WO1999042048A1 - An apparatus and method for distraction osteogenesis of small al veolar bone - Google Patents

An apparatus and method for distraction osteogenesis of small al veolar bone Download PDF

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Publication number
WO1999042048A1
WO1999042048A1 PCT/US1999/003384 US9903384W WO9942048A1 WO 1999042048 A1 WO1999042048 A1 WO 1999042048A1 US 9903384 W US9903384 W US 9903384W WO 9942048 A1 WO9942048 A1 WO 9942048A1
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WO
WIPO (PCT)
Prior art keywords
rod
alveolus
bone
bone segment
cylmdncal
Prior art date
Application number
PCT/US1999/003384
Other languages
French (fr)
Inventor
Martin Chin
Original Assignee
Martin Chin
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 Martin Chin filed Critical Martin Chin
Publication of WO1999042048A1 publication Critical patent/WO1999042048A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
    • A61B17/66—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
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/171—Guides or aligning means for drills, mills, pins or wires for external fixation
    • 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
    • A61B17/666—Alignment, compression or distraction mechanisms for jaw bones, e.g. subcutaneous distractors with external access for alveolar distraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S606/00—Surgery
    • Y10S606/907—Composed of particular material or coated

Definitions

  • the present invention relates to distraction osteogenesis, and in particular, distraction osteogenesis of small alveolar bone
  • Distraction osteogenesis refers to a technique for growing bone or osteogenesis material, as well as soft tissue, by separating two bone segments Generally, an osteotomy, such as a Lefort III osteotomy, is performed which partitions a bone into two bone segments External distraction osteogenesis devices are then attached to the bone segments through soft tissue or a skin layer These external distraction osteogenesis devices may mclude rods and ⁇ ngs or other cumbersome metal components The distraction osteogenesis devices form a gap between the bone segments by exerting pressure between the bone segments As the gap between the bone segments widens, the body's own natural healing capacity fills the void with new bone and adjacent soft tissue Once the desired bone formation is achieved, the area is allowed to heal and consolidate Often, the distraction osteogenesis device is then removed
  • an Ilizarov distractor is used m lengthening individuals' limbs, such as a leg
  • an Ilizarov distractor may include external metal rings which are then secured to two bone segments m a leg These metal ⁇ ngs are then attached by a rod assembly which may be used to form a gap between the two bone segments and thus allow for the formation of new bone
  • a descnption of an Ilizarov distractor may be found in U S Patent No 4,615,338, issued to Ilizarov, et al on October 7, 1986 and entitled “Automatic Compression - Distraction Apparatus"
  • Distraction osteogenesis devices may also be used in growing bone in the craniofacial region of small children Often, distraction osteogenesis devices are used on small children who are missing bone due to birth abnormalities or accidents While distraction osteogenesis devices are often used on children, distraction osteogenesis devices may be used on adults and animals as well
  • distraction osteogenesis devices are generally external, which may cause a number of problems or complications Often, cumbersome metal rods and ⁇ ngs located external to an individual's skin are used to distract or separate bone segments Individuals, and in particular small children, may fall and mjure themselves on the protruding metal edges Further, small children may complicate the distraction osteogenesis procedure by improperly adjusting the osteogenesis distraction device
  • the distraction osteogenesis device may require multiple entry points to an individual's skin and thus may create multiple scars Distraction osteogenesis devices requiring multiple entry points may also increase the likelihood of infection due to the multiple openings in the individual's skin Also, individuals undergoing the distraction osteogenesis procedure have to cope with an external device which is not cosmetically appealing
  • distraction osteogenesis devices are attached to bone segments in such a way that the pomt of fixation to the bone transfers force during activation
  • a distraction osteogenesis device may be attached to a bone segment by a bone screw or rod which transfers a substantial amount of force during activation or when the distraction osteogenesis device is exerting pressure between the bone segments By having the bone screw transfer a substantial amount of the force during activation, the distraction osteogenesis device may be dislodged from the bone
  • distraction osteogenesis devices are activated using constant rates which do not reflect the individual's healing abilities Regardless of the age or condition of the individual, distraction osteogenesis devices are activated by widening the gap between bone segments 25- 50 mm four times per day This conventional activation rate results m bone growth as low as 20 mm in 20 days Accordingly, an individual may have to be under constant medical supervision for up to 20 days An individual could be an outpatient, but would need to return to the hospital four times per day for adjustments Present distraction osteogenesis device activation techniques do not take mto account an individual's ability to grow bone at a greater or lesser rate By usmg this constant rate, bone may grow too quickly and lock the distraction osteogenesis device, or in the alternative, bone may grow too slowly, requiring a longer pe ⁇ od of time that the distraction osteogenesis device is necessary
  • distraction osteogenesis devices are often difficult to attach because limited bone is available There may be different amounts of bone caused by different types of birth abnormalities or accidents Further, microsurgical reconstruction may be desired For example, a distraction osteogenesis device may be necessary for a dental implant surgery on a bone graft not large enough to place a dental implant Thus, small alveolar bone distraction osteogenesis devices are required to accommodate bone and space limitations Therefore, it is desirable to provide a distraction osteogenesis device which is submergible, or beneath an individual's skin or soft tissue The distraction osteogenesis device then could be permanently positioned withm an mdividual, thereby eliminating the need for surgery in removing the device, including the associated nsks and costs The distraction osteogenesis device then would be more cosmetically appealing and reduce the likelihood of infection, injury and or sca ⁇ ng Further, it is desirable to have a distraction osteogenesis device which does not have to be customized for each mdividual Manufacturing and medical costs would then be substantially reduced by using a standard distraction osteogenesis device and method, rather than customizing distraction osteogenesis devices and methods for
  • an apparatus for distractmg a first bone segment from a second bone segment
  • the apparatus comp ⁇ ses a first implantable member for couplmg the first bone segment and a second implantable member for coupling the second bone segment
  • Submergible means is coupled to the first member and the second member which positions the first member a distance from the second member responsive to a force
  • the submergible means includes a threaded rod portion
  • the apparatus includes activating means for transferring a force to the submergible means
  • the activating means includes a cannula, a torque wrench adapter and a torque wrench
  • the apparatus includes means for removing the activating means
  • the first and second members transfer a substantial amount of the force
  • the activating means transfers a force generating a maximum pressure in order to achieve a maximum distance
  • a submergible device for distracting a first segment of alveolus from a second segment of alveolus to allow for bone generation
  • the submergible device comp ⁇ ses a rod havmg a threaded portion, including an end, a base and an activation end
  • a first member is coupled to the first segment of alveolus and has an openmg for inserting the rod end
  • a second member is coupled to the second segment of alveolus and has an opening for positioning the threaded portion of the rod The rod transfers a force agamst the second member, creating a distance between the first and second alveolus segments
  • a method for forming alveolar bone includes the steps of (a) cutting the alveolus mto first and second segments, (b) secu ⁇ ng a first plate to the first segment of alveolus, (c) forming an opening in the second segment of alveolus, (d) secu ⁇ ng a second transport plate to the second segment of alveolus, (e) msertmg a rod mto the openmg of the second segment of alveolus and through the second plate openmg to the first plate, and (f) exerting a force on the rod to displace the first segment of alveolus from the second segment of alveolus
  • a small alveolar bone device for distracting a first segment of alveolus from a second segment of alveolus to allow for bone generation
