WO2020202098A1 - Clou intramédullaire - Google Patents

Clou intramédullaire Download PDF

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Publication number
WO2020202098A1
WO2020202098A1 PCT/IB2020/053209 IB2020053209W WO2020202098A1 WO 2020202098 A1 WO2020202098 A1 WO 2020202098A1 IB 2020053209 W IB2020053209 W IB 2020053209W WO 2020202098 A1 WO2020202098 A1 WO 2020202098A1
Authority
WO
WIPO (PCT)
Prior art keywords
seats
intramedullary nail
nail
arm
terminal end
Prior art date
Application number
PCT/IB2020/053209
Other languages
English (en)
Inventor
Enrico PAGANELLI
Original Assignee
Paganelli Enrico
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 Paganelli Enrico filed Critical Paganelli Enrico
Publication of WO2020202098A1 publication Critical patent/WO2020202098A1/fr

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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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
    • A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly

Definitions

  • the present invention refers to an intramedullary nail, suitable for use in a bone synthesis process (osteosynthesis).
  • the intramedullary nail is configured to be inserted within, and to be fixed to, a damaged bone, in particular fractured, by applying one or more fixing screws.
  • the invention further provides a centering device designed to guide the insertion of the fixing screws in the intramedullary nail.
  • intramedullary or endoprosthetic nails is widespread in the treatment of damaged bone structures.
  • Such medical aids contribute to the regeneration of the bone structure, in particular they are used to promote osteosynthesis of the bones of femur and tibia, for example in case of fracture of the femoral neck.
  • the intramedullary nails are inserted within the bone marrow and fixed to the bone structure to be repaired.
  • Known intramedullary nails such as those used in the treatment of proximal femoral fractures, generally have a cylindrical shape.
  • the intramedullary nails of the known type provide that, after the nail being inserted, it must be correctly oriented so as to centre the ante version of the femoral neck and allow the subsequent centering of cephalic screws. This step is followed by the aid of radiographic systems, which allow to show the angular position of the nail. This requires a long time, as each radiographic projection require on average 5 to 7 minutes.
  • a further disadvantage lies in the difficulty of being able to achieve the distal and proximal locking screws with the hole of the nail during the surgical act on the femur.
  • US2018/0078292A1 further shows a variant wherein the option of stabilizing the nail by provisionally introducing Kirchner wires in a percutaneous way to stabilize the nail, once the correct ante version has been achieved, is provided.
  • the nails shown cannot be used in different anatomical variants in terms of inclination and do not have a shape which reproduces the normal curvature existing between the apex of the trochanter (introduction area) and the medullary canal of the femur.
  • the technical problem posed and solved by the present invention is therefore that of providing a medical device which allows to overcome the drawbacks above mentioned with reference to the prior art.
  • the present invention provides an intramedullary nail which bears a plurality of seats or holes for the housing of fixing screws to the bone, each having a configuration that determines a different insertion direction, i.e. a different orientation, of the screw.
  • the devised nail allows to facilitate and simplify the insertion operations in a patient’s femur.
  • the devised nail allows the correct ante version of the femoral neck to be centered with the cephalic screw, in comparison to other nails known in the state of the art, which require to be rotated after the introduction within the femoral canal.
  • the devised nail allows the ante version of the neck to be centered with the guide wire for the cephalic screw, before being introduced within the femoral canal.
  • the nail enters directly with the correct femoral ante version sliding on the guide wire.
  • the nail bears a single opening at a proximal end, which partially reproduces the profiles of three circular holes for housing the cephalic screw, each having different angles (respectively 125°, 130° and 135°) for insertion within the femoral head.
  • This conformation of the opening allows the use of a single nail in different anatomical conditions (normal neck of 130°, coxa plana, coxa valga). This allows to reduce the surgical department store with a reduction in terms of costs and storage.
  • the housing of the proximal and distal locking screws is characterized by a system of grooves partially embedded to each other. This allows a greater tolerance when being introduced and allows easy centering even in the case of minimal angular displacements of the target arm.
  • the solidity of the coupling between the intramedullary nail of the invention and the bone is ensured by the insertion of the cephalic screw, which is stabilized by means of a locking screw of the cephalic screw (shaped to reproduce the same angle of the latter) and by the distal locking screw.
  • a further advantage of the invention therefore consists in allowing a reduction in operation times (and therefore in the risk of infections for the patient) and in a decrease in the exposure for medical personnel to radiation.
  • the intramedullary nail further has an opening or slit passing through a proximal end, which actually results in a bifurcation of the terminal portion of the nail.
  • the opening has a shaped profile bearing curved carvings, to reproduce an overlap of one or more holes configured to allow the insertion of the fixing screws.
