WO1998051241A1 - Implantable re-bar devices - Google Patents
Implantable re-bar devices Download PDFInfo
- Publication number
- WO1998051241A1 WO1998051241A1 PCT/US1998/009528 US9809528W WO9851241A1 WO 1998051241 A1 WO1998051241 A1 WO 1998051241A1 US 9809528 W US9809528 W US 9809528W WO 9851241 A1 WO9851241 A1 WO 9851241A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- implantable device
- cross
- thread
- protuberance
- sectional profile
- Prior art date
Links
- 239000000463 material Substances 0.000 claims abstract description 39
- 238000000034 method Methods 0.000 claims abstract description 20
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims abstract description 20
- 239000001506 calcium phosphate Substances 0.000 claims abstract description 15
- 229910000389 calcium phosphate Inorganic materials 0.000 claims abstract description 13
- 235000011010 calcium phosphates Nutrition 0.000 claims abstract description 13
- 230000009969 flowable effect Effects 0.000 claims description 15
- 229910019142 PO4 Inorganic materials 0.000 claims description 4
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 4
- 239000010452 phosphate Substances 0.000 claims description 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 3
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
- 229910052791 calcium Inorganic materials 0.000 claims description 2
- 239000011575 calcium Substances 0.000 claims description 2
- 239000001488 sodium phosphate Substances 0.000 claims description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 2
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 2
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 2
- 229940078499 tricalcium phosphate Drugs 0.000 claims description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 2
- 239000012265 solid product Substances 0.000 claims 3
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims 2
- 239000012736 aqueous medium Substances 0.000 claims 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 abstract description 50
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- 230000004927 fusion Effects 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 3
- 239000007943 implant Substances 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 208000010392 Bone Fractures Diseases 0.000 description 2
- 206010017076 Fracture Diseases 0.000 description 2
- 208000013201 Stress fracture Diseases 0.000 description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 description 2
- ZBZJARSYCHAEND-UHFFFAOYSA-L calcium;dihydrogen phosphate;hydrate Chemical compound O.[Ca+2].OP(O)([O-])=O.OP(O)([O-])=O ZBZJARSYCHAEND-UHFFFAOYSA-L 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 2
- 238000001727 in vivo Methods 0.000 description 2
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 2
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
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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, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
- A61L24/02—Surgical adhesives or cements; Adhesives for colostomy devices containing inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/866—Material or manufacture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/28—Bones
- A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
Definitions
- the field of this invention is implantable medical devices.
- Implantable medical devices such as bone screws play a prominent role in orthopaedics. Orthopaedic surgeons use screws for interfragmentary fixation, fastening soft tissue to bone, holding plates or nails to bone, and the like. As such, screw devices find use in a variety of orthopaedic procedures.
- screws in orthopaedic applications fix bone to bone. Screws also find use in applications where one wishes to hold soft tissue, such as tendons or ligaments, to bone. Yet another application in which screws find use is the fixation of plates or rods to bone, where one such instance is spinal fixation.
- the bone screws known as pedicle screws, are used in conjunction with other medical devices, such as rods or plates, that hold vertebrae in place until bone fusion occurs.
- the pedicle screw is inserted through the pedicle bone of the vertebra into the cancellous region of the vertebral body.
- Important parameters include head shape, shank diameter, core (minor) diameter, thread (external, major) diameter, thread shape, thread pitch, cannulation and the like.
- cortical screws are designed to bite in cortical bone, are characterized by being threaded for the full length of the shaft of the screw, and are often used in lagging fragments of bone together or to hold implants, such as side plates, to bone.
- Cancellous screws are characterized by having a larger thread diameter and greater pitch than cortical screws, and a long shank portion which is free of threading.
- Herbert screws differ from cancellous or cortical screws in that the screw head is threaded.
- Figs. 1 A and IB provide representations of typical cortical and cancellous bone screws.
- a typical cortical bone screw is depicted in Fig. 1 A, where 2 indicates the pitch, 4 indicates the root diameter, 6 indicates the thread depth and 8 indicates the hexagonal drive head.
- a typical cannulated cancellous bone screw is depicted in Fig. IB, where 5 indicates the cannulation.
