DE102007029067A1 - Bone structure-material donor, particularly for needful supply of bone material to be applied during patient treatment, has material chamber filled with bone substitute material and another material chamber - Google Patents

Abstract

The bone structure-material donor has a material chamber filled with bone substitute material. Another material chamber is provided for filling with autogenously bone material. Both the material chambers are connected at the output with a common discharge opening for the material.

Description

The This invention relates to a bone augmentation material dispenser, in particular for the demand-oriented provision of during a Patient treatment to be applied bone material.

One common, usually even primary Target in preimplantoligical or other surgical procedures, especially in the dental field including the preservation of the bony Structures of the patient. If, however, in the area of the alveolus An extraction or trauma missing bone walls, is usually sought, the remaining bone structures for Socketpreservation by suitable osteoconductive or -inductive replacement materials to support, so that subsequently in the healing process rebuilding the affected Structures particularly favored becomes. However, this prophylaxis is particularly effective in the dental field not always. Many dental patients go only after years of Tooth loss in treatment and desire a rehabilitation, if a conventional prosthetic restoration due to extreme Atrophy no longer possible is. Also the change Implant positioning away from the surgically oriented to the prosthetically meaningful in the context of the so-called backward Planning requires the restoration of bony defects.

For the augmentation or targeted support the healing-related regeneration or new formation of bone substance Different products are available, with the (also referred to as "gold standard") preferred Approach particularly in the extensive vertical regeneration still the patient's own bone is. As this, however, at best in limited quantity available has been, for quite some time after suitable replacement or supplementary materials searched. about the millennia became the most diverse in this context Materials, such. B. coconut shells, but also already dog bone, for the Implantation used.

since the second half In the 19th century, for example, by Ollier, replacement materials after their origin in autogenous, allogenic and xenogeneic bone grafts or substitute materials. Autogenic bone means that donor and recipient the same individual. Even today, autogenous bone is referred to as the "gold standard" and as preferred therapeutic approach since it is the only one Graft material that has an osteogenic property, d. H. the graft is directly involved in education and development involved in bones. The great Disadvantage, however, lies in the extraction of autogenous bone material, which often requires a second intervention. Serve in the dental field as extraoral donor regions often the iliac crest, the tibial plateau or the skullcap. Intraoral can bone from the mandibular symphysis, the maxillary tuber or the ramus mandibulae. The advantage of the intraoral Bone removal with the easy to use BoneTrap, lies in reduced morbidity for the Patients.

in the Unlike autogenous bone has a so-called allogeneic bone graft though not the same individual, but the same species as Origin. The graft can be both from a living second person or a corpse. The advantage of tissue bank-controlled allografts of body donors lies in the great availability. However, there is a problem with the use of such graft materials as with organ transplants always a residual risk in terms of transmission of infectious diseases (wherein, for example, transmission of HIV has a 1: 1.6 million chance) and antigenic defense responses Recipient, since even allografts of corpses cause immune reactions in recipients can. To the antigenicity allogeneic bone is usually lyophilized, so that he then mineralized (FDBA = Freeze Dried Bone Allograft) or in demineralized form (DFDBA = Demineralized Freeze Dried Bone Allograft). Both have opposite autogenous Bone grafts have the disadvantage of missing osteogenic property, d. H. when augmented with allografts, it always has to with a longer bone formation time be counted.

FDBA and DFDBA are designed both through osteoinduction (= the ability to to support the differentiation of mesenchymal stem cells) as well through osteoconduction (= the ability to To support bone growth along the surface, d. H. a guardrail for to represent the bone-forming cells) form bones. The difference between FDBA and DFDBA lies in the mineralization or demineralization. A demineralization should thereby bone collagen and growth factors, such as Bone Morphogenetic Proteins (BMPs).

In addition to autogenous and allogenic bone grafts, so-called bone replacement materials have been used more and more in recent years (currently there are 43 different bone replacement materials available on the bone replacement in dental surgery on the German market). A major advantage of bone replacement materials is that they do not require a second intervention with the donor. Another advantage of many bone replacement materials is due to their syn the lack of infection risk, so that a transmission of viruses, bacteria and also prions is very small. Only bone substitute materials of animal origin (= xenogeneic bone substitute materials) have a minimal residual risk for the transmission of prions, although the actual production process, the knowledge and the verification of the origin of the raw material almost exclude a protein transfer. Nevertheless, there is a duty to inform about these bone replacement materials. In addition to the absence of the second intervention and the risk of infection, a bone substitute material should meet other requirements, such. As a sufficient stability, an optimal absorption behavior, good processing and manageable cost development.

