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WO2001080753A2 - Vis d'interference pour la corticale - Google Patents

Vis d'interference pour la corticale Download PDF

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Publication number
WO2001080753A2
WO2001080753A2 PCT/US2001/012888 US0112888W WO0180753A2 WO 2001080753 A2 WO2001080753 A2 WO 2001080753A2 US 0112888 W US0112888 W US 0112888W WO 0180753 A2 WO0180753 A2 WO 0180753A2
Authority
WO
WIPO (PCT)
Prior art keywords
screw
bone
head
drive
interference
Prior art date
Application number
PCT/US2001/012888
Other languages
English (en)
Other versions
WO2001080753A3 (fr
Inventor
Jamie M. Grooms
Kevin Carter
David H. Dulebohn
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 AU2001255530A priority Critical patent/AU2001255530A1/en
Publication of WO2001080753A2 publication Critical patent/WO2001080753A2/fr
Publication of WO2001080753A3 publication Critical patent/WO2001080753A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—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
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • A61B17/861—Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver
    • A61B17/862—Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver at the periphery of the screw head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A61B17/8877—Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit
    • A61B17/8883—Screwdrivers, spanners or wrenches characterised by the cross-section of the driver bit the driver bit acting on the periphery of the screw head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
    • A61B17/8886—Screwdrivers, spanners or wrenches holding the screw head
    • A61B17/8891—Screwdrivers, spanners or wrenches holding the screw head at its periphery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—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
    • A61B17/8635—Tips of screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8645—Headless screws, e.g. ligament interference screws
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0805—Implements for inserting tendons or ligaments
    • 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
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • 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
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • A61F2002/30866—Rounded threads

