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WO2002009597A2 - Tenon cortical diaphysaire - Google Patents

Tenon cortical diaphysaire Download PDF

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Publication number
WO2002009597A2
WO2002009597A2 PCT/US2001/024145 US0124145W WO0209597A2 WO 2002009597 A2 WO2002009597 A2 WO 2002009597A2 US 0124145 W US0124145 W US 0124145W WO 0209597 A2 WO0209597 A2 WO 0209597A2
Authority
WO
WIPO (PCT)
Prior art keywords
implant
dowel
bone
holes
biomedical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2001/024145
Other languages
English (en)
Other versions
WO2002009597A3 (fr
Inventor
Russell S. Donda
Nicholas E. Grivas
Jamie M. Grooms
Kevin C. Carter
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Regeneration Technologies Inc
Original Assignee
Regeneration Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Regeneration Technologies Inc filed Critical Regeneration Technologies Inc
Priority to AU2001280962A priority Critical patent/AU2001280962A1/en
Publication of WO2002009597A2 publication Critical patent/WO2002009597A2/fr
Publication of WO2002009597A3 publication Critical patent/WO2002009597A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
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    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0017—Angular shapes
    • A61F2230/0019—Angular shapes rectangular
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0034—D-shaped
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0082—Three-dimensional shapes parallelepipedal
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Definitions

  • the invention provides a novel dowel machined from the cortex of bone diaphyses and methods of use thereof.
  • ii. Background It is common for patients presenting with spinal trauma or pathology to require the fusion of two or more vertebra, hi the art, a standard solution to this problem is to create a cavity between two adjacent vertebra to accept the insertion of a dowel made from bone or another material.
  • a dowel known as the Cloward Dowel has been in use for many years. That device is a generally circular pin made by drilling an allogeneic or autogenic plug from the cancellous bone of the ilium (i.e., the hip bone).
  • this bone has two cortical surfaces (i.e., it is bicortical) and has an open, latticed or porous structure between the two cortical surfaces.
  • dowels have very poor biomechanical properties, principally being susceptible to compression. Accordingly, such dowels present the major danger of collapsing prior to fusion of the adjacent vertebra between which such a dowel is inserted.
  • a dowel of greater biomechanical properties has been produced from allogeneic femoral or tibial condyles (i.e., the rounded prominence at the end of the femur or tibia where such bones articulate with other bones).
  • the result of drilling a plug from such a condyle is a unicortical dowel.
  • Such unicortical dowels are available from most tissue banks, including the University of Florida Tissue Bank, Inc., (see, for example, our Allograft Catalog, product numbers 280012, 280014, and 280016; this catalog and these products are available on request by calling 904-462-3097, or by calling 1-800- OAGRAFT, or by writing to the University of Florida Tissue Bank, Inc., 1 Progress Boulevard., P.O.
  • 5,015,247 discloses a threaded spinal implant which, when placed between two adjacent vertebrae, directly participates and is incorporated in the ensuing fusion.
  • the implant is made of a hollow metal casing which is filled with osteo genie material. A plurality of perforations are provided in the casing so that bone can grow into and out of the implant. Metal threads and tabs are provided to insert and prevent backing out of the implant, respectively.
  • that implant is made out of metal and thus is a foreign object which is inserted into the spine and is thus never fully incorporated into the fusion.
  • the implant is preferably made of titanium, production of the implant requires the use of specialized metal molding and machining, and production of the implant material itself, which is expensive.
  • a further major disadvantage of such a device is that it requires FDA approval for use, while the FDA has already approved grafting of human bones. Accordingly, the implant disclosed in the '247 patent is quite different from the diaphysial cortical dowel of the instant invention. Likewise for the many patents reviewed in the background section of that patent, to which the reader's attention is directed for a further understanding of the background of the instant invention. The disclosure of the '247 patent is hereby incorporated by reference for this purpose.
  • a flexible prosthesis and a method for making such prostheses are disclosed.
  • the process includes machining a bone, demineralizing the bone to impart a desired degree of flexibility and tanning to render the material non- antigenic.
  • This patent is generally similar in disclosure to the disclosure found in the '853 patent discussed above, except that the particular applicability of the disclosed process to the production of an outer ear prosthesis is emphasized.
  • a particular claim is directed to the production of a spinal disc.
  • diaphysial cortical segments to make dowels nor is there any disclosure of the particular advantages achievable by use of such bone segments, as is disclosed herein.
  • a bone induction method which consists of implanting a bone morphogenetic, protein-free ceramic in the soft tissue or bone of an animal.
  • the ceramic disclosed as preferable is calcium phosphate and the use of such material for achieving spinal intervertebral joint fusions (disk arthroplasty) is suggested.
  • the material and product of the '303 patent aside from its possible use for a purpose similar to that for which the instant product is designed, bears little or no resemblance to the instant invention.
