WO2006051401A2 - Medical device for the guided regeneration and modelling of bone and method for producing said device - Google Patents
Medical device for the guided regeneration and modelling of bone and method for producing said device Download PDFInfo
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- WO2006051401A2 WO2006051401A2 PCT/IB2005/003379 IB2005003379W WO2006051401A2 WO 2006051401 A2 WO2006051401 A2 WO 2006051401A2 IB 2005003379 W IB2005003379 W IB 2005003379W WO 2006051401 A2 WO2006051401 A2 WO 2006051401A2
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- bone
- medical device
- attachment
- hereinbefore
- regeneration
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- 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
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- A61F2/2803—Bones for mandibular reconstruction
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- 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
- A61C8/0003—Not used, see subgroups
- A61C8/0004—Consolidating natural teeth
- A61C8/0006—Periodontal tissue or bone regeneration
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- 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
- A61C8/0031—Juxtaosseous implants, i.e. implants lying over the outer surface of the jaw bone
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Definitions
- the present invention concerns a medical device able to be used for the regeneration and modeling of bone, by detaching soft tissues from bone tissues, forming between them an interspace sufficient to obtain a so-called "tent effect".
- the present invention also concerns the method for producing said medical device which in medical terminology is also known as a grid with membrane.
- the device according to the invention can be used in various medical-surgical specializations, such as for example dentistry, odonto-stomatology, orthopedics, implantation of surgical osteo-integrated prostheses, conditioned and personalized anatomical prostheses, and also in the field of maxillo-facial surgery and osteosynthesis.
- Known grids have a standardized flat shape, and are provided with holes with a fixed diameter, which therefore require, at the moment of use, to be cut and modeled according to the bone anatomy desired.
- known grids have holes with a relatively large diameter, for example in the order of about 1.20 ⁇ 0.2 mm, in order to allow them to be attached to the bone by means of osteosynthesis screws, so as not to cause infections and exposure.
- the holes are widened according to the diameter of the pitch of the osteosynthesis screw, with the aid of tungsten millers or other tools with a high number of revolutions.
- Membranes of a known type such as have been used until now, can be indifferently of the re-absorbable or non re- absorbable type, even if they are not always perfectly tolerated by the patient's organism.
- the positioning of the known medical device with respect to the bone portion to be regenerated therefore provides the modeling and attachment to the bone of both the metal grid and also of the membrane, so as to obtain the "tent effect".
- the known solution creates a relatively great thickness, for example about 1.3 mm, due to the overlapping of the grid and membrane, which makes it difficult to suture the soft tissues, and can lead to possible lacerations of the latter during the patient's normal activities, with a consequent failure of the operation and possible infection of the parts affected.
- the American patent US-B-6,409,764 discloses medical methods and objects for the regeneration of bone or periodontal tissue in which, in order to obtain the so- called "tent effect", the presence of a membrane or cage is provided, made of soft and flexible material, necessarily located below the protective element made of hard material.
- the European patent EP-A-O 622 052 discloses a method for producing a membrane to control the regeneration of the bone, in which the presence of metal spacer inserts is always provided between the bone part treated and the lower part of the membrane, in order to keep the membrane distanced from the bone part and obtain the so-called "tent effect".
- One purpose of the present invention is to achieve a medical device for the guided regeneration of bone which has a reduced thickness with respect to known devices, so as to limit to a minimum the disadvantages connected to the positioning of the grid and the membrane, the suture and possible laceration of the soft tissues.
- Another purpose of the present invention is to achieve a medical device for the regeneration of bone wherein the positioning and attachment to the bone is simple and rapid to effect.
- Another purpose of the present invention is to perfect a method for producing said medical device, which allows to personalize the latter to the real requirements of the individual patient and the real bone part on which it has to be applied.
- the Applicant has devised, tested and embodied the present invention to overcome the shortcomings of the state of the art and to obtain these and other purposes and advantages.
- a medical device for the guided regeneration of bone is able to be disposed between a bone surface and a corresponding soft tissue, to define between them an interspace in which the bone regeneration takes place.
