US20170172635A1 - Orthopedic Fixation Screw With Bioresorbable Layer - Google Patents
Orthopedic Fixation Screw With Bioresorbable Layer Download PDFInfo
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- US20170172635A1 US20170172635A1 US15/451,521 US201715451521A US2017172635A1 US 20170172635 A1 US20170172635 A1 US 20170172635A1 US 201715451521 A US201715451521 A US 201715451521A US 2017172635 A1 US2017172635 A1 US 2017172635A1
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- screw
- bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8033—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/74—Devices for the head or neck or trochanter of the femur
- A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
- A61B17/746—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to a plate opposite the femoral head
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8605—Heads, i.e. proximal ends projecting from bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/866—Material or manufacture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
- A61B17/8033—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
- A61B17/8047—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers wherein the additional element surrounds the screw head in the plate hole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/864—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, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
Definitions
- This invention relates to screws used with fixation devices for the treatment of bone fractures using flexible and rigid osteosythesis.
- Conventional bone plates and screws may be used for treating fractures involving severely comminuted bone or missing bone segments.
- These conventional systems may also be described as “flexible osteosynthesis” or “biological osteosynthesis” and are particularly well-suited to promoting healing of the fracture by compressing the fracture ends together and drawing the bone into close apposition with other fragments and the bone plate. They are particularly useful in the treatment of comminuted fractures in the diaphyseal region of bones or in regions with severe segmental bone loss. In the case of these fractures, it is imperative to maintain proper bone length while correcting fracture fragments for proper anatomic alignment. With flexible osteosynthesis, the fracture zone is not directly affixed or manipulated, and consequently, the blood circulation in this area is not inhibited.
- Bone plates designed for flexible osteosynthesis thus operate similarly to a locking, intramedullary nail, which is anchored only in the metaphyses.
- Flexible osteosynthesis repair constructs allow for micromotion across the fracture site stimulating callous formation. Since the angular relationships between the plate and screws are not fixed, they can change postoperatively, leading to mal-alignment and poor clinical results.
- the primary mechanism for the change in angular relationship is related to energy storage. Threading a bone screw into bone compresses the bone against the plate. The compression results in high strain in the bone, and, consequently, energy storage. With the dynamic loading resulting from physiological conditions, loosening of the plate and screw and loss of the stored energy can result.
- non-locking screws Conventional bone screws, i.e. screws that are not secured to a plate so that a fixed angular relationship between the plate and screw is maintained (hereinafter “non-locking screws”) effectively compress bone fragments, but possess a low resistance to shear force that can lead to loosening of the screw.
- locking screws have a limited capability to compress bone fragments. Additionally, locking screws hold the construct in such a rigid position that micromotion across the fracture site may be impeded thereby inhibiting callous formation. Though used successfully for certain fractures, rigid osteosynthesis has been shown to promote the occurrence of non-unions at the fracture site.
- a locking screw has threading on an outer surface of its head that mates with corresponding threading on the surface of a plate hole to lock the screw to the plate.
- Bone plates having threaded holes for accommodating locking screws are known.
- German Patent Application No. 43 43 117 discloses a bone plate with threaded holes for locking screws. Locking screws have a high resistance to shear force that ensure stability at the bone screw/plate hole interface, but possess a limited ability to compress bone fragments.
- the surgeon is thus enabled to expose the fracture site to a period of stability followed by controlled micromotion thus stimulating bony healing.
- the invention concerns an orthopedic fixation device for connecting a first bone portion to a second bone portion.
- the device comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a screw is insertable though at least one of the holes extending through the body.
- the screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft.
- a head is attached to the proximal end of the shaft.
- a layer of bioresorbable material is positioned surrounding a second portion of the shaft, either adjacent to the head or in spaced relation to the head.
- the layer of bioresorbable material has an outer surface engageable with the body to initially fix the screw at a desired angular position relatively to the body.
- the screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- an orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a layer of bioresorbable material is positioned on the body within at least one of the holes.
- a screw is insertable though the at least one hole.
- the screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft.
- a head is attached to the proximal end of the shaft.
- a second portion of the shaft, adjacent to the head, or in spaced relation to the head, is engageable with the bioresorbable layer to initially fix the screw at a desired angular position relatively to the body.
- the screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- the device comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a screw is insertable though at least one of the holes extending through the body.
- the screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extending along at least a first portion of the shaft.
- a head is attached to the proximal end of the shaft.
- the head has a surface portion contiguous with the proximal end of the shaft.
- a layer of bioresorbable material is positioned on the surface portion of the head contiguous with the proximal end of the shaft.
- the layer of bioresorbable material has an outer surface engageable with the body to initially fix the screw at a desired angular position relatively to the body.
- the screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- the device comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a layer of bioresorbable material is positioned on the body within at least one of the holes.
- a screw is insertable though the at least one hole.
- the screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft.
- a head is attached to the proximal end of the shaft. The head has a surface portion contiguous with the proximal end of the shaft.
- the surface portion contiguous with the proximal end of the shaft is engageable with the bioresorbable layer to initially fix the screw at a desired angular position relatively to the body.
- the screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- Another orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body having a bone contacting surface and an obverse surface arranged opposite to the bone contacting surface.
- a side surface extends between the bone contacting surface and the obverse surface.
- a plurality of holes extending through the body. At least one channel is positioned within either or both the obverse surface and the bone contacting surface and extends from one of the holes to the side surface.
- an orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body having a bone facing surface, an obverse surface arranged opposite to the bone facing surface, and a plurality of holes extending through the body between the bone facing surface and the obverse surface.
- a plurality of projections are positioned on the bone facing surface and extend outwardly away therefrom.
- Another orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a fastener is insertable though at least one of the holes extending through the body.
- the fastener comprises a shaft having a distal end and an oppositely disposed proximal end.
- a head is attached to the proximal end of the shaft.
- a layer of bioresorbable material is positioned surrounding a portion of the shaft, adjacent to the head, or in spaced relation to the head.
- the layer of bioresorbable material has an outer surface engageable with the body to initially fix the fastener at a desired angular position relatively to the body.
- the fastener is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- an orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body for linking the first bone portion to the second bone portion.
- the body has a plurality of holes extending therethrough.
- a fastener is insertable though at least one of the holes extending through the body.
- the fastener comprises a shaft having a distal end and an oppositely disposed proximal end.
- a head is attached to the proximal end of the shaft.
- the head has a surface portion contiguous with the proximal end of the shaft.
- a layer of bioresorbable material is positioned on the surface portion of the head contiguous with the proximal end of the shaft.
- the layer of bioresorbable material has an outer surface engageable with the body to initially fix the fastener at a desired angular position relatively to the body.
- the fastener is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- the bioresorbable material is selected form the group consisting of polylactic acid (PLA), poly-L-lactic-co-glycolic acid (PLGA), poly-D/L-lactic acid with or without polyglycolic acid (PDLLA, PDLLA-co-PGA), poly-L-lactic acid with or without ⁇ -tricalcium phosphate (PLLA, PLLA-TCP), poly-L-lactic acid with hydroxyapatite (PLLA-HA), polycaprolactone (PCL), polycaprolactone-Calcium Phosphate (PCL-CaP), poly(L-lactide-co-D,L-lactide) (PLADLA), hydroxyapatite (HA), tricalcium phosphate ( ⁇ -TCP), nanodiamond particles (ND) and combinations thereof.
- PLA polylactic acid
- PLGA poly-L-lactic-co-glycolic acid
- PLLA poly-D/L-lactic acid with or without polyglycolic acid
- bioresorbable material that expand upon contact with bodily fluids.
- the bioresorbable material is selected form the group consisting of copolymer lactic glycolic acid, biodegradeable self-expanding poly-L,D-lactide, PDLLA comprising D-Lactide and L-lactide and poly-L-lactide and poly- ⁇ -caprolactone homopolymers, methylmethacrylate and acrylic acid and cross linking agent allymelhacrylate, and combinations thereof.
- the invention also encompasses a method of treating a bone fracture in a living organism having a plurality of bone fragments.
- the method comprises:
- FIG. 1 is a longitudinal sectional view of a bone plate fixation system
- FIG. 2 is a longitudinal sectional view of a hip screw fixation system
- FIG. 3 is an elevational view of an intramedullary rod fixation system
- FIGS. 4-9 are partial sectional views of bone screws having a layer of bioresorbable material thereon;
- FIGS. 10, 11, 11A, 12-14, 14A, 15-20, 20A, 21 and 21A are detailed elevational views of bone screws having features for facilitating attachment of a layer of bioresorbable material thereto;
- FIGS. 22-27 are elevational views of pins having a layer of bioresorbable material thereon;
- FIGS. 28-31, 31A, 32-38 and 38A are elevational views of pins having features for facilitating attachment of a layer of bioresorbable material thereto;
- FIGS. 39-44 are partial sectional views of bone screws having a layer of bioresorbable material thereon;
- FIGS. 45-48, 48A, 49-53, 53A, 54 and 54A are detailed elevational views of bone screws having features for facilitating attachment of a layer of bioresorbable material thereto;
- FIGS. 55-60 are elevational views of pins having a layer of bioresorbable material thereon;
- FIGS. 61-64, 64A, 65-69, 69A, 70 and 70A are elevational views of pins having features for facilitating attachment of a layer of bioresorbable material thereto;
- FIGS. 71, 71A, 72, 72A, 73, 73A, 74 and 74A are partial sectional views of a portion of a fixation device having a bioresorbable layer thereon;
- FIGS. 75-77 are elevational views of fasteners used with the fixation device
- FIGS. 78, 78A, 79, 79A, 80, 80A, 81, 81A, 82, 82A, 83, 83A, 83B and 83C are partial sectional views of a portion of a fixation device illustrating rigid to flexible osteosynthesis transformation;
- FIGS. 84 and 85 are isometric views of an example bone plate embodiment
- FIGS. 86 and 87 are partial isometric views of example embodiments of bone plate details
- FIGS. 88-91 are cross sectional views showing different embodiments of the bone plate shown in FIGS. 84-87 ;
- FIG. 92 is an elevational view of an alternate embodiment of a bone plate according to the invention.
- FIGS. 1 through 3 illustrate example orthopedic fixation devices 10 according to the invention.
- FIG. 1 shows device 10 having a body 12 , in this example, a bone plate 14 .
- Bone plate 14 has a plurality of holes 16 which receive fasteners 18 for attaching the bone plate 14 to bone portions 20 a and 20 b for the repair of a fracture 22 .
- Example fasteners 18 include bone screws 24 , and pins 26 .
