US20230355367A1 - Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset - Google Patents

Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset Download PDF

Info

Publication number
US20230355367A1
US20230355367A1 US18/224,617 US202318224617A US2023355367A1 US 20230355367 A1 US20230355367 A1 US 20230355367A1 US 202318224617 A US202318224617 A US 202318224617A US 2023355367 A1 US2023355367 A1 US 2023355367A1
Authority
US
United States
Prior art keywords
location
implant
implants
patient
tracking
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
US18/224,617
Inventor
Robert W. Emery, III
Scott A. Merritt
Lars Hansson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
X-Nav Technologies LLC
Original Assignee
X-Nav Technologies 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 X-Nav Technologies LLC filed Critical X-Nav Technologies LLC
Priority to US18/224,617 priority Critical patent/US20230355367A1/en
Assigned to X-Nav Technologies, LLC reassignment X-Nav Technologies, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HANSSON, LARS, EMERY, ROBERT W., III, MERRITT, SCOTT A.
Publication of US20230355367A1 publication Critical patent/US20230355367A1/en
Pending legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0048Connecting the upper structure to the implant, e.g. bridging bars
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00Dental auxiliary appliances
    • A61C19/04Measuring instruments specially adapted for dentistry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003Not used, see subgroups
    • A61C8/0009Consolidating prostheses or implants, e.g. by means of stabilising pins
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T7/00Image analysis
    • G06T7/50Depth or shape recovery
    • G06T7/55Depth or shape recovery from multiple images
    • G06T7/593Depth or shape recovery from multiple images from stereo images
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • A61B2034/105Modelling of the patient, e.g. for ligaments or bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2048Tracking techniques using an accelerometer or inertia sensor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2055Optical tracking systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2063Acoustic tracking systems, e.g. using ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0089Implanting tools or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61CDENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0093Features of implants not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00Preparations for dentistry
    • A61K6/50Preparations specially adapted for dental root treatment
    • A61K6/58Preparations specially adapted for dental root treatment specially adapted for dental implants
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00Indexing scheme for image analysis or image enhancement
    • G06T2207/10Image acquisition modality
    • G06T2207/10004Still image; Photographic image
    • G06T2207/10012Stereo images
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06TIMAGE DATA PROCESSING OR GENERATION, IN GENERAL
    • G06T2207/00Indexing scheme for image analysis or image enhancement
    • G06T2207/30Subject of image; Context of image processing
    • G06T2207/30004Biomedical image processing
    • G06T2207/30036Dental; Teeth

