TWI688364B - Disposable endoscope group and endoscope device - Google Patents
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- TWI688364B TWI688364B TW107128726A TW107128726A TWI688364B TW I688364 B TWI688364 B TW I688364B TW 107128726 A TW107128726 A TW 107128726A TW 107128726 A TW107128726 A TW 107128726A TW I688364 B TWI688364 B TW I688364B
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Abstract
一種可拋棄式內視鏡組及內視鏡裝置,可拋棄式內視鏡組係於其影像擷取模組與轉向控制模組之外側套設彈性套管,以及膜管密合套設於影像擷取模組、轉向控制模組與彈性套管的外側,內視鏡裝置包括可拋棄式內視鏡組以及可拆組連接於可拋棄式內視鏡組後端之操作模組,可拋棄式內視鏡組使用後拋棄,杜絕因重複使用而產生之感染問題,非侵入人體的操作模組則能重複使用,另藉由彈性套管之高彎曲性與伸縮變形的彈性,搭配膜管的高彎曲性,使可拋棄式內視鏡組整體具備大彎曲角度之彎曲變形能力,而能有效降低對腸壁的推擠與壓迫,減少對人體胃腸壁的損傷。A disposable endoscope set and an endoscope device. The disposable endoscope set is sleeved with elastic sleeves on the outside of its image capture module and steering control module, and the membrane tube is tightly sleeved on The outside of the image capture module, steering control module and elastic sleeve. The endoscope device includes a disposable endoscope group and an operation module that is detachably connected to the rear end of the disposable endoscope group. Disposable endoscope sets are discarded after use, to eliminate infection problems caused by repeated use, the operation module of non-invasive human body can be reused, and by the high flexibility of the elastic sleeve and the elasticity of expansion and contraction, with the film The high flexibility of the tube makes the disposable endoscope set as a whole capable of bending and deforming at a large bending angle, which can effectively reduce the pushing and pressing of the intestinal wall and reduce the damage to the human gastrointestinal wall.
Description
本發明係關於一種適用於大腸鏡裝置或其他等內視鏡裝置等醫療器材中,且具備降低操作中造成腸壁穿孔、損傷,以及避免重複使用而發生細菌感染、病毒感染等問題的可拋棄式內視鏡組及內視鏡裝置。The present invention relates to a disposable device suitable for use in medical equipment such as a colonoscopy device or other endoscopy devices, and capable of reducing intestinal wall perforation and damage during operation, as well as avoiding repeated use of bacterial infections and viral infections. Endoscope group and endoscope device.
如大腸鏡、胃鏡等內視鏡裝置係廣泛應用人體之胃、腸等消化道檢查等用途的之醫療器材。以結構較複雜的大腸鏡70為例,如圖11所示,其包括一大腸鏡組件71以及一操作模組72,該大腸鏡組件71中具有影像擷取單元711、轉向機構712、導線713、流體導管714以及包覆前述各構件的實心外覆體715,該操作模組72連接於該大腸鏡組件71後端,該操作模組72具有處理單元、轉向控制元件721與顯示器722等,該大腸鏡70能以大腸鏡組件71伸入人體的大腸內,其中,可經由流體導管714對大腸內部注入氣體,使大腸擴張,以便於大腸鏡組件71於大腸內推進。另經由大腸鏡組件71之影像擷取單元711擷取大腸腸壁內面的影像,影像擷取單元711取得的影像資料能夠經由處理單元處理後顯示器722中呈現,其中還可經由流體導管714對大腸內部注入水液清洗腸壁,以利擷取腸壁影像。Endoscopy devices such as colonoscopes and gastroscopes are medical devices that are widely used in the examination of the digestive tract such as the stomach and intestines of the human body. Taking the
在前述使用大腸鏡70對人體之大腸進行檢查的過程中,如圖11及圖12所示,由於人體之大腸60具有許多彎折部位61、62、63、64,當以大腸鏡組件伸入人體的大腸內,由於該大腸鏡組件71中之影像擷取單元711、轉向機構712、導線713、流體導管714等係以實心外覆體715定型,大腸鏡組件71之每一單位長度的可彎曲角度偏小,柔軟性不足。造成大腸鏡組件71自人體之肛門伸入直腸,接續沿著大腸的腸道轉向行進的操作過程中,大腸鏡組件71會對大腸腸壁產生,尤其是醫師操作大腸鏡組件71朝大腸轉曲處或深處推進時,易使大腸鏡組件71對大腸腸壁產生大力量的推擠與壓迫作用,因而,在大腸鏡70的操作過程中存在有許多技術困難性以及易造成腸壁穿孔之風險。During the aforementioned inspection of the human large intestine using the
據統計,使用大腸鏡進行人體之大腸檢查程序,因大腸鏡造成腸壁穿孔之發生機率約為千分之3至千分之5。基於該腸壁穿孔之發生機率偏高,如何操作大腸鏡等內視鏡裝置順利地沿著胃腸彎曲轉向行進,減少對胃腸產生推擠與壓迫,為目前內視鏡裝置之技術領域中,重要的研發的項目之一。According to statistics, the use of colonoscopy for human colon examination procedures, the incidence of bowel wall perforation caused by colonoscopy is about 3 to 5 per 1,000. Due to the high incidence of perforation of the intestinal wall, how to operate an endoscope device such as a colonoscopy to smoothly turn along the bend of the gastrointestinal tract and reduce the pushing and compression of the gastrointestinal tract is important in the current technical field of endoscope devices One of the research and development projects.
