CN102378600B - 具有增强的热传递的冷冻外科仪器 - Google Patents
具有增强的热传递的冷冻外科仪器 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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Abstract
利用改进的热传递特性的冷冻外科仪器和方法。冷冻手术装置包括：管状壳体；冷冻剂供应通道；热交换增强构件，位于壳体中，沿壳体的纵向轴线布置；环形冷却通道，位于热交换增强构件与管状壳体之间；尖头冷却和冷冻剂流引导段，将冷冻剂流的温度传导至尖头；以及绝缘元件，位于管状壳体中。
Description
发明人：Nir Berzak，Simon Sharon，Igal Shteiman，Eytan Shilder
背景技术
1.技术领域
本发明的实施方式总体上涉及冷冻手术装备，并且更具体地，涉及冷冻手术治疗方法和装置，该方法和装置在外表面与内部流体冷冻剂之间具有增强的热传递。
2.相关技术的说明
冷冻探针众所周知用于执行冷冻手术程序，当液体冷冻剂从外部来源供应至冷冻探针时这些冷冻探针“沸腾”液体冷冻剂。通常，冷冻剂以两相流体的形式被输送至冷冻探针。这由于以下事实引起，即液体冷冻剂的某一小部分在到达冷冻探针的途中，因为输送软管不完美的热绝缘而不可避免地被蒸发。不应用特殊的措施，就不能通过在冷冻尖头(冷冻探针的远侧段)的内部腔室中完全分开液体相和气体相来改善冷冻剂的两相条件。另外，特别对于作为冷冻剂的氮的使用，液体氮通过产生氮气垫与更温暖的实心表面相互作用，其称为赖登福效应(Liedenfrost effect)，因而相当大地降低从较温暖表面吸收热量的能力。不应用这样的特殊手段，就不能完全地使用冷冻剂的液体小部分，来促使尽可能靠近目标表面发生流体冷冻剂的部分相变而有效地冷冻被治疗的组织。
已知该问题的解决方法。例如，美国专利No.4,726,194以导管及其主动加热为特征，液体氮流动通过该导管。为了扩大沸腾可利用的容积，该导管在填充有原棉的膨胀室中终止。
另外一个实例是美国专利No.4,082,096，其以接收液体氮的可变形块为特征，该块被液体氮不能透过的膜所包围。
其他的实例包括美国专利No.5,520,682、No.6,565,556、No.4,946,460、No.7,189,228和No.5,674,218，其中的每一个都以膨胀室为特征。
发明内容
背景技术并未提供一种克服以下问题的解决方法，该问题是在冷冻外科仪器(例如冷冻探针)内引起靠近较温暖表面发生沸腾。
申请人通过考虑沸腾的氮流体流动的性质，已发现对于背景技术中这些问题的有利解决方法。他们的发现提供了不受背景技术的缺点阻碍的解决方法。
本发明的实施方式提供一种冷冻外科仪器，其具有独特定位和布置的热交换器。该热交换器位于冷冻剂供应通道和/或冷冻尖头中。该构造/布置促进与冷冻剂的热交换。
本发明的实施方式克服背景技术中的以上问题，这是通过以下方式：促使流体流过环形通道，促使流体在压力下流至冷冻手术仪器的内表面，或者通过冷却一个增强元件，该增强元件的至少一部分直接与冷冻手术仪器的外表面接触，或者它们的组合。
靠近于冷冻手术仪器内表面的减小的用于流动的横截面，以及通过部分相变过程的流体的膨胀，使得相当大地增加流动的速度，并且因而增加从内表面至流体的热传递。在控制该结构内的期望特殊位置或元件上的温度传递的同时，该结构允许两相冷冻剂流入和流出冷冻外科仪器。在将流体压在仪器内表面上的情形中，沸腾更靠近该表面发生，因而增加热传递。将流体的液体相带至靠近冷冻尖头的内表面附近，以及在内表面上引导获得的随后沸腾和蒸发的液体相，以便解决以上问题。该元件可由金属或陶瓷或其他任何材料制成，该材料在冷冻剂流体的沸腾条件的低温下保持其完整性。
