HK1098661B - Device for providing spongy bone with bone substitute or bone reinforcing material - Google Patents

Description

Device for providing cancellous bone with bone substitute or bone reinforcing material

Technical Field

The invention relates to a device for providing cancellous bone with bone substitute and/or bone reinforcing material, wherein at least one perforating device is provided for perforating at least one hole in the cancellous bone, and at least one flushing or cleaning device is provided for flushing or cleaning the hole with a cleaning agent. The invention also relates to a bone substitute and/or bone reinforcing material and a method.

Background

Spinal bone grafting is a technique for injecting a biocompatible material into cancellous vertebral bone. After a period of time, the injected substance hardens, thereby obtaining an internal support for fixing the vertebrae and thus alleviating pain and reducing the risk of vertebral collapse.

The substance is injected into the vertebra through a needle, and in this case, it is necessary to apply high pressure to the substance, typically 1MPa or more. There is therefore a significant risk that tissue material in the vertebra, such as blood and fat, is pressed out into the blood vessels or into the gap of the bone fracture, so that said material can affect the adjacent nerves. There is also obviously a risk that the injected material is pressed out into crevices or adjacent tissue. This is well known and the pressed out material and fat can reach the blood vessels and lungs, leading to worse oxygenation, a decrease in blood pressure, and in special cases death.

By inserting an additional needle into the vertebra, there is a risk of leakage (note the publications at points 1 and 2 in the attached reference list at the end of the description). Typically, such an additional needle is kept open or preferably connected to a suction hose for generating a suction effect (note the disclosure in point 3 of the attached reference list). However, the prior art does not achieve any decisive effect.

Various perforating and cleaning devices for perforating and cleaning vertebrae are known from e.g. US 6440138, US 6716216, US 6719761 and US 6740090, but none of these publications describes the creation of a vacuum in the vertebrae for safely sucking bone substitute and/or bone reinforcing material into said vertebrae.

Disclosure of Invention

An object of the present invention is to eliminate the above-mentioned problems and this is solved by the device according to the invention, which provides a device for equipping spongy bone with bone substitute or bone reinforcing material, wherein at least one perforating device is provided for perforating at least one hole in the spongy bone, and at least one cleaning device is provided for cleaning the hole by means of a cleaning agent, at least one supply device is provided for allowing the supply of bone substitute or bone reinforcing material into the spongy bone, and at least one vacuum source is provided for generating a vacuum in the hole of the spongy bone for sucking the cleaning agent into the hole and sucking cleaning agent and tissue material out of the hole, and the vacuum source is also provided for generating a vacuum which is adapted to suck bone substitute or bone reinforcing material into the spongy bone and/or to be easily inserted into the spongy bone and adapted after the cleaning agent and tissue material have been sucked out of the hole The bone substitute or bone reinforcing material is distributed into the pores without the bone substitute or bone reinforcing material penetrating into the blood vessels.

By perforating the spongy bone and washing it, tissue material and other material can be flushed from the hole and from its side surfaces, whereby said side surfaces become rough or uneven surfaces with recesses into which bone substitute and/or bone reinforcing material can be penetrated by creating a vacuum in the hole, without the risk of said bone substitute and/or bone reinforcing material penetrating into blood vessels.

Drawings

The invention will be further explained below with reference to the drawing, in which

FIG. 1 is a schematic view of a device according to the present invention as it would be used to perforate a cancellous vertebra, shown in cross-section;

FIG. 2 is a portion of the device of FIG. 1 during flushing or cleaning of a hole in cancellous vertebral bone;

FIG. 3 is a partial device according to the present invention during the process of drawing bone substitute and/or bone reinforcing material into the vertebral bone;

FIG. 4 is a cross-sectional view of a cancellous vertebra in which bone substitute and/or bone reinforcing material has been injected under pressure through a needle into the vertebra according to the prior art; and

fig. 5 is a cross-sectional view of a cancellous vertebra, wherein bone substitute and/or bone reinforcing material has been drawn into the vertebra by a device according to the present invention.

