EP2020963A2

EP2020963A2 - Device for cleaning bones or bone pieces

Info

Publication number: EP2020963A2
Application number: EP07718395A
Authority: EP
Inventors: Aleksandar Vujanic; Christoph Kment; Dusan Vujanic
Original assignee: IMA Integrated Microsystems Austria GmbH
Current assignee: IMA Integrated Microsystems Austria GmbH
Priority date: 2006-05-15
Filing date: 2007-04-19
Publication date: 2009-02-11
Also published as: WO2007131249A2; WO2007131249A3; AT9318U1

Abstract

In a device for cleaning bones (18) or bone pieces, with a central cleaning unit (5) and with containers that can be connected to the latter and that hold cleaning liquid and used cleaning liquid, the central cleaning unit (5) and the containers are designed as exchangeable parts and are connected releasably to a receiving unit (2), and the containers are designed as bags (4) and are received at least partially in pressure chambers (3) secured on the receiving unit (2).

Description

Device for cleaning bones or pieces of bone

The invention relates to a device for cleaning bones or bone pieces with a central cleaning unit and to these connectable containers for cleaning fluid and spent cleaning fluid.

Worldwide, a very large number of people are implanted with bone. Incidentally, since body-related material provides relatively high compatibility, bone pieces are also suitable as a carrier material for bringing medication directly to defined application sites. Tissue banks have been set up to meet the need for implant material. In order to ensure a corresponding amount of implant material, it has already been proposed to subject cancellous bones to cleaning. The cleaning methods that have become known in this context are usually time-consuming and technologically complex, with correspondingly high criteria being set for cleaning with regard to the desired application in order to prevent a risk of infection.

The cancellous structure of the bone substance is preferably used for such a cleaning, in which, however, cleaning is made more difficult by the high number of channels, cavities and blind holes. A corresponding surface cleaning does not lead to the desired result with regard to this structure. For example, to ensure proper cleaning, granulation of bone into very small pieces followed by cleaning in a drum under the action of a variety of different liquid chemicals has been proposed. A disadvantage of this method is that the granules obtained in this way are not easy to handle for larger implants. Bone implants are adapted to the particular purpose and it is therefore advantageous if the respectively required shape of the implant can be made by cutting from a larger piece of bone. Larger pieces of bone, however, are again only to be cleaned with greater effort, the known cleaning methods are usually also so time-consuming that it is hardly possible to provide the appropriate amount of material required also in an economical manner.

From WO 2004/075935 Al a cleaning method and a corresponding device has already become known in this connection, in which the bones to be cleaned are first cut into disk-shaped parts, after which the cleaning agent is pressurized via one or more nozzles onto the surface of the disk-shaped parts is sprayed, wherein preferably the spraying of the bones takes place simultaneously from two or more directions. Due to the pressure application, a correspondingly deep penetration into the channels, cavities and blind holes of the spongy structures was ensured in this embodiment, wherein mechanical cleaning was made possible in addition to the chemical cleaning due to the mechanical impulse applied by pressure application in each case.

Another method or apparatus for cleaning bones can be found in US 2002/0081959 A1. The bone is hereby cut into small pieces, washed with water, dried and then treated with lipophilic solvents, e.g. Ethanol, freed from lipids. The bone material is in this case sprayed by means of nozzles with the cleaning medium under pressure, wherein a plurality of nozzles are disclosed in a circular arrangement, wherein the lower part of the nozzles is rotatably mounted.

To obtain the desired purity, as required in particular in a cleaning of bones, which in the sequence to be used as an implant material, the previously known cleaning devices must be completely disinfected after each cleaning process. In this case, the spent cleaning liquid must first be removed from the cleaning unit and disposed of accordingly, after which the cleaning unit itself is completely cleaned using appropriate disinfectants or by ultrasound or by irradiation in order to be usable again for a subsequent cleaning operation. Such disinfecting is both time-consuming and expensive, and therefore, the present invention aims to provide a cleaning device which eliminates the need for disinfecting between each cleaning operation.