本发明的一方面是提供一种冷冻外科仪器，其包括：管状壳体，具有纵向轴线，近端(proximal end)和在远端处的尖头(tip)；冷冻剂供应通道，沿纵向轴线从近端延伸至远端，该冷冻剂供应通道具有接近于近端的上游部分和接近于远端的下游部分；热交换增强构件，位于壳体中，沿纵向轴线布置，并且围绕供应通道的下游部分中的至少一些；环形冷却通道，位于热交换增强构件与管状壳体之间，该环形冷却通道与冷冻剂排出通道相通，环形冷却通道中的冷冻剂吸收环形冷却通道中的热量；尖头冷却和冷冻剂流引导段(tip cooling and cryogen flow directing section)，位于远端处并且与冷冻剂供应通道相通，该尖头冷却和冷冻剂流引导段使冷冻剂流的流动偏转至尖头，以便冷却该尖头；以及绝缘元件，位于管状壳体中，沿纵向轴线布置，围绕冷冻剂供应通道的一部分，并且在近端和热交换增强构件之间，该绝缘元件和冷冻剂供应通道的下游端限定热交换区域的边界。
本发明的另一方面提供一种冷冻外科仪器，其包括：管状壳体，具有纵向轴线、近端、和尖头远端；冷冻剂供应通道，沿纵向轴线从近端延伸至远端，该供应通道具有接近于近端的上游部分和接近于远端的下游部分；热交换增强构件，位于壳体中，沿纵向轴线布置，并且围绕供应通道的下游部分中的至少一些，该增强构件具有围绕纵向轴线沿圆周布置并纵向延伸穿过该增强构件的多个返回通路；流偏转器(flow deflector，导流片)，位于尖头与供应通道之间，该流引导器被适配并构造成将从供应通道流出的冷冻剂流偏转至返回通路并且吸收热量，由此冷却尖头，该流引导器固定地并且与供应通道隔开地布置。冷冻剂供应通道中的冷冻剂流推动从冷冻剂供应通道流出的冷冻剂流入返回通路中。多个返回通路的横截面积的总和大约等于供应通道的横截面积。
本发明的另一方面提供一种冷冻探针，其包括：管状壳体，具有纵向轴线、近端和在远端处的尖头；热交换增强构件，位于壳体中，沿纵向轴线布置，接近于远端，该增强构件具有沿纵向轴线延伸穿过其中的冷冻剂供应通道并且具有径向流动段(radial flow section)，冷冻剂通过该段径向流过该增强构件；外围返回通道，位于增强构件与管状壳体之间，该外围返回通道与径向流动段和冷冻剂排出通道相通；以及尖头冷却和冷冻剂流引导段，位于远端处并与冷冻剂供应通道相通，尖头冷却和冷冻剂流引导段将冷冻剂流的温度传导至该尖头。在冷冻剂供应通道中的冷冻剂流推动冷冻剂穿过径向流动段进入外围返回通道中。
本发明的又一方面提供一种冷冻外科仪器，其包括：轴，具有中心轴线、上游冷冻剂供应段、下游热交换区域、以及在轴的与冷冻剂供应段相对一端处的实心尖头；热交换增强构件，位于轴中的热交换区域中并沿中心轴线延伸，该增强构件具有沿中心轴延伸穿过其中的轴向冷冻剂输送通道；冷冻剂返回通道，位于热交换增强构件与轴之间；以及冷冻剂流偏转器，位于尖头与热交换增强构件之间，该偏转器与该增强构件隔开并且被适配并构造成将膨胀的冷冻剂偏转至返回通道。该冷冻外科仪器不包括冷冻剂膨胀室。
又一方面提供了一种冷冻外科仪器，其包括：轴，具有中心轴线、上游冷冻剂供应段、下游热交换区域、及在轴的与冷冻剂供应段相对一端处的实心尖头；热交换增强构件，位于轴中的热交换区域中并沿中心轴线延伸，该增强构件具有沿中心轴线延伸穿过其中的轴向冷冻剂输送通道和冷冻剂返回通道；以及冷冻剂流偏转器，位于尖头与热交换增强构件之间，该偏转器与该增强构件隔开并且被适配并构造成将冷冻剂偏转至返回通道中。该冷冻外科仪器不包括冷冻剂膨胀室。
