WO2013005130A1 - Appareil de fixation pour fractures de l'os - Google Patents

Appareil de fixation pour fractures de l'os Download PDF

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Publication number
WO2013005130A1
WO2013005130A1 PCT/IB2012/053188 IB2012053188W WO2013005130A1 WO 2013005130 A1 WO2013005130 A1 WO 2013005130A1 IB 2012053188 W IB2012053188 W IB 2012053188W WO 2013005130 A1 WO2013005130 A1 WO 2013005130A1
Authority
WO
WIPO (PCT)
Prior art keywords
fixator
blocking elements
fixator according
blocking
pair
Prior art date
Application number
PCT/IB2012/053188
Other languages
English (en)
Other versions
WO2013005130A9 (fr
Inventor
Matteo Mantovani
Original Assignee
Ncs Lab 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
Application filed by Ncs Lab S.R.L. filed Critical Ncs Lab S.R.L.
Publication of WO2013005130A1 publication Critical patent/WO2013005130A1/fr
Publication of WO2013005130A9 publication Critical patent/WO2013005130A9/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6425Devices extending alongside the bones to be positioned specially adapted to be fitted across a bone joint
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6416Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/60Surgical 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
    • A61B17/64Devices extending alongside the bones to be positioned
    • A61B17/6466Devices extending alongside the bones to be positioned with pin-clamps movable along a solid connecting rod

