BR102018006277A2

BR102018006277A2 - PERIOSTEAL DISTRIBUTOR FOR BONE GROWTH

Info

Publication number: BR102018006277A2
Application number: BR102018006277-8A
Authority: BR
Inventors: Vinicius Tatsumoto Favarini; Leonardo Taira
Original assignee: Vinicius Tatsumoto Favarini; Leonardo Taira
Priority date: 2018-03-28
Filing date: 2018-03-28
Publication date: 2019-10-15

Abstract

distrator periosteal para crescimento ósseo. este é um produto relacionado aos setores de odontologia e medicina. refere-se o presente a um dispositivo de distração periosteal que permite um crescimento ósseo local através da separação gradual do periósteo (tecido que recobre o osso) em relação ao osso subjacente. o dispositivo consegue propor a neoformação óssea (crescimento ósseo) em uma região determinada no corpo humano. este crescimento ósseo permitirá realizar reabilitações orais e instalação de implantes dentários em áreas que antes não eram conseguidas. além disso, quando usado em áreas estéticas, pode promover uma melhora significativa do local afetado. o dispositivo é formado por um implante inserido intra-ósseo com parafuso e membrana, que permitem formação do espaço adequado para que haja o crescimento ósseo.periosteal distractor for bone growth. This is a product related to the dentistry and medicine sectors. refers herein to a periosteal distraction device that permits local bone growth through gradual separation of the periosteum (tissue covering the bone) from the underlying bone. The device can propose bone neoformation (bone growth) in a specific region in the human body. This bone growth will allow oral rehabilitation and implantation of dental implants in areas that were previously not achieved. In addition, when used in aesthetic areas, it can promote significant improvement of the affected site. The device is formed by an intraosseous implant with screw and membrane, which allow the formation of adequate space for bone growth.

Description

“DISTRATOR PERIOSTEAL PARA CRESCIMENTO ÓSSEO”“PERIOSTEAL DISTRACTOR FOR BONE GROWTH”

1. Refere-se o presente a um dispositivo de distração periosteal que permite um crescimento ósseo local através da separação gradual do periósteo (tecido que recobre o osso) em relação ao osso subjacente. O dispositivo consegue propor a neoformação óssea (crescimento ósseo) em uma região determinada no corpo humano. Este crescimento ósseo permitirá realizar reabilitações orais e instalação de implantes dentários em áreas que antes não eram conseguidas. Além disso, quando usado em áreas estéticas, pode promover uma melhora significativa do local afetado. O dispositivo é formado por um implante inserido intra-ósseo com parafuso e membrana, que permitem formação do espaço adequado para que haja o crescimento ósseo.1. The present refers to a periosteal distraction device that allows local bone growth through the gradual separation of the periosteum (tissue covering the bone) in relation to the underlying bone. The device is able to propose bone neoformation (bone growth) in a specific region of the human body. This bone growth will allow for oral rehabilitation and installation of dental implants in areas that were previously not achieved. In addition, when used in aesthetic areas, it can promote a significant improvement in the affected area. The device is formed by an implant inserted intraosseous with screw and membrane, which allow the formation of the adequate space for bone growth.

2. Destina-se o presente a oferecer uma solução prática, segura e eficiente, através de uma resolução clínica, principalmente para casos/tratamentos em que há insuficiência óssea e as técnicas vigentes são resolvem adequadamente ou com previsibilidade.2. The present is intended to offer a practical, safe and efficient solution, through a clinical resolution, mainly for cases / treatments in which there is bone insufficiency and the current techniques are resolved properly or with predictability.

3. O dispositivo é formado por um implante inserido intra-ósseo, roscado internamente, onde é rosqueado um parafuso unido a uma membrana. Ao ser rotacionado há um distanciamento entre o implante intra-ósseo e a membrana unida ao parafuso, deixando um espaço para que haja o crescimento ósseo. Possuindo ainda um instrumento para auxiliar na remoção do implante intra-ósseo.3. The device is formed by an implant inserted intraosseous, internally threaded, where a screw attached to a membrane is threaded. When rotated, there is a gap between the intraosseous implant and the membrane attached to the screw, leaving a space for bone growth. It also has an instrument to assist in removing the intraosseous implant.

