WO2016073053A1 - Systèmes d'alignement d'instrument dentaire - Google Patents

Systèmes d'alignement d'instrument dentaire Download PDF

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Publication number
WO2016073053A1
WO2016073053A1 PCT/US2015/045535 US2015045535W WO2016073053A1 WO 2016073053 A1 WO2016073053 A1 WO 2016073053A1 US 2015045535 W US2015045535 W US 2015045535W WO 2016073053 A1 WO2016073053 A1 WO 2016073053A1
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WIPO (PCT)
Prior art keywords
assembly
base unit
guide
coronal
instrument
Prior art date
Application number
PCT/US2015/045535
Other languages
English (en)
Inventor
Paul Alan CRANDALL
Frederick C. THOMPSON
Jennifer T. STRONG
Original Assignee
FPJ Enterprises, LLC
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 FPJ Enterprises, LLC filed Critical FPJ Enterprises, LLC
Priority to US14/832,170 priority Critical patent/US20150359479A1/en
Publication of WO2016073053A1 publication Critical patent/WO2016073053A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C1/00—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design
    • A61C1/08—Machine parts specially adapted for dentistry
    • A61C1/082—Positioning or guiding, e.g. of drills
    • A61C1/084—Positioning or guiding, e.g. of drills of implanting tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/02—Devices for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis
    • A61B6/027—Devices for diagnosis sequentially in different planes; Stereoscopic radiation diagnosis characterised by the use of a particular data acquisition trajectory, e.g. helical or spiral
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/08—Auxiliary means for directing the radiation beam to a particular spot, e.g. using light beams
    • A61B6/51—
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/58—Testing, adjusting or calibrating apparatus or devices for radiation diagnosis
    • A61B6/589—Setting distance between source unit and patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C2201/00—Material properties
    • A61C2201/005—Material properties using radio-opaque means

Definitions

  • This disclosure relates generally to tools, systems, and methods for preparing a bore hole in a patient's mouth to receive a dental implant.
  • Word Usage
  • Align or Alignment Placed in a prescribed relationship.
  • an object is aligned to another object if set in a particular orientation relative to the another object.
  • the relationship may be co-linear, parallel, perpendicular, or any other prescribed relationship.
  • a dental implant or simply an implant or sometimes an endosseous implant is a surgical component the interfaces with the bone of the jaw to act as an orthodontic anchor for a dental prosthesis such as a crown that covers the implant rather than an existing tooth to form a prosthetic tooth.
  • Other prosthetic devices such as bridges, dentures, may be connected to one or more implants.
  • an abutment is placed on the implant and the dental prosthesis is then connected to the abutment.
  • An implant may support a single prosthetic tooth.
  • One implant may support more than one prosthetic tooth.
  • Several implants may be used to support a larger prosthetic.
  • the planned implant trajectory is something created within the planning software to compromise the ideal trajectory for restorative and aesthetic purposes to make modifications in light of the anatomic features as viewed in the virtual model of the implant site within the planning system software.
  • FIG. 1 shows a flow chart for a prior art method 1000 to create a bore for receipt of a dental implant.
  • a surgical guide (sometimes called surgical template) is created to guide the drilling system used to create the bore to receive the implant.
  • the surgical guide may be made based upon computer images of the treatment area so that that the surgical guide is custom fit for use in the patient's mouth.
  • the surgical guide can be said to have two main components, the guide sleeves and the contact surface.
  • the contact surface provides a custom fit with the patient's mouth (gums, jawbone, and teeth).
  • One or more guide sleeves (sometimes guide cylinders) within the drill guide are used to orient and guide the drilling system to create a bore at the desired location and with the desired angulation (distal-mesial and inner-outer).
  • the goal is to get the bore for the implant created so that the apical end of the bore and all sides of the bore are fully enclosed in bone.
  • the drilling should not damage nearby anatomic structures, including nerves or roots of adjacent teeth.
  • the implant placement should be compatible with the intended prosthetic solution and not complicate the creation of the prosthetic solution to compensate for an awkward placement of the implant.
  • Step 1010 Create Treatment Plan.
  • the dentist weighs patient needs, anatomic conditions, and patient objectives to determine a treatment plan.
  • the inputs may include photos, dental impressions, X-ray images, and an examination by the dentist.
  • one of several types of surgical guides are selected. The basic details of the four most common types of surgical guides are:
  • Step 1020 Data Collection to Fabricate Surgical Guide.
  • the patient has a CBCT scan taken of the surgical site without a scan appliance.
  • this technique is most commonly used with partially edentulous arches, bone supported guides and bone reduction guides. Due to the guide resting on teeth or bone this information is more accurately mapped by the CBCT scan than soft tissue. STL files from intraoral scans or model scans can also be overlaid more accurately than edentulous cases.
  • Dual Scan Technique is most commonly used with partially edentulous arches, bone supported guides and bone reduction guides. Due to the guide resting on teeth or bone this information is more accurately mapped by the CBCT scan than soft tissue. STL files from intraoral scans or model scans can also be overlaid more accurately than edentulous cases.
  • the scan appliance (sometimes scan prosthesis) has fiduciary markers that help to visualize the desired tooth set-up in the CT and CBCT three-dimensional images. Sometimes the fiduciary markers are simply a radiopaque liner applied to the interior surface of denture. These images help to determine how to place the patient's implants from a clinical as well as an esthetic point of view. For a mucosa- supported guide, it's the scan appliance that makes it possible to fabricate the guide.