Definitions

  • An improved dental/maxillofacial implant method and apparatus is disclosed, and, more particularly a dental and maxillofacial prosthesis that is guided into position to fit on the patient’s jaw and maxillofacial structures without the use of a surgical guide.
  • the method involves the use of an image-guided navigation system to determine the position of the prosthesis on the patient’s jaw and maxillofacial region and placing the prosthesis accurately without the use of a physical surgical guide.
  • Physical guides are presently used to orient a pre-surgically fabricated prosthesis to the implants.
  • the problem with these physical guides is that they require large incisions and complex fabrication techniques often utilizing stacked, indexed guides and frame sets. If the guides are not accurately aligned related to the bone they often do not fit the patient properly. In regions outside the oral cavity they are often impossible to place into the maxillofacial defect.
  • a method for determining final locations of a set of implants relative to a three-dimensional dataset includes the steps of (i) providing a three-dimensional dataset including a planned location of the set of implants; a location of a set of implants surgically to be placed in a patient; and an actual location of a patient as provided by a patient tracker attached to the patient, wherein a transform relates the patient tracker to the three-dimensional dataset; (ii) using a tracking system to measure the location of the set of implants simultaneously with the patient tracker; and (iii) communicating a final location of the set of implants relative to the three-dimensional dataset.
  • the step of providing the three-dimensional dataset includes obtaining the three-dimensional dataset from a three-dimensional radiograph.
  • the three-dimensional radiograph may be a cone beam computed tomogram.
  • the three-dimensional radiograph may be an intra-oral scan.
  • the step of providing the three-dimensional dataset preferably includes accessing digital files representing the three-dimensional dataset by a navigation system.
  • the tracking system includes registering digital datasets representative of the planned location of the set of implants, the location of the set of implants, and the actual location of the patient are then registered to each other within a common coordinate system.
  • the steps of registering the planned location of the set of implants, the location of the set of implants, and the actual location of the patient includes spatially aligning common features of each imagining modality using rigid-body transformation.
  • the method may include determining the planned location of the set of implants.
  • the step of determining the planned location of the set of implants includes outlining anatomical features of the patient.
  • the step of determining the planned location of the set of implants may include determining a desired position and a desired angulation of the set of implants.
  • the step of determining the planned location of the set of implants includes determining a hole size of for receiving the set of implants.
  • step of determining the hole size is calculated by using a formula defined as Do + 2 (Et + H x tan(Ea)).
  • a method of dynamically tracking an implant procedure includes the steps of (i) receiving by a tracking system a first digital data set representative of a three-dimensional radiograph obtained of a patient; (ii) determining a planned implant location for a dental implant based on the first digital dataset; (iii) attaching an implant tracking fiducial to the dental implant; (iv) attaching a patient tracking fiducial to the patient; (v) positioning the tracking system relative to the patient; (vi) using the tracking system to measure a location of the implant tracking fiducial simultaneously with a location of the patient tracking fiducial; and (vii) communicating the planned implant location relative to the location of the implant tracking fiducial.
  • the method may include registering the implant tracking fiducial to the tracking system.
  • the implant tracking fiducial may include a plate with a printed pattern.
  • the method may include the step of forming holes in the dental implant.
  • the step of forming holes in the dental implant includes determining a hole size by using a formula defined as Do + 2 (Et + H x tan(Ea)).
  • the method may optionally include a further step of projecting image coordinates of the planned implant location into the tracking system.
  • the method includes the step of using the planned implant location to cue the tracking system where to look for the implant tracking fiducial.
  • the implant tracking fiducial may be in a shape of a protruding portion of the dental implant.
  • FIG. 1 is a cross-sectional view of a dynamically guided support structure according to the present invention shown in the stages of being mounted on a bone.
  • FIG. 2 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of an alignment support system for locating a prosthesis on multiple implants with abutments for the implants located on the implants before attachment.
  • FIG. 3 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of the alignment support system for FIG. 2 as it provides guidance on placement of the prosthesis.
  • FIG. 4 is a perspective view of a portion of a patient’s jaw illustrating the prosthesis of FIG. 3 with the abutments attached to the prosthesis.
  • FIG. 5 is a perspective view of a portion of a patient’s jaw illustrating the prosthesis of FIG. 4 with the alignment support system removed.
  • FIG. 6 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of an alignment support system for locating a prosthesis in place on the jaw with the alignment support system attached.
  • FIG. 7 is a schematic illustration of the calculations used to determine the size of the prosthetic holes as they relate to the dynamically guided navigation system.
  • the present invention is directed to a system and method to allow a dentist to plan an implant position prior to surgery using a dynamic navigation system, plan the prosthesis related to the implant plan and then accurately relate the prosthesis to the patient’s anatomy and the newly placed implants without the use of a physical surgical guide. Minimal incisions are used as no guides are necessary.
  • the prosthesis includes an alignment support structure for assisting with the proper positioning of the prosthesis with respect to the patient anatomy during fitting, and one or more implant fixation systems for final fixation of the prosthesis to the anatomy, each of which consists of a fixation feature, which in the preferred embodiment is a hole in the prosthesis, an abutment that will be rigidly attached to the fixation feature, and an implant that will be drilled into the patient’s bone and that will be removably mated to the abutment.
  • a fixation feature which in the preferred embodiment is a hole in the prosthesis, an abutment that will be rigidly attached to the fixation feature, and an implant that will be drilled into the patient’s bone and that will be removably mated to the abutment.
  • the system involves first obtaining a pre-surgical data set that is acquired from the patient through an image scanning.
  • the pre-surgical digital data set is to be used by the dynamic image navigation system for planning the implant and then the prosthesis.
  • This digital data set may be obtained using any conventional means, and may include a three dimensional radiograph; a computed tomogram or cone beam computed tomogram; an intraoral digital scan; digital scans of models; and/or digital photographs, either 2D or 3D.
  • a three dimensional radiograph is taken, preferably a cone beam computed tomogram (CBCT) taken with or without radiographic markers or fiducials attached rigidly to the patient’s skeleton/bone structure in the area of the scan, either with screws or a removable device.
  • CBCT cone beam computed tomogram
  • a scanning appliance with markers/fiducials may be attached to the patient’s mouth at the time of the radiograph to assist with the surgical planning.
  • CBCT cone beam computed tomogram
  • a scanning appliance with markers/fiducials may be attached to the patient’s mouth at the time of the radiograph to assist with the surgical planning.
  • U.S. Pat. 9,402,691 the disclosure of which is incorporated herein by reference in its entirety. This appliance may be custom-made with fiducials or, alternatively, could be the patient’s denture or a dental appliance that has fiducials attached.
  • the CBCT may be taken with the patient’s teeth touching, in occlusion, or with the teeth separated. If the patient has no teeth, the dentures or scanning appliance may or may not be touching or in occlusion.
  • the radiograph is preferably stored in a digital imaging and communication (DICOM) format.
  • intra-oral optical scans may, optionally, be used in the surgical planning.
  • Intra-oral scans are typically stored in a surface format consisting of a triangulated irregular network (TIN) of 3D points representing one or more surfaces of a patients anatomy.
  • Intra-oral scans are typically registered via matching surface contour information with a surface extracted from the 3D radiograph.
