CN116058940A - 皮下递送工具 - Google Patents
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Abstract
皮下植入工具和使用该工具植入皮下装置的方法。工具可包括:具有纵向延伸的凹部的工具主体,该凹部具有远侧开口;隧切器,其在工具主体的远端处从凹部的远侧开口延伸。工具可包括柱塞,该柱塞可滑动地配合在工具主体凹部的至少一部分内。凹部可被构造成接纳可植入装置,并且当所述装置在凹部中如此定位时,隧切器优选地在从装置侧向移置的位置处从凹部向远侧延伸。柱塞在凹部内向远侧的移动使装置向远侧离开凹部并与隧切器并排且在隧切器以外前进。
Description
本发明专利申请是国际申请号为PCT/US2014/023912,国际申请日为2014年3月14日,进入中国国家阶段的申请号为201480015082.5,名称为“皮下递送工具”的发明专利申请的分案申请。
背景技术
监测设备在测量患者的各种物理参数中的应用是熟知的。使用皮下监测装置的需要越来越大,该装置允许医生获得信息而无需将患者连接到外部机器,和/或本来不可以在办公环境中再现。术语“皮下”通常暗指在皮肤之下和在皮肤下方的肌肉***外部的患者体内的位置。例如,一种可植入装置包括监测患者的心跳以便检测表明心律失常的一过性症状的能力,该装置允许医生在比模拟的测试情景中使用外部监测设备更长的时间段内查看数据。然而,为了成功植入可植入的皮下装置,植入工具应当例如确保该装置不被植入肌肉中,减少外科医生与伤口之间的接触,在办公环境中使用以最大程度减轻患者不适并最大程度减小对侵入性手术的需求,并且有能力在患者体内反复再造相同尺寸的切口部位。
示例性的现有技术***工具包括在Wengreen等人的美国专利申请公开No.2010/0094252中示出的那些。
发明内容
另外的适用范围将从本文提供的描述变得显而易见。应当理解,描述和具体示例仅意图用于举例说明,而并非意图限制本公开的范围。
示例性实施例提供了皮下植入工具和使用该工具植入皮下微型装置的方法。本发明提供了一种注射器状工具,该工具包括工具主体(下称“柄部”),该工具主体具有中空的向远侧纵向延伸的凹部(例如,内孔或通道)并且具有远侧开口,所述装置可以被递送通过该开口。该装置优选地还包括位于内孔或通道内的可移动柱塞。提供切开工具以用于制作通过其植入皮下装置的切口。
该装置可以例如植入胸部的区域中。具体的推荐位置通常将在相关联的产品手册内提供。在一个实施例中,在装置的主体上的两个电极监测患者的皮下心电图(ECG)。该装置可以响应于患者激活或响应于自动检测的心律失常而记录ECG。示例性装置公开于下列专利中:Anderson的美国专利申请公开No.2009/0036917;Wengreen等人的美国专利申请公开No.2010/0094252;Hoeppner等人的美国专利申请公开No.2012/0283705;授予Klein等人的美国专利No.5,987,352;授予Lee等人的美国专利No.6,412,490和7,035,684;以及授予Duffin等人的美国专利No 6,230,059。
切开工具设计成利用单次运动形成具有可重复的宽度和深度的切口。该工具由刀片和柄部构成,刀片设计用于制作可重复的切口,柄部设计用于工效学地贴合手部。切开工具旨在制作简单且可重复的切口。在一些备选实施例中,用于在患者皮肤中制作开口的诸如套管针、牵开器(spreader)、手术刀等的其它机构可以被代替。
***工具将装置穿过切口递送到皮下组织中。该工具设计成确保装置被递送到密闭的囊袋中,以便以高度可重复的方式使电极与周围组织的接触最大化,并且由柄部和柱塞两部分构成。柄部由下列部分构成:内孔或通道部段,其用来在植入期间保持装置并引导装置;以及突起,其向通道远侧延伸并且用来钝切植入物路径,以便装置在被植入的同时向下行进。当装置位于通道中时,隧切器(tunneler)在从装置侧向移置的位置处从通道向远侧延伸。柱塞用来使装置向远侧离开柄部,穿过切口,与隧切器并排且在隧切器之外并且沿着由隧切器形成的植入物路径推到最终植入位置。
装置通常被加载到***工具柄部的通道部段内并且与***工具柱塞和切开工具两者一起无菌地包装。
