WO2014015942A1 - Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system - Google Patents

Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system Download PDF

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Publication number
WO2014015942A1
WO2014015942A1 PCT/EP2013/001965 EP2013001965W WO2014015942A1 WO 2014015942 A1 WO2014015942 A1 WO 2014015942A1 EP 2013001965 W EP2013001965 W EP 2013001965W WO 2014015942 A1 WO2014015942 A1 WO 2014015942A1
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WO
WIPO (PCT)
Prior art keywords
end portion
fixation system
bone
pins
external
Prior art date
Application number
PCT/EP2013/001965
Other languages
French (fr)
Inventor
Daniele Venturini
Original Assignee
Orthofix S.R.L.
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
Priority to CA2878967A priority Critical patent/CA2878967C/en
Application filed by Orthofix S.R.L. filed Critical Orthofix S.R.L.
Priority to US14/417,051 priority patent/US10631896B2/en
Priority to ES13744426.1T priority patent/ES2573282T3/en
Priority to AU2013295399A priority patent/AU2013295399B2/en
Priority to JP2015523439A priority patent/JP6495168B2/en
Priority to CN201380039262.2A priority patent/CN104487010B/en
Priority to BR112015001589-1A priority patent/BR112015001589B1/en
Priority to EP13744426.1A priority patent/EP2877111B1/en
Priority to MX2015001048A priority patent/MX2015001048A/en
Priority to KR1020157003726A priority patent/KR102171796B1/en
Publication of WO2014015942A1 publication Critical patent/WO2014015942A1/en
Priority to IL236921A priority patent/IL236921A/en
Priority to HK15105960.8A priority patent/HK1204905A1/en

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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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6458—Devices extending alongside the bones to be positioned with pin-clamps fixed at ends of connecting element
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/645—Devices extending alongside the bones to be positioned comprising a framework
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6466—Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66—Alignment, compression or distraction mechanisms
    • 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
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/8635—Tips of screws