- the example orthopedic fixation device 10 in FIG. 2 is a hip screw 28 , the hip screw comprising a body 12 having holes 16 which receive fasteners 18 .
- the fasteners include bone screws 24 and pins 26 as well as other components such as compressing screw 24 a .
- FIG. 1 shows device 10 having a body 12 , in this example, a bone plate 14 .
- Bone plate 14 has a plurality of holes 16 which receive fasteners 18 for attaching the bone plate 14 to bone portions 20 a and 20 b for the repair of a fracture 22 .
- FIG. 3 illustrates an intramedullary rod 30 , the rod comprising a body 12 having holes 16 to receive fasteners 18 , such as bone screws 24 and or pins 26 for attachment of the rod to bone portions 20 a and 20 b.
- the body, screws and pins are made of biocompatible materials such as stainless steel and titanium.
- orthopedic fixation devices are illustrative examples of the invention disclosed herein, but are not meant to limit application of the invention, it being understood that the detailed descriptions of the various components which follow apply to the devices disclosed herein as well as similar devices used for orthopedic fixation in the treatment of bone fractures as well as other disorders.
- the invention may be used in spinal fixation systems, in particular, to anterior cervical plating systems.
- FIG. 4 shows an example bone screw 24 , comprising a shaft 32 , the shaft having a distal end 34 and an oppositely disposed proximal end 36 to which a head 38 is attached.
- Shaft 32 has external helical screw threads 39 extending along at least a portion of the shaft.
- Cutting flutes 40 may be positioned at the distal end 34 of the shaft 32 , and the screw 24 may be cannulated, having a duct 42 therethrough.
- a layer of bioresorbable material 44 is positioned surrounding a portion of the shaft 32 adjacent to the head 38 .
- the layer of bioresorbable material may be formed on the shaft 32 by injection molding techniques for example.
- the layer of bioresorbable material 44 has an outer surface 46 which is engageable with the body 12 of the device 10 (see FIGS. 1-3 ) to initially fix the screw 24 at a desired angular position relatively to the body 12 .
- the screw 24 becomes angularly movable relatively to the body 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below.
- Outer surface 46 may be smooth, as shown in FIGS. 4-6 and may comprise a cylindrical surface 48 ( FIG. 4 ), a conical surface 50 ( FIG. 5 ) or a spherical surface 52 , shown in FIG. 6 . Other surface shapes are also feasible.
- the smooth outer surface 46 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into the outer surface 46 upon contact between the outer surface 46 and the body 12 as explained below.
- the outer surface 46 may have external helical screw threads 54 which are compatible with internal screw threads in holes 16 of the body 12 to effect angular fixation of the screw 24 relative to the body 12 .
- Threads 54 may have the same or different pitch from threads 39 on the shaft 32 .
- Threaded outer surface 46 may comprise a cylindrical surface 56 as shown in FIG. 7 , a conical surface 58 as shown in FIG. 8 , or a spherical surface 60 as shown in FIG. 9 .
- FIGS. 10 -13 show a screw 24 having the external threads 39 extending along the entire length of shaft 32 .
- FIGS. 11 and 11A show a screw 24 having a plurality of ribs 62 projecting radially outwardly from the shaft 32 .
- ribs 62 extend lengthwise along the shaft 32 .
- FIG. 12 shows an embodiment wherein the ribs are oriented helically around shaft 32 .
- the surface feature may comprise grooves or channels 64 .
- the channels 64 may extend lengthwise along the shaft 32 as shown in FIG. 14 , also shown in cross section in FIG. 14A , or circumferentially around the shaft as shown in FIG. 15 , or the channels may be arranged in a helical pattern as shown in FIG. 16 .
- Additional surface features to facilitate attachment of the bioresorbable layer 44 to shaft 32 include knurling 66 as shown in FIG. 17 or a rough textured surface 68 as shown in FIG. 18 .
- the rough textured surface 68 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting the shaft 32 .
- FIG. 19 shows a shaft 32 having a reversed tapered portion 70 adjacent to head 38 . Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of the shaft 32 over a portion of the proximal end 36 near the head 38 .
- FIGS. 20 and 20A show a shaft 32 with an oval cross section
- FIGS. 21 and 21A show a shaft having a polygonal cross section.
- FIG. 22 shows an example pin 26 , comprising a shaft 72 , the shaft having a distal end 74 and an oppositely disposed proximal end 76 to which a head 78 is attached.
- the pin 26 may be cannulated, having a duct 80 therethrough.
- a layer of bioresorbable material 44 is positioned surrounding a portion 82 of the shaft 72 adjacent to the head 78 .
- the layer of bioresorbable material may be formed on the shaft 72 by injection molding techniques for example.
- the layer of bioresorbable material 44 has an outer surface 84 which is engageable with the body 12 of the device 10 (see FIGS. 1-3 ) to initially fix the pin 26 at a desired angular position relatively to the body 12 .
- the pin 26 becomes angularly movable relatively to the body 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below.
- Outer surface 84 may be smooth, as shown in FIGS. 22-24 and may comprise a cylindrical surface 88 ( FIG. 22 ), a conical surface 90 ( FIG. 23 ) or a spherical surface 92 , shown in FIG. 24 . Other surface shapes are also feasible.
- the smooth outer surface 84 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into the outer surface 84 upon contact between the outer surface 84 and the body 12 as explained below.
- the outer surface 84 may have external helical screw threads 94 which are compatible with internal screw threads in holes 16 of the body 12 to effect angular fixation of the pin 26 relative to the body 12 .
- Threaded outer surface 84 may comprise a cylindrical surface 96 as shown in FIG. 25 , a conical surface 98 as shown in FIG. 26 , or a spherical surface 100 as shown in FIG. 27 .
- FIGS. 28-30 show a pin 26 having a plurality of ribs 102 projecting radially outwardly from the shaft 72 .
- ribs 102 extend lengthwise along the shaft 72 .
- FIG. 29 shows an embodiment wherein the ribs are oriented helically around shaft 72 .
- the surface feature may comprise grooves or channels 104 .
- the channels 104 may extend lengthwise along the shaft 72 as shown in FIG. 31 , also shown in cross section in FIG. 31A , or circumferentially around the shaft as shown in FIG. 32 , or the channels may be arranged in a helical pattern as shown in FIG. 33 .
- Additional surface features to facilitate attachment of the bioresorbable layer 44 to shaft 72 include knurling 106 as shown in FIG. 34 or a rough textured surface 108 as shown in FIG. 35 .
- the rough textured surface 108 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting the shaft 72 .
- FIG. 36 shows a shaft 72 having a reversed tapered portion 110 adjacent to head 78 . Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of the shaft 72 over a portion of the proximal end 76 near the head 78 .
- FIGS. 37 and 37A show a shaft 32 with an oval cross section, whereas FIGS. 38 and 38A show a shaft having a polygonal cross section.
- FIG. 39 shows another example bone screw 25 , comprising a shaft 33 , the shaft having a distal end 35 and an oppositely disposed proximal end 37 to which a head 31 is attached.
- Head 31 has a surface portion 31 a contiguous with the proximal end 37 of shaft 33 .
- Shaft 33 has external helical screw threads 39 extending along at least a portion of the shaft.
- Cutting flutes 41 may be positioned at the distal end 35 of the shaft 33 , and the screw 25 may be cannulated, having a duct 43 therethrough.
- a layer of bioresorbable material 45 is positioned surrounding the surface portion 31 a of head 31 contiguous with the proximal end 37 of shaft 33 .
- the layer of bioresorbable material may be formed on the head 31 by injection molding techniques for example.
- the layer of bioresorbable material 45 has an outer surface 47 which is engageable with the body 12 of the device 10 (see FIGS. 1-3 ) to initially fix the screw 25 at a desired angular position relatively to the body 12 .
- the screw 25 becomes angularly movable relatively to the body 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below.
- Outer surface 47 may be smooth, as shown in FIGS. 39-41 and may comprise a cylindrical surface 49 ( FIG. 39 ), a conical surface 51 ( FIG. 40 ) or a spherical surface 53 , shown in FIG. 41 . Other surface shapes are also feasible.
- the smooth outer surface 47 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into the outer surface 47 upon contact between the outer surface 47 and the body 12 as explained below.
- the outer surface 47 may have external helical screw threads 55 which are compatible with internal screw threads in holes 16 of the body 12 to effect angular fixation of the screw 25 relative to the body 12 .
- Threads 55 may have the same or different pitch from threads 39 on the shaft 33 .
- Threaded outer surface 47 may comprise a cylindrical surface 57 as shown in FIG. 42 , a conical surface 59 as shown in FIG. 43 , or a spherical surface 61 as shown in FIG. 44 .
- FIGS. 45-47 show a screw 25 having a plurality of ribs 63 projecting radially outwardly from the head 31 .
- ribs 63 extend toward the shaft 33 .
- FIG. 47 shows an embodiment wherein the ribs are oriented helically around head 31 .
- the surface feature may comprise grooves or channels 65 .
- the channels 65 may extend toward the shaft 33 as shown in FIG. 48 , also shown in cross section in FIG. 48A , or circumferentially around the shaft as shown in FIG. 49 , or the channels 65 may be arranged in a helical pattern as shown in FIG. 50 .
- Additional surface features to facilitate attachment of the bioresorbable layer 45 to head 31 include knurling 67 as shown in FIG. 51 or a rough textured surface 69 as shown in FIG. 52 .
- the rough textured surface 69 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting the shaft 33 . Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of the head 31 .
- FIGS. 53 and 53A show a head 31 with an oval cross section
- FIGS. 54 and 54A show a head 31 having a polygonal cross section.
- FIG. 55 shows an example pin 27 , comprising a shaft 73 , the shaft having a distal end 75 and an oppositely disposed proximal end 77 to which a head 79 is attached.
- Head 79 has a surface portion 79 a contiguous with the proximal end 77 of shaft 73 .
- the pin 27 may be cannulated, having a duct 81 therethrough.
- a layer of bioresorbable material 45 is positioned surrounding the surface portion 79 a of head 79 contiguous with the proximal end 77 of shaft 73 .
- the layer of bioresorbable material may be formed on the head 79 by injection molding techniques for example.
- the layer of bioresorbable material 45 has an outer surface 85 which is engageable with the body 12 of the device 10 (see FIGS. 1-3 ) to initially fix the pin 27 at a desired angular position relatively to the body 12 .
- the pin 27 becomes angularly movable relatively to the body 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below.