To solve this problem, the device according to the invention is essentially characterized in that the central cleaning unit and the container are formed as replacement parts and releasably connected to a receiving unit and that the container is formed as a bag and at least partially accommodated in fixed to the receiving unit pressure chambers. Due to the fact that those components of the cleaning device which come into direct contact with cleaning fluid or soiled cleaning fluid and the bone or bone piece to be cleaned are designed as replacement parts, these parts removed after each cleaning procedure can be removed in a simple manner and by a correspondingly new one Parts are replaced. Disinfecting the soiled parts is therefore no longer necessary. The central cleaning unit and the containers for the cleaning liquid and the spent cleaning liquid are thus formed as disposable or disposable parts, for ease of interchangeability, these disposable parts are detachably connected to a receiving unit. The container, which recording the cleaning fluid or the used cleaning fluid serve, according to the invention are designed as a bag, whereby a cost-effective training is ensured, since usually with cheap plastic bags Auslangen can be found. According to the invention, the bags are at least partially accommodated in pressure chambers defined on the receiving unit, and after a corresponding pressure has been built up in the pressure chamber, the cleaning liquid contained in the bag is placed under a corresponding pressure, without the bag itself being stressed in any way.

In this case, two bags are preferably used, one bag being filled with fresh cleaning liquid and the other bag being used for receiving the used cleaning liquid. The cleaning liquid thus flows from the bag filled with fresh cleaning liquid through corresponding nozzles through the central cleaning unit and can then be collected in the bag disposed opposite the first bag for the spent cleaning liquid.

In order to be able to carry out one or more further cleaning steps after such a first cleaning step using the same cleaning liquid, the design is preferably developed in such a way that the pressure chambers and the central cleaning unit are pivotably mounted about a common pivot axis. In this case, the relevant parts of the entire device can be pivoted, for example, by 180 ° after a first cleaning step, so that the bag filled with at least partially used cleaning liquid enters the position of the bag originally filled with fresh cleaning liquid, whereupon a further cleaning step passes through the at least partially ver - Needed cleaning fluid can be made through the cleaning unit. In order to apply the cleaning fluid under a corresponding pressure to the bone or bone piece to be cleaned, the embodiment is preferably developed in such a way that the pressure chambers each have closure means for sealing the bag in a fluid-tight manner. Thus, if the bag is suitably closed, a corresponding pressure in the pressure chamber and therefore at the same time also in the bag can be built up, the application of the cleaning liquid in the sequence preferably via a separate pressure line to ensure that the liquid outlet via a correspondingly small, through the Pressure line defined passage cross section under a correspondingly high pressure. For this purpose, the training is preferably further developed such that the bag is connected to a pressure line which connects the bag, bypassing the closure means with the central cleaning unit.

In order to be able to build up a corresponding pressure in the pressure chambers, the pressure chambers preferably each have a pressurized water connection, wherein, for example, a conventional H ₂ 0 standard connection can be used.

In order to ensure efficient cleaning, the embodiment is further preferably developed in such a way that the cleaning unit has a plurality of nozzles, which are fed by the pressure line. In order to ensure an application of the cleaning liquid to as many surfaces of the bone to be cleaned as possible, a plurality of nozzles is preferably arranged on opposite sides of the bone holder in the cleaning unit. The axes of the nozzles can in this case be arranged substantially parallel to one another. Preferably, the training is developed such that the nozzles are at least partially oriented in directions different from each other, so that the application of the Cleaning liquid can be made simultaneously from different directions. The nozzles may in this case preferably be designed with an adjustable spray angle and / or adjustable spray direction.

Because the cleaning agent is sprayed onto the surface under pressure via one or more nozzles, a corresponding penetration into the channels, cavities or blind holes of spongy structures can also be ensured. Due to the mechanical impulse applied in each case by the application of pressure, in addition to the chemical cleaning, a mechanical cleaning is made possible, wherein, in particular with the choice of correspondingly easily evaporating cleaning agents, such as diethyl ether, after the impact of the liquid jet together with the mechanical cleaning by the evaporation a particularly intensive and pore-deep cleaning of the cavities and blind holes as well as a deep penetration into channels is ensured.

