CN101401720B - 用于单切口手术的张开密封锚定装置 - Google Patents
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Abstract
本公开涉及一种在微创手术操作期间使用的手术锚定装置。所述手术锚定装置包括主体构件和至少部分地位于主体构件中的扩张器。主体构件包括适于由使用者手动接合的手柄段和具有多个可张开段及多个凸面的可张开件。手柄段在第一或正常状态与手柄段被至少部分地倒置的第二状态之间弹性转换。可张开件的凸面配置为在插入时与扩张器的远端接合,使得可张开件可以从初始状态转换到主体构件固定或锚定在组织中的切口中的张开状态。
Description
相关申请的交叉引用
[0001]本申请要求引用2007年10月5日在美国提出的申请号为60/997,844的美国专利申请的权益和优先权,其全部内容引用在此作为参考。
技术领域
[0002]本公开涉及一种在手术操作期间利于进入病人的内腔的装置及该装置的使用方法。更具体地,本公开涉及一种手术锚定装置,该手术锚定装置适于插进组织中的切口,并适于密封容纳一个或多个手术器件,以便与组织和手术器件或物体均形成基本液体紧密密封。
背景技术
[0003]今天,为了减少对患者的损伤和恢复时间,与常规操作中典型所需的大切口相比,许多手术操作通过皮肤中的小切口进行。通常,这种操作被称为“内窥镜”,除非在患者的腹部进行的情况下该操作被称为“腹腔镜”。在本公开中,术语“微创”应被理解为包括内窥镜和腹腔镜两者。在典型的微创操作期间,如手术进入装置的手术器件(例如套管针及插管组件或内窥镜)通过组织中的切口插进患者的身体。
[0004]通常,手术器件插入患者的身体前,注入气体被用于使目标手术位置周围的区域扩大以形成更大的更易进入的工作区域。相应地,需要维持在切口处及手术器件或物体周围的基本液体紧密密封,以便防止注入气体的溢出以及被扩大的手术工作区域的放气和坍塌。
[0005]为了这个目的,包括瓣膜、密封件等各种装置被使用在微创操作过程期间,并在本领域中广泛公知。但是,仍不断需要自动锚定装置,该自动锚定装置能够直接插进组织中的切口且在维持被吹入的工作区的完整性的同时能够容纳各种手术器件。
发明内容
[0006]在本公开的一个方案中,手术锚定装置包括限定了沿其纵轴延伸的纵向主体通道的主体构件,可至少部分地位于主体构件的纵向通道内的扩张器,以及相对于扩张器安装的密封件。
[0007]主体构件包括适于在第一初始状态与第二张开状态之间转换的可张开件;主体构件的可张开件包括由可以基本为纵向的狭缝分隔的多个可张开段,以及多个相对于由主体构件限定的纵轴斜向设置的内凸面。在一实施例中,每个可张开段包括一内凸面。可张开件进一步包括适于当主体构件处于第一初始状态时利于主体构件在组织中的推进的外螺旋形螺纹。
[0008]主体构件还包括适于由使用者手动接合的手柄段。手柄段相对于主体构件的纵轴径向向外下垂。手柄段适于在正常状态与至少部分地倒置状态之间转换。手柄段可以由弹性材料构成并具有适于当手柄段处于正常状态时与组织接触的周凸缘。周凸缘适于在手柄段从至少部分地倒置状态转换到正常状态时建立与组织的真空密封。
[0009]扩张器尺寸为当插入可张开件时使可张开件转换到第二张开状态,从而利于主体构件相对于组织的固定。扩张器限定了用于容纳的纵向扩张通道和手术器件通道;扩张器尺寸为在扩张器插入主体构件的纵向通道时与凸面接触,以将可张开段相对于纵轴至少径向向外移动并使可张开件转换到第二张开状态。
[0010]密封件适于建立与容纳在扩张器中的手术器件相关的基本密封。在可选实施例中,密封件可以包括凝胶材料或自动愈合的泡沫材料。
[0011]从以下本公开的各种实施例的详细说明,对于本领域的技术人员而言,此处公开的瓣膜的上述和其他特征将变得更加明显。
附图说明
[0012]以下结合附图描述本公开的各种实施例,其中:
[0013]图1为根据本公开的原理的手术锚定装置的侧视立体图,示出了主体构件和扩张器。
[0014]图2为图1的手术锚定装置的侧视截面图,其中扩张器从主体构件移除。
[0015]图3为图2的手术锚定装置的侧视截面图,其中扩张器插进主体构件。
[0016]图4为图1的手术锚定装置的俯视立体图,示出了密封件的细节。
[0017]图5为手术锚定装置的主体构件的侧视平面图,示出了处于第一倒置状态的手柄段。
[0018]图6为手术锚定装置的主体构件的侧视平面图,示出了处于第二正常状态的手柄段。
[0019]图7为手术锚定装置的侧视平面图,示出了插进主体构件的扩张器,以及处于第二张开状态的主体构件的可张开件。
具体实施方式
