US20110087161A1

US20110087161A1 - Device for providing spongy bone with bone substitute and/or bone reinforcing material, bone substitute and/or bone reinforcing material and method

Info

Publication number: US20110087161A1
Application number: US12/911,198
Authority: US
Inventors: Lars Lidgren; Torgny Lundgren; Pär Arvidsson; Sven Jönsson
Original assignee: Bone Support AB
Current assignee: Bone Support AB
Priority date: 2003-11-11
Filing date: 2010-10-25
Publication date: 2011-04-14
Also published as: US20070161943A1; ES2333436T3; CN1878516B; JP2007510495A; ATE442111T1; SE0302983D0; KR20060120104A; EP2316364A2; PL1689331T3; EP2316364A3; HK1098661A1; AU2004286807B2; AU2004286807A1; WO2005044154A1; CA2545436C; US20110082417A1; US7935121B2; EP1689331A1; DE602004023111D1; EP2039312A1

Abstract

The present invention relates to a device for providing spongy bone with bone substitute and/or bone reinforcing material, wherein at least one perforating device (4) is provided for making at least one hole (5) in the spongy bone (1) and wherein at least one flushing or rinsing device (6) is provided for flushing or rinsing the hole (5) with a rinsing agent (7). At least one vacuum source (9) is provided for generating a vacuum in the hole (5) in the spongy bone (1) for sucking and/or facilitating insertion or feeding of the bone substitute and/or bone reinforcing material (3) into said spongy bone (1). The invention also relates to bone substitute and/or bone reinforcing material and methods in connection with the invention.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/578,734, filed May 10, 2006, allowed July 27, 2010, which is a National Stage Entry of PCT International Application No. PCT/SE2004/001626, filed Nov. 10, 2004, which claims the benefit of priority of Swedish Application No. 0302983-2, filed Nov. 11, 2003. All of the above listed applications are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a device for providing spongy bone with bone substitute and/or bone reinforcing material, wherein at least one perforating device is provided for making at least one hole in the spongy bone and wherein at least one flushing or rinsing device is provided for flushing or rinsing the hole with a rinsing agent. The invention further relates to a bone substitute and/or bone reinforcing material and a method.

BACKGROUND OF THE INVENTION

Vertebroplasty is a technique according to which biocompatible material is injected into a spongy vertebra. After some time, the injected material hardens, whereby an inner support is obtained for fixing the vertebra and thereby alleviate pain and reduce the risk of vertebral collapse.
The material is injected into the vertebra through a needle and in doing so, it is necessary to subject the material to high pressure, often one or more MPa. Hereby, there is an obvious risk that tissue material, e.g. blood and fat, in the vertebra is pressed out into the blood vessels or into fracture gaps such that said material can affect adjacent nerves. There is also an obvious risk that the injected material is pressed out into fracture gaps or into adjacent tissue. This is well known and the material and fat being pressed out can reach the blood vessels and the lungs, resulting in a poorer oxygenation, blood pressure reduction and, in exceptional cases, death.
By inserting an extra needle into the vertebra, the risk of leakage (note publications in the enclosed reference list, point 1 and 2, in the end of the description). Normally, this extra needle is left open or preferably connected to a suction hose for generating a suction effect (note publication in the enclosed reference list, point 3). However, any decisive effect is not reached with the prior art.
Various hole making and rinsing devices for making holes in and rinsing of vertebrae are known from e.g. U.S. Pat. No. 6,440,138, U.S. Pat. 6,716,216, U.S. Pat. No. 6,719,761 and U.S. 6,740,090, but none of these publications describes generation of a vacuum in the vertebrae for providing safe suction of bone substitute and/or bone reinforcing material into said vertebrae.