- Outer surface 85 may be smooth, as shown in FIGS. 55-57 and may comprise a cylindrical surface 89 ( FIG. 55 ), a conical surface 91 ( FIG. 56 ) or a spherical surface 93 , shown in FIG. 57 . Other surface shapes are also feasible.
- the smooth outer surface 85 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into the outer surface 85 upon contact between the outer surface 85 and the body 12 as explained below.
- the outer surface 85 may have external helical screw threads 95 which are compatible with internal screw threads in holes 16 of the body 12 to effect angular fixation of the pin 27 relative to the body 12 .
- Threaded outer surface 85 may comprise a cylindrical surface 97 as shown in FIG. 58 , a conical surface 99 as shown in FIG. 59 , or a spherical surface 101 as shown in FIG. 60 .
- FIGS. 61-63 show a pin 27 having a plurality of ribs 103 projecting radially outwardly from the head 79 .
- ribs 103 extend toward the shaft 73 .
- FIG. 63 shows an embodiment wherein the ribs 103 are oriented helically around head 79 .
- the surface feature may comprise grooves or channels 105 on head 79 .
- the channels 105 may extend toward the shaft 73 as shown in FIG. 64 , also shown in cross section in FIG. 64A , or circumferentially around the head as shown in FIG. 65 , or the channels 105 may be arranged in a helical pattern as shown in FIG. 66 .
- Additional surface features to facilitate attachment of the bioresorbable layer 45 to head 79 include knurling 107 as shown in FIG. 67 or a rough textured surface 109 applied to the head as shown in FIG. 68 .
- the rough textured surface 109 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting the head 79 . Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of the head 79 .
- FIGS. 69 and 69A show a head 79 with an oval cross section
- FIGS. 70 and 70A show a head having a polygonal cross section.
- FIGS. 71-74 show detailed cross sectional views of alternate embodiments of holes 16 in body 12 , which represent, for example, the holes through bone plate 14 , shown in FIG. 1 , hip screw 28 , shown in FIG. 2 , and intramedullary rod 30 , shown in FIG. 3 .
- FIG. 71 shows hole 16 in body 12 having a countersink surface 112 surrounding hole 16 .
- the countersink hole in this example is conical.
- FIG. 72 shows a spherical countersink surface 114 .
- the countersink surfaces 112 and 114 permit angular motion of the fasteners 18 relative to the body 12 when the fasteners are released from the body by absorbtion of the bioresorbable material as described below.
- FIG. 73 shows a conical undercut surface 116 matched with a conical countersink surface 112
- FIG. 74 illustrates a spherical undercut surface 118 matched with a spherical countersink surface 114 .
- a layer of bioresorbable material 44 may be positioned on the body 12 within at least one of the holes 16 .
- the layer 44 takes the form of an annulus 120 and has an inwardly facing surface 122 which may be cylindrical and/or conical as shown in FIGS. 71 and 73 , as well as spherical, as shown in FIGS. 72 and 74 . Other shapes are also feasible.
- Inwardly facing surface 122 may be smooth as shown in FIGS. 71-74 , or may have internal screw threads 124 as shown in FIGS. 71A-74A .
- fasteners 128 and 132 may be a bone screw ( FIG. 75 ) or a pin ( FIG. 76 ).
- a fastener 134 shown in FIG. 77 , may have a cutting edge 136 which cuts internal screw threads into the smooth inwardly facing surface 122 as the fastener is rotated.
- fastener 134 may be a bone screw or a pin, a bone screw being shown by way of example. It is further understood that fasteners having a layer of bioresorbable material thereon, as shown in FIGS. 4-9, 22-27, 39-44, and 55-60 may also be used with a body having bioresorbable material as shown in FIGS. 71-74 and 71A-74A .
- FIGS. 78-83 illustrate operation of the fixation device according to the invention.
- These figures represent a body 12 having holes 16 that receive fasteners 18 .
- the body could be, for example, part of a bone plate as shown in FIG. 1 , a hip screw as shown in FIG. 2 , an intramedullary rod as shown in FIG. 3 , or another fixation device.
- the fasteners are bone screws and pins as described above.
- FIG. 78 shows bone screw 24 having the bioresorbable layer 44 on a portion of screw shaft 32 adjacent to the head 38 .
- the outer surface 46 of the layer 44 engages the body and rigidly fixes the angular orientation of the screw relative to the body (the threaded portion of shaft 32 engages the bone, not shown for clarity). Engagement between the layer 44 and the body 12 may be through any of the example mechanisms described above.
- outer surface 46 may have external screw threads that engage compatible internal screw threads within hole 16 ; the outer surface 46 may be smooth and a cutting edge (not shown) positioned within hole 16 cuts external threads in the layer 44 ; or, the outer surface 46 of layer 44 may depend on friction between the it and the body portion surrounding the hole to provide the desired angular fixation. When all, or at least a portion, of the layer 44 is resorbed, as shown in FIG.
- the screw 24 is free to move angularly relatively to the body 12 , as evidenced by the canted position shown, and thus the interaction between the body 12 and the bone is transformed from a region of rigid fixation to a region of flexible osteosynthesis which permits micromotion across a fracture site stimulating callous formation and bony healing.
- Angular rigidity of the screw may be augmented by the particular shape of the layer 44 , for example, a conical, tapered shape being advantageous for rigidity.
- Angular motion of the screw 24 is further controlled through the use of countersink and undercut surfaces as described above and shown in FIGS. 71-74 .
- the layer of bioresorbable material 44 is positioned on the body 12 within at least one of the holes 16 .
- the outer surface 46 of the layer 44 engages the screw and rigidly fixes the angular orientation of the screw relative to the body.
- Engagement between the layer 44 and the screw may be through any of the example mechanisms described above.
- outer surface 46 may have internal screw threads that engage compatible external screw threads on the screw 24 ; the outer surface 46 may be smooth and a cutting edge (as shown at 136 in FIG.
- the screw 24 cuts internal threads in the layer 44 as the screw is rotated, the internal threads engaging external threads on the screw; or, the outer surface 46 of layer 44 may depend on friction between it and the screw shaft to provide the desired angular fixation.
- the screw 24 is free to move angularly relatively to the body 12 and thus transform the engagement between body and bone from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing.
- Angular rigidity of the screw may be augmented by the particular shape of the layer 44 , for example, a conical, tapered shape being advantageous for rigidity.
- Angular motion of the screw 24 is further controlled through the use of countersink and undercut surfaces as described above and shown in FIGS. 71-74 .
- FIGS. 80 and 80A show another embodiment wherein the bioresorbable material layer 44 is positioned on both the screw 24 and the body 12 .
- interaction between the outer surfaces 46 of the layers 44 on the screw 24 and on the body 12 initially fixes the angular orientation of the screws relatively to the body. Interaction may be through friction between the surfaces or threaded engagement. Countersink and undercut surfaces may again be used to control the limits of relative angular motion between the screw and the body.
- the layers 44 or a portion thereof, are resorbed, the screws 24 are no longer rigidly fixed and may move angularly with respect to the body 12 as shown in FIG. 80A , thereby providing the advantages of both the rigid and flexible osteosynthesis systems.
- a bone screw 25 has the bioresorbable layer 45 on a portion of the head 31 .
- the outer surface 47 of the layer 45 engages the body and rigidly fixes the angular orientation of the screw relative to the body.
- Engagement between the layer 45 and the body 12 may be through any of the example mechanisms described above.
- outer surface 47 may have external screw threads that engage compatible internal screw threads within hole 16 ; the outer surface 47 may be smooth and a cutting edge (not shown) positioned within hole 16 cuts external threads in the layer 45 , or, the outer surface 47 of layer 45 may depend on friction between the it and the body portion surrounding the hole to provide the desired angular fixation.
- the screw 25 When all, or at least a portion, of the layer 45 is resorbed, as shown in FIG. 81A , the screw 25 is free to move angularly relatively to the body 12 and thus transform from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing.
- Angular rigidity of the screw may be augmented by the particular shape of the layer 45 , for example, a conical, tapered shape as shown being advantageous for rigidity.
- Angular motion of the screw 25 is further controlled through the use of countersink and undercut surfaces as described above and shown in FIGS. 71-74 .
- the layer of bioresorbable material 45 is positioned on the body 12 within at least one of the holes 16 .
- the outer surface 47 of the layer 45 engages the screw's head 31 and rigidly fixes the angular orientation of the screw relative to the body. Engagement between the layer 45 and the screw head 31 may be through any of the example mechanisms described above.
- outer surface 47 may have internal screw threads that engage compatible external screw threads on the head 31 ; the outer surface 47 may be smooth and a cutting edge (not shown) positioned on the screw 25 cuts internal threads in the layer 45 , or, the outer surface 47 of layer 45 may depend on friction between it and the head to provide the desired angular fixation.
- the screw 25 is free to move angularly relatively to the body 12 and thus transform from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing.
- Angular rigidity of the screw may be augmented by the particular shape of the layer 45 , for example, a conical, tapered shape (shown) being advantageous for rigidity.
- Angular motion of the screw 25 is further controlled through the use of countersink and undercut surfaces as described above and shown in FIGS. 71-74 .
- FIGS. 83 and 83A show another embodiment wherein the bioresorbable material layer 45 is positioned on both the head 31 of screw 25 and the body 12 .
- interaction between the outer surfaces 47 of the layers 45 on the screw 25 and on the body 12 as shown in FIG. 80 , initially fixes the angular orientation of the screws relatively to the body. Interaction may be through friction between the surfaces or threaded engagement. Countersink and undercut surfaces may again be used to control the limits of relative angular motion between the screw and the body.
- the layers 45 or a portion thereof, are resorbed, the screws 25 are no longer rigidly fixed and may move angularly with respect to the body 12 as shown in FIG. 83A , thereby providing the advantages of both the rigid and flexible osteosynthesis systems.
- FIGS. 83B and 83C Another embodiment is shown in FIGS. 83B and 83C , wherein screw 25 has a head 31 with a substantially smooth side surface 31 a and a layer of bioresorbable material 45 on the top of the head 31 .
- Bioresorbable layer 45 engages the body 12 using screw threads 95 which mate with compatible internal threads in hole 16 and initially fix the angular orientation of the screw relative to the body. Screw threads 95 may be molded into the bioresorbable layer 45 when it is applied to the screw 25 , or the layer 45 may be initially smooth and the threads cut, for example, as the screw is threaded into the hole 16 .
- the bioresorbable layer 45 is resorbed, as shown in FIG.
- the screw 25 no longer fixedly engages the body 12 and is free to rotate angularly relative to the body.
- a counter sunk screw is shown by way of example, but other shapes of screw heads and bioresorbable layers, such as cylindrical, conical and spherical shapes, are equally feasible.
