TW201821121A - Collapsible nasal ejecting catheter - Google Patents

Abstract

A collapsible nasal ejecting catheter, made of thermoplastic elastomer or other soft and elastic materials, can be operated by the patient to insert into nasal cavity and nasopharynx. The catheter comprises a catheter body and a connector, having a flat closed end and an open end on the opposite side. There are multiple side-holes near the closed end. This catheter, when connected to a syringe, can eject multiple strong thin spouts within the nasal cavity or nasopharynx for cleansing mucus and crust. The flat close end and the collapsibility facilitate better navigation of the catheter through the slit like space of nasal cavity to reach the deeper and narrower region to improve the flushing efficacy and also can avoid incidental insertion into sinus.

Description

可塌陷鼻腔噴射導管  Collapse nasal jet catheter  

本發明是有關於一種鼻腔沖洗導管，特別是指一種可深入鼻腔深處及鼻咽清洗黏稠分泌物，以改善慢性鼻竇炎症狀之創新設計。 The invention relates to a nasal irrigation catheter, in particular to an innovative design which can penetrate deep into the nasal cavity and clean the visceral secretions of the nasopharynx to improve the symptoms of chronic sinusitis.

以症狀持續超過12週為診斷條件的慢性鼻竇炎雖不會直接致命，卻是令人困擾的疾病。目前慢性鼻竇炎並無治癒的方法，其症狀包含鼻塞、喉嚨異物感及咳嗽等症狀會持續困擾病人，甚至一生。抗生素只是對急性感染之治療，而外科手術的目的是移除阻塞或擴大鼻腔內通路以改善黏液之排放，並避免鼻竇炎急性發作。不管做何治療，疾病之機轉並未改變，症狀仍然存在，因此，耳鼻喉科醫師均建議輔以濕潤鼻腔的長期居家治療，一般建議每天至少濕潤鼻腔兩次，因為無法治癒需要終生居家治療。(Wikipedia,key word：chronic sinusitis,Medscape,Treatment,Long-term monitoring) Chronic sinusitis, which is diagnosed with symptoms for more than 12 weeks, is not directly fatal, but it is a troublesome disease. At present, there is no cure for chronic sinusitis. Symptoms such as nasal congestion, foreign body sensation of the throat and cough will continue to plague the patient, even for a lifetime. Antibiotics are only treatments for acute infections, and the purpose of surgery is to remove obstructions or enlarge the intranasal pathways to improve mucus emissions and avoid acute exacerbations of sinusitis. Regardless of the treatment, the mechanism of the disease has not changed, and the symptoms still exist. Therefore, otolaryngologists recommend long-term home treatment with moist nasal cavity. It is generally recommended to moisturize the nasal cavity at least twice a day because it cannot be cured and needs lifelong home treatment. . (Wikipedia, key word: chronic sinusitis, Medscape, Treatment, Long-term monitoring)

參閱圖1、2，為人體鼻腔內的矢狀剖面與冠狀剖面視圖，與鼻子的外觀相似，鼻腔正面呈現上窄下寬的三角形，鼻腔由鼻中膈分隔成左右兩個空間。在每一個空間中，介於寬闊的前方鼻前庭90及後方鼻咽91之間的鼻腔本體是由三片彎曲的板狀結構隔成三個稍微彎曲的隙縫狀通路，及一個臨中膈空間。此三片由上向下漸大之板狀結構稱為上鼻甲A、中鼻甲B，及下鼻甲C，而三個由上向下漸大之通路則為上鼻通道A1、中鼻通道B1及下鼻通道C1。中鼻通道常分為約2cm之下降段(B1D)及約1cm之水平段(B1H)兩段。臨中膈空間以上、中、下鼻甲A、B、C下緣區分為上、中、下臨中膈空間D1、D2、D3。三個 鼻甲，鼻中膈及鼻腔側壁均由骨骼構成骨架，表面再覆被黏膜，以此增加表面積使鼻腔本體之空間成為隙縫狀通路並具有兩個功能：1.調整吸入空氣之濕度及溫度。2.過濾空氣中顆粒狀物質，預防其掉入氣管及肺臟(參閱nasal cavity,wikipedia)。此三個鼻通道除向內與臨中膈空間，向前與鼻前庭90及向後與鼻咽相通外，為彼此獨立的空間。所有黏液都由鼻腔旁邊及上面的四對鼻竇(上頜竇、前額竇、篩狀竇、蝶狀竇)分泌，並從位於上鼻通道A1(篩狀竇後三分之一)、中鼻通道B1(上頜竇、前額竇及篩狀竇前三分之二)及鼻咽頂部(蝶狀竇)的幾個圓形細小開口(通常1mm或更小)排出。慢性鼻竇炎病人求診時多已有嚴重鼻塞之症狀，而且無法回復正常狀態，因此難以回憶其發生的過程，但其致病機轉(pathophysiology)可由感冒的過程來說明。 Referring to Figures 1 and 2, the sagittal section and the coronal section of the human nasal cavity are similar to the appearance of the nose. The front of the nasal cavity presents a narrow, wide triangle, and the nasal cavity is divided into two left and right spaces by the nasal septum. In each space, the nasal body between the wide front nasal vestibule 90 and the posterior nasopharynx 91 is divided into three slightly curved slit-like passages by three curved plate-like structures, and a temporary space. . The three plate-like structures that are gradually enlarged from the top to the bottom are called the upper turbinate A, the middle turbinate B, and the inferior turbinate C, and the three channels that are enlarged from the top to the bottom are the upper nasal passage A1 and the middle nasal passage B1. And the lower nasal passage C1. The middle nasal passage is often divided into a descending section of about 2 cm (B1D) and a horizontal section of about 1 cm (B1H). The lower edges of the middle, lower, middle and lower turbinate A, B, and C are divided into upper, middle, and lower median spaces D1, D2, and D3. The three turbinate, the nasal sinus and the side wall of the nasal cavity are skeletons composed of bones, and the surface is covered with mucous membranes, so as to increase the surface area, the space of the nasal cavity becomes a slit-like passage and has two functions: 1. Adjusting the humidity and temperature of the inhaled air. . 2. Filter the particulate matter in the air to prevent it from falling into the trachea and lungs (see nasal cavity, wikipedia). The three nasal passages are independent of each other except for the inward and medial space, forward and nasal vestibule 90 and rearward communicating with the nasopharynx. All mucus is secreted by the four pairs of sinuses (maxillary sinus, prefrontal sinus, sinus sinus, sphenoid sinus) beside the nasal cavity and above, and from the upper nasal passage A1 (one third of the posterior sinus), the middle nose Channels B1 (two-thirds of the maxillary sinus, prefrontal sinus, and anterior sinus sinus) and several small circular openings (usually 1 mm or less) of the nasopharynx (the sphenoid sinus) are excreted. Patients with chronic sinusitis often have symptoms of severe nasal congestion and are unable to return to normal conditions, so it is difficult to recall the process of their occurrence, but their pathophysiology can be explained by the process of cold.

鼻腔的排出物可以由感冒的過程來了解，感冒初期會流鼻水，鼻水是不含黏液的液體會完全蒸發；接下來是容易排出稍具黏性的鼻涕；再來是不易排出且呈濃稠狀的黏液；接著是呈半固態膠質狀的半鼻屎；最後則是可從鼻前庭90挖出的固態的鼻屎，這是黏液的四種型態。慢性鼻竇炎就是黏液及鼻屎堆積在鼻腔本體所造成的症狀。感冒症狀不會超過4星期，慢性鼻竇炎則是不知病因卻不斷分泌黏液的疾病，只有慢性鼻竇炎才會症狀持續超過12星期，如果症狀超過12星期且無其他腫瘤造成鼻塞，即可確定診斷。另外，過敏性鼻炎，雖也有嚴重之鼻塞症狀，但必定有大量的鼻水，也不會有喉嚨異物感，只要過敏原消失就會恢復正常，是間斷性發作週期性或季節性的疾病，而慢性鼻竇炎的症狀是鼻水太少黏液太黏所造成，其症狀是經年累月永遠困擾病人。 The discharge of the nasal cavity can be understood by the process of catching a cold. The nose will have a runny nose at the beginning of the cold. The nasal water will be completely evaporated without the mucus. The next step is to easily discharge the slightly sticky nose; it is not easy to discharge and thick. The mucus is followed by a semi-nasal gelatinous semi-nasal sinus; the last is a solid snot that can be excavated from the nasal vestibule 90, which is the four types of mucus. Chronic sinusitis is a symptom caused by mucus and nasal discharge in the nasal body. The symptoms of colds will not exceed 4 weeks. Chronic sinusitis is a disease that secretes mucus without knowing the cause. Only chronic sinusitis will last for more than 12 weeks. If the symptoms are more than 12 weeks and no other tumor causes nasal congestion, the diagnosis can be confirmed. . In addition, allergic rhinitis, although there are severe nasal congestion symptoms, but there must be a large amount of nasal water, there is no throat foreign body sensation, as long as the allergens disappear, it will return to normal, is a periodic or seasonal disease of intermittent episodes, and The symptoms of chronic sinusitis are caused by too little nasal fluid and too much mucus. The symptoms are that the patient will be plagued for years.

