TW201943393A - Method for producing an operation-guiding structure - Google Patents

Method for producing an operation-guiding structure Download PDF

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TW201943393A
TW201943393A TW107147228A TW107147228A TW201943393A TW 201943393 A TW201943393 A TW 201943393A TW 107147228 A TW107147228 A TW 107147228A TW 107147228 A TW107147228 A TW 107147228A TW 201943393 A TW201943393 A TW 201943393A
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image
guide element
bone
plate
manufacturing
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TW107147228A
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TWI690303B (en
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陳敏嘉
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陳敏嘉
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Abstract

A dental operation-guiding structure includes a bite plate, a marking plate, and at least one connection frame connecting the bite plate and the marking plate. The bite plate is occluded by lower and upper teeth of a human body. The marking plate includes a plate body and at least one window penetrating the plate body. The plate body is adjacent to a tissue surface, and the window defines a position to be operated. By occluding the dental operation-guiding structure, practical positions, patterns and ranges for the operation can be easily defined. The method for producing the dental operation-guiding structure overlaps a 3D bone image of a target object onto a 3D teeth-mold image thereof to obtain a reconstructed 3D image including clear contours of bones and soft tissues, bases on the reconstructed 3D image to design the dental operation-guiding structure, and finally produces the dental operation-guiding structure by 3D printing.

Description

手術導引元件的製法    Method for manufacturing surgical guide element   

本發明係相關於一種牙科手術導引元件及其製法,尤指一種可藉由病人牙齒咬合定位並定義出需進行手術之區域,以輔助牙科手術進行的牙科手術導引元件及其製法。 The present invention relates to a dental surgery guiding element and a manufacturing method thereof, and more particularly, to a dental surgery guiding element and a manufacturing method thereof that can be positioned and defined by a patient's teeth in order to assist the surgery.

目前牙科相關的外科手術,例如但不侷限於側窗鼻竇增高術(Lateral Window Sinus Lifting)及壓電性齒槽去皮質骨矯正術(Piezoelectic Alveolar Decortictin For Ortodontic Treatment)等,幾乎都是仰賴執行手術的醫師自身的專業與經驗,來決定手術時實際動刀的具體位置、形狀與範圍。以側窗鼻竇增高術來說,常用於在進行後牙區植牙前,藉由在上頷鼻竇側面的骨板開孔並將鼻竇黏膜往上撥開及填入骨粉,將該處的上頷骨厚度增加後,再進行人工植牙程序。而壓電性齒槽去皮質骨矯正術,常用於在進行牙齒矯正的過程中,藉由將正在矯正中之牙齒施以齒槽去皮質骨術,在各牙齒之間齒槽骨上切割上、下方向延伸的細切割道,並以壓電性震動器對其施以高速微震動,可活化齒槽骨細胞重塑能力,加速牙齒移動而能縮短牙齒矯正所需的時間。 At present, dental-related surgical operations, such as but not limited to Lateral Window Sinus Lifting and Piezoelectic Alveolar Decortictin For Ortodontic Treatment, are almost always performed The physician's own expertise and experience determine the specific position, shape and range of the actual knife during the operation. For the side window sinus augmentation technique, it is often used before the posterior tooth implantation. It is used to open the hole in the bone plate on the side of the maxillary sinus and pull the sinus mucosa upward and fill it with bone powder. After the thickness of the sacrum increases, the artificial dental implant procedure is performed. Piezoelectric alveolar osteosynthesis is commonly used in the process of orthodontics, by applying alveolar decortical osteosynthesis to the teeth being corrected, cutting the alveolar bone between the teeth. The fine cutting path extending in the lower direction and applying a high-speed micro-vibration to it with a piezoelectric vibrator can activate the alveolar bone cell remodeling ability, accelerate the tooth movement and shorten the time required for orthodontics.

雖然,在進行此類牙科相關的外科手術之前,都會先藉由例如X光照相、或是電腦斷層掃描(Computed Tomography;簡稱CT)等方式來獲得手術目標物的三維(以下簡稱3D)影像,供醫師事前評估手術時實際動刀的具體位置、形狀與範圍。然而,由於此類X光照相或電腦斷層掃描,都只能獲得骨骼的清晰3D影像,而對於覆蓋於骨骼表面上的其他人體軟組織,例如牙齦、牙肉等,就無法獲得清晰3D影像。並且,即使實行 軟組織翻瓣後可以看見硬組織,也常常因為周圍皮瓣的限制與妨礙而常常難以準確定位手術切割區域,導致醫師只能依據自身專業與經驗,由目視到的人體組織外觀,去猜測或估計其下方骨骼與X光照相或電腦斷層掃描結果相對應的關係,無法單單由目視到的人體組織外觀便精準確認手術時實際動刀的具體位置、形狀與範圍。除此之外,由於在手術過程中,切割人體軟組織所流出的血液會流動甚至遮蔽手術的區域,影響醫師的視覺判斷,進而降低醫師控制其動刀位置、形狀與範圍的精確度。此外,倘若醫師本身的專業或經驗不足時,更可能因為在手術過程中錯估其動刀的位置、形狀或範圍,而導致手術效果打折扣、甚至對人體造成其他後遺症或傷害,例如在執行側窗鼻竇增高術時開孔錯位或是過大而造成鼻竇穿孔或加重術後腫脹與疼痛程度、或是執行齒槽去皮質骨矯正術時傷到牙根造成牙齒無端失去活性等等。因此,現有牙科相關的外科手術方式仍有進一步改良的空間。 Although before performing such dental-related surgical operations, three-dimensional (hereinafter referred to as 3D) images of surgical targets are obtained by means of, for example, X-ray photography or computerized tomography (CT). For the physician to evaluate the specific position, shape and range of the actual moving knife before surgery. However, as a result of such X-ray photography or computer tomography, only clear 3D images of bones can be obtained, while other soft tissues such as gums and plaques covering the surface of bones cannot obtain clear 3D images. In addition, even if hard tissue can be seen after performing soft tissue flaps, it is often difficult to accurately locate the surgical cutting area due to the limitations and obstructions of the surrounding flaps, resulting in the physician's visual appearance of human tissue based on his own professional and experience. To guess or estimate the relationship between the underlying bones and the results of X-ray photography or computer tomography, it is impossible to accurately confirm the specific position, shape and range of the actual moving knife during surgery based on the appearance of human tissue alone. In addition, during the surgery, the blood flowing out of the cut human soft tissue will flow or even cover the area of the operation, which affects the physician's visual judgment, thereby reducing the accuracy of the physician's control of the position, shape and range of the moving knife. In addition, if the physician's own expertise or experience is insufficient, the position, shape, or range of the moving knife may be miscalculated during the operation, which may result in a reduction in the surgical effect and even cause other sequelae or injuries to the human body, such as on the side of the executive side. The misalignment of the openings during the window sinus augmentation surgery may cause the perforation of sinuses or increase the degree of swelling and pain after sinus perforation, or damage to the root of the teeth during alveolar decortical orthodontic surgery, which may result in ineffective tooth loss. Therefore, there is still room for improvement in the existing dental-related surgical methods.

