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WO2024161253A1 - Endoprothèse à stabilité primaire améliorée - Google Patents

Endoprothèse à stabilité primaire améliorée Download PDF

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Publication number
WO2024161253A1
WO2024161253A1 PCT/IB2024/050716 IB2024050716W WO2024161253A1 WO 2024161253 A1 WO2024161253 A1 WO 2024161253A1 IB 2024050716 W IB2024050716 W IB 2024050716W WO 2024161253 A1 WO2024161253 A1 WO 2024161253A1
Authority
WO
WIPO (PCT)
Prior art keywords
endoprosthesis
structures
macrostructure
bone
joint part
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2024/050716
Other languages
English (en)
Inventor
Gabriel Tschupp
Stefan Saladin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synthes Bettlach GmbH
Original Assignee
Mathys AG Bettlach
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE202023100431.8U external-priority patent/DE202023100431U1/de
Application filed by Mathys AG Bettlach filed Critical Mathys AG Bettlach
Publication of WO2024161253A1 publication Critical patent/WO2024161253A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • AHUMAN NECESSITIES
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    • 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
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    • 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
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    • A61F2002/30028Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
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    • A61F2002/30841Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
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    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30879Ribs
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    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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    • A61F2310/00796Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Definitions

  • the disclosure relates to an endoprosthesis having improved primary stability.
  • the document WO 2023/003929 Al relates to an anchored implant having a base plate and a separate anchor.
  • the base plate and the anchor are individual components configured to be installed separately in or on the bone of the patient in order to provide a fixing of the base plate to a portion of the bone, such as, for example, a (resected) tibia.
  • the anchored implant device can be configured with an adjustment feature so as to enable the base plate to move in a superior-inferior direction in order to maintain a flush attachment of the base plate to a prepared bone surface in an abnormal state, such as when an anchor is situated at an insufficient depth within the bone.
  • a contoured implant device may comprise a device having contoured features configured to engage with corresponding features of a prepared portion of a prepared knee joint.
  • the anchored implant device in particular the contouring, does not achieve improved primary stability.
  • an endoprosthesis is provided. At least a portion of a surface of the endoprosthesis facing the corresponding bone and/or joint part has a macrostructure for securing the primary stability of the endoprosthesis.
  • the macrostructure has an edge steepness of at least 70 degrees.
  • the edge steepness is an edge steepness relative to a plane, in particular an edge steepness relative to a horizontal plane. Additionally or alternatively, the edge steepness is at least 75 degrees, preferably at least 80 degrees, particularly preferably at least 90 degrees, very particularly preferably at least 95 degrees. Additionally or alternatively, the edge steepness of the macrostructure is also achieved by at least one undercut.
  • the primary stability for example, may thus be further improved.
  • the surface facing the corresponding bone and/or the joint part has at least 30 percent, preferably at least 50 percent, particularly preferably at least 80 percent, very particularly preferably 100 percent, of the macrostructure.
  • the surface facing the corresponding bone and/or the joint part is in particular a contact surface in relation to the corresponding bone and/or joint part.
  • the endoprosthesis can thus be connected to the bone in a form-fitting manner, for example over a large area, in particular over the entire surface of the endoprosthesis.
  • the macrostructure has honeycomb-like structures, in particular honeycomb-like ribs, and/or corrugated structures, in particular corrugated ribs, and/or zigzag structures, in particular zigzag ribs, and/or tire-tread- like structures, in particular tire-tread-like ribs, and/or barb-like structures, in particular barbs, and/or bent anchoring pegs, in particular bent pegs, and/or star-shaped anchoring pegs, in particular star-shaped pegs, and/or fins, in particular fins having thickened portions in the corresponding implantation direction, and/or nub-like structures, in particular nubs, and/or cam-like structures, in particular cams, and/or polygonal structures, in particular polygon structures.
  • the macrostructure has a plurality of mandrels and/or pins and/or spikes.
  • the endoprosthesis can be manufactured from a flexible material and/or biomaterials and/or artificial cartilage, in particular by means of the large-area or wholesurface connection.
