the bionic microthorn attachment structure 12 includes thorn roots 121 and microthorns 122, the microthorns 122 are composed of a thorn body 1221 and a thorn tip 1222, the microthorns 122 are linear or J-shaped or a combination of the two, The thorn body 1221 and/or the thorn tip 1222 of the thorn 122 can touch the cavity tissue to realize the attached anchoring function.

在一个实施方式中,本申请提供的具有仿生微刺依附结构的植入器械1为滤器,如图1所示,腔体组织为血管壁,依附架11为自膨式支架,骨架111具有弹性,依附架11还包括与依附架11固定 连接的中心件13,多根骨架111由中心件13朝外发散并围成立体结构,立体结构呈现为灯笼形、葫芦形、蘑菇形、伞形、碗形、锥形的一种或多种组合,腔体组织为血管壁。在一个优选的实施方式中,中心件13设置有抓取机构15,抓取机构15便于将滤器从目标位置抓取并取出到体外。In one embodiment, the implanted device 1 provided by the present application with the bionic microthorn attachment structure is a filter, as shown in FIG. 1 , the cavity tissue is a blood vessel wall, the attachment frame 11 is a self-expanding stent, and the frame 111 has elasticity , the attachment frame 11 also includes a central piece 13 fixedly connected with the attachment frame 11, a plurality of skeletons 111 diverge outward from the central piece 13 and enclose a three-dimensional structure, and the three-dimensional structure presents a lantern-shaped, gourd-shaped, mushroom-shaped, umbrella-shaped, One or more combinations of bowl shape and cone shape, and the cavity tissue is the blood vessel wall. In a preferred embodiment, the central piece 13 is provided with a grabbing mechanism 15, which facilitates grabbing the filter from the target position and taking it out of the body.

图2为仿生微刺依附结构12局部示意图,仿生微刺依附结构12中的微刺122为仿自然界中的部分植物的果实、叶或茎的外表面上疏生的微刺122,具有柔软、纤细的特点,这类植物包括但不限于苍耳、葎草、云实、杠板归、芡实、簕菜、悬钩子、大蓟、刺蓼、刺三加,使得仿生微刺依附结构12具有类绒毛特性,用于实现与血管壁的依附式锚定。在本申请中,单个微刺122在形态上呈直线形或J形,当呈J形时,微刺122的刺身1221即相当于“字母J”的竖直段,刺尖1222即相当于“字母J”的弯钩段,J形微刺122的刺尖1222可挂在血管壁上,使得J形微刺122具有良好的依附式锚定性,避免深度且直接刺入血管壁而造成的创伤;当微刺122呈直线形时,直线形微刺122可起增加粗糙度的作用,能够显著增加微刺122和血管壁之间的静摩擦力,增强对血管壁的依附力;优选的,当微刺122的刺尖1222极微小时,例如,刺尖1222的尖端点与刺身1221的距离≤0.5mm,使得J形的刺尖1222呈微米级的折形钩状(如图8d所示)或弧形钩状(如图8c所示),这不仅赋予微刺122兼具J形和直线形的优点,更能发挥出微刺122对血管的依附式锚定的功能。2 is a partial schematic diagram of the biomimetic microthorn attachment structure 12. The microthorns 122 in the biomimetic microthorn attachment structure 12 are sparse microthorns 122 on the outer surface of the fruit, leaf or stem of some plants imitating in nature, with soft, The characteristics of slenderness, such plants include but are not limited to cocklebur, humulus japonicus, yunshi, gangbangui, gorgonian, gourd, rubus, thistle, polygonum thorn, and Acanthopanax thorn, so that the bionic microthorn attachment structure 12 has Villi-like properties for adherent anchoring to the vessel wall. In the present application, a single microthorn 122 is linear or J-shaped in shape. When it is in a J shape, the thorn body 1221 of the microthorn 122 is equivalent to the vertical segment of the "letter J", and the thorn tip 1222 is equivalent to the "letter J". The hook segment 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 a good anchoring property, avoiding the trauma caused by deep and direct penetration into the blood vessel wall When the microthorns 122 are linear, the linear microthorns 122 can play a role in increasing the roughness, which can significantly increase the static friction between the microthorns 122 and the blood vessel wall, and enhance the adhesion to the blood vessel wall; preferably, when When the thorn tips 1222 of the micro thorns 122 are extremely small, for example, the distance between the tip point of the thorn tips 1222 and the thorn body 1221 is less than or equal to 0.5 mm, so that the J-shaped thorn tips 1222 are in the shape of a micron folded hook (as shown in FIG. 8d ) Or arc-shaped hook shape (as shown in FIG. 8c ), which not only gives the micro-stab 122 the advantages of both J-shape and straight-line shape, but also exerts the function of anchoring the blood vessel by the micro-spine 122 .

在一个实施方式中,定义:刺身1221的长度为L1,刺尖1222的曲线长度为L2,刺身1221朝外的延长线方向与刺尖1222远端朝外的延长线方向之间的夹角为β,刺身1221长度L1、刺尖1222曲线长度L2以及夹角β满足如下数学关系:0.2mm≤L1≤5mm,0≤L2≤3mm,0≤β≤150°,优选关系如下:0.5≤L1≤2mm,0≤L2≤1mm,90°≤β≤150°,使得微刺122具有仿植物表面上的疏生微刺的浅短的特点,直线形微刺122长度小于所述J形微刺122长度,如图3所示,通过调节参数L1、L2以及β,能够便于刺尖1222触碰到血管壁,增加依附式锚定的有效性,同时能够有效保证无损伤地接触血管壁,避免了传统滤器锚定装置刺入程度太深,从而导致损伤血管壁。In one embodiment, it is defined that the length of the sashimi 1221 is L1, the length of the curve of the thorn tip 1222 is L2, and the angle between the direction of the outward extension line of the sashimi 1221 and the direction of the outward extension line of the distal end of the thorn tip 1222 is β, the length L1 of the sashimi, the length L2 of the curve of the thorn, and the angle β satisfy the following mathematical relationships: 0.2mm≤L1≤5mm, 0≤L2≤3mm, 0≤β≤150°, and the optimal relationship is as follows: 0.5≤L1≤ 2mm, 0≤L2≤1mm, 90°≤β≤150°, so that the microthorns 122 have the characteristics of being shallow and short like the sparse microthorns on the surface of plants, and the length of the straight microthorns 122 is shorter than the J-shaped microthorns 122 Length, as shown in Fig. 3, by adjusting the parameters L1, L2 and β, it is convenient for the thorn tip 1222 to touch the blood vessel wall, which increases the effectiveness of the attached anchoring, and can effectively ensure that it contacts the blood vessel wall without damage, avoiding the need for Traditional filter anchoring devices penetrate too deeply, causing damage to the vessel wall.

在一个优选的实施方式中,仿生微刺依附结构12的总数量在3个至100个之间,为充分发挥出直线形和J形微刺122在前述及后续提及的各自优点,直线形的数量占比应在50%和99%之间;在另一个优选的实施方式中,在每根骨架111上设置的仿生微刺依附结构12的数量在1个至10个之间,这样设计使得仿生微刺依附结构12密布于依附架11的骨架111的外表面,增加了依附架11与血管壁的接触概率,保证了依附架11在植入时与血管壁接触的各个位置均能实现有效的依附式锚定,进一步增加了锚定强度,避免了因锚定强度不足而引起的滤器脱落风险。在一个优选的实施方式中,当微刺122形状为直线形时,微刺122的刺身1221即为刺尖1222,优选的,直线形的微刺122的刺身1221长度L1≤1mm,能够充分发挥出微刺122的依附式锚定性,避免深度且直接刺入血管壁而造成的创伤。In a preferred embodiment, the total number of the bionic microthorn attachment structures 12 is between 3 and 100. In order to give full play to the respective advantages of the linear and J-shaped microthorns 122 mentioned above and later, the linear The proportion of the number of thorns should be between 50% and 99%; in another preferred embodiment, the number of biomimetic microthorn attachment structures 12 arranged on each skeleton 111 is between 1 and 10, so designed The bionic micro-thorn attachment structure 12 is densely covered on the outer surface of the skeleton 111 of the attachment frame 11, which increases the contact probability between the attachment frame 11 and the blood vessel wall, and ensures that the attachment frame 11 can be in contact with the blood vessel wall at each position during implantation. Effective attachment anchoring further increases the anchoring strength and avoids the risk of filter shedding caused by insufficient anchoring strength. In a preferred embodiment, when the shape of the microthorns 122 is linear, the thorns 1221 of the microthorns 122 are the thorn tips 1222. Preferably, the length L1 of the thorns 1221 of the linear microthorns 122 is less than or equal to 1 mm, which can give full play to the The attached anchorage of the micro-thorn 122 avoids the trauma caused by deep and direct penetration into the vessel wall.