  • a bite index is useful in that it shows the relationship of the biting surfaces and thus indicates the relationship between the two jawbones.
  • a bite index in a fully edentulous arch is taken with the dentures in place to capture how one jawbone is oriented relative to the other jawbone.
  • a wax up is made on the stone model.
  • the wax up is a practical representation of the position and shape of the prosthetic tooth.
  • the data collected has to be merged in a format that is readable by the implant surgery guide planning software.
  • the case type and the surgical guide type there can be different steps to accomplish this.
  • the common steps are listed for various surgical guide types. Those of skill in the art will recognize that particular implementations of planning software and preferences may mean that additional data files are obtained and loaded.
  • Step 1040 Case Planning.
  • the location and trajectory of the implant or implants is selected within a virtual model of the patient's mouth.
  • the planning software is used to plan the location, depth and angulation of the implant.
  • the three-dimensional information that has been imported into the software is displayed two-dimensionally.
  • the user selects two-dimensional slices that show the surgical location or locations. These slices demonstrate the availability of bone volume in that area.
  • the user may be able to view a proposed restorative space in that slice.
  • This restorative space can be represented by the digital scan of a wax up, the scan appliance or a digitally created tooth. If there is no restorative space represented then the user locates and angles the implant to a position that looks best in the hard tissue and guesses the proper restorative angulation of the implant. If the software provides a restorative space then the user picks the best angle and location of the implant that matches the bone volume and restorative space. This position is subjective and there is no accurate or practical method to measure the proposed implant location to other anatomical landmarks. Most software does not demonstrate or include the user in planning the framework of the guide.
  • Step 1050 Electronic Transfer.
  • the data for the surgical plan is electronically transferred to the lab.
  • the lab designs and manufactures the surgical guide.
  • Step 1060 Guide Manufacture.
  • the lab creates the surgical guide using manufacturing techniques which may include work by hand, milling, CAD/CAM methods, or other methods known to those of skill in the art.
  • the surgical guide receives one or more guide sleeves to attempt to reproduce the positioning and angulation of the implants based upon results of case planning and the surgery as envisioned in the virtual model.
  • the dental office blocks out of their schedule one to four hours for the procedure.
  • the surgical guide is secured at the surgical site and drilling is performed according to implant protocol.
  • a dental office with a CBCT scanner can anesthetize a patient, secure the surgical guide, and then transport the patient from the treatment room to an imaging room at the facility with the CBCT scanner.
  • the source of the problem may have been improper positioning of the patient during the CBCT scan used during the planning process as the planning software makes certain assumptions about the orientation of the patient with respect to the CBCT scan.
  • the source of the problem may be an error made during the process of planning the implant trajectory as the process may allow substantial latitude to the dentist to move the implant trajectory in any direction or change angulation in any direction. Some choices may not be what the dentist really intended. As the surgical guide is not made in the presence of the dentist, the error may not be caught until the patient is back at the dental office and ready for the implant to be placed.
  • a surgical guide may be inappropriate and not provide a desired implant trajectory for drilling. If the surgical guide is rejected in favor of a new guide, the planning steps may need to be repeated (especially if it is not immediately clear what caused the problem with the surgical guide). This means that the dental practice loses productivity for the procedure room and team assembled to drill and place the implant. The patient is inconvenienced by having to schedule another visit several weeks out. This need to scrap the surgical guide is likely to cause the patient to doubt the process or the dentist and wonder just how accurate the next surgical guide will be. If the lab has a fair number of surgical guides that must be done over, that loss of revenue will be passed along in higher prices for the surgical guides.
  • the guide sleeve is augmented with another sleeve that fits within the guide sleeve so that a small diameter drill bit may be used initially followed by one or more intermediate diameter drill bits and finally a final drill bit that is used with the guide sleeve without any inner sleeve.
  • the process is cooled by spraying water on the drill bit although this process is less than desirable in that is requires an assistant to attempt to spray irrigant towards the drill bit through a window which is not easy given there is limited room for hands and devices within the patient's mouth.
  • the '752 places impression compound around the surgical site and adjacent anatomy.
  • a positioning aid 4 is placed into the impression compound.
  • An apical portion of the positioning aid 4 will leave a negative impression in the impression compound.
  • the apical portion 5 is not round so the positioning aid is not free to rotate around an apical to coronal axis of the positioning aid after the impression compound has hardened.
  • the shape of the apical portion 5 also precludes removing the positioning aid and placing the positioning aid back into hardened impression compound at a rotational position different from the initial rotational position.
  • the positioning aid is adapted to be visible in an MRI image or X-ray image and the impression compound cures to be radiolucent.
  • a drilling direction is selected relative to the negative impression of the apical part of the positioning aid 4 (called a connecting part 7).
  • a drill guide 8 is created to fit an apical portion of the drill guide 8 within the void left by the positioning aid 4 and limits the drill guide 8 to a single orientation.
  • a bore 9 through the drill guide 8 may be used to guide a series of drill bits of increasing sizes by a placing series of sleeves 12 in the bore 9 to constrict the effective inner diameter of the bore 9.
  • the drill guide 8 is made from an ablative process such as grinding or milling to remove material from a block having a pre-formed bore.
  • an ablative process such as grinding or milling to remove material from a block having a pre-formed bore.
  • the block would need to be of a material of sufficient hardness and heat tolerance to serve as a limit on a rapidly spinning shaft of a drill bit while maintaining dimensional integrity so as to continue to limit the movement of the drill bit shaft relative to the desired drilling direction.