Detailed Description

In these figures, different parts of a device for preparing spongy bone 1, for example a vertebra 2, for receiving bone substitute and/or bone reinforcing material 3 and for positioning said material in said vertebra are shown. The device comprises at least one perforating device 4 for perforating at least one hole 5 in the vertebra 2, at least one flushing or cleaning device 6 for flushing or cleaning the hole with a cleaning agent 7, and at least one feeding device 8 allowing bone substitute and/or bone reinforcing material 3 to be sucked into and/or inserted into the vertebra.

At least one vacuum source 9 is provided in order to create a vacuum in the hole 5 of the vertebra 2 for sucking and/or easily inserting bone substitute and/or bone reinforcing material 3 into said vertebra.

The perforation means 4 can be designed in different ways and the cleaning means 6 can also be so. In the exemplary embodiment of fig. 1 and 2, the perforating and washing devices 4, 6 are combined into a device 10, wherein the device comprises an outer tube member 11 which can be positioned at the vertebra 2. In the tube member 11, a piercing member 12 is provided which is movable coaxially and/or in a rotational direction with respect to the tube member. The perforating member 12 has and/or cooperates with a perforating element 13, which can be designed in various ways. As an example of the perforating element 13, one end of the perforating member 12 is shown, which can be retracted into the outer tube member 11 when it is positioned on the vertebra 2 and which bends when it is expelled out of said tube member. When the perforating member 12 is rotated, the curved perforating element 13 will perforate 5 in the vertebra 2.

The movement of the perforating member 12 can be obtained by means of a suitable type of drive unit 14.

In the exemplary embodiment, the perforating member 12 is designed as an inner tube member 15. The rinsing agent container 16 is connected to the inner tube member 15 by means of a connecting means 17, which connecting means 17 allows the rinsing agent 7 to be supplied from the container 16 to 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, the collecting device 27, and the vacuum source 9, as well as the inner tube member 15, so that the outer tube member 11 may guide the rinsing agent 7 into the hole 5 and be sucked out of the hole through the inner tube member 15. The perforating device 4 is preferably used to perforate at least two holes 5 in the vertebra 2. Since this bone is permeable to air and may be provided with bone substitute and/or bone reinforcing material 3, the holes 5 are positioned such that they are interconnected by extending into each other (as shown in fig. 3) or by having cancellous bone 1 in them.

A vacuum source 9 is provided to suck rinsing agent 7 through the hole 5 and is preferably connected to the outer tube member 11 for sucking rinsing agent 7 and tissue material and other material out of said hole 5 through said outer tube member.

Between the outer tube member 11 and the vacuum source 9, a collecting device 27 is preferably provided for collecting the cleaning agent 7 and the tissue material and other material brought out of the holes 5.

The cleaning device 6 is preferably provided to flush or clean the side 5a of the aperture 5, so that recesses 5b and the like are formed therein, while tissue material and other material is flushed away from said side. Advantageously, as the bone substitute and/or bone reinforcing material 3 can penetrate into the recesses 5b by means of the vacuum generated in the holes 5.

In the embodiment shown in fig. 3, the outer tube member 11 has the equivalent of a first cannula or needle 19 form which can cooperate with a perforating device (not shown) for perforating the first hole 5 in the vertebra 2. A second cannula or needle 20 is connected to the vacuum source 9 and may also cooperate with a perforating device (not shown) for perforating the second hole 5 in the vertebra 2.

The supply device 8 shown in fig. 3 may have a container 18 for mixing different components for producing bone substitute and/or bone reinforcing material 3 and/or for storing them. The container 18 is connected or connectable to a first cannula or needle 19 insertable into the vertebra 2, and the cannula or needle 19 is adapted to guide bone substitute and/or bone reinforcing material 3 into the hole 5 of the vertebra 2. A second cannula or needle 20 can be inserted into the vertebra 2 and connected to a vacuum source 9, wherein the vacuum source is adapted to create a vacuum in the hole 5, so that bone substitute and/or bone reinforcing material 3 is sucked into the hole and/or for easily inserting or supplying the substance into the hole.

The vacuum source 9 may be a syringe pump 21 which is operated or driven by a suitable compressed medium from a compressed medium device 22. The syringe pump 21 can be driven by compressed air, for example, and is connected by a compressed air conduit 23 to a compressed medium device 22 in the form of a compressed air device. Such a device may be built in a hospital or other location where the syringe pump 21 should be used. Alternatively, syringe pump 21 may be operated or driven by other commercially available gases, represented by the dashed lines in FIG. 3.