配合參閱圖3，慢性鼻竇炎病患的分泌物，因過於黏稠，無論是用力擤鼻涕，或是用力抽吸都很難完 全移除。黏液容易黏附在狹窄空間造成局部阻塞，阻塞則無空氣經過因而少接觸空氣而保持液態，但如重力超過附著力，則依病人之姿勢順著重力向前向下或向後較寬處移動，向前滑入鼻前庭90或向下流入下方較大的空間成為習知的鼻涕，更進一步乾化成為鼻屎；也會向後滑入鼻咽91，此即習知的黏液倒流，也很難用抽吸或吞嚥的動作來清除。未能移除而滯留在鼻腔的黏液不像鼻水會蒸發消失，如滑入較大的空間則成為薄層，因未完全阻塞會受呼吸空氣的乾化縮小體積，一層一層黏附於鼻腔內並自位於中鼻通道B1及上鼻通道A1之鼻竇開口處向外漫延，終於造成持續且嚴重的鼻塞。黏液繼續從上鼻通道及中鼻通道之開口排出，形成懸吊於鼻腔上方之狀態，而黏液的最前端即其最下部份因仍與空氣接觸，反而成為最堅硬的鼻屎狀態。流入鼻咽的黏液之命運也與在鼻腔內相同，會重覆乾化及累積之過程，而且鼻咽91是上下走向寬闊的呼吸通道，流入其內之黏液乾化速度更快，不管是液態之黏液或固態的鼻屎都會再向下滑落，都有掉入氣管的可能，因此會引起喉嚨異物感及咳嗽等症狀，對病人的困擾不亞於鼻塞，持續的咳嗽甚至會限制病人的社交活動。鼻塞、喉嚨異物感及咳嗽等症狀也會影響睡眠，造成睡眠不足及精神不振的不良後果。最後，這些症狀如果放任不管，黏液及鼻屎終將阻塞鼻竇出口，造成黏液堆積鼻竇內而引發急性鼻竇炎，需要嚴峻的內科和/或外科治療，但急性發作控制之後，持續分泌黏液仍然不變，症狀仍然存在。 Referring to Figure 3, the secretions of patients with chronic sinusitis are too viscous, and it is difficult to remove them completely, either by forceful snoring or by forceful aspiration. The mucus easily adheres to the narrow space to cause partial obstruction, and the obstruction has no air passing through and thus less contact with the air to maintain the liquid state. However, if the gravity exceeds the adhesion force, the patient moves in the posture according to the gravity to move forward or backward to the wider position. Before slipping into the nasal vestibule 90 or flowing down into the larger space below, it becomes a known snot, and further becomes dry into a snot; it also slides back into the nasopharynx 91, which is a well-known mucus reflux, which is difficult to use. Aspiration or swallowing action to clear. The mucus that has not been removed and stays in the nasal cavity does not evaporate like the nasal water. If it slides into a larger space, it becomes a thin layer. Because it is not completely blocked, it will be dried by the air to reduce the volume, and one layer adheres to the nasal cavity. It spreads outward from the sinus opening in the middle nasal passage B1 and the upper nasal passage A1, eventually causing a persistent and severe nasal congestion. The mucus continues to drain from the opening of the upper nasal passage and the middle nasal passage, forming a state of suspension above the nasal cavity, and the foremost part of the mucus, which is still in contact with the air, becomes the hardest nasal state. The fat flow into the nasopharynx is also the same as in the nasal cavity, which will repeat the process of dryness and accumulation, and the nasopharynx 91 is a wide and deep breathing passage, and the mucus flowing into it is more quickly dried, regardless of the liquid state. The mucus or solid nasal sputum will fall down again, and there is a possibility of falling into the trachea, which may cause symptoms such as foreign body sensation and cough in the throat. It is no more than a nasal congestion, and the continuous cough can even limit the socialization of the patient. activity. Nasal congestion, throat foreign body sensation and coughing can also affect sleep, resulting in poor sleep and lack of energy. Finally, if these symptoms are left unchecked, mucus and snot will eventually block the sinus outlet, causing mucus to accumulate in the sinus and cause acute sinusitis. Severe medical and/or surgical treatment is required, but after the acute attack control, the mucus is still not secreted. Change, the symptoms still exist.

體外實驗可觀察到，黏液四種型態之互相改變，鼻涕暴露在空氣中可成為黏液，黏液暴露在空氣中可成為半鼻屎，半鼻屎可成為堅硬之鼻屎。從鼻涕變成堅硬之鼻屎，體積可以相差十倍，其時間長短依空氣濕度及流通程度而定。反之，堅硬的鼻屎泡在水中約一小時後，可成為半鼻屎，半鼻屎可成為黏液，時間更久之後可成為鼻 涕。因此濕潤鼻腔做為慢性鼻竇炎的輔助治療，聽起來相當合理，但如圖1、2、3所示，鼻腔本體是三個鼻通道及一個臨中膈空間所構成狹窄隙縫狀的複雜結構，並非是空無一物的空洞空間。鼻腔本體可從鼻前庭90到體外，也可以從鼻咽到口腔再到體外，更是人體內獨一無二前後都通到體外的開放空間(口腔也是開放空間，但是有肌肉群可以自主運動，是屬於可以打開及關閉的空洞空間)。從外部灌注沖洗液，必定先從前後洩漏出去，而且因為鼻甲的阻隔，不管用何種姿勢都無法充滿整個鼻腔本體，而且濕潤不一定能清除黏液，濕潤鼻腔說起來容易，但清除黏液卻困難重重。 In vitro experiments can be observed that the four types of mucus change each other, the snot can be mucus when exposed to the air, and the mucus can become a semi-nasal sputum when exposed to the air, and the semi-nasal sputum can become a hard snot. From the snot to the hard snot, the volume can vary by a factor of ten, depending on the air humidity and circulation. Conversely, a hard nasal sputum can become a semi-nasal sputum after about one hour in the water. The semi-nasal sputum can become a mucus, and it can become a snot after a longer time. Therefore, moist nasal cavity as an auxiliary treatment for chronic sinusitis, sounds quite reasonable, but as shown in Figures 1, 2, and 3, the nasal cavity is a complex structure of three narrow passages and a narrow gap formed by a temporary space. It is not a hollow space that is empty. The nasal cavity can be from the nasal vestibule 90 to the outside of the body, or from the nasopharynx to the oral cavity to the outside of the body. It is also the open space outside the body that is unique to the body (the oral cavity is also an open space, but the muscle group can move autonomously, it belongs to The void space that can be opened and closed). Infusion of the rinsing fluid from the outside must first leak out from the front and back, and because of the blockage of the turbinate, the entire nasal cavity body cannot be filled regardless of the posture, and the moistening does not necessarily remove the mucus. It is easy to wet the nasal cavity, but it is difficult to remove the mucus. Heavy.

再以下列實驗模擬沖洗鼻腔的機制如下：以水平水柱噴射黏附於直立塑膠板之黏液、半鼻屎及鼻屎，水柱強度再依垂直向上之長度區分為：45cm以下之低壓水柱，45cm至90cm之中壓水柱及90cm以上之高壓水柱。如此可以觀察到：低壓水柱能使黏液變成稀薄的鼻涕，也能使半鼻屎表面變成黏液，但無法改變堅硬的鼻屎；中壓水柱可使黏液及半鼻屎變成易於流動的鼻涕，也可使堅硬的鼻屎表面變成濃稠的黏液；高壓水柱則可使堅硬的鼻屎直接剝離滑落，半鼻屎黏液及鼻涕更容易被直接沖走。因此，沖洗效果與水柱垂直高度直接相關。 The following experiment simulates the mechanism of rinsing the nasal cavity as follows: the horizontal water column sprays the mucus, the semi-nasal sputum and the nasal sputum adhered to the upright plastic plate. The strength of the water column is further divided into the low-pressure water column below 45 cm, 45 cm to 90 cm. Medium pressure water column and high pressure water column above 90cm. It can be observed that the low-pressure water column can make the mucus into a thin nasal sin, and can also make the surface of the semi-nasal sin become mucus, but it can not change the hard snot; the medium-pressure water column can make the mucus and the semi-nasal sputum become easy-flowing snot, also The surface of the hard nose can be turned into a thick mucus; the high-pressure water column can make the hard nose directly peel off, and the semi-nasal mucus and the nose are more easily washed away. Therefore, the flushing effect is directly related to the vertical height of the water column.

參閱圖4、5，為中華民國發明第I542371號專利，此專利文件是申請人所申請之前案(以下簡稱前案)，其目的是改善原鼻腔沖洗導管發明第I515025號專利之缺點。其改善方法為：1.以邊孔總面積控制水柱高度，並以水柱高度區分為高壓、中壓，及低壓導管611，但高壓導管611必需使用較大較耐壓之導管611，此高壓導管611雖能清除大部份結痂及粘液改善鼻塞症狀，但無法抵達較深較狹窄之處，更細更多的小水柱雖增加對正隙縫狀空間的機會，效果仍未完全滿意；2.以管腔內留置探針8 改善微導管之操控性，但微導管611水柱弱沖洗效率差，而且實際製造1mm外徑之導管已經不易，但嚴重病人之鼻腔狹窄處甚至小至0.5mm，更難深入；而且微導管曾經誤入蝶狀竇(sphenoid sinus)，有電腦斷層攝影足以証明(附件1，沖鼻導管誤入蝶狀竇之電腦斷層攝影)。另外親友使用的經驗，鼻塞症狀雖可立即改善，但喉嚨異物感及咳嗽仍未能持續改善達到理想之狀況，而且大小兩種導管必需搭配使用，甚至需要電腦斷層攝影測量中鼻通道及上鼻通道之寬度以選取適當的導管，仍覺不便，仍有持續改善的必要。 Referring to Figures 4 and 5, the Patent No. I542371 of the Republic of China is hereby incorporated by reference in its entirety (hereinafter referred to as the present disclosure), the purpose of which is to improve the disadvantages of the original nasal irrigation catheter invention No. I515025. The improvement method is as follows: 1. The height of the water column is controlled by the total area of the side holes, and the height of the water column is divided into high pressure, medium pressure, and low pressure conduit 611, but the high pressure conduit 611 must use a larger pressure resistant conduit 611, which is a high pressure conduit. Although 611 can remove most of the scars and mucus to improve the symptoms of nasal congestion, but can not reach the deeper and narrower parts, the thinner and more small water column increases the chance of the gap space, the effect is still not completely satisfactory; Indwelling probe 8 in the lumen improves the handling of the microcatheter, but the microcatheter 611 water column is weakly flushed, and the actual manufacturing of the 1 mm outer diameter catheter is not easy, but the nasal cavity of the severe patient is even as small as 0.5 mm. Difficult to go deep; and microcatheter has been mistaken into the sphenoid sinus (sphenoid sinus), there are computer tomography enough to prove (Attachment 1, the CT catheter into the sphenoid sinus computed tomography). In addition, the experience of relatives and friends, although the nasal congestion symptoms can be improved immediately, but the foreign body sensation and cough of the throat still can not be improved to achieve the desired condition, and the two catheters must be used together, even the need for computed tomography to measure the nasal passage and upper nose. The width of the channel to select the appropriate catheter is still inconvenient and there is still a need for continuous improvement.

以上是我們尚未公開的人體試驗經驗，尤其是病人自己操作可能誤入鼻竇，是不可能憑空想像的。對其他人而言，在本案申請日以前，沒有任何人會在沒有專利在手之前題下研究此案；即使認真研究也會發現前案非常合理，難以找到缺點，而如認為前案療效不佳，也正好証明全世界醫學專家的共識確有道理(Wikipedia,key word：chronic sinusitis,Medscape Reference； Wikipedia,keyword：chronic sinusitis Mayo Clinic；Wikipedia,keyword：sinusitis,University of Maryland Medical Center-sinusitis,page 11-12)：沖鼻治療無效時要考慮開刀之建議；另外前案尚未商品化，無法做人體試驗，不可能發現此案之缺點。因此改善此案以造福病人，我們責無旁貸。因為我們身兼醫師、病人及技術領域業者三種角色，經過兩年的在親友之間不斷試驗，才能完成本案。 The above is our unexplained human experience, especially if the patient's own operation may be mistaken into the sinus, it is impossible to imagine. For others, no one will study the case without the patent before the application date of the case; even if you study it carefully, you will find that the case is very reasonable and it is difficult to find the shortcomings. Good, it just proves that the consensus of medical experts around the world makes sense (Wikipedia, key word: chronic sinusitis, Medscape Reference; Wikipedia, keyword: chronic sinusitis Mayo Clinic; Wikipedia, keyword: sinusitis, University of Maryland Medical Center-sinusitis, page 11-12): When the nasal treatment is invalid, it is necessary to consider the proposal of the knife; otherwise, the previous case has not been commercialized, and it is impossible to do human trials. It is impossible to find the shortcomings of the case. Therefore, we are duty-bound to improve the case for the benefit of patients. Because we are in the three roles of doctors, patients and technical practitioners, after two years of continuous experimentation between relatives and friends, the case can be completed.

