WO2011042407A1 - Device for synthesis of bone fractures - Google Patents

Device for synthesis of bone fractures Download PDF

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Publication number
WO2011042407A1
WO2011042407A1 PCT/EP2010/064781 EP2010064781W WO2011042407A1 WO 2011042407 A1 WO2011042407 A1 WO 2011042407A1 EP 2010064781 W EP2010064781 W EP 2010064781W WO 2011042407 A1 WO2011042407 A1 WO 2011042407A1
Authority
WO
WIPO (PCT)
Prior art keywords
plate
holes
head
screws
diameter
Prior art date
Application number
PCT/EP2010/064781
Other languages
French (fr)
Inventor
Roberto Rotini
Enrico Guerra
Original Assignee
Hit Medica Spa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hit Medica Spa filed Critical Hit Medica Spa
Priority to US13/500,298 priority Critical patent/US20120203285A1/en
Priority to ES10773590.4T priority patent/ES2554335T3/en
Priority to EP10773590.4A priority patent/EP2485669B1/en
Publication of WO2011042407A1 publication Critical patent/WO2011042407A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
    • A61B17/8057—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded the interlocking form comprising a thread
    • 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

Definitions

  • the present invention relates to a device for synthesis of bone fractures.
  • the aim of the present invention is therefore to achieve a device capable to overcome the drawbacks of the known devices and to be economically profitable compared with the traditional ones.
  • a device for synthesis of bone fractures comprising a plate and screws for locking said plate.
  • Said plate is made from biocompatible and radiolucent plastic material suitable to permit a radiographic control and an easy explantation of the plate and is provided with through holes for the screws fixing the plate on the bone.
  • Said screws comprise a threaded shank having an external diameter less than the diameter of said holes and a head having a thread with an external diameter greater than the diameter of said holes so as to permit insertion of the screws according to a plurality of directions and inclination with respect to the axis of the holes in the plate, said head being suitable to engage said holes by self-threading.
  • the holes of the plate are substantially cylindrical and have a diameter such as to permit angular selection of the screw shank relative to the plate.
  • the head is substantially cylindrical and has a helical thread with spiral rings having an external diameter greater than the diameter of the holes so that, when the head is screwed in the holes, the spiral rings engage the hole wall by self-threading so as to lock the screw in the selected angulation.
  • FIG. 1 shows a perspective view of a plate according to the invention
  • -figure 2 is an enlarged view of a portion of the plate of figure 1 ;
  • FIG. 3 is a view of a screw partially screwed through the plate
  • figure 4 is a view of a screw entirely screwed through the plate of figure 1.
  • the reference 1 designates a plate according to the invention comprising a bar entirely made from a biocompatible plastic material POLYETHRETHERKETONE, well known by name of PEEK and suitable to facilitate the explantation of the plate.
  • a biocompatible plastic material POLYETHRETHERKETONE, well known by name of PEEK and suitable to facilitate the explantation of the plate.
  • this biocompatible plastic material is radiolucent to make the radiocontrol easy and advantageously strengthened by means of carbon fibres.
  • the shape of the plate may be any according to the shape of the bone near to the fracture to be reduced.
  • references 2 and 3 indicate the bone and the fracture edges respectively.
  • plate 1 a plurality of through holes is formed (see figure 4) the number and disposition of which along the plate depend from the design of the plate and from the anatomical zones in which the use is intended.
  • the holes 4 are preferably cylindrical and their diameter depends from the size of screws 5 which are driven through the holes 4 to lock the plate 1 on the bone 2 and to join the bone portions that compose the fracture 3.
  • the screws 5 comprise a head 6 and a shank 7.
  • the head 6 comprises a core 8, around which a helical thread 9 extends helically having one or two starts according to the screw type, whereby the spiral rings of the threads have a substantially triangular or orthopaedic section and an external diameter which is greater than the diameter of the hole 4.
  • the head 6 is cylindrical in shape.
  • the core 8 is cylindrical and has a diameter smaller than that of the hole 4 so that, when the head 6 is screwed in the hole 4, the thread 9 engages the wall of the hole 4.
  • the core 8 may present a conical shape.
  • the head 6 at the end opposite to the shank 7, is provided with a collar 10 having a diameter greater than the external diameter of the thread 9, which collar 10 acts as arrest on the upper face of the plate 1 when the head 6 is completely threaded in the hole 4 as it will appear in the following.
  • the lower face of the collar 10 comprises a indentation 11 which engages the plate 1 thus preventing unscrewing of the screw 5 in case of bone failure.
  • the shank 7 comprises a thread 12, for example having spiral rings with substantial triangular or usual in orthopaedic threads and an external diameter smaller than that of the core 8 and therefore such as to render the shank 7 loose when driven through the hole 4.
  • the difference between the diameter of the hole 4 of the plate 1 and the external diameter of the thread of the shank 7 is preferably such as to permit the latter to reach an inclination of at least 15° with respect to the axis A of the hole 6.
  • the structure of the screws 5 is completed by a recess 13 formed in the head 6 (see figure 4) and having a polygonal shape to permit engagement of an alien spanner by means of which the user may carry out screwing of the screws.
  • the plate 1 may be positioned with high simplicity. Indeed after the plate 1 has been positioned on the bone 2, the screws 5 are applied and the axis B may be arranged with respect to axis A of the holes, according to the inclination necessary to drive the screws into the various areas of the bone 2 which are in condition to give a sufficiently firm grip able to consent reduction of the fracture 3.
  • the screw 5 is screwed until the thread 9 of the head 6 abuts the plate 1.
  • the present invention suggests a solution with the substantial advantage that the head 6, owing to a thread 9 having a greater diameter, after being forced into the hole 4, permits to nullify the clearance of the increased holes 4 and consequently to firmly lock the plate 1.
  • the threads 9, 12 have a small pitch difference.
  • the selection of angulation and locking of the screws is not limited as in the prior art.
  • the plastic material, e.g. PEEK, of the plate permits the threads of the screws to penetrate by self-drilling the inner wall of the hole also in case of relevant angulation with respect to the plane thus achieving solid anchoring of the screws to the plate.
  • radiolucent plastic material unlike to a radio-opaque material (stainless steel, titanium alloy of common use) permits a more efficacious radiographic control of the fracture both in operating field, including the possibility to improve the implantation of the plate, and during periodical post operative controls in order to verify the progress of the recovery of the fracture.
  • Another very important aspect of the invention is the possibility to easily explant the plate 1, contrary to the difficulties found in the explantation of metal plates having threaded holes. In fact in these plates the head of the screws engages the threaded hole of the plate and the unscrewing of the screws during explantation is laborious because of the threads which get stuck between the screw head and the plate.
  • the plate 1 is provided with a perimetric stiffening rib 14 (see figures 1, 2).
  • a perimetric stiffening rib 14 see figures 1, 2.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Device for synthesis of bone (2) fractures (3), comprising a plate (1) and screws (5) for locking said plate. The plate (1) is entirely made from biocompatible and radiolucent plastic material suitable to permit a radiographic control and an easy explantation of the plate and is provided with through holes (4) for the screws (5) fixing the plate (1) on the bone (2). The screws (5) comprise a threaded shank (7) having an external diameter less than the diameter of said holes (4) and a head (6) having a thread with an external diameter greater than the diameter of said holes (4) so as to permit insertion of the screws (5) according to a plurality of directions and inclination with respect to the axis of the holes (4) in the plate (1), said head (6) being suitable to engage said holes (4) by self-threading.

