CN1684647A - 用于泪液系统的贯穿鼻腔的方法及导管 - Google Patents
用于泪液系统的贯穿鼻腔的方法及导管 Download PDFInfo
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Abstract
将一个用于治疗患者泪液系统的充胀体导管(130)贯穿患者的鼻腔,而不采用导丝或弯曲固定件。该导管(130)是一种不锈钢微管(136),具有足够的刚性及纵向强度,可使导管(130)经由一个小密闭创口从患者的鼻腔插入到泪囊内。该导管(130)有一个近侧杆(139)和一个远侧部(137),远侧部由一个弯头(138)来定位,其相对近侧杆(139)的定位角为70°至115°,最好为90°。远侧部(137)附近装有一个可充胀件(134)。该小密闭创口是利用器械(102,104)在中囊、泪窝及鼻腔侧壁上穿小孔而形成的。在鼻腔内插入导管(130)。接下来使远侧部(137)穿过该创口,并向导管(130)输入加压流体。
Description
技术领域
本发明涉及一种用于治疗泪液系统的方法及导管,具体说涉及一种用于治疗泪液系统的贯穿鼻腔的方法及用于该方法的充胀体导管。
背景技术
为了充分理解本发明,有必要探讨一下泪液系统的解剖学及生理学。泪腺的眼窝部分位于颞部眼窝处,用于产生泪膜的泪液层。泪管从泪腺的眼窝部分穿过相邻的睑泪腺,在上部终端处排空。上下眼睑内的小辅助泪腺也可产生泪液。泪液浸没眼睛的表面,然后排入到上下中部眼睑的泪孔及泪管内。泪液从泪管流入泪囊内,并沿鼻泪管进入鼻内。
鼻泪管可能因先天或后天获得而堵塞。如果鼻泪管堵塞,泪液便不再能从眼睛表面经由泪液系统排入鼻内。泪液会充满眼框,并从眼睑溢出到面部上。患者必须不停地用纸巾擦拭眼睛。此外,泪液滞留在泪囊内后,便会滋生细菌,在许多情况下泪囊会受到感染(泪囊炎)。泪囊炎会使泪囊肿胀发红,产生疼痛。脓液会从泪囊内渗出并不断地遮盖住眼睛。此时抗菌素对泪囊炎无效,必须做外科手术。目前,除了抗菌素可暂时控制感染之外,尚无医疗手段能治疗获得性鼻泪管堵塞。
但通过外科手术可改善这一状况。泪囊鼻腔造瘘术(DCR)是一种可解决鼻泪管堵塞的外科手术。在DCR中,在泪囊与鼻子之间切开一个新创口(孔洞)。这样可使泪液从泪囊通过DCR孔洞流入鼻内。外切或内切式DCR需要在鼻子侧面切入。在一种开放式DCR中,外科医生在鼻骨及鼻粘膜上切开一个直径超过17mm的大创口。这种方法有严重的致病性,恢复期较长,可能留下疤痕并造成出血。与之相反,内窥镜DCR则具有极小的致病性,它无需内切,而且可迅速恢复。可采用充胀体导管、激光或传统的外科器械来实施内窥镜DCR。激光内窥镜DCR需要昂贵耗时的激光,而且成功率较低。采用传统外科器械的内窥镜DCR对眼睛及周围组织有危险性,因为要从泪囊及鼻腔侧壁取出细胞组织,而器械则在鼻腔内朝向眼睛及眼窝运动。出血及肿胀可能使相关组织的分辨变得困难。
人们已经发现,充胀体导管DCR与激光或采用传统外科器械的内窥镜DCR相比,是一种更安全更廉价形式的DCR。在固定充胀体导管时,使它从泪囊延伸,穿过孔洞并伸入到鼻内。由于通过充胀来产生充胀体DCR孔洞,而不是借助于内切或激光能量,因而对周围眼球及眼窝组织没有危险,而且细胞组织创伤较小。
如美国专利No.5,021,043及5,169,043所示,本人在这之前曾与人合作发明了用于泪液系统的充胀体导管。这些充胀体导管经由小直径(大约0.5mm)的细微泪孔及泪管从眼睛插入泪囊内,并通过预定的孔洞延伸到鼻内。充胀体导管的空心外形直径必须非常小,以便能从小直径的细微泪管内穿过而不伤害它。通过限定该空心小直径,可将充胀体的空心直径限制到5mm。然而5mm直径的孔洞大大小于外部DCR的17mm直径孔洞,从而可提高充胀体DCR孔洞的术后收缩率。大直径充胀体可产生大直径孔洞,可提高手术成功率。
