US20140277183A1 - Fixation of orthopaedic devices - Google Patents
Fixation of orthopaedic devices Download PDFInfo
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- US20140277183A1 US20140277183A1 US14/204,129 US201414204129A US2014277183A1 US 20140277183 A1 US20140277183 A1 US 20140277183A1 US 201414204129 A US201414204129 A US 201414204129A US 2014277183 A1 US2014277183 A1 US 2014277183A1
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- fixation material
- orthopaedic implant
- base device
- bone
- adhesive force
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- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/146—Porous materials, e.g. foams or sponges
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- 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
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
- A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
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- A—HUMAN NECESSITIES
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8028—Cushions, i.e. elements forming interface between bone plate and bone
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, 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
- A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
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- 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
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, 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
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/41—Anti-inflammatory agents, e.g. NSAIDs
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/412—Tissue-regenerating or healing or proliferative agents
- A61L2300/414—Growth factors
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- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
Definitions
- the present invention relates to orthopaedic devices, and more particularly, to orthopaedic implants.
- Orthopaedic implants are known that are implanted into the body to achieve various surgical objectives. Such implants include bone pins, bone screws and bone plates.
- the implantation period of the implant can vary from a short period, such as a couple of days, to the end of a patient's life. During the implantation period, the implant will experience natural forces caused by surrounding anatomy structures due to static and dynamic conditions of the anatomy structures. These natural forces can cause the implant to either loosen from the implantation site or, worse, ultimately detach from the implant site.
- the implant is usually fixated to the implantation site by bone screws, which must be screwed into the implantation site.
- the implant can also be bonded to the implantation site with an adhesive, such as bone cement, or materials can be attached to the implant that encourage natural ingrowth of tissue onto or into the implant. Natural tissue ingrowth will help to fixate the implant in place and can form a strong bond with the implant.
- a similar problem can occur with devices that are meant to be temporary, i.e., have a relatively short implantation period.
- the device can become too integrated with the body and become very difficult to remove, which can lead to trauma at the implantation site during removal.
- the present invention provides an orthopaedic implant with a fixation material attached to the implant that is configured to provide a minimally sufficient adhesive force to resist natural pull out of the implant caused by forces acting on the implant during implantation and bone ingrowth.
- the invention in one form is directed to an orthopaedic implant including a base device with a device surface and a fixation material attached to the base device.
- the fixation material is attached to at least one portion of the device surface and is configured to provide a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth
- the invention in another form is directed to a method of manufacturing an orthopaedic implant.
- the method includes providing a base device that has a surface area and determining a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth.
- a proper amount of a fixation material sufficient to provide an adhesive force equal to the determined minimally sufficient adhesive force is determined and the fixation material is applied to the device surface.
- the fixation material is stopped.
- the invention in yet another form is directed to a method of performing an orthopaedic surgery.
- the method includes providing an orthopaedic implant having a device surface and a fixation material attached to the device surface.
- the fixation material is configured to provide a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth.
- the orthopaedic implant is implanted at an implantation site within a patient.
- the implantation of the orthopaedic implant is revised by applying a revisionary force to the orthopaedic implant that is slightly greater than the minimally sufficient adhesive force.
- An advantage of the present invention is that it provides an orthopaedic implant that can withstand natural pull out forces when implanted within a patient while not requiring excessive force to remove, if necessary.
- FIG. 1 is a perspective view of an embodiment of an orthopaedic implant of the present invention
- FIG. 2 is another perspective view of the orthopaedic implant shown in FIG. 1 ;
- FIG. 3 is a cross-sectional view of the orthopaedic implant shown in FIG. 2 along line A-A;
- FIG. 4 is a perspective view of another embodiment of an orthopaedic implant of the present invention.
- FIG. 5 is a cross-sectional view of the orthopaedic implant shown in FIG. 4 along line A-A;
- FIG. 6 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 7 is a sectional view of the orthopaedic implant shown in FIG. 6 ;
- FIG. 8 is a sectional view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 9 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 10 is a sectional view of the orthopaedic implant shown in FIG. 9 ;
- FIG. 11 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 12 is a sectional view of the orthopaedic implant shown in FIG. 11 ;
- FIG. 13 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 14 is a sectional view of the orthopaedic implant shown in FIG. 13 ;
- FIG. 15 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 16 is a sectional view of the orthopaedic implant shown in FIG. 15 ;
- FIG. 17 is a before and after exploded view of forming yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 18 is another before and after exploded view of forming yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 19 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 20 is another perspective view of the orthopaedic implant shown in FIG. 19 ;
- FIG. 21 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 22 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- FIG. 23 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention.