Description

"DEVICE FOR SYNTHESIS OF BONE FRACTURES"
* * * *
FIELD OF THE INVENTION
The present invention relates to a device for synthesis of bone fractures.
BACKGROUND OF THE INVENTION
For synthesis of bone fractures the use of special metal plates is known which are properly shaped to be locked on the outer side of the bone by means of screws. For example, for synthesis of trochanter or femur neck fractures plates, are used which are placed on the fracture edges and fixed by means of screws which are driven with proper inclination in order to penetrate the bone parts which appear to be solid and less injured and therefore able to assure a firm reduction of the fracture.
However the plates generally used present some locking difficulties owing to the fact that the plates do not always permit that the screws are steadily inserted into the fractured segments of the bone with exact and sufficient inclination. In order to permit that the screws assume a greater inclination, it has been suggested to insert an auxiliary bushing or washer between the plate and the screw head having a hemispherical seat to accommodate the complementary head of the screws so as to create an articulation allowing the screws to assume the required inclination. On the other hand the interposition of bushings involves evident economic increase and their use requires an appreciable rise of the plate dimension to get sufficient space for the creation of a hemispherical seat suitable to lodge the screw head.
SUMMARY OF THE INVENTION
The aim of the present invention is therefore to achieve a device capable to overcome the drawbacks of the known devices and to be economically profitable compared with the traditional ones.
This aim is achieved with a device for synthesis of bone fractures, comprising a plate and screws for locking said plate. Said plate is made from biocompatible and radiolucent plastic material suitable to permit a radiographic control and an easy explantation of the plate and is provided with through holes for the screws fixing the plate on the bone. Said screws comprise a threaded shank having an external diameter less than the diameter of said holes and a head having a thread with an external diameter greater than the diameter of said holes so as to permit insertion of the screws according to a plurality of directions and inclination with respect to the axis of the holes in the plate, said head being suitable to engage said holes by self-threading.
According to some embodiments of the present invention, the holes of the plate are substantially cylindrical and have a diameter such as to permit angular selection of the screw shank relative to the plate. Moreover, in some embodiments, the head is substantially cylindrical and has a helical thread with spiral rings having an external diameter greater than the diameter of the holes so that, when the head is screwed in the holes, the spiral rings engage the hole wall by self-threading so as to lock the screw in the selected angulation.
BRIEF DESCRIPTION OF THE DRAWINGS
Further characteristics and advantages of the present invention will become more apparent from the following description of a preferred but not exclusive embodiment, illustrated by way of example in the accompanying drawings wherein:
- figure 1 shows a perspective view of a plate according to the invention;
-figure 2 is an enlarged view of a portion of the plate of figure 1 ;
- figure 3 is a view of a screw partially screwed through the plate;
- figure 4 is a view of a screw entirely screwed through the plate of figure 1.
DETAILED DESCRIPTION OF A PREFERENTIAL FORM OF
EMBODIMENT
In figures 1 and 2 the reference 1 designates a plate according to the invention comprising a bar entirely made from a biocompatible plastic material POLYETHRETHERKETONE, well known by name of PEEK and suitable to facilitate the explantation of the plate. Preferably this biocompatible plastic material is radiolucent to make the radiocontrol easy and advantageously strengthened by means of carbon fibres.
The shape of the plate may be any according to the shape of the bone near to the fracture to be reduced. In figure 1, references 2 and 3 indicate the bone and the fracture edges respectively. In plate 1 a plurality of through holes is formed (see figure 4) the number and disposition of which along the plate depend from the design of the plate and from the anatomical zones in which the use is intended. The holes 4 are preferably cylindrical and their diameter depends from the size of screws 5 which are driven through the holes 4 to lock the plate 1 on the bone 2 and to join the bone portions that compose the fracture 3.
The screws 5 comprise a head 6 and a shank 7. The head 6 comprises a core 8, around which a helical thread 9 extends helically having one or two starts according to the screw type, whereby the spiral rings of the threads have a substantially triangular or orthopaedic section and an external diameter which is greater than the diameter of the hole 4. In some embodiments, the head 6 is cylindrical in shape. In some particular embodiments, the core 8 is cylindrical and has a diameter smaller than that of the hole 4 so that, when the head 6 is screwed in the hole 4, the thread 9 engages the wall of the hole 4. Likewise the core 8 may present a conical shape.