这样便引出了5,021,043专利第7栏29行和图4以及5,169,386专利第8栏34行和图4中披露的概念,其中,在需要采用大直径充胀体时,使充胀导管贯穿鼻腔。然而如这些专利所示,充胀导管经由一个导丝来插入。尽管该技术是有用的,但它涉及多个耗时步骤,包括在泪液系统内插入导丝,然后经由导丝来分别推动充胀体导管。该技术需要设置导丝,穿过泪管进入鼻内。医生将止血器或其它器械伸入鼻内,箝住导丝并将其从外鼻孔拉出。接着使柔性充胀体导管通过导丝穿过鼻子,并经由鼻腔侧壁进入泪囊,或者穿过鼻泪管进入泪囊。但是该方法存在以下问题。首先,在鼻内可能难以确定导丝的位置并将其箝住,即使只发生轻微的出血。导丝可能向后穿入咽喉(咽部),而不是处于外鼻孔方向。通常难以将充胀体从鼻腔拉入泪囊,而且将充胀体及导丝拉入泪囊需要较大的力量。在拉动导丝时,会使它在细微泪管内滑动,这可能导致术后二次纤维变性从而造成泪管堵塞。
5,169,386专利还披露了另一种充胀导管,它不采用导丝,但也没有贯穿鼻腔插入该导管的建议。该导管的纵向强度及侧向抗弯结构均类似于标准眼科探针,具有足够的柔性,能适应泪液系统的外形轮廓。该导管出厂时为直线状,但该导管可在0°-30°之间弯曲,以适应眼科探针的弯曲形状。在导管内插入一个弯曲固定件,以保持导管远侧端的弯曲形状,并增加纵向刚性和挠曲刚性,从而增强它在泪液系统收缩部内的受力性。该导管采用不锈钢微管,其外径为0.022英寸,内径为0.017英寸。
该导管不适于贯穿鼻腔插入。该管没有足够的刚性及纵向强度来使空心充胀体导管从鼻腔经由鼻腔侧壁及泪窝内的一个小密闭创口进入到泪囊。此外,弯曲形远侧部不具有可随时插入创口的角度。
发明内容
本发明的充胀体导管可贯穿鼻腔,进入指定的DCR孔洞区。该导管具有较大的空心轮廓,因而空心直径大于通过细微泪管来导入的充胀体导管。本发明的充胀体导管无需采用导丝,因而不会发生导丝破坏细微泪管的现象。较大直径的充胀体DCR孔洞在手术后不可能变窄,因而可提高手术成功率。
本发明的充胀体导管有一个不锈钢微管,具有足够的刚性及纵向强度,可使空心充胀体导管经由一个在鼻腔侧壁及泪窝内形成的预制小密闭创口从鼻腔插入泪囊内。微管的远侧端部有一个圆形弯头,其使远侧部相对长近侧部或杆的定位角为70°至115°,最好为90°。外科医生利用该弯头,可转动或移动长近侧导管杆的位置,使远侧充胀体导管部分定位,从而以适于各患者的各种角度从鼻腔进入到泪囊。由于微管具有刚性及强度,因而既不需要导丝,也不需要弯曲保持件。
充胀体导管的远侧部从弯头外侧至导管末端的长度为14mm,该长度对于在鼻腔内转动是足够短的,而对于具有足够长度和直径的导管与微管相接从而使充胀体DCR孔洞充胀又是足够长的。
导管由可充胀材料制成,其第一颈部由粘接剂粘接到微管的远侧部的极远侧部,其第二颈部由粘接剂粘接到近侧杆的远侧端、弯头及远侧部的近侧端上。这样所采用的充胀体工作部分可延长,这是因为充胀体的粘接区包括弯头和微管近侧长部分的相邻部分。导管的近侧端有一个带有翼部或膨胀块的凸耳锁块,从而可使导管通过充胀装置与管路相接。医生利用翼部或膨胀块,可更容易地握持、操控及推动充胀体导管。
根据本发明的方法,在泪囊与鼻腔之间形成一个很大的孔洞,贯穿鼻腔插入一个极大的充胀体。该充胀体是空心的,以便于将具有足够刚性的导管穿入在鼻腔至鼻腔侧壁及泪窝内形成的预制创口,并进入泪囊内。接下来使充胀体充胀,以扩大创口,并产生很大的孔洞。不用导丝便可插入充胀体导管。
