本創作係關於一種導航裝置，特別是指一種可反映植入物與器械於空間中之相對關係以輔助器械施用之導航裝置。
The present invention relates to a navigation device, and more particularly to a navigation device that reflects the relative relationship of the implant to the device in space to aid in the application of the device.
骨折為醫學臨床上常見的創傷，一般骨科手術對骨折的處理方式會先透過外力將骨折部位的骨頭復位，再利用固定器固定骨折部位，以使骨折部位保持在較佳的癒合位置，避免骨頭癒合後留下肢體變形之後遺症。
用於植入骨折部位以固定骨頭的植入型固定器稱為骨板，目前又以鎖固型骨板為最大宗，傳統上將鎖固型骨板植入骨折部位的手術稱為開創復位內固定法（open reduction internal fixation，ORIF），此種方式需將骨折部位附近的組織沿骨板上鎖固孔的分布方向切開，並以鑽頭對應鎖固孔在骨頭上鑽孔，再將鎖固型骨釘鎖入鎖固孔及骨頭內，以將骨板固定於骨折部位，其優點在於具有良好的手術視野以及提供較佳的機械穩定性，但由於第一創口較大，容易引發感染、延遲癒合等副作用。
為使骨板植入手術所需的第一創口縮小，醫學界導入微創手術的概念，發展出微創內固定系統（less invasive stabilization system，LISS）來進行骨板植入手術，此種方式僅需於骨折部位切開大小足夠植入骨板之第一創口，將骨板植入後，可利用組裝於骨板的導引裝置導引手術器械對應鎖固孔的位置於體表開出鎖固骨釘所需之第一創口，以使鑽頭進入鑽孔並導引骨釘鎖入，而不需大範圍地切開組織，除了用於將骨板植入之第一創口範圍較大以外，其餘第一創口僅需足夠將骨釘鎖入，因此相對於傳統的ORIF手術，LISS手術第一創口小、可降低感染機會、使癒合速度較快且留下的疤痕較不明顯，而逐漸成為主流的骨板植入手術方式。
然，由於人體組織較軟且具有較大的彈性，容易使得導引裝置發生偏斜而影響鑽頭鑽入體表以及骨釘鎖入骨板之位置和角度，因此，臨床上也發展出可用於骨科手術的導航裝置，利用定位裝置碰觸骨頭以對骨頭進行定位與尺寸量測，並以電腦依據骨頭的尺寸模擬骨頭的三維立體影像，並可配合斷層掃描或一般光學鏡頭拍攝的實體影像輔助骨科手術的進行，不過由於此種導航裝置僅能模擬骨頭的立體影像，無法顯示骨板等植入物被植入手術部位後的位置與角度，因此僅能作為將植入物植入手術部位時的位置參考，無法於後續固定植入物時導引手術器械到對應植入物固定處的手術部位組織，目前此種導航裝置多用於脊椎重建手術或人工關節替換手術，而少見於骨板植入手術。
此外，不管是使用ORIF或LISS系統進行骨板植入手術，在鎖入骨釘之前，都需先使用套筒插於鎖固孔中以導引鑽頭於正確位置與角度對骨頭鑽孔，之後再以深度器量測鑽孔深度，以決定隨後使用之骨釘尺寸，因此必須於每一個鎖固孔反覆下刀、架設套筒、鑽孔、測量尺寸與鎖固骨釘，手續繁雜，也使得所需的手術時間與麻醉時間延長，使手術執行人員負荷與手術風險皆隨之升高。
有鑑於此，本創作提供一種導航裝置，跳脫傳統骨科手術中以手術部位骨頭作為定位對象的觀念，而改為定位植入物與需施用的器械，並顯示其於空間中之相對位置，以導引器械對應於已植入的植入物而正確地施用於施用部位：使用時首先顯示先行建立於器械導航元件之植入物參數資料，隨後由導航裝置定位植入物與所需施用的器械，再依植入物參數資料與定位結果進行顯示，另外也可將計算得到的植入物與器械相對距離、相對角度、操作指示以及定位提示等資訊反映給操作人員，以導引器械的施用。由於本創作提供的裝置是以植入物與需施用的器械作為定位對象，可解決習知技術中將骨頭作為定位對象而無法得知植入物確切位置以及相對於植入物的器械施用部位等問題，而可不藉助習知微創手術中的導引裝置找到對應鎖固孔的部位下刀做出第一創口，也不需以套筒導引鑽頭以確保鑽頭鑽入骨頭的角度正確，且可省略以深度器量測鑽孔深度的步驟，利用導航裝置直接進行引導，而達到簡化操作步驟、提升操作可信賴度、減輕操作執行人員負擔以及降低操作風險等效果。
Fracture is a common clinical trauma. In general, orthopedic surgery treats the fracture by first removing the bone at the fracture site by external force, and then fixing the fracture site with a fixator to keep the fracture site in a better healing position and avoid bones. After healing, the sequelae of limb deformation are left behind.
The implant-type fixator for implanting the fracture site to fix the bone is called the bone plate. At present, the lock-type bone plate is the largest. The surgery for inserting the lock-type bone plate into the fracture site is called the initiation reduction. Open reduction (ORIF), in this way, the tissue near the fracture site should be cut along the distribution direction of the locking hole on the bone plate, and the hole should be drilled in the bone corresponding to the locking hole, and then the lock The solid bone nail is locked into the locking hole and the bone to fix the bone plate to the fracture site. The advantage is that it has a good surgical field of view and provides better mechanical stability, but it is easy to cause infection because the first wound is large. Delayed healing and other side effects.
In order to reduce the first wound required for bone plate implantation, the medical community introduced the concept of minimally invasive surgery and developed a minimal invasive stabilization system (LISS) for bone plate implantation. Only the first wound of the bone plate is inserted into the fracture site, and after the bone plate is implanted, the guiding device assembled on the bone plate can be used to guide the position of the surgical instrument corresponding to the locking hole to open the lock on the body surface. The first wound required for the bone nail to allow the drill bit to enter the borehole and guide the bone nail to lock in without the need to extensively incise the tissue, except for the larger range of the first wound for implanting the bone plate. The remaining first wounds only need to be enough to lock the nails. Therefore, compared with the traditional ORIF surgery, the first wound of the LISS operation is small, which can reduce the chance of infection, make the healing faster and the scars are less obvious, and gradually become Mainstream bone plate implantation surgery.
However, due to the softness of the human tissue and the greater elasticity, it is easy to cause the guiding device to deflect and affect the position and angle of the drill bit into the body surface and the bone nail locking into the bone plate. Therefore, it is also clinically developed for orthopedics. The navigation device of the operation uses the positioning device to touch the bone to position and measure the bone, and simulates the three-dimensional image of the bone according to the size of the bone by the computer, and can assist the orthopedics with the solid image captured by the tomography or the general optical lens. The operation is performed, but since the navigation device can only simulate the stereoscopic image of the bone and cannot display the position and angle of the implant after the implant is implanted into the surgical site, it can only be used when implanting the implant into the surgical site. The positional reference cannot guide the surgical instrument to the surgical site of the corresponding implant fixation at the time of fixing the implant. Currently, the navigation device is mostly used for spinal reconstruction or artificial joint replacement surgery, and is rarely found in bone grafting. Into the surgery.
In addition, whether using the ORIF or LISS system for bone plate implantation, before locking the nail, it is necessary to insert the sleeve into the locking hole to guide the drill bit to drill the hole at the correct position and angle, and then The depth of the hole is measured by the depth gauge to determine the size of the bone nail to be used later. Therefore, it is necessary to repeatedly cut the knife, erect the sleeve, drill the hole, measure the size and lock the nail in each of the locking holes, and the procedure is complicated. The required operative time and anesthesia time are prolonged, which increases the risk of surgery executives and surgery.