Definitions

  • This invention relates to a novel interference screw made of bone and methods of use thereof in the field of orthopedics.
  • Adequate fixation of graft material is one of the more important factors in successful outcome of cruciate ligament reconstruction. Numerous methods of graft fixation have been employed, including screw and washer, staples, buttons, and interference screws. Potential problems with residual hardware include chronic pain, migration, and loss of bone stock.
  • interference screws are known in the art for use in fixation of cervical grafts (Zou et al., 1991) anterior cruciate ligaments (Matthews et al., 1989.; Barrett et al., 1995; Kousa et al., 1995; Lemos et al., 1995; Kohn et al., 1994; Firer, P. 1991 ).
  • metallic or synthetic interference screws were utilized.
  • Several such screws have been patented. Thus, for example, U.S. Patent Nos.
  • the standard Cloward type dowel for cervical interbody fusion is a cylindrical dowel of bone taken from the iliac crest
  • Dr. Vich disclosed a technique in which there is required "the intraoperative threading of the cylindrical bone graft (either autologous or heterologous) to be implanted into the appropriate intervertebral space". Screw threads were placed in the graft with a small, previously sterilized die, and the graft was then screwed into a cylindrical bed in the intervertebral body.
  • the entire disclosure is directed to production and use of a threaded intervertebral fusion implant.
  • That implant is a bicortical dowel having an intermediate region composed of soft, porous cancellous bone, wholly inappropriate and too weak for use in the instant invention.
  • the differences between cortical bone and cancellous bone implant healing are reviewed by Burchardt (Burchardt, 1983). There is no disclosure or suggestion of an interference screw made entirely of cortical bone.
  • the novel interference screw of this invention is manufactured from cortical allograft bone to be used, for example, in fixation of cruciate ligament grafts.
  • the interference screw of this invention has an immediate fixation strength that is comparable to metallic interference screws, and has the advantage of leaving no residual hardware while contributing to bone stock.
  • Another object is to provide an interference screw made from bone which is capable of fusing with the bone into which it is implanted, thereby contributing to, rather than detracting from, bone stock in the area of the ligament or other implant.
  • Another object is to provide a self-tapping bone screw.
  • Another object is to provide a method for making an allograft interference screw.
  • Another object is to provide a method for using the allograft interference screw.
  • Figure 1 A is a photograph of one embodiment of this invention.
  • Figure IB is a schematic of the embodiment shown in Figure 1A.
  • Figures 2A-2C show various stages in the use of a bone interference screw of this invention.
  • Figure 3 is a cross-section of an implanted bone interference screw of this invention.
  • Figure 4 is a graph showing the load to failure of bone as compared to metal interference screws.
  • Figure 5 A is a schematic of a "blank" cortical dowel.
  • Figure 5B is a head-on projection of the tip of the screw before machining the thread.
  • Figure 5 C is an end-on projection of the screw-head before machining into a drive head.
  • Figure 5D is a schematic of the finished screw of this invention.
  • Figure 5E is a detail of the screw thread.
  • Figure 5F is a representation of one embodiment of the screw head.
  • Figure 5G is an alternate embodiment of the screw drive head.
  • Figure 5H is an alternate embodiment of the screw drive head.
  • Figure 51 is a top view of the screw head shown in cross-section in Figure 5H.
  • Figure 5J is a side view of a drive means.
  • Figure 5K is an end-on view of the drive means shown in Figure 5J.
  • Figure 5L shows a pinching drive means in cross-section.
  • Figure 5M is an end-on view of the driver means of Figure 5K.
  • Figures 6A-6C is an exploded view of the driver means of Figures 5L and 5M.
  • Figure 7 shows a cortical bone fixation plate with screw holes machined therein.
  • Figures 8A-8D show an embodiment of the bone interference screw with an internal drive feature.
  • Figure 9 shows a graft protector according to this invention.
  • the method for preparing and using the interference screw of this invention comprises the steps of obtaining a fragment of bone from the cortex of an appropriate donor bone and machining the thread, tip and drive-head of the screw.
  • FIG. 1A there is shown a photograph of an exemplary embodiment of the bone interference screw of this invention, and in Figure IB, there is provided a schematic of the same embodiment of the screw, showing several of the key dimensions of the screw.
  • the length of this screw, as shown in Figure IB, is about 25 mm, and the diameter, as shown in Figure IB, is about 7 mm.
  • a square head is provided which matingly fits a square drive socket of an appropriate screw-driving implement.
  • a terminus which may be inserted into a pre-drilled cavity.
  • the threads of the screw preferably cover approximately between about 75% and 95%, and most preferably about 85% of the length of the screw, with the remaining fraction of the screw being devoted to the drive-head.
