CN118266933A - System and method for cylindrical jack in the basket measurement and ablation catheter with flexible circuit - Google Patents

Abstract

Translated fromChinese

所公开的技术包括医疗探头，该医疗探头包括大致圆柱形结构，该大致圆柱形结构具有近侧圆形基部、大致平行于该近侧圆形基部的远侧圆形基部、沿着纵向轴线在该近侧圆形基部与该远侧圆形基部之间延伸的多个脊、以及与该多个脊中的一个或多个脊联接的柔性电路基板的一个或多个条带，从而围绕该纵向轴线限定内部容积。该多个脊包括沿着脊的至少一部分定位的三分叉点，以及从该三分叉点延伸的脊分支，该脊分支还包括二分叉点。该柔性电路基板的一个或多个条带还包括设置在该基板的表面上的一条或多条导电迹线。

The disclosed technology includes a medical probe including a generally cylindrical structure having a proximal circular base, a distal circular base generally parallel to the proximal circular base, a plurality of ridges extending between the proximal circular base and the distal circular base along a longitudinal axis, and one or more strips of a flexible circuit substrate coupled to one or more of the plurality of ridges to define an interior volume about the longitudinal axis. The plurality of ridges include a trifurcation point located along at least a portion of the ridges, and a ridge branch extending from the trifurcation point, the ridge branch also including a bifurcation point. The one or more strips of the flexible circuit substrate also include one or more conductive traces disposed on a surface of the substrate.

Description

Translated fromChinese

用于圆柱形笼标测的系统和方法及有柔性电路的消融导管Systems and methods for cylindrical cage mapping and ablation catheters with flexible circuits

相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS

本申请根据35 U.S.C.§119要求先前于2022年12月29日提交的美国临时专利申请号63/477,754的优先权权益，该临时专利申请的全部内容据此以引用方式并入本文，如同在本文中完整地阐述一样。This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63/477,754, previously filed on December 29, 2022, the entire contents of which are hereby incorporated by reference into this document as if fully set forth herein.

技术领域Technical Field

本发明整体涉及医疗装置，并且具体地涉及具有电极的导管，并且进一步但非排他性地涉及适用于标测、消融或诱导心脏组织和肺静脉的不可逆电穿孔(IRE)的导管。The present invention relates generally to medical devices and particularly to catheters having electrodes and further, but not exclusively, to catheters suitable for mapping, ablating or inducing irreversible electroporation (IRE) of cardiac tissue and pulmonary veins.

背景技术Background technique

电生理学导管通常用于标测心脏的电活动或诱导对心脏组织区域的消融，以停止或改变不想要的电信号从心脏的一个部分到另一个部分的传播。许多电生理学导管具有篮状电极阵列。具体地，具有篮状电极阵列的导管是已知的，并且在例如美国专利5,772,590、6,748,255和6,973,340中有所描述，这些专利中的每一个都以引用并入本文，并附于优先权申请U.S.63/477,754的附录中。一些消融方法使用不可逆电穿孔(IRE)来使用非热消融方法消融心脏组织。IRE向组织递送短脉冲高压，并生成不可恢复的细胞膜透化作用。先前在专利文献中提出了使用多电极导管向组织递送消融或不可逆电穿孔(IRE)能量。被构造用于IRE消融的系统和装置的示例在美国专利公布2021/0169550A1(现为美国专利11,660,135)、2021/0169567A1、2021/0169568A1、2021/0161592A1(现为美国专利11,540,877)、2021/0196372A1、2021/0177503A1和2021/0186604A1(现为美国专利11,707,320)中公开，这些专利公布中的每个专利公布均以引用方式并入本文并附于优先权申请U.S.63/477,754的附录中。Electrophysiology catheters are commonly used to map the electrical activity of the heart or induce ablation of cardiac tissue areas to stop or change the propagation of unwanted electrical signals from one part of the heart to another. Many electrophysiology catheters have basket electrode arrays. Specifically, catheters with basket electrode arrays are known and described in, for example, U.S. Patents 5,772,590, 6,748,255 and 6,973,340, each of which is incorporated herein by reference and attached to the appendix of priority application U.S.63/477,754. Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using non-thermal ablation methods. IRE delivers short pulses of high voltage to tissue and generates irreversible cell membrane permeabilization. Previously, it was proposed in the patent literature to use a multi-electrode catheter to deliver ablation or irreversible electroporation (IRE) energy to tissue. Examples of systems and devices constructed for IRE ablation are disclosed in U.S. Patent Publications 2021/0169550A1 (now U.S. Patent 11,660,135), 2021/0169567A1, 2021/0169568A1, 2021/0161592A1 (now U.S. Patent 11,540,877), 2021/0196372A1, 2021/0177503A1, and 2021/0186604A1 (now U.S. Patent 11,707,320), each of which is incorporated herein by reference and is attached as an appendix to priority application U.S. 63/477,754.

心脏组织的区域可通过导管标测以识别异常电信号。可使用相同或不同的导管进行消融。一些示例性导管包括其上设置有电极的多个脊。电极通常附接到脊并通过钎焊、焊接或使用粘合剂固定在适当位置。此外，多个线性脊通常通过将线性脊的两个端部附接到管状轴(例如，推进管)来组装在一起以形成球状篮。球形篮组件能够检测左心房或右心房的电功能。然而，因为肺静脉的横截面通常不是完美的圆形而是更像椭圆形，所以具有平面电极阵列的大致圆柱形组件可以提供对肺静脉处或附近的心脏组织的电功能的更均匀的检测。然而，由于脊和电极的尺寸较小，将电极粘附到脊，然后由多个线性脊形成球状篮可能是一项艰巨的任务，这增加了制造时间和成本，并增加了电极因不当结合或未对准而失效的机会。因此，需要的是形成改进的医疗探头的装置和方法，其通常可有助于减少制造所需的时间和另选的导管几何形状。Areas of cardiac tissue can be mapped by catheters to identify abnormal electrical signals. Ablation can be performed using the same or different catheters. Some exemplary catheters include multiple ridges on which electrodes are disposed. Electrodes are typically attached to the ridges and fixed in place by brazing, welding, or using adhesives. In addition, multiple linear ridges are typically assembled together to form a spherical basket by attaching the two ends of the linear ridges to a tubular shaft (e.g., a push tube). The spherical basket assembly is capable of detecting the electrical function of the left atrium or the right atrium. However, because the cross-section of the pulmonary vein is typically not a perfect circle but more like an ellipse, a roughly cylindrical assembly with a planar electrode array can provide a more uniform detection of the electrical function of cardiac tissue at or near the pulmonary vein. However, due to the small size of the ridges and electrodes, it may be a difficult task to adhere the electrodes to the ridges and then form a spherical basket from multiple linear ridges, which increases manufacturing time and cost, and increases the chances of failure of the electrodes due to improper bonding or misalignment. Therefore, what is needed is a device and method for forming an improved medical probe, which can generally help reduce the time required for manufacturing and alternative catheter geometries.

发明内容Summary of the invention

描述和示出了医疗探头和相关方法的各种实施方案。本公开包括医疗探头，其可包括大致圆柱形的结构。大致圆柱形结构可包括近侧圆形基部、大致平行于近侧圆形基部的远侧圆形基部、沿纵向轴线在近侧圆形基部与远侧圆形基部之间延伸的多个脊以及联接到该多个脊中的一个或多个脊的柔性电路基板的一个或多个条带。每个脊可包括沿着该脊的至少一部分定位的三分叉点，以及从三分叉点延伸的脊分支，脊分支还包括二分叉点。Various embodiments of medical probes and related methods are described and illustrated. The present disclosure includes a medical probe that may include a generally cylindrical structure. The generally cylindrical structure may include a proximal circular base, a distal circular base generally parallel to the proximal circular base, a plurality of ridges extending between the proximal circular base and the distal circular base along a longitudinal axis, and one or more strips of a flexible circuit substrate coupled to one or more of the plurality of ridges. Each ridge may include a trifurcation point located along at least a portion of the ridge, and ridge branches extending from the trifurcation point, the ridge branches also including a bifurcation point.

本公开包括构造医疗探头的方法。该方法可包括将柔性电路基板制造成一个或多个条带；将该一个或多个条带定位在包括多个脊的大致圆柱形结构之上；以及将该多个脊构造成从管状构型沿纵向轴线径向向外延伸，以限定大致圆柱形结构。The present disclosure includes a method of constructing a medical probe. The method may include manufacturing a flexible circuit substrate into one or more strips; positioning the one or more strips over a generally cylindrical structure including a plurality of ridges; and configuring the plurality of ridges to extend radially outward from the tubular configuration along a longitudinal axis to define the generally cylindrical structure.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

图1是根据本发明的实施方案的包括医疗探头的医疗系统的示意性图解，该医疗探头的远侧端部包括具有电极的大致圆柱形结构；1 is a schematic illustration of a medical system including a medical probe having a distal end including a generally cylindrical structure having electrodes according to an embodiment of the present invention;

图2A是示出了根据本发明的实施方案的处于膨胀形式的医疗探头的透视图的示意性图解；2A is a schematic illustration showing a perspective view of a medical probe in an expanded form according to an embodiment of the present invention;

图2B是示出了根据本发明的实施方案的处于塌缩形式的医疗探头的侧视图的示意性图解；FIG2B is a schematic illustration showing a side view of a medical probe in a collapsed form according to an embodiment of the present invention;

图3A是示出了根据本发明的实施方案的具有处于膨胀形式的正弦笼的医疗探头的透视图的示意性图解；3A is a schematic illustration showing a perspective view of a medical probe having a sinusoidal cage in an expanded form according to an embodiment of the present invention;

图3B是示出了根据本发明的实施方案的具有处于塌缩形式的正弦笼的医疗探头的侧视图的示意性图解；3B is a schematic illustration showing a side view of a medical probe having a sinusoidal cage in a collapsed form, according to an embodiment of the present invention;

图4A是示出了根据本发明的实施方案的医疗探头的分解侧视图的示意性图解；FIG4A is a schematic illustration showing an exploded side view of a medical probe according to an embodiment of the present invention;

图4B是示出了根据本发明的实施方案的中空管中的二分叉设计的侧视图的示意性图解；4B is a schematic illustration showing a side view of a bifurcated design in a hollow tube according to an embodiment of the present invention;

图5是示出了根据本发明的实施方案的具有处于膨胀形式的推进管的医疗探头的侧视图的示意性图解；5 is a schematic illustration showing a side view of a medical probe with a propulsion tube in an expanded form according to an embodiment of the present invention;

图6A和图6B是示出了根据本发明的实施方案的与表面接触时压缩的多个脊的侧视图的示意性图解；6A and 6B are schematic illustrations showing side views of a plurality of ridges compressed when in contact with a surface according to an embodiment of the present invention;

图7A是示出了根据本发明的实施方案的形成大致圆柱形结构的多个脊的侧视图的示意性图解；7A is a schematic illustration showing a side view of a plurality of ridges forming a generally cylindrical structure in accordance with an embodiment of the present invention;

图7B是根据本发明的实施方案的沿着图7A的大致圆柱形结构的二分叉点的示意性图解；7B is a schematic illustration of a bifurcation point along the generally cylindrical structure of FIG. 7A , according to an embodiment of the present invention;

图7C是示出了根据本发明的实施方案的形成大致圆柱形结构的多个脊的顶视图的示意性图解；7C is a schematic illustration showing a top view of a plurality of ridges forming a generally cylindrical structure in accordance with an embodiment of the present invention;

图7D是根据本发明的实施方案的沿着图7C的大致圆柱形结构的三分叉点的示意性图解；FIG7D is a schematic illustration of a trifurcation point along the generally cylindrical structure of FIG7C , in accordance with an embodiment of the present invention;

图8A是示出了根据本发明的实施方案的具有处于膨胀形式的正弦笼的大致圆柱形结构的侧视图的示意性图解；8A is a schematic illustration showing a side view of a generally cylindrical structure having a sinusoidal cage in an expanded form in accordance with an embodiment of the present invention;

图8B是示出了根据本发明的实施方案的具有处于膨胀形式的正弦笼的大致圆柱形结构的顶视图的示意性图解；8B is a schematic illustration showing a top view of a generally cylindrical structure having a sinusoidal cage in an expanded form in accordance with an embodiment of the present invention;

图8C是示出了根据本发明的实施方案的图8A的柔性电路基板的条带的横截面视图的示意性图解，其中柔性电路基板的条带具有嵌入在外表面和内表面上的电极；8C is a schematic illustration showing a cross-sectional view of the strip of flexible circuit substrate of FIG. 8A , wherein the strip of flexible circuit substrate has electrodes embedded on the outer and inner surfaces, in accordance with an embodiment of the present invention;

图9A至图9D是示出了根据本发明的实施方案的具有电极和电迹线的柔性电路基板的条带的示意性图解；并且9A-9D are schematic illustrations showing a strip of a flexible circuit substrate having electrodes and electrical traces according to an embodiment of the present invention; and

图10是示出了根据本发明的实施方案的组装具有大致圆柱形结构的医疗探头的另一方法的流程图。10 is a flow chart illustrating another method of assembling a medical probe having a generally cylindrical structure according to an embodiment of the present invention.