  • U.S. Patent No. 5,171,279 a method for subcutaneous suprafascial pedicular internal fixation of vertebrae of the spine is disclosed to facilitate graft fusion.
  • the method included excision of the nucleus of an affected disc, preparation of a bone graft, instrumentation of the vertebrae for fixation, and introduction of a bone graft into the resected nuclear space.
  • Metallic fixation hardware is disclosed as the principal aspect of the claimed invention. Accordingly, aside from dealing with the same general problem, the invention disclosed and claimed in the '279 patent bears little resemblance to the diaphysial cortical dowel and method of the instant invention.
  • the diaphysial cortical dowel of this invention is an implant useful in cervical or thoracic and lumbar fusions.
  • the dowel is preferably obtained from the allogeneic fibula, radius, ulna and occasionally, from small humeri.
  • the dimensions of such dowels are typically between about 8-15 mm in length (depth) and about 10-14 mm in diameter.
  • the dowel is preferably obtained from the humerus, femur or tibia.
  • each dowel has the feature of having the natural intra-medullary canal of the source bone forming a cavity through the dowel, perpendicular to the length of the dowel, which can be pre-packed with allogeneic cancellous bone, autogenous bone fragments, hydroxyapatite, bio glass, mixtures of these elements or any other bioceramic or osteogenic material to promote rapid fusion of the vertebrae between which the dowel is inserted.
  • dowels are generally referred to herein as "diaphysial" cortical dowels.
  • the present invention provides a generally cylindrical dowel of cortical bone having a canal through the dowel generally perpendicular to the long axis of the dowel.
  • the method for preparing and using the diaphysial cortical dowel of this invention comprises the steps of obtaining a plug from the diaphysis of an appropriate donor bone.
  • the donor will have been extensively screened for communicable diseases, cancer, and at-risk behavior prior to acceptance of the donor bone for dowel formation.
  • the plug is then machined, preferably in a class 10 clean room, to the dimensions desired.
  • a groove is inscribed on the circumference of the dowel to prevent backing-out of the dowel.
  • Another option is to inscribe a thread onto the circumference of the dowel. Chamfering of the forward end of the dowel which is to be inserted into a cavity formed between adjacent vertebrae is also preferred.
  • an instrument attachment hole is machined in the opposite end of the dowel from the chamfered end.
  • a score mark is inscribed on the cortical end into which the instrument attachment hole is machined so that the surgeon can align the intra-medullary canal so that the canal is parallel with the length of the recipient's spinal column.
  • the surgeon creates a cavity between two adjacent vertebra that are to be fused.
  • the autogenous bone fragments may be collected and packed into the intra- medullary canal of the diaphysial cortical dowel, or the dowel may be used with a prepacked osteogenic composition.
  • the dowel is mounted on an instrument via the instrument attachment hole and carefully inserted into the cavity created between the adjacent vertebrae to be fused. Over a period of several months, it is found that substantial fusion of the adjacent vertebrae occurs.
  • Another object is to improve patient incendence of safe and satisfactory fusion.
  • Another object of this invention is to provide a dowel for vertebral fusions which has improved biomechanical properties over standard Cloward Dowels and unicortical dowels known in the art.
  • Another object of this invention is to provide a method for making a novel diaphysial cortical dowel.
  • Another object of this invention is to provide a method for using the novel diaphysial cortical dowel of this invention.
  • Figure 1 A depicts the structure of a standard unicortical dowel known in the art.
  • Figure IB depicts the structure of a standard Cloward Dowel known in the art.
  • Figure 1C depicts the structure of one embodiment of the diaphysial cortical dowel of this invention.
  • Figure 2A depicts the ACF dowel with the instrument attachment hole and score mark.
  • Figure 2B depicts the ATIF or ALIF dowel with the instrument attachment hole and score mark.
  • FIG A and 3B depict one embodiment of this invention in which the dowel is threaded.
  • FIGC and 3D depict one embodiment of this invention in which the dowel is grooved.
  • Figure 4A is a side view of a dowel "blank" of this invention.
  • Figure 4B is an end view of the dowel "blank”.
  • Figure 5 A is a threaded dowel of this invention.
  • Figure 5B is an end-on view of the threaded dowel.
  • Figure 5C is a detail of one embodiment of the thread of one embodiment of the threaded dowel of this invention.
  • Figure 6A is a top plan view of one embodiment of a dowel threader of this invention.
  • Figure 6B is a side view of the dowel threader of this invention.
  • Figure 6C is an end-on view of the dowel threader of this invention showing the elements of the cutter assembly.
  • Figure 7A is a detailed view of a single tooth of one cutter blade of the dowel threader.
  • Figure 7B is an end-on view of the tooth profile.
  • Figure 7C is a global side view of a cutter blade.
  • Figure 7D is a detailed side view of cutter blade 421.
  • Figure 7E is a detailed side view of cutter blade 422.