Definitions

  • the present invention relates to a fixator for bone fractures.
  • the present invention relates to an external fixation device, used in surgery to maintain the ends of a fractured bone in position and enable the recalcification and consolidation thereof and formation of bone callus.
  • fixation devices have the aforementioned support and blocking elements connected to one another by suitable guides, for example carbon bars, along which the individual supports can slide and lock into place as needed, so as to be adapted to the size of the patient and extent of the fractured part.
  • Bone screws are generally coplanar, parallel to one other, but they can also have a convergent configuration, aligned along the same junction line and placed on the same side in relation to the fracture, above all to reduce the external encumbrance produced by the fixator.
  • a fracture is generally secured with at least two supports, one for each part of fractured bone; on a same support there are generally present at least two receptacles for the insertion of the same number of bone screws, which are parallel to one another and aligned with the main development direction of the fixation device and thus of the bone to be set.
  • articulated joints are provided to maintain the two parts in a stable angled position. These joints are given a suitable inclination before being applied to the patient's bone.
  • the presently known devices do not enable ample flexibility in managing the modes of intervention on the fracture to be treated and are not always easy to apply or comfortable for the patient.
  • the technical task at the basis of the present invention is to propose a fixator for bone fractures which overcomes the drawbacks of the above-mentioned prior art.
  • fixation device for bone fractures which permits greater versatility and freedom in the positioning of bone screws, with the possibility of fastening the same in points not necessarily aligned along the bone.
  • a further object of the present invention is to propose a fixator for bone fractures capable of being adapted, as necessary, to the extent of the bone and of the fracture to be set, as well as to the size of the patient and conformation of the upper or lower limb to be treated.
  • an object of the present invention is to realize a fixator for bone fractures that is modular, comprises supports that can be mounted according to need, is relatively simple to apply to the patient and forms a stable device which treats the bone damage in an effective manner.
  • the task of the present invention is to propose a fixator for fractures which allows mobility of the patient's joints which are not damaged, so as to be more comfortable and permit a more rapid postoperative recovery.
  • the stated technical task and specified objects are substantially achieved by a fixator for fractures comprising the technical features disclosed in one or more of the appended claims. Further characteristics and advantages of the invention will be more apparent from an approximate, and hence non-restrictive, description of some preferred, but not exclusive embodiments of a fixator for fractures, as illustrated in the appended drawings, in which:
  • FIG. 1 is a perspective view of a first embodiment of a fixator for bone fractures in accordance with the present invention
  • figure 2 is the fixator of figure 1 in a different operative position
  • FIG. 1 - figure 2a is a side view of the fixator shown in figures 1 and 2;
  • FIG. 3 is a perspective view of a second embodiment of the fixator for bone fractures in accordance with the present invention.
  • figure 4 is the fixator of figure 2 in a different operative position
  • FIG. 5 shows a sectional view of a detail of the fixator of the present invention, in particular a section of a support for accommodating a bone screw;
  • FIG. 6 shows a mobile connection which comprises a hinged joint 21 suitable for permitting the rotation of a pair of blocking elements 2 with respect to one another around a rotation axis coinciding with the anatomical rotation axis of the joint;
  • FIG. 7 shows another form of mobile connection which is realised by directly exploiting the two bars 8, to which blocking elements are respectively constrained, each of which blocking elements supporting two bone screws 5;
  • FIG. 8 shows a further type of mobile connection that realises a coupling enabling controlled rotations to be carried out in at least one plane perpendicular to the longitudinal dimension of the bones to which the fixation is applied.
  • the present invention comprises an external fixation device or fixator, to be used in the repair of acute, chronic and traumatic lesions of the upper and lower limbs.
  • a fixator is used to immobilise, compress, realign and lengthen bones, repair fractures and permit the reconstruction of bones, of the hands and feet in particular, but not only.
  • the fixator 1 comprises a plurality of blocking elements 2, preferably connectable in pairs, each comprising at least a first 3 and a second 4 support for inserting and positioning at least one bone screw 5.
  • Each blocking element 2 has a substantially arched shape and is preferably made of thermoplastic polymeric material which guarantees radiotransparency and is suitable for biomedical use, e.g. polyetheretherketone or PEEK.
  • each blocking element 2 has respective longitudinal axes 3 a and 4a which are inclined with respect to one another by a predetermined angle a.
  • Said angle a is acute and comprised between 45° and 80°, preferably between 45° and 75°, for example 55°, as is better visible in figure 2a.
  • Each longitudinal axis 3 a and 4a is aligned along an insertion direction X of a respective bone screw 5 internally of the respective support 3 or 4.
  • the supports 3 and 4 are aligned along the arc of the blocking element 2, arranged in an angled position with respect to one another.
  • the first support 3 a is situated in the vicinity of a first end 2a of the blocking element 2, whereas the second support 4a is situated at a second end 2b of the blocking element 2.
  • the longitudinal axes 3 a and 4a of the two supports 3 and 4 present on each blocking element 2 are contained in a plane that is transversal to a main development direction S of the fixator 1.
  • the fixator 1 in fact, extends prevalently along the length of the bone to be set.
  • the longitudinal axes 3 a and 4a are inclined with respect to one another, thus identifying angularly alternative positions for positioning the bone screw 5 in each blocking element 2. Therefore, the first 3 and the second 4 support identify, according to fixation requirements, alternative positions for fixing a bone screw 5. Preferably, for each blocking element 2 only one support is used, either the first or the second, according to the relative position between fixator and bone or according to the type of fracture. This enables a great adaptability of the fixator to any clinical situation, thus allowing the surgeon an ample margin of positioning.
  • each support 3 and 4 comprises a threaded body 6, preferably cylindrical in shape and having a bevelled end 6a, shaped according to a conical conformation.
  • Each support 3 and 4 further comprises a nut 7 which can be screwed onto the threaded body 6 so as to tighten the bone screw 5 inside support thereof, 3 or 4.
  • the nut 7 is internally conical so as to mate with the bevelled end 6a of the body 6.
  • Each blocking element 2 exhibits at one end 2a a broadening 9 for connection with an adjacent blocking element 2.
  • the blocking elements 2 are advantageously connected, at least two by two, by means of a bar 8 passing internally of the broadening 9, which identifies the first end 6a.
  • the first support 3 is preferably located between said broadening 9 and the second end 2b of the blocking element 2, where the second support 4 is located.
  • Said bar preferably made of carbon, is inserted into a hole passing through each broadening 9 and maintains the connection between the two blocking elements 2 by interlocking them.
  • the blocking element 2 can slide along the bar 8 up to the desired position, so as to enable the length of the fixator 1 to be adjusted as well.
  • each blocking element 2 it is possible to rotate each blocking element 2 slightly around the connecting bar 8 so as to adjust the inclination thereof and adapt the fixator 1 to the limb to be treated and facilitate the positioning thereof.