弯头之后的远侧端部分很短,以使导管能在鼻腔内定位,从而使远侧端达到预制创口的高度。然后根据各患者的解剖需要转动或移动导管,以使远侧端与预制创口对齐。将远侧端推入预制创口内,并达到空心充胀体在创口内的位置。接下来使充胀体充胀,使创口扩大到已充胀的充胀体的外径大小,这样便形成了极大的孔洞。
由于本插入方法需要贯穿鼻腔来插入充胀体导管,因而可避免因插入到细微泪管内而引起的创伤。本发明的导管及方法可提供一种令人满意的内窥镜DCR,从而可避免由外部(切入)DCR所带来的创伤。本发明的导管及方法可产生较高的外科手术成功率。
附图说明
图1是本发明的泪液充胀体导管优先实施方式的示意图。
图1a是图1的充胀体导管远侧部末端的放大示意图。
图2是本发明方法的一个步骤的示意图,表示患者的鼻泪管受堵,金属探针已穿过泪孔、泪管、泪囊及泪窝和鼻腔侧壁上的多个点并进入到鼻腔。
图3是表示本发明方法的另一个步骤的示意图,其中,神经挂钩联接鼻腔,被推入到鼻腔侧壁及泪窝上的小创口内并移动,从而将这些小创口联成一个大创口。
图4是表示本发明方法的又一个步骤的示意图,其中,本发明的空心充胀体导管已插入到鼻腔内,而且被推入到鼻腔侧壁及泪窝的小创口内,并进入到泪囊内。
图5是表示本发明方法的一个步骤的示意图,其中,充胀体已充胀的充胀体导管处于孔洞及泪囊内。
图6是本发明充胀体导管另一个实施方式中远侧部末端的放大示意图。
图7是表示本发明方法中另一个实施方式的方法步骤的示意图。
详细说明
如图1及图1a所示,本发明的充胀体导管130由管子136来组成,该管最好是一种不锈钢硬回火微管,配有一个半径为0.13英寸的圆形弯头138,从而使远侧部137相对近侧部139的定位角为70°至115°,最好为90°。从远侧部137的远侧端184至微管136的近侧部139的外壁的距离为4mm至30mm,最好为14mm,如图1所示。微管136的远侧端184是闭合的,而近侧端142是开启的。然而管136的内腔可在远侧部137内相距远侧端184为10mm之处闭合,使远侧端184保持开启,从而与探针嵌合,如图6及图7所示。微管136的近侧端142插入到一个模具内,以形成凸耳144。向模具内注入加热了的塑料,形成与近侧端142相接的凸耳144。凸耳144的内径与微管136的外径相匹配。凸耳144带有翼部143或其它增大部或膨胀块,以使医生能更好地握持和操控充胀体导管130。从近侧端142至远侧端184来测量,导管130的长度为4英寸至10英寸,最好为6英寸,如图1所示。管子136的壁厚应能保证足够的刚度及纵向强度,从而使空心导管的远侧部137能从患者鼻腔侧壁上的预制小封闭创口中穿过。在某些场合下,这可能需要足够的压力。人们已发现,壁厚至少为0.035英寸的管是令人满意的。管子外径最好为0.083英寸,内径为0.039英寸,壁厚为0.044英寸。
导管130在远侧部137上有一个开孔140,通过在管子136内临时插入一个可废弃的金属丝来形成。在将微管136插入到凸耳144内之前进行该操作。在管136内切出一个贯通槽沟,其相距远侧端184的距离大约为2mm至14mm,最好为4mm,从而形成开孔140。槽沟深度约为管136直径的三分之一。用磨轮除去毛边,取出可废弃的金属丝并废弃。
导管130具有足够的纵向强度及耐侧向弯曲力(刚性),使空心导管可从在鼻腔侧壁及泪窝中最初预制的创口中穿过,并进入泪囊内。在某些场合下,这可能需要足够的压力。
