WO2018044188A1 - Implant destiné à réparer les défauts osseux - Google Patents

Implant destiné à réparer les défauts osseux Download PDF

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Publication number
WO2018044188A1
WO2018044188A1 PCT/RU2016/000579 RU2016000579W WO2018044188A1 WO 2018044188 A1 WO2018044188 A1 WO 2018044188A1 RU 2016000579 W RU2016000579 W RU 2016000579W WO 2018044188 A1 WO2018044188 A1 WO 2018044188A1
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WO
WIPO (PCT)
Prior art keywords
implant
elements
bone
implants
carbon
Prior art date
Application number
PCT/RU2016/000579
Other languages
English (en)
Russian (ru)
Inventor
Олег Викторович БАРЗИНСКИЙ
Сергей Константинович Гордеев
Игорь Михайлович БЕЛОВ
Елена Сергеевна ИВАНОВА
Светлана Борисовна КОРЧАГИНА
Валерий Алексеевич МЕДИК
Сергей Васильевич КОЛЕСОВ
Original Assignee
Олег Викторович БАРЗИНСКИЙ
Сергей Константинович Гордеев
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
Application filed by Олег Викторович БАРЗИНСКИЙ, Сергей Константинович Гордеев filed Critical Олег Викторович БАРЗИНСКИЙ
Priority to PCT/RU2016/000579 priority Critical patent/WO2018044188A1/fr
Publication of WO2018044188A1 publication Critical patent/WO2018044188A1/fr