- an orthopaedic implant 30 which generally includes a base device 32 and a fixation material 34 attached to the base device 32 .
- the base device 32 shown is a bone pin that can reside within a patient for a short period of time.
- the base device 32 can be constructed of metals commonly used in orthopaedic implants such as titanium, cobalt chrome and stainless steel.
- the base device can be constructed of biocompatible polymers such as polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyethylene (PE) and blends thereof.
- the fixation material 34 attached to the base device 32 is shaped as a thin band wrapped around the circumference of the base device 32 .
- the fixation material 34 can be a porous polymer or metal that has a roughened surface 36 to provide immediate fixation of the device 30 due to frictional forces and to encourage quick tissue ingrowth into the fixation material 34 .
- the roughened surface 36 can have customized surface properties for a specific tissue type and desired tissue ingrowth amount or rate. Such surface properties can include a surface energy density, wettability and electrostatic charge.
- Polymers and metals that can act as the fixation material 34 include PEEK, PLA, PGA, PE, titanium, cobalt chrome and stainless steel.
- Pores 38 of the fixation material 34 can be sized to allow or prevent ingrowth of tissue into the fixation material 34 . Additionally, biologically active substances can be included in the pores 38 to encourage or limit tissue ingrowth into the fixation material 34 , as well as provide other useful properties such as antimicrobial activity to reduce the risk of infection.
- the orthopaedic implant 30 is a small diameter bone pin that will likely be removed within a few weeks of implantation, a strong interface between surrounding tissue and the orthopaedic implant 30 is undesirable as it will cause removal of the orthopaedic implant 30 to be unnecessarily difficult.
- a relatively small band of fixation material 34 is necessary to provide a minimally sufficient adhesive force that will resist pull out of the orthopaedic implant 30 while it is implanted in a patient while not causing excessive adhesive force that could make the device 30 difficult to remove.
- the fixation material 34 has a relatively low thickness T (0.010′′) and a width W (“0.050”) significantly greater than the thickness T.
- a thickness T range of about 0.005′′ to 0.015′′ and a width W range of about 0.020′′ to 0.125′′ can be appropriate dimensions for the fixation material 34 shaped as a band to provide the minimally sufficient adhesive force. It is also contemplated that there can be multiple fixation materials attached to the base device 32 , which would alter the dimensions of each fixation material region. An additional design consideration when shaping and placing the fixation material 34 on a small diameter pin is that the pin won't provide much leverage to apply torque and overcome the adhesive force provided by the fixation material 34 .
- an orthopaedic implant 40 which includes a base device 42 , shown here as a large diameter pin, with a fixation material 44 attached to the pin 42 .
- the fixation material 44 can be the same as the fixation material 34 described previously.
- the fixation material 44 can be shaped as a band around the circumference of the pin 42 , similar to the previously described small diameter pin 32 .
- the band of fixation material 44 can have a thickness T ranging from about 0.015′′ to 0.050′′ and a width W ranging from about 0.020′′ to 0.125′′.
- the pin 42 can also have a groove 46 formed on the outer surface 48 of the pin 42 where the fixation material 44 attaches to the pin 42 .
- the groove 46 can have a varying depth that changes how proud an outer surface 50 of the fixation material 44 is relative to the outer surface 48 of the pin 42 .
- the fixation material 44 has a thickness T of 0.020′′, but the outer surface 50 only elevates 0.010′′ relative to the outer surface 48 of the pin 42 .
- Having the groove 46 in the pin 42 allows for a thicker fixation material 44 , which will increase the potential bone ingrowth and adhesive force, with a smaller increase in the overall diameter of the device 40 .
- the groove 46 also provides more surface area of the pin 42 to utilize for attachment to the fixation material 44 .
- a large diameter pin can have a larger minimally sufficient adhesive force but still be easily removed because the large diameter pin 42 provides more leverage to apply torque and overcome the adhesive force provided by the fixation material 44 .
- an orthopaedic implant 60 which includes a base device 62 , shown as a bone screw, and a fixation material 64 attached to the bone screw 62 .