充胀体134最好由聚对苯二甲酸乙酯来形成,其长度约为4mm至30mm,最好为14mm,工作空心直径为2mm至14mm,最好为9mm,其用于泪液系统。充胀体有一个远侧颈部170、一个远侧锥面区172、一个中心区174、一个近侧锥面区176以及一个近侧颈部178。在安装过程中,用异丙醇来清洗管子136,然后涂上底剂“Loctite 770”。充胀体被置于管136的远侧端之上,使远侧颈部170的远侧端与管136的远侧端184对齐。采用诸如氰基丙烯酸酯之类的粘合剂。可向Loctite公司购买“Loctite 4081”这种可用的粘合剂。将粘合剂涂到远侧颈部170的远侧端以及近侧颈部178的近侧端,分别形成粘合层180及182。利用一个直径约为0.010英寸至0.014英寸的金属丝小芯线将粘合剂涂到充胀体颈部170、178上。粘合剂在毛细作用下渗入颈部内。近侧颈部178及近侧锥面区176可被粘接到管136的远侧部137上,或者也可越过弯头138,延伸到管136的近侧部139的远侧端部。近侧颈部178延伸到弯头138及近侧部139后,可以使更大长度的工作直径即中心区174处于管136的远侧部137上。
图2表示本发明方法的第一步骤。将Bowman探针102穿过患者眼睛的上泪孔4、上泪管6、综合泪管8及泪囊10,然后穿过中囊壁11、泪窝骨12以及鼻腔侧壁44进入鼻腔38内。将探针102拉回到泪囊10内,然后穿过中囊壁11、泪窝骨12以及鼻腔侧壁44的四或五个区域,进入鼻腔38。将中囊壁11、泪窝12以及鼻腔侧壁44中的多个创口18联接成一个预制创口19(图4),其方法是:如图3所示,边摇摆边移动探针102,或者使神经挂钩104进入鼻腔38内,并将其推入创口18内,然后拖动神经挂钩104并横穿多个创口。
参见图4,使贯穿鼻腔的空心泪液充胀体导管130进入鼻腔38内,并将远侧部137推入通过联接鼻腔侧壁44、泪窝12及泪囊10的中壁11内的小创口18而形成的预制创口19内,从而使充胀体导管130的远侧部137的远侧端184延长至泪囊10内。
充胀体导管130的近侧端142上的凸耳固定块144与提供压力流体的充胀装置的管112远侧端110相连接。如图5所示,充胀体134被充胀至9巴压力,并持续20秒,以扩展创口19,从而形成孔洞120,然后被泄放。远侧部137的位置被重新微调,以保证充分的充胀,然后再次充胀至9巴压力并持续20秒。接下来,充胀体134被泄放并从鼻腔38抽出,留下一个在泪囊10与鼻腔38之间形成的大孔洞120。
图6表示本发明充胀体导管的另一种实施方式。在该实施方式中,导管230有一个远侧部237,其与导管130及区段137相同,如图1所示,不同点是管子136是封闭的。如上所述,图1中的远侧部137在其远侧端184处封闭,在图6的实施方式中,管子236及远侧部237由处于槽沟140与远侧端284之间的封闭壁286来封闭。由于远侧部237在槽沟140之后封闭,因而当压力空气施加到管子236上时,流体仍然流经槽沟140,以使充胀体134充胀。但此时在封闭壁286与远侧端284之间应有一个开口端管子288。
如图7所示,如果探针202的外径稍微小于管子288的内径,该开口端管子288便可用来容纳探针202的一端。与开口端管子288相嵌合的该探针可用于将远侧端284移动到一个合适的位置上,从而如上所述,与通过使充胀体134充胀而扩大的创口19相嵌合。
上述的本发明介绍只用于说明目的,业内人士可知,在不脱离发明精神及范围的前提下,可进行其它的修改及实施等,对此应予以理解。
Claims (23)
1、一种充胀体导管,用于使分隔患者的泪囊与患者的鼻腔的侧壁上的预制小密闭鼻腔创口充胀,包括:
一个导管体,其有一个近侧端、一个近侧部、一个远侧端和一个远侧部;
一个可充胀件,处于所述远侧部的周围,所述远侧部有一个槽沟;
所述导管体在靠近所述远侧端即所述槽沟之处封闭;
提供装置,其向所述导管体的所述近侧端提供压力流体,所述压力流体流经所述槽沟,以使所述可充胀件充胀,从而使所述预制创口充胀;以及