SUMMARY OF THE INVENTION

The object of the present invention has been to eliminate the abovementioned problem and this is arrived at while the invention has been given the characterizing features of each of the subsequent claims.
By making a hole in the spongy bone and rinse it, tissue material and other material can be flushed away from the hole and the sides thereof, such that said sides get rough or uneven surfaces with depressions into which the bone substitute and/or bone reinforcing material can be brought to penetrate by generating a vacuum in the hole and without risking that said bone substitute and/or bone reinforcing material penetrates into the blood paths.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further described below with reference to the accompanying drawings, in which:

FIG. 1 is a schematic view of a device according to the invention when making a hole in a spongy vertebra shown in section;

FIG. 2 illustrates parts of the device of FIG. 1 during flushing or rinsing of the hole made in the spongy vertebra;

FIG. 3 illustrates parts of the device according to the invention during suction of bone substitute and/or bone reinforcing material into the vertebra;

FIG. 4 is a sectional view of a spongy vertebra in which bone substitute and/or bone reinforcing material has been injected with pressure through a needle according to prior art; and

FIG. 5 is a sectional view of a spongy vertebra into which bone substitute and/or bone reinforcing material has been sucked by means of a device according to the invention.

In the figures, different parts of a device for preparing spongy bone 1, e.g. a vertebra 2, to receive bone substitute and/or bone reinforcing material 3, and for locating said material in said vertebra is schematically illustrated. Said device comprises at least one perforating device 4 for making at least one hole 5 in the vertebra 2, at least one flushing or rinsing device 6 for flushing or rinsing said hole with rinsing agent 7 and at least one supply device 8 which permits suction and/or insertion of bone substitute and/or bone reinforcing material 3 into the vertebra.
At least one vacuum source 9 is provided to generate a vacuum in the hole 5 in the vertebra 2 for sucking and/or facilitate insertion of bone substitute and/or bone reinforcing material 3 into said vertebra.
The perforating device 4 can be designed in many different ways and so can also the rinsing device 6. At the exemplary embodiment of FIGS. 1 and 2, the perforating and rinsing devices 4, 6 are combined to a device 10 including an outer tube member 11 which can be located at the vertebra 2. In the tube member 11 there is provided a perforating means 12 which is movable relative to said tube member in coaxial and/or rotary direction. The perforating means 12 has and/or cooperates with a perforating member 13 which can be designed in many ways. As an example of a perforating member 13, it is shown an end portion of the perforating means 12 which can be retracted into the outer tube member 11 when this is located at the vertebra 2 and which is bent when it is expelled out of said pipe member. When the perforating means 12 is rotated, the bent perforating member 13 will make the hole 5 in the vertebra 2.
The movements of the perforating means 12 can be obtained by means of a drive unit 14 of a suitable type.
At the exemplary embodiment, the perforating means 12 is designed as an inner tube member 15. A rinsing agent container 16 is connected to this inner tube member 15 through a connecting device 17 which permits feeding of rinsing agent 7 from the container 16 into the inner tube member 15 irrespective of whether said inner tube member is rotatable or not. Alternatively, the rinsing agent container 16 may be connected to the outer tube member 11 and the collecting device 27 and the vacuum source 9 to the inner tube member 15, such that the outer tube member 11 can lead rinsing agent 7 into the hole 5 and be sucked out of said hole through the inner tube member 15. The perforating device 4 is used preferably for making at least two holes 5 in the vertebra 2. These holes 5 are located such that they communicate with each other either by extending into each other (as is illustrated in FIG. 3) or by having spongy bone 1 between them since such bone is pervious to air and can be provided with bone substitute and/or bone reinforcing material 3.