  • Intra-oral optical scans provide additional information about soft-tissue boundaries and are less susceptible to image artifacts that can lead to ambiguity in determining hard-tissue structure, so can assist in planning around the anatomical features.
  • the invention contemplates the use of laser scans of physical models, which may or may not be used. These models may, for example be wax-ups of the desired restorative result, the patient’s existing denture, or a provisional prosthesis.
  • Three- or two- dimensional photographs in digital format may also be used.
  • the digital files are brought into (accessed by) the image navigation system planning software.
  • the digital data files may be imported into the navigation system, or the software can access the digital data files from a stored location (which can be local or remote).
  • the digital datasets are then registered to one another to bring them into a common coordinate system.
  • the registration consists of spatially aligning common features of each imaging modality using a rigid-body transformation in order to minimize the spatial disparity between the common features once aligned.
  • this typically involves first extracting an isosurface or other surface estimate from the CBCT scan by analyzing high-gradient regions of the CBCT scan data, then determining an alignment between the surface estimate and the intra-oral scan data.
  • 2D or 3D photos can also be registered to the 3D dataset by determining the relationship between coordinate system of the camera that produced them and the CBCT scan, which is done by determining correspondences between feature points in both modalities and using either a perspective N-points algorithm for 2D images, or an absolute orientation algorithm for 3D images.
  • Alternative registration algorithms can be contemplated which similarly minimize the matching disparity between modalities.
  • the arch form also referred to as the panoramic curve
  • the arch form can be manually marked by the doctor by marking control points at key locations (e.g., known tooth locations) along the patient’s arch, and then connected using a spline curve.
  • key locations e.g., known tooth locations
  • Nerve canals can also be manually marked by the surgeon by defining control points in cross-sectional slices of the CBCT scan.
  • the hard tissue (bone and teeth) is automatically segmented within the CBCT scan by analyzing the HU values in the CBCT scan to determine interfaces between hard tissue and soft tissue or air.
  • Teeth and sinus can be further segmented based on anatomical atlas analysis and/or shape-prior analysis.
  • other items of the patient’s anatomy may be segmented either in a doctor-assisted manner or in a fully-automated way.
  • the doctor uses the image navigation system planning software to plan which implants to use and plan the locations for them, as well as the amount of bone reduction needed during the surgery.
  • the level of the implant platforms, where the prosthesis will ultimately engage with the implants is determined by considering the height of the desired prosthesis and the vertical engagement overlap between the prosthesis and the implants.
  • the bone reduction is then planned to allow proper spacing between the bone and the desired prosthesis.
  • the prosthesis is planned, with space for soft tissue under the prosthesis.
  • Planning consists both of determining the position and angulation of the prosthesis, as well as its shape.
  • Position and angulation can be manipulated by the doctor in the planning software by dragging the prosthesis in cross-sectional slices in the planning software.
  • Shape can be defined based upon a scan of a wax-up, by the results of a design from a 3D modeling software, or by adjusting, stretching, and merging 3D models of virtual teeth with a portion of the bone anatomy extracted from the CBCT scan or intra-oral scan.
  • the amount of vertical space for soft tissue must be noted.
  • the size of the holes in the prosthesis will be calculated based upon the accuracy of the dynamic image navigation system. The following deviations are considered: Angular deviation; Horizontal coronal deviation; Horizontal apical deviation; and Vertical deviation.
  • the hole size is determined by using the following mathematical formula (Formula 1) incorporating the accuracy of the dynamic image navigation system, the vertical position of the planned prosthesis, the entry and exit of the implant components. See. FIG. 7 .
  • each support system 10 consists of a central pin 20 and two alignment features 22 , which assist in aligning the prosthetic P in its proper orientation when placed in the patient’s mouth.
  • three or more of these support systems are used, and are spread throughout locations on the arch, for example one support system in the anterior and one support system posterior on each side of the arch. It is contemplated that the central pin(s) 20 will be located on the prosthesis P so as to contact areas on the bone B where implants 30 will not be placed.
  • the support structure 10 may also consist of other arrangements and combinations of central pins and alignment features, or may consist of only central pins or alignment features.
  • the central pin 20 is configured to project into the bone B, below the level of the planned implant platform, or the level of bone reduction, preferably by a minimum of 3 mm.
  • the central pin’s full length below the planned prosthesis is, therefore, calculated to be the length for accommodating soft tissue (if any) plus the projected length into the bone B below the level of the bone reduction or the platform height.
  • a planned hole 24 is drilled into the patient’s bone B (osteotomy) for the central pin 20 and is preferably larger than the pin, by a margin that is determined by the accuracy of the navigation system. This is calculated using the lateral and vertical margins of error of the navigation system.
  • the alignment features preferably engage the bone surface B below the level of the planned implant platforms.
  • the shape of these bone supports may vary but they preferably complement the shape of “virgin” bone to engage with it, and are sufficiently rigid to prevent distortion.
  • the alignment features 22 are depicted as curved “arms” in the figures, it should be readily apparent that the alignment features could be tapered or straight “arms”.
  • the alignment features 22 are designed to provide temporary alignment and lateral support for the prosthesis Important anatomic structures should be avoided.
  • the support system 10 for each prosthesis should be designed to accommodate these anatomic structures.
  • the planned prosthesis is manufactured with the alignment support system incorporated directly into the prosthesis, and made out of the same material as the prosthetic, with the intention that the alignment features and central pins will be cut off once the surgery is complete.
  • the implant positions are navigated using the dynamic image-guided navigation system and the surgical plan, and the osteotomies for the central pins of the alignment support system are navigated and holes drilled into the bone.
  • the implants 30 are then placed in the bone.
  • the implants and implant abutment 34 form a two-piece attachment mechanism that will provide the long-term attachment between the bone and the prosthetic once the alignment support system is removed. Implants and abutments are well known and, therefore, no detailed discussion is necessary.
  • the implants 30 will remain screwed into and engage the bone, and typically have a female internal mounting thread.
  • the abutments 34 are typically designed to be removably screwed into the implant 30 via a screw (not shown) through the abutment which engages with the internal implant threads.
  • a screw not shown
  • the attachment mechanism varies widely.
  • the prefabricated prosthesis P is placed over the abutments 32 and the central pin(s) 20 are engaged in their appropriate bone holes 24 (osteotomies).
  • FIG. 3 The buccal and lingual, palatal and labial alignment features 22 of the alignment support system are then pushed into contact with the bone B, which helps to set the final vertical position with respect to the bone.
  • the patient is placed in their final bite, occlusion, so that the patient’s opposing dentition comes in contact with and aligns with complementary occlusal surface of the prosthesis. This bite forces the prosthesis to move into a position where the occlusion happens at many points to provide the best level of comfort to the patient.
  • a dental adhesive material is injected into the holes in the prosthesis to affix the prosthesis to the abutments in order to fix the prosthesis in its final position.
  • FIG. 4 The prosthesis, and its now-fixed abutments are removed from the mouth and the alignment support systems are removed from the prosthesis by cutting using dental instruments.
  • FIG. 5 The prosthesis is then finished and put in place.
  • FIG. 6 The prosthesis is then finished and put in place.
  • the prosthesis can be manufactured prior to the surgery without the prosthetic holes.
  • the prosthetic holes can then be milled in the doctor’s office before or after placing the implants.
  • the holes can accurately be drilled by using the same tracking system as used for guidance of the osteotomy, by first attaching a tracking fiducial to the prosthesis and then registering the prosthesis to the tracking system, which can be performed e.g., by using a keyed connection to the tracking fiducial, or by touching or scanning over portions of the prosthesis with a tracked surgical instrument.