Definitions

  • the present invention relates to an elongated pin for an external modular fixation system for temporary and /or permanent fixation applications and to an external modular fixation system using said pin.
  • External fixation systems are widely used to treat bone fractures and to connect two or more bone fragments to each other.
  • Known systems employ bone screws, pins and/ or wires that are inserted into the bones and that use external structural elements such as fixation clamps, fixation rods, bars and rings to provide a rigid frame structure to hold the bone fragments in an intended place until a permanent healing.
  • each long bone has a stable fixation and that each fracture is contained in a stable manner.
  • fixation systems that are mainly used as permanent fixation systems to provide bone fracture healing, for instance the system as disclosed in EP 1 284 666 for the same Applicant.
  • temporary fixation systems are lighter and simpler but also less stable when compared to known permanent external fixation systems and manufacturers provide different catalogue products to clearly identify the two different fields of application and their corresponding products.
  • temporary and permanent external fixation systems can often be differentiated by the shape and structure of their respective clamps.
  • permanent external fixation systems and devices provide a high degree of stiffness and stability to control forces of lateral bending and torque during the treatment.
  • This stiffness and stability derive in part from the alignment of the bars of the fixator along the lengthwise axis of the bone that is being treated, partly through the inherent rigidity of the system and partly from the number of screws and bone interfaces.
  • the technical problem of the present invention is that of providing an elongated pin for an external modular fixation system for temporary and/ or permanent fixation applications and an external modular fixation system using said pin, to offer stable and robust fixation of bone fragments while keeping the entire system extremely light to avoid problems of infection, while ensuring at the same time that the application of the system by a surgeon is straightforward.
  • Another aim of the present invention is that of providing an elongated pin for a modular fixation system that can be driven into the bone without the use of bone screws, which makes it possible to limit the gripping action to just the cortical portion of the fractured bone.
  • Another purpose of the present invention is that of allowing the same fixation system to be used also for bone lengthening procedures in preadolescent children or in adults.
  • the basic idea of the present invention is based on providing an elongated pin or rod with a threaded end that is implanted into only the cortical portion of the fractured bone and fixed to a plate clamp element; a group of at least three of such pins is fixed on a single clamp plate element and the pins are implanted according to different, non-coplanar directions to create a strong gripping action without reaching or damaging the medullary canal.
  • an elongated pin for an external modular fixation system for temporary and/ or permanent fixation applications for the treatment of bone fractures according to claim 1 of the present invention.
  • the invention further relates to an external modular fixation system for temporary and/ or permanent fixation applications for the treatment of bone fractures and connecting two or more bone fragments to each other according to claim 7.
  • FIG. 1A- 1C show different views of an external modular fixation system according to the present invention for the temporary or permanent treatment of bone fractures of lower and upper limbs;
  • FIG. 2 shows a portion of an external modular fixation system presenting a minor constructional modification in comparison with the system of Figures 1A-1C;
  • FIG. 3 is a perspective view of an external modular fixation system according to a different embodiment of the present invention.
  • FIG. 4 is a perspective view of an external modular fixation system presenting a minor constructional modification with respect to the system of Figure 3;
  • FIG. 5 is a view of an elongated pin according to a first embodiment for the external modular fixation system of the present invention
  • FIGS. 6A-6C show an enlargement of a conical end portion of the elongated pin of Figure 5 before the application of the thread;
  • FIGS. 7A-7D show the thread profile of the threaded conical end portion of the elongated pin of Figure 5 after the application of the thread;
  • FIG. 8 is a view of an elongated pin according to a second embodiment of the external modular fixation system of the present invention.
  • FIGS 10A- 10D show the thread profile of the threaded conical end portion of the elongated pin of Figure 8 after the application of the thread.
  • the reference number 1 globally and schematically indicates an external modular fixation system for the treatment of bone fractures and, more specifically, for temporary and/ or permanent fixation applications in a method according to the present invention.
  • the modular system 1 includes a number of elongated pins or rods 2 having a particular structure.
  • a modular clamp fixation device allows the pins 2 to be connected in a free and modular manner.
  • the elongated pin presents an elongated stem 3 extending along a longitudinal axis with an end portion 4 and a tip for insertion into a bone.
  • the stem 3 is essentially cylindrical in shape although other shapes are possible.
  • the end portion 4 with tip has a conical shape with an external thread, forming a conical threaded end portion for insertion into the cortical portion of a bone.
  • the profile of the opposite end 5 of the rod 2 is shaped to receive the engagement of a wrench or a spanner or for being inserted in a motor- driven torque-controlled drill.
  • the threaded end portion 4 is shown in the enlarged view of Figure 7 A showing an embodiment in which the extension of the threaded conical end portion 4 along the longitudinal axis of the pin is equal to the diameter of the stem; this extension is specifically selected so that the conical end portion penetrates only the cortical portion of the bone.
  • the rod diameter may be between 3.5 mm and 6.0 mm according to the application.
  • Preferred diameter sizes of the stem 3 of the pin are 4.0 mm and 5.0 mm, even if this value should not be considered as limiting the rights of the Applicant.
  • the length of the monocortical pin 2 may be from 80 mm to 160 mm, depending on the requirements of its particular application.
  • the chosen length can be either 105 mm, 125 mm or 145 mm.
  • the stem 3 has a diameter of 5 mm.
  • the length of the threaded conical end portion 4 taken along the longitudinal axis of the pin 2, shown in figure 7A, is equal to 5 mm, which means that the threaded end portion extends along a portion that is equal to the diameter of the stem 3.
  • the monocortical pin 2 is made of stainless steel with a relatively high elastic modulus that gives a predetermined rigidity to the stem 3 and, at the same time, a good resistance at the threaded end 4.
  • the threaded end portion 4 is:
  • the thread shape 6 has a helical profile and it is obtained at the tip end 4 of the monocortical pin or rod 2.
  • the conical end portion 4 has a drill- shaped point 7.
  • the conical angle of the threaded profile having a conical shape is set at 26°.
  • the threaded conical end portion 4 has an external diameter size of 1.9 mm at the tip.
  • the drill-shaped point 7 has a point angle of about 85°- 120°, preferably of 90°, as shown in Figure 6B.
  • the tip of the conical end portion has a size of 0 0.7 mm.
  • the thread pitch is equal to 1 mm.
  • the threaded end portion 4 has a total length of preferably 5.0 mm with an additional length of about 1.0 mm of the undercut, as shown in Figure 7A. Therefore, the length of the thread end portion 4 is commensurate to the diameter of stem 3. The total number of threads is five.
  • the depth of thread of the helical profile is uniform along the conical end portion.
  • Figures 8- 10D show an alternative embodiment of the threaded end portion 4 of the monocortical pin or rod 2.
  • the diameter of the rod is equal to 4.0 mm
  • the depth of thread of the helical profile is not uniform along the conical end portion.
  • Figures 6A and 9A show a base cone of the distal conical end portion of the pin having diameters of 5 mm and 4 mm respectively;
  • figures 6B, 6C and 10B, IOC show the sharpening of the tip without thread of the distal conical end portion of the pin, with diameters of 5 mm and 4 mm respectively;
  • figures 7A-7D and 10A- 10D show the finished tip with threaded distal conical end portion of the pin, with diameters of 5 mm and 4 mm respectively.
  • the pin of figure 8 is particularly suited for pediatric applications, for instance in treatments for preadole scent children.
  • the ratio between the length of the threaded end portion 4 of the rod 2 and the diameter of the stem 3 is 1- 1.2, preferably about 1 ;
  • the threaded end portion 4 presents self-drilling, self-cutting and self- tapping features.
  • the result of this selection provides for single thread profiles that are particularly thin and sharp, offering a large gripping surface during the penetration of the conical end portion into the cortical portion of the bone.
  • Simple structure means greater ease in bone distraction.
  • the external fixation systems 1 and 10 make use of two groups of pins 2, a proximal group 21 and a distal group 31.
  • the proximal group 21 includes at least three pins 2 that have their respective threaded conical ends inserted into the cortical bone portion at predetermined proximal distances from the bone fracture.
  • the distal group 31 includes at least three pins 2 that have their respective threaded conical ends inserted into the cortical bone portion at predetermined distal distances from the bone fracture.
  • Two of the three pins 2 of the proximal group 21 present respective converging longitudinal axes and may be considered to be on the same plane. This plane is parallel to the plane of a proximal clamp plate element 22.
  • Figures 1A- 1C show a proximal clamp plate element 22 and a distal clamp plate element 32.
  • other clamp plate elements 62 can be used in a parallel fashion with respect to the proximal and distal plates 22 or 32 to improve the stability of the external modular fixator system of the present invention, as shown in the embodiment of figure 2 and as will become clear from the following paragraphs.