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones

Definitions

  • the invention relates to medicine, namely to surgery, traumatology and orthopedics and can be used in the surgical treatment of inflammatory and degenerative degenerative bone diseases, as well as bone injuries.
  • Bone fragments of the patient or artificial materials with biocompatibility and a sufficient level of strength are used as implants.
  • materials of various classes are used for the manufacture of implants: metals (titanium), ceramics (aluminum and zirconium oxides, biosital, hydroxyapatite) and some synthetic polymers (high molecular weight polyethylene, polymethyl methacrylate, etc.).
  • Metallic, polymeric and many other materials used as implants have a number of disadvantages. Numerous studies have shown that the use of metal implants - especially for inflammatory bone diseases - often leads to bone resorption, and metal ions, diffusing into the surrounding tissue, cause their damage - metal lake. The disadvantages of metal implants include fatigue of metals and their susceptibility to corrosion.
  • Ceramic materials having many advantages, are too fragile and have a high modulus of elasticity in comparison with bone tissue, which does not allow smooth transfer of the load from the implant to the bone and, ultimately, leads to bone resorption.
  • a known implant is described in RF patent J s 2204361 [prior. 07/04/2000, Cl. A61F2 / 44], which the authors chose as the closest analogue.
  • the implant is made of a carbon-carbon composite material containing a carbon matrix and a carbon fiber reinforcing frame.
  • the implant material is entirely carbon and is a durable, porous composite with biocompatibility.
  • the implant may be in the form of a cylinder, prism or tablet.
  • Known implants have a sufficient level of strength, good biocompatibility, after surgical use are well fixed in the bone.
  • a disadvantage of the known implants is the difficulty in ensuring the conformity of the shape, first of all, of the length of the implant to the dimensional features of bone defects encountered in surgical practice, especially of the spine.
  • the use of implants of the required length is required. Therefore, during the operation, it is necessary to have a large size range of implant lengths in the operating room, for example, in the range of 30 - 90 mm with a step of 2 mm, which requires the organization of production of implants of a very wide range and is difficult.
  • the objective of the invention is the creation of an implant that increases the efficiency of its use in the replacement of bone defects due to better match the length of the implant to the length of the replaced bone defect and simplify the production of implants.
  • the implant for the replacement of bone defects made of a carbon-carbon material containing a carbon matrix and a reinforcing frame of carbon fibers is made in the form of two or more elements having an internal thread or a through hole with a diameter of not less than the diameter of the thread, fastened one or more studs having the same diameter thread as the elements, so that the end elements have an internal thread, and the elements between them have an internal thread ennyuyu thread or a through hole.
  • the implant elements are in the form of a cylinder with a through threaded hole located along the axis of the cylinder, and one stud is used to assemble the implant.
  • the implant elements are in the form of a cylinder with a through threaded hole located along the axis of the cylinder, and two or more studs are used to assemble the implant.
  • the elements are in the form of a cylinder with two blind threaded holes located along the axis of the cylinder, and one or more studs are used to assemble the implant.
  • the studs have a through hole on their axis, the diameter of which is not more than 0.5 of the diameter of the studs.
  • the diameter of the hole in the pin is more than 0.5 of its diameter, its strength, and therefore the strength of the entire implant, is significantly reduced.
  • the end elements forming the implant have on the surface forming the ends of the implant, grooves or relief, for example, in the form of pyramids.
  • one or more elements have grooves or holes on their outer surface for fixing the implant with a tool to insert the implant into the bone defect.
  • the space inside the element formed by the ends of the studs that have not come into contact is filled with a drug.
  • the implant proposed in this technical solution consists of a carbon-carbon material containing a carbon matrix and a reinforcing frame of carbon fibers, for example, a multidirectional frame of rods formed of carbon fibers located along the axis of the rods or, for example, a frame braided of carbon fibers, or, for example, a framework obtained by adding layers of fabric from carbon fibers.
  • the carbon matrix binds the carbon fibers of the reinforcing framework, thus forming a composite.
  • the carbon composite material used for the manufacture has high biocompatibility, strength, and fixation (support) properties.
  • the proposed implant consists of individual elements. There are at least two of them in the implant. Each element preferably has a cylindrical shape, although the shape of the element may be different from a cylinder, for example, a prism, an elliptical cylinder, a cylinder with a cut-off plane parallel to the axis of the cylinder, a cylindrical segment. Elements have holes along the height of the implant, for example, along the axis of the cylinder, if the element has a cylindrical shape. These holes may be through or deaf. Through holes are threaded or may not be threaded. Blind holes, in the case of a cylindrical element, are located on the bases of the cylinder, are oriented along the axis of the element and have a thread.
  • the elements of the implant are connected to the implant using one or more studs having threads of the same diameter as the threads of the internal holes in the elements. Studs can have different lengths. So, for example, the length of the stud can be equal to the sum of the lengths of the elements of the implant, as shown in figure 1, or less than the sum of their lengths, and if necessary, more.
  • the studs may have an inner hole along their axis. The diameter of the hole, preferably not more than 0.5 of the diameter of the stud, which allows you to maintain high strength studs.
  • Figure 1 shows the implant, the assembly of which is made of three elements and one stud. All elements of the implant shown in FIG. 1 have threaded holes.
  • the assembly of the elements in the implant can be carried out by several studs, for example two, as shown in Fig.2.
  • the length of the studs is selected from the lengths of the implants, based on considerations of ensuring the strength of the fastening of the elements with studs.
  • Fig. 3 shows an implant that also includes three elements, two of which - the extreme elements - have threaded through holes, and the third, located between the extreme ones, has a threaded through hole. Due to the threading of the extreme elements, all elements of the implant are fixed in a single assembly - an implant to replace bone defects.
  • the implant can also be used elements with blind threaded holes, as shown in Fig.4.
  • the assembly of elements in the implant is carried out with shorter studs.
  • the studs may have a hole along the axis of the stud, as shown in FIG.
  • the extreme elements may have grooves on the outer surface (for example, 0.5 - 2 mm deep and 1-3 mm wide) or a relief, for example, in the form of pyramids. Such grooves or relief increase the area of contact of the implant surface with the bone tissues into which the implant is installed, and increase the strength of its fixation in the bone-carbon block formed after the operation.
  • the grooves can be filled with osteoinductive or osteconductive material to accelerate the formation of a bone-carbon block in the area of implantation.
  • FIG. 6 shows one of the possible options.
  • such grooves may also have elements located inside the implant.
  • one or more elements have grooves or holes on their outer surface, as shown in FIG. 7. These grooves or holes are necessary for fixing the implant with a tool to insert the implant into the bone defect. Therefore, the shape and dimensions of the grooves and holes are determined by the tool used to install the implants.
  • the assembly of elements can be carried out in such a way that a cavity is formed between the studs, which, if necessary, can be filled with a drug (Fig. 8), for example, anti-inflammatory.
  • a drug for example, anti-inflammatory.
  • the implant after its installation in the patient’s body, acts as a drug container, slowly releasing the drug into the patient’s body through the pores of the elements of the implant.
  • the lengths of the individual elements are selected so that it is most convenient to assemble implants of any desired length. For example, using elements of implants with a length of 14, 16, 18 and 24 mm, you can assemble an implant of any length from 30 to 90 mm in increments of 2 mm. This simplifies the production of implants by reducing the range of parts, and also simplifies the selection of the implant of the desired length during the operation, thereby increasing the effectiveness of surgical intervention.
  • Figure 2 An example of an implant for the replacement of bone defects.
  • Fig. 3 An example of an implant for replacing bone defects with part of the elements that do not have an internal thread.
  • Figure 4 An example of an implant for replacing bone defects with elements having two blind threaded holes.
  • Figure 5 An example of an implant for the replacement of bone defects with a through hole in the hairpin.
  • Fig.7 An example of an implant for the replacement of bone defects with grooves on the outer surface of the elements.
  • Fig. 8 Example of an implant for replacing bone defects with a drug.
  • Designations in the figures 1 - an implant element having a through inner hole with a thread, 2 - an implant element having a through inner hole without a thread, 3 - an implant element having a blind inner threaded hole, 4 - a hairpin, 5 - a drug cavity , 6 - grooves on the elements.
  • the implant consists of two elements, each of which has a cylindrical shape: diameter 26 mm and height 14 mm.
  • Each element of the implant has a through hole with an M10 thread along the axis of the cylinder.
  • the elements of the implant are connected using a stud having the same thread.
  • the length of the stud is 28 mm.
  • the total length of the implant is 28 mm. If necessary, during the operation to replace a defect with a length of 30 mm, the implant is disassembled and an implant is assembled, consisting of one element with a height of 14 mm and one element with a height of 16 mm, using the same pin.
  • the implant assembly time of the required length does not exceed 1 min.
  • the application of the present invention provides the implementation of implants that combine biological compatibility, strength, fixation properties associated with the characteristics of the carbon material from which they are made. Due to the collection of implants from individual elements, better compliance with the forms of a large group of replaceable bone defects was ensured. Thereby, an increase in the effectiveness of the use of implants in the replacement of bone defects and intervertebral discs and simplification of their production is achieved. Implants are practicable and technically tested.

