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CN106726008A - A kind of valve and preparation method thereof - Google Patents

A kind of valve and preparation method thereof Download PDF

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Publication number
CN106726008A
CN106726008A CN201710005019.9A CN201710005019A CN106726008A CN 106726008 A CN106726008 A CN 106726008A CN 201710005019 A CN201710005019 A CN 201710005019A CN 106726008 A CN106726008 A CN 106726008A
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CN
China
Prior art keywords
valve
polyurethane
supporting part
prefabricated
finished product
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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.)
Granted
Application number
CN201710005019.9A
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Chinese (zh)
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CN106726008B (en
Inventor
周诚
夏家红
赵光锋
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Individual
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Individual
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Priority to CN201710005019.9A priority Critical patent/CN106726008B/en
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Classifications

    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415Manufacturing methods
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/14Dipping a core
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/20Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00Materials or treatment for tissue regeneration
    • A61L2430/20Materials or treatment for tissue regeneration for reconstruction of the heart, e.g. heart valves

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Manufacturing & Machinery (AREA)
  • Prostheses (AREA)

Abstract

The invention provides a kind of valve and preparation method thereof, including, support and leaflet;The valve that the support is arranged in the flexible leaflet as prepared by this method is molded by Best-Effort request coating method dip coating, so that leaflet is integrally formed with support, with service life higher, support is not good with blood directly contact antithrombotic effect in itself, valve can obtain aperture area in manufacturing process, ensure sufficient aperture area and reduce the disqualification rate of finished product, have production technology simple relative to prior art step simultaneously, controllability is stronger, beneficial to the batch production of valve.