  • Each pin 2 of the proximal group 21 is supported by and fixed on the clamp plate element 22 at the free ends 5 of the pins that project toward the external part of the modular fixator 1.
  • the proximal clamp plate element 22 is substantially a plate with a predetermined thickness, rounded edges and a shape that is slightly curved like a circular segment, as shown clearly in Figure 1C.
  • the plate 22 is provided with a number of holes 23, distributed regularly, to receive corresponding bolt 24 and nut 25 elements that fix the pin 2 to the plate 22.
  • the bolt 24 has a through-hole through which the pin 2 passes, which is then blocked in a stable position by tightening the nut 25.
  • a third pin 2 of the proximal group is also inserted in the cortical portion of the bone but extending with its longitudinal axis in a third direction that differs from the direction of the other two pins of the group of proximal pins. In this manner the three pins of the proximal group are not coplanar to each other.
  • the third pin 2 is implanted with its threaded end portion 4 in an area of the cortical bone that is closer to the fracture than the position of the first two pins 2 of the proximal group 21 and fixed by a corresponding bolt 24 and nut 25 in a central position of the clamp plate 22.
  • This third pin is placed between the two other pins 2 of the proximal group 21.
  • the other two pins 2 are fixed on the same side of the clamp plate 22 while the third pin in the middle is fixed to the other side of the clamp plate 22; together these three pins form the proximal group 21.
  • the proximal group is set up to include four pins 2 instead of three; two pins 2 are blocked on the first clamp plate element 22 and the other two pins 2 are blocked on the second clamp plate element 62, as shown for instance in Figure 2.
  • proximal clamp plate elements 22 and 62 When a couple of proximal clamp plate elements is used, the two proximal clamp elements 22 and 62 are placed in parallel and spaced apart by spacer rods 27 and 28 inserted into holes 23 at the extremities of both proximal clamp plate elements 22 and 62, where they are blocked by a respective nut 29.
  • each clamp plate element 22 and 62 may be positioned with different converging angles and may be fixed in different positions on the corresponding plates by means of nut and bolt couplings.
  • the same configuration with a couple of clamp plate elements can be provided at the distal position so that the distal group 31 may be arranged in a manner similar to the proximal group 21.
  • Two pins 2 of the distal group 31 have respective converging longitudinal axes and may be considered to be on the same plane. This plane is parallel to the plane of a clamp plate element 32.
  • the figures 1A- 1C show both the proximal clamp plate element 22 and the distal clamp plate element 32 that are fixed in the fixator system 1 in parallel fashion.
  • proximal and distal groups 21 and 31 are mounted on the external modular fixation system of the present invention by spacer rods 30 and 40 which extend parallel to each other and which are attached to the extremities of the clamp plate elements 22 and 32.
  • spacer rods 30, 40 may comprise a respective dynamic distractor element to allow the distance between the proximal group 21 and the distal group to be adjusted as desired, which would permit the fixator system 1 to be used also for limb lengthening applications, as will be explained later.
  • Each pin 2 of the distal group 31 is supported by and fixed on the clamp plate element 32 in the proximity of the free ends 5 of the pins that project toward the external part of the modular fixator 1.
  • the distal clamp plate element 32 is structurally identical to the proximal clamp plate element 22; it is a plate with a predetermined thickness and a shape that is slightly curved like a circular segment.
  • the distal clamp plate element 32 is also provided with a number of holes 33, distributed regularly, to receive corresponding bolt 24 and nut 25 elements to fix the pin 2 to the plate 32.
  • Each bolt 24 has a through-hole through which a corresponding pin 2 passes that is then blocked in a stable position by tightening the nut 25.
  • a third pin 2 of the distal group is also inserted in the cortical portion of the bone but extending with its longitudinal axis in a third direction that differs from the direction of the other two pins of the group of distal pins. In this manner the three pins of the distal group are not coplanar to each other.
  • the third pin 2 is implanted with its threaded end portion 4 in an area of the cortical bone that is closer to the fracture than the position of the first two pins 2 of the distal group 31 and fixed by a corresponding bolt 24 and nut 25 in a central position of the clamp plate 32.
  • This third pin is placed between the two other pins 2 of the distal group 31.
  • the other two pins 2 are fixed on the same side of the clamp plate 32 while the third pin in the middle is fixed to the other side of the clamp plate 22; together these three pins form the distal group 31.
  • the distal group is set up to include four pins 2 instead of three; two pins 2 are blocked on the first clamp plate element 22 and the other two pins 2 are blocked on the second clamp plate element 62.
  • the two distal clamp elements 22 and 62 are placed in parallel and spaced apart by spacer rods 27 and 28 inserted into holes 23 at the extremities of both distal clamp plate elements 22 and 62, where they are blocked by a respective nut 29.
  • each clamp plate element 22 and 62 may be positioned with different converging angles and may be fixed in different positions on the corresponding plates by means of nut and bolt couplings.
  • Figure 3 With reference to the other embodiment of the external modular fixation system 10 of the present invention, shown in Figure 3, it represents a customized version of the embodiments shown in Figures 1A- 1C and 2.
  • proximal and distal clamp plate elements are identified by the numerals 52 and 72 respectively, because their structure is slightly different from the structure of the clamp plate elements 22 and 32 of the first embodiment.
  • clamp plate elements 52 and 72 are also shaped like a circular segment. They have a respective central projecting portion 55, 75 which projects in a direction away from the bone, and they are slidably mounted on a common fixation rod 65.
  • each central projecting portion 55, 75 may be integrally formed with a couple of parallel proximal clamp plate elements 52, 54 of the proximal group 41 and with a couple of parallel distal clamp plate elements 72, 74 of the distal group 51 respectively, thus forming a proximal clamp body consisting of a single piece comprising the couple of parallel proximal clamp plate elements 52, 54 and the central projecting portion 55 and a distal clamp body consisting of a single piece comprising the couple of parallel distal clamp plate elements 72, 74 and the central projecting portion 75.
  • the central projecting portion 55, 75 confers a particular rigidity to the proximal clamp body and to the distal clamp body.
  • Each central projecting portion 55, 75 may be shaped as a slide to be supported by fixation rod 65, as clearly shown in the example of Figure 3.
  • Figure 3 allows the use of a single distraction element 35 that is placed parallel to said fixation rod 65 for the dynamic distraction between the proximal and distal clamp body.
  • Figure 4 shows an external modular fixation system 10' very similar to the embodiment of figure 3.
  • the central projecting portions 55', 75' project for a portion that is greater than the projecting portion of the embodiment illustrated in figure 3.
  • These much longer projecting portions 55', 75' are slidably mounted on a common rail rod 65'.
  • the distraction element 35 is directly fixed to the central projecting portions 55', 75'.
  • the fixing clamp blocks three of the elongated pins in a fixed position with their longitudinal axes not coplanar with each other.
  • the group of three pins on different planes forms a hyperstatic structure.
  • the modular fixation system of the present invention may be employed in a technique of femoral or tibial lengthening over an intramedullary nail for applications in both children and adults, as disclosed hereafter.
  • the present invention allows for the implementation of a new technique for tibial or femural lengthening simultaneously using or combining the modular external fixator 1 , 1 ' or 10, 10' of the present invention together with an intramedullary nail.
  • the external fixator 1, 1 ' or 10, 10' and the intramedullary nail are applied together at the moment of osteotomy.
  • this technique improves alignment and shortens the time with respect to using traditional external fixation devices using pins that penetrate into the medullary canal.
  • a nail is inserted into the medullary cavity of the bone while the external fixator of the present invention is fixed only to the cortical portion of the bone.
  • the lengthening phase by callotasis is performed with the external fixator system of the present invention.
  • the nail is blocked by distal screws while the external fixator is removed during the phase of callus consolidation that normally takes three months.
  • the basic idea is that of dividing the treatment into different phases while keeping the nail inside the medullary canal in-between the two treatment phases.
  • the invention involves just the elongated pins 2 that are driven into only the first cortical portion of the bone without penetrating into the medullary canal, which consequently remains free to receive the nail.
  • the diameter of the pins 2 is important to avoid skin problems. Therefore the reduced dimension of the threaded end portion 4 and the pin stem 3 create fewer complications and greater acceptance of the external fixation system by patients.
  • the number and positioning of the pins 2 in a sort of triangular configuration both at the proximal and the distal portions of the fixator is a guarantee of a strong fixation of the whole fixator structure.
  • the pins 2 are implanted only in the cortical bone portion and they do not penetrate the medullary canal, thereby avoiding any risk of infection as there is no contact between the nail and the external fixation pins.
  • the lengthening of the bone may be followed by a corresponding distraction of the modular fixation system.
  • the screws are generally positioned at both ends of the nail on opposite sides of the lengthening zone.
  • the external fixation system may then be removed during the same operation.
  • this approach eliminates the risk of pin infection and muscle tethering by the pins, and causes less pain and discomfort.