- the invention also encompasses a method of treating a bone fracture in a living organism having a plurality of bone fragments.
- the method comprises:
- the fasteners used in the method according to the invention include bone screws and pins as described herein.
- the bioresorbable material may be located on the fastener, on the body, or on both the fastener and the body.
- the angular orientation of the fasteners relative to the body may be fixed by frictional engagement between the body and the bioresorbable layer on the fastener, by frictional engagement between the fastener and the bioresorbable layer on the body, or between bioresorbable layers on both the body and the fastener.
- the angular orientation of the fasteners relative to the body may be also fixed by engagement between internal screw threads on the body and external screw threads on the bioresorbable layer on the fastener, by engagement between external screw threads on the fastener and internal screw threads on the bioresorbable layer on the body, or between internal and external screw threads on the bioresorbable layers on both the body and the fastener, respectively.
- the body may be part of a fixation device, such as a bone plate, a hip screw, an intramedullary rod and the like.
- FIGS. 84 and 85 show an example body 12 in the form of a bone plate 140 according to the invention.
- Plate 140 comprises a bone contacting surface 142 ( FIG. 85 ) and an obverse surface 144 ( FIG. 84 ) arranged opposite to the bone contacting surface 142 .
- Side surfaces 146 extend between the bone contacting and obverse surfaces 142 and 144 .
- a plurality of holes 148 extend between the bone contacting surface 142 and the obverse surface 144 .
- Holes 148 receive fasteners 18 , which could be bone screws as shown in FIGS. 4-9 and 39-44 , and/or pins as shown in FIGS. 22-27, and 55-60 (fastener 18 is shown as a bone screw by way of example).
- the holes 148 may be round, as well as non-round, for example oval or elliptical as shown in FIGS. 86 and 87 . Other, more complicated shapes are also feasible.
- One or more cutting edges 137 may be positioned in the holes to cut threads in a bioresorbable material layer positioned on the fastener 18 as described above.
- the holes may also be countersunk and undercut as described above.
- a layer of bioabsorbable material 44 may be positioned within one or more of the holes 148 similar to the embodiments illustrated in FIGS. 71-74 and 71A-74A .
- the plate 140 comprises a plurality of channels 150 positioned within either or both the obverse surface 144 and the bone contacting surface 142 .
- Each channel 150 extends from a hole 148 to a side surface 146 and facilitates the flow of bodily fluids to and from the hole.
- This flow of fluids allows bioresorbable layers 44 , either on the plate 140 or the fasteners 18 , or on both, to be readily resorbed to transform the plate 140 from operation as a rigid osteosynthesis device to a flexible osteosynthesis device.
- the angular orientation of fasteners 18 which could be bones screws and/or pins as described above, is fixed with respect to the plate 140 .
- the layers are resorbed the fasteners are free to move angularly with respect to the plate 14 and thereby permit the micromotions conducive to callous formation and bony healing.
- Channels 150 as shown in FIGS. 84 and 85 comprise a concave, conical surface. Note that in the example shown, the width of the channel where it intersects side surface 146 is greater than where the channel intersects the hole 148 . Channels 150 may have different cross sectional shapes from those shown in FIG. 85 . As shown in FIG. 88 , the channel 150 may have a spherical shape; FIG. 89 shows a channel 150 having a “V” cross sectional shape; FIG. 90 shows a channel 150 having a cylindrical or “U” cross sectional shape, and FIG. 91 shows a channel 150 having a trapezoidal cross sectional shape. Other channel shapes are also feasible.
- the body 12 represented by an example bone plate 152 has a plurality of projections 154 on its bone facing side 156 .
- Projections 154 act as spacers to stand the plate 152 in spaced relation away from bone to permit bodily fluids to flow to and from holes 158 in the plate to facilitate resorbtion of the bioresorbable material on the plate and/or the fasteners use to attach the plate to the bone.
- Projections 154 may be integrally formed with the plate or attached thereto as separate components.
- the hip screw 28 shown in FIG. 2 may use a layer of bioabsorbable material 44 surrounding a portion of the shaft adjacent to the head of the compressing screw 24 a.
- screw 24 which secures the intramedullary rod 30 to bone portion 20 b, may have a layer of bioresorbable material 44 positioned on a portion of the screw shaft in spaced relation away from the head.
- Pin 26 may also have a layer of bioresorbable material positioned along its shaft as well.
- the bioresorbable materials comprising the layers attached to the fasteners, such as the bone screws and pins, as well as the layers on the body, such as the bone plate, the plate associated with the hip screw, and the intramedullary rod may comprise polymer materials and/or polymer-glass/ceramic including (but not limited to) polylactic acid (PLA), poly-L-lactic-co-glycolic acid (PLGA), poly-D/L-lactic acid with or without polyglycolic acid (PDLLA, PDLLA-co-PGA), poly-L-lactic acid with or without ⁇ -tricalcium phosphate (PLLA, PLLA-TCP), poly-L-lactic acid with hydroxyapatite (PLLA-HA), polycaprolactone (PCL), polycaprolactone-Calcium Phosphate (PCL-CaP), poly(L-lactide-co-D,L-lactide) (PLADLA), hydroxyapatite (HA), tricalcium phosphate ( ⁇ -
- bioresorbable materials which expand when in contact with bodily fluids, or by the action of heat or ultrasonic waves may also be feasible for use with the fixation device according to the invention.
- Such materials include copolymer lactic glycolic acid (80/20), biodegradeable self-expanding poly-L,D-lactide, PDLLA comprising D-Lactide and L-lactide and poly-L-lactide and poly- ⁇ -caprolactone homopolymers.
- Expanding or swelling polymeric materials include the monomers methylmethacrylate and acrylic acid and cross linking agent allymelhacrylate. Material layers made of these materials swell by absorbtion of body fluids and thereby produce fixation between the fastener and the bone plate, hip screw or intramedullary rod by an interference fit.
- Selective degradation of the bioresorbable material layer may be controlled at the discretion of the surgeon or healthcare practitioner through various means including focal hydrolysis with acids, alkalis or enzymes. Other means of inducing degradation include the exposure of the bioresorbable layer to UV light or radiation, oxidation, high temperatures, ultrasound and focused high intensity acoustic pulses.
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Abstract
An orthopedic screw is used in a fixation device for treating fractures. The device has a body with holes to accept the bone screws. The bone screws have a layer of bioresorbable material on a surface portion of the head of the screw contiguous with the shaft. Engagement between the bone screws and the body is initially through the bioresorbable material, which engagement rigidly fixes the relative angular orientation between the bone screws and the body when the device is applied to a bone. As the bioresrobable material is resorbed the angular relation between the bone screws and the body is no longer rigidly fixed, thereby effecting a transformation from rigid osteosysthesis to flexible osteosynthesis to allow micromotion between the bone fragments which promotes healing.
Description
- This application is a continuation of and claims priority to U.S. patent application Ser. No. 14/876,162, filed Oct. 6, 2016, which application is a continuation of and claims priority to U.S. patent application Ser. No. 13/953,095, filed Jul. 29, 2013, now U.S. Pat. No. 9,179,956 issued Nov. 10, 2015, which is a continuation of and claims priority to U.S. patent application Ser. No. 12/730,661, filed Mar. 24, 2010, now U.S. Pat. No. 8,506,608, issued Aug. 13, 2013, which patent claims priority to U.S. Provisional Application No. 61/162,987 filed Mar. 24, 2009, the applications all being hereby incorporated by reference herein.
- This invention relates to screws used with fixation devices for the treatment of bone fractures using flexible and rigid osteosythesis.
- The clinical success of plate and screw systems for internal fixation of fractures is well-documented. Current systems offer the surgeon a choice of conventional plates and screws, locking plates and screws, or various types of combination plates and screws.
- Conventional bone plates and screws may be used for treating fractures involving severely comminuted bone or missing bone segments. These conventional systems may also be described as “flexible osteosynthesis” or “biological osteosynthesis” and are particularly well-suited to promoting healing of the fracture by compressing the fracture ends together and drawing the bone into close apposition with other fragments and the bone plate. They are particularly useful in the treatment of comminuted fractures in the diaphyseal region of bones or in regions with severe segmental bone loss. In the case of these fractures, it is imperative to maintain proper bone length while correcting fracture fragments for proper anatomic alignment. With flexible osteosynthesis, the fracture zone is not directly affixed or manipulated, and consequently, the blood circulation in this area is not inhibited.
- Bone plates designed for flexible osteosynthesis thus operate similarly to a locking, intramedullary nail, which is anchored only in the metaphyses. Flexible osteosynthesis repair constructs allow for micromotion across the fracture site stimulating callous formation. Since the angular relationships between the plate and screws are not fixed, they can change postoperatively, leading to mal-alignment and poor clinical results.
- The primary mechanism for the change in angular relationship is related to energy storage. Threading a bone screw into bone compresses the bone against the plate. The compression results in high strain in the bone, and, consequently, energy storage. With the dynamic loading resulting from physiological conditions, loosening of the plate and screw and loss of the stored energy can result.
- Conventional bone screws, i.e. screws that are not secured to a plate so that a fixed angular relationship between the plate and screw is maintained (hereinafter “non-locking screws”) effectively compress bone fragments, but possess a low resistance to shear force that can lead to loosening of the screw.
- The development of plates incorporating a fixed angular relationship between the bone plate and screws have been developed to combat this problem. Methods of securing the screw to the plate are known as so-called “locking plates”, “locking screws” or “rigid osteosynthesis”. This type of fixation is particularly useful in treating peri-articular fractures, simple shaft fractures (where nailing is impossible), as well as osteotomies. Aside from the possibility of anatomical repositioning, the bone itself supports and stabilizes the osteosynthesis, which allows for the possibility of putting stress on the extremity earlier and without pain.
- Securing the screw in a fixed angle to the plate reduces the incidence of loosening. As the relationship between the locking screws and the plate is fixed, locking screws provide a high resistance to shear or torsional forces.
- However, locking screws have a limited capability to compress bone fragments. Additionally, locking screws hold the construct in such a rigid position that micromotion across the fracture site may be impeded thereby inhibiting callous formation. Though used successfully for certain fractures, rigid osteosynthesis has been shown to promote the occurrence of non-unions at the fracture site.
- A locking screw has threading on an outer surface of its head that mates with corresponding threading on the surface of a plate hole to lock the screw to the plate. Bone plates having threaded holes for accommodating locking screws are known. For example, German Patent Application No. 43 43 117 discloses a bone plate with threaded holes for locking screws. Locking screws have a high resistance to shear force that ensure stability at the bone screw/plate hole interface, but possess a limited ability to compress bone fragments.