  • the prosthetic holes could be made using an in-office milling machine, which could be simplified by incorporating mechanical registration features to reproducibly place the prosthesis into a known alignment within the milling machine prior to milling. In-office drilling of the prosthesis holes has the advantage that the implant plan may be changed on the day of surgery if surgical conditions find that the initially planned implant locations are not clinically acceptable.
  • the shapes and locations of the prosthetic holes can be determined by measuring the final implant locations rather than by using the planned implant locations.
  • the surgeon would first attach an implant fiducial onto each of the placed implants, using a keyed attachment mechanism that is designed to mate with the implant’s attachment system in the same way that implant abutments attach to implants. The surgeon then positions the tracking system relative to the patient such that each tracking fiducial can be measured simultaneously with, and relative to the patient tracking fiducial. It should be noted that each implant tracking fiducial does not necessarily need to be measured simultaneously with each other, only with the patient tracking fiducial.
  • This measurement allows for determining the final location of each implant relative to the original DICOM coordinate system that formed the basis of the prosthesis design.
  • An example of such a patient tracking system and patient tracking fiducial is described in more detail in U.S. Pat. 9,943,374.
  • the implant fiducial on each implant could be a small plate with a printed pattern of corners or dots, a constellation of 3 or more reflective spheres, which would be tracked using triangulation of feature points.
  • the implant fiducial could be a unique, asymmetric shape, such as a scan body, whose shape could be reconstructed by the stereo tracking system and matched to the fiducial’s geometric model using, for example, the iterated closest points (ICP) algorithm.
  • ICP iterated closest points
  • the tracking system could track the shape of the protruding portion of the implant itself, rather than using a separate implant fiducial.
  • the computational complexity of measuring the tracking fiducial locations can be reduced by using the planned implant locations to cue the system where to look for the tracking fiducials. Once the patient tracking fiducial has been identified, the 3D locations of the planned implant locations are known and can be projected into the tracking system’s image coordinates, allowing a search to take place only in the neighborhood of those locations in the images, or if using ICP, allows the iteration to begin with the model in its planned location and to converge to its final measured location.
  • An intra-oral scanner can also be used for measuring final implant locations instead of a dynamic navigation system. The scanner will reconstruct the surface of the dental anatomy, along with the surfaces of scan bodies attached to the implants. Identifying the scan bodies in the intra-oral scan and registering these surfaces to the anatomical surfaces in the CBCT scan allows the final implant locations to be computed with respect to the DICOM coordinate system.
  • the holes would not be present in the prefabricated prosthetic, so they could instead be determined at the time of surgery. Once final implant locations are measured, the surgeon could then drill new holes using the tracking system, or have the holes milled. Similarly, the surgeon could enlarge existing prosthetic holes if the final implant positions shifted from their planned locations by more than the tolerance of the holes allows, The process of measuring final implant locations and enlarging holes could be an optional follow-up step performed if the prosthetic is found to not seat properly due to excessive implant placement error by the surgeon.
  • the central pin may be omitted.
  • implant abutment sleeves which are typically smooth-walled plastic sleeves that attach to the top of the abutment using a retention screw, can be used for lateral alignment stability when setting occlusion. These abutment sleeves would mate with complementary features machined into the prosthesis.
  • different pins may be used, e.g., removable and reuseable pins could be used and could be made of titanium or other materials.
  • the alignment features can also be made of different materials and attached into the prosthetic.
  • the mating system for these alignment features could allow for reusable alignment of varying sizes, which would allow the user to fine-tune the fit by adjusting to shorter or longer supports or supports with different curvatures if, for example, the prosthesis cannot be brought into occlusion as planned.
  • the alignment support system could be dynamic, rather than a mechanical alignment system.
  • the prosthesis can be brought into occlusion and temporarily affixed to the opposing dentition in occlusion.
  • the jaw position could then be manipulated until the prosthesis is in the desired position relative to the surgical jaw.
  • the tracking system would determine the position by measuring a tracking fiducial attached to the surgical jaw simultaneously with a tracking fiducial attached to the prosthesis, and would provide feedback to assist in properly positioning the mandible to bring the prosthesis and the surgical jaw into proper (as-planned) alignment.
  • the prosthesis Once in alignment, the prosthesis would be affixed to the abutments by injecting dental material into the holes, thereby preserving the desired alignment. This process could be assisted by using materials to shim the prosthesis so it would remain more stable while the dental material cures in the holes.
  • the prosthesis can be machined from various materials, including ceramics such as Zirconia, plastics such as PEEK, PMMA, and composite materials.
  • the prosthesis could also be grown using 3D printing method as known to those skilled in the art.
  • the prosthesis could include integrated metal support structures e.g., to support the alignment support pins or to support a keyed tracking fiducial, or could include machined fiducial touch features that would allow the surgeon to touch the fiducial features with a tracked instrument in order to assist the surgeon in registering the alignment of the prosthesis to an attached tracking fiducial.
  • Variations in the dynamic guidance system can be used.
  • Optical tracking systems based on multi-camera triangulation or monocular triangulation, time of flight, or wave-front technologies could be used, as well as electromagnetic tracking, inertial sensing, ultrasonic or field effect technologies could be used.
  • robotic navigation systems can be used to assist in drilling the actual osteotomies and the holes in the prosthetic. This would have the benefit of reducing the component of error due to the surgeon’s ability to follow the implant plan, which would result in the holes being oversized by a smaller margin.
  • the present invention has been described for placing a fitted dental prosthesis within an oral cavity, the invention can also be used to attach any implant supported maxillofacial prosthesis within or on any maxillofacial structure, for example, eye, nose, ear, maxilla, mandible, zygoma or frontal bone.
  • the system or systems described herein may be implemented on any form of computer or computers and the algorithms and programs may be implemented as dedicated applications or in client-server architectures, including a web-based architecture, and can include functional programs, codes, and code segments.
  • the computer system of the present invention may include a software program be stored on a computer and/or storage device (e.g., mediums), and/or may be executed through a network.
  • the computer steps may be implemented through program code or program modules stored on a storage medium.
  • the computer processes herein may be described in terms of various processing steps. Such processing steps may be realized by any number of hardware and/or software components that perform the specified functions.
  • the described embodiments may employ various integrated circuit components, e.g., memory elements, processing elements, logic elements, look-up tables, and the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices.
  • the elements of the described embodiments are implemented using software programming or software elements the invention may be implemented with any programming or scripting language such as C, C++, Java, assembler, or the like, with the various algorithms being implemented with any combination of data structures, objects, processes, routines or other programming elements.
  • Functional aspects may be implemented in algorithms that execute on one or more processors.
  • the embodiments of the invention could employ any number of conventional techniques for electronics configuration, signal processing and/or control, data processing and the like.
  • the words “mechanism” and “element” are used broadly and are not limited to mechanical or physical embodiments, but can include software routines in conjunction with processors, etc.