  • Figure 8 A is a side elevational view of a further embodiment of the subject dowel comprising holes channeling from the outside surface of dowel to the inside canal.
  • Figure 8B is a perspective view of the embodiment shown in Figure 8 A.
  • Figure 8C is an end plan view of the embodiment shown in Figure 8 A.
  • Figure 8D is a transverse sectional view along the AA axis shown in Figure 8C.
  • Figure 8E is a side view of the embodiment shown in Figure 8 A.
  • Figure 9 A is a side elevational view of a further embodiment of the subject invention.
  • Figure 9B is a perspective view of the embodiment shown in Figure 9 A.
  • Figure 9C is an end plan view of the embodiment shown in Figure 9 A.
  • Figure 9D is a transverse sectional view along the AA axis shown in Figure 9C
  • Figure 9E is a side view of the embodiment shown in Figure 9 A.
  • Figure 10A is a side elevational view of another embodiment of the subject invention.
  • Figure 10B is a perspective view of the embodiment shown in Figure 10A.
  • Figure IOC is an end plan view of the embodiment shown in Figure 10A.
  • Figure 10D is a transverse sectional view along the AA axis shown in Figure IOC.
  • Figure 10E is a side view of the embodiment shown in Figure 10A.
  • Figure 11A is a perspective view of a further embodiment of the subject invention that comprises a hex drive through both ends of the implant.
  • Figure 1 IB is an end plan view of the embodiment shown in Figure 11A.
  • Figure 11C is a transverse sectional view along the AA axis shown in Figure
  • Figure 1 ID is a side view of the embodiment shown in Figure 11 A.
  • Figure 12 A is a perspective view of another embodiment of the subject invention that comprises a hex drive through one end of the implant.
  • Figure 12B is a end plan view of the embodiment shown in Figure 12 A.
  • Figure 12C is a transverse sectional view along the AA axis shown in Figure 12B.
  • Figure 12D is a side view of the embodiment shown in Figure 12A.
  • Figure 13A is a perspective view of a further implant of the subject invention that pertains to a Smith Robinson implant comprising a plurality of holes.
  • Figure 13B is an elevational side view of the embodiment shown in Figure 13 A.
  • Figure 13C is an end plan view of the embodiment shown in Figure 13 A.
  • Figure 13D is a transverse sectional view along the AA axis shown in Figure
  • Figure 13C is a side view of the embodiment shown in Figure 13 A.
  • Figure 13E is a side view of the embodiment shown in Figure 13 A.
  • Figure 14 is a perspective view of a further embodiment of the subject invention that pertains to an elongated implant comprising a central cavity and a plurality of holes.
  • the diaphysial cortical dowel of this invention is a graft useful in cervical or thoracic and lumbar fusions.
  • the dowel is perferably obtained from the fibula, radius, ulna and occasionally, from small humeri.
  • the dimensions of such dowels are typically between about 8- 15mm in length (depth) and about 14- 20mmin diameter.
  • the dowel is obtained as a transverse plug from the diaphysial of these long bones.
  • the bone plugs are obtained using a diamond or hard metal tipped cutting bit which is water cleaned and cooled.
  • Commercially available bits e.g.
  • a machine for obtention of endo- and cortical dowels consists of a pneumatic driven miniature lathe which is fabricated from stainless steel and anodized aluminum. It has a spring loaded carriage which travels parallel to the cutter. The carriage rides on two runners which are 1.0 inch (2.54 cm) stainless rods and has a travel distance of approximately 8.0 inches (20.32 cm). One runner has set pin holes on the running rod which will stop the carriage from moving when the set pin is placed into the desired hole.
  • the carriage is moveable from side to side with a knob which has graduations in metric and in English. This allows the graft to be positioned.
  • On this carriage is a vice with clamps the graft and holds it in place while the dowel is being cut.
  • the vice has a cut out area in the jaws to allow clearance for the cutter.
  • the lathe has a drive system which is a pneumatic motor with a valve controller which allows a desired RPM to be set.
  • the carriage is manually pulled back and locked in place with a set pin.
  • the graft is loaded into the vice and is aligned with the cutter.
  • the machine is stared and the RPM is set, by using a knob on the valve control.
  • the set pin which allows the graft to be loaded onto the cutter to cut the dowel. Once the cutter has cut all the way through the graft the carriage will stop on a set pin.
  • sterile water is used to eject dowel out of the cutter. It is fully autoclavable and has a stainless steel vice and/or clamping fixture to hold grafts for cutting dowels.
  • the graft can be positioned to within 0.001" (0.03 mm) of an inch which creates dowel uniformity during the cutting process.
  • the cutter used in conjunction with the above machine can produce dowels ranging from 5 mm to 30 mm diameters and the sizes of the cutters are 10.6 mm; 11.0 mm; 12.0 mm; 13.0 mm; 14.0 mm; 16.0 mm; and 18.0 mm.
  • the composition of the cutters is stainless steel with a diamond powder cutting surface which produces a very smooth surface on the wall of the dowels.
