Development of a new implant system and surgical device prototype at Medimetál Kft. (Q3929892): Difference between revisions

From EU Knowledge Graph
Jump to navigation Jump to search
(‎Changed an Item: add summary)
(‎Changed an Item: Adding English translations)
Property / summary
 
A)The aim of the project is to develop the prototype of the new generation of bone surgery trochanter implant system and the related surgical toolkit with the complex further development of the existing “Z” tip. trochanter system of project owner Medimetál Kft. The aim of the R & D project is to develop an innovative trochanter implant system containing 3 key elements not used by other manufacturers, which allows the removal of the deep implant residue in the ovaries and reduces the soft tissue pain resulting from the lateral pressure of the dynamic screw, and by developing the surgical technique increases the accuracy of the anatomical reposition and prevents redisocation during surgery. The R & D project is based on the hypothesis of Medimetál Kft., which provides a solution to the critical areas identified in the state of the art: • Removing a broken implant • Relieving Lateral soft tissue pressure irritation • inhibition of thigh head rotation during surgery B)Project R & D category: Experimental development The 1 milestone of the R & D project can be broken down into 4 tasks, with a duration of 24 months. Task 1: Construction and technological design Duration: Month 1-6. Collection and analysis of research data: Geometric interactions of trochanter fractures and implants; analysis of postoperative CT and/or X-ray images; the development of stress zones after implantation; implant fatigue cycle as a function of load; implant fracture analysis; surface characteristics of broken implants, accessibility alternatives to broken implants; the effect of surgical technology on the development of an unoptimal implant-bone connection; cases of lateral soft tissue stress; it’s an evaluation. Construction design: The starting point of the design is the existing “Z” type trochanter implant system of the project promoter. The R & D project is based on the hypothesis of the project promoter Medimetál Kft. and is carried out with a complete further development of the existing system requiring technical and human medicine research. Construction design takes place in 3 main areas of the hypothesis: post-removal of the broken part of the implant, reducing the pressure point in soft tissues, reducing the displacements during surgery. Planning is carried out in the following areas: Fitting of 3D CT bone model and implant model, designing recording prior to intraoperative redlocation, simulating broken pieces, designing additional interfaces, redesigning lateral screw end, fitting surgical instruments based on the modified implant, designing additional surgical tools, rebuilding surgical technology. As a result of the design, a complex transformation of the existing bone surgery implant system is carried out, together with the modification and addition of the existing surgical toolkit. Technological design: Designing the prototype production technology. Writing CNC programs; design of devices; selection and provision of tools; determination and provision of material demand; identification of the need for cooperation; planning and securing capacity requirements. Task 2: Prototyping Duration: Months 4-12. Manufacturing of Trochanter Implant System: Based on the design and design of the technology, the production of prototypes, i.e. the production of various components of the trochanter implant system. The operation tests of new tools, the adjustment of the machining parameters, the testing of tool and program variants, the manufacture of implant variants, the checking of fits and ensuring the functionality of new tools must be carried out. The manufacturer of the individual clamping device for machining and the manufacturer of special heat-resistant, disinfectable silicone handles of operating equipment are coated. Production of related surgical devices: The new generation trochanter implant system requires the modification and addition of the existing surgical toolkit. Manufacture of new or modified operating theatres and complete the entire operating theatre. The manufacturer of a special x-ray-passing carbon-composite arm is involved. Task 3: Mechanical and clinical trials Duration: Months 10-21. Mechanical tests: Examination of the fit and functioning of implants and surgical devices; checking the accuracy of the modified target device; strength test of the modified implant; material analysis of operating theatre devices; heat treatment control; test test on bone model. Bay Logi Kft. has been involved to carry out the mechanical tests. Clinical trials: Clinical trial; x-rays of clinical use; medical evaluation; definition of corrective steps. KwakLab and Saasco were included in clinical trials. Clinical trials assess the actual applicability of implants under real real conditions. Task 4: Finalisation of the prototype Duration: Months 19-24 finalisation of Prototype: Based on the research development results of the R & D project, the implant system and the related surgical toolkit technical tec (English)
