CN108348229A - 牵开器 - Google Patents

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CN108348229A
CN108348229A CN201680012705.2A CN201680012705A CN108348229A CN 108348229 A CN108348229 A CN 108348229A CN 201680012705 A CN201680012705 A CN 201680012705A CN 108348229 A CN108348229 A CN 108348229A
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retractor
light source
discharge flue
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拉尔夫·斯威夫特·杰弗里
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Onetrak surgery Co.,Ltd.
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OBP Medical Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00561Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00902Material properties transparent or translucent
    • A61B2017/00915Material properties transparent or translucent for radioactive radiation
    • A61B2017/0092Material properties transparent or translucent for radioactive radiation for X-rays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/309Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using white LEDs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/007Aspiration
    • A61B2218/008Aspiration for smoke evacuation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

一个实施例方面包括照明手术牵开器,包括具有顶面及底面、近端及远端的刀部,刀部包括设置于远端的操作部、设置于近端的鞍部及连接操作部与鞍部的桶部;手持部与鞍部相连;照明组合件包括至少一个光源、至少一块电池及用于给光源通电的激活装置,照明装置与牵开器永久地连接。其他方面在说明书和权利要求书中是显而易见的。

Description

牵开器
相关申请的交叉参考
本申请要求于2015年6月3日提出申请,名称为“手术器械”的美国临时专利申请号为62/170,280的优先权,以及于2015年11月23日提出申请,名称为“牵开器”的美国临时专利申请号62/258,806的优先权。在此将这些申请的全部内容合并加以参考。
发明内容
在此描述的实施方式涉及手术器械,尤其涉及一种牵开器,可提供集成光源和圆刀,形成用于医生视野的无阻挡的照明观察槽。
干扰医生视野的光源或者未能合适地照亮视野的光源会阻碍医生看清楚关键部位。例如,当进行解剖时,潜在血源可能将血液排入解剖腔,若没合适的处理,这些血源会引起术后感染。当用胸部牵开器进行隆胸或者造胸手术时,这种关注是相关的。
传统的胸部牵开器由于在视野上缺少合适的照明可能导致血液排入解剖腔。