  • sterile water is used to cool and remove debris from graft and/or dowel as the dowel is being cut (hydro infusion). The water travels down through the center of the cutter to irrigate as well as clean the dowel under pressure. In addition, the water aides in ejecting the dowel from the cutter.
  • Plugs having a depth of about 8 mm to about 30 mm are generally acceptable, with appropriate gradations in length and diameter naturally being available at the option of the machinist. Accordingly, for cervical dowels, also referred to herein as anterior cervical fusion or ACF dowels, lengths of 8 mm, 9 mm, up to about 15 mm are desirable. Dowels of differing diameter are most conveniently obtained as follows: Diameter Source
  • a consenting donor i.e., a donor card or other form of acceptance to serve as a donor
  • a consenting donor i.e., a donor card or other form of acceptance to serve as a donor
  • communicable diseases and pathogens including human immunodeficiency virus, cytomegalovirus, hepatitis B, hepatitis C and several other pathogens.
  • each dowel Since the dowels are obtained from transverse plugs across the diaphysis of long bones, each dowel has the feature of having the natural intra-medullary canal of the source bone forming a cavity through the dowel perpendicular to the length of the dowel.
  • the canal cavity in the long bone is, in vivo, filled with bone-marrow.
  • no such natural cavity exists and the cancellous bone that forms the body of such dowels tends to be too brittle to accept machining of such a cavity.
  • the instant dowels by the nature of their origin, are already available with such a cavity.
  • the cavity can then be packed with autogenous bone fragments from the recipient (i.e., when the cavity between adjacent vertebrae is formed, the removed bone fragments can be used as an autogenous packing), hydroxyapatite, BIOGLASS®, mixtures of these elements or any other osteogenic material to promote rapid fusion of the vertebrae between which the dowel is inserted.
  • Bioactive glasses are generally composed of SiO , Na 2 O, CaO, and P 2 O 5 .
  • a preferred bioactive glass, BIOGLASS® 45S5 contains these compounds in the following respective weights: 45%, 24.5%, 24.4%, and 6%.
  • the method for preparing and using the diaphysial cortical dowel of this invention comprises the steps of obtaining a plug from the diaphysis of an appropriate donor bone.
  • the donor will have been extensively screened for communicable diseases, cancer, and at-risk behavior prior to acceptance of the donor bone for dowel formation.
  • the plug is then machined, preferably in a class 10 clean room, to the dimensions desired.
  • the machining is preferably conducted on a lathe such as a jeweler's lathe or machining tools may be specifically designed and adapted for this purpose.
  • a lathe such as a jeweler's lathe or machining tools may be specifically designed and adapted for this purpose.
  • Specific tolerances for the dowels and reproducibility of the product dimensions are important features for the successful use of such dowels in the clinical setting.
  • a groove is inscribed on the circumference of the dowel to prevent backing-out of the dowel, thereby forming a rib on the dowel which acts as a stop.
  • Another option is to inscribe a thread onto the circumference of the dowel. Machining of such grooves and threads on standard Cloward Dowels and even on unicortical dowels known in the art is difficult if not impossible due to the brittle cancellous nature of such dowels.
  • the dowels of this invention have the advantage of having very good biomechanical properties amenable to such machining.
  • the forward end of the dowel which is to be inserted into a cavity formed between adjacent vertebrae is preferably chamfered by appropriate abrasive means known in the art such as machining, filing or sanding.
  • abrasive means known in the art such as machining, filing or sanding.
  • the curvature of the chamfered end aids in the ease of insertion.
  • the tolerance for the chamfering is fairly liberal and the desired object is merely to round or slightly point the end of the dowel that is to be inserted into the cavity formed between adjacent vertebrae to be fused.
  • an instrument attachment hole is machined, for example by drilling. It is preferable that this end have a generally flat surface to accept the instrument for insertion of the dowel into the recipient.
  • the dowel will be of such dimensions as to fit standard insertion tools, such as those produced by Midas-Rex, e. h addition, it is preferred that a score mark be inscribed on the instrument attachment site of the dowel so that the surgeon can align the intra-medullary canal so that the canal is parallel with the length of the recipient's spinal column. With the aid of the score mark, once the dowel is inserted into the intervertebral cavity that is formed by the surgeon, even once the canal is no longer visible, proper alignment is possible.
  • Figure 1A the standard unicortical dowel 100 known in the art, having a cortical surface 10, a drilled instrument attachment hole 15, and a body of brittle cancellous bond 20.
  • FIG IB there is shown the standard bicortical dowel 200 known in the art having two cortical surfaces 10, a drilled instrument attachment hole 15, and a body of brittle cancellous bone 20.
  • the novel dowel 300 of this invention is shown having a cortical surface 10 into which an instrument attachment hole 15 and alignment score mark 16 may be machined (not shown as these elements are optional but preferred).