  • inventive concepts are illustrated in a series of examples, some examples showing more than one inventive concept. Individual inventive concepts can be implemented without implementing all details provided in a particular example. It is not necessary to provide examples of every possible combination of the inventive concepts provide below as one of skill in the art will recognize that inventive concepts illustrated in various examples can be combined together in order to address a specific application.
  • the assembly having a base unit created to at least partially conform to patient anatomy adjacent to a surgical site that will receive a bore; the base unit having an open passageway from an apical side of the base unit to a coronal side of the base unit.
  • the assembly also having a measurement jig to allow a set of measurements to be collected regarding an outer position of bone volume in a plane near a plane containing the specific linear trajectory, the measurement jig anchored to the instrument guide.
  • the instrument guide may be replaced by placing an end of the measurement jig into the open passageway of the base unit and precluded from rotation within the passageway with a coronal to apical centerline of the end of the measurement jig aligned with the specific linear trajectory.
  • the assembly having a base unit created to at least partially conform to patient anatomy adjacent to a surgical site that will receive a bore; the base unit having an open passageway from an apical side of the base unit to a coronal side of the base unit.
  • the assembly also having an instrument guide placed into the open passageway of the base unit and precluded from rotation within the passageway with a coronal to apical centerline of the instrument guide is aligned with the specific linear trajectory.
  • the assembly also having a guide component to align an X-ray beam from an X- ray source in a specific relationship with a coronal face of the instrument guide and an alignment assembly to align the guide component, the alignment assembly anchored to a portion of the instrument guide.
  • the instrument guide may be replaced by placing an end of the assembly into the open passageway of the base unit and precluded from rotation within the passageway with a coronal to apical centerline of the end of the assembly aligned with the specific linear trajectory.
  • Some of the teachings of the present disclosure may be summarized as a method for obtaining information about patient anatomy relative to a specific linear trajectory into a patient's jawbone. The method including placing a base unit on a region of a patient's mouth including an area located coronally to a proposed point of entry into the patient's jawbone, the base unit having an open passageway from a coronal side of the base unit to an apical side of the base unit.
  • the method also including mounting an instrument assembly upon the instrument guide so that the instrument assembly cannot rotate around the coronal to apical centerline of the instrument guide and using the instrument assembly to obtain information about patient anatomy relative to the specific linear trajectory into the patient's jawbone wherein the information is collected with a known spatial relationship to the specific linear trajectory.
  • the end of the instrument assembly may be positioned co-linear with the specific linear trajectory or may be placed at a known offset from the specific linear trajectory but parallel to the specific linear trajectory.
  • the instrument guide may be a guide sleeve with a bore having a centerline co- linear with the specific linear trajectory.
  • the guide sleeve may be placed directly into a base unit or the guide sleeve may be placed into a cartridge which is placed into a frame which serves as the base unit.
  • FIG. 1 is a flowchart of the prior art process for preparing a bore to receive a dental implant.
  • FIG. 2 shows a model of the relevant portion of a patient's mouth.
  • FIG. 3 shows a cross-section taken on the inner-outer by apical-coronal plane revealing the bone volume at the plane of interest.
  • FIG. 4 shows a planning process for a cartridge reflecting the restorative trajectory.
  • FIG. 6 shows a proposed frame interacting with a tooth.
  • FIG. 7 shows a frame with chamber to receive removable cartridge.
  • FIG. 8 is an outer-mesial perspective view showing the use of a probe.
  • FIG. 9 is another outer-mesial perspective view of the components from FIG. 8 but with the frame and the cartridge rendered invisible so as to allow for viewing of the inserted probe tip.
  • FIG. 10 shows a guide ring which orients the X-ray source and the components that orient the guide ring.
  • FIG. 11 shows a top perspective view of FIG. 10 with a partial cross section in the inner-outer by apical-coronal plane.
  • FIG. 12 shows a partial cross section of a frame, cartridge, and guide sleeve in the inner-outer by apical-coronal plane.
  • FIG. 13 shows an exploded diagram to explain the positioning of sensor holder relative to the guide sleeve.
  • FIG. 14 shows part of the planning process where an intermediate trajectory for a proposed implant.
  • FIG. 15 is a perspective view of an exploded diagram that introduces the measurement jig for collecting bone volume contour information.
  • FIG. 16 provides an outer-coronal perspective view of a measuring jig placed for taking of measurements.
  • FIG. 18 shows a planning model that has the arrays of measurements providing a contour of bone volume
  • FIG. 19 is an outer-coronal perspective view of an exploded diagram that includes the surgical cartridge and shows the optional irrigation ports.
  • FIG. 21 sets forth the flowchart for the high level process steps for a sequence to guide one or more drill bits along a surgical trajectory for an implant.
  • FIG. 22 shows an alternative round guide sleeve with irrigation slots.
  • the drill trajectory should allow for the final bore to be created with a desirable tolerance between the surface of the drilled bore and the edge of the jaw bone towards the inside of the mouth (lingual/palatal side), the edge of the jaw bone towards the outside of the mouth (facial, or buccal-towards cheeks, sometimes labial-towards lips).
  • the drill trajectory should allow for the final bore to be created with a desirable tolerance between the surface of the drilled bore and the adjacent teeth (mesial and distal).
  • the drill trajectory should allow for the final bore to be created with a desirable tolerance between the surface of the drilled bore and the apical end of the jawbone.
