WO2019046273A1 - Système de distraction mandibulaire à ancrage crânien - Google Patents

Système de distraction mandibulaire à ancrage crânien Download PDF

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Publication number
WO2019046273A1
WO2019046273A1 PCT/US2018/048302 US2018048302W WO2019046273A1 WO 2019046273 A1 WO2019046273 A1 WO 2019046273A1 US 2018048302 W US2018048302 W US 2018048302W WO 2019046273 A1 WO2019046273 A1 WO 2019046273A1
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WIPO (PCT)
Prior art keywords
distraction
mandible
mandibular
bone
bone plate
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PCT/US2018/048302
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English (en)
Inventor
Edward P. BUCHANAN
David KHECHOYAN
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Envue Imaging Inc.
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.)
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Publication date
Application filed by Envue Imaging Inc. filed Critical Envue Imaging Inc.
Publication of WO2019046273A1 publication Critical patent/WO2019046273A1/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
    • A61B17/60—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
    • A61B17/663—Alignment, compression or distraction mechanisms for jaw bones, e.g. subcutaneous distractors with external access
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical 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
    • A61B17/8071—Cortical 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 discloses a mandibular distraction system which comprises a cranial anchor as part of or in combination with a mandibular distractor.
  • the use of the system of the present invention is for treatments of congenital, developmental, post-surgical and traumatic defects.
  • Skeletal deformities such as maxillomandibular hypoplasia, facial asymmetry, or congenital micrognathia, have been treated via osteotomies followed by acute orthopedic movements and skeletal fixation, with or without interpositional bone grafts.
  • Modulating de novo bone growth through distraction osteogenesis is a process of new bone formation between the surfaces of bone segments gradually separated by incremental traction. The incremental traction is applied to stretch the reparative callus which joins the divided bone segments.
  • a surgical intervention can be used to reconstruct an underformed mandible to properly perform its intended functions, such as providing a stable and functional airway. This is achieved by positioning the tongue and soft tissues in an appropriate location in relation to the other aerodigestive structures, performing masticatory functions, or contributing to natural balance of the facial skeleton.
  • an osteotomy i.e., surgically cutting a bone to create two separate segments. Bone plates of a distractor can be fixed to each segment of the cut bone, in which the bone plates are secured to each of the bone segments on opposite sides of the osteotomy.
  • the distractor device includes a distraction mechanism, such as a threaded rod, that enables the distance between the bone plates to slowly increase over time allowing the growth of new bone between the bone segments, i.e., osteogenesis.
  • the new bone growth increases as the distractor is turned to reach the new desired length.
  • the distraction process is then halted and the distractor is then removed after giving enough time for full bone mineralization.
  • the distraction mechanism is usually actuated by a separate tool, such as a screw driver-like hand tool.
  • Distraction osteogenesis process is performed by gradually separating the bone plates to generate traction. The traction generates tension within the callus to stimulate the growth and formation of new bone. Further separation of the bone plates allows further bone growth to occur.
  • the distraction osteogenesis process is repeated to achieve the desired bone configuration and clinical outcome.
  • Mandibular size such as retrognathia or micrognathia
  • the mandibular deformity of the patient contributes to a direct effect on breathing, eating, and sleeping.
  • the underdevelopment of the mandible can contribute to the underdevelopment of the maxillary growth.
  • the facial balance of the patient can be normalized by advancing the mandible relative to the maxilla that can directly affect the position of the soft tissues which are intimately related and dependent on the position of the mandible.
  • the distraction osteogenesis occurs by lengthening the mandible in both vertical and horizontal dimensions.
  • the osteotomy usually occurs across the ramus or angle of the mandible on both sides on the mandible to avoid the tooth beds.
  • a pair of distractors are attached to the mandible by securing individual bone plate to each bone segment across the osteotomy gap with mechanical fasteners, such as screws.
