US20070043373A1 - Devices and method for widening bone cavities - Google Patents
Devices and method for widening bone cavitiesDownload PDFInfo
- Publication number
- US20070043373A1 US20070043373A1US11/449,860US44986006AUS2007043373A1US 20070043373 A1US20070043373 A1US 20070043373A1US 44986006 AUS44986006 AUS 44986006AUS 2007043373 A1US2007043373 A1US 2007043373A1
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- United States
- Prior art keywords
- widening device
- widening
- tab
- extension
- osteal
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Links
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Classifications
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
- A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
- A—HUMAN NECESSITIES
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
- A61B17/8858—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc laterally or radially expansible
- A—HUMAN NECESSITIES
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- A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
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- A61B90/03—Automatic limiting or abutting means, e.g. for safety
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- A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
Definitions
- the present inventionrelates to a widening device for bone cavities, for example intervertebral cavities or cavities of the tibial plate, the astragalus, or the wrist.
- the present inventionrelates, for example, to a widening device suitable for kyphoplasty operations.
- the present inventionfurther relates to an injection device for bone cavities, for example intervertebral cavities or cavities of the tibial plate, the astragalus, the wrist and the like.
- the present inventionrelates, for example, to a device for kyphoplasty suitable to inject liquid cement in a vertebral body for the reconstruction of the same.
- the present inventionfurther relates to a method for widening and filling bone cavities.
- Widening devices for use in intravertebral cavitiesare known to be inserted in a relaxed configuration in a vertebral body and then widened to an expanded configuration to restore the shape of the vertebral body, thereby forming a suitable cavity therein which is subsequently filled, for example with liquid cement, bone bits or bone filler of various types.
- the known widenersare not able to ensure a controlled expansion inside the vertebral body, i.e. they are not suitable to provide a volume-controlled tridimensional cavity having a desired configuration.
- a cavity having a well defined sizeis indispensable for the reconstruction of a collapsed vertebral body for example consequently to a trauma or bone degeneration.
- the problem of the present inventionis to provide a widening device resolving the drawbacks mentioned with reference to the prior art.
- FIG. 1is a perspective view of a widening device according to the present invention
- FIG. 2is a cut-away view of the widening device from FIG. 1 ;
- FIG. 3is a perspective view of the widening device from FIG. 1 with the addition of accessories;
- FIG. 4Ais a magnification of the detail IV from FIG. 1 ;
- FIGS. 4B and 4Care magnifications of the detail IV from FIG. 1 , according to further embodiments of the present invention.
- FIG. 5Ais a sectional view of the detail IV from FIG. 1 taken along line V-V from FIG. 4 ;
- FIGS. 5B-5Dshow the detail from FIG. 5A comprising a sheath according to different embodiments of the invention
- FIG. 6is a sectional view of the device from FIG. 1 ;
- FIG. 7is a magnification of the detail VII from FIG. 6 ;
- FIG. 8is a magnification of the detail VIII from FIG. 6 ;
- FIG. 9is a sectional view of FIG. 3 ;
- FIG. 10is a magnification of the detail X from FIG. 9 ;
- FIG. 11is a magnification of the detail XI from FIG. 9 ;
- FIG. 12is a magnification of the detail XII from FIG. 9 ;
- FIGS. 13A and 13Bare perspective views of a detail of the device from FIG. 1 in an expanded configuration, according to further embodiments of the present invention.
- FIGS. 13C and 13Dare axonometric projections of the details from FIGS. 13A and 13B respectively;
- FIGS. 14A-14Dare perspective views of a detail from FIG. 1 in a relaxed configuration and in expanded configurations according to different embodiments, respectively;
- FIGS. 15A-15Dare front views of FIGS. 14A-14D , respectively;
- FIG. 16A-16Dare insertion diagrams of widening devices in collapsed osteal bodies, in a relaxed configuration
- FIGS. 17A-17Dare insertion diagrams of the widening devices of FIGS. 16A-16D in restored osteal bodies, in an expanded configuration;
- FIG. 18is a perspective view of an injection device according to the invention, in an open configuration of the device;
- FIG. 19is a perspective view of the injection device from FIG. 18 , in a closed configuration of the device;
- FIG. 20is a side view of the injection device from FIG. 18 in an initial injection step configuration
- FIG. 21is a side view of the injection device from FIG. 18 in a final injection step configuration
- FIG. 22is a perspective view of the injection device from FIG. 18 as being inserted in an osteal body, for example a vertebral body, at the beginning of the injection step;
- FIG. 23is a perspective view of the injection device from FIG. 18 as being inserted in an osteal body, for example a vertebral body, at the end of the injection step;
- FIG. 24is a perspective view of an injection device according to a further embodiment of the invention.
- FIG. 25is a cut-away sectional view of the device from FIG. 24 ;
- FIG. 26is a sectional view of the device from FIG. 24 , at the beginning of the injection step;
- FIG. 27is a sectional view of the device from FIG. 24 , at the end of the injection step;
- FIG. 28is a perspective view of the injection device from FIG. 24 as being inserted in an osteal body, at the beginning of the injection step;
- FIG. 29is a perspective view of the injection device from FIG. 24 inserted inside an osteal body, for example a vertebral body, at the end of the injection step;
- FIG. 30is a perspective view of a device for the insertion either of bone bits or bone filler in an osteal body, for example a vertebral body.
- a widening devicesuitable to provide a cavity within an osteal body, for example a vertebral body 6 , a tibial plate 6 ′, an astragalus 6 ′′, a wrist 6 ′′′ asnd the like.
- widening deviceit is intended a widening device suitable for restore collapsed osteal structures, for example because of trauma or aging, by restoring at least partially the degenerated or collapsed osteal structure and by creating a cavity to be stabilized, for example by subsequent injection of osteal cement or other biocompatible material.
- the widening device 4has an elongate shape as a whole and develops along an extension axis X, between a proximal end 8 and a distal end 10 .
- axial directionwill be designated a direction parallel to the extension axis X
- radial directionwill be designated a perpendicular direction to the extension axis X and incident thereto.
- the widening device 4comprises a cylindrical shank 12 , extending from the proximal end 8 to the distal end 10 .
- the shank 12comprises a first through hole 13 arranged on the side of the proximal end 8 .
- a tube 14externally and coaxially thereto, relative to axis X, such as to at least partially cover the shank 12 .
- the tube 14extends between a first end 14 ′, facing the proximal end 8 , and a second end 14 ′′, facing the distal end 10 .
- the tube 14comprises an aperture 16 having an axial extension L, arranged on the side of first end 14 ′.
- the shank 12is provided with a threaded length 24 for a knob 28 to be associated thereto according to a screw-nut type coupling.
- a sleeve 32arranged between the distal end 10 and the proximal end 8 .
- the sleeve 32comprises a pin 36 mechanically connecting the sleeve 32 with the shank 12 and the tube 14 such as to rotatably lock both of them, relative to the X axis.
- the pin 36has a smaller diameter than said extension L of aperture 16 .
- said pin 36is inserted in the sleeve 32 such as to intercept the first hole 13 of shank 12 and aperture 16 of tube 14 .
- the second end 14 ′′ of tube 14comprises the distal end of shank 12 therein.
- the profile of end 14 ′′ of tube 14identifies a first strike 38 .
- a spacer 40coaxial with the shank 12 , said spacer 40 at least partially intercepting the threaded length 24 .
- a stop element 44suitable to receive the knob 28 in abutment.
- the stop element 44is one-piece with the tube 14 at the first end 14 ′.
- the spacer 40 and the tube 14are suitable to axially slide along the extension axis X relative to shank 12 .
- the spacer 40can axially slide relative to shank 12 for a length being almost equal to the axial distance between the end of spacer 40 facing the stop element 44 and the stop element.
- the tube 14can axially slide relative to shank 12 to the extent of the backlash present between the aperture 16 and the pin 36 .
- a cylindrical terminal 48which, on the opposite side to the shank 12 , comprises a second strike 52 , of a substantially greater diameter than the diameter of shank 12 .
- the terminal 48is removably associated to shank 12 , such as by means of a threaded connection.
- the terminal 48comprises a pivot suitable to be screwed to the free end of shank 12 , and the pivot head provides said first strike 38 .
- An elastically deformable element 56is mounted along the extension axis X, coaxially to the terminal 48 .
- the elastically deformable element 56is cylindrical and hollow as a whole and is suitable to be fitted on terminal 48 .
- the elastically deformable element 56comprises a central body 57 with a diameter d, axially defined by a first and second collar 58 ′, 58 ′′ with a diameter D greater than the diameter d of the central body 57 .
- the elastically deformable element 56further comprises an inserting portion 59 , connected to first collar 58 ′ and axially extending from the opposite side to second collar 58 ′′.
- the inserting portion 59is suitable to be inserted in the inner diameter of tube 14 and extends such that, in an assembly configuration and in the relaxed configuration, between the inserting portion 59 and shank 12 an axial backlash G is identified.
- the axial backlash Gis almost equal to the axial extension L of aperture 16 .