  • the blocking elements 2 can also be mounted symmetrically with respect to the connecting bar 8 so as to easily secure both sides of the fracture. Two pairs of fixing elements 2 are advantageously connectable to one another, as illustrated in figures 1-4.
  • connection between two pairs of blocking elements 2 can be achieved by means of a mobile connection 10, which enables the rotation of a pair of blocking elements 2 with respect to one another around a rotation axis Z parallel to the longitudinal axis 4a of the second support 4, situated at the end opposite to the one exhibiting the broadening 9.
  • a main development direction S of the fixator 1 which direction substantially coincides with the extension of the bars 8 which connect each pair of blocking elements 2, the rotation axis Z around which the pairs of fixing elements 2 rotate is orthogonal to said direction S and substantially coincides with the rotation axis between two adjacent phalanges.
  • This situation is preferably adoptable, in fact, when it is necessary to reconstruct portions of bone connected together by means of mobile joints that can maintain their natural mobility even during the postoperative period.
  • two adjacent phalanges for example the phalanx and middle phalanx of the hands or feet need to be reconstructed, but relative mobility between the two parts does not compromise perfect healing, it is possible to fix one pair of blocking elements 2 to one phalanx and another pair to the other one and connect them by means of a mobile connection 10 situated at the hinged joint of the hand or foot (figures 2 and 4) ⁇
  • FIGS 1 and 2 illustrate a first embodiment of the fixator 1 of the present invention.
  • the particularity of the first embodiment resides in the type of mobile connection 10 which comprises a hinged connection 1 1.
  • said hinged connection 11 comprises a pair of a pair of L-shaped con rods 12 hinged together.
  • Each con rod 12, moreover, is hinged to a corresponding blocking element 2, each belonging to different pairs.
  • the con rods 12 reciprocally connect the first ends 2a of the two adjacent blocking elements 2 belonging to different pairs.
  • the con rods 12 are made of polymeric material, e.g. PEEK.
  • the hinged system formed by the con rods 12 permits articulation of the finger, for example at an angle a between 0° and 90°, irrespective of the centre of instantaneous rotation.
  • Figure 1 illustrates the first embodiment of the fixator of the present invention in an extended position, whereas in figure 2 the same fixator is shown in the position that enables bending of the finger d, schematically represented, and thus mobility of the joint.
  • Figures 3 and 4 illustrate the second embodiment of the fixator 1, specifically, the fixator with an alternative form of the mobile connection 10.
  • the mobile connection comprises a pin 13, which similarly permits the rotation of the two pairs of blocking elements 2, with respect to one another, around the same axis of rotation Z as described for the first embodiment.
  • the pin 13 connects the second ends 2b of the two adjacent blocking elements 2 belonging to different pairs.
  • the rotation axis Z coincides with the rotation axis of the pin 13 and the centre of instantaneous rotation is imposed using a Kirschner wire.
  • the vicinity of the imposed centre to the anatomical one reduces the discrepancies due to movement, which would result in discomfort and bother for the patient.
  • Figure 3 illustrates the fixator according to this first embodiment, in an extended position, whereas figure 4 illustrates the same fixator when the joint is bent.
  • the invention thus achieves the set objectives.
  • the fixator of the present invention is extremely versatile.
  • it can be constructed by assembling together the blocking elements best suited to the particular fracture and arranging them in the best position such as to ensure both the operating flexibility of the surgeon and patient comfort and tolerance.
  • fixator described can be lengthened according to the length of the phalanx and permits greater freedom in arranging bone screws in alternative positions according to need.
  • each blocking element which can be mounted symmetrically with respect to the connecting bar, making the fixator adaptable for use on any side or part of the limb to be treated.
  • a further large advantage of the fixator in question is given by the possibility of articulating a fractured fmger thanks to the mobile connection.
  • the mobility of the joint permits a better and more rapid postoperative recovery.
  • the limb is not immobilised for a long period, which would complicate subsequent rehabilitation, as occurs with prior art devices.
  • figure 6 shows a mobile connection that comprises a hinged joint 21 suitable for enabling rotation of a pair of blocking elements 2 with respect to one another around a rotation axis which is made to coincide with the anatomical rotation axis of the joint.
  • the hinged joint 21 reciprocally connects two respective blocking elements 2, arranged contiguously to one another, of two pairs of adjacent blocking elements 2. It is provided with a mechanism, activatable from outside by means of a knob 22, designed to facilitate relative rotation between the said two pairs of adjacent blocking elements.
  • This mobile connection is characterized by a blocking element which gives the possibility to the patient, in rehabilitation phase, to increase gradually and independently the bending angle of the fmger for the reacquisition of the articular mobility.
  • FIG. 7 shows a mobile connection that is realised by directly exploiting the two bars 8 to which the blocking elements are respectively constrained.
  • the blocking elements 20 differ from those shown in the embodiments previously illustrated in that each element supports two bone screws 5.
  • This mobile connection realised at the two adjacent ends of the two bars 8, comprises a spherical joint coupling 23 in which the two parts (i.e. the bars) are reciprocally fixable by means of a screw connection of a known type, which enables blocking and releasing in a simple manner.
  • This type of connection like the particularity of the two blocking elements 20 - each of which accommodating two bone screws 5 - makes it possible to greatly reduce the overall dimensions of the fixator . This makes the embodiment particularly useful for paediatric use.
  • a mobile connection realised by means of an arched transversal element 24, which is solidly connected to a first blocking element 20' and removably constrained to a second blocking element 20" by means of a coupling that enables controlled rotations around bones, such as, for example the metacarpus.
  • a fixator for derotative osteotomy which uses the coupling of a pin 25 in a slot 26 afforded in the arched transversal element 24.
  • a pin 25, fixed to the blocking element 20" is provided with screwing means for the removable fastening thereof to the slot 26 in the desired position.
  • the fixation device described is made with materials and technologies that can be perfectly adapted to any surgical necessity.
  • the material making up the device is radiotransparent in order to enable the state of the fracture to be monitored by x-rays while the fixator is still in place.
  • fixator is easily applicable and has a rapid and effective stabilisation.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Selon l'invention, un appareil de fixation pour fractures de l'os comprend une pluralité d'éléments de blocage (2) comportant chacun au moins un premier (3) et un second (4) support d'insertion des vis à os (5) respectives situées le long de l'axe longitudinal (3a, 4a) d'au moins un des deux supports (3, 4). Le premier (3) et le second (4) support de chaque élément de blocage (2) sont disposés en position inclinée l'un par rapport à l'autre, de sorte que leur axe longitudinal (3 a, 4 a) respectif forme entre eux un angle compris, de préférence, entre 45° et 65°.
PCT/IB2012/053188 2011-07-06 2012-06-25 Appareil de fixation pour fractures de l'os WO2013005130A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMO2011A000165 2011-07-06
IT000165A ITMO20110165A1 (it) 2011-07-06 2011-07-06 Fissatore per fratture ossee.

