WO2015055112A1 - Medical catheter and radio frequency treatment system - Google Patents

Medical catheter and radio frequency treatment system Download PDF

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Publication number
WO2015055112A1
WO2015055112A1 PCT/CN2014/088568 CN2014088568W WO2015055112A1 WO 2015055112 A1 WO2015055112 A1 WO 2015055112A1 CN 2014088568 W CN2014088568 W CN 2014088568W WO 2015055112 A1 WO2015055112 A1 WO 2015055112A1
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WIPO (PCT)
Prior art keywords
medical catheter
annular end
electrodes
end portion
force
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PCT/CN2014/088568
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French (fr)
Chinese (zh)
Inventor
梁波
张清淳
杨谦谦
蔡丽妮
孙毅勇
谭家宏
郭小静
王慧
Original Assignee
上海微创电生理医疗科技有限公司
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Publication of WO2015055112A1 publication Critical patent/WO2015055112A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure

Definitions

  • the present invention relates to a medical catheter and radiofrequency treatment system.
  • Radiofrequency ablation is a rapid development of minimally invasive surgery, which uses the radio frequency current thermal effect generated by high-frequency electromagnetic waves to make tissue coagulative necrosis and achieve therapeutic effects.
  • Radiofrequency ablation has been clinically applied in the treatment of arrhythmia, benign prostatic hyperplasia, various types of substantial tumors.
  • Radiofrequency ablation includes ablation catheters and ablation devices; for the treatment of atrial fibrillation, the ablation catheter enters the body via the vein and reaches the ablation chamber. After the electrode on the catheter is energized, it forms a circuit with the diffused electrode in vitro, and the tissue around the electrode is in the tissue. The charged ions are oscillated by the current, generating bioheat, and solidifying the heart tissue with abnormal electrical signals.
  • the annular catheter is one of the ablation catheters.
  • the electrodes are evenly distributed on the ring, which can form an interconnected annular ablation wound during ablation, eliminating multiple point ablation, saving operation time and reducing the risk of surgery. .
  • the inventors have found that the adherence of the annular catheter to the surface of the blood vessel wall or tissue is very important, and uneven adherence or even a virtual paste may result in uneven ablation depth, which makes the doctor have to carry out. Repeated ablation has increased the risk of surgery.
  • the adhesion force of the catheter electrode to the blood vessel wall or the organ is also very important, and the ablation effect can be optimized by controlling the adhesion force of the catheter electrode.
  • the present invention provides a medical catheter and radiofrequency treatment system that facilitates control of the contact force of the annular catheter with the vessel wall or organ surface.
  • a medical catheter is provided.
  • the medical catheter of the present invention has an annular end with a plurality of electrodes thereon; the annular end is further provided with one or more force sensors for sensing the ring The contact force of the end portion with other objects.
  • the force sensor is located between adjacent ones of the electrodes or inside the electrodes.
  • the number of the electrodes is 4 to 10.
  • the annular end is a multi-lumen tube or a single lumen tube, a wire connecting the electrode, a wire connecting the force sensor, and a shaping wire distributed in the multi-lumen tube or located in the single In the lumen.
  • the multi-lumen tube is a two-chamber tube, comprising a first lumen for placing a wire connecting the electrode and a wire connecting the force sensor, and a second lumen for placing a shaping wire.
  • the multi-lumen tube comprises a plurality of lumens, and one of the lumens has an adjustable filament.
  • the multi-lumen tube comprises a plurality of lumens, and one of the lumens has a saline tube therein.
  • the medical catheter comprises three force sensors respectively disposed between adjacent ones of the electrodes, and the three force sensors are distributed along the circumferential direction of the annular end.
  • the circumferential gap distance between the three force sensors is 0.1 MM to 0.4 MM;
  • the medical catheter comprises two force sensors respectively disposed between adjacent ones of the electrodes, the two force sensors respectively covering the outer side and the front side of the annular end portion in the circumferential direction.
  • the circumferential gap distance between the two force sensors is 0.05 MM to 0.2 MM.