4. O dispositivo é formado por três parte principais: implante intraósseo, parafuso e membrana, desenvolvidos em titânio, material reabsorvível, biodegradável e similares.4. The device consists of three main parts: intraosseous implant, screw and membrane, developed in titanium, resorbable material, biodegradable and the like.

Petição 870180025066, de 28/03/2018, pág. 6/22Petition 870180025066, of March 28, 2018, p. 6/22

2/72/7

5. O implante intra-ósseo é inserido em uma cavidade criada previamente por fresas cirúrgicas, de tal modo que o mesmo fique fixo. Nestas condições, o parafuso, que pode ser desenvolvido em tamanhos e configurações diferentes de acordo com a necessidade, é inserido dentro deste implante intra-ósseo de tal modo que a parte da rosca fique inserida no implante. A rosca externa do parafuso é encaixada e rosqueada na rosca interna do implante intra-ósseo; a membrana fica interposta entre a superfície óssea e o tecido periosteal e o restante do parafuso fica a um nível acima da mucosa, permitindo a rotação do parafuso com uma chave digital.5. The intraosseous implant is inserted into a cavity previously created by surgical cutters, in such a way that it is fixed. In these conditions, the screw, which can be developed in different sizes and configurations according to the need, is inserted into this intraosseous implant in such a way that the thread part is inserted in the implant. The external thread of the screw is fitted and threaded on the internal thread of the intraosseous implant; the membrane is interposed between the bone surface and the periosteal tissue and the rest of the screw is at a level above the mucosa, allowing the rotation of the screw with a digital key.

6. A membrana é fixa no parafuso e possui seu movimento rotacional de forma independente, ou seja, ao rotacionar o parafuso, a membrana não realiza em conjunto esta rotação, apenas se distancia do osso.6. The membrane is fixed on the screw and has its rotational movement independently, that is, when rotating the screw, the membrane does not perform this rotation together, it only moves away from the bone.

7. A configuração externa do implante intra-ósseo não o permite rotacionar após sua inserção óssea. Deste modo, pode apresentar ângulos vivos (formato poligonal) ou sentido da rosca oposta ao sentido do parafuso adjunto à membrana; podendo ainda ser rosqueado externamente, neste caso é travado no osso de tal modo que se mantenha fixo durante o processo de distração óssea.7. The external configuration of the intraosseous implant does not allow it to rotate after its bone insertion. In this way, it can have sharp angles (polygonal shape) or direction of the thread opposite to the direction of the screw attached to the membrane; it can also be threaded externally, in this case it is locked in the bone in such a way that it remains fixed during the bone distraction process.

Inconvenientes observados atualmente:Currently observed drawbacks:

8. A cirurgia bucomaxilofacial tem tido muitos avanços no âmbito de reconstrução óssea. Os modelos atuais de reconstrução óssea, tecnicamente comprovados, podem ser resumidos em métodos de enxertia e distração óssea. Estas técnicas, apesar de comprovadas cientificamente, apresentam situações de uma relativa ineficiência e, além disso, grande dificuldade técnica de execução. Dentre as diversas8. Oral and maxillofacial surgery has made many advances in the field of bone reconstruction. The current technically proven models of bone reconstruction can be summarized in methods of bone grafting and distraction. These techniques, despite being scientifically proven, present situations of relative inefficiency and, in addition, great technical difficulty of execution. Among the

Petição 870180025066, de 28/03/2018, pág. 7/22Petition 870180025066, of March 28, 2018, p. 7/22

3/7 situações clínicas com necessidade de neoformação óssea, há situações em que estas técnicas não satisfazem a necessidade de reabilitação oral; por exemplo, situações onde há necessidade de ganho vertical de osso, frequentes em região posterior de mandíbula ou áreas estéticas.3/7 clinical situations with the need for new bone formation, there are situations in which these techniques do not satisfy the need for oral rehabilitation; for example, situations where there is a need for vertical bone gain, frequent in the posterior region of the mandible or aesthetic areas.

9. Atualmente não existe um dispositivo no mercado que consiga uma neoformação óssea através deste método.9. There is currently no device on the market that can achieve bone neoformation through this method.