- Implantable rebar devices and methods for their use are provided.
- the subject devices include at least one element having a planar surface with at least one protuberance, where the protuberance has a cross-sectional profile that is substantially continuous.
- the cross-sectional profile is further characterized in that the radius of curvature at any point along the profile ranges from about 0J mm to 10 mm.
- the subject implantable devices are particularly suited for use in conjunction with bone structural augmentation materials, such as calcium phosphate cements.
- the subject rebar devices find use in a variety of applications, including interfragmentary fixation, fastening soft tissue to bone, or holding plates or nails to bone, and the like.
- Figs. 1A and IB provide a representation of a prior art cortical bone and cancellous bone screw, respectively, where each screw configuration comprises a bone cutting functionality, i.e. a thread with a sharp cutting edge.
- Fig. 2 provides a representation of a cross-sectional profile of an implantable device according to the subject invention.
- Figs. 3 to 11 are depictions of various implantable rebar devices according to the subject invention.
- Figs. 12 to 18 are depictions of alternative implantable rebar devices according to the subject invention.
- Implantable rebar devices and methods for their use are provided.
- Common to the rebar devices of the subject invention is the presence of a planar surface having a protuberance, where the protuberance has a cross-sectional profile which is substantially continuous.
- the radius of curvature at any point along the cross-sectional profile ranges from about 0J mm to 10 mm.
- the subject devices find use in a variety of applications, including interfragmentary fixation, fastening soft tissue to bone, or holding plates or nails to bone, and are particularly designed for use in conjunction with a structural augmentation material, such as a calcium phosphate cement.
- the devices of the subject invention are implantable, by which is meant that they are dimensioned so as to be capable of being introduced into a living organism.
- Organisms into which the subject devices are capable of being introduced are generally mammals, including: domestic animals, e.g. horses, goats, pigs, cows, etc.; rare or exotic animals, e.g. zoo animals such as lions, tigers, elephants, bears, etc.; pets, e.g. cats, dogs; and humans.
- domestic animals e.g. horses, goats, pigs, cows, etc.
- rare or exotic animals e.g. zoo animals such as lions, tigers, elephants, bears, etc.
- pets e.g. cats, dogs
- humans e.g. cats, dogs
- the device dimensions may vary widely within the following ranges, depending on the intended usage of the device.
- the width ranges from about 0.5 mm to 50 mm, usually from about 1 mm to 20 mm and more usually from about 2 mm to 15 mm.
- the length ranges from about 5 mm to 250 mm, usually from about 10 to 200 mm and more usually from about 10 to 75 mm.
- the height ranges from about 1 to 10 mm, usually from about 1 to 5 mm and more usually from about 1 to 3 mm.
- the subject devices have at least one element which is characterized by the presence of a planar surface, flat or curved, with at least one protuberance emerging or arising therefrom.
- the entire outer surface of the device may be the planar surface or only a portion of the outer surface of the device may be the planar surface characterized by the presence of at least one protuberance.
- the planar surface from which the protuberance arises may be the planar surface of a plate-like object such that it extends in two dimensions.
- the planar surface may be the surface of an object having a curvilinear cross-sectional shape, e.g. as found on the outer surface of a cylinder or cone, such that it extends through three dimensions.
- the planar surface will appear to be substantially smooth to the naked eye in that there will be no apparent abnormalities, irregular depressions, cracks, etc.
- the protuberance is characterized by having a cross-sectional profile that is substantially continuous.
- the cross-sectional profile is the border or edge line of the protuberance that is produced by cutting through the protuberance along its shortest axis, i.e. the width of a ridge-like protuberance or the diameter of a hemispherical protuberance.
- a representative cross-sectional profile is shown in Fig. 2.
- the cross-sectional profile 20 arises or emerges from the plane 22 as a continuous reentrant curve 26 which extends through a convex protuberance 24 and returns to the plane as a second continuous reentrant curve 28, where the inception and termination of the cross-sectional profile is tangential and parallel to the planar surface 22.
- the cross-sectional profile line is a curvilinear smooth line.