目前,胸部牵开器需要大量辅助照明,这种照明昂贵且难以组装,每次使用后需要清理和再处理,并且由于缺乏定制的胸部牵开器,因此无法在期望的位置上提供充足的光线。换言之,在患者进行手术前,医生必须组装和紧固独立光源到胸部牵开器上。这些辅助光源不能为医生提供将光线聚集在手术区域的特定部位的能力,并且不能在不干扰医生视野的前提下照亮手术区域的特定部位。
进一步地,附接在牵开器上的辅助光源需要昂贵的准备与构件,为了确保患者不发生交叉感染,必须在每位患者术后进行再处理。若未进行充分地再处理,则会发生一个患者至另一个患者的交叉感染。另外,即使对光源进行了再处理,也不能保证达到100%的有效再处理,许多医院报道患者的交叉感染是由于再处理的不充分或者错误造成的。
因此,由此可见,需要一种牵开器,可提供集成光源和圆刀,形成用于医生视野的无阻挡的照明观察槽。
一个示例性方面包括照明手术牵开器,其包括:具有顶面和底面的刀部;从刀部近端以一角度延伸的手持部;连接手持部及刀部的弯折部;和照明组合件,其包括至少一个光源、至少一块电池及用于给光源通电的激活装置,并且照明组合件永久地连接牵开器;其中刀部、手持部及弯折部由玻璃纤维增强聚合物模塑成型。
一个示例性方面包括照明手术牵开器,其包括:具有顶面和底面的刀部;从刀部近端以一角度延伸的手持部;连接手持部及刀部的弯折部;和照明组合件,其包括至少一个光源、至少一块电池及用于给光源通电的激活装置,并且照明件永久地连接牵开器;其中刀部、手持部及弯折部由低导电性聚合物模塑成型。
一个示例性方面包括照明手术牵开器,其包括:具有顶面和底面的刀部;从刀部近端以一角度延伸的手持部;连接手持部及刀部的弯折部;和照明组合件,其包括至少一个光源、至少一块电池及用于给光源通电的激活装置,并且照明组合件永久地连接弯折部;其中刀部、手持部及弯折部由射线透射性的聚合物模塑成型。
在多种实施方式中:(1)聚合物是50%的玻璃纤维增强聚合物;(2)聚合物是聚芳酰胺化合物;(3)聚合物是热塑性结晶聚合物;(4)聚合物是芳族二胺和芳族二羧酸酐的热塑性结晶聚合物;(5)聚合物是玻璃纤维增强聚芳酰胺;(6)聚合物是至少50%的玻璃纤维增强;(7)聚合物的弯曲模量至少为17Gpa;(8)聚合物的弯曲强度至少为375Mpa;(9)聚合物的冲击强度至少为100J/M;(10)照明组合件永久地连接弯折部;和/或(11)聚合物的导电率小于10-6A。
本领域的技术人员在查看此处所提供的所附附图及详细的说明书之后,进一步的特征及优点对于他们来说是显而易见的。
附图的简单说明
图1为实施例的侧视图;
图2为实施例的二维图;
图3为实施例的爆炸图;
图4为实施例的透视图;
图5为实施例的后视图;
图6为清楚起见,移除照明组合件的实施例的透视图;
图7为实施例的主视图;
图8为实施例的俯视图;
图9为实施例的仰视图;
图10为实施例的俯视图;
图11为实施例的主呈角度视图;
图12为实施例的后视图;
图13为实施例的侧透视图;
图14为实施例的俯透视图;
图15为实施例的倒置视图;
图16为实施例的侧透视图;
图17为实施例的后透视图;
图18为实施例的俯透视图;
图19为实施例的侧视图;
图20为实施例的侧视图;
图21为实施例的侧视图;
图22为实施例的另一视图;
图23为显示实施例的射线透射性的荧光透视图像;及
图24显示了多种塑料的弯曲强度及弯曲模量。
选择实施例的详细说明
以下对一些特定实施例进行详细说明。未以限制意义进行本说明,而是仅仅为了示例本牵开器的基本原理的目的进行本说明。
宽泛地讲,一个或更多实施例提供手术牵开器,其包括集成光源及圆刀,形成用于医生视野的无阻挡的照明观察槽。具有集成光源的手术牵开器防止由外部光源所引起的问题,即在操作腔内产生投射阴影。为解决此问题,手术牵开器的集成光源指向与牵开器远端相同的方向,这使光线被导向进行切割的相同的点。
手术牵开器可提供基本垂直连接于刀部的手持部,刀部可形成弓形(弯曲)形状的桶部,该桶部限定观察槽。其中刀部连接鞍部与操作部,设计操作部的尺寸适用于手术。鞍部与手持部连接,同时形成接收光源的凹腔,设置光源与凹腔,并设计它们的尺寸,以及适合使从光源发出的光束被向下导向至观察槽。