The head 6 at the end opposite to the shank 7, is provided with a collar 10 having a diameter greater than the external diameter of the thread 9, which collar 10 acts as arrest on the upper face of the plate 1 when the head 6 is completely threaded in the hole 4 as it will appear in the following. Advantageously, in order to render the screw 5 more secure against unscrewing once it is tightened, the lower face of the collar 10 comprises a indentation 11 which engages the plate 1 thus preventing unscrewing of the screw 5 in case of bone failure.
The shank 7 comprises a thread 12, for example having spiral rings with substantial triangular or usual in orthopaedic threads and an external diameter smaller than that of the core 8 and therefore such as to render the shank 7 loose when driven through the hole 4. The difference between the diameter of the hole 4 of the plate 1 and the external diameter of the thread of the shank 7 is preferably such as to permit the latter to reach an inclination of at least 15° with respect to the axis A of the hole 6.
The structure of the screws 5 is completed by a recess 13 formed in the head 6 (see figure 4) and having a polygonal shape to permit engagement of an alien spanner by means of which the user may carry out screwing of the screws.
From the above description it will appear evident that the plate 1 may be positioned with high simplicity. Indeed after the plate 1 has been positioned on the bone 2, the screws 5 are applied and the axis B may be arranged with respect to axis A of the holes, according to the inclination necessary to drive the screws into the various areas of the bone 2 which are in condition to give a sufficiently firm grip able to consent reduction of the fracture 3. In a first phase when the plate 1 has been positioned on the bone 2, by means of an alien spanner engaging the recess 13, the screw 5 is screwed until the thread 9 of the head 6 abuts the plate 1. At this moment, a further screwing of the screw 5 causes abutment of the plate 1 on the bone 2 owing to the pressure of the first spiral ring of the thread 9 of the head 6 on the plate 1. When the pressure exerted by the thread 9 on the plate 1 is over a certain value, forced penetration of the thread 9 into the hole 4 begins and the collar 10, acting on the plate 1, causes the definitive tightening on the bone 2.
It will be observed that while locking of the plate 1 on the bone 2 is resulting from a first traction effect exerted by the thread 12 of the shank 7, screwing of the thread 9 gives as result to set at zero the clearance of the screw 5 in the hole 4 and therefore the even if very small displacement that the plate 1 could do and compromise the firmness of the plate 1 and of the fracture 3.
In fact, in order to permit the inclination of the screws 5 according to the necessity required from the appearance of the fracture 3, it would be necessary to provide increase of the hole dimension. However the increase would cause excessive clearance which will have as consequence a locking inadequate and suitable to induce displacement of the plate 1.
On the contrary the present invention suggests a solution with the substantial advantage that the head 6, owing to a thread 9 having a greater diameter, after being forced into the hole 4, permits to nullify the clearance of the increased holes 4 and consequently to firmly lock the plate 1. Advantageously, in order to create a compression effect between plate 1 and bone 2, the threads 9, 12 have a small pitch difference.
Moreover, with the present invention the selection of angulation and locking of the screws is not limited as in the prior art. In fact, the plastic material, e.g. PEEK, of the plate permits the threads of the screws to penetrate by self-drilling the inner wall of the hole also in case of relevant angulation with respect to the plane thus achieving solid anchoring of the screws to the plate.
Thus the described device achieves the intended aims. The use of radiolucent plastic material, unlike to a radio-opaque material (stainless steel, titanium alloy of common use) permits a more efficacious radiographic control of the fracture both in operating field, including the possibility to improve the implantation of the plate, and during periodical post operative controls in order to verify the progress of the recovery of the fracture. Another very important aspect of the invention is the possibility to easily explant the plate 1, contrary to the difficulties found in the explantation of metal plates having threaded holes. In fact in these plates the head of the screws engages the threaded hole of the plate and the unscrewing of the screws during explantation is laborious because of the threads which get stuck between the screw head and the plate.
Numerous modifications and variations are possible in the practical embodiment of the invention. Advantageously the plate 1 is provided with a perimetric stiffening rib 14 (see figures 1, 2). Instead of one rib it is possible to provide few ribs arranged so as to stiff the zones of the plate which are subjected to the greatest efforts.