- the cross-sectional profile is further characterized in that the radius of curvature at any point on the profile is from about 0J mm to 10 mm, usually from about 0.5 mm to 5 mm and more usually from about 1 mm to 3 mm, where by radius of curvature is meant the radius of the circle which has the same curvature as the curve at that particular point along the profile.
- R,, R 2 and R 3 are all between about 0J mm and 10 mm.
- the cross-sectional profile will have three distinct inflection points, i.e.
- the crest angle of the protuberance i.e. that angle at the intersection of the tangents of the two flanking inflection points, will range from about 179° to 10°, usually from about 90° to 30° and more usually from about 60° to 45°.
- the height of the protuberance i.e.
- the distance between the crest and the planar surface from which the protuberance emerges will be at least about 0.5 mm, and usually at least about 1 mm, where the height may be 10 mm or higher, but will usually not exceed about 5 mm and more usually will not exceed about 3 mm.
- the protuberance may be a compact, isolated structure covering only a small portion of the surface of the plane, e.g. a hemispherical structure, or the protuberance may be extended across substantially the entire planar surface, e.g. a thread.
- the protuberance is a structure that extends across substantially the entire planar surface, such as a thread
- the thread may be one continuous thread or be discontinuous, where there are gaps between portions of the thread.
- substantially all of the planar surface may be covered by one or more distinct protuberances, such that there is no visible portion of the planar surface, e.g. where the at least one protuberance is a plurality of threads positioned adjacent to each other and spread across the planar surface.
- the implantable device of the subject invention is an elongate member which has a base configuration of a cylinder or cone as found in conventional screw devices.
- the outer surface of the cylinder or cone is the planar surface from which the protuberance arises.
- the protuberance will be a thread which extends the length of the cone.
- the thread may be a continuous thread or a discontinuous thread, where in a discontinuous thread there are one or more gaps or spaces positioned along the helix of the thread.
- the thread will typically wind around the base cylinder or cone structure of the device in a helical fashion, where the thread pitch will range from about 0.1mm to 50 mm, usually from about 0.5 mm to 30 mm and more usually from about 2 mm to 15 mm. In certain embodiments, the thread pitch will be such that there is substantially no visible planar surface of the base cone or cylinder structure. In many such embodiments, there may be more than one distinct thread on the surface of the cylinder or cone. In the above screw-type embodiments of the subject devices, the thread height will typically range from about 0J mm to 15 mm, usually from about 0.5 mm to 10 mm and more usually from about 1 mm to 5 mm.
- the inner diameter of the base structure e.g.
- the ratio of the outer to inner diameter of the device will be at least about 0J , usually at least about 0.3 and more usually at least about 0.6, where the ratio may be as high as 0.9, but will usually not exceed about 0.7.
- the rebar implantable devices of the subject invention may be fabricated to provide for ease of insertion or removal from a physiological site.
- the subject rebar devices may be configured to include one or more screw head features at either or both ends of the device, where such features serve a variety of purposes such as in the introduction and/or retrieval of the rebar from the bone site; in securing the rebar device to an implant device such as a plate or rod, and the like.
- the rebar devices may be cannulated, where cannulation provides for use of the subject devices in conjunction with guide wires, as is known in the art. Hollow passageways in the subject devices may also serve as conduits for cement-like materials during implantation of the device, as described in greater detail below.
- device 30 comprises a core or shaft portion of circular cross-section. Extending from the otherwise smooth surface 32 are a plurality of protrusions or bumps or ridges 34 symmetrically positioned over the entire surface of the device.
- the bumps 34 are characterized by being free of any sharp corners or angles and having a cross-sectional profile as shown in Fig. 2.
- Fig. 3B provides a representation of a related embodiment, in which the ridges are positioned differently across the surface of the device. In both of these embodiments and many others of the subject invention, the ridges are perpendicular to the axis of the device, represented by the dashed arrow.
- Fig. 4 provides a representation of another embodiment of the subject device. In Fig.
- device 40 comprises a shaft portion 42 having a circular cross-section.
- shaft 42 On the surface of shaft 42 are a plurality of symmetrically positioned hemispherically-shaped bumps 44, which have a cross-sectional profile as shown in Fig. 2.