- the axial distance between the first and second collars 58 ′, 58 ′′is almost equal to the distance between the first and second strikes 38 , 52 ; in other words, in a relaxed configuration, the central body 57 is inserted with substantially no backlash between both strikes 38 , 52 .
- the elastically deformable element 56is not subjected to axial loads and is substantially parallel to the extension axis X.
- the elastically deformable element 56has a variable thickness along said extension axis X; in other words, the radial thickness of the elastically deformable element 56 varies advantageously along a parallel direction to said extension axis X.
- the elastically deformable element 56is preferably made of a polymeric material, an elastomer, a rubber and the like.
- the preferred materials to be usedare characterized by a high modulus of elasticity value, such as to ensure high distraction forces and resistance to considerable loads, as well as characterized by a low ratio of the modulus of elasticity and the yield stress, such as to minimize the risk of yield due to great deformation.
- metal, composite or polymeric materialsas well as shape-memory, metal or polymeric materials can also be used.
- the deformable element 56comprises at least one tab 60 which, in the relaxed or undeformed configurations, extends substantially parallel to axis X.
- the elastically deformable element 56comprises at least one tab 60 having a prevalent extension along a median line M, between a first collar 58 ′ and a second collar 58 ′′, said median line M extending so that a line, which is parallel to axis X and which passes through an intersection point between the tab 60 and the first collar 58 ′, does not pass through an intersection point between the tab and the second collar 58 ′′.
- the elastically deformable element 56comprises at least one tab 60 which, in a relaxed or undeformed configuration, extends along a helicoidal path with respect to said axis X.
- the tab 60extends along a helicoidal path with respect to axis X, according to a helix angle a.
- the elastically deformable element 56comprises at least one tab 60 having a preferred extension along a median line or axis M, said median axis M having a helicoidal extension with respect to said axis X.
- Said median axis Mextends according to a helix angle ⁇ , said angle being defined between a line perpendicular to a line parallel to axis X and passing through said median axis M, and said median axis M.
- median axis M of the tabit is intended a line passing through a median line of the tab which is also a curvilinear symmetry axis for the tab.
- the helix angle ⁇is preferably comprised between 60 and 85 degrees, and most preferably is equal to 80 degrees. According to an embodiment, said helix angle a is constant, along the extension of the tab 60 . According to another embodiment, the helix angle ⁇ is variable along the extension of the tab 60 ; in other words the tab 60 , along its extension, wraps around axis X according to a variable helix angle ⁇ .
- the helix angle ⁇is greater near first and second collars 58 ′, 58 ′′.
- said tab 60 along its helicoidal extensionpresents a thickness, being measured with respect to a radial direction incident with said axis X and contained in a plane perpendicular to said axis X, said thickness being variable along the helicoidal extension of the tab 60 .
- the at least one tab 60is formed in the elastically deformed element 56 by means of longitudinal grooves 64 if the tab has a longitudinal extension parallel to axis X; otherwise the tab 60 is formed in the elastically deformed element 56 by means of helicoidal grooves 64 ′ if the tab has a helicoidal extension with respect to axis X.
- Said helicoidal grooves 64 ′may be obtained by a CNC machine having a working head which moves along a helicoidal direction so as to cut away material from a solid tubular element and to obtain said grooves.
- the grooves 64 , 64 ′end with slots 68 , for example of a circular shape.
- each tab 60has a central portion 72 and two side portions 76 ′, 76 ′′ being axially arranged on opposite sides to the central portion 72 .
- the side portions 76 ′, 76 ′′are in turn connected to the respective collars 58 ′, 58 ′′ through attachment portions 80 ′, 80 ′′.
- the tabs 60have a midplane S perpendicular to the extension axis X and positioned in the middle of central portion 72 ; in other words, the side portions 76 ′, 76 ′′ and the attachment portions 80 ′, 80 ′′ have the same axial extension. According to further embodiments, the side portions 76 ′, 76 ′′ and/or the attachment portions 80 ′, 80 ′′ have different axial extensions.
- the tabs 60have only one side portion 76 ′ or 76 ′′ and do not exhibit the midplane S, i.e. the central portion is directly connected to the respective collar 58 ′ or 58 ′′.
- central body 57can have an outer diameter varying along the longitudinal extension of the same.
- each tab 60advantageously has radial thicknesses varying along the extension axis X.
- This variation in the thicknessescan be discrete, such that the elastically deformable element 56 has marked variations in the thickness for example at the interface areas between the central portion 72 and the side portions 76 ′, 76 ′′ or between the side portions 76 ′, 76 ′′ and the attachment portions 80 ′, 80 ′′.
- this variation in the thicknessesis gradual and continuous, i.e. said interface areas between the central portion 72 and the side portions 76 ′, 76 ′′ or between the side portions 76 ′, 76 ′′ and the attachment portions 80 ′, 80 ′′ are suitably linked up to one another in the thicknesses thereof.
- each tab 60gradually decreases towards the attachment portions 80 ′, 80 ′′.
- each tab 60has, relative to a perpendicular plane to the extension axis X, a section shaped like a ring sector, having a minor arch 84 facing the axis X and a major arch 88 facing outwardly.
- the elastically deformable element 56has a plurality of tabs 60 ; according to some preferred embodiments, such as illustrated for example in FIGS. 14A-14D , the elastically deformable element 56 has three or four tabs symmetrically or asymmetrically arranged relative to the extension axis X.
- said elastically deformable element 56comprises a sheath 92 extending between the attachment portions 80 ′, 80 ′′ such as to wrap or cover said tabs 60 .
- the sheath 92has a substantially axial-symmetrical extension coaxial with the extension axis X.
- the sheath 92has a cylindrical extension, with a substantially constant diameter, such as to at least partially adhere to tabs 60 also in a relaxed configuration.
- the sheath 92has a cylindrical extension with a varying diameter such as to adhere, in a relaxed configuration, to the elastically deformable element 56 at the collars 58 ′, 58 ′′.
- the sheath 92has an ellipsoidal extension as a whole in a relaxed configuration, having a varying diameter along the extension of said axis X, for example such as to come in contact with tabs 60 at the collars 58 ′, 58 ′′ and not at the central portion 72 of tabs 60 .
- the sheath 92can be double-lobe shaped or however have a varying section along the longitudinal extension of sheath 92 , said section being taken on a perpendicular plane to axis X.
- the sheath 92has a constant thickness along the extension thereof.
- the sheath 92has a varying thickness along the extension thereof; for example the sheath 92 has a thickening 93 at the connecting portions to the elastically deformable element 56 and a thinning 94 in a portion comprised between said connecting portions and facing for example the central body 57 of tabs 60 .
- the sheath 92is made of an elastic material such as a polymer, an elastomer, a rubber, and is suitable to be matched to the tabs 60 in the deformed configuration.
- the sheath 92is associated to the elastically deformable element 56 by glueing at the first and second collars 58 ′, 58 ′′.
- the widening device 4comprises a cylindrical cannula 96 suitable to cover the tube 14 in the length comprised between the distal end 10 and sleeve 32 .
- said cannula 96is provided with a threaded bush 100 at a connecting end 106 facing the sleeve 32 ; the bush 100 acts as an adjusting sleeve to tailor the insertion depth of the widening device 4 inside the osteal body 6 , 6 ′, 6 ′′, 6 ′′′.
- said cannula 96is provided with a gripping end 104 , suitable to be locked on the cortex of an osteal body 6 , like a vertebral body 6 , a tibial plate 6 ′, an astragalus 6 ′′ or a wrist 6 ′′′, such as to form a guide for the widening device 4 to be inserted therein, and also for the insertion of a probe to first inspect the interior of the osteal body 6 , 6 ′, 6 ′′, 6 ′′′.
- the cannula 96allows the use, i.e. the coupling with endoscopic, microscopic systems and for biopsy sampling.
- the cannula 96is advantageously suitable to at least partially house a cement injection device 112 to fill the osteal cavity with liquid cement.
- the injection device 112comprises a grip element 116 suitable to allow the grip by a user and having a pusher 118 for example of a cylindrical shape, integrally connected to the grip element 116 .
- the pusher 118is coaxial to the extension axis X.
- the grip element 116further comprises at least one seat 120 .
- a lid 122On the grip element 116 there is hinged a lid 122 , suitable to rotate from an open position, such as illustrated for example in FIG. 18 , to a closed position such as illustrated for example in FIG. 19 .
- the lid 122further comprises a window 123 and a corresponding graduated scale suitable to measure the relative translation between a control element 126 and the grip element 116 .
- the lid 122ends with a stop 124 having a notch 125 .
- control element 126mechanically connected to a plate 130 , of a circular shape having a second hole 134 .
- control element 126comprises at least one guide 138 suitable to be at least partially housed within said seat 120 , such that the motion of the control element 126 relative to the grip element 116 is guided substantially along a stroke T according to a direction parallel to axis X.
- a cylindrical needle 140hollow and suitable to be housed within the cannula 96 , is mechanically associated to the plate 130 through said second hole 134 such that an injection end 144 of needle 140 is fluidically connected to chamber 135 .