有鑑於此，本發明之目的是在設計一種有效又易於操作之導管，具體而言是設計一種可以噴射強勁水柱，可以深入狹窄的隙縫狀空間，又不會誤入鼻竇之多功能導管。本發明的手段是在提供一種可塌陷之鼻腔噴射導管，可配合一注射筒灌注沖洗液以沖洗鼻腔及鼻咽；該導 管包含一導管本體及一銜接器，該導管本體具有一封閉末端及一相反於該封閉末端之開放端，且靠近該封閉末端處形成有複數邊孔；該導管本體是以熱塑性彈性體或其他柔軟具彈性之材質製成，可供病人自行操作置入鼻腔及鼻咽，其特徵在於：該導管本體之最小管壁厚度不大於0.45mm，且該扁平狀封閉末端之最大寬度不小於1mm。 In view of this, the object of the present invention is to design an effective and easy to operate catheter, in particular, to design a multifunctional catheter that can spray a strong water column and can penetrate deep into a narrow space without erroneously entering the sinus. The method of the present invention provides a collapsible nasal cavity ejecting catheter, which can be filled with a syringe to flush the nasal cavity and the nasopharynx; the catheter comprises a catheter body and an adapter, the catheter body having a closed end and a catheter Conversely, the open end of the closed end is formed with a plurality of side holes near the closed end; the catheter body is made of a thermoplastic elastomer or other soft and elastic material, and can be placed by the patient into the nasal cavity and the nasopharynx The feature is that the minimum wall thickness of the catheter body is no more than 0.45 mm, and the maximum width of the flat closed end is not less than 1 mm.

本發明的又一技術手段，是在於上述扁平狀封閉末端之最大寬度大於該導管本體之最小直徑。 Yet another technical means of the present invention is that the maximum width of the flat closed end is greater than the minimum diameter of the catheter body.

本發明的再一技術手段，是在於上述之該導管之硬度介於80 Shore A以下，管壁厚度不大於0.45mm。 A further technical means of the present invention is that the duct has a hardness of less than 80 Shore A and a wall thickness of not more than 0.45 mm.

本發明的另一技術手段，是在於上述之該導管之硬度介於80-90 Shore A，管壁厚度不大於0.40mm。 Another technical means of the present invention is that the duct has a hardness of 80-90 Shore A and a wall thickness of not more than 0.40 mm.

本發明的又一技術手段，是在於上述之該導管之硬度在90 Shore A以上，管壁厚度不大於0.35mm。 According to still another aspect of the present invention, the catheter has a hardness of 90 Shore A or more and a tube wall thickness of not more than 0.35 mm.

本發明之有益功效在於，該導管之扁平狀封閉末端及可塌陷性使其易於順行於鼻腔內之隙縫狀空間，進入遠小於導管外徑之狹窄空間，並噴出較強勁細長水柱，達到更佳的沖洗目的，而且可以避免誤入鼻竇。 The beneficial effect of the invention is that the flat closed end of the catheter and the collapsibility make it easy to follow the slit space in the nasal cavity, enter a narrow space far smaller than the outer diameter of the catheter, and eject a relatively strong slender water column to reach a more Good rinsing purpose, and can avoid getting into the sinus.

B1D‧‧‧下降段 B1D‧‧‧Descent

B1H‧‧‧水平段 B1H‧‧‧ horizontal section

D‧‧‧臨中膈空間 D‧‧‧Linzhong Space

D1‧‧‧上臨中膈空間 D1‧‧‧On the middle of the space

D2‧‧‧中臨中膈空間 D2‧‧‧中中中膈空间

D3‧‧‧下臨中膈空間 D3‧‧‧Let's go to Lieutenant Space

E‧‧‧鼻前庭 E‧‧‧ nasal vestibule

F‧‧‧上鼻甲 F‧‧‧Upper turbinate

F1‧‧‧上鼻通道 F1‧‧‧Upper nasal passage

G‧‧‧中鼻甲 G‧‧‧中鼻甲

G1‧‧‧中鼻通道 G1‧‧‧ Middle nose channel

H‧‧‧下鼻甲 H‧‧‧Lower Turbines

H1‧‧‧下鼻通道 H1‧‧‧ lower nasal passage

J‧‧‧鼻咽 J‧‧‧ Nasopharyngeal

6‧‧‧鼻腔噴射導管 6‧‧‧Nasal jet catheter

61‧‧‧導管本體 61‧‧‧ catheter body

611‧‧‧扁平狀封閉末端 611‧‧‧flat closed end

612‧‧‧開放端 612‧‧‧Open end

613‧‧‧邊孔 613‧‧‧ side hole

614‧‧‧管壁 614‧‧‧ wall

615‧‧‧管腔 615‧‧‧ lumen

62‧‧‧銜接器 62‧‧‧Connector

7‧‧‧注射筒 7‧‧‧Syringe

71‧‧‧容置件 71‧‧‧ 容 容

72‧‧‧擠壓件 72‧‧‧Extrusion

圖1是人體鼻腔內的矢狀剖面視圖；圖2是圖1中線段a-a鼻腔後半部的冠狀剖面視圖；圖3是一鼻腔後半部的冠狀剖面視圖，說明慢性鼻竇炎患者之黏液及鼻屎由上臨中膈空間、上鼻通道及中鼻通道堆積到下臨中膈空間之態樣；圖4是剖面示意圖，說明中華民國發明第I542371號之「鼻腔沖洗導管」；圖5是一局部剖視示意圖，說明中華民國發明第I542371號之「鼻腔沖洗導管」之銜接器與導管本體的銜接態樣，以及探針之安全設計； 圖6是一立體分解示意圖，說明本發明鼻腔噴射導管之組成；圖7是一截面示意圖，說明本發明之導管本體的自然狀態；圖8是一截面示意圖，說明本發明之導管本體的塌陷狀態；圖9是一局部剖視示意圖，說明本發明導管本體末端及扁平狀封閉末端之態樣；圖10是圖9中線段b-b的截面示意圖；圖11是圖9中線段c-c的截面示意圖；圖12是一鼻腔後半部的冠狀剖面視圖，說明發明第I542371號之高壓導管只能放在中鼻通道之水平段的態樣；圖13是一鼻腔後半部的冠狀剖面視圖，說明本發明之可塌陷鼻腔噴射導管可以置入中鼻通道之下降段的態樣；圖14是一鼻腔後半部的冠狀剖面視圖，說明本發明之可塌陷鼻腔噴射導管可以置入上臨中膈空間的態樣；圖15是一鼻腔後半部的冠狀剖面視圖，說明本發明之可塌陷鼻腔噴射導管可以置入上鼻通道的態樣；及圖16是人體鼻腔內的矢狀剖面視圖，說明本發明之可塌陷鼻腔噴射導管可以經由上鼻通道進入鼻咽進行沖洗的態樣。 Figure 1 is a sagittal cross-sectional view of the human nasal cavity; Figure 2 is a coronal cross-sectional view of the posterior half of the nasal cavity of the line aa of Figure 1; Figure 3 is a coronal cross-sectional view of the posterior half of the nasal cavity, illustrating mucus and nasal discharge of patients with chronic sinusitis From the upper middle space, the upper nasal passage and the middle nasal passage to the lower middle space, Figure 4 is a schematic cross-sectional view showing the "nasal irrigation catheter" of the Republic of China invention No. I542371; Figure 5 is a part A cross-sectional view showing the interface between the adapter of the "nasal irrigation catheter" of the Republic of China invention No. I542371 and the catheter body, and the safety design of the probe; FIG. 6 is a perspective exploded view showing the nasal injection catheter of the present invention. Figure 7 is a schematic cross-sectional view showing the natural state of the catheter body of the present invention; Figure 8 is a schematic cross-sectional view showing the collapsed state of the catheter body of the present invention; and Figure 9 is a partial cross-sectional view showing the catheter body of the present invention Figure 10 is a schematic cross-sectional view of the line segment bb of Figure 9; Figure 11 is a schematic cross-sectional view of the line segment cc of Figure 9; Figure 12 is a nasal cavity A coronal section view of the half, illustrating a state in which the high pressure catheter of the invention No. I542371 can only be placed in the horizontal section of the middle nasal passage; FIG. 13 is a coronal section view of the posterior half of the nasal cavity, illustrating the collapsible nasal jet catheter of the present invention Figure 14 is a coronal cross-sectional view of the posterior half of the nasal cavity, illustrating the collapsible nasal jet catheter of the present invention can be placed into the upper medial space; Figure 15 is a A coronal cross-sectional view of the posterior part of the nasal cavity, illustrating a state in which the collapsible nasal jet catheter of the present invention can be placed in the upper nasal passage; and FIG. 16 is a sagittal cross-sectional view of the nasal cavity of the human body, illustrating that the collapsible nasal jet catheter of the present invention can be The state of rinsing through the upper nasal passage into the nasopharynx.

有關本發明之相關申請專利特色與技術內容，在以下配合參考圖式之三個較佳實施例的詳細說明中，將可清楚地呈現。 The details of the related patents and the technical contents of the present invention will be clearly shown in the following detailed description of the three preferred embodiments with reference to the drawings.

在進行詳細說明之前，值得一提的是，類似的元件是以相同的元件編號來作表示，且以下僅先就元件之構成及連接關係作各個實施例之介紹說明，至於詳細之製程參數、使用操作過程，及功效說明則敘述於後。 Before the detailed description, it is worth mentioning that similar components are denoted by the same component numbers, and only the components and connection relationships of the components are first described in the following embodiments. As for the detailed process parameters, The operating procedures and efficacy instructions are described below.

參閱圖6，為本發明可塌陷鼻腔噴射導管6，其可配合一注射筒7灌注沖洗液以沖洗人體之鼻腔及鼻咽。 Referring to Figure 6, a collapsible nasal spray catheter 6 of the present invention can be used in conjunction with a syringe 7 to infuse irrigation fluid to flush the nasal cavity and nasopharynx of the human body.