- the bone screw 62 can be constructed of biocompatible metals and polymers, similar to previously described base devices, and the fixation material 64 can be made of a material similar to that of previously described fixation materials.
- the bone screw 62 has a head end 66 , a distal end 68 and a plurality of threads 70 formed on a surface 72 of the bone screw 62 .
- the fixation material 64 forms a small patch on the distal end 68 of the bone screw 62 .
- the threads 70 of the bone screw 62 will provide some adhesive force to keep the bone screw 62 in place during implantation, so the fixation material patch 64 acts to provide additional adhesive force at the distal end 68 , if necessary, to resist natural pull out of the bone screw 62 .
- an orthopaedic implant 80 which includes a bone screw 62 similar to that shown in FIGS. 6 and 7 having a fixation material 82 attached to the distal end 68 of the bone screw 62 .
- the fixation material 82 can be formed from any fixation material previously described.
- the fixation material 82 is formed as a “dot” of material on the distal end 68 of the bone screw 62 to provide additional adhesive force to the bone screw 62 .
- an orthopaedic implant 90 which includes a bone screw 92 similar to that shown in FIGS. 6 , 7 and 8 having a fixation material 94 attached to a surface 96 of the bone screw 92 between threads 98 formed on the surface 96 of the bone screw 92 .
- the fixation material 94 can be formed from any fixation material previously described.
- the fixation material 94 has a helical shape that wraps around the circumference of the bone screw 92 between the threads 98 . In this configuration, the fixation material 94 provides a substantial amount of adhesive force to resist natural pull out of the device 90 .
- Such a configuration may be desirable for bone screws that are intended to have a longer implantation period, where additional fixation of the bone screw is desirable.
- an orthopaedic implant 100 which includes a bone screw 101 similar to that shown in FIGS. 6 , 7 , 8 and 9 having a fixation material 102 attached near a distal end 103 of the bone screw 101 between the distal end 103 and threads 104 and 106 .
- the fixation material 102 can be formed from any fixation material previously described. This configuration allows for the fixation material 102 to provide less fixation force than orthopaedic implant 90 , previously described. Such a configuration is better suited for bone screws that are intended to have shorter implantation periods, where too much additional fixation of the bone screw would make removal unnecessarily difficult.
- an orthopaedic implant 110 which includes a base device 112 , shown as a bone screw, with holes 114 formed through a surface 116 of the bone screw 112 between threads 118 .
- the holes 114 are located axially in valleys 120 between the threads 118 and go through to the centerline of the screw 112 .
- the holes 114 can be placed along the full length of the screw 112 .
- the screw 112 is a cannulated screw having an inner chamber 120 that has a fixation material 122 bonded inside the inner chamber 120 .
- FIGS. 15 and 16 show a similar embodiment, with fewer holes 114 formed through the bone screw 112 and the holes 114 being concentrated near a distal end 126 of the bone screw 112 .
- a base device 130 is shown before and after being prepared into an orthopaedic implant 132 of the present invention.
- the base device 130 is a screw blank that has had elongated pockets 134 machined within. These elongated pockets 134 are filled with a fixation material 136 , which can be any fixation material previously described. Following filling of the elongated pockets 134 with the fixation material 136 , threads 138 can be cut into the base device 130 and fixation material 136 to form the completed orthopaedic implant 132 .
- the threads 138 will be composed of approximately half fixation material 136 and half material of the base device 130 , giving the orthopaedic implant 132 a substantial amount of fixation material 136 to provide adhesive force during implantation and also placing the fixation material 136 into intimate contact with surrounding anatomy structures during implantation.
- Such a configuration can be particularly useful when the orthopaedic implant 132 is intended to be a long-term implant.
- the base device 140 is shown before and after being prepared into an orthopaedic implant 142 .
- the base device 140 is a screw blank with a minor diameter d1 between a head end 144 and a distal end 146 .
- a fixation material 148 which can be any fixation material previously described, is bonded to a section of the base device 140 having minor diameter d1 to create a diameter d2 similar to that of the head end 146 and distal end 148 . Threads 150 are then formed into the fixation material 148 to create the completed orthopaedic implant 142 .
- an orthopaedic implant 160 that includes a base device 162 , shown as a bone plate, and a fixation material 164 attached to the bone plate 162 .