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)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne le domaine de la médecine et notamment la chirurgie, la traumatologie et de l'orthopédie et peut être utilisée pour le traitement chirurgical des maladies osseuses dégénératives dystrophiques ainsi que des lésions osseuses. L'objectif de l'invention consiste à créer un implant qui puisse assurer une plus grande efficacité de son utilisation lors du remplacement des défauts osseux grâce à une meilleure correspondance de la longueur de l'implant à celle du défaut osseux à remplacer et une fabrication d'implants simplifiée. L'objectif visé est réalisé en ce que l'implant pour remplacer les défauts osseux fait d'un matière carbonée / carbone, qui comporte une matrice carbonée et une carcasse d'armature en fibres de carbone, est constitué de deux ou plusieurs éléments possédant un filet femelle ou un trou débouchant dont le diamètre est au moins égal à celui du filet, qui est assemblé au moyen de deux ou plusieurs goupilles comportant le même filet, en termes de diamètre, que les éléments, de sorte que les éléments d'extrémité aient un filet femelle et les éléments disposés entre eux ait soit un filet femelle soit un trou débouchant. Les implants proposés allient la compatibilité biologique, la résistance mécanique, les propriétés de fixation liées aux particularités de la matière carbonée ayant servi à leur fabrication et grâce à la possibilité d'assembler les implants à partir d'éléments isolés, ce qui assure une meilleure conformité aux formes d'un vaste groupe de défauts osseux à remplacer. Cela permet d'augmenter l'efficacité d'utilisation des implants lors du remplacement de défauts osseux et de disques intervertébraux ainsi que de simplifier leur fabrication.
PCT/RU2016/000579 2016-08-29 2016-08-29 Implant destiné à réparer les défauts osseux WO2018044188A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/RU2016/000579 WO2018044188A1 (fr) 2016-08-29 2016-08-29 Implant destiné à réparer les défauts osseux

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/RU2016/000579 WO2018044188A1 (fr) 2016-08-29 2016-08-29 Implant destiné à réparer les défauts osseux

Publications (1)

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WO2018044188A1 true WO2018044188A1 (fr) 2018-03-08

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4320086A1 (de) * 1993-06-17 1994-12-22 Peter Brehm Modularer Schaft für ein Revisionshüftprothesensystem
RU2204361C2 (ru) * 2000-07-04 2003-05-20 Государственное Унитарное Предприятие "Центральный Научно-Исследовательский Институт Материалов" Протез тела позвонка
BY13197C1 (fr) * 2007-08-08 2010-06-30
RU2010105687A (ru) * 2007-07-18 2011-08-27 БАЙОДАЙНЕМИКС ЭлЭлСи (US) Имплантируемая сетка, используемая при мышечно-костных травмах, ортопедической реконструкции и восстановления мягких тканей
US20120265303A1 (en) * 2007-10-30 2012-10-18 Aesculap Implant Systems, Llc Vertebral body replacement device and method for use to maintain a space between two vertebral bodies within a spine

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4320086A1 (de) * 1993-06-17 1994-12-22 Peter Brehm Modularer Schaft für ein Revisionshüftprothesensystem
RU2204361C2 (ru) * 2000-07-04 2003-05-20 Государственное Унитарное Предприятие "Центральный Научно-Исследовательский Институт Материалов" Протез тела позвонка
RU2010105687A (ru) * 2007-07-18 2011-08-27 БАЙОДАЙНЕМИКС ЭлЭлСи (US) Имплантируемая сетка, используемая при мышечно-костных травмах, ортопедической реконструкции и восстановления мягких тканей
BY13197C1 (fr) * 2007-08-08 2010-06-30
US20120265303A1 (en) * 2007-10-30 2012-10-18 Aesculap Implant Systems, Llc Vertebral body replacement device and method for use to maintain a space between two vertebral bodies within a spine

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