該可塌陷鼻腔噴射導管6包含一導管本體61及一銜接器62，該導管本體61是以熱塑性彈性體或其他柔軟具彈性之材質製成，可供病人自行操作置入鼻腔及鼻咽中，該導管本體61具有一扁平狀封閉末端611及一相反於該扁平狀封閉末端611之開放端612，且該導管本體61上靠近該扁平狀封閉末端611處形成有複數邊孔613。 The collapsible nasal jet catheter 6 comprises a catheter body 61 and an adapter 62. The catheter body 61 is made of a thermoplastic elastomer or other soft and elastic material, and can be placed into the nasal cavity and the nasopharynx by the patient. The duct body 61 has a flat closed end 611 and an open end 612 opposite to the flat closed end 611, and a plurality of side holes 613 are formed in the duct body 61 near the flat closed end 611.

該注射筒7具有一容置件71，及一設置於該容置件71內之擠壓件72，該容置件71內可盛裝液體，該擠壓件72將容至於該擠壓件72之液體擠入該導管本體61中，再藉由壓力由該複數邊孔613向外噴出。 The syringe 7 has a receiving member 71 and a pressing member 72 disposed in the receiving member 71. The receiving member 71 can contain liquid, and the pressing member 72 will accommodate the pressing member 72. The liquid is squeezed into the duct body 61 and is ejected outward from the plurality of side holes 613 by pressure.

該銜接器62之一端是連接該導管本體61之開放端612，另一端是連接該注射筒7，以使該注射筒7中的液體輸送至該導管本體61中。 One end of the adapter 62 is connected to the open end 612 of the catheter body 61, and the other end is connected to the syringe 7 to deliver the liquid in the syringe 7 into the catheter body 61.

參閱圖7、8，為該導管本體61之截面圖，該導管本體61是由一管壁614，及由該管壁614圍繞界定出之一管腔615，可以盛裝液體並供沖洗液體通過。 Referring to Figures 7 and 8, a cross-sectional view of the catheter body 61 is defined by a tube wall 614 and surrounded by the tube wall 614 to define a lumen 615 for containing liquid and for rinsing liquid to pass.

該管壁614是由柔軟且具彈性之材質所製成，因此自然狀態下該管壁614形成正圓(如圖7所示)。但由該管壁614外界施與一外力後(圖7、8中未顯示)，該管壁614將塌陷並形成橢圓(如圖8所示)。 The tube wall 614 is made of a soft and resilient material so that the tube wall 614 forms a perfect circle in its natural state (as shown in Figure 7). However, after an external force is applied from the outside of the tube wall 614 (not shown in Figures 7 and 8), the tube wall 614 will collapse and form an ellipse (as shown in Figure 8).

配合參閱圖9、10、11，為該導管本體61之封閉末端611的剖視圖，該導管本體61上之複數邊孔613。 Referring to Figures 9, 10 and 11, a cross-sectional view of the closed end 611 of the catheter body 61, a plurality of side holes 613 in the catheter body 61.

其中，線段b-b為設置複數邊孔613的區域，當該導管本體61內之液體壓力大於外界，液體將會從該複數邊孔613向外噴出，線段c-c為該導管本體61之扁平狀封閉末端611，是以熱融或技術領域業者所熟悉之其他方法將該導管本體61壓扁封閉。接近扁平狀封閉末端611 之導管本體61必定成為橢圓形再逐漸過渡至導管原來之圓形。橢圓形之長徑必大於圓形之直徑，橢圓形之短徑必小於圓形之直徑。此過渡長度依材質硬度、管壁厚度及導管內外徑而定。 Wherein, the line segment bb is an area in which the plurality of side holes 613 are provided. When the liquid pressure in the duct body 61 is greater than the outside, liquid will be ejected outward from the plurality of side holes 613, and the line segment cc is the flat closed end of the duct body 61. 611, the catheter body 61 is flattened and closed by other methods familiar to those skilled in the art. The catheter body 61 near the flat closed end 611 must be elliptical and then gradually transition to the original circular shape of the catheter. The long diameter of the ellipse must be larger than the diameter of the circle, and the short diameter of the ellipse must be smaller than the diameter of the circle. This transition length depends on the material hardness, the wall thickness, and the inner and outer diameter of the conduit.

本導管之特徵為：1.可塌陷性，及；2.扁平狀封閉末端。 The catheter is characterized by: 1. collapsibility, and; 2. flat closed end.

第1特徵：可塌陷性。以彈性材質製造的導管遇壓力會變形，壓力解除則恢復原形，壓力越大變形越大，但外徑越小、材質越硬及管壁614厚度越大，其抵抗變形能力也越大，反之亦然。而越接近完全塌陷變形所需的壓力大增，因此管腔615塌陷一半之效率最佳，所以定義管腔615塌陷一半為可塌陷。導管61與鼻腔粘膜互相擠壓，在未引起痛覺而管腔615塌陷一半稱為無傷害可塌陷。在耳鼻喉科領域，以紗布或填塞裝置(packing device)填塞鼻腔做為止血的手段是眾所週知，醫學文獻也多有填塞壓力不可過高之建議，卻查不到確切的壓力數值，但同屬呼吸系統之氣管則有不少研究報告提到確切數值，這些報告都建議氣管內管擠壓氣管之壓力(cuff pressure of endotracheal tube)不可超過30mmHg=40.8cmH₂O，主要考量氣管內管需使用連續數天或更久，如壓力太大，容易引起氣管壞死等併發症，因此我們採用此為無傷害標準壓力。二年多來我們一直以前案之高壓噴射導管用於沖鼻治療，並未有鼻腔特別疼痛之問題或鼻腔粘膜壞死之併發症，我們曾以壓力計測量前案之高壓噴射導管在高壓灌注時之管腔壓力，所得結果為1~4大氣壓，瞬間甚至可達5大氣壓，此壓力雖不一定在整個沖鼻治療過程都直接施壓於鼻腔黏膜，但仍可證明沖鼻治療中鼻腔黏膜之耐壓應大於氣管之耐壓數值(40.8cmH₂O)。因正常人中鼻通道及下鼻通道最寬約為3mm，因此設定外徑3mm為標準導管尺寸， 再以無傷害標準壓力施壓於各種硬度材質之標準尺寸導管，以測試其管腔615塌陷一半(即可塌陷)之厚度，求取此材質之無傷害可塌陷最大管壁厚度。以下是實驗所得各種硬度材質之無傷害可塌陷最大管壁614厚度：Pebax(polyether block amide)4033(硬度約90 Shore A)為約0.40mm管壁厚度；Pebax 3533(硬度約80~82 Shore A)約為0.45mm管壁厚度；Pebax 2533(硬度約74~77 Shore A)約為0.50mm管壁614厚度；60 Shore A之silicone約為0.55mm；50 Shore A之silicone約為0.60mm管壁614厚度。 The first feature: collapsibility. The pipe made of elastic material will be deformed when the pressure is applied, and the pressure will be restored to the original shape. The greater the pressure, the larger the deformation, but the smaller the outer diameter, the harder the material and the greater the thickness of the pipe wall 614, the greater the resistance to deformation, and vice versa. Also. The pressure required to get closer to the complete collapse deformation is greatly increased, so that the efficiency of collapse of the lumen 615 is optimal, so that the collapse of the lumen 615 is defined as being collapseable. The catheter 61 and the nasal mucosa are mutually squeezed, and the lumen 615 collapses half without causing pain and is said to be injurious. In the field of otolaryngology, the means of filling the nasal cavity with gauze or packing device is well known. The medical literature also has many suggestions that the filling pressure should not be too high, but the exact pressure value cannot be found, but the same is true. There are many research reports on the trachea of the respiratory system. The reports suggest that the cuff pressure of endotracheal tube should not exceed 30mmHg=40.8cmH ₂ O. The main consideration is that the endotracheal tube needs to be used. For several days or more, if the pressure is too high, it is easy to cause complications such as tracheal necrosis, so we use this as the standard of no harm. For more than two years, we have been using high-pressure jet catheters for nasal treatment. There are no special pain problems in the nasal cavity or complications of nasal mucosal necrosis. We used a pressure gauge to measure the high pressure injection catheter of the previous case during high pressure perfusion. The lumen pressure, the result is 1 to 4 atmospheres, and even up to 5 atmospheres in an instant. Although this pressure does not directly apply pressure to the nasal mucosa during the entire nasal treatment process, it can still prove the nasal mucosa in the nasal treatment. The withstand voltage should be greater than the withstand voltage of the trachea (40.8cmH ₂ O). Because the normal nasal passage and the lower nasal passage are about 3mm wide, the outer diameter of 3mm is set as the standard catheter size, and the standard size catheter of various hardness materials is pressed at the non-injury standard pressure to test the lumen 615 collapse. The thickness of half (ie, collapse) can be obtained without damage to the maximum wall thickness of the material. The following are the maximum thickness of the wall 614 of the various hardness materials obtained by the experiment: Pebax (polyether block amide) 4033 (hardness about 90 Shore A) is about 0.40 mm wall thickness; Pebax 3533 (hardness about 80~82 Shore A) ) about 0.45mm wall thickness; Pebax 2533 (hardness about 74~77 Shore A) is about 0.50mm wall thickness 614; 60 Shore A silicone is about 0.55mm; 50 Shore A's silicone is about 0.60mm wall 614 thickness.

因為符合條件的材質很多，無法一一試驗，以上只是較易取得之材質，以測試各種硬度之可塌陷最大管壁厚度，不一定是日後商品化之材質。傳統製造概念之鼻腔沖洗導管的外徑不能大於鼻通道3mm之最大橫徑，但本案是可塌陷導管又具有扁平狀封閉末端611，不受此3mm之限制，也許可達5mm甚至更大，外徑如更大，無傷害可塌陷最大管壁厚度也會增大。 Because there are many materials that meet the requirements, it is impossible to test them one by one. The above is just a relatively easy material to test the maximum wall thickness of collapsible hardness of various hardnesses, not necessarily the material of future commercialization. The outer diameter of the nasal irrigation catheter of the conventional manufacturing concept cannot be larger than the maximum transverse diameter of the nasal passage of 3 mm, but in this case, the collapsible catheter has a flat closed end 611, which is not limited by this 3 mm, and may be up to 5 mm or more. If the diameter is larger, the maximum wall thickness will increase if there is no damage.

因本案是要像微導管(外徑1mm以下)一樣可以進入狹窄的最深處，因此扁平狀封閉末端611之厚度以不大於1mm為原則，較佳為不大於0.9mm，又考量完全塌陷不易，因此管壁614厚度設定為不大於0.45mm。 Because the case is like a microcatheter (outer diameter of 1 mm or less), it can enter the deepest part of the stenosis. Therefore, the thickness of the flat closed end 611 is not more than 1 mm, preferably not more than 0.9 mm, and it is difficult to completely collapse. Therefore, the thickness of the pipe wall 614 is set to be not more than 0.45 mm.