Property / summary: A)The aim of the project is to develop the prototype of the new generation of bone surgery trochanter implant system and the related surgical toolkit with the complex further development of the existing “Z” tip. trochanter system of project owner Medimetál Kft. The aim of the R & D project is to develop an innovative trochanter implant system containing 3 key elements not used by other manufacturers, which allows the removal of the deep implant residue in the ovaries and reduces the soft tissue pain resulting from the lateral pressure of the dynamic screw, and by developing the surgical technique increases the accuracy of the anatomical reposition and prevents redisocation during surgery. The R & D project is based on the hypothesis of Medimetál Kft., which provides a solution to the critical areas identified in the state of the art: • Removing a broken implant • Relieving Lateral soft tissue pressure irritation • inhibition of thigh head rotation during surgery B)Project R & D category: Experimental development The 1 milestone of the R & D project can be broken down into 4 tasks, with a duration of 24 months. Task 1: Construction and technological design Duration: Month 1-6. Collection and analysis of research data: Geometric interactions of trochanter fractures and implants; analysis of postoperative CT and/or X-ray images; the development of stress zones after implantation; implant fatigue cycle as a function of load; implant fracture analysis; surface characteristics of broken implants, accessibility alternatives to broken implants; the effect of surgical technology on the development of an unoptimal implant-bone connection; cases of lateral soft tissue stress; it’s an evaluation. Construction design: The starting point of the design is the existing “Z” type trochanter implant system of the project promoter. The R & D project is based on the hypothesis of the project promoter Medimetál Kft. and is carried out with a complete further development of the existing system requiring technical and human medicine research. Construction design takes place in 3 main areas of the hypothesis: post-removal of the broken part of the implant, reducing the pressure point in soft tissues, reducing the displacements during surgery. Planning is carried out in the following areas: Fitting of 3D CT bone model and implant model, designing recording prior to intraoperative redlocation, simulating broken pieces, designing additional interfaces, redesigning lateral screw end, fitting surgical instruments based on the modified implant, designing additional surgical tools, rebuilding surgical technology. As a result of the design, a complex transformation of the existing bone surgery implant system is carried out, together with the modification and addition of the existing surgical toolkit. Technological design: Designing the prototype production technology. Writing CNC programs; design of devices; selection and provision of tools; determination and provision of material demand; identification of the need for cooperation; planning and securing capacity requirements. Task 2: Prototyping Duration: Months 4-12. Manufacturing of Trochanter Implant System: Based on the design and design of the technology, the production of prototypes, i.e. the production of various components of the trochanter implant system. The operation tests of new tools, the adjustment of the machining parameters, the testing of tool and program variants, the manufacture of implant variants, the checking of fits and ensuring the functionality of new tools must be carried out. The manufacturer of the individual clamping device for machining and the manufacturer of special heat-resistant, disinfectable silicone handles of operating equipment are coated. Production of related surgical devices: The new generation trochanter implant system requires the modification and addition of the existing surgical toolkit. Manufacture of new or modified operating theatres and complete the entire operating theatre. The manufacturer of a special x-ray-passing carbon-composite arm is involved. Task 3: Mechanical and clinical trials Duration: Months 10-21. Mechanical tests: Examination of the fit and functioning of implants and surgical devices; checking the accuracy of the modified target device; strength test of the modified implant; material analysis of operating theatre devices; heat treatment control; test test on bone model. Bay Logi Kft. has been involved to carry out the mechanical tests. Clinical trials: Clinical trial; x-rays of clinical use; medical evaluation; definition of corrective steps. KwakLab and Saasco were included in clinical trials. Clinical trials assess the actual applicability of implants under real real conditions. Task 4: Finalisation of the prototype Duration: Months 19-24 finalisation of Prototype: Based on the research development results of the R & D project, the implant system and the related surgical toolkit technical tec (English) / rank
 