具体实施方式Detailed ways

应结合附图来阅读下面的具体实施方式，其中不同附图中相同元件的编号相同。附图(未必按比例绘制)描绘了所选择的实施方案，并不旨在限制本发明的范围。详细描述以举例的方式而非限制性方式示出本发明的原理。此描述将明确地使得本领域技术人员能够制备和使用本发明，并且描述了本发明的若干实施方案、适应型式、变型形式、替代形式和用途，包括目前据信是实施本发明的最佳方式。The following specific embodiments should be read in conjunction with the accompanying drawings, wherein the same elements in different drawings are numbered the same. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

如本文所用，针对任何数值或范围的术语“约”或“大约”指示允许零件或部件的集合实现如本文所述的其预期要达到的目的的合适的尺寸公差。更具体地，“约”或“大约”可指列举值的值±20％的范围，例如“约90％”可指71％至110％的值范围。As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values from 71% to 110%.

如本文所用，术语“患者”、“受体”、“用户”和“受检者”是指任何人或动物受检者，并不旨在将系统或方法局限于人使用，但本主题发明在人类患者中的使用代表优选的实施方案。此外，“患者”、“受体”、“用户”和“受检者”的脉管系统可以是人或任何动物的脉管系统。应当理解，动物可以是各种任何适用的类型，包括但不限于哺乳动物、兽医动物、家畜动物或宠物类动物等。例如，动物可以是专门选择具有与人类相似的某些特性的实验动物(例如，大鼠、狗、猪、猴等)。应当理解，受检者可以是例如任何适用的人类患者。同样，术语“近侧”是指更靠近操作者或医师的位置，而“远侧”是指更远离操作者或医师的位置。As used herein, the terms "patient," "receptor," "user," and "subject" refer to any human or animal subject, and are not intended to limit the systems or methods to human use, but the use of the subject invention in human patients represents a preferred embodiment. In addition, the vascular system of the "patient," "receptor," "user," and "subject" can be the vascular system of a human or any animal. It should be understood that the animal can be of any suitable type, including but not limited to mammals, veterinary animals, livestock animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to those of humans. It should be understood that the subject can be, for example, any suitable human patient. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

如本文所讨论的，“医师”可包括医生、外科医生、技师、科学家，或者与将用于治疗药物难治性心房纤颤的多电极导管递送到受检者相关联的任何其他个体或递送仪表装置。As discussed herein, a "physician" may include a doctor, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter to a subject for treating drug-refractory atrial fibrillation.

如本文所讨论的，当涉及本公开的装置和相应系统时，术语“消融”是指被配置为通过利用非热能(诸如不可逆电穿孔(IRE))来减少或防止细胞中不稳定心脏信号的生成的部件和结构特征部，在本公开中可互换地称为脉冲电场(PEF)和脉冲场消融(PFA)。在本公开全文中使用的“消融”，在涉及本公开的装置和对应系统时是指用于某些病症的心脏组织的非热消融，包括但不限于心律失常、心房扑动消融、肺静脉隔离、室上性心动过速消融和心室性心动过速消融。术语“消融”还包括实现相关领域技术人员所理解的各种形式的身体组织消融的已知方法、装置和系统。As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

如本文所讨论的，术语“双极”和“单极”当用于指消融方案时描述在电流路径和电场分布方面不同的消融方案。“双极”是指利用如下所述两个电极之间的电流路径的消融方案，这两个电极都定位在治疗部位处；在这两个电极中的每个电极处的电流密度和电通量密度通常大致相等。“单极”是指利用如下所述两个电极之间的电流路径的消融方案，其中包括高电流密度和高电通量密度的一个电极定位在治疗部位处，并且包括相对较低电流密度和较低电通量密度的第二电极远离治疗部位定位。As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation protocols describe ablation protocols that differ in current paths and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, wherein one electrode including a high current density and a high electric flux density is positioned at the treatment site, and a second electrode including a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

如本文所讨论的，术语“双相脉冲”和“单相脉冲”是指相应的电信号。“双相脉冲”是指包括正电压相位脉冲(本文中称为“正相位”)和负电压相位脉冲(本文中称为“负相位”)的电信号。“单相脉冲”是指仅包括正相或负相的电信号。优选地，配置提供双相脉冲的系统以防止向患者施加直流电压(DC)。例如，相对于接地或其他公共基准电压，双相脉冲的平均电压可为零伏。另外地或另选地，系统可包括电容器或其他保护部件。在本文中描述了双相和/或单相脉冲的电压振幅，应当理解，所表达的电压振幅是正电压相和/或负电压相中的每一者的近似峰值振幅的绝对值。双相脉冲和单相脉冲的每一相优选具有正方形形状，其在大部分相持续时间期间包括基本上恒定的电压振幅。双相脉冲的相由相间延迟在时间上分开。相间延迟持续时间优选地小于或大约等于双相脉冲的相的持续时间。相间延迟持续时间更优选地为双相脉冲的相的持续时间的约25％。As discussed herein, the terms "biphasic pulse" and "monophasic pulse" refer to corresponding electrical signals. "Biphasic pulse" refers to an electrical signal including a positive voltage phase pulse (referred to herein as "positive phase") and a negative voltage phase pulse (referred to herein as "negative phase"). "Monophasic pulse" refers to an electrical signal including only a positive phase or a negative phase. Preferably, the system providing the biphasic pulse is configured to prevent the application of a direct current voltage (DC) to the patient. For example, the average voltage of the biphasic pulse may be zero volts relative to ground or other common reference voltage. Additionally or alternatively, the system may include a capacitor or other protective component. The voltage amplitude of the biphasic and/or monophasic pulses is described herein, and it should be understood that the voltage amplitude expressed is the absolute value of the approximate peak amplitude of each of the positive voltage phase and/or the negative voltage phase. Each phase of the biphasic pulse and the monophasic pulse preferably has a square shape, which includes a substantially constant voltage amplitude during most of the phase duration. The phases of the biphasic pulse are separated in time by an interphase delay. The interphase delay duration is preferably less than or approximately equal to the duration of the phase of the biphasic pulse. The interphase delay duration is more preferably about 25% of the duration of a phase of the biphasic pulse.

如本文所讨论的，术语“管状”和“管”应广义地理解，并且不限于为正圆柱体的或横截面为完全圆周的或在其整个长度上具有均匀横截面的结构。例如，管状结构通常被示出为基本上呈正圆柱体的结构。然而，在不脱离本公开范围的情况下，管状结构可具有锥形或弯曲外表面。As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, tubular structures are often shown as structures that are substantially perfect cylinders. However, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

如本文所用，术语“温度额定值”被定义为部件在其寿命期间可承受而不引起热损坏(诸如部件的熔融或热降解(例如，炭化和碎裂))的最大连续温度。As used herein, the term "temperature rating" is defined as the maximum continuous temperature that a component can withstand during its lifetime without causing thermal damage, such as melting or thermal degradation (eg, charring and cracking) of the component.

本公开涉及利用端部执行器的系统、方法或用途和装置，该端部执行器包括电极，该电极附连到定位在脊之上的膜。本公开的示例性系统、方法和装置可能特别适用于对心脏组织进行标测和IRE消融以治疗心律失常。消融能量通常由导管的末端部分提供给心脏组织，该末端部分可沿着待消融的组织递送消融能量。一些示例性导管在末端部分处包括三维结构并且被配置为从定位在三维结构上的各种电极施用消融能量。可使用荧光镜透视检查来使结合有此类示例性导管的消融规程可视化。The present disclosure relates to systems, methods or uses and devices utilizing an end effector comprising an electrode attached to a membrane positioned above a ridge. Exemplary systems, methods and devices of the present disclosure may be particularly useful for mapping and IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by an end portion of a catheter that can deliver the ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the end portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such exemplary catheters.

使用诸如射频(RF)能量和冷冻消融的热技术的应用来校正故障心脏的心脏组织消融是众所周知的规程。通常，为了使用热技术成功消融，需要在心肌的各个位置测量心脏电极电位。此外，消融期间的温度测量提供了能够实现消融功效的数据。通常，对于使用热消融的消融规程，在实际消融之前、期间和之后测量电极电位和温度。Ablation of cardiac tissue using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation to correct a malfunctioning heart is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, cardiac electrode potentials need to be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that can be used to achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation.

RF方法可具有可能导致组织炭化、灼伤、蒸汽爆裂、膈神经麻痹、肺静脉狭窄和食道瘘的风险。冷冻消融是RF消融的替代方案，其可减少与RF消融相关联的一些热风险。然而，与RF消融相比，操纵冷冻消融装置和选择性地施加冷冻消融通常更具挑战性；因此，冷冻消融在可由电消融装置到达的某些解剖几何形状中不可行。RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve palsy, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

如本公开中所讨论的IRE是可用于房性心律失常消融的非热细胞死亡技术。为了使用IRE/PEF进行消融，施加双相电压脉冲来破坏心肌的细胞结构。双相脉冲是非正弦的，并且可基于细胞的电生理学被调谐以靶向细胞。相比之下，为了使用RF进行消融，施加正弦电压波形以在治疗区域处产生热，在治疗区域中无区分地加热所有细胞。因此，IRE具有避开相邻的热敏结构或组织的能力，这将在减少已知受消融或分离模态影响的可能并发症方面具有益处。除此之外或另选地，可使用单相脉冲。IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE/PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. The biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells indiscriminately in the treatment area. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

可以通过跨生物细胞施加脉冲电场来诱导电穿孔，以导致在细胞膜中可逆(临时)或不可逆(永久性)地产生孔。在施加脉冲电场时，细胞具有升高得超过静态电位的跨膜静电位。当跨膜静电位保持低于阈值电位时，电穿孔是可逆的，这意味着当去除所施加的脉冲电场时孔可闭合，并且细胞可自我修复并存活。如果跨膜静电位升高得超过阈值电位，则电穿孔是不可逆的，并且细胞变得永久可渗透。因此，细胞因失去稳态而死亡，通常因程序性细胞死亡或凋亡而死亡，据信与其他消融方式相比，这会留下更少的疤痕组织。通常，不同类型的细胞具有不同的阈值电位。例如，心脏细胞具有大约500V/cm的阈值电位，而对于骨，阈值电位为3000V/cm。阈值电位的这些差异允许IRE基于阈值电位来选择性地靶向组织。Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to loss of homeostasis, usually by programmed cell death or apoptosis, which is believed to leave less scar tissue than other ablation methods. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V/cm, while for bones, the threshold potential is 3000V/cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potentials.