[0020]在以下的附图和说明中,相同的附图标记代表类似的或相同的部件,正如本领域中传统及公知的,术语“近”将表示在使用装置时装置距临床医师最近的一端,而术语“远”将表示距临床医师最远的一端。
[0021]现在结合图1和图2,公开了在如微创操作的手术操作中使用的手术锚定装置1000。锚定装置1000包括主体构件10和至少部分地位于主体构件10中的扩张器300。主体构件10限定了纵轴“A”及纵向延伸通道12,并包括手柄段100和可张开件200。
[0022]手柄段100相对于主体构件10的纵轴“A”径向向外下垂,并包括具有孔口104的外表面102,孔口104形成在外表面102中并尺寸为容纳扩张器300。外表面102从孔口104到周凸缘106向外延伸。如以下所讨论的,周凸缘106适于与组织“T”接触并建立基本真空质量密封。(见图6和图7)。
[0023]手柄段100适于由使用者手动接合及在第一或正常状态(见图1至图4)与第二状态(见图5)之间弹性转换。在第一状态,手柄段100的外表面102展示周凸缘106指向远侧的基本远曲率(distalcurvature)。在第二状态,手柄段100至少部分倒置使得外表面102的至少一部分展示基本近曲率使得周凸缘106指向近侧。在该状态下,如以下进一步详细讨论,手柄段100更适于配置为由使用者手动接合以利于可张开件200插入切口14(图5)。应指出的是,当手柄段100处于第一状态时由使用者接合也是可以的。手柄段100可以由任何适合的生物相容性材料形成,该生物相容性材料为足够柔性以允许手柄段100在第一与第二状态之间弹性转换,其包括但不限于弹性材料。
[0024]可张开件200从手柄段100向远侧延伸,并与手柄段100的孔口104基本对准使得当插入时扩张器300可以穿过孔口104而进入可张开件200。在其远端202处,可张开件200限定开口204,开口204尺寸为允许扩张器300的远端304穿过开口204。可张开件200适于从第一或初始状态(图6)转换到第二或张开状态(图7)。
[0025]可张开件200限定了足够提供经皮进入患者的下腔、器官等(未示出)的长度“L”。可张开件200包括多个可张开段206、多个内凸面208和外螺旋形螺纹210。
[0026]可张开段206由两个或更多狭缝212限定。在一实施例中,狭缝212以基本纵向方式延伸。但是,狭缝212的可选构造没有超出本公开的范围。如以下进一步详细讨论,当可张开件200从初始状态向张开状态转换时,可张开段206径向向外张开。
[0027]内凸面208相对于由主体构件10限定的纵轴“A”斜向设置。如以下进一步详细讨论,内凸面208配置为当内凸面208插进主体构件10的纵向通道12时与扩张器300的锥形外表面308接合,以利于可张开件200从初始状态向张开状态的转换。在一实施例中,每个可张开段206包括一内凸面208。外螺旋形螺纹210设置在可张开件200的外表面上。当可张开件200插进切口14时螺旋形螺纹与组织“T”接合以便利于主体构件10的向远侧推进。另外,螺旋形螺纹210可以辅助将主体构件10锚定在组织“T”内。
[0028]可张开件200可以由任何适合的生物相容性材料形成,该生物相容性材料具有足够弹性以允许可张开件200在其初始与张开状态之间弹性转换,其包括但不限于弹性材料。
[0029]在第一或正常状态中,可张开件200配置为用于插进切口14并限定了第一直径“D1”。当扩张器300插入时,扩张器300的远端304与内凸面208接合。当扩张器300向远侧推进通过纵向通道12时,其远端304迫使内凸面208及可张开段206向外,从而可张开件200转换到其张开状态。在其张开状态,可张开件200限定第二且更大直径“D2”。
[0030]扩张器300具有近端302,近端302包括密封件400和手柄部306,手柄部306配置为在扩张器300经过主体构件10向远侧推进时由使用者抓住。
[0031]扩张器300限定纵向通道308,纵向通道308在扩张器300中从其近端302到其限定了开口310的远端304延伸。纵向通道308限定直径“D”并配置为可移除式地容纳一个或多个手术器件“I”(图7),例如套管针、内窥镜或手术吻合器。纵向通道308的直径“D”可以在大约3mm至大约15mm范围内,或可以基本在大约5mm至大约12mm范围内。但是,此处关注的是具有基本较大及较小尺寸的手术器件的使用,如限定了具有基本较大或较小尺寸“D”的纵向通道308以便容纳这种手术器件的扩张器300。在一实施例中,纵向张开通道308由至少一个隔件分隔成多个单腔(未示出)。每个单腔可以为基本类似或基本不同的尺寸,每个单腔配置以容纳手术器件。