本发明的进一步方面提供一种使用冷冻外科仪器的治疗方法。该方法包括：提供冷冻外科仪器；将该冷冻外科仪器插入待治疗的组织中；将冷冻剂输送至冷冻外科仪器的供应通道；通过封闭冷冻手术装置的尖头的反射表面，从供应通道反射冷冻剂；以及迫使冷冻剂穿过冷冻外科仪器的热交换区域，以便在反射表面处以及热交换区域处发生部分相变。
本发明的又一方面提供一种使用冷冻外科仪器的治疗方法。该方法包括：提供冷冻外科仪器；将该冷冻外科仪器插入待治疗的组织中；通过冷冻外科仪器的供应通道输送冷冻剂至冷冻外科仪器的中空尖头，以便冷冻剂在该尖头处沸腾；以及通过封闭冷冻手术装置的尖头的反射表面，从供应通道反射冷冻剂
本发明的这些、另外的和/或其他方面和/或优点：在以下的详细描述中阐述；可能从详细描述中推断出；和/或通过本发明的实践获知。
附图说明
从结合附图的对实施方式的详细描述中，本发明将变得更容易理解，附图中：
图1a是依照本发明实施方式的冷冻探针的纵向横截面图，具有为返回流提供的环形冷却通道和封闭尖头；
图1b更详细示出图1a的冷冻探针的一部分；
图1c是沿图1a的线I的冷冻探针的横截面图；
图2是依照本发明实施方式的冷冻探针的纵向横截面图，具有环形冷却通道，该通道设置用于开放冷冻尖头的返回流；
图3a是依照本发明实施方式的冷冻探针的纵向横截面图，具有多个凹槽，这些凹槽设置用于封闭冷冻尖头的返回流并且用于改进温度传递；
图3b是沿图3a的线II截取的冷冻探针的横截面图；
图4a是依照本发明实施方式的冷冻探针的纵向横截面图，具有多个凹槽，这些凹槽设置用于封闭冷冻尖头的返回冷冻剂流；
图4b是沿图4a的线II的冷冻探针的横截面图；
图5是依照本发明实施方式的冷冻探针的纵向横截面图，具有环形冷却通道，该通道设置用于开放冷冻尖头的返回流；
图6是依照本发明实施方式的冷冻探针的纵向横截面图，具有环形冷却通道，该通道设置用于封闭、任选的实心冷冻尖头的返回流；以及
图7和图8是流程图，图解治疗的各自示例方法，其每个都依照本发明的实施方式。
具体实施方式
现在将详细参考本发明的实施方式，这些实施方式的实例在附图中被图解，其中贯穿全文，同样的参考标号涉及同样的元件。通过参照附图，下面描述这些实施方式以解释本发明。
除非另外定义，此处使用的所有技术和科学术语都具有本发明所属技术领域的普通技术人员所通常理解的相同意思。虽然类似或等价于在此描述的方法和材料的一些方法和材料可用于实践或测试本发明，在以下描述适当的方法和材料。在冲突的情形下，专利说明书(包括定义)将进行控制。另外，这些材料、方法和实例仅为示例性的而非旨在限制。
术语“冷冻外科仪器(cryosurgical instrument)”在此涉及任何类型的冷冻仪器，包括但不限于冷冻探针和冷冻导管(cryocatheter)。虽然说明书中心围绕冷冻探针，其仅为示例性的目的，而非旨在限制。
参照图1a-1c，冷冻探针100包括管状壳体108，该壳体具有纵向轴线、近端和在远端处的尖头105(冷冻尖头)。优选尖头105是封闭的、任选的实心尖头，在其近端处由反射表面110封闭，该反射表面用作冷冻剂引导段，以倒转冷冻剂的流动。反射表面110还将冷冻剂流的温度传导至尖头105，并且还将尖头105从冷冻剂供应通道102分离。冷冻剂供应通道102沿纵向轴线从近端延伸至远端，冷冻剂供应通道102具有接近于近端的上游部分和接近于远端的下游部分。冷冻剂供应通道102从冷冻剂进口109接收冷冻剂，并且将冷冻剂供应至反射表面110。反射表面110示出为相对于流动方向的平坦垂直表面，然而反射表面可使用其他形状和方向，以改变引入流朝向返回冷却通道的方向。如所示出的，任选地并优选地，冷冻探针100缺乏膨胀室。
