Surgical guide and implant with registration components

Abstract

A surgical guide is used in computer-assisted orthognathic surgery or similar bone surgeries. The guide is configured to correctly position osteotomy marking members and implant fixing screw receiving holes on the bone surface of a patient, and / or correctly position the cutting of an osteotomy or the drilling of implant fixing screw receiving holes. The guide has a bone conforming member and a dental interface member connected by a bridging member. The inner surfaces of the bone conforming member and the dental interface member conform to the morphological surfaces of the patient's bone and teeth. The dental interface member abuts against the front and side portions of the teeth. A fixing implant with a similar design can also be provided.

Description

Technical Field

[0001] The present invention generally relates to osteotomy cutting and drilling guides and bone fixation implants for orthognathic surgery or related bone treatments involving osteotomy or bone repair, particularly where the guides and implants are shaped and constructed based on computer-aided design to conform to the surface topography of the bone. More specifically, the present invention relates to such guides and implants that are provided with registration members or structures to ensure correct positioning and alignment of the devices on the bone surface. Even more specifically, the present invention relates to such guides and implants in which the registration members abut against the sides of the teeth and fit within the gaps between adjacent teeth. Background Art

[0002] For the sake of discussion and without intending to limit the field of application, the guides and implants will be discussed mainly with reference to orthognathic surgery, also known as maxillofacial corrective surgery or jaw corrective surgery, which is designed to correct jaw and facial conditions related to structure, growth, sleep apnea, TMJ (temporomandibular joint) disorders, malocclusion problems due to skeletal disharmony, or other orthodontic problems of the oral cavity that are not easily treated with braces. For example, in a typical orthognathic surgery in oral surgery, the bone is cut, moved, modified, and re-aligned to correct dentofacial deformities. The term "osteotomy" refers to the division or resection of bone. Osteotomies can be performed on the maxilla (such as a LeFort I osteotomy), the mandible (such as a sagittal split osteotomy), or the chin (such as a genioplasty).

[0003] Modern orthognathic surgery utilizes computer-aided design and manufacturing techniques, whereby technicians create virtual or physical three-dimensional models of the patient's pre-operative and post-operative states, showing the current configuration of the jaw and / or face before surgery and the desired configuration after surgery. Guides are manufactured that are used to cut osteotomies and / or mark osteotomy positions on the maxilla, mandible, or chin, and for drilling holes to receive bone fixation screws. Fixation implants are also fabricated that are constructed such that when the fixation implants are attached to the bone segments after osteotomy, the bone segments will be correctly positioned relative to each other. The guides conform to the pre-operative configuration of the patient's bone structure such that the surgeon can easily position the guide in the correct location. The surgeon then uses the guide to mark the positions for osteotomy and to mark or drill through the apertures in the guide, which are correctly positioned to receive bone screws for fastening the fixation implants to the bone segments that are positioned in the desired post-operative relationship. Alternatively, the guide can be made as a physical structure to guide an osteotome saw rather than using the guide for marking purposes.

[0004] One type of guide is referred to as an occlusal guide because a portion of the guide is designed to abut and rest on the upper surface of the teeth. Typically, the guide is made of a plastic material, and a portion of the guide is configured to match or conform to the surfaces of a plurality of adjacent teeth, typically four or five. This portion is commonly referred to as a splint and is the part of the guide that ensures proper positioning and alignment. A bridging member then connects the splint to one or more bone-conforming members that are configured to conform to a portion of the bone surface on the maxilla, mandible, or chin. Due to computer-aided manufacturing techniques, the guide does not become misaligned on the patient because the splint portion will mate with the plurality of teeth in only a single position that correctly aligns and positions the one or more bone-conforming members on the bone surface. While this occlusal guide structure is useful, the size of the device, particularly the size of the splint portion that conforms to the tooth surface, can interfere with or make difficult the marking of the osteotomy and the drilling of the fixation holes.

[0005] Once the osteotomy and screw-receiving holes are created, the guide is removed and the fixation implants are attached to the separated bone segments. These fixation implants are fabricated to conform to the desired postoperative configuration of the patient's bone structure, and, like the guide, the inner surface of the implant that abuts the patient's tissue is configured to conform to the surface topography of the area to which it is attached.