Description

A kind of valve and preparation method thereof
Technical field
The present invention relates to cardiac valves field, more particularly to a kind of valve and preparation method thereof.
Background technology
The artificial valve of current Clinical practice has two major classes, and one is mechanical prosthetic valve, is mainly made by pyrolytic carbon.With St- Jude Medical and Carbomedics mechanical prosthetic valve are representative.Long service life is characterized in, but its leaflet is rigid leaflet sheet Structure, leaflet folding sound is larger, because of blood compatibility reason, it is necessary to lifelong Anticoagulation of Warfarin, its thrombosis and bleeding Risk has a strong impact on therapeutic effect and patients ' life quality.Two is biovalve, with valve made of cattle pericardium and porcine aortic valve as representative. It is good with haemodynamics, it is not required to the advantage of long-term anti-freezing, but its calcification in vivo, decay, make its service life shorter, it is many Number is adapted only to gerontal patient.
The content of the invention
For the drawbacks described above and problem of prior art, the purpose of the embodiment of the present invention be to provide a kind of long service life and The good valve of antithrombotic effect.
In order to achieve the above object, the present invention provides following technical scheme:A kind of valve preparation method, including, following step Suddenly:
S1:Cylindrical die is soaked in polyurethane solutions, using Best-Effort request coating method on cylindrical die surface Prepare polyurethane inner membrance;
S2:Valve bracket is taken, the outer surface that valve bracket is set in polyurethane inner membrance is obtained into prefabricated valve semi-finished product, will Prefabricated valve semi-finished product are soaked in polyurethane solutions, are coated in prefabricated valve surface of semi-finished using Best-Effort request coating method poly- Urethane adventitia;The demoulding, obtains prefabricated valve;
S3:Moulding is arranged to prefabricated valve, valve finished product is obtained.
Wherein, the step S3 includes:
S301:Prefabricated valve includes supporting part and polyurethane film portion, by the unnecessary polyurethane film at the outlet end of supporting part Excision, the polyurethane film at supporting part liquid inlet is inwardly overturn, and is stretched out from the outlet end of supporting part, and extending area forms annular Open leaflet;
S302:The circumference trisection point of ring-shape open leaflet end is pasted by 5%THF solution and is fixed on supporting part Outlet end, makes it be consistent with human heart valve closure state shape, obtains valve semi-finished product;
S303:Valve semi-finished product are placed in 80-90 DEG C of drying box, 8-12 hours is incubated, valve finished product is obtained.
Wherein, the step S2 includes:
After step coats polyurethane adventitia using Best-Effort request coating method in prefabricated valve surface of semi-finished, also including such as Lower step:
S201:Reinforcement is taken, reinforcement is pasted on supporting part by binding agent, use Best-Effort request coating method supporting part Surface forms reinforcement polyurethane adventitia.
Wherein, the polyurethane solutions mass concentration is 5-30%.
Wherein, the preparation method of the polyurethane solutions is:By in PU grain dissolutions to THF solution, stir, and it is quiet Put 1-2h..
Wherein, the material of the support elects stainless steel as.
A kind of valve, including by the moulding poly- ammonia including annular frame supporting part and leaflet portion for obtaining of tubular polyurethane film Ester valve, also including ring support, the ring support is embedded in the annular frame supporting part of the polyurethane valve.
Wherein, the tubular polyurethane film is coated on the ring support surface, from the liquid inlet of the ring support to Outer extension;The extension of tubular polyurethane film is to upset, extreme circumferential trisection point and the annular inside the ring support The outlet end of support is fixedly connected.
Wherein, the ring support surface sets reinforcement.
Wherein, the ring support surface is smooth mirror surface.
Valve as prepared by this method is by soaking lifting shaping so that leaflet is integrally formed with support, with higher Service life, support is good with contacting blood antithrombotic effect, and valve can obtain aperture area in manufacturing process, it is ensured that Sufficient aperture area simultaneously reduces the disqualification rate of finished product, while have production technology simple relative to prior art step, can Control property is stronger, beneficial to the batch production of valve.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to embodiment or existing The accompanying drawing to be used needed for having technology description is briefly described, it should be apparent that, drawings in the following description are only this Some embodiments of invention, for those of ordinary skill in the art, without having to pay creative labor, may be used also Other accompanying drawings are obtained with according to these accompanying drawings.
Fig. 1 is stereogram of the invention;
Fig. 2 is top view of the invention.
Specific embodiment
Below in conjunction with embodiments of the invention, technical scheme is clearly and completely described, it is clear that Described embodiment is only a part of embodiment of the invention, rather than whole embodiments.Based on the implementation in the present invention Example, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made is belonged to The scope of protection of the invention.
Used as embodiment, a kind of valve preparation method takes cylindrical die, and the diameter of cylindrical die is less than valve bracket Diameter, diameter elects 10-30mm, scope needed for covering is clinical as.The material of cylindrical die is preferably stainless steel, and surface is polished to Minute surface, seamless and corner angle.Using Best-Effort request coating method, cylindrical die is soaked in polyurethane solutions, soaks 10 points Clock, by cylindrical die with 2.5 × 10-3M/s is at the uniform velocity lifted, so as to prepare polyurethane inner membrance on cylindrical die surface.Wherein, The mass concentration of polyurethane solutions is 5-30%, preferably 15%.Preparation method be by PU grain dissolutions in THF solution, Stir, and stand 1-2h.Preferably, by PU grain dissolutions to THF solution, stir, stand 1.5 hours.Take valve Membrane support, valve bracket is ring support, and the two ends of valve bracket are respectively liquid inlet and the outflow of blood supply liquid of the inflow of blood supply liquid Outlet end, valve bracket is set in film outer surface in polyurethane, the polyurethane inner membrance outside the liquid inlet of valve bracket Length is longer than the length of valve bracket.Prefabricated valve semi-finished product are obtained after the completion of suit.Using Best-Effort request coating method, will be prefabricated Valve semi-finished product are soaked in polyurethane solutions, are soaked 5 minutes, by cylindrical die with 2.5 × 10-3M/s is at the uniform velocity lifted, so that Polyurethane adventitia is coated in prefabricated valve surface of semi-finished.In be coated on for valve bracket by polyurethane adventitia and polyurethane inner membrance, Valve bracket is set not expose, it is to avoid with blood directly contact, to lift antithrombotic property, increase the service life.Polyurethane film and Under valve bracket gets on from cylindrical die, the demoulding obtains prefabricated valve.Moulding is arranged to prefabricated valve, human heart valve is formed Film shape.So as to obtain valve finished product.
Arrange moulding concretely comprising the following steps:
Valve bracket position is supporting part in prefabricated valve, and remaining position is polyurethane film portion, by entering for supporting part Polyurethane film excision at liquid end, will avoid valve bracket is exposed during excision.By the polyurethane at supporting part liquid inlet Film is turned inside out to supporting part, and is stretched out from the outlet end of supporting part, and extending area is pruned, and makes extending area higher than branch The outlet end 10-30mm of support part.Extending area forms ring-type and opens leaflet, and a diameter of valve in theory that ring-type opens leaflet is opened Maximum gauge is put, the openings of sizes of valve can be measured in the process, filter out substandard product, reduce finished product not Qualification rate, and cause that the big I of valve orifice is accurately measured.The end of ring-shape open leaflet, circumference trisection point are passed through 5%THF solution pastes the outlet end for being fixed on supporting part, it is consistent with human heart valve closure state shape, obtains valve Semi-finished product.Valve semi-finished product are placed in 80-90 DEG C of drying box, preferably 80 DEG C, be incubated 8-12 hour, acquisition valve into Product.
In one embodiment, prefabricated valve can also be reinforced by reinforcement, improves the service life of valve.Reinforcing side Formula is to take reinforcement, and reinforcement is pasted on into supporting part by binding agent, and the selection of binding agent is existing binding agent, preferably, THF solution.The prefabricated valve that will reinforce reinforcement using Best-Effort request coating method is soaked in polyurethane solutions, in supporting part Surface forms reinforcement polyurethane adventitia.
Leaflet thickness is determined by soak time, number of times, can be 0.02mm to 2mm, depending on different parts valve to leaflet Across valve pressure, pliability, the requirement of intensity.Valve sinus portion refers to the part between annular leaflet and support, made by the present invention Leaflet pliability is high, open abundant, and blood can fully be squeezed out sinus portion when open, and blood is difficult to stop gathering in sinus portion, is difficult shape Into thrombus.
Preferably, the outlet end of ring support is crown-shaped.
According to Fig. 1-2, a kind of valve as made by the above method, including is obtained by tubular polyurethane film is moulding Polyurethane valve including annular frame supporting part and leaflet portion, also including ring support 2, the ring support 2 is embedded in institute State in the annular frame supporting part of polyurethane valve 1.Wherein, the tubular polyurethane film is coated on the ring support surface, Stretch out from the liquid inlet of the ring support;The extension of tubular polyurethane film overturns to inside the ring support, end Circumference trisection point 3 is held to be fixedly connected with the outlet end of the ring support.Wherein, the ring support surface sets and strengthens Muscle.Wherein, the ring support surface is smooth mirror surface.
The above, specific embodiment only of the invention, but protection scope of the present invention is not limited thereto, and it is any Those familiar with the art the invention discloses technical scope in, change or replacement can be readily occurred in, should all contain Cover within protection scope of the present invention.Therefore, protection scope of the present invention described should be defined by scope of the claims.