  • the drive-head may have any shape that allows sufficient torque to be applied to the head of the screw to drive the screw into a pre-drilled cavity of appropriate diameter.
  • the drive-head may be square, as shown in Figures 1 A and IB, hexagonal, metric socket shaped or standard socket shaped.
  • the head may have a machined, recessed Allen-wrench, star headed driver, Phillips head or slotted head purchase for torque application.
  • the drive recess may, for example, be that shown in U.S. Patent No. 5,470,334, the disclosure of which is herein incorporated by reference, for receiving a rotatable driver.
  • the threads of the screw of this invention may be of like dimensional arrangement to that shown in the 5,470,334 patent.
  • the drive and thread arrangement disclosed in U.S. Patent No. 5,364,400 is herein incorporated by reference as being acceptable and desirable for the bone interference screw of the present invention.
  • the thread will have a height of about 0.045 inches.
  • the bone screw of this invention may have a diameter between about 4 mm and about 12 mm, for ACL implant fixation, and preferably being about; 5 mm, 7 mm, 9 mm, 10 mm or 11 mm in diameter.
  • the length of the bone screw may be between about 8 mm and 70 mm, preferably being about 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, 30 mm, or 40 mm in length.
  • the same screw may be used for soft tissue attachment, with or without the addition of a flange being incorporated into the design of the head portion.
  • Bone screws of this invention having appropriate) length and diameter could also be used to advantage and with greater strength in applications such as, for example, the vertebral fusion procedure described by J.M. Vich (Vich, 1985), or it may be used to affix any number of other implants. For these differing purposes, it will be recognized that diameters as small as 4 mm and as large as 30 mm may be appropriate.
  • 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.
  • the cortical sections are removed from linear aspects of the femur or from the anterior cortex of the tibia, and is preferably first machined into a dowel or "blank".
  • a dowel of the cortical bone is then machined, preferably in a class 10 clean room, to the dimensions desired.
  • the machining is preferably conducted on a graduated die, a grinding wheel, a lathe, or machining tools may be specifically designed and adapted for this purpose. Specific tolerances for the screws and reproducibility of the product dimensions are important features for the successful use of such screws in the clinical setting.
  • a thread is cut on the circumference of the screw and a head cut to allow an appropriate driving tool to screw the interference device into a cavity machined by a surgeon, for example, adjacent to a ligamentous implant.
  • the forward end or tip of the screw which is to be inserted into a cavity formed by a surgeon adjacent the ligament or other implant is preferably fashioned by appropriate means known in the art, such as machining, to produce a tip of any desired geometry, such as a pointed tip, a rounded tip or a flush tip.
  • a drive-head is machined, for example, by creating a square or hexagonal head.
  • a square or hexagonal recess may also be drilled into the screw.
  • the final machined product may be stored, frozen or freeze-dried and vacuum-sealed for later use.
  • Figure 5 A there is shown a number of preferred features in a bone interference screw of this invention.
  • a "blank" indicated generally by numeral 10, as produced prior to finishing.
  • the blank's length is depicted by a first dimension 11, which is either in inches or is assigned a relative value of unity.
  • a second dimension, 12 is provided, representing approximately 0.85 of the length 11.
  • a third dimension, 13, and a fourth dimension, 14, are each provided, each representing approximately 0.10 of the length 11.
  • a fifth dimension, 12a is provided, representing the dimension 12 minus the dimensions 13 and 14.
  • the forward end of the blank, 15, destined to become the "point" of the screw, has a tapered angle over the dimension 14, tapering from a diameter 16a of about 0.285 inches (which may also be assigned a relative value of unity and all other subsequently provided measurements being scaled appropriately) at point 16 to a diameter 17a of about 0.190 at point 17.
  • a centerdrill on the cylindrical centerline.
  • the tapering and centerdrill at point 21 is shown in the head-on projection shown in Figure 5B.
  • This centerdrill is helpful in the machining of the screw.
  • the centerdrill 21 may be extended throughout the dimension 11 as a centerbore in the screw to provide a cannulated screw. In this fashion, the screw may be guided into position by sliding the screw over a guide-wire, guide-pin or k-wire, all of which are conventional in the art.
  • the centerbore of the cannulated screw need be no greater in diameter than about 0.5-3 mm, to avoid weakening the screw.
  • the tapering of the screw blank, as described, is important to avoid the production of "feathery" edges upon machining of the thread. Such feathering may be encountered if a uniformly cylindrical blank is used to machine the thread.
  • FIG 5D there is shown the screw after machining of the screw thread 22.
  • the machined thread root diameter 23 is about 0.190 across the entire dimension 12.
  • the thread crest diameter 24 over the dimension 12a is about 0.280 after machining,