緣此,本發明之主要目的係在提供一種牙科手術導引元件,藉由病人牙齒咬合定位該導引元件來直接定義出需進行手術的具體位置、形狀與範圍,讓醫師在執行手術過程中可以明確且精準地得知需動刀的具體位置、形狀與範圍,藉以輔助牙科手術進行,降低因血液遮蔽影響手術精準度,且能減少手術後遺症或傷害的發生機率。 For this reason, the main object of the present invention is to provide a dental surgery guide element, which can be used to directly define the specific position, shape, and range of the operation to be performed by the patient's teeth in occlusion. It can clearly and accurately know the specific position, shape and range of the moving knife to assist dental surgery, reduce the accuracy of the operation due to blood masking, and reduce the incidence of sequelae or injuries.

本發明之另一目的係在提供一種牙科手術導引元件的製法,藉由把透過電腦斷層掃描獲得的清晰骨骼3D影像,結合透過口腔3D掃描器或是牙弓模型獲得的清晰牙模3D影像,可獲得包含骨骼及軟組織之清晰輪廓的一重組後的3D影像;並依據該重組後的3D影像來設計該導引元件,可精確定義出手術時需動刀的具體位置、形狀與範圍。之後,再藉由3D列印的方式製造該導引元件。 Another object of the present invention is to provide a method for manufacturing a dental surgery guide element, by combining a clear 3D image of a bone obtained through computer tomography with a clear 3D image of a dental model obtained through an oral 3D scanner or a dental arch model. A reconstituted 3D image containing clear contours of bones and soft tissues can be obtained; and the guide element is designed based on the restructured 3D image, which can precisely define the specific position, shape and range of the moving knife during surgery. After that, the guide element is manufactured by 3D printing.

為達上述目的,本發明提供一種牙科手術導引元件,適用於一人體的牙科相關手術操作,其包括:一咬合板,可供該人體的上、下牙齒咬合,使該咬合板被咬合定位於該上、下牙齒之間; 一定位片,其包括有一片體、及貫穿該片體的至少一開窗;至少一連接架,連接於該咬合板與該定位片之間;其中,當該咬合板是被咬合並定位於該上、下牙齒之間時,該定位片的片體是鄰靠於該人體的一組織表面、且該至少一開窗的位置就是將被進行手術的位置。 In order to achieve the above object, the present invention provides a dental surgery guide element, which is suitable for a dental related surgical operation of a human body, and includes: an occlusal plate, which can be used to occlude the upper and lower teeth of the human body, so that the occlusal plate is occluded and positioned Between the upper and lower teeth; a positioning piece including a piece of body and at least one opening window penetrating through the piece of body; at least one connecting frame connected between the bite plate and the positioning piece; wherein, when When the bite plate is bitten and positioned between the upper and lower teeth, the piece of the positioning sheet is adjacent to a tissue surface of the human body, and the position of the at least one window is the position where the operation will be performed. .

於一實施例中,於該咬合板的上、下表面分別具有複數咬合結構;該複數咬合結構是分別對應於該上、下牙齒的形狀與位置。 In an embodiment, the upper and lower surfaces of the occlusal plate respectively have a plurality of occlusal structures; the plurality of occlusal structures respectively correspond to the shape and position of the upper and lower teeth.

於一實施例中,該導引元件是以3D列印的方式製造;並且,該至少一開窗的形狀與範圍就是將被進行手術之區域的形狀與範圍。 In one embodiment, the guiding element is manufactured by 3D printing; and the shape and range of the at least one window is the shape and range of the area to be operated.

於一實施例中,該導引元件是適用於進行一側窗鼻竇增高術,並且,該定位片之該片體的位置是鄰靠於該人體的上顎鼻竇外的該組織表面,且該至少一開窗的位置、形狀與範圍就是進行該側窗鼻竇增高術時需把該人體骨板開孔的位置、形狀與範圍。 In one embodiment, the guiding element is suitable for performing side window sinus augmentation, and the position of the piece of the positioning sheet is adjacent to the surface of the tissue outside the maxillary sinus of the human body, and the at least The position, shape and scope of a window opening is the position, shape and scope of opening the human bone plate when performing the side window sinus augmentation.

於一實施例中,該導引元件是適用於進行一齒槽去皮質骨矯正術;並且,該至少一開窗是包括複數個上、下方向延伸的細開槽,各該細開槽的位置、形狀與範圍就是進行該齒槽去皮質骨矯正術時需把該人體皮質骨切割的位置、形狀與範圍;此外,於該片體上更設有複數貫穿小孔位於各該細開槽之間。 In an embodiment, the guide element is suitable for performing alveolar decortical orthopedic surgery; and the at least one opening window includes a plurality of fine grooves extending in upper and lower directions, each of the fine grooves The position, shape, and range are the positions, shapes, and ranges of the human cortical bone that need to be cut during the alveolar decortical orthopedic surgery. In addition, a plurality of through-holes are provided on the sheet body in each of the fine slots. between.

為達上述目的,本發明還提供一種牙科手術導引元件的製法,該製法包括:步驟(A):取得該人體預定將進行該手術操作之一目標物的至少一3D影像;步驟(B):重組該目標物的該至少一3D影像,以獲得可顯現出該目標物之一骨骼及一軟組織的輪廓的一重組後的3D影像;步驟(C):依據步驟(B)所獲得的該重組後的3D影像,設計該導引元件的一咬合板、一定位片及至少一連接架;其中,該咬合板可供該人體的上、下牙齒咬合而定位於該上、下牙齒之間;該定位片包括有一片體、及貫穿該片體的至少一開窗;該至少一連接架是連接於該咬合板與該定位片之間;當該咬合板是被咬合並定位於該上、下牙齒之間時,該定位片的片體是鄰靠於該目標物的一組織表面、且該至少一開窗的位置 就是將被進行手術的位置;以及步驟(D):以3D列印的方式製造該導引元件。 To achieve the above object, the present invention also provides a method for manufacturing a dental surgery guide element, the method includes: step (A): obtaining at least one 3D image of a target object that the human body is scheduled to perform the surgical operation; step (B) : Recombining the at least one 3D image of the target object to obtain a reconstructed 3D image showing the outline of a bone and a soft tissue of the target object; step (C): the obtained according to step (B) After the reorganized 3D image, an occlusal plate, a positioning piece, and at least one connecting frame of the guiding element are designed; wherein, the occlusal plate can be used to occlude the upper and lower teeth of the human body and be positioned between the upper and lower teeth. The positioning piece includes a piece body and at least one opening window penetrating through the piece body; the at least one connecting frame is connected between the bite plate and the positioning piece; when the bite plate is bitten and positioned on the piece Between the lower teeth, the piece of the positioning piece is adjacent to a tissue surface of the target, and the position of the at least one window is the position where the operation will be performed; and step (D): in a 3D row The guide element is manufactured in a printed manner.