[0032]扩张器300可以由任何生物相容性材料形成。该生物相容性材料具有足够刚性以便当其插入纵向通道12时促使可张开件200的可张开段206向外,从而可张开件200从其正常状态转换到其张开状态。
[0033]现在结合图4和图7,密封件400与扩张器300的近端302相连,也可以安装在近端302上。密封件400限定孔口402并适于当手术器件“I”插入时从闭合状态(图4)转换到打开状态(图7)。在闭合状态,孔口402限定大约0mm的第一尺寸“DS1”以便基本上防止在没有手术器件“I”时注入气体(未示出)从其中溢出。当手术器件“I”插入时,孔口402被强行打开,从而将密封件400转换到打开状态。在该状态下,孔口402限定了基本接近手术器件“I”的直径“DI”的第二尺寸“DS2”,使得密封件400与手术器件“I”形成基本液体紧密密封,从而基本上防止注入气体从密封件400溢出。手术器件“I”将通常限定基本在大约5mm至大约12mm范围内的直径。相应地,在第二状态下,孔口402将通常限定也基本在大约5mm至大约12mm范围内的第二尺寸“DS2”。但是,此处关注具有基本较大和较小直径的手术器件的使用,如具有适于容纳这种手术器件的孔口402的密封件400。
[0034]密封件400可以由任何生物相容性材料形成,该生物相容性材料为性质上至少半刚性使得密封件400可以在闭合与打开状态之间转换。密封件400可以是适合预期目的的任何密封件或瓣膜,即用于可移除式地容纳与其为密封关系的手术器件,包括但不限于狭缝瓣膜或零闭合瓣膜。
[0035]现在将讨论在微创操作的过程期间锚定装置1000的使用和功能。首先,腹腔(未示出)被吹入适合的如,例如CO2气体的生物相容性气体,使得腔壁被提高并远离其中容纳的内部器官和组织,提供进入腹腔的更大空间。如领域中的传统方式,注入可以用气腹针或类似设备进行。在注入前或随后,在组织“T”中产生切口14,切口14的尺寸可以根据手术操作的情况而变化。
[0036]在锚定装置1000插进切口14前,将扩张器300从主体构件10移除。此后,临床医师可以将手柄段100从第一状态(图1至图4)转换到第二状态(图5),以利于手柄段100的手动接合和主体构件10的插入。为了实现该转换,使用者至少部分地倒置手柄段100使得外表面102展示近曲率。当处于第二状态时,临床医师可以更容易地抓住手柄段100,例如,周凸缘106周围。
[0037]然后,可张开件200的远端206插入切口14并通过切口14向远侧推进。可选地,在插入期间临床医师可以旋转主体构件10,例如,箭头“B”的顺时针方向,使得螺旋形螺纹210利于可张开件200的向远侧推进。在可张开件200已经完全插进患者的组织“T”后,手柄段100返回到其第一状态使得周凸缘106与组织“T”接合。手柄段100可以形成与组织“T”的基本真空密封(见图6和图7)。
[0038]随后,扩张器300通过手柄段100中的孔口104插入纵向主体通道202,向远侧通过及插进可张开件200。在扩张器300的向远侧推进时,其远端304接合内凸面208,从而迫使多个可张开段206向外以及使可张开件200从正常状态(图6)转换到张开状态(图7)。如前讨论的,在正常状态,可张开件200限定第一直径“D1”,在张开状态,可张开件200限定第二且更大直径“D2”。
[0039]在从第一状态到第二状态的转换期间,可张开件200向外张开,向组织“T”施加力“F”使切口14扩大。力“F”在组织“T”中产生试图闭合切口14的对应偏置力“FB”。力“F”和“FB”合作用以基本液体紧密密封的方式将可张开件200固定和锚定在组织“T”中,使得基本上防止注入气体围绕锚定装置1000溢出。另外,当插入组织“T”时,螺旋形螺纹210设置在组织“T”的远侧或近侧,从而进一步确保固定和将可张开件200锚定在组织“T”中。
[0040]最后,插入手术器件“I”及通过与扩张器300的近端302相连的密封件400,通过纵向扩张通道308及最终通过位于扩张器300的远端304的开口310将其向远侧推进。因此,可以使用手术器件“I”实施剩余手术操作。
[0041]当手术操作完成时,手术器件“I”通过密封件400从扩张器300移除。然后扩张器300通过纵向主体通道202和通过手柄段100中的孔口104从可张开件200移除。在扩张器300的移除期间,力“F”消失,组织“T”中的对应的偏置力“FB”也消失,从而利于可张开件200的移除。然后使用者可以将手柄段100从第一状态转换到第二状态及从切口14移除主体构件10,在移除期间可选择地旋转主体构件10。然后可以闭合切口14。
[0042]虽然此处结合附图已经描述了本公开的示意实施例,但是上述说明、公开及附图不应该被视为限制,而仅仅是具体实施例的范例。因此,应理解的是,该公开并不局限于这些精确的实施例,本领域的技术人员可以施加没有超出该公开的范围或实质的各种其他改变和改进。