So far no bone substitute material could meet all requirements to 100%, and Thus, no bone substitute material has yet been developed which replace the autologous bone as a preferred or "gold standard" Main reason is as well as with the allograft, in the missing osteogenic Potency, although in some studies with some bone replacement materials an osteoinductive property is described. The request, Which probably almost all bone substitutes used today fulfill, is a good osteoconduction, d. H. that the replacement materials a kind of guide rail for all form cells involved in bone formation.

Initially came Bone replacement mainly used in oral and maxillofacial surgery. It was more autologous in traumatology as well as in tumor surgery Bones used for reconstructive purposes. Only the defect replenishment after Cystectomies could occur in the dental Surgery using bone replacement materials are well cared for. But for many years, with the steady growth of Implantology a bone substitute in any surgically oriented practice no longer indispensable. Were years ago often economic Reasons, d. H. that the cost of an implant over the possibilities of the patient, the limiting factor, it can be seen today, that often the missing bone supply makes an implantation impossible can, since at least a vertical dimension of 6-8 mm and needed in the transverse direction of 5 mm. And right there can then be a bone replacement remedy. For big bone deficits However, a substitute material is not enough. The "gold standard" is always there still in the transplantation of autogenous bone alone or at smaller graft retrieval in combination with a bone replacement material.

A Such use of a combination of autogenous bone and a Bone replacement material and / or substances that promote bone growth promote, is therefore to be preferred in view of the described shortage. To do this the substances or substances mentioned are mixed. The mixing usually takes place in an extra for that provided vessel or reservoir.

It There are several methods for obtaining autogenous bone. The bone is usually made using a bone-rich technique using metal-cutting techniques Part of the body taken. Most of the bone is from the upper or lower jaw, off taken from other areas at the head or at the hip. It usually comes scraping, oscillating, pulsating and / or rotating cutting Tools for use. Either the autonomic bone after the Splitting off from the human body with help tools (probe, tweezers, etc.) laboriously collected, or it gives a technique that while the bone splitting is used and the bone or the bone cane right in one for that provided vessel or a reservoir receives.

So can z. B. in the product "Safe-Scaper" the bone chips Scraping be taken directly into a storage container. The product "Bone-Trap" is a filter, the bone chips from Blood and other human secretions separates. Before the introduction an implant or dental implant, a hole is drilled in the bone. While of drilling will be the blood, other secretions and the resulting Sucked away bone chips. The "bone trap" is located in Absaugstrang. In this way you can the bone chips from the blood and the rest Secretions are separated and used for bone formation. to simplified removal of the bone chips from the bone trap will be one Rod introduced into the bone trap, which has a movable punch drives the bone chips pushes out of the bone trap.

If not enough autonomous bone available is bone autonomous bone usually bone replacement material and / or a substance that promotes bone growth, added. The bone substitute material and / or the substances that promote bone growth mostly in one for that stored container stored. For simplified removal of the bone substitute material and / or the Substances that promote bone growth, the container can be squeezed or has one sliding stamp, the material or substances the container pushes out.

1a and 1b show a container, which has a stamp provided for emptying.

Should the autonomous bone with the bone substitute material and / or a or several substances that promote bone growth usually happens separately outside the containers, for storing the bone and the bone substitute material and / or one or more substances that promote bone growth are. Then another container needed in which the mixing of said materials into an applicable, takes place as a bone-forming material suitable mass. The mixing can also be done directly at the bone defect site of the patient.

A Such provision of administrable bone structure substance However, is relatively expensive, and also in an undesirable manner the flexibility and also during the actual therapy achievable availability is limited.

Of the The invention is therefore based on the object, a bone structure material dispenser specify a reliable and flexible, especially needs-based provision of several Components or constituents of formed bone augmentation material allows in a particularly simple manner.

These Task is solved according to the invention with a first filled with bone substitute material chamber and with a second, to be filled with autogenous bone material provided material chamber, both Material chambers on the output side with a common discharge opening for the material are connected.

advantageous Embodiments of the invention are the subject of the dependent claims.