现在参考图1至图22,一个或更多实施例可以包括集成有照明组合件205的手术牵开器100,手术牵开器100可包括通常垂直地连接于刀部120的手持部110。手持部110可与刀部120在鞍部210处连接,刀部120可从近端130延伸至远端140,其中近端130与手持部110在鞍部210处连接。
刀部120可由任何足够弹性的可模压材料制成,包括但不限于聚苯乙烯、聚碳酸酯、玻璃填充尼龙等等,尽管如此所述,但优选玻璃增强聚芳酰胺,因为它具有超高强度、射线透射性及低导电率。
刀部120可形成鞍部210、桶部215及操作部220。
刀部120可从近端130延伸至远端140,其中桶部215连接鞍部210与操作部220。
桶部215可沿其长度方向形成弓形使弓形的槽向上定向,定义为“观察槽”,如附图所示。
鞍部210以类似碗状结构形成。鞍部210可形成凹腔605用于接收照明组件205。可以提供弹簧或其它紧固件(未示出),以将照明组合件205固定于凹腔605内。
照明组合件205可包括串联在一起的光源305、开关310及电源315,电源315可包括电池,例如按钮类型的电池,适用于仅储存单次使用的充足能量。可选地,电池可是多次使用的可重复使用或者可充电的电池。光源305可被外罩320罩住,光源可包括LED、OLED、白炽灯或者其他适合发出光束的光源。开关310可是由绝缘材料制成的光片,例如Mylar带,适用于断路电源315和光源305的串联电路,因此移除开关310会导致电源315激活光源305。在一些实施方式中,开关310可使用任何激活电源/给电源305供电的现有方式,例如,但不限于,按钮开关、拨动开关、磁簧开关或者滑动开关。
可以设计凹腔605与光源305的尺寸,适于使光束沿观察槽被导向,朝向刀部120的远端140。如图2和图6所示,示例了光源305被置于鞍部210内并被向下导向至桶部215的观察槽。如图所示,外罩320设于观察槽的下方,因此在最终使用者的视野之外。
为了不阻碍上述视野,操作部220可以向下呈角度的远离观察槽。操作部220可大体上是平的和/或大体上呈正方形或长方形,相对桶部215设有远端,该远尖端带许多凸脊710,设计远尖端和凸脊710的尺寸适用于将胸部凹腔的组织从解剖区域中抓起,有助于最终使用者进行解剖操作。为了抓住胸部组织,凸脊710可设置任何合适的宽度和尺寸。
使用牵开器的方法可以包括以下步骤:可以提供一种以上公开的手术牵开器100。使用者在进行手术之前将手术牵开器100从无菌包装袋中取出。使用者可以移除开关310给光源305通电。使用者然后可以在患者身上做一个切口,用手术牵开器100通过此切口创建口袋,口袋用于隆胸、造胸或者其他与胸部相关的手术。当手术结束时,牵开器100可以被丢弃,因为光源305可以被设计为不可替换,并且电源提供的光源只够用于单次使用,因此在一次使用之后,允许对本实施方式进行处理。
在一些实施方式中,手术牵开器100可适用于形成适于其它操作的牵开器,例如鼻牵开器、脊柱牵开器、矫形牵开器及用于其它手术的牵开器。所有这些牵开器与本实施方式中涉及组装、照明及单次使用保持完全一致。
在一些实施方式中,牵开器可用于由机器人操作的医疗操作。这种机器人也需要照明牵开器使手术区域可视化,机器人操作也受益于增强的视野,及消除患者交叉感染风险的单次使用构件。实施方式将包括用于连接医疗机器人的合适的连接特征。
图10至图22描述的实施方式包括设有光源1020的牵开器100,光源1020位于朝向或临近桶部215的远端140。应当注意,在此讨论的参考这些实施方式的一些或所有特征可能用于结合或代替先前公开的实施方式中的一些或所有特征。
现在参照图10至图20,牵开器100可包括设置于更接近操作部220位置的光源1020。光源1020可设置于朝向桶部215的远端,光源1020可设置于远端140附近任一点,包括在桶部215和操作部220内。
光源1020可包括宽散射角,例如100度角,或者其任何适合变化的角。通过使用宽散射LED,可获得宽散射角。由于产生宽散射角及其位置朝向刀部的远端140,使用光源1020可为设置于操作部220前方的整个操作区域提供光线。