Abstract

An approach is disclosed that involves creating an implant-supported prosthesis that is dynamically guided into position using an image-guided navigation system into position in a patient’s mouth without the use of a surgical guide.

Description

    RELATED APPLICATIONS
  • This application is a divisional of and claims priority to U.S. Pat. Application 16/582,666, filed Sep. 25, 2019, which is related to and claims priority from United States Provisional Application 62/737,539, filed Sep. 27, 2018. The disclosures of both applications are incorporated herein by reference in their entireties.
  • FIELD OF THE INVENTION
  • An improved dental/maxillofacial implant method and apparatus is disclosed, and, more particularly a dental and maxillofacial prosthesis that is guided into position to fit on the patient’s jaw and maxillofacial structures without the use of a surgical guide. The method involves the use of an image-guided navigation system to determine the position of the prosthesis on the patient’s jaw and maxillofacial region and placing the prosthesis accurately without the use of a physical surgical guide.
  • BACKGROUND
  • The use of surgical navigation in the head and neck has made significant advancements in the past few years. Presently, systems are used in otolaryngology, neurosurgery and oral and maxillofacial surgery for a variety of surgical procedures. Some examples of the existing technologies are disclosed in US Pat. Nos. 9,943,374, 9,402,691, 9,844,324, the disclosures of which are each incorporated herein by reference in its entireties.
  • Recent advances allow dentists, oral and maxillofacial surgeons and maxillofacial prosthodontists to place dental implants accurately without the use of physical surgical guides using these image guided navigation systems. Once the implants are placed, relating a prefabricated dental and maxillofacial prosthesis to the implants has remained a challenge.
  • Physical guides are presently used to orient a pre-surgically fabricated prosthesis to the implants. The problem with these physical guides is that they require large incisions and complex fabrication techniques often utilizing stacked, indexed guides and frame sets. If the guides are not accurately aligned related to the bone they often do not fit the patient properly. In regions outside the oral cavity they are often impossible to place into the maxillofacial defect.
  • A need exists for an improved system for accurately and easily placing a prosthesis to an implant with minimal trauma to the patient.
  • SUMMARY OF THE INVENTION
  • A method for determining final locations of a set of implants relative to a three-dimensional dataset is disclosed in one embodiment. The method includes the steps of (i) providing a three-dimensional dataset including a planned location of the set of implants; a location of a set of implants surgically to be placed in a patient; and an actual location of a patient as provided by a patient tracker attached to the patient, wherein a transform relates the patient tracker to the three-dimensional dataset; (ii) using a tracking system to measure the location of the set of implants simultaneously with the patient tracker; and (iii) communicating a final location of the set of implants relative to the three-dimensional dataset.
  • Preferably the step of providing the three-dimensional dataset includes obtaining the three-dimensional dataset from a three-dimensional radiograph.
  • The three-dimensional radiograph may be a cone beam computed tomogram.
  • The three-dimensional radiograph may be an intra-oral scan.
  • The step of providing the three-dimensional dataset preferably includes accessing digital files representing the three-dimensional dataset by a navigation system.
  • In an embodiment the tracking system includes registering digital datasets representative of the planned location of the set of implants, the location of the set of implants, and the actual location of the patient are then registered to each other within a common coordinate system.
  • Optionally the steps of registering the planned location of the set of implants, the location of the set of implants, and the actual location of the patient includes spatially aligning common features of each imagining modality using rigid-body transformation.
  • In an embodiment, the method may include determining the planned location of the set of implants.
  • Preferably the step of determining the planned location of the set of implants includes outlining anatomical features of the patient.
  • It is contemplated that the step of determining the planned location of the set of implants may include determining a desired position and a desired angulation of the set of implants.
  • Preferably the step of determining the planned location of the set of implants includes determining a hole size of for receiving the set of implants.
  • In an embodiment that step of determining the hole size is calculated by using a formula defined as Do + 2 (Et + H x tan(Ea)).
  • In an embodiment, a method of dynamically tracking an implant procedure is discloses. The method includes the steps of (i) receiving by a tracking system a first digital data set representative of a three-dimensional radiograph obtained of a patient; (ii) determining a planned implant location for a dental implant based on the first digital dataset; (iii) attaching an implant tracking fiducial to the dental implant; (iv) attaching a patient tracking fiducial to the patient; (v) positioning the tracking system relative to the patient; (vi) using the tracking system to measure a location of the implant tracking fiducial simultaneously with a location of the patient tracking fiducial; and (vii) communicating the planned implant location relative to the location of the implant tracking fiducial.
  • In an embodiment the method may include registering the implant tracking fiducial to the tracking system.
  • It is contemplated that the implant tracking fiducial may include a plate with a printed pattern.
  • The method may include the step of forming holes in the dental implant.
  • In an embodiment the step of forming holes in the dental implant includes determining a hole size by using a formula defined as Do + 2 (Et + H x tan(Ea)).
  • The method may optionally include a further step of projecting image coordinates of the planned implant location into the tracking system.
  • Preferably the method includes the step of using the planned implant location to cue the tracking system where to look for the implant tracking fiducial.
  • The implant tracking fiducial may be in a shape of a protruding portion of the dental implant.
  • The foregoing and other features of the invention and advantages of the present invention will become more apparent in light of the following detailed description of the preferred embodiments, as illustrated in the accompanying figures. As will be realized, the invention is capable of modifications in various respects, all without departing from the invention. Accordingly, the drawings and the description are to be regarded as illustrative in nature, and not as restrictive.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • For the purpose of illustrating the invention, the drawings show a form of the invention that is presently preferred. However, it should be understood that the invention is not limited to the precise arrangement and instrumentalities show in the drawings. It should also be understood that the invention is not limited to the anatomic location illustrated but may be used in or on any maxillofacial structure suitable for the use of dental implants.
  • FIG. 1 is a cross-sectional view of a dynamically guided support structure according to the present invention shown in the stages of being mounted on a bone.
  • FIG. 2 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of an alignment support system for locating a prosthesis on multiple implants with abutments for the implants located on the implants before attachment.
  • FIG. 3 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of the alignment support system for FIG. 2 as it provides guidance on placement of the prosthesis.
  • FIG. 4 is a perspective view of a portion of a patient’s jaw illustrating the prosthesis of FIG. 3 with the abutments attached to the prosthesis.
  • FIG. 5 is a perspective view of a portion of a patient’s jaw illustrating the prosthesis of FIG. 4 with the alignment support system removed.
  • FIG. 6 is a perspective view of a portion of a patient’s jaw illustrating one embodiment of an alignment support system for locating a prosthesis in place on the jaw with the alignment support system attached.
  • FIG. 7 is a schematic illustration of the calculations used to determine the size of the prosthetic holes as they relate to the dynamically guided navigation system.
  • DETAILS DESCRIPTION OF THE INVENTION
  • The present invention is directed to a system and method to allow a dentist to plan an implant position prior to surgery using a dynamic navigation system, plan the prosthesis related to the implant plan and then accurately relate the prosthesis to the patient’s anatomy and the newly placed implants without the use of a physical surgical guide. Minimal incisions are used as no guides are necessary. In a preferred embodiment, the prosthesis includes an alignment support structure for assisting with the proper positioning of the prosthesis with respect to the patient anatomy during fitting, and one or more implant fixation systems for final fixation of the prosthesis to the anatomy, each of which consists of a fixation feature, which in the preferred embodiment is a hole in the prosthesis, an abutment that will be rigidly attached to the fixation feature, and an implant that will be drilled into the patient’s bone and that will be removably mated to the abutment.
  • The system involves first obtaining a pre-surgical data set that is acquired from the patient through an image scanning. The pre-surgical digital data set is to be used by the dynamic image navigation system for planning the implant and then the prosthesis. This digital data set may be obtained using any conventional means, and may include a three dimensional radiograph; a computed tomogram or cone beam computed tomogram; an intraoral digital scan; digital scans of models; and/or digital photographs, either 2D or 3D.
  • To obtain the digital data set, a three dimensional radiograph is taken, preferably a cone beam computed tomogram (CBCT) taken with or without radiographic markers or fiducials attached rigidly to the patient’s skeleton/bone structure in the area of the scan, either with screws or a removable device. If desired, a scanning appliance with markers/fiducials may be attached to the patient’s mouth at the time of the radiograph to assist with the surgical planning. One type of appliance is disclosed in U.S. Pat. 9,402,691 the disclosure of which is incorporated herein by reference in its entirety. This appliance may be custom-made with fiducials or, alternatively, could be the patient’s denture or a dental appliance that has fiducials attached. The CBCT may be taken with the patient’s teeth touching, in occlusion, or with the teeth separated. If the patient has no teeth, the dentures or scanning appliance may or may not be touching or in occlusion. The radiograph is preferably stored in a digital imaging and communication (DICOM) format.