  • the distractor In order to move the two bone segments, i.e., the distal (in the front side of the jaw) and proximal segments of the osteotomized mandible, farther away from each other, the distractor is turned to separate the bone plates gradually. As the distal and proximal segments of the osteotomized mandible move farther apart to allow bone regeneration, the distal segment of the mandible should move more anterior, so that the lower mandibular incisors move toward a position which is in better relationship with the upper maxillary incisors.
  • the first and the second bone plates are formed as a separation type, and the relative position and turning angle of two bone segments can be readily and accurately adjusted to improve the accuracy and efficiency of performing distraction osteogenesis.
  • US patent no. 9,622,801 (Alruhaimi, Mandibular Distractor Device) discloses a mandibular distractor device to attach to opposing sides of a mandible for performing distraction osteogenesis, which comprises a distractor body and an activation bar.
  • the activation bar can be threaded to an interior wall of the anterior plate and rotated incrementally to disengage the threaded portion of the activation bar from the threaded interior wall of the anterior plate.
  • Chinese application CN 104644252 discloses a sectional type arc-shaped distraction osteogenesis device which comprises an arc-shaped guide rail with a working end connected with a driving device as a control device.
  • the driving device is connected with a pressurization passage and a pressure relief passage which are arranged in the arc-shaped guide rail.
  • US patent no. 6,471,706 Bl discloses a bone distractor by providing affixation members to attach to the bone segments including a screw having a rotatable member engaging the affixation members for distraction.
  • the affixation members comprise resorbable material that is resorbed in the body after distraction is complete to minimize the size of the surgical without removing the non-resorbable screw.
  • the bone plates which are secured to the bone segments move away from one another to generate traction to lengthen the bone.
  • This lengthening process exerts equal forces across the distractor system and into the tissues surrounding the mandible through distraction by turning the distractor system.
  • the distraction forces which are applied to the bone segments also create tension in the soft tissues surrounding mandibular movement.
  • the forces exerted on the distal segment of the mandible are often desirable by moving the distal mandibular segment farther in the anterior- posterior facial dimension to correct the micrognathia or retrognathia.
  • the soft tissues may not accommodate the large musculoskeletal movements, leading to compromised function and esthetics (Cope-1999).
  • the forces exerted on the soft tissue during the active phase of distraction can limit the amount of ideal mandibular movement.
  • the soft tissues surrounding the mandibular movement such as skin, muscle, and fascia, can exert increasing amount of forces against the mandibular movement. This increasing force can be transferred to the area of the mandible with the least amount of resistance. For patients with large mandibular distraction, such as greater than 1 cm, this increasing force can be transmitted to TMJ causing permanent damage of TMJ.
  • US patent no. 5,855,580 discloses a device for the distraction of bone segments without damaging tissue by providing a mounting with geometrical and substantially linear longitudinal axis, along which two complementary halves are adjustably movable by an adjusting device with an increase of their mutual distance. Also, US patent no.
  • 7,771,434 discloses a distractor having at least a pair of opposing bone plates secured distally and proximally to a pair of bone segments, wherein the mounting brackets for securing the bone plates to the distractor means comprise abutment members that extend into the gap and abut the exposed ends of the two bone segments, such that distraction force is transferred to the bone segments by both the bone plates and the abutment members.
  • the amount of mandibular distraction achieved with the commonly used devices is limited by the limitation of the soft tissues in accommodating the mandibular movement in considering the potential damage that can be done to TMJ. Furthermore, increasing distraction force leads to the increase of the force exerted onto the TMJ, which results in significant pain. This further leads to an inability to achieve the desired distraction.
  • the present invention provides a mandibular distraction osteogenesis system which comprises a cranial anchor as part of or in combination with a mandibular distraction device for use during mandibular distraction osteogenesis of a patient, such as for the treatment of congenital, developmental, post-surgical and traumatic defects.
  • the mandibular distraction system of the present invention comprises a fixed distraction activation mechanism associated with the mandible distractor to move a proximal segment of an osteotomized mandible away from a distal segment of an osteotomized mandible.