此外,現有之大腸鏡等內視鏡皆屬昂貴的醫療器材,基於醫療成本考量,無法使用後即丟棄。以大腸鏡為例,其連接於操作模組上的大腸鏡組件中使用之影像擷取單元、轉向機構、導線、流體導管以及包覆前述各構件的實心外覆體,難以使用滅菌釜以攝氏溫度121℃、1.2kgs/cm 2大氣壓力以及處理時間15分鐘之方式進行滅菌程序。目前醫療院所皆係依標準消毒、殺菌等程序處理後,再重複使用。惟前述標準消毒與殺菌程序,並無法使大腸鏡組件達到完全滅菌的程度。亦即使用過的大腸鏡組件縱使經過嚴謹的多道標準的消毒、殺菌程序,也無法確保大腸鏡組件達到完全滅菌的狀態。一旦通過消毒、殺菌程序處理後之大腸鏡組件中仍有細菌或病毒殘留存活時,之後使用該大腸鏡的被檢查者易因細菌或病毒移轉而發生細菌感染、病毒感染等風險。 In addition, existing endoscopes such as colonoscopes are expensive medical equipment. Due to medical cost considerations, they cannot be discarded after use. Taking a colonoscope as an example, the image capturing unit, steering mechanism, wire, fluid conduit, and solid outer covering covering the aforementioned components used in the colonoscope assembly connected to the operation module make it difficult to use a sterilizer to centigrade The sterilization procedure was carried out at a temperature of 121°C, an atmospheric pressure of 1.2 kgs/cm 2 and a treatment time of 15 minutes. At present, medical institutions are treated according to standard disinfection and sterilization procedures, and then reused. However, the aforementioned standard sterilization and sterilization procedures cannot achieve complete sterilization of colonoscopy components. In other words, even if the used colonoscopy components have passed rigorous multi-standard sterilization and sterilization procedures, the colonoscopy components cannot be completely sterilized. Once bacteria or viruses remain in the colonoscope assembly after being sterilized and sterilized, the examinee who uses the colonoscope afterwards is susceptible to bacterial infection, virus infection and other risks due to the transfer of bacteria or viruses.
在現有醫療器材的技術領域,為了解決前述細菌感染、病毒感染等問題,已有器材使用拋棄式的技術概念,例如針頭等。惟在大腸鏡等內視鏡裝置之領域中,基於內視鏡裝置整體機構的精密性、複雜性與可靠性等因素,在昂貴的器材成本下,現有大腸鏡等內視鏡皆維持重複使用的方式,以致在大腸鏡等內視鏡裝置使用過程中,仍無法克服因內視鏡組件重複使用而發生細菌感染、病毒感染等問題。In the technical field of existing medical devices, in order to solve the aforementioned problems of bacterial infection, viral infection, etc., existing devices use disposable technical concepts, such as needles and the like. However, in the field of endoscope devices such as colonoscopy, based on the precision, complexity and reliability of the overall mechanism of the endoscope device, under the cost of expensive equipment, existing endoscopes such as colonoscopes are maintained for repeated use In this way, during the use of an endoscope device such as a colonoscope, it is still impossible to overcome the problems of bacterial infection and virus infection caused by repeated use of the endoscope component.
本發明之主要目的在於提供一種可拋棄式內視鏡組及內視鏡裝置,解決現有內視鏡組件之彎曲性不佳,易對胃腸壁產生推擠與壓迫而發生胃腸穿孔之問題,以及內視鏡組件重複使用易發生細菌感染、病毒感染等問題。The main purpose of the present invention is to provide a disposable endoscope set and endoscope device to solve the problem of poor bending of the existing endoscope assembly, and easy to push and compress the gastrointestinal wall to cause gastrointestinal perforation, and The repeated use of endoscope components is prone to problems such as bacterial infection and virus infection.
為了達成前揭目的,本發明所提出之內視鏡組係包括: 一影像擷取模組,其包括一前端導塊、一影像擷取單元、一導線單元以及一連接部件,該影像擷取單元設於該前端導塊中,該導線單元電性連接該影像擷取單元,且該導線單元之後端連接該連接部件; 一轉向控制模組,其係裝設於該影像擷取模組之側邊,該轉向控制模組包括一轉向構件,該轉向構件連接該前端導塊; 一彈性套管,其係套設於該影像擷取模組與該轉向控制模組之外側,該彈性套管位於該前端導塊與該連接部件之間,該彈性套管之後端連接該連接部件,該彈性套管之前端連接該前端導塊或該轉向構件,該彈性套管具備彎曲與沿著長度方向伸縮的彈性;以及 一膜管,其係套設於該影像擷取模組、該轉向控制模組與該彈性套管的外側,該膜管之前端密合固接該前端導塊之後端,該膜管之後端密合固接該連接部件之前端,該彈性套管的外周緣接觸該膜管之內側壁。In order to achieve the above-mentioned purpose, the endoscope set proposed by the present invention includes: an image capture module, which includes a front-end guide block, an image capture unit, a wire unit, and a connecting part, the image capture The unit is set in the front-end guide block, the wire unit is electrically connected to the image capturing unit, and the rear end of the wire unit is connected to the connecting component; a steering control module, which is installed in the image capturing module On the side, the steering control module includes a steering member connected to the front guide block; an elastic sleeve sleeved on the outside of the image capture module and the steering control module, the elastic sleeve The tube is located between the front end guide block and the connecting part, the rear end of the elastic sleeve is connected to the connecting part, the front end of the elastic sleeve is connected to the front end guide block or the steering member, the elastic sleeve is provided with a bending and along the length Elasticity in direction expansion and contraction; and a membrane tube sleeved on the outside of the image capture module, the steering control module and the elastic sleeve, the front end of the membrane tube is tightly fixed to the rear end of the front guide block , The rear end of the membrane tube is tightly fixed to the front end of the connecting member, and the outer periphery of the elastic sleeve contacts the inner side wall of the membrane tube.