  • Different dentists may have different preferences for how they choose a drill trajectory based upon the patient anatomy.
  • a set of rules for determining a drill trajectory based on patient anatomy may be called a drill trajectory protocol or implant protocol.
  • One implant protocol may focus on a different set of landmarks on the patient anatomy than a set of landmarks used for a different implant protocol.
  • a restorative trajectory is the three-dimensional position, angle, and height for implant placement determined by the anatomical needs for restoring form and function with no regard to the available anatomical structures for osseointegration of the implant.
  • the implant has a purpose of providing an anchor for a prosthetic device.
  • the restorative trajectory has a focus on positioning the prosthetic device so that the prosthetic device is ideally placed relative to other teeth and landmarks to provide the desired traits with respect to chewing, appearance, and other characteristics known in the dental arts.
  • a multi-piece surgical guide with a frame and a removable cartridge that can receive the guide sleeve is manufactured in accordance with the restorative trajectory from the planning process.
  • the cartridge 150 and frame 104 may be created at the dental facility using one of the known processes for additive manufacturing.
  • One such additive manufacturing process is 3D printing although one of skill in the art would be able to use one or more of the many processes in additive manufacturing to convert appropriate data files for the frame and cartridge into three-dimensional objects.
  • the additive material process and material used will need to be selected to accommodate the need for the frame to correspond to the shapes of teeth in the patient's mouth (for non-edentulous procedures). Creating a form that corresponds to the shape of teeth presents challenges in the slopes required to mirror the shape of teeth. Another complication is that the tooth may narrow from a largest cross section to a smaller cross-section near the coronal edge of the soft tissue.
  • FIG. 7 shows a frame 104 with chamber 108 to receive removable cartridge 150.
  • the chamber 108 may have an apical-coronal depth that is less than the apical-coronal depth of the cartridge 150 so that the cartridge 150 extends beyond the coronal edge of the frame 104. Extending the cartridge 150 above the coronal edge of the frame 104 facilitates removal of the cartridge 150 from the frame 104.
  • Removable cartridge 150 has an opening 154 (not visible here as the guide sleeve 180 is present) for receipt of a guide sleeve 180.
  • Guide sleeve 180 has a bore 184 running from the coronal face 196 to the apical face 194 (not visible here) to allow an instrument to reach the soft tissue and the jawbone beyond.
  • the opening 154 in the cartridge 150 may be symmetric as with the hexagonal shaped opening 154.
  • Through bore 184 in the guide sleeve 180 is aligned to be perpendicular from the apical face 194 and coronal face 196 of the guide sleeve 180.
  • the bore 184 is located in the middle of the guide sleeve 180.
  • the guide sleeve 180 may be a reusable part made from a material that allows for machining close tolerances for the stop flange 192, bore 184, and other dimensions. If the guide sleeve 180 is to be used with different patients, the guide sleeve 180 will need to tolerate at least one sterilization process known in the dental arts. Surgical stainless steel is one suitable material for the guide sleeve. [00133] Use of the Restorative Cartridge.
  • FIG. 8 and FIG. 9 show two views of a probe 304 with a narrowed probe tip 308 and probe outer diameter 312 which fits snuggly within the bore 184 of the guide sleeve 180 so that the probe 304 strikes the soft tissue surface 862 and penetrates to the bone crest 854.
  • the insertion depth of the probe 304 as the probe tip 308 rests on the bone crest 854 may be discerned by markings 316 placed on the probe 304. Assessing depth with a level of accuracy of 175 th of a millimeter is more than sufficient for this process.
  • the markings 316 can be translated to provide a distance between the probe tip 308 and the coronal face 196 of the guide sleeve 180.
  • some frames 104 may have a closed end if the distal or mesial end of the frame 104 is in a location without a tooth to straddle.
  • the probe 304, guide sleeve 180 and cartridge 150 may be removed to expose a probe bore 886 in the soft tissue 858.
  • the depth of soft tissue 858 may be measured by placing a washer (not shown here) on probe 304 near the probe tip 308 and inserting the probe to the bone crest 854. The washer will be forced to move in a coronal direction on the probe 304. The distance of the washer from the probe tip 308 can be measured after the probe is removed from the mouth to provide a measurement of the depth of the soft tissue 858.
  • An X-ray of the surgical site along with radiographic opaque markers on the inserted components is helpful for planning the surgical trajectory.
  • a preferred process is to use an alignment system 400 for the X-ray that is aligned with the restorative trajectory.
  • FIG. 10 shows a guide ring 408 which orients the X-ray source (not shown here).
  • a set of axes (704, 708, and 712) is presented in FIG. 10 as the guide ring 408 is aligned relative to these axes.
  • the set of axes has been moved away from the restorative trajectory 804 to avoid undue clutter but the axes are all defined based upon the restorative trajectory 804 (not shown here but aligned with the centerline of the drill bit 440).
  • the guide ring 408 aligns the X-ray source 404 along the inner-outer axis 704 with respect to the surgical site and perpendicular to a plane defined by the apical-coronal axis 712 for the restorative trajectory and the distal-mesial axis 708.
  • the X-ray source 404 (not shown here) is aligned with the outer hex ridge 198 which is itself aligned by the alignment of the opening 154 (See FIG. 8) of the cartridge 150 to be aligned with the plane defined by the inner-outer axis 704 and the apical-coronal axis 712 for the restorative trajectory.
  • the guide ring 408 has a guide ring arm 412 to offset the guide ring 408 from a spacer arm 416.