The vacuum source 9 is provided to suck rinsing agent 7 through the hole 5 and it is preferably connected to the outer tube member 11 for sucking, through said outer tube member, rinsing agent 7 and tissue material and other material out of said hole 5.
Between the outer tube member 11 and the vacuum source 9 there is preferably a collecting device 27 for collecting rinsing agent 7 and tissue material and other material brought along therewith out of the hole 5.
The rinsing device 6 is preferably provided also to flush or rinse the sides 5 a of the hole 5 such that depressions 5 b and similar are formed therein while tissue material and other material is flushed off said sides. This is advantageous since bone substitute and/or bone reinforcing material 3, by means of the vacuum generated in the hole 5, can be brought to penetrate into the depressions 5 b.
At the embodiment illustrated in FIG. 3, the outer tube member 11 has its equivalent in a first cannula or needle 19 which can cooperate with a perforating device (not shown) for making a first hole 5 in the vertebra 2. A second cannula or needle 20 is connected to a vacuum source 9 and this second cannula can also cooperate with a perforating device (not shown) for making a second hole 5 in the vertebra 2.
The supply device 8 illustrated in FIG. 3 may have a container 18 for mixing various components for production of bone substitute and/or bone reinforcing material 3 and/or for storage thereof. The container 18 is connected or connectable to a first cannula or needle 19 which can be inserted into the vertebra 2 and which is adapted to lead bone substitute and/or bone reinforcing material 3 into the holes 5 in the vertebra 2. A second cannula or needle 20 can be inserted into the vertebra 2 and is connected to the vacuum source 9, which is adapted to generate a vacuum in the holes 5 such that bone substitute and/or bone reinforcing material 3 is sucked into said holes and/or for facilitating insertion or feeding of said material into said holes.
The vacuum source 9 can be an injector pump 21 which is run or driven by a suitable compressed medium from a compressed-medium device 22. The injector pump 21 may e.g. be driven by compressed air and connected, through a compressed-air conduit 23, to a compressed-medium device 22 in the form of a compressed-air device. This device may be built into a hospital or other locality in which the injector pump 21 shall be used. Alternatively, the injector pump 21 can be run or driven by another commercially available gas as is indicated with broken lines in FIG. 3.
The compressed-medium device 22 can operate the injector pump 21 with a compressed-medium pressure of 4, 5-8, 5 bar and the injector pump 21 may be of a type which is placed on the floor and which has a foot pedal 24 for its operation. Thus, the injector pump 21 can be started by tilting the foot pedal 24 in one direction and stopped by tilting the foot pedal 24 in the opposite direction. As an example of a usable injector pump 21 in this connection one can mention an injector pump of the type used for producing bone cement as defined in U.S. patent specification 5,328,262 and sold under the product name Scan Vacuum Pump™ by the company Scandimed International AB, Sjöbo, Sweden.
The injector pump 21 is preferably provided to generate a vacuum in all the holes 5 of the spongy bone 1 such that said holes are filled or can be filled with bone substitute and/or bone reinforcing material 3 and/or a vacuum such that the bone substitute and/or bone reinforcing material 3 is distributed therein, preferably without any or any substantial portions thereof being sucked into the second cannula 20.
The injector pump 21 can be provided to generate a vacuum of between −0.5 bar and −0, 92 bar in the spongy bone 1, which vacuum corresponds to a 70% and 90% absolute vacuum. In many cases it is sufficient that the injector pump 21 generates a vacuum of between −0.7 bar and −0.8 bar in the spongy bone 1.
The injector pump 21 is preferably provided to suck tissue material such as blood and fat out of the holes 5 of the spongy bone 1 and into the second cannula 20 before bone substitute and/or bone reinforcing material 3 is sucked into the spongy bone 1 through the first cannula 19.
In at least one connecting conduit 25 between the second cannula 20 (the inlet end of which is the end which is inserted into a hole 5 of the spongy bone 1) and the injector pump 21, there may be provided a non-return valve device 26 and/or a collecting device 27 and/or a monomer filter 28 (if the bone substitute and/or bone reinforcing material 3 is of bone cement type) and/or a bacteria filter 29.