在一个实施方式中,仿生微刺依附结构12还包括限位机构123,刺根121与限位机构123相互配合,用于限定微刺122在骨架111上的相对位置,能起到有效防止微刺122因疲劳失效发生断裂的作用。如图4所示,在本实施例中,限位机构123为设置在骨架111上的孔槽,用于将仿生微刺依附结构12固定在骨架111上,仿生微刺依附结构12与孔槽在位置上形成对应,同时其刺根121至少部分区域位于孔槽内,刺根121与孔槽相互配合,用于限定微刺122在骨架111上的相对位置。如图5a和图5b所示,在一个实施方式中,每个仿生微刺依附结构12至少包含1个刺根121与2个微刺122,微刺122与孔槽在位置和数量上一一对应,刺根121至少部分区域与骨架111贴合,刺根121呈U形或回形结构,并贯穿于两个孔槽。本实施例中,仿生微刺依附结构12与依附架11的骨架111采用组合式结构,这种设计的优势在于:a)微刺122的长短粗细可调,而市场上大部分滤器的倒刺与依附架11为同一根管子一体激光雕刻成型,受限于原材料的设计限制,这种倒刺往往硬而粗,增加了倒刺断裂风险;b)制造商在生产制造过程中,一旦发现某个或某些微刺122的长度过长或过短、大小过粗或过细,便可临时性更换长度或粗细更佳的微刺122,实现针对患者临床需求的个性化定制“种刺”(播种微刺)功能,确保每个微刺122都能最大程度地发挥出依附式锚定功能,当然也可针对因微刺122存在不良品,进行性能无损性地返工,避免现有技术因倒刺的不良品使得整个器械全部报废最终导致制造商生产成本的增加。作为一个优选的实施方式,每个微刺122均共面,在此基础上,刺根121贯穿于两个相邻的孔槽,从而避免多个刺根121可能的重叠导致所用的输送鞘管2的鞘径增加,作为更优选的实施方式,每个仿生微刺依附结构12由具有弹性及形状记忆性的丝材依次穿过相邻的两个孔槽而成,选用的丝材的横截面积≤0.3mm 2,所述丝材的长径比在2和40范围内,使得微刺122具有纤细、柔软的特点,在这一前提下,术者在手术过程中一旦发现某个或某些直线形微刺122的长 度过长,存在刺穿血管壁的高风险,便可机动性地裁剪成长度更为适宜的微刺122,实现针对患者个性化临床需求的“调刺”(调节刺长)功能,因而确保依附式锚定的无损伤优点和特性,避免深度且直接刺入血管壁而造成的创伤;进一步地,丝材的材质包括但不仅限于钴铬合金、镍钛合金、316L不锈钢、纯钽、钛合金、黄金、铂铱合金,其横截面积在0.002mm 2和0.015mm 2之间,便能最大程度地发挥出前述提及的仿生微刺依附结构12的类绒毛特性,并有效实现与血管壁的依附式锚定功能。在此值得特别说明的是,正是由于微刺122纤细、浅短、柔软的特点,能有效实现与血管壁的依附式锚定功能,而非深度刺入组织锚定,使得术者便于在手术中或手术后的任何时刻视需要进行回收、取出,即便是当植入器械,如本实施例的滤器植入一定时间(例如6个月),已发挥出血栓过滤的既定功效后,植入器械的骨架与微刺在血管壁上被大量的新生内皮组织所覆盖或包裹,植入器械的微刺也能轻易地从血管壁上脱出,或者从大量的新生内皮组织中抽出,进而实现植入器械的回收和取出。 In one embodiment, the bionic micro-thorn attachment structure 12 further includes a limiting mechanism 123, and the thorn roots 121 cooperate with the limiting mechanism 123 to limit the relative position of the micro-thorns 122 on the skeleton 111, which can effectively prevent microthorns. The thorn 122 acts as a fracture due to fatigue failure. As shown in FIG. 4 , in this embodiment, the limiting mechanism 123 is a hole and groove provided on the skeleton 111 for fixing the bionic microthorn attachment structure 12 on the skeleton 111 . The bionic microthorn attachment structure 12 and the hole slot The positions correspond to each other, and at least part of the thorns 121 are located in the holes and grooves. The thorns 121 and the holes cooperate with each other to define the relative positions of the microthorns 122 on the skeleton 111 . As shown in FIG. 5a and FIG. 5b, in one embodiment, each bionic microthorn attachment structure 12 includes at least one thorn root 121 and two microthorns 122, and the microthorns 122 and the holes are one in position and number Correspondingly, at least a part of the thorn root 121 is attached to the frame 111 , and the thorn root 121 is in a U-shaped or return-shaped structure, and runs through the two holes and grooves. In this embodiment, the bionic microthorn 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 microthorns 122 are adjustable, while the barbs of most filters on the market are The same tube as the attachment frame 11 is formed by laser engraving in one piece. Due to the design limitations of raw materials, such barbs are often hard and thick, which increases the risk of barb breakage; b) During the manufacturing process, once the manufacturer finds If the length of one or some of the microthorns 122 is too long or too short, and the size is too thick or too thin, the microthorns 122 with better length or thickness can be temporarily replaced to realize the personalized customized "seed thorns" according to the clinical needs of patients ( Sowing micro-thorns) function to ensure that each micro-thorn 122 can maximize the attached anchoring function. Of course, it can also perform non-destructive rework for defective products due to the micro-thorn 122, so as to avoid the failure of the existing technology. Defective thorns make the entire device scrapped and eventually lead to increased production costs for the manufacturer. As a preferred embodiment, each micro-thorn 122 is coplanar, and on this basis, the thorn roots 121 run through two adjacent holes, so as to avoid the possible overlapping of multiple thorn roots 121, which may lead to the use of the delivery sheath. The sheath diameter of the The cross-sectional area is less than or equal to 0.3mm 2 , and the length-diameter ratio of the wire is in the range of 2 and 40, so that the microthorns 122 have the characteristics of slenderness and softness. The length of some linear micro-thorns 122 is too long, and there is a high risk of piercing the blood vessel wall, so it can be flexibly cut into micro-thorns 122 with a more suitable length, so as to realize the "adjustment of the needles" according to the individual clinical needs of patients ( Adjusting the thorn length) function, thus ensuring the non-invasive advantages and characteristics of the attachment anchoring, avoiding the trauma caused by deep and direct piercing into 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, its cross-sectional area is between 0.002mm 2 and 0.015mm 2 , which can maximize the above-mentioned bionic microthorn attachment structure 12. Villi characteristics, and effectively realize the attached anchoring function with the blood vessel wall. It is worth mentioning here that it is precisely because of the slender, short, and soft characteristics of the micro-thorn 122 that it can effectively achieve the function of anchoring with the blood vessel wall, rather than deeply penetrating the tissue for anchoring, which makes it easier for the operator to At any time during or after the operation, it can be recovered and taken out as needed, even when the implanted device, such as the filter in this embodiment, has been implanted for a certain period of time (for example, 6 months), and has exerted its intended effect of thrombus filtering. The skeleton and microspurs of the implanted device are covered or wrapped by a large amount of neo-endothelial tissue on the blood vessel wall, and the micro-spurs of the implanted device can also be easily prolapsed from the blood vessel wall, or extracted from a large number of neo-endothelial tissues, thereby realizing Recovery and removal of implanted devices.

如图6所示,在一个实施方式中,在任意一个骨架111长径方向的截面上,分别定义骨架111的厚度为P1,孔槽的自身长度为P2,任意两个相邻的孔槽的间距为P3,依附架11的中轴线为m,刺身1221朝外的延长线方向与骨架111远离中轴线m的方向之间的夹角为ω,则参数P1、P2以及ω分别满足如下数学关系:0.05mm≤P1≤0.5mm,0.05mm≤P2≤4mm,0.5mm≤P3≤10mm,30°≤ω<180°,调节P1、及P2的具体参数能够实现夹角ω和微刺122总数量的调整,确保与血管壁接触的每个刺尖1222都能够朝向血管壁,增强依附式锚定的有效性,同时通过调节参数P3能够对微刺122的总数量进行调整。在一个优选的实施方式中,上述数学关系如下:0.1mm≤P1≤0.3mm,0.1mm≤P2≤2mm,0.5mm≤P3≤2mm,60°≤ω≤150°。As shown in FIG. 6 , in one embodiment, on the cross section of any skeleton 111 in the longitudinal direction, the thickness of the skeleton 111 is respectively defined as P1, the length of the hole slot itself is P2, and the length of any two adjacent holes and slots is defined as P2. The distance is P3, the central axis of the attachment frame 11 is m, the angle between the direction of the outward extension of the sashimi 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 realize the included angle ω and the total number of microthorns 122 The adjustment of , ensures that each thorn tip 1222 in contact with the vessel wall can face the vessel wall, enhancing the effectiveness of the attached anchoring, and at the same time, the total number of microthorns 122 can be adjusted by adjusting the parameter P3. In a preferred embodiment, the above mathematical relationship is as follows: 0.1mm≤P1≤0.3mm, 0.1mm≤P2≤2mm, 0.5mm≤P3≤2mm, 60°≤ω≤150°.

