Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
  • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
  • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
  • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
  • A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
  • A61C8/0028—Pins, needles; Head structures therefor
• • 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
  • A61F2/30—Joints
  • A61F2/30721—Accessories
  • A61F2/30749—Fixation appliances for connecting prostheses to the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS 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
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/02—Inorganic materials
  • A61L31/022—Metals or alloys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS 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
  • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
  • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
  • A61L31/148—Materials at least partially resorbable by the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00964—Material properties composite
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
  • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
• • 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
  • A61F2/30—Joints
  • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
  • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
  • A61F2002/3006—Properties of materials and coating materials
  • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive

Definitions

• the present invention relates to a bioabsorbable nail for the fixation of membranes, which are used to cover bone defect sites or for attaching natural and artificial bone replacement parts to bone.
• tooth loss periodontitis or by the contact pressure of dentures can be a bone degradation of the jaw bone (jaw removal) done.
• dental implants are in this case a type of abutment anchored in the jawbone, which have the function of an artificial tooth root. If there is too little bone, permanent stable integration of the implant can not be guaranteed.
• a bone augmentation can be done at a time when the bone supply is insufficient, ie in advance of the actual implantation, or at the same time as the actual implantation of the denture.
• autologous bone from the same individual, which must first be taken from the patient at a suitable location, or foreign material is used.
• the foreign material may be of natural origin, such as donor bone, or made synthetically.
• Synthetic bone substitutes such as hydroxyapatite and calcium phosphate, are mostly used in the form of chips or granules.
• Autologous bone material is mostly used in the form of drill cuttings.
• the bone regeneration material can not migrate or is washed out and also to the penetration and ingrowth of soft tissue cells in the filled bone defect (slower regenerating hard tissue) is prevented, this is closed with a covering membrane (principle of the membrane-protected bone regeneration - guided bone regeneration, GBR) covering membranes are known from the prior art.
• Conventional cover membranes of the prior art are usually attached to the bone with nails or screws made of metals such as titanium to prevent slipping. A mere jamming or sewing the cover membranes is not sufficient.
• the time for healing is generally between 12 and 20 weeks.
• No. 5,957,690 A discloses a cover membrane made of the flexible plastic material polytetrafluoroethylene (PTFE).
• PTFE polytetrafluoroethylene
• a covering film formed from inelastic tension-free and permanently deformable titanium and a corresponding nail for fixing the position are disclosed in EP 0 809 979 A1.
• Non-absorbable fixatives such as titanium nails or screws, or non-resorbable cover membrane have the disadvantage that after the use of bone replacement material and the healing of the wound, the non-absorbable attachment means and covering membrane must be removed by surgery before the actual dental implant can be used can. This represents a considerable irritation of the affected area.
• natural or artificial bone replacement parts are attached to the adjacent bone by means of different fixation aids.
• non-absorbable fixatives usually have to be surgically removed from the body once the bone is healed.
• the object of the present invention was therefore to provide an alternative fastening means which avoids the known disadvantages of the prior art.
• the fixation nail for temporarily securing transplantable tissue, bone parts, and bone substitutes by covering or attaching natural and artificial bone replacement parts to bone has a round and flat nail tip of 0.50 to 6.0 mm in diameter
• the thickness of the nail head is 0.10 to 2.0 mm
• the fixation nail has a nail point formed with a sharp point, the length of which is between 0.5 times to 2 times the diameter of the nail head, and the pin thickness of between 0.15 times and 0.5 times the diameter of the nail head, wherein the fixation nail consists of a biocompatible, biocorrodible magnesium alloy composed of metallic magnesium of at least 90 wt% and less than 0.1 wt% aluminum, less than 0.1 wt% copper, less than Contains 0.1% by weight of iron and less than 0.1% by weight of nickel as physiologically undesirable impurities.
