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This invention concerns the surgical guide design and accompanying surgical kits for image-guided dental implant treatment. A surgical guide is usually designed according to the specification of a selected surgical kit and implant platform. In this invention the surgical guides are designed independent of implant brands and their surgical kits, used with a universal surgical kit, and can be adapted even if treatment plans have to be modified after the guides are made. This gives the doctors the flexibility to choose implants, and to adjust treatment plans.
An image-guided implant planning solution designs and makes surgical guides, which have drill guiding holes and will fit onto patients' anatomy so that the doctors can drill implant holes with the guidance of those holes, and the implants can be placed at the planned locations and orientations. The surgical guides are used together with surgical kits in actual treatment. A surgical kit in this disclosure means the drills and any other hand pieces to guide the drilling operations together with surgical guides. It should not be considered as a package of models and tools customized for individual patient and deliver to doctors, as in US-2010/0105011 by Karkar, et al.
The existing patent disclosures and publications are mainly concerned of the geometric shape of the surgical guides, how they are created from CT scan or other data source, and how hole locations and orientations on the surgical guides can be derived from the treatment plans, but not how the parameters are chosen. Poirier (U.S. Pat. No. 6,814,575) discussed the basic idea of inferring surgical guide model from jaw bone and tissue images, and a device to drill holes. Surgical kit and guide parameters are not discussed. Trevor (U.S. Pat. No. 8,105,018B2) introduced rotational position indicators on a surgical guide. Swaelens, et al. (U.S. Pat. No. 5,768,134) investigated the approach to make surgical guides with focus on how the base model is derived from imaging data so that the model can sit on the patient's anatomy. Llop (U.S. Ser. No. 12/683,319) designed surgical guides with open-sized slots instead of drilling holes. Harbor (U.S. Ser. No. 12/818,522) suggested a surgical guide design that uses two holes on two thin layers to guide the drills. In published software systems, the surgical guide design is, typically not a part of the treatment planning software. Manufacturers design and make surgical guides in house for various surgical kits, such as those from Nobel Biocare, Biomet 3i, etc. Gao (U.S. Ser. No. 12/795,045) introduced an integrated system for treatment planning and surgical guide design according to surgical kits. All of the publications imply that the drill-guide holes have the same diameter as the implants, or, have the sizes that surgical kits required.
In order for a surgical guide to be used in a treatment, it has to be designed for a specific surgical kit.
An image guided surgical kit includes a lot of components as indicated in “NobelGuide: Concept manual for guided surgery”. As far as the drill guidance is concerned, the interested parts include drills as item 11, 12 and 13, and drilling keys as item 5, 6 and 7 in the figure. A drill corresponds to a drilling step in a surgery. An implant drilling typically can include two or three steps, so two or three drills will be used. Since a surgical guide is normally designed for the last drilling step, drilling keys are inserted into surgical guides to provide guidance to the pilot and intermediate drills accordingly. In the remainder of this disclosure, a surgical kit refers to a set of drills and their corresponding drilling keys.
There are flexibility issues with such an approach where a surgical guide is designed for the surgical kit corresponding to implant brands. First, when a surgical guide is designed, a surgical kit has to be specified, and later on the surgeon has to use this surgical kit. A surgeon typically uses only implants from one or two manufacturers. If he/she wants to mix implant platforms, he/she has to get all kinds of surgical kits, which is however not practical because there are so many implant manufacturers, each of them has various implant sizes, and there is no standard size series in the industry, nor universal surgical kits. Moreover, for the surgical guide manufacturing, the metal drilling sleeves have to be made for various implant sizes and their corresponding surgical kits. In most situations, the batch volume of specific drilling sleeves is extremely low, which practically prevents small manufacturers or dental labs from offering surgical guide manufacturing services at reasonable price. No publication has been found that tries to address this issue.
The design of a surgical guide has essentially two components, as indicated in
When a doctor drills an implant hole, he/she will drill a couple of times, from small diameter to the final size. The series of drilling is called drilling sequences. The drills are called pilot drill, intermediate drill or final drill. The final drill has the size of the implant. The drilling operations between pilot drill and final drill are referred as intermediate drills.
The diameter of the cylindrical hole 2 is determined by the implant size and surgical kit. For example in
This invention first addresses the choice of diameters of the drill guiding holes in
Secondly this invention addresses the prolongation issue. Shown in
As a result, a surgical guide designed with the said method will include a base model, prolongation indexing features and drill-guiding holes, the diameters of which are not implant diameters but the preferred diameters. Treatment plan accompanying such a surgical guide will include drilling instructions accordingly.