  • the crest diameter decreases over the dimensions 13 and 14.
  • the screw will preferably have a pitch of between about 5 threads per inch to about 40 threads per inch, and a diameter between about 2-15 mm, thereby defining the thread profile.
  • pitch i.e., the distance 25a
  • diameter i.e., the diameter of the threaded portion of the screw- is tapered, such that, for example, a screw having a length of 10-12 mm has a diameter which tapers from about 12 mm down to about 6 mm at the tip end of the screw.
  • FIG 5F there is shown a preferred machined head shape, referred to herein as a "dog bone-shape," thus providing a “dog bone-head screw”.
  • the diameter is machined to about 0.186 at dimension 26, and about 0.11 at dimension 27. No centerbore hole is shown, as the cannulation is an optional albeit referred embodiment.
  • Figure 5G there is shown an alternate machined head shape, referred to herein as a “twister” head having a pair of "wings", 33 which engage an appropriate drive means.
  • FIG 5H there is show ⁇ _ in cross-section a further head design, referred to herein as the "sunken groove” design. In this design a square groove 33 is drilled into the head of the screw.
  • Figure 51 there is shown the generally circular screw head with a square groove 33 drilled therein.
  • a drive means optimized for driving a preferred dog bone-head shaped, twister-head shaped, or sunken groove head interference screw is provided.
  • Figure 5J is a side-view of the driver showing a shaft 28 which may be turned by a handle or other means at 29.
  • a recessed drive slot 30 is provided into which the dog bone-head or twister-head of the interference screw fits. Shown end-on in Figure 5K are the drive slot, 30, and the shaft 28.
  • the dog-bone shaped recess 30 engages the dog bone-head of the screw, to apply rotating torque thereto.
  • the driver may be made from stainless steel, titanium or like material.
  • the driver is modified as required to mate with a twister-shaped head by fashioning the recess 30 to accommodate this shape.
  • a rigid mating square headed drive means that fits into the machined square groove provides ample torque to insert that screw.
  • Attached to the outer shaft 28 is an outer shaft handle 29 (not shown) and attached to the inner shaft 28a is an inner shaft handle 29a (not shown).
  • an outer shaft insert 36 is welded into place.
  • the outer shaft insert 36 is seen to have a pair of inwardly projecting driver lugs 37a and 37b.
  • the ends of the forwardly projecting prongs 31 are seen.
  • This drive means is prepared, as shown in Figures 6A through 6C, by preparing an outer shaft insert 36 with a pair of inwardly projecting driver lugs 37a and 37b.
  • the insert has an upper segment 38 with a first diameter that matches the diameter of the outer shaft 28.
  • a second segment, 39 has a smaller outer diameter than that of the outer shaft 28, but an inner diameter that is still large enough to accommodate the inner shaft 28a.
  • the outer shaft insert 36 may be inserted into the outer shaft 28 and welded at point 35, while the inner shaft 28a may be slid into the outer shaft 28 and still be rotatable therein.
  • the outer shaft 28 is shown in Figure 6B, and the inner shaft 28a is shown in Figure 6C.
  • the forwardly projecting prongs 31 optionally may have a serrated gripping surface 40.
  • the bone-shaped head of a preferred screw of this invention is inserted into the drive recess 30.
  • the driver lugs 37a and 37b will naturally engage the walls of the head of the screw.
  • the outer shaft handle 29 is used to hold the screw as the inner shaft handle 29a is rotated slightly ("torque applied" in Figure 6C) so that the forwardly projecting prongs 31 engage the opposite sides of the screw head to create a pinching action.
  • the pinching action occurs because the prongs 31 force the screw head against the driver lugs 37a and 37b.
  • the driver lugs 37a and 37b then are used to exert a torque in the opposite direction when the screw is screwed into the recipient's bone.
  • the two handles may optimally interlock by an appropriate interlocking means to maintain the slight torque need to keep the screw head pinched.
  • This embodiment of the driver is amenable to laproscopic procedures where a screw may need to be "threaded” through tight spaces and orifices created in tissue.
  • the same drive head may be used to engage and drive the twister head screw.
  • the bone screw of this invention may be used to secure a standard titanium or like fixation plate as in a vertebral fusion.
  • Figure 7 there is shown a design for a novel cortical bone plate 41 machined from cortical bone of tibia.
  • Several screw holes 42 are shown in the plate.
  • the interference screw of this invention is screwed through the screw holes 42 to hold the plate in appropriate fixation position so that adjacent vertebrae may be fused.
  • the screw holes 42 be tapered, or counter-sunk so that once screwed into the screw hole, the screw head may be ground down so as to be flush with the surface of the bone plate.
  • the head of the bone screw it is necessary for the head of the bone screw to have a greater diameter than that of the shaft of the bone screw or the hole in the bone plate, in order for the screw to provide a plate retention action.