In view of this, the present invention provides a navigation device that breaks away the concept of using the bone of the surgical site as a positioning object in the conventional orthopedic surgery, and instead locates the implant and the device to be applied, and displays its relative position in the space. The guiding device is correctly applied to the application site corresponding to the implanted implant: firstly, the implant parameter data established prior to the device navigation element is first displayed, and then the implant is positioned by the navigation device and the desired application The device is then displayed according to the implant parameter data and the positioning result, and the calculated relative distance, relative angle, operation indication and positioning prompt of the implant and the instrument can also be reflected to the operator to guide the device. Application. Since the device provided by the present invention is based on the implant and the device to be applied, the prior art can solve the problem that the bone is used as the positioning object and the exact position of the implant and the device application site relative to the implant cannot be known. The problem is that the first wound can be made by the lower knife without the aid of the guiding device in the conventional minimally invasive surgery, and the drill bit is not required to guide the drill bit to ensure the angle of the drill bit into the bone is correct. The step of measuring the drilling depth by the depth device can be omitted, and the guiding device can be directly guided by the navigation device, thereby achieving the effects of simplifying the operation steps, improving the operation reliability, reducing the burden on the operation operator, and reducing the operation risk.
本創作之目的，在於提供一種導航裝置，，其可利用器械導航元件取得對應植入物與器械之定位資料，並配合預先儲存之植入物參數資料顯示定位結果，反映植入物與器械之相對位置。
為達上述之目的，本創作提出一種導航裝置，其包含一植入物、一器械以及一器械導航元件，該植入物包含一第一定位資料，該器械包含一第二定位資料，該導航裝置包含一記憶單元、一定位單元以及一處理單元，配合上述導航裝置使用步驟，該記憶單元中儲存有一第一參數資料，該定位單元可接收或讀取該第一定位資料與該第二定位資料並傳送該第一定位資料與該第二定位資料至該處理單元，該處理單元分別連接於該記憶單元與該定位單元，取得該第一參數資料、該第一定位資料與該第二定位資料後即依據該第一參數資料、該第一定位資料與該第二定位資料進行運算以產生一運算結果，最後使該顯示單元顯示該運算結果，以反映該植入物與該器械於空間中之相對關係。
為達上述之目的，本創作提出一種導航裝置，包含一植入物、一定位件、一器械以及一器械導航元件，該定位件設置於該植入物並包含一第一定位資料，該器械包含一第二定位資料，該導航裝置包含一記憶單元、一定位單元以及一處理單元，配合上述導航裝置使用步驟，該記憶單元中儲存有一第一參數資料，該定位單元可接收或讀取該第一定位資料與該第二定位資料並傳送該第一定位資料與該第二定位資料至該處理單元，該處理單元分別連接於該記憶單元與該定位單元，取得該第一參數資料、該第一定位資料與該第二定位資料後即依據該第一參數資料、該第一定位資料與該第二定位資料進行運算以產生一運算結果，最後使該顯示單元顯示該運算結果，以反映該植入物與該器械於空間中之相對關係。
The purpose of the present invention is to provide a navigation device that can use the device navigation component to obtain the positioning data of the corresponding implant and the instrument, and display the positioning result with the pre-stored implant parameter data to reflect the implant and the device. relative position.
In order to achieve the above object, the present invention provides a navigation device comprising an implant, an instrument and a device navigation component, the implant comprising a first positioning data, the device comprising a second positioning data, the navigation The device includes a memory unit, a positioning unit, and a processing unit. The navigation unit stores a first parameter data, and the positioning unit can receive or read the first positioning data and the second positioning. And transmitting the first positioning data and the second positioning data to the processing unit, the processing unit is respectively connected to the memory unit and the positioning unit, and obtains the first parameter data, the first positioning data, and the second positioning After the data, the first parameter data, the first positioning data and the second positioning data are operated to generate an operation result, and finally the display unit displays the operation result to reflect the implant and the device in space. The relative relationship between them.
In order to achieve the above purpose, the present invention provides a navigation device comprising an implant, a positioning member, an instrument and a device navigation component, the positioning component being disposed on the implant and comprising a first positioning material, the device The navigation device includes a memory unit, a positioning unit, and a processing unit. The navigation unit stores a first parameter data, and the positioning unit can receive or read the navigation unit. Transmitting the first positioning data and the second positioning data to the processing unit, the processing unit is respectively connected to the memory unit and the positioning unit, and obtains the first parameter data, the After the first positioning data and the second positioning data, the first parameter data, the first positioning data and the second positioning data are calculated to generate an operation result, and finally the display unit displays the operation result to reflect The relative relationship of the implant to the device in space.
茲為使 貴審查委員對本創作之結構特徵及所達成之功效有更進一步之瞭解與認識，謹佐以較佳之實施例及配合詳細之說明，說明如後：