  • each of the mandrels and/or pins and/or spikes has a length between 4 mm and 8 mm, preferably between 5 mm and 7 mm, particularly preferably between 5.5 mm and 6.5 mm, very particularly preferably approximately 6 mm. Additionally or alternatively, at least some, preferably each, of the mandrels and/or pins and/or spikes is designed like an arrow or as an arrow.
  • the arrow may advantageously be designed in particular in the sense of a barb.
  • each of the mandrels and/or pins and/or spikes has a diameter between 0.5 mm and 2.5 mm, preferably between 1 mm and 2 mm, particularly preferably between 1.3 mm and 1.7 mm, very particularly preferably approximately 1.5 mm.
  • the primary stability for example, may thus be further improved.
  • the corresponding structures of the macrostructure are designed to be larger and/or deeper in regions in which stronger loads and/or a lower bone quality are to be expected with respect to the corresponding bone and/or joint part.
  • a varying bone stiffness in relation to the corresponding bone interface can thus be catered to in an efficient manner, for example.
  • the endoprosthesis in particular a base material of the endoprosthesis, has or consists of a flexible material and/or biomaterial.
  • the flexible material and/or the biomaterial in particular has a thickness between 0.5 mm and 8 mm, preferably between 0.9 mm and 6 mm, particularly preferably between 1 mm and 5 mm, very particularly preferably between 1.5 mm and 2.5 mm.
  • corresponding tissue damage may thus be kept as low as possible.
  • the endoprosthesis in particular a base material of the endoprosthesis, has and/or consists of plastic, preferably polyetherketone (PEK) and/or poly ether ether ketone (PEEK) and/or PEEEK and/or PEEKK and/or PEEEKK and/or PEKEKK and/or polyaryletherketone (PAEK) and/or polyethylene (PE) and/or cross- linked PE and/or ultra-high molecular weight polyethylene (UHMWPE) and/or cross-linked UHMWPE, and/or UHMWPE with vitamin E added, and/or polycarbonate urethane (PCU), and/or hydrogel, and/or metal, preferably titanium and/or tantalum, and/or an alloy, preferably cobalt-chromium-molybdenum (CoCrMo) and/or a titanium alloy, and/or ceramic, preferably aluminum oxide-reinforced zirconium dioxide and
  • the endoprosthesis may be at least partially or completely an allograft, autograft, xenograft or a synthetic implant.
  • the size of the corresponding structures of the macrostructure is determined in each case as a function of the bone density and/or load, in particular pressure and/or shear load, of the corresponding bone and/or joint part.
  • the corresponding load gradient and/or the corresponding bone quality may thus be taken into account in a particularly efficient manner in the design of the structures.
  • the size of the corresponding structures of the macrostructure is determined according to the following formula:
  • G is the size of the corresponding structures of the macrostructure, where a is a first constant, where b is a second constant, where B is the load, in particular pressure and/or shear load, of the corresponding bone and/or joint part, and where D is the bone density of the corresponding bone and/or joint part.
  • the use of a finite-element method can thus be dispensed with, which not only simplifies the production of the endoprosthesis, but also lowers the corresponding production costs.
  • At least a portion of a surface, which faces the corresponding bone and/or joint part, preferably the surface, which faces the corresponding bone and/or joint part, of the endoprosthesis is designed to enable or facilitate growth adhesion to the corresponding bone and/or joint part.
  • cement-free anchoring can thus be achieved.
  • At least the part of the surface, which faces the corresponding bone and/or joint part, preferably the surface, which faces the corresponding bone and/or joint part, of the endoprosthesis has titanium and/or titanium particles and/or calcium phosphate.
  • corresponding growth adhesion can thus be enabled or facilitated in a particularly efficient manner.
  • Fig. 1 shows exemplary honeycomb-like ribs in particular for the large-area anchoring of the corresponding implant within the meaning of the disclosure
  • Fig. 2 shows exemplary macrostructures as a function of load and bone quality in the context of the large-area anchoring within the meaning of the disclosure
  • Fig. 3 shows an exemplary macrostructure within the meaning of the disclosure, by means of which in particular a high stiffness of the endoprosthesis in a corresponding main- load direction is achieved.
  • the disclosure is independent of the corresponding shape of the endoprosthesis.
  • this can relate to the anterior and/or posterior surface of a femur endoprosthesis or also other endoprostheses.
