CN112386286A - 解剖电极、外科器械及用于制造切割电极的方法 - Google Patents
解剖电极、外科器械及用于制造切割电极的方法 Download PDFInfo
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Abstract
发明的方法用来制造用于外科器械(11)的解剖电极,其中该方法避免在解剖电极(23)处附接塑料体后施加用于分离解剖电极(23)的横截面的力。对于制造解剖电极(23)而言,它从设有额定断裂位置(30)的材料坯料(29)开始。它的尺寸确定为使其分离在特别低的力的情况下是可能的,使得力也可通过塑料体传递。额定断裂位置(30)将材料坯料(29)分成第一区段(31)和第二区段(32),第一区段专门用于材料坯料(29)在模具(37)中的处理和定位,第二区段在模具中空空间(40)中自支承地突出且由塑料包覆成型。在移除后,第一区段(31)可容易地从解剖电极(23)断裂。产生的断裂边缘(44)形成理想的切割刃。
Description
技术领域
本发明涉及一种用于制造用于外科器械、尤其是融合和解剖器械的解剖电极的方法,以及通过该方法制造的解剖电极和包括相应切割电极的外科器械。
背景技术
US8740901B2公开了一种用于密封和切割脉管(即,用于组织融合和解剖)的外科器械,其中组织密封以及组织解剖是通过电进行的。限定在两个夹爪部件的凸缘处的密封电极用于组织密封,该电极通过夹持在凸缘之间的组织传导电流,让组织加热并由此凝结。以此方式,可将由器械夹紧的脉管关闭。因此,容纳在其中一个夹爪部件中的解剖电极用于脉管解剖。取决于实施例,解剖电极可嵌入带有不同深度的绝缘材料中,使得仅解剖电极的窄侧和其平坦侧的部分是可接近的。
EP0852480B1示出了一种手术刀状的电外科器械,平坦且呈刮铲状的电极在其两个平坦侧上设有厚绝缘涂层。该涂层也覆盖窄侧,但是在那里相对薄。因此,源自器械的射频电流将主要流经器械的边缘。
从EP3132765A1也已知这种器械。该器械在设有解剖电极的其上夹爪部件中包括绝缘体,该绝缘体在中央包括朝相对的夹爪部件的反支承件对准的窄壁区段。解剖电极嵌入在该壁区段的窄侧中。
从US2016/0249975A1基本上也可看出带有切割电极的绝缘体的构造。解剖电极由具有不同欧姆电阻的窄条状金属部分形成。
另外的现有技术由US8,394,094B2形成。其提出在两个绝缘元件之间支承解剖电极,两个绝缘元件覆盖解剖电极的平坦侧并且不覆盖解剖电极的窄侧。
外科器械中所看到的趋势转向精致但是却非常强大且可靠操作的器械。这种器械必须在短时间内产生尽可能精确的切割。为了能够同时进行组织凝结,这以尽可能低的电流进行。特别是在其中凝结电极和解剖电极以有限的功率同时从同一发生器馈送的情况下,实现节能切割可能相当重要。
已经证明,由此解剖电极的几何形状及其绝缘是决定性的。然而,对应的解剖电极难以制造。
发明内容
由此出发,本发明的目的在于提供一种用于制造解剖电极的方法。
该目的通过根据权利要求1的方法解决:
发明的方法是基于从导电材料提供平坦的材料坯料(优选地金属板坯料),其包括形成后续的电极的区段以及仅用于处理的区段。材料坯料设有额定断裂位置,额定断裂位置将材料坯料分成第一区段和第二区段。第一区段仅用于处理,而第二区段形成后续的电极。材料坯料例如是薄金属板,其厚度取决于应用可具有1/10mm的分数直到多个1/10mm的范围。在优选的实施例中,厚度具有0.1mm的量。金属可为钢,其中钢优选是不易延展的,特别是不可塑性变形的。
额定断裂位置优选由线状区形成,在该线状区中,金属板坯料的厚度减小。厚度减小可通过沿材料坯料的一个平坦侧(优选地从其一个边缘延伸到另一边缘)的直的或弧形的凹槽形成。备选地,也可提供两个凹口或凹槽,其布置在材料坯料的两个相对的平坦侧并且具有相同的位置和相同的路线。换句话说,它们彼此平行地定向并且限定与材料坯料的平坦侧正交的区域。