  • the spacer arm 416 is connected to an egress arm 420 which carries the orientation alignment out of the mouth of the patient for use by the spacer arm 416 and guide ring arm 412.
  • a centerline of the egress arm 420 is perpendicular to the plane defined by the inner-outer axis 704 and the apical-coronal axis 712 for the restorative trajectory.
  • FIG. 11 shows a top perspective view of FIG. 10 with a partial cross section in the inner-outer 704 by apical-coronal 712 plane. Visible in FIG. 11 are guide ring 408, guide ring arm 412, spacer arm 416, egress arm 420, a portion of guide sleeve 180, a portion of cartridge 150, and a portion of frame 104. Also visible is drill bit 440.
  • FIG. 12 shows a partial cross section of a frame 104, cartridge 150, and guide sleeve 180 in the inner-outer 704 by apical-coronal 712 plane.
  • the drill bit 440 is not shown in cross section.
  • the drill bit 440 has distal cutting section 444.
  • the maximum width of the distal cutting section 444 is wider than the width of the intermediate section 448.
  • the intermediate section 448 is constrained by the bore 184 as it passes through the coronal section 202 of the guide sleeve 180. This constraint between coronal section 202 and the intermediate section 448 maintains the trajectory of the distal cutting section 444.
  • FIG. 12 also shows the stop flange plane 162 surrounded by the stop flange perimeter 166.
  • the geometry of the surgical site is captured by the female hex sleeve 432 so that through a series of perpendicular connections, other components can be aligned with the surgical site.
  • the sensor holder 480 holds the X-ray sensor 484 in a sensor cavity 498.
  • the sensor holder 480 is positioned by a sensor spacer 492 that engages a second cavity 488 in bidirectional hub 428 and engages a spacer receptacle 496 on the sensor holder 480.
  • the bidirectional hub 428 may be rotated 180 degrees to place the sensor holder 480 to the left of the bidirectional hub 428 and the guide ring 408 to the right of the bidirectional hub 428 so that all quadrants of the mouth may be used with the X-ray alignment system 400.
  • An alternative would be to have a bidirectional hub 428 that did not rotate but had a first cavity 424 that matches the second cavity 488 so that either cavity could receive either the spacer arm 416 or the sensor spacer 492.
  • An X-ray taken with the X-ray source 404 aligned with the guide ring 408 will provide X-rays to the X-ray sensor 484 in a known relationship with the surgical site. After the digital data from the X-ray sensor 484 is within the procedure planning program auto- calibration with the known shape and position of the guide sleeve 180 sets the three axes:
  • the guide sleeve 180 as a landmark, other biological landmarks may be identified automatically or manually on the X-ray results.
  • the biological landmarks may include bone crests 854.
  • the distance from the coronal face 196 of the guide sleeve 180 may be compared with the probe depth to the coronal face 196 of the guide sleeve 180 when a probe was inserted through the bore 184 in the guide sleeve 180 through the soft tissue 858 to the bone crest 854.
  • the bone crest 854 indications available from the X-ray data include bone crest 854 indications for the entire distal-mesial range.
  • the implant may be planned to have a coronal face at a desired distance from at least one biological landmark such as bone crest 854, soft tissue surface 862, CEJ (cementoenamel junction), or contact.
  • contact is where the anatomical crown meets the anatomical root.
  • the planning process could align the coronal face 754 (shown below) of the implant with any other biological landmark of relevance to the implant planning protocol.
  • the coronal face 754 of the implant 750 can be planned to be placed zero millimeters above the bone crest 854.
  • the nearby roots of adjacent teeth may be identified automatically or manually.
  • the apical edge of the bone volume may be identified automatically or manually.
  • a safety zone may be used to ensure the planned surgical trajectory stays safely clear of the apical edge of the bone volume. For example if the total length of bone in the apical-coronal direction is 1 1 millimeters and a 2 millimeter safety edge is desired then the depth of available bone is 9 millimeters.
  • FIG. 14 shows part of the planning process where an intermediate trajectory 812 for a proposed implant 750. As there is a process to modify the restorative trajectory 804 to become the surgical trajectory 814, during the process there may be trajectory iterations which we can call intermediate trajectory 812.
  • the trajectory 812 is shown within the safe bone volume 852 which is set off by safety margins from total bone volume 850.
  • the safety margin on the distal side 770 may be different than the safety margin on the mesial side 774.
  • the implant length is selected to not extend beyond the safe bone volume 852 from the bone crest 854. Many other relationships between the implant and anatomic features may help shape the surgical trajectory 814.
  • the restorative trajectory 804 may be modified based upon the input from the two-dimensional X-ray to make adjustments in location and angulation in the distal-mesial 708 by apical-coronal 712 plane.
  • the drilling depth to be used for the osteotomy is selected based on the proposed distance between the coronal face 196 of the guide sleeve 180 and the intended apical depth of the implant 750. This distance is the sum of the distances between the coronal face 196 of the guide sleeve 180 and the bone crest 854 and the length of the selected implant 750 (assuming a zero millimeter offset between the coronal face 754 of the implant 750 and the bone crest 854).
  • FIG. 15 it is useful to get a profile of the bone volume in the inner- outer 704 by apical-coronal 712 plane that contains the restorative trajectory 804. This may be accomplished with precision by placing a measurement jig 504 in a known location relative to the known location of the coronal section 202 of the guide sleeve 180.