- Said interspace is achieved by means of a single element which supports the soft tissue with respect to the bone surface.
- the single element has at least an attachment zone which allows it to be attached to the bone surface, and at least a separation zone which separates the flow of blood in the soft tissue from the flow of blood in the bone surface, so as to promote the bone regeneration.
- Said attachment zone comprises a plurality of attachment seatings each of which is suitable to accommodate a corresponding attachment member, such as for example an osteosynthesis screw or suchlike.
- each of said attachment seatings comprises a substantially circular central hole, from which at least a hollow branches off radially, preferably two or more, able to cooperate with the thread of said attachment member so as to prevent the accidental dis-association of the latter from said element.
- the single element is advantageously made of a flexible material and has a reduced thickness with respect to the state of the art; said thickness for example varies from about 0.1 mm to about 0.4 mm.
- the thickness of the entire medical device is reduced, thus eliminating the problem of the correct positioning of the membrane and the disadvantages due to the difficulty of suturing the soft tissues, and the possible lacerations of the latter during the patient's normal activities.
- the medical device can be made using a method which uses real anatomical modeling on the patient for whom the device is made, starting from the results of an X-ray, CAT scan (Computed Axial Tomography), or similar detection techniques, and by means of a CAM program (computer aided manufacturing), instead of hand-modeling on the patient.
- a method which uses real anatomical modeling on the patient for whom the device is made, starting from the results of an X-ray, CAT scan (Computed Axial Tomography), or similar detection techniques, and by means of a CAM program (computer aided manufacturing), instead of hand-modeling on the patient.
- - fig. 1 shows a plane view of the medical device for the regeneration of bone according to the present invention
- - figs. 2a-2c show in sequence three steps of a first type of positioning of the medical device in fig. 1;
- - figs. 3a-3c show in sequence three steps of a second type of positioning of the medical device in fig. 1;
- - fig. 4 is an example of a CAT; - figs. 5 to 8 show some examples of application of one or more medical devices according to the present invention.
- a medical device 10 is used for the regeneration and modeling of bone in various medical- surgical specializations such as dentistry, odonto- stomatology, orthopedics, implantation of prostheses or other.
- the medical device 10 comprises a single element 11, made of flexible material, such as for example titanium, stainless steel, nontoxic plastic materials or other, and has a very limited thickness, for example comprised between 0.1 mm and 0.4 mm, so that it can easily be bent and attached to a bone surface 12 to be regenerated, in order to define an interspace 13 between the bone surface 12 and the soft tissues 14 normally disposed around the bone surface 12.
- a single element 11 made of flexible material, such as for example titanium, stainless steel, nontoxic plastic materials or other, and has a very limited thickness, for example comprised between 0.1 mm and 0.4 mm, so that it can easily be bent and attached to a bone surface 12 to be regenerated, in order to define an interspace 13 between the bone surface 12 and the soft tissues 14 normally disposed around the bone surface 12.
- the element 11 is substantially flat and without bends, so that it can be modeled and bent directly by the surgeon at the moment of positioning.
- the element 11 in order to reduce the time required for the bone regeneration, can have a pre-determined anatomical shape depending on the specific bone or bone regions on which it is applied, or it can be pre-shaped in a personalized manner on the patient, according to previous X-rays, CAT scans or other techniques that detect the shape and disposition of the bone.
- the element 11 is made curved so that, at rest, it already assumes the necessary shape to be associated with the bone or the bone region on which it has to be positioned.
- the element 11 comprises two attachment zones 15, disposed peripherally, and a substantially central separation zone 16.
- Each of the attachment zones 15 comprises a plurality of attachment seatings 17, each one having a central hole 17a, substantially circular and from which one or more hollows 17b branch off radially.
- attachment seatings 17 are housed corresponding osteosynthesis screws 19, by means of which the element 11 is attached to the bone surface 12, defining the interspace 13.
- each central hole 17a is comprised between 0.5 mm and 1.5 mm, and is equal to the diameter of the core of the osteosynthesis screws 19.