Around the mixing of bone and bone substitute material and or one or more substances that promote bone growth can simplify at least two storage containers be connected to each other. The connection can be made via a on the containers attached training and or Anformung take place. These off and or Anformung should be designed so that the bone substitute material and or one or more substances that promote bone growth promote filled container in the bone filled container engages and or vice versa.

A particularly simple construction especially with regard to a reliable and reproducible sharing of necessary components for Generation of the bone structure substance is achievable by in an advantageous embodiment of the first and the second material chamber each one emptying punch is assigned, the emptying punch for a synchronized Emptying are coupled together. Both containers have a movable one and provided for emptying stamp, they can also with each other be connected and thus when emptying or during application the substances over the discharge opening be moved simultaneously. By this simultaneous shifting and thus simultaneous emptying can on the one hand the bone and the bone substitute material and / or one or more substances, that promote bone growth, on the other hand applied together and thus without further active Influence of the user during of emptying are mixed together. This simplifies with high operational safety, the mixing process, shortens the Time of surgery and reduces its risk.

To the Connecting and simplified mixing is particularly suitable for a component, which preferably over at least three connections features. The at least two chambers for storing bones on the one hand and the bone substitute material and / or one or more substances, that promote bone growth, are advantageously the output side with this component connected to its third port in the style of a Y-or Tee expediently with the discharge opening connected is. By pressing the two punches or in a preferred embodiment of each other connected stamps, the materials are pressed into the component or tee and leave the component together through another connection or the discharge opening.

For the needs-based provision of the bone-forming material formed from the components, the components should advantageously be mixed appropriately. For this purpose, the discharge opening of the bone augmentation material dispenser provided for the material is preceded by a mixing element in an advantageous development. Namely, a favorable method for automatically and reliably mixing bones on the one hand and bone substitute material and / or one or more substances promoting bone growth during discharge is that the bone or the autogenous bone material on the one hand and the bone substitute material and / or one or more substances which promote bone growth, on the other hand, first each introduced into separate containers or material chambers and are transferred when emptying both containers in the exit region of both containers or material chambers in another container, a chamber or a conduit, in which before the final leaving the containers a mixture takes place. The mixing element preferably arranged in the interior of the component or a line can be designed in particular advantageously as a spiral, as a wing mixer or as another suitable component which swirls the flow of the materials, so that the substances are mixed during the flow through the component without further external intervention ,

2a . 2 B and 2c show in the manner of an embodiment of the invention a possible design of such a component. It eliminates three connections, two of which advantageously have the same orientation. The third port is advantageously mounted opposite the other two ports in the manner of a Y or T-piece. For improved mixing is suitable as a mixing element, a spiral-shaped component, which can be inserted into the third, connected to the discharge port.

In very particularly advantageous embodiment of the bone structure material dispenser are all of them with said components or constituents of the bone building material made in contact sterilizable components, so that they neither chemically nor biologically with the bone and the bone substitute material and / or the substance (s) that promote bone growth. Advantageously, these components are sterilized after manufacture and packed sterile.

In a particularly advantageous embodiment, the containers or material chambers permanent, permanent or insoluble with each other connected. Preferably, the first and the second material chamber are for this purpose arranged in a common housing or thus form a component which has at least the two mentioned Has chambers. This container can in turn be composed of one or more components and / or be connected to other components.

The number of chambers may vary as well as their geometric arrangement. 3a . 3b . 3c show in the manner of an embodiment possible variants of the arrangement of chambers, wherein at least one of these chambers is filled with a bone substitute material and / or one or more substances that promote bone growth. The unfilled chamber (s) are characterized in that advantageously at least one wall is at least partially designed like a sieve or at least one sieve is inserted and / or attached in at least one chamber.

It are in this embodiment also at least two of the chambers each with a movable Equipped stamp, which is intended for emptying the chambers, wherein the punches are also preferably connected to each other. These Stamps preferably have the geometric shape of the emptied Chamber. This shape can be round, oval, or angular or a combination to accept these forms. Preferably, the punches have in their Geometry a partial surface a circle.

In at least one of the at least and preferably two ports or Discharge lines of these chambers is preferably a component inserted, which in the manner of a mixing element when emptying the chambers the flow so influenced that the mixing of the located in the chambers Substances favored becomes. This component is preferably placed where all substances are in a channel.

The at least two chambers, wherein at least one of these chambers with Bone substitute material and / or one or more substances containing the Promote bone growth, filled is, preferably, all interconnected, so that an exchange of gases, liquids and other substances (bone and bone substitute material and or one or more substances that promote bone growth) take place can.

