• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The present invention relates to a sternum replacement implant.
    公开号:FR3037803A1
    申请号:FR1555761
    申请日:2015-06-23
    公开日:2016-12-30
    发明作者:Daniel Setton；Fabrice Fiorenza；Francois Bertin；Frank Sturtz；Eric Denes；Delphine Donnez
    申请人:I Ceram；
    IPC主号:
    专利说明:

    [0001] The present invention relates to an implant for substituting the sternum. In the case of single lesions or serious infections, total sternectomy can be performed. This is the case of radiation-induced sternum cancers (and bone metastases on the sternum) and postoperative mediastinum (DFO), which occurs following a post-operative complication of the sternum during cardiac procedures. We are therefore looking for replacement implants of the sternum. Until today, two solutions are available to the surgeon, including cardiovascular or orthopedic. The sternum can be replaced by a titanium prosthesis, but it presents a high risk of infection and causes artifacts that interfere with X-rays, while presenting a significant psychological weight for the patient. We can also proceed with the construction during the operation of a custom made piece of bone cement (PMMA) with the addition of metal fasteners, but again with an infectious risk and an extension of the duration of the intervention, difficulty of attachment due to the lack of drilling and heat released at the time of shaping with risk of burns. Furthermore, secondary osseointegration of the implant is sought within a time period compatible with the physiological requirements.
    [0002] The subject of the invention is therefore a sternum substitution implant based on alumina ceramics.
    [0003] The ceramic, based on Al 2 O 3 alumina, is advantageously porous. This ceramic alumina is known per se but it can be used doped by some other materials such as Zirconia. The porosity (open and interconnected) of this ceramic may in particular be between 40 and 80%, preferably between 60 and 70%, advantageously around 65%. The pore size is typically 200 to 600 μm, preferably 400 μm. Porosity / pore size is measured by mercury porosimetry. Porosity is defined as the difference between the volume occupied by the pores on the total volume, the total volume being the sum of the pore volume and the alumina. As the mass of alumina is defined by the volume and the density, by weighing the sample and knowing its total volume, it is possible to determine by difference the pore volume and therefore the (open) porosity. Porous alumina, the material constituting the implant according to the invention, allows secondary osseointegration of the implant at about 3 months. The compressive strength is advantageously between 20 and 60 MPa, advantageously greater than 40 MPa.
    [0004] It is generally possible to use any known process for the preparation of porous alumina, in particular by impregnation with a foam, pre-sintering at a temperature above 1200 ° C., overpreging with a slip, and sintering at a temperature above 1600 ° C. In particular, it is possible to use a process comprising the following steps: - (A) supply of a porogenic material (foam type, for example polyurethane foam, serving in particular to regulate the porosity and the pore size) and impregnation of the porogenic material with a suspension of alumina ceramic particles (alumina slip) optionally mixed with various organic additives such as binders, plasticizers and dispersants; - (B) drying in an oven; - (C) low temperature heat treatment (less than 700 ° C) to remove foam and organic constituents from the slurry; then - (D) sintering at a temperature above 1500 ° C.
    [0005] The method described in patent application FR2823674 can advantageously be used. In particular, the ceramic matrix of the invention can be prepared by carrying out the process described therein. In the preferred embodiment, after the implementation of the first two phases as described above (phases A, B), the porous ceramic part is pre-sintered at a temperature above 1200 ° C., which makes it confers superior cohesion (phase C '). The cycle continues with a new soaking of the piece in another suspension of ceramic particles (phase E). The viscosity of this concentrated suspension is controlled by various organic auxiliaries (binders, plasticizers, dispersants), to be adapted to a homogeneous impregnation of the pre-sintered porous part. After further drying in an oven (phase B ') and pyrolysis of the organic auxiliaries of the suspension (phase C), the ceramic part is finally sintered at a temperature above 1600 ° C following a suitable cycle (phase D').
    [0006] This over-impregnation process enhances the mechanical properties of the sintered ceramic and increases its resistance by a coefficient 2, in particular the compressive stress at break. Such a ceramic is available from the applicant, under the reference Ceramil®.
    [0007] The desired shape can be given to the die by machining or conformation directly during sintering. Figure 1 is a top view of the implant (1) according to the invention. The implant has lateral holes (2a, 2b, 2c), of diameter for example between 0.8 and 4mm. It is possible to proceed by machining, in particular by ultrasound, to perform the bores. The implant with holes can then be sutured to the costal cartilages. The implant thus offers surgeons additional convenience thanks to the holes made which allow a simplified anchoring of the implant.
    [0008] FIG. 2 is another view of the implant (2) according to the invention. The implant is in the form of a curved ovoid plate, which has an anatomical geometry. This allows a filling of the resected area respecting the physiology of the rib cage.
    [0009] After performing anatomical scans, the surgeon makes a cutaneous incision including the path and entry point of the biopsy, cuts the ribs and performs excision and ablation of the tumor. The surgeon sets up the implant, makes the necessary sutures and covers it with a flap of pectoralis major.
    [0010] The implant in position is shown in FIG. 3. The ceramic sternum according to the invention offers a total biocompatibility allowing a durable bone integration. The non-use of metal parts makes it possible to perform radiographies without artefacts and thus to benefit from quality imaging to improve clinical monitoring.
