TW201735955A - Nasal flushing catheter - Google Patents

Nasal flushing catheter Download PDF

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TW201735955A
TW201735955A TW105110726A TW105110726A TW201735955A TW 201735955 A TW201735955 A TW 201735955A TW 105110726 A TW105110726 A TW 105110726A TW 105110726 A TW105110726 A TW 105110726A TW 201735955 A TW201735955 A TW 201735955A
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catheter
nasal
mucus
closed end
catheter body
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TW105110726A
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吳麗秋
李慧萱
李蒼牧
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吳麗秋
李慧萱
李蒼牧
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Abstract

A nasal flushing catheter, made of silicone or other soft and elastic material, can be operated by the user himself or herself. The catheter comprises a closed end and an open end on the opposite side. There are multiple side-holes near the closed end. This catheter, when adapted to a connector and further connected to a syringe, can eject multiple strong thin spouts within the nasal cavity and nasopharynx for cleansing mucus and crust. The catheter may contain at least one stylet to improve its controllability. By a given injection rate of 10cc/sec using a syringe, the average vertical height of spouts can be predicted by the total area of side-holes, the catheter is therefore classified as following: 1. a low pressure catheter, having 3.367 mm2~4.123 mm2 of total areas of side-holes to eject 30 to 45 cm spouts; 2. a medium pressure catheter, having 2.381 mm2~3.367 mm2 of total area of side-holes to eject 45 to 90 cm spouts and 3. a high pressure catheter, having less than 2.381 mm2 of total area of side-holes to eject longer than 90 cm spouts.

Description

鼻腔沖洗導管 Nasal irrigation 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 the nasal cavity and the nasopharynx to clean the viscous secretions 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、喉嚨異物感及咳嗽這些主觀上難過的感覺會持續困擾病人,甚至一生。抗生素只是對急性感染之治療,而外科手術則是用以移除阻塞或擴大鼻腔內通路以改善黏液排放,以避免鼻竇炎急性發作之手段。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。(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. The symptoms include nasal congestion, foreign body sensation of the throat and cough. These subjective feelings of sadness continue to plague the patient, even for a lifetime. Antibiotics are only treatments for acute infections, and surgery is a means of removing obstructions or expanding intranasal access to improve mucus discharge to avoid an acute onset 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. . (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至圓形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。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.增加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的四對鼻竇分泌,並從位於上鼻通道A1、中鼻通道B1及鼻咽頂部的幾個開口排出。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-to-circular structures, and a Lieutenant 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 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. Three The 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. Increasing 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 four pairs of sinuses next to the nasal cavity and is expelled from several openings located in the upper nasal passage A1, the middle nasal passage B1 and the nasopharynx. 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,但必定伴隨大量的鼻水,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纏住病人。 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 must be accompanied by a large amount of nasal water, there will be no foreign body sensation of the throat, as long as the allergens disappear, it will return to normal, is a disease of intermittent seizures, and the symptoms of chronic sinusitis are The nose is too little mucus to be too sticky, and the symptoms are that the patient is always entangled over the years.

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。未能移除而滯留在鼻腔的黏液不像鼻水會蒸發消失,而是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之鼻竇開口向外漫 延,終於造成持續且嚴重的鼻塞。黏液與其他流體不同,容易黏附在狹窄空間,因黏著力不易隨重力下沉,且因從上鼻通道及中鼻通道之開口排出,因此由上向下漫延,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。此黏液雖難以去除,但未完全乾化之前仍會隨著重力滑動。黏液如向前滑入鼻前庭90就成為習知的鼻涕或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。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 completely remove them, either by forceful blowing of the nose or by forceful aspiration. The mucus that has not been removed and stays in the nasal cavity does not evaporate like the nasal water, but is dried by the compressed air to reduce the volume, adheres layer by layer to the nasal cavity and from the sinus opening in the middle nasal passage B1 and the upper nasal passage A1. Outrage Delay, finally causing persistent and severe nasal congestion. Unlike other fluids, mucus tends to adhere to a narrow space. Because the adhesion is not easy to sink with gravity, and it is discharged from the opening of the upper nasal passage and the middle nasal passage, it spreads from the top to the bottom and forms a state of hanging above the nasal cavity. The foremost part of the mucus, which is the lowermost part of the mucus, is still in contact with the air, and instead becomes the hardest nasal state. Although this mucus is difficult to remove, it will slide with gravity before it is completely dried. If the mucus slides forward into the nasal vestibule 90, it becomes a known snot or further drys into a snot; it also slides back into the nasopharynx 91, which is a known mucus reflux, and it is difficult to use suction or swallowing. To clear. 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,而且濕潤鼻腔是手段,沖洗出黏液及鼻屎並改善症狀才是目的,濕潤鼻腔說起來容易,如何達到目的才是困難所在。 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-snoring after about one hour in the water, and a half-snot can become a mucus, which 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, too It can be from the nasopharynx to the mouth and then to the outside of the body. It is also the open space that is unique to the body before and after the body (the mouth is also an open space, but there are muscle groups that can move autonomously, which is a hollow space that can be opened and closed). Perfusion 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 nasal cavity is a means to wash out the mucus and nasal discharge and improve the symptoms. Wetting the nose is easy to say, and how to achieve it is the difficulty.

綜觀所有的市售濕潤鼻腔的產品以及未見上市的發明專利,可以發現除供水機制的不同外,單一出水口的巨大噴頭則未見改變,都只能放在鼻前庭90來沖洗鼻腔。參閱圖4,以中華民國新型第M418689號「隨身洗鼻器」專利為例,該洗鼻器包括:一擠壓部10及一噴嘴20。該擠壓部10係具有一內部空間11,該噴嘴20係具有一噴出口21及一往該擠壓部10內部空間11延伸之延伸管部22。當該內部空間11裝有水並由外向內施壓,而使該擠壓部10收縮時,壓力會將位於該內部空間11中的水推入該延伸管部22,進而由該噴出口21噴出。 Looking at all the products of commercially available moist nasal cavity and the invention patents that have not been listed, it can be found that except for the difference of the water supply mechanism, the huge nozzle of the single outlet has not changed, and can only be placed in the nasal vestibule 90 to flush the nasal cavity. Referring to FIG. 4, taking the patent of the "Natural Nasal Washer" of the Republic of China No. M418689, the nasal washer includes a pressing portion 10 and a nozzle 20. The pressing portion 10 has an internal space 11 having a discharge port 21 and an extension pipe portion 22 extending toward the internal space 11 of the pressing portion 10. When the inner space 11 is filled with water and is pressed from the outside to the inside to contract the pressing portion 10, the pressure pushes the water located in the inner space 11 into the extension pipe portion 22, and further, the discharge port 21 ejection.

由此可見,所有的沖鼻器都只能放在鼻前庭90噴出由前向後之單方向水柱。參閱圖3,依流體向壓力低處渲洩的原理,水柱只能噴向寬敞、較少黏液堆積的下鼻通道C1,由於鼻甲的阻隔,單方向的水柱無法直接噴到堆積在上面較狹小之中鼻通道B1及上鼻通道A1的黏液及鼻屎,只能寄望水柱碰撞鼻甲所產生的向上微弱散射,另外,沖洗液因呼吸的關係也無法停留在下鼻通道。如為了增強散射而加強水壓不但無法達到目的,反而會使大量的水沖向鼻咽,容易沖進氣管,產生嗆水或損傷黏膜的副作用。 Thus, all the nasal devices can only be placed in the nasal vestibule 90 to eject a single direction water column from front to back. Referring to Figure 3, according to the principle that the fluid is discharged to the lower pressure, the water column can only be sprayed to the lower nasal channel C1 with more mucus accumulation. Due to the blockage of the turbinate, the water column in one direction cannot be directly sprayed onto the narrower one. The mucus and nasal discharge of the middle nasal passage B1 and the upper nasal passage A1 can only hope for the upward weak scattering caused by the water column colliding with the turbinate. In addition, the flushing fluid cannot stay in the lower nasal passage due to the breathing relationship. For example, in order to enhance the scattering, the water pressure can not achieve the purpose, but will cause a large amount of water to rush to the nasopharynx, which is easy to flush the air inlet tube, causing side effects of drowning or damage to the mucous membrane.