本創作之導航裝置之特色在於：以植入施用部位之植入物與需施用於該部位之器械作為定位對象並配合預先儲存之植入物參數資料，顯示植入物與器械於空間中之相對關係，克服習知技術中無法得知植入物確切位置而不利調整器械施用位置之技術問題，故可引導操作人員調整器械之位置，以輔助器械之施用。
請一併參閱第一圖與第二圖，其係本創作第一實施例之實施流程圖與元件示意圖；如第一圖所示，本創作之導航裝置使用步驟係包含：
步驟ST1：顯示預先儲存之一植入物之一第一參數資料；
步驟ST2：取得對應該植入物之一第一定位資料；
步驟ST3：取得對應一器械之一第二定位資料；及
步驟ST4：顯示對應於該第一參數資料之一第二定位資料。
如第二圖所示，本創作之導航裝置係實施於一施用部位2，該導航裝置係包含一器械導航元件1、一植入物3以及一器械4；該器械導航元件1包含一記憶單元10、一定位單元12、一處理單元14以及一顯示單元16，並以該處理單元14為中心，分別與該記憶單元10、該定位單元12以及該顯示單元16相連結，該記憶單元10預先儲存有對應該植入物3之一第一參數資料S1。
步驟ST1中，該顯示單元16顯示預先儲存於該記憶單元10之該第一參數資料S1；步驟ST2中，該定位單元12取得對應於該植入物3之該第一定位資料S2並傳送該第一定位資料S2至該處理單元14；步驟ST3中，該定位單元12取得對應於該器械4之該第二定位資料S3並傳送該第二定位資料S3至該處理單元14，使該處理單元14獲得該第二定位資料S3並可依據該第二定位資料S3、該第一定位資料S2以及該第一參數資訊S1進行運算而得到一運算結果R1；步驟ST4中，該顯示單元16即顯示該運算結果R1，而對應該第一參數資料S1顯示該第二定位資料S3；即，於操作人員將該植入物3植入該施用部位2，以及於施用部位2施用該器械4之過程中，該顯示單元16可對應該第一參數資料S1顯示該第二定位資料S3以反映出該器械4與該植入物3於空間中之相對位置，協助操作人員於該施用部位2中找到施用該器械4之正確位置。
再參閱第一圖，步驟ST3該處理單元14取得該器械4對應之該第二定位資料S3後至該顯示單元16顯示對應於該第一參數資料S1之該第二定位資料S3前，可進一步包含一步驟：
步驟ST40：該處理單元依該第一定位資料與該第二定位資料計算該植入物與該器械間之一相對位置與一相對角度。
該第一定位資料S2包含一第一座標P1，該第二定位資料S3包含一第二座標P2，該第一座標P1與該第二座標P2皆可為一平面座標、一空間座標或一角座標，該處理單元14依該第一定位資料S2與該第二定位資料S3計算所得到之該運算結果R1包含一相對位置S4與一相對角度S5，且同樣可由該顯示單元16顯示，以提供操作人員作為施用該器械4之參考。
復參閱第一圖，該步驟ST40後可進一步包含：
步驟ST50：該處理單元分別比對該相對距離與一預設距離以及該相對角度與一預設角度，並發出一操作指示；
步驟ST60：該處理單元判斷該相對距離符合該預設距離且該相對角度符合該預設角度；及
步驟ST61：該處理單元發出一定位提示。
前述步驟ST4與ST40中，當操作人員對應該顯示單元16顯示之該第二定位資訊S3、該相對位置S4以及該相對角度S5調整該器械4時，該定位單元可12即時接收該第二定位資訊S3並定位該器械4，該處理單元14即持續更新該第二定位資訊S3，配合該第一定位資訊S2與該第一參數資訊S1進行運算，計算出即時之該相對距離S4與該相對角度S5。
於步驟ST50中，該處理單元14可將該相對距離S4與一預設距離進行比對，且將該相對角度S5與一預設角度進行比對，並依比對結果發出一操作指示S8，指示該器械4應移動之距離與方向，該操作指示S8可顯示於該顯示單元16，以引導操作人員將該器械4調整至適當之施用位置與角度，如前述，步驟ST50亦為一即時反應之步驟，隨著該器械4之移動調整而更新該操作指示S8；步驟ST60中，當該處理單元14判斷該相對距離S4符合該預設距離且該相對角度S5符合該預設角度時，即進入步驟ST61，該處理單元14發出一定位提示S6，該定位提示S6可顯示於該顯示單元16，以告知操作人員此時該器械4即位於最適當之施用位置與角度，操作人員即可就該器械4所處之位置及角度施用該器械4，若該處理單元14並未判斷該相對距離S4符合該預設距離且該相對角度S5符合該預設角度，則可持續進行步驟ST50，至操作人員將該器械4調整至適當施用位置，而進行步驟ST61為止。
請繼續參閱第二圖，該記憶單元10可進一步儲存有該器械4之一第二參數資料S7，於步驟ST40中，該處理單元14即可依據該第二參數資料S7與前述該第一參數資料S1、該第一定位資料S2、該第二定位資料S3共同運算出該運算結果R1，可使該處理單元14更能掌握該器械4於空間中之位置或外形，而得到更完善之器械導航效果。
此外，該器械導航元件1可進一步包含一語音單元17與一輔助影像單元18：該語音單元17係與該處理單元14相連接，並播放該處理單元14運算得到之該運算結果R1，如該相對距離S4、該相對角度S5，以及該操作指示S8、該定位提示S6；該輔助影像單元18則可拍攝該施用部位2之一第三影像S9，該第三影像S9可為一光學影像或一斷層掃描影像，該顯示單元16亦可顯示該第三影像S9，以輔助操作人員施用該器械4。
本創作之導航裝置中使用之該植入物可分為兩種，一種包含該第一定位資料，另一種不包含該第一定位資料，而需另外使用一定位件，該定位件包含該第一定位資料，且設置於該植入物；另，該定位單元取得該第一定位資料與該第二定位資料之方式有兩種，一種由該植入物或該定位件與該器械主動發出該第一定位資料與該第二定位資料，而由該定位單元接收，另一種方式中該植入物或該定位件與該器械不具有主動發出訊號之能力，而由該定位單元主動讀取該第一定位資料與該第二定位資料；由上述兩種機構上的差異交叉搭配，而使本創作之導航裝置至少包含以下四種實施態樣。
請一併參閱第三A圖及第三B圖，其係本創作第二實施例之實施流程圖與元件示意圖；如第三A圖所示，本實施例中導航裝置使用之步驟與第一實施例大致相同：
步驟ST1：顯示預先儲存之一植入物之一第一參數資料；
步驟ST21：接收該植入物發出之一第一定位資料；
步驟ST31：接收一器械發出之一第二定位資料；
步驟ST40：該處理單元依該第一定位資料與該第二定位資料計算該植入物與該器械間之一相對位置與一相對角度；
步驟ST50：該處理單元分別比對該相對距離與一預設距離以及該相對角度與一預設角度，並發出一操作指示；
步驟ST60：該處理單元判斷該相對距離符合該預設距離且該相對角度符合該預設角度；及
步驟ST61：該處理單元發出一定位提示。
如第三B圖所示，本實施例中該植入物3係為鎖固式之一骨板，該第一參數資料S1即包含該骨板之長、寬、高、鎖固孔數量、鎖固孔位置以及一第一影像I1，該器械4則為一手術刀，該第二參數資料S7即包含該手術刀之長、寬、高。
步驟ST1中，該顯示單元16顯示預先儲存於該記憶單元10之該第一參數資料S1包含之該第一影像I1，該第一影像I1係模擬該植入物3之外觀。
步驟ST21中，由操作人員將該植入物3經由一第一創口20植入該施用部位2，並由該第一創口20鎖入複數固定件30，使該植入物3固定於該施用部位內2之至少一骨頭22，該些固定件30即為鎖固式之複數骨釘，本實施例中該植入物3包含該第一參數資料S1且可主動發出該第一參數資料S1，該定位單元12接收該植入物3發出之該第一定位資料S2並傳送該第一定位資料S2至該處理單元14，該處理單元14即獲得該第一定位資料S2並對該第一參數資料S1進行定位，以利後續獲得該第二定位資料S3時計算及模擬該植入物3與該器械4於空間中之相對位置，其中該第一定位資料S2包含一第一座標P1，本實施例中該第一座標P1為一空間座標，而可細分為一第一X座標P1x、一第一Y座標P1y以及一第一Z座標P1z，該植入物3可同時發送該第一X座標P1x、該第一Y座標P1y以及該第一Z座標P1z，使該處理單元14經由該定位單元12取得該植入物3於空間中之位置。
步驟ST31中，操作人員於該施用部位2使用該器械4，本實施例中該器械4包含該第二參數資料S7且可主動發出該第二參數資料S7，該定位單元12接收該器械4發出之該第二定位資料S3並傳送該第二定位資料S3至該處理單元14，該處理單元14即獲得該第二定位資料S3，其中該第二定位資料S3包含一第二座標P2，本實施例中該第二座標P2為一空間座標，而可細分為一第二X座標P2x、一第二Y座標P2y以及一第二Z座標P2z，該器械4可同時發送該第二X座標P2x、該第二Y座標P2y以及該第二Z座標P2z，使該處理單元14經由該定位單元12取得該器械4於空間中之位置資訊，以用於後續之運算過程。
步驟ST40中，該處理單元14即可將該第一參數資訊S1、該第二參數S7、該第一定位資料S2以及該第二定位資料S3加以運算而得到一運算結果R1，該運算結果R1包含一相對位置S4與一相對角度S5。
步驟ST4中，該顯示單元16即顯示該運算結果R1，該運算結果R1包含該相對位置S4與該相對角度S5，並顯示相對於該第一參數資料S1之該第二定位資料S3，該第二定位資料S3可隨該器械4之移動而變動，如圖所示，該第二定位資料S3包含一第二影像I2，且該第二影像I2可模擬該器械4之外觀，且該第二影像I2之顯示位置對應該第一影像I1，而可反映出該器械4與該植入物3於空間中之相對位置，除了影像之變動以外，該第二座標P2所包含之該第二X座標P2x、該第二Y座標P2y以及該第二Z座標P2z等數值亦會隨著該器械4之移動而變動。
後續步驟ST50至步驟ST61與第一實施例大致相同，在此即不多作贅述，透過本實施例之實施，操作人員可透過該顯示單元16顯示之該運算結果R1包含之第一參數資訊S1與相對於該第一參數資訊S1之該第二定位資訊S3，獲得該骨板與該手術刀之相對位置，以對照該顯示單元顯示之該第一影像I1與該第二影像I2或該操作指示S8調整該手術刀之位置，到達該施用部位2之一體表24上對應該式骨板上之一鎖固孔32之位置時，該顯示單元16可顯示該處理單元14發出之一定位提示S6，操作人員即可於此時該手術刀下方之該體表24下刀，產生一第二創口240，以便後續將一骨釘鎖入該骨板中。
請參考第四A圖及第四B圖，其係本創作第三實施例之實施流程圖與元件示意圖；如第四A圖所示，本實施例中導航裝置使用之步驟與第二實施例大致相同：
步驟ST1：顯示預先儲存之一植入物之一第一參數資料；
步驟ST22：讀取該植入物之一第一定位資料；
步驟ST32：讀取一器械之一第二定位資料；
步驟ST40：該處理單元依該第一定位資料與該第二定位資料計算該植入物與該器械間之一相對位置與一相對角度；
步驟ST50：該處理單元分別比對該相對距離與一預設距離以及該相對角度與一預設角度，並發出一操作指示；
步驟ST60：該處理單元判斷該相對距離符合該預設距離且該相對角度符合該預設角度；及
步驟ST61：該處理單元發出一定位提示。
如第四B圖所示，本實施例中該植入物3係為鎖固式之一骨板，該第一參數資料S1即包含該骨板之長、寬、高、鎖固孔數量、鎖固孔位置以及一第一影像I1，該器械4則為一手術刀，該第二參數資料S7即包含該手術刀之長、寬、高。另，與第二實施例不同，本實施例中該植入物3與該器械4無法主動發出訊號，需以該定位單元12主動讀取該第一定位資料S2與該第二定位資料S3，該定位單元12延伸出二線路，其中一線路之末端包含一探針120，另一線路之末端則連接於該器械4。