Solução:Solution:

10. Portanto, pensando em oferecer uma solução prática, segura e eficiente, foi desenvolvido o produto em questão. Apresentando ainda diversos benefícios, que podem ser destacados em:10. Therefore, thinking about offering a practical, safe and efficient solution, the product in question was developed. Also presenting several benefits, which can be highlighted in:

• Redução de custos;• Cost reduction;

• Evita procedimentos mais invasivos e complexos;• Avoids more invasive and complex procedures;

• Pode substituir o enxerto ósseo;• Can replace the bone graft;

• Evita complicações ao usuário;• Avoids complications for the user;

• Eficiência no tratamento;• Efficiency in treatment;

• Pode reduzir o tempo de tratamento;• It can reduce the treatment time;

• Permite crescimento ósseo de forma eficiente;• Allows bone growth efficiently;

• Elevado potencial de comercialização;• High commercialization potential;

• Produto de necessidade comum;• Product of common need;

• Exequibilidade industrial;• Industrial feasibility;

• Inovações merecedoras deste privilégio de patente.• Innovations worthy of this patent privilege.

Estado da técnica:State of the art:

11. Até a presente data, não há no mercado, de modo operacional, um dispositivo que consiga promover uma neoformação óssea através da distração periosteal.11. To date, there is no device on the market that can promote bone neoformation through periosteal distraction.

Petição 870180025066, de 28/03/2018, pág. 8/22Petition 870180025066, of March 28, 2018, p. 8/22

4/74/7

12. Portanto, visando propor uma solução inédita e eficiente, foram realizadas pesquisas de anterioridades no Banco de Dados do IN PI Instituto Nacional da Propriedade Industrial e foram encontrados os seguintes processos:12. Therefore, in order to propose an unprecedented and efficient solution, previous searches were carried out in the IN PI Database, National Institute of Industrial Property and the following processes were found:

13. US 6758673 B2, depositada em 05/12/2001, sob o título de “Periosteal distraction. Devices and methods for gradual displacing of the periosteal tissue covering bones. The gap developing between the bone and the displaced periosteal tissue will be filled with bone callus as it is in distractionosteogenesis. The devices and methods allow formation of bone in distraction osteogenesis without cutting a segment of the bone.13. US 6758673 B2, deposited on 12/05/2001, under the title “Periosteal distraction. Devices and methods for gradual displacing of the periosteal tissue covering bones. The gap developing between the bone and the displaced periosteal tissue will be filled with bone callus as it is in distractionosteogenesis. The devices and methods allow formation of bone in distraction osteogenesis without cutting a segment of the bone.

14. EP 1765202 A4, depositado em 07/06/2005, sob o título de “Periosteal distraction. Devices and methods for gradual displacing of the soft tissues covering bones. The gap developing between the bone and the displaced soft tissue will be filled with bone callus as it is in distraction osteogenesis. The devices and methods allow formation of bone in distraction osteogenesis without cutting a segment of the bone. The devices and methods are particularly useful in dental implantology for vertical ridge augmentation by displacing the periosteal tissue and for sinus lift by displacing the Schneiderian membrane. The devices and methods can also regenerate soft tissue between the bone and the displaced soft tissue.14. EP 1765202 A4, deposited on 06/07/2005, under the title “Periosteal distraction. Devices and methods for gradual displacing of the soft tissues covering bones. The gap developing between the bone and the displaced soft tissue will be filled with bone callus as it is in distraction osteogenesis. The devices and methods allow formation of bone in distraction osteogenesis without cutting a segment of the bone. The devices and methods are particularly useful in dental implantology for vertical ridge augmentation by displacing the periosteal tissue and for sinus lift by displacing the Schneiderian membrane. The devices and methods can also regenerate soft tissue between the bone and the displaced soft tissue.

15. EP 2180843 A1, depositado em 18/07/2008, sob o título de Device and method for periosteal distractionosteogenesis. A device for periosteal distraction osteogenesis, comprises: a substantially plate shaped transport element (2) configured to be inserted into a subperiosteal interface zone (24) located between a face region (30) of a bone and a periosteum region (28) associated thereto, whereby a15. EP 2180843 A1, deposited on 07/18/2008, under the title Device and method for periosteal distractionosteogenesis. A device for periosteal distraction osteogenesis, comprises: a substantially plate shaped transport element (2) configured to be inserted into a subperiosteal interface zone (24) located between a face region (30) of a bone and a periosteum region (28) associated thereto whereby a