本申请中仿生微刺依附结构12兼具柔性和弹性,具有类绒毛特性,用于实现与血管壁的依附式锚定,当微刺122接触血管壁组织时,能够发生适应性弯曲形变,利于微刺122无损地依附在血管壁上,增强其依附式锚定功能。进一步地,微刺122在受到外力作用下,能够以刺根121为中心,实现在每根骨架111外表面方向上自由转动和变形,如图7a所示,当植入血管内时,因血管身弯曲或者器械释放位置的不同,部分微刺122的朝向以及夹角ω能够发生适应性改变,增强了微刺122的依附式锚定性,而不会刚硬且笔直地深度刺入血管内壁组织,对血管壁无损伤,同时当J形微刺适应性地接触血管组织时,能和直线形微刺相互配合,形成“自锁”结构,增加了约束,加强了对血管壁附的牢固性,如图7b所示,因此整个仿生微刺依附结构122具有自适应性,增强对血管壁的依附式锚定功能,在此值得特别说明的是,为了实现此功能目的,设置的直线形微刺122的刺身1221长度应小于所述J形微刺122的刺身1221长度,以便于二者的刺尖1222均能接触到血管壁,此外,为了最大程度地发挥因“自锁”结构带来的依附牢固性增强功能,应采用多组直线形微刺122和J形微刺122间隔性重复设计,如图7b所示,因此整个仿生微刺依附结构12具有自适应性,增强对血管壁依附式锚定功能。图8a至图8e分别为常规滤器的单个倒刺结构与本申请中的单个微刺122结构对比图,常规滤器的倒刺通常为形态与骨架111完全固定的直倒刺或大钩刺,且整体刚硬、笔直、粗长,完全不能自适应地发生变形,在血管内只能以固定的角度过深地扎入血管壁,容易引发损伤血管壁的风险,而本申请的微刺122的刺身1221和刺尖1222具有纤细、浅短且柔软等形态和性能特点,且刺尖12221微小并呈微米级的钩状,因此无论从形态结构还是功能上,都具有传统倒刺结构所无法比拟的优势。In the present application, the biomimetic microthorn attachment structure 12 has both flexibility and elasticity, and has villi-like characteristics, and is used to realize the attachment anchoring with the blood vessel wall. The microspine 122 adheres to the vessel wall non-destructively, enhancing its adherent anchoring function. Further, under the action of external force, 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, as shown in FIG. Depending on the bending of the body or the release position of the device, the orientation and angle ω of some of the microspurs 122 can be adaptively changed, which enhances the attachment and anchoring of the microspurs 122 without penetrating the inner wall of the blood vessel rigidly and straightly. , no damage to the blood vessel wall, and at the same time, when the J-shaped micro-thorns adaptively contact the vascular tissue, it can cooperate with the linear micro-thorns to form a "self-locking" structure, which increases the restraint and strengthens the firmness of the vessel wall. , as shown in FIG. 7b , therefore the entire bionic micro-thorn attachment structure 122 has self-adaptation and enhances the attached anchoring function to the blood vessel wall. The length of the sashimi 1221 of the thorns 122 should be smaller than the length of the sashimi 1221 of the J-shaped micro-thorns 122, so that the thorn tips 1222 of both can contact the blood vessel wall. The attachment firmness enhancement function of the bionic microthorn should be designed with multiple groups of linear microthorns 122 and J-shaped microthorns 122 at intervals, as shown in Figure 7b. Therefore, the entire bionic microthorn attachment structure 12 is self-adaptive and enhances the adhesion to the blood vessel wall. Dependent anchoring feature. 8a to 8e are respectively a comparison diagram of a single barb structure of a conventional filter and a structure of a single micro-thorn 122 in the present application, the barb of a conventional filter is usually a straight barb or a large barb whose shape is completely fixed with the skeleton 111, and The whole is rigid, straight, thick and long, and cannot be deformed adaptively at all. In the blood vessel, it can only be inserted into the blood vessel wall too deeply at a fixed angle, which is easy to cause the risk of damage to the blood vessel wall. The sashimi 1221 and the thorn tip 1222 are slender, short, and soft in shape and performance, and the thorn tip 12221 is tiny and has a micron-level hook shape, so both in terms of morphological structure and function, it has the traditional barb structure. The advantages.

如图9所示,在一个实施方式中,在依附架11的近心端设有仿生微刺依附结构12,这些仿生微刺依附结构12的刺身1221和/或刺尖1222朝向近心端一侧,能有效防止器械内已抓捕的血栓在回收过程中反向脱出,起到血栓防脱的作用。As shown in FIG. 9 , in one embodiment, a bionic micro-thorn attachment structure 12 is provided at the proximal end of the attachment frame 11 , and the thorn bodies 1221 and/or the thorn tips 1222 of these bionic micro-thorn attachment structures 12 face the proximal end. It can effectively prevent the captured thrombus in the device from being reversely dislodged during the recovery process, and play the role of preventing the thrombus from dislodging.

本申请的依附架11由具有弹性和形状记忆性的医用金属管材经一体式激光切割并通过热处理定型而成,或者由具有弹性和形状记忆性的医用金属或高分子丝材经一体式编织并通过热处理定型而成,或者由具有弹性和形状记忆性的医用高分子材料经一体式热加工成型直接制成,此处提及的医用金属包括但不仅限于钴铬合金、镍钛合金。The attachment frame 11 of the present application is made of a medical metal tube with elasticity and shape memory that is integrally laser-cut and shaped by heat treatment, or is made of a medical metal or polymer wire with elasticity and shape memory that is integrally woven and formed. It is formed by heat treatment, or directly made from a medical polymer material with elasticity and shape memory through integral thermal processing. The medical metals mentioned here include but are not limited to cobalt-chromium alloy and nickel-titanium alloy.

实施例二Embodiment 2

参考图10a和图10b,以第一个实施例为基础,在实施例二中,依附架11包括围绕体125,围绕体125缠绕在骨架111上,并至少包裹与骨架111贴合的刺根121,用于增强骨架111与仿生微刺依附结构12的连接强度。围绕体125这一设计还具有如下优点:a)围绕体125避免部分或全部骨架111与血管壁直接接触,降低了金属离子的析出量,提高生物相容性;b)降低摩擦系数,减少依附架11在输送鞘管2中的收释放阻力;c)增加平滑性,体验手感更加;d)增强依附架11的抗疲劳耐久性,对依附架11起到“二次保护”的作用,避免了依附架11在血管内因长期腐蚀或疲劳失效引发的断裂风险; e)增加力的传递性,确保滤器出鞘时各骨架111受力均匀、无明显卡顿感;f)增强刺根121与骨架111的贴合度及位置限定性,如图10a和图10b所示,通过调整围绕体125的缠绕包裹力度,有利于确保刺根121最大程度地贴合于骨架111,使所需输送鞘管2的鞘径最小化,扩大适宜人群范围,尤其适合具有血管入路细小特点的人群;g)能够对微刺122角度进行微调节,确保微刺122对血管壁的损伤将至最低;h)在依附架11上设置薄膜的实施例六中,围绕体125可预埋或隐藏薄膜与依附架11缝合连接的缝线127,避免了滤器重复收释放过程中缝线127直接与输送系统鞘管内表面接触而造成磨损断裂;i)通过改变围绕体125的单层厚度和缠绕圈数,来调整围绕体125在径向方向上的整体厚度,进而实现外露于骨架111微刺122的长度可调性,例如,当术者根据临床需要,发现某些患者的血管壁非常薄,需要最大程度的降低外露于骨架111的微刺122的长度,此时术者便可机动性且即时性地增加围绕体125的缠绕圈数来达到既定目的,在一定程度上实现临床需求的个性化定制。10a and 10b, based on the first embodiment, in the second embodiment, the attachment frame 11 includes a surrounding body 125, the surrounding body 125 is wrapped around the frame 111, and at least wraps the thorns that fit with the frame 111 121, for enhancing the connection strength between the skeleton 111 and the bionic microthorn attachment structure 12. The design of the surrounding body 125 also has the following advantages: a) the surrounding body 125 avoids direct contact of part or all of the skeleton 111 with the blood vessel wall, which reduces the amount of metal ion precipitation and improves biocompatibility; b) reduces the friction coefficient and reduces attachment The retraction and release resistance of the rack 11 in the delivery sheath 2; c) increase the smoothness, and experience a better hand feeling; d) enhance the anti-fatigue durability of the attachment rack 11, and play the role of "secondary protection" for the attachment rack 11 to avoid To avoid the risk of fracture of the attachment frame 11 caused by long-term corrosion or fatigue failure in the blood vessel; e) increase the force transmission, to ensure that each frame 111 is uniformly stressed when the filter is unsheathed, and there is no obvious stuck feeling; f) strengthen the thorn root 121 and The fit and position of the skeleton 111 are limited, as shown in Figures 10a and 10b, by adjusting the wrapping strength of the surrounding body 125, it is beneficial to ensure that the thorns 121 fit the skeleton 111 to the greatest extent, so that the required delivery sheath The sheath diameter of the tube 2 is minimized, and the range of suitable people is expanded, especially for people with small vascular access; g) The angle of the micro-stab 122 can be finely adjusted to ensure that the damage to the blood vessel wall by the micro-stab 122 will be minimized; h ) In the sixth embodiment in which the film is arranged on the attachment frame 11, the surrounding body 125 can pre-embed or hide the suture 127 that is sutured and connected between the film and the attachment frame 11, so as to prevent the suture 127 from being directly connected to the delivery system sheath during the repeated retraction and release of the filter. The inner surface of the tube contacts and causes wear and tear; i) by changing the thickness of the single layer and the number of winding turns of the surrounding body 125, the overall thickness of the surrounding body 125 in the radial direction is adjusted, and then the length of the micro-thorns 122 exposed on the skeleton 111 can be adjusted. Tonality, for example, when the surgeon finds that the blood vessel wall of some patients is very thin according to clinical needs, the length of the microspurs 122 exposed on the skeleton 111 needs to be reduced to the greatest extent. The number of winding turns around the body 125 is increased to achieve the intended purpose, and to a certain extent, the personalized customization of clinical needs can be achieved.

在一个实施方式中,在每根骨架111上设置有一个或多个固定结构1251,围绕体125的近端和/或远端与骨架111通过固定结构1251实现有效连接或位置限定,如图11所示。在一个优选的实施方式中,在每根骨架111的近心端和远心端分别设置有固定结构1251,该固定结构1251为贯穿骨架111的通孔,围绕体125穿过近心端上的通孔实现连接后,紧密缠绕并包裹通孔之间的骨架111和所有刺根121,最终穿过远心端上的通孔并实现连接。通过打结等形式将围绕体125连接在固定结构1251上,能够进一步约束围绕体125在骨架111上的位置,加强围绕体125在骨架111上的强度,避免松脱。在另一个优选的实施方式中,围绕体125由单根具有柔性的圆线或扁线缠绕并包裹大部分或所有的骨架111、所有刺根121,并穿过所有通孔,最终形成闭环,这种由单根围绕体125进行绕制的优势在于,最大程度减少围绕体125与固定结构1251的打结次数,减少了打结头的个数,避免了因打结头过多而增加了整个依附架11的收释放阻力,同时也简化了制作工艺,提升了产品的生产效率,同时通过与通孔的相互配合,增强连接的有效性和牢固性,确保下述围绕体125在骨架111上保持既定的缠绕形态,避免在出入输送鞘管2的过程中,围绕体125沿着骨架111发生相对于骨架111的滑动,导致减弱或无法发挥上述提及的围绕体125的功效。In one embodiment, each skeleton 111 is provided with one or more fixing structures 1251, and the proximal and/or distal ends of the surrounding body 125 and the skeleton 111 are effectively connected or defined by the fixing structures 1251, as shown in FIG. 11 . shown. In a preferred embodiment, the proximal end and the distal end of each skeleton 111 are respectively provided with fixing structures 1251, the fixing structures 1251 are through holes passing through the skeleton 111, and the surrounding body 125 passes through the holes on the proximal end. After the through-holes are connected, the skeleton 111 and all the thorns 121 between the through-holes are tightly wrapped and wrapped, and finally pass through the through-holes on the distal end to realize the connection. Connecting the surrounding body 125 to the fixed structure 1251 by knotting or the like can further constrain the position of the surrounding body 125 on the skeleton 111, strengthen the strength of the surrounding body 125 on the skeleton 111, and avoid loosening. In another preferred embodiment, the surrounding body 125 is wound by a single flexible round wire or flat wire and wraps most or all of the skeleton 111, all the thorns 121, and passes through all the through holes, and finally forms a closed loop, The advantage of this method of winding by a single surrounding body 125 is that the number of knots between the surrounding body 125 and the fixing structure 1251 is minimized, the number of knotted heads is reduced, and the increase in the number of knotted heads is avoided. The retraction and release resistance of the entire attachment frame 11 also simplifies the manufacturing process and improves the production efficiency of the product. At the same time, through the mutual cooperation with the through holes, the effectiveness and firmness of the connection are enhanced to ensure that the following surrounding body 125 is in the frame 111. In order to prevent 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, the surrounding body 125 can be prevented from being reduced or unable to exert the function of the surrounding body 125 mentioned above.