额定断裂位置可通过磨削、铣削、蚀刻、压纹、辊磨或类似方法来产生,这些方法适合于局部减小材料坯料的厚度。此外,也可能通过一系列穿孔或槽或通过局部材料改变(例如通过局部材料脆化)来形成额定断裂位置。局部材料脆化可由热引起,例如通过局部激光硬化。
在下一步骤中,将具有额定断裂位置的材料坯料插入模具的刻模中,其在接触的情况下包围第一区段,使得第二区段在模具的凹处或中空空间中突出。由此,模具优选地构造成使得额定断裂位置精确地定位在中空空间的边缘处。在下一步骤中,将塑料插入模具中,使得其围绕第二区段流动,并有可能渗透通过设在第二区段中的穿孔。因此,获得了塑料体与第二区段之间的形状配合。优选的模制工艺是注射模制。
在打开模具并移除其中保持有材料坯料的塑料体之后,使材料坯料的第一区段在第二区段的额定断裂位置处断裂(例如通过手或借助于镊子或另一合适的工具)。沿塑料体的边缘形成断裂边缘,在该断裂边缘处,材料坯料的第二区段保持未覆盖而作为完成的切割刃。
由于断裂,切割刃很粗糙,并且不需要后处理。最大限度地减少了由于后续处理步骤造成的塑料体的损坏或应力。解剖电极的金属板优选对称地布置在塑料体中。
该方法允许直接在塑料体处产生导电的、近似线状的优选为金属的切割刃,该切割刃可构造为呈一个部分或多个部分的形式,而无需使解剖电极的平坦侧的部分保持未覆盖。为了分离第一区段,抓取器、钳子等不必接近任何表面区域。切割刃可与塑料体齐平终止,或略微伸出塑料体,或者也可略微终止于塑料体的邻接表面以下。由于电流在解剖电极的窄断裂边缘上的限制,制造因此简单并且以可靠的工艺方式可实现高质量,并且允许产生最高的切割质量。由此,解剖电极可由金属或导电陶瓷构成。发明的方法允许特别精确地制造解剖电极,其中电极居中地嵌入塑料体中,使得电极两侧的塑料壁具有相同的厚度。
如果材料坯料的第一区段至少与第二区段一样大,则在制造期间的处理以及将第一区段与利用塑料体包覆成型的剩余第二区段的后续分离也可非常容易手动地进行。
如果第一区段通过至少一个且优选地至少两个销定位在模具中的正确位置,则获得材料坯料在模具中的特别可靠的定位。
额定断裂位置优选地构造成具有减小的材料厚度的窄条状(即,线状)区域。它可通过对材料坯料的一侧或两侧进行磨削、辊磨或蚀刻或其他方式形成。材料厚度减小的区域可为凹槽。凹槽可具有圆形、矩形、梯形、三角形或弧形的横截面。不受其形状支配,凹槽优选地为材料坯料的厚度的至少三分之一那么深,且更优选地为材料坯料的厚度的一半那么深。凹槽深度以及材料坯料的厚度必须正交于材料厚度的一个平坦侧测量。如果凹槽从两侧插入到材料坯料中,其深度具有为材料坯料的厚度的优选1/6至1/4的量。
利用上述发明的方法产生的解剖电极包括塑料体,其中嵌入了从材料坯料的第二区段露出的电极。它包括未覆盖的断裂边缘,该断裂边缘形成电切割刃。
优选地,塑料体由柔性塑料、特别是弹性塑料(诸如,例如硅树脂或类硅树脂的塑料)、弹性体等构成。
优选地,电极包括均匀恒定的厚度,其中电极可在断裂边缘的正好附近具有减小的厚度,使得形成邻接断裂边缘的渐缩区。该渐缩区有助于切割刃处的电流集中,使得可实现快速且适当的切割。
塑料体优选地构造成至少延伸直到渐缩区,并且进一步优选地延伸到渐缩区中或越过渐缩区,使得电极的未覆盖的断裂表面优选地不大于解剖电极的横截面。这意味着电极的侧面优选地由塑料覆盖直到断裂边缘。
塑料体包括在断裂边缘的两侧的面,其宽度优选地小于电极的厚度(宽度)的两倍。这避免了组织挫伤和机械分离,并确保了完全或主要电气地而非机械地进行所需的切割。
附图说明
本发明的优选实施例的进一步的细节从附图、说明书或权利要求书得出。附图示出:
图1是呈示例性构造并在简化透视图中的外科器械,
图2是由根据图1的器械支承的工具的简化垂直切割示图,
图3是根据图2的工具的解剖电极的简化透视图,
图4是用于制造解剖电极的材料坯料的侧视图,