於一實施例中,步驟(A)所述之該至少一3D影像是包括:該目標物的一骨骼3D影像、以及該目標物含軟組織的一牙模3D影像;其中,該骨骼3D影像是藉由一斷層掃描機進行斷層掃描的方式獲得,且該牙模3D影像是藉由以下其中之一方式獲得:以一口腔3D掃描器進行掃描、或是先取得一牙弓模型後再對該牙弓模型進行3D掃描;其中,該牙模3D影像與該骨骼3D影像都包含至少一該牙齒的影像。 In an embodiment, the at least one 3D image described in step (A) includes: a 3D image of a bone of the target and a 3D image of a dental mold containing soft tissue; wherein the 3D image of the bone is Obtained by means of tomography using a tomograph, and the 3D image of the dental model is obtained by one of the following methods: scanning with an oral 3D scanner, or obtaining a dental arch model before The dental arch model is 3D scanned; both the 3D image of the dental model and the 3D image of the bone include at least one image of the tooth.

於一實施例中,步驟(B)更包括有下列步驟:步驟(B1):判定該目標物的一骨骼密度範圍;以及步驟(B2):依據該骨骼密度範圍來重組該目標物的該至少一3D影像;其中,該重組後的3D影像是藉由將該牙模3D影像疊合於該骨骼3D影像、並使該牙模3D影像所包含之至少一該牙齒的影像對準於該骨骼3D影像所包含之至少一相同該牙齒的影像所獲得。 In an embodiment, step (B) further includes the following steps: step (B1): determining a bone density range of the target object; and step (B2): reorganizing the at least of the target object according to the bone density range. A 3D image; wherein the reconstructed 3D image is obtained by superimposing the dental mold 3D image on the bone 3D image and aligning the image of at least one tooth included in the dental mold 3D image with the bone The 3D image includes at least one image of the same tooth.

於一實施例中,步驟(C)所述設計該導引元件的方式,是依據該牙模3D影像來設計該咬合板,並依據該骨骼3D影像來設計該定位片,且依據所設計出之該咬合板及該定位片來設計能把該定位片連接於該咬合板、且又不會影響手術時的視線與操作過程的該至少一連接架。 In an embodiment, the method for designing the guiding element described in step (C) is to design the occlusal plate based on the 3D image of the dental mold, design the positioning piece according to the 3D image of the bone, and design according to the design. The bite plate and the positioning piece are used to design the at least one connecting frame capable of connecting the bite piece to the bite plate without affecting the sight and operation during the operation.

10,30‧‧‧導引元件 10,30‧‧‧Guide elements

11,31‧‧‧咬合板 11,31‧‧‧occlusal plate

111,311‧‧‧塊狀體 111,311‧‧‧lumps

112,312‧‧‧咬合結構 112,312‧‧‧occlusal structure

12,32‧‧‧定位片 12,32‧‧‧ Positioning film

121,321‧‧‧片體 121,321‧‧‧pieces

122,322‧‧‧開窗 122,322‧‧‧window

13,33‧‧‧連接架 13,33‧‧‧Connector

323‧‧‧小孔 323‧‧‧small hole

90‧‧‧目標物 90‧‧‧ target

91‧‧‧骨板 91‧‧‧ bone plate

92‧‧‧組織表面 92‧‧‧ Tissue surface

93‧‧‧牙齒 93‧‧‧Tooth

94‧‧‧鼻竇腔 94‧‧‧Sinus cavity

21~25,221,222‧‧‧步驟 21 ~ 25,221,222‧‧‧step

圖一是本發明之牙科手術導引元件的第一實施例被人體咬合時的示意圖。 FIG. 1 is a schematic view of a first embodiment of a dental surgery guide element according to the present invention when it is engaged by a human body.

圖二是圖一所示之本發明該導引元件第一實施例的立體示意圖。 FIG. 2 is a schematic perspective view of the first embodiment of the guiding element of the present invention shown in FIG. 1. FIG.

圖三是本發明之牙科手術導引元件的製法的一實施例流程圖。 FIG. 3 is a flowchart of an embodiment of a method for manufacturing a dental surgery guide element according to the present invention.

圖四是本發明之牙科手術導引元件的第二實施例的立體示意圖。 FIG. 4 is a schematic perspective view of a second embodiment of the dental surgery guide element of the present invention.

圖五是圖四所示之本發明之牙科手術導引元件第二實施例被人體咬合時的示意圖。 FIG. 5 is a schematic view of the second embodiment of the dental surgery guide element of the present invention shown in FIG. 4 when it is engaged by a human body.

為了能更清楚地描述本發明所提出之牙科手術導引元件及其製法,以下將配合圖式詳細說明之。 In order to more clearly describe the dental surgery guide element and its manufacturing method provided by the present invention, it will be described in detail below with reference to the drawings.

本發明之牙科手術導引元件,主要是藉由病人牙齒咬合定位該導引元件的方式,來直接定義出需進行手術的具體位置、形狀與範圍,讓醫師在執行手術過程中可以明確且精準地得知需動刀的具體位置、形狀與範圍,藉以輔助牙科手術進行,可降低因血液遮蔽影響手術精準度,且能減少手術後遺症或傷害的發生機率。本發明之牙科手術導引元件的製法,乃是藉由把透過電腦斷層掃描獲得的清晰骨骼3D影像,結合透過口腔3D掃描器或是牙弓模型獲得的清晰牙模3D影像,可獲得包含骨骼及軟組織之清晰輪廓的一重組後的3D影像;並依據該重組後的3D影像來設計該導引元件,可精確定義出手術時需動刀的具體位置、形狀與範圍。之後,再藉由3D列印的方式製造該導引元件。 The dental surgical guide element of the present invention mainly defines the specific position, shape and range of the operation to be performed by means of positioning the guide element by the teeth of the patient, so that the physician can be clear and precise during the operation. Knowing the specific position, shape and range of the moving knife to assist dental surgery can reduce the accuracy of the operation due to blood masking, and reduce the incidence of sequelae or injuries. The method for manufacturing the dental surgery guide element of the present invention is to obtain a bone including a bone by combining a clear 3D image of a bone obtained through computer tomography with a clear 3D image of a dental model obtained through an oral 3D scanner or a dental arch model. And a clear 3D image of the soft tissue and a reorganized 3D image; and designing the guide element based on the reorganized 3D image can accurately define the specific position, shape and range of the knife to be moved during surgery. After that, the guide element is manufactured by 3D printing.