  • spot connections such as pegs, fins, or the like.
  • the corresponding anchoring of the endoprosthesis is advantageously created via a macro-structured surface of the endoprosthesis. It should be noted that the corresponding bone may likewise be provided with a macrostructure, which preferably generates a very large number of anchoring points.
  • the macro- structured surface or macrostructure used in particular for anchoring may preferably have honeycomb-like ribs 10 according to Fig. 1.
  • this shape results in a corresponding shear force being able to be absorbed in all directions, which is illustrated by way of example with the aid of reference signs 11, 12, 13 in Fig. 1.
  • the macrostructure has an edge steepness of at least 70 degrees.
  • the macrostructure may have corrugated structures, in particular corrugated ribs, and/or zigzag structures, in particular zigzag ribs, and/or tire-tread-like structures, in particular tire-tread-like ribs, and/or barb-like structures, in particular barbs, and/or bent anchoring pins, in particular bent pegs, and/or starshaped anchoring pegs, in particular star-shaped pegs, and/or fins, in particular fins having thickened portions in the corresponding implantation direction, and/or nub-like structures, in particular nubs, and/or cam-like structures, in particular cams, and/or polygonal structures, in particular polygon structures.
  • An additional or alternative option consists of many individual points which are so close to one another that a quasi full-surface connection is also produced. These individual points may be many small spikes, for example having approximately 1.5 mm diameter and/or approximately 6 mm height or length.
  • the macrostructure may have a plurality of mandrels and/or pins.
  • each, of the mandrels and/or pins and/or spikes may be designed like an arrow or as an arrow, in particular in the sense of a barb.
  • each of the mandrels and/or pins and/or spikes has such a corresponding diameter/length ratio, so that although they can dissolve relatively quickly, in particular if a corresponding solution is intended, they do not break or bend during the corresponding implantation.
  • the values for diameter and length already indicated above are particularly advantageous.
  • each of the mandrels and/or pins and/or spikes it is advantageous for at least a portion, preferably each of the mandrels and/or pins and/or spikes to have a length between 4 mm and 8 mm, preferably between 5 mm and 7 mm, particularly preferably between 5.5 mm and 6.5 mm.
  • each of the mandrels and/or pins and/or spikes it is in principle advantageous for at least some, preferably each of the mandrels and/or pins and/or spikes to have a diameter between 0.5 mm and 2.5 mm, preferably between 1 mm and 2 mm, particularly preferably between 1.3 mm and 1.7 mm.
  • each of the mandrels and/or pins and/or spikes may have magnesium and/or titanium.
  • Mandrels and/or pins and/or spikes, which have more magnesium than titanium preferably have a larger diameter than mandrels and/or pins and/or spikes which have less magnesium than titanium.
  • the load on the bone may be different over the course of the corresponding surface.
  • the expected bone stiffness may also vary on the corresponding bone interface. This situation is illustrated with the aid of Fig. 2.
  • the curve with reference sign 21 illustrates the corresponding bone density, while the curve with reference sign 22 relates to the corresponding load.
  • This load gradient and the bone quality may be incorporated into the design of the structures, which can be seen from the macrostructure or the anchoring structures 23 in Fig. 2.
  • the structures may be designed to be larger and/or deeper than in regions with small or smaller loads and good or better bone quality.
  • both the corresponding endoprosthesis 24 and the corresponding bone 25 are shown in Fig. 2.
  • the size of the corresponding structures of the macrostructure 23 may be determined in each case as a function of the bone density 21 and/or load 22, in particular pressure and/or shear load, of the corresponding bone 25.
  • the size of the corresponding structures of the macrostructure 23 may be determined according to the following formula:
  • G is the size of the corresponding structures of the macrostructure 23, where a is a first constant, where b is a second constant, where B is the load, in particular pressure and/or shear load, of the corresponding bone 25, and where D is the bone density of the corresponding bone 25.
  • the macrostructure 23 has an edge steepness of 90 degrees.
  • the edge steepness is an edge steepness relative to a plane, in particular relative to a horizontal plane.