  • the device comp ⁇ ses a cylind ⁇ cal member havmg a threaded inner surface coupled to the first segment of alveolus
  • a rod adapter having a threaded outer surface and a threaded inner surface mates to the threaded inner surface of the cyhndncal member
  • a rod having a threaded outer surface mates to the threaded inner surface of the rod adapter The rod transfers a force agamst the second segment of alveolus, creating a distance between the first and second alveolus segments
  • a method for forming small alveolar bone includes the steps of (a) forming an opemng in the alveolus, (b) inserting the cyhnd ⁇ cal member into the opening m the alveolus, (c)
  • Fig 1 illustrates an alveolar distraction osteogenesis apparatus, including an alveolar distraction device, cannula, torque wrench adapter and torque wrench according to the present mvention
  • Figs 2a-b illustrate an alveolar distraction osteogenesis rod, cannula and torque wrench adapter accordmg to the present mvention
  • Figs 3a-c illustrate alveolar distraction osteogenesis plates according to the present mvention
  • Figs 4a-b illustrate the steps of inserting an alveolar distraction osteogenesis device
  • Fig 5a illustrates activatmg an inserted alveolar distraction osteogenesis device
  • Fig 5b illustrates an inserted activated alveolar distraction osteogenesis device
  • Fig 6 illustrates a cannula removal device according to the present invention 7
  • Fig 7 illustrates an alveolar distraction osseointegrated cyhnd ⁇ cal member according to another embodiment of the present invention
  • Fig 8 illustrates an alveolar distraction obturating screw according to another embodiment of the present invention
  • Fig 9 illustrates an alveolar distraction d ⁇ ll guide according to another embodiment of the present invention
  • Fig 10 illustrates an alveolar distraction rod adapter for use with a hexagonal drive wrench according to another embodiment of the present invention
  • Fig 11 illustrates an alveolar distraction rod adapter for use with a slot screw dnver according to another embodiment of the present invention
  • Fig 12a illustrates a small alveolar bone before insertion of an alveolar distraction device according to another embodiment of the present invention
  • Fig 12b illustrates the inserted alveolar distraction device in an activated position accordmg to another embodiment of the present invention
  • Fig 12c illustrates an expanded view of the inserted alveolar distraction device m an activated position accordmg to another embodiment of the present mvention
  • Fig 12d illustrates the inserted alveolar distraction device after activation accordmg to another embodiment of the present mvention
  • Fig 1 illustrates alveolar distraction osteogenesis apparatus 68
  • the alveolar distraction osteogenesis apparatus 68 is used to form bone in the alveolus which may be missmg due to an accident or birth abnormality Often, alveolus must be formed m order for dental implants to be used
  • the alveolar distraction osteogenesis apparatus 68 mcludes a torque wrench 30, adapter 32 and cannula 31
  • the alveolar distraction osteogenesis apparatus 68 also includes an alveolar distraction osteogenesis device 69
  • the alveolar distraction osteogenesis device 69 includes a rod 60 havmg base 61, activation end 62 and end 60a
  • the alveolar distraction osteogenesis device 69 also includes a transport bone segment plate 63 and stabilizing plate 64 Plates 63 and 64 may be secured by screws 66 and 65, respectively
  • Figs 2a-b illustrate two embodiments of an alveolar distraction osteogenesis device 69 shown m Fig 1 Fig 2a illustrates a nonsubmergible alveolar distraction osteogenesis device, while Fig 2b illustrates a submergible alveolar distraction osteogenesis device
  • the nonsubmergible alveolar distraction osteogenesis device in Fig 2a mcludes rod 70, cannula 72 and adapter 73 Rod 70 includes base 71 and end 78
  • the submergible alveolar distraction osteogenesis device shown in Fig 2b includes rod 74, cannula 76 and adapter 77 Rod 74 includes base 75 and end 79
  • the nonsubmergible alveolar distraction osteogenesis device illustrated m Fig 2a has a rod 70 with a base 71 which may be positioned substantially above soft tissue and/or a skin layer, while base 75 of rod 74 is positioned below soft tissue and/or a skin layer
  • the alveolar distraction osteogenesis device illustrated in Fig 2b has a diameter of approximately
  • Figs 3a-c illustrate the transport bone segment plate 63 and stabilizing plate 64 illustrated m Fig 1
  • stabilizing plate 64 consists of a titamum member havmg openmgs 81, 82 and 83 In an embodiment, a greater or lesser amount of openings may be used Openings 82 and 83 are used to fix plate 64 to bone with inserted screws Further, embodiments may not require plate 64 if the bone mate ⁇ al is sufficiently hard
  • the titamum member may be bent approximately 90° between openmgs 81 and 82, as seen in plate 64 of Fig 1, to fit the alveolus
  • opemng 83 is an approximately 1 mm openmg for positioning a rod, such as rod end 79 shown m Fig 2b
  • transport bone segment plate 63 also is a titamum member havmg three openmgs 84, 85 and 86, as illustrated in Figs 3b-c In an embodiment, a greater or lesser amount of openmgs may be used Openings 85 and 86 are used to fix transport bone segment plate 63 to bone with inserted screws
  • both plates 64 and 63 are available from Pfizer Pharmaceuticals, Inc , located at Valley Lab, Inc , P O Box 9015, 5920 Longbow D ⁇ ve, Boulder, CO 80301-9015
  • the screws, such as screws 66 and 65, as shown in Fig 1, are also available from Pfizer Pharmaceuticals, Inc
  • the diameter of washer-shaped member 87 surrounding openmg 84 is approximately 175 mches, while openings at 85 and 86 are approximately 1 0 mm
  • the width of the washer-shaped member 87 is approximately 5 mm
  • the threaded portion of opening 84 has a diameter of approximately 2 mm and a pitch of 4 mm per
  • a computed tomography scan of the area for distraction osteogenesis may be obtained Alveolar distraction osteogenesis device 69 may then be manufactured using the information from computed tomography For example, the length of rod 60 may be determined from this imaging information Moreover, the amount of bone available and/or number of screws used to affix the alveolar distraction osteogenesis device, may be estimated based upon the image information In the preferred embodiment, a customized alveolar distraction osteogenesis device is not used and alveolar distraction osteogenesis device 69 having the above-descnbed configuration and size suitable for a majonty of individuals is used
  • the alveolar distraction osteogenesis device may be implanted, and is thus submergible, beneath a layer of soft tissue
  • the alveolar distraction osteogenesis device is less likely to scar and is more cosmetically appealing and comfortable than external distraction osteogenesis devices
  • a submerged alveolar distraction osteogenesis device is less likely to become infected than external devices
  • the fixation points, in particular screws, which fix the plates to bone do not transfer a substantial amount of force during activation
  • the screws are used to fix the plates and are inserted substantially perpendicular to the pressure separatmg the bone segments
  • the alveolar distraction osteogenesis device may also be activated usmg a maximum pressure, rather than at conventional constant activation rates, as will be desc ⁇ bed
  • Figs 7-11 illustrate an alveolar distraction osteogenesis apparatus according to another embodiment which is preferably used with small and thin bone segments
  • Fig 7 illustrates the osseointegrated transport cyhndncal member 131
  • the transport cylmd ⁇ cal member 131 is a titanium member having a cylmdncal body with an internal openmg 132 andacurvedend 133 Internal opening 132 is threaded and used to couple threaded portion 10 of rod 60 via an adapter during the distraction
  • the outside diameter of the transport cyhnd ⁇ cal member 131 is approximately 3 3 mm and the length is approximately 0 20 in
  • the threaded portion of the opening 132 has a diameter of approximately 3 mm and a pitch of 0 5 mm
  • the transport cylindrical member 131 is covered with a coating 138 of bondable titanium plasma or hydroxlyappatite which enhances the osseomtegration process
  • cylindrical member 131 is modified from a dental implant part available from Ste ⁇ -Oss
  • Fig 8 illustrates an obturating screw 134 which is a titanium member having a threaded portion 135 and a circular top 136 having a slot 137
  • the obturating screw 134 and top 136 are inserted into the internal opening 132 of the transport cylindrical member 131 by a slotted screw driver engaged in slot 137
  • the obturating screw 134 prevents growing bone and tissue from growmg mto the internal opening 132 during the healmg phase of osseomtegration
  • the threaded portion of obturatmg screw 134 has a diameter of approximately 3 mm and a pitch of 0 5 mm
  • the top 136 has a diameter of approximately 3 3 mm and the total length of obturatmg screw 134 is approximately 0 20 in
  • the obturating screw 134 is modified from a dental implant part available from
  • Fig 9 illustrates a dnll guide 139 which is a titamum member havmg a threaded portion 140, a circular top 141 and an internal opening 142