图12a~图12c为围绕体125在局部骨架111上不同的绕制方式示意图,围绕体125的绕制方式包括直绕式、斜绕式、交叉绕式的一种或多种组合,其中直绕式操作简单、效率高;斜绕式的骨架111收释放鞘的顺畅性更佳;交叉绕式的绕制则牢固性更强,生产厂商可根据不同的需求选择最佳的缠绕方式。围绕体125的绕制层数在1层和5层之间,层数过多,虽会增加绕制牢固强度,但整体体积增加,增加了依附架11在输送鞘管2中的收释放阻力,术者体验感降低。12a to 12c are schematic diagrams of different winding methods of the surrounding body 125 on the partial skeleton 111. The winding methods of the surrounding body 125 include one or more combinations of straight winding, oblique winding, and cross winding. The winding type has simple operation and high efficiency; the oblique winding type skeleton 111 has better smoothness in retracting and releasing the sheath; the cross winding type winding is more firm, and the manufacturer can choose the best winding method according to different needs. The number of winding layers of the surrounding body 125 is between 1 layer and 5 layers. If the number of layers is too large, although the winding firmness will increase, the overall volume will increase, which increases the retraction and release resistance of the attachment frame 11 in the delivery sheath 2 , the experience of the operator is reduced.

在一个优选的实施方式中,围绕体125为具有柔性的医用线材/丝材/带材,其横截面形状包括圆形、椭圆形、矩形的一种和多种的组合。在另一个优选的实施方式中,围绕体125是由缝线127缠绕而成,缝线127的材质包括聚对苯二甲酸乙二醇酯(PET)、聚四氟乙烯(PTFE)、超高分子量聚乙烯(UHMWPE)、聚丙烯(PP)、聚酰胺(PA)、聚对二氧环乙酮(PDO)、聚乙醇酸(PGA)、聚乳酸(PLA)、聚乙丙交酯(PGLA)、聚己内酯(PCL)、蚕丝、羊肠、动物肌腱组织,或具有显影效果的医用金属和/或医用高分子材料。In a preferred embodiment, the surrounding body 125 is a flexible medical wire/wire/strip, and its cross-sectional shape includes one or a combination of a circle, an ellipse, and a rectangle. 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), polydioxetone (PDO), polyglycolic acid (PGA), polylactic acid (PLA), polyglycolide (PGLA) ), polycaprolactone (PCL), silk, sheep intestine, animal tendon tissue, or medical metal and/or medical polymer materials with developing effect.

如图13所示,在一个实施方式中,围绕体125自身的外表面上可设置有一个或多个局部凸起,局部凸起自身形成倒刺结构,该倒刺结构朝向血管壁,能够起到进一步增强锚定的效果。As shown in FIG. 13 , in one embodiment, one or more partial protrusions may be provided on the outer surface of the surrounding body 125 itself, and the partial protrusions themselves form a barb structure, and the barb structure faces the blood vessel wall and can lift the to further enhance the anchoring effect.

在另一个实施方式中,围绕体125为能够与骨架111和/或微刺122相互脱离的结构,当植入器械1植入到血管内一定时间,骨架111连同围绕体125被大量新生内皮组织所覆盖,使得植入器械与血管壁牢牢固定住而不便于二者直接脱离,此时围绕体125便可与骨架111和微刺122相互脱离,使得骨架和微刺从围绕体125中抽出,最终植入器械1得以回收、取出体外,因而实现植入器械1的可取出功能。进一步地,围绕体125由可降解的材料制成,且该材料降解的周期小于植入时间,使得植入器械1植入到血管内既定时间后,围绕体125已降解,这种情况下,骨架111和微刺122可轻易与血管壁相互脱离,进而实现植入器械1的可取出功能,符合这种性能的材料包括但不仅限于聚对二氧环乙酮(PDO)、聚乙醇酸(PGA)、聚乳酸(PLA)、聚乙丙交酯(PGLA)、聚己内酯(PCL)、壳聚糖等。In another embodiment, the surrounding body 125 is a structure that can be separated from the skeleton 111 and/or the microspurs 122. When the implant device 1 is implanted into the blood vessel for a certain period of time, the skeleton 111 and the surrounding body 125 are surrounded by a large amount of new endothelial tissue. covered, so that the implantation device and the blood vessel wall are firmly fixed and not convenient for the two to be directly detached. 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 can be pulled out from the surrounding body 125. Finally, the implanted device 1 can be recovered and taken out of the body, thus realizing the removable function of the implanted device 1 . Further, 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 implantation 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 microthorns 122 can be easily detached from the blood vessel wall, thereby realizing the removable function of the implanted device 1. Materials that meet this performance include but are not limited to polydioxanone (PDO), polyglycolic acid ( PGA), polylactic acid (PLA), polyglycolide (PGLA), polycaprolactone (PCL), chitosan, etc.

实施例三Embodiment 3

参考图14,相比实施例一和实施例二,实施例三与实施例一和实施例二不同之处在于,依附架11设有自中心结构124,在一个实施方式中,自中心结构124位于由骨架111的近心端和/或远心端,且是由骨架111中心向外发散形成的卷曲状结构,卷曲状结构为椭圆形、圆形或二维螺旋线结构的一种或多种,如图15a~图15c所示,且每个卷曲状结构所在的平面均与中轴线m共面,卷曲结构外表 面设有仿生微刺依附结构12,仿生微刺依附结构12的刺身1221和/或刺尖1222指向仅近心端一侧,卷曲状结构具有弹性和形状记忆性;在一个优选的实施方式中,卷曲状结构的卷曲方向为向内卷曲,卷曲状结构末端延长线方向与中轴线m朝向远端的方向之间的夹角σ满足:0°≤σ≤90°,卷曲状结构的圈数n满足:0.25≤n≤1.5。在另一个优选的实施方式中,自中心结构124为由各个骨架111相互连接形成三维波状和/或网状结构,如图16a~图16c所示。自中心结构124的优点在于:a)具有弹性和形状记忆性的卷曲结构直接接触血管壁的四周,对血管壁提供足够且稳定的径向支撑力,因此滤器在使用过程中,能使得整个依附架11保持优异的自中心性,避免了滤器因长期受血流冲击而发生移位偏移现象;b)卷曲结构表面设有仿生微刺依附结构12,进一步增强了卷曲结构与血管壁之间的支撑力,增强了依附架11的稳定性;c)卷曲结构采用曲线设计,使得卷曲结构与血管壁之间的接触方式为点接触,减少血管内膜爬覆,延长滤器的使用周期,便于滤器植入后的取出。Referring to FIG. 14 , compared with Embodiment 1 and Embodiment 2, Embodiment 3 is different from Embodiment 1 and Embodiment 2 in that the attachment frame 11 is provided with a self-centering structure 124 . In one embodiment, the self-centering structure 124 It is located at the proximal end and/or the distal end of the skeleton 111, and is a coil-like structure formed by the outward divergence of the center of the skeleton 111. 15a to 15c, and the plane where each curled structure is located is coplanar with the central axis m, the outer surface of the curled structure is provided with a bionic microthorn attachment structure 12, and the sashimi 1221 of the bionic microthorn attachment structure 12 And/or the thorn tip 1222 points to only the proximal side, the curled structure has elasticity and shape memory; in a preferred embodiment, the curling direction of the curled structure is inward curling, and the direction of the extension line of the end of the curled structure The included angle σ with the direction of the central axis m toward the distal end satisfies: 0°≤σ≤90°, and the number of turns n of the curled structure satisfies: 0.25≤n≤1.5. In another preferred embodiment, the self-center structure 124 is a three-dimensional wave-like and/or network-like structure formed by interconnecting the skeletons 111 , as shown in FIGS. 16 a to 16 c . The advantages of the self-center structure 124 are: a) The curled structure with elasticity and shape memory directly contacts the periphery of the blood vessel wall, providing sufficient and stable radial support force to the blood vessel wall, so the filter can make the entire attachment during use. The frame 11 maintains excellent self-centering, which prevents the filter from being displaced and offset due to long-term impact of blood flow; b) The surface of the curled structure is provided with a bionic micro-thorn attachment structure 12, which further enhances the gap between the curled structure and the blood vessel wall. The supporting force of 11 enhances the stability of the attachment frame 11; c) the curled structure adopts a curve design, so that the contact between the curled structure and the blood vessel wall is point contact, which reduces the vascular intima crawling, prolongs the service life of the filter, and facilitates Removal after filter implantation.