如图10所示,光源1020可与照明组合件205的一些或者全部特征相关联,包括光源305、开关310及电源315。
进一步地,在此实施方式中,操作部220可包括一体的凸脊710,如图13所示,在使用牵开器100时其用于抓住组织。
设有通道外壳1010的排烟通道1105设置于桶部215内部,可从一端延伸直至操作部220。在一些实施方式中,排烟通道1105及外壳1010可在操作部220的一端延伸到操作部220的一部分中。通道1105可以是定义为桶部215的空腔。
在第二端,排烟通道外壳1010可以被锚定于鞍部210,然后排烟通道1105可延伸至位于手持部110内的中空空间,这样,手持部110可以包括中空空间,用于接收排烟通道1105及外壳1010。
如图所示,排烟通道外壳1010可以在特定点呈一角度,排烟通道1105也可包括光源1020。光源1020还可以包括光源架1115。
设置联结外壳1010的通道1105是为了使空气与烟雾通过外壳1010与桶部215之间的缝隙进入通道1105,从而导引烟雾远离医生的视野,缝隙可设置于光源1020的两边。
如图14所示,排烟通道1105及外壳1010可以从牵开器100的远端140、临近操作部220朝向手持部110延伸。
通道1105引导在其入口处接收的空气及烟雾朝向手持部110,入口设置于刀部120的远端。因此,通道1105作为空气导管,移动空气/烟雾远离切口部位和/或医生的视野。
真空源可以附接于牵开器100,真空源可与手持部110的任何部位连接,包括手持部110的底部、鞍部的远端。可选地,真空源可附接于手持部110的任何适当的位置,或者可在鞍部210位置直接附接于外壳1010。
手持部110可以为中空的且作为空气管道,烟雾或者空气可以在手持部110入口处离开通道1105,手持部可以包括与通道1105相通的中空室,手持部110可以包括一部分通道1105,其与外壳1010的其余部分是一体的。可选地,手持部110可以包括与通道1105相通的第二外壳,并且可以接收来自通道1105的烟雾/空气。真空源可以附接于手持部110的底部。
可操作真空源以提供吸力,通过通道1105,移动空气/烟雾远离切口部位或医生的视野。空气/烟雾在开口处进入通道1105,朝向鞍部210穿过通道1105,进入手持部110,该开口由位于刀尖附近的外壳1010与桶部215之间的缝隙产生。真空源将空气/烟雾从手持部吸出。
如图15所示的牵开器100的倒置视图,通道1105与外壳1010下降至手持部110的底部1520。外壳1010包括位于底部1520处的连接件1410,可流动地连接通道1105与真空源,驱使烟雾/空气排出通道。
如图11至图13所示,为了使烟雾从操作部位排除,排烟通道1105有利地紧靠操作部220。进一步地,为使光源1020产生的光线聚集到由操作部220牵引的区域,光源1020以一个角度设置,此角度与操作部220相对于桶部215的向下角度类似或基本相同。
光源1020也可以可替代地以与桶部215基本相似的角度设置,并且可以不随操作部向下倾斜。由于光源1020的宽散射角,这仍旧可使光源照亮操作区域。
然而,进一步以操作部220的角度举例,尤其当其向下倾斜时在远端的角度。凸脊710连同在其操作部220的刀部120以及操作部的正方形一起提供了使用时抓住组织的最佳方法及装置。
如图15和图17所示,刀部可以120包括一个或多个定位槽1510,设于刀部下侧。可操作定位槽1510以将外壳1010固定到位。定位槽1510也可以可选地设计为并非是为了在手术过程中抓住组织,例如当刀部120插入体腔内时。
如图16所示,每个定位槽1510包括一个孔,孔尺寸可容纳外壳1010的固定片1605。为将外壳1010固定于刀部120的顶部位置,将外壳1010的固定片1605插入定位槽1510的孔中。定位槽1510的尺寸使得孔尺寸比与其相连的固定片1605尺寸小。孔凸起且光滑,使体组织被抓起而远离孔。
如图21所示,定位槽1510可以包括凸起且光滑的部分。基于此特征,当插入并固定于定位槽1510内时,固定片1605凹入孔中,并且不会从定位槽1510中突出。这就确保了定位槽1605的端部不会勾住或抓住组织。