本公开的解决方案包括用于优选地通过施加有效地在心肌组织中诱导电穿孔的脉冲电场来从定位在心肌组织附近的导管电极施加电信号的系统和方法。该系统和方法可通过诱导不可逆电穿孔来有效消融靶向组织。在一些示例中，该系统和方法可有效诱导可逆电穿孔作为诊断规程的一部分。当利用电极施加的电低于允许细胞修复的目标组织的电场阈值时，发生可逆电穿孔。可逆电穿孔不杀死细胞，但允许医师查看可逆电穿孔对靶位置附近的电激活信号的影响。用于可逆电穿孔的示例性系统和方法在美国专利公布2021/0162210中公开，该专利公布的全部内容以引用方式并入本文并附于优先权申请U.S.63/477,754的附录中。The solution of the present disclosure includes a system and method for applying an electrical signal from a catheter electrode positioned near myocardial tissue, preferably by applying a pulsed electric field that effectively induces electroporation in myocardial tissue. The system and method can effectively ablate the targeted tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrode is lower than the electric field threshold of the target tissue that allows cell repair. Reversible electroporation does not kill cells, but allows physicians to view the effects of reversible electroporation on electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021/0162210, the entire contents of which are incorporated herein by reference and attached to the appendix of priority application U.S.63/477,754.

脉冲电场及其诱导可逆电穿孔和/或不可逆电穿孔的效力可能受系统的物理参数和电信号的双相脉冲参数影响。物理参数可包括电极接触面积、电极间距、电极几何形状等。本文呈现的示例一般包括适于有效诱导可逆电穿孔和/或不可逆电穿孔的物理参数。电信号的双相脉冲参数可包括电压振幅、脉冲持续时间、脉冲相间延迟、脉冲间延迟、总施加时间、递送的能量等。在一些示例中，可调整电信号的参数以在给定相同物理参数的情况下诱导可逆和不可逆电穿孔两者。包括IRE的各种消融系统和方法的示例在美国专利公布2021/0169550A1(现为美国专利11,660,135)、2021/0169567A1、2021/0169568A1、2021/0161592A1(现为美国专利11,540,877)、2021/0196372A1、2021/0177503A1和2021/0186604A1(现为美国专利11,707,320)中公开，这些专利公布中的每个专利公布的全部内容均以引用方式并入本文并附于优先权申请U.S.63/477,754的附录中。The effectiveness of pulsed electric field and its induction of reversible electroporation and/or irreversible electroporation may be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples presented herein generally include physical parameters suitable for effectively inducing reversible electroporation and/or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse interphase delay, pulse interdelay, total application time, energy delivered, etc. In some examples, the parameters of the electrical signal may be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are disclosed in U.S. Patent Publications 2021/0169550A1 (now U.S. Patent 11,660,135), 2021/0169567A1, 2021/0169568A1, 2021/0161592A1 (now U.S. Patent 11,540,877), 2021/0196372A1, 2021/0177503A1 and 2021/0186604A1 (now U.S. Patent 11,707,320), the entire contents of each of which are incorporated herein by reference and attached as an appendix to priority application U.S.63/477,754.

为了在IRE(不可逆电穿孔)规程中递送脉冲场消融(PFA)，电极与被消融的组织接触的表面积应足够大。如下文所述，医疗探头包括大致圆柱形结构，该大致圆柱形结构具有近侧圆形基部、大致平行于近侧圆形基部的远侧圆形基部、沿着纵向轴线在近侧圆形基部与远侧圆形基部之间延伸的多个脊以及联接到该多个脊中的一个或多个脊的柔性电路基板的一个或多个条带，从而围绕纵向轴线限定内部容积。该多个脊包括沿着脊的至少一部分定位的三分叉点，以及从该三分叉点延伸的脊分支，该脊分支还包括二分叉点。该柔性电路基板的一个或多个条带还包括设置在该基板的表面上的一条或多条导电迹线。柔性电路基板的条带还包括联接到基板的内表面的一个或多个参考电极，使得参考电极与外表面上的相应电极共同定位，以限定一对堆叠的电极。In order to deliver pulsed field ablation (PFA) in an IRE (irreversible electroporation) procedure, the surface area of the electrode in contact with the ablated tissue should be large enough. As described below, the medical probe includes a generally cylindrical structure having a proximal circular base, a distal circular base substantially parallel to the proximal circular base, a plurality of ridges extending between the proximal circular base and the distal circular base along a longitudinal axis, and one or more strips of a flexible circuit substrate connected to one or more of the plurality of ridges, thereby defining an internal volume around the longitudinal axis. The plurality of ridges include a trifurcation point located along at least a portion of the ridge, and a ridge branch extending from the trifurcation point, the ridge branch also including a bifurcation point. The one or more strips of the flexible circuit substrate also include one or more conductive traces disposed on the surface of the substrate. The strips of the flexible circuit substrate also include one or more reference electrodes connected to the inner surface of the substrate, so that the reference electrode is co-located with a corresponding electrode on the outer surface to define a pair of stacked electrodes.

参考图1，该图示出了示例的基于导管的电生理学标测和消融系统10。系统10包括多个导管，这些导管由医师24经由皮肤穿过患者23的血管系统插入心脏12的腔室或血管结构中。通常，将递送护套导管插入心脏12中的期望位置附近的左心房或右心房中。然后，可将多个导管插入递送鞘导管中，以便到达该期望位置。该多个导管可包括专用于感测心内电描记图(IEGM)信号的导管、专用于消融的导管和/或专用于感测和消融两者的导管。本文示出了被构造用于感测IEGM的示例性导管14。医师24使包括医疗探头16的导管14的远侧末端28在肺静脉处或附近与心脏壁接触，以用于感测心脏12中的靶标部位。对于消融，医师24会类似地将包括医疗探头16的消融导管的远侧端部带到用于消融的靶标部位。Referring to FIG. 1 , an exemplary catheter-based electrophysiology mapping and ablation system 10 is shown. The system 10 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and/or a catheter dedicated to both sensing and ablation. An exemplary catheter 14 configured for sensing IEGM is shown herein. The physician 24 brings the distal end 28 of the catheter 14 including the medical probe 16 into contact with the heart wall at or near the pulmonary vein for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter including the medical probe 16 to the target site for ablation.

医疗探头16是示例性探头，其包括任选地分布在远侧末端28处的多个脊22之上并且被配置为感测IEGM信号的一个和优选地多个电极26。医疗探头16可另外包括嵌入在远侧末端28中或其附近的位置传感器29，以用于跟踪远侧末端28的位置和取向。任选地且优选地，位置传感器29是基于磁性的位置传感器，其包括用于感测三维(3D)位置和取向的三个磁线圈。如图2A中更详细示出的，医疗探头16可包括柔性电路基板70的一个或多个条带，其定位在多个脊22之上并且联接到一些单独的脊220的至少一部分。位置传感器29可以是常规的线圈传感器、基于扁平PCB的传感器或可变形电磁环传感器。尽管未示出，但位置传感器29可替代地定位在篮状组件28上或设计成单独的脊22。在一些实施方案中，单独的脊22可以是绝缘的并充当位置传感器。The medical probe 16 is an exemplary probe that includes one and preferably multiple electrodes 26 that are optionally distributed over multiple ridges 22 at the distal end 28 and are configured to sense IEGM signals. The medical probe 16 may additionally include a position sensor 29 embedded in or near the distal end 28 for tracking the position and orientation of the distal end 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation. As shown in more detail in FIG. 2A, the medical probe 16 may include one or more strips of a flexible circuit substrate 70 that are positioned over multiple ridges 22 and coupled to at least a portion of some individual ridges 220. The position sensor 29 may be a conventional coil sensor, a flat PCB-based sensor, or a deformable electromagnetic ring sensor. Although not shown, the position sensor 29 may alternatively be positioned on the basket assembly 28 or designed as an individual ridge 22. In some embodiments, the individual ridge 22 may be insulated and act as a position sensor.

在一些实施方案中，医疗探头16可包括可变形电磁环传感器。用于可变形电磁环传感器的各种系统和方法的示例在美国专利11,304,642和10,330,742以及美国专利公开2018/0344202A1和2020/0155224A1中给出，这些专利和专利公开中的每一个均以引用方式并入本文并且附于优先权申请U.S.63/477,754的附录中。In some embodiments, the medical probe 16 may include a deformable electromagnetic ring sensor. Examples of various systems and methods for deformable electromagnetic ring sensors are given in U.S. Patents 11,304,642 and 10,330,742 and U.S. Patent Publications 2018/0344202A1 and 2020/0155224A1, each of which is incorporated herein by reference and is attached in the appendix to priority application U.S. 63/477,754.

基于磁性的位置传感器29可与定位垫25一起操作，该定位垫包括被配置为在预定工作空间中产生磁场的多个磁线圈32。导管14的远侧末端28的实时位置可基于利用定位垫25生成的磁场进行跟踪，并且由基于磁性的位置传感器29感测。基于磁性的位置感测技术的细节描述于美国专利5,391,199、5,443,489、5,558,091、6,172,499、6,239,724、6,332,089、6,484,118、6,618,612、6,690,963、6,788,967、6,892,091中，这些专利中的每个专利均以引用方式并入本文并且附于优先权申请U.S.63/477,754的附录中。The magnetic-based position sensor 29 can operate with the positioning pad 25, which includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined working space. The real-time position of the distal tip 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 29. The details of the magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference and attached to the appendix of priority application U.S. 63/477,754.

系统10包括一个或多个电极贴片38，该一个或多个电极贴片被定位成与患者23的皮肤接触，以为定位垫25以及电极26的基于阻抗的跟踪建立位置参考。对于基于阻抗的跟踪，电流被引导朝向电极26并且在电极皮肤贴片38处被感测，使得可经由电极贴片38对每个电极的位置进行三角测量。基于阻抗的位置跟踪技术的细节描述于美国专利7,536,218、7,756,576、7,848,787、7,869,865和8,456,182中，这些专利中的每个专利均以引用方式并入本文并且附于优先权申请U.S.63/477,754的附录中。The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference and is attached in the appendix to priority application U.S. 63/477,754.

记录器11显示利用体表ECG电极18捕获的电描记图21以及利用导管14的电极26捕获的心内电描记图(IEGM)。记录器11可包括用于起搏心律的起搏能力并且/或者可电连接到独立的起搏器。Recorder 11 displays electrograms 21 captured using body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and/or may be electrically connected to a separate pacemaker.

系统10可包括消融能量发生器50，该消融能量发生器适于将消融能量传导到被配置用于消融的导管的远侧末端处的一个或多个电极。由消融能量发生器50生成的能量可包括但不限于射频(RF)能量或脉冲场消融(PFA)能量(包括可用于实现不可逆电穿孔(IRE)的单极或双极高电压DC脉冲)，或它们的组合。The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

患者接口单元(PIU)30是被配置为在导管、电生理装备、电源和用于控制系统10的操作的工作站55之间建立电连通的接口。系统10的电生理装备可包括例如多个导管、定位垫25、体表ECG电极18、电极贴片38、消融能量发生器50和记录器11。任选地且优选地，PIU30另外包括用于实现导管的位置的实时计算并且用于执行ECG计算的处理能力。The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, a positioning pad 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

工作站55包括存储器、带有加载有适当操作软件的存储器或存储装置的处理器单元，以及用户界面能力。工作站55可提供多个功能，任选地包括：(1)对心内膜解剖结构进行三维(3D)建模，并且渲染模型或解剖标测图20以在显示装置27上显示；(2)在显示装置27上，以叠加在渲染的解剖标测图20上的代表性视觉标记或图像，显示由所记录的电描记图21所编译的激活序列(或其他数据)；(3)显示心脏腔室内的多个导管的实时位置和取向；以及(4)在显示装置27上，显示感兴趣的部位(诸如已施加消融能量之处)。一种体现系统10的元件的商品可以CARTO^TM3系统购自Biosense Webster,Inc.,31TechnologyDrive,Suite200,Irvine,CA 92618,USA。Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (4) displaying on display device 27 sites of interest (such as where ablation energy has been applied). A commercial product embodying elements of system 10 is available as the CARTO^™ 3 system from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

图2A是示出了医疗探头16的透视图的示意性图解，该医疗探头包括大致圆柱形结构60，该大致圆柱形结构在不受约束时(诸如通过在插入管80的远侧端部83处从插入管内腔82中推出)处于膨胀形式。图2A所示的医疗探头16缺少图1所示的导引鞘。图2B示出了在导引鞘的插入管80内处于塌缩形式的大致圆柱形结构60。在医疗规程期间，医师24可通过将管状轴84从插入管80中伸出，致使圆柱形结构60离开插入管80并转变为膨胀形式来展开圆柱形结构60。FIG. 2A is a schematic illustration showing a perspective view of a medical probe 16 including a generally cylindrical structure 60 in an expanded form when unconstrained (such as by being pushed out of an insertion tube lumen 82 at a distal end 83 of an insertion tube 80). The medical probe 16 shown in FIG. 2A lacks the guide sheath shown in FIG. 1 . FIG. 2B shows the generally cylindrical structure 60 in a collapsed form within the insertion tube 80 of the guide sheath. During a medical procedure, a physician 24 can deploy the cylindrical structure 60 by extending the tubular shaft 84 from the insertion tube 80, causing the cylindrical structure 60 to exit the insertion tube 80 and transform into the expanded form.