图5是带有材料坯料的模具的展开图,其正交于模具的分离平面切开,
图6是在额定断裂位置的区域内的材料坯料的部分切割示图,
图7是在额定断裂位置的区域中的材料坯料的备选实施例的部分切割示图,
图8是设有塑料体的材料坯料,用于制造解剖电极,
图9是第一实施例中的垂直部分切割示图中的解剖电极,以及
图10是根据图9的示图但是在修改的实施例中的解剖电极。
具体实施方式
图1示出了外科器械11,其特别地构造成用于患者的腹腔镜治疗。器械11包括壳体12,该壳体12上设有把手13和手杆14。工具17支承在远离壳体12延伸的柄15的远端16处。该工具包括第一夹爪部件18和第二夹爪部件19,通过促动手杆14可使第一夹爪部件和第二夹爪部件中的至少一个朝向彼此移动和远离彼此移动,以便能够将组织夹在中间。
夹爪部件18,19形成钳状工具17,其构造成用于组织密封和/或组织解剖。为此,夹爪部件18,19可与电压源的不同极连接,并由此在其支腿之间限定凝结间隙20,21,如例如大体上从EP3132765A1公知的那样。在这些凝结间隙20,21之间优选地布置有弹性的反支承件22,并且在相对的夹爪部件19中布置有解剖电极23。它包括安装区段或基部区段24和壁区段25,两者均由塑料、优选地由弹性塑料构成,其中优选地由金属构成的电极26嵌入壁区段25中,并且如果适用的话,还至少部分地在基部区段24中延伸。在面侧27处,仅电极26的窄边缘28保持未覆盖。除此以外,电极26嵌入壁区段25和基部区段24中,使得其电绝缘。
工具17还可为另一器械的一部分,例如可以以内窥镜方式使用的器械或构造成用于开放式手术用途的器械。
解剖电极23的制造如下:
如图4中所示,制造从材料坯料29开始。材料坯料29由合适的电极材料构成,例如钢合金、钛合金或导电陶瓷。优选地,材料坯料29由弹簧弹性材料构成,但是该弹簧弹性材料不提供任何显著的塑性变形能力。特别地,材料的断裂点在没有事先塑性变形的情况下达到是优选的。
材料坯料29设有优选呈线形的额定断裂位置30,其将材料坯料29的第一区段31与第二区段32分开。第二区段32形成后续的电极26,而第一区段31仅用于临时处理。额定断裂位置30是材料坯料29的材料的线状削弱部,例如借助于在材料坯料29中制造的凹槽33,如从图7明白的那样。代替仅在材料坯料29的一个平坦侧上设置的一个凹槽33,额定断裂位置30也可由彼此平行地设在材料坯料29的平坦侧的背对彼此的两个凹槽33,34形成,如图6中所示的那样。由此,两个凹槽33,34沿相同的路径延伸并且布置在相同的位置。
与仅设置一个凹槽33还是设置两个凹槽33,34无关,它们可通过任何合适的方法来制造,例如通过磨削、铣削、压纹、辊磨或蚀刻。凹槽33,34的横截面可取决于所选择的方法和期望的边缘形状产生为圆形、成角度、三角形、四边形、梯形的或不确定的形式,特别地通过蚀刻方法。然而,凹槽的深度和宽度也通过蚀刻方法限定。
可在第一区段31中提供一个或多个定位结构,例如呈定位孔35,36的形式。它们可用于例如将材料坯料29定位在具有两个半模38,39的模具37(如从图5明白的那样)中。
半模38,39分别在材料坯料的第一区段31的区域中设有以其形式和深度构造的刻模,如果模具37闭合,材料坯料29在第一区段31处被保持,其中两个半模38,39在第一区段31处二维地靠紧。特别地,半模38,39的保持第一区段31的区域在额定断裂位置30处基本上平齐地终止。如果关闭模具37,则在第二区段32周围产生中空空间40,第二区段32以悬臂方式延伸到该中空空间40中。然而,该中空空间40在额定断裂位置30处齐平地终止。
为了在闭合模具37的情况下制造解剖电极23,区段32填充有合适的塑料(例如硅树脂),其由此也可穿过可在第二区段32中构造的孔41,以用于材料坯料处的塑料的形状配合固定。孔的形状可为圆形或成角度的。