  • It is also contemplated that intra-oral optical scans may, optionally, be used in the surgical planning. Intra-oral scans are typically stored in a surface format consisting of a triangulated irregular network (TIN) of 3D points representing one or more surfaces of a patients anatomy. Intra-oral scans are typically registered via matching surface contour information with a surface extracted from the 3D radiograph. Intra-oral optical scans provide additional information about soft-tissue boundaries and are less susceptible to image artifacts that can lead to ambiguity in determining hard-tissue structure, so can assist in planning around the anatomical features. In addition, the invention contemplates the use of laser scans of physical models, which may or may not be used. These models may, for example be wax-ups of the desired restorative result, the patient’s existing denture, or a provisional prosthesis.
  • Three- or two- dimensional photographs in digital format may also be used.
  • The digital files are brought into (accessed by) the image navigation system planning software. For example, the digital data files may be imported into the navigation system, or the software can access the digital data files from a stored location (which can be local or remote). The digital datasets are then registered to one another to bring them into a common coordinate system. The registration consists of spatially aligning common features of each imaging modality using a rigid-body transformation in order to minimize the spatial disparity between the common features once aligned. In the case of registering intra-oral scans to CBCT scans, this typically involves first extracting an isosurface or other surface estimate from the CBCT scan by analyzing high-gradient regions of the CBCT scan data, then determining an alignment between the surface estimate and the intra-oral scan data. 2D or 3D photos can also be registered to the 3D dataset by determining the relationship between coordinate system of the camera that produced them and the CBCT scan, which is done by determining correspondences between feature points in both modalities and using either a perspective N-points algorithm for 2D images, or an absolute orientation algorithm for 3D images. Alternative registration algorithms can be contemplated which similarly minimize the matching disparity between modalities.
  • Using the image navigation system planning software, the relevant anatomy is outlined and mapped to determine location of pertinent anatomy. The arch form, also referred to as the panoramic curve, can be manually marked by the doctor by marking control points at key locations (e.g., known tooth locations) along the patient’s arch, and then connected using a spline curve. These splines can also be automatically detected based upon an algorithmic analysis of the CBCT data. Nerve canals can also be manually marked by the surgeon by defining control points in cross-sectional slices of the CBCT scan. The hard tissue (bone and teeth) is automatically segmented within the CBCT scan by analyzing the HU values in the CBCT scan to determine interfaces between hard tissue and soft tissue or air. This can also be performed with doctor in the loop, where the segmentation can be seeded or further refined by human interaction. Teeth and sinus can be further segmented based on anatomical atlas analysis and/or shape-prior analysis. Depending on the surgical location and procedure, other items of the patient’s anatomy may be segmented either in a doctor-assisted manner or in a fully-automated way.
  • The doctor uses the image navigation system planning software to plan which implants to use and plan the locations for them, as well as the amount of bone reduction needed during the surgery. The level of the implant platforms, where the prosthesis will ultimately engage with the implants, is determined by considering the height of the desired prosthesis and the vertical engagement overlap between the prosthesis and the implants. The bone reduction is then planned to allow proper spacing between the bone and the desired prosthesis.
  • Next, the prosthesis is planned, with space for soft tissue under the prosthesis. Planning consists both of determining the position and angulation of the prosthesis, as well as its shape. Position and angulation can be manipulated by the doctor in the planning software by dragging the prosthesis in cross-sectional slices in the planning software. Shape can be defined based upon a scan of a wax-up, by the results of a design from a 3D modeling software, or by adjusting, stretching, and merging 3D models of virtual teeth with a portion of the bone anatomy extracted from the CBCT scan or intra-oral scan. The amount of vertical space for soft tissue must be noted. The size of the holes in the prosthesis will be calculated based upon the accuracy of the dynamic image navigation system. The following deviations are considered: Angular deviation; Horizontal coronal deviation; Horizontal apical deviation; and Vertical deviation.
  • The hole size is determined by using the following mathematical formula (Formula 1) incorporating the accuracy of the dynamic image navigation system, the vertical position of the planned prosthesis, the entry and exit of the implant components. See. FIG. 7 .
  • D n = D o + 2 E t + H x tan E a ­­­Formula 1
    • Where Dn = New over-drilled diameter
    • Do = Original diameter
    • Et = Translational component of error
    • H = Distance from implant platform to prosthesis
    • Ea =Angular component of error
  • The system then calculates the attributes of the dynamically guided prosthesis to aid in manufacturing. Digital dynamically-guided prosthetic alignment support structure is planned. In a preferred embodiment, the alignment support structure is comprised of multiple alignment support systems. Referring to FIGS. 1 - 6 , each support system 10 consists of a central pin 20 and two alignment features 22, which assist in aligning the prosthetic P in its proper orientation when placed in the patient’s mouth. In a preferred embodiment, three or more of these support systems are used, and are spread throughout locations on the arch, for example one support system in the anterior and one support system posterior on each side of the arch. It is contemplated that the central pin(s) 20 will be located on the prosthesis P so as to contact areas on the bone B where implants 30 will not be placed. They may be placed mesial or distal to any planned implant below the planned prosthesis. Fewer support systems can be used if sufficient stability can be achieved. The support structure 10 may also consist of other arrangements and combinations of central pins and alignment features, or may consist of only central pins or alignment features. The central pin 20 is configured to project into the bone B, below the level of the planned implant platform, or the level of bone reduction, preferably by a minimum of 3 mm. The central pin’s full length below the planned prosthesis is, therefore, calculated to be the length for accommodating soft tissue (if any) plus the projected length into the bone B below the level of the bone reduction or the platform height. A planned hole 24 is drilled into the patient’s bone B (osteotomy) for the central pin 20 and is preferably larger than the pin, by a margin that is determined by the accuracy of the navigation system. This is calculated using the lateral and vertical margins of error of the navigation system.
  • On the buccal and lingual, or palatal and labial sides of the central pin 20, two alignment features 22 are provided. The alignment features preferably engage the bone surface B below the level of the planned implant platforms. The shape of these bone supports may vary but they preferably complement the shape of “virgin” bone to engage with it, and are sufficiently rigid to prevent distortion. Although the alignment features 22 are depicted as curved “arms” in the figures, it should be readily apparent that the alignment features could be tapered or straight “arms”. The alignment features 22 are designed to provide temporary alignment and lateral support for the prosthesis Important anatomic structures should be avoided. Thus, the support system 10 for each prosthesis should be designed to accommodate these anatomic structures. In the preferred embodiment, the planned prosthesis is manufactured with the alignment support system incorporated directly into the prosthesis, and made out of the same material as the prosthetic, with the intention that the alignment features and central pins will be cut off once the surgery is complete.
  • At the time of surgery, small incisions are made to expose the sites of the implants and reduce the bone. The implant positions are navigated using the dynamic image-guided navigation system and the surgical plan, and the osteotomies for the central pins of the alignment support system are navigated and holes drilled into the bone. The implants 30 are then placed in the bone. The implants and implant abutment 34 form a two-piece attachment mechanism that will provide the long-term attachment between the bone and the prosthetic once the alignment support system is removed. Implants and abutments are well known and, therefore, no detailed discussion is necessary. The implants 30 will remain screwed into and engage the bone, and typically have a female internal mounting thread. The abutments 34 are typically designed to be removably screwed into the implant 30 via a screw (not shown) through the abutment which engages with the internal implant threads. There are many other implant/abutment systems and the attachment mechanism varies widely. Once the implant 30 has been placed, the prefabricated implant abutments 32 are then temporarily attached to the implants 30. FIG. 2 . The abutments 32 will ultimately be glued into holes in the prosthetic, and will be the mechanism by which the prosthetic is attached to the implants 30, but attaching the abutment 32 to the implant 30 at this point ensures that the abutments 32 will be properly aligned to their respective implants 30 once the abutments 32 have been glued in place in the prosthetic P. The prefabricated prosthesis P is placed over the abutments 32 and the central pin(s) 20 are engaged in their appropriate bone holes 24 (osteotomies). FIG. 3 . The buccal and lingual, palatal and labial alignment features 22 of the alignment support system are then pushed into contact with the bone B, which helps to set the final vertical position with respect to the bone. The patient is placed in their final bite, occlusion, so that the patient’s opposing dentition comes in contact with and aligns with complementary occlusal surface of the prosthesis. This bite forces the prosthesis to move into a position where the occlusion happens at many points to provide the best level of comfort to the patient. Once in occlusion, a dental adhesive material is injected into the holes in the prosthesis to affix the prosthesis to the abutments in order to fix the prosthesis in its final position.
  • Once the adhesive material has set, the abutments are detached from the implants. FIG. 4 . The prosthesis, and its now-fixed abutments are removed from the mouth and the alignment support systems are removed from the prosthesis by cutting using dental instruments. FIG. 5 . The prosthesis is then finished and put in place. FIG. 6 .
  • Numerous alternate embodiments exist.