可塌陷噴射導管與一般導管完全不同。可塌陷性是專為進入狹窄隙縫狀空間之鼻腔噴射導管6的特殊設計，塌陷進入狹窄隙縫狀空間之後要噴射水柱必經加壓灌注使其恢復原狀之過程，因此可塌陷與加壓灌注必需一起考量。一般導管之設計以表面平滑及大小均一(或末端漸細)為原則，為適應人體空間雖都有某種程度的彎曲能力，但正常使用情況絕不允許塌陷，塌陷會造成一個面向(one dimension)增大、外徑大小不一及表面粗糙之結果，違反表面平滑及大小均一(或末端漸細)之原則，由體外置入體 內或由體內拔除，都會傷害組織，完全違反最小傷害原則。另外，一般導管之功能為引流(流體在不施力的自然狀態從管腔外之人體空間流向管內再流出體外)、抽吸(流體在施力的狀態從管腔615外之人體空間流向管內再流出體外)或低壓供輸流體(流體在低壓狀態從管腔615內流向管外之人體空間)；引流、抽吸或低壓供輸流體功能都取決於管腔截面積，管壁614塌陷會妨礙引流、抽吸或低壓供輸功能，違反一般導管的設計原理。除鼻腔外人體之其他空間都是封閉空間，一般導管都使用在封閉空間，不能設計具有加壓噴射功能(具有較小的邊孔總面積)，因加壓噴射的強勁水柱會造成發炎物質逆流進入血液造成敗血症(需要引流、抽吸之空間都有發炎現象)，也可能局部壓力瞬間上升導致空間外壁破裂。而可塌陷導管供輸液體必經加壓灌注使其恢復原狀之過程，此恢復原狀之過程難以控制壓力，加壓灌注會瞬間增壓產生強勁水柱，因此可塌陷導管可能產生以上之副作用，不能用於封閉空間，只適用於鼻腔之沖鼻治療，也與其他導管不同。 The collapsible spray conduit is completely different from the general conduit. Collapse is a special design of the nasal jet catheter 6 designed for entering the narrow gap space. After the collapse into the narrow gap space, the jet water column must be pressurized and infused to restore the original state, so the collapse and pressurized infusion must be Consider together. Generally, the design of the catheter is based on the principle of smooth surface and uniform size (or tapered at the end). Although it has a certain degree of bending ability to adapt to the human body space, the normal use condition must not be collapsed, and the collapse will cause a dimension (one dimension). The result of increased size, different outer diameter and rough surface, in violation of the principle of smooth surface and uniform size (or tapered at the end), which is inserted into the body or removed from the body, will damage the tissue and completely violate the principle of minimum damage. In addition, the function of the general catheter is drainage (the fluid flows from the human body space outside the lumen to the outside of the lumen and then out of the body in a natural state where no force is applied), and the suction (the fluid flows from the human body space outside the lumen 615 in a state of applying force) The tube is recirculated outside the body or the low pressure is supplied to the fluid (the fluid flows from the lumen 615 to the human body outside the tube at a low pressure); the function of drainage, suction or low pressure supply and delivery depends on the lumen cross-sectional area, and the wall 614 Collapse can impede drainage, suction, or low-pressure supply, in violation of the general catheter design principles. Except for the nasal cavity, the other space of the human body is a closed space. Generally, the catheter is used in an enclosed space. It cannot be designed with a pressurized jetting function (with a small total area of side holes). The strong water column due to the pressurized jet will cause the inflammatory material to flow backward. Entering the blood causes sepsis (the space that needs drainage and suction is inflammatory), and it is also possible that the local pressure rises instantaneously and the outer wall of the space is broken. However, the process of retracting the conduit for the liquid to be returned to the original state by pressurized infusion, the process of restoring the original state is difficult to control the pressure, and the pressurized perfusion will instantaneously pressurize to generate a strong water column, so the collapsible catheter may have the above side effects, and cannot It is used in enclosed spaces and is only suitable for nasal treatment of nasal cavity, and is also different from other catheters.

第2特徵：扁平狀封閉末端611。非圓即扁，圓形是兩個面向(two dimensions)大小相同，而扁平狀則泛指兩個面向(two dimensions)大小不同，因此除兩個面向(two dimensions)大小相同之圓形外例如三角形、菱形等皆屬之。扁平狀封閉末端之最大寬度大於導管直徑，違反大小均一或末端漸細之原則。但人體之鼻腔是前後走向上窄下寬的隙縫狀空間(參考圖2)，左右寬度以mm計，而上下高度則以cm計，兩個面向(two dimensions)差異非常大，此特殊情形與人體內其他空間完全不同，因此，導管之圓形設計成已非必要，末端也不必兩個面向(two dimensions)都不大於近端，相反地，扁平狀封閉未端611更有利於順行於隙縫狀空間，茲說明如下：導管之橫斷面為圓形，其外圓周長(Outer Circnmference) 等於外徑(Outer Diameter)*圓週率，等式為OC=OD * 3.14；內腔圓周長(Inner Circumference)等於內徑(Inner diameter)*圓週率，等式為IC=IR * 3.14。 Second feature: flat closed end 611. The non-circle is flat, the circle is the same size of the two dimensions, and the flat shape refers to the difference in the size of the two dimensions, so that in addition to the two dimensions of the two dimensions, for example, Triangles, diamonds, etc. belong to it. The maximum width of the flat closed end is greater than the diameter of the catheter, in violation of the principle of uniform size or tapered end. However, the nasal cavity of the human body is a slit-like space with a narrow front and a back width (refer to Fig. 2), the left and right widths are in mm, and the upper and lower heights are in cm, and the two dimensions are very different. This special case is The other spaces in the human body are completely different. Therefore, the circular design of the catheter is unnecessary, and the ends do not need to have two dimensions that are no larger than the proximal end. Conversely, the flat closed end 611 is more favorable for antegrade The gap-like space is described as follows: the cross section of the duct is circular, and the outer circumference is equal to the outer diameter (Outer Diameter) * pi, the equation is OC = OD * 3.14; the inner circumference is long (Inner Circumference) is equal to the inner diameter * pi, and the equation is IC = IR * 3.14.

舉例而言，第一實施例(圖9、10、11)為以2mm外徑0.25mm管壁614厚度之導管，其扁平狀封閉末端611之寬度(W)為兩邊管壁厚度(t)加內腔圓周塌陷後之寬度，等式為W=2t+ID*3.14/2，數值為W=0.5+1.5*3.14/2=2.855mm，寬度遠大於直徑2mm，但厚度只有0.5mm；如管腔615塌陷一半，則2mm之導管可穿過1.25mm=2-(1.5/2)mm之狹窄空間。 For example, the first embodiment (Figs. 9, 10, 11) is a catheter having a thickness of 2 mm outer diameter 0.25 mm of the wall 614, and the width (W) of the flat closed end 611 is the thickness of the two side walls (t) plus The width of the inner cavity after collapse, the equation is W=2t+ID*3.14/2, the value is W=0.5+1.5*3.14/2=2.855mm, the width is much larger than the diameter 2mm, but the thickness is only 0.5mm; The cavity 615 collapses half, and the 2 mm conduit can pass through a narrow space of 1.25 mm = 2 (1.5/2) mm.

第二實施例是3mm外徑、2.4mm內徑及0.3mm管壁614厚度之導管，其扁平狀封閉末端611之寬度為0.6+2.4*3.14/2=4.368mm，仍遠大於直徑3mm，但厚度只有0.6mm；如管腔615塌陷3/4(管徑越大遇壓塌陷越大)，則3mm之導管可穿過1.2mm=3-(2.4 *3/4)mm之狹窄空間。 The second embodiment is a 3 mm outer diameter, 2.4 mm inner diameter and 0.3 mm tube wall 614 thickness conduit having a flat closed end 611 having a width of 0.6 + 2.4 * 3.14 / 2 = 4.368 mm, still much larger than the diameter of 3 mm, but still The thickness is only 0.6mm; if the lumen 615 collapses 3/4 (the larger the diameter, the greater the pressure collapse), the 3mm conduit can pass through a narrow space of 1.2mm = 3-(2.4 * 3/4) mm.

第三實施例是1.5mm外徑、1.2mm內徑及0.15mm管壁614厚度之導管，其扁平狀封閉末端611之寬度為0.3+1.2*3.14/2=2.184mm，也遠大於直徑1.5mm，但厚度只有0.3mm；如管腔615塌陷3/4，則1.5mm之導管可穿過0.6mm=1.5-0.9mm之狹窄空間。 The third embodiment is a 1.5 mm outer diameter, 1.2 mm inner diameter and 0.15 mm tube wall 614 thickness conduit having a flat closed end 611 having a width of 0.3 + 1.2 * 3.14 / 2 = 2.184 mm and also much larger than a diameter of 1.5 mm. However, the thickness is only 0.3mm; if the lumen 615 collapses 3/4, the 1.5mm catheter can pass through a narrow space of 0.6mm = 1.5-0.9mm.

此三個實施例均証明扁平狀封閉未端611更有利於順行於隙縫狀空間，但扁平狀封閉末端611遠大於導管直徑，違反大小均一或末端漸細之導管設計原則，只適用於在鼻腔之操作。此處所述扁平狀封閉末端611之寬度大於導管之直徑，其中導管專指與封閉末端相接之導管末端具有圓形截面之處，因導管可能末端漸細再銜接扁平狀封閉末端611，此種情況，扁平狀封閉末端611之寬度不一定大於導管本體61之最大直徑。 All of the three embodiments prove that the flat closed end 611 is more advantageous for antegrade in the slot-like space, but the flat closed end 611 is much larger than the diameter of the catheter, and the principle of conduit design that is uniform in size or tapered is only applicable to The operation of the nasal cavity. The width of the flat closed end 611 is greater than the diameter of the catheter, wherein the catheter is specifically referred to as having a circular cross-section at the end of the catheter that terminates in the closed end, as the catheter may taper at the end and engage the flat closed end 611. In this case, the width of the flat closed end 611 is not necessarily greater than the largest diameter of the catheter body 61.

本案發明人深深體會慢性鼻竇炎病人之痛 苦，卻無法得到有效的治療，因深入研究彈性導管的特性，終於發現技術領域業者所捨棄不用的導管之塌陷性及扁平狀封閉末端611反而有利於沖鼻治療，值得善加利用。 The inventor of this case deeply understands the pain of patients with chronic sinusitis, but can not get effective treatment. Due to the in-depth study of the characteristics of elastic catheters, it is finally found that the collapse of the unused catheter and the flat closed end 611 of the technical field are beneficial to the manufacturer. Nasal treatment is worth making good use of.