- Figs. 5 A to 5C provide three additional embodiments of rebar devices of the subject invention.
- the planar surface 52 of the device 50 is characterized by the presence of a continuous thread 54 that has a cross-sectional profile as shown in Fig. 2.
- the device of Fig. 5B is analogous to that shown in Fig. 5A except that the 54 is discontinuous.
- the device in Fig. 5C is a variation of that shown in Fig. 5B.
- Fig. 6 provides a representation of yet another embodiment of the subject invention, where device shown in Fig. 6 finds particular use as a fixation device in vertebral bodies, especially for placement through the pedicle of a vertebral body.
- the cross-sectional profile of ridge 64 extending from planar surface 62 is as shown in Fig. 2.
- Fig. 7 provides a representation of a sliding hip screw according to the subject invention, in which a single helical protuberance having a cross section as shown in Fig. 2 extends across the surface of one end of the shaft.
- Figs 8A and 8B show rebar cancellous bone screws according to the subject invention, where the thread is continuous in Fig. 8A and discontinuous in Fig. 8B.
- Fig. 9 provides a representation of a rebar shaft screw according to the subject invention, where a single helical protuberance having a cross section as shown in Fig. 2 extends across the surface of one end of the shaft.
- Fig. 10 depicts a rebar spondylolysis screw according to the subject invention.
- Fig. 11 provides a representation of a cannulated, vented rebar screw according to the subject invention.
- the subject rebar devices may be fabricated from a variety of different materials, where the particular material chosen may depend on a number of distinct parameters, including: the level of support required; the particular application in which the device is to be used, e.g. whether the device is to be used in conjunction with additional implant devices, such as plates or rods; the length of time the device is to remain in the patient; the desire for resorption or removal, and the like.
- Materials from which the subject rebar devices may be fabricated include: biocompatible, medical grade metals such as 316L stainless steel and titanium (commercially pure or alloys thereof); polymeric compounds, both standard and reinforced composites, as well as bioresorbable compounds, such as PLA, PLG and the like.
- the subject devices may be fabricated according to any one of a number of methods known to those of skill in the art, where the particular method chosen for fabrication of a particular rebar device will generally depend on the particular characteristics of the device, such as the material from which it is to be made, the dimensions it is to have, and the like. Methods that may be employed include tooling, molding, and the like.
- the devices will usually (though not necessarily) be used in conjunction with a structural augmentation material which is capable of setting into a solid structural product from an initial flowable paste-like consistency.
- a structural augmentation material which is capable of setting into a solid structural product from an initial flowable paste-like consistency.
- a variety of structural augmentation materials are known and may be employed.
- the structural augmentation material used in the subject methods will typically be a flowable, paste-like material that is capable of setting up into a solid structural material in a physiological environment, such as that found in the cancellous region of a bone.
- materials that are capable of non-exothermic setting are biocompatible and bioresorbable.
- materials that are capable of non-exothermic setting are biocompatible and bioresorbable.
- materials that are capable of non-exothermic setting are biocompatible and bioresorbable.
- calcium phosphate cement materials are particularly useful in particular interest.
- Calcium phosphate cements suitable for use in the subject methods will be flowable for an initial period of time following preparation and be capable of setting in an in vivo fluid environment into a solid apatitic product.
- the subject cements will comprise dry components and a liquid component which, upon combination, form a paste-like flowable composition capable of setting into a calcium phosphate apatitic material, preferably hydroxyapatite, and more preferably a carbonated hydroxyapatite, i.e. dahllite, having a carbonate substitution of from 2 to 10 %, usually 2 to 8 % by weight of the final product.
- Calcium phosphate cements which are suitable for use in the subject methods include those cements described in U.S. Patent Nos.
- the dry components of the cements suitable for use in the subject methods will comprise at least a calcium source and a phosphate source.
- the dry components of the cements employed in the subject methods comprise a homogeneous storage-stable mixture of calcium carbonate, tricalcium phosphate, preferably ⁇ -tricalcium phosphate, more preferably reactive ⁇ -tricalcium phosphate, as described in U.S. Pat. No. 5,569,442 the disclosure of which is herein incorporated by reference, and monocalcium phosphate monohydrate.