  • the present mandibular distraction system comprises a cranial anchor comprising a first end that includes a first bone plate configured and adapted for attachment to the patient's skull, and an elongated member at a second end thereof; and a mandible distractor comprising a distraction activation mechanism, a second bone plate configured and adapted for attachment to a distal segment of an osteotomized mandible, and a third bone plate configured and adapted for attachment is secured to a proximal segment of the osteotomized mandible; wherein the elongated member at the second end of the cranial anchor is attached to the mandible distractor to securely hold the second bone plate in a fixed position, and wherein the distraction activation mechanism is operatively associated with the mandible distractor to move the third bone plate away from the second bone plate.
  • the cranial anchor of the mandibular distraction system of the present invention may include an articulating joint between the first bone plate and the elongated member to allow for movement of the mandible, wherein the articulating joint is a ball-and-socket joint.
  • the second end of the cranial anchor is attached to the distraction activation mechanism of the mandibular distractor near the second bone plate, wherein the second and third bone plates of the mandible distractor each comprises a footplate.
  • the mandibular distraction system of the present invention further comprises a distractor rod surrounding the distraction activation mechanism and extending away from the mandibular distractor.
  • the cranial anchor of the mandibular distraction system of the present invention includes an articulating joint between the first bone plate and the elongated member to allow for position adjustment of the elongated member as the distraction activation mechanism moves the third bone plate, wherein the second end of the cranial anchor is attached to the distraction activation mechanism of the mandibular distractor near the second bone plate, and wherein the second and third bone plates of the mandible distractor each comprises a footplate.
  • This preferred mandibular distraction system further comprises a distractor rod surrounding the distraction activation mechanism and extending away from the mandibular distractor, wherein the articulating joint is a ball-and-socket joint, wherein each bone plate includes a plurality of openings for receiving bone screws.
  • the present invention also relates to a method for mandibular distraction osteogenesis which comprises: providing a mandibular distraction system having a distraction activation mechanism and three bone plates for providing points of attachments to the craniofacial skeleton of a patient in need of mandibular distraction, with the first point including a first bone plate configured for attachment to the patient' s cranial bone at the parietal bone of the skull, the second point including a second bone plate configured for attachment to the distal segment of the patient's osteotomized mandible, and the third point including a third bone plate configured for attachment to the proximal segment of the patient's osteotomized mandible; fixing the first and second bone plates with an elongated member to prevent movement therebetween when the distraction activation mechanism moves the third bone plate away from the second bone plate, thus minimizing or preventing pressure on the patient's temporomandibular joint coincident with the mandibular distraction.
  • the bone plates in this method of the present invention include a number of openings therein; and attaching the bone plates to the patient with bone screws.
  • the mandibular distraction system in this method of the present invention includes an articulating joint to allow movement of the patient's mandible and provide the ability to open and close during distraction.
  • the present invention also relates to a further method for mandibular distraction osteogenesis by utilizing a mandibular distraction system comprising: a cranial anchor comprising a first end that includes a first bone plate configured and adapted for attachment to the patient's skull, and an elongated member at a second end thereof; and a mandible distractor comprising a distraction activation mechanism, a second bone plate configured and adapted for attachment to a distal segment of an osteotomized mandible, and a third bone plate configured and adapted for attachment is secured to a proximal segment of the osteotomized mandible; wherein the elongated member at the second end of the cranial anchor is attached to the mandible distractor to securely hold the second bone plate in a fixed position, and wherein the distraction activation mechanism is operatively associated with the mandible distractor to move the third bone plate away from the second bone plate.
  • a mandibular distraction system comprising: a cranial anchor comprising a
  • This method of the present invention comprises: providing this mandibular distraction system with the first bone plate configured for attachment to the patient's cranial bone at the parietal bone of the skull, the second bone plate configured for attachment to the distal segment of the patient's osteotomized mandible, and the third bone plate configured for attachment to the proximal segment of the patient's osteotomized mandible; fixing the first and second bone plates with an elongated member to prevent movement therebetween when the distraction activation mechanism moves the third bone plate away from the second bone plate, thus minimizing or preventing pressure on the patient's temporomandibular joint coincident with the mandibular distraction.