本案之特殊設計在功能上所產生的差別可以說明如下：因為邊孔613水柱初始速度(V ₀)可以決定其垂直高度h，其等式如下：V ₀=gt或t=V ₀/g，其中g為重力常數9.8m/sec²、t為至垂直頂點的時間，又最高垂直頂點為h，則h=1/2(gt ²)，以t=V ₀/g代入，則或，又邊孔613水柱平均初始速度(V ₀)取決於灌注速度(IR)及邊孔總面積(TA,Total Area)，其等式如下：V ₀=IR/TA，以此代入等式可得(IR/TA)²=2gh，因此水柱垂直高度與灌注速度之平方成正比，灌注速度雖與外部施壓有關，但仍受限於管腔流速，而管腔615流速受限於與管腔615截面積且與其成正比，因此水柱垂直高度與管腔615截面積之平方成正比。 The difference in function of the special design of this case can be explained as follows: because the initial velocity ( V ₀ ) of the water hole of the side hole 613 can determine its vertical height h, the equation is as follows: V ₀ = gt or t = V ₀ / g , Where g is the gravity constant 9.8 m / sec ² , t is the time to the vertical apex, and the highest vertical vertex is h , then h = 1/2 ( gt ² ), substituted with t = V ₀ / g , then or The average initial velocity ( V ₀ ) of the water hole 613 depends on the perfusion rate (IR) and the total area of the side hole (TA, Total Area). The equation is as follows: V ₀ = IR / TA , which is substituted into the equation. Available ( IR / TA ) ² = 2 gh , so the vertical height of the water column is proportional to the square of the perfusion rate. Although the perfusion rate is related to external pressure, it is still limited by the lumen flow rate, while the lumen 615 flow rate is limited by The cross-sectional area of the lumen 615 is proportional to it, so the vertical height of the water column is proportional to the square of the cross-sectional area of the lumen 615.

在第一實施例中，穿過1.25mm之狹窄空間，傳統導管只能用1.25mm外徑，但本導管可用2mm外徑；假設導管之外徑、內徑及管壁614厚度均具有相同比例，則2mm導管之內徑比1.25mm導管大1.6倍，截面積大2.56倍，流速與灌注速度增2.56倍，水柱垂直高度增6.55倍。 In the first embodiment, the conventional catheter can only use an outer diameter of 1.25 mm through a narrow space of 1.25 mm, but the outer diameter of the catheter can be 2 mm; it is assumed that the outer diameter, the inner diameter and the thickness of the tube wall 614 have the same ratio. The inner diameter of the 2mm catheter is 1.6 times larger than the 1.25mm catheter, the cross-sectional area is 2.56 times larger, the flow rate and perfusion rate are increased by 2.56 times, and the vertical height of the water column is increased by 6.55 times.

在第二實施例中，同樣地，穿過1.2mm之狹窄空間，傳統導管只能用1.2mm外徑，但本導管可用3mm外徑，假設導管之外徑、內徑及管壁614厚度也具有相同比例，則3mm導管之內徑比1.2mm導管大2.5倍，截面積大6.25倍，水柱垂直高度增39倍。 In the second embodiment, similarly, the conventional catheter can only use an outer diameter of 1.2 mm through a narrow space of 1.2 mm, but the outer diameter of the catheter can be 3 mm, assuming that the outer diameter, the inner diameter of the catheter, and the thickness of the wall 614 are also With the same ratio, the inner diameter of the 3mm catheter is 2.5 times larger than the 1.2mm catheter, the cross-sectional area is 6.25 times larger, and the vertical height of the water column is increased by 39 times.

在第三實施例中，穿過0.6mm之狹窄空間，傳統導管只能用0.6mm外徑，但本導管可用1.5mm外徑，假設導管之外徑、內徑及管壁614厚度也都具有相同比例，則1.5mm導管之內徑比0.6mm導管大2.5倍，截面積大6.25倍，水柱垂直高度大39倍。因為沖洗效果與水柱 垂直高度直接相關，不管39倍還是6.55倍都是非常巨大的差異，都會巨大地善沖洗效果。 In the third embodiment, the conventional catheter can only use an outer diameter of 0.6 mm through a narrow space of 0.6 mm, but the outer diameter of the catheter can be 1.5 mm, assuming that the outer diameter, the inner diameter of the catheter, and the thickness of the wall 614 are also At the same ratio, the inner diameter of the 1.5mm conduit is 2.5 times larger than the 0.6mm conduit, the cross-sectional area is 6.25 times larger, and the vertical height of the water column is 39 times larger. Because the flushing effect is directly related to the vertical height of the water column, whether it is 39 times or 6.55 times is a very large difference, it will greatly improve the flushing effect.

在狹窄空間，已塌陷之本導管可能無法完全恢復圓形，但即使如此，塌陷之管腔截面積仍比傳統導管大，茲說明如下：圓周之計算公式為C=3.14*R，其中C為圓周，R為圓之直徑；圓面積之計算公式為S=0.785*R²；橢圓周長之計算公式為L=2πb+4(a-b)，其中a為長軸半徑，b為短軸半徑，此公式可改寫為a=(L+4b-2πb)/4；橢圓面積之計算公式為S=πab；π為圓周率3.14 In a confined space, the collapsed conduit may not fully recover its shape, but even so, the collapsed lumen cross-sectional area is still larger than that of a conventional catheter, as explained below: The calculation formula for the circumference is C=3.14*R, where C is The circumference, R is the diameter of the circle; the calculation formula of the circular area is S=0.785*R ² ; the calculation formula of the elliptical circumference is L=2πb+4(ab), where a is the long axis radius and b is the short axis radius. It can be rewritten as a=(L+4b-2πb)/4; the ellipse area is calculated as S=πab; π is the pi 3.14

在第一實施例中，本導管外徑為2mm，內徑為1.5mm，內腔圓周長L為4.71mm，在狹窄空間塌陷成為短軸外徑1.25mm之橢圓，其短軸內腔直徑為0.75mm，短軸內腔半徑b=0.375mm，則其長軸內腔半徑a=(L+4b-2πb)/4=(4.71+1.5-2.355)/4=1.34mm，此橢圓內腔截面積為S=3.14*a*b=3.14*1.34*0.375=1.57785mm²。與本導管相對應之外徑1.25mm傳統導管如與具有相同比例之外徑及管壁，則其內腔直徑為1.25mm*0.75=0.9375mm，其內腔截面積為S=0.9375*0.9375*0.785=0.6899mm²。兩相比較，本導管塌陷後內腔截面積與傳統導管之比為1.57785/0.6899=2.287倍，水柱高度仍可達2.287*2.287=5.23倍。 In the first embodiment, the outer diameter of the catheter is 2 mm, the inner diameter is 1.5 mm, the inner circumferential length L is 4.71 mm, and the narrow space is collapsed into an ellipse having a short axis outer diameter of 1.25 mm, and the short axis inner cavity diameter is 0.75mm, the short axis lumen radius b = 0.375mm, then the long axis lumen radius a = (L + 4b - 2πb) / 4 = (4.71 + 1.5 - 2.355) / 4 = 1.34mm, this elliptical lumen The area is S = 3.14 * a * b = 3.14 * 1.34 * 0.375 = 1.57785 mm ² . The conventional 1.25 mm outer diameter of the catheter corresponding to the catheter has the same ratio of the outer diameter and the wall of the tube, and the lumen diameter is 1.25 mm * 0.75 = 0.9375 mm, and the lumen cross-sectional area is S = 0.9375 * 0.9375 * 0.785 = 0.6899 mm ² . Comparing the two phases, the ratio of the cross-sectional area of the lumen to the conventional catheter after the collapse of the catheter is 1.57785/0.6899=2.287 times, and the height of the water column can still reach 2.287*2.287=5.23 times.

在第二實施例中，本導管外徑為3mm，內腔直徑為2.4mm，內腔圓周長L=3.14*2.4=7.536mm，在狹窄空間塌陷成為1.2mm外徑短軸(短軸內腔直徑0.6mm，短軸內腔半徑b=0.3mm)之橢圓，則其長軸內腔半徑為a=(L+4b-2 π b)/4=(7.536+1.2-2*3.14*0.3)/4=1.713mm，而橢圓內腔截面積為S=3.14*a*b=3.14*a*b=3.14*1.713*0.3=1.6136mm²。與本導管相對應之外徑1.2mm傳統導管如與具有相同比例之外徑及管壁，則其內腔直徑為 1.2mm*0.8=0.96mm，其內腔截面積為S=0.9375*0.9375*0.785=0.7234mm²。兩相比較，本導管塌陷後內腔截面積與傳統導管之比為1.713/0.7234=2.23倍，水柱高度仍可達2.23*2.23=4.97倍。 In the second embodiment, the outer diameter of the catheter is 3 mm, the inner cavity diameter is 2.4 mm, the inner circumferential length L=3.14*2.4=7.536 mm, and collapses in a narrow space to become a short axis of 1.2 mm outer diameter (short axis lumen) For an ellipse with a diameter of 0.6 mm and a short-axis lumen radius b = 0.3 mm), the radius of the long-axis lumen is a = (L + 4b - 2 π b) / 4 = (7.536 + 1.2 - 2 * 3.14 * 0.3) /4=1.713mm, and the elliptical lumen cross-sectional area is S=3.14*a*b=3.14*a*b=3.14*1.713*0.3=1.6136mm ² . If the conventional catheter with an outer diameter of 1.2 mm corresponding to the catheter has the same ratio of the outer diameter and the wall of the tube, the lumen diameter is 1.2 mm*0.8=0.96 mm, and the lumen cross-sectional area is S=0.9375*0.9375*. 0.785 = 0.7234 mm ² . Comparing the two phases, the ratio of the cross-sectional area of the inner cavity to the conventional catheter after the collapse of the catheter is 1.713/0.7234=2.23 times, and the height of the water column is still 2.23*2.23=4.97 times.

在第三實施例中，本導管外徑為1.5mm，內腔直徑為1.2mm，內腔圓周長為3.768mm，在狹窄空間塌陷成為0.6mm外徑短軸(短軸內徑0.3mm，短軸內腔半徑b=0.15mm)之橢圓，則其長軸內腔半徑a=(L+4b-2πb)/4=(3.768+4*0.15-2*3.14*0.15)/4=0.8565mm，而橢圓內腔截面積為S=3.14*a*b=3.14*0.8565*0.15=0.4034mm²。與本導管相對應之外徑0.6mm傳統導管如與具有相同比例之外徑及管壁，則其內腔直徑為0.6mm*0.8=0.48mm，其內腔截面積為S=0.48*0.48*0.785=0.180864mm²。兩相比較，本導管塌陷後內腔截面積與傳統導管之比為0.4034/0.180864=2.23倍，水柱高度仍可達2.23*2.23=4.97倍。 In the third embodiment, the outer diameter of the catheter is 1.5 mm, the inner cavity diameter is 1.2 mm, the inner cavity circumference is 3.768 mm, and the narrow space collapses to a 0.6 mm outer diameter short axis (the short axis inner diameter is 0.3 mm, short). The ellipse of the inner cavity radius b = 0.15 mm), the radius of the long axis lumen a = (L + 4b - 2πb) / 4 = (3.768 + 4 * 0.15 - 2 * 3.14 * 0.15) / 4 = 0.8565 mm, The elliptical lumen cross-sectional area is S=3.14*a*b=3.14*0.8565*0.15=0.4034mm ² . The conventional catheter with an outer diameter of 0.6 mm corresponding to the catheter has the same ratio of the outer diameter and the wall of the tube, and the lumen diameter is 0.6 mm*0.8=0.48 mm, and the lumen cross-sectional area is S=0.48*0.48*. 0.785=0.180864mm ² . Comparing the two phases, the ratio of the cross-sectional area of the lumen to the conventional catheter after the collapse of the catheter is 0.4034/0.180864=2.23 times, and the height of the water column is still 2.23*2.23=4.97 times.