在一个优选的实施方式中,卷曲状结构是由骨架111的末端进一步朝末端方向延伸所形成的,使得滤器在自然无约束状态下呈“蘑菇形”,如图17所示,这种“蘑菇形”具有柔韧性和回弹性,既具有足够的径向支撑,同时在血液冲刷下使得整个依附架11能够在轴向上自动调整位置,具有减震缓冲效果,保证了滤器能够牢固地依附在血管壁上。In a preferred embodiment, the crimp-like structure is formed by the end of the skeleton 111 extending further toward the end, so that the filter has a "mushroom shape" in a natural unconstrained state, as shown in Figure 17, this "mushroom" It has flexibility and resilience, not only has sufficient radial support, but also enables the entire attachment frame 11 to automatically adjust its position in the axial direction under the blood flushing, which has the effect of shock absorption and buffering, ensuring that the filter can be firmly attached to the on the walls of blood vessels.

实施例四Embodiment 4

相比实施例一,实施例四与实施例一不同之处在于,在一个实施方式中,在骨架111外表面上的仿生微刺依附结构12的近心端设有保护结构1223,该保护结构1223为半球体状、椭球体状、曲线状、折线状或多个形状的组合,图18a~图18c为几种保护结构1223的图示,定义在自然无约束状态下,微刺122与骨架111之间的垂直高度为L3,微刺保护结构1223与骨架111的最远距离为L4,则L3与L4满足如下关系:L3<L4,与此同时,保护结构1223与骨架111的连接点或连接区与设置有仿生微刺依附结构12的骨架为朝近心端方向收敛的倾斜式设计,使得微刺122的刺尖1222或微刺122的最尖端位于保护结构1223外,因而微刺122能够触碰到血管壁,当滤器收入输送鞘管2中时,保护结构1223直接与输送鞘管2内壁接触,因此避免了微刺122直接接触输送鞘管2内壁引起的刮鞘或出入鞘不畅,如图19所示,当滤器放置到目标血管后,保护结构1223在一定程度上减少骨架111与血管壁的接触面积,有助于实现滤器植入后的可取出功能。保护结构1223可由依附架11一体式加工,也可通过添加焊接材料进行焊接、添加胶水进行粘接、添加额外配件等的结合、摩擦适配、交织、啮合、互锁或者上述方式的组合接合在一起,如图20所示。Compared with Example 1, Example 4 is different from Example 1 in that, in one embodiment, a protection structure 1223 is provided at the proximal end of the bionic microthorn attachment structure 12 on the outer surface of the skeleton 111 . The protection structure 1223 is a hemisphere shape, ellipsoid shape, curve shape, polyline shape or a combination of multiple shapes. Figures 18a to 18c are illustrations of several protective structures 1223, defined in a natural unconstrained state, the microthorns 122 and the skeleton The vertical height between 111 is L3, and the farthest distance between the micro-thorn protection 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 of the protection structure 1223 and the skeleton 111 or The connection area and the skeleton provided with the bionic micro-thorn attachment structure 12 are inclined designs that converge toward the proximal end, so that the thorn tips 1222 of the micro-thorns 122 or the most pointed ends of the micro-thorns 122 are located outside the protection structure 1223, so the micro-thorns 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, thus avoiding the scraping or in-out of the sheath caused by the micro-thorns 122 directly contacting the inner wall of the delivery sheath 2. As shown in FIG. 19 , after the filter is placed in the target blood vessel, the protective structure 1223 reduces the contact area between the skeleton 111 and the blood vessel wall to a certain extent, which is helpful for realizing the removable function of the filter after implantation. The protective structure 1223 can be integrally processed by the attachment frame 11, or can be joined by adding welding material for welding, adding glue for bonding, adding additional accessories, etc., friction fitting, interlacing, meshing, interlocking, or a combination of the above. together, as shown in Figure 20.

实施例五Embodiment 5

如图21和图22所示,相比实施例一,实施例四与实施例一不同之处在于,在一个实施方式中,骨架111的最外围区域设有凸缘结构112,凸缘结构112外表面设有仿生微刺依附结构12,这种设计的优势在于,最大程度地降低滤器外表面与血管壁的接触面积,减少血管内膜增生或粘结导致滤器容易被血管内膜包覆的情况发生,避免了回收时滤器对血管壁造成的撕裂损伤;此外,凸缘结构112外表面密布的仿生微刺依附结构12使得滤器与血管壁之间的接触方式为点接触,在一定程度上延长了回收周期。As shown in FIGS. 21 and 22 , compared with the first embodiment, the fourth embodiment is different from the first embodiment in that, in one embodiment, the outermost peripheral area of the skeleton 111 is provided with a flange structure 112 , and the flange structure 112 The outer surface is provided with a bionic micro-thorn attachment structure 12. The advantage of this design is that it minimizes the contact area between the outer surface of the filter and the blood vessel wall, and reduces the proliferation or adhesion of the intima of the blood vessel, which causes the filter to be easily covered by the intima of the blood vessel. In addition, the bionic micro-thorn attachment structure 12 densely covered on the outer surface of the flange structure 112 makes the contact between the filter and the blood vessel wall a point contact, to a certain extent The payback period has been extended.

实施例六Embodiment 6

参考图23,相比实施例一~实施例五,实施例六与前述实施例不同之处在于,依附架11表面设置有柔性的薄膜126,薄膜126依附并连接在骨架111上,薄膜126柔软并具有微孔,微孔可过滤血液,但能阻挡血栓,能够起到有效抓捕血管内血栓的作用。在一个实施方式中,可使用缝线127使薄膜126与依附架11远心端面缝合连接在一起(简称缝膜),缝线127通过缠绕、捆绑及打结等方式,使薄膜126固定于依附架11的骨架111上,其中骨架111上可设计多个预留孔位以便于穿线缝合。图24a和图24b为缝线127在骨架111上的两种缠绕形式,图24a为预埋式,即通过将缝线127穿过骨架111远端面的围绕体125,使部分缝线127埋藏在围绕体125内部,达到预埋的效果,或者将缝线127事先缠绕在骨架111上,再绕制围绕体125,使得缝线127埋藏在围绕体125和骨架111近端面之间;图24b为隐藏式,缝线127缠绕在围绕体125之间的凹槽内部,使缝线127不外凸。这两种缠绕形式的优点在于,缝线127预埋或者隐藏在围绕体125内,使得依附架11在收释放鞘时,缝线127不会直接接触输送鞘管22内壁,避免了多次收释放操作使缝线127磨损断裂,图25为目前市场上常规滤器缝线127的缠绕方式,此时在依附架11近端面的缝线127直接暴露在外表面,该区域的缝线127势必会接触输送鞘管2的内壁,当滤器重复收释放时,会引发缝线127磨损断裂的风险,导致薄膜126与依附架11固定不牢固,甚至引发薄膜126脱落,最终影响薄膜126的封堵功能。适用 于制作薄膜126的具有柔性的材料包括聚四氟乙烯、膨体聚四氟乙烯、聚酯、硅酮、聚氨酯弹性体、聚酰胺、硅胶、聚烯烃、可降解材料如聚乳酸、聚乙烯醇、以及动物组织等,缝线127可由聚丙烯、聚酰胺、聚酯、超高分子量聚乙烯、聚四氟乙烯等不可吸材料制成,也可为羊肠组织、聚乳酸、聚乙醇酸类等可吸收材料制成。Referring to FIG. 23 , compared with Embodiments 1 to 5, Embodiment 6 is different from the previous embodiments in that the surface of the attachment frame 11 is provided with a flexible film 126 , the film 126 is attached and connected to the skeleton 111 , and the film 126 is soft And it has micropores, which can filter blood, but can block thrombus, and can effectively capture thrombus in blood vessels. In one embodiment, the film 126 and the distal end face of the attachment frame 11 can be sutured and connected together with the suture 127 (referred to as the suture film). On the frame 111 of the frame 11, a plurality of reserved holes can be designed on the frame 111 to facilitate threading and sewing. Figures 24a and 24b show two winding forms of the suture 127 on the frame 111. Figure 24a is a pre-buried type, that is, by passing the suture 127 through the surrounding body 125 on the distal surface of the frame 111, part of the suture 127 is buried Inside the surrounding body 125, the effect of pre-embedding is achieved, or the suture 127 is wound on the skeleton 111 in advance, and then the surrounding body 125 is wound, so that the suture 127 is buried between the surrounding body 125 and the proximal end surface of the skeleton 111; Fig. 24b is a concealed type, and the suture 127 is wound inside the groove between the surrounding bodies 125, so that the suture 127 does not protrude. The advantage of these two wrapping forms is that the suture 127 is pre-buried or hidden in the surrounding body 125, so that when the attachment frame 11 retracts the sheath, the suture 127 does not directly contact the inner wall of the delivery sheath 22, thus avoiding multiple retractions. The release operation causes the sutures 127 to be worn and broken. Figure 25 shows the winding method of the conventional filter sutures 127 on the market. At this time, the sutures 127 on the proximal surface of the attachment frame 11 are directly exposed on the outer surface, and the sutures 127 in this area are bound to be Contacting the inner wall of the delivery sheath 2, when the filter is repeatedly retracted and released, it will cause the risk of wear and tear of the suture 127, resulting in the film 126 and the attachment frame 11 being not firmly fixed, and even causing the film 126 to fall off, which ultimately affects the blocking function of the film 126. . Suitable flexible materials for the film 126 include polytetrafluoroethylene, expanded polytetrafluoroethylene, polyester, silicone, polyurethane elastomers, polyamides, silicones, polyolefins, degradable materials such as polylactic acid, polyethylene Alcohol, animal tissue, etc. The suture 127 can be made of polypropylene, polyamide, polyester, ultra-high molecular weight polyethylene, polytetrafluoroethylene and other non-absorbable materials, and can also be sheep intestine tissue, polylactic acid, polyglycolic acid Class and other absorbable materials.