返回冷冻剂进入热交换增强元件101与管状壳体104的内表面之间的环形冷却通道107，增加冷冻剂的速度并且增强冷冻探针100与冷冻剂之间的热传递。热交换区域111如箭头所示：在热交换区域111处从外部环境吸收热量。然后冷冻剂通过冷冻剂排出通道103离开冷冻探针。
热绝缘体104优选地终止从冷冻探针100和冷冻剂排出通道103中的冷冻剂流的热传递，由此确定热交换区域111的边界。
图1b更详细地示出热交换增强元件101、尖头105、环形冷却通道107和管状壳体108。另外，通过箭头106示出冷冻剂流的方向，当冷冻剂到达反射表面110时，并然后通过环形冷却通道107返回。环形冷却通道107的尺寸优选被调整以便提供上述增加的冷冻剂速度，从而优选地，环形冷却通道107的横截面面积与供应通道102的横截面面积具有相同的等级，并且其中返回通道107中的冷冻剂流动的速度比在供应通道102中的冷冻剂流动的速度大；对于典型的冷冻探针，环形冷却通道107的这些尺寸将任选地并优选地达到1-2mm，但是更优选为0.1mm至0.3mm。反射表面110还优选地由任何适合传导冷至尖头105的材料构造，该尖头自身由适合变冷的材料构造；用于两个部件的材料的非限制性实例包括但不限于导热的金属，或者纯金属、合金或者合成物。
在冷冻探针100的操作中，冷冻剂通过冷冻剂进口109进入冷冻剂供应通道102，并且沿冷冻剂供应通道102向下移动直到其到达反射表面110。然后，冷冻剂冷却尖头105，并且然后通过环形冷却通道107返回，并且通过环形排出通道103被排出。
参照图2，冷冻探针200与冷冻探针100构造类似，除了探针200特征是中空尖头205。膨胀室210位于尖头105中(取代上述图1a和图1b中的冷冻探针100的反射表面)。
在冷冻探针200的操作中，冷冻剂通过冷冻剂进口209进入冷冻剂供应通道202，并且沿冷冻剂供应通道202向下移动直到其进入膨胀室210。然后冷冻剂在膨胀室210中膨胀并直接冷却尖头205。然后部分相变的冷冻剂通过环形冷却通道207返回，并且通过冷冻剂排出通道203排出。
膨胀室210与供应通道202的下游部分相通，并且被布置(i)以允许冷冻剂从供应通道202流出以膨胀并且冷却尖头205，并且(ii)以引导已流出冷冻剂供应通道202的膨胀冷冻剂流入环形冷却通道207中。由于在与205接触的周围吸热，热交换区域211增加至包括尖头205。
参照图3和3b，冷冻探针300特征是封闭、任选地实心尖头305，以及反射表面310优选位于尖头305处。如所示出的，与冷冻探针100同样的，冷冻探针300优选地缺乏膨胀室。与冷冻探针100不同的，冷冻探针300特征是多个凹槽307，这些凹槽优选为直凹槽，并且起用于接收膨胀的返回冷冻剂的多个返回通路的作用；凹槽307优选与冷冻剂排出通道303相通，用于然后将冷冻剂排出冷冻探针300。凹槽307围绕供应通道302的下游部分的至少一部分，并且优选关于纵向轴线沿圆周布置并纵向延伸。
以上构造增加返回流的速度。通过增加返回流的速度并且促使在凹槽307中发生冷冻剂的部分相变，热量通过在凹槽307处的沸腾直接从冷冻探针300吸收，并且通过引导热量通过接触表面301与308间接地吸收。热绝缘体304终止从冷冻探针300的热传递。热交换区域311如箭头所示：热量在热交换区域311处从外部环境吸收。
如图3b中所示，冷冻剂通过冷冻剂供应通道302移动，并且通过直凹槽307返回，这些凹槽位于管状壳体308的边缘处。