- FIGS. 24-29A further embodiment of an injection device 112 ′ will be now described, such as illustrated for example in FIGS. 24-29 , wherein the elements or parts in common with the embodiment illustrated above will be indicated with the same numeral provided with primes.
- the injection device 112 ′has a cartridge configuration as a whole, of main extension P.
- the injection device 112 ′comprises a hollow grip element 116 ′ of a cylindrical shape suitable to be held by a user.
- the grip element 112 ′At an inner side wall 150 the grip element 112 ′ comprises a first threading 152 with pitch M′.
- the grip element 112 ′Opposite to the first threading 152 , relative to the main extension P, the grip element 112 ′ comprises a flange 154 having longitudinal guides 156 arranged parallel to the main extension P.
- a first cylindrical and hollow ring nut 158is suitable to mesh with said first threading 152 at a first control portion 160 such as to be coaxially mounted to the grip element 116 ′ and internally thereto.
- the first ring nut 158opposite to the first control portion 160 , comprises a second control portion 162 provided at an inner part, i.e. towards the extension axis P, with an inner threading of pitch M′′, other than said pitch M′.
- pitch M′′ of second threading 164is greater than pitch M′ of first threading 152 ; preferably pitch M′′ is about twice the pitch M′.
- the first ring nut 158opposite to the second threading 164 , comprises a neck 166 provided with a notch 168 .
- a control element 126 ′preferably in the form of a hollow knob.
- the control element 126 ′is removably fastened to the neck 166 , through a bayonet-type arrangement, by means of at least one stake 170 suitable to be locked within said notch 168 .
- a barrel 172 for the at least one stake 170 to be mounted theretois interposed between the control element 126 ′ and the neck 166 there is interposed a barrel 172 for the at least one stake 170 to be mounted thereto; the barrel 172 is provided with a spring 173 such as to force said stake against the corresponding notch 168 .
- the control element 126 ′comprises a bell 174 suitable to house said barrel 172 and suitable to be at least partially inserted in the first ring nut 158 from the neck 166 .
- the bell 174axially ends with a stop surface 175 , such as of a disc-shape type.
- control element 126 ′, the barrel 172 and the first ring nut 158are preferably rotatably integral to one another.
- the second ring nut 176having an outwardly threaded portion 178 suitable to mesh with the second threading 164 .
- the second ring nut 176comprises at least one pivot 180 suitable to be housed within said longitudinal guides 156 , such as to longitudinally slide therealong; furthermore, the second ring nut 176 comprises an abutment surface 182 of a circular ring shape.
- a cylindrical plug 184arranged at the opposite end of the control element 126 ′, and preferably comprising a threaded ring 186 suitable to be screwed on the threaded bush 100 .
- first ring nut 158 and the second ring nut 176are coaxially and partially mounted within the grip element 116 ′ such as to define a substantially cylindrical chamber 135 ′.
- the injection device 112 ′is suitable to contain within said chamber 135 ′ a substantially cylindrical syringe 188 comprising a syringe body 190 enclosing a cement cartridge 136 ′ to be injected, a pusher 118 ′ being associated thereto, which is suitable to compress said cement cartridge 136 ′.
- the cement cartridge 136 ′opposite to the pusher 118 ′, is fluidically connected to a needle 140 ′ and according to an embodiment, the syringe body 190 is one-piece with the needle 140 ′.
- the cannula 96is further suitable to be connected to a funnel 200 , at the proximal end.
- Said funnel 200is suitable to allow bone bits, i.e. bone fragments, such as taken from the iliac crest or generally bone substitute to be inserted therein.
- the cannula 96allows a rammer, i.e. an elongate cylindrical body having a rounded end, suitable to compact the bone bits or the bone substitute inserted therein, to be inserted within the cavity of a vertebral body 6 , tibial plate 6 ′, astragalus 6 ′′, wrist 6 ′′′, by means of the cannula 96 .
- a rammeri.e. an elongate cylindrical body having a rounded end, suitable to compact the bone bits or the bone substitute inserted therein, to be inserted within the cavity of a vertebral body 6 , tibial plate 6 ′, astragalus 6 ′′, wrist 6 ′′′, by means of the cannula 96 .
- the cortical and sponge tissues of the osteal body 6like for example a vertebral body 6 , a tibial plate 6 ′, an astragalus 6 ′′, a wrist 6 ′′′, are pierced with a punch such as to enable the cannula 96 to be firmly fixed to the osteal body 6 , 6 ′, 6 ′′, 6 ′′′.
- An endoscopemay be firstly inserted in said cannula 96 to inspect the interior of the osteal body 6 , 6 ′, 6 ′′, 6 ′′′.
- the cannula 96can then house the widening device 4 therein.
- the above threaded bush 100can be used to act as the adjustment sleeve.
- the elastically deformable elementcan be then expanded 56 .
- the knob 28can be rotated on the threaded length 24 of shank 12 , by holding the sleeve 32 at the same time, such as to cause the shank 12 to be tensioned, which is rotatably locked by the pin 36 of sleeve 32 .
- the shank 12translatably drags the terminal 48 and the elastically deformable element 56 which in turn pushes the first strike 38 of tube 14 .
- the tube 14translates at first towards the proximal end until completely recovering the backlash between the pin 36 and the aperture 16 .
- knob 28generates the compression of the elastically deformable element 56 between the first and second strike 38 , 52 . Following said compression the tabs 60 , subjected to a compression load, tend to inflect outwardly, thereby taking an expanded or deflected configuration, such as arch-shaped.
- the tabs 60can be advantageously encircled by the sheath 92 filling the gaps or grooves 64 between the tabs 60 .
- the widening device 4can be disabled.
- the passage from the deformed configuration to the undeformed or relaxed configurationdoes not take place by applying another external force, but by removing the initial deformation force, i.e. by unloading the shank 12 and the elastically deformable element 56 accordingly.
- the widening device 4can be then extracted and the injection device 112 , 112 ′ or the funnel 200 can be subsequently inserted to fill the osteal cavity with liquid cement or bone bits, respectively.
- the cartridge 136has been inserted in chamber 135 , and the lid 122 has been closed, one holds the grip element 116 and presses the control element 126 , such as to approach i.e. move the control element 126 backward towards the grip element 116 .
- the cartridge 136is compressed between the plate 130 translatably dragged by the grip element 116 and the pusher 118 .
- the cement contained in the cartridge 136tends to flow inside the needle 140 and to exit through the injection end 144 of the same.
- the injection end 144moves backward during the injection step, by a stroke T equal to the translation stroke of the control element 126 .
- the amount of cement to be injectedcan be controlled by directly reading the translation of needle 140 with the aid of a graduated scale on window 123 of lid 122 .
- control element 126 ′is first extracted by disengaging the stake 170 from notch 168 of neck 166 , and the barrel 172 is removed to gain access to chamber 135 ′.
- the syringe 188 provided with needle 140 ′is inserted in the chamber 135 ′ such as to bring the cement cartridge 136 ′ in abutment against the abutment surface 182 of second ring nut 176 .
- the control element 126 ′is then reassembled such as to bring the end surface 175 of bell 174 in contact with the pusher 118 ′.
- syringe 188is housed coaxially to the injection device 112 ′ as well as axially constrained from opposite sides, i.e. between the control element 126 ′ and the second ring nut 176 .
- the pusher 118 ′ of syringe 188is in abutment against the stop surface 175 of the control element 126 ′, such as to prevent the pusher 118 ′ to move backwards according to a backward direction r; whereas the syringe body 190 abuts against the abutment surface 182 of second ring nut 176 , such that the syringe body 190 cannot be moved according to a forward motion relative to a forward direction f opposite to said backward direction r.
- the outwardly threaded portion 178is first engaged on bush 100 such as to house the needle 140 ′ of injection device 112 ′ within the cannula 96 and form a fluidical connection between the cement cartridge 136 , the injection end 144 and the cavity of the osteal body 6 , 6 ′, 6 ′′, 6 ′′′.
- the grip element 116 ′To perform the injection, one holds the grip element 116 ′ and rotates the control element 126 ′ such as to rotatably drag the first ring nut 158 ; particularly the first ring nut 158 , by screwing on the grip element 116 ′, moves forward, i.e. it translates towards needle 140 ′, according to the forward direction f.
- the second ring nut 176meshes in turn with the grip element 116 ′ and, since it cannot rotate relative to the grip element 116 ′ due to the coupling between pivots 180 and longitudinal guides 156 of flange 154 , it translates away from needle 140 ′, according to the backward direction r opposite to said forward direction f. Therefore, following the rotation of the control element 126 ′, the first and second ring nuts 158 , 176 translate along extension P in opposite directions f,r thus approaching each other respectively.
- the abutment surface 182 of second ring nut 176 when being translatingurges the cement cartridge 136 which is compressed between the syringe body 190 in abutment against the abutment surface 182 and pusher 118 ′, which cannot move backward according to backward direction r due to the stop surface 175 .