A universal surgical kit accompanying such a surgical guide is then introduced. The kit includes drills and drilling keys that are designed based on the preferred diameters other than the actual implant brand.
A computer system to design surgical guides with this approach includes a base model creator, a preferred diameter selector, a feature modeler to add holes, drilling sleeves and prolongation indexing features, as well as a treatment plan generator that creates drilling instructions according to the guide design and the universal surgical kit.
In surgical guide design, a base model will be first created to fit onto the patient anatomy before geometric features are added. There have been various approaches to generate a base model, and to add additional form features. This is not the topic of this invention, so it is assumed that a base model has been created. Usually drilling sleeves will be inserted into a surgical guide model. They can prevent the guide from being cut. There could be various designs of the sleeves. This invention does not limit the actual geometric design of the drilling sleeves. Only the three key parameters of a guide-drilling hole or sleeve are concerned: inner diameter, thickness, and height.
Implant diameters vary from one manufacturer to another. There is no standard dimension series. Surgical guides and their targeted surgical kits from manufacturers are designed to drill implant holes to those diameters.
A series of diameters are defined as an arithmetic progression in an embodiment. The diameters start from 1.5 mm, and increase by 0.5 mm each step, up to 7 mm. There's barely any implant bigger than that, but new sizes can be added if needed. These diameter values are called preferred diameters. For any given implant, its preferred diameter is the closest and smaller one in the series. For example, a 3.4 mm implant has a preferred diameter of 3.0 mm.
An embodiment is shown in
For an implant without tapering, its diameter at the top and the bottom are essentially the same. Its preferred diameter can be located by looking up the preferred series such as the table in
The reason to introduce preferred diameter is that an implant hole can be drilled up to its preferred diameter using a surgical guide, and then drilled to the final size without a surgical guide. In this invention, drill-guiding holes, or the drilling sleeves, are designed for the preferred diameters other than the actual implant sizes. This way the guide design is limited to the preferred diameters instead of all the possible implant sizes.
Reducing the variations of drilling sleeves is also an objective. One approach is to have a uniform thickness for all the sleeves. The goal of doing so is to reduce the number of possible sizes of the sleeves and thus to reduce the manufacturing cost. In prior art where surgical guides are designed according to surgical kits, the drilling sleeves have to match implant diameters (NobelGuide, Concept manual for guided surgery, 2011).
Next, the top planar faces of drill guiding holes, or essentially the top faces of drilling sleeves need to be determined. As in
The solution is to customize the prolongation value. Increasing the prolongation will lift the location of the drilling sleeves so as to maintain the height of the sleeve, and avoid trimming the sleeve.
When a drilling sleeve is not used, the surgical guide in this invention includes the following features: a base model derived from either bone/tooth model for a bone/tooth borne surgical guide, or derived from tissue model for a soft-tissue borne surgical guide; drill guiding holes, whose parameters are chosen from the preferred diameter list as described above; form features to indicate drilling prolongations.
If the prolongation for an implant is customized, the doctor who will perform the treatment needs to be reminded. Indexing feature is introduced to indicate the value of a prolongation so that the doctor can control the drilling depth accordingly without referring to a printed plan or computer program. This is shown in
Another category of surgical guide design in this invention uses drilling sleeves. A guide includes the following features: a base model derived from either bone/tooth model for a bone/tooth borne surgical guide, or derived from tissue model for a soft-tissue borne surgical guide; drilling sleeves, whose inner diameters are chosen from the preferred diameter list as described above; form features to indicate drilling prolongations.
Drilling sleeves typically are tubes, with or without flange 15 as shown in
Accompanying the surgical guide as above is a surgical kit, which can be adopted in any guided surgery with any implant brand. The surgical kit is designed for the drills of preferred diameters and is referred as universal surgical kit. As mentioned earlier, only the drills and drilling keys of a surgical kit are interested in this invention. For each diameter in the preferred list, there is a set of drills with different length, and drilling keys of the same size. A surgical kit includes such sets of drills and keys for all the preferred diameters.