图22列举了固定在定位槽内,未从定位槽1510突出的固定片1605的剖面。固定片1605在架子2210周围弯曲并卡于此位置,以至于固定片1605底部与架子2210顶部之间的接触防止固定片1605与架子2210分离。
架子2210位于定位槽1510的对面。定位槽1510位于刀部120的下侧上,并且由从下侧穿透刀部120的模具结构形成。模具结构的穿透形成刀部120上的孔,例如定位槽1510,如图所示,定位槽1510被固定片1605填充。为防止定位槽捕获组织,优选使定位槽1510尺寸最小化,同样限制位于刀部120下侧上的孔的数量为一个孔。
因此,牵开器100采用仅在架子2210位置穿透刀部120的模具结构成型。定位槽1510的形成孔的尺寸最小化,其尺寸等于或近似等于架子2210的宽度。
在一实施方式中,制造过程包括利用模具结构而形成位于刀部下侧中、架子2210对面的孔(例如,定位槽1510的孔)。通过仅在架子位置穿透刀部120,未在刀部下侧上的其他位置穿透刀部,在手术时可以面对患者的下侧上的孔仅仅与架子同宽,因此,孔的尺寸可减少患者组织的捕获。
然而,通过减少用于定位槽1510的孔的面积,设置与架子2210具有相同宽度的一个孔,在制造过程中,固定片1605不能弯曲至适合架子2210周围的位置。
如图22所示,因此制造过程中,从模具结构中在刀部120顶侧、在面对组织的下侧的对面形成附加孔2220,为了允许固定片1605弯曲。
形成孔2220为了使固定片1605弯曲。孔2220的位置优选设于刀部120的顶侧,远离组织接触。孔2220未通过刀部120的宽度,从而最小化在牵开器100的患者面对侧上附加孔的结构。
如图21至图22所示,由于多种模具的使用,定位槽1510的尺寸为普通孔宽度的一半。因此,仅仅具有光滑凸面的固定槽1510提供了最小的组织抓取。
在一实施方式中,牵开器100由注塑模具设计成型,应当注意到,收缩孔比固定片1605小,仅在注塑模具设计中可能如此,不适用于金属牵开器。
牵开器100进一步包括开/关的开关1705,位于手持部110的底部,开关1705可以位于邻接连接件1410。开关1705控制一个或多个光源及真空源。
图18示例了除去外壳1010的牵开器100。示例了位于排烟外壳1010下方的通道1105、腔室从临近操作部220的桶部215的远端延伸,经过鞍部210,进入到位于手持部110中的腔室1810。烟雾可从临近操作部220的入口穿过,于外壳1010下方,穿过通道1105,进入到手持部腔室1810。烟雾穿过内部腔室1810并通过连接件1410排出手持部,该连接件与排烟软管相连,并且利用真空源的吸力。
图18至图20示例了与光源1020的电连接,其通常被排烟外壳1010置于通道1105中的适合位置。电线1820从光源1020起延长至手持部110中的电源。电源被开关1705控制。电源可以包含仅供单次使用的充足电量。
如图19所示,牵开器100包括组合件1910。组合件1910可以与牵开器本体分开制造或生产。组合件1910可以包括一个或更多个电源1920、电线1820、开关1705及光源1020。
在制造方法的实施例中,组合件1910可以作为预成型件被插入手持部110的底部。组合件1910可以从底部被插入手持部110的腔室,通过手持部110,从手持部110的顶部伸出,与鞍部210相邻。之后将组合件1910置于桶部215上,位于通道1105内,此处组合件1910的光源1020及电线1820被置于接收槽1830中。之后将外壳1010置于通道1105,包括1910之上,并在此卡合。
利用排烟通道1105将烟雾移除医生视野的方法可以包括下列内容。在手术或者程序中形成烟雾,例如,电烧灼工具的使用。该烟雾可能会干扰医生的视线,尤其干扰视野。光源1020可以聚集于医生的视野。在进行手术的过程中,可以打开真空源,并且烟雾可以通过排烟通道被吸入到牵开器。烟雾可以穿过排烟通道进入手持部,从手持部底部排出。
应当注意的是,在此公开的整个牵开器及连接部件,包括刀部/手持部、手持部外壳和外壳,与低成本注塑成型完全兼容,可由低成本塑料制成。进一步地,整个牵开器组合件最适用于单次使用和用即弃产品。