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Abstract

The invention relates to an elongated pin (2) for an external modular fixation system for temporary and/ or permanent fixation applications to treat bone fractures and to connect two or more bone fragments to each other, comprising an elongated stem (3) extending along a longitudinal axis with a first end portion (4) and an opposite second end portion (5), said first end portion (4) having a tip for the insertion of the first end portion (4) into a bone, wherein said first end portion (4) has a conical shape with an external thread, forming a conical threaded end portion, the extension of said conical threaded end portion along the longitudinal axis being determined by the depth of penetration of the conical end portion limited to only the cortical portion of the bone.

Description

Title: Elongated pin for an external modular fixation system for temporary and/ or permanent fixation applications and external modular fixation system.
DESCRIPTION
Technical Field
The present invention relates to an elongated pin for an external modular fixation system for temporary and /or permanent fixation applications and to an external modular fixation system using said pin.
Prior art
External fixation systems are widely used to treat bone fractures and to connect two or more bone fragments to each other. Known systems employ bone screws, pins and/ or wires that are inserted into the bones and that use external structural elements such as fixation clamps, fixation rods, bars and rings to provide a rigid frame structure to hold the bone fragments in an intended place until a permanent healing.
In other treatments local conditions surrounding the individual fracture may occasionally preclude permanent fracture fixation, or the fracture may be concomitant with other fractures in an overall injury pattern that will require lengthy surgery before permanent fixation can be completed or before other fixation devices may be applied.
Even in such cases, however, some or all of the fractures can be treated by external fixation systems that are specifically designed for temporary fixation and that can therefore be considered temporary systems, for instance as disclosed in EP 2 319 436 for the same Applicant.
In any case, it is very important that at the end of the primary treatment each long bone has a stable fixation and that each fracture is contained in a stable manner.
In this technical field there are also many fixation systems that are mainly used as permanent fixation systems to provide bone fracture healing, for instance the system as disclosed in EP 1 284 666 for the same Applicant.
Generally speaking temporary fixation systems are lighter and simpler but also less stable when compared to known permanent external fixation systems and manufacturers provide different catalogue products to clearly identify the two different fields of application and their corresponding products. Moreover, temporary and permanent external fixation systems can often be differentiated by the shape and structure of their respective clamps.
Still in general terms, permanent external fixation systems and devices provide a high degree of stiffness and stability to control forces of lateral bending and torque during the treatment.
This stiffness and stability derive in part from the alignment of the bars of the fixator along the lengthwise axis of the bone that is being treated, partly through the inherent rigidity of the system and partly from the number of screws and bone interfaces.
It would be highly desirable to have the possibility to use an external fixation system combining the characteristics of simplicity and lightness of a temporary fixation system and the characteristics of robustness and stability of a permanent fixation system, but so far all methods known from prior art solutions have not produced efficient results.
The technical problem of the present invention is that of providing an elongated pin for an external modular fixation system for temporary and/ or permanent fixation applications and an external modular fixation system using said pin, to offer stable and robust fixation of bone fragments while keeping the entire system extremely light to avoid problems of infection, while ensuring at the same time that the application of the system by a surgeon is straightforward.
Another aim of the present invention is that of providing an elongated pin for a modular fixation system that can be driven into the bone without the use of bone screws, which makes it possible to limit the gripping action to just the cortical portion of the fractured bone. Another purpose of the present invention is that of allowing the same fixation system to be used also for bone lengthening procedures in preadolescent children or in adults.
Summary of the invention
The basic idea of the present invention is based on providing an elongated pin or rod with a threaded end that is implanted into only the cortical portion of the fractured bone and fixed to a plate clamp element; a group of at least three of such pins is fixed on a single clamp plate element and the pins are implanted according to different, non-coplanar directions to create a strong gripping action without reaching or damaging the medullary canal.
According to the above inventive idea the technical problem is solved by an elongated pin for an external modular fixation system for temporary and/ or permanent fixation applications for the treatment of bone fractures according to claim 1 of the present invention.
The invention further relates to an external modular fixation system for temporary and/ or permanent fixation applications for the treatment of bone fractures and connecting two or more bone fragments to each other according to claim 7.
The dependent claims outline preferred and particularly advantageous embodiments of the elongated pin and of the apparatus respectively, according to the invention.
Further features and advantages will be apparent from the following description of some preferred, but not exclusive, embodiments of the present invention, with reference to the attached drawings, given by way of non-limiting examples.
Brief description of the drawings
- Figures 1A- 1C show different views of an external modular fixation system according to the present invention for the temporary or permanent treatment of bone fractures of lower and upper limbs; - Figure 2 shows a portion of an external modular fixation system presenting a minor constructional modification in comparison with the system of Figures 1A-1C;
- Figure 3 is a perspective view of an external modular fixation system according to a different embodiment of the present invention;
- Figure 4 is a perspective view of an external modular fixation system presenting a minor constructional modification with respect to the system of Figure 3;
- Figure 5 is a view of an elongated pin according to a first embodiment for the external modular fixation system of the present invention;
- Figures 6A-6C show an enlargement of a conical end portion of the elongated pin of Figure 5 before the application of the thread;
- Figures 7A-7D show the thread profile of the threaded conical end portion of the elongated pin of Figure 5 after the application of the thread; - Figure 8 is a view of an elongated pin according to a second embodiment of the external modular fixation system of the present invention;
- Figures 9A-9C show an enlargement of a conical end portion of the elongated pin of Figure 8 before the application of the thread;
- Figures 10A- 10D show the thread profile of the threaded conical end portion of the elongated pin of Figure 8 after the application of the thread.
Detailed description
With reference to figures 1A- 1C, the reference number 1 globally and schematically indicates an external modular fixation system for the treatment of bone fractures and, more specifically, for temporary and/ or permanent fixation applications in a method according to the present invention.
The modular system 1 includes a number of elongated pins or rods 2 having a particular structure. A modular clamp fixation device allows the pins 2 to be connected in a free and modular manner. The elongated pin presents an elongated stem 3 extending along a longitudinal axis with an end portion 4 and a tip for insertion into a bone. The stem 3 is essentially cylindrical in shape although other shapes are possible.
The end portion 4 with tip has a conical shape with an external thread, forming a conical threaded end portion for insertion into the cortical portion of a bone.
In the following lines we will refer to this pin or rod 2 with the adjective monocortical to stress the fact that the threaded end portion 4 is inserted only into the cortical portion of the bone without penetrating into the medullary canal.
The profile of the opposite end 5 of the rod 2 is shaped to receive the engagement of a wrench or a spanner or for being inserted in a motor- driven torque-controlled drill.
The threaded end portion 4 is shown in the enlarged view of Figure 7 A showing an embodiment in which the extension of the threaded conical end portion 4 along the longitudinal axis of the pin is equal to the diameter of the stem; this extension is specifically selected so that the conical end portion penetrates only the cortical portion of the bone.
The rod diameter may be between 3.5 mm and 6.0 mm according to the application. Preferred diameter sizes of the stem 3 of the pin are 4.0 mm and 5.0 mm, even if this value should not be considered as limiting the rights of the Applicant.
The length of the monocortical pin 2 may be from 80 mm to 160 mm, depending on the requirements of its particular application.
With reference to the pin 2 shown in figure 5, the chosen length can be either 105 mm, 125 mm or 145 mm.
The stem 3 has a diameter of 5 mm. The length of the threaded conical end portion 4 taken along the longitudinal axis of the pin 2, shown in figure 7A, is equal to 5 mm, which means that the threaded end portion extends along a portion that is equal to the diameter of the stem 3.
A person skilled in the art may appreciate that the diameter combined with the length of the pin 2 will lend a particularly slender aspect to the pin.
Preferably the monocortical pin 2 is made of stainless steel with a relatively high elastic modulus that gives a predetermined rigidity to the stem 3 and, at the same time, a good resistance at the threaded end 4.
The threaded end portion 4 is:
self-drilling
self-cutting, and
self-tapping.
Hereinafter we will disclose a few specific and preferred values of the thread shape 6 and profile that are given as indicative examples of preferred measurements only, without any intention to limit the Applicant's rights.
The thread shape 6 has a helical profile and it is obtained at the tip end 4 of the monocortical pin or rod 2.
The conical end portion 4 has a drill- shaped point 7.
The conical angle of the threaded profile having a conical shape is set at 26°.
The threaded conical end portion 4 has an external diameter size of 1.9 mm at the tip.
The drill-shaped point 7 has a point angle of about 85°- 120°, preferably of 90°, as shown in Figure 6B.
The tip of the conical end portion has a size of 0 0.7 mm.
The thread pitch is equal to 1 mm.
The threaded end portion 4 has a total length of preferably 5.0 mm with an additional length of about 1.0 mm of the undercut, as shown in Figure 7A. Therefore, the length of the thread end portion 4 is commensurate to the diameter of stem 3. The total number of threads is five.
In the embodiment of Figures 5-7D, the depth of thread of the helical profile is uniform along the conical end portion.
Figures 8- 10D show an alternative embodiment of the threaded end portion 4 of the monocortical pin or rod 2.
The embodiment of Figures 8- 10D differs from the embodiment of Figures 5-7D in that:
- the diameter of the rod is equal to 4.0 mm
- the number of threads is equal to four;
- the depth of thread of the helical profile is not uniform along the conical end portion.
All measurements in many of the figures 5- 10D are given in mm., even where not explicitly indicated.
Figures 6A and 9A show a base cone of the distal conical end portion of the pin having diameters of 5 mm and 4 mm respectively; figures 6B, 6C and 10B, IOC show the sharpening of the tip without thread of the distal conical end portion of the pin, with diameters of 5 mm and 4 mm respectively; figures 7A-7D and 10A- 10D show the finished tip with threaded distal conical end portion of the pin, with diameters of 5 mm and 4 mm respectively.
The pin of figure 8 is particularly suited for pediatric applications, for instance in treatments for preadole scent children.
For adult applications it would be advisable to use a threaded end portion with a total length of 5 mm; in that case the diameter of the stem 3 may be 5 mm as well.
In any case, both embodiments of the pin disclosed here and shown in the enclosed figures share certain common features:
- the ratio between the length of the threaded end portion 4 of the rod 2 and the diameter of the stem 3 is 1- 1.2, preferably about 1 ;
- the threaded end portion 4 presents self-drilling, self-cutting and self- tapping features.
The result of this selection provides for single thread profiles that are particularly thin and sharp, offering a large gripping surface during the penetration of the conical end portion into the cortical portion of the bone.
Testing by the Applicant provided surprising results in terms of high performance in the pull-out force applied to remove the pin 2 implanted in the cortical portion of a bone. The applied force was over 250 N for tests with low-density sawbones.
Moreover, during other tests performed with sawbones with a density of 50 PCF a pull-out force of about 484 N and a tightening torque of 0,95 Nm were measured, which is comparable to a regular screw implanted in the bone up to the medullary canal.
The pin of the present invention obtains a series of advantageous results listed below:
1) Pin less invasive for the skin;
2) Easy insertion without bone breakage;
3) Axial load of about 500 [N] (during bone lengthening with a nail in the medullary canal);
4) Simple structure means greater ease in bone distraction.