  • the surface facing the corresponding bone 25 may have at least 30 percent, preferably at least 50 percent, particularly preferably at least at least 80 percent, very particularly preferably 100 percent, of the macrostructure 23.
  • the surface facing the corresponding bone 25 is in particular a contact surface in relation to the corresponding bone 25.
  • this contact surface may be designed such that it is free of additional anchoring elements, for example pegs and/or fins.
  • the endoprosthesis 24, in particular a base material of the endoprosthesis 24, may have and/or consist of plastic, preferably polyetherketone (PEK) and/or poly ether ether ketone (PEEK) and/or PEEEK and/or PEEKK and/or PEEEKK and/or PEKEKK and/or polyaryletherketone (PAEK) and/or polyethylene (PE) and/or crosslinked PE and/or ultra-high molecular weight polyethylene (UHMWPE) and/or cross-linked UHMWPE, and/or UHMWPE with vitamin E added, and/or polycarbonate urethane (PCU), and/or hydrogel, and/or metal, preferably titanium and/or tantalum, and/or an alloy, preferably cobalt-chromium-molybdenum (CoCrMo) and/or a titanium alloy, and/or ceramic, preferably aluminum oxide-reinforced zirconium dioxide and/or aluminum oxide and
  • plastic preferably polyetherketone
  • the endoprosthesis 24, in particular a base material of the endoprosthesis 24, may have a coating that allows corresponding growth adhesion, preferably a coating having calcium phosphate and/or titanium and/or titanium particles.
  • At least a portion of a surface, which faces the corresponding bone 25, preferably the surface, which faces the corresponding bone 25, of the endoprosthesis 24 may be designed to enable or facilitate growth adhesion to the corresponding bone 25.
  • At least the portion of the surface, which faces the corresponding bone 25, preferably the surface, which faces the corresponding bone 25, of the endoprosthesis 24 may have titanium and/or titanium particles and/or calcium phosphate.
  • the endoprosthesis within the meaning of the disclosure may advantageously be connected to the bone over the entire surface.
  • elements such as pegs and/or fins may be dispensed with. Dispensing with these elements facilitates a later revision of the implant. Moreover, bone loss is also less in the case of such a revision.
  • an implant which is only connected to the bone at individual regions must typically be inherently stiff.
  • the whole-surface connection allows in particular that the endoprosthesis may be manufactured within the meaning of the disclosure from a flexible material, for example plastic, such as PMMA and/or artificial cartilage.
  • a flexible material for example plastic, such as PMMA and/or artificial cartilage.
  • biomaterials which are specifically structured is also conceivable.
  • the endoprosthesis, in particular a base material of the endoprosthesis to have or consist of a flexible material and/or biomaterial.
  • the flexible material and/or the biomaterial may have in particular a thickness between 0.5 mm and 8 mm, preferably between 0.9 mm and 6 mm, particularly preferably between 1 mm and 5 mm, very particularly preferably between 1.5 mm and 2.5 mm.
  • a further advantage is in particular that by using an endoprosthesis within the meaning of the disclosure, the strength is generated substantially by the corresponding bone and very thin and flexible endoprostheses are thus possible. Especially in endoprostheses used for the early treatment of a local defect, it is important that they can later be revised with a conventional endoprosthesis. For this purpose, tissue damage must be kept to a minimum.
  • the endoprosthesis may also have or consist of human cartilage within the meaning of the disclosure.
  • a piece of cartilage may preferably be removed by means of a laser at a location of the human body at which it is in particular not required, and, in particular after the cartilage is provided with the macrostructure, may preferably be inserted with the aid of a laser at the correspondingly desired location.
  • Fig. 3 illustrates an exemplary macrostructure 31 within the meaning of the disclosure, by means of which in particular a high stiffness of the endoprosthesis is achieved in a corresponding main load direction.
  • the corresponding bone may likewise be provided with a macrostructure which preferably generates a very large number of anchoring points.
  • the corresponding bone is also provided with a macrostructure 32 which interacts with the macrostructure 31 of the endoprosthesis, in particular in such a way that the endoprosthesis may be inserted in a corresponding lateral force direction.
  • the endoprosthesis is very stiff in a corresponding main loading direction. For example, a lifting of the endoprosthesis in the corresponding edge regions can thus be reliably avoided.