In very particularly advantageous embodiment of this embodiment of bone augmentation material dispenser are all of them with the mentioned components or constituents of the bone augmentation material in contact parts sterilizable executed, so that they are neither chemically nor biologically with the bone and the bone substitute material and / or the substance (s) that promote bone growth. Advantageously, these components are sterilized after manufacture and packed sterile.

In a particularly advantageous embodiment, an empty chamber is centrally located in the vessel. Around this chamber are at least one further chamber filled with bone substitute material and / or one or more substances promoting bone growth, such as in the manner of another embodiment 3d . 3e is shown. Advantageously, one of the material chambers is thus designed as a central channel, around which a number of further material chambers, preferably in the manner of segmental chambers forming a circumferential jacket space in their entirety, are arranged.

Preferably, there are four more chambers around the central chamber, preferably two opposing chambers with bone and / or one or more substances that promote bone growth are filled. At least one of the partitions between the central chamber and the outer unfilled chambers is preferably at least partially provided with holes (area per hole suitably less than 4 mm ² ) and thus shaped like a sieve.

Of the Advantage of multiple chambers in a container or interconnected Containers, wherein at least one chamber or container of bone substitute material and / or one or more substances affecting bone growth promote, is filled, is in particular that autogenous bone z. B. by suction taken during drilling or other metal cutting operations and this Chamber be fed without further treatment measures can and when emptying the chambers a mixture of bone and bone substitute material and / or one or more substances affecting bone growth promote, present. In alternative or additional advantageous embodiment, which is generally an immediate use the suctioned or otherwise ingested, autogenous bone material containing material with reliable removal unusable because too big Components allowed, the second, is intended for this material Material chamber upstream of a filter element upstream.

By the filling more than one of the at least three chambers has the advantageous opportunity to choose when emptying, whether one or more of the bone substitute material and / or a or more substances that promote bone growth, filled chambers deflated and then be mixed with autogenous bone. That way that can mixing ratio between autogenous bone and bone substitute material and / or a or more substances that promote bone growth and especially selected according to need become. For this flexibility in providing the bone augmentation material even further favor, is at least in another or alternative advantageous embodiment one of the material chambers downstream of a metering valve.

The container with the extra Components can consist of metals, metal oxides or glass, but are preferably made of plastic.

• 1. Behältnis mit Stempel und Stab zum entleeren von Substanzen (a geschlossen)(b offen)
• 2. Y-Verbinder mit und ohne Mischelement (a geschlossen) (b offen) (c offen mit Spirale)
• 3. unterschiedliche Anordnungen für Kammern
• 4. Zentrale Kammer mit Kammern außen herum

The figures, in which exemplary embodiments of the invention are shown, show:

• 1. Container with stamp and rod for emptying substances (a closed) (b open)
• 2. Y-connector with and without mixing element (a closed) (b open) (c open with spiral)
• 3. different arrangements for chambers
• 4. Central chamber with chambers outside

Separate Elements, the advantageous developments of the bone structure material dispenser are of course in any way and not limited to the respective individual example advantageous combinable with each other.

1a shows an exploded view of a container 3 with a stamp 2 and a slider 1 , 1b shows an assembled construction of a chamber in a container 3 that is about the operation of the slider 1 the stamp 2 can be moved and emptied.

2a shows a component with three connections. In 2 B is the component of 2a shown cut open. It has two entrances which have a thickening and an outlet opening into a discharge opening. In 2c is in the output as a mixing element a component 5 inserted, which swirls through flowing media and favors the mixing in this way. 2d shows a component 6 which has an entrance 61 and an entrance 62 both in a chamber provided as a mixing element 63 lead. In the chamber 63 will be media that are beyond the inputs 61 and 62 in the chamber 63 arrive, mix and leave the chamber 63 over the exit 64 ,

3a - 3d show different possibilities several chambers 71 in a component 7 to arrange. The number of chambers can be between 2 ( 3f ) and many vary. In 3e shows a container 7 with chambers 71 and 72 that can take on different sizes and shapes. The outer geometry of the container may vary.

4a shows a container 7 with a chamber 71 which is characterized in that it is externally formed over formations and formations ( 73 and 74 ), which favor the attachment of other components. In a favorable embodiment, several of these containers can be fastened together by using the interlocking protrusions and formations ( 4b ). The attachment of at least two containers can also be possible with tools and / or other components.