本導管之塌陷部份即使在加壓灌注中完全不膨脹，水柱高度仍可達4.97倍以上，再加上某種程度之膨脹，水柱必然更強；而且這是計算最狹窄處最深處之塌陷狀況，此最大塌陷部份只佔導管在5cm之長度之鼻腔本體路徑中之一部份，而導管約長15cm，塌陷部份所佔比率更小，因此塌陷部份對管腔流速之影響還會更小，水柱高度應會更強。 The collapsed portion of the catheter does not expand at all during the pressurized infusion, and the height of the water column can still reach 4.97 times or more, and with some degree of expansion, the water column is necessarily stronger; and this is the calculation of the deepest part of the collapse at the narrowest point. In the condition, the largest collapsed portion only accounts for one part of the nasal body path of the catheter at a length of 5 cm, and the catheter is about 15 cm long, and the proportion of the collapsed portion is smaller, so the effect of the collapsed portion on the lumen flow rate is It will be smaller and the height of the water column should be stronger.

結論：本案之特殊設計會巨大地改善沖洗效果。 Conclusion: The special design of this case will greatly improve the flushing effect.

本案其他優點及考量：因沖鼻治療屬每天執行的居家治療，器材必需重複使用，而本案如前所述可採用較大管徑，也可配合使用適當的材質硬度及管壁614厚度得到較佳的操控性，因此不需內置探針就可抵達狹窄空間，沒有因重複使用致探針可能突出管外傷及病人或重金 屬釋出等問題。 Other advantages and considerations of this case: Because the nasal treatment is a daily home treatment, the equipment must be reused, and the case can be used with a larger diameter as described above, or with the appropriate material hardness and wall thickness 614. Excellent handling, so you can reach the narrow space without the built-in probe. There is no problem that the probe may protrude from the tube and the patient or heavy metal is released due to repeated use.

本導管因具有可塌陷性及扁平狀封閉末端611，很容易抵達上鼻通道及中鼻通道之最狹窄之頂端。例如第三實施例，1.5mm導管，可塌陷導管可穿過小於1mm鼻竇開口之0.6mm之狹窄空間，但扁平狀封閉末端611之寬度(2.034mm)卻遠大於1mm，不可能穿過鼻竇約1mm圓形之開口，因而足以避免誤入鼻竇；相反地，傳統之導管，如果可以進入1mm的狹窄空間，則其圓形封閉末端必不大於1mm，就可能意外進入鼻竇，而進入鼻竇並非沖洗鼻腔之目的，其後果說明如下。 The catheter has a collapsible and flat closed end 611 that easily reaches the narrowest tip of the upper nasal passage and the middle nasal passage. For example, in a third embodiment, a 1.5 mm catheter, the collapsible catheter can pass through a narrow space of 0.6 mm less than 1 mm of sinus opening, but the width of the flat closed end 611 (2.034 mm) is much larger than 1 mm, and it is impossible to pass through the sinus. 1mm round opening, so it is enough to avoid getting into the sinus; conversely, if the traditional catheter can enter the narrow space of 1mm, its round closed end must be no more than 1mm, it may accidentally enter the sinus, and it is not flushed into the sinus. The purpose of the nasal cavity is described below.

以導管進入鼻竇，並以沖洗液沖洗是醫師在開刀中治療鼻竇炎之方法，此開刀方法必需內視鏡及X光透視引導並確認進入鼻竇。這是非常專業的開刀技術，醫師必需經過特殊訓練，進入鼻竇不易不難想像。既已進入，必須一次清除鼻竇內之粘液及發炎物質，否則有開刀失敗的風險，因此必須使用抽吸功能良好之導管。所謂抽吸是指流體在加力狀態下自管外流向管內，而抽吸功能是指流體自管外流向管內之流速，此流速取決於邊孔大小、數量及邊孔總面積，最終與邊孔總面積成正比。而抽吸粘稠易阻塞之粘液或固態物質，邊孔大而少比小而多有利，因此抽吸導管必定具有大的邊孔及大的邊孔總面積，此邊孔設計原理與本案之鼻腔噴射導管6(邊孔小而多，小的邊孔總面積，因水柱強度與邊孔總面積之平方成反比)完全相反。病人以噴射導管自行沖洗鼻腔，完全無法確認導管所在位置，但必定高壓灌注大量沖洗液以強勁細長水柱沖洗，因鼻腔是開放空間，再多沖洗液也會馬上流失，不會有任何問題，但如意外進入鼻竇，因鼻竇是封閉空間，而且出口已被導管塞住，大量灌注沖洗液無法排出，可能引發急性鼻竇炎，而且高壓水柱更可能導致發炎物質逆流進入血液造成敗血症，甚至可能瞬間壓力太大，導致鼻竇破 裂，波及鄰近之腦膜，產生腦膜炎。 It is a method for the physician to treat sinusitis in the operation of the sinus by catheter into the sinus and flushing with the irrigating solution. This method of surgery requires endoscopy and X-ray fluoroscopy to guide and confirm the entry into the sinus. This is a very professional knife-cutting technique. Physicians must undergo special training and it is not difficult to imagine entering the sinus. If it has entered, the mucus and inflammatory substances in the sinus must be removed once, otherwise there is a risk of failure to open the knife, so a catheter with good suction function must be used. The so-called suction means that the fluid flows from the outside of the tube to the tube under the force-added state, and the suction function refers to the flow rate of the fluid flowing from the outside of the tube to the tube. The flow rate depends on the size and quantity of the side holes and the total area of the side holes. It is proportional to the total area of the side holes. The suction of the sticky and easy to block mucus or solid material, the side hole is large and less than small and more favorable, so the suction catheter must have a large side hole and a large side hole total area, the design principle of this side hole and the case Nasal jet catheter 6 (small and large side holes, the total area of small side holes, inversely proportional to the square of the water column strength and the total area of the side holes) is completely opposite. The patient rinses the nasal cavity by the jet catheter, and the position of the catheter cannot be confirmed at all. However, the high-pressure perfusion solution must be flushed with a strong slender water column. Since the nasal cavity is open space, more washing liquid will be lost immediately, without any problem, but If accidentally enters the sinus, because the sinus is a closed space, and the outlet has been plugged by the catheter, a large amount of perfusion irrigation fluid can not be discharged, may cause acute sinusitis, and the high pressure water column is more likely to cause inflammatory substances to flow back into the bloodstream to cause sepsis, and even may be instantaneous pressure Too large, causing rupture of the sinus, affecting the adjacent meninges, causing meningitis.

因此傳統的圓形封閉末端可能導致意外進入鼻竇，引起嚴重的併發症，是很危險的設計，導管提供者必須負責，這也是我們的前案遲未商品化的原因。為了避免誤入鼻竇，本案扁平狀封閉末端611之最大寬度以不小於1mm為原則，較佳為不小於1.2mm，或1.5mm，或2mm，或更大。 Therefore, the traditional rounded closed end may cause accidental entry into the sinuses, causing serious complications, and is a dangerous design. The catheter provider must be responsible, which is why our previous case has not been commercialized. In order to avoid inadvertent entry into the sinus, the maximum width of the flat closed end 611 of the present case is not less than 1 mm, preferably not less than 1.2 mm, or 1.5 mm, or 2 mm, or more.

導管之材質雖可達90-100 Shore A，但越硬材質無傷害可塌陷最大管壁厚度越薄，既可塌陷，扁平狀封閉末端必不會太硬，也可製成平順之圓弧狀，仍不會傷害病人。 Although the material of the catheter can reach 90-100 Shore A, the harder the material can be collapsed, the thinner the wall thickness, the thinner the wall thickness, the lower the end, the flat end should not be too hard, or the smooth arc shape can be made. Still will not hurt the patient.

因此，選用適當之可塌陷之材質及管壁614厚度，即可達到以較大導管、遠為強勁之水柱沖洗鼻腔上方狹窄的空間之目的。 Therefore, by selecting the appropriate collapsible material and the thickness of the wall 614, it is possible to flush the narrow space above the nasal cavity with a large catheter and a far-reaching water column.

因為手工製造之前案導管，在專利申請前已親身試用，至今已逾二年，而且本案之導管也試用近半年，因此我們有機會比較不同導管的差異，也了解病人的感受，病人可以接受每天清洗鼻腔的惱人工作，只要症狀獲得足夠的改善。 Because the hand-made catheter was hand-tested before the patent application, it has been more than two years, and the catheter of this case has been tried for nearly half a year. Therefore, we have the opportunity to compare the differences between different catheters and understand the patient's feelings. The patient can accept the daily. Annoying work to clean the nasal cavity as long as the symptoms are adequately improved.

參閱圖12~15，人體之鼻腔是由三片板狀結構隔成三個稍微彎曲的隙縫通路，此三片板狀結構分別為上鼻甲F、中鼻甲G，及下鼻甲H，而三個通路則為上鼻通道F1、中鼻通道G1及下鼻通道H1。因為鼻腔是左、右對稱，在鼻腔近中央處即稱為臨中膈空間D，該臨中膈空間D又可區分為上臨中膈空間D1、中臨中膈空間D2，及下臨中膈空間D3。圖12~15為鼻腔後半部的冠狀剖面視圖，說明所有鼻通道F1、G1、H1都呈上狹下寬彎曲之狀況，中鼻通道甚至分為約2m高度之下降段B1D(粘液由上而下)及1cm左右長度之水平段B1H兩段。所有以上所述空氣通路之狹窄都是結痂經年累月一層一層粘附所造成。 Referring to Figures 12-15, the nasal cavity of the human body is divided into three slightly curved gap passages by three plate-like structures. The three plate-like structures are the upper turbinate F, the middle turbinate G, and the inferior turbinate H, and three The passage is the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage H1. Because the nasal cavity is left and right symmetrical, in the near center of the nasal cavity, it is called the Linzhong 膈 space D. The lining space D can be divided into the upper middle space D1, the middle middle space D2, and the lower middle.膈 Space D3. Figure 12~15 is a coronal cross-sectional view of the posterior half of the nasal cavity, showing that all nasal passages F1, G1, and H1 are in a wide and narrow width. The middle nasal passage is even divided into a descending section B1D of about 2 m in height (mucus from above) Lower) and two segments of the horizontal section B1H of about 1 cm in length. The narrowness of all of the above air passages is caused by the adhesion of the knots over the years.