  • In one such embodiment, the prosthesis can be manufactured prior to the surgery without the prosthetic holes. The prosthetic holes can then be milled in the doctor’s office before or after placing the implants. The holes can accurately be drilled by using the same tracking system as used for guidance of the osteotomy, by first attaching a tracking fiducial to the prosthesis and then registering the prosthesis to the tracking system, which can be performed e.g., by using a keyed connection to the tracking fiducial, or by touching or scanning over portions of the prosthesis with a tracked surgical instrument. Alternately, the prosthetic holes could be made using an in-office milling machine, which could be simplified by incorporating mechanical registration features to reproducibly place the prosthesis into a known alignment within the milling machine prior to milling. In-office drilling of the prosthesis holes has the advantage that the implant plan may be changed on the day of surgery if surgical conditions find that the initially planned implant locations are not clinically acceptable.
  • In a further embodiment, the shapes and locations of the prosthetic holes can be determined by measuring the final implant locations rather than by using the planned implant locations. In the measurement process, the surgeon would first attach an implant fiducial onto each of the placed implants, using a keyed attachment mechanism that is designed to mate with the implant’s attachment system in the same way that implant abutments attach to implants. The surgeon then positions the tracking system relative to the patient such that each tracking fiducial can be measured simultaneously with, and relative to the patient tracking fiducial. It should be noted that each implant tracking fiducial does not necessarily need to be measured simultaneously with each other, only with the patient tracking fiducial. This measurement, in combination with the patient tracker registration, allows for determining the final location of each implant relative to the original DICOM coordinate system that formed the basis of the prosthesis design. An example of such a patient tracking system and patient tracking fiducial is described in more detail in U.S. Pat. 9,943,374. The implant fiducial on each implant could be a small plate with a printed pattern of corners or dots, a constellation of 3 or more reflective spheres, which would be tracked using triangulation of feature points. Alternately, the implant fiducial could be a unique, asymmetric shape, such as a scan body, whose shape could be reconstructed by the stereo tracking system and matched to the fiducial’s geometric model using, for example, the iterated closest points (ICP) algorithm. In a further embodiment, the tracking system could track the shape of the protruding portion of the implant itself, rather than using a separate implant fiducial. The computational complexity of measuring the tracking fiducial locations can be reduced by using the planned implant locations to cue the system where to look for the tracking fiducials. Once the patient tracking fiducial has been identified, the 3D locations of the planned implant locations are known and can be projected into the tracking system’s image coordinates, allowing a search to take place only in the neighborhood of those locations in the images, or if using ICP, allows the iteration to begin with the model in its planned location and to converge to its final measured location. One advantage of measuring the final implant location is that this removes the component of error associated with the surgeon’s skill at following their plan, which leaves only the tracking system’s intrinsic error, which is generally smaller and, therefore, allows the prosthetic holes to be oversized by a smaller margin. An intra-oral scanner can also be used for measuring final implant locations instead of a dynamic navigation system. The scanner will reconstruct the surface of the dental anatomy, along with the surfaces of scan bodies attached to the implants. Identifying the scan bodies in the intra-oral scan and registering these surfaces to the anatomical surfaces in the CBCT scan allows the final implant locations to be computed with respect to the DICOM coordinate system.
  • In a further embodiment, the holes would not be present in the prefabricated prosthetic, so they could instead be determined at the time of surgery. Once final implant locations are measured, the surgeon could then drill new holes using the tracking system, or have the holes milled. Similarly, the surgeon could enlarge existing prosthetic holes if the final implant positions shifted from their planned locations by more than the tolerance of the holes allows, The process of measuring final implant locations and enlarging holes could be an optional follow-up step performed if the prosthetic is found to not seat properly due to excessive implant placement error by the surgeon.
  • Variations of the alignment support system can be used. The central pin may be omitted. Instead, implant abutment sleeves, which are typically smooth-walled plastic sleeves that attach to the top of the abutment using a retention screw, can be used for lateral alignment stability when setting occlusion. These abutment sleeves would mate with complementary features machined into the prosthesis. Alternately, different pins may be used, e.g., removable and reuseable pins could be used and could be made of titanium or other materials. The alignment features can also be made of different materials and attached into the prosthetic. The mating system for these alignment features could allow for reusable alignment of varying sizes, which would allow the user to fine-tune the fit by adjusting to shorter or longer supports or supports with different curvatures if, for example, the prosthesis cannot be brought into occlusion as planned.
  • In a further embodiment, the alignment support system could be dynamic, rather than a mechanical alignment system. In this approach, the prosthesis can be brought into occlusion and temporarily affixed to the opposing dentition in occlusion. The jaw position could then be manipulated until the prosthesis is in the desired position relative to the surgical jaw. The tracking system would determine the position by measuring a tracking fiducial attached to the surgical jaw simultaneously with a tracking fiducial attached to the prosthesis, and would provide feedback to assist in properly positioning the mandible to bring the prosthesis and the surgical jaw into proper (as-planned) alignment. Once in alignment, the prosthesis would be affixed to the abutments by injecting dental material into the holes, thereby preserving the desired alignment. This process could be assisted by using materials to shim the prosthesis so it would remain more stable while the dental material cures in the holes.
  • Variations in the prosthesis can be foreseen. The prosthesis can be machined from various materials, including ceramics such as Zirconia, plastics such as PEEK, PMMA, and composite materials. The prosthesis could also be grown using 3D printing method as known to those skilled in the art. The prosthesis could include integrated metal support structures e.g., to support the alignment support pins or to support a keyed tracking fiducial, or could include machined fiducial touch features that would allow the surgeon to touch the fiducial features with a tracked instrument in order to assist the surgeon in registering the alignment of the prosthesis to an attached tracking fiducial.
  • Variations in the dynamic guidance system can be used. Optical tracking systems, based on multi-camera triangulation or monocular triangulation, time of flight, or wave-front technologies could be used, as well as electromagnetic tracking, inertial sensing, ultrasonic or field effect technologies could be used. Likewise, robotic navigation systems can be used to assist in drilling the actual osteotomies and the holes in the prosthetic. This would have the benefit of reducing the component of error due to the surgeon’s ability to follow the implant plan, which would result in the holes being oversized by a smaller margin.
  • While the present invention has been described for placing a fitted dental prosthesis within an oral cavity, the invention can also be used to attach any implant supported maxillofacial prosthesis within or on any maxillofacial structure, for example, eye, nose, ear, maxilla, mandible, zygoma or frontal bone.
  • The system or systems described herein may be implemented on any form of computer or computers and the algorithms and programs may be implemented as dedicated applications or in client-server architectures, including a web-based architecture, and can include functional programs, codes, and code segments. The computer system of the present invention may include a software program be stored on a computer and/or storage device (e.g., mediums), and/or may be executed through a network. The computer steps may be implemented through program code or program modules stored on a storage medium.
  • For the purposes of promoting an understanding of the principles of the invention, reference has been made to the preferred embodiments illustrated in the drawings, and specific language has been used to describe these embodiments. However, no limitation of the scope of the invention is intended by this specific language, and the invention should be construed to encompass all embodiments that would normally occur to one of ordinary skill in the art.
  • The computer processes herein may be described in terms of various processing steps. Such processing steps may be realized by any number of hardware and/or software components that perform the specified functions. For example, the described embodiments may employ various integrated circuit components, e.g., memory elements, processing elements, logic elements, look-up tables, and the like, which may carry out a variety of functions under the control of one or more microprocessors or other control devices. Similarly, where the elements of the described embodiments are implemented using software programming or software elements the invention may be implemented with any programming or scripting language such as C, C++, Java, assembler, or the like, with the various algorithms being implemented with any combination of data structures, objects, processes, routines or other programming elements. Functional aspects may be implemented in algorithms that execute on one or more processors. Furthermore, the embodiments of the invention could employ any number of conventional techniques for electronics configuration, signal processing and/or control, data processing and the like. The words “mechanism” and “element” are used broadly and are not limited to mechanical or physical embodiments, but can include software routines in conjunction with processors, etc.
  • The particular implementations shown and described herein are illustrative examples of the invention and are not intended to otherwise limit the scope of the invention in any way. For the sake of brevity, conventional electronics, control systems, software development and other functional aspects of the systems (and components of the individual operating components of the systems) may not be described in detail.
  • Finally, the steps of all methods described herein are performable in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. Numerous modifications and adaptations will be readily apparent to those skilled in this art without departing from the spirit and scope of the invention.