该多个脊22中的每个脊220可具有椭圆形(例如，圆形)或矩形(其可呈现为平坦)横截面，并且包含形成脊的柔性弹性材料(例如，形状记忆合金，诸如镍钛，也称为镍钛诺)，如本文将更详细描述的。脊220可具有大约0.6mm的标称宽度，并且可低至0.2mm或高至1.5mm。每个脊的厚度可标称地为0.09mm并且可在0.05mm至0.2mm之间变化。应注意，宽度和厚度的这些值可根据所期望的刚度而变化。Each ridge 220 of the plurality of ridges 22 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as Nitinol) forming the ridge, as will be described in more detail herein. The ridges 220 may have a nominal width of approximately 0.6 mm and may be as low as 0.2 mm or as high as 1.5 mm. The thickness of each ridge may nominally be 0.09 mm and may vary between 0.05 mm and 0.2 mm. It should be noted that these values for width and thickness may vary depending on the desired stiffness.

如图2A所示，大致圆柱形结构60包括近侧圆形基部62和远侧圆形基部65，使得近侧基部62和远侧基部65大致平坦和平行。在一些示例中，远侧圆形基部65包括比近侧圆形基部62小的半径，使得大致圆柱形结构60逐渐变细，其中近侧部分大于远侧部分。另选地，一些示例性医疗探头16具有大致圆柱形结构60，其远侧圆形基部65处的半径大于近侧圆形基部62处的半径，使得大致圆柱形结构60逐渐变细，其中远侧部分大于近侧部分。如图所示，远侧圆形基部65的半径类似于近侧圆形基部62。As shown in FIG. 2A , the generally cylindrical structure 60 includes a proximal circular base 62 and a distal circular base 65, such that the proximal base 62 and the distal base 65 are generally flat and parallel. In some examples, the distal circular base 65 includes a radius that is smaller than the proximal circular base 62, such that the generally cylindrical structure 60 tapers gradually, wherein the proximal portion is larger than the distal portion. Alternatively, some exemplary medical probes 16 have a generally cylindrical structure 60 having a radius at the distal circular base 65 that is larger than the radius at the proximal circular base 62, such that the generally cylindrical structure 60 tapers gradually, wherein the distal portion is larger than the proximal portion. As shown, the radius of the distal circular base 65 is similar to that of the proximal circular base 62.

在一些实施方案中，圆柱形结构60还包括定位在多个脊22之上的柔性电路基板70的一个或多个条带。电路基板70和多个脊22限定大致圆柱形结构60内的内部容积66。柔性电路基板70的条带允许流体进入内部容积66，使得在电路基板70的外部与内部容积66之间存在流体连通。如图所示，柔性电路基板70的条带包括定位在电路基板70的表面上的电极26。In some embodiments, the cylindrical structure 60 further includes one or more strips of a flexible circuit substrate 70 positioned over the plurality of ridges 22. The circuit substrate 70 and the plurality of ridges 22 define an interior volume 66 within the generally cylindrical structure 60. The strips of the flexible circuit substrate 70 allow fluid to enter the interior volume 66 such that fluid communication exists between the exterior of the circuit substrate 70 and the interior volume 66. As shown, the strips of the flexible circuit substrate 70 include electrodes 26 positioned on a surface of the circuit substrate 70.

图3A是示出了具有大致圆柱形结构60的示例性医疗探头16的示意性图解，该圆柱形结构具有多个脊22，当处于膨胀形式时，该多个脊沿着纵向轴线86近似正弦地行进。柔性电路基板70的一个或多个条带可以是线形的并且联接到一个或多个脊220的至少一部分。当处于塌缩形式时，诸如抵靠插入管80的壁被约束时，正弦脊可以沿着中间的一部分扭转，如图3B所示。在医疗规程期间，医师24可通过将管状轴84从插入管80中伸出，致使圆柱形结构60离开插入管80，解扭，并转变为膨胀形式来展开圆柱形结构60。FIG3A is a schematic illustration showing an exemplary medical probe 16 having a generally cylindrical structure 60 having a plurality of ridges 22 that, when in an expanded form, run approximately sinusoidally along a longitudinal axis 86. One or more strips of the flexible circuit substrate 70 may be linear and coupled to at least a portion of the one or more ridges 220. When in a collapsed form, such as when constrained against the wall of the insertion tube 80, the sinusoidal ridges may twist along a portion of the middle, as shown in FIG3B. During a medical procedure, the physician 24 may deploy the cylindrical structure 60 by extending the tubular shaft 84 from the insertion tube 80, causing the cylindrical structure 60 to exit the insertion tube 80, untwist, and transform into an expanded form.

图4A是医疗探头16的分解侧视图，示出了具有电极阵列的柔性电路基板70的一个或多个条带，该电极阵列包括在大致平坦表面上的外部电极26a、内部或参考电极26b和标测电极26c。如图2A和图3A所示，柔性电路基板70的条带装配在膨胀成大致圆柱形形状的多个脊22之上。大致圆柱形结构60可经由合适的技术(诸如粘合剂或模制)物理地连接到管状构件84。在未示出的一个实施方案中，可沿着近侧环222设置孔眼以及在管状构件84的表面上设置定位器，以帮助组装以及将脊物理保持到管状构件84上。FIG4A is an exploded side view of the medical probe 16, showing one or more strips of a flexible circuit substrate 70 having an electrode array, the electrode array including an external electrode 26a, an internal or reference electrode 26b, and a mapping electrode 26c on a generally flat surface. As shown in FIGS. 2A and 3A, the strips of the flexible circuit substrate 70 are assembled on a plurality of ridges 22 expanded into a generally cylindrical shape. The generally cylindrical structure 60 can be physically connected to the tubular member 84 via a suitable technique (such as an adhesive or molding). In one embodiment not shown, eyelets can be provided along the proximal ring 222 and locators can be provided on the surface of the tubular member 84 to aid in assembly and physically retain the ridges to the tubular member 84.

多个脊22可被折叠或以其他方式弯曲，使得每个脊220或近侧环222可插入到管状轴84的远侧端部85中(如图4A所示)。尽管在图3中未示出，但是应当理解，在将电路基板70定位在多个脊22之上并且将脊22插入到管状轴84中以形成医疗探头16之前，可将电极26附接到柔性电路基板70的条带中。如前所述，脊22可包含柔性弹性材料(例如，形状记忆合金，诸如镍钛(也称为镍钛诺))，当大致圆柱形结构60从管状轴84展开时，该柔性弹性材料使得大致圆柱形结构60转变为其膨胀形式。The plurality of spines 22 may be folded or otherwise bent so that each spine 220 or proximal ring 222 may be inserted into the distal end 85 of the tubular shaft 84 (as shown in FIG. 4A ). Although not shown in FIG. 3 , it should be understood that the electrodes 26 may be attached to the strip of flexible circuit substrate 70 prior to positioning the circuit substrate 70 over the plurality of spines 22 and inserting the spines 22 into the tubular shaft 84 to form the medical probe 16. As previously described, the spines 22 may include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium (also known as Nitinol)) that allows the generally cylindrical structure 60 to transition to its expanded form when the generally cylindrical structure 60 is deployed from the tubular shaft 84.

转向图4B，脊组件可由中空管状圆柱形原材料210制成，使得近侧环222和远侧环225为一体式材料。如图4A所示，将管状原材料210切割成脊组件所需的形状。此后，如本领域技术人员已知的，可将切割后的管210定形(或热定形)以提供图4A所示的大致圆柱形构型。如图所示，中空管210具有沿着中空管210的长度大致均匀的第一直径D1，但在不受约束时，圆柱形结构60膨胀至图4A所示的第二直径D2。圆柱形结构的远侧环225和近侧环220保持中空管210的第一直径D1。在一些实施方案中，膨胀形式的圆柱形结构的直径可为约15mm±5mm。Turning to FIG. 4B , the spine assembly can be made of a hollow tubular cylindrical raw material 210 such that the proximal ring 222 and the distal ring 225 are a one-piece material. As shown in FIG. 4A , the tubular raw material 210 is cut into the shape required for the spine assembly. Thereafter, as known to those skilled in the art, the cut tube 210 can be shaped (or heat-set) to provide a generally cylindrical configuration as shown in FIG. 4A . As shown, the hollow tube 210 has a first diameter D1 that is generally uniform along the length of the hollow tube 210 , but when unconstrained, the cylindrical structure 60 expands to a second diameter D2 as shown in FIG. 4A . The distal ring 225 and the proximal ring 220 of the cylindrical structure maintain the first diameter D1 of the hollow tube 210 . In some embodiments, the diameter of the cylindrical structure in the expanded form may be approximately 15 mm ± 5 mm.

在本文所述和图4B所示的一些实施方案中，多个脊22中的每个脊220包括沿着脊的至少一部分定位的三分叉点219和二分叉点217。三分叉点219或二分叉点217中的一个可沿着脊的至少一部分定位在远侧圆形基部65与近侧圆形基部62之间。作为一个示例，图4A示出了在远侧圆形基部65内的三分叉点219，而二分叉点217定位在远侧圆形基部65与近侧圆形基部62之间。多个脊22中的每个脊220还包括在三分叉点219至二分叉点216之间的第一脊分支216。每个脊220还可以包括定位在三分叉点219之后的第二脊分支216'。在三分叉点219处，脊被保持在中间并且形成在远侧圆形基部65与近侧圆形基部62之间延伸的中间部分218，并且当圆柱形结构60处于膨胀形式时是最外侧部分。在一些示例性医疗探头16中，圆柱形结构60在远侧圆形基部65与近侧圆形基部62之间具有从约10mm至约20mm范围内的长度。优选地，圆柱形结构60在近侧端部212与远侧端部215之间的长度L约为15mm。In some embodiments described herein and shown in FIG. 4B , each ridge 220 in the plurality of ridges 22 includes a trifurcation 219 and a bifurcation 217 located along at least a portion of the ridge. One of the trifurcation 219 or the bifurcation 217 may be located between the distal circular base 65 and the proximal circular base 62 along at least a portion of the ridge. As an example, FIG. 4A shows the trifurcation 219 within the distal circular base 65, while the bifurcation 217 is located between the distal circular base 65 and the proximal circular base 62. Each ridge 220 in the plurality of ridges 22 also includes a first ridge branch 216 between the trifurcation 219 and the bifurcation 216. Each ridge 220 may also include a second ridge branch 216' located after the trifurcation 219. At the trifurcation point 219, the ridge is held in the middle and forms an intermediate portion 218 extending between the distal circular base 65 and the proximal circular base 62, and is the outermost portion when the cylindrical structure 60 is in the expanded form. In some exemplary medical probes 16, the cylindrical structure 60 has a length ranging from about 10 mm to about 20 mm between the distal circular base 65 and the proximal circular base 62. Preferably, the length L of the cylindrical structure 60 between the proximal end 212 and the distal end 215 is about 15 mm.