如上所述之可拋棄式內視鏡組中,其還包括一導管與一轉向操作組件,該導管之前端裝設於該前端導塊中,且該導管之前端的管口顯露於前端導塊外,該導管之後端穿過該連接部件且伸出該連接部件之外側;該轉向操作組件連接該影像擷取模組之連接部件,且該轉向操作組件包括一連接部件以及設於該連接部件上的轉向旋鈕,該轉向控制模組還包括一操控線組,該操控線組之一端連接該轉向構件,且該操控線組沿著該彈性套管與該膜管內部延伸至該連接部件中,該操控線組之另一端連接該轉向旋鈕,該連接部後端具有一轉接頭,該轉接頭電性連接該該影像擷取模組之導線單元。As mentioned above, the disposable endoscope set further includes a catheter and a steering operation component, the front end of the catheter is installed in the front end guide block, and the nozzle of the front end of the catheter is exposed outside the front end guide block , The rear end of the catheter passes through the connecting member and extends outside the connecting member; the steering operation component is connected to the connection component of the image capturing module, and the steering operation component includes a connection component and is provided on the connection component The steering knob of the steering control module further includes a steering wire group, one end of the steering wire group is connected to the steering member, and the steering wire group extends into the connecting member along the inside of the elastic sleeve and the membrane tube, The other end of the control cable group is connected to the steering knob. The rear end of the connection part has an adapter, and the adapter is electrically connected to the wire unit of the image capture module.
為了達成前揭目的,本發明提出之內視鏡裝置係包括: 一如上所述的可拋棄式內視鏡組,該影像擷取模組之連接部件中具有一接頭單元,該接頭單元電性連接所述導線單元;以及 一操作模組,係可拆組地連接該可拋棄式內視鏡組,該操作模組包括一操作本體以及一轉向操作組件,該操作本體包括一基座,該基座內部具有一處理單元,基座後端設有一顯示器,該基座前端具有一組接部,該組接部中具有一接頭,該接頭與該顯示器電性連接該處理單元,該轉向操作組件裝設於該操作本體的組接部上,該轉向操作組件包括一轉向旋鈕,該可拋棄式內視鏡組係以該連接部件插接於該操作模組之組接部,該連接部件中之接頭單元與該組接部中之接頭電性連接,該轉向控制模組之操控線組另一端連接該轉向旋鈕。In order to achieve the purpose of the foregoing disclosure, the endoscope device proposed by the present invention includes: a disposable endoscope set as described above, and the connecting part of the image capturing module has a joint unit, and the joint unit is electrically Connected to the wire unit; and an operation module, which is detachably connected to the disposable endoscope group, the operation module includes an operation body and a steering operation component, the operation body includes a base, the There is a processing unit inside the base, and a display is provided at the rear of the base. The front end of the base has a group of connecting parts. The group of connecting parts has a connector. The connector and the display are electrically connected to the processing unit. The assembly is mounted on the assembly part of the operation body. The steering operation assembly includes a steering knob. The disposable endoscope set is inserted into the assembly part of the operation module with the connection part. The connection part The joint unit in is electrically connected to the joint in the assembly part, and the other end of the steering wire group of the steering control module is connected to the steering knob.
為了達成前揭目的,本發明另外提出之內視鏡裝置係包括: 一如上所述的可拋棄式內視鏡組,所述可拋棄式內視鏡組還包括一轉向操作組件,該轉向操作組件連接該影像擷取模組之連接部件,且該轉向操作組件包括一連接部件以及設於該連接部件上的轉向旋鈕,該連接部件連接該影像擷取模組之連接部件,該轉向控制模組包括一操控線組,該操控線組之一端連接該轉向構件,且該操控線組沿著該彈性套管與該膜管內部延伸至該連接部件中,該操控線組之另一端連接該轉向旋鈕,該連接部後端具有一轉接頭,該轉接頭電性連接該該影像擷取模組之導線單元;以及 一操作模組,係可拆組地連接該可拋棄式內視鏡組,該操作模組包括一操作本體,該操作本體包括一基座,該基座內部具有一處理單元,基座後端設有一顯示器,該基座前端具有一組接部,該組接部中具有一接頭,該接頭與該顯示器電性連接該處理單元,該可拋棄式內視鏡組以該連接部件插接於該操作模組之組接部,連接部件中之接頭單元與該組接部中之接頭電性連接。In order to achieve the purpose of the foregoing disclosure, the endoscope device additionally proposed by the present invention includes: a disposable endoscope set as described above, and the disposable endoscope set further includes a steering operation component, the steering operation The component is connected to the connection part of the image capture module, and the steering operation component includes a connection part and a steering knob provided on the connection part, the connection part is connected to the connection part of the image capture module, and the steering control mode The group includes a steering wire group, one end of the steering wire group is connected to the steering member, and the steering wire group extends into the connecting member along the inside of the elastic sleeve and the membrane tube, and the other end of the steering wire group is connected to the The steering knob has an adapter at the rear end of the connecting portion, the adapter is electrically connected to the wire unit of the image capture module; and an operation module is detachably connected to the disposable interior view Mirror group, the operation module includes an operation body, the operation body includes a base, the base has a processing unit, a display is provided at the rear of the base, and a set of connecting parts is provided at the front of the base There is a connector in the part, the connector and the display are electrically connected to the processing unit, the disposable endoscope set is connected to the assembly part of the operation module with the connection part, the connection unit in the connection part and the The joints in the assembly section are electrically connected.