請參閱圖一及圖二,分別為本發明之牙科手術導引元件的第一實施例被人體(病人)咬合時的示意圖、以及該導引元件第一實施例的立體示意圖。本發明所述之導引元件是適用於一人體的牙科相關手術操作,例如但不侷限於如圖一及圖二所示的第一實施例中,該導引元件是適用於進行側窗鼻竇增高術(Lateral Window Sinus Lifting)的結構。 Please refer to FIG. 1 and FIG. 2, respectively, which are schematic diagrams of a first embodiment of a dental surgery guiding element of the present invention when it is bitten by a human body (patient), and perspective views of the first embodiment of the guiding element. The guiding element according to the present invention is suitable for dental related surgical operations on a human body. For example, but not limited to the first embodiment shown in FIGS. 1 and 2, the guiding element is suitable for performing side window sinuses. Structure of Lateral Window Sinus Lifting.

於本發明之第一實施例中,該導引元件10包括:一咬合板11、一定位片12及至少一連接架13。該咬合板11可供該人體的上、下牙齒93咬合,使該咬合板11被咬合定位於該上、下牙齒93之間。於該咬合板11的一塊狀體111的上、下表面分別具有複數咬合結構112,且該複數咬合結構112是分別對應於該上、下牙齒93的形狀與位置。該定位片12包括有一片體121、及貫穿該片體121的至少一開窗122。該至少一連接架13是連接於該咬合板11與該定位片12之間,使得該定位片12能被該至少一連接架13支撐並保持在該咬合板11上預定的位置。當該咬合板11是被咬合並定位於人體的該上、下牙齒93之間時,該定位片的片體是鄰靠於該人體的上顎鼻竇(亦即,欲進行手術的目標物90)外的一組織表面92,且該至少一開窗122的位置、形狀與範圍就是進行該側窗鼻竇增高術時需把該人體骨板91開孔的位置、形狀與範圍。藉此,當醫師進行側窗鼻竇增高 術時,可直接依據該定位片12之該開窗122的位置、形狀與範圍來進行開孔進入鼻竇腔94,無須猜測覆蓋於人體軟組織92下方的骨骼(骨板91)位置、也不會受到血液遮蔽的影響,進而能提高手術精確度、並降低手術後遺症或傷害的發生機率。此外,本發明僅需藉由上、下牙齒93咬住該咬合板11,便可把該導引元件10及其定位片12定位在正確的位置上,無須其他結合或定位手段,例如但不侷限於:以黏膠黏合、以螺絲鎖固、或以夾具夾合等手段全部都不需要。換言之,當使用本發明之牙科手術導引元件10時,病人的上、下牙齒93在牙科手術的進行過程中是呈現咬合狀態,而非張開大嘴的狀態。 In the first embodiment of the present invention, the guiding element 10 includes: an engaging plate 11, a positioning piece 12, and at least one connecting frame 13. The occlusal plate 11 can be used to engage the upper and lower teeth 93 of the human body, so that the occlusal plate 11 is bitten and positioned between the upper and lower teeth 93. The upper and lower surfaces of the one-piece body 111 of the occlusal plate 11 each have a plurality of occlusal structures 112, and the plurality of occlusal structures 112 correspond to the shape and position of the upper and lower teeth 93, respectively. The positioning sheet 12 includes a sheet body 121 and at least one window 122 passing through the sheet body 121. The at least one connecting frame 13 is connected between the engaging plate 11 and the positioning piece 12, so that the positioning piece 12 can be supported by the at least one connecting frame 13 and maintained at a predetermined position on the engaging plate 11. When the occlusal plate 11 is bitten and positioned between the upper and lower teeth 93 of the human body, the piece of the positioning piece is adjacent to the maxillary sinuses of the human body (ie, the target 90 to be operated on) An external tissue surface 92 and the position, shape, and range of the at least one window 122 are the positions, shapes, and ranges of the human bone plate 91 that need to be opened during the side window sinus augmentation. Therefore, when the physician performs side window sinus augmentation, he can directly open the hole into the sinus cavity 94 according to the position, shape and scope of the window 122 of the positioning sheet 12, without guessing the bones covering the soft tissue 92 of the human body. The position of the (bone plate 91) is not affected by blood shielding, which can improve the accuracy of surgery and reduce the incidence of sequelae or injuries. In addition, the present invention only needs to bite the occlusal plate 11 by the upper and lower teeth 93 to position the guide element 10 and its positioning piece 12 in the correct position, without the need for other combining or positioning means, such as but not Limited to: All methods such as adhesive bonding, screw locking, or clamp clamping are not required. In other words, when using the dental surgery guide element 10 of the present invention, the upper and lower teeth 93 of the patient are in an occluded state during the progress of the dental operation, rather than a state of widening the mouth.

請參閱圖三,為本發明之牙科手術導引元件的製法的一實施例流程圖,該導引元件是適用於一人體的牙科相關手術操作,該製法包括以下步驟: Please refer to FIG. 3, which is a flowchart of an embodiment of a method for manufacturing a dental surgery guide element according to the present invention. The guide element is suitable for a dental operation related to a human body. The manufacturing method includes the following steps:

步驟21:取得該人體預定將進行該手術操作之一目標物的至少一3D影像。於本實施例中,所述之該至少一3D影像是包括:該目標物的一骨骼3D影像、以及該目標物含軟組織的一牙模3D影像。其中,該骨骼3D影像是藉由電腦斷層掃描機(CT)進行斷層掃描的方式獲得,其是以可供電腦判讀與處理的數位資訊檔的型式存在,例如但不侷限於:副檔名為”.STL”的數位資訊檔。該牙模3D影像是藉由以下其中之一方式獲得:以一口腔3D掃描器對該人體的口腔內部進行掃描來獲得該牙模3D影像;或者,先藉由印模材料以傳統印牙模的方式取得一牙弓模型後,再對該牙弓模型以3D掃描器進行3D掃描來獲得該牙模3D影像。該牙模3D影像同樣也是以可供電腦判讀與處理的數位資訊檔的型式存在,例如但不侷限於:副檔名為”.STL”的數位資訊檔。其中,無論是該牙模3D影像或是該骨骼3D影像,都同樣會包含該目標物處的複數牙齒的影像。 Step 21: Obtain at least one 3D image of the target that the human body is scheduled to perform the surgical operation on. In this embodiment, the at least one 3D image includes: a 3D image of a bone of the target and a 3D image of a dental mold containing the soft tissue of the target. The 3D image of the bone is obtained by means of tomographic scanning by a computer tomography scanner (CT). It exists as a digital information file that can be interpreted and processed by a computer, such as, but not limited to, an extension named ".STL" digital information file. The dental mold 3D image is obtained by one of the following methods: scanning the inside of the human's oral cavity with an oral 3D scanner to obtain the dental mold 3D image; After obtaining a dental arch model in the same manner, 3D scanning is performed on the dental arch model with a 3D scanner to obtain a 3D image of the dental mold. The dental mold 3D image also exists in a type of digital information file that can be read and processed by a computer, such as, but not limited to, a digital information file with an extension ".STL". Wherein, whether it is the 3D image of the dental mold or the 3D image of the bone, the image of the plurality of teeth at the target object is also included.