The compressed medium device 22 may operate the injection pump 21 at a compressed medium pressure of 4.5-8.5bar, and the injection pump 21 may be of the type placed on the ground and it has a foot pedal 24 for operating it. Thus, the syringe pump 21 may be activated by tilting the foot pedal 24 in one direction and deactivated by tilting the foot pedal 24 in the opposite direction. In this connection, as an example of a syringe pump 21 which can be used, one can think of a syringe pump for producing bone, which is defined in U.S. patent specification 5328262 and is available from swedenScandimed International AB corporation of^TM(Scan Vacuum Pump) is sold under the name.

Such a syringe pump 21 is preferably provided for creating a vacuum in all holes 5 in the spongy bone 1, so that said holes can be filled or can be filled with bone substitute and/or bone reinforcing material 3, and/or for creating a vacuum so that bone substitute and/or bone reinforcing material 3 is distributed therein, preferably without any or a substantial part of the same being sucked into the second cannula 20.

The syringe pump 21 may be provided to generate a vacuum in the spongy bone 1 of between-0.5 bar and-0.92 bar, which corresponds to 70% and 90% of the absolute vacuum. In many cases it will be sufficient that the syringe pump 21 generates a vacuum of between-0.7 bar and-0.8 bar in the cancellous bone 1.

A syringe pump 21 is preferably provided for sucking tissue material, such as blood and fat, out of the holes 5 of the spongy bone 1 and through the first cannula 19 into the second cannula 20 before bone substitute and/or bone reinforcing material 3 is sucked into the spongy bone 1.

In at least one connecting conduit 25 between the second cannula 20, the inlet end of which is the end inserted in the hole 5 in the spongy bone 1, and the syringe pump 21, a one-way valve 26 and/or a collecting device 27 and/or a monomer filter 28 (if the bone substitute and/or the bone reinforcing material 3 is of the osseous type) and/or a bacteria filter 29 are/is provided.

The collecting device 27 may be a container placed on the floor and closed or sealed by a lid. A portion of the connecting conduit 25 connected to the second cannula 20 is directed through the cap and a small distance down into the container. Another part of the connecting duct 25 is also directed through the lid and a little way 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 downwards in the container and is thus prevented from being sucked again towards the injection pump 21 and into said pump. If a monomer filter 28 and/or a bacterial filter 29 is provided between the collecting device 27 and the syringe pump 21, it is also possible to prevent tissue material from being sucked in there.

The monomer filter 28 may be a carbon filter and it is adapted to prevent monomer gases generated during the production of bone substitute and/or bone reinforcing material 3 in the form of bone mass from being sucked into the injection pump 21 and discharged to the environment. The advantages of having such a monomer filter 28 are illustrated in the publication according to point 4 of the enclosed reference list. If the connecting conduit 25 is open or unintentionally opened and air is sucked into the holes 5 through this opening in the presence of a vacuum in the holes, a bacteria filter 29 may be provided to prevent bacteria from entering the holes 5 of the spongy bone 1.

The monomer filter 28 and the bacteria filter 29 may be provided in a portion of the connection conduit 25 connecting the collection device 27 and the syringe pump 21.

A one-way valve 26, which may preferably be arranged 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 open or unintentionally opened, wherein a suction in the direction of the holes 5 of the spongy bone 1 will be created if a vacuum is present in the holes 5 when the conduit 25 is open.

The container 18 may comprise 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 simultaneously with or later than the vacuum created in the injection pump 21.

The schematically depicted feeding device 30 has a feeding member 31 which is replaceably mounted relative to the container 18 and which can be manually replaced for discharging bone substitute and/or bone reinforcing material 3 from the container 18 and through the first cannula 19 into the hole 5 of the spongy bone 1.

The container 18 can finally be used as a mixing container for mixing the components required for the production of such bone substitute and/or bone reinforcing material 3, wherein the bone substitute and/or bone reinforcing material 3 hardens after it has been injected into the holes 5 of the spongy bone 1. Such mixing may be achieved by a mixing device or any other means. Such mixing device is preferably manually movable back and forth within container 18 and ultimately relatively rotatable therein to mix the ingredients.