  • the stop flange 192 of the guide sleeve 180 fits within a stop flange perimeter 166 (See FIG. 12) to rest on a stop flange plane 162 (See FIG. 12) within cartridge 150 so that the coronal side of the stop flange 192 is flush with a coronal face 170 of the cartridge 150.
  • a female hex 508 of the measurement jig 504 fits over the coronal section 202 of the guide sleeve and flush with the coronal face 170 of the cartridge.
  • a spacer arm 512 sets the array arm 516 a known offset from the restorative trajectory 804.
  • a probe tip 558 of measuring pin 550 may be inserted through a pin guide 520 in the array arm 516 to move a collar 554 relative to the probe tip 558. When the probe tip 558 is pressed through the soft tissue 858 to the edge of the bone volume 850 (not shown here), the precise location of the edge of the bone volume 850 at a known apical offset from the coronal face 196 of the guide sleeve 180 may be discerned from the movement of the collar 554.
  • FIG. 16 provides a perspective view of a measuring jig 504 placed for taking of measurements.
  • the array arm 516 of the measurement jig 504 has a series of pin guides 520 arranged on midline 528 allow bone contour measurements to be taken in the plane containing the restorative trajectory 804.
  • the measuring pin 550 is shown with probe tip 558 not visible as the probe tip 558 is inserted through the collar-side face 532 of the array arm 516.
  • Additional pin guides 524 may be added distally and mesially of the midline 528 in the event that a dentist wishes to get additional readings. This may be useful if the planning process has moved the intermediate trajectory 812 distally or mesially relative to the restorative trajectory 804 in response to the input from the X-ray.
  • a bore 540 aligned with the restorative trajectory 804 allows a guide sleeve caddy such as drill bit 440 to be used to place the guide sleeve 180 in the cartridge 150 and then remain in place as the measuring jig 504 is put into place and used.
  • FIG. 17 shows an example of an array of bone volume contour points obtained from use of an alternative measuring jig 504.
  • the measuring jig 504 shown in FIG. 17 differs from the measuring jig 504 shown in FIG. 15 and FIG. 16 in that the array arm 516 is not flat with a single plane for the collar-side face 532 but is stepped to partially approximate the surface of the soft tissue 858.
  • the operation of the alternative measuring jig 504 is the same as discussed above.
  • a probe tip 558 (not shown here) of a measuring pin 550 (not shown here) is moved towards the restorative trajectory 804 through a pin guide 520 which separates the collar 554 (not shown here) from the probe tip 558 (not shown here) and provides a distance separating the edge of the bone volume 850 from the collar-side face 532.
  • the difference being that the collar-side face 532 for pin guide 536 is closer to the restorative trajectory 804 than is the collar-side face for other pin guides 520.
  • the differences are known to the planning software, the differences are handled.
  • the coronal end of the female hex 508 and spacer arm 512 is not shown in FIG. 17 so that the coronal face 196 of the guide sleeve 180 may be indicated.
  • the software may use the intersection of the restorative trajectory 804 with the coronal face 196 of the guide sleeve 180 as the 0,0,0 point for the coordinate system for inner-outer axis 704, distal-mesial axis 708, and apical-coronal axis 712. As the midline 528 (see FIG.
  • FIG. 18 shows a planning model that has the arrays of measurements providing a contour of bone volume 850 in the inner-outer 704 by apical-coronal 712 plane containing the restorative trajectory 804. Offsets 868 are used to create a safe bone volume 852. The offset 868 on the outer side does not have to be equal to the offset 868 on the inner side.
  • FIG. 18 shows an intermediate trajectory 812 which has been moved by offset 820. Offset trajectory 806 is then tilted by angle 824 versus the offset trajectory 806. Note that the offset and angulation in the inner-outer 704 by apical-coronal 712 plane would not be visible in a view of the distal-mesial 708 by apical-coronal 712 plane. Likewise, an earlier translation or angulation of the trajectory made in response to the two-dimensional X-ray would not be visible in FIG. 18.
  • the restorative trajectory may be modified by a distal-mesial offset, a distal-mesial angulation, an inner-outer offset, and an inner-outer angulation. While the depth and width of the drilled bore is not part of the surgical trajectory 814, these features are part of the surgical plan. The depth and width of the bore for the implant may also be modified during the planning process for the surgical trajectory.
  • the coronal face 196 of the guide sleeve 180 as a drill stop allows the depth of the drilling process to be controlled by the combination of the apical-coronal height of the surgical cartridge 150, the positioning of the chamber 108 in the frame 104, and the apical-coronal height of the guide sleeve 180.
  • the desired depth is a function of the total bone volume 850 and offset resulting in safe bone volume 852 and a nominal length of implant 750 from the coronal face of the implant 750 which is often set at the bone crest 854.
  • the restorative trajectory 804 is modified by the anatomic inputs from a two-dimensional X-ray that is taken in a known orientation with respect with the restorative trajectory 804.
  • a bone contour is obtained transverse to the two-dimensional X-ray.
  • a digital file is sent to a device to create the surgical cartridge 149 with the surgical trajectory 814.
  • the surgical cartridge 149 may differ from the cartridge 150 for the restorative trajectory 804 in that the centerline of the surgical trajectory 814 may be offset from the centerline of the coronal face 170 of the surgical cartridge 149. Further, the surgical trajectory 814 may not be perpendicular relative to the apical face 174 of the surgical cartridge 149.
  • the coronal face 170 of the surgical cartridge 149 may not be parallel to the apical face 174 of the surgical cartridge 149 in order to provide any desired angulation in either or both of the distal-mesial 708 direction or the inner-outer 704 direction.