  • the present invention also relates to a use of the mandibular distraction system of the present invention for treatment of congenital, developmental, post-surgical and traumatic defects, wherein the ability of the patient' s mandible to open and close provides cranial facial movement that involves the mandible and maxilla at the LeFort I, II or III levels.
  • FIG. 1 shows a profile view of a mandibular distraction system including a cranial anchor, an articulating joint, a distractor rod and a mandibular distractor.
  • FIG. 2 shows an anterior-posterior view of the craniofacial skeleton with a cranial anchored mandibular distraction system.
  • FIG. 3 shows a lateral view of the craniofacial skeleton with the mandibular distraction system in place.
  • FIG. 4 shows a right oblique view of the cranial anchored mandibular distraction system in place on a simulated patient.
  • FIG. 5 shows a left oblique view of the cranial anchored mandibular distraction system in place on a simulated patient.
  • the present invention relates generally to the field of medical distraction devices in the field of bone fixation, repair and regeneration, and more particularly relates to such devices and methods utilized in mandibular distraction osteogenesis.
  • the present invention provides a mandibular distraction system and a method of use thereof, comprising a cranial anchor and a mandibular distractor for the use of mandibular distraction osteogenesis for treatments of congenital, developmental, post-surgical and traumatic defects.
  • the present invention provides a mandibular distraction system which comprises a cranial anchor as part of or in combination with a mandibular distractor.
  • the mandibular distraction system of the present invention provides a system that is anchored on the cranium to unload the forces that are exerted on temporomandibular joint (TMJ) during mandibular distraction, which provides a stable position for mandibular distraction based on the cranium to relieve the tension exerted on TMJ.
  • TMJ temporomandibular joint
  • the mandibular distraction system of the present invention comprises a cranial anchor and a mandible distractor.
  • the cranial anchor of the mandibular distraction system of the present invention comprises a first bone plate, an elongated member, and an articulating joint, such as a ball-and-socket joint, wherein the articulating joint is located between the first bone plate and the elongated member to allow for movement of the mandible.
  • the cranial anchor of the present invention comprises a first end that includes a first bone plate configured and adapted for attachment to the patient's skull, and an elongated member at a second end thereof.
  • the mandible distractor of the mandibular distraction system of the present invention comprises a distraction activation mechanism (such as a distractor rod that is engaged by a conventional activation tool), a second bone plate, and a third bone plate.
  • the mandible distractor of the present invention comprises a distraction activation mechanism, a second bone plate configured and adapted for attachment to a distal segment of an osteotomized mandible, and a third bone plate configured and adapted for attachment is secured to a proximal segment of the osteotomized mandible, wherein the elongated member at the second end of the cranial anchor is attached to the mandible distractor to securely hold the second bone plate in a fixed position, wherein the distraction activation mechanism is operatively associated with the mandible distractor to move the third bone plate away from the second bone plate.
  • the second end of the cranial anchor is attached to the distraction activation mechanism of the mandibular distractor near the second bone plate, wherein the mandibular distraction system further comprises a distractor rod surrounding the distraction activation mechanism and extending away from the mandibular distractor.
  • the bone plates comprise footplates which are used to attach the bone plates to the mandible or skull.
  • a first bone plate is attached to a patient's skull
  • a second bone plate is secured to the distal segment of the osteotomized mandible
  • a third bone plate is secured to the proximal segment of the osteomized mandible.
  • the footplates include a number of openings therein to attach the bone plates to the patient with bone screws.
  • the mandibular distraction system of the present invention comprises three points of attachments to the craniofacial skeleton, i.e. the cranial bone, the proximal segment of the osteotomized mandible and the distal segment of the osteotomized mandible.
  • the distal segment of the osteotomized mandible is defined as the bone segment in the front side of the jaw.
  • the proximal segment of the osteotomized mandible is the bone segment which contains the condyle of the mandible.
  • temporal or parietal bone is preferable due to their linear relationships with the ramus of the mandible.