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,但無法撼動堅硬的鼻屎;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。 The following experiment simulates the mechanism of flushing 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, and the water column strength is further divided into the vertical length: 45 cm or less. Pressurized water column, medium pressure water column of 45cm to 90cm and high pressure water column of 90cm or more. It can be observed that the low-pressure water column can make the mucus into a thin nasal sputum, and can also make the surface of the semi-nasal sin become mucus, but can not shake 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.

因此沖洗或濕潤鼻腔的機轉如下,其一是水柱直接穿透黏液、半鼻屎或鼻屎的底層,使其立即從附著處脫落,是為立即、直接、完全的清除效應;其二是射出的水柱部份穿透黏液、半鼻屎或鼻屎,使其表層變成易於流動的狀態,或者是沖洗液長時間與黏液、半鼻屎及鼻屎接觸使其軟化的濕潤作用,是為延後、間接、部分的濕潤效應。濕潤效應只有部分清除效果,必須加上病人用力排出才較有效果,否則滯留鼻腔又回復惡性循環,因此水柱越強沖洗效果越佳。 Therefore, the machine for flushing or moisturizing the nasal cavity is as follows. One is that the water column directly penetrates the bottom layer of the mucus, the semi-nasal or the nasal sin, so that it immediately falls off from the attachment, which is an immediate, direct and complete scavenging effect; the second is The injected water column partially penetrates the mucus, the semi-nasal snot or the snot, making the surface layer easy to flow, or the moisturizing effect of the rinsing liquid which is softened by contact with mucus, semi-nasal sputum and nasal sputum for a long time. Delayed, indirect, partial wetting effects. The moist effect has only a partial removal effect, and it must be added with the patient's force to discharge it. Otherwise, the nasal cavity is regained a vicious cycle, so the stronger the water column, the better the flushing effect.

以此治療機轉來檢視現有市售沖鼻器,雖然能噴出平行於鼻腔前後走向的強勁水柱,但因鼻甲及黏液的阻隔,只能噴向寬敞的下鼻通道及下臨中膈空間,而無法達到黏稠分泌物主要堆積的中鼻通道及上鼻通道,而散射的水柱太微弱,沖洗效果非常有限。 This treatment machine is used to view the existing commercially available rattles. Although it can spray a strong water column parallel to the front and back of the nasal cavity, it can only be sprayed to the spacious lower nasal passage and the lower middle space due to the blockage of the turbinate and mucus. However, the middle nasal passage and the upper nasal passage, which are mainly accumulated by the thick secretions, cannot be reached, and the scattered water column is too weak, and the flushing effect is very limited.

參閱圖5,再以此實驗來檢視中華民國第101125880號「鼻通道沖洗導管裝置」發明專利申請案,該案揭露了一種末端封閉且開設有複數邊孔32之導管31。該導管31可經由較寬敞的中鼻通道B1及下鼻通道C1深入鼻咽91,由於該導管31能置入狹窄的鼻通道,並噴出垂直於導管31的水柱,因此可以清除其所到之處的黏液,但是,此導管31只能噴出30cm水柱,對於鼻屎及半鼻屎而言,依上述實驗只有間接的濕潤效應。另一方面,該案所揭露之導管31,其銜接處係以鋼針套入導管31本體之入水端,鋼針的內徑會限制水流量,也進一步限制了 噴出水柱的壓力。 Referring to Fig. 5, this experiment is used to examine the invention patent application of the "Nose Channel Flushing Catheter Device" of the Republic of China No. 101125880, which discloses a catheter 31 having a closed end and a plurality of side holes 32. The catheter 31 can penetrate the nasopharynx 91 via the relatively wide middle nasal passage B1 and the lower nasal passage C1. Since the catheter 31 can be placed into the narrow nasal passage and sprayed out of the water column perpendicular to the conduit 31, the catheter can be removed. Mucus at the site, however, this catheter 31 can only spray 30 cm water column, for the nasal and semi-nasal sputum, according to the above experiment only indirect moist effect. On the other hand, the catheter 31 disclosed in the present case has a steel needle inserted into the water inlet end of the body of the catheter 31, and the inner diameter of the steel needle limits the water flow, and further limits the water flow. The pressure of the water jet.

回顧圖3,嚴重的慢性鼻竇炎病人,中鼻通道B1及下臨中膈空間D3以上常充滿黏液及堅硬的鼻屎,需要高壓水柱才能穿透此鼻屎,也有病人雖未完全阻塞,但其上鼻通道A1、中鼻通道B1及下鼻通道C1都很狹窄。因為鼻腔沖洗導管必需以柔軟材質製造才能避免傷害病人,因此細小之導管必定太軟而無法操作。傳統上,探針可以增加導管之鋼直性使其易於操控。但傳統探針都具有突出導管近端、方便移除之把柄,在灌注操作前需先拔出,清洗每邊鼻腔導管至少重複進出3次,如此清洗兩邊鼻腔探針需重複進出導管至少6次,非常不方便。更重要的是需要操針之導管外徑及內徑都很小,導管又是柔軟材質製造,探針置入導管並非容昜,因此傳統探針應用在導管沖鼻治療實務上並不可行。 Looking back at Figure 3, in patients with severe chronic sinusitis, the middle nasal passage B1 and the lower medial space above D3 are often filled with mucus and hard nasal discharge. High pressure water column is required to penetrate the nasal sinus, and some patients are not completely obstructed, but The upper nasal channel A1, the middle nasal channel B1 and the lower nasal channel C1 are both narrow. Because the nasal irrigation catheter must be made of a soft material to avoid injury to the patient, the small catheter must be too soft to operate. Traditionally, probes have increased the straightness of the steel tube for easy handling. However, the conventional probes have a handle that protrudes from the proximal end of the catheter and is easy to remove. It needs to be pulled out before the perfusion operation, and the nasal catheter is cleaned at least three times in and out, so that the nasal probes on both sides need to be repeated at least 6 times. ,very inconvenient. What's more important is that the outer diameter and inner diameter of the catheter need to be small, the catheter is made of soft material, and the probe is not allowed to be placed in the catheter. Therefore, the traditional probe application is not feasible in the catheter treatment.

因此,本發明之目的為設計一種更佳的導管以沖洗狹窄彎曲的鼻通道及寬闊的鼻咽,其特徵在於:該沖洗導管包含一導管本體及一套接在該導管本體外部的銜接器,該導管本體是以矽膠及乳膠其中之一或其它柔軟且具彈性之材質製成,可供使用者自行操作置入鼻腔及鼻咽,該導管本體具有一封閉端及一相反於該封閉端之開放端,且靠近該封閉端處形成有複數邊孔。 Accordingly, it is an object of the present invention to design a better catheter for rinsing a narrow curved nasal passageway and a broad nasopharynx, characterized in that the irrigation catheter comprises a catheter body and a set of adapters attached to the exterior of the catheter body. The catheter body is made of one of silicone and latex or other soft and elastic material, and can be manually placed into the nasal cavity and the nasopharynx by the user. The catheter body has a 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.