• a degradable covering membrane is used together with the biocompatible and biocorrodible fixation nail in the maxillofacial surgery, a complete absorption of both the wound-covering membrane and the fixation aid, namely the fixation nails according to the invention, takes place in the course of wound healing - which generally lasts for 12-20 weeks.
• the fixation aid namely the fixation nails according to the invention.
• the surgeon can place a dental implant without first having to remove residual membrane, adjuvant or titanium pins. Even with bone defects at other body sites eliminates the surgical removal of non-absorbable fixative by using the fixation nail of magnesium according to the invention.
• the advantage over comparable fixation pins or fixation nails made of titanium or stainless steel is that the magnesium nails according to the invention, together with the mostly likewise degradable covering tissue, such as collagen membrane, are completely absorbed by the body in the course of the healing and not by renewed surgical intervention or must be removed during the placement of the actual dental implant.
• Magnesium also has a bone-promoting effect (Switzer, E.N., Absorbable Metallic Osteosynthesis Data, Studies on Resorption Behavior in the Guinea Pig Model, Dissertation, University of Veterinary Medicine Hannover, 2005). It is also known that the magnesium ions liberated during absorption stimulate bone formation (WO 2015/133963 A).
• the diameter of the nail head is 1, 5 to 4.0 mm
• the length of the pointed nail pin is 0.75 to 8.0 mm
• the thickness of the nail head 0.4 to 1, 0 mm and the thickness of the nail head Nail pin 0.22 to 2.0 mm.
• the nail head is preferably designed in the form of a drawing board pin.
• the diameter of the nail head is preferably 2.5 mm, that the length of the pointed nail pin is preferably 2.4 mm, that the thickness of the nail head is preferably 0.6 mm, and that the thickness of the nail pin is a maximum of 0, 8 mm.
• the firm fixation of the covering membrane is achieved by impressing or hammering the magnesium nail according to the invention into the jawbone.
• the fixation nails are used at transplant sites that are difficult to access, for example in the area of the lower and upper jaw.
• the surgeon uses a thin pencil-shaped application device, which includes the head of the nail with clamps and allows positioning at a suitable location. Subsequently, the nail is pressed in with the aid of the applicator or hammered into the bone with a surgical hammer.
• the nail pin must have a certain mechanical stability, which is given primarily by the material thickness of the pin and the chemical composition and the manufacturing process of the alloy. The wide head of the nail prevents the nail from being driven completely through the covering membrane.
• the nail pin has at least one barb.
• the nail pin has one or two barbs in the region of the lower half of the pin length.
• the one or more barbs are preferably generated by radial twisting of the nail pin by 0.1 to 0.4 mm.
• the magnesium nail must for a certain time ensure a firm fixation of the introduced bone material covering membrane or the transplanted bone piece.
• the rate of absorption of the magnesium nail is determined primarily by the chemical composition of the alloy and its preparation. Additions of certain alloying elements, especially of zinc, zirconium and rare earth metals (alloys of yttrium, lanthanum, neodymium, dysprosium and others) both increase the mechanical stability of the magnesium pins and their absorption rate. influenced.
• the stated minimum and maximum limits for the composition of these alloys are chosen so that absorption in the time frame of healing of the bone graft or bone structure is completely guaranteed.
• the physiological safety of magnesium nails is determined primarily by the content of unavoidable impurities. Therefore, maximum amounts of physiologically questionable trace elements are indicated.
• the impurities are limited by aluminum, iron, nickel and copper to values each below 0.1% by weight. In general, the actual amounts of impurities are preferably below 0.01 wt.%.
• the fixing nail consists of a biocorrodible magnesium alloy which is composed of metallic magnesium of at least 80% by weight, a proportion of zinc of 0.1 to 3.0% by weight, a proportion of Zirconium from 0.1 to 3.0% by weight, a proportion of rare earth metals of 0.1 to 10.0% by weight and less than 0.1% by weight aluminum, less than 0.1% by weight Copper, less than 0.1 wt% iron, and less than 0.1 wt% nickel as physiologically undesirable impurities, the remainder being 100 wt% magnesium. It is preferable that, from the proportion of rare earth metals of 0.1 to 10.0 wt% in total, the yttrium content is 1.5 to 5 wt%.
• the magnesium-based alloy contains 0.10 to 2.00 wt% zirconium, 0.01 to 0.80 wt% zinc, 1.50 to 5.00 wt% yttrium and 2.50 to 5.00 % By weight of other rare earth metals.
• the magnesium-based alloys have, based on the alloy as a whole, a content of physiologically undesired impurities of the metals iron, copper, nickel and aluminum of less than 0.02% by weight each.