Normal rank
Property / summary: A)The aim of the project is to develop the prototype of the new generation of bone surgery trochanter implant system and the related surgical toolkit with the complex further development of the existing “Z” tip. trochanter system of project owner Medimetál Kft. The aim of the R & D project is to develop an innovative trochanter implant system containing 3 key elements not used by other manufacturers, which allows the removal of the deep implant residue in the ovaries and reduces the soft tissue pain resulting from the lateral pressure of the dynamic screw, and by developing the surgical technique increases the accuracy of the anatomical reposition and prevents redisocation during surgery. The R & D project is based on the hypothesis of Medimetál Kft., which provides a solution to the critical areas identified in the state of the art: • Removing a broken implant • Relieving Lateral soft tissue pressure irritation • inhibition of thigh head rotation during surgery B)Project R & D category: Experimental development The 1 milestone of the R & D project can be broken down into 4 tasks, with a duration of 24 months. Task 1: Construction and technological design Duration: Month 1-6. Collection and analysis of research data: Geometric interactions of trochanter fractures and implants; analysis of postoperative CT and/or X-ray images; the development of stress zones after implantation; implant fatigue cycle as a function of load; implant fracture analysis; surface characteristics of broken implants, accessibility alternatives to broken implants; the effect of surgical technology on the development of an unoptimal implant-bone connection; cases of lateral soft tissue stress; it’s an evaluation. Construction design: The starting point of the design is the existing “Z” type trochanter implant system of the project promoter. The R & D project is based on the hypothesis of the project promoter Medimetál Kft. and is carried out with a complete further development of the existing system requiring technical and human medicine research. Construction design takes place in 3 main areas of the hypothesis: post-removal of the broken part of the implant, reducing the pressure point in soft tissues, reducing the displacements during surgery. Planning is carried out in the following areas: Fitting of 3D CT bone model and implant model, designing recording prior to intraoperative redlocation, simulating broken pieces, designing additional interfaces, redesigning lateral screw end, fitting surgical instruments based on the modified implant, designing additional surgical tools, rebuilding surgical technology. As a result of the design, a complex transformation of the existing bone surgery implant system is carried out, together with the modification and addition of the existing surgical toolkit. Technological design: Designing the prototype production technology. Writing CNC programs; design of devices; selection and provision of tools; determination and provision of material demand; identification of the need for cooperation; planning and securing capacity requirements. Task 2: Prototyping Duration: Months 4-12. Manufacturing of Trochanter Implant System: Based on the design and design of the technology, the production of prototypes, i.e. the production of various components of the trochanter implant system. The operation tests of new tools, the adjustment of the machining parameters, the testing of tool and program variants, the manufacture of implant variants, the checking of fits and ensuring the functionality of new tools must be carried out. The manufacturer of the individual clamping device for machining and the manufacturer of special heat-resistant, disinfectable silicone handles of operating equipment are coated. Production of related surgical devices: The new generation trochanter implant system requires the modification and addition of the existing surgical toolkit. Manufacture of new or modified operating theatres and complete the entire operating theatre. The manufacturer of a special x-ray-passing carbon-composite arm is involved. Task 3: Mechanical and clinical trials Duration: Months 10-21. Mechanical tests: Examination of the fit and functioning of implants and surgical devices; checking the accuracy of the modified target device; strength test of the modified implant; material analysis of operating theatre devices; heat treatment control; test test on bone model. Bay Logi Kft. has been involved to carry out the mechanical tests. Clinical trials: Clinical trial; x-rays of clinical use; medical evaluation; definition of corrective steps. KwakLab and Saasco were included in clinical trials. Clinical trials assess the actual applicability of implants under real real conditions. Task 4: Finalisation of the prototype Duration: Months 19-24 finalisation of Prototype: Based on the research development results of the R & D project, the implant system and the related surgical toolkit technical tec (English) / qualifier
 