在一些实施方案中，多个脊22可任选地仅具有二分叉点。例如，图4B的中空管210可以用第二二分叉点217代替三分叉点219。在此类示例中，第二脊分支216'将变成中间部分218。In some embodiments, the plurality of ridges 22 may optionally have only bifurcations. For example, the hollow tube 210 of FIG. 4B may replace the trifurcations 219 with a second bifurcations 217. In such examples, the second ridge branch 216' will become the middle portion 218.

图5是示出了医疗探头16的侧视图的示意性图解，该医疗探头16具有大致圆柱形结构60，该大致圆柱形结构具有多个脊22、柔性电路基板70的一个或多个条带以及推杆88。如图所示，推杆88可装配在近侧环222内并沿纵向轴线86在圆柱形结构60的内部容积66内移动。推杆88还可以包括嵌入在远侧末端28中或附近的位置传感器29，以用于跟踪处于膨胀构型的医疗探头16的位置和取向。如图所示，柔性电路基板70可包括面向外的电极26a、面向内的电极26b和标测电极26c。标测电极26c可以是常规的线圈传感器、基于扁平PCB的传感器或可变形电磁环传感器。尽管未示出，但标测电极26c可替代地定位在大致圆柱形结构60上或设计成多个脊22中的单独的脊。FIG. 5 is a schematic diagram showing a side view of a medical probe 16 having a generally cylindrical structure 60 having a plurality of ridges 22, one or more strips of a flexible circuit substrate 70, and a push rod 88. As shown, the push rod 88 can be assembled in the proximal ring 222 and move along the longitudinal axis 86 in the internal volume 66 of the cylindrical structure 60. The push rod 88 can also include a position sensor 29 embedded in or near the distal end 28 for tracking the position and orientation of the medical probe 16 in the expanded configuration. As shown, the flexible circuit substrate 70 can include an outward-facing electrode 26a, an inward-facing electrode 26b, and a mapping electrode 26c. The mapping electrode 26c can be a conventional coil sensor, a flat PCB-based sensor, or a deformable electromagnetic ring sensor. Although not shown, the mapping electrode 26c can be alternatively positioned on the generally cylindrical structure 60 or designed as a separate ridge in the plurality of ridges 22.

参考电极可被配置为测量来自与接触组织的电极直接相邻的流体和/或血液的电信号。因此，参考电极与接触组织是绝缘的，并且所收集的所得信号是非局部远场信号。来自该参考电极的信息可用于抵消来自相邻的组织接触电极的远场信号，以确保组织接触电极仅收集局部信息。The reference electrode can be configured to measure electrical signals from fluid and/or blood directly adjacent to the electrode contacting the tissue. Thus, the reference electrode is insulated from the contacting tissue, and the resulting signals collected are non-local far-field signals. Information from the reference electrode can be used to cancel far-field signals from adjacent tissue contacting electrodes to ensure that the tissue contacting electrode collects only local information.

在一些实施方案中，多个脊22中的单独的脊220可被绝缘并充当位置传感器。在一些实施方案中，推杆88可包括在远侧末端28处的消融电极98，该消融电极98穿过大致圆柱形结构60的远侧环225装配。In some embodiments, individual ridges 220 of the plurality of ridges 22 may be insulated and act as position sensors. In some embodiments, push rod 88 may include ablation electrode 98 at distal tip 28 that fits through distal ring 225 of generally cylindrical structure 60.

图6A和图6B是示出了如上所述从中空管210切下并由于接触靶标的力而压缩的多个脊22的侧视图的示意性图解。多个脊22膨胀至无约束长度L，压缩至压缩长度CL，并且由于多个脊22的三分叉和二分叉而柔性地移动大致圆柱形结构60。如本领域技术人员将理解的，将二分叉或三分叉定位在沿着圆柱形结构60的纵向轴线86的不同位置处可以改变圆柱形结构60的柔性或者可以允许用于医疗探头16的不同的膜和/或电极阵列设计。6A and 6B are schematic illustrations showing side views of a plurality of ridges 22 cut from a hollow tube 210 and compressed due to the force of contacting a target as described above. The plurality of ridges 22 expand to an unconstrained length L, compress to a compressed length CL, and flexibly move the generally cylindrical structure 60 due to the trifurcation and bifurcation of the plurality of ridges 22. As will be appreciated by those skilled in the art, positioning the bifurcation or trifurcation at different locations along the longitudinal axis 86 of the cylindrical structure 60 can change the flexibility of the cylindrical structure 60 or can allow for different membrane and/or electrode array designs for the medical probe 16.

图7A是示出了具有二分叉点217和三分叉点219两者的多个脊22的侧视图的示意性图解。多个脊22膨胀至近侧环222与远侧环225之间的无约束长度L，使得当由于接触组织诸如心脏的力而被压缩时，多个脊22能够由于二分叉和三分叉而柔性地移动。在膨胀形式中，多个脊22的近侧环222和远侧环225具有第一直径D1，如上所述，该第一直径基本上等于中空管的直径。在膨胀形式中，多个脊22膨胀至第二直径D2。如图7B所示，单个脊的特写图像示出了中间部分218、二分叉点217和两个脊分支216。图7C示出了膨胀至第二直径D2的多个脊22以及三分叉点219的顶视图，其中的一个在图7D中以特写示出。FIG. 7A is a schematic illustration showing a side view of a plurality of ridges 22 having both a bifurcation 217 and a trifurcation 219. The plurality of ridges 22 expand to an unconstrained length L between the proximal ring 222 and the distal ring 225 so that when compressed due to the force of contacting tissue such as the heart, the plurality of ridges 22 are able to flexibly move due to the bifurcation and trifurcation. In the expanded form, the proximal ring 222 and the distal ring 225 of the plurality of ridges 22 have a first diameter D1, which, as described above, is substantially equal to the diameter of the hollow tube. In the expanded form, the plurality of ridges 22 expand to a second diameter D2. As shown in FIG. 7B, a close-up image of a single ridge shows a middle portion 218, a bifurcation 217, and two ridge branches 216. FIG. 7C shows a top view of the plurality of ridges 22 and the trifurcation 219 expanded to the second diameter D2, one of which is shown in close-up in FIG. 7D.

图8A和图8B是示出了多个脊22的另一个三分叉设计的侧视图和顶视图的示意性图解，该设计具有相对于纵向轴线86沿着中间部分218的曲线。如图所示，脊可以是正弦的，但是设计也可以是合适的曲线，使得当从塌缩形式(图3B)转变为如图8B所示的膨胀形式时，多个脊22扭转。多个脊22膨胀至无约束长度L，使得当由于接触组织诸如心脏的力而被压缩时，多个脊22能够由于脊的设计而柔性地移动。8A and 8B are schematic illustrations showing side and top views of another trifurcated design of the plurality of spines 22 having a curve along the middle portion 218 relative to the longitudinal axis 86. As shown, the spines can be sinusoidal, but the design can also be a suitable curve so that the plurality of spines 22 twist when transitioning from the collapsed form (FIG. 3B) to the expanded form as shown in FIG8B. The plurality of spines 22 expand to an unconstrained length L so that when compressed due to the force of contacting tissue such as the heart, the plurality of spines 22 can move flexibly due to the design of the spines.

图8C是示出了具有嵌入在外表面和内表面上的电极的图8A的膜的横截面视图的示意性图解。在一些实施方案中，面向外的电极26a和面向内的电极26b形成堆叠的电极26d，因为它们在柔性电路基板70的条带的相对两侧对准，如图8C所示。Fig. 8C is a schematic illustration of a cross-sectional view of the membrane of Fig. 8A having electrodes embedded on the outer and inner surfaces. In some embodiments, the outwardly facing electrodes 26a and the inwardly facing electrodes 26b form stacked electrodes 26d because they are aligned on opposite sides of the strip of flexible circuit substrate 70, as shown in Fig. 8C.

图9A至图9D是示出了具有电极26和电迹线96的柔性电路基板70的条带的示意性图解。在一些实施方案中，电迹线96被嵌入在电路基板内并且被示为连接一个或多个电极26的线，电极被联接到柔性电路基板70的外表面，如图9A和图9C所示。在图8C中更详细地示出，电极26设置在柔性电路基板70外表面上和柔性电路基板70内表面上，使得电极限定一对堆叠的电极26d。设置在柔性电路基板内表面上的电极26b可用作参考电极。参考电极可以测量来自医疗探头16的内部容积66中的流体的电信号，以降低噪声、提高标测精度等。9A to 9D are schematic illustrations showing a strip of a flexible circuit substrate 70 having electrodes 26 and electrical traces 96. In some embodiments, the electrical traces 96 are embedded within the circuit substrate and are shown as lines connecting one or more electrodes 26, which are connected to the outer surface of the flexible circuit substrate 70, as shown in FIGS. 9A and 9C. As shown in more detail in FIG. 8C, the electrodes 26 are disposed on the outer surface of the flexible circuit substrate 70 and on the inner surface of the flexible circuit substrate 70, so that the electrodes define a pair of stacked electrodes 26d. The electrode 26b disposed on the inner surface of the flexible circuit substrate can be used as a reference electrode. The reference electrode can measure electrical signals from the fluid in the internal volume 66 of the medical probe 16 to reduce noise, improve mapping accuracy, etc.

在本文所述的实施方案中，定位在圆柱形结构60的柔性电路基板70上的一个或多个电极26可被配置为将消融能量(RF和/或IRE)递送到心脏26中的组织。多个脊22可与电极26电绝缘，以防止电极26对相应的脊220的电弧放电。另外，电极还可用于确定医疗探头16的位置和/或测量生理特性，诸如心脏26中的组织上的相应位置处的局部表面电势。电极26可被偏置成使得一个或多个电极26a的更大部分从大致圆柱形结构60面向外，使得一个或多个电极26a向外远离圆柱形结构60(即，朝向心脏12组织)而不是向内递送更大量的电能。In the embodiments described herein, one or more electrodes 26 positioned on the flexible circuit substrate 70 of the cylindrical structure 60 can be configured to deliver ablative energy (RF and/or IRE) to tissue in the heart 26. The plurality of ridges 22 can be electrically insulated from the electrodes 26 to prevent arcing of the electrodes 26 to the corresponding ridges 220. In addition, the electrodes can also be used to determine the position of the medical probe 16 and/or measure physiological properties, such as local surface potential at corresponding locations on tissue in the heart 26. The electrodes 26 can be biased so that a greater portion of the one or more electrodes 26a faces outward from the generally cylindrical structure 60, so that the one or more electrodes 26a deliver a greater amount of electrical energy outwardly away from the cylindrical structure 60 (i.e., toward the heart 12 tissue) rather than inwardly.

理想地适合于形成电极26的材料的示例包括金、铂和钯(以及它们的相应合金)。这些材料还具有高热导率，这允许在组织上生成的最小热量(即，通过递送到组织的消融能量)通过电极传导到电极的背面(即，电极在脊状物的内侧上的部分)，并且然后传导到心脏12中的血池。Examples of materials that are ideally suited for forming electrode 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablative energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode on the inside of the ridge), and then to the blood pool in the heart 12.