Publications (2)

Publication Number Publication Date
WO2013005130A1 true WO2013005130A1 (fr) 2013-01-10
WO2013005130A9 WO2013005130A9 (fr) 2013-03-07

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PCT/IB2012/053188 WO2013005130A1 (fr) 2011-07-06 2012-06-25 Appareil de fixation pour fractures de l'os

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IT (1) ITMO20110165A1 (fr)
WO (1) WO2013005130A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110037783A (zh) * 2019-05-31 2019-07-23 山东威高医疗科技有限公司 基于电磁导航手术系统的用于辅助骨折复位的固定支架
WO2021041634A1 (fr) 2019-08-27 2021-03-04 Surgical Design Innovations Ii, Llc Dispositif de fixation de doigts modulaire et systèmes et procédés associés

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3985127A (en) * 1975-06-11 1976-10-12 Mstislav Vasilievich Volkov Apparatus for surgical treatment of the knee joint
RU2220676C2 (ru) * 2000-02-03 2004-01-10 Государственное учреждение науки Российский научный центр "Восстановительная травматология и ортопедия" им. акад. Г.А. Илизарова Устройство наружной транспедикулярной фиксации позвоночника и способ его использования
EP1857063A1 (fr) * 2005-03-03 2007-11-21 Sunmedix Co., Ltd. Dispositif de fixation de plaie externe
US20100076435A1 (en) * 2008-09-28 2010-03-25 Maryam Eslami Device for facilitating the healing of bone including Olecranan

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3985127A (en) * 1975-06-11 1976-10-12 Mstislav Vasilievich Volkov Apparatus for surgical treatment of the knee joint
RU2220676C2 (ru) * 2000-02-03 2004-01-10 Государственное учреждение науки Российский научный центр "Восстановительная травматология и ортопедия" им. акад. Г.А. Илизарова Устройство наружной транспедикулярной фиксации позвоночника и способ его использования
EP1857063A1 (fr) * 2005-03-03 2007-11-21 Sunmedix Co., Ltd. Dispositif de fixation de plaie externe
US20100076435A1 (en) * 2008-09-28 2010-03-25 Maryam Eslami Device for facilitating the healing of bone including Olecranan

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110037783A (zh) * 2019-05-31 2019-07-23 山东威高医疗科技有限公司 基于电磁导航手术系统的用于辅助骨折复位的固定支架
CN110037783B (zh) * 2019-05-31 2024-03-22 山东威高医疗科技有限公司 基于电磁导航手术系统的用于辅助骨折复位的固定支架
WO2021041634A1 (fr) 2019-08-27 2021-03-04 Surgical Design Innovations Ii, Llc Dispositif de fixation de doigts modulaire et systèmes et procédés associés
EP4021324A4 (fr) * 2019-08-27 2023-09-27 Surgical Design Innovations II, LLC Dispositif de fixation de doigts modulaire et systèmes et procédés associés

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Publication number Publication date
WO2013005130A9 (fr) 2013-03-07
ITMO20110165A1 (it) 2013-01-07

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