- calcium carbonate will be present in the cement in an amount ranging from about 5 to 25 wt. %, usually from about 5 to 20 wt. %, and more usually 10 to 20 wt.
- the ⁇ -tricalcium phosphate component will be present in an amount ranging from about 60 to 95 wt. %, usually from about 65 to 90 wt. % and more usually from about 70 to 90 wt. % of the entire weight of the dry components.
- the ⁇ -tricalcium phosphate is the reactive ⁇ -tricalcium phosphate described in U.S. Pat. No. 5,569,442, the disclosure of which is herein incorporated by reference.
- the monocalcium phosphate monohydrate component will be present in an amount ranging from about 1 to 20 wt.%, usually from about 1 to 15 wt. % and more usually from about 2 to 15 wt. % of the entire weight of the dry components.
- the cement will comprise a liquid component, e.g. setting solution or lubricant, in addition to the dry components described above.
- the setting solution will be a carbonate or phosphate containing solution at a pH in the range of 6 to 11 , preferably 7 to 9, wherein the concentration of carbonate or phosphate in the solution will preferably range from 0.05 to 0.5 molal (m), with a 0.05 to 0J molal (m) sodium phosphate solution being particularly preferred.
- the dry components and the liquid components will be combined using any suitable means to produce a homogeneous, flowable paste-like material.
- suitable means of combining the dry and liquid components is a mortar and pestle, with which the liquid and solid components are mixed manually to produce the flowable paste.
- the flowable paste prepared from the dry and liquid components, as described above, will be sufficiently flowable to be introduced through a suitable delivery means, such as a needle, cannula or other introduction means, such as through hollow passageways built into the implantable device of the subject invention.
- a suitable delivery means such as a needle, cannula or other introduction means, such as through hollow passageways built into the implantable device of the subject invention.
- the cements employed in the subject methods are characterized by their ability to remain flowable for a limited period of time after which they set up into a solid apatitic product, where the cements are capable of setting up into the solid apatitic product in vivo, despite the presence of physiologic fluids, such as blood.
- the cements generally remain flowable for a period of time ranging from about 2 to 30 min, usually from about 5 to 15 min, and more usually from about 5 to 10 min, where preferred cements are those cements which set within a clinically relevant period of time, where clinically relevant period of time means a period of time usually less than about 15 min, more usually less than 12 min.
- a physiological site will be prepared first as desired, e.g. a fracture will be reduced, loose tissue will be removed, etc., and then the implantable device and the augmentation material will be introduced.
- the implantable device may be introduced prior to, after or at substantially the same time as the augmentation material is introduced, depending on the particular procedure being performed.
- the implantable device will be introduced first, and the augmentation material will then be introduced through the implantable device.
- kits for use in orthopaedic, dental, craniomaxillofacial and related applications at least include the subject implantable devices in combination with instructional material on how to use the devices, where the instructional material may be present on one or more of: packaging, labeling or a package insert of the kit.
- the kits may further comprise one or more components of an augmentation structural material with which the device is to be used, where the components may be one or more of the components of a calcium phosphate cement, such as the dry and liquid components of such a cement, as described above, where the components may be present in the same or different containers as is practicable, e.g. dry reactants in one container and liquid components in a second container.
- the kits may further comprise devices which aid in the delivery of the structural material to a physiological site of interest, e.g. needles, cannulas and the like, as well as devices for preparing the physiological site, such as spatulas, probes, etc.
- rebar bone fixation devices that are characterized by the lack of a bone cutting functionality, such as a sharp angled or sharp cornered thread component as is found in prior art bone screw devices.
- These rebar devices of the subject invention may or may not comprise a thread feature.
- the thread will not be configured to have a sharp cutting edge.
- the edge may be smooth or cornered, where the thread feature does comprise a corner, where the term corner is used to refer to the intersection of two planar surfaces, the corner will in many embodiments typically form an angle which is greater than 90 °, so that the thread feature does not serve as a bone cutting functionality of the device.
- the rebar devices of the subject invention may be fabricated in a variety of configurations.
- the rebars will have a cylindrical type configuration, whereby the term "cylindrical” is used broadly to refer to any type configuration which is characterized by having an overall cylindrical shape.