- the syringe body 190moves backward together with the abutment surface 182 of second ring nut 176 and drags the needle 140 ′ in its backward motion along the backward direction r. Consequently, following the rotation of the control element 126 ′, needle 140 ′, and particularly the injection end 144 of needle 140 ′, moves backward by a stroke T according to the backward direction r.
- the first ring nut 158translatably drags the control element 126 ′ towards the second ring nut 176 . Therefore, the stop surface 175 of the control element 126 ′ urges in turn the pusher 118 ′ of syringe 188 according to the forward direction f and further compresses the cement cartridge 136 ′. Following this compression the cement tends to exit through the injection end 144 of needle 140 ′ and from the latter to the inside of the osteal cavity.
- the pivots 180slide in the longitudinal guides 156 and by being visible from the outside of the injection device 112 ′, also provide a visual indication of the feeding state of the injection, i.e. the amount of cement being injected.
- a graduated scaleto give an indication of the amount of cement being injected.
- the cement capsule 136 ′stops being subjected to compression and the cement flow through needle 140 ′ is stopped.
- the widening deviceallows to overcome the drawbacks of the prior art widening devices.
- the widening deviceallows to provide a cavity within an osteal body, such a vertebral body, an astragalus, a tibial plate, a wrist, in a controlled manner, i.e. by providing predetermined expansion configurations which can be adjusted according to different types of osteal bodies and different surgical indications.
- the widening deviceensures an active expansion, by generating a cavity of a defined shape without being subjected to deformations by the bone tissue of the osteal body, the mechanical characteristics of which are typically not isotropic and omogeneous.
- the covering sheathby filling the grooves comprised between the tabs, ensures continuity to the deformable element thereby preventing the individual tabs from getting entangled within the osteal body tissue, thereby allowing the deformed configuration to return to the relaxed configuration.
- the presence of the sheath covering the tabsprevents any inclusion of bone material within the elastically deformable element, which case may hinder the tab closing motion, i.e. their return to the undeformed configuration.
- the devicehas a solidity of the created volume, it is to say the volume of the device in an expanded configuration, which is greater than the arrangement with longitudinal tabs.
- solidityit is intended the ratio between solid and void zones, it is to say between the zone comprising the tabs, which contribute to the widening of the cavity, and the interstices among the tabs which do not exerte any widening action of the osteal tissue.
- a greater solidity of the deformable elementgrants a controlled expansion, in spite of the anisotropy of the spongeous tissue in the cavity of the osteal body.
- a high solidityavoids the event of gripping of the tabs in the spongeous tissue and does not require the use of sheaths or membranes, suitable for fill said voids or interstices among tabs.
- the particular varying-thickness configuration along the tabs both with longitudinal extension and with elicoidal extensionallows to provide greater thicknesses in the tab areas subjected to greater loads and lower thicknesses in the areas where, following the deformation, great bending is desired without yielding the material. In fact, any yield may hinder the elastic return of the deformable portion from the deformed configuration to the relaxed configuration.
- the deformable elementBy providing the deformable element as one-piece, the resistance of the tabs to high work load is ensured. Particularly, the presence of the slots to the tab ends prevents the risk that any crack may propagate.
- the tabsare therefore beams fitted to the ends, which when subjected to compression, instabilize and inflect outwardly, i.e. away from the extension X axis.
- This arrangementprovides a particular stiffness to the deformable portion and allows to vary the stiffness of the tabs by acting on the variation of thicknesses.
- the backward motion of the needle during the cement injectionensures an optimum filling of the osteal cavity because the injection end moves gradually and automatically backward as the cavity is being filled. A uniform and omogeneous distribution of the cement being injected in the bone cavity is thereby ensured. Furthermore, due to the backward motion of the needle, overpressures in the osteal body are prevented which may give origin to leakages of cement dangerous for the spinal marrow if, for example, the osteal body is a vertebral body.
- the configuration of the cannula provided with a tailored bushallows to associate different devices to this cannula for an operation of widening and restoring of an osteal cavity, such as a kyphoplasty operation, after only one access port has been made in the osteal cortical area and only one cannula has been inserted as the guide member.
- the bushallows to change the axial position of each of the devices being inserted, particularly the insertion depth of the distal end of the widening device and the needle injection end.
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Abstract
Description
- The present invention relates to a widening device for bone cavities, for example intervertebral cavities or cavities of the tibial plate, the astragalus, or the wrist.
- Particularly it relates to a widening device suitable to restore collapsed bone structures, for example because of trauma or aging, restoring at least partially the collapsed or degenerated bone structure and creating a cavity to be stabilized, for example, with a following injection of bone cement or another biocompatible material. The present invention relates, for example, to a widening device suitable for kyphoplasty operations.
- The present invention further relates to an injection device for bone cavities, for example intervertebral cavities or cavities of the tibial plate, the astragalus, the wrist and the like. The present invention relates, for example, to a device for kyphoplasty suitable to inject liquid cement in a vertebral body for the reconstruction of the same.
- The present invention further relates to a method for widening and filling bone cavities.
- Widening devices for use in intravertebral cavities are known to be inserted in a relaxed configuration in a vertebral body and then widened to an expanded configuration to restore the shape of the vertebral body, thereby forming a suitable cavity therein which is subsequently filled, for example with liquid cement, bone bits or bone filler of various types.
- The known wideners are not able to ensure a controlled expansion inside the vertebral body, i.e. they are not suitable to provide a volume-controlled tridimensional cavity having a desired configuration.
- The provision of a cavity having a well defined size is indispensable for the reconstruction of a collapsed vertebral body for example consequently to a trauma or bone degeneration.
- The problem of the present invention is to provide a widening device resolving the drawbacks mentioned with reference to the prior art.
- These drawbacks and limitations are resolved by a widening device in accordance with claim1.
- Other embodiments of the widening device according to the invention are described in the subsequent claims.
- Further characteristics and the advantages of the present invention will be better understood from the description below of preferred and non-limiting exemplary embodiments thereof, wherein:
FIG. 1 is a perspective view of a widening device according to the present invention;FIG. 2 is a cut-away view of the widening device fromFIG. 1 ;FIG. 3 is a perspective view of the widening device fromFIG. 1 with the addition of accessories;FIG. 4A is a magnification of the detail IV fromFIG. 1 ;FIGS. 4B and 4C are magnifications of the detail IV fromFIG. 1 , according to further embodiments of the present invention;FIG. 5A is a sectional view of the detail IV fromFIG. 1 taken along line V-V fromFIG. 4 ;FIGS. 5B-5D show the detail fromFIG. 5A comprising a sheath according to different embodiments of the invention;FIG. 6 is a sectional view of the device fromFIG. 1 ;FIG. 7 is a magnification of the detail VII fromFIG. 6 ;FIG. 8 is a magnification of the detail VIII fromFIG. 6 ;FIG. 9 is a sectional view ofFIG. 3 ;FIG. 10 is a magnification of the detail X fromFIG. 9 ;FIG. 11 is a magnification of the detail XI fromFIG. 9 ;FIG. 12 is a magnification of the detail XII fromFIG. 9 ;FIGS. 13A and 13B are perspective views of a detail of the device fromFIG. 1 in an expanded configuration, according to further embodiments of the present invention;FIGS. 13C and 13D are axonometric projections of the details fromFIGS. 13A and 13B respectively;FIGS. 14A-14D are perspective views of a detail fromFIG. 1 in a relaxed configuration and in expanded configurations according to different embodiments, respectively;FIGS. 15A-15D are front views ofFIGS. 14A-14D , respectively;FIG. 16A-16D are insertion diagrams of widening devices in collapsed osteal bodies, in a relaxed configuration;FIGS. 17A-17D are insertion diagrams of the widening devices ofFIGS. 16A-16D in restored osteal bodies, in an expanded configuration;FIG. 18 is a perspective view of an injection device according to the invention, in an open configuration of the device;FIG. 19 is a perspective view of the injection device fromFIG. 18 , in a closed configuration of the device;FIG. 20 is a side view of the injection device fromFIG. 18 in an initial injection step configuration;FIG. 21 is a side view of the injection device fromFIG. 18 in a final injection step configuration;FIG. 22 is a perspective view of the injection device fromFIG. 18 as being inserted in an osteal body, for example a vertebral body, at the beginning of the injection step;FIG. 23 is a perspective view of the injection device fromFIG. 18 as being inserted in an osteal body, for example a vertebral body, at the end of the injection step;FIG. 24 is a perspective view of an injection device according to a further embodiment of the invention;FIG. 25 is a cut-away sectional view of the device fromFIG. 24 ;FIG. 26 is a sectional view of the device fromFIG. 24 , at the beginning of the injection step;FIG. 27 is a sectional view of the device fromFIG. 24 , at the end of the injection step;FIG. 28 is a perspective view of the injection device fromFIG. 24 as being inserted in an osteal body, at the beginning of the injection step;FIG. 29 is a perspective view of the injection device fromFIG. 24 inserted inside an osteal body, for example a vertebral body, at the end of the injection step;FIG. 30 is a perspective view of a device for the insertion either of bone bits or bone filler in an osteal body, for example a vertebral body.- The elements or element parts in common between the embodiments described below will be indicated with the same numerals.
