WO2022022332A1 - Instrument implanté ayant des structures de fixation de spinule bionique - Google Patents

Instrument implanté ayant des structures de fixation de spinule bionique 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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WIPO (PCT)
Prior art keywords
thorn
micro
attachment
skeleton
stent
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PCT/CN2021/107357
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English (en)
Chinese (zh)
Inventor
李彪
邵烨
吕世文
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宁波迪创医疗科技有限公司
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.)
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Publication date
Priority claimed from CN202021519994.5U external-priority patent/CN212879437U/zh
Priority claimed from CN202010740896.2A external-priority patent/CN112022260A/zh
Application filed by 宁波迪创医疗科技有限公司 filed Critical 宁波迪创医疗科技有限公司
Publication of WO2022022332A1 publication Critical patent/WO2022022332A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/01—Filters 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 .

Abstract

La présente invention concerne un instrument implanté (1) ayant des structures de fixation de spinule bionique, comprenant au moins une endoprothèse de fixation (11) ; l'endoprothèse de fixation (11) est une endoprothèse auto-expansible ou une endoprothèse expansible par ballonnet, l'endoprothèse de fixation (11) comprend une pluralité d'armatures (111) et une pluralité de structures de fixation de spinule bionique (12), les structures de fixation de spinule bionique (12) sont disposées sur la surface externe des armatures (111), la forme des structures de fixation de spinule bionique (12) imite des spinules formées de manière éparse sur une surface de plante, chaque structure de fixation de spinule bionique (12) comprend une racine (121) et des spinules (122), les spinules (122) sont chacune composées d'un corps (1221) et d'une pointe (1222), les spinules (122) sont linéaires ou en forme de J ou une combinaison des deux, et les corps (1221) et/ou les pointes (1222) des spinules (122) sont aptes à toucher un tissu de lumière, de façon à obtenir une fonction d'ancrage de fixation.
PCT/CN2021/107357 2020-07-28 2021-07-20 Instrument implanté ayant des structures de fixation de spinule bionique WO2022022332A1 (fr)

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CN202021519994.5U CN212879437U (zh) 2020-07-28 2020-07-28 一种具有仿生微刺依附结构的植入器械
CN202021519994.5 2020-07-28
CN202010740896.2 2020-07-28
CN202010740896.2A CN112022260A (zh) 2020-07-28 2020-07-28 一种具有仿生微刺依附结构的植入器械

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CN112022259A (zh) * 2020-07-28 2020-12-04 宁波迪创医疗科技有限公司 一种具有仿生微刺依附结构的密网支架
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AU2005232726A1 (en) * 2004-04-12 2005-10-27 Cook Medical Technologies Llc Stent graft repair device
CN103598902A (zh) * 2013-11-14 2014-02-26 先健科技(深圳)有限公司 左心耳封堵器
US20200146807A1 (en) * 2016-10-27 2020-05-14 Cook Medical Technologies Llc Prosthesis with branched portion
CN107126241A (zh) * 2017-06-16 2017-09-05 宁波迪创医疗科技有限公司 一种可完全回收和重复释放的生物腔体锚定装置
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