  • the nail thus configured is therefore‘open’ in a disto-proximal direction, having a shape that can be overall assimilated to a tuning fork.
  • Another feature available in preferred embodiments of the nail according to the present invention is that of having a partially curved shape, so as to define a harmonic curvature in the proximal part of the nail which reproduces the normal curvature existing between the apex of the trochanter (introduction area) and the canal medullary femur. This allows an easier introduction avoiding the pointing effects during the introduction operation.
  • the curvature is concentrated at a proximal end of the nail, affecting a portion which extends for about 1 ⁇ 3 of the length of the nail itself.
  • the curvature develops to determine an angle of 20° between the proximal part of the nail and the longitudinal axis of development of the bone (femoral ⁇ tibial, depending on the bone structure involved).
  • this angle corresponds to the angle between the apex of the greater trochanter and the femoral canal for the femur, while it corresponds to the angle between the anterior tibial apophysis and the axis of the bone for the tibia.
  • This curved shape of the nail allows to adopt a more superficial entry point both in the femur (the apex of the greater trochanter) and for the tibia (anterior tibial apophysis).
  • the advantages achieved are the possibility of conducting surgery on the femur with the patient in a supine position, using a practically percutaneous approach, while for application to the tibia there is no need to interrupt the patellar tendon to meet the tibial plateau.
  • the access route is the lateral meta-epiphysis of the femur, completely avoiding knee joint exposure.
  • the intramedullary nail is cannulated, that is, it has a tubular conformation that is expressed in the presence of a through cavity from the proximal end to the proximal end.
  • This cavity is configured to allow the insertion of a guide wire, useful in reducing and milling the channel.
  • the configuration above described allows to perform an insertion of the guide wire for the cephalic screw before inserting the nail, making the surgical strategy simpler.
  • the intramedullary nail according to the present invention allows to intercept the already positioned guide wire, to find the ante version of the femoral neck without the need to proceed by attempts.
  • a still further advantage associated with the conformation of the intramedullary nail according to the present invention is that of reducing the stress on the bone it is applied thereto, as well as allowing an aided centering of the ante version of the femoral neck.
  • the present invention further provides a centering device to guide the insertion of screws apt to fix the nail to the bone.
  • the centering device reproduces the tuning fork configuration of the intramedullary nail already described.
  • the centering device achieving the cephalic guide wire, allows a correct rotation of the nail since the beginning, overcoming the problem of searching the ante version of the existing femoral neck for the nails from prior art.
  • the use of a centering device which reproduced the tuning fork conformation of the nail allows to drastically reduce the surgical times required to search the coupling of the cephalic screw with the femoral ante version.
  • FIG. 1 shows a perspective view of a first preferred embodiment of an intramedullary nail according to the present invention
  • FIG. 1 shows an enlarged view of a detail of Figure 1 ;
  • FIG. 3 shows a side view of a second preferred embodiment of an intramedullary nail according to the present invention
  • FIG. 4 shows a perspective view of the embodiment of Figure 3, in which fixing screws inserted in first seats of housing and in second seats of housing formed in the intramedullary nail are shown;
  • FIG. 5 shows a perspective view of a preferred embodiment of a medical kit for bone synthesis process according to the present invention, comprising a preferred embodiment of a centering device and an intramedullary nail according to the embodiment shown in Figures 2 and 3;
  • FIG. 6 shows a perspective view of a configuration of insertion within a bone of the intramedullary nail shown in Figures 2 and 3;
  • FIG. 7 and 8 respectively show perspective views of a configuration of insertion within a bone of the intramedullary nail shown in Figure 1 ;
  • Figure 9 shows a side view of an insertion configuration within a tibia bone of the intramedullary nail shown in Figure 1 .
  • a first preferred embodiment of an intramedullary nail according to the present invention is overall denoted by 1 .
  • the intramedullary nail 1 of the invention is suitable for promoting a bone synthesis process when inserted within a medullary area of a damaged bone, in particular fractured.
  • the nail 1 is configured to be fixed to the latter by applying one or more fixing screws.
  • the intramedullary nail of the invention is designed in particular for applications to the tibia bone.
  • the nail 1 has an elongated conformation and extends between a proximal terminal end 3 and a distal terminal end 4.
  • the nail 1 can have an extension according to a line or longitudinal development direction L, but preferably there is a proximal terminal portion which is developed according to a curved direction C to avoid injuries of the patellar tendon, as will be better described below.
  • the nail 1 bears a plurality of first seats 50a, 50b, 50c, each configured to allow the housing of a respective fixing screw 55, in particular a cephalic screw.