Now, with specific reference to Figures 1 to 4 an implementation of the pin 2 in the external modular fixation systems 1 and 10 of the present invention will be disclosed.
The external fixation systems 1 and 10 make use of two groups of pins 2, a proximal group 21 and a distal group 31.
The proximal group 21 includes at least three pins 2 that have their respective threaded conical ends inserted into the cortical bone portion at predetermined proximal distances from the bone fracture. Similarly, the distal group 31 includes at least three pins 2 that have their respective threaded conical ends inserted into the cortical bone portion at predetermined distal distances from the bone fracture.
Two of the three pins 2 of the proximal group 21 present respective converging longitudinal axes and may be considered to be on the same plane. This plane is parallel to the plane of a proximal clamp plate element 22. Figures 1A- 1C show a proximal clamp plate element 22 and a distal clamp plate element 32. However, other clamp plate elements 62 can be used in a parallel fashion with respect to the proximal and distal plates 22 or 32 to improve the stability of the external modular fixator system of the present invention, as shown in the embodiment of figure 2 and as will become clear from the following paragraphs.
Each pin 2 of the proximal group 21 is supported by and fixed on the clamp plate element 22 at the free ends 5 of the pins that project toward the external part of the modular fixator 1.
The proximal clamp plate element 22 is substantially a plate with a predetermined thickness, rounded edges and a shape that is slightly curved like a circular segment, as shown clearly in Figure 1C.
The plate 22 is provided with a number of holes 23, distributed regularly, to receive corresponding bolt 24 and nut 25 elements that fix the pin 2 to the plate 22.
The bolt 24 has a through-hole through which the pin 2 passes, which is then blocked in a stable position by tightening the nut 25.
Advantageously, a third pin 2 of the proximal group is also inserted in the cortical portion of the bone but extending with its longitudinal axis in a third direction that differs from the direction of the other two pins of the group of proximal pins. In this manner the three pins of the proximal group are not coplanar to each other.
More specifically, the third pin 2 is implanted with its threaded end portion 4 in an area of the cortical bone that is closer to the fracture than the position of the first two pins 2 of the proximal group 21 and fixed by a corresponding bolt 24 and nut 25 in a central position of the clamp plate 22.
This third pin is placed between the two other pins 2 of the proximal group 21. The other two pins 2 are fixed on the same side of the clamp plate 22 while the third pin in the middle is fixed to the other side of the clamp plate 22; together these three pins form the proximal group 21.
When an additional clamp plate element 62 is used to form a double clamp plate element, the proximal group is set up to include four pins 2 instead of three; two pins 2 are blocked on the first clamp plate element 22 and the other two pins 2 are blocked on the second clamp plate element 62, as shown for instance in Figure 2.
When a couple of proximal clamp plate elements is used, the two proximal clamp elements 22 and 62 are placed in parallel and spaced apart by spacer rods 27 and 28 inserted into holes 23 at the extremities of both proximal clamp plate elements 22 and 62, where they are blocked by a respective nut 29.
The two pairs of pins fixed on each clamp plate element 22 and 62 may be positioned with different converging angles and may be fixed in different positions on the corresponding plates by means of nut and bolt couplings.
The same configuration with a couple of clamp plate elements can be provided at the distal position so that the distal group 31 may be arranged in a manner similar to the proximal group 21.
Two pins 2 of the distal group 31 have respective converging longitudinal axes and may be considered to be on the same plane. This plane is parallel to the plane of a clamp plate element 32. The figures 1A- 1C show both the proximal clamp plate element 22 and the distal clamp plate element 32 that are fixed in the fixator system 1 in parallel fashion.
The proximal and distal groups 21 and 31 are mounted on the external modular fixation system of the present invention by spacer rods 30 and 40 which extend parallel to each other and which are attached to the extremities of the clamp plate elements 22 and 32.
These spacer rods 30, 40 may comprise a respective dynamic distractor element to allow the distance between the proximal group 21 and the distal group to be adjusted as desired, which would permit the fixator system 1 to be used also for limb lengthening applications, as will be explained later.
Each pin 2 of the distal group 31 is supported by and fixed on the clamp plate element 32 in the proximity of the free ends 5 of the pins that project toward the external part of the modular fixator 1.
The distal clamp plate element 32 is structurally identical to the proximal clamp plate element 22; it is a plate with a predetermined thickness and a shape that is slightly curved like a circular segment.
The distal clamp plate element 32 is also provided with a number of holes 33, distributed regularly, to receive corresponding bolt 24 and nut 25 elements to fix the pin 2 to the plate 32.
Each bolt 24 has a through-hole through which a corresponding pin 2 passes that is then blocked in a stable position by tightening the nut 25.
Advantageously, a third pin 2 of the distal group is also inserted in the cortical portion of the bone but extending with its longitudinal axis in a third direction that differs from the direction of the other two pins of the group of distal pins. In this manner the three pins of the distal group are not coplanar to each other.
More specifically, the third pin 2 is implanted with its threaded end portion 4 in an area of the cortical bone that is closer to the fracture than the position of the first two pins 2 of the distal group 31 and fixed by a corresponding bolt 24 and nut 25 in a central position of the clamp plate 32.
This third pin is placed between the two other pins 2 of the distal group 31. The other two pins 2 are fixed on the same side of the clamp plate 32 while the third pin in the middle is fixed to the other side of the clamp plate 22; together these three pins form the distal group 31.
When an additional clamp plate element 62 is used to form a double clamp plate element, the distal group is set up to include four pins 2 instead of three; two pins 2 are blocked on the first clamp plate element 22 and the other two pins 2 are blocked on the second clamp plate element 62.
When a couple of distal clamp plate elements is used, the two distal clamp elements 22 and 62 are placed in parallel and spaced apart by spacer rods 27 and 28 inserted into holes 23 at the extremities of both distal clamp plate elements 22 and 62, where they are blocked by a respective nut 29.
The two pairs of pins fixed on each clamp plate element 22 and 62 may be positioned with different converging angles and may be fixed in different positions on the corresponding plates by means of nut and bolt couplings. With reference to the other embodiment of the external modular fixation system 10 of the present invention, shown in Figure 3, it represents a customized version of the embodiments shown in Figures 1A- 1C and 2.
In this embodiment the proximal and distal clamp plate elements are identified by the numerals 52 and 72 respectively, because their structure is slightly different from the structure of the clamp plate elements 22 and 32 of the first embodiment.
More specifically, these clamp plate elements 52 and 72 are also shaped like a circular segment. They have a respective central projecting portion 55, 75 which projects in a direction away from the bone, and they are slidably mounted on a common fixation rod 65.
Advantageously, each central projecting portion 55, 75 may be integrally formed with a couple of parallel proximal clamp plate elements 52, 54 of the proximal group 41 and with a couple of parallel distal clamp plate elements 72, 74 of the distal group 51 respectively, thus forming a proximal clamp body consisting of a single piece comprising the couple of parallel proximal clamp plate elements 52, 54 and the central projecting portion 55 and a distal clamp body consisting of a single piece comprising the couple of parallel distal clamp plate elements 72, 74 and the central projecting portion 75.
The manner of supporting the pins 2 with bolt and nut couplings is substantially identical to the embodiment previously disclosed.
Advantageously, the central projecting portion 55, 75 confers a particular rigidity to the proximal clamp body and to the distal clamp body. Each central projecting portion 55, 75 may be shaped as a slide to be supported by fixation rod 65, as clearly shown in the example of Figure 3.
The embodiment of Figure 3 allows the use of a single distraction element 35 that is placed parallel to said fixation rod 65 for the dynamic distraction between the proximal and distal clamp body.
Figure 4 shows an external modular fixation system 10' very similar to the embodiment of figure 3. Here the central projecting portions 55', 75' project for a portion that is greater than the projecting portion of the embodiment illustrated in figure 3. These much longer projecting portions 55', 75' are slidably mounted on a common rail rod 65'. The distraction element 35 is directly fixed to the central projecting portions 55', 75'.
Of the utmost importance in the modular fixation system of the present invention is the fact that the fixing clamp blocks three of the elongated pins in a fixed position with their longitudinal axes not coplanar with each other.
Thanks to this particular arrangement the group of three pins on different planes forms a hyperstatic structure.
The modular fixation system of the present invention may be employed in a technique of femoral or tibial lengthening over an intramedullary nail for applications in both children and adults, as disclosed hereafter.
As a matter of fact the present invention allows for the implementation of a new technique for tibial or femural lengthening simultaneously using or combining the modular external fixator 1 , 1 ' or 10, 10' of the present invention together with an intramedullary nail.
The external fixator 1, 1 ' or 10, 10' and the intramedullary nail are applied together at the moment of osteotomy.
Used in combination with the modular fixation system of the invention, this technique improves alignment and shortens the time with respect to using traditional external fixation devices using pins that penetrate into the medullary canal.
A nail is inserted into the medullary cavity of the bone while the external fixator of the present invention is fixed only to the cortical portion of the bone.
The lengthening phase by callotasis is performed with the external fixator system of the present invention.
In this manner it is possible to control callus formation according to lengthening speed and physiological requirements.
Once the lengthening phase is completed, the nail is blocked by distal screws while the external fixator is removed during the phase of callus consolidation that normally takes three months.
Therefore the time in which the external fixator is applied is reduced by more than half when compared with prior art solutions.
It should be considered that an external fixator is generally not readily accepted, especially by children.
Possible problems of angular deviations during the lengthening phase with the external fixator mounted, are greatly reduced with the system of the present invention, as the lengthening is guided inside the medullary canal by the presence of the nail.
Therefore, according to the invention, the basic idea is that of dividing the treatment into different phases while keeping the nail inside the medullary canal in-between the two treatment phases. To avoid any contact with screws normally used in traditional external fixation, the invention involves just the elongated pins 2 that are driven into only the first cortical portion of the bone without penetrating into the medullary canal, which consequently remains free to receive the nail.
Also the diameter of the pins 2 is important to avoid skin problems. Therefore the reduced dimension of the threaded end portion 4 and the pin stem 3 create fewer complications and greater acceptance of the external fixation system by patients.
The number and positioning of the pins 2 in a sort of triangular configuration both at the proximal and the distal portions of the fixator is a guarantee of a strong fixation of the whole fixator structure.
In essence the pins 2 are implanted only in the cortical bone portion and they do not penetrate the medullary canal, thereby avoiding any risk of infection as there is no contact between the nail and the external fixation pins.
Therefore thanks to this invention this technique can even be implemented in tibial lengthening over nails for children, which will overcome all counter-indications and risks of causing growth arrest through serious infection.
As the limb is lengthened, one end of the bone slides over the nail and the new bone is grown around it.
The lengthening of the bone may be followed by a corresponding distraction of the modular fixation system.
After the bone is lengthened, the patient returns to the operating room for the insertion of special screws that lock the nail to the bone. The screws are generally positioned at both ends of the nail on opposite sides of the lengthening zone.
The external fixation system may then be removed during the same operation.
Among other advantages, this approach eliminates the risk of pin infection and muscle tethering by the pins, and causes less pain and discomfort.
This process shortens the total treatment time with an external fixator by more than half. However, tibia or femur lengthening over nails may not be appropriate for all patients, particularly for patients whose problem is linked to an infection, or for young children.