[0006] While such guides and implants have significantly improved orthognathic surgery by eliminating the need for the surgeon to manually manipulate the guide or implant to achieve an "optimal fit", there is still room for error in the placement and positioning of the guide or implant during surgery, and it is still time-consuming to find the exact location of the correct configuration. Therefore, an object of the present invention is to produce guides and implants that reduce the likelihood of misplacement and that have registration members or structures, where the registration members abut the sides of the teeth and fit into the spaces between adjacent teeth. Summary of the Invention

[0007] In short, the present invention in various embodiments is a guide or skeletal fixation implant for osteotomy and drilling in computer-aided orthognathic surgery or similar bone repair or bone modification surgeries, or a kit combination of such guides and implants. The guide is configured to correctly position osteotomy marking members and implant fixing screw receiving holes on the bone surface of a patient, and / or correctly position the cutting of the osteotomy or the drilling of the implant fixing screw receiving holes. The guide includes at least one registration or dental interface member, one or more bone conforming members, and one or more bridging members. The registration or dental interface member is configured to reside in a gap or valley formed between the exposed sides of adjacent teeth. The bone conforming members are configured to conform to the bone surface topography of the maxilla, mandible, or chin. The bridging members connect one or more bone conforming members to the dental interface member. The bone conforming members include drilling guide orifices and osteotomy marking or cutting surfaces. The implant is configured to correctly position the bone conforming members on the bone segment after performing the osteotomy. The implant includes at least one registration or dental interface member and one or more bridging members. The registration or dental interface member is configured to reside in a gap or valley formed between the exposed sides of adjacent teeth. The bridging members connect the dental interface member to the bone conforming members. One or more bridging members and at least one dental interface member are configured such that they can be removed from the bone conforming members after the bone conforming members are attached to the bone segment.

[0008] In one embodiment, the dental interface member is a generally U-shaped or semi-circular member located around a single tooth. The dental interface member is configured to abut the facial or buccal (i.e., front outside) surface of the exposed tooth crown and has a pair of curved or hooked arm members that reside adjacent to and abut the mesial and distal (i.e., the sides adjacent to the middle and the rear sides of the middle respectively) surfaces of the exposed tooth crown. In alternative embodiments, the guide and implant have one or more dental interface members, each of which is mounted on a dedicated bridging member, wherein the dental interface member does not surround a single tooth but is configured to abut the mesial, facial, and distal sides of the crown of the first tooth and the mesial, facial, and distal sides of the crown of the second adjacent tooth.

[0009] Through computer-aided design, one or more dental interface members have an inner tooth conforming surface that conforms to the exposed crown surface. In this way, for the dental interface member, there is only a single position that can correctly fit and align with the tooth crown, thus ensuring the correct placement and positioning of the bone conforming members of the guide or implant.

[0010] In an alternative overview, the present invention is a guide for surgical osteotomy and drilling constructed by computer-aided design, comprising: at least one bone conforming member having a bone conforming inner surface conforming to the surface topography of the patient's bone, and including osteotomy markings or cutting structures and drilling guide orifices; at least one dental interface member having a tooth conforming inner surface conforming to the surface topography of the patient's teeth, and adapted to laterally abut against the facial, mesial, and distal sides of the patient's teeth, but not against the upper surface of the patient's teeth; and a bridging member connecting the bone conforming member to the dental interface member; wherein at least one bone conforming inner surface and at least one tooth conforming inner surface are customized to fit the patient. Further, in the present invention, at least one dental interface member includes a U-shaped body, paired arm members, and a facial abutment portion; wherein at least one dental interface member includes a W-shaped body, a mesial abutment portion, a distal abutment portion, a central gap abutment portion, and a first and a second facial abutment portion; further including an extension arm and an abutment member extending from the mesial portion; and / or wherein at least one dental interface member includes two dental interface members.

[0011] In addition, the present invention is a kit including the guide and a bone fixation implant constructed by computer-aided design, the implant comprising: at least one implant bone conforming member having an implant bone conforming inner surface conforming to the surface topography of the patient's bone; at least one implant dental interface member having an implant tooth conforming inner surface conforming to the surface topography of the patient's teeth, and adapted to laterally abut against the facial, mesial, and distal sides of the patient's teeth, but not against the upper surface of the patient's teeth; and an implant bridging member connecting the implant bone conforming member to the implant dental interface member; wherein at least one implant bone conforming inner surface and at least one implant tooth conforming inner surface are customized to fit the patient. Further, in such an invention, at least one dental interface member includes a U-shaped body, paired arm members, and a facial abutment portion, wherein at least one implant dental interface member includes a U-shaped body, paired arm members, and a facial abutment portion; wherein at least one dental interface member includes a W-shaped body, a mesial abutment portion, a distal abutment portion, a central gap abutment portion, and a first and a second facial abutment portion, wherein at least one implant dental interface member includes a W-shaped body, a mesial abutment portion, a distal abutment portion, a central gap abutment portion, and a first and a second facial abutment portion; further including an extension arm and an abutment member extending from the mesial portion, and the implant further includes an extension arm and an abutment member extending from the mesial portion; and / or wherein at least one dental interface member includes two dental interface members, and at least one implant dental interface member in the implant includes two implant dental interface members. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Shows the inner side of an embodiment of a guide configured as a genioplasty guide and having paired tooth interface members, each tooth interface member configured to abut a single non - adjacent tooth on facial, mesial, and distal surfaces.