如上所述，PIU 30和工作站55包括用于冲洗的控制器，其将冲洗流体递送到医疗探头16。尽管未示出，但多个冲洗开口可被定位在大致圆柱形结构60的内部容积66内并且成角度，以将冲洗流体喷射或以其他方式分散到给定电极26或心脏12中的组织。由于电极26不包括递送冲洗流体的冲洗开口，因此所述的配置使得热量能够从组织传递到电极在多个脊22的内侧上的部分(即，在消融规程期间)，并且电极26可通过经由冲洗开口使冲洗流体对准电极26在脊22的内侧上的部分来进行冷却。As described above, the PIU 30 and workstation 55 include a controller for irrigation that delivers irrigation fluid to the medical probe 16. Although not shown, a plurality of irrigation openings may be positioned within the interior volume 66 of the generally cylindrical structure 60 and angled to spray or otherwise disperse irrigation fluid to a given electrode 26 or tissue in the heart 12. Since the electrode 26 does not include an irrigation opening to deliver irrigation fluid, the configuration described enables heat to be transferred from the tissue to the portion of the electrode on the inner side of the plurality of ridges 22 (i.e., during an ablation procedure), and the electrode 26 may be cooled by directing irrigation fluid through the irrigation openings to the portion of the electrode 26 on the inner side of the ridges 22.

柔性电路基板70可包括多个近侧附接点72和远侧附接点75(如图9A所示)。尽管未示出，但膜70可由平面材料设计而成，其中远侧附接点75位于中心，并且材料沿着纵向轴线86向近侧延伸。柔性电路基板70可由生物相容性电绝缘材料制成，诸如聚酰胺-聚醚(Pebax)共聚物、聚对苯二甲酸乙二酯(PET)、聚氨酯、聚酰亚胺、聚对二甲苯、有机硅以及它们的组合。在一些示例中，绝缘材料可包括生物相容性聚合物，包括但不限于聚乙基苯、聚二甲基硅氧烷、聚乙醇酸、聚-L-乳酸、聚己酸酯(polycaprolactive)、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚酰胺、聚酰亚胺、乙烯乙酸乙烯酯、聚偏二氟乙烯、聚碳酸酯、聚丙烯、聚乙烯、聚氨酯、聚对苯二甲酸乙二酯、聚萘二甲酸乙二酯、聚酐、聚己内酯、聚对二氧环己酮、聚丁内酯、聚戊内酯、聚(丙交酯-共-乙交酯)、聚二甲基硅氧烷、有机硅、环氧树脂、含氟聚合物、聚四氟乙烯，选择某些聚合物的比例以控制炎症反应的程度。柔性电路基板70可有助于将多个脊22、电迹线96或穿过柔性电路基板70的导线与电极26绝缘，以防止电极26对脊22的电弧放电和/或穿过柔性电路基板70的导线的机械磨损。The flexible circuit substrate 70 may include a plurality of proximal attachment points 72 and distal attachment points 75 (as shown in FIG. 9A ). Although not shown, the membrane 70 may be designed from a planar material with the distal attachment point 75 located in the center and the material extending proximally along the longitudinal axis 86. The flexible circuit substrate 70 may be made from a biocompatible electrically insulating material such as polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and combinations thereof. In some examples, the insulating material may include a biocompatible polymer, including but not limited to polyethylbenzene, polydimethylsiloxane, polyglycolic acid, poly-L-lactic acid, polycaprolactive, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyamide, polyimide, ethylene vinyl acetate, polyvinylidene fluoride, polycarbonate, polypropylene, polyethylene, polyurethane, polyethylene terephthalate, polyethylene naphthalate, polyanhydride, polycaprolactone, polydioxanone, polybutyrolactone, polyvalerolactone, poly(lactide-co-glycolide), polydimethylsiloxane, silicone, epoxy, fluoropolymer, polytetrafluoroethylene, the proportions of certain polymers being selected to control the extent of the inflammatory response. The flexible circuit substrate 70 may help insulate the plurality of ridges 22, electrical traces 96, or wires passing through the flexible circuit substrate 70 from the electrode 26 to prevent arcing of the electrode 26 to the ridges 22 and/or mechanical wear of the wires passing through the flexible circuit substrate 70.

图10是示出了根据本发明的实施方案的制造医疗探头16的方法1000的流程图。方法1000可包括将柔性电路基板70制造成一个或多个条带(步骤1002)。制造电迹线可在将一个或多个电极26对准在柔性电路基板70上的一条或多条电迹线96内之前或同时完成(步骤1004)。柔性电路基板70可包括电极阵列，该电极阵列包括面向外(相对于医疗探头)的电极26a、面向内的或参考电极26b以及标测电极26c。电极可被定位成使得电极26沿着柔性电路基板70或柔性电路基板70的相邻条带从相邻电极26偏移。另选地，电极26可对准在线性阵列内，该线性阵列基本上等于柔性电路基板70的相邻条带。理想地适合于形成电极26的材料包括金、铂和钯(以及它们的相应合金)。柔性电路基板70可由平面弹性材料切割而成。平面弹性材料可包括形状记忆合金，诸如镍-钛(也称为镍钛诺)或生物相容性聚合物，包括但不限于聚乙基苯、聚二甲基硅氧烷、聚乙醇酸、聚-L-乳酸、聚己酸酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚酰胺、聚酰亚胺、乙烯乙酸乙烯酯、聚偏二氟乙烯、聚碳酸酯、聚丙烯、聚乙烯、聚氨酯、聚对苯二甲酸乙二酯、聚萘二甲酸乙二酯、聚酐、聚己内酯、聚对二氧环己酮、聚丁内酯、聚戊内酯、聚(丙交酯-共-乙交酯)、聚二甲基硅氧烷、有机硅、环氧树脂、含氟聚合物、聚四氟乙烯或它们的组合。在一些示例中，方法1000可通过气相沉积(例如，化学气相沉积(CVD)、物理气相沉积(PVD)或原子层沉积(ALD))来形成膜。对于气相沉积，可以沉积镍钛诺层，接着是薄绝缘层，然后是导电迹线和电极层。在一些示例中，方法1000可通过光刻方法、溅射方法(例如，旋涂、直写溅射或溅射涂覆)、印刷(例如，3D印刷)、电沉积、光刻来形成膜。FIG. 10 is a flow chart showing a method 1000 for manufacturing a medical probe 16 according to an embodiment of the present invention. The method 1000 may include manufacturing a flexible circuit substrate 70 into one or more strips (step 1002). The manufacturing of electrical traces may be completed before or simultaneously with aligning one or more electrodes 26 within one or more electrical traces 96 on the flexible circuit substrate 70 (step 1004). The flexible circuit substrate 70 may include an electrode array including electrodes 26a facing outward (relative to the medical probe), inward or reference electrodes 26b, and mapping electrodes 26c. The electrodes may be positioned so that the electrodes 26 are offset from adjacent electrodes 26 along the flexible circuit substrate 70 or adjacent strips of the flexible circuit substrate 70. Alternatively, the electrodes 26 may be aligned in a linear array that is substantially equal to adjacent strips of the flexible circuit substrate 70. Ideally suitable materials for forming the electrodes 26 include gold, platinum, and palladium (and their corresponding alloys). The flexible circuit substrate 70 may be cut from a planar elastic material. The planar elastic material may include a shape memory alloy such as nickel-titanium (also known as nitinol) or a biocompatible polymer including, but not limited to, polyethylbenzene, polydimethylsiloxane, polyglycolic acid, poly-L-lactic acid, polycaproate, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyamide, polyimide, ethylene vinyl acetate, polyvinylidene fluoride, polycarbonate, polypropylene, polyethylene, polyurethane, polyethylene terephthalate, polyethylene naphthalate, polyanhydride, polycaprolactone, polydioxanone, polybutyrolactone, polyvalerolactone, poly(lactide-co-glycolide), polydimethylsiloxane, silicone, epoxy, fluoropolymer, polytetrafluoroethylene, or a combination thereof. In some examples, method 1000 may form a film by vapor deposition (e.g., chemical vapor deposition (CVD), physical vapor deposition (PVD), or atomic layer deposition (ALD)). For vapor deposition, a nitinol layer can be deposited, followed by a thin insulating layer, and then a conductive trace and electrode layer. In some examples, method 1000 can form a film by photolithography, sputtering (e.g., spin coating, direct write sputtering, or sputter coating), printing (e.g., 3D printing), electrodeposition, photolithography.

方法1000还包括将柔性电路基板70的一个或多个条带定位在包括多个脊22的大致圆柱形结构60之上(步骤1006)。柔性电路基板70的条带可被紧固在多个脊22之上，如本文所述。如受益于本公开的本领域技术人员将理解的，紧固柔性电路基板70的条带可包括将近侧附接点72附接到多个脊22的近侧环222或附接到管状轴84。方法1000可包括将多个脊22构造成从纵向轴线86径向向外延伸以限定大致圆柱形结构60(步骤1008)。将多个脊22构造成径向向外延伸可包括从中空管210切割设计，以形成定形(或热定形)的脊，从而提供大致圆柱形结构60。中空管210可包括形状记忆合金诸如镍钛合金(也称为镍钛诺)、钴铬合金或任何其他合适的材料。如上所述，多个脊22包括沿着脊210的至少一部分的二分叉和/或三分叉。The method 1000 also includes positioning one or more strips of the flexible circuit substrate 70 over the generally cylindrical structure 60 including the plurality of ridges 22 (step 1006). The strips of the flexible circuit substrate 70 may be fastened over the plurality of ridges 22 as described herein. As will be appreciated by those skilled in the art having the benefit of this disclosure, fastening the strips of the flexible circuit substrate 70 may include attaching the proximal attachment point 72 to the proximal ring 222 of the plurality of ridges 22 or to the tubular shaft 84. The method 1000 may include configuring the plurality of ridges 22 to extend radially outward from the longitudinal axis 86 to define the generally cylindrical structure 60 (step 1008). Configuring the plurality of ridges 22 to extend radially outward may include cutting the design from the hollow tube 210 to form shaped (or heat set) ridges to provide the generally cylindrical structure 60. The hollow tube 210 may include a shape memory alloy such as nickel titanium alloy (also known as Nitinol), a cobalt chromium alloy, or any other suitable material. As described above, the plurality of ridges 22 include bifurcations and/or trifurcations along at least a portion of the ridges 210 .

在一些示例中，步骤1002至1008可作为同时的步骤或作为一系列步骤而发生。In some examples, steps 1002 through 1008 may occur as simultaneous steps or as a series of steps.

方法1000可包括将每个脊210或近侧环222插入到尺寸被设定成横穿脉管系统的管状轴84的内腔中，使得大致圆柱形结构60定位在医疗探头16的远侧端部处，并且相应的脊220能够从管状构型移动到弓形构型。Method 1000 may include inserting each spine 210 or proximal ring 222 into the lumen of a tubular shaft 84 sized to traverse vasculature such that the generally cylindrical structure 60 is positioned at the distal end of the medical probe 16 and the corresponding spine 220 is capable of moving from a tubular configuration to an arcuate configuration.

如本领域的技术人员将理解的，方法1000可包括本文中描述的所公开技术的各种特征中的任一者且可取决于特定构造而变化。因此，方法1000不应被解释为限于本文明确描述的特定步骤和步骤顺序。需注意，虽然医疗探头的示例性实施方案优选地用于标测、IRE或PFA，但也在本发明的范围内的是，将医疗探头单独地仅用于RF消融(具有外部接地电极的单极模式或双极模式)，或者顺序地(在IRE模式下的某些电极和在RF模式下的其他电极)或同时地(在IRE模式下的电极组和在RF模式下的其他电极)与IRE消融和RF消融组合使用。As will be appreciated by those skilled in the art, method 1000 may include any of the various features of the disclosed technology described herein and may vary depending on the particular configuration. Therefore, method 1000 should not be construed as limited to the specific steps and order of steps explicitly described herein. It should be noted that while the exemplary embodiments of the medical probe are preferably used for mapping, IRE, or PFA, it is also within the scope of the present invention to use the medical probe alone for RF ablation only (monopolar mode or bipolar mode with external ground electrodes), or in combination with IRE ablation and RF ablation, either sequentially (certain electrodes in IRE mode and other electrodes in RF mode) or simultaneously (electrode groups in IRE mode and other electrodes in RF mode).