Claims

1. Elongated pin (2) for an external modular fixation system for temporary and/ or permanent fixation applications to treat bone fractures and to connect two or more bone fragments to each other, comprising an elongated stem (3) extending along a longitudinal axis with a first end portion (4) and an opposite second end portion (5), said first end portion (4) having a tip for the insertion of the first end portion (4) into a bone, characterized in that said first end portion (4) has a conical shape with an external thread, forming a conical threaded end portion, the extension of said conical threaded end portion along the longitudinal axis being determined by the depth of penetration of the conical end portion limited to only the cortical portion of the bone.
2. Elongated pin according to claim 1 , wherein the extension of the conical threaded end portion along the longitudinal axis is substantially equal to the diameter of the stem.
3. Elongated pin according to claim 1 or 2, wherein the threaded end portion (4) is self-drilling, self-cutting and self-tapping.
4. Elongated pin according to any of the preceding claims, wherein the profile of the second end portion (5) of the elongated pin (2) is shaped for engagement by a spanner or a drill chuck.
5. Elongated pin according to any of the preceding claims, wherein the depth of the thread of the helical profile is uniform along the conical end portion.
6. Elongated pin according to any of the preceding claims, wherein the extension of the conical end portion is about 3.5 - 6.0 mm.
7. External modular fixation system for temporary and/ or permanent fixation applications to treat bone fractures and to connect two or more bone fragments to each other, comprising at least three identical elongated pins (2), each pin (2) comprising an elongated stem (3) extending along a longitudinal axis with a first end portion (4) and an opposite second end portion (5), said first end portion (4) having a tip for the insertion of the first end portion (4) into only the first cortical portion of the bone, wherein the extension of the conical threaded end portion along the longitudinal axis is substantially equal to the diameter of the stem (3) .
8. External modular fixation system according to claim 7 comprising a first fixation clamp element (22) blocking three of said elongated pins in a fixed position, said three pins being blocked in their respective positions with their longitudinal axes coplanar to each other.
9. External modular fixation system according to claim 8, comprising a second fixation clamp element (32) blocking three further elongated pins in a fixed position, said three further pins being blocked in their respective positions with their longitudinal axes not coplanar to each other, the first and second fixation clamp (22, 32) being connected to each other by spacer rods (30,40) to form a single rigid structure.
10. External modular fixation system according to claim 9, wherein said first and second clamp elements (22,32) comprise respectively first and second plate elements (22, 32, 62 52, 72) of a predetermined thickness and slightly curved like a circular segment.
1 1. External modular fixation system according to claim 10, wherein said clamp plate elements (22, 32, 62, 52, 72) are provided with a number of holes (23, 33), regularly distributed, for receiving corresponding bolt (24) and nut (25) elements to attach the pins (2) to the clamp elements (22, 32).
12. External modular fixation system according to claim 1 1 , wherein said first and second clamp plate elements (52, 54; 72,74) comprise a central projecting portion (55, δδ') to be connected to a common fixation rod (65; 65*) .
13. External modular fixation system according to claim 12, wherein said central projecting portion (55; 55) is integrally formed with two parallel clamp plate elements (52, 54; 72, 74).
14. External modular fixation system according to claim 13, wherein said central projecting portion (55 ) is slidably mounted on a rail rod {65) that connects said first and second clamp elements.
15. External modular fixation system according to claim 14, wherein a distraction element (35) is directly fixed to the central projecting portions (55', 75').
PCT/EP2013/001965 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system WO2014015942A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CN201380039262.2A CN104487010B (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
US14/417,051 US10631896B2 (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
ES13744426.1T ES2573282T3 (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixing system for temporary and / or permanent fixing applications and external modular fixing system
AU2013295399A AU2013295399B2 (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
JP2015523439A JP6495168B2 (en) 2012-07-25 2013-07-04 Elongated pin for external modular fixation system for temporary and / or permanent fixation applications, and external modular fixation system
CA2878967A CA2878967C (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
BR112015001589-1A BR112015001589B1 (en) 2012-07-25 2013-07-04 elongated pin for an external modular clamping system, for temporary and / or permanent clamping applications, and external modular clamping system
KR1020157003726A KR102171796B1 (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
MX2015001048A MX2015001048A (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system.
EP13744426.1A EP2877111B1 (en) 2012-07-25 2013-07-04 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
IL236921A IL236921A (en) 2012-07-25 2015-01-25 Elongated pin for an external modular fixation system for temporary and/or permanent fixation applications and external modular fixation system
HK15105960.8A HK1204905A1 (en) 2012-07-25 2015-06-23 Elongated pin for an external modular fixation system for temporary and or permanent fixation applications and external modular fixation system