- All of the different embodiments of the subject rebar devices featured in Figs. 12 to 19 have a cylindrical configuration, as that term is used herein.
- the subject devices may have, for example, hexagonal, star, square internal and/or external drive configuration, where the configuration may be the same along the entire length or core of the device or differ from one end to the other.
- the surface of the rebar core may be smooth or modified in a variety of different ways.
- the rebar may comprise surface indentations, recessions or impressions, protrusions, ridges, bumps, threads, one or more passageways extending through the device, and the like, where such features will typically be present to provide purchase within the hardened structural augmentation material with which the subject devices are often employed and to maintain fracture proximity and alignment.
- the dimensions of the rebar devices will vary greatly depending on the particular application in which they are to be employed. The dimensions of a particular rebar device according to the subject invention will be chosen primarily on their intended use, and may be readily determined by those of skill in the art. Where the rebar devices are used in the place of conventional bone screws, the rebars may have dimensions that are roughly analogous to those dimensions of the corresponding bone screws.
- rebar device 120 comprises a circular cross-sectioned core component or drive 122.
- core 122 On the surface of core 122 is a single thread 124 which runs the entire length of the core 122.
- the thread is characterized by having a gradual pitch and a shape that is devoid of any bone cutting edges, since the angles formed at the planar intersections of the surfaces of the threads, i.e. 126 & 128, are greater than 90 °.
- Hexagonal indentations 129 are provided at either end of the device.
- device 130 is a single, cylindrical wire which is shaped as a single helix.
- a rebar device 140 having a core component 141 with two gradual threads or fins, 142 and 143, which form paddle shape cross -sections at either end of the device, 144 and 145.
- At one end of the device is a hexagonal indentation 146.
- the basic configuration of device 140 may be modified in a number of ways. One way the device may be modified is to have an undefined transition between the core and fin components, so than the surface of the fin components gradually transition into the core component, such the core component loses its circular cross-section as shown in Fig. 14.
- Another modification that may be made is to modify the shapes of paddle sections 144 and 145, so that they are the same or reversed to that shown in Fig. 14, such that the cross-sectional shape of paddle 144 is rectangular as shown for paddle 145.
- Device 140 and modified versions thereof as described above, is particularly suited for use in spinal fusion as a substitute for traditional pedicle screws.
- pedicle screws are inserted through the pedicle portion of the vertebra into the cancellous region of the vertebral body.
- the screw serves as an attachment point for a rod or plate.
- the body portion of the device i.e. that comprising paddle 144, will first be inserted through the pedicle.
- the device will slowly be turned to one side, such that following insertion, paddle portion 144 in its final position in the vertebral body is horizontal to its initial position prior to insertion, and paddle 145 fits snugly in the oblong pedicle.
- the device may be used in conjunction with structural augmentation materials, as described in greater detail below.
- Fig. 15 depicts yet another alternative embodiment of the subject rebar devices.
- device 150 has a core 152 with a star shaped cross-section. Extending from the core is a plurality of symmetrically positioned fins 154 which have sharp angle or corners 156. However, since the fins are not configured as threads, these sharp corners do not surface as bone cutting functionalities in device 150.
- Device 150 is further characterized by having a hexagonal indentation 158.
- device 160 comprises core 162 of circular cross-section. The surface of core 162 is characterized by a plurality of hemispherical indentations or depressions 164 symmetrically positioned over the entire surface of core 162.
- device 170 comprises core 172 of circular cross-sectional shape. End 176 is tapered while end 178 has a head configuration with a hexagonal indentation 179.
- the entire length of core 172 is characterized by the presence of a single thread 174 of gradual pitch, where the thread is configured to have a shape that is devoid of any bone cutting edges, since the angles formed at the planar intersections of the surfaces of the threads, i.e. 173 and 175, are greater than 90 °.
- device 180 is similar to device 170.
- Core component 182 comprises a single thread 184 running its entire length, where thread 184 has a shape that is devoid of any bone cutting edges, since the angles formed at the planar intersections of the surfaces of the threads, i.e. 186J88, are greater than 90 °.