步驟22:重組該目標物的該至少一3D影像,以獲得可顯現出該目標物之一骨骼及一牙模(含軟組織)的輪廓的一重組後的3D影像。於本實施例中,此步驟22更包括以下步驟:步驟221:判定該目標物的一骨骼密度範圍;以及步驟222:依據該骨骼密度範圍來重組該目標物的該至少一3D影像。 Step 22: Reorganize the at least one 3D image of the target object to obtain a reconstructed 3D image that can show the outline of a bone of a target object and a dental mold (including soft tissue). In this embodiment, this step 22 further includes the following steps: step 221: determine a bone density range of the target object; and step 222: reconstruct the at least one 3D image of the target object according to the bone density range.

由於每個人的骨骼密度(Bone Mineral Density或稱Bone Mass;簡稱BMD)都不相同,而不同骨骼密度會對電腦斷層掃描的影像產生影響。舉例來說,一般人的骨骼密度值若換算成電腦斷層掃描機(CT)圖像中用來表示符合一般sprial CT規範之相對密度的CT值單位「亨式單位(Hounsfield Unit;簡稱HU)」是介於60~300HU之間。因此,對於具有相對較低密度(60~200HU)的骨骼、與具有相對較高密度(201~300HU)的骨骼,其兩者在電腦斷層掃描所得到的骨骼3D影像中的影像輪廓清晰度就會有差異。相對地,若是使用專業牙科用的CBCT(Cone-beam CT)斷層掃描機的規範下的影像密度範圍數值則會有差異、其使用單位也不同。於CBCT規範下,是用影像強度來表示(Input image intensity)來判斷骨骼之相對密度;一般來說,於CBCT規範下,正常人的骨骼密度值是介於300~2000之間;低密度骨骼值為300以下,而高密度骨骼值則為2000以上。所以,於本實施例中,可使用例如Mimics Innovation Suite之類的3D影像處理軟體來判斷及選定該目標物的適合的骨骼密度範圍值後,再依據所選定之該骨骼密度範圍值所對應的該骨骼3D影像,以確保於該骨骼3D影像中所顯示的骨骼影像輪廓是清晰且精確的。 Because each person's bone density (Bone Mineral Density or Bone Mass; BMD for short) is different, different bone density will affect the image of computer tomography. For example, if the bone density value of an ordinary person is converted into a CT value unit in a computer tomography (CT) image used to represent the relative density in accordance with the general spritical CT specification, the "Hounsfield Unit (HU)" is Between 60 ~ 300HU. Therefore, for bones with relatively low density (60 to 200 HU) and bones with relatively high density (201 to 300 HU), the sharpness of the image contours in the bone 3D image obtained by computer tomography is There will be differences. In contrast, if a CBCT (Cone-beam CT) tomography scanner is used, the image density range values will be different, and the units used will be different. Under the CBCT standard, the relative density of bones is determined by the input image intensity; generally, under the CBCT standard, the bone density value of normal people is between 300 and 2000; low density bones The value is 300 or less, while the high-density bone value is 2000 or more. Therefore, in this embodiment, 3D image processing software such as Mimics Innovation Suite can be used to determine and select a suitable bone density range value for the target, and then according to the selected bone density range value corresponding to The bone 3D image ensures that the outline of the bone image displayed in the bone 3D image is clear and accurate.

於本實施例中,該重組後的3D影像,是藉由操作電腦輔助3D設計軟體,例如但不侷限於前述之Mimics Innovation Suite,將該牙模3D影像疊合於該骨骼3D影像、並使該牙模3D影像所包含之至少一該牙齒的影像對準於該骨骼3D影像所包含之至少一相同該牙齒的影像所獲得。因此,本發明之該重組後的3D影像將會同時包含該目標物之骨骼(骨板)及牙模(含軟組織)兩者的清晰輪廓,可大幅改善習知技術僅單純使用骨骼3D影像來評估手術位置與範圍易導致手術不精確的缺失。於本實施例中,該重組後的3D影像同樣是以副檔名為”.STL”的數位資訊檔的型式存在。 In this embodiment, the reconstructed 3D image is obtained by operating computer-aided 3D design software, such as but not limited to the aforementioned Mimics Innovation Suite, superimposing the dental mold 3D image on the bone 3D image and An image of at least one tooth included in the 3D image of the dental mold is obtained by aligning an image of at least one identical tooth included in the 3D image of the bone. Therefore, the recombined 3D image of the present invention will contain both the clear contours of the target's bones (bone plates) and dental molds (including soft tissues), which can greatly improve the conventional technology by using only bone 3D images. Assessing the location and scope of the surgery can lead to inaccurate misses. In this embodiment, the reconstructed 3D image also exists as a digital information file with the extension ".STL".