point in time: 8 February 2022
Timestamp+2022-02-08T00:00:00Z
Timezone+00:00
CalendarGregorian
Precision1 day
Before0
After0

Revision as of 20:56, 8 February 2022

Project Q3929892 in Hungary
Language Label Description Also known as
English
Development of a new implant system and surgical device prototype at Medimetál Kft.
Project Q3929892 in Hungary

    Statements

    0 references
    0 references
    180,734,821 forint
    0 references
    499,769.73 Euro
    0.00276521 Euro
    3 December 2021
    0 references
    929,735.291 Euro
    0.0027336256 Euro
    15 December 2021
    0 references
    340,110,690.629 forint
    0 references
    53.140135 percent
    0 references
    1 February 2018
    0 references
    31 December 2019
    0 references
    Medimetál Gyógyászati Termékeket Gyártó és Forgalmazó Korlátolt Felelősségű Társaság
    0 references
    0 references

    47°53'56.36"N, 20°22'27.73"E
    0 references
    A)A projekt célja újgenerációs csontsebészeti trochanter implantátum rendszer és a kapcsolódó műtéti eszközkészlet prototípusának kifejlesztése a projektgazda Medimetál Kft. meglévő „Z” tip. trochanter rendszerének komplex továbbfejlesztésével. A K+F projekt célja olyan más gyártóknál sem alkalmazott 3 kulcselemet tartalmazó innovatív trochanter implantátum rendszer kifejlesztése, amely a velőűrben mélyen bent maradt implantátum-maradvány eltávolítását lehetővé teszi, illetve a dinamikus csavar laterális nyomásából adódó lágyrészfájdalmat csökkenti továbbá a műtéti technika fejlesztésével az anatómiai repozíció pontosságát növeli és a műtét közbeni rediszlokációt megakadályozza. A K+F projekt az Medimetál Kft. hipotézisén alapul, amely megoldást kínál a technika állásában feltárt kritikus területekre: • Eltört implantátum kivétele • Laterális lágyrész nyomás irritáció csökkentése • Combfej rotációgátlása műtét közben B)A projekt K+F kategóriája: Kísérleti fejlesztés A K+F projekt 1 mérföldköre és ezen belül 4 feladatra bontható, időtartama 24 hónap. 1. feladat: Konstrukciós és technológiai tervezés Időtartama: 1.-6. hónap. Kutatási adatok gyűjtése és analízise: Trochanter-törések és implantátumok geometriai kölcsönhatásai; posztoperatív CT- és/vagy röntgenfelvételek elemzése; stressz-zónák kialakulása az implantátum beültetését követően; implantátum-fáradási ciklus a terhelés függvényében; implantátum-törési jelleg elemzése; törött implantátumok felületi jellegzetességei, törött implantátumok megközelíthetőségi alternatívái; műtéti technológia hatása a nem optimális implantátum-csont kapcsolat kialakulására; laterális lágyrész-stressz esetei; kiértékelés. Konstrukciós tervezés: A tervezés kiindulópontja a projektgazda meglévő „Z” típusú trochanter implantátumrendszere. A K+F projekt a projektgazda Medimetál Kft hipotézisén alapul, és a meglévő rendszer komplett, műszaki- és humánorvosi kutatásokat is igénylő továbbfejlesztésével történik. A konstrukciós tervezés a hipotézis 3 fő területén történik: az implantátum beletört részének utólagos eltávolítása, a lágyrészekbe nyúló nyomáspont csökkentése, a műtét közbeni elmozdulások csökkentése. A tervezés a következő területeken történik: 3D CT-csontmodell és implantátum-modell illesztése, intraoperatív rediszlokációt megelőző rögzítés tervezése, törött darab szimulálása, kiegészítő kapcsolódási felületek kialakítása, laterális csavarvég áttervezése, műtéti eszközök illesztése az átalakított implantátum alapján, kiegészítő műtéti eszközök tervezése, műtéti technológia újraépítése. A tervezés eredményeként a meglévő csontsebészeti implantátum rendszer komplex átalakítása történik, amelyhez a meglévő műtéti eszközkészlet módosítása és kiegészítése párosul. Technológiai tervezés: A prototípus gyártástechnológiájának tervezése. CNC-programok írása; készülékek tervezése; szerszámok kiválasztása és biztosítása; anyagigény meghatározása és biztosítása; kooperációs igény meghatározása; kapacitásigény tervezése, biztosítása. 2. feladat: Prototípus gyártás Időtartama: 4.-12. hónap Trochanter implantátum rendszer gyártása: A konstrukciós és a technológia tervezés alapján a prototípus gyártása, azaz a trochanter implantátum rendszer különböző elemeinek legyártása. Ennek során elvégzendő az új szerszámok műveleti próbái, a megmunkálási paraméterek beállítása, szükséges esetben szerszám- és programváltozatok kipróbálása illetve implantátum-változatok legyártása, illeszkedések ellenőrzése és a működőképesség biztosítása. Bevonásra kerül a megmunkáláshoz szükséges egyedi befogó rögzítő készülék gyártója és a műtőeszközök speciális hőálló, fertőtleníthető szilikon nyeleinek gyártója. Kapcsolódó műtéti eszközkészlet legyártása: Az újgenerációs trochanter implantátum rendszer igényli a meglévő műtéti eszközkészlet módosítását és kiegészítését. Új illetve módosított műtőeszközök gyártása és a teljes műtőkészlet komplettírozása. Bevonásra kerül a speciális röntgenáteresztő karbon-kompozit anyagból készülő célzókar gyártója. 3. feladat: Mechanikai és klinikai vizsgálatok Időtartama: 10.-21. hónap Mechanikai vizsgálatok: Implantátumok és műtéti eszközök illeszkedésének, működésének vizsgálata; módosított célzóeszköz pontosságának vizsgálata; módosított implantátum szilárdsági vizsgálata; műtőeszközök anyag-analízise; hőkezelési ellenőrzés; próbaműködés vizsgálata csontmodellen. A mechanikai vizsgálatok elvégzéséhez bevonásra kerültek a Bay Logi Kft. Klinikai vizsgálatok: Klinikai próba; klinikai alkalmazás röntgenfelvételei; orvostechnikai kiértékelés; korrekciós lépések meghatározása. A klinikai vizsgálatokba a KwakLab és Saasco került bevonásra. A klinikai vizsgálatok az implantátumok tényleges valós körülmények közötti tényleges alkalmazhatóságát értékelik. 4. feladat: Prototípus véglegesítése Időtartama: 19.-24. hónap Prototípus véglegesítése: A K+F projekt kutatási fejlesztési eredményei alapján az implantátum rendszer és a kapcsolódó műtéti eszközkészlet műszaki tec (Hungarian)