  • the system of the present invention provides the benefits of transferring the forces generated by mandibular distraction to the cranial skeleton or the distal segment of the osteotomized mandible, preferably to the distal segment of the osteotomized mandible.
  • the forces exerted on the proximal segment of the osteotomized mandible are unloaded during distraction to reduce or eliminate the forces exerted on TMJ.
  • the present invention also provide a method for mandibular distraction osteogenesis by providing a mandibular distraction system having a distraction activation mechanism and three bone plates for providing points of attachments to the craniofacial skeleton of a patient, with the first point including a first bone plate attached to the patient's cranial bone at the parietal bone of the skull, the second point including a second bone plate attached to the distal segment of the patient's osteotomized mandible, and the third point including a third bone plate attached to the proximal segment of the patient's osteotomized mandible.
  • the method further comprises fixing the first and second bone plates with an elongated member in a predetermined fixed distance to prevent movement therebetween when the distraction activation mechanism moves the third bone plate away from the second bone plate, thus minimizing or preventing pressure on the patient' s temporomandibular joint coincident with the mandibular distraction.
  • the mandibular distraction system in this method of the present invention includes an articulating j oint to allow movement of the patient's mandible and provide the ability to open and close during distraction.
  • the mandibular distractor of the mandibular distraction system of the present invention can be any known mandibular distractors or any mandibular distractors with similar operating mechanisms. Examples of known mandible distractors are described in
  • a mandibular distractor has a distractor rod, such as a threaded rod, as the main body including two bone plates for attaching to the bone segments of mandible, i.e., the proximal segment of the osteotomized mandible and the distal segment of the osteotomized mandible.
  • the mandibular distractor has a distraction activation mechanism that enables the distance between the bone plates to slowly increase over time, such as by rotating an actuator arm, e.g., an activation arm, using a conventional activation tool, to initiate the distraction activation mechanisms for separating the bone plates.
  • the mandibular distractor can be turned or actuated to reach a new desired or predetermined length for position adjustment.
  • the mandibular distractor of the present invention can have a straight or a curvilinear vector, i.e., a straight or curve main body, depending on surgeon preference and desired postoperative result.
  • the mandibular distraction can be performed on a unilateral or bilateral basis depending on the deformity.
  • the mandibular distraction system of the present invention can be utilized on both sides of the mandible to correct bilateral mandible problems, as seen in microganthia or retrognathia.
  • Unilateral mandible distraction is commonly used for unilateral deformities, i.e. craniofacial macrosomia, radiation damage, or traumatic accidents.
  • the system of the present invention can be applied in both intra-oral and percutaneous approaches.
  • the cranial anchor of the mandibular distraction system of the present invention is attached to the temporal or parietal bone through an incision in the scalp.
  • the cranial anchor can be fixed to one side of the bone of the head through footplates secured by screws to obtain a rigid attachment.
  • the cranial anchor can be made of a metal that is approved by the FDA (US Food and Drug Administration) for use in humans.
  • the cranial anchor can be buried under the skin or soft tissue or be exposed externally.
  • the cranial anchor can be made of a metal such as stainless steel to provide a rigid and solid fixation point. Since the cranial anchor provides a rigid fixation point to the cranial bone, the majority of the forces generated by mandibular distraction in the mandibular distraction system of the present invention is exerted on the distal segment of the osteotomized mandible. Therefore, the distraction system of the present invention provides the benefits of reducing or eliminating the forces exerted on the proximal segment of the osteotomized mandible. As a result, the forces exerted on the proximal segment of the osteotomized mandible are unloaded during mandibular distraction to reduce or eliminate the forces exerted on TMJ. It can reduce or eliminate the chance of causing permanent damage of TMJ and reduce the significant pain at the TMJ during mandibular distraction. It also contributes to a more predictable mandibular distraction process.
  • the soft tissues of the lower face surrounding the mandibular movement can exert increasing amount of forces against the mandibular movement.
  • the system of the present invention can unload this increasing amount of forces exerted on the proximal segment of the osteotomized mandible.
  • the cranial anchor is attached to an articulating mechanical socket or an articulating j oint.