- Since fractures cannot always be treated with both types of osteosynthesis at the same fixation point, surgeons must frequently compromise because bone plate screw holes only allow him to choose between one of these two types of continuous osteosynthesis discussed above. The ideal fracture stabilization construct would allow the surgeon to choose between continuous flexible osteosynthesis, continuous rigid osteosynthesis and temporary rigid osteosynthesis transforming to flexible osteosynthesis within a pre-defined time period.
- By having the option to rigidly fix a fracture fragment via a known location for a pre-determined period of time and allowing that rigid fixation to transform into a region of flexible osteosynthesis, the surgeon is thus enabled to expose the fracture site to a period of stability followed by controlled micromotion thus stimulating bony healing.
- The invention concerns an orthopedic fixation device for connecting a first bone portion to a second bone portion. The device comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A screw is insertable though at least one of the holes extending through the body. The screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft. A head is attached to the proximal end of the shaft. A layer of bioresorbable material is positioned surrounding a second portion of the shaft, either adjacent to the head or in spaced relation to the head. The layer of bioresorbable material has an outer surface engageable with the body to initially fix the screw at a desired angular position relatively to the body. The screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- In another embodiment, an orthopedic fixation device for connecting a first bone portion to a second bone portion according to the invention comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A layer of bioresorbable material is positioned on the body within at least one of the holes. A screw is insertable though the at least one hole. The screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft. A head is attached to the proximal end of the shaft. A second portion of the shaft, adjacent to the head, or in spaced relation to the head, is engageable with the bioresorbable layer to initially fix the screw at a desired angular position relatively to the body. The screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- In another embodiment of an orthopedic fixation device for connecting a first bone portion to a second bone portion, the device comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A screw is insertable though at least one of the holes extending through the body. The screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extending along at least a first portion of the shaft. A head is attached to the proximal end of the shaft. The head has a surface portion contiguous with the proximal end of the shaft. A layer of bioresorbable material is positioned on the surface portion of the head contiguous with the proximal end of the shaft. The layer of bioresorbable material has an outer surface engageable with the body to initially fix the screw at a desired angular position relatively to the body. The screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- In another embodiment of an orthopedic fixation device for connecting a first bone portion to a second bone portion according to the invention, the device comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A layer of bioresorbable material is positioned on the body within at least one of the holes. A screw is insertable though the at least one hole. The screw comprises a shaft having a distal end and an oppositely disposed proximal end. External helical screw threads extend along at least a first portion of the shaft. A head is attached to the proximal end of the shaft. The head has a surface portion contiguous with the proximal end of the shaft. The surface portion contiguous with the proximal end of the shaft is engageable with the bioresorbable layer to initially fix the screw at a desired angular position relatively to the body. The screw is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- Another orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body having a bone contacting surface and an obverse surface arranged opposite to the bone contacting surface. A side surface extends between the bone contacting surface and the obverse surface. A plurality of holes extending through the body. At least one channel is positioned within either or both the obverse surface and the bone contacting surface and extends from one of the holes to the side surface.
- Another embodiment of an orthopedic fixation device for connecting a first bone portion to a second bone portion comprises a body having a bone facing surface, an obverse surface arranged opposite to the bone facing surface, and a plurality of holes extending through the body between the bone facing surface and the obverse surface. A plurality of projections are positioned on the bone facing surface and extend outwardly away therefrom.
- Another orthopedic fixation device for connecting a first bone portion to a second bone portion according to the invention comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A fastener is insertable though at least one of the holes extending through the body. The fastener comprises a shaft having a distal end and an oppositely disposed proximal end. A head is attached to the proximal end of the shaft. A layer of bioresorbable material is positioned surrounding a portion of the shaft, adjacent to the head, or in spaced relation to the head. The layer of bioresorbable material has an outer surface engageable with the body to initially fix the fastener at a desired angular position relatively to the body. The fastener is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- Another embodiment of an orthopedic fixation device for connecting a first bone portion to a second bone portion according to the invention comprises a body for linking the first bone portion to the second bone portion. The body has a plurality of holes extending therethrough. A fastener is insertable though at least one of the holes extending through the body. The fastener comprises a shaft having a distal end and an oppositely disposed proximal end. A head is attached to the proximal end of the shaft. The head has a surface portion contiguous with the proximal end of the shaft. A layer of bioresorbable material is positioned on the surface portion of the head contiguous with the proximal end of the shaft. The layer of bioresorbable material has an outer surface engageable with the body to initially fix the fastener at a desired angular position relatively to the body. The fastener is angularly movable with respect to the body upon resorbtion of at least a portion of the bioresorbable layer.
- In the example embodiments described the bioresorbable material is selected form the group consisting of polylactic acid (PLA), poly-L-lactic-co-glycolic acid (PLGA), poly-D/L-lactic acid with or without polyglycolic acid (PDLLA, PDLLA-co-PGA), poly-L-lactic acid with or without β-tricalcium phosphate (PLLA, PLLA-TCP), poly-L-lactic acid with hydroxyapatite (PLLA-HA), polycaprolactone (PCL), polycaprolactone-Calcium Phosphate (PCL-CaP), poly(L-lactide-co-D,L-lactide) (PLADLA), hydroxyapatite (HA), tricalcium phosphate (β-TCP), nanodiamond particles (ND) and combinations thereof. Another example includes bioresorbable material that expand upon contact with bodily fluids. In a specific example embodiment, the bioresorbable material is selected form the group consisting of copolymer lactic glycolic acid, biodegradeable self-expanding poly-L,D-lactide, PDLLA comprising D-Lactide and L-lactide and poly-L-lactide and poly-ε-caprolactone homopolymers, methylmethacrylate and acrylic acid and cross linking agent allymelhacrylate, and combinations thereof.
- The invention also encompasses a method of treating a bone fracture in a living organism having a plurality of bone fragments. The method comprises:
-
- attaching a body to at least two of the bone fragments using a plurality of fasteners joining the body to the fragments;
- fixing an angular orientation of at least one of the fasteners in relation to the body using a bioresorbable material positioned between the fastener and the body, the bioresorbable material contacting the one fastener and the body and preventing relative rotation therebetween;
- allowing the bioresorbable material to be resorbed by the living organism, thereby allowing relative rotation between the one fastener and the body.
-
FIG. 1 is a longitudinal sectional view of a bone plate fixation system; -
FIG. 2 is a longitudinal sectional view of a hip screw fixation system; -
FIG. 3 is an elevational view of an intramedullary rod fixation system; -
FIGS. 4-9 are partial sectional views of bone screws having a layer of bioresorbable material thereon; -
FIGS. 10, 11, 11A, 12-14, 14A, 15-20, 20A, 21 and 21A are detailed elevational views of bone screws having features for facilitating attachment of a layer of bioresorbable material thereto; -
FIGS. 22-27 are elevational views of pins having a layer of bioresorbable material thereon; -
FIGS. 28-31, 31A, 32-38 and 38A are elevational views of pins having features for facilitating attachment of a layer of bioresorbable material thereto; -
FIGS. 39-44 are partial sectional views of bone screws having a layer of bioresorbable material thereon; -
FIGS. 45-48, 48A, 49-53, 53A, 54 and 54A are detailed elevational views of bone screws having features for facilitating attachment of a layer of bioresorbable material thereto; -
FIGS. 55-60 are elevational views of pins having a layer of bioresorbable material thereon; -
FIGS. 61-64, 64A, 65-69, 69A, 70 and 70A are elevational views of pins having features for facilitating attachment of a layer of bioresorbable material thereto; -
FIGS. 71, 71A, 72, 72A, 73, 73A, 74 and 74A are partial sectional views of a portion of a fixation device having a bioresorbable layer thereon; -
FIGS. 75-77 are elevational views of fasteners used with the fixation device; -
FIGS. 78, 78A, 79, 79A, 80, 80A, 81, 81A, 82, 82A, 83, 83A, 83B and 83C are partial sectional views of a portion of a fixation device illustrating rigid to flexible osteosynthesis transformation; -
FIGS. 84 and 85 are isometric views of an example bone plate embodiment; -
FIGS. 86 and 87 are partial isometric views of example embodiments of bone plate details; -
FIGS. 88-91 are cross sectional views showing different embodiments of the bone plate shown inFIGS. 84-87 ; and -
FIG. 92 is an elevational view of an alternate embodiment of a bone plate according to the invention. -
FIGS. 1 through 3 illustrate exampleorthopedic fixation devices 10 according to the invention.FIG. 1 showsdevice 10 having abody 12, in this example, abone plate 14.Bone plate 14 has a plurality ofholes 16 which receivefasteners 18 for attaching thebone plate 14 tobone portions Example fasteners 18 include bone screws 24, and pins 26. The exampleorthopedic fixation device 10 inFIG. 2 is a hip screw 28, the hip screw comprising abody 12 havingholes 16 which receivefasteners 18. Again, the fasteners include bone screws 24 and pins 26 as well as other components such as compressingscrew 24 a.FIG. 3 illustrates anintramedullary rod 30, the rod comprising abody 12 havingholes 16 to receivefasteners 18, such as bone screws 24 and or pins 26 for attachment of the rod tobone portions - These three orthopedic fixation devices are illustrative examples of the invention disclosed herein, but are not meant to limit application of the invention, it being understood that the detailed descriptions of the various components which follow apply to the devices disclosed herein as well as similar devices used for orthopedic fixation in the treatment of bone fractures as well as other disorders. For example, the invention may be used in spinal fixation systems, in particular, to anterior cervical plating systems.