能噴出強勁水柱外徑較大之前案高壓導管本體61只能放在較寬的水平段B1H(顯示於圖12)，因水柱不能轉彎抵達下降段B1D，因而效果不佳；如使用前案之內置探針之細小導管，雖可抵達下降段，但因水柱弱效率差；但使用尺寸與前案高壓導管相當之本案可塌陷導管本體61，卻可放置於狹窄之下降段B1D(顯示於圖13)，如上所述可得到最佳的沖洗效果。因本案兼具微導管之細小及大導管之操控性之優點，實際操作時，在扁平狀封閉末端611之前導下，導管如緊貼鼻中膈向上向後即可抵達上臨中膈空間D1(參閱圖14)或臨近之上鼻通道F1(參閱圖15)；如稍向上向外向後也很容易抵達中鼻通道G1之狹窄下降段B1D(圖13)。確實可達到以大導管沖洗小隙縫狀空間的目的。 The high-pressure conduit body 61 can only be placed in a wide horizontal section B1H (shown in Figure 12), because the water column cannot turn to reach the falling section B1D, so the effect is not good; if the case is used The small catheter with built-in probe can reach the descending section, but the water column is weakly inefficient; but the case can be collapsed in the case of the high-pressure catheter of the previous case, but can be placed in the narrow section B1D (shown in the figure) 13), as described above, the best rinsing effect can be obtained. Because this case has the advantages of small microcatheter and large catheter manipulation, in actual operation, before the flat closed end 611 is guided, the catheter can reach the upper middle space D1 if it is close to the middle of the nose. See Figure 14) or near the upper nasal passage F1 (see Figure 15); it is easy to reach the narrow descending section B1D of the middle nasal passage G1 (Figure 13). It is indeed possible to flush the small gap space with a large duct.

前案高壓導管本體61即使能勉強放置在下降段B1D之下方，強勁細長的水柱也能對正隙縫向上噴射，但平行之向量等於零，平行於隙縫狀之水柱無法剝離下降段B1D上下2cm長度之結痂，只具有濕潤結痂之效應。但結痂吸水膨脹，已經狹窄的空間變成完全阻塞，症狀反而加重。傳統沖鼻器由前向後單一方向的水柱如用於這種鼻腔通路狹窄之病人也無法剝離鼻腔本體5cm長度前後徑之結痂，同樣反而加重病情，這可能是醫學專家所認為沖鼻治療無效要考慮開刀的病人。 Even if the high-pressure conduit body 61 can be placed barely below the falling section B1D, the strong and slender water column can spray upwards on the positive slit, but the parallel vector is equal to zero, and the water column parallel to the slit can not peel off the lower section of the descending section B1D by 2 cm. Scarring, only has the effect of moist scarring. However, the swelled water swells, and the already narrow space becomes completely blocked, and the symptoms are aggravated. The traditional squirting device from the front to the back of the single direction of the water column, such as the patient used for this narrow nasal passage can not peel the nose of the nasal body 5cm length anterior and posterior diameter, but also aggravate the condition, which may be considered by medical experts to be ineffective for nasal treatment. Consider the patient who is operating the knife.

但放置於狹窄之下降段B1D上方之本案本案可塌陷導管本體61，因強勁水柱直接垂直噴射鄰近之結痂，其所需穿透剝離的只是以mm計算的結痂厚度，因此效果顯著。同樣地，放置於上臨中膈空間D1(參閱圖14)及上鼻通道F1(參閱圖15)之本案本案可塌陷導管本體61，也可以強勁水柱垂直噴射鄰近之以mm計算之結痂，因此比只能放置下方中臨中膈空間D2或下臨中膈空間D3之前案高壓導管效果顯著。 However, the present case placed above the narrow descending section B1D can collapse the catheter body 61. Since the strong water column directly injects the adjacent knot directly, the required penetration and peeling is only the thickness of the knot calculated in mm, so the effect is remarkable. Similarly, the case placed in the upper middle space D1 (see FIG. 14) and the upper nasal passage F1 (see FIG. 15) can collapse the catheter body 61, and the strong water column can vertically spray the adjacent knot calculated in mm. Therefore, the high-pressure catheter has a significant effect compared to the case where only the lower middle middle space D2 or the lower middle space D3 can be placed.

配合參閱圖12~16，因上鼻通道F1較狹窄，粘液容易造成阻塞，空氣無法流通，粘液因缺少乾化作用而保持液態，容易向後流動堆積在上鼻通道F1與鼻咽J頂部之交接處。相反地，中鼻通道G1之粘液雖也會流入鼻咽，但中鼻通道G1因較上鼻通道F1寬，粘液大部份下滑成為薄層，容易受進出空氣之乾化成為固態之結痂，只有少部份流向鼻咽J。因此倒流入鼻咽J之粘液主要來自上鼻通道F1。因此沖洗鼻咽J之粘液仍以經由上鼻通道F1直接抵達鼻咽J頂部再以強勁水柱沖洗才能得到最佳的效果，但鼻咽J頂部就有蝶狀竇之開口，只有本案才能達此目的並避免誤入蝶狀竇。 Referring to Figures 12~16, because the upper nasal passage F1 is narrow, the mucus is likely to cause obstruction, the air cannot circulate, the mucus remains liquid due to lack of drying, and it is easy to flow back and accumulate in the intersection of the upper nasal passage F1 and the top of the nasopharynx J. At the office. Conversely, the mucus of the middle nasal passage G1 also flows into the nasopharynx, but the middle nasal passage G1 is wider than the upper nasal passage F1, and most of the mucus slides down into a thin layer, which is easily dried by the influent air into a solid knot. Only a small part of the flow to the nasopharynx J. Therefore, the mucus that flows down into the nasopharynx J mainly comes from the upper nasal passage F1. Therefore, the mucus of the nasopharynx J is flushed directly to the top of the nasopharynx J via the upper nasal passage F1 and then washed with a strong water column to obtain the best effect, but the sinusoidal sinus has an opening at the top of the nasopharynx J. Only in this case can this be achieved. Objective and avoid accidental entry into the sphenoid sinus.

經由以上實施例之敘述，可知本發明鼻腔噴射導管6確實具有以下功效增進之處：藉由扁平封閉末端611及可塌陷之導管本體61特性，使較大之導管可以深入狹窄之沖洗目標，可以噴出遠為強勁或數量更多細長水柱達到更佳的沖洗目的，並可避免誤入鼻竇之危險，也可以省去以電腦斷層攝影測量中鼻通道及上鼻通道之寬度以選取適當尺寸的導管的麻煩，真正達到有效又方便之目的。 Through the description of the above embodiments, it can be seen that the nasal injection catheter 6 of the present invention does have the following enhancements: by the characteristics of the flat closed end 611 and the collapsible catheter body 61, the larger catheter can penetrate deep and narrow the irrigation target, Spouting a strong or a large number of slender water column for better irrigation purposes, and avoiding the risk of accidental entry into the sinus, it is also possible to eliminate the width of the nasal passage and the upper nasal passage by computer tomography to select the appropriate size of the catheter The trouble is really effective and convenient.

本發明鼻腔噴射導管6，可克服習知沖鼻導管難以完全沖洗鼻腔深處之缺點，可真正改善慢性鼻竇炎患者之症狀，並減少使用過程中的不適感，便利於病人外出使用。 The nasal cavity ejecting catheter 6 of the invention can overcome the shortcomings of the conventional nasal catheter which is difficult to completely wash the deep part of the nasal cavity, can truly improve the symptoms of the patient with chronic sinusitis, and reduce the discomfort during use, and facilitate the patient to go out for use.

惟以上所述者，僅為本發明之較佳實施例而已，當不能以此限定本發明實施之範圍，即大凡依本發明申請專利範圍及發明說明內容所作之簡單的等效變化與修飾，皆仍屬本發明專利涵蓋之範圍內。 The above is only the preferred embodiment of the present invention, and the scope of the invention is not limited thereto, that is, the simple equivalent changes and modifications made by the scope of the invention and the description of the invention are All remain within the scope of the invention patent.

Claims (5)

一種可塌陷鼻腔噴射導管，可配合一注射筒灌注沖洗液以沖洗鼻腔及鼻咽；該導管包含一導管本體及一銜接器，該導管本體具有一扁平狀封閉末端及一相反於該封閉末端之開放端，且靠近該封閉末端處形成有複數邊孔，該導管本體是以熱塑性彈性體或其他柔軟具彈性之材質製成，可供病人自行操作置入鼻腔及鼻咽；其特徵在於：該導管本體之扁平狀封閉末端之最大寬度不小於1mm且其管壁最小厚度不大於0.45mm。  A collapsible nasal jet catheter can be filled with a syringe to flush the nasal cavity and the nasopharynx; the catheter comprises a catheter body and an adapter, the catheter body having a flat closed end and a opposite end to the closed end The open end is formed with a plurality of side holes near the closed end, and the catheter body is made of a thermoplastic elastomer or other soft and elastic material, and can be manually placed into the nasal cavity and the nasopharynx by the patient; The flat closed end of the catheter body has a maximum width of not less than 1 mm and a minimum wall thickness of the tube body of not more than 0.45 mm.   依據申請專利範圍第1項所述之可塌陷鼻腔噴射導管，其中，該扁平狀封閉末端之最大寬度大於導管本體之最小直徑。  The collapsible nasal spray catheter of claim 1, wherein the flat closed end has a maximum width greater than a minimum diameter of the catheter body.   依據申請專利範圍第1或2項所述之可塌陷鼻腔噴射導管，其中，該導管之硬度介於80 Shore A以下，管壁厚度不大於0.45mm。  The collapsible nasal cavity ejecting catheter according to claim 1 or 2, wherein the catheter has a hardness of less than 80 Shore A and a wall thickness of not more than 0.45 mm.   依據申請專利範圍第1或2項所述之可塌陷鼻腔噴射導管，其中，該導管之硬度介於80-90 Shore A，管壁厚度不大於0.40mm。  The collapsible nasal spray catheter of claim 1 or 2, wherein the catheter has a hardness of 80-90 Shore A and a wall thickness of no greater than 0.40 mm.   依據申請專利範圍第1或2項所述之可塌陷鼻腔噴射導管，其中，該導管之硬度在90 Shore A以上，管壁厚度不大於0.35mm。  The collapsible nasal cavity ejecting catheter according to claim 1 or 2, wherein the catheter has a hardness of more than 90 Shore A and a wall thickness of not more than 0.35 mm.