装置可定位在通道内柱塞远侧处,使得当柱塞向远侧移动时,装置离开工具主体向远侧推进到组织中。通常,装置将采取细长主体的形式,其长度大于其厚度和宽度,如在上文引用的已公布的专利申请No.2010/0094252中所示。装置可以沿着其纵向轴线在近端和远端之间延伸。工具主体的纵向通道或内孔可以至少部分地适形于装置的外部构型,并且更典型地适用于沿其纵向轴线截取的装置的横截面。如果像上文讨论的装置那样,装置的宽度大于其深度和/或换句话讲围绕其纵向轴线径向不对称,该特征允许装置在保持其所需取向的同时推进到组织中,如下文更详细地讨论的。
优选地,装置的最终***部位位于离切口部位较短距离处。如上所述,柄部优选地设有从内孔的远侧开口向远侧延伸的细长的突起或隧切器,该突起或隧切器可穿过切口***组织中,以在组织中形成路径,装置在被柱塞推动时可沿着该路径推进。当这样***时,隧切器的远端优选地位于装置远端的所需位置处。隧切器的长度因此优选地至少等于且优选地一定程度地大于皮下装置的长度。
另外的实施例提供了植入皮下微型装置的方法,该方法包括:将由工具的实施例描述的解剖主体***植入部位,其中解剖主体包括微型装置;以及递送微型装置。
附图说明
通过下面的详细描述并结合附图,示例性实施例将被更清楚地理解。图1-10表示本文所述的非限制性的示例性实施例。
图1是示例性的可植入装置和相关联的工具柄部的立体图。
图2是示例性的可植入装置的立体图。
图3是根据示例性实施例的切开工具的立体图。
图4A、4B和4C分别是图3的切开工具的俯视图、侧视图和仰视图。
图5A和5B是根据本发明的示例性实施例的工具柄部和柱塞的立体图。
图6A、6B、6C、6d和6E分别是工具柄部的远端视图、剖切视图、俯视图、仰视图和近端视图。
图7A和7B是穿过图6C所示工具柄部的剖视图。
图8A、8B、8C和8D分别是图5B的柱塞的远端视图、剖切视图、俯视图和近端视图。
图9A、9B和9C分别是图8D所示柱塞的剖视图、侧视图和仰视图。
图10是流程图,示出了根据示例性实施例的将装置递送到皮下部位的方法。
具体实施方式
现在将参照附图更全面地描述各种示例性实施例,在附图中示出了一些示例性实施例。在附图中,层和区域的厚度可能为清楚起见而夸大。
因此,虽然示例性实施例能够具有各种修改和替代形式,但其实施例在附图中以举例方式示出并且将在本文中详细描述。然而,应当理解,并非有意将示例性实施例限制为所公开的特定形式,恰恰相反,示例性实施例将涵盖落入本发明的范围内的所有修改、等同物和替代形式。贯穿附图的描述,类似的数字表示类似的元件。
应当理解,虽然术语“第一”、“第二”等可以在本文中用来描述各种元件,但这些元件不应受这些术语的限制。这些术语仅用来区别一个元件与另一元件。例如,在不脱离示例性实施例的范围的情况下,第一元件可以被称为第二元件,并且类似地,第二元件可以被称为第一元件。如本文所用,术语“和/或”包括相关的所列项目中的一个或多个的任何和所有组合。
应当理解,当元件被称为“连接”或“联接”到另一元件时,它可以直接连接或联接到其它元件或者可以存在中间元件。相反,当元件被称为“直接连接到”或“直接联接到”另一元件时,不存在中间元件。用来描述元件之间的关系的其它词应以类似的方式解释(例如,“在...之间”与“直接在...之间”,“相邻”与“紧邻”等)。
本文所用的技术术语仅用来描述特定实施例,而并非旨在限制示例性实施例。如本文所用,单数形式“一个”、“一种”和“该”也旨在包括复数形式,除非上下文明确表示不是这样。还应当理解,当在本文中使用时,术语“包括”、“包括了”、“包含”和/或“包含了”指定了所述特征、整体、步骤、操作、元件和/或部件的存在,但并不排除一个或多个其它特征、整体、步骤、操作、元件、部件和/或其组合的存在或增加。
在本文中可以为了便于说明而使用诸如“下面”、“之下”、“下部”、“之上”、“上部”等空间相对术语来描述如图所示的一个元件或者一特征与另一个元件或特征之间的关系。应当理解,空间相对术语旨在涵盖除了在附图中描绘的取向之外在使用或操作中的装置的不同取向。例如,如果图中的装置被翻转,则被描述为在其它元件或特征“以下”或“下面”的元件将因此被定向为在其它元件或特征“之上”。因此,例如,术语“之下”可涵盖上方和下方两者的取向。装置可以被定向成其它方式(旋转90度或以其它取向观察或参考),并且本文所用空间上相对的描述符应相应地解释。