  • the intramedullary canal 30 and the chamfered insertion end 40 also optional but preferred.
  • Also not shown but easily inscribed due to the strength of the dowel 300 are circumferential ribbing or threads.
  • FIG 2 there is shown the ACF dowel in Figure 2A and the ATIF or the ALIF dowel in Figure 2B. Also shown, in addition to what is shown in Figure 1, are the score mark 16 and the instrument hole 15. hi figures 3A and 3B, the threaded 31 and grooved 32 dowel of this invention are shown. While those skilled in the art would know how to prepare a grooved or threaded dowel of this invention based on the forgoing disclosure and the disclosure of application serial number 08/587,070, one specific technique for preparation of preferred embodiments of this invention is discussed herein.
  • a side view of a diaphysial cortical dowel of this invention which may be used as is, or which may be further machined to have grooves or threads.
  • dowel diameter, length and thread pitch are provided. Those skilled in the art will recognize that these specifics may be appropriately scaled, depending on the size of the dowel required for any given application.
  • a blank dowel which may be used to machine an 18mm diameter by 28mm length threaded dowel.
  • Various features of the dowel blank are shown: the cortical bone 10, the tapped instrument attachment hole 15, the intra-medullary canal 30, and the chambered forward end of the dowel, 40.
  • the following dimensions are also provided in inches and/or millimeters: 50-0.630" (16.0mm); 51-0.100" (2.54mm); 52-3.512" (13mm); 53-1.024" (26mm); 54-0.50" (1.3mm); 55-0.150” (3.8mm); 56-0.217” (5.5mm).
  • a regular or irregular hole having a diameter 58 no greater than about 0.551" (14mm) is preferred to avoid the walls of the dowel from being too thin, and so that a minimum wall thickness 59 at the root of the thread, on both sides of the canal, is preferably 4mm or more.
  • FIG 5B an end-on view, from the orientation of the double arrows shown, shows the instrument attachment hole 15 and score mark 16 or driver slot 56.
  • a right hand thread with ten threads per inch at a helix angle at the root diameter of about 2.8892° is provided as follows: the pitch 60-0.100" (2.5mm); the thread angle 61-60°; the thread crest width 62a-0.025" (0.64mm); the thread height 63-0.039 (1mm); and the radius of thevarious thread angle as it changes 64 is typically about 0.010" (0.254mm).
  • FIG. 6A there is shown a top view of a thread cutter 400.
  • a handle 401 attached to a drive shaft 402 having a threaded portion 403 or a graduated segment means for controlled incremental advancement of the drive shaft 402 upon rotation of the handle 401.
  • Support means 404 and 405 are provided for alignment and support of the shaft 402, with either or both support means having matching threads, (in this illustration, only support means 405 would have matching threads, while support means 404 would have a hole which may have bearings to assist in rotation of the handle 401 and shaft 402), or like graduated segment means for controlled incremental advancement of the drive shaft 402.
  • a protruding element 407 which corresponds in width to the driver slot 56 on the rear end of the dowel of this invention.
  • a housing for the cutter assembly described further below.
  • the supports 404 and 405 and the housing 408 for the cutter assembly are all mounted on a steady, solid, preferably weighty base unit 409 via screws, welding, or like attachment means at 407 a-f.
  • cutter blades assembly 420 (compromising cutter blades 421 and 422 and guide plates 424 and 425, see Figure 6C), is shown affixed to the cutter assembly housing 408, and an approximate travel distance 411 from the fully backed out terminal end of the drive shaft 406, to the end of the cutter assembly 420 is shown. This distance must be sufficient to allow insertion of a dowel blank and advancement of the blank through the cutter assembly 420 to allow a fully threaded dowel to emerge from the cutter assembly.
  • FIG 6C an end-on view (from the direction shown by the double arrows in Figure 6B) of the cutter assembly 420 and cutter assembly housing 408 is provided.
  • the elements of this embodiment of the cutter assembly are now described in further detail: corresponding 421 and 422 cutter blades are held in place in the housing 408 by fixation wedges 423 a and 423b while guide while guide plates 424 and 425, having no cutting teeth, are held in place by fixation wedges 423c and 423d.
  • Fixation wedges 423a-d are held in place by screws 426a-d.
  • cutter blades 421 and 422 and guide plates 424 and 425 may be fixed inplace by increasing the tension created by tightening screws 426a-d, which draws the fixation wedges 423a-dinto the housing 408, thereby clamping these elements in place.
  • the diameter of the dowel that may be threaded according to this device is defined by the diameter of the aperture 427 created between the cutter blades 421 and 422 and the guide plates 424 and 425.
  • all of the foregoing elements should preferably be manufactured from durable materials such as 440 stainless steel, or like materials.
  • the cutting surfaces 421a and 422a of the blades 421 and 422, described in greater detail below, are made from hard metal.
  • the cutting edges 421a and 422a are disposed in relation to each other so that they are on axis.