在冷冻探针300的操作中，冷冻剂通过冷冻剂进口309进入冷冻剂供应通道302，并且沿冷冻剂供应通道302向下移动直到其到达反射表面310。然后冷冻剂通过冷却反射表面310并且还通过冷却凹槽307来冷却尖头305。膨胀的冷冻剂然后通过凹槽307返回，并且通过冷冻剂排出通道303排出。
优选地，多个凹槽307的横截面面积总和大约等于供应通道302的横截面面积，并且由于部分相变，凹槽307中的冷冻剂流动的速度比供应通道302中的冷冻剂流动的速度大。
参照图4a-4c，冷冻探针400与冷冻探针300的结构类似，除了直凹槽407位于内部，接近冷冻剂供应通道402但是在其外部，并且被管状壳体408的内表面密封地覆盖(capped)。热交换区域411如箭头所示：在热交换区域411处从外部环境吸收热量。冷冻剂从热交换增强元件401吸收热量，热交换增强元件进而通过热传导性从热交换区域411中的管状壳体408吸收热量。仅通过冷冻剂供应通道402和直凹槽407冷却401。
在冷冻探针300和400两者中，冷冻剂的两相流(液体和气体)优选进入尖头305或405。然后该两相流暴露于尖头305或405的吸热表面部分，并且又以两相流被排出。在排出的两相流中，气体比液体的比率更高，然而，开口横截面与冷冻剂排出通道303或403的横截面大小类似，以便排出的两相流的速度更快。
参照图5，冷冻探针500的特征是中空尖头505，该中空尖头直接从冷冻剂供应通道502接收冷冻剂，并且随后冷却。冷冻剂通过多个径向通孔510返回至环形冷却通道507。优选地，在中空尖头505和环形冷却通道507表面上冷冻剂在压力下被迫穿过通孔510。因此，通孔510优选地延伸至中空尖头505中，该中空尖头用作膨胀室。环形冷却通道507如上述操作。
在冷冻探针500的操作中，冷冻剂通过冷冻剂进口509进入冷冻剂供应通道502，并且沿冷冻剂供应通道502向下移动直到其到达中空尖头505。然后冷冻剂膨胀并冷却尖头505。如所示出的，尖头505任选地特征是中空尖头505上的另外的实心尖头530，其在中空尖头505被冷却时被冷却。膨胀的冷冻剂然后通过通孔510返回至环形冷却通道507，由此提供对中空尖头505的另外冷却，并且通过冷冻剂排出通道303排出。冷冻剂流的方向如箭头506所示。
优选地，返回通道507的横截面面积大约等于供应通道502的横截面面积，并且还优选地，冷冻剂供应通道502中的冷冻剂流推动冷冻剂穿过径向流动段进入外围返回通道507。
参照图6，冷冻探针600在有些方面类似冷冻探针100，在于反射表面610封闭尖头605，尖头可任选地为实心。反射表面610优选地在尖头605与供应通道602之间起流偏转器的作用，并且固定地且与供应通道602隔开地布置。冷冻剂被推动通过环形冷却通道607，该环形冷却通道优选地特征是在径向流动段中的多个径向通孔631。这样的径向通孔631增加用于冷冻剂沸腾的空间，从而冷冻剂冷通过冷却反射表面610和返回通道607中的径向通孔631冷却尖头605。
图7是流程图，其图解依照本发明实施方式的冷冻外科仪器的治疗方法。该冷冻外科仪器可为作为非限制性实例的冷冻探针100、300、400和600中的任何一个。
在操作10中，提供冷冻外科仪器。在操作20中，将冷冻外科仪器插入待治疗的组织中。在操作30中，冷冻剂进入冷冻剂供应通道。在操作40中，冷冻剂被封闭尖头的反射表面反射，该尖头任选地为实心。在操作50中，冷冻剂被迫通过冷冻外科仪器的热交换区域，从而在反射表面处和在热交换区域处发生部分相变。在操作60中，沸腾的冷冻剂引起在冷冻尖头处形成冰球，并且引起周围组织结冰。