  • the dnll guide 139 is inserted mto the internal openmg 132 of the transport cylmdncal member 131 and used as protection for the threads in the internal openmg 132 of the transport cylmdncal member 131 durmg dnlhng of the alveolus segment
  • the threaded portion of the d ⁇ ll guide 139 has a diameter of approximately 3 mm, a pitch of 0 5 mm, and a length of approximately 0 1 mches
  • the circular top 141 has a diameter of approximately 3 3 mm
  • the total length of drill guide 139 is approximately 5 0 mm having an internal opemng 142 with a diameter of approximately 2 05 mm
  • dnll guide 139 is modified from a dental 11 implant part available from
  • Fig 10 illustrates a rod adapter 143 which is a titanium member havmg a threaded outer portion 144, a hexagonal top 145 and a threaded internal opening 146
  • the rod adapter 143 is inserted into the internal openmg 132 of the transport cylmd ⁇ cal member 131 and reduces the internal opening diameter of the transport cylindrical member 131 so that rod 60 may be activated by a hexagonal drive wrench
  • the rod adapter 143 is prefe ⁇ ed in distraction procedures where insertion of the rod adapter may be difficult due to the position of the cylindrical member 131
  • the rod adapter 131 facilitates insertion because it is self-retaining with a self locking hexagonal dnve wrench
  • the rod adapter 143 is also preferred when there is not limited space in the distraction procedure
  • the threaded outer portion 144 of the rod adapter 143 has a diameter of approximately 3 mm, a pitch of 0 5 mm, and a length of approximately 0 125 mches
  • the hexagonal top 145 has a diameter of approximately 4 0 mm and the total length of rod adapter 143 is approximately 0 25 in
  • rod adapter 143 is modified from a dental implant part available from Attachments International located at 600 S Amphlett Blvd , San Mateo, CA, 94402
  • the diameter of the threaded internal openmg of the part is machined down from 1 6 mm to 2 0 mm and the bottom of the part is removed by drilling so that a cylmder is formed
  • Fig 11 illustrates another embodiment of a rod adapter 147 which is activated by a slot screw driver
  • the slot screw d ⁇ ver rod adapter 147 is similar to rod adapter 143 except hexagonal top 145 is removed
  • the hexagonal top 145 of rod adapter 143 occupies space that bone may be transported mto during distraction
  • rod adapter 147 allows for greater distraction because rod 60 may be inserted mto the alveolar bone up to 3 0 mm further Rod adapter 147 is preferred in limited spaces or when greater bone growth is desired
  • rod adapter 147 is modified from a dental implant part in the same manner as rod adapter 143, and is available from Attachments International located at 600 S Amphlett Blvd , San Mateo, CA, 94402 12
  • Figs 4a-b illustrate a surgical view of an osteotomy and an inserted alveolar distraction osteogenesis device according to the present invention
  • Figs 4a-b illustrate a rod 60 inserted into stabilizing plate 64 and transport bone segment plate 63
  • an osteotomy is performed on the alveolus to form upper alveolus segment 88 and lower alveolus segment 89
  • An opening 100 is then dnlled into the lower alveolus segment 89
  • Stabilizing plate 64 is then positioned on the upper alveolus segment 88
  • bone transport segment plate 63 is positioned on the lower alveolus segment
  • Bone screws then may be positioned through openings 81, 82, 85 and 86 to fix the plates 63 and
  • Figs 4a-b illustrate a plate 64 without a screw in opening 81 Rod 60 is then inserted mto opening 100 through lower alveolus segment 89 and through opening 84 of plate 63 Rod end 60a is then positioned in opening 83 of plate 64
  • the alveolar distraction osteogenesis device may be activated using atorque wrench
  • Adapter 32 includes a rod 32a having a tapered bayonet end 32b for fitting rod activation end 62 Cannula 31 is first positioned over rod 60, in particular activation end 62 Adapter 32 is then used to couple rod 60 by msertmg rod 32a mto cannula 31 A hammer is then used to lodge the tapered end 32b of adapter 32 mto activation end 62 of rod 60 Torque wrench 30 is then coupled to adapter interface 32c
  • the torque wrench 30 may be available from Interpore International, 181 Technology Dnve, Irvine, California 92618
  • a predetermined torque setting corresponding to a distraction pressure is then set on torque wrench 30 Torque wrench 30 is then rotated m order to create a force which separates plates 63 and 64 and thus upper alveolus segment 88 and lower alveolus segment 89
  • the torque wrench 30 setting corresponds to a pressure exerted by alveolar distraction osteogenesis device 69
  • the relationship between a torque wrench 30 setting and exerted alveolar distraction osteogenesis device 69 pressure is determined before inserting device 69 For example, it was discovered during clinical evaluations that a 14 Newton cm and 13
  • 18 Newton cm torque wrench setting corresponds to 7 kg and 9 kg of pressure exerted by distraction osteogenesis device 69
  • the amount of torque applied is based upon the maximum pressure the soft tissue can withstand without changing color, rather than using a constant activation rate This is observed after insertion and before closing Before the soft tissue or skin is sutured, alveolar distraction osteogenesis device
  • Fig 6 illustrates a cannula and rod removal device 44, according to the present invention
  • Cannula and rod removal device 44 along with alien wrench 40, is used to remove a cannula 31 and activation rod 32a after activation Torque wrench interface adapter 32c, as illustrated in Fig 1, is removed before usmg the cannula and rod removal device 44
  • Torque wrench adapter interface 32c is coupled to activation rod 32a by a set screw which may be loosened to remove adapter interface 32c
  • Cannula 31 is secured by clamp 42 by rotatmg alien wrench 40
  • the cannula can be removed by rotating knob 43 and holdmg cylmd ⁇ cal portion 41, forcing a piston against activation rod 32a in cannula 31
  • the cannula 31 and rod 32a are then dislodged and may be removed 14
  • Fig 5b illustrates a submerged alveolar distraction osteogenesis device in which only base 61 of rod 60 is visible
  • base 61 may be used to position a temporary dental prosthesis
  • the alveolar distraction device is implanted and has a more cosmetically appealmg appearance
  • Figs 12a-d illustrate a surgical view of an osteotomy and an inserted alveolus distraction osseomtegration device according to another embodiment of the present mvention
  • Fig 12a illustrates an alveolar bone 148 before insertion of the alveolar distraction device 130
  • an opening 149 is first dnlled into the alveolar bone 148
  • an approximately 3 3 mm wide opening is formed
  • the transport cylindrical member 131 covered with a coating 138 of bondable titanium plasma or hydroxlyappatite, is then positioned in the alveolar bone 148
  • An obturating screw 134 is inserted into the internal opening 132 of the transport cylindrical member 131 to protect the internal threads of
  • Rod 60 is then inserted into openmg 149 through the alveolus segment and through 15 openmg 146 of the rod adapter 143 Rod 60 extends through hole 153 and rod end 60a is then positioned against the second alveolus bone segment 152
  • a stabilizing plate 64 as descnbed above in the first embodiment, may or may not be utilized in the second embodiment The use of a stabilizing plate 64 is dependent upon whether the bone material of the second bone segment 152 is sufficiently hard
  • the alveolar distraction device according to the second embodiment may be activated usmg a hexagonal drive wrench or slot screw driver that mates with the base 61 of rod 60
  • base 61 is hexagonally shaped or circular having a slot
  • the cannula 31, adapter 32 and end 62 are not utilized in activation of the alveolar distraction device according to the second embodiment
  • cannula and rod removal device 44 illustrated in Fig 6 is not necessary in the second embodiment
  • a constant activation rate may be used to exert a force between the first alveolus bone segment 151 and the second alveolus bone segment 152 by setting the hexagonal dnve wrench to a predetermined setting or using a slot screw driver
  • the constant activation rate may be from approximately 0 5 mm to approximately 2 0 mm per day, thus ensuring optimal bone growth
  • the rod 60 remains m the bone for approximately 3 to 5 weeks
  • the rod 60 is then removed by rotating the base 61 clockwise A Trephin

Abstract

An apparatus, and method for osteogenesis distraction of small alveolar bone is provided. The alveolar distraction osteogenesis device may be affixed to small and thin bone segments. An alveolar distraction osteogenesis device according to the first embodiment includes a submergible first and second members (63, 64) along with a threaded rod (60). An alveolar distraction osteogenesis device according to a second embodiment includes an osseous integrated cylindrical member (131) along with an adaptable threaded rod (60) which may be used with a stabilizing plate (64). The alveolar distraction osteogenesis device is activated using a hexagonal drive wrench or a slot screw driver. In order to allow for bone growth and/or distraction, a constant activation rate between bone segments is applied by torque.