应当理解的是,在牵开器的优点中,消除了使用单独排烟工具的需要。另外,提供明亮的光源用来照亮手术腔室。
在一实施方式中,手术牵开器包括与刀部连接的手持部,刀部可垂直连接于手持部,例如以90度角或者近似90度角。在其它实施方式中,刀部可以任何合适的角度与手持部连接,例如30度、45度、110度或者其他合适的角度。
在一实施方式中,刀部包括鞍部、弯曲的桶部、操作部及通道外壳。鞍部与手持部相邻,形成凹腔。弯曲的桶部位于鞍部的远端,定义为通道,在桶部的内部设有照明组件。操作部位于桶部远端且由桶部向下呈角度。通道外壳设于桶部内通道之上,并且适用于将照明组件固定于适当位置。
在一实施方式中,牵开器的操作部基本呈正方形形状,包括许多设于桶部远端的凸脊,凸脊可以具有任意合适的尺寸。可以设计凸脊的尺寸,用于抓住组织并将组织抓离操作区域。
在一实施方式中,照明组件与操作部相邻,包括光源、开关、单次使用电源及外罩。
在一实施方式中,牵开器的通道是排烟通道,其从桶部延伸,通过鞍部,进入手持部的中空空间中。
在一实施方式中,排烟通道通过一段手持部长度延伸至位于手持部底部的连接件。真空源通过连接件联结于手持部的底部,真空源的联结提供排烟通道与真空源之间的流体连接,这提供了移除烟雾的吸力。
在一实施方式中,手术牵开器包括手持部及与手持部连接的刀部。刀部包括与手持部相邻和形成凹腔的鞍部;位于鞍部远端弯曲的桶部,定义为通道,桶部包括位于桶部内的照明组件;位于桶部远端且由桶部向下呈角度的操作部;设置在桶部内通道之上的通道外壳,适用于将照明组件固定于适当位置,通道外壳包括多个固定片;多个位于刀部下侧上的定位槽,设计定位槽尺寸为最小化定位槽的孔的尺寸,并包括光滑并凸起的几何形状,以在没有抓起的情况下有利于组织的移动。设计每个固定片的尺寸以适合多个定位槽中的一个,并且可操作定位槽而固定通道上的通道外壳在适当位置。
因此,提供一种自照亮的牵开器,可为手术腔室提供明亮、无阴影的光。根据本发明,还提供一种两用排烟通道以及将光源联结于牵开器的光源架。根据本发明,进一步提供一种单次使用电池和允许制造高质量牵开器的大量生产的可塑性塑料部件,患者可负担得起单次使用,减少感染风险。根据本发明,更进一步地提供一种正方形形状的呈角度的牵开器刀部,具有在使用牵开器的过程中用于抓住组织的一体的凸脊。
在一个或更多个实施方式中,刀部、手持部及弯曲部(这里集中称作“本体”)一体成型。在至少一个实施例中,本体成型的材料是坚硬、刚性、轻便的塑料(如聚合物)。合适的塑料的例子之一是玻璃纤维增强聚芳酰胺化合物,其具有高强度及刚性、表面光泽及抗蠕变性。一个实施例采用50%的玻璃纤维增强聚芳酰胺化合物,但是本领域的技术人员会明白在不脱离本发明的精神和范围的情况下可使用其他百分比。
聚芳酰胺是芳族二胺和芳族二羧酸酐的热塑性结晶聚合物,具有很好的耐热、耐火及耐化学性,在高温下的保留性能,非导电性、机械性及刚性,但耐光性及加工性低。本领域的技术人员会明白也可采用其它具有合适强度及刚性的塑料。
在一个或更多个实施方式中,本体由塑料(例如玻璃纤维增强聚芳酰胺)制成,具有射线透射性和非导电性中的至少一种性能。如这里用的,“射线透射性”指对辐射有高的透明度,以至于当拍摄图像,例如,X射线图像时可使用此装置。这里所用的“非导电性”指基本上的非导电性。
如图23所示,射线透射性的优势在于,当拍摄X射线图像时可使用此装置,不会拍出模糊的基本结构。图23中的“OBP”是实施方式中由位于刀部下方的金属刻字产生的,用来显示射线透射性。左侧更黑暗的图像是不锈钢对照刀部,由于其对于X射线的不透明度而显示为黑色。
在此描述的实施方式可以为牵开器的尖端提供光线且仍保留高的射线透射性(尽可能达99%)。现有技术装置具有,例如,在拍摄X射线图像时阻碍视线的光纤电缆,即使装置由塑料制成。当然,金属装置根本不是射线透射性的。
这种射线透射性指,在手术中使用图像技术之前无需移除这里描述的牵开器,这可加快需要解剖识别和/或装置定位的过程进行。
相对于金属牵开器来说,非导电性的优势在于它提供对患者改进的安全性。患者可能会感觉到低至0.001A的电流,并且较大的电流会伤害患者,这里描述的实施方式将电流限制为小于10-6A,这样大大减少了电危害。
