WO2018100221A1 - Distracteur mandibulaire - Google Patents

Distracteur mandibulaire Download PDF

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Publication number
WO2018100221A1
WO2018100221A1 PCT/ES2017/070783 ES2017070783W WO2018100221A1 WO 2018100221 A1 WO2018100221 A1 WO 2018100221A1 ES 2017070783 W ES2017070783 W ES 2017070783W WO 2018100221 A1 WO2018100221 A1 WO 2018100221A1
Authority
WO
WIPO (PCT)
Prior art keywords
distractor
mandibular
jaw
bushing
distension
Prior art date
Application number
PCT/ES2017/070783
Other languages
English (en)
Spanish (es)
Inventor
Pilar RUBIO BUENO
Original Assignee
Fundación Para La Investigación Biomedica Del Hospital Universitario De La Princesa
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 Fundación Para La Investigación Biomedica Del Hospital Universitario De La Princesa filed Critical Fundación Para La Investigación Biomedica Del Hospital Universitario De La Princesa
Publication of WO2018100221A1 publication Critical patent/WO2018100221A1/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
    • A61B17/66Alignment, compression or distraction mechanisms
    • A61B17/663Alignment, compression or distraction mechanisms for jaw bones, e.g. subcutaneous distractors with external access
    • 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
    • A61B17/66Alignment, compression or distraction mechanisms
    • 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8004Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with means for distracting or compressing the bone or bones
    • 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A61B17/8071Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the jaw