本發明的另一技術手段,是在於上述之沖洗導管內更設置一支末端漸細的探針。 Another technical means of the present invention is to provide a probe with a tapered end in the above-mentioned irrigation catheter.

本發明的又一技術手段,是在於上述之沖洗導管內更設置複數支長度遞減的探針。 Another technical means of the present invention is to provide a plurality of probes of decreasing length in the irrigating catheter.

本發明的再一技術手段,是在於上述之導管本體上之複數邊孔的總面積介於3.367mm 2~4.123mm 2According to still another aspect of the present invention, the total area of the plurality of side holes on the catheter body is between 3.367 mm 2 and 4.123 mm 2 .

本發明的另一技術手段,是在於上述之導 管本體上之複數邊孔的總面積介於2.381mm 2~3.367mm 2Another technical means of the present invention is that the total area of the plurality of side holes on the catheter body is between 2.381 mm 2 and 3.367 mm 2 .

本發明的又一技術手段,是在於上述之導管本體上之複數邊孔的總面積小於2.381mm 2According to still another aspect of the present invention, the total area of the plurality of side holes on the catheter body is less than 2.381 mm 2 .

本發明的再一技術手段,是在於上述之導管本體上之複數邊孔越接近封閉端,越呈密集分佈。 A further technical means of the present invention is that the closer the plurality of side holes on the catheter body are to the closed end, the denser the distribution.

本發明的另一技術手段,是在於前述導管本體之外徑不大於1.0mm,而其內設置外徑不大於0.1mm的探針。 Another technical means of the present invention is that the outer diameter of the catheter body is not more than 1.0 mm , and the probe having an outer diameter of not more than 0.1 mm is disposed therein.

本發明的又一技術手段,是在於前述導管本體之封閉端上更開設有一端孔。 Another technical means of the present invention is that an end hole is further formed on the closed end of the catheter body.

本發明之有益功效在於,藉由內置探針改善導管之操控性,可深入沖洗目標區,並藉由銜接器及邊孔總面積的設計,可以噴出多重強勁細長水柱,達到更佳的沖洗目的。 The beneficial effect of the invention is that the built-in probe can improve the handling of the catheter, and the target area can be deeply washed, and the design of the adapter and the total area of the side holes can be used to spray multiple strong and slender water columns for better flushing purposes. .

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

I‧‧‧臨中膈空間 I‧‧‧Linzhong Space

I1‧‧‧上臨中膈空間 I1‧‧‧Proposed to the Lieutenant Space

I2‧‧‧中臨中膈空間 I2‧‧‧中中中膈空间

I3‧‧‧下臨中膈空間 I3‧‧‧Proposed to the Lieutenant Space

J‧‧‧鼻咽 J‧‧‧ Nasopharyngeal

6‧‧‧鼻腔沖洗導管 6‧‧‧ nasal irrigation catheter

61‧‧‧導管本體 61‧‧‧ catheter body

611‧‧‧封閉端 611‧‧‧closed end

612‧‧‧開放端 612‧‧‧Open end

613‧‧‧邊孔 613‧‧‧ side hole

614‧‧‧端孔 614‧‧‧End hole

62‧‧‧銜接器 62‧‧‧Connector

7‧‧‧注射筒 7‧‧‧Syringe

8‧‧‧探針 8‧‧‧ probe

MC‧‧‧黏液或鼻屎 MC‧‧‧mucus or nasal discharge

圖1是人體鼻腔內的矢狀剖面視圖;圖2是圖1中線段aa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,說明中華民國新型第M418689號之「隨身洗鼻器」;圖5是立體分解示意圖,說明中華民國第101125880號「鼻通道沖洗導管裝置」;圖6是一立體分解示意圖,說明本發明鼻腔沖洗導管之第一較佳實施例;圖7是一上視示意圖,說明該導管具有複數越靠近封閉端越呈密集分佈的邊孔; 圖8是一局部剖視示意圖,說明本發明鼻腔沖洗導管之第二較佳實施例;圖9是一局部剖視示意圖,說明本發明鼻腔沖洗導管之第三較佳實施例;圖10是一局部剖視示意圖,說明本發明鼻腔沖洗導管之第四較佳實施例;圖11是一局部剖視示意圖,說明本發明鼻腔沖洗導管之第五較佳實施例;圖12是一局部剖視示意圖,說明本發明之一銜接器與導管本體的銜接態樣;圖13是一局部剖視示意圖,說明本發明之銜接器與導管本體的銜接態樣,以及探針之安全設計;圖14是一鼻腔後半部的冠狀剖面視圖,說明抵達上鼻通道集中鼻通道之彎曲及狹窄路徑;圖15是人體鼻腔內的矢狀剖面視圖,說明該導管置於中鼻通道進行沖洗的態樣;圖16是人體鼻腔內的矢狀剖面視圖,說明該導管置於上鼻通道進行沖洗的態樣;圖17是人體鼻腔內的冠狀剖面視圖,說明該導管置於下臨中膈空間進行沖洗的態樣;及圖18是人體鼻腔內的矢狀剖面視圖,說明該導管置於鼻咽並進行沖洗的態樣。 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 next to the middle space; Figure 4 is a schematic cross-section showing the new Chinese version of M418689 "Portable Nasal Washer"; Figure 5 is a three-dimensional FIG. 6 is a perspective exploded view showing a first preferred embodiment of the nasal irrigation catheter of the present invention; FIG. 7 is a schematic top view showing the catheter; a side hole having a dense distribution as the complex number is closer to the closed end; Figure 8 is a partial cross-sectional view showing a second preferred embodiment of the nasal irrigation catheter of the present invention; Figure 9 is a partial cross-sectional view showing a third preferred embodiment of the nasal irrigation catheter of the present invention; FIG. 11 is a partial cross-sectional view showing a fifth preferred embodiment of the nasal irrigation catheter of the present invention; FIG. 12 is a partial cross-sectional view showing a fourth preferred embodiment of the nasal irrigation catheter of the present invention; FIG. 13 is a partial cross-sectional view showing the interface between the adapter and the catheter body of the present invention, and the safety design of the probe; FIG. 14 is a schematic view of the connector; The coronal section view of the posterior half of the nasal cavity illustrates the curved and stenotic path of the nasal passage in the upper nasal passage; Figure 15 is a sagittal section view of the nasal cavity of the human body, indicating the catheter is placed in the middle nasal passage for washing; Figure 16 It is a sagittal section view of the human nasal cavity, indicating that the catheter is placed in the upper nasal passage for washing; Figure 17 is a coronal cross-sectional view of the human nasal cavity, indicating that the catheter is placed underneath Diaphragmatic aspect flushing space; and FIG. 18 is a cross-sectional sagittal view of a human body within the nasal cavity, nasopharynx indicating that the catheter is placed and aspects flushing.

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五個較佳實施例的詳細說明中,將可清楚的呈現。 The details of the related patents and the technical contents of the present invention will be apparent from the following detailed description of the preferred embodiments of the accompanying 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、7,為本發明鼻腔沖洗導管6之第一較佳實施例。在該第一較佳實施例中,該鼻腔沖洗導管6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 Figures 6 and 7, a first preferred embodiment of the nasal irrigation catheter 6 of the present invention is shown. In the first preferred embodiment, the nasal irrigation catheter 6 can be filled with a syringe 7 to flush the nasal cavity and nasopharynx of the human body.