  • This is achieved by simply machining the bone screw to have a tapered head, as in a standard metal machine screw, such that once screwed into the bone plate, the top of the screw head is flush, thereby eliminating the need to grind down the screw-head.
  • the entire fusion, including adjacent vertebrae, interference screws and bone plate all resorb over time as the fusion proceeds, and there is no need for subsequent removal of any hardware.
  • the clinical advantages of the instant bone interference screw are that it maintains bone stock, and there is no residual hardware as a result of use of the interference screw.
  • a screw of this invention having the appropriate dimensions is selected by the surgeon, based on the needs of the particular patient undergoing the implant.
  • the screw is mounted on an appropriate driver which has a drive-head that mates with the head machined on the screw opposite the pointed, rounded or flush forward end.
  • the screw is carefully driven partially into the cavity created for insertion of the implant and partially into the solid bone adjacent to the implant which is thereby locked into place.
  • the screw is driven until the drive-head is flush with the implant site.
  • a means for driving the bone screw wherein an internal drive is created.
  • an axial bore or cannulation through the longitudinal axis of the screw is created by drilling, laser, electrical discharge machining, or alternate means capable of forming a bore through a longitudinal axis of a cortical bone screw, whether now known or hereafter developed.
  • a form is imparted to the internal canal by pushing or drawing an appropriate broach through the cannulation.
  • the broach preferably comprises a cascade of cutting edges that progressively change from the round shape of the pilot hole to a desired shape for receiving an appropriate driver.
  • an interference screw 800 is provided wherein there is no drive head. Rather there is a front end 810 and a rear end 820, an external thread form 830.
  • an end-on view viewed from the rear 820 of the screw 800 showing a hexagonal internal drive form 840.
  • FIG 8C there is shown an end-on view of the front 810 of the screw, showing the anterior aspect of the hexagonal drive form 840 at the front end of the screw.
  • FIG 8D there is shown a perspective view of the screw 800 showing the front end of the screw 810, the internal hex drive 840, the thread form 830, and the rear end of the screw 820.
  • this screw is slid over a guide-wire, which itself is inserted along-side a tissue, such as a bone block attached to a tendon for ACL reconstruction.
  • a hex head driver is inserted into the internal driveway 840, and torque is applied to the screw, causing the screw to bite into the canal and bone block, thereby forming an interference fit.
  • the internal hex drive has unexpectedly enhanced resistance to fracture under torsional loads, as compared, for example, to screws with an external square head drive.
  • a novel graft protector which is used in conjunction with the screw of the present invention to prevent damage of, for example, a bone-tendon-bone graft upon implantation of the interference screw.
  • a graft protector 900 is provided comprising a handle 910, a shaft 920 and a graft protection sleeve 930.
  • the shaft 920 comprises a concavity 925 for receiving the shaft of a driver onto which an interference screw according to this invention is affixed.
  • the screw is placed such that the graft protection sleeve 930 prevents contact of the screw with the bone-tendon-bone graft until such time as the screw has been positioned to avoid damage to any portion of the graft.
  • the graft protector 900 may be rotated to expose the cutting thread of the interference screw which is then torqued into interference contact with the graft and graft tunnel.
  • interference screw of this invention is preferably composed of cortical bone, due to the natural strength of cortical bone.
  • One method by which greater flexibility may be conferred on the screw or bone plate is to completely demineralize the bone, partially demineralize the bone, or demineralize portions thereof.
  • Means for bone demineralization or partial demineralization are known in the art and are hereby incorporated by reference. By way of example, it is known that by exposure of bone to even relatively dilute acidic solutions, minerals are leached from the bone matrix, leaving a substantially flexible collagen matrix.
  • portions of the bone By masking portions of the bone thus treated, portions of the bone may be retained in a mineralized state.
  • portions of the bone may be retained in a mineralized state.
  • different degrees of demineralization may be achieved at will.
  • allograft interference screws having dimensions of 7 mm by 25 mm were manufactured from the ante ⁇ or cortex of fresh frozen human tibias
  • five conventional cannulated interference screws (7 mm by 25 mm) were used in parallel
  • Six fresh frozen human cadavenc femora were used for the implants Patellar bone- tendon-bone grafts having a width of 1 1 mm with bone plugs of 25 mm length were implanted
  • a standard guide wire was placed m the condyle of the distal femur and an 11 mm reamer was used to drill over the wire
  • a pathway was fashioned for the allograft screw parallel to the plug using sequential dilators from 3 to 6 mm
  • Self-tapping allograft screws were placed with a custom socket driver for interference fit