所述导管体由微管形成,其具有足够的刚度及纵向强度,从而当所述可充胀件被泄放时,使所述导管能从所述鼻腔穿过所述鼻腔侧壁的所述预制创口,并进入所述泪囊内。
2、如权利要求1所述的充胀体导管,其特征在于,所述导管体由不锈钢形成,其壁厚至少为0.035英寸。
3、如权利要求2所述的充胀体导管,其特征在于,所述导管体的外径为0.083英寸,内径为0.039英寸,壁厚为0.044英寸。
4、如权利要求1所述的充胀体导管,其特征在于,所述远侧部有一个圆形弯头,其使所述远侧部相对所述近侧部成为70°至115°角。
5、如权利要求4所述的充胀体导管,其特征在于,所述远侧部相对所述近侧部成90°角。
6、如权利要求1所述的充胀体导管,其特征在于,所述导管体在所述远侧端封闭。
7、如权利要求1所述的充胀体导管,其特征在于,所述导管体在与所述远侧端相隔以及所述槽沟与所述远侧端之间的部位被封闭,在此提供所述远侧部的开放端远侧部,所述开放端远侧部可与探针的一端相嵌合,以帮助引导所述导管体。
8、一种充胀体导管,用于使分隔患者的泪囊与患者的鼻腔的鼻腔侧壁上的预制创口充胀,包括:
一个导管体,其有一个近侧端、一个近侧部、一个远侧端和一个远侧部;
一个可充胀件,处于所述远侧部的周围,所述远侧部有一个槽沟;
所述导管体在靠近所述远侧端即所述槽沟之处被封闭;
提供装置,其向所述导管体的所述近侧端提供压力流体,所述压力流体流经所述槽沟,以使所述可充胀件充胀,从而使所述预制创口充胀;以及
所述远侧部有一个圆形弯头,其使所述远侧部相对所述近侧部成70°至115°角。
9、如权利要求8所述的充胀体导管,其特征在于,所述远侧部相对所述近侧部成90°角。
10、如权利要求8所述的充胀体导管,其特征在于,所述可充胀件包括一个远侧颈部、一个中心区以及一个近侧颈部,所述近侧颈部与所述远侧部的近侧端及所述弯头相粘接,所述远侧颈部同所述槽沟与所述远侧端之间的所述远侧部相粘接,从而使更长的所述中心区处于所述远侧部之上。
11、如权利要求8所述的充胀体导管,其特征在于,所述可充胀件包括一个远侧颈部、一个中心区以及一个近侧颈部,所述近侧颈部与所述远侧部的近侧端、所述近侧部的远侧端以及所述弯头相粘接,所述远侧颈部同所述槽沟与所述远侧端之间的所述远侧部相粘接,从而使更长的所述中心区处于所述远侧部之上。
12、一种在分隔患者的泪囊与鼻腔的鼻腔侧壁上形成较大创口的方法,包括:
提供一种充胀体导管,其具有导管体,由一个近侧部、一个弯头以及一个相对所述近侧部成70°至115°角的远侧部来形成;一个可充胀件,安装于所述远侧部的周围,一个槽沟在所述可充胀件中从所述远侧部的侧壁穿过;所述导管体在远离所述槽沟之处被封闭;以及提供装置,其向所述导管体的近侧端提供压力流体,以使所述可充胀件充胀;
利用一个或多个外科器械,形成一个小密闭预制创口,穿过患者的中囊壁、泪窝及所述鼻腔侧壁,所述创口的尺寸为在所述可充胀件被泄放的情况下,可紧凑地容纳所述远侧部;
在所述可充胀件被泄放的情况下,将所述导管体的所述远侧部推入所述预制创口内;以及
将所述压力流体输入到所述导管体的所述近侧端及所述槽沟内,以使所述可充胀体及所述预制创口充胀。
13、如权利要求12所述的方法,其特征在于,还包括:使所述可充胀体泄放,重新微调所述远侧部的位置,使所述可充胀件重新充胀,以保证所述预制创口的充分充胀。
14、如权利要求12所述的方法,其特征在于,所述可充胀件被充胀至9巴压力,并持续20秒。
15、如权利要求12所述的方法,其特征在于,形成所述预制创口的所述步骤包括:将一个Bowman探针穿过患者的上泪孔、上泪管、综合泪管及泪囊,然后使所述探针穿过患者的中囊壁、泪窝骨以及鼻腔侧壁,进入患者的鼻腔内,以形成一个小创口。