步驟ST1如第二實施例，步驟ST22中植入該骨板後操作人員需以該探針120接觸印刷於該骨板上之一定位標記36，才能使該定位裝置12讀取該第一定位資料S2，該第一定位資料S2包含一第一座標P1，該第一座標P1為一空間座標，而可細分為一第一X座標P1x、一第一Y座標P1y以及一第一Z座標P1z，該定位單元12可於該探針120接觸該定位標記36時，由該植入物3同時讀取該第一X座標P1x、該第一Y座標P1y以及該第一Z座標P1z，並傳送至該處理單元14，使該處理單元14經由該定位單元12取得該植入物3於空間中之位置；步驟ST32中該定位單元12可由連接於該手術刀之線路讀取該第二定位資料S3，該第二定位資料S3包含一第二座標P2，該第二座標P2為一空間座標，而可細分為一第二X座標P2x、一第二Y座標P2y以及一第二Z座標P2z，該定位單元12可由與該器械4相連接之導線同時讀取該第二X座標P2x、該第二Y座標P2y以及該第二Z座標P2z，並傳送至該處理單元14，使該處理單元14經由該定位單元12取得該器械4於空間中之位置。
後續步驟S40至步驟ST61與第二實施例大致相同，在此不多作贅述，本創作可選擇使該植入物3主動發送該第一定位資料S2或被動由該定位單元12讀取，而皆可達到器械導航之功效。
如前所述，該植入物可分為兩種，一種包含該第一定位資料，另一種不包含該第一定位資料，而需另外將包含該第一定位資料之一定位件設置於該植入物，而有以下兩種實施態樣。
請參考第五A圖及第五B圖，其係本創作第四實施例之實施流程圖及元件示意圖；如第五A圖所示，本實施例中手術導航裝置使用之步驟與第二實施例大致相同：
步驟ST1：顯示預先儲存之一植入物之一第一參數資料；
步驟ST23：將一定位件設置於該植入物，接收該定位件發出之一第一定位資料；
步驟ST31：接收一手術器械之一第二定位資料；
步驟ST40：該處理單元依該第一定位資料與該第二定位資料計算該植入物與該器械間之一相對位置與一相對角度；
步驟ST50：該處理單元分別比對該相對距離與一預設距離以及該相對角度與一預設角度，並發出一操作指示；
步驟ST60：該處理單元判斷該相對距離符合該預設距離且該相對角度符合該預設角度；及
步驟ST61：該處理單元發出一定位提示。
如第五B圖所示，本實施例中該植入物3係為鎖固式之一骨板，該第一參數資料S1即包含該骨板之長、寬、高、鎖固孔數量、鎖固孔位置以及一第一影像I1，該器械4則為鎖固式且具有自攻螺紋之一骨釘，該第二參數資料S7即包含該骨釘之長、寬、高或半徑、長度，其中該植入物3不包含該第一定位資料S2，故，本實施例中該導航裝置需進一步包含一定位件34，該定位件34係為鎖固式且具有自攻螺紋之一骨釘，且該骨釘包含該第一定位資料S2，本實施例中該定位件34與該器械4可主動發出訊號，該定位裝置12可接收該定位件34與該器械4發出之該第一定位資料S2與該第二定位資料S3。
步驟ST1如第二實施例，步驟ST23中操作人員將該骨板植入該施用部位2後，以包含該第一定位資料S2之該骨釘鎖入該骨板之一鎖固孔32以及該骨板下方之該骨頭22，而可同時達到加入該定位件34與固定該植入物3之效果，由於本實施例中該定位件34包含該第一參數資料S1且可主動發出該第一參數資料S1，即該定位單元12接收該定位件34發出之該第一定位資料S2，該第一定位資料S2包含一第一座標P1，該第一座標P1為一空間座標，而可細分為一第一X座標P1x、一第一Y座標P1y以及一第一Z座標P1z，該定位單元12可同時接收該第一X座標P1x、該第一Y座標P1y以及該第一Z座標P1z，並傳送至該處理單元14，使該處理單元14間接取得該植入物3於空間中之位置；步驟ST32中該定位單元12可接收該器械4主動發出之該第二定位資料S3，該第二定位資料S3包含一第二座標P2，該第二座標P2為一空間座標，而可細分為一第二X座標P2x、一第二Y座標P2y以及一第二Z座標P2z，該定位單元12可同時接收該第二X座標P2x、該第二Y座標P2y以及該第二Z座標P2z，並傳送至該處理單元14，使該處理單元14取得該器械4於空間中之位置。
後續步驟S40至步驟ST61與第二實施例大致相同，在此不多作贅述，本實施例係透過一定位件對該植入物進行間接定位，配合對該器械之定位與運算，而同樣可達到器械導航之功效，透過本實施例之實施，操作人員可透過該顯示單元16顯示之第一參數資訊S1與相對於該第一參數資訊S1之該第二定位資訊S3，獲得該骨板與該骨釘之相對位置，以對照該顯示單元顯示之該第一影像I1與該第二影像I2或該操作指示S8調整該骨釘之位置與角度，當該骨釘位於最適合鎖入該骨板之位置及角度時，該顯示單元16可顯示該處理單元14發出之一定位提示S6，操作人員即可就此時該骨釘所處之位置及角度將該骨釘鎖入該骨板中，且，由該骨釘鑽入該骨頭22時該定位單元12取得之該相對距離S4即可得知該鎖固式骨釘進入之深度，而可避免操作人員將該鎖固式骨釘鎖入過深而破壞該骨頭22。
請參考第六A圖及第六B圖，其係本創作第五實施例之實施流程圖及元件示意圖；如第六A圖所示，本實施例中導航裝置使用之步驟與第三實施例大致相同：
步驟ST1：顯示預先儲存之一植入物之一第一參數資料；
步驟ST24：將一定位件設置於該植入物，讀取該定位件之一第一定位資料；
步驟ST32：讀取一器械之一第二定位資料；
步驟ST40：該處理單元依該第一定位資料與該第二定位資料計算該植入物與該器械間之一相對位置與一相對角度；
步驟ST50：該處理單元分別比對該相對距離與一預設距離以及該相對角度與一預設角度，並發出一操作指示；
步驟ST60：該處理單元判斷該相對距離符合該預設距離且該相對角度符合該預設角度；及
步驟ST61：該處理單元發出一定位提示。
如第五B圖所示，本實施例中該植入物3係為鎖固式之一骨板，該第一參數資料S1即包含該骨板之長、寬、高、鎖固孔數量、鎖固孔位置以及一第一影像I1，該器械4則為鎖固式且具有自攻螺紋之一骨釘，該第二參數資料S7即包含該骨釘之長、寬、高或半徑、長度，其中該植入物3不包含該第一定位資料S2，故，本實施例中該導航裝置同樣需包含一定位件34，該定位件34係為鎖固式且具有自攻螺紋之一骨釘，且該骨釘包含該第一定位資料S2，本實施例中該定位件34與該器械4可主動發出訊號，該定位裝置12可接收該定位件34與該器械4發出之該第一定位資料S2與該第二定位資料S3。
步驟ST1如第三實施例，步驟ST23中操作人員將該骨板植入該施用部位2後，以包含該第一定位資料S2之該骨釘鎖入該骨板之一鎖固孔32以及該骨板下方之該骨頭22，而可同時達到加入該定位件34與固定該植入物3之效果，該定位單元12即可透過感應方式讀取該定位件34包含之該第一定位資料S2，該第一定位資料S2包含一第一座標P1，該第一座標P1為一空間座標，而可細分為一第一X座標P1x、一第一Y座標P1y以及一第一Z座標P1z，該定位單元12可同時接收該第一X座標P1x、該第一Y座標P1y以及該第一Z座標P1z，並傳送至該處理單元14，使該處理單元14間接取得該植入物3於空間中之位置；步驟ST32中該定位單元12同樣可透過感應方式讀取該器械4包含之該第二定位資料S3，該第二定位資料S3包含一第二座標P2，該第二座標P2為一空間座標，而可細分為一第二X座標P2x、一第二Y座標P2y以及一第二Z座標P2z，該定位單元12可同時接收該第二X座標P2x、該第二Y座標P2y以及該第二Z座標P2z，並傳送至該處理單元14，使該處理單元14取得該器械4於空間中之位置。
後續步驟S40至步驟ST61與第三實施例大致相同，在此不多作贅述，本實施例係透過一定位件對該植入物進行間接定位，配合對該器械之定位與運算，而同樣可達到器械導航之功效。
綜上所述，本創作係一種導航裝置，其定位至少一植入物與至少一器械，並顯示該植入物與該器械於空間中之相對關係，並計算該植入物與該器械間之一相對距離與一相對角度以作出一操作指示或一提示，以輔助將該植入物植入一施用部位之操作進行，而達到簡化操作步驟、提升操作可信賴度、減輕操作人員負擔以及降低操作風險等效果。
故本創作實為一具有新穎性、進步性及可供產業利用者，應符合我國專利法所規定之專利申請要件無疑，爰依法提出創作專利申請，祈 鈞局早日賜准專利，至感為禱。
惟以上所述者，僅為本創作之較佳實施例而已，並非用來限定本創作實施之範圍，舉凡依本創作申請專利範圍所述之形狀、構造、特徵及精神所為之均等變化與修飾，均應包括於本創作之申請專利範圍內。
In order to give your review board members a better understanding and understanding of the structural features and the efficacies achieved, please refer to the best examples and detailed explanations to illustrate:
The navigation device of the present invention is characterized in that the implant and the device to be applied to the site are used as positioning objects and the pre-stored implant parameter data is used to display the implant and the device in space. The relative relationship overcomes the technical problem that the exact position of the implant cannot be known in the prior art and the position of the instrument is not adjusted, so that the operator can be guided to adjust the position of the device to assist the application of the device.
Please refer to the first figure and the second figure, which are schematic flowcharts and components of the first embodiment of the present invention; as shown in the first figure, the steps of using the navigation device of the present invention include:
Step ST1: displaying a first parameter data of one of the implants pre-stored;
Step ST2: obtaining first positioning data corresponding to one of the implants;
Step ST3: Acquire a second positioning data corresponding to one of the instruments; and Step ST4: Display second positioning data corresponding to one of the first parameter data.
As shown in the second figure, the navigation device of the present invention is implemented in an application site 2, the navigation device comprises a device navigation component 1, an implant 3 and an instrument 4; the device navigation component 1 comprises a memory unit A positioning unit 12, a processing unit 14 and a display unit 16 are respectively connected to the memory unit 10, the positioning unit 12 and the display unit 16 with the processing unit 14 as a center. The memory unit 10 is pre- A first parameter data S1 corresponding to one of the implants 3 is stored.