Claims (20)

1. A method for determining final locations of a set of implants relative to a three-dimensional dataset, the method comprising the steps of:
a. providing a three-dimensional dataset including a planned location of the set of implants; a location of a set of implants surgically to be placed in a patient; and an actual location of a patient as provided by a patient tracker attached to the patient, wherein a transform relates the patient tracker to the three-dimensional dataset;
b. using a tracking system to measure the location of the set of implants simultaneously with the patient tracker; and
c. communicating a final location of the set of implants relative to the three-dimensional dataset.
2. The method of claim 1, wherein providing the three-dimensional dataset includes obtaining the three-dimensional dataset from a three-dimensional radiograph.
3. The method of claim 2, wherein the three-dimensional radiograph is a cone beam computed tomogram.
4. The method of claim 2, wherein the three-dimensional radiograph is an intraoral scan.
5. The method of claim 1, wherein providing the three-dimensional dataset includes accessing digital files representing the three-dimensional dataset by a navigation system.
6. The method of claim 5, wherein using the tracking system includes registering digital datasets representative of the planned location of the set of implants, the location of the set of implants, and the actual location of the patient are then registered to each other within a common coordinate system.
7. The method of claim 6, wherein registering the planned location of the set of implants, the location of the set of implants, and the actual location of the patient includes spatially aligning common features of each imagining modality using rigid-body transformation.
8. The method of claim 1, further comprising determining the planned location of the set of implants.
9. The method of claim 8, wherein determining the planned location of the set of implants includes outlining anatomical features of the patient.
10. The method of claim 9, wherein determining the planned location of the set of implants includes determining a desired position and a desired angulation of the set of implants.
11. The method of claim 10, wherein determining the planned location of the set of implants includes determining a hole size of for receiving the set of implants.
12. The method of claim 11, wherein determining the hole size is calculated by using a formula defined as Do + 2 (Et + H x tan(Ea)).
13. A method of dynamically tracking an implant procedure comprising:
receiving by a tracking system a first digital data set representative of a three-dimensional radiograph obtained of a patient;
determining a planned implant location for a dental implant based on the first digital dataset;
attaching an implant tracking fiducial to the dental implant;
attaching a patient tracking fiducial to the patient;
positioning the tracking system relative to the patient; and
using the tracking system to measure a location of the implant tracking fiducial simultaneously with a location of the patient tracking fiducial; and
communicating the planned implant location relative to the location of the implant tracking fiducial.
14. The method of claim 13, further comprising registering the implant tracking fiducial to the tracking system.
15. The method of claim 13, wherein the implant tracking fiducial includes a plate with a printed pattern.
16. The method of claim 13, further comprising forming holes in the dental implant.
17. The method of claim 16, wherein forming holes in the dental implant includes determining a hole size by using a formula defined as Do + 2 (Et + H x tan(Ea)).
18. The method of claim 13, further comprising projecting image coordinates of the planned implant location into the tracking system.
19. The method of claim 13, further comprising using the planned implant location to cue the tracking system where to look for the implant tracking fiducial.
20. The method of claim 13, wherein the implant tracking fiducial is a shape of a protruding portion of the dental implant.
US18/224,617 2018-09-27 2023-07-21 Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset Pending US20230355367A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US18/224,617 US20230355367A1 (en) 2018-09-27 2023-07-21 Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862737539P 2018-09-27 2018-09-27
US16/582,666 US11771537B2 (en) 2018-09-27 2019-09-25 MElHOD for dynamically guiding a dental oral and maxillofacial prosthesis
US18/224,617 US20230355367A1 (en) 2018-09-27 2023-07-21 Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US16/582,666 Division US11771537B2 (en) 2018-09-27 2019-09-25 MElHOD for dynamically guiding a dental oral and maxillofacial prosthesis

Publications (1)

Publication Number Publication Date
US20230355367A1 true US20230355367A1 (en) 2023-11-09

Family

ID=69945580

Family Applications (2)

Application Number Title Priority Date Filing Date
US16/582,666 Active 2042-06-18 US11771537B2 (en) 2018-09-27 2019-09-25 MElHOD for dynamically guiding a dental oral and maxillofacial prosthesis
US18/224,617 Pending US20230355367A1 (en) 2018-09-27 2023-07-21 Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US16/582,666 Active 2042-06-18 US11771537B2 (en) 2018-09-27 2019-09-25 MElHOD for dynamically guiding a dental oral and maxillofacial prosthesis

Country Status (1)

Country Link
US (2) US11771537B2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210153959A1 (en) * 2019-11-26 2021-05-27 Intuitive Surgical Operations, Inc. Physical medical element affixation systems, methods, and materials
US20210343017A1 (en) * 2020-04-30 2021-11-04 Medtronic, Inc. Post operative implantation site monitoring and medical device performance

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1893121B1 (en) * 2005-05-27 2018-07-11 Bernard Weissman Improvements in components for permanent removable and adjustable dentures and bridges
US8231388B2 (en) * 2008-03-04 2012-07-31 Grant Dental Technology Corporation Dental implant
WO2013164411A1 (en) * 2012-05-03 2013-11-07 3Shape A/S Automated production of dental restoration
US9844324B2 (en) * 2013-03-14 2017-12-19 X-Nav Technologies, LLC Image guided navigation system
JP5849278B2 (en) * 2013-08-20 2016-01-27 株式会社ナントー Prosthesis manufacturing method
US9168114B2 (en) * 2013-10-17 2015-10-27 B & D Dental Corp. Method of making a dental prosthesis
US10507090B2 (en) * 2014-08-12 2019-12-17 Hangzhou Erran Technology Co., Ltd. Dental all-ceramic restoration and manufacturing method thereof
US10639132B2 (en) * 2014-09-12 2020-05-05 Italo Lozada Dental prosthesis
US9402691B2 (en) * 2014-09-16 2016-08-02 X-Nav Technologies, LLC System for determining and tracking movement during a medical procedure
US9943374B2 (en) * 2014-09-16 2018-04-17 X-Nav Technologies, LLC Image guidance system for detecting and tracking an image pose
KR101630669B1 (en) * 2015-05-19 2016-06-15 김용협 Bond structure in the abutment and implant crown
US20180280121A1 (en) * 2017-03-30 2018-10-04 Ico Dental, Inc. Dental implant systems and methods of implantation
US20190029778A1 (en) * 2017-07-25 2019-01-31 Implant Solutions, Inc. Method for correcting a dental prosthetic mounted upon an angularly-offset installed one-piece miniature dental implant

Also Published As

Publication number Publication date
US20200100881A1 (en) 2020-04-02
US11771537B2 (en) 2023-10-03

Similar Documents

Publication Publication Date Title
US10179034B2 (en) Bracket system and method for planning and producing a bracket system for the correction of tooth malpositions
Vercruyssen et al. Computer‐supported implant planning and guided surgery: a narrative review
Somogyi‐Ganss et al. Accuracy of a novel prototype dynamic computer‐assisted surgery system
US8348669B1 (en) Surgical template and method for positioning dental casts and dental implants
US10321959B2 (en) Method of surgical planning
KR102114015B1 (en) Virtually designing a customized healing abutment
US7905726B2 (en) Surgical guide for dental implant and methods therefor
US20230355367A1 (en) Method for dynamically guiding a dental oral and maxillofacial prosthesis using a 3d dataset
US20180014911A1 (en) Paired templates for placing dental implants and enhancing registration for denture prosthetics attached to the implants
EP1486900A1 (en) Method and system for manufacturing a surgical guide
Chang et al. Intraoperative navigation for single-splint two-jaw orthognathic surgery: From model to actual surgery
US20140244016A1 (en) Surgical guide and method
Landaeta-Quinones et al. Computer-assisted surgery: Applications in dentistry and oral and maxillofacial surgery
US20170143445A1 (en) Method and apparatus for operating a dental diagnostic image generation system
Yeshwante et al. Mastering dental implant placement: A review
Deeb et al. Computer-aided planning and placement in implant surgery
KR102215068B1 (en) Apparatus and Method for Registrating Implant Diagnosis Image
CN109700531B (en) Individual mandible navigation registration guide plate and registration method thereof
CN109700532B (en) Individualized craniomaxillary face navigation registration guide plate and registration method thereof
Henriques Dynamic navigation by innovative registration
Champleboux et al. A fast, accurate and easy method to position oral implant using computed tomography: Clinical validations
Xiaojun et al. A computer-aided oral implantology system
US20220104885A1 (en) Patient specific dynamic navigation tracker arm mount apparatus and method
Stephen et al. Computer guided implant surgery
US20210137656A1 (en) Systems and methods for locating and verifying the anatomic position of a full-arch dental prosthetics

Legal Events

Date Code Title Description
STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

AS Assignment

Owner name: X-NAV TECHNOLOGIES, LLC, PENNSYLVANIA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EMERY, ROBERT W., III;MERRITT, SCOTT A.;HANSSON, LARS;SIGNING DATES FROM 20190721 TO 20220829;REEL/FRAME:064523/0310