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

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.

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.