  • each of the first seats 50a, 50b, 50c extends according to a respective insertion direction Da, Db, Dc of the fixing screw 55.
  • Each insertion direction Da, Db, Dc defines a corresponding angle a a, Ob, a c with respect to the longitudinal development direction L.
  • This longitudinal development direction corresponds to a main development direction of the tibia bone when the nail is being inserted therein, as shown in Figure 6.
  • the angles a a , Ob, a c thus defined have different amplitudes from each other.
  • the aforementioned first seats 50a, 50b, 50c are formed at the proximal terminal end
  • the first seats 50a, 50b, 50c are partially superimposed and preferably aligned according to the longitudinal development direction L, as shown in Figure 1 .
  • the nail 1 comprises three first seats 50a, 50b, 50c, each shaped to define a respective angle a a, ( 3 ⁇ 4, a c of amplitude comprised between about 125° and about 135°, in particular a first angle a a of amplitude equal to about 125°, a second angle Ob of amplitude equal to about 130°, and a third angle a c of amplitude equal to about 135°.
  • the intramedullary nail of the invention can be advantageously used for any type of conformation of the bone to be treated, being possible to choose the correct angle for inserting the fixing screw among those determined by each of the first seats 50a, 50b, 50c.
  • the nail 1 preferably bears a plurality of second seats, denoted in the enlargement of Figure 2 by 62a, 62b, 62c, configured for the insertion of further fixing screws 55.
  • the second seats 62a, 62b, 62c are preferably partially superimposed and also arranged aligned according to the longitudinal development direction L.
  • the second seats 62a, 62b, 62c are preferably formed at the distal terminal end
  • Each of the first seats 50a, 50b, 50c and of the second seats 62a, 62b, 62c defines a channel passing through the nail 1 for housing the fixing screws, which preferably has a substantially circular section, even more preferably a section of constant area.
  • the housing channels of the fixing screws defined by them are mutually interpenetrated.
  • the intramedullary nail 1 has an at least partially tuning fork conformation.
  • the nail 1 comprises first arm 91 and a second arm 92 which have a respective free terminal end 91 1 , 912 at the proximal end 4 of nail 1 .
  • the through opening 6 is at least partially shaped to define the plurality of first seats 50a, 50b, 50c and/or the plurality of second seats 62a, 62b, 62c.
  • the through opening 6 is shaped to define the second seats 62a, 62b, 62c.
  • the nail 1 preferably comprises a curved portion 2 at the proximal terminal end 3, wherein the first seats 50a, 50b, 50c are formed.
  • Curved portion 2 develops according to a main curved development direction C.
  • a main curved development direction C Preferably, considered a straight line tangent to the main curved development direction C at the proximal terminal end 3, this defines an angle of about 20° with respect to the longitudinal development direction L.
  • the nail 1 preferably has a substantially cylindrical overall configuration, curved at the proximal end 3 and having a decreasing section proceeding from the proximal end 3 towards the proximal end 4.
  • an intramedullary nail 10 suitable for being applied to a femoral bone shown in Figures 3 and 4, and 7 to 9, is provided.
  • the elements of the nail 10 which have the same characteristics as those already described with reference to the first embodiment will not be further described, and are denoted in the figures attached by the same numerical references.
  • the nail 10 has a through opening 6, according to what already described, shaped to define both the first seats 50a, 50b, 50c and the second seats 62a, 62b, 62c. Therefore, the nail 10 according to the second embodiment has a through opening 6 which has a greater extension, according to the line L, with respect to the nail 1 of the first embodiment. Furthermore, according to this configuration, the first seats 50a, 50b, 50c and the second seats 62a, 62b, 62c for the housing of the fixing screws 55 are communicating through the same opening 6.
  • the nail 10 preferably has an exclusively straight extension, with an overall configuration substantially cylindrical, having a decreasing section proceeding from the proximal end 3 towards the proximal end 4.
  • both embodiments of the intramedullary nail 1 , 10 provide that this may have an overall tubular conformation, i.e. bearing an internal cavity passing through from the proximal end 3 to the proximal end 4, apt to allow the passage of a guide wire for the correct positioning of the nail 1 , 10 itself.
  • the present invention further provides a centering device 100 associated with an intramedullary nail 1 , 10 according to the present invention, of which a preferred embodiment is shown in Figure 5.
  • the centering device 100 is configured for inserting the intramedullary nail 1 , 10 within a bone and for fixing the intramedullary nail 1 , 10 to the bone by inserting fixing screws 55.
  • the centering device 100 comprises a guide arm 9 of the fixing screws 55, which extends from its own proximal end 300 to its own proximal end 400 - the latter being preferably a free terminal end - according to a longitudinal development direction U.
  • the guide arm 9 comprises a plurality of first seats 550a, 550b, 550c, each configured to allow the housing of a respective fixing screw 55.
  • the first seats 550a, 550b, 550c are formed at the proximal end 300.
  • the first seats 550a, 550b, 550c are partially superimposed and aligned according to the longitudinal development direction U.