A valve means 32 may be provided for on the one hand closing or interrupting the bone substitute and/or bone reinforcing material 3 supplied through the first cannula 19 into the holes 5 of the spongy bone 1 until the syringe pump 21 has created a suitable vacuum therein. When this is done, the valve means 32 may be opened for allowing bone substitute and/or bone reinforcing material 3 to be sucked into the holes 5 of the spongy bone 1 by means of the syringe pump 21. The valve means 32 may be positioned on the first cannula 19 or on the connecting conduit between the container 18 and the first cannula 19. The valve device 32 may be manually operated by a control handle 33.

As an alternative to the embodiment of the flushing or cleaning device 6 described above, said device can be combined with the supply device 8. In this alternative embodiment, the rinsing agent container 16 of the flushing device 6 may be connected to the first cannula 19 by means of, for example, a valve device 32, in which case the valve device 32 may be a three-way valve, which allows to open the supply of rinsing agent to the vertebra 2 and to close the supply of bone substitute and/or bone reinforcing material 3 to the vertebra 2, or to interrupt the supply of rinsing agent and to open the supply of substance.

The rinsing agent 7 may be of different types and it may be, for example, distilled water, or a sodium chloride solution and/or a detergent and/or comprise at least one trombolytic substance, such as heparin, streptokinase, urokinase, TPA and/or other substances that dissolve clots and thrombi.

The bone substitute and/or bone reinforcing material 3 may consist essentially of a mineral or ceramic, which may be mixed with a hardening agent, such as water. These substances may be selected from the group comprising calcium sulphate-alpha-hemihydrate, calcium sulphate-beta-hemihydrate, calcium sulphate dihydrate, calcium carbonate, alpha-tricalcium phosphate, hydroxyapatite, dicalcium phosphate dihydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, beta-tricalcium phosphate, calcium deficient hydroxyapatite (calcium deficient hydroxyapatite), monocalcium phosphate monohydrate, monocalcium phosphate, calcium pyrophosphate, precipitated hydroxyapatite, carbonaceous apatite (calcium phosphate), octacalcium phosphate, amorphous calcium phosphate, oxyapatite, apatite carbonate and calcium carbonate.

The ceramic material may be calcium aluminate, which forms part of the product Doxa T (www.doxa.se/pdf/nyhet — 1.pdf) from the company Doxa (company Doxa).

An X-ray contrast agent may be added to said ceramic bone substitute and/or bone reinforcing material 3, such as a water-soluble non-ionic X-ray contrast agent selected from the group comprising iohexol (iohexol), ioversol (ioversol), iopamidol (iopamide), iotrolan (iotralan), metrizamide, iodecimol (ioglucide), ioglucitol (ioglucamide), ioglucaniline (ioglumide), iogulamide (iogulamide), iobipro (iomeprol), iopentol (iopentol), iopromide (iopromide), iosarcol (iosarcol), iosimide (iosimide), iosixol (iosutal), ioxilan (ioxilan), ioraol (frotal), and iodexol (iodecol).

Alternatively, the bone substitute and/or bone reinforcing material 3 may be a hardenable bone cement comprising a polymer and a monomer component. The polymer may be Polymethylmethacrylate (PMMA) and the monomer may be methylmethacrylate (MMA). Poly(s) are polymerizedThe compound matrix material may be Cortoss from the company Orthovita, usa^TMAnd (5) producing the product. For composition see www.orthovita.com/products/cortoss/outstech specs. Another polymer matrix material may be a product from parallelax pharmaceuticalsAcrylic resin PMMA. (www.parallax-medical.com/go/9192b550-5642-1157-a432-d7a2b98310fe)。

The bone substitute and/or bone reinforcing material 3 may consist of an inorganic material and/or a ceramic combined with a polymer material.

The advantages of the present invention are apparent when comparing the filling degree or filling rate of the vertebra 2 of fig. 4 and 5. In the vertebra 2 in 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 appears clearly 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 through the cannula or needle according to the invention, and it appears clearly from fig. 5 that a substantial part of the vertebra 2 has been filled with bone substitute and/or bone reinforcing material 3, without said bone substitute and/or bone reinforcing material 3 having been pressed into the blood vessels.