If the cleaning agent is ejected through a plurality of nozzles with mutually different axis of their beam, the complex surface structure of cancellous bone substances can be taken into account. With appropriate nozzle heads such a plurality of differently oriented nozzles can be realized in a simple manner, being used with advantage as a cleaning agent for the spray cleaning diethyl ether and / or alcohol. In particular, the use of diethyl ether under a pressure of about 2 to 3 bar results in the impact of the detergent to "micro-explosions" and evaporation, with maximum protection of the surface structure by the formation of turbulence in the micro-cavities mechanical and chemical cleaning in a very short time succeed. The required cleaning time can be further reduced by the fact that the bone discs and / or the nozzles are pivoted during the spraying process. After the cleaning process, in which initially a lipid freedom can be ensured by selecting appropriate detergents, for which, for example, a multiple treatment with ether and / or alcohol is expedient in the further treatment steps with oxidants and buffer solutions, the elimination of germs and an optically attractive appearance Achieved bone. However, these subsequent steps need not be performed by spraying, but can also be realized by inserting the bones or bone slices in the solution and occasionally panning.

In order to create defined and repeatable conditions when spraying the bone or bone piece with cleaning liquid, it is preferably provided that the cleaning chamber has a holder for the bone or bone piece to be cleaned. The holder may in this case preferably be rotatably mounted so that spraying can take place from several sides in a simple manner. In order to be able to realize the drive for the rotation of the bone holder in the simplest possible way without external energy sources, the training is preferably further developed such that the holder is arranged on an impeller whose drive is formed by a drive wheel associated with the impeller, the is fed by cleaning fluid from the bag.

Finally, in order to enable a multiple use of the same cleaning liquid before the elements of the cleaning device formed as disposable parts are exchanged, it is preferably provided that the bag is connected to the cleaning unit with the interposition of a filter. In such a filter, the coarsest impurities are trapped so as not to come in contact with the bone to be cleaned again in the sequence. The invention will be explained in more detail with reference to an embodiment schematically illustrated in the drawing. 1 shows a front view of the cleaning device according to the invention and FIG. 2 shows a side view. 3 shows a front view of a modified embodiment of the device according to the invention.

In Fig.l a trough 1 is designated, which receives a bone cleaning device. A receiving unit 2 is provided, on which a central cleaning unit 5 is releasably fixed. In addition to the central cleaning unit 5, two pressure chambers 3 are attached to the receiving unit 2, each receiving a bag 4, such as an elastic pressure bag. As can be seen in particular from Figure 2, the pressure chambers 3 are made in two parts and have a base part 19 and a cover part 20, wherein the cover part 20 is designed to be removable in order to facilitate the insertion of the bag 3. After insertion of the bag 3, the lid part 20 is placed, with a circumferential seal 7 is provided to ensure the appropriate tightness of the pressure chamber 3. The pressure chambers 3 each have a vent 6 and closure means. The closing of the bag 4 can in this case be such that an outlet opening of the bag between the base part and the lid part 20 of the pressure chamber 3 is clamped. Alternatively, a separate closure lid can be provided, as is designated, for example, in the modified embodiment according to FIG.

To the pressure bag 4, a respective pressure line 8 is connected, which passes through the wall of the pressure chamber 3 and is connected to the cleaning unit 5. The cleaning unit 5 has on two opposite sides in each case a plurality of nozzles 15, which are directed against the bone piece 18 to be cleaned, which is formed in the present case as a bone slice. The bone piece 18 is held on an impeller 13 which is rotatably mounted about an axis 12. The holder of the bone piece 18 may in this case be formed, for example, by radial webs, as they are denoted by 17. The impeller 13 is associated with a drive nozzle 14, which directs a liquid jet against the blades of the impeller 13 and thereby causes the impeller 13 in rotation.

In the following, the operation of the bone cleaning device according to the invention will be described in more detail. As already mentioned, the device consists of a disposable insert and reusable components. The disposable component consists of two bags 4, which open into a common cleaning unit 5. One of the bags 4 is filled with cleaning liquid. At the beginning of the cleaning process, the cleaning unit 5 is opened and a piece of bone, for example a bone slice, inserted into the holder 17 of the impeller 12 and fixed there. Thereafter, the cleaning unit 5 is closed, whereupon the cleaning unit 5 is inserted with the attached bags 4 in the rotatably mounted receiving unit 2, wherein the bags 4 are received in the respective pressure chambers 3. The full bag filled with fresh cleaning fluid is at the bottom and the empty bag at the top. Thereafter, the pressure chambers 3 are closed, wherein the full, filled with cleaning liquid bag is sealed. Depending on the variant, the sealing takes place in the region of the bag (design according to FIG. 1 and FIG. 2) or in the region of the cleaning chamber neck, wherein the bag seal is designated 9 (embodiment according to FIG. 3).