  • the medical catheter includes a force sensor disposed between adjacent ones of the electrodes.
  • the force sensor is a piezoelectric film sensor.
  • the piezoelectric film sensor has a thickness of 0.05 MM to 0.5 MM.
  • a radio frequency treatment system is provided.
  • the radiofrequency treatment system of the present invention including a radio frequency ablation instrument, further includes a medical catheter of the present invention coupled to the radiofrequency ablation instrument.
  • the catheter operator can grasp the relationship between the annular end portion and the blood vessel or the organ by adding a force sensor between the electrodes of the annular end of the medical catheter or the inner side of the electrode.
  • the adherence condition helps to control the contact force between the annular catheter and the vessel wall or organ surface. When applied to ablation surgery, it can improve the quality of ablation surgery and reduce the risk of surgery.
  • FIG. 1 is a schematic diagram of a radio frequency treatment system in accordance with an embodiment of the present invention.
  • FIG. 2 is a schematic illustration of a circular catheter for mapping or ablation within a blood vessel in accordance with an embodiment of the present invention
  • FIG. 3 is a schematic view showing the structure of an annular end portion of a catheter according to an embodiment of the present invention.
  • FIG. 4 is a schematic view showing the internal structure of an annular end portion of a catheter according to an embodiment of the present invention.
  • Figure 5 is a schematic illustration of the internal structure of another annular end of a catheter in accordance with an embodiment of the present invention.
  • FIGS. 6 and 7 are schematic views of an internal structure of still another annular end portion of a catheter according to an embodiment of the present invention.
  • the radiofrequency treatment system 10 primarily includes a radio frequency ablation device 11 and a catheter 12.
  • the catheter 12 has a proximal end and a distal end, a proximal end 121 coupled to the control handle 124, a distal end having a deflectable intermediate section 122, and an annular end 123.
  • a plurality of sensing electrodes (not shown in Fig. 1) are uniformly assembled to the annular end portion of the catheter, and the preferred number of electrodes is 4-10, which can balance manufacturing feasibility and measurement accuracy.
  • the electrode has a mapping or mapping and ablation function, which can take electrical signals of tissues such as the heart, and can also ablate the designated tissue sites.
  • the control handle 124 is connected to the radio frequency ablator 11 through a connecting wire 13 for The deflection of the intermediate section 122 is controlled and the diameter of the annular end 123 is adjusted.
  • a force sensor (not shown in Fig. 1) is mounted at a position between the above-mentioned electrodes for sensing the end portion of the annular end portion 123 and other objects such as the blood vessel wall or the organ/ Contact force on the outer surface.
  • the force sensor transmits the sensing signal back to the radio frequency ablation device 11 through the wire 13.
  • the radio frequency ablation device 11 includes a force sensing processing system to indicate the contact of the annular end portion 123 with other objects on the control panel 141.
  • FIG. 2 is a schematic illustration of a circular catheter for mapping or ablation within a blood vessel in accordance with an embodiment of the present invention.
  • the annular end portion 21 of the catheter is guided by the guiding sheath 22, enters the vein or artery 23, and reaches the designated position, and then returns to a ring shape under the action of the shaped wire; the operator adjusts the annular end portion 21 to the blood vessel wall.
  • the operator can refer to the reading to adjust the ring diameter, so that the electrode 211 on the annular end portion 21 (the plurality of black blocks in the figure are a plurality of electrodes) and the blood vessel wall have Optimal contact force and perform mapping or ablation.
  • each electrode 211 is generally opposite to the advancing direction of the annular end portion 21 in the vein or artery 23, that is, directed from the front of the annular end portion 21 to the ring shape.
  • the annular end portion 21 can be adjusted in diameter from 10 mm to 50 mm.
  • the annular catheter 21 can be mapped or ablated either in the blood vessel or at the entrance of the blood vessel.
  • FIG. 3 is a schematic illustration of the structure of an annular end of a catheter in accordance with an embodiment of the present invention.