藉由前揭內視鏡組與內視鏡裝置之發明,其具備以下諸多優點: 1、有效降低操作過程中,對人體腸壁的損傷:本發明可拋棄式內視鏡組中,係利用彈性套管對內視鏡組中的影像擷取模組與轉向控制模組提供必要的支撐性,且具有優異的可撓性,並搭配柔軟性的薄形膜管包覆著彈性套管及其內部的影像擷取模組與轉向控制模組提供無菌障壁之機構,其中,藉由彈性套管之高彎曲性與伸縮變形的彈性,搭配薄形膜管的高彎曲性,使可拋棄式內視鏡組整體具備大彎曲角度之彎曲變形能力,使可拋棄式內視鏡組伸入人體之大腸等腸道內部時,於操作過程中,該可拋棄式內視鏡組能夠易於受控轉向以及大彎曲角度的彎曲變形,故能有效降低對腸壁的推擠與壓迫,減少對人體腸壁的損傷。 2、製造成本低:承上所述,本發明可拋棄式內視鏡組藉由彈性套管套設於影像擷取模組與轉向控制模組外側,以及搭配具有柔軟性的薄形膜管包覆著彈性套管及其內部的影像擷取模組與轉向控制模組,其中之彈性套管與薄形膜管為現有易製造取得的物件,其製造成本低,故相較於現有高價位的內視鏡裝置,及現有內視鏡裝置使用後須消毒、殺菌的作業成本,本發明具備使用後立即拋棄之經濟效益。 3、杜絕細菌或病毒等感染之問題:承上所述,因本發明可拋棄式內視鏡組藉其整體結構創作,相較於目前常用的大腸鏡裝置等內視鏡裝置,本發明可拋棄式內視鏡組能夠大幅降低製造成本,故能採取使用後立即拋棄的實施方式,杜絕現有內視鏡裝置重複使用易因滅菌不完全而發生細菌或病毒感染之問題。 4、減少後續對內視鏡組之滅菌處理程序:承上所述,本發明之內視鏡組為可拋棄式組件,使用後立即丟棄,不重複使用,故無須對使用後的內視鏡組再施以滅菌處理的程序,確保內視鏡裝置使用的安全性。With the invention of the front endoscope set and endoscope device, it has the following advantages: 1. Effectively reduce the damage to the intestinal wall of the human body during operation: the present invention can be used in the disposable endoscope set The elastic sleeve provides the necessary support for the image capture module and the steering control module in the endoscope group, and has excellent flexibility. It is coated with a flexible thin film tube to cover the elastic sleeve and The internal image capture module and steering control module provide a mechanism for aseptic barriers. Among them, the high flexibility of the elastic sleeve and the elasticity of expansion and contraction, combined with the high flexibility of the thin film tube, make it disposable The endoscope set as a whole has the ability to bend and deform at a large bending angle, so that when the disposable endoscope set extends into the human intestine and other intestines, the disposable endoscope set can be easily controlled during operation The steering and the bending deformation at a large bending angle can effectively reduce the pushing and pressing of the intestinal wall and reduce the damage to the human intestinal wall. 2. Low manufacturing cost: As mentioned above, the disposable endoscope set of the present invention is sleeved on the outside of the image capture module and the steering control module by an elastic sleeve, and is equipped with a flexible thin film tube The elastic sleeve and its internal image capturing module and steering control module are covered. The elastic sleeve and the thin film tube are the objects that are easy to manufacture and obtain. The manufacturing cost is low, so it is higher than the existing. The price of the endoscope device and the operation cost of the existing endoscope device must be disinfected and sterilized after use. The present invention has the economic benefits of being discarded immediately after use. 3. Eliminate the problems of infections such as bacteria or viruses: As mentioned above, because the disposable endoscope set of the present invention is created by its overall structure, compared with the currently used colonoscope device and other endoscope devices, the present invention can The disposable endoscope set can greatly reduce the manufacturing cost, so it can be taken to be discarded immediately after use, to eliminate the problem that the existing endoscope device is reused and is prone to bacterial or viral infections due to incomplete sterilization. 4. Reduce the subsequent sterilization treatment procedures for the endoscope group: as mentioned above, the endoscope group of the present invention is a disposable component, which is immediately discarded after use and is not reused, so there is no need to use the endoscope after use The group then applied sterilization procedures to ensure the safety of the use of the endoscope device.