In step ST1, the display unit 16 displays the first parameter data S1 stored in the memory unit 10 in advance; in step ST2, the positioning unit 12 obtains the first positioning data S2 corresponding to the implant 3 and transmits the The first positioning data S2 is sent to the processing unit 14; in step ST3, the positioning unit 12 obtains the second positioning data S3 corresponding to the device 4 and transmits the second positioning data S3 to the processing unit 14, so that the processing unit The second positioning data S3 is obtained, and an operation result R1 is obtained according to the second positioning data S3, the first positioning data S2, and the first parameter information S1. In step ST4, the display unit 16 displays The operation result R1, and the second positioning data S3 is displayed corresponding to the first parameter data S1; that is, the process of implanting the implant 3 into the application site 2 by the operator, and applying the device 4 to the application site 2 The display unit 16 can display the second positioning data S3 corresponding to the first parameter data S1 to reflect the relative position of the instrument 4 and the implant 3 in the space, and assist the operator in finding the application site 2. Apply this 4 of mechanically correct position.
Referring to the first figure, after the processing unit 14 obtains the second positioning data S3 corresponding to the device 4, the processing unit 14 may further display the second positioning data S3 corresponding to the first parameter data S1. Includes one step:
Step ST40: The processing unit calculates a relative position between the implant and the instrument and a relative angle according to the first positioning data and the second positioning data.
The first positioning data S2 includes a first coordinate P1, and the second positioning data S3 includes a second coordinate P2. The first coordinate P1 and the second coordinate P2 can each be a plane coordinate, a space coordinate or a corner coordinate. The operation result R1 calculated by the processing unit 14 according to the first positioning data S2 and the second positioning data S3 includes a relative position S4 and a relative angle S5, and can also be displayed by the display unit 16 to provide an operation. The person serves as a reference for the application of the device 4.
Referring to the first figure, the step ST40 may further include:
Step ST50: The processing unit respectively compares the relative distance with a preset distance and the relative angle with a preset angle, and issues an operation indication;
Step ST60: The processing unit determines that the relative distance meets the preset distance and the relative angle conforms to the preset angle; and Step ST61: the processing unit issues a positioning prompt.
In the foregoing steps ST4 and ST40, when the operator adjusts the device 4 corresponding to the second positioning information S3, the relative position S4 and the relative angle S5 displayed by the display unit 16, the positioning unit 12 can receive the second positioning immediately. Information S3 and positioning the device 4, the processing unit 14 continuously updates the second positioning information S3, and the first positioning information S2 is operated with the first parameter information S1 to calculate the relative distance S4 and the relative Angle S5.
In step ST50, the processing unit 14 may compare the relative distance S4 with a preset distance, and compare the relative angle S5 with a preset angle, and issue an operation indication S8 according to the comparison result. Indicates the distance and direction that the instrument 4 should be moved. The operation indication S8 can be displayed on the display unit 16 to guide the operator to adjust the instrument 4 to an appropriate application position and angle. As described above, step ST50 is also an immediate response. a step of updating the operation indication S8 as the movement of the device 4 is adjusted; in step ST60, when the processing unit 14 determines that the relative distance S4 meets the preset distance and the relative angle S5 conforms to the preset angle, Proceeding to step ST61, the processing unit 14 issues a positioning prompt S6, which can be displayed on the display unit 16 to inform the operator that the device 4 is at the most appropriate application position and angle at this time, and the operator can The device 4 is applied at a position and an angle of the device 4, and if the processing unit 14 does not determine that the relative distance S4 meets the preset distance and the relative angle S5 conforms to the preset angle, The ST50 step, the operator to adjust the instrument to a proper application position 4, carried out up to step ST61.