- the bone plate 162 has a bare surface 166 and multiple openings 168 that are sized to allow bone screws (not shown) to be passed through.
- the openings 168 are shaped so that when the bone screws are driven into a bone, they will hold the bone plate 162 in place.
- the bone plate 162 can be made of biocompatible metals such as titanium, cobalt chrome and stainless steel, but can also be made of a biocompatible polymer such as PEEK.
- a polymer bone plate 162 could offer advantages over more common metal bone plates, such as higher compression and adjustable stiffening.
- the fixation material 164 is attached to a bottom surface (not shown) that is opposed to the bare surface 166 and will be in contact with the bone during implantation.
- the fixation material 164 can be any fixation material previously described.
- the fixation material 164 forms a layer on the bottom surface of the bone plate 162 . Since bone screws will be going through the openings 168 , the fixation material 164 does not cover the openings 168 . If the bone plate 162 had a bare bottom surface, the only fixation that the bone plate 162 would have when implanted would be provided by friction from the bone screws implanted in the bone.
- the bone plate 162 By attaching the fixation material 164 to the bottom surface of the bone plate 162 , the bone plate 162 is provided with adhesive force of its own: initially from the roughness of the fixation material and later from bone ingrowth into the fixation material 164 .
- the fixation material 164 is shown covering the entire bottom surface of the bone plate 162 , the amount of fixation material 164 could be altered to provide a desired amount of adhesive force to the bone plate.
- an orthopaedic implant 170 that includes the bone plate 162 of FIGS. 19 and 20 with a fixation material 172 attached at one end 174 of the bone plate 162 .
- the fixation material 172 is shaped as a patch and can be any fixation material previously described. By attaching the fixation material 172 to only one end 174 of the bone plate 162 , bone ingrowth and fixation will only occur at the end 174 of the plate with the fixation material 172 , allowing an opposite end 176 to float to whatever degree the attached bone screws allow. Such a configuration allows for a dynamic bone plate 170 .
- an orthopaedic implant 180 that includes the bone plate 162 of FIGS. 19 , 20 and 21 with two regions of a fixation material 182 attached at both ends 184 , 186 of the bone plate 162 .
- the regions of fixation material 182 are shaped as dots of material and can be any fixation material previously described. Attaching the fixation material 182 to both ends 184 , 186 of the bone plate 162 provides bone ingrowth, and therefore fixation, at both ends 184 , 186 of the bone plate 162 .
- an orthopaedic implant 190 is shown that includes the bone plate 162 of FIGS. 19 , 20 , 21 and 22 with three regions of a fixation material 192 surrounding the openings 168 of the bone plate 162 .
- the fixation material 192 can be any fixation material previously described. Bone ingrowth into the fixation material 192 around the openings 168 provide additional fixation to the bone plate 162 in those regions. Such a configuration could be desirable if the bone screws are to be removed after implantation or do not provide enough fixation of the bone plate 162 on their own.
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Abstract
Description
- This is a non-provisional application based upon U.S. provisional patent application Ser. No. 61/787,507, entitled “FIXATION OF ORTHOPAEDIC DEVICES”, filed Mar. 15, 2013, which is incorporated herein by reference.
- 1. Field of the Invention
- The present invention relates to orthopaedic devices, and more particularly, to orthopaedic implants.
- 2. Description of the Related Art
- Orthopaedic implants are known that are implanted into the body to achieve various surgical objectives. Such implants include bone pins, bone screws and bone plates. The implantation period of the implant can vary from a short period, such as a couple of days, to the end of a patient's life. During the implantation period, the implant will experience natural forces caused by surrounding anatomy structures due to static and dynamic conditions of the anatomy structures. These natural forces can cause the implant to either loosen from the implantation site or, worse, ultimately detach from the implant site.
- To prevent the loosening and detachment of an orthopaedic implant from its implantation site, the implant is usually fixated to the implantation site by bone screws, which must be screwed into the implantation site. The implant can also be bonded to the implantation site with an adhesive, such as bone cement, or materials can be attached to the implant that encourage natural ingrowth of tissue onto or into the implant. Natural tissue ingrowth will help to fixate the implant in place and can form a strong bond with the implant.
- One problem that arises with implanted devices is that there is a risk that a revision surgery, to remove the implant, may be required due to reasons such as an incorrect placement, an unforeseen event or an infection causing the implant to prematurely fail. In such cases, removing the implant can be a traumatic event for anatomy structures around the site if a lot of force is required to loosen the implant and remove it.