依據前揭發明內容揭示之技術內容,本發明包括一種可拋棄式內視鏡組以及一種包括所述可拋棄式內視鏡組之內視鏡裝置。如圖1至圖3所示之各種實施例,所述內視鏡裝置1A、1B、1C還包括一操作模組3A、3B、3C,所述可拋棄式內視鏡組2A係可拆組地連接該操作模組3A、3B、3C,其中,所述可拋棄式內視鏡組2A屬侵入人體的器具於使用後拋棄,杜絕重複使用易因滅菌不完全而發生細菌或病毒感染之問題,所述操作模組3A、3B、3C非屬侵入人體的器具,則能通過消毒、殺菌程序後,重複再使用。以下分別就可拋棄式內視鏡組與內視鏡裝置各種具體實施例提出說明。According to the technical content disclosed in the foregoing disclosure, the present invention includes a disposable endoscope set and an endoscope device including the disposable endoscope set. As shown in various embodiments shown in FIGS. 1 to 3, the
如圖4至圖6所示,係揭示所述可拋棄式內視鏡組2A、2B、2C之數種實施例,所述可拋棄式內視鏡組2A、2B、2C之組成構造係包括一影像擷取模組10、一轉向控制模組20、一彈性套管30A、30B、30C以及一膜管40。As shown in FIGS. 4 to 6, several embodiments of the
如圖4至圖6所示,該影像擷取模組10包括一前端導塊11、一影像擷取單元12、一導線單元13以及一連接部件14A,該影像擷取單元12係設於該前端導塊11中,該影像擷取單元12包含一微型影像擷取元件與一發光元件,並具備照明與影像擷取功能,所述微型影像擷取元件可為高解析度之感光耦合元件(Charge-coupled Device , CCD)或互補式金屬氧化物半導體感測元件(Complementary Metal-Oxide Semiconductor , CMOS)等,所述發光元件則可選用發光二極體元件(Light-emitting diode , LED);所述導線單元13係電性連接該影像擷取單元12的微型影像擷取元件與發光元件,所述導線單元13包括一組訊號傳輸線與一組導線,提供訊號與電流傳輸功能,所述導線單元13之後端穿設於該連接部件14A中。As shown in FIGS. 4 to 6, the image capturing
如圖4至圖6所示,該轉向控制模組20係裝設於該影像擷取模組10之側邊,該轉向控制模組20包括一轉向構件21,該轉向構件21連接該前端導塊11,該轉向控制模組20能被操作改變該影像擷取模組10之前端導塊11的方向。該轉向控制模組20可選用目前已知內視鏡裝置使用的任一型式轉向控制模組,並能以手動或電動操作方式控制轉向。於本實施例中,揭示該轉向控制模組20為手動操控制機構,其包括一所述轉向構件21以及一操控線組22,該轉向構件21連接於該影像擷取模組10之前端導塊11後端,該操控線組22連接轉向構件21,該操控線組22能被驅動而帶動轉向構件21改變前端導塊11的方向。As shown in FIGS. 4 to 6, the
如圖4至圖6所示,該彈性套管30A、30B、30C係金屬材料(如:鋼系金屬)或非金屬材料(如:塑膠)製成的長條狀之管體,該彈性套管30A、30B、30C係套設於該影像擷取模組10與該轉向控制模組20之外側,該彈性套管30A、30B、30C位於該前端導塊11與該連接部件14A之間,該彈性套管30A、30B、30C之後端連接該連接部件14A,該彈性套管30A、30B、30C之前端可以固接於該轉向控制模組20之轉向構件21(配合參看圖1、圖3及圖8所示),或者,該彈性套管30A、30B、30C之前端跨越該轉向控制模組20之轉向構件21而朝前延伸且固接該前端導塊11(配合參看圖2及圖9所示),該彈性套管30A、30B、30C至少具備可任意角度彎曲以及沿著長度方向伸縮的彈性。As shown in FIGS. 4-6, the
如圖4、圖5所示之實施例,該彈性套管30A、30B係選用線狀彈性條螺旋繞設而成之彈簧式管體,並具有多個依序串聯的單元環圈,使該彈性套管30A、30B被操作時,具有可任意角度彎曲、長度方向伸縮與徑向變形等彈性。As shown in the embodiments shown in FIG. 4 and FIG. 5, the
如圖4所示的實施例,該彈性套管30A可為壓縮彈簧或拉伸彈簧,該彈性套管30A於常態下,該彈性套管30A至少一部分相鄰排列的單元環圈31A之間具有一間距,亦即相鄰排列的單元環圈31A不接觸而具有間距,該彈性套管30A之外徑尺寸、線狀彈性條之線徑尺寸以及間距尺寸等依產品項目以及所述變形變形量等參數而設定。以大腸鏡產品為例,該彈性套管30A之外徑尺寸約為8mm~14mm,所述線狀彈性條之線徑約為0.5mm~1mm,所述間距約為1mm至10mm,或可進一步依產品的需求而調整間距的尺寸。該彈性套管30A的複數單元環圈31A之間具有間距,故該彈性套管30A整體具有多數空間,而能減少其外周面面積,減少操作時的摩擦。As shown in the embodiment shown in FIG. 4, the
如圖5所示的實施例,該彈性套管30B為拉伸彈簧,該彈性套管30B於常態下,多個單元環圈係依序相鄰併列抵接,相鄰單元環圈相互接觸而無間距。藉此,使該彈性套管30B之每一單位長度具有較大彎曲變形量。該彈性套管30B之外徑尺寸與線狀彈性條之線徑尺寸等依產品項目,以及所述變形變形量等參數而設定。以大腸鏡產品為例,該彈性套管30B之外徑尺寸約為8mm~14mm,所述線狀彈性條之線徑約為0.5mm~1mm。As shown in the embodiment shown in FIG. 5, the
如圖6及圖7所示之實施例,該彈性套管30C可以選用由多個環片圈體依序活動串聯而成之彈性管體,或者,該彈性套管也可以選用長條狀彈片螺旋繞設而成之彈性管體,使該彈性套管30C具有可任意角度彎曲、長度方向伸縮與徑向變形等彈性。該彈性套管30C之外徑尺寸與線狀彈性條之線徑尺寸等依產品項目,以及所述變形變形量等參數而設定。以大腸鏡產品為例,該彈性套管30C之外徑尺寸約為8mm~14mm,所述環片圈體或所述長條狀彈片厚度約為0.5mm~0.8mm。As shown in the embodiments shown in FIG. 6 and FIG. 7, the