Description

1
AN APPARATUS AND METHOD FOR DISTRACTION OSTEOGENESIS OF SMALL ALVEOLAR BONE
Inventor
Martin Chin This application is a continuation-in-part of Serial No 08/732,064. filed on
October 16, 1996
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to distraction osteogenesis, and in particular, distraction osteogenesis of small alveolar bone
Cross-reference to Related Applications
The following U S patents are assigned to the assignee of the present application, are related to the present application and their disclosures are incorporated herein by reference (A) U S Patent Application Serial No 08/732,064, filed on October 16, 1996 by Martin Chin and entitled AN APPARATUS AND METHOD FOR SUBMERGIBLE,
SELF-RETAINING DISTRACTION OSTEOGENESIS
(B) U S Divisional Patent Application Serial No 09/006, 143 filed on January
13, 1998 by Martin Chin and entitled AN APPARATUS AND METHOD FOR SUBMERGIBLE, SELF-RETAINING ZYGOMA DISTRACTOR which is a divisional of U S Patent Application Seπal No 08/732,064
Descnption of the Related Art
Distraction osteogenesis refers to a technique for growing bone or osteogenesis material, as well as soft tissue, by separating two bone segments Generally, an osteotomy, such as a Lefort III osteotomy, is performed which partitions a bone into two bone segments External distraction osteogenesis devices are then attached to the bone segments through soft tissue or a skin layer These external distraction osteogenesis devices may mclude rods and πngs or other cumbersome metal components The distraction osteogenesis devices form a gap between the bone segments by exerting pressure between the bone segments As the gap between the bone segments widens, the body's own natural healing capacity fills the void with new bone and adjacent soft tissue Once the desired bone formation is achieved, the area is allowed to heal and consolidate Often, the distraction osteogenesis device is then removed
An example of a distraction osteogenesis device is an Ilizarov distractor Typically, an Ilizarov distractor is used m lengthening individuals' limbs, such as a leg In this application, an Ilizarov distractor may include external metal rings which are then secured to two bone segments m a leg These metal πngs are then attached by a rod assembly which may be used to form a gap between the two bone segments and thus allow for the formation of new bone A descnption of an Ilizarov distractor may be found in U S Patent No 4,615,338, issued to Ilizarov, et al on October 7, 1986 and entitled "Automatic Compression - Distraction Apparatus "
Distraction osteogenesis devices may also be used in growing bone in the craniofacial region of small children Often, distraction osteogenesis devices are used on small children who are missing bone due to birth abnormalities or accidents While distraction osteogenesis devices are often used on children, distraction osteogenesis devices may be used on adults and animals as well
A number of problems are encountered in using present distraction osteogenesis devices First, distraction osteogenesis devices are generally external, which may cause a number of problems or complications Often, cumbersome metal rods and πngs located external to an individual's skin are used to distract or separate bone segments Individuals, and in particular small children, may fall and mjure themselves on the protruding metal edges Further, small children may complicate the distraction osteogenesis procedure by improperly adjusting the osteogenesis distraction device
The distraction osteogenesis device may require multiple entry points to an individual's skin and thus may create multiple scars Distraction osteogenesis devices requiring multiple entry points may also increase the likelihood of infection due to the multiple openings in the individual's skin Also, individuals undergoing the distraction osteogenesis procedure have to cope with an external device which is not cosmetically appealing
A second problem encountered with distraction osteogenesis devices regards customizing devices for individuals Generally, a distraction osteogenesis device used for one individual would not be suitable for another In distraction osteogenesis devices used in the craniofacial area, distraction osteogenesis devices must be measured to fit specific surface areas of craniofacial bones Also, individuals may have different amounts of bone caused by different types of birth abnormalities or accidents, thus requiring customized distraction osteogenesis devices due to limited bone Third, distraction osteogenesis devices are attached to bone segments in such a way that the pomt of fixation to the bone transfers force during activation For example, a distraction osteogenesis device may be attached to a bone segment by a bone screw or rod which transfers a substantial amount of force during activation or when the distraction osteogenesis device is exerting pressure between the bone segments By having the bone screw transfer a substantial amount of the force during activation, the distraction osteogenesis device may be dislodged from the bone
Fourth, distraction osteogenesis devices are activated using constant rates which do not reflect the individual's healing abilities Regardless of the age or condition of the individual, distraction osteogenesis devices are activated by widening the gap between bone segments 25- 50 mm four times per day This conventional activation rate results m bone growth as low as 20 mm in 20 days Accordingly, an individual may have to be under constant medical supervision for up to 20 days An individual could be an outpatient, but would need to return to the hospital four times per day for adjustments Present distraction osteogenesis device activation techniques do not take mto account an individual's ability to grow bone at a greater or lesser rate By usmg this constant rate, bone may grow too quickly and lock the distraction osteogenesis device, or in the alternative, bone may grow too slowly, requiring a longer peπod of time that the distraction osteogenesis device is necessary
Fifth, distraction osteogenesis devices are often difficult to attach because limited bone is available There may be different amounts of bone caused by different types of birth abnormalities or accidents Further, microsurgical reconstruction may be desired For example, a distraction osteogenesis device may be necessary for a dental implant surgery on a bone graft not large enough to place a dental implant Thus, small alveolar bone distraction osteogenesis devices are required to accommodate bone and space limitations Therefore, it is desirable to provide a distraction osteogenesis device which is submergible, or beneath an individual's skin or soft tissue The distraction osteogenesis device then could be permanently positioned withm an mdividual, thereby eliminating the need for surgery in removing the device, including the associated nsks and costs The distraction osteogenesis device then would be more cosmetically appealing and reduce the likelihood of infection, injury and or scaπng Further, it is desirable to have a distraction osteogenesis device which does not have to be customized for each mdividual Manufacturing and medical costs would then be substantially reduced by using a standard distraction osteogenesis device and method, rather than customizing distraction osteogenesis devices and methods for each mdividual The distraction osteogenesis device also should be affixed to bone in such a way that a substantial amount of the force used in activation is not transferred through a fastening device (I e , screw, pm or rod) Moreover, the distraction osteogenesis device should be activated at a rate which optimizes bone growth Finally, it is desirable to provide a distraction osteogenesis device which may be affixed to small and thin bone segments The distraction osteogenesis device could then be utilized in more surgical procedures
SUMMARY OF THE INVENTION
According to an aspect of the present invention, an apparatus is provided for distractmg a first bone segment from a second bone segment The apparatus compπses a first implantable member for couplmg the first bone segment and a second implantable member for coupling the second bone segment Submergible means is coupled to the first member and the second member which positions the first member a distance from the second member responsive to a force
Accordmg to another aspect of the present invention, the submergible means includes a threaded rod portion
Accordmg to another aspect of the present mvention, the apparatus includes activating means for transferring a force to the submergible means According to another aspect of the present invention, the activating means includes a cannula, a torque wrench adapter and a torque wrench
Accordmg to another aspect of the present invention, the apparatus includes means for removing the activating means According to another aspect of the present invention, the first and second members transfer a substantial amount of the force