It is also apparent from fig. 5 that the negative pressure generated by the vacuum source 9 provides a uniform and complete distribution of the bone substitute and/or bone reinforcing material 3 in the hole 5 and in the recesses 5b of the side edges 5a of the hole 5.

The invention is not limited to the description in the above description and the drawings but may be varied within the scope of the following claims. Thus, the vacuum source 9 may be another electric or pneumatic or manual or in any other way driven vacuum pump instead of the syringe pump 21, the hole 5 may be more than one hole and enclose parts thereof, the rinsing agent 7 may be something other than what is described, and the bone substitute and/or bone reinforcing material 3 may be of another type than what is described.

There may be a device for applying pulses, such as suction and/or insertion movements, to the bone substitute and/or bone reinforcing material 3 in the holes 5 of the spongy bone 1. Furthermore, there may be a device for applying a reciprocating suction and/or insertion movement to the bone substitute and/or bone reinforcing material 3 in the holes 5 of the spongy bone 1.

There may also be a device for pulsating suction and/or supply of the rinsing agent 7 through the holes 5 of the spongy bone 1.

Said means may be determined by pulsing the vacuum source 9 and/or its vacuum generating means and/or by pulsing the feeding means 30.

Reference directory

1) Aebili N, Krebs J, Schwenke D, Davis G, Theis JC. cardiovascular loads with and without vents during multiple spinal transplants: experimental study in sheep. A spine 2003; 28(14): 1504-11.

2) Fat and bone marrow embolism during transdermal spinal implants by Koessler MJ, Aebili N, Pitto RP.. Painless anesthesia 2003; 97: 293-294.

3) Lidgren, La rs. bone substitute. Karger Gazette 2003 phase 65; bones and joints.

4) Kirby BS, Doyle A, Gilula LA. caused acute bronchospasm during transdermal implantation due to exposure to polymethacrylate gas. AJR J Roentgenol.2003, month 2; 180(2): 543-4.

Claims (48)

1. A device for providing cancellous bone with bone substitute or bone reinforcing material,

wherein at least one perforating device (4) is provided for perforating at least one hole (5) in the spongy bone (1), and

at least one cleaning device (6) is provided for cleaning the holes (5) by means of a cleaning agent (7),

at least one feed device (8) is provided for allowing feeding of bone substitute or bone reinforcing material (3) to the holes (5) in the spongy bone (1), and

at least one vacuum source (9) for generating a vacuum in the holes (5) of the spongy bone (1) is provided for sucking rinsing agent (7) into the holes (5) and sucking rinsing agent (7) and tissue material out of the holes (5),

characterized in that a vacuum source (9) is provided for generating a vacuum which is adapted to suck and/or easily insert bone substitute or bone reinforcing material (3) into the spongy bone (1) after the rinsing agent (7) and tissue material have been sucked out of the holes (5) and to distribute the bone substitute or bone reinforcing material (3) into the holes without the bone substitute or bone reinforcing material penetrating into the blood vessels.

2. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1, characterized in that the vacuum source (9) is provided for generating the vacuum in the holes (5) of the spongy bone (1) so that the bone substitute or bone reinforcing material (3) is sucked into the holes (5) and distributed therein without a major portion thereof being sucked out of the holes (5).

3. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that a collecting device (27) is provided for collecting tissue material sucked out of the holes (5) of the spongy bone (1) by the vacuum source (9) in order to prevent tissue material from being sucked into the vacuum source (9) and/or into the monomer filter (28) and/or into the bacteria filter (29).

4. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that a monomer filter (28) is provided for preventing toxic gases produced during the production of the bone substitute or bone reinforcing material (3) from being discharged into the environment.

5. A device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that a bacteria filter (29) is provided for preventing bacteria from entering the holes (5) of the spongy bone (1) in the event that the connection between the vacuum source (9) and the spongy bone (1) is unintentionally opened.

6. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 3, characterized in that a one-way valve device (26) is provided for preventing tissue material and/or bacteria from being sucked into the holes (5) of the spongy bone (1) in the event that the connection between the vacuum source (9) and the holes (5) of the spongy bone (1) is unintentionally opened.

7. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 6, characterized in that the one-way valve means (26) is positioned between the hole (5) in the spongy bone (1) and the collecting means (27).

8. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 6, characterized in that a one-way valve device (26) is positioned between the monomer filter (28) and/or the bacteria filter (29) and the holes (5) of the spongy bone (1).

9. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the container (18) for producing and/or storing bone substitute or bone reinforcing material (3) is provided with a feeding device (30) for feeding bone substitute or bone reinforcing material (3) from the container (18) into the holes (5) of the spongy bone (1) while the vacuum source (9) generates a vacuum in the holes.

10. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the container (18) for producing and/or storing bone substitute or bone reinforcing material (3) is provided with a feeding device (30) for feeding bone substitute and/or bone reinforcing material (3) from the container (18) into the holes (5) of the spongy bone (1) after the vacuum source (9) has created a vacuum in the holes.

11. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 9, characterized in that the feed device (30) is manually operable.

12. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 10, characterized in that the feed device (30) is manually operable.

13. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the vacuum source (9) is arranged so as to create a vacuum between 0.5bar and 0.92bar in the holes (5) of the spongy bone (1).

14. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 13, characterized in that a vacuum source (9) is provided in order to create a vacuum between 0.7bar and 0.8bar in the holes (5) of the spongy bone (1).

15. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that valve means (32) are provided for closing or interrupting the supply of bone substitute or bone reinforcing material (3) into the holes (5) of the spongy bone (1) until the vacuum source (9) has created a suitable vacuum in the holes, and that the valve means (32) are arranged to be opened to allow the supply of bone substitute or bone reinforcing material (3) so that it can be sucked into the holes (5) of the spongy bone (1) when the suitable vacuum is measured in the holes.

16. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that at least a first and a second cannula or needle (19, 20) can be inserted into the spongy bone (1) such that they are simultaneously directed into the holes (5) of the spongy bone, and in that the first cannula or needle (19) is connected to a container (18) for producing and/or storing bone substitute or bone reinforcing material (3), while the second cannula or needle (20) is connected to a vacuum source (9).

17. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 16, characterized in that the rinsing device (6) comprises a rinsing agent container (16) connected to a first cannula or needle (19) for introducing rinsing agent (7) through the first cannula (19) into the hole (5) of the spongy bone (1) and out of the hole (5) to lead a second cannula or needle (20).

18. Device for providing cancellous bone with bone substitute or bone reinforcing material according to claim 17, characterized in that valve means (32) are provided for opening the supply of bone substitute or bone reinforcing material (3) or for opening the supply of rinsing agent (7) through the first cannula or needle (19).

19. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the cleaning device (6) is provided for cleaning the side faces (5a) of the holes (5) so that tissue material and other material are flushed therefrom in order to form recesses (5b) in the side faces (5a) of the cleaning holes (5) into which recesses (5b) bone substitute or bone reinforcing material (3) can penetrate.

20. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that a vacuum source (9) is provided for sucking the rinsing agent (7) through the holes (5) of the spongy bone (1).

21. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 20, characterized in that the vacuum source (9) for sucking rinsing agent (7) through the holes (5) of the spongy bone (1) is the same vacuum source as the vacuum source for sucking and/or easily inserting bone substitute or bone reinforcing material (3) into said holes (5).

22. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the perforating device (4) comprises an outer tube part (11) that can be positioned at the spongy bone (1), and a perforating part (12) that is coaxial in said outer tube part (11) and/or movable in the direction of rotation, and that the perforating part (12) comprises and/or is fitted with a perforating element (13) for perforating (5) the spongy bone (1).

23. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 22, characterized in that the perforated member (12) comprises an inner tube member (15) for conducting rinsing agent (7) into or out of the holes (5) in the spongy bone (1).

24. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 23, characterized in that the outer tube member (11) or the inner tube member (15) is connected to a vacuum source (9), wherein the vacuum source (9) is adapted to suck rinsing agent (7) through the holes (5) of the spongy bone (1) and to lead rinsing agent out of said holes through the outer tube member (11).