本文所述的公开技术可根据以下条款来进一步理解：The disclosed technology described herein can be further understood according to the following terms:

条款1：一种医疗探头，包括：大致圆柱形结构，所述大致圆柱形结构包括：近侧圆形基部；远侧圆形基部，所述远侧圆形基部基本上平行于所述近侧圆形基部；多个脊，所述多个脊沿着纵向轴线延伸，接合所述远侧圆形基部和所述近侧圆形基部，每个脊包括：三分叉点，所述三分叉点沿着所述脊的至少一部分定位，和脊分支，所述脊分支从所述三分叉点延伸并且还包括二分叉点；和柔性电路基板的一个或多个条带，所述一个或多个条带联接到所述多个脊中的一个或多个脊。Item 1: A medical probe comprising: a generally cylindrical structure, the generally cylindrical structure comprising: a proximal circular base; a distal circular base, the distal circular base being substantially parallel to the proximal circular base; a plurality of ridges extending along a longitudinal axis, joining the distal circular base and the proximal circular base, each ridge comprising: a trifurcation, the trifurcation being positioned along at least a portion of the ridge, and ridge branches, the ridge branches extending from the trifurcation and also comprising a bifurcation; and one or more strips of a flexible circuit substrate, the one or more strips being coupled to one or more of the plurality of ridges.

条款2：根据条款1所述的医疗探头，所述多个脊中的每个脊在所述大致圆柱形结构的远侧端部处接合。Clause 2: The medical probe of clause 1, each ridge of the plurality of ridges joined at a distal end of the generally cylindrical structure.

条款3：根据条款1所述的医疗探头，所述多个脊被构造成从管状构型移动至膨胀的圆柱形构型。Clause 3: The medical probe of clause 1, the plurality of ridges being configured to move from a tubular configuration to an expanded cylindrical configuration.

条款4：根据条款1至3中任一项所述的医疗探头，所述大致圆柱形结构包括大致平坦的远侧部分圆形基部。Clause 4: The medical probe of any one of clauses 1 to 3, the generally cylindrical structure comprising a generally flat distal portion circular base.

条款5：根据条款1至4中任一项所述的医疗探头，所述大致圆柱形结构包括位于所述远侧圆形基部与所述近侧圆形基部之间的中间部分，所述中间部分具有从约10mm至约20mm范围内的长度。Clause 5: The medical probe of any one of clauses 1 to 4, the generally cylindrical structure comprising a middle portion between the distal circular base and the proximal circular base, the middle portion having a length ranging from about 10 mm to about 20 mm.

条款6：根据条款1至5中任一项所述的医疗探头，其中，所述多个脊沿着所述纵向轴线线性行进。Clause 6: The medical probe of any one of clauses 1 to 5, wherein the plurality of ridges run linearly along the longitudinal axis.

条款7：根据条款1至5中任一项所述的医疗探头，其中，所述多个脊沿着所述纵向轴线正弦地行进。Clause 7: The medical probe of any one of clauses 1 to 5, wherein the plurality of ridges run sinusoidally along the longitudinal axis.

条款8：根据条款1至7中任一项所述的医疗探头，所述多个脊中的每个脊在所述大致圆柱形结构的近侧端部处接合。Clause 8: The medical probe of any of clauses 1 to 7, each ridge of the plurality of ridges joined at a proximal end of the generally cylindrical structure.

条款9：根据条款1至8中任一项所述的医疗探头，其中，所述远侧圆形基部具有比所述近侧圆形基部小的半径。Clause 9: The medical probe of any one of clauses 1 to 8, wherein the distal circular base has a smaller radius than the proximal circular base.

条款10：根据条款1至8中任一项所述的医疗探头，其中，所述远侧圆形基部具有比所述近侧圆形基部大的半径。Clause 10: The medical probe of any one of clauses 1 to 8, wherein the distal circular base has a larger radius than the proximal circular base.

条款11：根据条款1至8中任一项所述的医疗探头，其中，所述远侧圆形基部具有近似等于所述近侧圆形基部的半径。Clause 11: The medical probe of any of clauses 1 to 8, wherein the distal circular base has a radius approximately equal to the proximal circular base.

条款12：根据条款1至11中任一项所述的医疗探头，每个脊在所述大致圆柱形结构的远侧端部处会聚成远侧环，并且在所述大致圆柱形结构的近侧端部处会聚成近侧环。Clause 12: The medical probe of any of clauses 1 to 11, each ridge converging into a distal ring at a distal end of the generally cylindrical structure and converging into a proximal ring at a proximal end of the generally cylindrical structure.

条款13：根据条款1至12中任一项所述的医疗探头，所述大致圆柱形结构还包括位于所述多个脊中的一个或多个脊上的一个或多个电磁定位线圈。Clause 13: The medical probe of any of clauses 1 to 12, the generally cylindrical structure further comprising one or more electromagnetic localization coils located on one or more of the plurality of ridges.

条款14：根据条款1至13中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带在所述大致圆柱形结构的远侧端部处接合。Clause 14: The medical probe of any of clauses 1 to 13, the one or more strips of the flexible circuit substrate joined at a distal end of the generally cylindrical structure.

条款15：根据条款1至13中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带在所述大致圆柱形结构的近侧端部处接合。Clause 15: The medical probe of any of clauses 1 to 13, the one or more strips of the flexible circuit substrate joined at a proximal end of the generally cylindrical structure.

条款16：根据条款1至15中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带包括至少四个条带。Clause 16: The medical probe of any one of clauses 1 to 15, wherein the one or more strips of the flexible circuit substrate include at least four strips.

条款17：根据条款1至16中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带包括八个条带。Clause 17: The medical probe of any of clauses 1 to 16, wherein the one or more strips of the flexible circuit substrate include eight strips.

条款18：根据条款1至17中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带还包括设置在所述基板的表面上的一条或多条导电迹线。Clause 18: The medical probe of any of clauses 1 to 17, the one or more strips of flexible circuit substrate further comprising one or more conductive traces disposed on a surface of the substrate.

条款19：根据条款1至18中任一项所述的医疗探头，所述柔性电路基板的一个或多个条带由平面材料形成。Clause 19: The medical probe of any one of clauses 1 to 18, wherein the one or more strips of the flexible circuit substrate are formed of a planar material.

条款20：根据条款1至19中任一项所述的医疗探头，其中，柔性电路基板的所述条带包括联接到所述基板的外表面的一个或多个电极。Clause 20: The medical probe of any of clauses 1 to 19, wherein the strip of flexible circuit substrate includes one or more electrodes coupled to an outer surface of the substrate.

条款21：根据条款20所述的医疗探头，所述柔性电路基板的条带还包括一个或多个参考电极，所述一个或多个参考电极联接到所述基板的内表面，使得所述参考电极与所述外表面上的相应电极共同定位，以限定一对堆叠的电极。Item 21: According to the medical probe of Item 20, the strip of flexible circuit substrate also includes one or more reference electrodes, and the one or more reference electrodes are connected to the inner surface of the substrate so that the reference electrodes are co-positioned with corresponding electrodes on the outer surface to define a pair of stacked electrodes.

条款22：根据条款20所述的医疗探头，所述一个或多个电极被配置为供应电信号以便将治疗程序应用于所述一个或多个电极所接触的组织。Clause 22: The medical probe of clause 20, the one or more electrodes being configured to supply an electrical signal to apply a therapeutic procedure to tissue contacted by the one or more electrodes.

条款23：根据条款1至22中任一项所述的医疗探头，其中，所述一个或多个电极被配置为递送用于不可逆电穿孔的电脉冲，所述脉冲具有至少900伏的峰值电压。Clause 23: The medical probe of any of clauses 1 to 22, wherein the one or more electrodes are configured to deliver electrical pulses for irreversible electroporation, the pulses having a peak voltage of at least 900 volts.

条款24：根据条款1至23中任一项所述的医疗探头，其中，所述一个或多个电极被配置为递送在所述大致圆柱形结构内流动的流体的参考信号。Clause 24: The medical probe of any of clauses 1 to 23, wherein the one or more electrodes are configured to deliver a reference signal of a fluid flowing within the generally cylindrical structure.

条款25：根据条款1至24中任一项所述的医疗探头，所述医疗探头还包括靠近所述管状轴的所述远侧端部设置的冲洗开口，所述冲洗开口被构造成将冲洗流体递送到所述一个或多个电极。Clause 25: The medical probe of any of clauses 1 to 24, further comprising an irrigation opening disposed proximate the distal end of the tubular shaft, the irrigation opening configured to deliver an irrigation fluid to the one or more electrodes.

条款26：根据条款1至25中任一项所述的医疗探头，其中，所述多个脊包含镍钛诺。Clause 26: The medical probe of any of clauses 1 to 25, wherein the plurality of ridges comprises nitinol.

条款27：根据条款1至25中任一项所述的医疗探头，其中，所述多个脊包含金属股线。Clause 27: The medical probe of any one of clauses 1 to 25, wherein the plurality of spines comprise metal strands.

条款28：根据条款1至27中任一项所述的医疗探头，其中，所述柔性电路基板的一个或多个条带包含镍钛诺。Clause 28: The medical probe of any of clauses 1 to 27, wherein the one or more strips of the flexible circuit substrate comprise nitinol.

条款29：根据条款1至27中任一项所述的医疗探头，其中，所述柔性电路基板的一个或多个条带包含惰性生物相容性聚合物。Clause 29: The medical probe of any of Clauses 1 to 27, wherein the one or more strips of the flexible circuit substrate comprise an inert biocompatible polymer.

条款30：根据条款29所述的医疗探头，所述惰性生物相容性聚合物选自由以下组成的组：聚乙基苯、聚二甲基硅氧烷、聚乙醇酸、聚-L-乳酸、聚己酸酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚酰胺、聚酰亚胺、乙烯乙酸乙烯酯、聚偏二氟乙烯、聚碳酸酯、聚丙烯、聚乙烯、聚氨酯、聚对苯二甲酸乙二酯、聚萘二甲酸乙二酯、聚酐、聚己内酯、聚对二氧环己酮、聚丁内酯、聚戊内酯、聚(丙交酯-共-乙交酯)、聚二甲基硅氧烷、有机硅、环氧树脂、含氟聚合物、聚四氟乙烯或它们的组合。Item 30: According to the medical probe described in Item 29, the inert biocompatible polymer is selected from the group consisting of: polyethylbenzene, polydimethylsiloxane, polyglycolic acid, poly-L-lactic acid, polycaproate, polyhydroxybutyrate, polyhydroxyvalerate, polydioxanone, polyamide, polyimide, ethylene vinyl acetate, polyvinylidene fluoride, polycarbonate, polypropylene, polyethylene, polyurethane, polyethylene terephthalate, polyethylene naphthalate, polyanhydride, polycaprolactone, polydioxanone, polybutyrolactone, polyvalerolactone, poly(lactide-co-glycolide), polydimethylsiloxane, silicone, epoxy resin, fluoropolymer, polytetrafluoroethylene or a combination thereof.

条款31：一种构造医疗探头的方法，所述方法包括：将柔性电路基板制造成一个或多个条带；将所述一个或多个条带定位在包括多个脊的大致圆柱形结构之上；以及将所述多个脊构造成从管状构型沿纵向轴线径向向外延伸，以限定大致圆柱形结构。Item 31: A method of constructing a medical probe, the method comprising: manufacturing a flexible circuit substrate into one or more strips; positioning the one or more strips over a generally cylindrical structure including a plurality of ridges; and configuring the plurality of ridges to extend radially outward from a tubular configuration along a longitudinal axis to define the generally cylindrical structure.

条款32：根据条款31所述的方法，还包括：切割具有接合中心点的所述柔性电路基板的一个或多个条带；以及将所述接合中心点定位在所述大致圆柱形结构的远侧端部处。Clause 32: The method of clause 31, further comprising: cutting one or more strips of the flexible circuit substrate having a joint center point; and positioning the joint center point at a distal end of the generally cylindrical structure.