    0 references
    A)The aim of the project is to develop the prototype of the new generation of bone surgery trochanter implant system and the related surgical toolkit with the complex further development of the existing “Z” tip. trochanter system of project owner Medimetál Kft. The aim of the R & D project is to develop an innovative trochanter implant system containing 3 key elements not used by other manufacturers, which allows the removal of the deep implant residue in the ovaries and reduces the soft tissue pain resulting from the lateral pressure of the dynamic screw, and by developing the surgical technique increases the accuracy of the anatomical reposition and prevents redisocation during surgery. The R & D project is based on the hypothesis of Medimetál Kft., which provides a solution to the critical areas identified in the state of the art: • Removing a broken implant • Relieving Lateral soft tissue pressure irritation • inhibition of thigh head rotation during surgery B)Project R & D category: Experimental development The 1 milestone of the R & D project can be broken down into 4 tasks, with a duration of 24 months. Task 1: Construction and technological design Duration: Month 1-6. Collection and analysis of research data: Geometric interactions of trochanter fractures and implants; analysis of postoperative CT and/or X-ray images; the development of stress zones after implantation; implant fatigue cycle as a function of load; implant fracture analysis; surface characteristics of broken implants, accessibility alternatives to broken implants; the effect of surgical technology on the development of an unoptimal implant-bone connection; cases of lateral soft tissue stress; it’s an evaluation. Construction design: The starting point of the design is the existing “Z” type trochanter implant system of the project promoter. The R & D project is based on the hypothesis of the project promoter Medimetál Kft. and is carried out with a complete further development of the existing system requiring technical and human medicine research. Construction design takes place in 3 main areas of the hypothesis: post-removal of the broken part of the implant, reducing the pressure point in soft tissues, reducing the displacements during surgery. Planning is carried out in the following areas: Fitting of 3D CT bone model and implant model, designing recording prior to intraoperative redlocation, simulating broken pieces, designing additional interfaces, redesigning lateral screw end, fitting surgical instruments based on the modified implant, designing additional surgical tools, rebuilding surgical technology. As a result of the design, a complex transformation of the existing bone surgery implant system is carried out, together with the modification and addition of the existing surgical toolkit. Technological design: Designing the prototype production technology. Writing CNC programs; design of devices; selection and provision of tools; determination and provision of material demand; identification of the need for cooperation; planning and securing capacity requirements. Task 2: Prototyping Duration: Months 4-12. Manufacturing of Trochanter Implant System: Based on the design and design of the technology, the production of prototypes, i.e. the production of various components of the trochanter implant system. The operation tests of new tools, the adjustment of the machining parameters, the testing of tool and program variants, the manufacture of implant variants, the checking of fits and ensuring the functionality of new tools must be carried out. The manufacturer of the individual clamping device for machining and the manufacturer of special heat-resistant, disinfectable silicone handles of operating equipment are coated. Production of related surgical devices: The new generation trochanter implant system requires the modification and addition of the existing surgical toolkit. Manufacture of new or modified operating theatres and complete the entire operating theatre. The manufacturer of a special x-ray-passing carbon-composite arm is involved. Task 3: Mechanical and clinical trials Duration: Months 10-21. Mechanical tests: Examination of the fit and functioning of implants and surgical devices; checking the accuracy of the modified target device; strength test of the modified implant; material analysis of operating theatre devices; heat treatment control; test test on bone model. Bay Logi Kft. has been involved to carry out the mechanical tests. Clinical trials: Clinical trial; x-rays of clinical use; medical evaluation; definition of corrective steps. KwakLab and Saasco were included in clinical trials. Clinical trials assess the actual applicability of implants under real real conditions. Task 4: Finalisation of the prototype Duration: Months 19-24 finalisation of Prototype: Based on the research development results of the R & D project, the implant system and the related surgical toolkit technical tec (English)
    8 February 2022
    0 references
    Eger, Heves
    0 references

    Identifiers

    GINOP-2.1.7-15-2016-01336
    0 references