  • Figure 7A provides a detail of the cutter, which maintains true tooth form from top to bottom, so that the cutter can be sharpened by surface grinding the face. This is achieved by wire-cutting the teeth such that there is about a 5° incline 62c between the descending vertices at the front and rear of each tooth, and about an 8° incline 62d between the front and rear of the top of each tooth. This aspect can best be seen in cutter blade end-on view 7B. Also, the thickness of the cutter blade, 62e, preferably about 0.100" (2.54mm), can be seen in that figure.
  • the angle 61 in figure 7 A is preferably about 60°.
  • the width of the top of the tooth 62b is preferably about 0.025" (0.635mm).
  • the pitch 60 is preferably about 0.100" (2.5mm).
  • FIG 7C there is shown an overall view of the cutter assembly housing 408.
  • the entire length of the cutter blade 421b is about 1.650" (4.2cm).
  • Fixation wings 421c and 42 Id are provided to allow proper seating of the cutter blade upon insertion into the housing 408. At 0, a line is provided on cutter blades 421 and 422, which allows for appropriate registration between cutter blades 421 and 422 during manufacture thereof.
  • blade 422 Upon insertion into the housing B408B, it is critical that the blades and the teeth thereon are appropriately registered so that as blade 421 cuts into the bone dowel as it is rotationally advanced through the cutter assembly 420, blade 422 is appropriately situated so that its matching teeth are in phase with the thread inscribed by the teeth on blade 421. This is accomplished by a combination of the fixation wings 421d and 421c properly seating in the housing 408 such that the wall 421e abuts the housing 408 and the housing 408 walls about the insides of wings 421 d and 421c.
  • FIG 7D there is provided a top view of cutting edge 421a.
  • the cutter blade 421 has twelve cutting teeth, numbered in figure 431-442.
  • the height of the tooth is incremented by about 0.004" (0.1mm), starting from about 0.002" (0.5mm) at 431, until the final tooth height is reached, in this example, of 0.039" (1mm) at 441 and 442.
  • the truncated teeth 431-440 feed into the dowel being cut along the 30° line so that the teeth cut only two sides.
  • the dotted line 443 shows the final pitch and form that the cutter will cut in the bone dowel. Similar to the foregoing description for figure 7D above, the cutting edge 422a is shown in greater detail in figure 7E, with eleven teeth 451-461 spread over the length of the blade. At 451, the first tooth at 0.004" (0.1mm) in this example is encountered by the blank and at each successive tooth, an increase of about 0.004" (0.1mm) is made until the final tooth height of about 0.039" (1mm) reached at 460 and 461. Again, the dotted line 443 shows the final pitch and form that the cutter will cut in the bone dowel.
  • the cutter blades 421 and 422 are placed into the housing 408, clamped into place via fixation wedges 423 and the screws 426, after the blades have been properly seated and the two blades have been properly seated and the two blades are perfectly aligned.
  • a blank dowel is then loaded into the orifice 427 and the drive shaft with the protruding element 407 is inserted into the driver slot 56 of the dowel 300.
  • the score mark 16 may be machined as a groove (driver slot 56) which mates with the protruding element 407 such that rotational torque may be transmitted to the dowel.
  • He groove may be oriented parallel to, perpendicular to, or at any other desired orientation with respect to the intramedullary canal of the dowel.
  • the handle 401 is turned, forcing the dowel to rotate and advance incrementally through the cutter assembly 420, thereby increasing the thread defined by the cutter blades 421 and 422 into the cylindrical surface (circumference) of the dowel.
  • Figures 8A-8D a further embodiment of the subject dowel 800 is shown that comprises one or more holes 810 fo ⁇ ned in the implant 800.
  • the holes are preferably positioned such that the canal 30 can communicate with the cortical surface 10.
  • Figure 8B shows a perspective view of the subject dowel 800, having a first chamfered end 820 proximate to instrument hole 15 and score mark 16 and a second chamfered end 822 on the opposite end of the dowel 800.
  • Figure 8C is an end plan view of the dowel 800 which shows the instrument hole 15 and score mark 16.
  • Figure 8D shows a transverse section of dowel 800 along the AA axis shown in Figure 8C.
  • Figure 8E represents a side view of dowel 800.
  • embodiments 900 and 1000 of the subject implants are shown that comprise a hex drive 905, 1005, adapted for positioning the implant in place.
  • hex drive 905 is provided on both ends of implant 900, which allows the insertion of a drive tool through the entire implant.
  • Hex drive 1005 is provided on only one end of the implant 1000.
  • a tool having ridges to engage the hex drive 905, 1005 is inserted into the implant, whereby the implant can be inserted into an area of need and then rotated as desired. It will be apparent to those skilled in the art that other commercially available (or yet developed) tools and/or instruments can be used in conjunction with the subject implants.
  • implants 900 and 1000 are provided with holes 910, 1010 to facilitate delivery of biologically active substances disposed in canal 30.