[0013] Figure 2 Is located on the mandible Figure 1 of the guide.

[0014] Figure 3 Is similar to Figure 1 a perspective view of a guide of the embodiment.

[0015] Figure 4 Shows the inner side of an alternative embodiment of a guide configured as a mandibular guide and having tooth interface members configured to abut two adjacent teeth.

[0016] Figure 5 Is located on the mandible Figure 4 of the outer side of the guide.

[0017] Figure 6 Is located on the mandible Figure 4 of the upper side of the guide.

[0018] Figure 7 Shows the inner side of an alternative embodiment of a guide configured as a maxillary guide and having tooth interface members configured to abut two adjacent teeth.

[0019] Figure 8 Is located on the maxilla Figure 4 of the outer side of the guide.

[0020] Figure 9 Shows the inner side of an alternative embodiment of a guide configured as a maxillary guide and having tooth interface members configured to abut two adjacent teeth and extend across a gap to a third tooth.

[0021] Figure 10 Is located on the maxilla Figure 9 of the guide. Detailed Description

[0022] Generally, the present invention in various embodiments is a customized surgical guide 10 or a skeletal fixation implant 50, either alone or in a kit, for computer - assisted orthognathic surgery or similar bone repair or bone modification surgeries, the guide 10 or implant 50 including a bone - conforming member or bone - conforming plate 13 and a registration or tooth interface member 11 connected by a bridging member 12.

[0023] The bone conforming member 13 includes a bone conforming inner surface 14 created and constructed by computer-aided design, and the bone conforming inner surface 14 conforms to the bone surface topography of a specific patient at a desired placement position on the patient's bone or tissue. The bone conforming member 13 of the guide 10 further includes osteotomy markings or cutting structures 32, such as edges or grooves, and / or drilling guide apertures 33.

[0024] The tooth interface member 11 includes a tooth conforming inner surface 15 created and constructed by computer-aided design to laterally abut the positive and side portions (i.e., facial, mesial, and distal) of the exposed surface of a specific patient's tooth 91 or adjacent teeth 91. In one embodiment, the tooth interface member 11 may include a generally U-shaped body 21 with opposing arm members 22 and a facial abutment 23 for abutting a single tooth 91. In other embodiments, the tooth interface member 11 may include a generally W-shaped body 40 with a central gap abutment 43, a mesial abutment 41, a distal abutment 42, a first facial abutment, and a second facial abutment 44 / 45, and may include an extension 46 extending across a tooth gap to another tooth 91. The arm members 22, the central gap abutment 43, the mesial abutment 41, and the distal abutment 42 are sized and configured such that they do not surround or encircle the posterior half of the tooth 91, such that these elements can be inserted only into the front portion of the gap or valley between adjacent teeth 91 to a sufficient distance to properly register or position the bone conforming member 13. In this way, the tooth interface member 11 abuts one or more teeth 91, but does not grip or hold the teeth 91, and can be easily retracted from the teeth 91.

[0025] The bridging member 12 can be configured to serve as a handle or grip. For the implant 50, the bridging member 12 is sized, configured, and made of a material such that the bridging member 12 and the tooth interface member 11 can be easily separated after the body conforming member 13 is attached to the bone segment.

[0026] In Figures 1 to 3 In a representative embodiment of the surgical guide 10 shown as a genioplasty (chin) guide, the tooth interface member 11 has a generally U-shaped or semi-circular body 21 located around a single tooth, and has a facial abutment 23 and paired curved or hooked arm members 22. The facial abutment 23 is configured to abut the facial or buccal (i.e., front outer) surface of the tooth crown 91, and the paired curved or hooked arm members 22 reside adjacent to and abut the mesial and distal (i.e., side) surfaces of the tooth 91. The combination of the arm members 22 and the facial abutment 23 defines the tooth conforming inner surface 15, which conforms to the surface topography of the tooth 91 it abuts due to computer-aided design. This feature, combined with the bone conforming inner surface 14 also created by computer-aided design, ensures that the guide 10 will be properly positioned to mark or cut the bone.