Definitions

  • the present invention relates to a mandibular distractor and a kit comprising said distractor, preferably applied to jaw lengthening techniques in the field of maxillofacial surgery.
  • Mandibular distractors are devices used in the field of surgery, mainly to correct malformations in the jaw by means of bone distraction. This technique is less aggressive than other surgical techniques and has undergone a great development in the last decades, giving rise to numerous technical applications and a great variety of devices oriented to this field.
  • the mandibular distraction technique involves performing a cut or osteotomy in the jaw and fixing it, under anesthesia, of an external or internal device (called a distractor) that is equipped with means for separating each mandibular portion separated by said cut. Therefore, by applying said means to the cutting region, stretching of the bone callus is caused, effectively lengthening the mandibular bone.
  • a distractor an external or internal device
  • distracting devices allow elongation of the jaw of the order of 1 mm / day, which can be performed at the patient's home after undergoing surgery.
  • a distinction is made between a first phase of elongation (which usually lasts a few weeks) and a subsequent phase of consolidation, over a period of several months.
  • part of the prosthesis stands out as a foreign element precisely in an area as visible as the face, creates problems related to the aesthetics of the patient, with its possible negative effect on the social and working life of the same, as a result of the excessive volume of known distractors and their corresponding application techniques.
  • the present invention proposes a solution to the aforementioned technical problems, by means of a novel mandibular distractor of titanium or any other similar alloy that can be left permanently anchored to the bone (such as joint prostheses) or of a compatible absorbable, miniaturized material and configured to adapt to the space between the masseter muscle and the external bone cortex of the ascending limb of the jaw, and in intimate apposition to the latter, without adding an excessive additional volume on it and without exceeding, the plate or system of lower fixation, the anatomical limit of the basilar of the mandibular angle, called gonion cephalometric point (Go), which minimizes or completely prevents foreign body reaction problems, as is usual in today's devices.
  • gonion cephalometric point Go
  • a first object of the invention relates to a mandibular distractor comprising two connected and cooperating distension arms, each of which is equipped with one or more fixing means to the jaw of an individual, and where said fixation means are configured to anchor, during the use of the distractor, a first arm of distention to the proximal segment of the ascending limb of the jaw, and a second arm of distension to anchor to the distal segment of the ascending branch of the jaw, the mentioned segments (proximal and distal) being separated by an osteotomy (surgically controlled fracture).
  • connection between the stretching arms is made by a system of a bushing comprised in one of the arms and a coaxial rod comprised in the other arm, where said bushing and rod are configured to move relatively longitudinally promoting, during its application, the elongation or distension of the proximal fragment of the ascending limb of the jaw in relation to the distal fragment of the jaw.
  • the distractor also comprises an internal traction system housed in said bush and connected to the rod through a transmission means, adapted to transmit the movement generated by the drive system to the rod, propitiating the mandibular distention.
  • the internal traction system is configured with wireless or cable connection means to an external activation system, operable remotely from the distractor itself, for the activation of said internal traction system.
  • the external activation system comprises a remote operated electromagnetic device.
  • the electromagnetic device actuated to distance comprises a set of cooperating magnets arranged in the external system and in the internal system.
  • the external activation system comprises a device connected to the internal traction system by means of an intraoral cable.
  • the attachment of the intraoral cable to the internal tensile system is removable.
  • the distractor comprises titanium, or other similar alloy and / or a resorbable material as manufacturing material.
  • the fixing means comprise fixing screws of titanium, or other similar alloy and / or of a resorbable material.
  • the internal traction system has a lateral access perpendicular to the bushing, an upper access parallel to the bushing, or a double diametral access perpendicular to the bushing, on both sides thereof.
  • a second object of the invention relates to a mandibular distention kit comprising a distractor according to any of the embodiments described herein, in combination with an external activation system of said distractor. Problems associated with known distractors protruding like an appendix from the lower part of the jaw are avoided with the distractor of the invention.
  • the distractor of the invention by being at a distance from the user's skin, prevents trauma and any other type of interference, since, externally, the distractor of the invention has no element in sight. In addition, as there is no exposure to the outside of the distractor, the risk of skin infections and deeper infections is also reduced.
  • the distractor of the invention can be used to correct malformations in the jaw and also to solve other conditions that can be solved by a mandibular enlargement, by increasing the upper pharyngeal volume and tensing the muscles, such as sleep apnea in adults. , whose prevalence, according to the most recent publications, could reach 25% of the adult population; or obstructive apnea in children, who may need permanent tracheotomy if the obstruction is not surgically resolved.
  • Figure 1 shows an externally operable mandibular distractor, belonging to the state of the art.
  • Figures 2a-2b illustrate a schematic of the distractor of the invention in use, where its main elements can be seen.
  • Figures 3a-3b show two embodiments of the distractor of the invention, in combination with an external activation system, operable at a distance.
  • known mandibular distractors generally comprise two connected and cooperating mandibular distention arms (1, 2), each of which is equipped with one or more fixing means ( 3, 3 ') to the jaw of an individual.
  • Said fixing means (3, 3 ') are configured to anchor, during the use of the distractor, a first arm (1) of distension to the ascending branch (4) of the jaw, and to anchor the second arm (2) of distension to the main body (5) of the jaw, said ascending branch (4) and said main body (5) being separated by an osteotomy (6).
  • the fixing means (3, 3 ') preferably comprise fixing screws.
  • connection between the arms (1, 2) of distension is preferably carried out by means of a bushing system (7) comprised in one of the arms (1) and of a coaxial rod (8) comprised in the other arm (2).
  • Said bushing (7) and rod (8) are configured to move relatively longitudinally, thus causing distension of the ascending limb (4) relative to the main body (5) of the jaw.
  • the distractor of the invention is advantageously equipped with an internal traction system (9) housed in said bushing (7) and connected with the rod (8) through a transmission means (10) such as a screw, threaded, a piston and / or the like, which transmits the movement generated by the internal traction system (9) to the rod (8), promoting the mandibular distention
  • a transmission means (10) such as a screw, threaded, a piston and / or the like, which transmits the movement generated by the internal traction system (9) to the rod (8), promoting the mandibular distention
  • the internal traction system (9) is an internal element that is preferably housed in the bushing (7), in order not to add additional volume to the assembly formed by the distractor.
  • Figures 2 and 3 of this document show an example where the internal traction system (9) has a side access, it can be arranged, in other embodiments, parallel to the bushing (7), or with a double diametral access perpendicular to the bushing (7), on both sides thereof, so that the distractor can be used interchangeably on the left or right side of the jaw.
  • the distractor external activation system (1 1) may comprise, for example, a remote-operated electromagnetic device.
  • Said electromagnetic device may comprise a set of magnets arranged in the external system (1 1) and in the internal system (9).
  • the external activation system (1 1) may comprise an intraoral device, for example connected via a cable (12) to the internal traction system (9).
  • the cable (12) is connected to said system (9) prior to its fixation to the patient's jaw, so that, once fixed, the cable (12) is exited through a small orifice of the patient's intraoral mucosa.
  • Said cable (12) is connected, externally, to the activation set of the external system (1 1), to send the corresponding operating instructions to the internal traction system (9). Once the mandibular distension phases are completed, it is possible to remove the cable (12) (for example, by pulling it), releasing it from the distractor.
  • kits comprising a mandibular distractor according to any of the embodiments described herein, in combination with an external activation system (1 1).
  • the distractor and the kit of the invention can be applied completely internally to the patient, while maintaining its external activation ability.
  • the external activation system (1 1) by keeping the distractor fixed to the jaw, either to complete the period of bone consolidation of the treatment, or permanently.
  • resorbable type materials or highly biocompatible titanium and which can be left for life anchored to the bone as if it were a prosthesis or osteosynthesis material, are preferably used.
  • the symmetrical arrangement of the two arms (1, 2) of the mandibular distention and of the fixation means (3, 3 '), according to the embodiment shown in Figures 2a-2b makes the distractor can use interchangeably for the right or left side of the jaw. This represents a great functional and economic advantage both in production and in its application to the patient, since it reduces intervention times and eliminates the risk of confusion of using a device on the opposite side.
  • Another advantage of the distractor of the invention with respect to the state of the art is that it allows its fixation at the level of the mandibular basilar.
  • known distractors are based on a bulky stem that, when submerging the device, pose a greater risk of tissue damage at the start of the lengthening treatment. This risk is eliminated with the proposed solution, where the intervention and treatment space is substantially reduced, for the benefit of the patient.