該第一較佳實施例之特徵在於,該鼻腔沖洗導管6包含一導管本體61及一套接在該導管本體61外部的銜接器62,該導管本體61是以矽膠及乳膠其中之一或其它柔軟且具彈性之材質所製成,並可供使用者自行操作置入鼻腔及鼻咽中,該導管本體61具有一封閉端611及一相反於該封閉端611之開放端612,且該導管本體61上靠近該封閉端611處形成有複數邊孔613,且該導管本體61上之複數邊孔613越接近該封閉端611處,越呈密集分佈(顯示於圖7)。 The first preferred embodiment is characterized in that the nasal irrigation catheter 6 comprises a catheter body 61 and a set of adapters 62 connected to the outside of the catheter body 61. The catheter body 61 is one of silicone and latex or the like. The soft and elastic material is made for self-operating operation into the nasal cavity and the nasopharynx. The catheter body 61 has a closed end 611 and an open end 612 opposite to the closed end 611, and the catheter A plurality of side holes 613 are formed in the body 61 near the closed end 611, and the closer the plurality of side holes 613 on the duct body 61 are to the closed end 611, the denser the distribution (shown in FIG. 7).

參閱圖8,為本發明鼻腔沖洗導管6之第二較佳實施例,該第二較佳實施例與該第一較佳實施例大致相同,相同之處於此不再贅述,不同之處在於,本發明之鼻腔沖洗導管6還內置有一支末端漸細的探針8。 Referring to FIG. 8, a second preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the first preferred embodiment, and the same is not described herein again, except that The nasal irrigation catheter 6 of the present invention also incorporates a probe 8 with a tapered end.

參閱圖9,為本發明鼻腔沖洗導管6之第三較佳實施例,該第三較佳實施例與該第一較佳實施例大致相同,不同之處在於,本發明之鼻腔沖洗導管6還內置有複數支長度遞減的探針8。本實施例中該複數探針8之數量為3根,實際實施時,也可以是其他數量,當不以此為限。 Referring to Figure 9, a third preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the first preferred embodiment, except that the nasal irrigation catheter 6 of the present invention is further A plurality of probes 8 having a decreasing length are built in. In this embodiment, the number of the plurality of probes 8 is three, and in actual implementation, other numbers may be used, unless otherwise limited.

參閱圖10,為本發明鼻腔沖洗導管6之第四較佳實施例,該第四較佳實施例與該第三較佳實施例大致相同,相同之處於此不再贅述,不同之處在於,該導管本體61之外徑不大於1.0mm,並定義其為微導管。該鼻腔沖洗導管6內置有複數支外徑不大於0.1mm且長度遞減的探針8。 Referring to FIG. 10, a fourth preferred embodiment of the nasal irrigation catheter 6 of the present invention is substantially the same as the third preferred embodiment, and the same is not described herein again, except that The outer diameter of the catheter body 61 is no more than 1.0 mm and is defined as a microcatheter. The nasal irrigation catheter 6 has a plurality of probes 8 having an outer diameter of not more than 0.1 mm and a decreasing length.

參閱圖11,為本發明鼻腔沖洗導管6之第 五較佳實施例,該第五較佳實施例與該第四較佳實施例大致相同,相同之處於此不再贅述,不同之處在於,該導管本體61之封閉端611上更開設有一端孔614,該鼻腔沖洗導管6內置有一外徑不大於0.1mm且末端漸細的探針8。 FIG. 11 is a fifth preferred embodiment of the nasal irrigation catheter 6 of the present invention. The fifth preferred embodiment is substantially the same as the fourth preferred embodiment, and the details are not described herein again, except that The closed end 611 of the catheter body 61 is further provided with an end hole 614. The nasal irrigation catheter 6 has a probe 8 having an outer diameter of not more than 0.1 mm and a tapered end.

以下就本發明之鼻腔沖洗導管6於導管之製造邊孔與垂直水柱高度的關係邊孔製造及數量配置導管與邊孔的相互關係探針之設計銜接器注射筒之選用實際使用操作及功效增進等各個面向作詳細之說明。 The following is the manufacture of the nasal irrigation catheter 6 of the present invention, the relationship between the side hole and the vertical water column height , the manufacture and quantity configuration of the side hole, the relationship between the catheter and the side hole , the design of the probe , the selection of the adapter, and the syringe. Detailed descriptions of each aspect, such as actual use operations and enhancements .

導管製造Catheter manufacturing

該導管本體61由矽膠、乳膠或其它柔軟且具彈性之材質製成,且該導管本體61具有一開放端612及一封閉端611,近封閉端611處設置有複數邊孔613。鼻腔中最大的下鼻通道H1及下臨中膈空間I3,一般人在4mm以下,患者可能在2.5mm甚至1.5mm以下;最小的上鼻通道,一般人在1.5mm以下,患者可能在1mm以下,因此,本案之導管外徑以4mm以下為原則,較佳地,是介於0.5~2.5mm。導管外徑小於1.0mm稱微導管,其內徑可能只有0.6mm甚至只有0.3mm,灌注操作中容易爆裂,其封閉端如加設開孔可降低此風險。管壁則在1mm以下,較佳地,是介於0.1~0.6mm。邊孔在1mm以下,較佳地,是介於0.1~0.5mm。 The catheter body 61 is made of silicone rubber, latex or other soft and elastic material, and the catheter body 61 has an open end 612 and a closed end 611, and a plurality of side holes 613 are disposed near the closed end 611. The largest lower nasal passage H1 in the nasal cavity and the lower medial space I3, the average person is below 4mm, the patient may be below 2.5mm or even 1.5mm; the smallest upper nasal passage, the average person is below 1.5mm, the patient may be below 1mm, so the patient may be below 1mm, so the patient may be below 1mm In this case, the outer diameter of the catheter is 4 mm or less, preferably 0.5 to 2.5 mm. The outer diameter of the catheter is less than 1.0 mm. The microcatheter may have an inner diameter of only 0.6 mm or even 0.3 mm . It is easy to burst during the perfusion operation, and the closed end can reduce the risk if it is provided with an opening. The wall of the tube is below 1 mm, preferably between 0.1 and 0.6 mm. The side holes are 1 mm or less, preferably 0.1 to 0.5 mm.