还应该指出的是,在一些备选实施中,所指功能/动作可不按附图中所指顺序进行。例如,连续示出的两个数字实际上可以基本上同时地执行,或者有时可以以颠倒的顺序执行,视所涉及的功能/动作而定。
除非另行定义,本文使用的所有术语(包括技术术语和科学术语)都具有示例性实施例就所属领域内的普通技术人员所通常理解的相同含义。还应当理解,例如在通常使用的字典中定义的那些的术语应当解释为具有与它们在相关技术的背景中的含义一致的含义,并且不应被解释为理想化或过度正式的含义,除非本文中这样明确地限定。
示例性实施例涉及皮下植入工具和植入皮下微型装置的方法。图1至10示出了此类皮下植入工具的各种示例性实施例。
图1显示了与柄部100纵向对齐的可植入装置10,柄部100被布置用于将装置10***柄部100的通道102中。装置的近端20被***柄部的通道102的远端108中并且向近侧推进,直到装置的近端30定位成与柄部100内的内部止挡表面(未示出)相邻。在该点处,装置的远端20将与柄部100的近端相邻。通道102的开放的上部部分允许直观确认装置10被合适地***通道中。隧切器104向通道102的远端108的远侧延伸。隧切器的远端106在其上表面面向患者身体之外的情形下被置于由切开工具制成的切口中,并且被推进以在其中装置的远端20与切口的开口相邻的点处提供皮下组织的钝切。柄部100接着被旋转180度,使得隧切器104此时在装置上方(相对于患者的皮肤向外)。这在柄部上赋予向上的压力以有助于临时扩大切口并确保装置不会在向远侧推进到组织中时逸出。装置10接着在通道102内通过图5B所示柱塞向远侧的移动并且沿着隧切器104被推进,直到其被合适地定位在组织内,并且从切口的开口向远侧移置短距离。徽标112有助于提醒医师在***柱塞并推进装置之前旋转柄部。
图2更详细地显示了装置10。在该视图中可以看到,装置包括两个电极12和14,分别相邻于装置的近端和远端定位。当植入时,位于装置的上表面16上的电极12优选地朝皮肤面向外。这样,当装置如上文所讨论那样被置于柄部中时,电极12面向下并且通过通道的开放的上部部分不可见,以允许确认向柄部内的恰当***。
如图所示的示例性装置10大体上采取细长的矩形棱柱的形式,其具有倒圆的拐角和倒圆的远端部分。装置的倒圆的远端有助于允许其推进到身体组织内,在其推进时提供对组织的钝切。由于装置的横截面显著大于隧切器的横截面,装置将紧凑地定位在组织内,从而减小在电极附近形成气泡的机会,并且也有助于将装置维持在其所需位置。装置具有如图所示的长度(L)、宽度(W)和深度(D)。在该特定实施例中,宽度大于深度,提供沿着装置的纵向轴线的径向不对称性,并且有助于将装置维持在其合适的取向,使得上表面16在植入后面向外。可以可选地在装置的近端处设置缝合线孔18,以允许医师根据需要将装置缝合到下面的组织。可以可选地设置突起22,以防止装置在植入后的纵向移动。
如上文所讨论的,柄部的通道的内表面优选地被构造成对应于装置的外部构型。如在下文中更详细讨论的,柄部的通道的构型被构造成接合装置的倒圆的拐角,从而防止装置在柄部内旋转。
图3示出了切开工具200,其设有弯曲的塑性柄部210,柄部210配有平坦的带尖头的刀片220,刀片220的宽度等于切口的所需宽度。柄部设计用于舒适地保持在位,以允许刀片以浅角度推进通过皮肤,从而避免损伤下面的肌肉组织。
图4A、4B和4C显示了切开装置200的俯视图、侧视图和仰视图。如图4A所示,手指抓握部234和232的不同着色以及在上表面上徽标236的布置均有助于医师确保刀片的取向是正确的,以提供所需的浅穿透角度。
图5A和5B显示了在将柱塞***柄部之前的柄部100和柱塞300。在柄部旋转使得其带有标记112的上表面此时朝患者的皮肤面向内之后,柱塞300的远端302接着被***柄部的近端110中的开口内并且***柄部的通道102中。
柱塞设有凹槽306,凹槽306沿着柱塞的下表面的长度一直延伸至下文讨论的远侧止挡表面。柄部的近端中的开口包括突起,该突起对应于柱塞的下表面中的凹槽,从而确保其在柄部内的合适取向。柱塞近端附近的标记308有助于医师确定柱塞处于合适的取向,以便***柄部中。