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP12177909 2012-07-25
EP12177909.4 2012-07-25

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US (1) US10631896B2 (en)
EP (1) EP2877111B1 (en)
JP (1) JP6495168B2 (en)
KR (1) KR102171796B1 (en)
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AU (1) AU2013295399B2 (en)
BR (1) BR112015001589B1 (en)
CA (1) CA2878967C (en)
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ES (1) ES2573282T3 (en)
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016001427A1 (en) * 2014-07-03 2016-01-07 Stryker Trauma Gmbh Conical end cap for intramedullary nail
JP2017503618A (en) * 2014-01-24 2017-02-02 オーソフィックス エス．アール．エル． Elongated pins for external fixator applications
JP2017086148A (en) * 2015-11-02 2017-05-25 学校法人静岡理工科大学 External skeletal fixator
JP2018501938A (en) * 2015-01-19 2018-01-25 オーソフィックス エス．アール．エル． Elongated pins for external fixator applications

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2883395C (en) * 2012-09-06 2018-05-01 Solana Surgical, Llc External fixator
US9943337B2 (en) 2015-12-03 2018-04-17 Globus Medical, Inc. External fixator assembly
US9872707B2 (en) 2015-12-03 2018-01-23 Globus Medical, Inc. External fixator assembly
US10682160B2 (en) 2015-12-03 2020-06-16 Globus Medical, Inc. External fixator assembly
US10136919B2 (en) 2015-12-03 2018-11-27 Globus Medical, Inc. External fixator assembly
CN105909660A (en) * 2016-06-06 2016-08-31 丽水市伊凡家模具科技有限公司 Mechanical part
US10874433B2 (en) 2017-01-30 2020-12-29 Stryker European Holdings I, Llc Strut attachments for external fixation frame
CN110613499B (en) * 2019-10-17 2020-10-09 中国医学科学院北京协和医院 Osteotomy guide plate for body surface lower limb deformity correction operation and preparation method thereof
US11737786B2 (en) 2019-12-31 2023-08-29 Orthopediatrics Corp. Multiple track system for positioning of bone segments
US11413070B2 (en) 2021-11-22 2022-08-16 New Standard Device, LLC Locking clamp and external fixation horns

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0557899A1 (en) * 1989-10-26 1993-09-01 Giuseppe Vrespa Cutter for enabling to form a precision frustoconical hole in bones
EP1042989A1 (en) * 1999-04-08 2000-10-11 Orthofix S.r.l. Improved bone screw for use in orthopedic surgery
US20050085754A1 (en) * 2002-02-11 2005-04-21 Gerd Werding Device for externally immobilizing broken bones
US20110125198A1 (en) * 2009-11-20 2011-05-26 Griffin T Hall Engaging predetermined radial preloads in securing an orthopedic fastener
US20110264149A1 (en) * 2010-04-27 2011-10-27 Dana Pappalardo Bone fixation system including k-wire compression