The collecting device 27 may be a container which is placed on the floor and closed or sealed by means of a cap. A portion of the connecting conduit 25, which is connected to the second cannula 20, is directed through the cap and a small distance down into the container. Another portion of the connecting conduit 25 is also directed through the cap and a small distance down into the container. When tissue material is sucked from the holes 5 of the spongy bone 1 to the collecting device 27, said material is collected down below in the container and is therefore prevented from being sucked further towards the injector pump 21 and into said pump. If there is a monomer filter 28 and/or a bacteria filter 29 between the collecting device 27 and the injector pump 21, the tissue material is prevented also from being sucked thereto.
The monomer filter 28 may be a carbon filter and is adapted to prevent monomer gases, generated during production of bone substitute and/or bone reinforcing material 3 in the form of bone cement, from being sucked into the injector pump 21 and discharged to the surroundings. The advantages with such a monomer filter 28 are described in the publication according to the enclosed reference list, point 4. The bacteria filter 29 is provided to prevent bacteria from entering or getting into the holes 5 of the spongy bone 1 if the connecting conduit 25 is opened or opens unintentionally and air is sucked therethrough to the holes 5 if there is a vacuum therein.
The monomer filter 28 and bacteria filter 29 may be provided in that portion of the connecting conduit 25 which connects the collecting device 27 with the injector pump 21.
The non-return valve device 26, which preferably can be provided in the connecting conduit 25 between the collecting device 27 and the second cannula 20, is adapted to prevent tissue material from being sucked out of the collecting device 27 and into the holes 5 of the spongy bone 1 if the connecting conduit 25 is opened or opens unintentionally such that a suction is generated therein towards the holes 5 of the spongy bone 1 if there is a vacuum therein.
The container 18 may include a feeding device 30 for feeding bone substitute and/or bone reinforcing material 3 out of the container 18 and into the holes 5 of the spongy bone 1 at the same time the injector pump 21 generates a vacuum therein or thereafter.
The feeding device 30 is schematically illustrated with a feed means 31 which is displaceably mounted relative to the container 18 and which can be displaced manually for discharge of bone substitute and/or bone reinforcing material 3 from the container 18 and through the first cannula 19 into the holes 5 of the spongy bone 1.
The container 18 may eventually be used as mixing container for mixing the components required for the production of such bone substitute and/or bone reinforcing material 3 that can be brought to harden after insertion thereof into the holes 5 of the spongy bone 1. This mixing can occur with a mixing means or in any other way. Such a mixing means can preferably be moved manually back and forth in the container 18 and is eventually rotated relative thereto for mixing the components.
A valve device 32 may be provided for, on one hand, close or interrupt the supply of bone substitute and/or bone reinforcing material 3 through the first cannula 19 to the holes 5 of the spongy bone 1 until the injector pump 21 has generated a suitable vacuum therein. When this is done, the valve device 32 may be opened for permitting suction of bone substitute and/or bone reinforcing material 3 into the holes 5 of the spongy bone 1 by means of the injector pump 21. The valve device 32 may be located on the first cannula 19 or on a connecting conduit between the container 18 and the first cannula 19. The valve device 32 may be manually operable by means of a control handle 33.
As an alternative to the embodiment of the flushing or rinsing device 6 described above, said device may be combined with the supply device 8. At this alternative, the rinsing agent container 16 of the rinsing device 6 may be connected to the first cannula 19 e.g. through the valve device 32 which in this case can be a three way valve permitting either that the supply of rinsing agent to the vertebra 2 is open and the supply of bone substitute and/or bone reinforcing material 3 to the vertebra 2 is closed or that said supply of rinsing agent is interrupted and said supply of material open.