-
FIG. 4 shows anexample bone screw 24, comprising ashaft 32, the shaft having adistal end 34 and an oppositely disposedproximal end 36 to which ahead 38 is attached.Shaft 32 has externalhelical screw threads 39 extending along at least a portion of the shaft. Cutting flutes 40 may be positioned at thedistal end 34 of theshaft 32, and thescrew 24 may be cannulated, having aduct 42 therethrough. In this embodiment, a layer ofbioresorbable material 44 is positioned surrounding a portion of theshaft 32 adjacent to thehead 38. The layer of bioresorbable material may be formed on theshaft 32 by injection molding techniques for example. The layer ofbioresorbable material 44 has anouter surface 46 which is engageable with thebody 12 of the device 10 (seeFIGS. 1-3 ) to initially fix thescrew 24 at a desired angular position relatively to thebody 12. Thescrew 24 becomes angularly movable relatively to thebody 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below. -
Outer surface 46 may be smooth, as shown inFIGS. 4-6 and may comprise a cylindrical surface 48 (FIG. 4 ), a conical surface 50 (FIG. 5 ) or aspherical surface 52, shown inFIG. 6 . Other surface shapes are also feasible. The smoothouter surface 46 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into theouter surface 46 upon contact between theouter surface 46 and thebody 12 as explained below. - As shown in
FIG. 7 , theouter surface 46 may have externalhelical screw threads 54 which are compatible with internal screw threads inholes 16 of thebody 12 to effect angular fixation of thescrew 24 relative to thebody 12.Threads 54 may have the same or different pitch fromthreads 39 on theshaft 32. Threadedouter surface 46 may comprise acylindrical surface 56 as shown inFIG. 7 , a conical surface 58 as shown inFIG. 8 , or aspherical surface 60 as shown inFIG. 9 . - To facilitate attachment of the
bioresorbable layer 44 to theshaft 32 of thebone screw 24, surface features may be positioned on a portion of the shaft adjacent to head 38. The surface features increase the surface area of the shaft to afford greater adhesion between thelayer 44 and theshaft 32, and also act as positive areas of contact which prevent relative rotation between the layer and the shaft. Examples of shaft surface features are shown inFIGS. 10 -13 .FIG. 10 shows ascrew 24 having theexternal threads 39 extending along the entire length ofshaft 32.FIGS. 11 and 11A show ascrew 24 having a plurality ofribs 62 projecting radially outwardly from theshaft 32. In this embodiment,ribs 62 extend lengthwise along theshaft 32. In another embodiment, shown inFIG. 12 , theribs 62 extend circumferentially around theshaft 32.FIG. 13 shows an embodiment wherein the ribs are oriented helically aroundshaft 32. - Alternately, as shown in
FIGS. 14-16 , the surface feature may comprise grooves orchannels 64. Thechannels 64 may extend lengthwise along theshaft 32 as shown inFIG. 14 , also shown in cross section inFIG. 14A , or circumferentially around the shaft as shown inFIG. 15 , or the channels may be arranged in a helical pattern as shown inFIG. 16 . - Additional surface features to facilitate attachment of the
bioresorbable layer 44 toshaft 32 includeknurling 66 as shown inFIG. 17 or a rough textured surface 68 as shown inFIG. 18 . The rough textured surface 68 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting theshaft 32.FIG. 19 shows ashaft 32 having a reversedtapered portion 70 adjacent to head 38. Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of theshaft 32 over a portion of theproximal end 36 near thehead 38.FIGS. 20 and 20A show ashaft 32 with an oval cross section, whereasFIGS. 21 and 21A show a shaft having a polygonal cross section. -
FIG. 22 shows anexample pin 26, comprising ashaft 72, the shaft having a distal end 74 and an oppositely disposedproximal end 76 to which ahead 78 is attached. Thepin 26 may be cannulated, having aduct 80 therethrough. In this embodiment, a layer ofbioresorbable material 44 is positioned surrounding aportion 82 of theshaft 72 adjacent to thehead 78. The layer of bioresorbable material may be formed on theshaft 72 by injection molding techniques for example. The layer ofbioresorbable material 44 has anouter surface 84 which is engageable with thebody 12 of the device 10 (seeFIGS. 1-3 ) to initially fix thepin 26 at a desired angular position relatively to thebody 12. Thepin 26 becomes angularly movable relatively to thebody 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below. -
Outer surface 84 may be smooth, as shown inFIGS. 22-24 and may comprise a cylindrical surface 88 (FIG. 22 ), a conical surface 90 (FIG. 23 ) or aspherical surface 92, shown inFIG. 24 . Other surface shapes are also feasible. The smoothouter surface 84 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into theouter surface 84 upon contact between theouter surface 84 and thebody 12 as explained below. - As shown in
FIG. 25 , theouter surface 84 may have externalhelical screw threads 94 which are compatible with internal screw threads inholes 16 of thebody 12 to effect angular fixation of thepin 26 relative to thebody 12. Threadedouter surface 84 may comprise acylindrical surface 96 as shown inFIG. 25 , aconical surface 98 as shown inFIG. 26 , or aspherical surface 100 as shown inFIG. 27 . - To facilitate attachment of the
bioresorbable layer 44 to theshaft 72 of thepin 26, surface features may be positioned on a portion of the shaft adjacent to head 78. The surface features increase the surface area of the shaft to afford greater adhesion between thelayer 44 and theshaft 72, and also act as positive areas of contact which prevent relative rotation between the layer and the shaft. Examples of shaft surface features are shown inFIGS. 28-30 .FIG. 28 shows apin 26 having a plurality ofribs 102 projecting radially outwardly from theshaft 72. In this embodiment,ribs 102 extend lengthwise along theshaft 72. In another embodiment, shown inFIG. 29 , theribs 102 extend circumferentially around theshaft 72.FIG. 30 shows an embodiment wherein the ribs are oriented helically aroundshaft 72. - Alternately, as shown in
FIGS. 31-33 , the surface feature may comprise grooves orchannels 104. Thechannels 104 may extend lengthwise along theshaft 72 as shown inFIG. 31 , also shown in cross section inFIG. 31A , or circumferentially around the shaft as shown inFIG. 32 , or the channels may be arranged in a helical pattern as shown inFIG. 33 . - Additional surface features to facilitate attachment of the
bioresorbable layer 44 toshaft 72 include knurling 106 as shown inFIG. 34 or a roughtextured surface 108 as shown inFIG. 35 . The roughtextured surface 108 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting theshaft 72.FIG. 36 shows ashaft 72 having a reversedtapered portion 110 adjacent to head 78. Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of theshaft 72 over a portion of theproximal end 76 near thehead 78.FIGS. 37 and 37A show ashaft 32 with an oval cross section, whereasFIGS. 38 and 38A show a shaft having a polygonal cross section. -
FIG. 39 shows anotherexample bone screw 25, comprising ashaft 33, the shaft having adistal end 35 and an oppositely disposedproximal end 37 to which ahead 31 is attached.Head 31 has asurface portion 31 a contiguous with theproximal end 37 ofshaft 33.Shaft 33 has externalhelical screw threads 39 extending along at least a portion of the shaft. Cuttingflutes 41 may be positioned at thedistal end 35 of theshaft 33, and thescrew 25 may be cannulated, having aduct 43 therethrough. In this embodiment, a layer ofbioresorbable material 45 is positioned surrounding thesurface portion 31 a ofhead 31 contiguous with theproximal end 37 ofshaft 33. The layer of bioresorbable material may be formed on thehead 31 by injection molding techniques for example. The layer ofbioresorbable material 45 has anouter surface 47 which is engageable with thebody 12 of the device 10 (seeFIGS. 1-3 ) to initially fix thescrew 25 at a desired angular position relatively to thebody 12. Thescrew 25 becomes angularly movable relatively to thebody 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below. -
Outer surface 47 may be smooth, as shown inFIGS. 39-41 and may comprise a cylindrical surface 49 (FIG. 39 ), a conical surface 51 (FIG. 40 ) or aspherical surface 53, shown inFIG. 41 . Other surface shapes are also feasible. The smoothouter surface 47 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into theouter surface 47 upon contact between theouter surface 47 and thebody 12 as explained below. - As shown in
FIG. 42 , theouter surface 47 may have externalhelical screw threads 55 which are compatible with internal screw threads inholes 16 of thebody 12 to effect angular fixation of thescrew 25 relative to thebody 12.Threads 55 may have the same or different pitch fromthreads 39 on theshaft 33. Threadedouter surface 47 may comprise acylindrical surface 57 as shown inFIG. 42 , aconical surface 59 as shown inFIG. 43 , or aspherical surface 61 as shown inFIG. 44 . - To facilitate attachment of the
bioresorbable layer 45 to theshaft 33 of thebone screw 25, surface features may be positioned on thesurface 31 a ofhead 31 contiguous with theproximal end 37 ofshaft 33. The surface features increase the surface area of the head to afford greater adhesion between thelayer 45 and thehead 31, and also act as positive areas of contact which prevent relative rotation between the layer and the head. Examples of head surface features are shown inFIGS. 45-47 .FIG. 45 shows ascrew 25 having a plurality ofribs 63 projecting radially outwardly from thehead 31. In this embodiment,ribs 63 extend toward theshaft 33. In another embodiment, shown inFIG. 46 , theribs 63 extend circumferentially around thehead 31.FIG. 47 shows an embodiment wherein the ribs are oriented helically aroundhead 31. - Alternately, as shown in
FIGS. 48-50 , the surface feature may comprise grooves orchannels 65. Thechannels 65 may extend toward theshaft 33 as shown inFIG. 48 , also shown in cross section inFIG. 48A , or circumferentially around the shaft as shown inFIG. 49 , or thechannels 65 may be arranged in a helical pattern as shown inFIG. 50 . - Additional surface features to facilitate attachment of the
bioresorbable layer 45 to head 31 include knurling 67 as shown inFIG. 51 or a rough textured surface 69 as shown inFIG. 52 . The rough textured surface 69 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting theshaft 33. Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of thehead 31.FIGS. 53 and 53A show ahead 31 with an oval cross section, whereasFIGS. 54 and 54A show ahead 31 having a polygonal cross section. -
FIG. 55 shows anexample pin 27, comprising ashaft 73, the shaft having a distal end 75 and an oppositely disposedproximal end 77 to which ahead 79 is attached.Head 79 has asurface portion 79 a contiguous with theproximal end 77 ofshaft 73. Thepin 27 may be cannulated, having aduct 81 therethrough. In this embodiment, a layer ofbioresorbable material 45 is positioned surrounding thesurface portion 79 a ofhead 79 contiguous with theproximal end 77 ofshaft 73. The layer of bioresorbable material may be formed on thehead 79 by injection molding techniques for example. The layer ofbioresorbable material 45 has anouter surface 85 which is engageable with thebody 12 of the device 10 (seeFIGS. 1-3 ) to initially fix thepin 27 at a desired angular position relatively to thebody 12. Thepin 27 becomes angularly movable relatively to thebody 12 when the bioresorbable layer, or a portion thereof, is absorbed as described in detail below. -
Outer surface 85 may be smooth, as shown inFIGS. 55-57 and may comprise a cylindrical surface 89 (FIG. 55 ), a conical surface 91 (FIG. 56 ) or aspherical surface 93, shown inFIG. 57 . Other surface shapes are also feasible. The smoothouter surface 85 may engage the body through frictional contact to fix the angular position of the screw, or external screw threads may be cut into theouter surface 85 upon contact between theouter surface 85 and thebody 12 as explained below. - As shown in
FIG. 58 , theouter surface 85 may have externalhelical screw threads 95 which are compatible with internal screw threads inholes 16 of thebody 12 to effect angular fixation of thepin 27 relative to thebody 12. Threadedouter surface 85 may comprise acylindrical surface 97 as shown inFIG. 58 , aconical surface 99 as shown inFIG. 59 , or aspherical surface 101 as shown inFIG. 60 . - To facilitate attachment of the
bioresorbable layer 45 to thehead 79 of thepin 27, surface features may be positioned on thesurface 79 a of thehead 79 contiguous withshaft 73. The surface features increase the surface area of the head to afford greater adhesion between thelayer 45 and thehead 79, and also act as positive areas of contact which prevent relative rotation between the layer and the head. Examples of head surface features are shown inFIGS. 61-63 .FIG. 61 shows apin 27 having a plurality ofribs 103 projecting radially outwardly from thehead 79. In this embodiment,ribs 103 extend toward theshaft 73. In another embodiment, shown inFIG. 62 , theribs 103 extend circumferentially around thehead 79.FIG. 63 shows an embodiment wherein theribs 103 are oriented helically aroundhead 79. - Alternately, as shown in