The tub 1 is closed to protect the environment from splash water. Thereafter, the receiving unit 2 is pivoted together with the attached parts of the cleaning device by 180 °, so that the full, filled with fresh cleaning liquid bag 4 comes to rest. The corresponding pivot axis may in this case according to the line 22 in Figure 2 or according to the line 23 in Fig.l run. Thereafter, the vent valves 6 are opened so that air trapped in the pressure chambers 3 can escape. Pure water is then pumped into the upper pressure chamber, the corresponding water connection being denoted by 16. The filling of water takes place until the upper pressure chamber 3 is full, whereupon the venting valve 6 is closed. Hydraulic pressure is then applied via the connection 16, which acts directly on the cleaning liquid contained in the bag when the upper bag is closed. In this case, the pressurized cleaning liquid can exit via the pressure line 8 and reach the central cleaning unit 5, the cleaning liquid being distributed to the plurality of high-pressure nozzles 15. The cleaning can be carried out until all the cleaning liquid has been squeezed out of the upper bag, the spent cleaning liquid, together with the material rinsed out of the bone, passing through a built-in filter 10 into the lower bag. Once the entire cleaning liquid has collected in the lower bag, the pressure water applied to the upper pressure chamber is turned off and the opening of the lower bag is closed. The vent valve of the upper pressure chamber is opened to drain the water from the pressure chamber. Thereafter, the upper bag is opened and there is again a VerSchwenkung of the entire device by 180 °, wherein the removed dirt particles are collected by dirt trap lips 11 so that they can not contaminate the bone again. Upon completion of the rotation, the full bag will again be at the top and another cleaning step may be taken.

Claims

Claims :

1. An apparatus for cleaning bones or bone pieces with a central cleaning unit and to these connectable containers for cleaning fluid and spent cleaning fluid, characterized in that the central cleaning unit (5) and the container formed as replacement parts and detachable with a receiving unit (2) are connected and that the container as a bag (4) formed and at least partially in the receiving unit (2) fixed pressure chambers (3) are accommodated.

2. Apparatus according to claim 1, characterized in that the pressure chambers (3) and the central cleaning unit about a common pivot axis (22, 23) are pivotally mounted.

3. Apparatus according to claim 1 or 2, characterized in that the pressure chambers (3) each have closure means for liquid-tight sealing of the bag (4).

4. Apparatus according to claim 1, 2 or 3, character- ized in that to the bag (4) a pressure line (8) is connected, which connects the bag (4), bypassing the closure means with the central cleaning unit (5).

5. Device according to one of claims 1 to 4, characterized in that the pressure chambers (3) each have a pressurized water connection (16).

6. Device according to one of claims 1 to 5, characterized in that the cleaning unit (5) has a plurality of nozzles (15) which are fed by the pressure line (8).

7. Device according to one of claims 1 to 6, characterized in that the cleaning chamber (5) has a holder (17) for the bone to be cleaned (18) or to be cleaned bone piece.

8. Device according to one of claims 1 to 7, characterized in that the holder (17) for the bone (18) or the bone piece is rotatably mounted.

9. Device according to one of claims 1 to 8, characterized in that the holder (17) on an impeller (13) is arranged, the drive of which the impeller (13) associated drive nozzle (14) is formed, the cleaning liquid from the bag (4) is fed.

10. Device according to one of claims 1 to 9, characterized in that in each case a plurality of nozzles (15) on opposite sides of the bone holder (17) in the cleaning unit (5) is arranged.

11. Device according to one of claims 1 to 10, characterized in that the axes of the nozzles (15) are arranged to extend substantially parallel to the axis of rotation (12) of the impeller (13).

12. Device according to one of claims 1 to 10, characterized in that the nozzles (15) are oriented at least partially in mutually different directions.

13. Device according to one of claims 1 to 12, characterized in that the nozzles (15) are formed with adjustable spray angle and / or adjustable spray direction.

14. Device according to one of claims 1 to 13, characterized in that the bag (4) with interposition a filter (10) is connected to the cleaning unit (5).