  • Figures 9B and 10B represent a perspective view of implants 900 and 1000, respectively.
  • Figures 9C and 10C represent an end plan view showing the hex drive 905 and 1005.
  • Figures 9D and 10D represent a cross- section of implants 900 and 1000 along the AA axis shown in Figures 9C and IOC.
  • Figures 9E and 10E show a side view of implants 900 and 1000.
  • Implants 900 and 1000 preferably, though not necessarily, comprise a first 920, 1020 and second 922, 1022 chamfered ends, which aid in the insertion and manipulation of the implants.
  • FIG. 11A-11D A cervical tapered dowel, such as that disclosed in co-pending application number 60/186,312 is depicted in Figures 11A-11D.
  • Figure 11A shows a perspective view of dowel 1100, having a tapered body resulting in a smaller diameter for the front end 1110, and a larger diameter for the back end 1120.
  • the back end 1120 comprises a hex drive 1130 formed therein for insertion and rotation of the implant.
  • Implant 1100 contains a canal 1140 for use of packing biologically active substances.
  • FIG 1 IB is an end plan view of implant 1100 showing the back end 1120 along with the hex drive 1130.
  • Figure 11C depicts a transverse section of implant 1100 along the AA axis shown in Figure 1 IB.
  • the hex drive 1130 is shown running from the front end 1110 to the back end 1120.
  • Figure 11D shows a side view of implant 1100, holes 1150, and screw threads 1170 which are inscribed from the front end 1110 to the back end 1120. The screw threads 1170 ease insertion and help to hold the implant in place.
  • Figures 12A-12D show an alternate embodiment of the cervical tapered dowel depicted in Figures 11A-11D and disclosed in co-pending application number 60/186,312.
  • Figure 12A shows a perspective view of implant 1200, having a tapered body resulting in a smaller diameter for the front end 1210 and a larger diameter for the back end 1220.
  • the back end 1220 contains an instrument hole 1230 along with a score mark 1240 for use with an insertion device to provide torque to the implant.
  • Implant 1200 contains a canal 1250 for packing biologically active substances along with holes 1260 that radiate from the canal 1250 to the cortical surface 1270.
  • Figure 12B is an end plan view of implant 1200 showing back end 1220 along with the instrument hole 1230 and the score mark 1240.
  • Figure 12C depicts a transverse section of implant 1200 along the AA axis shown in Figure 12B.
  • the instrument hole 1230 is shown extending partially through the implant into the canal 1250.
  • Figure 12D shows a side view of implant 1200.
  • the screw threads 1280 ease insertion and helps the implant retain its position once implanted.
  • Another implant that can embody the radiating holes according to the present invention includes the Cortical Bone Cervical Smith-Robinson Fusion Implant disclosed in co-pending application number 08/920,630, which is shown in Figures 13A-13E.
  • Figure 13A shows a perspective view of the D-shaped implant 1300, having a convexly curved wall 1310, three essentially rectangular walls 1320, two essentially rectangular top 1330 and bottom 1340 walls, and a basically circular canal 1350 for packing biologically active substances.
  • Figure 13B is a side view of the implant 1300 showing the curved wall 1310 and the holes 1360 which radiate from the canal 1350 (as shown in Figure 13 A) to the curved wall 1310 and each of the rectangular walls 1320.
  • Figure 13C depicts a top view of implant 1300 showing the canal 1350 and an external feature 1370, which comprises a set of teeth or ridges.
  • Figure 13C also shows that the edges 1380 between the curved wall 1310 and each of the rectangular walls 1320 are rounded.
  • Figure 13D shows a transverse section of implant 1300 along axis AA shown in figure 13C and the canal 1350 and holes 1360 formed in the structure of implant 1300.
  • Figure 13E is a side view of implant 1300 and the external feature 1370 inscribed on the top 1330 and bottom 1340 surfaces of the implant.
  • the external feature 1370 defines a tooth-like or ridge-like structure with teeth 1371 separated from each other by concavities 1372.
  • FIG. 14 is drawn to an elongated mineralized implant 1400 comprising a central cavity 1410 and a plurality of holes 1420.
  • This embodiment is based on one of the embodiments disclosed in co-pending application no. 09/585,772.
  • Those skilled in the art will appreciate that other known implants of various shapes and sizes, as well as those yet to be developed, would benefit from the provision of holes.
  • Particular examples of implants that can be modified to define a plurality of holes positioned throughout their structure include those taught in Application Serial Nos. 60/181,622; 09/363,208; 09/481,319; and 09/484,641; and U.S. Patent No. 6,033,438, all of whose teachings are incorporated by reference.
  • the plurality of holes or canals formed in the implant of this invention should not be so numerous or so large as to compromise the structural integrity or strength of the implant.
  • the holes are of a sufficiently small and fine dimension as to minimally affect torsional and compressive strengths of the implant, as compared to the implant sans the plurality of holes.