  • the articulating j oint can be a ball-and-socket joint which comprises a spherical part fitting into a spherical socket, allowing free movement within a specific conical volume, such as a ball in socket.
  • This articulating joint provides the benefits that the patient can have active or passive motion at the TMJ during the distraction process if required.
  • the articulating joint is made of rigid material, such as metal, to allow a rigid platform for mandibular distraction, which also allows the ability of opening and closing the mandible during the post-operative setting. Due to the rigidity of the system, the articulating component can provide the advantages of increasing the mobility of TMJ. It is particularly beneficial for post-operative mobility to accommodate normal activities of daily living, i.e. eating, chewing, or oral hygiene.
  • the system of the present invention can also serve as a primary driver in a cranial facial movement that involves the mandible and maxilla at the LeFort I, II or III levels.
  • the present invention relates to a use of a mandibular distraction system for treatment of congenital, developmental, post-surgical and traumatic defects, wherein the ability of the patient's mandible to open and close provides cranial facial movement that involves the mandible and maxilla at the LeFort I, II or III levels.
  • a LeFort fracture of the skull is a transfacial fracture of the mid face, involving the maxillary bone and surrounding structures in horizontal, pyramidal or transverse direction.
  • a cranial anchored mandible distraction device to unload the TMJ joint and to lengthen the mandible as well as maxilla at the LeForte I, II, or III level is another potential application of the mandibular distraction system of the present invention.
  • Patients with mandible hypoplasia can often present with maxillary hypoplasia, further causing a compression and compromise of their nasal and oral airways.
  • the system of the present invention has the potential to be used in combination with a maxillary and mandibular osteotomy and lengthening, to increase the space in the nasomaxillary and oropharyngeal airways.
  • This type of operation would involve an osteotomy of the maxilla at the LeForte I, II, or III levels, as well as bilateral mandibular osteotomies.
  • the maxilla and mandible would then be advanced together based on the driving function of the mandible distractor.
  • the mandible and maxillary transport segment would be secured to one another with intermaxillary wires or rubber bands so that face can truly be advanced in entirety from the cranial skeleton.
  • FIGs. 1-5 provide examples of the designs and uses of the mandibular distraction system of the present invention.
  • the system of the present invention comprises three points of attachments to the craniofacial skeleton, i.e., the cranial bone, the proximal segment of the osteotomized mandible and the distal segment (in the front side of the jaw) of the osteotomized mandible.
  • the system of the present invention is attached to the cranial bone through a cranial anchor, in which the cranial anchor comprises a footplate that is attached to the cranial skeleton at the level of the parietal or other cranial bone as shown in FIGs. 1 and 2.
  • the footplate of the cranial anchor can be secured by screws or other commonly used fixation techniques to the mandible.
  • the cranial anchor comprises a bone plate and an elongated member.
  • the bone plate and the elongated member are joined together by a movable joint, such as an articulating joint.
  • the elongated member of the cranial anchor is attached to the main body of the mandibular distractor as shown in FIG. 1, wherein the mandible distractor includes a distractor rod with a distraction activation mechanism.
  • the distractor rod is a rigid bar made of rigid material, such as metal, to allow a rigid platform for mandibular distraction.
  • the elongate member or bone plate of the cranial anchor is made of rigid material, such as metal, to allow a rigid platform for mandibular distraction.
  • FIG. 1 also shows a mandibular distractor which includes two bone plates and a distractor rod with a distraction activation mechanism.
  • the bone plates include footplates which are used to attach the bone plates to mandible.
  • One bone plate is secured to the distal segment of the osteotomized mandible, and the other bone plate is secured to the proximal segment of the osteomized mandible.
  • the design of the cranial anchor includes a rigid arm connected to a movable joint and the rigid arm subsequently connects to a distractor rod as shown in FIG. 1 in order to simulate the movement of TMJ during the mandibular distraction.
  • the design of the mandibular system of the present invention provides flexibility to allow the movement of the TMJ during mandibular distraction and also provides adequate accommodation for patient's daily activities during the activation stage of mandibular distraction and the consolidation phase.