如圖1至圖6所示,該膜管40係具有生物相容性與防水性之薄膜型管件,該膜管40套設於該影像擷取模組10、該轉向控制模組20與該彈性套管30A、30B、30C等三者的外側,該膜管40之前端密合固接該前端導塊11之後端,該膜管40之後端密合固接該連接部件14A之前端,該彈性套管30A、30B、30C的外周緣接觸該膜管40之內側壁,該膜管40具有高彎曲性。該膜管40與彈性套管30A、30B、30C之間的接觸連接狀態以及膜管40的管壁厚度,以不會對彈性套管30A、30B、30C的彎曲活動性與伸縮彈性等產生阻礙性干涉為原則,確保彈性套管30A、30B、30C之動作靈活性與順暢性。該膜管40之外徑係依產品項目的設定,於本較佳實施例中,所述膜管之管壁厚度尺寸為0.01mm~0.1mm。基於使用安全性,該膜管40係在無菌的環境中製造,且密合套設於該影像擷取模組10、該轉向控制模組20與該彈性套管30A、30B、30C的外側。As shown in FIGS. 1 to 6, the
如圖1至圖6所示,所述可拋棄式內視鏡組2A、2B、2C還可進一步包括一導管50,該導管50之前端裝設於該前端導塊11中,且該導管50之前端端口顯露於前端導塊11外,該導管50之後端係自該連接部件14A前端穿過該連接部件14A且伸出該連接部件14A之外側,用以連接外部的氣液供給設備,或者,該導管50也能提供切片器具或組織取樣器具等醫療檢驗器具穿設其中。As shown in FIGS. 1 to 6, the disposable endoscope sets 2A, 2B, and 2C may further include a
如圖1、圖2、圖8及圖9所示之可拋棄式內視鏡組2A、2B實施例中,該影像擷取模組10之連接部件14A內部設置一接頭單元,該接頭單元連接所述導線單元13之訊號傳輸線與導線,使影像擷取單元12以連接部件14A內部的接頭單元作為訊號與電流傳輸的外部電性連接媒介。所述接頭單元可選用現有的電性連接元件,於此不再贅述。該轉向控制模組20還包括一操控線組22,該操控線組22之一端連接該轉向構件21,且該操控線組22沿著該彈性套管30A、30B與該膜管40內部延伸至該連接部件14A中。In the embodiments of the disposable endoscope sets 2A and 2B shown in FIGS. 1, 2, 8, and 9, the connecting
如圖1、圖2、圖8及圖9所示,當前揭可拋棄式內視鏡組2A、2B實施例應用於內視鏡裝置1A、1B時,所述可拋棄式內視鏡組2A、2B係可拆組連接一組操作模組3A、3B,所述操作模組3A、3B包括一操作本體4以及一轉向操作組件5,該操作本體4包括一基座4A,該基座4A內部具有一處理單元,基座4A後端設有一顯示器4B,該基座4A下端形成一握持部,以握持部提供握持的部位,該基座4A前端具有一組接部4C,該組接部4C中具有一接頭,該接頭與顯示器4B電性連接該處理單元,該轉向操作組件5 裝設於該操作本體4的組接部4C上,該轉向操作組件5包括一轉向旋鈕5A,該可拋棄式內視鏡組2A、2B實施例,係以該連接部件14A、14C插接於該操作模組3A、3B之組接部4C,連接部件14A、14C中之接頭單元與該組接部4C中之接頭電性連接,該轉向控制模組20之操控線組22另一端連接該轉向旋鈕5A,使轉向旋鈕5A能夠經由操控線組22帶動該轉向構件21改變前端導塊11的方向。另一方面,影像擷取單元12擷取的影像資料能夠經由導線單元13傳輸至處理單元,並於顯示器4B中呈現影像。As shown in FIGS. 1, 2, 8 and 9, when the presently disclosed embodiments of the disposable endoscope set 2A, 2B are applied to the
如圖3所示之可拋棄式內視鏡組2C另一實施例,所述可拋棄式內視鏡組2C係進一步包括一轉向操作組件5,為使用後拋棄的物品。該影像擷取模組10之連接部件14A、14C內部設置一接頭單元,該接頭單元連接所述導線單元13之訊號傳輸線與導線,使影像擷取單元12以連接部件14A、14C內部的接頭單元作為訊號與電流傳輸的外部電性連接媒介。該轉向控制模組20還包括一操控線組22,該操控線組22之一端連接該轉向構件21,且該操控線組22沿著該彈性套管30A、30B、30C與該膜管40內部延伸至該連接部件14C中。該轉向操作組件5 係裝設於該連接部件14C中,該轉向操作組件5 包括一轉向旋鈕5A,該轉向旋鈕5A伸入連接部件14C中且連接該操控線組22的另一端,如圖9及圖10所示,使轉向旋鈕5A能夠經由操控線組22帶動該轉向構件21改變前端導塊11的方向。As shown in FIG. 3, another embodiment of the disposable endoscope set 2C, the disposable endoscope set 2C further includes a steering operation assembly 5, which is an object to be discarded after use. The connecting
如圖3所示,當前揭可拋棄式內視鏡組2C另一實施例應用於內視鏡裝置時,所述可拋棄式內視鏡組2C係可拆組連接一組操作模組3C,所述操作模組3C包括一操作本體4,該操作本體4包括一基座4A,該基座4A內部具有一處理單元,基座4A後端設有一顯示器4B,該基座4A下端形成一握持部,以握持部提供握持的部位,該基座4A前端具有一組接部4C,該組接部4C中具有一接頭,該接頭與顯示器4B電性連接該處理單元,該可拋棄式內視鏡組2C另一實施例係以該連接部件14C插接於該操作模組之組接部4C,連接部件14C中之接頭單元與該組接部4C中之接頭電性連接,使影像擷取單元12擷取的影像資料能夠經由導線單元13傳輸至處理單元,並於顯示器4B中呈現影像。As shown in FIG. 3, when another embodiment of the present
關於本發明可拋棄式內視鏡組及內視鏡裝置之使用,以應用於大腸鏡產品為例,以該內視鏡裝置對病患的大腸進行檢查過程中,如圖2、圖9至圖10所示,於檢查前,該可拋棄式內視鏡組2B之膜管40的外表面、前端導塊11的外表面等可以預先塗布潤滑性材料,增進該可拋棄式內視鏡組2B外表面的潤滑性。醫師一手手持該操作模組3B之操作本體4,另一手手持該可拋棄式內視鏡2B組經由病患的肛門、直腸伸入大腸內部,並通過影像擷取單元12擷取大腸腸壁內面的影像,使影像擷取單元12取得的影像資料能夠經由操作模組3B之處理單元處理後,於顯示器4B中呈現影像。Regarding the use of the disposable endoscope set and endoscope device of the present invention, taking the application of colonoscopy products as an example, the endoscope device is used to examine the patient's large intestine, as shown in Figures 2 and 9 to As shown in FIG. 10, before inspection, the outer surface of the