    [0011] The use of the implant according to the invention also allows a saving of operating time, which reduces the risk of infection, studies indicating that the extension of one hour of an operation multiplies the risk of infection by two. . The overall impact for the patient is also decreased. Indeed, the "natural" integration of the implant according to the invention limits the psychological effects of such an operation. Osteointegration facilitates the acceptance of the implant within the body and gives plasticity to the thorax after surgery. The ceramic sternum also ensures reproducibility of the operation; according to one embodiment, the sternum according to the invention is available in the form of a range of implants, with for example 3 implant sizes. 30
    权利要求:
    Claims (5)
    [0001]
    REVENDICATIONS1. Substitution implant (1) of the sternum comprising an alumina ceramic.
    [0002]
    2. Implant (1) according to claim 1, characterized in that the alumina ceramic has a volume porosity of 45 to 75% and a pore size of 200 to 600pm. 10
    [0003]
    3. Implant (1) according to claim 1 or 2, characterized in that the alumina ceramic is of the type obtained by impregnation of a foam, pre-sintering at a temperature above 1200 ° C, overpregnation with a slip, and sintering at a temperature above 1600 ° C. 15
    [0004]
    4. Implant (1) according to one of claims 1 to 3, in the form of a curved ovoid plate.
    [0005]
    5. Implant (1) according to one of claims 1 to 4, comprising lateral bores (2a, 2b, 2c) for suturing the costal cartilages.
    类似技术:
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    US20160206776A1|2016-07-21|Apparatus for producing a doughy bone cement shape
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    同族专利:
    公开号 | 公开日
    CN107872980A|2018-04-03|
    EP3313462B1|2019-11-27|
    EP3313462A1|2018-05-02|
    US20180177914A1|2018-06-28|
    US10729808B2|2020-08-04|
    FR3037803B1|2017-07-07|
    WO2016207255A1|2016-12-29|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    FR2823674A1|2001-04-19|2002-10-25|Limousine De Brevet Soc|Production of high-strength ceramic articles useful in bone surgery comprises impregnating a pre-sintered porous ceramic material with a concentrated suspension of ceramic particles and resintering it|WO2019038145A1|2017-08-25|2019-02-28|Ceramtec Gmbh|Ceramic part having at least one ceramic foam for medical applications|US3314420A|1961-10-23|1967-04-18|Haeger Potteries Inc|Prosthetic parts and methods of making the same|
    US3919723A|1974-05-20|1975-11-18|Friedrichsfeld Gmbh|Bone shaft or bone joint prosthesis and process|
    JPS59171546A|1983-03-18|1984-09-28|Ngk Spark Plug Co|Filler for bone substitute|
    JPH0575428B2|1984-07-23|1993-10-20|Kyocera Corp|
    JPH0323856A|1989-06-21|1991-01-31|Asahi Optical Co Ltd|Artificial tooth-root|
    WO1993017976A1|1992-03-09|1993-09-16|Turku Implant Team Oy|Bioactive glass as a bone substitute|
    US6364909B1|1995-07-18|2002-04-02|Iowa State University Research Foundation, Inc.|Method of restructuring bone|
    TW579372B|1998-07-29|2004-03-11|Sumitomo Chemical Co|Process for producing alumina sintered body|
    US7722676B2|2003-02-05|2010-05-25|Wright Medical Technology, Inc.|Articulating implant system|
    TW587933B|2003-04-30|2004-05-21|A Spine Holding Group Corp|Device for anchoring bone tissue|
    US8007533B2|2007-02-12|2011-08-30|Rti Biologics, Inc.|Progressive grip assembled bone-tendon-bone grafts, methods of making, and methods of use|
    CN101757683A|2010-01-14|2010-06-30|山东大学|Medical porous alumina based ceramic composite material|
    US20130017511A1|2011-07-15|2013-01-17|Shofu, Inc.|Implant fixture|US10543027B2|2017-01-11|2020-01-28|Zimmer Biomet CMF and Thoracic, LLC|Adjustable rib and sternal implant|
    CN109077831A|2018-10-23|2018-12-25|北京爱康宜诚医疗器材有限公司|Breastbone prosthetic appliance|
    CO2020003879A1|2020-03-30|2021-04-08|Techfit Digital Surgery Inc|One-piece sternum replacement implant|
    法律状态:
    2016-05-24| PLFP| Fee payment|Year of fee payment: 2 |
    2016-12-30| PLSC| Search report ready|Effective date: 20161230 |
    2017-04-28| PLFP| Fee payment|Year of fee payment: 3 |
    2018-07-30| PLFP| Fee payment|Year of fee payment: 4 |
    2020-04-06| PLFP| Fee payment|Year of fee payment: 6 |
    2021-06-10| PLFP| Fee payment|Year of fee payment: 7 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1555761A|FR3037803B1|2015-06-23|2015-06-23|IMPLANT OF SUBSTITUTION OF STERNUM|FR1555761A| FR3037803B1|2015-06-23|2015-06-23|IMPLANT OF SUBSTITUTION OF STERNUM|
    EP16733389.7A| EP3313462B1|2015-06-23|2016-06-22|Sternum replacement implant|
    PCT/EP2016/064482| WO2016207255A1|2015-06-23|2016-06-22|Sternum replacement implant|
    CN201680034435.5A| CN107872980A|2015-06-23|2016-06-22|Breastbone replacement implants|
    US15/735,997| US10729808B2|2015-06-23|2016-06-22|Sternum replacement implant|
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