步驟23:依據步驟22所獲得的該重組後的3D影像,來設計該導引元件的咬合板、定位片及至少一連接架的形狀與結構。其中,所述設計該導引元件的方式,是藉由操作電腦輔助3D設計軟體,依據該重組後的3D影像中由該牙模3D影像所顯示出的牙齒及牙模(軟組織)的外型輪廓,來設計該咬合板(包含咬合結構)的位置、形狀及範圍;並且,依 據該重組後的3D影像中由該骨骼3D影像所顯示出的骨板的外型輪廓,來設計該定位片(包含片體與開窗)的位置、形狀及範圍;此外,並依據所設計出之該咬合板及該定位片的相對位置與輪廓,來設計能把該定位片連接於該咬合板、且又不會影響手術時的視線與操作過程的該至少一連接架的位置、形狀及範圍。當完成該導引元件的設計後,即可將該導引元件的3D設計圖以數位資訊檔的型式輸出並儲存,例如但不侷限於:副檔名為”.STL”的數位資訊檔。此外,也可試著將該導引元件的3D設計圖組合、疊合回該骨骼3D影像、或是該牙模3D影像上,來檢查該導引元件所定義的手術位置、形狀及範圍是否精確。由於該咬合板是被牙齒咬合,所以其外型輪廓的設計必須考量到牙齦、牙肉的存在,所以,使用牙模3D影像所顯示出的牙齒及牙模(軟組織)的外型輪廓來設計該咬合板的位置、形狀及範圍,可以提高精確度。而該定位片因為是用來定義手術動刀的具體位置、形狀及範圍,所以,該定位片(包含片體與開窗)的位置、形狀及範圍應該使用該骨骼3D影像所顯示出的骨板的外型輪廓來進行設計,才能提高精確度。 Step 23: According to the reconstructed 3D image obtained in step 22, design the shape and structure of the bite plate, the positioning piece, and the at least one connecting frame of the guide element. Wherein, the way of designing the guide element is to operate the computer-aided 3D design software, according to the shape of the teeth and the dental mold (soft tissue) displayed by the dental mold 3D image in the reconstructed 3D image. Outline, to design the position, shape, and range of the occlusal plate (including the occlusal structure); and to design the positioning piece according to the outline of the bone plate shown by the bone 3D image in the reconstructed 3D image (Including the sheet body and the window) the position, shape, and range; in addition, according to the designed relative position and contour of the bite plate and the positioning piece, designing that the bite can be connected to the bite plate, and It will not affect the position, shape and range of the at least one connecting bracket during the sight and operation during the operation. After the design of the guide element is completed, the 3D design drawing of the guide element can be output and stored as a digital information file, such as, but not limited to, a digital information file with the extension ".STL". In addition, you can also try to combine the 3D design drawings of the guide element, superimpose it on the 3D image of the bone, or the 3D image of the dental mold to check whether the surgical position, shape and range defined by the guide element accurate. Since the occlusal plate is bitten by teeth, the design of its outline must consider the presence of gums and flesh. Therefore, the outline of the teeth and the mold (soft tissue) shown on the 3D image of the dental mold is used to design The position, shape and range of the bite plate can improve accuracy. Because the positioning piece is used to define the specific position, shape, and range of the surgical knife, the position, shape, and range of the positioning piece (including the body and the window) should use the bone shown in the 3D image of the bone. The contour of the board is designed to improve the accuracy.

步驟24:以3D列印的方式製造該導引元件。當完成導引元件的設計後,即可把該導引元件的數位資訊檔輸入至3D列印機,並以3D列印的方式製作出該導引元件的實品。於本實施例中,該導引元件的材質是使用醫療級環氧樹脂類的光固化樹脂材料。藉由3D列印機將膠狀或液態的光固化樹脂逐步列印出該導引元件的外型、同時以特定波長的光(例如但不侷限於紫外光)加以照射使材料固化,可以獲得符合該導引元件的3D設計圖的該導引元件實品。 Step 24: manufacturing the guide element by 3D printing. After the design of the guide element is completed, the digital information file of the guide element can be input to a 3D printer, and the actual product of the guide element can be produced by 3D printing. In this embodiment, the material of the guide element is a medical-grade epoxy-based photo-curable resin material. A 3D printer can be used to gradually print the shape of the light-curing resin in the form of a gel or liquid, and at the same time irradiate the material with a specific wavelength of light (such as but not limited to ultraviolet light) to cure the material. The actual guiding element conforms to the 3D design drawing of the guiding element.

步驟25:消毒。之後,將3D列印出之該導引元件實品進行消毒及其他後續處理,以供正式進行手術時使用。 Step 25: Disinfection. After that, the actual 3D printed guide element is sterilized and other subsequent processed for use in the formal operation.

請參閱圖四及圖五,分別為本發明之牙科手術導引元件的第二實施例的立體示意圖、以及該導引元件第二實施例被人體(病人)咬合時的示意圖。如圖四及圖五所示的第二實施例中,該導引元件是適用於進行壓電性齒槽去皮質骨矯正術(Piezoelectic Alveolar Decortictin For Ortodontic Treatment)的結構。 Please refer to FIGS. 4 and 5, which are schematic perspective views of the second embodiment of the dental surgery guide element according to the present invention, and schematic diagrams of the second embodiment of the guide element when the human body (patient) is engaged. In the second embodiment shown in FIG. 4 and FIG. 5, the guiding element has a structure suitable for performing piezoelectric alveolar decortictin For Ortodontic Treatment.