图8是流程图，其图解依照本发明实施方式的冷冻外科仪器的治疗方法。该冷冻外科仪器可为作为非限制性实例的冷冻探针200或500中的任何一个。
在操作10中，提供冷冻外科仪器。在操作20中，将冷冻外科仪器插入待治疗的组织中。在操作30中，冷冻剂进入冷冻剂供应通道。在操作40中，冷冻剂移动至中空的冷冻尖头。在操作50中，冷冻剂被压在冷冻尖头的表面上，从而在冷冻尖头处发生沸腾(以及任选地也发生在冷冻手术装置的热交换区域中)。在操作60中，部分相变的冷冻剂引起在冷冻尖头处形成冰球，并且引起周围组织结冰。
已提供各种特征/方面/部件/操作的实例，从而促进对本发明公开实施方式的理解。另外，已讨论不同的优选物，从而促进对本发明公开实施方式的理解。应理解的是，在此公开的所有实例和优选物旨在是非限制性的。
虽然已示出并个别地描述了本发明的所选实施方式，应理解的是，可组合所描述实施方式的至少一些方面。
同样虽然已示出并描述了本发明的所选实施方式，应理解的是，本发明不限于所描述的实施方式。而是，应认识到，在不偏离本发明的原理和精神的情况下，可对这些实施方式做出改变，本发明的范围由权利要求及其等价物来限定。
Claims (6)
1.一种冷冻外科仪器，包括：
管状壳体，具有纵向轴线、近端、和尖头远端；
冷冻剂供应通道，沿所述纵向轴线从所述近端延伸至所述尖头远端，所述供应通道具有接近于所述近端的上游部分和接近于所述尖头远端的下游部分；
热交换增强构件，位于所述壳体中，沿所述纵向轴线布置，并且围绕所述供应通道的下游部分中的至少一些，所述增强构件具有围绕所述纵向轴线沿圆周布置并纵向延伸穿过所述增强构件的多个返回通路；以及
流偏转器，位于所述尖头远端与所述供应通道之间，所述流偏转器被适配并构造成将从所述供应通道流出的冷冻剂流偏转至所述返回通路并且吸收热量，由此冷却所述尖头远端，所述流偏转器固定地并且与所述供应通道隔开地布置，
其中，所述冷冻剂供应通道中的冷冻剂流推动已从所述冷冻剂供应通道流出的冷冻剂流入所述返回通路中，并且
其中，所述多个返回通路的横截面积的总和大约等于所述供应通道的横截面积。
2.根据权利要求1所述的冷冻外科仪器，其中，所述返回通路是直的。
3.根据权利要求1所述的冷冻外科仪器，其中，所述冷冻剂吸收所述返回通路中的热量，并且在所述供应通路和所述返回通路中呈现两相流。
4.根据权利要求1所述的冷冻外科仪器，其中，所述多个返回通路布置在所述热交换增强构件的圆周外围并且由所述管状壳体的内表面密封地覆盖。
5.根据权利要求1所述的冷冻外科仪器，其中，所述多个返回通路布置在所述热交换增强构件中。
6.根据权利要求1所述的冷冻外科仪器，其中，所述返回通路邻近于所述冷冻剂供应通道的圆周外围。
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Also Published As
| Publication number | Publication date |
|---|---|
| EP2549941B1 (en) | 2018-11-21 |
| US7967815B1 (en) | 2011-06-28 |
| EP2549941A2 (en) | 2013-01-30 |
| CN102378600A (zh) | 2012-03-14 |
| WO2011119279A3 (en) | 2011-11-24 |
| WO2011119279A2 (en) | 2011-09-29 |
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