在另一个实施方式中,可将依附架11远近两个端面通过加热、胶水粘接、偶联剂连接等方式形成一体进行覆膜,所用材料可为具有孔隙结构的聚四氟乙烯(PTFE)、聚丙烯(PP)、聚对苯二甲酸乙二醇酯(PET)等。图26为经过覆膜后的依附架11局部图,此时依附架11的远近两个端面均被薄膜126覆盖,依附架11的部分骨架111被包裹在薄膜126内部。覆膜方式的优点在于,薄膜126与依附架11具有极佳的贴合度和平整度,同时薄膜126与依附架11的变形一致,依附架11在收释放过程中,覆膜后的薄膜126不会形成局部褶皱或凹陷,使滤器具有极佳的收释放性。在一种优选的实施方式中,当依附架11上围绕体125材质同为聚四氟乙烯时,薄膜126可以与围绕体125一体式覆膜成型。In another embodiment, the far and near end faces of the attachment frame 11 can be integrally coated by heating, glue bonding, coupling agent connection, etc., and the material used can be polytetrafluoroethylene (PTFE) with a porous structure. , polypropylene (PP), polyethylene terephthalate (PET), etc. 26 is a partial view of the attachment frame 11 after being covered with film. At this time, both the far and near ends of the attachment frame 11 are covered by the film 126 , and part of the skeleton 111 of the attachment frame 11 is wrapped inside the film 126 . The advantage of the film coating method is 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. No localized folds or depressions are formed, giving the filter excellent retractability. In a preferred embodiment, when the material of the surrounding body 125 on the attachment frame 11 is the same as Teflon, the film 126 can be integrally formed with the surrounding body 125 by lamination.

实施例七Embodiment 7

如图27~图28所示,实施例七中本申请提供的具有仿生微刺依附结构的植入器械1为空心管状的血管腔内支架,该血管腔内支架为自膨式支架,多根骨架111相互连接形成一层或多层的波状或网状结构,构成血管腔内支架的主体,起径向支撑血管或阻隔病变组织的作用;优选的,该血管腔内支架为覆膜支架,表面设有柔性薄膜126,薄膜126包裹在覆膜支架的骨架111表面,具有柔软且致密的特点,能起到隔离血液的作用,防止血液从所述覆膜支架表面渗出而流向血管的病变部位,如动脉夹层破口及假腔、动脉真性或假性动脉瘤。对于主动脉领域,特别是腹主动脉支架而言,目前市面上的支架近心端均设有裸支架或带倒刺裸支架用于增加近心端锚定区域,提高支架的抗移位性能,防止支架植入后受血流冲击而产生移位,防止由于支架移位造成支架近心端密封强度减弱产生内漏、或完全偏离预定释放位置导致支架治疗效果失效。为保障锚定强度,通常这种倒刺同样具有刚硬、笔直且粗长的特点,如图8a和图8b所示,这种倒刺结构易刺破血管壁,尤其在一些具有复杂弯曲特性的血管中,这类倒刺结构由于不能发生适应性变化,只能以固定的角度扎入血管壁中,极易引发损伤血管壁的风险。图27为本实施例带有裸支架结构的一种覆膜支架,裸支架的波段上设有多组仿生微刺依附结构12,在释放后,覆膜支架能够牢固依附在血管壁上,不仅对血管壁无损伤,而且不会受血流冲击产生移位,起到了精准定位的效果。As shown in FIGS. 27 to 28 , in the seventh embodiment, the implant device 1 with the bionic micro-thorn attachment structure provided by the present application is a hollow tubular intravascular stent, and the intravascular stent is a self-expanding stent with a plurality of The skeletons 111 are connected to each other to form one or more layers of wavy or mesh structure, which constitute the main body of the intravascular stent, and play the role of radially supporting the blood vessel or blocking the diseased tissue; preferably, the intravascular stent is a covered stent, The surface is provided with a flexible film 126, the film 126 is wrapped on the surface of the skeleton 111 of the stent-graft, and has the characteristics of being soft and dense, and can play the role of isolating blood, preventing blood from seeping out of the surface of the stent-graft and flowing to the blood vessels. Location, such as arterial dissection rupture and false lumen, true or false aneurysm of the artery. In the field of aorta, especially for abdominal aortic stents, the current stents on the market are equipped with bare stents or barbed bare stents at the proximal end to increase the anchoring area at the proximal end and improve the anti-displacement performance of the stents. , to prevent the stent from being displaced due to the impact of blood flow after implantation, to prevent endoleak due to the weakening of the sealing strength of the proximal end of the stent due to the displacement of the stent, or to completely deviate from the predetermined release position, resulting in the failure of the therapeutic effect of the stent. In order to ensure the anchoring strength, the barbs are usually rigid, straight and thick, as shown in Figure 8a and Figure 8b. In the blood vessels of vascular type, such barbed structures cannot adapt to changes and can only be inserted into the blood vessel wall at a fixed angle, which can easily lead to the risk of damage to the blood vessel wall. Figure 27 shows a stent-graft with a bare stent structure according to the present embodiment. The band of the bare stent is provided with multiple sets of bionic micro-thorn attachment structures 12. After release, the stent-graft can be firmly attached to the blood vessel wall, not only There is no damage to the blood vessel wall, and it will not be displaced by the impact of blood flow, which has the effect of precise positioning.

如图28所示,在一个优选的实施方式中,在支架主体的骨架111上设有若干仿生微刺依附结构12,这种设计的优势在于,取消覆膜支架中的裸支架设计,使覆膜支架自身对血管壁实现了依附式锚定功能,使得覆膜支架的适用范围更广,尤其是具有复杂弯曲形态的血管,例如主动脉弓,具有极佳的适应性,同时减少金属材料与血管壁的直接接触面积,降低金属离子的析出,增强了生物相容性。As shown in FIG. 28 , in a preferred embodiment, a plurality of bionic micro-thorn attachment structures 12 are arranged on the skeleton 111 of the stent body. The advantage of this design is that the design of the bare stent in the covered stent is eliminated, so that the covered stent can be covered. The stent-graft itself realizes the attached anchoring function to the vessel wall, making the stent-graft suitable for a wider range of applications, especially for vessels with complex curved shapes, such as the aortic arch. The direct contact area is reduced, the precipitation of metal ions is reduced, and the biocompatibility is enhanced.

实施例八Embodiment 8

参考图29,以实施例七为基础,实施例八与实施例七不同的是,实施例八中本申请提供的具有仿生微刺依附结构的植入器械1为空心管状的血管腔内支架,该血管腔内支架为球扩式支架,球扩式支架表面设有仿生微刺依附结构12,球扩式支架内可通球囊14,并经球囊14扩张至一定直径,当所述骨架111贴靠在所述腔体组织壁时,所述球囊14使得所述微刺122最大程度依附在腔体组织上,或者刺入到腔体组织内,当刺入到腔体组织时,由于仿生微刺依附结构12的微刺122具有纤细、浅短的特性,使得微刺122能够微小且较浅的刺入到血管内膜或中膜内,实现极微创化的锚定功能,这种锚定极为微创化且有效,避免上述现有刚硬、笔直且粗长的倒刺锚定技术而造成的种种设计弊端。Referring to FIG. 29 , on the basis of Embodiment 7, Embodiment 8 is different from Embodiment 7 in that the implant device 1 with the bionic micro-thorn attachment structure provided by the present application in Embodiment 8 is a hollow tubular intravascular stent, The intravascular stent is a balloon-expandable stent. The surface of the balloon-expandable stent is provided with a bionic micro-thorn attachment structure 12. The balloon-expandable stent can pass through a balloon 14 and is expanded to a certain diameter through the balloon 14. When the 111 abuts against the cavity tissue wall, the balloon 14 makes the microthorns 122 adhere to the cavity tissue to the greatest extent, or penetrate into the cavity tissue, and when pierced into the cavity tissue, Because the micro-thorns 122 of the bionic micro-thorn attachment structure 12 have the characteristics of slenderness and shortness, the micro-thorns 122 can penetrate into the intima or media of the blood vessel in a tiny and shallow way, so as to realize the extremely minimally invasive anchoring function. This kind of anchoring is extremely minimally invasive and effective, and avoids various design drawbacks caused by the above-mentioned existing rigid, straight and thick barb anchoring technology.