According to another aspect of the present invention, the activating means transfers a force generating a maximum pressure in order to achieve a maximum distance
According to another aspect of the present invention, a submergible device for distracting a first segment of alveolus from a second segment of alveolus to allow for bone generation is provided The submergible device compπses a rod havmg a threaded portion, including an end, a base and an activation end A first member is coupled to the first segment of alveolus and has an openmg for inserting the rod end A second member is coupled to the second segment of alveolus and has an opening for positioning the threaded portion of the rod The rod transfers a force agamst the second member, creating a distance between the first and second alveolus segments
According to another aspect of the present invention, a method for forming alveolar bone is provided The method includes the steps of (a) cutting the alveolus mto first and second segments, (b) secuπng a first plate to the first segment of alveolus, (c) forming an opening in the second segment of alveolus, (d) secuπng a second transport plate to the second segment of alveolus, (e) msertmg a rod mto the openmg of the second segment of alveolus and through the second plate openmg to the first plate, and (f) exerting a force on the rod to displace the first segment of alveolus from the second segment of alveolus
According to another aspect of the present mvention, a small alveolar bone device for distracting a first segment of alveolus from a second segment of alveolus to allow for bone generation is provided The device compπses a cylindπcal member havmg a threaded inner surface coupled to the first segment of alveolus A rod adapter having a threaded outer surface and a threaded inner surface mates to the threaded inner surface of the cyhndncal member A rod having a threaded outer surface mates to the threaded inner surface of the rod adapter The rod transfers a force agamst the second segment of alveolus, creating a distance between the first and second alveolus segments According to another aspect of the present invention, a method for forming small alveolar bone is provided The method includes the steps of (a) forming an opemng in the alveolus, (b) inserting the cyhndπcal member into the opening m the alveolus, (c) msertmg an obturatmg member in the cylmdπcal member to prevent bone and tissue from growing mto the cylindrical member while the alveolus grows into substantially intimate contact with the cylindrical member, (d) removing the obturating member, (e) inserting a dπll guide member in the cylindrical member, (f) forming a second opening in the alveolus with a drill guided by the dπll guide member, (g) removing the drill guide member, (h) cutting the alveolus into a first bone segment and a second bone segment, the first bone segment containing the cyhndπcal member and the second opening, (I) inserting a rod adapter into the cyhndπcal member, (j) inserting a rod mto the opemng of the alveolus and through the rod adapter to the second bone segment, and, (k) exerting a force on the rod in order to displace the first bone segment from the second bone segment
Other aspects and advantages of the present mvention can be seen upon review of the figures, the detailed descnption, and the claims which follow
BRIEF DESCRIPTION OF THE DRAWINGS
Fig 1 illustrates an alveolar distraction osteogenesis apparatus, including an alveolar distraction device, cannula, torque wrench adapter and torque wrench according to the present mvention Figs 2a-b illustrate an alveolar distraction osteogenesis rod, cannula and torque wrench adapter accordmg to the present mvention
Figs 3a-c illustrate alveolar distraction osteogenesis plates according to the present mvention
Figs 4a-b illustrate the steps of inserting an alveolar distraction osteogenesis device
Fig 5a illustrates activatmg an inserted alveolar distraction osteogenesis device Fig 5b illustrates an inserted activated alveolar distraction osteogenesis device Fig 6 illustrates a cannula removal device according to the present invention 7
Fig 7 illustrates an alveolar distraction osseointegrated cyhndπcal member according to another embodiment of the present invention
Fig 8 illustrates an alveolar distraction obturating screw according to another embodiment of the present invention Fig 9 illustrates an alveolar distraction dπll guide according to another embodiment of the present invention
Fig 10 illustrates an alveolar distraction rod adapter for use with a hexagonal drive wrench according to another embodiment of the present invention
Fig 11 illustrates an alveolar distraction rod adapter for use with a slot screw dnver according to another embodiment of the present invention
Fig 12a illustrates a small alveolar bone before insertion of an alveolar distraction device according to another embodiment of the present invention
Fig 12b illustrates the inserted alveolar distraction device in an activated position accordmg to another embodiment of the present invention Fig 12c illustrates an expanded view of the inserted alveolar distraction device m an activated position accordmg to another embodiment of the present mvention
Fig 12d illustrates the inserted alveolar distraction device after activation accordmg to another embodiment of the present mvention
DETAILED DESCRIPTION OF THE INVENTION
I Alveolar Distraction Osteogenesis Apparatuses
Fig 1 illustrates alveolar distraction osteogenesis apparatus 68 The alveolar distraction osteogenesis apparatus 68 is used to form bone in the alveolus which may be missmg due to an accident or birth abnormality Often, alveolus must be formed m order for dental implants to be used The alveolar distraction osteogenesis apparatus 68 mcludes a torque wrench 30, adapter 32 and cannula 31
The alveolar distraction osteogenesis apparatus 68 also includes an alveolar distraction osteogenesis device 69 The alveolar distraction osteogenesis device 69 includes a rod 60 havmg base 61, activation end 62 and end 60a The alveolar distraction osteogenesis device 69 also includes a transport bone segment plate 63 and stabilizing plate 64 Plates 63 and 64 may be secured by screws 66 and 65, respectively
Figs 2a-b illustrate two embodiments of an alveolar distraction osteogenesis device 69 shown m Fig 1 Fig 2a illustrates a nonsubmergible alveolar distraction osteogenesis device, while Fig 2b illustrates a submergible alveolar distraction osteogenesis device The nonsubmergible alveolar distraction osteogenesis device in Fig 2a mcludes rod 70, cannula 72 and adapter 73 Rod 70 includes base 71 and end 78 The submergible alveolar distraction osteogenesis device shown in Fig 2b includes rod 74, cannula 76 and adapter 77 Rod 74 includes base 75 and end 79 The nonsubmergible alveolar distraction osteogenesis device illustrated m Fig 2a has a rod 70 with a base 71 which may be positioned substantially above soft tissue and/or a skin layer, while base 75 of rod 74 is positioned below soft tissue and/or a skin layer Finally, the alveolar distraction osteogenesis device illustrated in Fig 2b has a diameter of approximately 1 6 mm and a pitch of 35 mm per revolution, while the alveolar distraction osteogenesis device illustrated m Fig 2a has a diameter of approximately 2 0 mm and a pitch of 4 mm per revolution
Figs 3a-c illustrate the transport bone segment plate 63 and stabilizing plate 64 illustrated m Fig 1 In an embodiment, stabilizing plate 64 consists of a titamum member havmg openmgs 81, 82 and 83 In an embodiment, a greater or lesser amount of openings may be used Openings 82 and 83 are used to fix plate 64 to bone with inserted screws Further, embodiments may not require plate 64 if the bone mateπal is sufficiently hard The titamum member may be bent approximately 90° between openmgs 81 and 82, as seen in plate 64 of Fig 1, to fit the alveolus In an embodiment, opemng 83 is an approximately 1 mm openmg for positioning a rod, such as rod end 79 shown m Fig 2b
In an embodiment, transport bone segment plate 63 also is a titamum member havmg three openmgs 84, 85 and 86, as illustrated in Figs 3b-c In an embodiment, a greater or lesser amount of openmgs may be used Openings 85 and 86 are used to fix transport bone segment plate 63 to bone with inserted screws In an embodiment, both plates 64 and 63 are available from Pfizer Pharmaceuticals, Inc , located at Valley Lab, Inc , P O Box 9015, 5920 Longbow Dπve, Boulder, CO 80301-9015 The screws, such as screws 66 and 65, as shown in Fig 1, are also available from Pfizer Pharmaceuticals, Inc In an embodiment, the diameter of washer-shaped member 87 surrounding openmg 84 is approximately 175 mches, while openings at 85 and 86 are approximately 1 0 mm In an embodiment, the width of the washer-shaped member 87 is approximately 5 mm The threaded portion of opening 84 has a diameter of approximately 2 mm and a pitch of 4 mm per revolution for rod 70 and approximately 1 6 mm and a pitch of 35 mm per revolution for rod 74 Threaded openmg 84 is used to position rod 60 As with plate 64, transport bone segment plate 63 may be bent approximately 90 ° between openings 85 and 84. as seen m transport bone segment plate 63 of Fig 1, to fit the alveolus