Petição 870180025066, de 28/03/2018, pág. 9/22Petition 870180025066, of March 28, 2018, p. 9/22

5/7 proximal side (4) of the transport element (2) is oriented towards said bone face region (30) and a distal side (6) of said transport element (2) is ori— ented away from said bone face region (30); - a mounting base (8; 8c, 8d) coupled to said transport element (2) through a pivotable connection (10; 10a); and actuation means for progressively moving said transport element (2) away from said bone face region (30) and thereby causing bone formation be— tween said bone face region (30) and said transport element (2). The mounting base (8; 8c, 8d) is configured for rigid attachment to a subperio— steal bone region (32) adjacent to said bone face region (30), and said actuation means comprise at least one threaded passage hole (14) in said transport ele— ment (2) for receiving therein a distraction screw (36).5/7 proximal side (4) of the transport element (2) is oriented towards said bone face region (30) and a distal side (6) of said transport element (2) is ori— ented away from said bone face region ( 30); - a mounting base (8; 8c, 8d) coupled to said transport element (2) through a pivotable connection (10; 10a); and actuation means for progressively moving said transport element (2) away from said bone face region (30) and thereby causing bone formation be— tween said bone face region (30) and said transport element (2). The mounting base (8; 8c, 8d) is configured for rigid attachment to a subperio— steal bone region (32) adjacent to said bone face region (30), and said actuation means comprise at least one threaded passage hole (14) in said transport ele— ment (2) for receiving therein a distraction screw (36).

16. WO 2003048347 A1, depositado em 05/12/2002, sob o título de “Periosteal distraction. Devices for gradual displacement of the soft tissues covering bones comprise a soft tissue displacer (77) for insertion to the bone-soft tissue interface and a displacing mechanism (81, 82) which moves the soft tissue displacer (77) from the bone so as to create a space between the bone and the soft tissue (79). This space between the bone and soft tissue will be filled with callus as it is in distraction osteogenesis without cutting a segment of bone. The devices are particularly useful in dental implantology for vertical augmentation by displacing the perosteal tissue (79) and for sinus lift by displacing the Schneiderian membrane. The devices and methods can also regenerate soft tissue between the bone and the displaced soft tissue (79).16. WO 2003048347 A1, deposited on 12/05/2002, under the title “Periosteal distraction. Devices for gradual displacement of the soft tissues covering bones comprise a soft tissue displacer (77) for insertion to the bone-soft tissue interface and a displacing mechanism (81, 82) which moves the soft tissue displacer (77) from the bone so as to create a space between the bone and the soft tissue (79). This space between the bone and soft tissue will be filled with callus as it is in distraction osteogenesis without cutting a segment of bone. The devices are particularly useful in dental implantology for vertical augmentation by displacing the perosteal tissue (79) and for sinus lift by displacing the Schneiderian membrane. The devices and methods can also regenerate soft tissue between the bone and the displaced soft tissue (79).

17. Conforme o resumo acima, os processos mencionados não possuem similaridade com o objeto da presente patente, motivo pelo qual17. According to the summary above, the mentioned processes are not similar to the object of the present patent, which is why

Petição 870180025066, de 28/03/2018, pág. 10/22Petition 870180025066, of March 28, 2018, p. 10/22

6/7 consideramos que não há impedimentos de ordem técnica nem legal para a obtenção do privilégio solicitado.6/7 we believe that there are no technical or legal impediments to obtaining the requested privilege.

18. Para uma perfeita visualização e compreensão da “DISTRATOR PERIOSTEAL PARA CRESCIMENTO ÓSSEO”, em questão, seguem os desenhos ilustrativos, onde:18. For a perfect visualization and understanding of the “PERIOSTEAL DISTRACTOR FOR BONE GROWTH”, in question, follow the illustrative drawings, where:

19. A fig. 1 - Apresenta vista superior do implante intra-ósseo;19. Fig. 1 - Presents a top view of the intraosseous implant;

20. A fig. 2 - Apresenta vista lateral do implante intra-ósseo;20. Fig. 2 - Presents a lateral view of the intraosseous implant;

21. A fig. 3 - Apresenta vista inferior do implante intra-ósseo;21. Fig. 3 - Presents a lower view of the intraosseous implant;

22. A fig. 4 - Apresenta vista lateral do implante intra-ósseo com o parafuso;22. Fig. 4 - Presents a lateral view of the intraosseous implant with the screw;

23. A fig. 5 - Apresenta vista em perspectiva do implante intra-ósseo com o parafuso;23. Fig. 5 - Shows a perspective view of the intraosseous implant with the screw;

24. A fig. 6 - Apresenta vista em perspectiva do dispositivo completo, sendo o implante intra-ósseo com o parafuso e a membrana.24. Fig. 6 - It presents a perspective view of the complete device, with the intraosseous implant with the screw and the membrane.