5a shows a container having inwardly facing moldings. 5b shows a component 8th , which has on the outside of formations. This part also has holes that can be used as a filter. The holes are preferably not evenly distributed over the component. Will the component 8th out 5b as in 5c pictured in the container 7 out 5a Introduced, the formations of the Be hälters 7 in the formations of the component 8th and the chambers a, b, c, d and e form ( 5c ).

5d shows the exploded view of a container in which one can store bone substitute material and / or one or more substances that promote bone growth. Furthermore, the construction features 5d through a filter that can secrete bone chips from blood and other secretions. After filling with bone chips, the bone and the stored bone substitute material and / or one or more substances promoting bone growth may be forced out of the structure. When pressed out, the media and substances are mixed.

The construction otherwise serves as a bone-building material dispenser. The construction includes a container 7 into which a component 8th is introduced, which has lateral holes. In three of the five chambers will each have a stamp 2 brought in. Subsequently, the container 7 with two closures in the connections 9 and 10 locked. The closures each have an opening that acts as an inlet and outlet. The connection 9 has two more openings. About these two openings and the third opening of the slider 1 introduced, over which the three stamps can be moved. The holes in component 8th , which have a passage to the chambers c and e, serve as a filter. About the holes in component 8th , which have a passage to the chambers b and d, enters the bone substitute material and / or one or more substances that promote bone growth in the chamber a.

5e shows a sectional view of the assembled construction or else the bone structure material dispenser. The direction of the arrow shows the course of the air when sucking away bone chips. The Stamp 2 in the component 8th prevents the air, secretions, blood and bone chips from passing directly through the component 8th be directed. The air, liquid media and solid substances are made along the arrows starting from the inlet 10 into the chamber a of the component 8th directed. In the component are solid substances that are larger than the openings in the component 8th , separated from smaller substances, liquid and gaseous media. The smaller substances, liquid and gaseous media pass through the openings in the component 8th into the chambers c and e. from there you get behind the stamp 2 again through the openings of the component 8th into the chamber a. From there, they leave the construction via the connection 9 , The bone chips are larger than the openings in the component 8th be in the chamber a beginning on the stamp 2 remain and fill the chamber a.

5f Figure 3 illustrates the process of mixing bone replacement material and / or one or more bone growth promoting substances and bone chips, and construction over the port 10 leave again. In the chambers b and d are bone replacement materials and / or one or more substances that promote bone growth. In the chamber a there are bone chips. Be the stamp 2 over the slider 1 operated, the bone substitute material and / or one or more substances that promote bone growth, via holes in the component 8th directed into the chamber a. The holes in component 8th which are a connection from the chambers b and d to the chamber a, are preferably all together smaller in area and in particular smaller by half than the cross-sectional area of the chambers b and d. In this way, pressure builds up in the chambers b and d when the pistons are actuated via the slide. Due to this pressure, the flow rate of the bone substitute material and / or one or more substances promoting bone growth increases in the bores of the component 8th and flows with increased speed in the chamber a filled with bone chips. This increase in flow rate favors the mixing of bone chips and bone replacement material and or one or more substances that promote bone growth.

1

pusher

2

stamp

3

container

4

component

5

component

6

component

7

container

8th

component

9

connection

10

connection

61

entrance

62

entrance

63

chamber

64

output

71

chamber

72

chamber

73

formation

74

conformation

Claims (7)

Bone structure material dispenser with a first, filled with bone replacement material material chamber and with a second, provided for filling with autogenous bone material material chamber, both material chambers on the output side with a common discharge opening for the material is connected. The bone augmentation material dispenser of claim 1, wherein the first and the second material chamber in a common casing are arranged. Bone structure material dispenser according to claim 1 or 2, whose discharge opening for the Material a mixing element is connected upstream. Bone structure material dispenser according to one of claims 1 to 3, the second material chamber on the input side, a filter element upstream. Bone structure material dispenser according to one of claims 1 to 4, whose first and second material chamber each have a discharge plunger is associated with the emptying punches for a synchronized emptying coupled together. Bone structure material dispenser according to one of claims 1 to 5, wherein at least one of the material chambers a metering valve is downstream. Bone structure material dispenser according to one of claims 1 to 6, in which one of the material chambers designed as a central channel is, around it, a number of other material chambers, preferably in the manner of a circumferential jacket space in its entirety forming segment chambers are arranged.