- Device 180 differs significantly from device 90 by having blunt ends without any additional features, such as heads, indentations or tapered regions.
- implantable devices of this embodiment characterized by the lack of a cutting edge may be fabricated and used as described above in connection with the primary embodiment of the subject invention in which the devices have at least one protuberance having a substantially continuous cross-sectional profile.
- implantable devices which provide for significant improvements over currently employed fixation instruments, such as bone screws, are provided.
- the subject devices are capable of being used to reinforce structural materials, e.g. enhancing tensile and/or compressive strength of such materials, without giving rise to stress fractures or other complications experienced with bone screws or other traditional fixation instruments.
- the subject devices also provide for superior purchase with the bone and/or augmentation material, as well as ease of insertion and removal.
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- General Health & Medical Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU73774/98A AU7377498A (en) | 1997-05-16 | 1998-05-14 | Implantable re-bar devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US4666897P | 1997-05-16 | 1997-05-16 | |
US60/046,668 | 1997-05-16 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998051241A1 true WO1998051241A1 (en) | 1998-11-19 |
Family
ID=21944731
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/009528 WO1998051241A1 (en) | 1997-05-16 | 1998-05-14 | Implantable re-bar devices |
Country Status (2)
Country | Link |
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AU (1) | AU7377498A (en) |
WO (1) | WO1998051241A1 (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE10133811A1 (en) * | 2001-05-23 | 2002-11-28 | Francesco Pedrazzini | Implant is provided with a scaly surface on which the position of individual scale formations in adjacent rows is staggered, while their orientation direction alternates |
WO2004071307A2 (en) * | 2003-02-05 | 2004-08-26 | Smith & Nephew, Inc. | Tissue anchor and insertion tool |
WO2008058403A1 (en) * | 2006-11-14 | 2008-05-22 | Synthes Gmbh | Device for fixing articulation fragments having cartilage |
EP2231031A1 (en) * | 2007-12-05 | 2010-09-29 | Daniel L. Martin | Flexible bone screw |
US8323315B2 (en) | 1998-12-30 | 2012-12-04 | Depuy Mitek, Inc. | Suture locking device |
US8623051B2 (en) | 2005-06-24 | 2014-01-07 | Smith & Nephew, Inc. | Tissue repair device |
US9078714B2 (en) | 2006-06-06 | 2015-07-14 | Bioretec Oy | Bone fixation device |
US9155563B2 (en) | 2009-11-09 | 2015-10-13 | Spinewelding Ag | Medical device, apparatus, and surgical method |
US9220494B2 (en) | 1999-12-02 | 2015-12-29 | Smith & Nephew, Inc. | Methods for tissue repair |
US9492160B2 (en) | 1999-12-02 | 2016-11-15 | Smith & Nephew, Inc. | Closure device and method for tissue repair |
US10646622B2 (en) | 1998-09-11 | 2020-05-12 | Gerhard Schmidmaier | Biologically active implants |
WO2020160722A1 (en) * | 2019-02-09 | 2020-08-13 | Schlenker Heiter-Julian | Bone-anchoring device for a pedicle access |
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US5094618A (en) * | 1991-04-26 | 1992-03-10 | Coltene/Whaledent, Inc. | Intermittent threaded dental posts |
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1998
- 1998-05-14 WO PCT/US1998/009528 patent/WO1998051241A1/en active Application Filing
- 1998-05-14 AU AU73774/98A patent/AU7377498A/en not_active Abandoned
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US4959064A (en) * | 1988-10-07 | 1990-09-25 | Boehringer Mannheim Corporation | Dynamic tension bone screw |