Since surgical guides are designed for the final preferred drills, pilot and intermediate drills need drilling keys. For any “P” or “I” in the figure, a drill key is required. For example, the drill key for the above intermediate drill is illustrated in the figure. It has an outer diameter of 4.00 mm, and an inner diameter of 3.0 mm. The left side of the key is a handle. Its actual shape does not matter.
In the actual embodiments, the shape of the drilling keys may have different designs, but their inner and outer diameters all belong to the preferred diameter list. The actual number of keys and their specifications are derived from the table in
Drilling sequence is also considered part of a surgical guide design, because a surgical guide itself does not contain adequate information for executing a treatment plan. Conventionally if a surgical guide is designed for specific surgical kit, the drilling instructions can be derived from the specification of the surgical kit. For the guide design in this invention, the drilling sequence is derived from the universal surgical kit.
Consequently, a treatment plan report accompanying a surgical guide of this invention will have the information about this flexible drilling sequence and the guidelines to adjust treatment plan, which are the differentiators of such a report. The drilling instruction for each implant includes the usage of the universal surgical kit, the preferred drill diameter of the implant, the suggested drilling sequences from pilot drill to the preferred drill, as well as the instructions to the final drills. For example, for a 4.3 mm implant, the preferred drill will be 4.0 mm, pilot drill is 2.0 mm, and intermediate drills can be chosen from the preferred diameter series, which can be for this case 3.0 mm. Those three drills will be using the surgical guide. The final 4.3 mm drill will be performed without the guide. The actual drill size is 4.3 mm, unless otherwise specified in the implant manufacturer's instruction.
The guideline to adjust treatment plan will essentially specify the adjustable range for each implant. In the above example, the 4.3 mm implant can be adjusted to any size D: 4.0 mm≦D<4.5 mm. In
The computer system to design surgical guides with the said method is shown in
The surgical guide design component 100 can be a standalone application that runs on any operation system, or, an integrated module of an application.
The data input module 150 receives treatment plan 145 from any possible source, either running software session or hard drive. A treatment plan here includes a geometric model 152 as a base for surgical guide design and/or patient scan image 154 where the surgical guide will be placed onto, as well as a list of implant entries 156 and their positioning parameters 158 in the coordinate system of the said geometric model. An implant entry includes its tooth number, diameter and length, manufacturer and its identification in the manufacturer's product catalog. Positioning parameters are the location and orientation data that can uniquely determine the location of the implant in the 3D space.
The base model generator 165 will create an offset model 170 from the input data, as shown in this figure. The procedure in general will select and extract a piece from the input model 152 using a “Select and Cut” tool 172, and make a solid body by an offset tool 173.
The Preferred Diameter Selector 175 in this figure includes two utilities. First is the tool 180 to define the preferred diameter series 182. A default embodiment of this tool is to have a list of diameters starting from 1.5 mm, ending at 7.0 mm, with a common difference of 0.5 mm. The tool will allow defining any series of values. The second tool 185 is to look up the preferred diameter for any given implant by its diameter, and identify the matched preferred diameters 187.
The feature modeler 190 in this figure will create surgical guide model 195. It first creates a base model from the treatment plan input as stated earlier, and then adds features so that the drill guiding holes, prolongation values and drill stopping face, as well as indexing features are realized. The orders these features are added can have different embodiments.
The treatment plan generator 200 outputs a report 205 with the implant information and drilling instructions. The differentiator of this generator is that it not only gives the drilling instructions for the planned implants according to the universal surgical kit as discussed above, but also outputs the plan adaption instructions 210. For each implant, it gives a range that the implant diameter can vary while the intended universal surgical kit can still be used, and it lists how the drills, drilling keys, and drilling steps should be changed as well.
The guide design system has an adaptive workflow in terms of surgical kit selection, even when a specific surgical kit brand instead of a universal surgical kit is used. Assuming implants in a treatment plan are from manufacturer ABC, but the surgical kit from ABC is not available. The user has surgical kit from EFG. Use one implant as example. The implant size from ABC is D1, surgical kit EFG has implant sizes D2<D1. D2 can be used as the preferred diameter of the implant from A. The surgical guide is designed for this preferred diameter. Drill diameters smaller than D2 can be chosen as pilot drill and intermediate drills. This will be listed in the generated drilling instructions. It will also be listed in the drilling instruction that the final drill of D1 will be drilled without surgical guide. Therefore for this adaptive process, a user interface tool in this surgical guide design system is needed to select any existing surgical kit and to use it as the base for preferred diameters.