柱塞被向远侧推进,从而将装置沿着隧切器此时面向内的表面推入切口中。装置由此沿着由隧切器限定的路径行进,以确保在组织内的合适布置。在***装置之后,柄部和柱塞被移除。
各种医学级材料可用来形成皮下植入工具的各种部件,例如,塑料、金属、橡胶、可净化材料等。皮下植入工具的示例性实施例可以是低成本、一次性的等。皮下植入工具也可被构造成与代替手动柱塞的已知的自动化注射***一起使用,该***使用例如压缩空气或其它惰性气体。
图6A、6B、6C、6d和6E分别是工具柄部100的远端视图、剖切视图、俯视图、仰视图和近端视图。在这些视图中,突起114是可见的。突起114提供面向远侧的止挡表面,该表面限制装置10向通道102内的***。该突起还接合柱塞300的下表面中的狭槽,从而确保柱塞在柄部内的合适取向。它还提供面向近侧的止挡表面,限制柱塞的远侧移动。柄部也显示为可选地设有在其下表面中的狭槽116,通过该狭槽可观察到柱塞和装置的推进。
图7A和7B是穿过图6C所示工具柄部的剖视图。在这些视图中,可以看到内拐角表面12、122、124和126的布置。这些表面与侧表面128和130一起布置成大体上对应于装置的拐角和侧表面,从而防止装置在柄部内旋转。突起114的面向远侧表面也在该视图中可见。
图8A、8B、8C和8D分别是图5B的柱塞的远端视图、剖切视图、俯视图和近端视图。在这些图中,可以看到凹槽306以及面向远侧的止挡表面310的构型,面向远侧的止挡表面310与柄部的突起114的面向近侧的表面接合以限制柱塞的远侧移动。
图9A、9B和9C分别是图8D所示柱塞的剖视图、侧视图和仰视图。在这些视图中,凹槽306更详细地可见。
图10是流程图,示出了根据本发明的***过程的优选实施例。在500中,使用切开工具制作切口。在510中,承载装置的柄部被***组织中,使得隧切器产生细长的钝切口,装置可沿着该切口推进。在该步骤中,装置相对于患者的身***于隧切器以外。在520中,承载装置的柄部被旋转,使得装置此时相对于患者的身体在隧切器以内。在530中,装置由柱塞沿着柄部且沿着隧切器的此时面向内的表面在皮下推进到患者的身体内。最后,在540中,柄部和隧切器被移除。
由此描述的示例性实施例允许皮下植入微创的装置。需注意,示例性实施例可以用于人类患者和动物患者两者。
虽然如此描述了本发明的示例性实施例,但很显然,这些示例性实施例可以以多种方式改变。这样的变型不应视为脱离本发明的示例性实施例的精神和范围,并且对于本领域技术人员将明显的所有这样的修改旨在包括在本发明的范围内。
Claims (15)
1.一种***,所述***包括:
构造成将可植入装置植入患者的皮下组织的植入工具,其中所述植入工具包括:
隧切器,所述隧切器包括第一近端和第一远端,其中所述隧切器构造成通过前进进入患者的皮肤中的开口来进行钝切以在皮下组织中形成植入路径;
柄部,所述柄部包括第二近端和第二远端,其中所述柄部构造成将所述可植入装置容纳在通道中,其中所述柄部形成有所述通道,所述通道包括位于所述第二近端的近端开口、位于所述第二远端的远端开口、以及在所述柄部的侧表面上的侧开口,其中所述可植入装置在所述通道中穿过所述侧开口可见,以及其中所述隧切器从所述柄部向远侧延伸,从而所述第一近端邻接所述第二远端;以及
柱塞,所述柱塞构造成在所述通道中运动穿过所述通道的所述近端开口;
其中,所述柱塞构造成沿着所述通道向远侧前进,以为了将所述可植入装置推出所述通道的所述远端开口,以及沿着所述隧切器的表面使所述可植入装置前进到所述皮下组织中的所述植入路径中;以及
其中,所述柱塞的远端构造成当所述柱塞沿着所述通道向远侧前进时推动所述可植入装置的近端。
2.如权利要求1所述的***,其特征在于,还包括切开工具,所述切开工具包括:
切开工具柄部;
刀片,所述刀片从所述切开工具柄部的远端延伸;以及
所述切开工具手柄上的一对切开工具手指抓握部,其中所述一对切开工具手指抓握部的每一个切开工具手指抓握部位于所述切开工具手柄中的凹进部中;
其中,所述刀片构造成通过前进进入患者的皮肤而在患者的皮肤中生成开口。
3.如权利要求2所述的***,其特征在于,所述切开工具手柄包括近侧部分、远侧部分和中间部分,其中所述中间部分以第一弯曲度向所述近侧部分弯曲,其中所述中间部分以第二弯曲度向所述远侧部分弯曲,以及其中所述第一弯曲度相对于所述切开工具的纵轴线与所述第二弯曲度相反。