The rinsing agent 7 may be of different types and it may e.g. be distilled water or a sodium chloride solution and/or be detergent and/or include at least one trombolytic substance, e.g. heparin, streptokinase, urokinase, TPA and/or other substances dissolving coagulum and thrombi.
The bone substitute and/or bone reinforcing material 3 may consist of primarily minerals or ceramics which can be mixed with a hardener, e.g. water. These substances may be selected from the group comprising calcium sulphate-α-hemihydrate, calcium sulphate-β-hemihydrate, calcium sulphate-dihydrate, calcium carbonate, α-tricalcium phosphate, hydroxyapatite, dicalcium phosphate-dihydrate, anhydrous dicalcium phosphate, tetracalcium phosphate, β-tricalcium phosphate, calcium deficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalcium phosphate, calcium-pyurophosphate, precipitated hydroxyapatite, carbonaceous apatite (dahlite), octacalcium phosphate, amorphous calcium phosphate, oxyapatite, carbonato apatite and calcium aluminate.
A ceramic material may be calcium aluminate, which forms part of the product Doxa T from the company Doxa (www.doxa.se/pdf/nyhet_—1.pdf).
X-ray contrast agents can be added to said ceramic bone substitute and/or bone reinforcing material 3, e.g. water soluble non-ionic X-ray contrast agents selected from the group comprising iohexol, ioversol, iopamidol, iotrolan, metrizamide, iodecimol, ioglucol, ioglucamide, ioglunide, iogulamide, iomeprol, iopentol, iopromide, iosarcol, iosimide, iotusal, ioxilan, iofrotal and iodecol.
Alternatively, the bone substitute and/or bone reinforcing material 3 can be a hardenable bone cement comprising polymer and monomer components. The polymer may be polymethylmethacrylate (PMMA) and the monomer methylmethacrylate (MMA). A polymer base material can be the product Cortoss™ from the company Orthovita in the U.S. For composition see www.orthovita.com/products/cortoss/oustechspecs.html. Another polymer base material can be the product SECOUR® Acrylic Resin PMMA from parallax medical inc. (www.parallax-medical.com/go/9192b550-56421157-a432-d7a2b98310fe).
The bone substitute and/or bone reinforcing material 3 may consist of a mineral and/or a ceramic in combination with polymer material.
The advantages with the invention is obvious when comparing the degree or ratio of fullness of the vertebra 2 of FIGS. 4 and 5. In the vertebra 2 of FIG. 4, the bone substitute and/or bone reinforcing material 3 has been pressed into said vertebra 2 through a cannula or needle and it clearly appears from FIG. 4 that only a part of the vertebra 2 is filled with bone substitute and/or bone reinforcing material 3. In the vertebra 2 of FIG. 5 however, the bone substitute and/or bone reinforcing material 3 has been sucked into the vertebra 2 in accordance with the invention through the cannula or needle and it is clearly evident from FIG. 5 that substantially larger parts of the vertebra 2 are filled with bone substitute and/or bone reinforcing material 3 without said material having been pressed out into the blood paths.
It is also obvious from FIG. 5 that the negative pressure generated by the vacuum source 9 has provided for a uniform and complete distribution of the bone substitute and/or bone reinforcing material 3 in the hole 5 and depressions 5 b in the sides 5 a of the hole 5.
The invention is not limited to what is described above and illustrated in the drawings, but may vary within the scope of subsequent claims. Thus, the vacuum source 9 may instead of an injector pump 21 be another vacuum pump which can be electrically operated or operated by gas or by hand or operated in any other way, that the hole 5 may be more than one hole and surrounding parts thereto, that the rinsing agent 7 may be another than those described and that the bone substitute and/or bone reinforcing material 3 may be of another type than those described.
There may be a device for imparting pulse like suction and/or insertion movements to the bone substitute and/or bone reinforcing material 3 into the hole(s) 5 in the spongy bone 1. Furthermore, there may be a device for imparting reciprocating suction and/or insertion movements to the bone substitute and/or bone reinforcing material 3 into the hole(s) 5 in the spongy bone 1.
There may also be a device for pulse like suction and/or feeding of the rinsing agent 7 through the hole(s) 5 in the spongy bone 1.
Said device may be defined by pulsating the vacuum source 9 and/or its vacuum generation and/or by generating pulses by means of the feeding device 30.