US5094618A (en) * | 1991-04-26 | 1992-03-10 | Coltene/Whaledent, Inc. | Intermittent threaded dental posts |
US5316478A (en) * | 1991-08-02 | 1994-05-31 | Wellesley Research Associates, Inc. | Dental post with cutting surfaces |
Cited By (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10646622B2 (en) | 1998-09-11 | 2020-05-12 | Gerhard Schmidmaier | Biologically active implants |
US8323315B2 (en) | 1998-12-30 | 2012-12-04 | Depuy Mitek, Inc. | Suture locking device |
US8512374B2 (en) | 1998-12-30 | 2013-08-20 | Depuy Mitek, Llc | Soft tissue locking device |
US9220494B2 (en) | 1999-12-02 | 2015-12-29 | Smith & Nephew, Inc. | Methods for tissue repair |
US9833231B2 (en) | 1999-12-02 | 2017-12-05 | Smith & Nephew, Inc. | Apparatus for tissue repair |
US9545251B2 (en) | 1999-12-02 | 2017-01-17 | Smith & Nephew, Inc. | Apparatus for tissue repair |
US9492160B2 (en) | 1999-12-02 | 2016-11-15 | Smith & Nephew, Inc. | Closure device and method for tissue repair |
DE10133811A1 (en) * | 2001-05-23 | 2002-11-28 | Francesco Pedrazzini | Implant is provided with a scaly surface on which the position of individual scale formations in adjacent rows is staggered, while their orientation direction alternates |
AU2004211913B2 (en) * | 2003-02-05 | 2010-03-04 | Smith & Nephew, Inc. | Tissue anchor and insertion tool |
WO2004071307A2 (en) * | 2003-02-05 | 2004-08-26 | Smith & Nephew, Inc. | Tissue anchor and insertion tool |
WO2004071307A3 (en) * | 2003-02-05 | 2005-03-24 | Smith & Nephew Inc | Tissue anchor and insertion tool |
US9314235B2 (en) | 2003-02-05 | 2016-04-19 | Smith & Nephew, Inc. | Tissue anchor and insertion tool |
US8623051B2 (en) | 2005-06-24 | 2014-01-07 | Smith & Nephew, Inc. | Tissue repair device |
US9173653B2 (en) | 2005-06-24 | 2015-11-03 | Smith & Nephew, Inc. | Tissue repair device |
US9078714B2 (en) | 2006-06-06 | 2015-07-14 | Bioretec Oy | Bone fixation device |
WO2008058403A1 (en) * | 2006-11-14 | 2008-05-22 | Synthes Gmbh | Device for fixing articulation fragments having cartilage |
US9468477B2 (en) | 2007-12-05 | 2016-10-18 | Syntorr, Inc. | Flexible bone screw |
US9931144B2 (en) | 2007-12-05 | 2018-04-03 | Syntorr, Inc. | Flexible bone screw |
US8808338B2 (en) | 2007-12-05 | 2014-08-19 | Syntorr, Inc. | Flexible bone screw |
EP2231031A1 (en) * | 2007-12-05 | 2010-09-29 | Daniel L. Martin | Flexible bone screw |
EP2231031A4 (en) * | 2007-12-05 | 2011-05-25 | Daniel L Martin | Flexible bone screw |
US9931145B2 (en) | 2007-12-05 | 2018-04-03 | Syntorr, Inc. | Flexible bone screw |
US10342587B2 (en) | 2009-11-09 | 2019-07-09 | Spinewelding Ag | Medical device, apparatus, and surgical method |
US9155563B2 (en) | 2009-11-09 | 2015-10-13 | Spinewelding Ag | Medical device, apparatus, and surgical method |
US9566099B2 (en) | 2009-11-09 | 2017-02-14 | Spinewelding Ag | Medical device, apparatus, and surgical method |
WO2020160722A1 (en) * | 2019-02-09 | 2020-08-13 | Schlenker Heiter-Julian | Bone-anchoring device for a pedicle access |
JP2022519783A (en) * | 2019-02-09 | 2022-03-24 | ミメオ メディカル ゲーエムベーハー | Bone anchor device for vertebral root access |
AU2020218873B2 (en) * | 2019-02-09 | 2022-06-30 | Mimeo Medical Gmbh | Bone-anchoring device for a pedicle access |
JP7133729B2 (en) | 2019-02-09 | 2022-09-08 | ミメオ メディカル ゲーエムベーハー | Bone anchor device for pedicle access |
US11638599B2 (en) | 2019-02-09 | 2023-05-02 | Mimeo Medical Gmbh | Bone-anchoring device for a pedicle access |
Also Published As
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AU7377498A (en) | 1998-12-08 |
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