[0027] In an alternative embodiment, as Figures 4 to 7 shown, the mandibular guide 10 has a dental interface member 11 with a W-shaped body 40 adapted to abut adjacent teeth 91. The W-shaped body 40 includes paired tooth-conforming surfaces 15, one defined by a combination of a mesial-central abutment 41, a first facial abutment 44, and a central-gap abutment 43, and the other defined by the central-gap abutment 43, a second facial abutment 45, and a distal abutment 42. The dental interface member 11 is connected to a bone-conforming member 13 by paired bridging members 12. The bone-conforming member 13 includes a bone-conforming inner surface 14, an osteotomy marker or cutting structure 32, and a drilling guide orifice 33. As Figure 5 and 6 shown, the dental interface member 11 abuts the front sides of paired adjacent teeth 91 such that the central-gap abutment 43 rests between two teeth 31, the distal abutment 42 abuts the distal side of the most distal tooth, the mesial-central abutment 41 abuts the mesial side of the most mesial tooth 91, and the two facial abutments 44 / 45 conform to and abut the facial surfaces of the teeth 91. The mesial-central abutment 41, the central-gap abutment 43, and the distal abutment 42 extend less than halfway into the gap between the teeth 91 to facilitate placement and removal. The combination of the tooth-conforming inner surface 15 of the dental interface member 11 and the bone-conforming inner surface 14 of the bone-conforming member 11, in combination with the relative configuration of the dental interface member 11, the bridging members 12, and the bone-conforming member 13, are all designed and manufactured by computer-aided design to match the surface topography of the patient's bone and teeth, thereby providing stable and fixed placement of the guide 10.

[0028] Figure 7 and Figure 8Illustrates another embodiment, in this case, the maxillary guide 10. It is constructed similarly to the mandibular guide 10 and includes a dental interface member 11 and a bone conforming member 13 connected by a bridging member 12. The guide 10 has a dental interface member 11 including a W-shaped body 40 adapted to abut adjacent teeth 91. The W-shaped body 40 includes a pair of tooth conforming surfaces 15, one defined by a combination of a proximal middle abutment 41, a first facial abutment 44, and a central gap abutment 43, and the other defined by the central gap abutment 43, a second facial abutment 45, and a distal abutment 42. The dental interface member 11 is connected to the bone conforming member 13 by a pair of bridging members 12, and the bone conforming member 13 includes a bone conforming inner surface 14, osteotomy markers or cutting structures 32, and drilling guide orifices 33. The dental interface member 11 abuts the front sides of a pair of adjacent teeth 91 such that the central gap abutment 43 rests between two teeth 31, the distal abutment 42 abuts the distal side of the most distal tooth, the proximal middle abutment 41 abuts the mesial side of the most mesial tooth 91, and the two facial abutments 44 / 45 conform to and abut the facial surfaces of the teeth 91. The proximal middle abutment 41, the central gap abutment 43, and the distal abutment 42 extend less than halfway into the gap between the teeth 91, making placement and removal easy. The combination of the tooth conforming inner surface 15 of the dental interface member 11 and the bone conforming surface 14 of the bone conforming member 11, together with the relative configuration of the dental interface member 11, the bridging member 12, and the bone conforming member 13, are all designed and manufactured by computer-aided design to match the surface topography of the patient's bone and teeth, thereby providing a stable and fixed placement of the guide 10.

[0029] Figure 9 and Figure 10 Shows another embodiment of the guide 10, in this case, a maxillary guide similar to the maxillary guide shown in Figure 7 and Figure 8 In this embodiment, the dental interface member 11 includes a dental interface member 11 that includes a W-shaped body 40 adapted to abut adjacent teeth 91. The W-shaped body 40 includes a pair of tooth conforming surfaces 15, one defined by a combination of a proximal middle abutment 41, a first facial abutment 44, and a central gap abutment 43, and the other defined by the central gap abutment 43, a second facial abutment 45, and a distal abutment 42, and also includes an extension arm 46 extending from the proximal middle abutment 41, and the extension arm 46 terminates at an abutment shoulder 47. This embodiment is applicable to the case where one or more teeth are missing, such that the extension arm 46 spans the gap so that the abutment shoulder 47 can abut the next proximal tooth 91 to better stabilize the guide 10.