在塑料固化并打开模具37之后,可将其上形成有塑料体42的材料坯料29从模具37移除。如图8中所示,额定断裂位置30现在直接邻接壁区段25的上端。如果适用,附接到材料坯料29的区段32的线缆43延伸出塑料体42。
为了完成解剖电极23,现在使第一区段31相对于塑料体42在由箭头P表征的方向上来回移动,由此第一区段31在额定断裂位置30处从第二区段断裂。由此形成断裂边缘44,如图9中所示的那样。从以前的凹槽32产生渐缩区段45,使得断裂边缘44的宽度小于嵌入塑料体中的第二区段32的厚度。断裂边缘44的宽度以及第二区段32的厚度在图9中水平地测量,即,在任何情况下正交于第二区段32的平坦侧。
壁区段25在断裂边缘44的两侧上在其面侧27包括平面或圆形的表面区段46,47,其宽度在所有情况下优选地为第二区段32的厚度的最多十倍,并且进一步优选地最多三倍,或者此外最多两倍。
虽然壁区段25可在面侧直接邻接渐缩区段45,如图9中所示的那样,但是它也可根据图10延伸到渐缩区段45中,使得渐缩区段45也可部分地或完全地由塑料覆盖并且仅断裂边缘44保持未覆盖。这样,实现了特别高的电流集中。
断裂边缘44由于断裂而可能是粗糙的,并且不需要后处理。根据图8,在使第二包覆成型区段32的第一区段31断裂之后,完成了切割电极23并且可将其安装在根据图1的器械中。在断裂边缘处,由于支持解剖的粗糙度,局部电流集中在解剖期间发生。然而,也可能通过例如抛光(特别是电抛光)来对断裂边缘进行后处理。
结合图5和图8-10描述的细节类似地适用于根据图6的材料坯料29和根据图7的材料坯料29。
发明的方法用来制造用于外科器械11的解剖电极,其中该方法避免了在将塑料体附接到解剖电极23之后施加用于分离解剖电极23的横截面的力。对于制造解剖电极23而言,它是从设有额定断裂位置30的材料坯料29开始。它的尺寸确定为使其分离在特别低的力的情况下是可能的,使得力也可通过塑料体传递。额定断裂位置30将材料坯料29分离成第一区段31以及第二区段32,第一区段31专门用于材料坯料29在模具37中的处理和定位,第二区段32在模具中空空间40中自支承地突出且由塑料包覆成型。
在移除之后,第一区段31可容易地从解剖电极23断裂。产生的断裂边缘44形成理想的切割刃。
参考标号列表
11 器械
12 壳体
13 把手
14 手杆
15 柄
16 柄15的远端
17 工具
18 夹爪部件
19 夹爪部件
20 凝结间隙
21 凝结间隙
22 反支承件
23 解剖电极
24 基部区段
25 壁区段
26 电极
27 面侧
28 解剖边缘
29 材料坯料
30 额定断裂位置
31 第一区段
32 第二区段
33 凹槽
34 凹槽
35 定位孔
36 定位孔
37 模具
38 半模
39 半模
40 中空空间
41 孔
42 塑料体
43 线缆
44 断裂边缘
45 渐缩区段
46 表面区段
47 表面区段
P 箭头。
Claims (15)
1.用于制造用于外科器械(11)、特别是融合和解剖器械的解剖电极(23)的方法,包括以下步骤:
提供材料坯料(29),
提供额定断裂位置(30),所述额定断裂位置布置在所述材料坯料(29)处,将所述材料坯料分成第一区段(31)和第二区段(32),
将设有所述额定断裂位置(30)的所述材料坯料(29)插入模具(37)中,所述模具包括刻模,所述刻模在接触的情况下保持所述第一区段(31)并在所述第二区段周围限定中空空间(40),
将塑料插入所述模具(37)中以用于产生包围所述第二区段(32)的塑料体(42),
打开所述模具(37)并移除其中保持有所述材料坯料(29)的所述塑料体(42),
使所述第一区段(31)沿所述额定断裂位置(30)从所述第二区段(32)断裂。
2.根据权利要求1所述的方法,其特征在于,所述第一区段(31)至少与所述第二区段(32)一样大。
3.根据前述权利要求中任一项所述的方法,其特征在于,所述第一区段(31)借助于至少一个定位结构(35)以正确的位置布置定位在所述模具(37)中。