於第二實施例中,該導引元件30包括:一咬合板31、一定 位片32及至少一連接架33。該咬合板31可供該人體的上、下牙齒93咬合,使該咬合板31被咬合定位於該上、下牙齒93之間。於該咬合板的一塊狀體311的上、下表面分別具有複數咬合結構312,且該複數咬合結構312是分別對應於該上、下牙齒93的形狀與位置。該定位片32包括有一片體321、及貫穿該片體的至少一開窗322。該至少一連接架33是連接於該咬合板31與該定位片32之間,使得該定位片32能被該至少一連接架33支撐並保持在該咬合板31上預定的位置。於第二實施例中,該至少一開窗322是包括複數個上、下方向延伸的細開槽,各該細開槽的位置、形狀與範圍就是進行該齒槽去皮質骨矯正術時需把該人體皮質骨切割的位置、形狀與範圍。此外,於該片體321上更設有複數貫穿小孔323位於各該細開槽322之間。其中,當該咬合板31是被咬合並定位於人體的該上、下牙齒93之間時,該定位片32的片體321是鄰靠於該人體的牙齦組織表面,且該至少一開窗322的位置、形狀與範圍就是進行該齒槽去皮質骨矯正術時需把該人體皮質骨切割、以及使用壓電性震動器施以高速微震動的位置、形狀與範圍。至於該至少一連接架33的形狀與位置,則是以避開該上、下牙齒93上所裝置的牙齒矯正器、且不會遮擋住醫師在切割皮質骨、以及使用壓電性震動器施以高速微震動時的視線範圍為佳。藉由該些細開槽(開窗322),可讓醫師在切割皮質骨、以及使用壓電性震動器施以高速微震動時,可以很明確、精準且毫不猶豫地得知應執行的具體位置、形狀與範圍,避免因執行誤差而傷害到鄰近的牙根。並且,由於在使用壓電性震動器施以高速微震動時會產生熱量,所以,一般在進行高速微震動時都會對手術區域施加水流予以降溫。本發明藉由在各該細開槽(開窗322)之間設置該些貫穿小孔323,可讓降溫用的水流順利流入與流出定位片32,提高降溫的效果。藉此,當醫師進行行壓電性齒槽去皮質骨矯正術時,可直接依據該定位片32之該開窗322(細開槽)的位置、形狀與範圍來進行切割皮質骨及施以高速微震動的操作,無須猜測覆蓋於人體軟組織下方的骨骼或牙根位置、也不會受到血液遮蔽的影響,進而能提高手術精確度、並降低手術後遺症或傷害的發生機率。 In the second embodiment, the guiding element 30 includes an engaging plate 31, a fixed piece 32, and at least one connecting frame 33. The occlusal plate 31 can be used to engage the upper and lower teeth 93 of the human body, so that the occlusal plate 31 is occluded and positioned between the upper and lower teeth 93. A plurality of occlusal structures 312 are respectively provided on the upper and lower surfaces of the one-piece body 311 of the occlusal plate, and the plurality of occlusal structures 312 correspond to the shape and position of the upper and lower teeth 93, respectively. The positioning sheet 32 includes a sheet body 321 and at least one opening window 322 passing through the sheet body. The at least one connecting frame 33 is connected between the engaging plate 31 and the positioning piece 32, so that the positioning piece 32 can be supported by the at least one connecting frame 33 and held at a predetermined position on the engaging plate 31. In the second embodiment, the at least one window 322 includes a plurality of fine slots extending in the upper and lower directions. The position, shape, and range of each of the fine slots are required to perform the alveolar decortical surgery. The position, shape, and extent of cutting the human cortical bone. In addition, a plurality of through-holes 323 are further formed in the sheet body 321 between the fine slots 322. Wherein, when the bite plate 31 is bitten and positioned between the upper and lower teeth 93 of the human body, the sheet body 321 of the positioning piece 32 is adjacent to the surface of the gum tissue of the human body, and the at least one window is opened The position, shape, and range of 322 are the positions, shapes, and ranges of cutting the human cortical bone and applying a high-speed micro-vibration using a piezoelectric vibrator during the alveolar decortical bone correction. As for the shape and position of the at least one connecting frame 33, it is to avoid the orthodontics installed on the upper and lower teeth 93, and not to block the doctor from cutting the cortical bone, and using a piezoelectric vibrator to apply The line of sight during high-speed micro-vibration is better. With these fine slots (windows 322), doctors can be clear, precise, and hesitant to know the specifics to be performed when cutting cortical bone and applying high-speed micro-vibrations using a piezoelectric vibrator. Position, shape, and extent to avoid damage to adjacent roots due to execution errors. In addition, since a high-speed micro-vibration is generated by using a piezoelectric vibrator, heat is generated. Therefore, when a high-speed micro-vibration is performed, a water flow is generally applied to the operating area to cool down. In the present invention, the through-holes 323 are provided between the fine slots (windows 322), so that the cooling water flow can smoothly flow into and out of the positioning piece 32, and the cooling effect is improved. Therefore, when the doctor performs piezoelectric alveolar decortical orthopedics, the cortical bone can be cut and applied directly according to the position, shape and range of the window 322 (fine slot) of the positioning sheet 32. The operation of high-speed micro-vibration does not need to guess the position of the bones or roots covered under the soft tissue of the human body, and it will not be affected by blood shielding, which can improve the accuracy of the operation and reduce the incidence of sequelae or injuries.

唯以上所述之實施例不應用於限制本發明之可應用範圍,本發明之保護範圍應以本發明之申請專利範圍內容所界定技術精神及其均等 變化所含括之範圍為主者。即大凡依本發明申請專利範圍所做之均等變化及修飾,仍將不失本發明之要義所在,亦不脫離本發明之精神和範圍,故都應視為本發明的進一步實施狀況。 However, the above-mentioned embodiments should not be used to limit the applicable scope of the present invention. The protection scope of the present invention should be the scope encompassed by the technical spirit defined by the scope of patent application of the present invention and its equivalent changes. That is to say, all equal changes and modifications made in accordance with the scope of the patent application of the present invention will still not lose the essence of the present invention, nor depart from the spirit and scope of the present invention, so they should be regarded as the further implementation status of the present invention.

Claims (10)