Please continue to refer to the second figure, the memory unit 10 can further store a second parameter data S7 of the device 4, in step ST40, the processing unit 14 can be based on the second parameter data S7 and the first parameter. The data S1, the first positioning data S2, and the second positioning data S3 jointly calculate the operation result R1, so that the processing unit 14 can better grasp the position or shape of the device 4 in the space, and obtain a more complete device. Navigation effect.
In addition, the device navigation component 1 can further include a voice unit 17 and an auxiliary image unit 18: the voice unit 17 is connected to the processing unit 14, and plays the operation result R1 calculated by the processing unit 14, as a relative distance S4, the relative angle S5, and the operation indication S8, the positioning prompt S6; the auxiliary image unit 18 can capture a third image S9 of the application site 2, the third image S9 can be an optical image or The image display unit 16 can also display the third image S9 to assist the operator in applying the instrument 4.
The implant used in the navigation device of the present invention can be divided into two types, one of which includes the first positioning data, and the other does not include the first positioning data, and another positioning component is needed, and the positioning component includes the first a positioning data is disposed on the implant; in addition, the positioning unit obtains the first positioning data and the second positioning data in two ways, and one is actively issued by the implant or the positioning component and the device The first positioning data and the second positioning data are received by the positioning unit. In another manner, the implant or the positioning component and the device do not have the ability to actively send signals, and the positioning unit actively reads The first positioning data and the second positioning data are cross-matched by the differences between the two mechanisms, so that the navigation device of the present invention includes at least the following four implementations.
Please refer to FIG. 3A and FIG. 3B together, which are schematic flowcharts and components of the second embodiment of the present invention; as shown in FIG. 3A, the steps and the first steps of the navigation device in this embodiment are used. The embodiments are roughly the same:
Step ST1: displaying a first parameter data of one of the implants pre-stored;
Step ST21: Receive one of the first positioning data issued by the implant;
Step ST31: Receive a second positioning data sent by a device;
Step ST40: The processing unit calculates a relative position between the implant and the instrument and a relative angle according to the first positioning data and the second positioning data;
Step ST50: The processing unit respectively compares the relative distance with a preset distance and the relative angle with a preset angle, and issues an operation indication;
Step ST60: The processing unit determines that the relative distance meets the preset distance and the relative angle conforms to the preset angle; and Step ST61: the processing unit issues a positioning prompt.
As shown in FIG. 3B, in the embodiment, the implant 3 is one of the locking type bone plates, and the first parameter data S1 includes the length, width, height, and the number of locking holes of the bone plate. The position of the locking hole and a first image I1, the instrument 4 is a scalpel, and the second parameter data S7 includes the length, width and height of the scalpel.
In step ST1, the display unit 16 displays the first image I1 included in the first parameter data S1 stored in the memory unit 10, and the first image I1 simulates the appearance of the implant 3.
In step ST21, the implant 3 is implanted into the application site 2 via a first wound 20 by the operator, and the plurality of fasteners 30 are locked by the first wound 20 to fix the implant 3 to the application. At least one bone 22 in the portion 2, the fixing member 30 is a locking plurality of bone nails. In the embodiment, the implant 3 includes the first parameter data S1 and can actively issue the first parameter data S1. The positioning unit 12 receives the first positioning data S2 sent by the implant 3 and transmits the first positioning data S2 to the processing unit 14. The processing unit 14 obtains the first positioning data S2 and the first The parameter data S1 is positioned to calculate and simulate the relative position of the implant 3 and the device 4 in the space when the second positioning data S3 is obtained, wherein the first positioning data S2 includes a first coordinate P1. In this embodiment, the first coordinate P1 is a space coordinate, and can be subdivided into a first X coordinate P1x, a first Y coordinate P1y, and a first Z coordinate P1z, and the implant 3 can simultaneously send the first coordinate. The X coordinate P1x, the first Y coordinate P1y, and the first Z coordinate P1z, the processing unit The position of the implant 3 in the space is obtained via the positioning unit 12.
In step ST31, the operator uses the device 4 at the application site 2. In this embodiment, the device 4 includes the second parameter data S7 and can actively issue the second parameter data S7, and the positioning unit 12 receives the device 4 The second positioning data S3 and the second positioning data S3 are sent to the processing unit 14, the processing unit 14 obtains the second positioning data S3, wherein the second positioning data S3 includes a second coordinate P2, the implementation In the example, the second coordinate P2 is a space coordinate, and can be subdivided into a second X coordinate P2x, a second Y coordinate P2y, and a second Z coordinate P2z, and the device 4 can simultaneously send the second X coordinate P2x, The second Y coordinate P2y and the second Z coordinate P2z enable the processing unit 14 to obtain the location information of the device 4 in the space via the positioning unit 12 for subsequent operations.
In step ST40, the processing unit 14 can calculate the first parameter information S1, the second parameter S7, the first positioning data S2, and the second positioning data S3 to obtain an operation result R1, and the operation result R1 A relative position S4 and a relative angle S5 are included.
In step ST4, the display unit 16 displays the operation result R1, and the operation result R1 includes the relative position S4 and the relative angle S5, and displays the second positioning data S3 with respect to the first parameter data S1. The second positioning data S3 can be changed according to the movement of the device 4. As shown, the second positioning data S3 includes a second image I2, and the second image I2 can simulate the appearance of the device 4, and the second The display position of the image I2 corresponds to the first image I1, and can reflect the relative position of the instrument 4 and the implant 3 in the space. In addition to the change of the image, the second coordinate P2 includes the second X. The values of the coordinates P2x, the second Y coordinate P2y, and the second Z coordinate P2z also vary with the movement of the instrument 4.
The subsequent steps ST50 to ST61 are substantially the same as the first embodiment, and the first parameter information S1 included in the operation result R1 displayed by the operator through the display unit 16 is not described here. Obtaining a relative position of the bone plate and the scalpel with the second positioning information S3 relative to the first parameter information S1 to compare the first image I1 and the second image I2 displayed by the display unit or the operation Instructing S8 to adjust the position of the scalpel, and when reaching a position on one of the body surface 24 of the application site 2 corresponding to one of the locking holes 32 of the bone plate, the display unit 16 can display a positioning prompt issued by the processing unit 14 S6, the operator can lower the body surface 24 under the scalpel at this time to generate a second wound 240 to lock a bone nail into the bone plate.
Please refer to FIG. 4A and FIG. 4B, which are schematic flowcharts and components of the third embodiment of the present invention; as shown in FIG. 4A, the steps of using the navigation device in the embodiment and the second embodiment Roughly the same:
Step ST1: displaying a first parameter data of one of the implants pre-stored;
Step ST22: reading one of the first positioning materials of the implant;
Step ST32: reading one of the second positioning data of one of the instruments;
Step ST40: The processing unit calculates a relative position between the implant and the instrument and a relative angle according to the first positioning data and the second positioning data;
Step ST50: The processing unit respectively compares the relative distance with a preset distance and the relative angle with a preset angle, and issues an operation indication;
Step ST60: The processing unit determines that the relative distance meets the preset distance and the relative angle conforms to the preset angle; and Step ST61: the processing unit issues a positioning prompt.
As shown in FIG. 4B, in the embodiment, the implant 3 is a one-piece bone plate, and the first parameter data S1 includes the length, width, height, and number of locking holes of the bone plate. The position of the locking hole and a first image I1, the instrument 4 is a scalpel, and the second parameter data S7 includes the length, width and height of the scalpel. In addition, unlike the second embodiment, in the embodiment, the implant 3 and the device 4 cannot actively send a signal, and the positioning unit 12 actively reads the first positioning data S2 and the second positioning data S3. The positioning unit 12 extends out of two lines, wherein one end of the line includes a probe 120, and the end of the other line is connected to the instrument 4.