- With reference to the above figures, with4 has been generally indicated a widening device suitable to provide a cavity within an osteal body, for example a
vertebral body 6, atibial plate 6′, anastragalus 6″, awrist 6′″ asnd the like. - By ‘widening device’ it is intended a widening device suitable for restore collapsed osteal structures, for example because of trauma or aging, by restoring at least partially the degenerated or collapsed osteal structure and by creating a cavity to be stabilized, for example by subsequent injection of osteal cement or other biocompatible material.
- The widening
device 4 has an elongate shape as a whole and develops along an extension axis X, between a proximal end8 and adistal end 10. - Herewith below, by axial direction will be designated a direction parallel to the extension axis X, and by radial direction will be designated a perpendicular direction to the extension axis X and incident thereto.
- The widening
device 4 comprises acylindrical shank 12, extending from the proximal end8 to thedistal end 10. - The
shank 12 comprises a first throughhole 13 arranged on the side of the proximal end8. - To the
shank 12 there is associated atube 14 externally and coaxially thereto, relative to axis X, such as to at least partially cover theshank 12. Thetube 14 extends between afirst end 14′, facing the proximal end8, and asecond end 14″, facing thedistal end 10. - The
tube 14 comprises anaperture 16 having an axial extension L, arranged on the side offirst end 14′. - At the proximal end8 the
shank 12 is provided with a threadedlength 24 for aknob 28 to be associated thereto according to a screw-nut type coupling. - To the
shank 12 andtube 14 is further coaxially associated asleeve 32, arranged between thedistal end 10 and the proximal end8. - The
sleeve 32 comprises apin 36 mechanically connecting thesleeve 32 with theshank 12 and thetube 14 such as to rotatably lock both of them, relative to the X axis. - The
pin 36 has a smaller diameter than said extension L ofaperture 16. - Particularly, in an assembly configuration, said
pin 36 is inserted in thesleeve 32 such as to intercept thefirst hole 13 ofshank 12 andaperture 16 oftube 14. Furthermore, in an assembly configuration, thesecond end 14″ oftube 14 comprises the distal end ofshank 12 therein. - The profile of
end 14″ oftube 14 identifies afirst strike 38. - Between the
sleeve 32 and theknob 28 there is inserted aspacer 40, coaxial with theshank 12, said spacer40 at least partially intercepting the threadedlength 24. - Between the
spacer 40 and theknob 28 there is inserted, coaxially with theshank 12, astop element 44, suitable to receive theknob 28 in abutment. Preferably, thestop element 44 is one-piece with thetube 14 at thefirst end 14′. - The
spacer 40 and thetube 14 are suitable to axially slide along the extension axis X relative toshank 12. - Particularly, the
spacer 40 can axially slide relative toshank 12 for a length being almost equal to the axial distance between the end ofspacer 40 facing thestop element 44 and the stop element. - The
tube 14 can axially slide relative toshank 12 to the extent of the backlash present between theaperture 16 and thepin 36. - At the
distal end 10, to theshank 12 there is associated acylindrical terminal 48 which, on the opposite side to theshank 12, comprises asecond strike 52, of a substantially greater diameter than the diameter ofshank 12. - Preferably, the terminal48 is removably associated to
shank 12, such as by means of a threaded connection. - According to an embodiment, the terminal48 comprises a pivot suitable to be screwed to the free end of
shank 12, and the pivot head provides saidfirst strike 38. - An elastically
deformable element 56 is mounted along the extension axis X, coaxially to the terminal48. - The elastically
deformable element 56 is cylindrical and hollow as a whole and is suitable to be fitted onterminal 48. - Preferably, the elastically
deformable element 56 comprises acentral body 57 with a diameter d, axially defined by a first andsecond collar 58′,58″ with a diameter D greater than the diameter d of thecentral body 57. - The elastically
deformable element 56 further comprises an insertingportion 59, connected tofirst collar 58′ and axially extending from the opposite side tosecond collar 58″. - The inserting
portion 59 is suitable to be inserted in the inner diameter oftube 14 and extends such that, in an assembly configuration and in the relaxed configuration, between the insertingportion 59 andshank 12 an axial backlash G is identified. - Preferably, the axial backlash G is almost equal to the axial extension L of
aperture 16. The axial distance between the first andsecond collars 58′,58″ is almost equal to the distance between the first andsecond strikes central body 57 is inserted with substantially no backlash between bothstrikes - In the relaxed configuration, the elastically
deformable element 56 is not subjected to axial loads and is substantially parallel to the extension axis X. - Advantageously, relative to a perpendicular plane to the extension axis X, the elastically
deformable element 56 has a variable thickness along said extension axis X; in other words, the radial thickness of the elasticallydeformable element 56 varies advantageously along a parallel direction to said extension axis X. - The elastically
deformable element 56 is preferably made of a polymeric material, an elastomer, a rubber and the like. The preferred materials to be used are characterized by a high modulus of elasticity value, such as to ensure high distraction forces and resistance to considerable loads, as well as characterized by a low ratio of the modulus of elasticity and the yield stress, such as to minimize the risk of yield due to great deformation. - Furthermore, metal, composite or polymeric materials, as well as shape-memory, metal or polymeric materials can also be used.
- Preferably, the
deformable element 56 comprises at least onetab 60 which, in the relaxed or undeformed configurations, extends substantially parallel to axis X. - According to a further embodiment, the elastically
deformable element 56 comprises at least onetab 60 having a prevalent extension along a median line M, between afirst collar 58′ and asecond collar 58″, said median line M extending so that a line, which is parallel to axis X and which passes through an intersection point between thetab 60 and thefirst collar 58′, does not pass through an intersection point between the tab and thesecond collar 58″. - According to a preferred embodiment, the elastically
deformable element 56 comprises at least onetab 60 which, in a relaxed or undeformed configuration, extends along a helicoidal path with respect to said axis X. Thetab 60 extends along a helicoidal path with respect to axis X, according to a helix angle a. In other words, the elasticallydeformable element 56 comprises at least onetab 60 having a preferred extension along a median line or axis M, said median axis M having a helicoidal extension with respect to said axis X. - Said median axis M extends according to a helix angle α, said angle being defined between a line perpendicular to a line parallel to axis X and passing through said median axis M, and said median axis M.
- By median axis M of the tab it is intended a line passing through a median line of the tab which is also a curvilinear symmetry axis for the tab.