REFERENCE LIST

1) Aebli Nt Krebs J, Schwenke D, Davis G, Theis J C. Cardiovascular charges during multiple vertebroplasty with and without vent-hole: an experimental study in sheep. Spine 2003;28(14):1504-11.
2) Koessler M J, Aebli N, pitto R P. Fat and Bone Marrow Embolism During Percutaneous Vertebroplasty. Anesth Analg 2003;97:293-294.
3) Lidgren, Lars. Bone Substitutes. Karger Gazette No. 65 2003; Bone and Joints.
4) Kirby B S, Doyle A, Gilula L A. Acute bronchospasm due to exposure to polymethacrylate vapours during percutaneous vertebroplasty. AJR J Roentgenol. 2003 Feb; 180 (2) :543-4.

Claims

1. A device for providing spongy bone with bone substitute and/or bone reinforcing material, including:

at least one perforating device (4) configured to make at least one hole (5) in the spongy bone (1),

at least one flushing or rinsing device (6) configured to flush or rinse the hole (5) with a rinsing agent (7),

at least one supply device (8) configured to supply the bone substitute and/or bone reinforcing material (3) to the hole (5) in the spongy bone (1), and

at least one vacuum source (9) configured to generate a vacuum in the hole (5) in the spongy bone (1), suck the rinsing agent (7) into the hole (5) in the spongy bone(1), and to suck rinsing agent (7) and tissue material out of said hole (5),

wherein said vacuum source (9) is further configured to suck the bone substitute and/or bone reinforcing material (3) into the hole (5) in the spongy bone (1) by imparting pulse like suction and/or insertion movements to the bone substitute and/or bone reinforcing material.

2. (canceled)

3. The device according to claim 1, wherein the vacuum source (9) is provided to generate a vacuum in the hole (5) of the spongy bone (1) which is adapted such that the bone substitute and/or bone reinforcing material (3) is sucked into said hole (5) and distributed therein without substantial portions thereof being sucked out of the hole (5).

4. The device according to claim 1, wherein the vacuum source (9) is provided to suck tissue material out of the hole (5) of the spongy bone (1) before bone substitute and/or bone reinforcing material (3) is sucked into the spongy bone (1).

5. The device according to claim 1, further comprising a collecting device (27) configured to collect tissue material which by the vacuum source (9) has been sucked out of the hole (5) of the spongy bone (1) for preventing tissue material from being sucked into the vacuum source (9) and/or into a monomer filter (28) and/or into a bacteria filter (29).

6. The device according to any preceding claim 1, further comprising a monomer filter (28) configured to prevent poisonous gases, which are generated during production of bone substitute and/or bone reinforcing material (3) from being discharged into the surroundings.

7. The device according to claim 1, further comprising a bacteria filter (29) configured to prevent bacteria from getting into the hole (5) of the spongy bone (1) if a connection between the vacuum source (9) and the spongy bone (1) is opened unintentionally.

8. The device according to claim 1, further comprising a non-return valve device (26) configured to prevent tissue material and/or any other material and/or bacteria from being sucked into the hole (5) of the spongy bone (1) if the connection between the vacuum source (9) and the hole (5) in the spongy bone (1) is opened unintentionally.

9. The device according to claim 5, further comprising a non-return valve device (26) configured to be located between the hole (5) in the spongy bone (1) and the collecting device (27).

10. The device according to claim 5, further including a non-return valve device (26) configured to be located between the monomer filter (28) and/or the bacteria filter (29) and the hole (5) in the spongy bone (1).

11. The device according to claim 1, further comprising a container (18) configured to produce and/or store bone substitute and/or bone reinforcing material (3), wherein the container includes a feeding device (30) configured to feed bone substitute and/or bone reinforcing material (3) out of the container (18) and into the hole (5) of the spongy bone (1) at the same time the vacuum source (9) generates a vacuum therein.

12. The device according to claim 1, further comprising a container (18) configured to produce and/or store bone substitute and/or bone reinforcing material (3), wherein the container (18) includes a feeding device (30) configured to feed bone substitute and/or bone reinforcing material (3) into the hole (5) of the spongy bone (1) after the vacuum source (9) has generated a vacuum therein.

13. The device according to claim 11, wherein the feeding device (30) is manually operable.

14. The device according to claim 1, wherein the vacuum source (9) is configured to generate a vacuum of between −0.5 bar and −0.92 bar in the hole (5) of the spongy bone (1).

15. The device according to claim 14, the vacuum source (9) is configured to generate a vacuum of between −0.7 and −0.8 bar in the hole (5) of the spongy bone (1).

16. The device according to claim 1, further comprising a valve device (32) configured to close or interrupt the supply of bone substitute and/or bone reinforcing material (3) to the hole (5) of the spongy bone (1) until the vacuum source (9) has generated a suitable vacuum therein, the valve device (32) being configured to open and permit supply of bone substitute and/or bone reinforcing material (3) such that said material is sucked into the hole (5) of the spongy bone (1) when said suitable vacuum has been measured therein.

17. The device according to claim 1, further comprising at least a first cannula or needle and a second cannula or needle (19, 20) configured to be insertable into the spongy bone (1) such that they are simultaneously directed into the hole (5) thereof, wherein the first cannula or needle (19) is connected to a container (18) for producing and/or storing the bone substitute and/or bone reinforcing material (3) while the second cannula or needle (20) is connected to the vacuum source (9).