25. Device according to claim 1 or 2, characterized in that the perforating means (4) can be provided with or comprise a number of units for perforating the spongy bone (1) with at least two holes (5) which extend inside each other or between which spongy bone (1) which can be penetrated by air and which is provided with bone substitute and/or bone reinforcing material (3) is present.

26. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the vacuum source (9) is a syringe pump (21) which can be operated by a compression medium.

27. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 26, characterized in that the injection pump (21) can be connected to a compressed-medium device (22) designed as a compressed-air device, wherein the compressed-air device is arranged at or near the location where the vacuum source (9) should be used.

28. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 27, characterized in that a syringe pump (21) can be connected to the compressed-medium device (22) using compressed air.

29. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 27 or 28, characterized in that an injection pump (21) can be connected to the compression medium device (22), which can operate the pump at a compression medium pressure of 4.5-8.5 bar.

30. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the vacuum source (9) is an electric vacuum pump.

31. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the vacuum source (9) is a pneumatic pump.

32. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the vacuum source (9) is operated manually.

33. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the spongy bone (1) is a spongy vertebral bone (2).

34. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the spongy bone (1) is a bone fracture resulting from osteoporosis.

35. Device for providing cancellous bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the cancellous bone (1) is a femoral or patellar fracture.

36. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the rinsing agent (7) is a sodium chloride solution.

37. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the rinsing agent (7) comprises a cleaning agent.

38. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the rinsing agent (7) comprises at least one trombolytic substance.

39. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the rinsing agent (7) is distilled water.

40. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the bone substitute or bone reinforcing material (3) which is sucked in and/or inserted into the spongy bone (1) by means of the vacuum source (9) is an inorganic material or a substantially inorganic material or a ceramic or a substantially ceramic material.

41. Device for providing spongy bone with bone substitute or bone reinforcing material according to claim 40, characterized in that the inorganic or ceramic material is a hardenable mineral or ceramic, which can be hardened in the spongy bone (1).

42. A device for providing cancellous bone with bone substitute or bone reinforcing material according to claim 41 wherein the inorganic material or ceramic is capable of being hardened by mixing with a hardening agent.

43. A device according to claim 40, for providing cancellous bone with bone substitute or bone reinforcing material, wherein the inorganic material or ceramic is selected from the group consisting of calcium sulphate-alpha-hemihydrate, calcium sulphate-beta-hemihydrate, calcium sulphate dihydrate, calcium carbonate, alpha-tricalcium phosphate, hydroxyapatite, dicalcium phosphate dihydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, beta-tricalcium phosphate, calcium deficient hydroxyapatite, monocalcium phosphate monohydrate, monocalcium phosphate, calcium pyrophosphate, precipitated hydroxyapatite, carbonaceous apatite, octacalcium phosphate, amorphous calcium phosphate, hydroxyapatite, carbonate apatite and calcium aluminate.

44. A device for providing cancellous bone with bone substitute or bone reinforcing material according to claim 40 wherein the X-ray contrast agent is mixed with the ceramic material.

45. A device for providing cancellous bone with bone substitute or bone reinforcing material according to claim 44 wherein the X-ray contrast agent is water soluble and non-ionic.

46. A device for equipping cancellous bone with a bone substitute or bone reinforcing material according to claim 45 wherein the water-soluble, non-ionic X-ray contrast agent is selected from the group consisting of iohexol, ioversol, iopamidol, iotrolan, metrizamide, iosixol, ioglucitol, ioglucamide, ioglucanilide, iogulamide, iopyral, iopentol, iopromide, iosarcol, iosimide, iosixamide, iosixol, ioxilan, iodol and iodilol.

47. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 1 or 2, characterized in that the bone substitute or bone reinforcing material (3) which is sucked in and/or inserted into the spongy bone (1) by means of the vacuum source (9) is a bone cement comprising polymer and monomer components, wherein the polymer is of the polymethyl methacrylate (PMMA) type and the monomer is of the Methyl Methacrylate (MMA) type, which components, after mixing with each other and after suction and/or insertion thereof into the spongy bone (1), harden into a bone cement.

48. Device for equipping spongy bone with bone substitute or bone reinforcing material according to claim 47, characterized in that the bone substitute and/or bone reinforcing material (3) consists of an inorganic material and/or a ceramic in combination with a polymer material.