- the radial distance of each hollow is about 0.1-0.5 mm, and is equal to the thickness of the thread of the osteosynthesis screws 19 (difference between the outer radius and radius of the core).
- the shape of the attachment seatings 17 allows to keep the osteosynthesis screws 19 associated with the element 11 even when it is separated from the bone, without the risk that the osteosynthesis screws 19 can be accidentally dis ⁇ associated from it.
- the association of the osteosynthesis screws 19 with the element 11 is maintained thanks to the coupling of the pitches of the threads of the screws 19 and the corresponding hollows 17b of the attachment seatings 17.
- This characteristic is particularly advantageous in the field of dental surgery where the accidental fall of an osteosynthesis screw 19 into the patient's mouth can also entail the risk of serious accidents for the patient.
- the reduced area of the hollows 17b greatly limits the overall section of the holes 17, which remain free, that is, in use, they are not affected by the osteosynthesis screws 19.
- the separation zone 16 comprises a plurality of micro- holes 20, with a diameter for example in the order of tenths of a millimeter, which allow to separate the flow of blood in the bone from the flow of blood in the soft tissues 14, promoting the bone regeneration inside the interspace 13.
- the disposition of the micro-holes 20 in the separation zone 16 also allows the element 11 to be stronger and more resistant to external physical compressions, thanks to the greater availability of resistant structure.
- the element 11 can comprise an attachment hole 21 which, as will be explained in detail hereafter, allows the medical device 10 to be positioned also in the presence of an osteo-integrated prosthesis 22.
- a first type of positioning of the medical device 10 provides a first step wherein the soft tissue 14 is cut at a point to define two lips 14a and 14b which are then scraped from the bone surface 12 to be regenerated and modeled.
- the medical device 10 is then interposed between the two lips 14a, 14b of soft tissue 14 and the bone surface 12, attached to one or more sides of the latter by means of the osteosynthesis screws 19, shaped to define the desired interspace 13, and finally attached to the other side of the bone surface 12, again by means of the osteosynthesis screws 19, to define its definitive installation.
- the medical device 10 according to the invention can also be positioned in the presence of an osteo-integrated prosthesis 22.
- another clamping of the element 11 is made, to the osteo-integrated prosthesis 22 present, by anchoring an upper part of the latter to the element 11, using an attachment screw 23 inserted in the attachment hole 21.
- a method according to the present invention for producing a medical device 10 of the type described above comprises the following steps:
- - a first step in which, from the radiologist's work station, the volumetric data are acquired, with good tomographical images, perpendicular or in directions made known, thus creating the axis of the bone area affected, developing with said axis known reference and measurement points, suitable for reading mathematical data of the tomographical images produced (fig. 4); - a second step of processing the mathematical data supplied by the radiologist, by means of a known program for calculators, dedicated to post-processing data, in order to develop tomographical images suitable for anatomical and radiological study, intended for the display, in virtual manner, for the reconstruction of the bone model available, making known in three-dimensional fashion the bone sizes to be corrected with the positioning of the medical device 10.
- the program for the calculator must allow to display in 3D (three construction axes of the solid model) the tomographical geometrical-mathematical data, supplied by the radiologist and concerning the bone part involved, allowing the graphical interaction thereof, the complete surgical-prosthetic planning and the identification of anatomic structures, of interest for the intervention, that could not otherwise be displayed;
- a fifth step of producing the medical device 10 using equipment and machine tools connected to CAD-CAM acquisition systems (three-dimensional solid working), able to create and model the anatomical and personalized medical device 10, so that the surgeon finds all the shapes he needs for the most simple application in the patient.
- CAD-CAM acquisition systems three-dimensional solid working
- Each medical device 10 thus made, including possible bulges provided in the third step, can also be partly overlapping over another medical device 10, creating, if necessary, a concatenation of devices, so as to cover greater non-rectilinear areas (figs. 5 and 7).