18. The device according to claim 17, wherein the flushing or rinsing device (6) comprises a rinsing agent container (16) which is connected to the first cannula or needle (19) for leading rinsing agent (7) into the hole (5) of the spongy bone (1) through said first cannula (19) and out of said hole (5) to the second cannula or needle (20).

19. The device according to claim 18, further comprising a valve device (32) configured to either open for supply of bone substitute and/or bone reinforcing material (3) or of rinsing agent (7) through the first cannula or needle (19).

20. The device according to claim 1, wherein the rinsing device (6) is configured to flush or rinse the sides (5 a) of the hole (5) so that tissue material and other material are flushed away therefrom such that depressions (5 b) are formed therein, into which the bone substitute and/or bone reinforcing material (3) can penetrate.

21. (canceled)

22. (canceled)

23. The device according to claim 1, wherein the perforating device (4) includes an outer tube member (11) located at the spongy bone (1), and a perforating means (12), wherein the perforating means (12) is configured to be movable in said outer tube member (11) in coaxial and/or rotary direction and includes and/or cooperates with a perforating member (13) for making the hole (5) in the spongy bone (1).

24. The device according to claim 23, wherein the perforating means (12) further includes an inner tube member (15) configured to direct rinsing agent (7) into or out of the hole (5) in the spongy bone (1).

25. The device according to claim 23, wherein the outer or inner tube member (11 or 15) is connected to a vacuum source (9) for sucking rinsing agent (7) through the hole (5) in the spongy bone (1) and out of said hole through the outer tube member (11).

26. The device according to claim 1, wherein the perforating device (4) further includes several units for making at least two holes (5) in the spongy bone (1), wherein the at least two holes are configured to either extend into each other, or be separated from one another with spongy bone (1) remaining therebetween, and wherein the sponging bone (1) remaining between the at least two holes (5) is penetrated by air and provided with bone substitute and/or bone reinforcing material (3).

27. The device according to claim 1, wherein the vacuum source (9) is an injector pump (21) operatable by a compressed medium.

28. The device according to claim 27, wherein the injector pump (21) is connected to a compressed-medium device (22) which is designed as a compressed-air device and is positionable in localities in or close to which the vacuum source (9) shall be used.

29. The device according to claim 28, wherein the injector pump (21) is connected to a compressed-medium device (22) with commercial gas.

30. The device according to claim 28, wherein the injector pump (21) is connected to a compressed-medium device (22) which is configured to operate said pump with a compressed-medium pressure of 4.5-8.5 bar.

31. The device according to claim 1, wherein the vacuum source (9) is an electrically operated vacuum pump.

32. The device according to claim 1, wherein the vacuum source (9) is a pump operated by gas.

33. The device according to claim 1, wherein the vacuum source (9) is operated by hand.

34. The device according to claim 1, characterized in that the spongy bone (1) is a spongy vertebra (2).

35. The device according to claim 1, wherein the spongy bone (1) is a fracture due to osteoporosis.

36. The device according to claim 1, wherein the spongy bone (1) is a femoral or knee fracture.

37. The device according to claim 1, wherein the rinsing agent (7) is a sodium chloride solution.

38. The device according to claim 1, wherein the rinsing agent (7) contains a detergent.

39. The device according to claim 1, wherein the flushing or rinsing device (6) contains the rinsing agent (7), and wherein the rinsing agent (7) contains at least one trombolytic substance.

40. The device according to claim 1, wherein flushing or rinsing device (6) contains the rinsing agent (7), and wherein the rinsing agent (7) is distilled water.

41. (canceled)

42. The device according to claim 1, further including a secondary device (9 and/or 30) configured to impart reciprocating suction and/or insertion movements to the bone substitute and/or bone reinforcing material (3) into the hole (5) in the spongy bone (1).

43. The device according to claim 1, further including a secondary device (9 and/or 30) configured to impart pulse like suction and/or feeding of the rinsing agent (7) through the hole (5) in the spongy bone (1).