Step ST1, as in the second embodiment, after the implanting the bone plate in step ST22, the operator needs to contact the one of the positioning marks 36 printed on the bone plate with the probe 120, so that the positioning device 12 reads the first positioning. The data S2, the first positioning data S2 includes a first coordinate P1, the first coordinate P1 is a space coordinate, and can be subdivided into a first X coordinate P1x, a first Y coordinate P1y, and a first Z coordinate P1z. The positioning unit 12 can simultaneously read the first X coordinate P1x, the first Y coordinate P1y, and the first Z coordinate P1z from the implant 3 when the probe 120 contacts the positioning mark 36, and transmit the first X coordinate P1y and the first Z coordinate P1z. The processing unit 14 is configured to obtain the position of the implant 3 in the space via the positioning unit 12; in step ST32, the positioning unit 12 can read the second positioning data from a line connected to the scalpel. S3, the second positioning data S3 includes a second coordinate P2, which is a space coordinate, and can be subdivided into a second X coordinate P2x, a second Y coordinate P2y, and a second Z coordinate P2z. The positioning unit 12 can simultaneously read the second X coordinate by a wire connected to the instrument 4 P2x, the second Y coordinate P2y, and the second Z coordinate P2z are transmitted to the processing unit 14, and the processing unit 14 obtains the position of the instrument 4 in the space via the positioning unit 12.
The subsequent steps S40 to ST61 are substantially the same as the second embodiment, and the present invention may select the host 3 to actively transmit the first positioning data S2 or passively read by the positioning unit 12, All can achieve the effect of device navigation.
As described above, the implant can be divided into two types, one includes the first positioning data, and the other does not include the first positioning data, and another positioning component including the first positioning data is additionally disposed on the Implants, but have the following two implementations.
Please refer to FIG. 5A and FIG. 5B, which are flowcharts and components of the fourth embodiment of the present invention. As shown in FIG. 5A, the steps and the second implementation of the surgical navigation device in this embodiment are used. The example is roughly the same:
Step ST1: displaying a first parameter data of one of the implants pre-stored;
Step ST23: A positioning member is disposed on the implant, and receiving the positioning component to emit one of the first positioning materials;
Step ST31: receiving a second positioning data of one of the surgical instruments;
Step ST40: The processing unit calculates a relative position between the implant and the instrument and a relative angle according to the first positioning data and the second positioning data;
Step ST50: The processing unit respectively compares the relative distance with a preset distance and the relative angle with a preset angle, and issues an operation indication;
Step ST60: The processing unit determines that the relative distance meets the preset distance and the relative angle conforms to the preset angle; and Step ST61: the processing unit issues a positioning prompt.
As shown in FIG. 5B, in the embodiment, the implant 3 is a one-piece bone plate, and the first parameter data S1 includes the length, width, height, and number of locking holes of the bone plate. The position of the locking hole and a first image I1, the instrument 4 is a locking type and has a self-tapping thread. The second parameter data S7 includes the length, width, height or radius and length of the nail. In the embodiment, the navigation device further includes a positioning member 34, which is a locking type and has a self-tapping thread. a nail, and the bone nail includes the first positioning data S2. In the embodiment, the positioning component 34 and the instrument 4 can actively send a signal, and the positioning device 12 can receive the positioning component 34 and the first device Positioning data S2 and the second positioning data S3.
Step ST1 is as in the second embodiment, after the operator inserts the bone plate into the application site 2 in step ST23, the bone nail containing the first positioning data S2 is locked into one of the locking holes 32 of the bone plate and the The bone 22 under the bone plate can simultaneously achieve the effect of adding the positioning member 34 and fixing the implant 3. Since the positioning member 34 includes the first parameter data S1 in the embodiment, the first parameter can be actively issued. The parameter data S1, that is, the positioning unit 12 receives the first positioning data S2 sent by the positioning component 34. The first positioning data S2 includes a first coordinate P1, and the first coordinate P1 is a space coordinate, and can be subdivided into a first X coordinate P1x, a first Y coordinate P1y, and a first Z coordinate P1z, the positioning unit 12 can simultaneously receive the first X coordinate P1x, the first Y coordinate P1y, and the first Z coordinate P1z, and Transfer to the processing unit 14 to make the processing unit 14 indirectly obtain the position of the implant 3 in the space; in step ST32, the positioning unit 12 can receive the second positioning data S3 actively issued by the device 4, the second The positioning data S3 includes a second coordinate P2, and the second coordinate P2 is a The coordinate can be subdivided into a second X coordinate P2x, a second Y coordinate P2y, and a second Z coordinate P2z, and the positioning unit 12 can simultaneously receive the second X coordinate P2x, the second Y coordinate P2y, and the The second Z coordinate P2z is transmitted to the processing unit 14 to cause the processing unit 14 to obtain the position of the instrument 4 in space.
The subsequent steps S40 to ST61 are substantially the same as the second embodiment, and are not described here. In this embodiment, the implant is indirectly positioned through a positioning member, and the positioning and operation of the device are matched. The effect of the navigation of the device is achieved. Through the implementation of the embodiment, the operator can obtain the bone plate and the first positioning information S1 displayed by the display unit 16 and the second positioning information S3 relative to the first parameter information S1. The relative position of the nail is used to adjust the position and angle of the nail according to the first image I1 and the second image I2 or the operation indication S8 displayed by the display unit, when the nail is located at the most suitable for locking the bone When the position and angle of the board are displayed, the display unit 16 can display a positioning prompt S6 issued by the processing unit 14, and the operator can lock the bone nail into the bone plate at the position and angle of the nail at this time. Moreover, the relative distance S4 obtained by the positioning unit 12 when the bone nail is drilled into the bone 22 can be used to know the depth of the locking bone nail, and the operator can be prevented from locking the locking bone nail into the bone. Too deep to destroy the bone twenty two.
Please refer to FIG. 6A and FIG. 6B, which are flowcharts and components of the fifth embodiment of the present invention; as shown in FIG. 6A, the steps of using the navigation device in the embodiment and the third embodiment Roughly the same:
Step ST1: displaying a first parameter data of one of the implants pre-stored;
Step ST24: A positioning member is disposed on the implant, and reading one of the first positioning materials of the positioning member;
Step ST32: reading one of the second positioning data of one of the instruments;
Step ST40: The processing unit calculates a relative position between the implant and the instrument and a relative angle according to the first positioning data and the second positioning data;
Step ST50: The processing unit respectively compares the relative distance with a preset distance and the relative angle with a preset angle, and issues an operation indication;
Step ST60: The processing unit determines that the relative distance meets the preset distance and the relative angle conforms to the preset angle; and Step ST61: the processing unit issues a positioning prompt.
As shown in FIG. 5B, in the embodiment, the implant 3 is a one-piece bone plate, and the first parameter data S1 includes the length, width, height, and number of locking holes of the bone plate. The position of the locking hole and a first image I1, the instrument 4 is a locking type and has a self-tapping thread. The second parameter data S7 includes the length, width, height or radius and length of the nail. The navigation device 3 does not include the first positioning data S2. Therefore, the navigation device in the embodiment also needs to include a positioning member 34. The positioning member 34 is a locking type and has a self-tapping thread. a nail, and the bone nail includes the first positioning data S2. In the embodiment, the positioning component 34 and the instrument 4 can actively send a signal, and the positioning device 12 can receive the positioning component 34 and the first device Positioning data S2 and the second positioning data S3.
Step ST1, as in the third embodiment, after the operator implants the bone plate into the application site 2, the bone nail containing the first positioning data S2 is locked into one of the locking holes 32 of the bone plate and the The bone piece 22 under the bone plate can simultaneously achieve the effect of adding the positioning member 34 and fixing the implant 3. The positioning unit 12 can read the first positioning data S2 included in the positioning member 34 through inductive manner. The first positioning data S2 includes a first coordinate P1, and the first coordinate P1 is a space coordinate, and can be subdivided into a first X coordinate P1x, a first Y coordinate P1y, and a first Z coordinate P1z. The positioning unit 12 can simultaneously receive the first X coordinate P1x, the first Y coordinate P1y, and the first Z coordinate P1z, and transmit the same to the processing unit 14, so that the processing unit 14 indirectly obtains the implant 3 in the space. The second positioning data S3 includes a second coordinate P2, which is a space, and the second positioning data S3 is included in the second positioning data S3. Coordinates, which can be subdivided into a second X coordinate P2x and a second Y coordinate P2 And a second Z coordinate P2z, the positioning unit 12 can simultaneously receive the second X coordinate P2x, the second Y coordinate P2y, and the second Z coordinate P2z, and transmit the same to the processing unit 14, so that the processing unit 14 The position of the instrument 4 in the space is obtained.