  • Each of the first seats 550a, 550b, 550c is configured in such a way as to determine a respective insertion direction Da’, Db’, Dc’ of the fixing screw 55, which defines a corresponding different angle a a ’, Ob’, a c ’ with respect to the longitudinal development direction U.
  • the angles a a ’, Ob’, a c ’ have an amplitude comprised between about 125° and about 135°.
  • the arm 9 comprises three first seats 550a, 550b, 550c, each configured in such a way as to determine a respective first, second and third insertion direction Da ', Db’, Dc’ which defines a respective first, second and third angle a a ’, Ob’, a c ’.
  • Each of these angles a a ’, Ob’, a c ’ respectively has an amplitude equal to about 125°, about 130° and about 135°.
  • the arm 9 Since the centering device 100 is associated with an intramedullary nail according to the first 1 or the second embodiment 10, the arm 9 has a conformation which on a case-by-case occasion substantially reproduces or reflects that of the nail itself.
  • the device 100 comprises a plurality of further second seats 662a, 662b, 662c, each being configured to allow the housing of a fixing screw 55, preferably formed at the proximal end 400.
  • the second seats 662a, 662b, 662c are partially superimposed and aligned according to the longitudinal development direction U.
  • the centering device 100 comprises a guide portion 9 preferably at least partially shaped as a tuning fork.
  • Such portion 9 comprises a first guide arm 991 and a second guide arm 992, respectively having a free terminal end at the proximal end 400 of the portion 9.
  • a through guide opening 70 is defined or better interposed between the first guide arm 991 and the second guide arm 992.
  • the through guide opening 70 is at least partially shaped to define the first seats 550a, 550b, 550c and/or the second seats 662a, 662b, 662c for the guide of the fixing screws 55 to be inserted within an intramedullary nail 1 , 10.
  • Each of the first seats 550a, 550b, 550c is configured in such a way as to determine a respective insertion direction Da’, Db’, Dc’ of a fixing screw 55, such insertion direction Da’, Db’, Dc’ defining a corresponding different angle a a ’, Ob’, ac’ with respect to the longitudinal development direction L’.
  • a guide wire is inserted (ferried by means of the guide offered by an X- ray machine), according to an angle of 125°, 130° or 135° with respect to the femur (a different angle is chosen among those listed above depending on the patient’s anatomy conditions). Once the correct angle has been identified, it is apparent in which of the first seats of housing of the intramedullary nail the cephalic screw is to be inserted.
  • the centering arm preferably has a tuning fork configuration which traces that of the nail, and with rotation equal to the nail itself (they are parallel), where, however, the three holes available for the cephalic screw (which respect the various angles previously discussed) are obviously inclined at this angle with respect to the holes on the nail.
  • the at least partially tuning fork configuration of the nail allows to intercept the previously placed guide wire, thus managing to find the ante version of the femoral neck without the need for multiple attempts (and radiographs).
  • the insertion of two guide wires is provided.
  • the surgeon learn about the given angle (confirmed by radiography) and can choose in which of the seats in the tuning fork portion of the nail the cephalic screw will have to be inserted, depending on the required angle of inclination.
  • the insertion of the first cephalic guide wire inside the femoral neck is initially carried out, intercepting the right angle.
  • the second guide wire is then inserted within the medullary canal of the femoral bone.
  • the evaluation of the angle and position of the locking and centering system is performed, after which the intramedullary nail is inserted.
  • a possible boring of the screw housing seats is realized to create space for larger size cephalic screws.
  • the nail is preferably hollow to allow a stabilizing screw to be inserted there inside, which settles on the fixing screw inserted within the nail, giving stability to the coupling.
  • a stabilizing screw there is the possibility of using a different stabilization screw, each with a terminal end, intended to settle on a lateral portion of the fixing screw, which is differently shaped.
  • the terminal end of the stabilization screw has a terminal surface inclined with respect to the longitudinal axis of the stabilization screw itself by an angle equal to the angle of inclination of the fixing screw (for example, 125°, 130°, 135°).
  • This angle corresponds to the angle of the guide wire, consequently this screw will rest on the cephalic screw, which is placed at a specific angle (within one of the three holes/seats of the nail).
  • the nail remains outside the trochanter, i.e. outside the bone.
  • the nail of the invention can be considered universal, because it allows it to be fixed according to different screw angles, depending on the patient, that can be due to the three different angles previously indicated.
  • the embodiment of the nail having a curved portion avoids damage to the patellar tendon.
  • the intramedullary nail of the invention is suitable for use in the treatment of all fractures of long bones (mainly femur, tibia, but further humerus).
  • the tuning fork is very deep, while in the diaphyseal fractures of the tibia the tuning fork is placed only in the lower part of the nail).
  • the holes for the cephalic screw are comprised in the tuning fork portion.
  • a stopper can be further applied which allows to block the guide wire in the corresponding hole at the right angle, in such a way as to realize an easier insertion of the cephalic screw within the corresponding hole.