FIGS. 64-66 , the surface feature may comprise grooves orchannels 105 onhead 79. Thechannels 105 may extend toward theshaft 73 as shown inFIG. 64 , also shown in cross section inFIG. 64A , or circumferentially around the head as shown inFIG. 65 , or thechannels 105 may be arranged in a helical pattern as shown inFIG. 66 . - Additional surface features to facilitate attachment of the
bioresorbable layer 45 to head 79 includeknurling 107 as shown inFIG. 67 or a rough textured surface 109 applied to the head as shown inFIG. 68 . The rough textured surface 109 may result from a powdered metal coating adhered to the shaft using epoxy, cyanoacrylate, or other adhesives, or may be formed by sand blasting thehead 79. Attachment of the bioabsorbable layer may also be facilitated by modifying the cross sectional shape of thehead 79.FIGS. 69 and 69A show ahead 79 with an oval cross section, whereasFIGS. 70 and 70A show a head having a polygonal cross section. -
FIGS. 71-74 show detailed cross sectional views of alternate embodiments ofholes 16 inbody 12, which represent, for example, the holes throughbone plate 14, shown inFIG. 1 , hip screw 28, shown inFIG. 2 , andintramedullary rod 30, shown inFIG. 3 .FIG. 71 shows hole 16 inbody 12 having acountersink surface 112 surroundinghole 16. The countersink hole in this example is conical.FIG. 72 shows aspherical countersink surface 114. The countersink surfaces 112 and 114 permit angular motion of thefasteners 18 relative to thebody 12 when the fasteners are released from the body by absorbtion of the bioresorbable material as described below. The range of angular motion of the fasteners is further augmented by the use of an undercutsurface 116 in conjunction with the countersink surface as shown inFIG. 73 . Undercutsurface 116 is positioned opposite to the countersink surface, meaning that the undercut surface is positioned surrounding thehole 16 on an opposite face of thebody 12.FIG. 73 shows a conical undercutsurface 116 matched with aconical countersink surface 112, whileFIG. 74 illustrates a spherical undercutsurface 118 matched with aspherical countersink surface 114. - In the embodiment shown in
FIG. 71 , a layer ofbioresorbable material 44 may be positioned on thebody 12 within at least one of theholes 16. Thelayer 44 takes the form of anannulus 120 and has an inwardly facingsurface 122 which may be cylindrical and/or conical as shown inFIGS. 71 and 73 , as well as spherical, as shown inFIGS. 72 and 74 . Other shapes are also feasible. Inwardly facingsurface 122 may be smooth as shown inFIGS. 71-74 , or may haveinternal screw threads 124 as shown inFIGS. 71A-74A . Whensurface 122 is threaded, the threads engageexternal threads 124 which are positioned onshaft 126 adjacent to the head of a fastener 128 as shown inFIG. 75 , or on ahead 130 of a fastener 132 as illustrated inFIG. 76 . Note that either or both fasteners 128 and 132 may be a bone screw (FIG. 75 ) or a pin (FIG. 76 ). When the inwardly facingsurface 122 is smooth it engages fasteners through friction, or, afastener 134, shown inFIG. 77 , may have a cutting edge 136 which cuts internal screw threads into the smooth inwardly facingsurface 122 as the fastener is rotated. Again,fastener 134 may be a bone screw or a pin, a bone screw being shown by way of example. It is further understood that fasteners having a layer of bioresorbable material thereon, as shown inFIGS. 4-9, 22-27, 39-44, and 55-60 may also be used with a body having bioresorbable material as shown inFIGS. 71-74 and 71A-74A . -
FIGS. 78-83 illustrate operation of the fixation device according to the invention. These figures represent abody 12 havingholes 16 that receivefasteners 18. The body could be, for example, part of a bone plate as shown inFIG. 1 , a hip screw as shown inFIG. 2 , an intramedullary rod as shown inFIG. 3 , or another fixation device. The fasteners are bone screws and pins as described above. -
FIG. 78 showsbone screw 24 having thebioresorbable layer 44 on a portion ofscrew shaft 32 adjacent to thehead 38. When thescrew 24 is inserted through thehole 16 inbody 12 and tightened, theouter surface 46 of thelayer 44 engages the body and rigidly fixes the angular orientation of the screw relative to the body (the threaded portion ofshaft 32 engages the bone, not shown for clarity). Engagement between thelayer 44 and thebody 12 may be through any of the example mechanisms described above. For example,outer surface 46 may have external screw threads that engage compatible internal screw threads withinhole 16; theouter surface 46 may be smooth and a cutting edge (not shown) positioned withinhole 16 cuts external threads in thelayer 44; or, theouter surface 46 oflayer 44 may depend on friction between the it and the body portion surrounding the hole to provide the desired angular fixation. When all, or at least a portion, of thelayer 44 is resorbed, as shown inFIG. 78A , thescrew 24 is free to move angularly relatively to thebody 12, as evidenced by the canted position shown, and thus the interaction between thebody 12 and the bone is transformed from a region of rigid fixation to a region of flexible osteosynthesis which permits micromotion across a fracture site stimulating callous formation and bony healing. Angular rigidity of the screw may be augmented by the particular shape of thelayer 44, for example, a conical, tapered shape being advantageous for rigidity. Angular motion of thescrew 24 is further controlled through the use of countersink and undercut surfaces as described above and shown inFIGS. 71-74 . - In an alternate embodiment, shown in
FIG. 79 , the layer ofbioresorbable material 44 is positioned on thebody 12 within at least one of theholes 16. When thescrew 24 is inserted through thehole 16 inbody 12 and tightened, theouter surface 46 of thelayer 44 engages the screw and rigidly fixes the angular orientation of the screw relative to the body. Engagement between thelayer 44 and the screw may be through any of the example mechanisms described above. For example,outer surface 46 may have internal screw threads that engage compatible external screw threads on thescrew 24; theouter surface 46 may be smooth and a cutting edge (as shown at 136 inFIG. 77 ) positioned on thescrew 24 cuts internal threads in thelayer 44 as the screw is rotated, the internal threads engaging external threads on the screw; or, theouter surface 46 oflayer 44 may depend on friction between it and the screw shaft to provide the desired angular fixation. When all, or at least a portion, of thelayer 44 is resorbed, as shown inFIG. 79A , thescrew 24 is free to move angularly relatively to thebody 12 and thus transform the engagement between body and bone from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing. Angular rigidity of the screw may be augmented by the particular shape of thelayer 44, for example, a conical, tapered shape being advantageous for rigidity. Angular motion of thescrew 24 is further controlled through the use of countersink and undercut surfaces as described above and shown inFIGS. 71-74 . -
FIGS. 80 and 80A show another embodiment wherein thebioresorbable material layer 44 is positioned on both thescrew 24 and thebody 12. In this example embodiment, interaction between theouter surfaces 46 of thelayers 44 on thescrew 24 and on thebody 12, as shown inFIG. 80 , initially fixes the angular orientation of the screws relatively to the body. Interaction may be through friction between the surfaces or threaded engagement. Countersink and undercut surfaces may again be used to control the limits of relative angular motion between the screw and the body. When thelayers 44, or a portion thereof, are resorbed, thescrews 24 are no longer rigidly fixed and may move angularly with respect to thebody 12 as shown inFIG. 80A , thereby providing the advantages of both the rigid and flexible osteosynthesis systems. - In another embodiment, shown in
FIG. 81 abone screw 25 has thebioresorbable layer 45 on a portion of thehead 31. When thescrew 25 is inserted through thehole 16 inbody 12 and tightened, theouter surface 47 of thelayer 45 engages the body and rigidly fixes the angular orientation of the screw relative to the body. Engagement between thelayer 45 and thebody 12 may be through any of the example mechanisms described above. For example,outer surface 47 may have external screw threads that engage compatible internal screw threads withinhole 16; theouter surface 47 may be smooth and a cutting edge (not shown) positioned withinhole 16 cuts external threads in thelayer 45, or, theouter surface 47 oflayer 45 may depend on friction between the it and the body portion surrounding the hole to provide the desired angular fixation. When all, or at least a portion, of thelayer 45 is resorbed, as shown inFIG. 81A , thescrew 25 is free to move angularly relatively to thebody 12 and thus transform from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing. Angular rigidity of the screw may be augmented by the particular shape of thelayer 45, for example, a conical, tapered shape as shown being advantageous for rigidity. Angular motion of thescrew 25 is further controlled through the use of countersink and undercut surfaces as described above and shown inFIGS. 71-74 . - In another alternate embodiment, shown in
FIG. 82 , the layer ofbioresorbable material 45 is positioned on thebody 12 within at least one of theholes 16. When thescrew 25 is inserted through thehole 16 inbody 12 and tightened, theouter surface 47 of thelayer 45 engages the screw'shead 31 and rigidly fixes the angular orientation of the screw relative to the body. Engagement between thelayer 45 and thescrew head 31 may be through any of the example mechanisms described above. For example,outer surface 47 may have internal screw threads that engage compatible external screw threads on thehead 31; theouter surface 47 may be smooth and a cutting edge (not shown) positioned on thescrew 25 cuts internal threads in thelayer 45, or, theouter surface 47 oflayer 45 may depend on friction between it and the head to provide the desired angular fixation. When all, or at least a portion, of thelayer 45 is resorbed, as shown inFIG. 82A , thescrew 25 is free to move angularly relatively to thebody 12 and thus transform from a region of rigid fixation to a region of flexible osteosynthesis and permit micromotion across a fracture site stimulating callous formation and bony healing. Angular rigidity of the screw may be augmented by the particular shape of thelayer 45, for example, a conical, tapered shape (shown) being advantageous for rigidity. Angular motion of thescrew 25 is further controlled through the use of countersink and undercut surfaces as described above and shown inFIGS. 71-74 . -
FIGS. 83 and 83A show another embodiment wherein thebioresorbable material layer 45 is positioned on both thehead 31 ofscrew 25 and thebody 12. In this example embodiment, interaction between theouter surfaces 47 of thelayers 45 on thescrew 25 and on thebody 12, as shown inFIG. 80 , initially fixes the angular orientation of the screws relatively to the body. Interaction may be through friction between the surfaces or threaded engagement. Countersink and undercut surfaces may again be used to control the limits of relative angular motion between the screw and the body. When thelayers 45, or a portion thereof, are resorbed, thescrews 25 are no longer rigidly fixed and may move angularly with respect to thebody 12 as shown inFIG. 83A , thereby providing the advantages of both the rigid and flexible osteosynthesis systems. - Another embodiment is shown in
FIGS. 83B and 83C , whereinscrew 25 has ahead 31 with a substantiallysmooth side surface 31 a and a layer ofbioresorbable material 45 on the top of thehead 31.Bioresorbable layer 45 engages thebody 12 usingscrew threads 95 which mate with compatible internal threads inhole 16 and initially fix the angular orientation of the screw relative to the body.Screw threads 95 may be molded into thebioresorbable layer 45 when it is applied to thescrew 25, or thelayer 45 may be initially smooth and the threads cut, for example, as the screw is threaded into thehole 16. When thebioresorbable layer 45 is resorbed, as shown inFIG. 83C , thescrew 25 no longer fixedly engages thebody 12 and is free to rotate angularly relative to the body. Note that a counter sunk screw is shown by way of example, but other shapes of screw heads and bioresorbable layers, such as cylindrical, conical and spherical shapes, are equally feasible. - The invention also encompasses a method of treating a bone fracture in a living organism having a plurality of bone fragments. The method comprises:
-
- attaching a body to at least two of the bone fragments using a plurality of fasteners joining the body to the fragments;
- fixing an angular orientation of at least one of the fasteners in relation to the body using a bioresorbable material positioned between the fastener and the body, the bioresorbable material contacting the one fastener and the body and preventing relative rotation therebetween;
- allowing the bioresorbable material to be resorbed by the living organism, thereby allowing relative rotation between the one fastener and the body.