44. The device according to claim 1, further including a bone substitute and/or bone reinforcing material, wherein the bone substitute and/or bone reinforcing material is at least one of a mineral material, a substantially mineral material, a ceramic, and a substantially ceramic material.

45. The device according to claim 44, wherein the mineral material or ceramic material is a hardenable mineral or ceramic which can be brought to harden in the spongy bone (1).

46. The device according to claim 45, wherein the mineral material or ceramic can be brought to harden by being mixed with a hardening agent.

47. The device according to claim 44, wherein the mineral material or ceramic is selected from the group comprising calcium sulphate-α-hemihydrate, calcium sulphate-β-hemihydrate, calcium sulphate-dihydrate, calcium carbonate, α-tricalcium phosphate, hydroxyapatite, dicalcium phosphate-dihydrate, anhydrous dicalcium phosphate, tetracalcium phosphate, β-tricalcium phosphate, calcium deficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalcium phosphate, calcium-pyurophosphate, precipitated hydroxyapatite, carbonaceous apatite (dahlite), octacalcium phosphate, amorphous calcium phosphate, oxyapatite, carbonato apatite and calcium aluminate.

48. The device according to claim 44, wherein an X-ray contrast agent is mixed with the ceramic material.

49. The device according to claim 48, wherein the X-ray contrast agent is water soluble and non-ionic.

50. The device according to claim 49, wherein the water soluble, non-ionic X-ray contrast agent is selected from the group comprising iohexol, ioversol, iopamidol, iotrolan, metrizamide, iodecimol, ioglucol, ioglucamide, ioglunide, iogulamide, iomeprol, iopentol, iopromide, iosarcol, iosimide, iotusal, ioxilan, iofrotal and iodecol.

51. The device according to claim 1, further including a bone substitute and/or bone reinforcing material (3), wherein the bone substitute and/or bone reinforcing material (3) is a bone cement including a polymer component, and a monomer component, wherein the polymer and monomer harden to bone cement after mixing with each other and feeding into the hole (5) of the spongy bone (1).

52. The device according to claim 51, wherein the bone substitute and/or bone reinforcing material (3) consists of mineral and/or ceramic in combination with polymer material.

53. A method for providing spongy bone with bone substitute and/or bone reinforcing material, wherein

at least one hole (5) is made in the spongy bone (1),

the at least one hole (5) is flushed or rinsed with rinsing agent (7), and

a vacuum is generated in the hole (5) for sucking and/or facilitating insertion or feeding of the bone substitute and/or bone reinforcing material (3) into the hole (5).

54. The method according to claim 53, wherein a vacuum is generated in the hole (5) for sucking rinsing agent (7) through said hole (5).

55. The method according to claim 53, wherein the rinsing agent (7) is brought to flush tissue material and other material away from the sides (5 a) of the hole (5) such that depressions (5 b) are formed therein and that bone substitute and/or bone reinforcing material (3) is brought to penetrate into said depressions (5 b).

56. A Method for providing spongy bone with bone substitute and/or bone reinforcing material (3), which is applied or provided in at least one hole (5) in the spongy bone (1) in which a vacuum is generated, wherein the bone substitute and/or bone reinforcing material (3) is brought to pulsate during its application in the spongy bone (1).

57. The method according to claim 56, wherein reciprocating movements are imparted to the bone substitute and/or bone reinforcing material (3) during its application in the hole (5) in the spongy bone (1).

58. A method for providing spongy bone with bone substitute and/or bone reinforcing material (3), which is applied or provided in at least one hole (5) in the spongy bone (1) in which a vacuum is generated and wherein the hole (5) is flushed or rinsed with rinsing agent (7) before application therein of the bone substitute and/or bone reinforcing material (3), wherein the rinsing agent (7) is sucked pulsatingly through the hole (5) in the spongy bone (1) by generating a pulsating vacuum in said hole (5).

59. The device according to claim 39, wherein the at least one trombolytic substance is chosen from heparin, streptokinase, urokinase, TPA, and other substances dissolving coagulum and thrombi, and mixtures thereof.

60. The device according to claim 51, wherein the polymer is polymethyl-methacrylate (PMMA)-type, and the monomer is methylmethacrylate (MMA)-type.