例如,电烧灼广泛应用于手术组织解剖中。由于不经意间产生破坏性的烧灼电流,金属牵开器的使用会使医生和患者处于使牵开组织受损的风险。牵开器经常被用于替换和牵开微小烧灼的敏感组织,如小肠或大肠(结肠)、肺或者主要血管。这些组织的烧灼损伤可引起重大并发症。另外,牵开器经常被用于在胸部和起搏器手术中建立手术组织袋,例如,关于这里所述的一些实施方式中所描述的非导电材料的使用,可阻止任何杂散电能对牵开组织造成损伤。因此提高了患者的安全性。
本领域的技术人员会明白,强度是材料和设计的参数,使用比所述材料更低强度的材料的设计需要更厚和更圆的材料。这两个特性会降低牵开器的优势,不应阻挡本体腔室的可见性。
弯曲强度代表材料在应力下断裂的极限。弯曲模量指材料在应力下弯曲的趋势。这两个参数对于牵开器设计以及由此的性能是至关重要的。首先,牵开器刀部必须足够薄而不能干扰使用牵开器的医疗手术。极薄的刀部会倾向于填充医生需要操作的人体上的孔。最佳的设计是具有足够薄的刀部,该刀部允许医生进行操作的空间。由于金属具有高弹性模量而采用典型的金属刀部。它们具有无限弯曲强度,因为它们弯曲而不是断裂。像0.5-2mm一样薄的金属刀部容易使用,这种厚度足够小而不会干扰医生在伤口或手术腔室中的操作空间。不锈钢金属可具有180Gpa的弯曲模量,对于大部分牵开器设计来讲,可抑制刀部在受到15磅的尖端压力下产生超过10mm的变形。
塑料注塑成型刀部需要更厚的刀部,因为它们具有更低的弯曲模量。刀部厚度呈立方体会增加刀部强度,但是在大部分医生应用中,不期望刀部厚度不超过2mm。如下面表1中所示,典型的塑料材料具有仅几个Gpa的弯曲模量及小于200Mpa的弯曲强度。在使用时,这些较低的参数值导致牵开器刀部大于10mm发生变形,并且在平均长度牵开器刀部(50-150mm长)的尖端处受到小于30磅的力时很可能发生断裂。
在使用过程中变形显著的牵开器刀部会使医生在医疗手术中牵引组织变得更加困难。受到小于30磅的力而发生断裂的牵开器刀部会对患者产生危险,因为断裂的刀部或者一片断裂的刀部可能进入患者体内而产生损伤。以下表格中列举的有塑料制成的牵开器刀部在10磅尖端力作用下通常弯曲大于20mm,并且在15磅(甚至更小)的尖端力下会断裂。
表1:聚合物的典型弯曲强度和弯曲模量
为了提高塑料的弯曲模量和弯曲强度,在一实施方式中,在塑料材料中加入玻璃纤维。图24显示了加入多种比例玻璃纤维的多种塑料。
综上可看出,加入玻璃纤维可以将一些塑料的弯曲强度提高至300Mpa或更高,将弯曲模量提高至16Gpa或更高。在一实施方式中,一种特定类型的塑料,聚丙烯酰胺被玻璃纤维浸渍以产生大于375Gpa的将弯曲强度和大于17Gpa的弯曲模量。
具备这些特性的塑料有能力产生厚度约为2mm的牵开器刀部,可承受大于30磅的尖端力而不发生断裂,且在15磅力的作用下变形小于10mm。此外,这种材料中的玻璃纤维最终会在表面“玻璃化”,而留下一种非常光滑的“金属样”表面光度,这在牵开器的应用中是高度期望的。
材料中的玻璃纤维也会减少在过载和断裂事件中产生材料尖碎片的可能性,断裂后产生钝边缘的趋势会减少如果牵开器过载和最终断裂,患者将受到损伤的可能性。
此外,材料断裂的方式在医疗应用中可能很重要,材料的断裂特征通常由冲击强度来测量。具有低表面强度(10-20J/M)的材料可能在应力下断裂成大量尖碎片,如果材料问题发生在医疗手术期间,这可能对患者造成危害。尖碎片可切患者的组织,并且大量这种碎片使断裂材料很难或者不可能从患者体内移除。
这里所述的应用于一些实施方式中的材料(例如玻璃纤维增强聚芳酰胺)具有高冲击强度(>100J/M),很少产生断裂构件边缘(并且所得到的边缘将变钝)。在产品过应力而导致材料断裂的过程中,这种断裂特性最小化患者受到的潜在危害。
应当明白的是,前面涉及本发明的示例性实施例,可在不脱离所要求保护的发明的精神和范围内进行修改。

Claims (35)

1.一种照明手术牵开器,其包括:
刀部,具有顶面及底面,近端及远端,所述刀部包括设置于远端的操作部,设置于近端的鞍部及连接所述操作部与所述鞍部的桶部;
手持部,连接所述鞍部;以及