  • surgical trajectory 814 that is not perpendicular to the apical face 174 of the surgical cartridge 149 could be implemented in a surgical cartridge 149 with a coronal face 170 parallel to the apical face 174 as the opening 154 does not have to be perpendicular with the coronal face 170 and the stop flange perimeter 166 could be interrupted by the coronal face 170.
  • the female hex sleeve 432 for the spacer arm 416 used for alignment of the X-ray guide ring 408 may be given a thickness that rests on the coronal face of the stop flange 192 and thus would not need to abut the coronal face 170 of the surgical cartridge 149.
  • the surgical cartridge 149 may be created with at least one irrigation bore 158.
  • irrigation fluids may be provided. More specifically, the irrigation fluids may be provided to the bore 184 in the guide sleeve 180 through an irrigation bore 188 aligned with the outer hex ridge 198 and in the apical section 206 of the guide sleeve 180.
  • irrigation bore 188 there may be a set of two to six irrigation bores 188 so that multiple orientations of the guide sleeve 180 within the surgical cartridge 149 align an irrigation bore 188 with the irrigation system.
  • An irrigation bore 188 needs to be aligned with an irrigation bore 158 in the surgical cartridge 149 and an irrigation bore 1 18 in the frame 104.
  • An irrigation tube 140 is used to provide irrigation during the surgical procedure to the irrigation bore 1 18 in the frame 104.
  • the irrigation bore 158 in the surgical cartridge 149 needs to be aligned with the irrigation bore 118 in the frame 104, the irrigation bore 158 provides an indication of proper orientation of the surgical cartridge 149 in the chamber 108 of the frame 104.
  • the chamber 108 in the frame 104 and the shape of cartridges 150 and 149 can be created so that only one possible insertion orientation is possible.
  • the irrigation tube 140 will provide a connection end 144 away from the surgical site so that a flexible tube (not shown here) can be connected to the connection end 144 to provide irrigation fluids.
  • the irrigation tube 140 may be made of stainless steel so that it may be sterilized and reused.
  • the insertion end 142 of the irrigation tube 140 may mate with the irrigation bore 118 of the frame 104 and with the irrigation bore 158 in the surgical cartridge 149.
  • the insertion end 142 of the irrigation tube 140 may be used to lock the cartridge 150 or 149 with the frame 104.
  • the insertion end 142 of the irrigation tube 140 does not enter into the irrigation bore 188 of the guide sleeve 180 so that the guide sleeve 180 may be inserted or removed without removing the irrigation tube 140.
  • the diameter of irrigation bore 188 is markedly different from the diameters of irrigation bore 158.
  • the surgical cartridge 149 with the surgical trajectory 814 may be designed to raise the coronal face 170 of the surgical cartridge 149 so that the coronal face 196 of the guide sleeve 180 is elevated so that the coronal face 196 of the guide sleeve 180 serves as a drill stop to limit the apical travel of the drill bit 440 to prevent creating a deeper bore in the bone than intended.
  • the drill would need to have a leading face that makes contact with the coronal face 196 of the guide sleeve 180 to limit the apical movement of the distal cutting section 444 of the drill bit 440.
  • a combination of a different nominal height guide sleeve 180 and an adjusted surgical cartridge 149 can be used to place the coronal face 196 of the guide sleeve 180 at an appropriate height to be a drill stop.
  • Some dentists may wish to take bone contour measurements with the surgical cartridge 150 used to position the guide sleeve 180 to bolster confidence that the surgical cartridge 150 was manufactured as intended and that the process has led to a surgical trajectory 814 that should be used for a drilling process.
  • FIG. 20 shows a drill drive 840 engaged with a drill bit 440 that is engaged with a guide sleeve 180. Visible portions of the drill bit 440 include the intermediate section 448, and distal cutting section 444. As discussed above, the maximum width of the distal cutting section 444 is too large to travel through the entire bore 184 of the guide sleeve 180 so that the guide sleeve 180 is captured and retained by the drill bit 440.
  • the irrigation fluids may be delivered only while the drill bit is rotating by linking the drill to the system that provided irrigation fluids.
  • the height of the coronal face 196 of the guide sleeve 180 may be set to be a drill stop to stop the stop surface 844 of the drill drive 840.
  • guide sleeve 180 Other elements of guide sleeve 180 visible in FIG. 20 include coronal face 196, stop flange 192, outer hex ridge 198, and apical face 194.
  • a sequence of guide sleeves 180 with progressively larger bores 184 may be provided to work with a set of drill bits 440 with distal cutting sections 444 and intermediate sections 448 that have progressively larger diameters.
  • the widest drill bit 440 will drill a bore not wider than the minor diameter of the threaded portion of the implant 750 so that the threads 762 on the implant 750 may engage with bone volume 850.
  • the bores 184 of the sequence of guide sleeves 180 may be designed to provide adequate maintenance of the intended surgical trajectory 814 by the interaction of the bore 184 towards the coronal face 196 of the guide sleeve 180 while retaining the ability to withdraw the distal cutting section 444 into an expanded bore 210 towards the apical face 194 of the guide sleeve 180. Having the ability to at least partially withdraw the distal cutting section 444 into the expanded bore 210 allows the guide sleeve 180 to be fully seated in the surgical cartridge 149 before the distal cutting section 444 is advanced into the bone volume 850.
  • the drilling process may initially use a first drill length and then switch to one or more longer drill lengths.