4.如权利要求2所述的***,其特征在于,所述一对切开工具手指抓握部定位成离所述切开工具柄部的所述远端比所述切开工具柄部的近端更近,从而所述切开工具的使用人能够舒适地握持所述切开工具并以相对于患者的皮肤呈一定角度地***所述刀片。
5.如权利要求1所述的***,其特征在于,所述柱塞包括止挡表面,所述止挡表面限制所述柱塞向远侧的运动。
6.如权利要求1所述的***,其特征在于,所述柱塞限定有凹槽。
7.如权利要求6所述的***,其特征在于,所述柄部限定有进入所述通道的突起,以及其中所述柱塞的所述凹槽与进入所述通道的所述突起相配合。
8.如权利要求1所述的***,其特征在于,还包括所述可植入装置,其中所述可植入装置的外部构造包括细长的矩形棱柱,并且其中所述可植入装置包括倒圆的远端部分。
9.如权利要求8所述的***,其特征在于,所述可植入装置包括长度、宽度和深度,其中所述可植入装置的宽度大于所述可植入装置的深度,从而所述可植入装置沿着所述可植入抓钩内置的纵轴线具有径向不对称性。
10.如权利要求1所述的***,其特征在于,还包括所述可植入装置、切开工具和无菌包装,其中在所述柄部的所述通道中的所述可植入装置、所述柱塞和所述切开工具包括在所述无菌包装之内。
11.如权利要求1所述的***,其特征在于,所述隧切器的长度大于所述可植入装置的长度。
12.一种***,所述***包括:
可植入装置,所述可植入装置包括两个电极,并构造成通过所述两个电极监测患者的心电图;以及
构造成将所述可植入装置植入患者的皮下组织的植入工具,其中所述植入工具包括:
隧切器,所述隧切器包括第一近端和第一远端:
柄部,所述柄部包括第二近端和第二远端,其中所述柄部限定有沿着所述植入工具的纵轴线延伸的通道,所述通道具有在所述第二远端处的远端开口和在所述第二近端处的近端开口,其中所述柄部构造成将所述可植入装置接纳在所述通道中;以及
柱塞,所述柱塞构造成在所述通道中运动穿过所述通道的所述近端开口;
其中,所述柱塞构造成将所述可植入装置通过所述远端开口推出所述通道;
其中,所述柄部限定有与所述远端开口分开的下开口,所述下开口在所述柄部的下表面的一部分上;
其中,所述可植入装置在所述通道中能够通过所述下开口观察到;
其中,所述隧切器从所述柄部向远侧延伸,使得所述第一近端邻接所述第二远端;
其中,所述隧切器的截面比所述柄部的截面短。
13.如权利要求12所述的***,其特征在于,
其中,所述隧切器构造成穿过患者的皮肤中的开口前进进入患者的所述皮下组织,并通过所述工具柄部的旋转而在所述皮下组织中旋转,以通过钝切而在所述皮下组织中形成植入路径;以及
其中,所述柄部构造成将所述可植入装置接纳在所述通道中,从而当所述隧切器前进到所述皮下组织中时所述可植入装置相对于患者的身体对于所述隧切器向外,并且在所述工具柄部旋转之后相对于患者的身体对于所述隧切器向内。
14.如权利要求13所述的***,其特征在于,所述柱塞构造成沿着所述通道向远侧前进,以为了沿着所述隧切器的相对于患者的身体向内的表面将所述可植入装置推出所述通道并进入所述皮下组织。
15.如权利要求12所述的***,其特征在于,所述下开口沿着所述柄部的所述下表面的所述部分从第一位置延伸到第二位置,其中所述第一位置在所述柄部的所述近端的远侧,其中所述第二位置在所述柄部的所述远端的近侧,以及其中所述第二位置在所述第一位置的远侧。
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USD945622S1 (en) * | 2020-06-25 | 2022-03-08 | Medtronic, Inc. | Implantable medical device |
TWD213467S (zh) | 2020-06-26 | 2021-08-21 | 南韓商Lg化學股份有限公司 | 用於注射器之柱塞桿及手指握柄 |
USD952852S1 (en) * | 2020-09-25 | 2022-05-24 | Medtronic, Inc. | Tibial implantable neurostimulator |
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