  • Fig. 3 also shows the insertion of the endoprosthesis in the corresponding auxiliary force direction in three steps.
  • a first step 1 the macrostructure 31 of the endoprosthesis is brought into position with respect to the macrostructure 32 of the bone.
  • the endoprosthesis is now moved until it is brought completely into contact with the bone in a third step 3 or until the two macrostructures 31, 32, which are in particular designed to be complementary to one another, interlock.
  • the macrostructure 31 can be seen, in particular, as a section or as a representative of a two-dimensionally extended macrostructure.
  • the corresponding endoprosthesis may in particular has a plurality of such macrostructures according to Fig. 3.
  • the macrostructure 31 or the part of a two-dimensionally extended macrostructure in particular has an arrow-like or roof-like notch or depression, preferably an arrow-like or roof-like notch or depression, wherein the corresponding arrow head or the corresponding roof is equilateral.
  • the tip of the corresponding arrow head or roof is preferably situated most deeply in the material of the endoprosthesis compared to the rest of the corresponding arrow head or roof.
  • the macrostructure 31 or the part of a two-dimensionally extended macrostructure in particular has a trapezoidal notch or depression, preferably a trapezoidal notch or depression, wherein the corresponding trapezoid is equilateral.
  • the base i.e., the longer of the two base sides of the corresponding trapezoid, is preferably situated most deeply in the material of the endoprosthesis compared to the remainder of the corresponding trapezoid. Further preferably, the trapezoidal notch or depression is arranged offset by approximately 90 degrees, in particular 90 degrees, with respect to the arrow-like or roof-like notch or depression.
  • the two macrostructures 31 and 32 can in particular be exchanged with one another.
  • the macrostructure 32 may be that of the endoprosthesis, whereas the macrostructure 31 can be that of the bone.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Rheumatology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une endoprothèse (24). Au moins une partie d'une surface de l'endoprothèse (24) faisant face à l'os (25) correspondant et/ou à la partie d'articulation a une macrostructure (23) pour sécuriser la stabilité primaire de l'endoprothèse (24). De plus, la macrostructure (23) a une pente de bord d'au moins 70 degrés.
PCT/IB2024/050716 2023-01-31 2024-01-25 Endoprothèse à stabilité primaire améliorée Ceased WO2024161253A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE202023100431.8 2023-01-31
DE202023100431.8U DE202023100431U1 (de) 2023-01-31 2023-01-31 Endoprothese und Endoprothesen-System
DE102023116374.4A DE102023116374A1 (de) 2023-01-31 2023-06-22 Endoprothese mit verbesserter primärstabilität
DE102023116374.4 2023-06-22

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WO2024161253A1 true WO2024161253A1 (fr) 2024-08-08

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007000061A1 (fr) * 2005-06-27 2007-01-04 Synthes Gmbh Procédé de fabrication d’un implant chirurgical
US20110313532A1 (en) * 2010-06-18 2011-12-22 Jessee Hunt Bone implant interface system and method
US20160228259A1 (en) * 2010-04-09 2016-08-11 DePuy Synthes Products, Inc. Intervertebral plant
US20170312084A1 (en) * 2016-04-27 2017-11-02 AOD Holdings, LLC Implant Device(s) Including Tapered Protrusions and Method(s) for Inserting the Same into Bone
WO2023003929A1 (fr) 2021-07-23 2023-01-26 Smith & Nephew, Inc. Dispositifs d'arthroplastie de genou

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007000061A1 (fr) * 2005-06-27 2007-01-04 Synthes Gmbh Procédé de fabrication d’un implant chirurgical
US20160228259A1 (en) * 2010-04-09 2016-08-11 DePuy Synthes Products, Inc. Intervertebral plant
US20110313532A1 (en) * 2010-06-18 2011-12-22 Jessee Hunt Bone implant interface system and method
US20170312084A1 (en) * 2016-04-27 2017-11-02 AOD Holdings, LLC Implant Device(s) Including Tapered Protrusions and Method(s) for Inserting the Same into Bone
WO2023003929A1 (fr) 2021-07-23 2023-01-26 Smith & Nephew, Inc. Dispositifs d'arthroplastie de genou

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