4.根据前述权利要求中任一项所述的方法,其特征在于,在插入所述模具(37)中之前,所述材料坯料(29)设有电连接导体(43)。
5.根据前述权利要求中任一项所述的方法,其特征在于,所述额定断裂位置构造为带有减小的材料厚度的线状区域。
6.根据权利要求5所述的方法,其特征在于,带有减小的材料厚度的所述区域由布置在所述材料坯料(29)的至少一个平坦侧的至少一个凹槽(33,34)形成。
7.根据权利要求6所述的方法,其特征在于,所述凹槽(33,34)通过蚀刻工艺产生。
8.解剖电极,特别是根据前述权利要求中任一项所述的方法制造的解剖电极,其特征在于,所述解剖电极包括塑料体(42),电极(26)嵌入所述塑料体中,所述电极具有保持未覆盖的断裂边缘(44)。
9.根据权利要求8所述的解剖电极,其特征在于,所述塑料体(42)由柔性塑料、特别是弹性塑料、特别是硅树脂制成。
10.根据权利要求8或权利要求9中的一项所述的解剖电极,其特征在于,所述电极(26)具有均匀恒定的厚度,并且在所述断裂边缘(44)的正好附近包括减小的厚度,使得形成邻接所述断裂边缘(44)的渐缩区段(45)。
11.根据权利要求10所述的解剖电极,其特征在于,所述塑料体(42)构造成延伸直到所述渐缩区段(45)。
12.根据权利要求10所述的解剖电极,其特征在于,所述塑料体(42)构造成延伸越过到所述渐缩区段(45)中。
13.根据权利要求8至权利要求12中任一项所述的解剖电极,其特征在于,所述解剖电极(23)包括由塑料穿透的孔(41)。
14.根据权利要求8至权利要求13中任一项所述的解剖电极,其特征在于,所述断裂边缘(44)的宽度小于所述电极(26)的厚度,优选地为所述电极(26)的厚度的至多一半那么大。
15.具有根据权利要求8至权利要求14中的任一项所述的解剖电极(23)的器械。
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- 2020-07-30 KR KR1020200094925A patent/KR20210020784A/ko unknown
- 2020-07-31 BR BR102020015739-6A patent/BR102020015739A2/pt active Search and Examination
- 2020-08-06 US US16/987,145 patent/US20210045802A1/en active Pending
- 2020-08-07 JP JP2020135169A patent/JP2021041152A/ja active Pending
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Also Published As
Publication number | Publication date |
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US20210045802A1 (en) | 2021-02-18 |
EP3777739A1 (de) | 2021-02-17 |
JP2021041152A (ja) | 2021-03-18 |
PL3777739T3 (pl) | 2022-06-20 |
BR102020015739A2 (pt) | 2021-02-23 |
KR20210020784A (ko) | 2021-02-24 |
RU2020126051A (ru) | 2022-02-07 |
EP3777739A8 (de) | 2021-03-31 |
EP3777739B1 (de) | 2022-04-20 |
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