另一方面,為使該可拋棄式內視鏡組2B易於伸入病患的大腸內部,於操作過程中,可以經由導管50對大腸內部注入氣體,使大腸擴張,以便該可拋棄式內視鏡組2B於大腸內推進。另為使影像擷取單元12能夠擷取腸壁清晰的影像,且可經由導管50對大腸內部注入水液清洗腸壁。On the other hand, in order to make the
再者,該可拋棄式內視鏡組2B伸入病患的大腸內部檢查的過程中,醫師也可以將切片器具或其他組織取樣器具經由導管50伸入病患的大腸內部,搭配影像擷取單元12擷取大腸腸壁內面的影像,以及影像擷取單元12取得的影像資料於顯示器4B中呈現影像,使醫師能夠精準地操作伸出前端導塊11外側的切片器具或組織取樣器具自大腸腸壁中進行組織切片,再予以取出,以便後續組織切片病理的檢驗作業。Furthermore, during the inspection of the
前述內視鏡裝置對病患的大腸進行檢查的操作過程中,醫師可以手持可拋棄式內視鏡組2A、2B、2C位於肛門外側的彈性套管30A、30B、30C的端部朝肛門方向推進,此時,藉由彈性套管30A、30B、30C具備長度方向伸縮彈性之性能,以緩衝方式軟性地推送前端導塊11朝大腸內部方向行進。當前端導塊11於大腸內部靠近彎曲部位時,醫師可操作該轉向操作組件5之轉向旋鈕5A,經由操控線組22帶動該轉向構件21改變前端導塊11的方向,接續手持可拋棄式內視鏡組2A、2B、2C朝大腸的深處繼續推進。During the operation of the aforementioned endoscope device to examine the patient's large intestine, the physician can hold the disposable endoscope sets 2A, 2B, 2C and the ends of the
於此過程中,當醫師操作所述可拋棄式內視鏡組2A、2B、2C深入人體的大腸推進時,該可拋棄式內視鏡組2A、2B、2C藉由彈性套管30A、30B、30C之彎曲彈性以及長度方向的伸縮彈性,對醫師操作可拋棄式內視鏡組2A、2B、2C時施加之推進力量,能夠提供適當的緩衝彈性,以柔軟性的彈性套管30A、30B、30C通過軟質膜管40接觸大腸腸壁,能夠降低推擠或壓迫大腸腸壁的力量,避免可拋棄式內視鏡組2A、2B、2C對腸壁過度壓迫大腸腸壁。In this process, when the physician operates the disposable endoscope set 2A, 2B, 2C to advance into the human large intestine, the disposable endoscope set 2A, 2B, 2C is passed through the
經由前述說明可知,本發明藉由前揭可拋棄式內視鏡組與內視鏡裝置之創作,使其於使用操作過程中,尤其是作為大腸鏡使用時,所述可拋棄式內視鏡組係利用彈性套管對內視鏡組中的影像擷取模組與轉向控制模組提供必要的支撐性,以及提供高彎曲性與伸縮變形的彈性,並搭配柔軟性的膜管包覆著彈性套管及其內部的影像擷取模組與轉向控制模組提供無菌障壁之機構,使可拋棄式內視鏡組整體具備大彎曲角度之彎曲變形能力,使該可拋棄式內視鏡組伸入人體之大腸等腸道內部之操作過程中,該可拋棄式內視鏡組能夠易於受控轉向以及大彎曲角度的彎曲變形,有效降低對腸壁的推擠與壓迫,減少對人體腸壁的損傷。It can be seen from the foregoing description that the present invention creates the disposable endoscope group and the endoscope device by the front, so that the disposable endoscope is used during the operation process, especially when used as a colonoscope. The system uses elastic sleeves to provide the necessary support for the image capture module and steering control module in the endoscope group, as well as to provide high flexibility and elasticity of deformation, and is covered with a flexible membrane tube The elastic sleeve and its internal image capturing module and steering control module provide a mechanism for aseptic barriers, so that the disposable endoscope set as a whole has a large bending angle bending deformation capability, so that the disposable endoscope set During the operation of extending into the human intestine and other intestines, the disposable endoscope set can easily control the steering and the bending deformation at a large bending angle, effectively reduce the pushing and pressing of the intestinal wall, and reduce the human intestine Wall damage.