  • FIG. 2 and FIG. 3 shows a cranial anchored mandibular distraction system having three points of attachments to the craniofacial skeleton, i.e., one to the cranial bone at the parietal bone of the skull, one to the proximal segment of the osteotomized mandible and one to the distal segment of the osteotomized mandible.
  • the cranial anchor includes an external articulating joint.
  • the external articulating j oint is attached to an elongated member which is attached to a mandible distractor, wherein the mandibular distractor includes a distraction activation mechanism, such as a distraction rod.
  • the mandible distractor encompasses the normal components of other described mandible distractors, such as bone plates attached to proximal and distal segments.
  • the proximal segment of the mandible is the bone segment which contains the mandibular condyle.
  • the distal segment of the mandible is defined as the bone segment in the front side of the jaw that contains the tooth containing elements of the mandible, including body and symphysis. These segments are separated by the mandibular osteotomy that is eventually distracted for growth purposes.
  • the mandibular segments are attached by the bone plates of the mandibular distractor.
  • the mandibular distractor is attached to the cranial portion of the system comprising an external articulating joint.
  • the bone plate attached to the proximal segment of the mandible is part of a mandibular distraction system which includes an articulating joint.
  • the articulating join provides the flexibility to facilitate the mandible to open and close during the distraction process. The purpose of this is to allow joint mobility during times of distraction, to prevent pressure on the TMJ coincident with mandibular distraction.
  • FIG. 4 shows the external portion of the system, wherein the external joint resides at the same level as the native temporomandibular joint. Attachments of the external joint to the cranial anchor and the internal mandibular distractor can partially be seen.
  • FIG. 5 shows the incisions and percutaneous access points for the system and the activation arm.
  • the mandibular distractor of the system of the present invention is an internal system which is secured to the mandible with screws.
  • the bone plates of the internal distractor comprise footplates.
  • the bone plate of the distractor is secured to the mandible bone segment via footplate with screws.
  • One bone plate is secured to the distal segment of the
  • the movable joint is external which connects to a distractor rod, wherein the distractor rod is directly connected to the main body of the internal mandibular distractor through a percutaneous hole of the skin at the level of the mandibular border. A small incision through the skin is made to allow the entrance of the distractor rod to connect to the main body of the internal mandibular distractor.
  • the mandible distractor is internal and rests against the ramus of the mandible, which is surgically implanted at the time of surgery for the use as a bilateral or unilateral device.
  • the internal mandibular distractor comprises an activation arm with a distraction activation mechanism, such as a distractor rod, in which the activation arm is attached to the main body of the internal mandibular distractor.
  • the activation arm emerges percutaneously through the skin and exits out at the hair baring scalp. The activation arm is turned or actuated to reach the new desired length during the activation phase of the distraction process.
  • the footplate of the proximal mandibular segment is attached to the distractor body and fixed with screws.
  • the footplate of the distal mandibular body is attached to the same distractor body and attached to the mandible with screws.
  • Fixation of mandible distractor as well as the cranial component is achieved by bone screws that are commonly used in facial surgery, usually made of metal (titanium), but in another iteration, plates and screws that dissolve on their own (i.e. resorbable) may be used for fixation purposes.
  • Resorbable plates and screws are commonly made up of a combination of polylactic and polyglycolic acid.
  • Example 1 Patient with Nager Syndrome suffering from significant micrognathia
  • Patient JS is a 9 year old boy born with Nager Syndrome suffering from significant micrognathia which compromises his airway, so a tracheostomy was required for JS from birth. He has had 2 mandible distractions in the past, one when he was an infant and another at the age of 5. These were done to try and increase the size of the airway so that the tracheostomy could be removed. The parents noted that the mandible distractions provided some benefit, but they were never able to remove the tracheostomy because the airway was still very restricted from the base of tongue. Further, as a result of the distractions, the child was only able to open his mouth about 0.5 cm, intra-incisal distance.