实施例九Embodiment 9

如图30所示,以实施例八为基础,实施例九与实施例八不同的是,实施例九中本申请提供的具有仿生微刺依附结构的植入器械1为空心管状的血管腔内支架,该空心管状的血管腔内支架为由金属丝编织形成的具有网格状的密网支架,每个网格的面积≤2.5mm 2,密网支架具有如下优点:a)有效阻隔血管上的病变部位,包括动脉夹层破口及假腔、动脉真性或假性动脉瘤,起到治疗效果;b)弯曲形变能力突出,能够适应各种解剖学形态的血管,特别是弯曲的血管和病变部位;c)网格的存在不会影响给体内重要脏器供血的分支血管的血流,具有长期的通畅保持性。在一种实施方式中,具体地,密网支架的网格作为小分支支架的通道接口来使用,这种情形下,首先将密网支架放置到目标位置后,从分支血管内通入导丝并穿过密网支架的其中一个网格,从而建立起小分支支架的通道接口,如图31所示,当密网支架由具有弹性和形状记忆性的丝材经编织制成使得密网支架的一个或多个网格具有形变自适应性时,选中的该网格及其附近区域的网格可发生适应性形变,使得密网支架的网格扩张 呈环绕式包裹住小分支支架的外周,最大程度地贴合在小分支支架的外表面上,如图32所示,不仅使密网支架与小分支支架充分适应目标放置区域的解剖学形态并形成“骑跨式”解剖固定,进而确保二者有效连接,还避免现有技术中小分支支架与主体支架在连接处无法有效密封,导致III型内漏的发生。作为优选的,所述小分支支架为直径至少比密网支架小一半的细径化的空心管状的血管腔内支架,且在小分支支架的外表面上设置有仿生微刺依附结构12,以增强主体支架与小分支支架的稳固性连接;在一个优选的实施方式中,密网支架的局部金属丝通过加工,形成具有一定厚度的扁平结构,在扁平结构表面上设有所述仿生微刺依附结构12,便于密网支架无损且牢固地依附在血管壁上,如图33所示。 As shown in FIG. 30 , based on the eighth embodiment, the difference between the ninth embodiment and the eighth embodiment is that the implant device 1 with the bionic micro-thorn attachment structure provided by the present application in the ninth embodiment is a hollow tubular intravascular cavity The stent, the hollow tubular intravascular stent is a grid-like dense mesh stent formed by weaving metal wires, and the area of each grid is less than or equal to 2.5mm 2 . The dense mesh stent has the following advantages: a) Effectively block the upper blood vessels The diseased parts of the disease, including the rupture of arterial dissection and false lumen, true or false aneurysm of the artery, have a therapeutic effect; b) The bending deformation ability is outstanding, and it can adapt to the blood vessels of various anatomical shapes, especially the curved blood vessels and lesions site; c) the existence of the mesh will not affect the blood flow of the branch blood vessels supplying blood to the important organs in the body, and has long-term patency maintenance. In one embodiment, specifically, the mesh of the dense mesh stent is used as the channel interface of the small branch stent. In this case, the dense mesh stent is first placed at the target position, and then the guide wire is passed from the branch blood vessel. And pass through one of the meshes of the dense mesh stent, thereby establishing the channel interface of the small branch stent, as shown in Figure 31, when the dense mesh stent is made of elastic and shape memory wire woven to make the dense mesh stent When one or more of the meshes have deformation adaptability, the meshes in the selected mesh and its nearby areas can be adaptively deformed, so that the mesh expansion of the dense mesh stent wraps around the periphery of the small branch stent. , to fit on the outer surface of the small branch stent to the greatest extent, as shown in Figure 32, not only make the dense mesh stent and the small branch stent fully adapt to the anatomical shape of the target placement area and form a "straddle-type" anatomical fixation, and then The effective connection between the two is ensured, and it is also avoided that the small branch stent and the main body stent in the prior art cannot be effectively sealed at the connection, resulting in the occurrence of type III endoleak. Preferably, the small branch stent is a thinned hollow tubular intravascular stent with a diameter at least half smaller than that of the dense mesh stent, and a biomimetic micro-thorn attachment structure 12 is provided on the outer surface of the small branch stent to The stable connection between the main body support and the small branch support is enhanced; in a preferred embodiment, the local metal wires of the dense mesh support are processed to form a flat structure with a certain thickness, and the bionic microthorns are arranged on the surface of the flat structure The attachment structure 12 is convenient for the dense mesh stent to be attached to the blood vessel wall without damage, as shown in FIG. 33 .

最后应当说明的是,以上所述仅为本申请的较佳的实施例而已,并不用于限制本申请,凡在本申请的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本申请的保护范围之内。Finally, it should be noted that the above descriptions are only preferred embodiments of the present application, and are not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present application shall be should be included within the scope of protection of this application.

Claims (14)