邊孔與垂直水柱高度的關係Relationship between edge hole and vertical water column height

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=gtt=V 0/g,其中g為重力常數9.8m/sec2t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h=1/2(g)(V 0/g)2=V 0 2/2g或V 0 2=2gh,又邊孔613水柱平均初始速度(V 0)取決於速度灌注(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V 0 2=2gh可得(IR/TA)2=2gh,或TA 2=IR 2/2gh,或。 雖然10cc、20cc、50cc、60cc及100cc的注射筒7都很容易取得,但考量操作性及避免大流量的嗆水現象,不宜使用大容量的注射筒7,而10cc注射筒可以說是大小適中,容易操作又不會產生嗆水現象的選擇,因此,本發明以10cc注射筒7作為標準注射筒。一般徒手操作10cc注射筒可以達到5cc/sec至15cc/sec之速度灌注(IR,Injection Rate),因此選擇5cc/sec至15cc/sec之中間值10cc/sec作為標準灌注速度,於此標準灌注速度下要產生30cm之水柱,需要邊孔613總面積 ;要產生45cm之水柱,則需要 邊孔總面積;同樣地以10cc/sec的 灌注速度要產生90cm之水柱,則需邊孔613總面積 。綜合以上,邊孔613總面積介 於3.367mm 2~4.123mm 2可以產生30~45cm低壓水柱之導管稱為低壓導管;邊孔總面積在介於2.381mm 2~3.367mm 2可以產生45~90cm中壓水柱之導管稱為中壓導管;邊孔總面積小於2.381mm 2,可產生90cm以上高壓水柱之導管稱為高壓導管。因前案已可噴出30cm之水柱,故本案低壓水柱定義為30~45cm。 Since the initial velocity ( V 0 ) of the water hole 613 can determine its vertical height h, its 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 vertical The time of the vertex, and the highest vertical vertex is h , then h = 1/2 ( gt 2 ), substituted with t = V 0 / g , then h = 1/2 ( g ) ( V 0 / g ) 2 = V 0 2 /2g or V 0 2 =2 gh , and the average initial velocity ( V 0 ) of the water column 613 depends on the velocity perfusion (IR) and the total area of the side holes (TA, Total Area). The equation is as follows: V 0 = IR / TA , which can be obtained by substituting the equation V 0 2 = 2 gh ( IR / TA ) 2 = 2 gh , or TA 2 = IR 2 /2 gh , or . Although the 10 cc , 20 cc , 50 cc , 60 cc, and 100 cc syringes 7 are easy to obtain, it is not advisable to use a large-capacity syringe 7 and 10 cc injections, considering the operability and avoiding large flow of water. The cartridge can be said to be moderately sized, easy to handle, and free from drowning. Therefore, the present invention uses a 10 cc syringe 7 as a standard syringe. Usually bare hands can reach 10 cc syringe 5 cc / sec to 15 cc / sec of the perfusion rate (IR, Injection Rate), so choose 5 cc / sec to 15 cc / sec intermediate value of 10 cc / sec as a standard perfusion rate At this standard perfusion rate, a water column of 30 cm is required, and the total area of the side holes 613 is required. To produce a 45cm water column, the total area of the side holes is required. Similarly, to produce a water column of 90 cm at a perfusion rate of 10 cc / sec, the total area of the side holes 613 is required. . In summary, the total area of the side hole 613 is 3.367 mm 2 ~ 4.123 mm 2 , and the tube which can produce 30~45 cm low pressure water column is called low pressure pipe; the total area of the side hole is between 2.381 mm 2 and 3.367 mm 2 can produce 45~90 cm The medium-pressure water column is called a medium-pressure pipe; the total area of the side holes is less than 2.381 mm 2 , and the pipe that can produce a high-pressure water column of more than 90 cm is called a high-pressure pipe. Because the previous case can spray 30cm water column, the low pressure water column in this case is defined as 30~45cm.

邊孔製造及數量配置Edge hole manufacturing and quantity configuration

邊孔613可以採用移除管壁之一部份的傳統方式製作,也可以用椎狀實心鋼針穿刺方法製造。4.123mm 2邊孔總面積可以製造0.5mm之圓形邊孔,其數量為4.123mm 2÷0.5mm÷0.5mm÷0.785=21個,也可以製造58個0.3mm之圓形邊孔或131個0.2mm圓形邊孔;3.367mm 2邊孔總面積可以製造0.5mm之圓形邊孔,其數量等於3.367mm 2÷0.5mm÷0.5mm÷0.785=17個,也可以製造47個0.3mm之圓形邊孔或107個0.2mm之圓形邊孔;同樣地2.381mm 2邊孔總面積可以製造12個0.5mm圓形邊孔,33個0.3mm圓形邊孔或75個0.2mm圓形邊孔。在灌注操作中,越接近封閉端之處,其管腔壓力越大,因此設計近封閉端611有較密集之邊孔613分佈(顯示於圖8),避 免末端局部膨脹,使其能承受最大管腔壓力,以噴出最強水柱。壓力越大邊孔需要越向封閉端611密集分佈。邊孔613總面積不變的情況下,邊孔613越小,邊孔613數量越多,分佈也越廣,可以沖洗更大範圍;邊孔613數量不變的情況下,邊孔613越小總面積也會越小,所產生的水柱也越強。 The side hole 613 can be made by a conventional method of removing a part of the wall of the tube, or can be manufactured by a solid steel needle puncture method. The total area of 4.123 mm 2 side holes can be made into circular holes of 0.5 mm . The number is 4.223 mm 2 ÷0.5 mm ÷0.5 mm ÷0.785=21, and 58 0.3 mm circular side holes or 131 can also be manufactured. 0.2 mm round side hole; 3.367 mm 2 side hole total area can be made 0.5 mm round side hole, the number is equal to 3.367 mm 2 ÷0.5 mm ÷0.5 mm ÷0.785=17, can also make 47 0.3 mm Round side holes or 107 round holes of 0.2 mm ; the same 2.381 mm 2 side hole total area can be made of 12 0.5 mm round side holes, 33 0.3 mm round side holes or 75 0.2 mm round Side hole. In the perfusion operation, the closer to the closed end, the greater the lumen pressure, so the design of the near closed end 611 has a denser side hole 613 distribution (shown in Figure 8), to avoid local expansion of the end, so that it can withstand the maximum The lumen pressure is used to eject the strongest water column. The greater the pressure, the more the holes need to be densely distributed toward the closed end 611. When the total area of the side holes 613 is constant, the smaller the side holes 613, the larger the number of side holes 613, the wider the distribution, and the larger the range can be washed; the smaller the number of side holes 613 is, the smaller the side holes 613 are. The smaller the total area, the stronger the water column produced.

導管與邊孔的相互關係Correlation between conduit and side hole

導管本體61外徑相同情形下,管壁愈厚, 內徑愈小,則愈耐高壓而不易產生彈性疲勞。彈性疲勞會 導致邊孔擴大,邊孔613總面積增加,水柱減弱的後果。 但管壁愈厚灌注阻力愈大,不利於灌注操作,彈性疲勞與操作方便必需取得平衡。依據前述實驗,水柱愈強沖洗效果愈佳,但沖洗操作中刺痛的感覺愈強,而且病情較輕者,黏液較不黏稠,堅硬的鼻屎較少,中壓或低壓水柱已經足以改善症狀,且中壓或低壓導管之邊孔總面積較大,邊孔613分佈較廣,可以沖洗較大的範圍。因此,三種導管都有其適應對象,都有其存在之必要。 When the outer diameter of the catheter body 61 is the same, the thicker the wall, The smaller the inner diameter, the higher the resistance to high pressure and the less elastic fatigue. Elastic fatigue As a result, the side hole is enlarged, the total area of the side hole 613 is increased, and the water column is weakened. However, the thicker the wall, the greater the perfusion resistance, which is not conducive to the perfusion operation. It is necessary to balance the elastic fatigue and the convenience of operation. According to the above experiment, the stronger the water column is, the better the rinsing effect is, but the stronger the tingling in the rinsing operation, and the milder the disease, the less sticky the mucus, the less the snot is, the medium or low pressure water column is enough to improve the symptoms. Moreover, the total area of the side holes of the medium or low pressure conduit is large, and the side holes 613 are widely distributed, and can wash a large range. Therefore, all three catheters have their own adaptation, and they all have their existence.