- A similar problem can occur with devices that are meant to be temporary, i.e., have a relatively short implantation period. The device can become too integrated with the body and become very difficult to remove, which can lead to trauma at the implantation site during removal.
- What is needed in the art is an orthopaedic implant that can resist natural pull out but does not require excessive force to remove.
- The present invention provides an orthopaedic implant with a fixation material attached to the implant that is configured to provide a minimally sufficient adhesive force to resist natural pull out of the implant caused by forces acting on the implant during implantation and bone ingrowth.
- The invention in one form is directed to an orthopaedic implant including a base device with a device surface and a fixation material attached to the base device. The fixation material is attached to at least one portion of the device surface and is configured to provide a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth
- The invention in another form is directed to a method of manufacturing an orthopaedic implant. The method includes providing a base device that has a surface area and determining a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth. A proper amount of a fixation material sufficient to provide an adhesive force equal to the determined minimally sufficient adhesive force is determined and the fixation material is applied to the device surface. When the proper amount of the fixation material is applied to the device surface, application of the fixation material is stopped.
- The invention in yet another form is directed to a method of performing an orthopaedic surgery. The method includes providing an orthopaedic implant having a device surface and a fixation material attached to the device surface. The fixation material is configured to provide a minimally sufficient adhesive force to resist natural pull out caused by forces acting on the base device after implantation and bone ingrowth. The orthopaedic implant is implanted at an implantation site within a patient. The implantation of the orthopaedic implant is revised by applying a revisionary force to the orthopaedic implant that is slightly greater than the minimally sufficient adhesive force.
- An advantage of the present invention is that it provides an orthopaedic implant that can withstand natural pull out forces when implanted within a patient while not requiring excessive force to remove, if necessary.
- The above-mentioned and other features and advantages of this invention, and the manner of attaining them, will become more apparent and the invention will be better understood by reference to the following description of embodiments of the invention taken in conjunction with the accompanying drawings, wherein:
-
FIG. 1 is a perspective view of an embodiment of an orthopaedic implant of the present invention; -
FIG. 2 is another perspective view of the orthopaedic implant shown inFIG. 1 ; -
FIG. 3 is a cross-sectional view of the orthopaedic implant shown inFIG. 2 along line A-A; -
FIG. 4 is a perspective view of another embodiment of an orthopaedic implant of the present invention; -
FIG. 5 is a cross-sectional view of the orthopaedic implant shown inFIG. 4 along line A-A; -
FIG. 6 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 7 is a sectional view of the orthopaedic implant shown inFIG. 6 ; -
FIG. 8 is a sectional view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 9 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 10 is a sectional view of the orthopaedic implant shown inFIG. 9 ; -
FIG. 11 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 12 is a sectional view of the orthopaedic implant shown inFIG. 11 ; -
FIG. 13 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 14 is a sectional view of the orthopaedic implant shown inFIG. 13 ; -
FIG. 15 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 16 is a sectional view of the orthopaedic implant shown inFIG. 15 ; -
FIG. 17 is a before and after exploded view of forming yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 18 is another before and after exploded view of forming yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 19 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 20 is another perspective view of the orthopaedic implant shown inFIG. 19 ; -
FIG. 21 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; -
FIG. 22 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention; and -
FIG. 23 is a perspective view of yet another embodiment of an orthopaedic implant of the present invention. - Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate embodiments of the invention and such exemplification are not to be construed as limiting the scope of the invention in any manner.