Claims (10)

1. a kind of valve preparation method, it is characterised in that including following steps:
S1:Cylindrical die is soaked in polyurethane solutions, is prepared on cylindrical die surface using Best-Effort request coating method Polyurethane inner membrance;
S2:Valve bracket is taken, the outer surface that valve bracket is set in polyurethane inner membrance is obtained into prefabricated valve semi-finished product, will be prefabricated Valve semi-finished product are soaked in polyurethane solutions, and polyurethane is coated in prefabricated valve surface of semi-finished using Best-Effort request coating method Adventitia;The demoulding, obtains prefabricated valve;
S3:Moulding is arranged to prefabricated valve, valve finished product is obtained.
2. a kind of valve preparation method according to claim 1, it is characterised in that the step S3 includes:
S301:Prefabricated valve includes supporting part and polyurethane film portion, by the unnecessary polyurethane film excision at the outlet end of supporting part, Polyurethane film at supporting part liquid inlet is inwardly overturn, is stretched out from the outlet end of supporting part, extending area forms ring-shape open Leaflet;
S302:The circumference trisection point of ring-shape open leaflet end is pasted by 5%THF solution be fixed on supporting part go out liquid End, makes it be consistent with human heart valve closure state shape, obtains valve semi-finished product;
S303:Valve semi-finished product are placed in 80-90 DEG C of drying box, 8-12 hours is incubated, valve finished product is obtained.
3. a kind of valve preparation method according to claim 1, it is characterised in that the step S2 includes:
After step coats polyurethane adventitia using Best-Effort request coating method in prefabricated valve surface of semi-finished, also including following step Suddenly:
S201:Reinforcement is taken, reinforcement is pasted on supporting part by binding agent, using Best-Effort request coating method in supporting part table Face forms reinforcement polyurethane adventitia.
4. a kind of valve preparation method according to claim 1, it is characterised in that the polyurethane solutions mass concentration is 5-30%.
5. a kind of valve preparation method according to claim 4, it is characterised in that the preparation method of the polyurethane solutions For:By in PU grain dissolutions to THF solution, stir, and stand 1-2h.
6. a kind of valve preparation method according to claim 1, it is characterised in that the material of the support is stainless steel.
7. a kind of valve, including by the moulding polyurethane including annular frame supporting part and leaflet portion for obtaining of tubular polyurethane film Valve, it is characterised in that also including ring support, the ring support is embedded the annular frame support in the polyurethane valve In portion.
8. a kind of valve according to claim 7, it is characterised in that the tubular polyurethane film is coated on the annular branch Frame surface, stretches out from the liquid inlet of the ring support;The extension of tubular polyurethane film to the ring support inside Upset, extreme circumferential trisection point is fixedly connected with the outlet end of the ring support.
9. a kind of valve according to claim 8, it is characterised in that the ring support surface sets reinforcement.
10. a kind of valve according to claim 8, it is characterised in that the ring support surface is smooth mirror surface.
CN201710005019.9A 2017-01-04 2017-01-04 A kind of valve and preparation method thereof Active CN106726008B (en)

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Application Number Priority Date Filing Date Title
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CN106726008B CN106726008B (en) 2019-01-22

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107320218A (en) * 2017-06-23 2017-11-07 董念国 Pulmonary artery intervenes valve support and pulmonary artery intervenes the preparation method of valve
CN113599023A (en) * 2021-07-16 2021-11-05 复旦大学附属中山医院 Intervention type artificial heart valve
WO2024041251A1 (en) * 2022-08-22 2024-02-29 杭州启明医疗器械股份有限公司 Valve material, method for preparing same and use thereof
WO2024041250A1 (en) * 2022-08-22 2024-02-29 杭州启明医疗器械股份有限公司 Polymer valve material, preparation method for integrally molding same, and use thereof

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