探針之設計Probe design

外徑越大、管壁越厚之導管本體61越硬也越易於操作,但受限於鼻腔的狹小空間,外徑必須小於狹窄處,導致導管本體61可能太軟而不易於操控,除需增強其硬度,也需要具有末端漸進的柔軟度,因此管腔內增設探針8,該探針8可以是經防鏽處理的金屬材質、碳纖維或其他具類似鋼直性(Stiffness)之材質製造。以碳纖維為例,碳纖維不需防鏽處理,鋼直性大於不鏽鋼,而且其直徑最細可達10微米,是一個值得推薦的材料。 The larger the outer diameter, the thicker the wall of the catheter, the harder the catheter body 61 is, the easier it is to operate, but limited by the narrow space of the nasal cavity, the outer diameter must be smaller than the narrow point, so that the catheter body 61 may be too soft and not easy to handle, except To enhance its hardness, it also needs to have a gradual softness at the end. Therefore, a probe 8 is added in the lumen, and the probe 8 can be made of rust-proof metal material, carbon fiber or other material having similar steel straightness. . Taking carbon fiber as an example, carbon fiber does not need anti-rust treatment, steel straightness is greater than stainless steel, and its diameter is up to 10 microns, which is a recommended material.

該探針8可以是末端漸細的單一探針8或長度遞減之複數探針8(顯示於圖8、9)。另外,有病人抵達上鼻通道及中鼻通道之路徑最狹窄處可能小於1.0mm,甚至只有0.5mm的寬度,必須更小的導管才能克服,此小於1.0mm 之微導管內徑可能只有0.6mm甚至只有0.3mm,因此探針8必須更小、硬度必須更大,如選用金屬材質建議採用防鏽處理過且不大於0.1mm的鎢合金探針(顯示於圖10、11),因為鎢是硬度最大的金屬。以上探針8之長度不可大於包含銜接器62之導管6,才不會突出導管6完全留置於管腔內,其近端固定於銜接器62之內壁。因為探針8不能移除,探針8越細於管腔內所佔據之空間越小,越有利於灌注速度。 The probe 8 can be a single probe 8 with a tapered end or a complex probe 8 of decreasing length (shown in Figures 8, 9). In addition, the narrowest path of the patient's access to the upper nasal passage and the middle nasal passage may be less than 1.0 mm , or even a width of 0.5 mm , which must be overcome by a smaller catheter. The inner diameter of the microcatheter less than 1.0 mm may be only 0.6 mm. Even only 0.3 mm , the probe 8 must be smaller and the hardness must be larger. For metal materials, it is recommended to use a tungsten alloy probe with rust-proof treatment of not more than 0.1 mm (shown in Figures 10 and 11) because tungsten is The hardest metal. The length of the probe 8 above cannot be greater than the conduit 6 containing the adapter 62 so that the protruding catheter 6 is not completely retained in the lumen, and the proximal end thereof is fixed to the inner wall of the adapter 62. Since the probe 8 cannot be removed, the thinner the probe 8 is, the smaller the space occupied by the lumen, and the better the perfusion rate.

銜接器Adapter

回顧圖5,習知之中華民國第101125880號「鼻通道沖洗導管裝置」,其銜接器之出水口是套入導管本體之入水口,其銜接器如不是限制了水流量,就是造成導管本體在銜接處被撐開,管壁變薄較無法承受灌注之壓力。因此,本案改採銜接器62之出水口以較大內徑包覆在導管入水口之外,排除水流量及灌注壓力之問題。在銜接處利用兩者之間的摩擦力及強力黏著劑形成牢固的銜接狀態。另外,微導管因為內徑很小,又需要內置探針8,更需要外套式的銜接器62(顯示於圖12)。探針8可以在銜接處固定於銜接器62之內璧或作其他安全性設計,預防灌注操作中隨著沖洗液向前移動(顯示於圖13)。 Referring back to Figure 5, the Chinese Patent No. 101125880 "Nose Channel Flushing Catheter Device" has a water outlet that fits into the water inlet of the catheter body. If the adapter does not restrict the water flow, the catheter body is connected. The area is stretched and the wall is thinner than the pressure of perfusion. Therefore, in the present case, the water outlet of the adapter 62 is covered with a larger inner diameter outside the inlet of the conduit to eliminate the problem of water flow and perfusion pressure. At the joint, a frictional force between the two and a strong adhesive are used to form a firm joint state. In addition, the microcatheter requires a built-in probe 8 because of its small inner diameter, and a jacketed adapter 62 (shown in Figure 12) is required. The probe 8 can be secured within the adapter 62 at the interface or other safety design to prevent the irrigation fluid from moving forward during the perfusion operation (shown in Figure 13).

注射筒之選用Selection of syringe

雖然20cc、30cc,及50cc之注射筒7都很容易取得,但因體積太大不易操作,而且流量太大容易產生嗆水的現象,所以10cc注射筒是一般病人最容易操作的選擇。但是,注射筒7之使用還必須配合導管本體61之管徑作調整。外徑2mm以上之導管本體61可使用10cc之注射筒7;1.5~2mm之導管本體61可使用5~10cc之注射筒7;1~1.5mm之導管本體61可使用1~5cc之注射筒7;1mm以下之微導管為避免導管爆裂可使用1~2cc之注射筒7。 Although the 20cc, 30cc, and 50cc syringes 7 are easy to obtain, the 10cc syringe is the easiest choice for general patients because it is too large to handle and the flow rate is too large to cause drowning. However, the use of the syringe 7 must also be adjusted in accordance with the diameter of the catheter body 61. The catheter body 61 having an outer diameter of 2 mm or more can use a syringe 10 of 10 cc; the catheter body 61 of 1.5 to 2 mm can use a syringe 7 of 5 to 10 cc; the catheter body 61 of 1 to 1.5 mm can use a syringe of 1 to 5 cc 7 A microcatheter of 1 mm or less can be used with a syringe 1 of 1 to 2 cc in order to avoid catheter bursting.

實際使用操作Actual operation

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,因此我們熟悉沖洗鼻腔的所有細節,並且體認:因為需要每天沖洗鼻腔,沖洗之效果病人自己最清楚。評估效果之項目有二,其一是客觀上沖洗中及沖洗後黏液流出的量,越多越好;其二是主觀上沖洗後,鼻塞、喉嚨異物感及咳嗽,這些難過感覺的改善程度。必須兩者都滿意至少也要可以接受才算具有效果,病人才會繼續使用。但是依病情的嚴重程度,一天、半天或更短的時間,症狀還是會再重複,仍須重複沖洗。如果有病人使用前案圖5之導管且已深入鼻腔(至少深入8~10cm以上)仍然沒有滿意的沖洗效果,則應該是沒有放入中鼻通道及上鼻通道兩個目標區,或是水柱強度不足以穿透鼻屎所致。此時應該先尋求醫師之協助,施行鼻腔、鼻竇之電腦斷層攝影,做一次電腦斷層攝影檢查有助於每天的沖洗,應該是值得的。 Because the hand-made catheter was hand-made before the patent application I have tried it for more than two years, and the catheter of this case has been tried for nearly half a year. Therefore, we are familiar with all the details of flushing the nasal cavity, and we recognize that the effect of washing is most clear because of the need to rinse the nasal cavity every day. There are two items for evaluating the effect. One is the amount of mucus outflow during and after rinsing, the more the better; the second is subjective rinsing, nasal congestion, throat foreign body sensation and cough, and the improvement of these feelings. Both must be satisfied and at least acceptable to be effective, and the patient will continue to use it. However, depending on the severity of the condition, the symptoms will repeat again in one day, half a day or less, and the rinse must be repeated. If a patient uses the catheter of Figure 5 in the previous case and has penetrated the nasal cavity (at least 8~10cm or more) and still has no satisfactory flushing effect, it should be placed in the two target areas of the middle nasal passage and the upper nasal passage, or the water column. Insufficient strength to penetrate the nose. At this point, you should first seek the assistance of a physician, perform a computed tomography of the nasal cavity and sinuses, and do a computed tomography examination to help the daily flushing. It should be worthwhile.