- The helix angle α is preferably comprised between 60 and 85 degrees, and most preferably is equal to 80 degrees. According to an embodiment, said helix angle a is constant, along the extension of the
tab 60. According to another embodiment, the helix angle α is variable along the extension of thetab 60; in other words thetab 60, along its extension, wraps around axis X according to a variable helix angle α. - Preferably, the helix angle α is greater near first and
second collars 58′,58″. - According to an embodiment, said
tab 60 along its helicoidal extension presents a thickness, being measured with respect to a radial direction incident with said axis X and contained in a plane perpendicular to said axis X, said thickness being variable along the helicoidal extension of thetab 60. - The at least one
tab 60 is formed in the elasticallydeformed element 56 by means oflongitudinal grooves 64 if the tab has a longitudinal extension parallel to axis X; otherwise thetab 60 is formed in the elasticallydeformed element 56 by means ofhelicoidal grooves 64′ if the tab has a helicoidal extension with respect to axis X. Saidhelicoidal grooves 64′ may be obtained by a CNC machine having a working head which moves along a helicoidal direction so as to cut away material from a solid tubular element and to obtain said grooves. - Advantageously, at ends facing the first and
second collars 58′,58″, respectively, thegrooves slots 68, for example of a circular shape. - According to an embodiment, each
tab 60 has acentral portion 72 and twoside portions 76′,76″ being axially arranged on opposite sides to thecentral portion 72. - The
side portions 76′,76″ are in turn connected to therespective collars 58′,58″ throughattachment portions 80′,80″. - According to an embodiment, the
tabs 60 have a midplane S perpendicular to the extension axis X and positioned in the middle ofcentral portion 72; in other words, theside portions 76′,76″ and theattachment portions 80′,80″ have the same axial extension. According to further embodiments, theside portions 76′,76″ and/or theattachment portions 80′,80″ have different axial extensions. - According to further embodiments, the
tabs 60 have only oneside portion 76′ or76″ and do not exhibit the midplane S, i.e. the central portion is directly connected to therespective collar 58′ or58″. - Furthermore, the
central body 57 can have an outer diameter varying along the longitudinal extension of the same. - Such as for example illustrated in
FIG. 5 , eachtab 60 advantageously has radial thicknesses varying along the extension axis X. This variation in the thicknesses can be discrete, such that the elasticallydeformable element 56 has marked variations in the thickness for example at the interface areas between thecentral portion 72 and theside portions 76′,76″ or between theside portions 76′,76″ and theattachment portions 80′,80″. According to a further embodiment this variation in the thicknesses is gradual and continuous, i.e. said interface areas between thecentral portion 72 and theside portions 76′,76″ or between theside portions 76′,76″ and theattachment portions 80′,80″ are suitably linked up to one another in the thicknesses thereof. - For example, at the
central portion 72, the greater thickness of eachtab 60 gradually decreases towards theattachment portions 80′,80″. - Furthermore, each
tab 60 has, relative to a perpendicular plane to the extension axis X, a section shaped like a ring sector, having aminor arch 84 facing the axis X and amajor arch 88 facing outwardly. - Preferably, the elastically
deformable element 56 has a plurality oftabs 60; according to some preferred embodiments, such as illustrated for example inFIGS. 14A-14D , the elasticallydeformable element 56 has three or four tabs symmetrically or asymmetrically arranged relative to the extension axis X. - According to an advantageous embodiment, said elastically
deformable element 56 comprises asheath 92 extending between theattachment portions 80′,80″ such as to wrap or cover saidtabs 60. - In the relaxed configuration of the elastically
deformable element 56, thesheath 92 has a substantially axial-symmetrical extension coaxial with the extension axis X. According to an embodiment, thesheath 92 has a cylindrical extension, with a substantially constant diameter, such as to at least partially adhere totabs 60 also in a relaxed configuration. According to a further embodiment, thesheath 92 has a cylindrical extension with a varying diameter such as to adhere, in a relaxed configuration, to the elasticallydeformable element 56 at thecollars 58′,58″. According to a further embodiment, thesheath 92 has an ellipsoidal extension as a whole in a relaxed configuration, having a varying diameter along the extension of said axis X, for example such as to come in contact withtabs 60 at thecollars 58′,58″ and not at thecentral portion 72 oftabs 60. Furthermore, thesheath 92 can be double-lobe shaped or however have a varying section along the longitudinal extension ofsheath 92, said section being taken on a perpendicular plane to axis X. - According to an embodiment the
sheath 92 has a constant thickness along the extension thereof. According to a further embodiment, such as illustrated inFIG. 5D , thesheath 92 has a varying thickness along the extension thereof; for example thesheath 92 has a thickening93 at the connecting portions to the elasticallydeformable element 56 and a thinning94 in a portion comprised between said connecting portions and facing for example thecentral body 57 oftabs 60. - Preferably, the
sheath 92 is made of an elastic material such as a polymer, an elastomer, a rubber, and is suitable to be matched to thetabs 60 in the deformed configuration. - According to an embodiment, the
sheath 92 is associated to the elasticallydeformable element 56 by glueing at the first andsecond collars 58′,58″. - According to an advantageous embodiment, the widening
device 4 comprises acylindrical cannula 96 suitable to cover thetube 14 in the length comprised between thedistal end 10 andsleeve 32. - Preferably, said
cannula 96 is provided with a threadedbush 100 at a connecting end106 facing thesleeve 32; thebush 100 acts as an adjusting sleeve to tailor the insertion depth of the wideningdevice 4 inside theosteal body - Advantageously, said
cannula 96 is provided with agripping end 104, suitable to be locked on the cortex of anosteal body 6, like avertebral body 6, atibial plate 6′, anastragalus 6″ or awrist 6′″, such as to form a guide for the wideningdevice 4 to be inserted therein, and also for the insertion of a probe to first inspect the interior of theosteal body cannula 96 allows the use, i.e. the coupling with endoscopic, microscopic systems and for biopsy sampling. - Furthermore, the
cannula 96 is advantageously suitable to at least partially house acement injection device 112 to fill the osteal cavity with liquid cement. - The
injection device 112 comprises agrip element 116 suitable to allow the grip by a user and having apusher 118 for example of a cylindrical shape, integrally connected to thegrip element 116. In an assembly configuration of theinjection device 112 on thecannula 96, thepusher 118 is coaxial to the extension axis X. Thegrip element 116 further comprises at least oneseat 120. - On the
grip element 116 there is hinged alid 122, suitable to rotate from an open position, such as illustrated for example inFIG. 18 , to a closed position such as illustrated for example inFIG. 19 . - The
lid 122 further comprises awindow 123 and a corresponding graduated scale suitable to measure the relative translation between acontrol element 126 and thegrip element 116. At an end facing the hinging end of thegrip element 116 onlid 122, thelid 122 ends with astop 124 having anotch 125. - To said
grip element 116 there is associated thecontrol element 126 mechanically connected to aplate 130, of a circular shape having asecond hole 134. - The
control element 126 and thegrip element 116 in a closed configuration, where thestop 125 and theplate 130 directly face each other, identify achamber 135 suitable to house acement cartridge 136 to be injected. - Preferably, the
control element 126 comprises at least oneguide 138 suitable to be at least partially housed within saidseat 120, such that the motion of thecontrol element 126 relative to thegrip element 116 is guided substantially along a stroke T according to a direction parallel to axis X. - A
cylindrical needle 140, hollow and suitable to be housed within thecannula 96, is mechanically associated to theplate 130 through saidsecond hole 134 such that aninjection end 144 ofneedle 140 is fluidically connected tochamber 135. - A further embodiment of an
injection device 112′ will be now described, such as illustrated for example inFIGS. 24-29 , wherein the elements or parts in common with the embodiment illustrated above will be indicated with the same numeral provided with primes. - The
injection device 112′ has a cartridge configuration as a whole, of main extension P. Theinjection device 112′ comprises ahollow grip element 116′ of a cylindrical shape suitable to be held by a user. At aninner side wall 150 thegrip element 112′ comprises afirst threading 152 with pitch M′. Opposite to thefirst threading 152, relative to the main extension P, thegrip element 112′ comprises aflange 154 havinglongitudinal guides 156 arranged parallel to the main extension P. - A first cylindrical and
hollow ring nut 158 is suitable to mesh with said first threading152 at afirst control portion 160 such as to be coaxially mounted to thegrip element 116′ and internally thereto. - The
first ring nut 158, opposite to thefirst control portion 160, comprises asecond control portion 162 provided at an inner part, i.e. towards the extension axis P, with an inner threading of pitch M″, other than said pitch M′. Advantageously, pitch M″ ofsecond threading 164 is greater than pitch M′ offirst threading 152; preferably pitch M″ is about twice the pitch M′. - The
first ring nut 158, opposite to thesecond threading 164, comprises aneck 166 provided with anotch 168. At theneck 166, to thefirst ring nut 158 there is associated acontrol element 126′ preferably in the form of a hollow knob. Particularly, thecontrol element 126′ is removably fastened to theneck 166, through a bayonet-type arrangement, by means of at least onestake 170 suitable to be locked within saidnotch 168. Between thecontrol element 126′ and theneck 166 there is interposed abarrel 172 for the at least onestake 170 to be mounted thereto; thebarrel 172 is provided with aspring 173 such as to force said stake against the correspondingnotch 168. - The
control element 126′ comprises abell 174 suitable to house saidbarrel 172 and suitable to be at least partially inserted in thefirst ring nut 158 from theneck 166. Thebell 174 axially ends with astop surface 175, such as of a disc-shape type. - In an assembly configuration, the
control element 126′, thebarrel 172 and thefirst ring nut 158 are preferably rotatably integral to one another. - To the
grip element 116′, opposite to thefirst threading 152, there is associated asecond ring nut 176 having an outwardly threadedportion 178 suitable to mesh with thesecond threading 164. Opposite to the outwardly threadedportion 178, along extension P, thesecond ring nut 176 comprises at least onepivot 180 suitable to be housed within saidlongitudinal guides 156, such as to longitudinally slide therealong; furthermore, thesecond ring nut 176 comprises anabutment surface 182 of a circular ring shape. To thesecond ring nut 176 is further associated acylindrical plug 184, arranged at the opposite end of thecontrol element 126′, and preferably comprising a threadedring 186 suitable to be screwed on the threadedbush 100. - In an assembly configuration, the
first ring nut 158 and thesecond ring nut 176 are coaxially and partially mounted within thegrip element 116′ such as to define a substantiallycylindrical chamber 135′. - The
injection device 112′ is suitable to contain within saidchamber 135′ a substantiallycylindrical syringe 188 comprising asyringe body 190 enclosing acement cartridge 136′ to be injected, apusher 118′ being associated thereto, which is suitable to compress saidcement cartridge 136′. Thecement cartridge 136′, opposite to thepusher 118′, is fluidically connected to aneedle 140′ and according to an embodiment, thesyringe body 190 is one-piece with theneedle 140′. - As illustrated for example in
FIG. 30 , thecannula 96 is further suitable to be connected to afunnel 200, at the proximal end. Saidfunnel 200 is suitable to allow bone bits, i.e. bone fragments, such as taken from the iliac crest or generally bone substitute to be inserted therein. - Furthermore, the
cannula 96 allows a rammer, i.e. an elongate cylindrical body having a rounded end, suitable to compact the bone bits or the bone substitute inserted therein, to be inserted within the cavity of avertebral body 6,tibial plate 6′,astragalus 6″,wrist 6′″, by means of thecannula 96. - The operation of the widening device according to the invention will be now described.