In an embodiment, a computed tomography scan of the area for distraction osteogenesis may be obtained Alveolar distraction osteogenesis device 69 may then be manufactured using the information from computed tomography For example, the length of rod 60 may be determined from this imaging information Moreover, the amount of bone available and/or number of screws used to affix the alveolar distraction osteogenesis device, may be estimated based upon the image information In the preferred embodiment, a customized alveolar distraction osteogenesis device is not used and alveolar distraction osteogenesis device 69 having the above-descnbed configuration and size suitable for a majonty of individuals is used
The alveolar distraction osteogenesis device may be implanted, and is thus submergible, beneath a layer of soft tissue Thus, the alveolar distraction osteogenesis device is less likely to scar and is more cosmetically appealing and comfortable than external distraction osteogenesis devices A submerged alveolar distraction osteogenesis device is less likely to become infected than external devices Also, the fixation points, in particular screws, which fix the plates to bone do not transfer a substantial amount of force during activation The screws are used to fix the plates and are inserted substantially perpendicular to the pressure separatmg the bone segments The alveolar distraction osteogenesis device may also be activated usmg a maximum pressure, rather than at conventional constant activation rates, as will be descπbed
Figs 7-11 illustrate an alveolar distraction osteogenesis apparatus according to another embodiment which is preferably used with small and thin bone segments Fig 7 illustrates the osseointegrated transport cyhndncal member 131 The transport cylmdπcal member 131 is a titanium member having a cylmdncal body with an internal openmg 132 andacurvedend 133 Internal opening 132 is threaded and used to couple threaded portion 10 of rod 60 via an adapter during the distraction In an embodiment, the outside diameter of the transport cyhndπcal member 131 is approximately 3 3 mm and the length is approximately 0 20 in The threaded portion of the opening 132 has a diameter of approximately 3 mm and a pitch of 0 5 mm The transport cylindrical member 131 is covered with a coating 138 of bondable titanium plasma or hydroxlyappatite which enhances the osseomtegration process In an embodiment, cylindrical member 131 is modified from a dental implant part available from Steπ-Oss located at 22895 Eastpark Dπve, Yorba Linda, CA, 92887 The threads on the internal opening are machined down to 3 0 mm The length of the part is shortened to 0 20 in The bottom of the part is removed by dnlhng so that a cylinder is formed, and an internal machined taper is removed from the top of the part
Fig 8 illustrates an obturating screw 134 which is a titanium member having a threaded portion 135 and a circular top 136 having a slot 137 The obturating screw 134 and top 136 are inserted into the internal opening 132 of the transport cylindrical member 131 by a slotted screw driver engaged in slot 137 The obturating screw 134 prevents growing bone and tissue from growmg mto the internal opening 132 during the healmg phase of osseomtegration The threaded portion of obturatmg screw 134 has a diameter of approximately 3 mm and a pitch of 0 5 mm The top 136 has a diameter of approximately 3 3 mm and the total length of obturatmg screw 134 is approximately 0 20 in In an embodiment, the obturating screw 134 is modified from a dental implant part available from
Sten-Oss located at 22895 Eastpark Dnve, Yorba Linda, CA, 92887 The diameter of the top of the part is machmed down from 4 0 mm to 3 3 mm
Fig 9 illustrates a dnll guide 139 which is a titamum member havmg a threaded portion 140, a circular top 141 and an internal opening 142 The dnll guide 139 is inserted mto the internal openmg 132 of the transport cylmdncal member 131 and used as protection for the threads in the internal openmg 132 of the transport cylmdncal member 131 durmg dnlhng of the alveolus segment The threaded portion of the dπll guide 139 has a diameter of approximately 3 mm, a pitch of 0 5 mm, and a length of approximately 0 1 mches The circular top 141 has a diameter of approximately 3 3 mm The total length of drill guide 139 is approximately 5 0 mm having an internal opemng 142 with a diameter of approximately 2 05 mm In an embodiment, dnll guide 139 is modified from a dental 11 implant part available from Attachments International located at 600 S Amphlett Blvd , San Mateo, CA, 94402 The diameter of the internal openmg of the part is machmed down from 1 6 mm to 2 05 mm
Fig 10 illustrates a rod adapter 143 which is a titanium member havmg a threaded outer portion 144, a hexagonal top 145 and a threaded internal opening 146 The rod adapter 143 is inserted into the internal openmg 132 of the transport cylmdπcal member 131 and reduces the internal opening diameter of the transport cylindrical member 131 so that rod 60 may be activated by a hexagonal drive wrench In an embodiment, the rod adapter 143 is prefeπed in distraction procedures where insertion of the rod adapter may be difficult due to the position of the cylindrical member 131 The rod adapter 131 facilitates insertion because it is self-retaining with a self locking hexagonal dnve wrench The rod adapter 143 is also preferred when there is not limited space in the distraction procedure The threaded outer portion 144 of the rod adapter 143 has a diameter of approximately 3 mm, a pitch of 0 5 mm, and a length of approximately 0 125 mches The threaded internal opemng 146 has a diameter of approximately 2 mm and a pitch of 0 4 mm
The hexagonal top 145 has a diameter of approximately 4 0 mm and the total length of rod adapter 143 is approximately 0 25 in In an embodiment, rod adapter 143 is modified from a dental implant part available from Attachments International located at 600 S Amphlett Blvd , San Mateo, CA, 94402 The diameter of the threaded internal openmg of the part is machined down from 1 6 mm to 2 0 mm and the bottom of the part is removed by drilling so that a cylmder is formed
Fig 11 illustrates another embodiment of a rod adapter 147 which is activated by a slot screw driver The slot screw dπver rod adapter 147 is similar to rod adapter 143 except hexagonal top 145 is removed The hexagonal top 145 of rod adapter 143 occupies space that bone may be transported mto during distraction In an embodiment, rod adapter
147 allows for greater distraction because rod 60 may be inserted mto the alveolar bone up to 3 0 mm further Rod adapter 147 is preferred in limited spaces or when greater bone growth is desired In an embodiment, rod adapter 147 is modified from a dental implant part in the same manner as rod adapter 143, and is available from Attachments International located at 600 S Amphlett Blvd , San Mateo, CA, 94402 12
II Alveolar Distraction Osteogenesis Device Inserting and Activating Methods
Figs 4a-b illustrate a surgical view of an osteotomy and an inserted alveolar distraction osteogenesis device according to the present invention Specifically, Figs 4a-b illustrate a rod 60 inserted into stabilizing plate 64 and transport bone segment plate 63 After determining the size of rod 60, an osteotomy is performed on the alveolus to form upper alveolus segment 88 and lower alveolus segment 89 An opening 100 is then dnlled into the lower alveolus segment 89 In an embodiment, an approximately 2 mm wide opening is formed Stabilizing plate 64 is then positioned on the upper alveolus segment 88 , while bone transport segment plate 63 is positioned on the lower alveolus segment Bone screws then may be positioned through openings 81, 82, 85 and 86 to fix the plates 63 and
64 to respective alveolus segments Figs 4a-b illustrate a plate 64 without a screw in opening 81 Rod 60 is then inserted mto opening 100 through lower alveolus segment 89 and through opening 84 of plate 63 Rod end 60a is then positioned in opening 83 of plate 64 The alveolar distraction osteogenesis device may be activated using atorque wrench
30 and adapter 32, as illustrated in Fig 5a Torque wrench 30, adapter 32 and cannula 31 are also illustrated in Fig 1 Adapter 32 includes a rod 32a having a tapered bayonet end 32b for fitting rod activation end 62 Cannula 31 is first positioned over rod 60, in particular activation end 62 Adapter 32 is then used to couple rod 60 by msertmg rod 32a mto cannula 31 A hammer is then used to lodge the tapered end 32b of adapter 32 mto activation end 62 of rod 60 Torque wrench 30 is then coupled to adapter interface 32c In an embodiment, the torque wrench 30 may be available from Interpore International, 181 Technology Dnve, Irvine, California 92618