  • a cranial anchored mandibular distraction system was used to help him with his airway and to help improve his range of motion of the mandible.
  • the procedure would be a mandible distraction combined with bilateral TMJ arthroplasties.
  • the distraction is used to lengthen the jaw, and the cranial anchored component allows the force of distraction to be concentrated off of the skull, and not placed on the TMJ joints. This would effectively unload the TMJ joints and allow for motion at the TMJ to allow for formation of a pseudo-joint.
  • the airway will increase in three dimensional size and the TMJ will be mobile so that the patient will be able to open and close their mouth in a normal range of motion (3-4 cm).
  • Patient LD is an 8 year old boy born with bilateral craniofacial macrosomia. He has a severely compromised airway with extrusion of the mandible and maxilla. His sleep study demonstrates significant obstructive sleep apnea. His Apnea Hypopnea Index (AHI) is 30. His otolaryngologist believes that a tracheostomy is needed to help improve his airway. The relationship of his mandible to maxilla is class one, but his cephalometric measurements demonstrate significant shortening of the mandibular ramus as well as posterior maxillary height. His mandibular plane angle is greater than normally seen (10-15 degrees).
  • a surgery that addresses both the maxilla and the mandible is indicated.
  • a combined LeFort III with mandible distraction is indicated to move both the maxilla and mandible.
  • the mandible distraction will be cranial anchored to provide a strong and consistent counter force to allow for movement of the mandible and maxilla forward to increase the airway in both naso- and oral- areas. This will prevent the patient from having to obtain a tracheostomy by lengthening the ramus and posterior maxillary heights, increasing the airway respectively.
  • Patient KA is a 13 -year-old girl with Goldenhar syndrome with bilateral hemifacial macrosomia.
  • KA' s right mandibular ramus and condyle exhibited comparatively greater hypoplasia accompanied by a rightward deviation of the chin.
  • Bilateral asymmetric mandibular distraction osteogenesis was used to correct her mandibular deformity with the need of externally offloading her TMJ to avoid subsequent ankylosis.
  • Distraction was subsequently performed at a rate of 1 mm/day without latency period.
  • the left mandible was distracted a total of 14 mm and the right mandible was distracted 20 mm over the first 14 and 20 postoperative days respectively.
  • Pre-operative Angle's class 2 malocclusion was intentionally mildly overcorrected to mild class 3 occlusion. Facial angle improved from about 81 to about 85 degrees.
  • the cranial anchored mandibular distraction systems were removed after a 3 -month consolidation period, and there was no evidence of TMJ pathology postoperatively on physical exam or imaging. The use of cranial anchored mandibular distraction systems allowed successful mandibular distraction osteogenesis without iatrogenic TMJ pathology.

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Abstract

La présente invention concerne un système de distraction mandibulaire et un procédé d'utilisation de celui-ci pour l'ostéogenèse par distraction mandibulaire qui comprend un ancrage crânien, un joint d'articulation, une tige de distracteur et un distracteur mandibulaire. L'utilisation du système de la présente invention est destinée à des traitements d'anomalies congénitales, du développement, post-chirurgicales et traumatiques.
PCT/US2018/048302 2017-08-30 2018-08-28 Système de distraction mandibulaire à ancrage crânien WO2019046273A1 (fr)

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CN113180777A (zh) * 2021-04-30 2021-07-30 吴萌萌 一种厚度可调的上颌骨截骨定位器
CN115120371A (zh) * 2021-09-29 2022-09-30 北京大学口腔医学院 一种锌合金牵张成骨器

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113180777A (zh) * 2021-04-30 2021-07-30 吴萌萌 一种厚度可调的上颌骨截骨定位器
CN113180777B (zh) * 2021-04-30 2022-07-15 吴萌萌 一种厚度可调的上颌骨截骨定位器
CN115120371A (zh) * 2021-09-29 2022-09-30 北京大学口腔医学院 一种锌合金牵张成骨器
CN115120371B (zh) * 2021-09-29 2023-12-15 北京大学口腔医学院 一种锌合金牵张成骨器

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