Claims

1) Device for synthesis of bone (2) fractures (3), comprising a plate (1) and screws (5) for locking said plate (1), characterized in that said plate (1) is entirely made from biocompatible and radiolucent plastic material suitable to permit a radiographic control and an easy explantation of the plate (1) and is provided with through holes (4) for the screws (5) fixing the plate (1) on the bone (2) and that said screws (5) comprise a threaded shank (7) having an external diameter less than the diameter of said holes (4) and a head (6) having a thread with an external diameter greater than the diameter of said holes (4) so as to permit insertion of the screws (5) according to a plurality of directions and inclination with respect to the axis of the holes (4) in the plate (1), said head (6) being suitable to engage said holes (4) by self-threading.
2) Device according to claim 1, characterized in that said radiolucent material is suitable to permit a radiographic control during reduction of the fracture.
3) Device according to one of the above claims 1 or 2, characterized in that said head (6), at the end opposite to the shank (7), is provided with a collar (10) having a diameter greater than the external diameter of the threading (9) of said head and suitable to act as abutment on the upper face of the plate when the head (6) is completely screwed in said hole (4).
4) Device according to claim 3, characterized in that said collar (10) is provided with an indentation (1 1) on the face facing said threading (9).
5) Device according to one of the above claims, characterized in that said biocompatible and radiolucent plastic material is POLYETHERETHER- KETONE known on the market as PEEK.
6) Device according to claim 5, characterized in that said biocompatible and radiolucent plastic material is POLYETHERETHER-KETONE known on the market as PEEK and stiffened with carbon fibres.
7) Device according to one of the above claims, characterized in that said biocompatible and radiolucent plastic material is suitable to aid explantation of the head (6) of the screws from the holes (4) of said plate (1).
8) Device according to one of the above claims, characterized in that said plate (1) is provided with stiffening ribs. 9) Device according to claim 8, characterized in that said plate (1) is provided with a perimetric stiffening rib (14).
10) Device according to one of the above claims, characterized in that said holes (4) of the plate (1) are substantially cylindrical and have a diameter such as to permit angular selection of the screw shank (7) relative to the plate (1), said head (6) being substantially cylindrical and having a helical thread (9) with spiral rings having an external diameter greater than the diameter of the holes (4) so that, when the head (6) is screwed in the holes (4), the spiral rings engage the hole wall by self-threading so as to lock the screw (5) in the selected angulation.
PCT/EP2010/064781 2009-10-05 2010-10-05 Device for synthesis of bone fractures WO2011042407A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US13/500,298 US20120203285A1 (en) 2009-10-05 2010-10-05 Device for synthesis of bone fractures
ES10773590.4T ES2554335T3 (en) 2009-10-05 2010-10-05 Bone fracture synthesis device
EP10773590.4A EP2485669B1 (en) 2009-10-05 2010-10-05 Device for synthesis of bone fractures