- The fasteners used in the method according to the invention include bone screws and pins as described herein. The bioresorbable material may be located on the fastener, on the body, or on both the fastener and the body. The angular orientation of the fasteners relative to the body may be fixed by frictional engagement between the body and the bioresorbable layer on the fastener, by frictional engagement between the fastener and the bioresorbable layer on the body, or between bioresorbable layers on both the body and the fastener. The angular orientation of the fasteners relative to the body may be also fixed by engagement between internal screw threads on the body and external screw threads on the bioresorbable layer on the fastener, by engagement between external screw threads on the fastener and internal screw threads on the bioresorbable layer on the body, or between internal and external screw threads on the bioresorbable layers on both the body and the fastener, respectively. The body may be part of a fixation device, such as a bone plate, a hip screw, an intramedullary rod and the like.
-
FIGS. 84 and 85 show anexample body 12 in the form of abone plate 140 according to the invention.Plate 140 comprises a bone contacting surface 142 (FIG. 85 ) and an obverse surface 144 (FIG. 84 ) arranged opposite to thebone contacting surface 142. Side surfaces 146 extend between the bone contacting andobverse surfaces holes 148 extend between thebone contacting surface 142 and theobverse surface 144.Holes 148 receivefasteners 18, which could be bone screws as shown inFIGS. 4-9 and 39-44 , and/or pins as shown inFIGS. 22-27, and 55-60 (fastener 18 is shown as a bone screw by way of example). Theholes 148 may be round, as well as non-round, for example oval or elliptical as shown inFIGS. 86 and 87 . Other, more complicated shapes are also feasible. One or morecutting edges 137 may be positioned in the holes to cut threads in a bioresorbable material layer positioned on thefastener 18 as described above. The holes may also be countersunk and undercut as described above. A layer ofbioabsorbable material 44 may be positioned within one or more of theholes 148 similar to the embodiments illustrated inFIGS. 71-74 and 71A-74A . - As best shown in
FIGS. 84 and 85 , theplate 140 comprises a plurality ofchannels 150 positioned within either or both theobverse surface 144 and thebone contacting surface 142. Eachchannel 150 extends from ahole 148 to aside surface 146 and facilitates the flow of bodily fluids to and from the hole. This flow of fluids allowsbioresorbable layers 44, either on theplate 140 or thefasteners 18, or on both, to be readily resorbed to transform theplate 140 from operation as a rigid osteosynthesis device to a flexible osteosynthesis device. When the bioresorbable layers are present, the angular orientation offasteners 18, which could be bones screws and/or pins as described above, is fixed with respect to theplate 140. When the layers are resorbed the fasteners are free to move angularly with respect to theplate 14 and thereby permit the micromotions conducive to callous formation and bony healing. -
Channels 150 as shown inFIGS. 84 and 85 comprise a concave, conical surface. Note that in the example shown, the width of the channel where it intersectsside surface 146 is greater than where the channel intersects thehole 148.Channels 150 may have different cross sectional shapes from those shown inFIG. 85 . As shown inFIG. 88 , thechannel 150 may have a spherical shape;FIG. 89 shows achannel 150 having a “V” cross sectional shape;FIG. 90 shows achannel 150 having a cylindrical or “U” cross sectional shape, andFIG. 91 shows achannel 150 having a trapezoidal cross sectional shape. Other channel shapes are also feasible. - As shown in
FIG. 92 , thebody 12 represented by an example bone plate 152 has a plurality ofprojections 154 on itsbone facing side 156.Projections 154 act as spacers to stand the plate 152 in spaced relation away from bone to permit bodily fluids to flow to and fromholes 158 in the plate to facilitate resorbtion of the bioresorbable material on the plate and/or the fasteners use to attach the plate to the bone.Projections 154 may be integrally formed with the plate or attached thereto as separate components. - Further by way of example applications of the invention, the hip screw 28, shown in
FIG. 2 may use a layer ofbioabsorbable material 44 surrounding a portion of the shaft adjacent to the head of the compressingscrew 24 a. As shown inFIG. 3 , screw 24, which secures theintramedullary rod 30 tobone portion 20 b, may have a layer ofbioresorbable material 44 positioned on a portion of the screw shaft in spaced relation away from the head.Pin 26 may also have a layer of bioresorbable material positioned along its shaft as well. - The bioresorbable materials comprising the layers attached to the fasteners, such as the bone screws and pins, as well as the layers on the body, such as the bone plate, the plate associated with the hip screw, and the intramedullary rod may comprise polymer materials and/or polymer-glass/ceramic including (but not limited to) polylactic acid (PLA), poly-L-lactic-co-glycolic acid (PLGA), poly-D/L-lactic acid with or without polyglycolic acid (PDLLA, PDLLA-co-PGA), poly-L-lactic acid with or without β-tricalcium phosphate (PLLA, PLLA-TCP), poly-L-lactic acid with hydroxyapatite (PLLA-HA), polycaprolactone (PCL), polycaprolactone-Calcium Phosphate (PCL-CaP), poly(L-lactide-co-D,L-lactide) (PLADLA), hydroxyapatite (HA), tricalcium phosphate (β-TCP) and combinations thereof. Nanodiamond particles may be admixed with the bioresorbable materials to increase their strength.
- Additionally, bioresorbable materials which expand when in contact with bodily fluids, or by the action of heat or ultrasonic waves may also be feasible for use with the fixation device according to the invention. Such materials include copolymer lactic glycolic acid (80/20), biodegradeable self-expanding poly-L,D-lactide, PDLLA comprising D-Lactide and L-lactide and poly-L-lactide and poly-ε-caprolactone homopolymers. Expanding or swelling polymeric materials include the monomers methylmethacrylate and acrylic acid and cross linking agent allymelhacrylate. Material layers made of these materials swell by absorbtion of body fluids and thereby produce fixation between the fastener and the bone plate, hip screw or intramedullary rod by an interference fit.
- Selective degradation of the bioresorbable material layer may be controlled at the discretion of the surgeon or healthcare practitioner through various means including focal hydrolysis with acids, alkalis or enzymes. Other means of inducing degradation include the exposure of the bioresorbable layer to UV light or radiation, oxidation, high temperatures, ultrasound and focused high intensity acoustic pulses.
Claims (1)
1. A method of treating a bone fracture in a living organism having a plurality of bone fragments, said method comprising:
attaching a body to at least two of said bone fragments using a plurality of fasteners joining said body to said fragments;
fixing an angular orientation of at least one of said fasteners in relation to said body using a bioresorbable material positioned between said fastener and said body, said bioresorbable material contacting said one fastener and said body and preventing relative rotation therebetween;
allowing said bioresorbable material to be resorbed by said living organism, thereby allowing relative rotation between said one fastener and said body.
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US16/373,159 US11389216B2 (en) | 2009-03-24 | 2019-04-02 | Orthopedic fixation screw with bioresorbable layer |
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US15/451,521 US20170172635A1 (en) | 2009-03-24 | 2017-03-07 | Orthopedic Fixation Screw With Bioresorbable Layer |
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2013
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2015
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2016
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2017
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2018
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Also Published As
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JP2012521800A (en) | 2012-09-20 |
US20190223926A1 (en) | 2019-07-25 |
US20160045237A1 (en) | 2016-02-18 |
WO2010111350A1 (en) | 2010-09-30 |
EP2410929A4 (en) | 2014-11-12 |
CA2794019A1 (en) | 2010-09-30 |
CA2794019C (en) | 2019-09-10 |
US9622803B2 (en) | 2017-04-18 |
US20140039566A1 (en) | 2014-02-06 |
JP2016195837A (en) | 2016-11-24 |
EP2410929B1 (en) | 2019-06-26 |
US20100249850A1 (en) | 2010-09-30 |
US9179956B2 (en) | 2015-11-10 |
US8506608B2 (en) | 2013-08-13 |
EP2410929A1 (en) | 2012-02-01 |
JP2014237026A (en) | 2014-12-18 |
US11389216B2 (en) | 2022-07-19 |
JP2018134468A (en) | 2018-08-30 |
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