如果此電腦斷層攝影檢查之結果如圖14所示,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。雖然沒有很多黏液或鼻屎MC造成阻塞,此圖顯示上鼻甲F、中鼻甲G,及下鼻甲H比正常人大,且上鼻通道F1、中鼻通道G1及下鼻通道H1比正常人狹窄,應該是堅硬的鼻屎黏附在鼻甲使其變大所造成的狹窄,又如果所使用的導管外徑大於狹窄處,則沖洗效果不佳可確認是未能進入目標區所致。因此必須檢視從前到後所有的冠狀剖面圖,量出其抵達路徑中最小的寬度,選用小於此寬度之導管本體61。由於探針8的設計使導管本體61具有良好的操控性。由圖14可見,從鼻前庭E經下臨中膈空間I3,再向外彎曲即可抵達中鼻通道G1,從鼻前庭E經下臨中膈空間I3及中臨中膈空間I2,再向外彎曲即可抵達上鼻通道F1,操作時將導管本體61緊貼鼻中膈沿著下 臨中膈空間I3向內向上並向後深入鼻腔約3~4cm,再向外彎曲並深入即可抵達中鼻通道G1(此狀態顯示於圖15);如果將導管本體61緊貼鼻中膈沿著下臨中膈空間I3及中臨中膈空間I2並向後深入鼻腔約5~6cm,再向外彎曲即可抵達上鼻通道F1目標區(此狀態顯示於圖16)。因為該導管本體61已直接抵達目標區,雖然此導管之流量較小,但已足夠清洗此非常狹窄之空間。 If the result of this computed tomography examination is shown in Fig. 14, the nasal cavity of the human body is divided into three slightly curved slit passages by three plate-like structures, and the three plate-like structures are the upper turbinate F and the middle turbinate G, respectively. And the inferior turbinate H, and the three pathways are the upper nasal channel F1, the middle nasal channel G1 and the lower nasal channel H1. Although there is not a lot of mucus or nasal sputum MC causing obstruction, this figure shows that the upper turbinate F, the middle turbinate G, and the inferior turbinate H are larger than normal, and the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage H1 are narrower than normal. It should be the narrowness caused by the hard nasal sinus sticking to the turbinates, and if the outer diameter of the catheter used is larger than the stenosis, the poor rinsing effect can be confirmed as failure to enter the target area. It is therefore necessary to examine all of the coronal sections from front to back, measuring the smallest width of the path of arrival, and selecting the catheter body 61 that is smaller than this width. Due to the design of the probe 8, the catheter body 61 has good handling. As can be seen from Fig. 14, from the nasal vestibule E to the middle space I3, and then outward bending to reach the middle nasal passage G1, from the nasal vestibule E to the middle of the space I3 and the middle of the middle space I2, then The outer nose channel F1 can be reached by bending outward, and the catheter body 61 is pressed close to the nose and down along the operation. Linzhong 膈 space I3 goes inward and backwards into the nasal cavity about 3~4cm, and then bends outward and goes deep to reach the middle nasal passage G1 (this state is shown in Figure 15); if the catheter body 61 is close to the nose Next to the middle space I3 and the middle space I2 and go back into the nasal cavity about 5~6cm, and then bend outward to reach the upper nasal channel F1 target area (this state is shown in Figure 16). Since the conduit body 61 has reached the target zone directly, although the flow of the conduit is small, it is sufficient to clean this very narrow space.

如果此電腦斷層攝影檢查之結果如圖17所示,由於黏液或鼻屎MC自狹窄的上鼻通道F1及中鼻通道G1向下堆積至下臨中膈空間I3,堆積之處空氣不流通,堆積處之下則為呼吸空氣進出之寬闊空間,因此其下緣反而成為接觸呼吸空氣之表層,易形成堅硬之鼻屎。有挖鼻屎經驗的人都知道,鼻屎之表層是堅硬的,但其內層常是尚含水份的黏液,所不同的是一般所挖到的鼻屎是位於鼻前庭E,但病人的鼻屎則是在手指無法觸及的狹窄鼻腔本體內。不但市售沖鼻器前後走向的水柱無法撼動此鼻屎,圖5之「鼻通道沖洗導管裝置」所產生上下左右30cm水柱也穿透力不足,此時可依病情嚴重程度,選用中壓導管或高壓導管放置於鼻屎下方的下臨中膈空間I3,利用強勁的水柱向上噴射,正如前述之噴射實驗,中、高壓水柱可以有更好的穿透力及清除效果,很快地改善鼻塞的症狀。 If the result of this computed tomography examination is shown in Fig. 17, the mucus or sinus MC is deposited from the narrow upper nasal passage F1 and the middle nasal passage G1 to the lower middle space I3, and the air at the accumulation is not circulated. Below the stack is a wide space for breathing air in and out, so the lower edge becomes the surface of the breathing air, which is easy to form a hard nose. Anyone who has experience in digging boo knows that the surface of the snot is hard, but the inner layer is often a mucus that is still hydrated. The difference is that the snot that is generally dug is located in the nasal vestibule E, but the patient The snot is in the narrow nasal cavity that the finger can't reach. Not only the water column in the forward and backward direction of the commercially available rattle can not shake the nose. The 30cm water column generated by the "nose channel irrigation catheter device" in Figure 5 also has insufficient penetrating power. At this time, the medium pressure catheter can be selected according to the severity of the disease. Or the high-pressure catheter is placed in the lower middle space I3 below the snot, and is sprayed upwards with a strong water column. As in the above-mentioned spray experiment, the medium and high-pressure water column can have better penetrating power and clearing effect, and quickly improve the nasal congestion. Symptoms.

參閱圖18,因為鼻咽J是寬闊的呼吸空氣必經之處,掉入鼻咽J的黏液因為空氣的乾化作用很快變成堅硬的鼻屎,市售沖鼻器單一方向之水柱,只能沖洗鼻咽J後壁,無法沖洗鼻咽J頂部及兩側,而且如加壓,其巨大水柱(直徑大多在1~2mm之間)必定伴隨大流量,容易產生嗆水的現象。前案導管之30cm水柱,雖可沖洗黏液,但對鼻屎穿透力不足效果不佳,在鼻咽J處難以發揮作用,這種情況下,依病情嚴重性,使用者可將中壓或高壓導管順著水平方向從下鼻通道H1、中鼻通道G1或臨中膈 空間I進入鼻咽J,再將導管往上翹可抵達該鼻咽J頂部,套上注射筒6可以噴出理想的水柱,清除鼻咽J上之黏液及鼻屎。 Referring to Figure 18, because the nasopharynx J is a must-have for the wide breathing air, the mucus that falls into the nasopharynx J quickly becomes a hard nasal sin due to the drying of the air, and the water column in the unidirectional direction of the commercially available ratchet is only It can wash the back wall of the nasopharynx J, can not wash the top and sides of the nasopharynx J, and if pressurized, its huge water column (mostly between 1~2mm in diameter) must be accompanied by a large flow rate, which is prone to waterlogging. The 30cm water column of the catheter of the previous case can wash the mucus, but the effect on the penetration of the sinus is not good, and it is difficult to play a role in the nasopharynx J. In this case, depending on the severity of the disease, the user can press the medium pressure or The high pressure catheter follows the horizontal direction from the lower nasal passage H1, the middle nasal passage G1 or the temporary middle Space I enters the nasopharynx J, and then the catheter is tilted up to reach the top of the nasopharynx J. The syringe 6 can be sprayed to spray the ideal water column to remove the mucus and nasal discharge on the nasopharynx J.