A predetermined torque setting corresponding to a distraction pressure is then set on torque wrench 30 Torque wrench 30 is then rotated m order to create a force which separates plates 63 and 64 and thus upper alveolus segment 88 and lower alveolus segment 89 The torque wrench 30 setting corresponds to a pressure exerted by alveolar distraction osteogenesis device 69 The relationship between a torque wrench 30 setting and exerted alveolar distraction osteogenesis device 69 pressure is determined before inserting device 69 For example, it was discovered during clinical evaluations that a 14 Newton cm and 13
18 Newton cm torque wrench setting corresponds to 7 kg and 9 kg of pressure exerted by distraction osteogenesis device 69 In an embodiment, the amount of torque applied is based upon the maximum pressure the soft tissue can withstand without changing color, rather than using a constant activation rate This is observed after insertion and before closing Before the soft tissue or skin is sutured, alveolar distraction osteogenesis device
69 is activated until the soft tissue begins to blanch Blanch occurs when the blood circulation m the soft tissue becomes impaired As a result, the soft tissue turns white This maximum torque setting is then used to maintain a maximum pressure between the bone segments The pressure is monitored throughout the day and additional torque is applied in order to maintain a maximum pressure This maximum pressure on the upper alveolus 88 and lower alveolus 89 requires the shortest activation period possible Using conventional activation rates allows for the pressure to decrease from a maximum range Throughout the distraction process of the present invention, this relatively constant maximum pressure is maintained and thus enables optimized bone growth In an alternate embodiment, constant activation rates such as distracting bone segments approximately 0 5 mm to approximately 2 00 mm per day are used if optimal bone growth is not required For example, distraction of small alveolar bone segments generally do not require growing large amounts of bone and a constant activation rate is preferable Cannula 31 and adapter 32 then may be removed, as will be described below and illustrated in Fig 6
Fig 6 illustrates a cannula and rod removal device 44, according to the present invention Cannula and rod removal device 44, along with alien wrench 40, is used to remove a cannula 31 and activation rod 32a after activation Torque wrench interface adapter 32c, as illustrated in Fig 1, is removed before usmg the cannula and rod removal device 44 Torque wrench adapter interface 32c is coupled to activation rod 32a by a set screw which may be loosened to remove adapter interface 32c Cannula 31 is secured by clamp 42 by rotatmg alien wrench 40 After the cannula 31 is secured, the cannula can be removed by rotating knob 43 and holdmg cylmdπcal portion 41, forcing a piston against activation rod 32a in cannula 31 The cannula 31 and rod 32a are then dislodged and may be removed 14
Fig 5b illustrates a submerged alveolar distraction osteogenesis device in which only base 61 of rod 60 is visible In an embodiment, base 61 may be used to position a temporary dental prosthesis Thus, the alveolar distraction device is implanted and has a more cosmetically appealmg appearance Figs 12a-d illustrate a surgical view of an osteotomy and an inserted alveolus distraction osseomtegration device according to another embodiment of the present mvention Specifically, Fig 12a illustrates an alveolar bone 148 before insertion of the alveolar distraction device 130 In Figs 12a-b, an opening 149 is first dnlled into the alveolar bone 148 In an embodiment, an approximately 3 3 mm wide opening is formed The transport cylindrical member 131, covered with a coating 138 of bondable titanium plasma or hydroxlyappatite, is then positioned in the alveolar bone 148 An obturating screw 134 is inserted into the internal opening 132 of the transport cylindrical member 131 to protect the internal threads of the transport cylmdncal member 131 from growing bone and tissue while the alveolus bone 148 grows mto substantially intimate contact with the transport cylindrical member 131 The transport cylmdπcal member 131 and screw 134 remains m place for approximately 3 to 5 months while the osseomtegration process occurs between the transport cylindrical member 131 and the alveolus bone 148 Once the transport cylmdncal member 131 is ngidly bonded to the alveolus bone 148, the obturating screw is removed and a second surgical method is performed The dnll guide 139 is then inserted mto the transport cylmdncal member 131 A surgical dπll is inserted into the opening of the drill guide 139 and a hole 153 is drilled further mto the alveolus bone 148 The dnll guide 139 protects the internal threads of the transport cylindrical member 131 durmg dnlling of the hole 153 m the alveolus bone 148 The hole 153 is located concentπcally with the transport cylmdncal member 131 The dnll guide 139 is then removed A drill and saw are then used to perform the osteotomy to mobilize the alveolus bone 148 containing the osseointegrated transport cylmdπcal member 131 and hole 153 The osteotomy forms a first bone segment 151 and a second bone segment 152 wherein the first bone segment 151 contains the cylmdncal member 131 and hole 153 A rod adapter 143 is inserted into the transport cylmdncal member 131 The rod adapter 143 has an opening 146 which reduces the internal thread diameter of the transport cylmdncal member
131 Rod 60 is then inserted into openmg 149 through the alveolus segment and through 15 openmg 146 of the rod adapter 143 Rod 60 extends through hole 153 and rod end 60a is then positioned against the second alveolus bone segment 152
A stabilizing plate 64, as descnbed above in the first embodiment, may or may not be utilized in the second embodiment The use of a stabilizing plate 64 is dependent upon whether the bone material of the second bone segment 152 is sufficiently hard
The alveolar distraction device according to the second embodiment may be activated usmg a hexagonal drive wrench or slot screw driver that mates with the base 61 of rod 60 In an embodiment, base 61 is hexagonally shaped or circular having a slot The cannula 31, adapter 32 and end 62 are not utilized in activation of the alveolar distraction device according to the second embodiment Similarly, cannula and rod removal device 44 illustrated in Fig 6 is not necessary in the second embodiment As discussed above, a constant activation rate may be used to exert a force between the first alveolus bone segment 151 and the second alveolus bone segment 152 by setting the hexagonal dnve wrench to a predetermined setting or using a slot screw driver The constant activation rate may be from approximately 0 5 mm to approximately 2 0 mm per day, thus ensuring optimal bone growth In an embodiment, once the distraction process is complete and the rod 60 is fully inserted, the rod 60 remains m the bone for approximately 3 to 5 weeks The rod 60 is then removed by rotating the base 61 clockwise A Trephine surgical hole saw is then used to mobilize and remove the cylmdncal member 131 and rod adapter 143 or 147 from the alveolar bone If a stabilizing plate 64 was utilized, it is then removed A dental implant may then be inserted
Although two surgical procedures are performed m the alveolar distraction device accordmg to the second embodiment, this device is prefened when distraction of small and thin alveolar bone is required The foregomg descnption of the preferred embodiments of the present mvention has been provided for the purposes of illustration and descnption It is not intended to be exhaustive or to limit the mvention to the precise forms disclosed Obviously, many modifications and vaπations will be apparent to practitioners skilled in the art The embodiments were chosen and descnbed in order to best explam the pnnciples of the mvention and its practical applications, thereby enabling others skilled m the art to understand the invention for vanous embodiments and with the vanous modifications as are 16 suited to the particular use contemplated It is intended that the scope of the invention be defined by the following claims and their equivalents What is claimed is

Claims

17 CLAIMS 1. An apparatus for distracting a first bone segment from a second bone segment, comprising: (a) an implantable first member for coupling the first bone segment; (b) a second implanted member for coupling the second bone segment; and, (c) submergible means, coupled to the first member and the second member, for positioning the first member a distance from the second member responsive to a force.