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Public Health (AREA)
- Oral & Maxillofacial Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Transplantation (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Dentistry (AREA)
- Epidemiology (AREA)
- Plastic & Reconstructive Surgery (AREA)
- Developmental Biology & Embryology (AREA)
- Neurosurgery (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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ITUD2004A000213 | 2004-11-12 | ||
IT000213A ITUD20040213A1 (en) | 2004-11-12 | 2004-11-12 | MEDICAL DEVICE FOR REGENERATION E |
Publications (2)
Publication Number | Publication Date |
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WO2006051401A2 true WO2006051401A2 (en) | 2006-05-18 |
WO2006051401A3 WO2006051401A3 (en) | 2006-12-28 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2005/003379 WO2006051401A2 (en) | 2004-11-12 | 2005-11-11 | Medical device for the guided regeneration and modelling of bone and method for producing said device |
Country Status (2)
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IT (1) | ITUD20040213A1 (en) |
WO (1) | WO2006051401A2 (en) |
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WO2009137947A1 (en) * | 2008-05-13 | 2009-11-19 | Andreas Grimm | Method for the production of a device for the targeted regeneration of bone tissue |
WO2010023332A1 (en) * | 2008-06-08 | 2010-03-04 | Diego Martin Pien Dain | Device for applying bone filler biomaterial in maxillary surgery |
ITFI20110158A1 (en) * | 2011-07-29 | 2013-01-30 | Erik Cocchetti | SYSTEM OF CALCINABLE COMPONENTS TO REALLIZE THE MEANS OF CONNECTION OF ORTHOPEDIC PROSTHESIS TO BONE TO WHICH THEY ARE INTENDED AND A METHOD FOR ITS REALIZATION. |
JP2014521434A (en) * | 2011-07-29 | 2014-08-28 | オステムインプラント カンパニー リミテッド | Alveolar bone regeneration membrane |
US20140349251A1 (en) * | 2011-12-23 | 2014-11-27 | Osstemimplant Co., Ltd. | Dental membrane |
JP2015066104A (en) * | 2013-09-27 | 2015-04-13 | 京セラメディカル株式会社 | Alveolar bone regeneration guiding membrane |
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EP2793734A4 (en) * | 2011-12-22 | 2015-08-26 | Mohamed Ikbal Ali | Devices and methods for enhancing bone growth |
DE102016000236A1 (en) | 2015-01-13 | 2016-07-14 | Reoss Gmbh | A method of making an attachment of a bone defect covering device; Device for covering and / or reconstruction of a bone defect site |
DE102015006154A1 (en) | 2015-05-08 | 2016-11-10 | Reoss Gmbh | Device for covering and / or reconstruction of a bone defect site; A method of making an attachment of a bone defect covering device |
KR20180005226A (en) * | 2015-05-08 | 2018-01-15 | 레오스 게엠베하 | Apparatus for covering and / or restoring a bone defect site, and method for manufacturing a cap of a covering apparatus for a bone defect site |
EP3087954B1 (en) * | 2015-04-27 | 2019-01-30 | Peter Kessler | Jaw bone transplant arrangement |
RU2797300C1 (en) * | 2022-12-07 | 2023-06-01 | федеральное государственное автономное образовательное учреждение высшего образования "Казанский (Приволжский) федеральный университет" (ФГАОУ ВО КФУ) | Method of using a dental porous intraosseous-subperiosteal implant |
DE102019118134B4 (en) | 2019-07-04 | 2023-11-30 | Reoss Gmbh | Method for producing a covering device for a bone defect site; Covering device for a bone defect site; |
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EP3087954B1 (en) * | 2015-04-27 | 2019-01-30 | Peter Kessler | Jaw bone transplant arrangement |
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RU2797300C1 (en) * | 2022-12-07 | 2023-06-01 | федеральное государственное автономное образовательное учреждение высшего образования "Казанский (Приволжский) федеральный университет" (ФГАОУ ВО КФУ) | Method of using a dental porous intraosseous-subperiosteal implant |
Also Published As
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ITUD20040213A1 (en) | 2005-02-12 |
WO2006051401A3 (en) | 2006-12-28 |
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