- Referring now to the drawings, and more particularly to
FIG. 1 , there is shown anorthopaedic implant 30 which generally includes abase device 32 and afixation material 34 attached to thebase device 32. Thebase device 32 shown is a bone pin that can reside within a patient for a short period of time. Thebase device 32 can be constructed of metals commonly used in orthopaedic implants such as titanium, cobalt chrome and stainless steel. Alternatively, the base device can be constructed of biocompatible polymers such as polyether ether ketone (PEEK), polylactic acid (PLA), polyglycolic acid (PGA), polyethylene (PE) and blends thereof. - The
fixation material 34 attached to thebase device 32 is shaped as a thin band wrapped around the circumference of thebase device 32. Thefixation material 34 can be a porous polymer or metal that has a roughenedsurface 36 to provide immediate fixation of thedevice 30 due to frictional forces and to encourage quick tissue ingrowth into thefixation material 34. The roughenedsurface 36 can have customized surface properties for a specific tissue type and desired tissue ingrowth amount or rate. Such surface properties can include a surface energy density, wettability and electrostatic charge. Polymers and metals that can act as thefixation material 34 include PEEK, PLA, PGA, PE, titanium, cobalt chrome and stainless steel.Pores 38 of thefixation material 34 can be sized to allow or prevent ingrowth of tissue into thefixation material 34. Additionally, biologically active substances can be included in thepores 38 to encourage or limit tissue ingrowth into thefixation material 34, as well as provide other useful properties such as antimicrobial activity to reduce the risk of infection. - As the
orthopaedic implant 30 is a small diameter bone pin that will likely be removed within a few weeks of implantation, a strong interface between surrounding tissue and theorthopaedic implant 30 is undesirable as it will cause removal of theorthopaedic implant 30 to be unnecessarily difficult. As can be seen inFIGS. 2 and 3 , only a relatively small band offixation material 34 is necessary to provide a minimally sufficient adhesive force that will resist pull out of theorthopaedic implant 30 while it is implanted in a patient while not causing excessive adhesive force that could make thedevice 30 difficult to remove. As shown inFIG. 3 , thefixation material 34 has a relatively low thickness T (0.010″) and a width W (“0.050”) significantly greater than the thickness T. For theorthopaedic device 30 shown, a thickness T range of about 0.005″ to 0.015″ and a width W range of about 0.020″ to 0.125″ can be appropriate dimensions for thefixation material 34 shaped as a band to provide the minimally sufficient adhesive force. It is also contemplated that there can be multiple fixation materials attached to thebase device 32, which would alter the dimensions of each fixation material region. An additional design consideration when shaping and placing thefixation material 34 on a small diameter pin is that the pin won't provide much leverage to apply torque and overcome the adhesive force provided by thefixation material 34. - Referring now to
FIGS. 4 and 5 , anorthopaedic implant 40 is shown which includes abase device 42, shown here as a large diameter pin, with afixation material 44 attached to thepin 42. Thefixation material 44 can be the same as thefixation material 34 described previously. When utilizing alarge diameter pin 42, the amount and geometry of thefixation material 44 will need to be changed to provide a minimally sufficient adhesive force that will resist natural pull out of thepin 42, due to increased size of thepin 42. As shown inFIGS. 4 and 5 , thefixation material 44 can be shaped as a band around the circumference of thepin 42, similar to the previously describedsmall diameter pin 32. The band offixation material 44 can have a thickness T ranging from about 0.015″ to 0.050″ and a width W ranging from about 0.020″ to 0.125″. As can be seen inFIG. 5 , thepin 42 can also have agroove 46 formed on theouter surface 48 of thepin 42 where thefixation material 44 attaches to thepin 42. Thegroove 46 can have a varying depth that changes how proud anouter surface 50 of thefixation material 44 is relative to theouter surface 48 of thepin 42. As seen inFIG. 5 , thefixation material 44 has a thickness T of 0.020″, but theouter surface 50 only elevates 0.010″ relative to theouter surface 48 of thepin 42. Having thegroove 46 in thepin 42 allows for athicker fixation material 44, which will increase the potential bone ingrowth and adhesive force, with a smaller increase in the overall diameter of thedevice 40. Thegroove 46 also provides more surface area of thepin 42 to utilize for attachment to thefixation material 44. As opposed to a small diameter pin, a large diameter pin can have a larger minimally sufficient adhesive force but still be easily removed because thelarge diameter pin 42 provides more leverage to apply torque and overcome the adhesive force provided by thefixation material 44. - Referring now to