  • the initial drill length may be extended 5 millimeters to a subsequent drill length.
  • an egress arm 420 with an appropriately sized female hex sleeve 432 must be used with the particular size of the guide sleeve family in use.
  • FIG. 21 sets forth the flowchart 2000 for the high level process steps for a sequence to guide one or more drill bits 440 along a surgical trajectory 814 for an implant 750.
  • Step 2010 Establish an Initial Trajectory. Using protocols known to those of skill in the art, determine a trajectory for a bore to provide an implant placement. This initial trajectory may be determined by the anatomical needs for restoring form and function with no regard to the available anatomical structures for osseointegration of the implant. Or it may be an initial estimate of a surgical trajectory which is tuned by the measurements taken from a guide sleeve oriented along this initial trajectory.
  • Step 2020 Create Frame & Cartridge. Create frame 104 and cartridge 150 based upon the initial which may be the restorative trajectory.
  • the cartridge 150 is designed to receive a guide sleeve 180.
  • Step 2030 Place frame over surgical site.
  • Step 2040 Place Cartridge in Frame.
  • the cartridge 150 may be placed into the frame 104 before the frame 104 is placed within the mouth of the patient.
  • Step 2050 Place Guide Sleeve Into Cartridge.
  • the guide sleeve 180 may be placed into the cartridge 150 before the cartridge is placed within the mouth of the patient. However, it is likely that the guide sleeve 180 will be conveyed to the cartridge 150 after the frame 104 and cartridge 150 are in place.
  • Step 2060 Assess Anatomy Relative to Initial Trajectory.
  • the present disclosure teaches specific tools to assess the position of bone volume and look for other anatomic features relative to the initial trajectory. Those of skill in the art may use the disclosed tools or other tools to assess the bone volume and other relevant anatomy using any tools known to those of skill in the art.
  • Step 2070 Create Surgical Trajectory. Using measurements to discern positions of relevant anatomy relative to the initial trajectory and intermediate trajectories 806 to create a surgical trajectory 814.
  • Step 2080 Create a Surgical Cartridge. Using the surgical trajectory 814 and a desired limit on the depth of a bore created to receive the implant, create a surgical cartridge 149 for use in orienting drill bits 440 to create a desired bore.
  • Step 2090 Insert Surgical Cartridge into Frame.
  • Step 2100 Use Surgical Cartridge with at least one Guide Sleeve to Guide Drill Bit.
  • the guide sleeves 180 are placed so the longitudinal centerline of the guide sleeve 180 defines the surgical trajectory 814 for the drilling process.
  • a series of drills bits 440 may be used to drill a sequence of bores along the surgical trajectory 814.
  • the drill bits 440 may increase in diameter to drill an appropriate sized bored for the planned implant 750.
  • a series of guide sleeves 180 with bores 184 of increasing diameter maintain the alignment of the series of drill bits 440 along the surgical trajectory 814.
  • the surgical cartridge 149 may be sized to work with the guide sleeves 180 to serve as a drill stop so that the drill bit 440 may only move apically a prescribed distance before the drill body contacts the coronal face 196 of the guide sleeve 180 to limit further apical travel of the distal cutting section 444 of the drill bit 440.
  • Preferred Additive Manufacturing Process & Materials Preferred Additive Manufacturing Process & Materials.
  • cartridge 150 or surgical cartridge 149 may be used to create a cartridge 150 or surgical cartridge 149.
  • One suitable choice is a fused filament fabrication printer using polylactic acid (commonly known as PLA). FDA compliant PLA is used in many other medical applications and if left in the body will safely degrade over time to lactic acid.
  • the material used for cartridges (150, 149) may be used for frames 104.
  • the frame 104 and initial cartridge 150 may be printed in approximately thirty minutes.
  • a subsequent cartridge may be printed in approximately ten minutes.
  • the frame 104 may be adjusted to fit the soft tissue 858 that is present.

Abstract

L'objet de l'invention est d'obtenir des informations anatomiques par rapport à une trajectoire linéaire spécifique dans la mâchoire d'un patient à l'aide d'une unité de base telle qu'un cadre positionné en couronne par rapport à un point d'entrée proposé, l'unité de base comportant un passage ouvert. Un guide-instrument tel qu'un manchon de guidage est placé dans l'unité de base ou une cartouche placée dans l'unité de base pour empêcher toute rotation du guide-instrument ; le guide-instrument étant positionné de façon que son axe central soit aligné sur la trajectoire linéaire spécifique. Le montage d'un ensemble instrument sur le guide-instrument de façon que l'ensemble instrument ne puisse pas tourner et l'utilisation de l'ensemble instrument pour obtenir des informations relatives à l'anatomie du patient par rapport à la trajectoire linéaire spécifique sont en outre décrits. Dans un autre mode de réalisation, le guide-instrument peut être omis et une extrémité de l'ensemble instrument insérée directement dans une ouverture dans l'unité de base ou une cartouche dans l'unité de base. L'ensemble instrument peut être utilisé pour obtenir des images radiographiques ou pour obtenir des informations sur un contour osseux. De nombreuses variantes sont décrites.
PCT/US2015/045535 2014-04-01 2015-08-17 Systèmes d'alignement d'instrument dentaire WO2016073053A1 (fr)

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US201562113352P 2015-02-06 2015-02-06
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TWI783995B (zh) * 2017-04-28 2022-11-21 美商尼奧西斯股份有限公司 進行導引口腔顎面程序方法及相關系統
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