照明组合件,包括至少一个光源、至少一块电池及用于给光源通电的激活装置,并且照明组合件永久地连接牵开器。
2.如权利要求1所述的牵开器,其中照明组合件永久地连接鞍部。
3.如权利要求1所述的牵开器,其中桶部限定照明观察槽。
4.如权利要求1所述的牵开器,其中光源是LED光源。
5.如权利要求1所述的牵开器,其中开关是一个接头片开关。
6.如权利要求1所述的牵开器,其中操作部向下地呈角度远离桶部。
7.如权利要求1所述的牵开器,其中操作部远离桶部的远尖端处设有多个凸脊。
8.如权利要求1所述的牵开器,其中光源设置于桶部中。
9.如权利要求1所述的牵开器,其中光源设置于操作部中。
10.如权利要求1所述的牵开器,其中光源是一种宽散射光源。
11.如权利要求1所述的牵开器,其中光源以基本平行于桶部的角度被提供。
12.如权利要求1所述的牵开器,其中光源以基本平行于操作部的角度被提供。
13.如权利要求1所述的牵开器,还包括排烟通道。
14.如权利要求13所述的牵开器,还包括用于所述排烟通道的外壳。
15.如权利要求13所述的牵开器,其中所述排烟通道设置为包括至少一部分所述光源。
16.如权利要求13所述的牵开器,其中所述排烟通道设置为包括至少一部分所述照明组合件。
17.如权利要求13所述的牵开器,其中所述排烟通道至少从所述刀部的所述远端延伸至所述手持部。
18.如权利要求13所述的牵开器,还包括用于真空源的连接件。
19.如权利要求14所述的牵开器,还包括将所述外壳与所述刀部连接的定位槽,其中所述外壳包括与所述定位槽对应的片体。
20.如权利要求19所述的牵开器,其中每个所述定位槽均包括凸起且光滑的部分。
21.一种手术牵开器,包括:
刀部,具有近端及远端;以及
手持部,与所述刀部的所述远端连接,
其中刀部及手持部由低导电率聚合物模塑制造。
22.如权利要求21所述的牵开器,还包括照明组件,该照明组件包括至少一个光源、至少一块电池及用于给光源通电的激活装置,并且照明组合件永久地连接牵开器。
23.如权利要求21所述的牵开器,还包括排烟通道。
24.如权利要求23所述的牵开器,还包括用于所述排烟通道的外壳。
25.如权利要求23所述的牵开器,其中所述排烟通道设置为包括至少一部分所述光源。
26.一种手术牵开器,包括:
刀部,具有顶面及底面,近端及远端;以及
手持部,与所述刀部的所述远端连接,
其中刀部及手持部由射线透射性聚合物模塑制造。
27.如权利要求26所述的牵开器,还包括照明组合件,该照明组合件包括至少一个光源、至少一块电池及一个用于给光源通电的激活装置,并且照明组合件永久地连接牵开器。
28.如权利要求26所述的牵开器,还包括排烟通道。
29.如权利要求28所述的牵开器,还包括用于所述排烟通道的外壳。
30.如权利要求28所述的牵开器,其中所述排烟通道设置为包括至少一部分所述光源。
31.一种照明手术牵开器,包括:
刀部,具有顶面及底面,近端及远端,所述刀部包括排烟通道;
手持部,与所述刀部的所述近端连接;以及
照明组合件,包括至少一个电源、至少一块电池及用于给光源通电的激活装置,并且照明组合件连接牵开器。
32.如权利要求31所述的照明手术牵开器,其中所述照明组合件永久地连接牵开器。
33.如权利要求32所述的照明手术牵开器,其中所述激活装置只允许操作者单次激活。
34.如权利要求31所述的照明手术牵开器,还包括用于所述排烟通道的外壳。
35.如权利要求31所述的照明手术牵开器,其中所述排烟通道设置为包括至少一部分所述光源。
CN201680012705.2A 2015-06-03 2016-06-02 牵开器 Pending CN108348229A (zh)

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ES2968069T3 (es) 2024-05-07
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US20160354072A1 (en) 2016-12-08

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