  • the holes are of a size between about 0.01 mm to about 0.5 mm, and more preferably, between about 0.05 and 0.1 mm in diameter.
  • Such holes or canals may be formed in the bone material with sufficiently fine drill bits, lasers or the like. It will also be appreciated that the holes or canals may penetrate all the way through the various implant embodiments disclosed herein, or may penetrate only partially into the implant.
  • the holes or canals may be disposed so as to be perpendicular, parallel or radially oriented with respect to any axis of the implant, depending on the particular implant and the implant location.
  • the implant may be contacted with cells prior to implantation.
  • bone implants according to this invention may be cultured with stem cells, fibroblasts, muscle cells, neuronal cells or the like or simply contacted therewith or be infused therewith prior to implantation.
  • the cells that are contacted with the implant are stem cells, such as those known in the art or which become known hereafter.
  • stem cells such as those known in the art or which become known hereafter.
  • human mesenchymal or other stem cells such as those disclosed in any of US Patent Nos.
  • the inventor has discovered that providing holes in the subject implants can control and improve the release and delivery of biologically active substances loaded in the canal 30, or otherwise infused, embedded or coated on or in the implants. Naturally, the rate of release will be dependent on the size and number of holes provided.
  • the canal of the subject dowels can be packed with various biologically active substances, including, but not limited to, growth factors, antibiotics, nucleic acids, proteins, peptides, antineoplastics, and anti-inflammatory compounds, and the like.
  • the plurality of holes taught herein can facilitate the migration and growth of cells and tissues into the implant. It will be appreciated that any appropriate carrier may be used in association with these biologically active
  • the composition may comprise a bone paste composition comprising cortical bone chips, cancellous bone chips, demineralized bone matrix powder (DBM), bioactive glass or other ceramics, growth factors, nucleic acids, proteins, peptides, carbohydrates, lipids and the like.
  • the substance packed in the canal is an osteogenic substance and/or comprises tissue regenerating growth factors. See, for example, WO98/40113.
  • the subject implants can be infused, soaked and/or coated with various biologically active substances.
  • the dowel could be mounted in a lathe, such as those known in the art and commercially available, for example from SHERLINE PRODUCTS INC., SAN MARCOS, CALIFORNIA 92069, and a cutter blade applied as the dowel is rotated.
  • the dowel of this invention may be conveniently incorporated into known fusion procedures.
  • the surgeon creates a cavity between adjacent vertebrae that are to be fused, using conventional surgical procedures.
  • the autogenous bone fragments produced in the formation of the cavity may be collected and packed into the intra-medullary canal of the diaphysial cortical dowel, or the dowel may be used with a pre-packaged osteogenic composition.
  • a dowel of the appropriate dimensions is selected by the surgeon, based on the size of the cavity created and the needs of the particular patient undergoing the fusion.
  • the dowel is mounted on an instrument via the instrument attachment hole and carefully inserted into the cavity created between the adjacent vertebra to be fused. For cervical fusions, only one dowel is needed. For lumbar fusions, two dowels may be required, hi any event, the dowels may be applied laparoscopically using currently available instrumentation. Over a period of several months, it is found that substantial fusion of the adjacent vertebrae occurs.

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Abstract

L'invention concerne un tenon obtenu par réalisation d'une cheville à partir de la tige (diaphyse) d'os de longueurs différentes. Le tenon comporte un canal intramédullaire pouvant être revêtu d'un matériau ostéogène quelconque. Le tenon présente une surface corticale dans laquelle une ouverture de fixation d'instrument peut être usinée, et sur laquelle une marque d'alignement peut être inscrite pour une orientation adéquate du canal intramédullaire. Le tenon comporte une extrémité d'insertion chanfreinée, et présente des propriétés biomécaniques ainsi que des propriétés d'induction de fusion vertébrale améliorées par rapport aux tenons habituels. L'invention concerne également différents types d'implants comportant une pluralité d'ouvertures destinées à faciliter la diffusion de substances biologiquement actives associées auxdits implants. L'implant selon l'invention peut par ailleurs être infusé et/ou noyé et/ou imbibé et/ou revêtu de substances biologiquement actives choisies parmi les facteurs de croissance, protéines morphogénétiques osseuses, cellules, antibiotiques, protéines, peptides, et acide nucléiques.
PCT/US2001/024145 2000-08-01 2001-08-01 Tenon cortical diaphysaire Ceased WO2002009597A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001280962A AU2001280962A1 (en) 2000-08-01 2001-08-01 Diaphysial cortical dowel

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US63017900A 2000-08-01 2000-08-01
US09/630,179 2000-08-01

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WO2002009597A3 WO2002009597A3 (fr) 2002-08-08

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US9380932B1 (en) 2011-11-02 2016-07-05 Pinnacle Spine Group, Llc Retractor devices for minimally invasive access to the spine
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