Claims (12)
1.一种手术锚定装置,其包括:
主体构件,其限定了沿主体构件的纵轴延伸的纵向通道,主体构件包括适于在第一初始状态与第二张开状态之间转换的可张开件,所述可张开件具有由狭缝分隔的相邻的第一和第二可张开段,其中当所述可张开件从第一初始状态向第二张开状态转换时,所述第一和第二可张开段径向向外张开;
扩张器,其至少部分地位于主体构件的纵向通道内,并且尺寸为在扩张器插入纵向通道时使可张开件转换到第二张开状态,从而利于主体构件相对于组织的固定,扩张器限定了用于容纳的纵向扩张通道和手术器件通道;以及
密封件,其相对于扩张器安装,密封件适于建立与容纳在扩张器中的手术器件相关的基本密封。
2.根据权利要求1所述的手术锚定装置,其中可张开件包括多个相对于纵轴斜向设置的内凸面,扩张器的尺寸为在扩张器插入主体构件的纵向通道时与内凸面接触,以使所述第一和第二可张开段相对于纵轴至少径向向外运动及使可张开件转换到第二张开状态。
3.根据权利要求2所述的手术锚定装置,其中所述第一和第二可张开段均包括一内凸面。
4.根据权利要求1所述的手术锚定装置,其中所述第一和第二可张开段由基本纵向的狭缝分隔。
5.根据权利要求2所述的手术锚定装置,其中可张开件包括适于当主体构件处于第一初始状态时利于主体构件在组织中推进的外螺旋形螺纹。
6.根据权利要求1所述的手术锚定装置,其中主体构件包括适于由使用者手动接合及相对于主体构件的纵轴径向向外下垂的手柄段。
7.根据权利要求6所述的手术锚定装置,其中手柄段适于在正常状态与至少部分地倒置的状态之间转换。
8.根据权利要求7所述的手术锚定装置,其中手柄段由弹性材料构成。
9.根据权利要求8所述的手术锚定装置,其中手柄段包括适于当手柄段处于正常状态时与组织接触的周凸缘。
10.根据权利要求9所述的手术锚定装置,其中周凸缘适于在手柄段从至少部分地倒置的状态转换到正常状态期间建立与组织的真空密封。
11.根据权利要求1所述的手术锚定装置,其中密封件包括凝胶材料。
12.根据权利要求1所述的手术锚定装置,其中密封件包括自动愈合的泡沫材料。
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2013
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2014
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2015
- 2015-03-06 JP JP2015044244A patent/JP2015142748A/ja active Pending
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2016
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Also Published As
Publication number | Publication date |
---|---|
ATE525968T1 (de) | 2011-10-15 |
CN101401720A (zh) | 2009-04-08 |
EP2044897A1 (en) | 2009-04-08 |
US20170007230A1 (en) | 2017-01-12 |
JP5390156B2 (ja) | 2014-01-15 |
AU2008229793A1 (en) | 2009-04-23 |
ES2373805T3 (es) | 2012-02-08 |
JP2009090110A (ja) | 2009-04-30 |
EP2044897B1 (en) | 2011-09-28 |
CA2640393C (en) | 2015-12-15 |
JP2015142748A (ja) | 2015-08-06 |
US20140303669A1 (en) | 2014-10-09 |
JP2014061393A (ja) | 2014-04-10 |
US8795326B2 (en) | 2014-08-05 |
US20090093850A1 (en) | 2009-04-09 |
US9474518B2 (en) | 2016-10-25 |
CA2640393A1 (en) | 2009-04-05 |
AU2008229793B2 (en) | 2013-03-21 |
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