The subsequent steps S40 to ST61 are substantially the same as the third embodiment, and are not described here. In this embodiment, the implant is indirectly positioned through a positioning member, and the positioning and operation of the device are matched. Achieve the power of device navigation.
In summary, the present invention is a navigation device that positions at least one implant and at least one instrument, and displays the relative relationship between the implant and the device in space, and calculates the interaction between the implant and the device. One of the relative distances and a relative angle to make an operational indication or a prompt to assist in the implantation of the implant into an application site, thereby achieving a simplified operational procedure, improving operational reliability, reducing operator burden, and Reduce the effects of operational risks.
Therefore, this creation is a novelty, progressive and available for industrial use. It should be in accordance with the patent application requirements stipulated in China's Patent Law. It is undoubtedly proposed to create a patent application according to law, and the Prayer Council will grant patents as soon as possible. prayer.
However, the above description is only for the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and the variations, modifications, and modifications of the shapes, structures, features, and spirits described in the scope of the patent application. , should be included in the scope of the patent application of this creation.
1‧‧‧導航裝置
10‧‧‧記憶單元
12‧‧‧定位單元
120‧‧‧探針
14‧‧‧處理單元
16‧‧‧顯示單元
17‧‧‧語音單元
18‧‧‧輔助影像單元
2‧‧‧施用部位
20‧‧‧第一創口
22‧‧‧骨頭
24‧‧‧體表
240‧‧‧第二創口
3‧‧‧植入物
30‧‧‧固定件
32‧‧‧鎖固孔
34‧‧‧定位件
36‧‧‧定位標記
4‧‧‧器械
I1‧‧‧第一影像
I2‧‧‧第二影像
P1‧‧‧第一座標
P1x‧‧‧第一X座標
P1y‧‧‧第一Y座標
P1z‧‧‧第一Z座標
P2‧‧‧第二座標
P2x‧‧‧第二X座標
P2y‧‧‧第二Y座標
P2z‧‧‧第二Z座標
S1‧‧‧第一參數資料
S2‧‧‧第一定位資料
S3‧‧‧第二定位資料
S4‧‧‧相對距離
S5‧‧‧相對角度
S6‧‧‧定位提示
S7‧‧‧第二參數資料
S8‧‧‧操作指示
S9‧‧‧第三影像
1‧‧‧Navigation device
10‧‧‧ memory unit
12‧‧‧ Positioning unit
120‧‧‧ probe
14‧‧‧Processing unit
16‧‧‧Display unit
17‧‧‧Speech unit
18‧‧‧Auxiliary image unit
2‧‧‧Application site
20‧‧‧First wound
22‧‧‧ bones
24‧‧‧ body surface
240‧‧‧Second wound
3‧‧‧ implants
30‧‧‧Fixed parts
32‧‧‧Lock hole
34‧‧‧ Positioning parts
36‧‧‧ Positioning Mark
4‧‧‧ instruments
I1‧‧‧ first image
I2‧‧‧second image
P1‧‧‧ first coordinates
P1x‧‧‧first X coordinates
P1y‧‧‧first Y coordinates
P1z‧‧‧First Z coordinate
P2‧‧‧ second coordinates
P2x‧‧‧Second X coordinate
P2y‧‧‧Second Y coordinate
P2z‧‧‧Second Z coordinate
S1‧‧‧ first parameter data
S2‧‧‧ first positioning data
S3‧‧‧Second positioning data
S4‧‧‧relative distance
S5‧‧‧ relative angle
S6‧‧‧ Positioning Tips
S7‧‧‧Second parameter data
S8‧‧‧Operation Instructions
S9‧‧‧ third image
第一圖為本創作第一實施例之實施流程圖；
第二圖為本創作第一實施例之元件示意圖；
第三A圖為本創作第二實施例之實施流程圖；
第三B圖為本創作第二實施例之元件示意圖；
第四A圖為本創作第三實施例之實施流程圖；
第四B圖為本創作第三實施例之元件示意圖；
第五A圖為本創作第四實施例之實施流程圖；
第五B圖為本創作第四實施例之元件示意圖；
第六A圖為本創作第五實施例之實施流程圖；
第六B圖為本創作第五實施例之元件示意圖。
The first figure is a flowchart of the implementation of the first embodiment of the creation;
The second figure is a schematic diagram of the components of the first embodiment of the creation;
The third A is a flowchart of the implementation of the second embodiment of the creation;
The third B is a schematic diagram of the components of the second embodiment of the creation;
The fourth A is a flowchart of the implementation of the third embodiment of the creation;
Figure 4B is a schematic diagram of the components of the third embodiment of the creation;
Figure 5 is a flow chart showing the implementation of the fourth embodiment of the present invention;
Figure 5B is a schematic diagram of components of the fourth embodiment of the present invention;
6A is a flowchart of implementation of the fifth embodiment of the present creation;
Figure 6B is a schematic view of the components of the fifth embodiment of the present invention.
1‧‧‧導航裝置1‧‧‧Navigation device
10‧‧‧記憶單元10‧‧‧ memory unit
12‧‧‧定位單元12‧‧‧ Positioning unit
14‧‧‧處理單元14‧‧‧Processing unit
16‧‧‧顯示單元16‧‧‧Display unit
17‧‧‧語音單元17‧‧‧Speech unit
18‧‧‧輔助影像單元18‧‧‧Auxiliary image unit
2‧‧‧施用部位2‧‧‧Application site
3‧‧‧植入物3‧‧‧ implants
4‧‧‧器械4‧‧‧ instruments
S1‧‧‧第一參數資料S1‧‧‧ first parameter data
S2‧‧‧第一定位資料S2‧‧‧ first positioning data
S3‧‧‧第二定位資料S3‧‧‧Second positioning data
S4‧‧‧相對距離S4‧‧‧relative distance
S5‧‧‧相對角度S5‧‧‧ relative angle
S6‧‧‧定位提示S6‧‧‧ Positioning Tips
S7‧‧‧第二參數資料S7‧‧‧Second parameter data
S8‧‧‧操作指示S8‧‧‧Operation Instructions
S9‧‧‧第三影像S9‧‧‧ third image
P1‧‧‧第一座標P1‧‧‧ first coordinates
P2‧‧‧第二座標P2‧‧‧ second coordinates
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW101224536UTWM451110U (en) | 2012-12-18 | 2012-12-18 | Navigation apparatus |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TW101224536UTWM451110U (en) | 2012-12-18 | 2012-12-18 | Navigation apparatus |
| Publication Number | Publication Date |
|---|---|
| TWM451110Utrue TWM451110U (en) | 2013-04-21 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TW101224536UTWM451110U (en) | 2012-12-18 | 2012-12-18 | Navigation apparatus |
| Country | Link |
|---|---|
| TW (1) | TWM451110U (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI507169B (en)* | 2012-12-18 | 2015-11-11 | ||
| TWI578261B (en)* | 2015-12-04 | 2017-04-11 | 財團法人金屬工業研究發展中心 | Pre-surgery planning system and pre-surgery planning method |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI507169B (en)* | 2012-12-18 | 2015-11-11 | ||
| TWI578261B (en)* | 2015-12-04 | 2017-04-11 | 財團法人金屬工業研究發展中心 | Pre-surgery planning system and pre-surgery planning method |
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