16、如权利要求15所述的方法,其特征在于,还包括重复所述探针的推入动作,从而在所述的中囊壁、泪窝骨以及鼻腔侧壁内形成若干个小创口,并进入所述鼻腔内。
17、如权利要求16所述的方法,其特征在于,还包括通过在所述若干个创口内边摆动边移动所述探针,来联接所述的若干个小创口,从而形成所述预制创口。
18、如权利要求16所述的方法,其特征在于,还包括通过使一个神经挂钩穿过所述若干个小创口,来联接所述的若干个小创口,从而形成所述预制创口。
19、如权利要求12所述的方法,其特征在于,所述导管体由具有足够的刚度及纵向强度的微管来形成,从而在所述可充胀件被泄放时,使所述远侧部能被推入所述预制创口内。
20、如权利要求12所述的方法,其特征在于,所述近侧部被引入患者的鼻腔,直至所述远侧部移动到与所述预制创口相邻的位置为止,转动所述近侧部,以使所述远侧部与所述预制创口对齐,从而便于所述远侧部进入到所述预制创口内。
21、如权利要求12所述的方法,其特征在于,所述导管体在接近所述导管体的远侧端处闭合,从而提供所述远侧部的一个开口部,所述方法还包括在所述开口部插入一个探针,以便于所述远侧部移动到所希望的位置。
22、一种在分隔患者的泪囊与鼻腔的鼻腔侧壁上形成较大创口的方法,包括:
提供一种充胀体导管,其具有由一个近侧部和一个远侧部形成的导管体;一个可充胀件,安装于所述远侧部的周围,一个槽沟在所述可充胀件中从所述远侧部的侧壁穿过;所述导管体在远离所述槽沟之处被封闭;以及提供装置,其向所述导管体的近侧端提供压力流体,以使所述可充胀件充胀,所述导管体由具有足够的刚度及纵向强度的微管来形成,从而在所述可充胀件被泄放时,使所述导管能从所述鼻腔穿过一个小密闭预制创口,进入所述泪囊内;
利用一个或多个外科器械,在所述鼻腔侧壁内形成一个预制创口,所述创口的尺寸为在所述可充胀件被泄放的情况下,可紧凑地容纳所述远侧部;
在所述可充胀件被泄放的情况下,将所述导管体的所述远侧部推入所述预制创口内;以及
将所述压力流体输入到所述导管体的所述近侧端及所述槽沟内,以使所述可充胀体及所述预制创口充胀。
23、如权利要求22所述的方法,其特征在于,还包括使所述可充胀件泄放,重新微调所述远侧部的位置,并重新充胀所述可充胀件,以保证所述预制创口的充分充胀。
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CN106073989A (zh) * | 2010-10-08 | 2016-11-09 | 西诺普西斯外科股份有限公司 | 与治疗鼻窦有关的植入装置、工具和方法 |
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CN110051468A (zh) * | 2019-03-08 | 2019-07-26 | 苏州莱诺医疗器械有限公司 | 一种鼻泪管球囊扩张导管 |
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EP1545647A4 (en) | 2008-04-30 |
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EP1545647B1 (en) | 2012-05-23 |
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US20130131713A1 (en) | 2013-05-23 |
JP2006515997A (ja) | 2006-06-15 |
MXPA05003261A (es) | 2005-10-18 |
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