- At first, the cortical and sponge tissues of the
osteal body 6, like for example avertebral body 6, atibial plate 6′, anastragalus 6″, awrist 6′″, are pierced with a punch such as to enable thecannula 96 to be firmly fixed to theosteal body - An endoscope may be firstly inserted in said
cannula 96 to inspect the interior of theosteal body - The
cannula 96 can then house the wideningdevice 4 therein. - In order to properly tailor the insertion depth of the widening
device 4 the above threadedbush 100 can be used to act as the adjustment sleeve. - The elastically deformable element can be then expanded56.
- Particularly, the
knob 28 can be rotated on the threadedlength 24 ofshank 12, by holding thesleeve 32 at the same time, such as to cause theshank 12 to be tensioned, which is rotatably locked by thepin 36 ofsleeve 32. - The
shank 12 translatably drags the terminal48 and the elasticallydeformable element 56 which in turn pushes thefirst strike 38 oftube 14. Thetube 14 translates at first towards the proximal end until completely recovering the backlash between thepin 36 and theaperture 16. - The rotation of
knob 28 generates the compression of the elasticallydeformable element 56 between the first andsecond strike tabs 60, subjected to a compression load, tend to inflect outwardly, thereby taking an expanded or deflected configuration, such as arch-shaped. - While being bent, the
tabs 60 can be advantageously encircled by thesheath 92 filling the gaps orgrooves 64 between thetabs 60. - Once the desired size has been obtained for the osteal cavity the widening
device 4 can be disabled. - By rotating the
knob 28 to the opposite direction the elasticallydeformable element 56 is unloaded and tends to return in the undeformed or relaxed configuration due to the elasticity oftabs 60. Thesheath 92 until being stressed by the action of thetabs 60, cooperates to the passage from the deformed configuration to the undeformed configuration. - Therefore, the passage from the deformed configuration to the undeformed or relaxed configuration does not take place by applying another external force, but by removing the initial deformation force, i.e. by unloading the
shank 12 and the elasticallydeformable element 56 accordingly. - The axial backlash between the
pin 36 and theaperture 16 ontube 14 ensures that, once theknob 28 has been completely unscrewed, thetabs 60 can completely stretch without having compression loaded residues. - On the contrary, there would be the risk for the elastically
deformable element 56 to be locked inside theosteal body cannula 96. - The widening
device 4 can be then extracted and theinjection device funnel 200 can be subsequently inserted to fill the osteal cavity with liquid cement or bone bits, respectively. - The operation of the
injection device 112 according to an embodiment will be now described. - Particularly, once the
cartridge 136 has been inserted inchamber 135, and thelid 122 has been closed, one holds thegrip element 116 and presses thecontrol element 126, such as to approach i.e. move thecontrol element 126 backward towards thegrip element 116. Thecartridge 136 is compressed between theplate 130 translatably dragged by thegrip element 116 and thepusher 118. The cement contained in thecartridge 136 tends to flow inside theneedle 140 and to exit through the injection end144 of the same. - During the backward motion of the
control element 126, the same drags theneedle 140 which tends to move backwards while the cement is being injected. Consequently, theinjection end 144 moves backward during the injection step, by a stroke T equal to the translation stroke of thecontrol element 126. The amount of cement to be injected can be controlled by directly reading the translation ofneedle 140 with the aid of a graduated scale onwindow 123 oflid 122. - The operation of the
injection device 112′ will be now described according to a further embodiment of the invention. - To assemble the
syringe 188 within theinjection device 112′, thecontrol element 126′ is first extracted by disengaging thestake 170 fromnotch 168 ofneck 166, and thebarrel 172 is removed to gain access tochamber 135′. - Thereafter, the
syringe 188 provided withneedle 140′ is inserted in thechamber 135′ such as to bring thecement cartridge 136′ in abutment against theabutment surface 182 ofsecond ring nut 176. Thecontrol element 126′ is then reassembled such as to bring theend surface 175 ofbell 174 in contact with thepusher 118′. In other words, following the assembly ofsyringe 188 to theinjection device 112′,syringe 188 is housed coaxially to theinjection device 112′ as well as axially constrained from opposite sides, i.e. between thecontrol element 126′ and thesecond ring nut 176. - Particularly, following the assembly, the
pusher 118′ ofsyringe 188 is in abutment against thestop surface 175 of thecontrol element 126′, such as to prevent thepusher 118′ to move backwards according to a backward direction r; whereas thesyringe body 190 abuts against theabutment surface 182 ofsecond ring nut 176, such that thesyringe body 190 cannot be moved according to a forward motion relative to a forward direction f opposite to said backward direction r. - The outwardly threaded
portion 178 is first engaged onbush 100 such as to house theneedle 140′ ofinjection device 112′ within thecannula 96 and form a fluidical connection between thecement cartridge 136, theinjection end 144 and the cavity of theosteal body - To perform the injection, one holds the
grip element 116′ and rotates thecontrol element 126′ such as to rotatably drag thefirst ring nut 158; particularly thefirst ring nut 158, by screwing on thegrip element 116′, moves forward, i.e. it translates towardsneedle 140′, according to the forward direction f. Thesecond ring nut 176 meshes in turn with thegrip element 116′ and, since it cannot rotate relative to thegrip element 116′ due to the coupling betweenpivots 180 andlongitudinal guides 156 offlange 154, it translates away fromneedle 140′, according to the backward direction r opposite to said forward direction f. Therefore, following the rotation of thecontrol element 126′, the first andsecond ring nuts - The
abutment surface 182 ofsecond ring nut 176 when being translating urges thecement cartridge 136 which is compressed between thesyringe body 190 in abutment against theabutment surface 182 andpusher 118′, which cannot move backward according to backward direction r due to thestop surface 175. Thesyringe body 190 moves backward together with theabutment surface 182 ofsecond ring nut 176 and drags theneedle 140′ in its backward motion along the backward direction r. Consequently, following the rotation of thecontrol element 126′,needle 140′, and particularly the injection end144 ofneedle 140′, moves backward by a stroke T according to the backward direction r. - Furthermore, while screwing and moving forward within the
grip element 116′, thefirst ring nut 158 translatably drags thecontrol element 126′ towards thesecond ring nut 176. Therefore, thestop surface 175 of thecontrol element 126′ urges in turn thepusher 118′ ofsyringe 188 according to the forward direction f and further compresses thecement cartridge 136′. Following this compression the cement tends to exit through the injection end144 ofneedle 140′ and from the latter to the inside of the osteal cavity. Thepivots 180 slide in thelongitudinal guides 156 and by being visible from the outside of theinjection device 112′, also provide a visual indication of the feeding state of the injection, i.e. the amount of cement being injected. Preferably, near thelongitudinal guides 156, there is provided, for example, a graduated scale to give an indication of the amount of cement being injected. - Advantageously, by dismounting the
control element 126′ during any cement injection step, thecement capsule 136′ stops being subjected to compression and the cement flow throughneedle 140′ is stopped. - As may be appreciated from what has been stated above, the widening device allows to overcome the drawbacks of the prior art widening devices.
- Particularly, the widening device according to the invention allows to provide a cavity within an osteal body, such a vertebral body, an astragalus, a tibial plate, a wrist, in a controlled manner, i.e. by providing predetermined expansion configurations which can be adjusted according to different types of osteal bodies and different surgical indications.
- In other words, the widening device ensures an active expansion, by generating a cavity of a defined shape without being subjected to deformations by the bone tissue of the osteal body, the mechanical characteristics of which are typically not isotropic and omogeneous.
- The covering sheath, by filling the grooves comprised between the tabs, ensures continuity to the deformable element thereby preventing the individual tabs from getting entangled within the osteal body tissue, thereby allowing the deformed configuration to return to the relaxed configuration.
- Advantageously, the presence of the sheath covering the tabs prevents any inclusion of bone material within the elastically deformable element, which case may hinder the tab closing motion, i.e. their return to the undeformed configuration.
- Thanks to the helicoidal arrangement of tabs, the device has a solidity of the created volume, it is to say the volume of the device in an expanded configuration, which is greater than the arrangement with longitudinal tabs. By solidity it is intended the ratio between solid and void zones, it is to say between the zone comprising the tabs, which contribute to the widening of the cavity, and the interstices among the tabs which do not exerte any widening action of the osteal tissue. A greater solidity of the deformable element grants a controlled expansion, in spite of the anisotropy of the spongeous tissue in the cavity of the osteal body. A high solidity avoids the event of gripping of the tabs in the spongeous tissue and does not require the use of sheaths or membranes, suitable for fill said voids or interstices among tabs.
- The particular varying-thickness configuration along the tabs both with longitudinal extension and with elicoidal extension, allows to provide greater thicknesses in the tab areas subjected to greater loads and lower thicknesses in the areas where, following the deformation, great bending is desired without yielding the material. In fact, any yield may hinder the elastic return of the deformable portion from the deformed configuration to the relaxed configuration.