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
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  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

Cette invention se rapporte à une vis d'interférence, que l'on obtient en usinant un fragment d'une autogreffe, d'une halogreffe ou d'une xénogreffe de corticale provenant d'un donneur ou provenant d'un os amputé du receveur. Cette vis d'interférence possède une surface corticale dans laquelle est usiné un filetage autotaraudeur. Cette vis d'interférence comporte une extrémité usinée, pointue, arrondie ou plate, et une extrémité usinée opposée qui s'adapte à un moyen de vissage et elle présente des avantages par rapport aux vis d'interférence traditionnelles connues dans la technique actuelle, étant donné que, après l'implantation, aucun matériel résiduel qui doit ensuite être retiré ne reste à l'endroit de l'implant.
PCT/US2001/012888 2000-04-20 2001-04-20 Vis d'interference pour la corticale WO2001080753A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001255530A AU2001255530A1 (en) 2000-04-20 2001-04-20 Cortical bone interference screw

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55353400A 2000-04-20 2000-04-20
US09/553,534 2000-04-20

Publications (2)

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WO2001080753A2 true WO2001080753A2 (fr) 2001-11-01
WO2001080753A3 WO2001080753A3 (fr) 2002-04-04

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102895024A (zh) * 2012-10-31 2013-01-30 刘畅 同种异体皮质骨横穿钉
CN103006309A (zh) * 2012-12-28 2013-04-03 刘畅 同种异体皮质骨横穿钉
US8961571B2 (en) 2007-11-19 2015-02-24 David Lee Method and apparatus for spinal facet joint fusion using irregularly shaped cortical bone implants

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Publication number Priority date Publication date Assignee Title
US2579438A (en) * 1946-02-15 1951-12-18 Puy Mfg Company Inc De Screw holding screw driver
DE1500829A1 (de) * 1965-07-01 1969-11-13 Boerge Martins Drehbares Geraet
US4171662A (en) * 1976-12-20 1979-10-23 Wright Line Inc. Security screw
ES283078Y (es) * 1984-11-30 1985-12-16 Otero Vich Jose M. Inserto oseo para artrodesis intersomatica cervical
EP0625887B1 (fr) * 1992-02-14 1998-10-14 Smith & Nephew, Inc. Vis et revetements polymeres a usage chirurgical
ES2124288T3 (es) * 1992-11-25 1999-02-01 Codman & Shurtleff Sistema de placas para osteosintesis.
US5423826A (en) * 1993-02-05 1995-06-13 Danek Medical, Inc. Anterior cervical plate holder/drill guide and method of use
US5507813A (en) * 1993-12-09 1996-04-16 Osteotech, Inc. Shaped materials derived from elongate bone particles
US6045554A (en) * 1996-07-16 2000-04-04 University Of Florida Tissue Bank, Inc. Cortical bone interference screw

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8961571B2 (en) 2007-11-19 2015-02-24 David Lee Method and apparatus for spinal facet joint fusion using irregularly shaped cortical bone implants
CN102895024A (zh) * 2012-10-31 2013-01-30 刘畅 同种异体皮质骨横穿钉
CN103006309A (zh) * 2012-12-28 2013-04-03 刘畅 同种异体皮质骨横穿钉

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WO2001080753A3 (fr) 2002-04-04
AU2001255530A1 (en) 2001-11-07

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