Family Cites Families (58)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE378008A (en) * 1931-03-07
US3915162A (en) * 1974-02-13 1975-10-28 Peter S Miller Orthopedic pin identification means
CA1077363A (en) * 1976-08-09 1980-05-13 Richard F. Kronner Fracture reducing and joint immobilizing apparatus
ES253459Y (en) * 1978-11-10 1982-04-16 EXTERNAL CLINICAL FIXER, OF HIGH STABILITY, TO REDUCE FRACTURES.
US4463753A (en) * 1980-01-04 1984-08-07 Gustilo Ramon B Compression bone screw
US4548199A (en) * 1981-11-13 1985-10-22 Agee John M Fracture splint
DE3244819A1 (en) * 1982-12-03 1984-06-07 Ortopedia Gmbh, 2300 Kiel DEVICE FOR EXTERNAL FIXING OF BONE FRAGMENTS
FR2572929B1 (en) * 1984-11-15 1987-09-04 Jawish Roger EXTERNAL FIXER FOR BONES AND JOINTS
SE455155B (en) * 1986-02-12 1988-06-27 Inst For Tillempad Bioteknolog SCREW SIZE FASTENER FOR PERMANENT ANCHORING IN BONE TAPE
FR2682281B1 (en) * 1991-10-11 1997-01-03 Sofamor PERCUTANEOUS SCREW, INTENDED TO SUPPORT IN PARTICULAR A STEREOTAXY FRAMEWORK
US5690633A (en) * 1994-09-23 1997-11-25 Smith & Nephew Richards, Inc. Orthopedic fracture fixation device
US5683389A (en) * 1994-12-05 1997-11-04 Smith & Nephew, Inc. External fixator for distal radius fractures
US5863292A (en) * 1996-09-26 1999-01-26 Tosic; Aleksandar Articulated external orthopedic fixation system and method of use
DE69836815T2 (en) * 1997-01-14 2007-10-11 Research Corp. Technologies, Inc., Tucson BONE PEN WITH ROTATION CUTTING TIP
US5943258A (en) * 1997-12-24 1999-08-24 Texas Instruments Incorporated Memory with storage cells having SOI drive and access transistors with tied floating body connections
US6019762A (en) * 1998-04-30 2000-02-01 Orthodyne, Inc. Adjustable length orthopedic fixation device
US6099529A (en) * 1998-10-26 2000-08-08 Musculoskeletal Transplant Foundation Allograft bone fixation screw method and apparatus
DK1042988T3 (en) * 1999-04-08 2008-05-19 Orthofix Srl Bone screw for external fixators
US6277119B1 (en) * 1999-10-21 2001-08-21 Electro-Biology, Inc. External fixation system
DE69930769T2 (en) * 1999-11-15 2007-01-11 Synthes Ag Chur DEVICE FOR DETERMINING REDUCTION PARAMETERS FOR THE SUBSEQUENT REPOSITIONING OF A BROKEN BONE
US6423062B2 (en) * 2000-02-18 2002-07-23 Albert Enayati Bioabsorbable pin for external bone fixation
US6423061B1 (en) * 2000-03-14 2002-07-23 Amei Technologies Inc. High tibial osteotomy method and apparatus
CN1281193C (en) 2000-05-26 2006-10-25 奥叟菲克斯国际公司 Disposable external fixation device
JP3337683B1 (en) * 2001-04-10 2002-10-21 吉野 健一 External fixation device
CA2391635C (en) * 2001-07-02 2007-12-18 Depuy France Device for joining bony parts
US6585736B2 (en) * 2001-09-19 2003-07-01 Mohammed A. Hajianpour Device for external fixation of a fractured radius with simultaneous clamping of multiple pins and with a fixture for applying extension to distal bone fragments
US9060809B2 (en) * 2001-10-18 2015-06-23 Orthoip, Llc Lagwire system and method for the fixation of bone fractures
US6716212B1 (en) * 2002-01-25 2004-04-06 Tyrone Sam Pickens Universal modular external fixation system
US6860883B2 (en) * 2002-02-11 2005-03-01 Pioneer Laboratories, Inc. External fixation apparatus and method
JP3740640B2 (en) * 2002-04-15 2006-02-01 廣章 野々宮 External fixator
US7758582B2 (en) * 2002-06-14 2010-07-20 Smith & Nephew, Inc. Device and methods for placing external fixation elements
US7517350B2 (en) * 2002-11-20 2009-04-14 Orthopediatrics Corp. Convertible threaded compression device and method of use
US7608074B2 (en) * 2003-01-10 2009-10-27 Smith & Nephew, Inc. External fixation apparatus and method
US7615051B2 (en) * 2003-02-21 2009-11-10 Synthes Usa, Llc Craniofacial fracture reduction assembly
CN1265767C (en) * 2003-04-25 2006-07-26 常州市第一人民医院 Restorer for vertebral body and puncture needle for pedicle of vertebral arch by prying operation through skin
JP2004350774A (en) * 2003-05-27 2004-12-16 Oomikku:Kk External fixation device and piercing pin attaching/detaching joint
US7169149B1 (en) * 2003-07-24 2007-01-30 Phoenix Orthopaedic Corporation Device for external fixation of a proximal fracture of the ulna with a clamped medullar pin and multiple clamped pins holding bone fragments
JP2006101896A (en) * 2004-09-30 2006-04-20 Keisei Ika Kogyo Kk External fixer
US20070173837A1 (en) * 2005-11-18 2007-07-26 William Marsh Rice University Bone fixation and dynamization devices and methods
US7731738B2 (en) * 2005-12-09 2010-06-08 Orthopro, Llc Cannulated screw
SE530328C2 (en) * 2006-09-21 2008-05-06 Henrik Hansson Device for fixing a bone fracture
WO2008085985A2 (en) * 2007-01-05 2008-07-17 Trans1 Inc. Percutaneous delivery of facet screws using depth control indicator
US7722611B2 (en) * 2007-03-05 2010-05-25 Depuy Products, Inc. Method of treating a clavicle fracture
ES2366053T3 (en) * 2007-05-03 2011-10-14 Medartis Ag FIXING DEVICE, COMBINATION OF A FIXING DEVICE WITH A LONGITUDINAL ELEMENT, SYSTEM WITH A COMBINATION OF THIS CLASS AS WELL AS AN OSTEOSYNTHESIS KIT.
US8157828B2 (en) * 2007-09-24 2012-04-17 MRI Interventions, Inc. Surgical marking tools and methods for marking a patient
US8343189B2 (en) * 2007-09-25 2013-01-01 Zyga Technology, Inc. Method and apparatus for facet joint stabilization
US8057473B2 (en) * 2007-10-31 2011-11-15 Wright Medical Technology, Inc. Orthopedic device
US8236006B2 (en) * 2008-01-17 2012-08-07 Life Spine, Inc. One step entry pedicular preparation device and disc access system
CN101998842B (en) * 2008-04-16 2013-08-07 新特斯有限责任公司 Apparatus and method for use with fracture table to reposition bone portions
US8083740B2 (en) * 2008-09-28 2011-12-27 Maryam Eslami Device for facilitating the healing of bone including Olecranan
ES2364412T3 (en) * 2009-02-16 2011-09-01 Stryker Trauma Ag BONE SCREW AND CORRESPONDING MANUFACTURING PROCEDURE.
JP5507113B2 (en) * 2009-04-24 2014-05-28 東京応化工業株式会社 Positive resist composition, resist pattern forming method, polymer compound and compound
ES2414532T3 (en) * 2009-11-06 2013-07-19 Orthofix S.R.L. Clamp for external orthopedic fixation device
US8771325B2 (en) * 2009-11-20 2014-07-08 T. Hall Griffin Tapered threaded orthopedic fastener engaging predetermined radial preloads
EP2667808B1 (en) * 2011-01-26 2015-08-26 Del Palma Orthopedics, LLC Lower extremity fusion devices
CN202235658U (en) * 2011-09-17 2012-05-30 王京生 Elastic intramedullary nail of clavicle
US20130172888A1 (en) * 2011-12-31 2013-07-04 Raul Necuze External fixator apparatus, especially for the treatment of hand lesions.
US8915914B2 (en) * 2012-07-25 2014-12-23 Orthofix S.R.L. Method for treating a fracture of a bone having a medullary canal

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0557899A1 (en) * 1989-10-26 1993-09-01 Giuseppe Vrespa Cutter for enabling to form a precision frustoconical hole in bones
EP1042989A1 (en) * 1999-04-08 2000-10-11 Orthofix S.r.l. Improved bone screw for use in orthopedic surgery
US20050085754A1 (en) * 2002-02-11 2005-04-21 Gerd Werding Device for externally immobilizing broken bones
US20110125198A1 (en) * 2009-11-20 2011-05-26 Griffin T Hall Engaging predetermined radial preloads in securing an orthopedic fastener
US20110264149A1 (en) * 2010-04-27 2011-10-27 Dana Pappalardo Bone fixation system including k-wire compression

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017503618A (en) * 2014-01-24 2017-02-02 オーソフィックス エス．アール．エル． Elongated pins for external fixator applications
WO2016001427A1 (en) * 2014-07-03 2016-01-07 Stryker Trauma Gmbh Conical end cap for intramedullary nail
AU2015282847B2 (en) * 2014-07-03 2017-09-28 Stryker European Operations Holdings Llc Conical end cap for intramedullary nail
US10258381B2 (en) 2014-07-03 2019-04-16 Stryker European Holdings I, Llc Conical end cap for intramedullary nail
US10799270B2 (en) 2014-07-03 2020-10-13 Stryker European Holdings I, Llc Conical end cap for intramedullary nail
JP2018501938A (en) * 2015-01-19 2018-01-25 オーソフィックス エス．アール．エル． Elongated pins for external fixator applications
JP2017086148A (en) * 2015-11-02 2017-05-25 学校法人静岡理工科大学 External skeletal fixator

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