一種手術導引元件的製法,該導引元件是適用於一手術操作,該製法包括:步驟(A):取得將進行該手術操作之一目標物的至少兩3D影像;所述之該至少兩3D影像是包括:該目標物的一骨骼的3D影像、以及該目標物包含一軟組織的3D影像;步驟(B):重組該目標物的該骨骼的3D影像以及該軟組織的3D影像,以獲得可同時顯現出該目標物之該骨骼及該軟組織的輪廓的一重組後的3D影像;其中,步驟(B)更包括有下列步驟:步驟(B1):判定該目標物的一骨骼密度範圍;以及步驟(B2):依據該骨骼密度範圍來重組該目標物的該骨骼的3D影像以及該軟組織的3D影像;其中,該重組後的3D影像是藉由將該軟組織的3D影像疊合於該骨骼的3D影像所獲得;步驟(C):依據步驟(B)所獲得的該重組後的3D影像,設計該導引元件;以及步驟(D):以3D列印的方式製造該導引元件。     A method for manufacturing a surgical guide element, the guide element is suitable for a surgical operation, the manufacturing method includes: step (A): obtaining at least two 3D images of a target object to be subjected to the surgical operation; said at least two The 3D image includes: a 3D image of a bone of the target, and a 3D image of the target including a soft tissue; step (B): reconstructing the 3D image of the bone of the target and the 3D image of the soft tissue to obtain A reconstructed 3D image of the skeleton of the target and the contour of the soft tissue can be simultaneously displayed; wherein step (B) further includes the following steps: Step (B1): determine a bone density range of the target; And step (B2): reconstructing the 3D image of the bone of the target object and the 3D image of the soft tissue according to the bone density range; wherein the reconstructed 3D image is superimposed on the 3D image of the soft tissue by Obtaining a 3D image of a bone; step (C): designing the guiding element according to the recombined 3D image obtained in step (B); and step (D): manufacturing the guiding element by 3D printing .     如申請專利範圍第1項所述之手術導引元件的製法,其中,於步驟(D)中,當依據步驟(C)完成該導引元件的設計後,即可把該導引元件的一數位資訊檔輸入至一3D列印機,並以3D列印的方式製作出該導引元件;其中,該導引元件的材質是使用醫療級環氧樹脂類的一光固化樹脂材料,藉由該3D列印機將膠狀或液態的該光固化樹脂逐步列印出該導引元件的外型、同時以特定波長的光加以照射使材料固化,可以獲得該導引元件。     According to the method for manufacturing a surgical guide element according to item 1 of the scope of patent application, in step (D), after completing the design of the guide element according to step (C), one of the guide elements can be The digital information file is input to a 3D printer, and the guide element is made by 3D printing. The material of the guide element is a photo-curable resin material made of medical-grade epoxy resin. The 3D printer prints the shape of the light-curing resin in a gel or liquid state gradually, and simultaneously irradiates the light with a specific wavelength of light to cure the material, so that the light-curing resin can be obtained.     如申請專利範圍第1項所述之手術導引元件的製法,其中,該導引元件是包括一板、一定位片及至少一連接架;其中,該板可被定位以進行該手術操作;該定位片包括有一片體、及貫穿該片體的至少一開窗;該至少一連接架是連接於該板與該定位片之間;其中,當該板是被定位時,該定位片的片體是鄰靠於該目標物的一組織表面、且該至少一開窗的位 置就是將被進行手術的位置。     The method for manufacturing a surgical guide element according to item 1 of the scope of patent application, wherein the guide element includes a plate, a positioning piece, and at least one connecting bracket; wherein the plate can be positioned to perform the surgical operation; The positioning sheet includes a sheet body and at least one opening window penetrating through the sheet body; the at least one connecting frame is connected between the board and the positioning sheet; wherein when the board is positioned, the positioning sheet The sheet body is adjacent to a tissue surface of the target object, and the position of the at least one window is the position where the operation will be performed.     如申請專利範圍第3項所述之手術導引元件的製法,其中,於步驟(C)中,所述設計該導引元件的方式,是依據該軟組織的3D影像來設計該板,並依據該骨骼的3D影像來設計該定位片,且依據所設計出之該板及該定位片來設計能把該定位片連接於該板、且又不會影響手術時的視線與操作過程的該至少一連接架     The method for manufacturing a surgical guide element according to item 3 of the scope of patent application, wherein in step (C), the method of designing the guide element is to design the board based on the 3D image of the soft tissue, and The positioning piece is designed based on the 3D image of the bone, and the at least the positioning piece can be connected to the plate according to the designed plate and the positioning piece without affecting the sight line and operation process during the operation. A connector     如申請專利範圍第3項所述之手術導引元件的製法,其中,該手術操作是人體的牙科相關手術操作,且該軟組織的3D影像是一牙模3D影像。     The method for manufacturing a surgical guide element according to item 3 of the scope of patent application, wherein the surgical operation is a dental-related surgical operation of a human body, and the 3D image of the soft tissue is a 3D image of a dental mold.     如申請專利範圍第5項所述之手術導引元件的製法,其中,於步驟(A)中,該骨骼的3D影像是藉由一斷層掃描機進行斷層掃描的方式獲得,且該牙模3D影像是藉由以下其中之一方式獲得:以一口腔3D掃描器進行掃描、或是先取得一牙弓模型後再對該牙弓模型進行3D掃描;其中,該牙模3D影像與該骨骼的3D影像都包含至少一牙齒的影像;並且,於步驟(B)中,該重組後的3D影像是藉由將該牙模3D影像所包含之至少一該牙齒的影像對準於該骨骼的3D影像所包含之至少一相同該牙齒的影像所獲得。     The method for manufacturing a surgical guide element according to item 5 of the scope of patent application, wherein in step (A), the 3D image of the bone is obtained by means of tomographic scanning by a tomography scanner, and the dental mold is 3D The image is obtained by one of the following methods: scanning with an oral 3D scanner, or obtaining a dental arch model and then performing 3D scanning on the dental arch model; wherein the 3D image of the dental mold and the bone The 3D images all include images of at least one tooth; and, in step (B), the reconstructed 3D image is aligned with the 3D of the bone by aligning the image of at least one of the teeth included in the dental mold 3D image. The image contains at least one image of the same tooth.     如申請專利範圍第5項所述之手術導引元件的製法,其中,該板是可供人體的上、下牙齒咬合的一咬合板;於步驟(C)中,所述設計該導引元件的方式,是依據該牙模3D影像來設計該咬合板,並依據該骨骼的3D影像來設計該定位片,且依據所設計出之該咬合板及該定位片來設計能把該定位片連接於該咬合板、且又不會影響手術時的視線與操作過程的該至少一連接架。     The method for manufacturing a surgical guide element according to item 5 of the scope of patent application, wherein the plate is an occlusal plate that can be used for the upper and lower teeth of the human body; in step (C), the guide element is designed The method is to design the occlusal plate based on the 3D image of the dental mold, design the positioning piece according to the 3D image of the bone, and design the occlusal plate to be connected according to the designed occlusal plate and the positioning piece. The at least one connecting bracket on the occlusal plate without affecting the sight and operation during the operation.     如申請專利範圍第7項所述之手術導引元件的製法,其中,該咬合板的上、下表面分別具有複數咬合結構;該複數咬合結構是分別對應於該上、下牙齒的形狀與位置。     The method for manufacturing a surgical guide element according to item 7 of the scope of patent application, wherein the upper and lower surfaces of the occlusal plate respectively have a plurality of occlusal structures; the plurality of occlusal structures respectively correspond to the shape and position of the upper and lower teeth. .     如申請專利範圍第7項所述之手術導引元件的製法,其中,該導引元件是適用於進行一側窗鼻竇增高術;該定位片之該片體的位置是鄰靠於該人體的上顎鼻竇外的該組織表面,且該至少一開窗的位置、形狀與範圍就是進行該側窗鼻竇增高術時需把該人體骨板開孔的位置、形狀與範圍。     The method for manufacturing a surgical guide element according to item 7 of the scope of patent application, wherein the guide element is suitable for performing side window sinus augmentation; the position of the sheet body of the positioning sheet is adjacent to the human body The surface of the tissue outside the maxillary sinuses, and the position, shape, and scope of the at least one window opening are the positions, shapes, and ranges of the human bone plates that need to be perforated during the side window sinus augmentation.     如申請專利範圍第7項所述之手術導引元件的製法,其中,該導引元件 是適用於進行一齒槽去皮質骨矯正術;該至少一開窗是包括複數個上、下方向延伸的細開槽,各該細開槽的位置、形狀與範圍就是進行該齒槽去皮質骨矯正術時需把該人體皮質骨切割的位置、形狀與範圍;此外,於該片體上更設有複數貫穿小孔位於各該細開槽之間。     The method for manufacturing a surgical guide element according to item 7 of the scope of patent application, wherein the guide element is suitable for performing alveolar decortical orthopedic surgery; the at least one opening window includes a plurality of upward and downward extensions The position, shape and range of each fine slot is the position, shape and range of the human cortical bone that needs to be cut during the alveolar decortical orthopedic correction. In addition, it is further provided on the sheet. A plurality of through-holes are located between each of the fine slots.    
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