[0030] The bone fixation implant 50 is designed and manufactured in the same way as the guide 10 by computer-aided methods such that the bone conforming member 13 and the tooth interface member 11 have a bone conforming inner surface 14 and a tooth conforming inner surface 15 respectively, and are connected by one or more bridging members 12. The difference is that the bone conforming member 12 of the implant 50 does not provide osteotomy markings or cutting structures because the osteotomy has been performed before the bone conforming member 13 is attached to the bone segment of the patient. Once attached, the bridging member 12 and the tooth interface member 11 are cut or otherwise separated from the bone conforming member 13 and removed therefrom.

[0031] Since the structure of the tooth interface member 11 is reduced compared to the splint portion of the plastic guide, it is necessary to use a harder material such as titanium to produce the guide 10 of the present invention.

[0032] To use the guide 10, the surgeon positions one or more tooth interface members 11 on one or more crowns such that the bone conforming member rests on the bone surface of the maxilla, mandible or chin. The surgeon uses the marking / cutting edge 31 to mark the osteotomy position and the position of the bone screw receiving holes, or alternatively uses the drilling guide orifice 33 to drill holes. Alternatively, the surgeon can first use the drilling guide orifice 33 to mark or drill holes and then use the marking / cutting edge 31 to perform the osteotomy. The guide 10 is then removed from the patient, the bone segment is repositioned into the desired configuration, and the fixation implant 50 is attached to the bone segment. The bridging member 12 and the tooth interface member 11 are cut or otherwise separated from the bone conforming member 13 and removed therefrom.

Claims

1. A guide for surgical osteotomy and drilling, the guide being constructed by computer-aided design, the guide comprising: At least one bone conforming member having a bone conforming inner surface conforming to the bone surface topography of a patient and including osteotomy markings or cutting structures and drilling guide orifices; At least one dental interface member having a tooth conforming inner surface conforming to the tooth surface topography of a patient, the at least one dental interface member being adapted to laterally abut the facial, mesial, and distal sides of the patient's teeth but not the upper surface of the patient's teeth; And A bridging member connecting the bone conforming member to the dental interface member; Wherein the at least one bone conforming inner surface and the at least one tooth conforming inner surface are customized to fit the patient.

2. The guide according to claim 1, characterized in that, The at least one dental interface member includes a U-shaped body, paired arm members, and a facial abutment.

3. The guide according to claim 1, characterized in that, The at least one dental interface member includes a W-shaped body, a mesial abutment, a distal abutment, a central gap abutment, and a first and a second facial abutment.

4. The guide according to claim 3, characterized in that The guide further includes an extension arm and an abutment member extending from the mesial portion.

5. The guide according to claim 2, characterized in that, The at least one dental interface member includes two dental interface members.

6. A kit comprising the guide according to claim 1 and a bone fixation implant constructed by computer-aided design, the implant comprising: At least one implant bone conforming member having an implant bone conforming inner surface conforming to the bone surface topography of a patient; At least one implant dental interface member having a tooth conforming inner surface conforming to the tooth surface topography of a patient, the at least one implant dental interface member being adapted to laterally abut the facial, mesial, and distal sides of the patient's teeth but not the upper surface of the patient's teeth; And An implant bridging member connecting the implant bone conforming member to the implant dental interface member; Wherein the at least one implant bone conforming inner surface and the at least one implant tooth conforming inner surface are customized to fit the patient.

7. The kit according to claim 6, characterized in that, The at least one dental interface member includes a U-shaped body, paired arm members, and a facial abutment, and wherein, The at least one implant dental interface member includes a U-shaped body, paired arm members, and a facial abutment.

8. The kit according to claim 6, wherein The at least one dental interface member includes a W-shaped body, a mesial abutment, a distal abutment, a central gap abutment, and a first and a second facial abutment, and wherein, The at least one implant dental interface member includes a W-shaped body, a mesial abutment, a distal abutment, a central gap abutment, and a first and a second facial abutment.

9. The kit according to claim 8, wherein The guide further includes an extension arm and an abutment member extending from the mesial portion, and the implant further includes an extension arm and an abutment member extending from the mesial portion.

10. The kit according to claim 7, characterized in that, In the guide, the at least one dental interface member includes two dental interface members, and in the implant, the at least one implant dental interface member includes two implant dental interface members.

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