• the magnesium-based alloy contains less than 0.01% by weight of aluminum, less than 0.20% by weight of iron, less than 0.20% by weight of manganese and less than 0.02% by weight each of copper and nickel.
• the magnesium-based alloy contains less than 0.01% by weight of aluminum, less than 0.20% by weight of zinc, less than 0.15% by weight of manganese, less than 0.20% by weight of lithium, less than 0 , 01 wt .-% silicon, less than 0.01 wt .-% iron, less than 0.03 wt .-% copper and less than 0.005 wt .-% nickel.
• the barbs it may be sufficient to make the point of the nail harpoon-shaped or lancet-shaped.
• the tip of the nail pin is harpoon-shaped
• the tip of the nail pin is lance-shaped.
• the nail head is dome-shaped.
• the nail pin can also be grooved over its entire length or part of its length, in particular to improve the initial anchoring in the bone and to prevent accidental withdrawal.
• the nail pin therefore has at least one, preferably 2 to 5 groove-shaped constrictions of 0.1 to 0.2 mm in the region of the lower third of the fixing pin. In one embodiment, the nail pin has at least one protrusion of 0.1 to 0.3 mm in the region of the lower third of the fixing pin.
• fixation nail according to the invention for the temporary fixation of stabilizing tissue in bone augmentations.
• the use of the fixation nail according to the invention is therefore not limited to the maxillofacial area, but can be used to fix natural or artificial stabilizing tissue as well as natural and artificial bone material on the body's own bone.
• fixation nail according to the invention for the temporary attachment of resorbable and non-resorbable cover membranes is provided in dental implantations.
• this is a use for temporary attachment of collagen-containing and bone-building tissue.
• Fig. 1 shows the fixation nail according to the invention with a harpoon-shaped tip of the nail pin.
• Fig. 2 shows the fixation nail according to the invention with a lance-shaped tip of the nail pin.
• Fig. 3 shows the fixation nail according to the invention with grooves in the nail pin.
• Fig. 4 shows the fixation nail according to the invention with a dome-shaped nail head.
• Fig. 5 shows a detailed drawing of a magnesium nail according to the invention for use in dentistry.
• FIG. 6 shows a three-dimensional representation of the magnesium nail according to the invention according to FIG.
• Figures 1 to 6 each show an embodiment of the fixing nail (1) according to the invention.
• This consists of a nail head (2) and a nail pin (3).
• the tip of the nail pin (3) may be harpoon-shaped (4) (Fig. 1) or lance-shaped (5) (Fig. 2) designed to ensure a firm anchorage in the bone.
• the nail pin (3) may be provided with grooves (6) over the entire length or part of its length (Fig. 3), in particular to improve the initial anchoring in the bone and to prevent accidental withdrawal.
• the nail head can be shaped like a dome (7 5 and 6 show a typical embodiment of the magnesium nail according to the invention which has been tested in the clinic A particularly suitable embodiment of the invention is shown in Fig. 5.
• the magnesium nail sketched there in a CAD drawing is characterized by a nail head of 2.5 mm diameter and a material thickness of 0.7 mm
• the nail pin is characterized by a length of 2.4 mm and a material thickness of 0.7 mm
• the nail pin has approximately in the middle of a cutout of 0.1 mm for forming a barb
• the nail head has bevels on the edge, which make it easier to grasp the pin with the applicator.
• FIG. 6 shows the magnesium nail according to the invention in a three-dimensional view. This magnesium nail is particularly suitable for use in bone augmentation in dental implantation. When using the magnesium nails according to the invention, in particular a nail corresponding to FIG. 5 and FIG. 6, all clinical requirements are met.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Veterinary Medicine (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Biomedical Technology (AREA)
• Epidemiology (AREA)
• Medical Informatics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Molecular Biology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Neurology (AREA)
• Inorganic Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Rheumatology (AREA)
• Cardiology (AREA)
• Transplantation (AREA)
• Dentistry (AREA)
• Prostheses (AREA)
• Materials For Medical Uses (AREA)
• Surgical Instruments (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

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Cited By (3)

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Citations (8)

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• 2015
  • 2015-11-26 DE DE102015120514.9A patent/DE102015120514A1/de not_active Withdrawn
• 2016
  • 2016-11-23 CN CN201680068606.6A patent/CN108882954A/zh active Pending
  • 2016-11-23 WO PCT/EP2016/078531 patent/WO2017089381A1/de not_active Ceased
  • 2016-11-23 EP EP16805339.5A patent/EP3380027B1/de active Active
  • 2016-11-23 US US15/777,131 patent/US20180325510A1/en not_active Abandoned
  • 2016-11-23 BR BR112018010652A patent/BR112018010652A8/pt active Search and Examination
  • 2016-11-23 JP JP2018526048A patent/JP2019500085A/ja active Pending

Patent Citations (8)

Non-Patent Citations (2)

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