- In fact, the return from the deformed configuration to the relaxed configuration takes place due to the elastic return of the material following the removal of the axial force which had caused the deformation, i.e. without applying another external force.
- This elastic return is favoured by the elastic action provided by the sheath which tends to cause both tabs to approach each other, thereby bringing them back to the undeformed configuration.
- By providing the deformable element as one-piece, the resistance of the tabs to high work load is ensured. Particularly, the presence of the slots to the tab ends prevents the risk that any crack may propagate.
- The tabs are therefore beams fitted to the ends, which when subjected to compression, instabilize and inflect outwardly, i.e. away from the extension X axis.
- This arrangement provides a particular stiffness to the deformable portion and allows to vary the stiffness of the tabs by acting on the variation of thicknesses.
- The backward motion of the needle during the cement injection ensures an optimum filling of the osteal cavity because the injection end moves gradually and automatically backward as the cavity is being filled. A uniform and omogeneous distribution of the cement being injected in the bone cavity is thereby ensured. Furthermore, due to the backward motion of the needle, overpressures in the osteal body are prevented which may give origin to leakages of cement dangerous for the spinal marrow if, for example, the osteal body is a vertebral body.
- The configuration of the cannula provided with a tailored bush allows to associate different devices to this cannula for an operation of widening and restoring of an osteal cavity, such as a kyphoplasty operation, after only one access port has been made in the osteal cortical area and only one cannula has been inserted as the guide member. The bush allows to change the axial position of each of the devices being inserted, particularly the insertion depth of the distal end of the widening device and the needle injection end.
- Those skilled in the art, aiming at satisfying contingent and specific requirements, will be able to carry out a number of modifications and variants to the above widening devices, which are all contemplated within the scope of the invention such as defined by the claims below.
Claims (25)
1. Widening device for bone cavities extending from a proximal end to a distal end along an extension axis, said distal end comprising an elastically deformable element, suitable to pass from a relaxed configuration for the positioning of the distal end within an osteal body to a deformed configuration to form a cavity within said osteal body,
said elastically deformable element comprises at least one tab suitable for widening a bone cavity by passing from a relaxed configuration to a deformed configuration,
wherein said elastically deformable element extends from a first collar to a second collar so that while said first and second collars approach to each other along said extension axis, said at least one tab bends in order to widen said internal cavity of the osteal body.
2. Widening device according toclaim 1 , wherein said at least one tab has, along its longitudinal extension, a thickness, as measured relative to a radial direction incident to said extension axis and contained in perpendicular plane to said extension axis, variable along the extension axis such as to vary the stiffness of at least one tab along the extension thereof.
3. Widening device according toclaim 2 , wherein said tab comprises a central portion and two side portions relative to said extension axis, opposite to said central portion, at least one of said side portions having a radial thickness other than the radial thickness of the central portion.
4. Widening device according toclaim 3 , wherein at least one tab comprises a central portion having a radial thickness decreasing towards the side portions.
5. Widening device according toclaim 1 , comprising a plurality of tabs separated from one another by means of grooves.
6. Widening device according toclaim 5 , wherein said grooves comprise slots at axial ends of the tabs.
7. Widening device according toclaim 1 , wherein said tabs are arranged in an axial-symmetrical manner relative to said extension axis.
8. Widening device according toclaim 1 , wherein said tabs are arranged in an asymmetrical manner relative to said extension axis.
9. Widening device according toclaim 1 , wherein a sheath suitable to cover said tabs is mechanically associated to said elastically deformable portion.
10. Widening device according toclaim 9 , wherein said sheath, in a relaxed configuration, is at least partially separated from said tabs.
11. Widening device according toclaim 9 , wherein said sheath has a radial thickness varying along the extension axis.
12. Widening device according toclaim 1 or2 , wherein the elastically deformable element comprises at least one tab having a prevalent extension along a median line, between a first collar and a second collar, said median line extending so that a line, which is parallel to extension axis and which passes through an intersection point between the tab and the first collar, does not pass through an intersection point between the tab and the second collar.
13. Widening device according toclaim 1 or2 , wherein said elastically deformable element comprises at least one tab having a predefined extension along a median line, said median line extending along a helicoidal path with respect to said extension axis.
14. Widening device according toclaim 13 , wherein said median line extends according to a helix angle, said helix angle being defined between a line perpendicular to a line parallel to extension axis and passing through said median axis, and said median axis.
15. Widening device according toclaim 14 , wherein said helix angle is comprised between 60 and 85 degrees.
16. Widening device according toclaim 15 , wherein said helix angle is equal to 80 degrees.
17. Widening device according toclaim 14 , wherein said helix angle is constant, along the extension of the tab.
18. Widening device according toclaim 14 , wherein the helix angle is variable along the extension of the tab.
19. Widening device according toclaim 18 , wherein the helix angle is greater near first and second collars which delimit axially the elastically deformable element.
20. Widening device accordingclaim 1 , comprising a cannula tubular, suitable for permit the passage of said elastically deformable element, in a relaxed configuration, into said cannula, for the insertion in said osteal body.
21. Widening device according toclaim 20 , wherein said cannula comprises a gripping end suitable to be firmly made integral to the osteal cortical area, and a connecting end comprising a bush suitable to be connected to said widening device.
22. Widening device according toclaim 21 , wherein said bush is suitable for being mechanically and selectively connected to a widening device for bone cavities, to a cement injection device and to a funnel for bone bits or bone substitute to be inserted within said bone cavity.
23. Method for widening an osteal body comprising the steps of:
making a cannula having a gripping end and a connecting end provided with a bush integral to the cortical area of an osteal body,
inserting in said cannula a widening device for bone cavities mechanically connected by means of said bush,
activating the widening device to form a bone cavity,
deactivating and disable the widening device,
inserting in said cannula a cement injection device mechanically connected by means of said bush,
injecting cement in the bone cavity.
24. Method for widening an osteal body comprising the steps of:
making a cannula having a gripping end and a connecting end provided with a bush integral to the cortical area of an osteal body,
inserting in said cannula a widening device mechanically connected by means of said bush,
activating the widening device to create a bone cavity,
deactivating and disabling the widening device,
inserting in said cannula a funnel mechanically connected by means of said bush,
inserting bone bits or bone substitute in the bone cavity, through said funnel.
25. Method according toclaim 23 or24 , wherein said widening device is a widening device according toclaim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/449,860US20070043373A1 (en) | 2004-05-19 | 2006-06-09 | Devices and method for widening bone cavities |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IT2004/000289WO2005110259A1 (en) | 2004-05-19 | 2004-05-19 | Intravertebral widening device, injection device, and kit and method for kyphoplasty |
| US10/502,717US7722612B2 (en) | 2004-05-19 | 2004-05-19 | Devices, kit and method for kyphoplasty |
| EP05425817AEP1787593A1 (en) | 2004-05-19 | 2005-11-18 | Device for creating bone cavities |
| US11/449,860US20070043373A1 (en) | 2004-05-19 | 2006-06-09 | Devices and method for widening bone cavities |
Related Parent Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IT2004/000289Continuation-In-PartWO2005110259A1 (en) | 2004-05-19 | 2004-05-19 | Intravertebral widening device, injection device, and kit and method for kyphoplasty |
| US10/502,717Continuation-In-PartUS7722612B2 (en) | 2004-05-19 | 2004-05-19 | Devices, kit and method for kyphoplasty |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| US20070043373A1true US20070043373A1 (en) | 2007-02-22 |
Family
ID=43533390
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| US10/502,717Expired - Fee RelatedUS7722612B2 (en) | 2004-05-19 | 2004-05-19 | Devices, kit and method for kyphoplasty |
| US11/449,860AbandonedUS20070043373A1 (en) | 2004-05-19 | 2006-06-09 | Devices and method for widening bone cavities |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US10/502,717Expired - Fee RelatedUS7722612B2 (en) | 2004-05-19 | 2004-05-19 | Devices, kit and method for kyphoplasty |
Country Status (5)
| Country | Link |
|---|---|
| US (2) | US7722612B2 (en) |
| EP (2) | EP1748739A1 (en) |
| CN (1) | CN1984613B (en) |
| AU (1) | AU2004319780A1 (en) |
| WO (1) | WO2005110259A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| CN1984613A (en) | 2007-06-20 |
| EP1748739A1 (en) | 2007-02-07 |
| AU2004319780A1 (en) | 2005-11-24 |
| WO2005110259A1 (en) | 2005-11-24 |
| US20060235417A1 (en) | 2006-10-19 |
| EP1787593A1 (en) | 2007-05-23 |
| US7722612B2 (en) | 2010-05-25 |
| CN1984613B (en) | 2010-09-29 |
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| AS | Assignment | Owner name:SINTEA BIOTECH S.P.A., ITALY Free format text:ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SALA, GIUSEPPE;GUERRA, PAOLO;PRESTAMBURGO, DOMENICO;AND OTHERS;REEL/FRAME:018369/0093 Effective date:20060925 | |
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