FIGS. 6 and 7 , anorthopaedic implant 60 is shown which includes abase device 62, shown as a bone screw, and afixation material 64 attached to thebone screw 62. Thebone screw 62 can be constructed of biocompatible metals and polymers, similar to previously described base devices, and thefixation material 64 can be made of a material similar to that of previously described fixation materials. Thebone screw 62 has ahead end 66, adistal end 68 and a plurality ofthreads 70 formed on asurface 72 of thebone screw 62. Thefixation material 64 forms a small patch on thedistal end 68 of thebone screw 62. Thethreads 70 of thebone screw 62 will provide some adhesive force to keep thebone screw 62 in place during implantation, so thefixation material patch 64 acts to provide additional adhesive force at thedistal end 68, if necessary, to resist natural pull out of thebone screw 62. - Referring now to
FIG. 8 , anorthopaedic implant 80 is shown which includes abone screw 62 similar to that shown inFIGS. 6 and 7 having afixation material 82 attached to thedistal end 68 of thebone screw 62. Thefixation material 82 can be formed from any fixation material previously described. In this embodiment, thefixation material 82 is formed as a “dot” of material on thedistal end 68 of thebone screw 62 to provide additional adhesive force to thebone screw 62. - Referring now to
FIGS. 9 and 10 , anorthopaedic implant 90 is shown which includes abone screw 92 similar to that shown inFIGS. 6 , 7 and 8 having afixation material 94 attached to asurface 96 of thebone screw 92 betweenthreads 98 formed on thesurface 96 of thebone screw 92. Thefixation material 94 can be formed from any fixation material previously described. As can be seen, thefixation material 94 has a helical shape that wraps around the circumference of thebone screw 92 between thethreads 98. In this configuration, thefixation material 94 provides a substantial amount of adhesive force to resist natural pull out of thedevice 90. Such a configuration may be desirable for bone screws that are intended to have a longer implantation period, where additional fixation of the bone screw is desirable. - Referring now to
FIGS. 11 and 12 , anorthopaedic implant 100 is shown which includes abone screw 101 similar to that shown inFIGS. 6 , 7, 8 and 9 having afixation material 102 attached near adistal end 103 of thebone screw 101 between thedistal end 103 andthreads fixation material 102 can be formed from any fixation material previously described. This configuration allows for thefixation material 102 to provide less fixation force thanorthopaedic implant 90, previously described. Such a configuration is better suited for bone screws that are intended to have shorter implantation periods, where too much additional fixation of the bone screw would make removal unnecessarily difficult. - Referring now to
FIGS. 13 and 14 , anorthopaedic implant 110 is shown which includes abase device 112, shown as a bone screw, withholes 114 formed through asurface 116 of thebone screw 112 betweenthreads 118. Theholes 114 are located axially invalleys 120 between thethreads 118 and go through to the centerline of thescrew 112. Theholes 114 can be placed along the full length of thescrew 112. Thescrew 112 is a cannulated screw having aninner chamber 120 that has afixation material 122 bonded inside theinner chamber 120. By havingholes 114 and thefixation material 122 inside theinner chamber 120, tissue will be chemoattracted to thefixation material 122 and fill in theholes 114, forming a strong interface with theorthopaedic implant 110. A wall thickness (not shown) between the minor diameter of thebone screw 112 and the inner wall of theinner chamber 120 should be in a range of approximately 1 mm to 1.5 mm. Studies have shown that bone will bridge a gap of approximately 1 mm to 1.5 mm to grow into a porous material, such as thefixation material 122.FIGS. 15 and 16 show a similar embodiment, withfewer holes 114 formed through thebone screw 112 and theholes 114 being concentrated near adistal end 126 of thebone screw 112. - Referring now to
FIG. 17 , abase device 130 is shown before and after being prepared into anorthopaedic implant 132 of the present invention. As can be seen, thebase device 130 is a screw blank that has had elongatedpockets 134 machined within. Theseelongated pockets 134 are filled with afixation material 136, which can be any fixation material previously described. Following filling of theelongated pockets 134 with thefixation material 136,threads 138 can be cut into thebase device 130 andfixation material 136 to form the completedorthopaedic implant 132. In this configuration, thethreads 138 will be composed of approximatelyhalf fixation material 136 and half material of thebase device 130, giving the orthopaedic implant 132 a substantial amount offixation material 136 to provide adhesive force during implantation and also placing thefixation material 136 into intimate contact with surrounding anatomy structures during implantation. Such a configuration can be particularly useful when theorthopaedic implant 132 is intended to be a long-term implant. - Referring now to