另一方面,本發明可拋棄式內視鏡組使用之彈性套管與膜管係選用易製造取得的現有物件,其製造成本低,故相較於現有高價位的內視鏡裝置,及現有內視鏡裝置使用後須消毒、殺菌的作業成本,本發明可拋棄式內視鏡組具備使用後立即拋棄之經濟效益,進而杜絕現有內視鏡裝置重複使用易因滅菌不完全而發生細菌或病毒感染之問題,並能減少後續對內視鏡組之滅菌處理程序。On the other hand, the elastic sleeve and membrane tube used in the disposable endoscope set of the present invention are selected from existing objects that are easy to manufacture and obtain. The manufacturing cost is low, so compared with the existing high-priced endoscope device, and the existing The operating cost of the endoscope device must be disinfected and sterilized after use. The disposable endoscope set of the present invention has the economic benefit of being immediately discarded after use, thereby preventing the existing endoscope device from being reused and being prone to bacteria or incomplete sterilization. Virus infection, and can reduce the subsequent sterilization treatment procedures for the endoscope group.
1A、1B、1C:內視鏡裝置 2A、2B、2C:可拋棄式內視鏡組 3A、3B、3C:操作模組 4:操作本體 4A:基座 4B:顯示器 4C:組接部 5:轉向操作組件 5A:轉向旋鈕 10:影像擷取模組 11:前端導塊 12:影像擷取單元 13:導線單元 14A、14C:連接部件 20:轉向控制模組 21:轉向構件 22:操控線組 30A、30B、30C:彈性套管 31A:單元環圈 40:膜管 50:導管 60:大腸 61、62、63、64:彎折部位 70:大腸鏡 71大腸鏡組件 711影像擷取單元 712轉向機構 713導線 714流體導管 715實心外覆體 72操作模組 721轉向控制元件 722顯示器1A, 1B, 1C:
圖1係本發明可拋棄式內視鏡裝置之第一較佳實施例的立體示意圖。 圖2係本發明可拋棄式內視鏡裝置之第二較佳實施例的立體示意圖。 圖3係本發明可拋棄式內視鏡裝置之第三較佳實施例的立體示意圖。 圖4係本發明可拋棄式內視鏡組之第一較佳實施例的立體分解示意。 圖5係本發明可拋棄式內視鏡組之第二較佳實施例的立體分解示意。 圖6係本發明可拋棄式內視鏡組之第三較佳實施例的立體分解示意。 圖7係圖6所示可拋棄式內視鏡組第三較佳實施例中的彈性套管局部剖面示意圖。 圖8係圖1所示可拋棄式內視鏡裝置第一較佳實施例的局部側視剖面示意圖。 圖9係圖2所示可拋棄式內視鏡裝置第二較佳實施例的局部側視剖面示意圖。 圖10係圖2所示可拋棄式內視鏡裝置第二較佳實施例受控彎曲轉向的示意圖。 圖11係已知大腸鏡裝置的立體示意圖。 圖12是圖11所示已知大腸鏡裝置伸入人體大腸中的平面示意圖。FIG. 1 is a schematic perspective view of a first preferred embodiment of the disposable endoscope device of the present invention. 2 is a schematic perspective view of a second preferred embodiment of the disposable endoscope device of the present invention. 3 is a perspective schematic view of a third preferred embodiment of the disposable endoscope device of the present invention. 4 is an exploded perspective view of the first preferred embodiment of the disposable endoscope set of the present invention. 5 is an exploded perspective view of the second preferred embodiment of the disposable endoscope set of the present invention. 6 is an exploded perspective view of the third preferred embodiment of the disposable endoscope set of the present invention. 7 is a partial cross-sectional schematic view of the elastic sleeve in the third preferred embodiment of the disposable endoscope set shown in FIG. 6. 8 is a schematic partial side cross-sectional view of the first preferred embodiment of the disposable endoscope device shown in FIG. 1. 9 is a partial side cross-sectional schematic diagram of the second preferred embodiment of the disposable endoscope device shown in FIG. 2. FIG. 10 is a schematic diagram of controlled bending steering of the second preferred embodiment of the disposable endoscope device shown in FIG. 2. Fig. 11 is a schematic perspective view of a known colonoscopy device. 12 is a schematic plan view of the known colonoscope device shown in FIG. 11 extending into the human large intestine.
1A:內視鏡裝置 2A:可拋棄式內視鏡組 3A:操作模組 4:操作本體 4A:基座 4B:顯示器 4C:組接部 5:轉向操作組件 5A:轉向旋鈕 10:影像擷取模組 11:前端導塊 12:影像擷取單元 14A:連接部件 20:轉向控制模組 21:轉向構件 30A:彈性套管 40:膜管 50:導管1A:
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US20140275765A1 (en) * | 2013-03-15 | 2014-09-18 | Steven C. Gebhart | Probe assembly and disposable cover particularly for use in endoscope applications of low coherence interferometry |
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TW200630066A (en) * | 2005-02-23 | 2006-09-01 | Chung Shan Inst Of Science | Disposable two-stage endoscope |
US20140350343A1 (en) * | 2011-09-22 | 2014-11-27 | Optimede Inc. | Disposable endoscope |
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