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SMSM-A-200900081 2009-10-05
SM200900081A SM200900081B (en) 2009-10-05 2009-10-05 Plate system for osteosynthesis with angular stability multi-axial screws in polymeric material.

Publications (1)

Publication Number Publication Date
WO2011042407A1 true WO2011042407A1 (en) 2011-04-14

Family

ID=41527631

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/064781 WO2011042407A1 (en) 2009-10-05 2010-10-05 Device for synthesis of bone fractures

Country Status (5)

Country Link
US (1) US20120203285A1 (en)
EP (1) EP2485669B1 (en)
ES (1) ES2554335T3 (en)
SM (1) SM200900081B (en)
WO (1) WO2011042407A1 (en)

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WO2013148942A1 (en) * 2012-03-28 2013-10-03 Biomet Manufacturing, Llc. Loose thread form for variable angle locking systems
US8709055B2 (en) 2009-01-16 2014-04-29 Carbofix Orthopedics Ltd. Composite material bone implant
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US9101427B2 (en) 2010-06-07 2015-08-11 Carbofix Orthopedics Ltd. Self tapping insert
US9526549B2 (en) 2012-01-16 2016-12-27 Carbofix Orthopedics Ltd. Bone screw with insert
EP2866706B1 (en) 2012-06-27 2018-09-19 Synthes GmbH Variable angle bone fixation device
US10154867B2 (en) 2010-06-07 2018-12-18 Carbofix In Orthopedics Llc Multi-layer composite material bone screw
US10617458B2 (en) 2015-12-23 2020-04-14 Carbofix In Orthopedics Llc Multi-layer composite material bone screw

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US9101417B2 (en) 2009-01-16 2015-08-11 Carbofix Orthopedics Ltd. Composite material bone implant
US10028777B2 (en) 2009-01-16 2018-07-24 Carbofix Orthopedics Ltd. Composite material bone implant
US8709055B2 (en) 2009-01-16 2014-04-29 Carbofix Orthopedics Ltd. Composite material bone implant
US9974586B2 (en) 2010-06-07 2018-05-22 Carbofix Orthopedics Ltd. Composite material bone implant
US10154867B2 (en) 2010-06-07 2018-12-18 Carbofix In Orthopedics Llc Multi-layer composite material bone screw
US10849668B2 (en) 2010-06-07 2020-12-01 Carbofix Orthopedics Ltd. Composite material bone implant
US9370388B2 (en) 2010-06-07 2016-06-21 Carbofix Orthopedics Ltd. Composite material bone implant
US9101427B2 (en) 2010-06-07 2015-08-11 Carbofix Orthopedics Ltd. Self tapping insert
US9526549B2 (en) 2012-01-16 2016-12-27 Carbofix Orthopedics Ltd. Bone screw with insert
EP2614787A1 (en) 2012-01-16 2013-07-17 Carbofix Orthopedics Ltd. Multi-axial bone plate fixation
WO2013148942A1 (en) * 2012-03-28 2013-10-03 Biomet Manufacturing, Llc. Loose thread form for variable angle locking systems
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SM200900081A (en) 2009-11-06
EP2485669B1 (en) 2015-08-26
ES2554335T3 (en) 2015-12-18
US20120203285A1 (en) 2012-08-09
SM200900081B (en) 2010-11-12
EP2485669A1 (en) 2012-08-15

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