FIG. 18 , abase device 140 is shown before and after being prepared into anorthopaedic implant 142. Thebase device 140 is a screw blank with a minor diameter d1 between ahead end 144 and adistal end 146. Afixation material 148, which can be any fixation material previously described, is bonded to a section of thebase device 140 having minor diameter d1 to create a diameter d2 similar to that of thehead end 146 anddistal end 148.Threads 150 are then formed into thefixation material 148 to create the completedorthopaedic implant 142. - Referring now to
FIGS. 19 and 20 , anorthopaedic implant 160 is shown that includes abase device 162, shown as a bone plate, and afixation material 164 attached to thebone plate 162. Thebone plate 162 has abare surface 166 andmultiple openings 168 that are sized to allow bone screws (not shown) to be passed through. Theopenings 168 are shaped so that when the bone screws are driven into a bone, they will hold thebone plate 162 in place. Thebone plate 162 can be made of biocompatible metals such as titanium, cobalt chrome and stainless steel, but can also be made of a biocompatible polymer such as PEEK. Apolymer bone plate 162 could offer advantages over more common metal bone plates, such as higher compression and adjustable stiffening. Thefixation material 164 is attached to a bottom surface (not shown) that is opposed to thebare surface 166 and will be in contact with the bone during implantation. Thefixation material 164 can be any fixation material previously described. In this embodiment, thefixation material 164 forms a layer on the bottom surface of thebone plate 162. Since bone screws will be going through theopenings 168, thefixation material 164 does not cover theopenings 168. If thebone plate 162 had a bare bottom surface, the only fixation that thebone plate 162 would have when implanted would be provided by friction from the bone screws implanted in the bone. By attaching thefixation material 164 to the bottom surface of thebone plate 162, thebone plate 162 is provided with adhesive force of its own: initially from the roughness of the fixation material and later from bone ingrowth into thefixation material 164. Although thefixation material 164 is shown covering the entire bottom surface of thebone plate 162, the amount offixation material 164 could be altered to provide a desired amount of adhesive force to the bone plate. - Referring now to
FIG. 21 , anorthopaedic implant 170 is shown that includes thebone plate 162 ofFIGS. 19 and 20 with afixation material 172 attached at oneend 174 of thebone plate 162. Thefixation material 172 is shaped as a patch and can be any fixation material previously described. By attaching thefixation material 172 to only oneend 174 of thebone plate 162, bone ingrowth and fixation will only occur at theend 174 of the plate with thefixation material 172, allowing anopposite end 176 to float to whatever degree the attached bone screws allow. Such a configuration allows for adynamic bone plate 170. - Referring now to
FIG. 22 , anorthopaedic implant 180 is shown that includes thebone plate 162 ofFIGS. 19 , 20 and 21 with two regions of afixation material 182 attached at both ends 184, 186 of thebone plate 162. The regions offixation material 182 are shaped as dots of material and can be any fixation material previously described. Attaching thefixation material 182 to both ends 184, 186 of thebone plate 162 provides bone ingrowth, and therefore fixation, at both ends 184, 186 of thebone plate 162. - Referring now to
FIG. 23 , anorthopaedic implant 190 is shown that includes thebone plate 162 ofFIGS. 19 , 20, 21 and 22 with three regions of afixation material 192 surrounding theopenings 168 of thebone plate 162. Thefixation material 192 can be any fixation material previously described. Bone ingrowth into thefixation material 192 around theopenings 168 provide additional fixation to thebone plate 162 in those regions. Such a configuration could be desirable if the bone screws are to be removed after implantation or do not provide enough fixation of thebone plate 162 on their own. - While this invention has been described with respect to at least one embodiment, the present invention can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.
Claims (20)
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JP2018075875A JP2018149309A (en) | 2013-03-15 | 2018-04-11 | Orthopedic implant and its manufacturing method |
US16/511,175 US20190336656A1 (en) | 2013-03-15 | 2019-07-15 | Fixation of orthopaedic devices |
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CA2896778C (en) | 2022-03-01 |
US20170252492A1 (en) | 2017-09-07 |
EP2967676A1 (en) | 2016-01-20 |
US10350332B2 (en) | 2019-07-16 |
JP2016513535A (en) | 2016-05-16 |
EP2967676A4 (en) | 2016-11-16 |
US20190336656A1 (en) | 2019-11-07 |
JP2018149309A (en) | 2018-09-27 |
ES2749121T3 (en) | 2020-03-19 |
EP2967676B1 (en) | 2019-09-18 |
CA2896778A1 (en) | 2014-09-25 |
WO2014150904A1 (en) | 2014-09-25 |
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