2. The apparatus of claim 1 , wherein the submergible means includes a threaded rod portion.
3. The apparatus of claim 1, further comprising: (a) activating means, coupled to the submergible means, for transferring a force.
4. The apparatus of claim 3, wherein the activating means comprises: (a) a cannula; (b) a torque wrench adapter; and, (c) a torque wrench.
5. The apparatus of claim 4, further comprising means for removing the activating means.
6. The apparatus of claim 1 , wherein the submergible means includes a threaded rod portion having a hexagonal base.
7. The apparatus of claim 6, further comprising: (a) activating means, coupled to the submergible means, for transferring a force. 8 The apparatus of claim 7, wherein the activating means compπses (a) hexagonal drive wrench for coupling to the hexagonal base of the submergible means
9 The apparatus of claim 6, wherein the submergible means is removed by rotating the hexagonal base clockwise
10 The apparatus of claim 1 , wherein the submergible means includes a threaded rod portion having a slotted circular base
11 The apparatus of claim 10, further compnsmg (a) activating means, coupled to the submergible means, for transfernng a force
12 The apparatus of claim 11, wherein the activatmg means comprises (a) a slot screw dnver for couplmg to the slotted circular base of the submergible means
13 The apparatus of claim 11 , wherem the submergible means is removed by rotating the slotted circular base clockwise
14 The apparatus of claim 1, wherem the first and the second members transfer a substantial amount of the force
15 The apparatus of claim 3 , wherem the activatmg means transfers a force generating a maximum pressure in order to achieve a maximum distance
16 The apparatus of claim 7, wherem the activatmg means transfers a force generated by a constant activation rate in order to achieve optimal bone growth 19 17 An osteogenesis distraction apparatus for distracting of a first alveolar bone segment from a second alveolar bone segment, compnsmg (a) a cylmdncal member having a threaded inner surface coupled to the first alveolar bone segment, (b) a rod adapter havmg a threaded outer surface and a threaded inner surface, the threaded outer surface for mating to the threaded inner surface of the cylindrical member, and (c) a rod having a base and a threaded outer surface for mating to the threaded inner surface of the rod adapter, wherein the rod is for positionmg the first alveolar bone segment a distance from the second alveolar bone segment, responsive to a force
18 The osteogenesis distraction apparatus of claim 17, further compnsmg an activatmg means coupled to the base of the rod for transfernng a force
19 The osteogenesis distraction apparatus of claim 18, wherein the activating means includes (a) a hexagonal drive wrench for couplmg to the base of the rod
20 The osteogenesis distraction apparatus of claim 18, wherein the activatmg means compπses (a) a slot screw driver for couplmg to the base of the rod
21 The osteogenesis distraction apparatus of claim 18, wherein the rod is removed by rotating the base clockwise
22 The osteogenesis distraction apparatus of claim 17, further compnsmg an obturating member having a threaded outer surface which mates with the threaded inner surface of the cylmdncal member, the obturatmg member for preventing bone from growmg into the cylmdncal member while the alveolus grows into substantially intimate contact with the cylmdncal member 20 23 The osteogenesis distraction apparatus of claim 17, further compnsmg a dnll guide member having a threaded outer surface and an inner openmg, the threaded outer surface for mating with the threaded inner surface of the cylmdncal member, and the inner opening for guiding a drill
24 The osteogenesis distraction apparatus of claim 17, wherein said cylindrical member is covered with a coating for enhancing an osseomtegration process
25 The osteogenesis distraction apparatus of claim 24, wherein said coating is a bondable titanium plasma
26 The osteogenesis distraction apparatus of claim 24, wherem said coatmg is a bondable hydroxlyappatite
27 A method for forming alveolus, compnsmg the steps of (a) forming an openmg m the alveolus, (b) msertmg the cylmdncal member into the opemng in the alveolus. (c) msertmg an obturatmg member in the cylindrical member to prevent bone and tissue from growmg mto the cylmdπcal member while the alveolus grows into substantially intimate contact with the cylmdπcal member, (d) removing the obturatmg member, (e) msertmg a dπll guide member in the cylmdncal member, (f) forming a second opemng in the alveolus with a dnll guided by the drill guide member, (g) removmg the dnll guide member, (h) cutting the alveolus into a first bone segment and a second bone segment, the first bone segment containing the cylmdncal member and the second opemng, (l) msertmg a rod adapter into the cylmdπcal member, (j) msertmg a rod into the openmg of the alveolus and through the rod adapter to the second bone segment, and, 21 (k) exerting a force on the rod in order to displace the first bone segment from the second bone segment
28 The method of claim 27, wherein the alveolus grows into substantially intimate contact with the cylindrical member for approximately 3 to 5 months
29 The method of claim 27, wherein the rod remains in the alveolus for approximately 3 to 5 weeks after complete activation
30 A method for forming alveolus, comprising the steps of (a) forming an opening m the alveolus, (b) inserting the cylmdncal member mto the opemng in the alveolus, (c) forming a second opening in the alveolus with a drill guided inserted into the cylmdncal member, (d) cutting the alveolus mto a first bone segment and a second bone segment, the first bone segment containing the cylmdncal member, (e) inserting a rod adapter into the cylmdncal member, (f) inserting a rod into the opemng of the alveolus and through the rod adapter to the second bone segment, and, (g) exerting a force on the rod in order to displace the first bone segment from the second bone segment
PCT/US1999/003384 1998-02-20 1999-02-17 An apparatus and method for distraction osteogenesis of small al veolar bone WO1999042048A1 (en)

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