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

Abstract

La présente invention concerne un clou intramédullaire (1 ; 10) destiné à un processus de synthèse osseuse, conçu pour être inséré dans un os endommagé et fixé à celui-ci par application d'une ou de plusieurs vis de fixation (55). Le clou intramédullaire (1 ; 10) présente une conformation allongée et s'étend entre une extrémité de terminal proximale (3) et une extrémité de terminal distale (4) selon une direction de développement longitudinale (L). Le clou intramédullaire (1 ; 10) comprend une pluralité de premiers sièges (50a, 50b, 50c), chacun étant conçu pour permettre le logement d'une vis de fixation respective (55), lesdits premiers sièges (50a, 50b, 50c) étant conçus de manière à déterminer une direction d'insertion respective (Da, Db, Dc) de la vis de fixation (55). Chaque direction d'insertion (Da, Db, Dc) définit un angle différent correspondant à (αa, αb, αc) par rapport à la direction de développement longitudinale (L).
PCT/IB2020/053209 2019-04-05 2020-04-03 Clou intramédullaire WO2020202098A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000005180 2019-04-05
IT102019000005180A IT201900005180A1 (it) 2019-04-05 2019-04-05 Chiodo endomidollare

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WO2020202098A1 true WO2020202098A1 (fr) 2020-10-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0853923A1 (fr) * 1997-01-21 1998-07-22 ORTHOFIX S.r.l. Clou de cavité intramedullaire pour la traitement des fractures de la hanche
US20080183171A1 (en) * 2007-01-26 2008-07-31 Ebi, L.P. Lockable intermedullary fixation device
US20180078292A1 (en) * 2016-09-22 2018-03-22 Globus Medical, Inc. Systems and methods for intramedullary nail implantation
US20180177537A1 (en) * 2016-12-28 2018-06-28 William Scott Van Dyke Joint compression instrumentation and methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0853923A1 (fr) * 1997-01-21 1998-07-22 ORTHOFIX S.r.l. Clou de cavité intramedullaire pour la traitement des fractures de la hanche
US20080183171A1 (en) * 2007-01-26 2008-07-31 Ebi, L.P. Lockable intermedullary fixation device
US20180078292A1 (en) * 2016-09-22 2018-03-22 Globus Medical, Inc. Systems and methods for intramedullary nail implantation
US20180177537A1 (en) * 2016-12-28 2018-06-28 William Scott Van Dyke Joint compression instrumentation and methods

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