Abstract

La présente invention concerne un distracteur mandibulaire comprenant deux bras (1, 2) de distension reliés et coopérants, chacun de ces bras étant équipé d'un ou de plusieurs moyens de fixation (3, 3') à la mâchoire d'un individu. Avantageusement, la liaison entre les bras (1, 2) de distension est réalisée au moyen d'un système présentant une douille (7) comprise dans l'un des bras (1) et une tige (8) coaxiale comprise dans l'autre bras (2), la douille (7) et la tige (8) étant conçues pour se déplacer longitudinalement l'une par rapport à l'autre, favorisant ainsi, pendant leur utilisation, la distension du segment ascendant (4) de la mâchoire par rapport au corps principal (5) de la mâchoire. Par conséquent, le distracteur comprend un système (9) interne de traction logé dans ladite douille (7) et relié à la tige (8) par un moyen de transmission (10), adapté pour transmettre le mouvement généré par le système (9) d'actionnement à la tige (8), favorisant ainsi la distension mandibulaire.
PCT/ES2017/070783 2016-11-29 2017-11-29 Distracteur mandibulaire WO2018100221A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES201631528A ES2670449B1 (es) 2016-11-29 2016-11-29 Distractor mandibular
ESP201631528 2016-11-29

Publications (1)

Publication Number Publication Date
WO2018100221A1 true WO2018100221A1 (fr) 2018-06-07

Family

ID=62242369

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2017/070783 WO2018100221A1 (fr) 2016-11-29 2017-11-29 Distracteur mandibulaire

Country Status (2)

Country Link
ES (1) ES2670449B1 (fr)
WO (1) WO2018100221A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999051160A1 (fr) * 1998-04-02 1999-10-14 The University Of Birmingham Dispositif de distraction
ES2223191T3 (es) * 1998-12-04 2005-02-16 Wittenstein Ag Dispositivo de distraccion.
US7753915B1 (en) * 2007-06-14 2010-07-13 August Eksler Bi-directional bone length adjustment system
WO2015132382A1 (fr) * 2014-03-06 2015-09-11 Mps Micro Precision Systems Ag Dispositif implantable
US9308026B2 (en) * 2011-04-20 2016-04-12 Ramon L. Ruiz Distractor device including multiple diameter internal post and related methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999051160A1 (fr) * 1998-04-02 1999-10-14 The University Of Birmingham Dispositif de distraction
ES2223191T3 (es) * 1998-12-04 2005-02-16 Wittenstein Ag Dispositivo de distraccion.
US7753915B1 (en) * 2007-06-14 2010-07-13 August Eksler Bi-directional bone length adjustment system
US9308026B2 (en) * 2011-04-20 2016-04-12 Ramon L. Ruiz Distractor device including multiple diameter internal post and related methods
WO2015132382A1 (fr) * 2014-03-06 2015-09-11 Mps Micro Precision Systems Ag Dispositif implantable

Also Published As

Publication number Publication date
ES2670449A1 (es) 2018-05-30
ES2670449B1 (es) 2019-03-07

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