条款33：根据条款31或32中任一项所述的方法，还包括将所述柔性电路基板的一个或多个条带紧固到所述大致圆柱形结构。Clause 33: The method of any of Clauses 31 or 32, further comprising securing one or more strips of the flexible circuit substrate to the generally cylindrical structure.

条款34：根据条款33所述的方法，还包括将所述柔性电路基板的一个或多个条带铰接到在所述大致圆柱形结构的所述远侧端部处的远侧环。Clause 34: The method of clause 33, further comprising hingedly attaching one or more strips of the flexible circuit substrate to a distal ring at the distal end of the generally cylindrical structure.

条款35：根据条款34所述的方法，还包括将所述柔性电路基板的一个或多个条带的至少一部分缝合到所述多个脊。Clause 35: The method of clause 34, further comprising stitching at least a portion of one or more strips of the flexible circuit substrate to the plurality of ridges.

条款36：根据条款33所述的方法，还包括将所述柔性电路基板的一个或多个条带附接到沿着所述多个脊定位的一个或多个铆钉。Clause 36: The method of clause 33, further comprising attaching one or more strips of the flexible circuit substrate to one or more rivets positioned along the plurality of ridges.

条款37：根据条款31至33中任一项所述的方法，还包括将所述柔性电路基板的一个或多个条带紧固到所述大致圆柱形结构的内表面和外表面。Clause 37: The method of any of clauses 31 to 33, further comprising securing one or more strips of the flexible circuit substrate to the inner and outer surfaces of the generally cylindrical structure.

条款38：根据条款31至37中任一项所述的方法，还包括将来自所述柔性电路基板的一条或多条电迹线连接到穿过所述医疗探头的管状轴行进的导线。Clause 38: The method of any of Clauses 31 to 37, further comprising connecting one or more electrical traces from the flexible circuit substrate to a wire running through the tubular shaft of the medical probe.

条款39：根据条款31至38中任一项所述的方法，还包括通过物理气相沉积来印刷柔性电路基板的一个或多个条带。Clause 39: The method of any of clauses 31 to 38, further comprising printing the one or more strips of the flexible circuit substrate by physical vapor deposition.

条款40：根据条款31至38中任一项所述的方法，还包括从包含镍钛诺的平面片材切割柔性电路基板的一个或多个条带。Clause 40: The method of any of Clauses 31 to 38, further comprising cutting one or more strips of the flexible circuit substrate from the planar sheet comprising nitinol.

条款41：根据条款31至40中任一项所述的方法，还包括将一个或多个电磁定位线圈定位在所述大致圆柱形结构的所述多个脊上。Clause 41: The method of any of clauses 31 to 40, further comprising positioning one or more electromagnetic locating coils on the plurality of ridges of the generally cylindrical structure.

条款42：根据条款31至41中任一项所述的方法，还包括沿着中空管的长度形成切口以形成所述多个脊，当压缩所述管的远侧端部和近侧端部时，所述多个脊轴向弯曲以形成所述大致圆柱形结构。Clause 42: The method of any one of clauses 31 to 41, further comprising forming cuts along the length of the hollow tube to form the plurality of ridges, the plurality of ridges bending axially to form the generally cylindrical structure when the distal and proximal ends of the tube are compressed.

条款43：根据条款42所述的方法，其中，沿着所述中空管的所述长度的所述切口形成所述多个脊，所述多个脊包括定位在所述管的所述近侧端部与所述远侧端部之间的三分叉点。Clause 43: The method of clause 42, wherein the cuts along the length of the hollow tube form the plurality of ridges, the plurality of ridges comprising a trifurcation point positioned between the proximal and distal ends of the tube.

条款44：根据条款43所述的方法，其中，沿着所述中空管的所述长度的所述切口还包括定位在从所述三分叉点延伸的脊分支上的二分叉点，所述二分叉点定位在所述管的所述近侧端部与所述远侧端部之间。Clause 44: The method of clause 43, wherein the cut along the length of the hollow tube further comprises a bifurcation point positioned on a spinal branch extending from the trifurcation point, the bifurcation point being positioned between the proximal end and the distal end of the tube.

上述实施方案以举例的方式被引用，并且本发明不受上文具体示出和描述的内容的限制。相反，本发明的范围包括上文描述和示出的各种特征的组合和子组合以及它们的变型和修改，本领域的技术人员在阅读上述描述时将会想到该变型和修改，并且该变型和修改并未在现有技术中公开。The above embodiments are cited by way of example, and the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub-combinations of the various features described and shown above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims (20)

Translated fromChinese

1.一种医疗探头，包括：1. A medical probe, comprising:大致圆柱形结构，其包括：A generally cylindrical structure comprising:近侧圆形基部；proximally rounded base;远侧圆形基部，所述远侧圆形基部大致平行于所述近侧圆形基部，多个脊，所述多个脊沿着纵向轴线延伸，接合所述远侧圆形基部和近侧圆形基部，每个脊包括：a distal circular base, the distal circular base being generally parallel to the proximal circular base, a plurality of ridges extending along the longitudinal axis, joining the distal circular base and the proximal circular base, each ridge comprising:三分叉点，所述三分叉点沿着所述脊的至少一部分定位，和a trifurcation point located along at least a portion of the spine, and脊分支，所述脊分支从所述三分叉点延伸并且还包括二分叉点；和a spinal branch extending from the trifurcation point and also including a bifurcation point; and联接到所述多个脊中的一个或多个脊的柔性电路基板的一个或多个条带。One or more strips of the flexible circuit substrate coupled to one or more of the plurality of spines.2.根据权利要求1所述的医疗探头，所述多个脊中的每个脊在所述大致圆柱形结构的远侧端部处接合。2 . The medical probe of claim 1 , each of the plurality of ridges joining at a distal end of the generally cylindrical structure.3.根据权利要求1所述的医疗探头，所述多个脊构造成从管状构造移动至膨胀的圆柱形构造。3. The medical probe of claim 1, the plurality of ridges configured to move from a tubular configuration to an expanded cylindrical configuration.4.根据权利要求1所述的医疗探头，所述大致圆柱形结构包括大致平坦的远侧部分圆形基部。4. The medical probe of claim 1, the generally cylindrical structure comprising a generally flat distal portion with a circular base.5.根据权利要求1所述的医疗探头，所述大致圆柱形结构包括在所述远侧圆形基部与所述近侧圆形基部之间的中间部分，所述中间部分具有从约10mm至约20mm范围内的长度。5. The medical probe of claim 1, the generally cylindrical structure comprising a middle portion between the distal circular base and the proximal circular base, the middle portion having a length ranging from about 10 mm to about 20 mm.6.根据权利要求1所述的医疗探头，其中，所述多个脊沿着所述纵向轴线线性行进。6. The medical probe of claim 1, wherein the plurality of ridges run linearly along the longitudinal axis.7.根据权利要求1所述的医疗探头，其中，所述多个脊沿着所述纵向轴线正弦地行进。7. The medical probe of claim 1, wherein the plurality of ridges run sinusoidally along the longitudinal axis.8.根据权利要求1所述的医疗探头，每个脊在所述大致圆柱形结构的远侧端部处会聚成远侧环，并且在所述大致圆柱形结构的近侧端部处会聚成近侧环。8. The medical probe of claim 1, each ridge converging into a distal ring at a distal end of the generally cylindrical structure and converging into a proximal ring at a proximal end of the generally cylindrical structure.9.根据权利要求1所述的医疗探头，所述大致圆柱形结构还包括在所述多个脊中的一个或多个脊上的一个或多个电磁定位线圈。9. The medical probe of claim 1, the generally cylindrical structure further comprising one or more electromagnetic localization coils on one or more of the plurality of ridges.10.根据权利要求1所述的医疗探头，所述柔性电路基板的一个或多个条带还包括设置在所述柔性电路基板的表面上的一条或多条导电迹线。10. The medical probe of claim 1, the one or more strips of the flexible circuit substrate further comprising one or more conductive traces disposed on a surface of the flexible circuit substrate.11.根据权利要求1所述的医疗探头，其中，柔性电路基板的所述条带包括联接到所述柔性电路基板的外表面的一个或多个电极。11. The medical probe of claim 1 , wherein the strip of flexible circuit substrate includes one or more electrodes coupled to an outer surface of the flexible circuit substrate.12.根据权利要求11所述的医疗探头，柔性电路基板的所述条带还包括一个或多个参考电极，所述一个或多个参考电极联接到所述柔性电路基板的内表面，使得所述参考电极与所述外表面上的相应电极共同定位，以限定一对堆叠的电极。12. The medical probe of claim 11 , the strip of flexible circuit substrate further comprising one or more reference electrodes coupled to an inner surface of the flexible circuit substrate such that the reference electrodes are co-located with corresponding electrodes on the outer surface to define a pair of stacked electrodes.13.根据权利要求11所述的医疗探头，其中，所述一个或多个电极配置成递送在所述大致圆柱形结构内流动的流体的参考信号。13. The medical probe of claim 11, wherein the one or more electrodes are configured to deliver a reference signal of a fluid flowing within the generally cylindrical structure.14.一种构造医疗探头的方法，所述方法包括：14. A method of constructing a medical probe, the method comprising:将柔性电路基板制造为一个或多个条带；fabricating the flexible circuit substrate into one or more strips;将所述一个或多个条带定位在包括多个脊的大致圆柱形结构之上；以及positioning the one or more strips over a generally cylindrical structure comprising a plurality of ridges; and将所述多个脊构造成沿着纵向轴线从管状构造径向向外延伸，以限定所述大致圆柱形结构。The plurality of ridges are configured to extend radially outwardly from the tubular structure along the longitudinal axis to define the generally cylindrical structure.15.根据权利要求14所述的方法，还包括：15. The method according to claim 14, further comprising:切割具有接合中心点的所述柔性电路基板的所述一个或多个条带；以及cutting the one or more strips of the flexible circuit substrate having a joint center point; and将所述接合中心点定位在所述大致圆柱形结构的远侧端部处。The center point of engagement is positioned at a distal end of the generally cylindrical structure.16.根据权利要求15所述的方法，还包括将所述柔性电路基板的所述一个或多个条带铰接到在所述大致圆柱形结构的所述远侧端部处的远侧环。16. The method of claim 15, further comprising hingedly connecting the one or more strips of the flexible circuit substrate to a distal ring at the distal end of the generally cylindrical structure.17.根据权利要求14所述的方法，还包括通过物理气相沉积来印刷柔性电路基板的一个或多个条带。17. The method of claim 14, further comprising printing the one or more strips of flexible circuit substrate by physical vapor deposition.18.根据权利要求14所述的方法，还包括沿着中空管的长度形成切口以形成所述多个脊，当压缩所述中空管的远侧端部和近侧端部时，所述多个脊轴向弯曲以形成所述大致圆柱形结构。18. The method of claim 14, further comprising forming cuts along a length of the hollow tube to form the plurality of ridges, the plurality of ridges axially bending to form the generally cylindrical structure when the distal and proximal ends of the hollow tube are compressed.19.根据权利要求18所述的方法，其中，沿着所述中空管的所述长度的所述切口形成所述多个脊，所述多个脊包括定位在所述中空管的所述近侧端部与所述远侧端部之间的三分叉点。19. The method of claim 18, wherein the cuts along the length of the hollow tube form the plurality of ridges, the plurality of ridges comprising a trifurcation point positioned between the proximal and distal ends of the hollow tube.20.根据权利要求19所述的方法，其中，沿着所述中空管的所述长度的所述切口还包括定位在从所述三分叉点延伸的脊分支上的二分叉点，所述二分叉点定位在所述中空管的所述近侧端部与所述远侧端部之间。20. The method of claim 19, wherein the cut along the length of the hollow tube further comprises a bifurcation point positioned on a spinal branch extending from the trifurcation point, the bifurcation point being positioned between the proximal end and the distal end of the hollow tube.