經由上述說明可知,使用者可選用具有探針8並適合其病情之導管6,因其具有良好的操控性,可以很容易將導管深入該上鼻通道F1、中鼻通道G1、下鼻通道H1及鼻咽J中,以效清除其中的黏液及鼻屎。 According to the above description, the user can select the catheter 6 having the probe 8 and suitable for the patient's condition. Because of its good handling, the catheter can be easily penetrated into the upper nasal passage F1, the middle nasal passage G1, and the lower nasal passage H1. And in the nasopharynx J, to remove the mucus and nasal discharge.

經由以上實施例之敘述,可知本發明鼻腔沖洗導管6確實具有以下功效增進之處: Through the description of the above embodiments, it can be seen that the nasal irrigation catheter 6 of the present invention does have the following enhancements:

一、藉由易於操控之微導管使直接沖洗狹窄的鼻通道成為可能。 1. It is possible to directly flush a narrow nasal passage by means of an easily controllable microcatheter.

二、藉由銜接器62的改進,在不加大管徑的條件下,獲得更為強勁的噴射水柱,增強間接沖洗的效果。 Second, by the improvement of the adapter 62, a more powerful jet water column can be obtained without increasing the diameter of the pipe, thereby enhancing the effect of indirect flushing.

三、以控制邊孔613總面積之方法設計水柱之強度,水柱越強清除效果越佳。 3. The strength of the water column is designed by controlling the total area of the side holes 613. The stronger the water column is, the better the cleaning effect is.

四、藉由導管之操控性可以控制導管本體61在鼻咽J的位置,並利用強勁的水柱清除鼻咽J上的黏液及鼻屎。 4. The position of the catheter body 61 at the nasopharynx J can be controlled by the manipulation of the catheter, and the mucus and nasal discharge on the nasopharynx J can be removed by a strong water column.

本發明鼻腔沖洗導管,可克服習知沖鼻器無法進行鼻腔深處沖洗之缺點,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,便利於使用者外出使用,故確實可以達成本發明之目的。 The nasal irrigation catheter of the invention can overcome the shortcomings that the conventional nasal device cannot perform deep nasal irrigation, can truly improve the symptoms of patients with chronic sinusitis, and reduce the discomfort during use, facilitating the user to go out, so it is true The object of the invention can be achieved.

惟以上所述者,僅為本發明之五個較佳實施例而已,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。 However, the above is only the five preferred embodiments of the present invention, and the scope of the invention is not limited thereto, that is, the simple equivalent changes made by the scope of the invention and the description of the invention are Modifications are still within the scope of the invention.

6‧‧‧鼻腔沖洗導管 6‧‧‧ nasal irrigation catheter

61‧‧‧導管本體 61‧‧‧ catheter body

611‧‧‧封閉端 611‧‧‧closed end

612‧‧‧開放端 612‧‧‧Open end

613‧‧‧邊孔 613‧‧‧ side hole

62‧‧‧銜接器 62‧‧‧Connector

7‧‧‧注射筒 7‧‧‧Syringe

8‧‧‧探針 8‧‧‧ probe

Claims (10)

一種鼻腔沖洗導管,可配合一注射筒灌注沖洗液以沖洗鼻腔及鼻咽:其特徵在於,該沖洗導管包含一導管本體及一套接在該導管本體外的銜接器,該導管本體是以矽膠及乳膠其中之一或其它柔軟且具彈性之材質製成,可供使用者自行操作置入鼻腔及鼻咽,該導管本體具有一封閉端及一相反於該封閉端之開放端,且靠近該封閉端處形成有複數邊孔。 A nasal irrigation catheter can be filled with a syringe to flush the nasal cavity and the nasopharynx: the irrigation catheter comprises a catheter body and a set of adapters connected to the outside of the catheter body, the catheter body is silicone And one of the latex or other soft and elastic material, which can be manually placed into the nasal cavity and the nasopharynx by the user. The catheter body has a closed end and an open end opposite to the closed end, and is adjacent to the A plurality of side holes are formed at the closed end. 依據申請專利範圍第1項所述之鼻腔沖洗導管,其中,該沖洗導管內更設置一支末端漸細的探針。 The nasal irrigation catheter of claim 1, wherein a further tapered probe is disposed in the irrigation catheter. 依據申請專利範圍第1項所述之鼻腔沖洗導管,其中,該沖洗導管內更設置複數支長度遞減的探針。 The nasal irrigation catheter of claim 1, wherein the irrigation catheter is further provided with a plurality of probes of decreasing length. 依據申請專利範圍第2或3項所述之鼻腔沖洗導管,其中,該導管本體之外徑不大於1.0mm,而其內設置外徑不大於0.1mm的探針。 The nasal irrigation catheter of claim 2, wherein the catheter body has an outer diameter of no more than 1.0 mm and a probe having an outer diameter of no more than 0.1 mm . 依據申請專利範圍第4項所述之鼻腔沖洗導管,其中,該導管本體之封閉端上更開設有一端孔。 The nasal irrigation catheter of claim 4, wherein the closed end of the catheter body is further provided with an end hole. 依據申請專利範圍第1~3項中任一項所述之鼻腔沖洗導管,其中,該導管本體上之複數邊孔的總面積介於3.367mm 2~4.123mm 2The nasal irrigation catheter of any one of claims 1 to 3, wherein the total area of the plurality of side holes on the catheter body is between 3.367 mm 2 and 4.123 mm 2 . 依據申請專利範圍第1~3項中任一項所述之鼻腔沖洗導管,其中,該導管本體上之複數邊孔的總面積介於2.381mm 2~3.367mm 2The nasal irrigation catheter of any one of claims 1 to 3, wherein the total area of the plurality of side holes on the catheter body is between 2.381 mm 2 and 3.367 mm 2 . 依據申請專利範圍第1~3項任一項所述之鼻腔沖洗導管,其中,該導管本體上之複數邊孔的總面積小於2.381mm 2The nasal irrigation catheter of any one of claims 1 to 3, wherein the total area of the plurality of side holes on the catheter body is less than 2.381 mm 2 . 依據申請專利範圍第7項所述之鼻腔沖洗導管,其中,該導管本體上之複數邊孔越接近封閉端,越呈密集分佈。 The nasal irrigation catheter of claim 7, wherein the closer the plurality of side holes on the catheter body are to the closed end, the denser the distribution. 依據申請專利範圍第8項所述之鼻腔沖洗導管,其中,該導管本體上之複數邊孔越接近封閉端,越呈密集分佈。 The nasal irrigation catheter of claim 8, wherein the closer the plurality of side holes on the catheter body are to the closed end, the denser the distribution.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018121459A1 (en) * 2016-12-26 2018-07-05 吴丽秋 Collapsible nasal-cavity spray catheter

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018121459A1 (en) * 2016-12-26 2018-07-05 吴丽秋 Collapsible nasal-cavity spray catheter
US11000450B2 (en) 2016-12-26 2021-05-11 Lih-Chiu Wu Collapsible nasal ejecting catheter

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