一种具有仿生微刺依附结构的植入器械(1),所述植入器械(1)至少包括依附架(11),所述依附架(11)为自膨式支架或球扩式支架,其中,所述依附架(11)包括多根骨架(111)和多个仿生微刺依附结构(12),所述仿生微刺依附结构(12)设置在所述骨架(111)的外表面上,所述仿生微刺依附结构(12)的形态为仿植物表面上的疏生微刺,所述仿生微刺依附结构(12)包括刺根(121)和微刺(122),所述微刺(122)由刺身(1221)和刺尖(1222)组成,所述微刺(122)呈直线形或J形或两者组合,所述微刺(122)的所述刺身(1221)和/或所述刺尖(1222)能够触碰到腔体组织,实现依附式锚定功能。An implant device (1) having a bionic micro-thorn attachment structure, the implant device (1) at least comprises an attachment frame (11), and the attachment frame (11) is a self-expanding stent or a ball-expanding stent, Wherein, the attachment frame (11) includes a plurality of skeletons (111) and a plurality of bionic microthorn attachment structures (12), and the biomimetic microthorn attachment structures (12) are arranged on the outer surface of the skeleton (111) , the biomimetic microthorn attachment structure (12) is in the form of sparse microthorns on the surface of imitation plants, the biomimetic microthorn attachment structure (12) includes thorn roots (121) and microthorns (122), and the microthorns The thorn (122) is composed of a sashimi (1221) and a thorn tip (1222), the micro-thorn (122) is straight or J-shaped or a combination of both, the sashimi (1221) of the micro-thorn (122) and /or the thorn tip (1222) can touch the cavity tissue to realize the attached anchoring function. 根据权利要求1所述的具有仿生微刺依附结构的植入器械(1),其中,所述微刺(1221)在接触所述腔体组织时,能够发生适应性弯曲形变,利于所述微刺(1221)无损地依附在所述腔体组织上,增强其依附式锚定功能。The implant device (1) with a biomimetic microthorn attachment structure according to claim 1, wherein when the microthorns (1221) are in contact with the cavity tissue, adaptive bending deformation can occur, which is beneficial to the microthorns (1221). The spines (1221) adhere non-destructively to the cavity tissue, enhancing its adherent anchoring function. 根据权利要求1和2中任一项所述的具有仿生微刺依附结构的植入器械(1),其中,定义:所述刺身(1221)的长度为L1,所述刺尖(1222)的曲线长度为L2,所述刺身(1221)朝外的延长线方向与所述刺尖(1222)远端朝外的延长线方向之间的夹角为β,所述刺身(1221)长度L1、所述刺尖(1222)曲线长度L2以及所述夹角β满足如下数学关系:0.2mm≤L1≤5mm,0<L2≤3mm,0≤β≤150°,所述直线形微刺(122)长度小于所述J形微刺(122)长度。The implant device (1) with a biomimetic micro-thorn attachment structure according to any one of claims 1 and 2, wherein, it is defined that the length of the thorn (1221) is L1, and the length of the thorn (1222) is L1. The length of the curve is L2, the included angle between the direction of the outward extension line of the sashimi (1221) and the direction of the outward extension line of the distal end of the thorn (1222) is β, the length of the sashimi (1221) L1, The curve length L2 of the thorn tip (1222) and the included angle β satisfy the following mathematical relationships: 0.2mm≤L1≤5mm, 0<L2≤3mm, 0≤β≤150°, the linear microthorn (122) The length is less than the length of the J-shaped thorns (122). 根据权利要求3所述的具有仿生微刺依附结构的植入器械(1),所述仿生微刺依附结构(12)还包括限位机构(123),所述限位机构(123)为设置在所述骨架(111)上的孔槽(1231),所述仿生微刺依附结构(12)与所述孔槽(1231)在位置上形成对应,所述刺根(121)至少部分区域位于所述孔槽(1231)内,所述刺根(121)与所述孔槽(1231)相互配合,用于限定所述微刺(122)在所述骨架(111)上的相对位置,或者,所述限位机构(123)为设置在所述骨架(111)上的局部缩颈结构、局部凸起结构、键槽结构的一种或多种,或者,所述限位机构(123)通过胶粘接、焊接或机械配合,实现所述骨架(111)与所述刺根(121)的固定连接。The implant device (1) with a bionic microthorn attachment structure according to claim 3, wherein the biomimetic microthorn attachment structure (12) further comprises a limiting mechanism (123), wherein the limiting mechanism (123) is set In the hole and groove (1231) on the skeleton (111), the biomimetic micro-thorn attachment structure (12) corresponds to the hole and groove (1231) in position, and at least part of the thorn root (121) is located in In the hole groove (1231), the thorn root (121) cooperates with the hole groove (1231) to define the relative position of the microthorn (122) on the skeleton (111), or , the limiting mechanism (123) is one or more of a local constriction structure, a partially raised structure, and a keyway structure arranged on the skeleton (111), or the limiting mechanism (123) passes through The fixed connection between the skeleton (111) and the thorn (121) is realized by gluing, welding or mechanical cooperation. 根据权利要求4所述的具有仿生微刺依附结构的植入器械(1),其中,每个所述仿生微刺依附结构(12)至少包含1个所述刺根(121)与2个所述微刺(122),所述微刺(122)与所述孔槽(1231)在位置和数量上一一对应,所述刺根(121)至少部分区域与所述骨架(111)贴合,所述刺根(121)呈U形或回形结构,且所述刺根(121)贯穿于两个所述孔槽(1231),每个所述仿生微刺依附结构(12)由具有弹性及形状记忆性的丝材依次穿过对应的两个所述孔槽(1231)而成,所述丝材的横截面积≤0.3mm2,所述丝材的长径比在2和40范围内,使得所述微刺(122)具有纤细、柔软的特点。The implant device (1) with a biomimetic micro-thorn attachment structure according to claim 4, wherein each of the biomimetic micro-thorn attachment structures (12) at least comprises one of the spines (121) and two of the the micro-thorns (122), the micro-thorns (122) and the holes (1231) are in one-to-one correspondence in position and number, and the spines (121) at least partially fit with the skeleton (111) , the thorns (121) have a U-shaped or loop-shaped structure, and the thorns (121) run through the two holes (1231), and each of the bionic microthorn attachment structures (12) is composed of a The elastic and shape memory wire is formed by passing through the corresponding two holes (1231) in turn, the cross-sectional area of the wire is ≤0.3mm2, and the length-diameter ratio of the wire is in the range of 2 and 40 inside, so that the microthorns (122) have the characteristics of slenderness and softness. 根据权利要求1至5任一所述的具有仿生微刺依附结构的植入器械(1),其中,在任意一个所述骨架(111)长径方向的截面上,分别定义所述骨架(111)的厚度为P1,所述孔槽(1231)自身的长度为P2,任意两个相邻的所述孔槽(1231)的间距为P3,所述刺身(1221)朝外的延长线方向与所述骨架(111)远离所述依附架(11)的中轴线m的方向之间的夹角为ω,其中参数P1、P2、P3以及ω分别满足如下数学关系:0.05mm≤P1≤0.5mm,0.05mm≤P2≤4mm,0.5mm≤P3≤10mm,30°≤ω<180°。The implant device (1) with a biomimetic micro-thorn attachment structure according to any one of claims 1 to 5, wherein, on a cross-section in the longitudinal direction of any one of the skeletons (111), the skeletons (111) are respectively defined ) thickness is P1, the length of the hole (1231) itself is P2, the distance between any two adjacent holes (1231) is P3, the direction of the outward extension of the sashimi (1221) is the same as The included angle between the directions of the frame (111) away from the central axis m of the attachment frame (11) is ω, wherein the parameters P1, P2, P3 and ω respectively satisfy the following mathematical relationship: 0.05mm≤P1≤0.5mm , 0.05mm≤P2≤4mm, 0.5mm≤P3≤10mm, 30°≤ω<180°. 根据权利要求1-6所述的具有仿生微刺依附结构的植入器械(1),所述植入器械(1)为滤器,所述腔体组织为血管壁,所述依附架(11)为自膨式支架,所述骨架(111)具有弹性,所述依附架(11)还包括中心件(13),多根所述骨架(111)由中心件13朝外发散并围成立体结构,具有阻挡血栓的功能,所述立体结构呈现为灯笼形、葫芦形、蘑菇形、伞形、碗形、锥形的一种或多种组合;The implant device (1) with a bionic microthorn attachment structure according to claims 1-6, wherein the implant device (1) is a filter, the cavity tissue is a blood vessel wall, and the attachment frame (11) It is a self-expanding stent, the frame (111) has elasticity, the attachment frame (11) also includes a center piece (13), and a plurality of the frames (111) diverge outward from the center piece 13 and enclose a three-dimensional structure , has the function of blocking thrombus, and the three-dimensional structure presents one or more combinations of lantern shape, gourd shape, mushroom shape, umbrella shape, bowl shape and cone shape; 或者,所述植入器械(1)为空心管状的血管腔内支架,所述血管腔内支架为自膨式支架或球扩支架,所述腔体组织为血管壁,所述血管腔内支架由多根所述骨架(111)相互连接形成一层或多层的波状或网状结构,起撑开血管或阻隔病变组织的作用。Alternatively, the implantation device (1) is a hollow tubular intraluminal stent, the intraluminal stent is a self-expanding stent or a ball-expanding stent, the cavity tissue is a blood vessel wall, and the intraluminal stent A plurality of the skeletons (111) are connected to each other to form one or more layers of wavy or mesh structure, which play the role of opening blood vessels or blocking diseased tissue. 根据权利要求7所述的具有仿生微刺依附结构的植入器械(1),其中,所述植入器械(1)为滤器时,在所述骨架(111)的内表面设有多个所述仿生微刺依附结构(12),所述仿生微刺依附结构的刺身(1221)和/或刺尖(1222)朝向腔体内流体流动方向或径向朝向腔体组织壁,防止植入器械(1)内已捕获的血栓在回收和释放调整过程中脱出。The implant device (1) with a bionic micro-thorn attachment structure according to claim 7, wherein when the implant device (1) is a filter, a plurality of all the The bionic micro-thorn attachment structure (12), the stab body (1221) and/or the thorn tip (1222) of the biomimetic micro-thorn attachment structure is oriented toward the fluid flow direction in the cavity or the radial direction toward the cavity tissue wall, preventing implantation of instruments ( 1) The captured thrombus within the recovery and release adjustment process is dislodged. 根据权利要求7或8所述的具有仿生微刺依附结构的植入器械(1),其中,所述依附架(11)包括保护结构(1223),所述保护结构(1223)设置在所述骨架(111)上,定义所述微刺(122)的最尖端与所述骨架(111)之间的距离为L3,所述微刺保护结构(1223)凸出所述骨架(111)的高度为L4,则L3与L4满足如下关系:L3<L4,所述微刺保护结构(1223)为半球体状、椭球体状、曲线状、折线状的一个或多个组合,使得所述植入器械(1)进出输送鞘管(2)的过程中,所述微刺依附结构(12)不接触到所述输送鞘管(2)内壁。The implant device (1) with a biomimetic microthorn attachment structure according to claim 7 or 8, wherein the attachment frame (11) comprises a protection structure (1223), and the protection structure (1223) is arranged on the On the skeleton (111), the distance between the most pointed end of the micro-thorn (122) and the skeleton (111) is defined as L3, and the micro-thorn protection structure (1223) protrudes from the height of 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 hemisphere, ellipsoid, curve, and polyline, so that the implantation During the process of entering and exiting the delivery sheath (2) of the instrument (1), the micro-stab attachment structure (12) does not contact the inner wall of the delivery sheath (2). 根据权利要求7或8所述的具有仿生微刺依附结构的植入器械(1),其中,所述依附架(11)设有自中心结构(124),所述自中心结构(124)由所述骨架(111)的末端进一步朝末端方向延伸所形成的卷曲状结构,所述卷曲状结构为椭圆形、圆形或二维螺旋线结构的一种或多种,且每个所述的卷曲状结构所在的平面均与所述依附架(11)的中轴线m共面;The implant device (1) with a bionic microthorn attachment structure according to claim 7 or 8, wherein the attachment frame (11) is provided with a self-centering structure (124), and the self-centering structure (124) is composed of The crimp-like structure formed by the end of the skeleton (111) further extending toward the end direction, the crimp-like structure is one or more of elliptical, circular or two-dimensional helical structures, and each of the The planes on which the curled structures are located are all coplanar with the central axis m of the attachment frame (11); 或者,所述自中心结构(124)是由所述中心件(13)中心向四周发散的多根骨架(111)所形成的卷曲状结构,所述卷曲状结构为椭圆形、圆形或二维螺旋线结构的一种或多种,且每个所述卷曲状结构所在的平面均与所述依附架(11)的中轴线m共面。Alternatively, the self-center structure (124) is a curled structure formed by a plurality of skeletons (111) divergent from the center of the center piece (13) to the surrounding, and the curled structure is an ellipse, a circle or two One or more kinds of dimensional helical structures, and the plane where each of the crimp-like structures is located is coplanar with the central axis m of the attachment frame (11). 根据权利要求8所述的具有仿生微刺依附结构的植入器械(1),其中,所述依附架(11)包括围绕体(125),所述围绕体(125)缠绕在所述骨架(111)上,并至少包裹与所述骨架(111)贴合的所述刺根(121),用于增强所述骨架(111)与所述仿生微刺依附结构(12)的连接强度,或者,所述围绕体(125)为能够与所述骨架(111)和/或所述微刺(122)相互脱离的结构。The implant device (1) with a bionic microthorn attachment structure according to claim 8, wherein the attachment frame (11) comprises a surrounding body (125), and the surrounding body (125) is wound around the frame (125). 111), and at least wrap the thorn roots (121) that fit with the skeleton (111), so as to enhance the connection strength between the skeleton (111) and the bionic microthorn attachment structure (12), or , the surrounding body (125) is a structure that can be separated from the skeleton (111) and/or the micro-thorns (122). 根据权利要求7所述的具有仿生微刺依附结构的植入器械(1),其中,所述植入器械(1)为滤器时,所述骨架(111)的最外围区域设有凸缘结构(112),所述凸缘结构(112)外表面设有所述仿生微刺依附结构(12),使所述骨架(111)与所述腔体组织不直接接触或最少化程度接触。The implant device (1) with a bionic micro-thorn attachment structure according to claim 7, wherein when the implant device (1) is a filter, the outermost peripheral region of the skeleton (111) is provided with a flange structure (112), the biomimetic micro-thorn attachment structure (12) is provided on the outer surface of the flange structure (112), so that the skeleton (111) and the cavity tissue are not in direct or minimal contact. 根据权利要求7所述的具有仿生微刺依附结构的植入器械(1),其中,所述植入器械(1)为空心管状的血管腔内支架,所述血管腔内支架为球扩式支架,所述球扩式支架内可通球囊(14),并经所述球囊(14)扩张至一定直径,当所述骨架(111)贴靠在所述腔体组织壁时,所述球囊(14)使得所述微刺(122)最大程度依附在所述腔体组织上,或者刺入到所述腔体组织内。The implant device (1) with a bionic micro-thorn attachment structure according to claim 7, wherein the implant device (1) is a hollow tubular intravascular stent, and the vascular stent is a ball-expandable stent A stent, wherein a balloon (14) can be passed through the ball-expandable stent, and is expanded to a certain diameter through the balloon (14), and when the skeleton (111) abuts against the cavity tissue wall, the The balloon (14) enables the micro-thorns (122) to adhere to the cavity tissue to the greatest extent, or to penetrate into the cavity tissue. 根据权利要求7所述的具有仿生微刺依附结构的植入器械(1),其中,所述植入器械(1)为空心管状的血管腔内支架,所述血管腔内支架为由丝材编织形成的具有网格状的密网支架,每个所述网格的面积≤2.5mm2,所述密网支架的一个或多个网格具有形变自适应性,当所述网格作为小分支支架的通道接口时,所述网格可扩张并贴合在所述小分支支架的外表面上,所述小分支支架为直径至少比密网支架小一半的细径化的空心管状的血管腔内支架。The implant device (1) with a biomimetic micro-thorn attachment structure according to claim 7, wherein the implant device (1) is a hollow tubular intravascular stent, and the intravascular stent is made of wire A dense mesh scaffold formed by weaving, the area of each mesh is ≤ 2.5mm2, and one or more meshes of the dense mesh scaffold have deformation adaptability, when the mesh is used as a small branch When the stent is a channel interface, the grid can expand and fit on the outer surface of the small branch stent, and the small branch stent is a thinned hollow tubular blood vessel cavity with a diameter at least half smaller than that of the dense mesh stent inner bracket.
PCT/CN2021/107357 2020-07-28 2021-07-20 Implanted instrument having bionic spinule attachment structures Ceased WO2022022332A1 (en)

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