25. De acordo com a ilustração e em seus pormenores, o “DISTRATOR PERIOSTEAL PARA CRESCIMENTO ÓSSEO”, é constituído por um dispositivo de distração periosteal que permite um crescimento ósseo local através da separação gradual do periósteo em relação ao osso subjacente (1), propondo uma neoformação óssea em uma região determinada no corpo humano, para realizar reabilitações com implantes dentários, caracterizado por ser formado por um implante intra-ósseo (2), roscado internamente (3), que é fixado numa cavidade criada previamente por fresas cirúrgicas e recebe um parafuso (4) rosqueado em seu interior (4A), sendo este constituído por uma peça arredondada (5), levemente cônica (6), com orifício central (7) para25. According to the illustration and in its details, the “PERIOSTEAL DISTRACTOR FOR BONE GROWTH”, consists of a periosteal distraction device that allows local bone growth through the gradual separation of the periosteum in relation to the underlying bone (1), proposing a new bone formation in a specific region in the human body, to perform rehabilitation with dental implants, characterized by being formed by an intra-bone implant (2), internally threaded (3), which is fixed in a cavity previously created by surgical cutters and receives a screw (4) threaded inside (4A), which consists of a rounded piece (5), slightly conical (6), with a central hole (7) for

Petição 870180025066, de 28/03/2018, pág. 11/22Petition 870180025066, of March 28, 2018, p. 11/22

7/7 encaixe da parte superior do parafuso (8) formada por uma cabeça (9) com dente protuberante para encaixe (10); possuindo ainda uma membrana intermediária (11) constituída por uma chapa (12) com pequenos orifícios (12) que é fixada ao parafuso (13).7/7 fitting the upper part of the screw (8) formed by a head (9) with protruding tooth for fitting (10); it also has an intermediate membrane (11) consisting of a plate (12) with small holes (12) that is fixed to the screw (13).

26. Pelas vantagens que oferece e por revestir-se de características verdadeiramente inovadoras, o “DISTRATOR PERIOSTEAL PARA CRESCIMENTO ÓSSEO” reúne as condições necessárias para merecer a Patente de Invenção.26. For the advantages it offers and for having truly innovative characteristics, the “PERIOSTEAL DISTRACTOR FOR BONE GROWTH” meets the necessary conditions to deserve the Patent of Invention.

Claims

1 ^a ) “PERIOSTEAL DISTRACTOR FOR BONE GROWTH” consists of a periosteal distraction device that allows local bone growth through the gradual separation of the periosteum from the underlying bone (1), proposing a new bone formation in a determined region in the human body , to perform oral rehabilitation, characterized by being formed by an intraosseous implant (2), internally threaded (3), which is fixed in a cavity previously created by surgical cutters and receives a screw (4) threaded inside (4A) , which consists of a rounded piece (5), slightly conical (6), with a central hole (7) for fitting the upper part of the screw (8) formed by a head (9) with protruding tooth for fitting (10); also having an intermediate membrane (11) consisting of a plate (12) with small holes (12A) and a central hole (12B) that is fixed to the screw (13).

2a) “PERIOSTEAL DISTRACTOR FOR BONE GROWTH”, according to claim one, is characterized by the screw (4), when rotated, allowing a distance between the bone surface (2) and the membrane (11) attached to the screw (4), leaving a space for bone growth.

3a) “PERIOSTEAL DISTRACTOR FOR BONE GROWTH”, according to claim one, is characterized by the membrane (11) being interposed between the bone surface and the periosteal tissue, and the rest of the screw (8) being at a level above the mucosa, allowing the rotation of the screw with a digital key, also having the membrane (11), its rotational movement independently.