  • the annular end portion 32 of the duct 31 has a plurality of electrodes 33, and a piezoelectric film sensor is interposed between the adjacent electrodes 33.
  • a piezoelectric film sensor 34 exposed after removal of the outer sleeve is shown in FIG.
  • the annular end portion 32 has a wire connecting the electrodes (specifically, a ring electrode wire, a temperature sensor wire, etc.), a wire connecting the force sensor, and a shaping wire.
  • the shaping wire is used to maintain the annular shape of the distal end of the catheter, and the material thereof is a metal material having shape memory such as nickel-titanium alloy or stainless steel, preferably Nitinol; or a polymer material having shape memory properties.
  • the annular end portion 32 may be a single lumen tube or a multi-lumen tube. If it is a multi-lumen tube, the above-mentioned wire and shaping wire are distributed in the multi-lumen tube, for example, in the case of a two-chamber tube, it may be a wire connecting the electrodes and The wire connecting the force sensor is located in the first lumen, and the shaping wire is located in the second lumen.
  • the annular end portion 32 may also be a four-chamber tube, and may also be provided with an adjustable wire. This structure is shown in FIG. 4.
  • FIG. 4 is a schematic view showing the internal structure of the annular end portion of the catheter according to an embodiment of the present invention. .
  • FIG. 4 shows a cross section between the electrodes on the annular end portion 32, that is, the AA cross section of FIG. 3.
  • the inside of the annular end portion 32 is a multi-lumen tube structure, and four chambers are shown.
  • the outer diameter of the multi-lumen tube in Figure 4 is preferably no greater than 8F.
  • the force sensor 34 of FIG. 3 is specifically illustrated in FIG. 4
  • the annular end portion 32 can be a five-chamber tube in which a saline tube can also be provided.
  • Fig. 5 is a schematic view showing the internal structure of another annular end portion of a catheter according to an embodiment of the present invention.
  • Figure 5 is also a cross-sectional view, the annular end portion 50 of the catheter has a plurality of chambers, respectively, which are provided with an adjustable wire, a shaped wire, an electrode wire, a thermocouple wire, and a force sensor wire.
  • a chamber is used to place the saline tube. Referring to FIG.
  • the piezoelectric film sensors 511 and 512 are respectively placed on the outer side surface of the annular end portion (part of the surface away from the center of the annular end portion) and directly in front (refer to FIG. 2, the direction of the arrow points from the front to the front) rear).
  • the piezoelectric film sensor is also fixed by a bonding material and then fixed in the sleeve.
  • the bonding material here may be a glue and an epoxy resin.
  • the force sensor employed in this embodiment is a piezoelectric film sensor that functions to enable the force sensor to be mounted to the end of the catheter having a toroidal shape and a curved surface. Based on the piezoelectric principle of the film, the piezoelectric film sensor can sensitively measure a force of 0 to 200 g with a sensitivity of ⁇ 1 g and a thickness of 0.05 MM to 0.5 MM. If it is necessary to measure the force applied to the end of the ring in all directions, it can be in the ring. Between the electrodes at the ends, three force sensors are evenly distributed on the tube wall, whereby the total number of force sensors is 3 (n-1), where n is the number of electrodes.
  • the pitch D1 of the piezoelectric film sensors 342, 343 (referring to the arc length of the circumference here) may be 0.1 MM to 0.4 MM. If it is provided only on the outer side and the upper side of the annular end portion, referring to FIG. 5, the pitch D2 of the piezoelectric film sensor (also referred to as the arc length of the circumference here) may be 0.05 MM to 0.2 MM. The spacing between the piezoelectric film sensors helps to reduce the amount of piezoelectric film sensor.
  • the piezoelectric film sensor can be adhered to the outer wall of the single-cavity tube or the multi-lumen tube by a bonding material, and then fixed to the sleeve (see the sleeve 48 in Fig. 4).
  • a bonding material can be selected from polyetheretherketone (PEEK) or block polyetheramide elastomer (PEBAX), but not Limited to these; the bonding material here may be a glue or an epoxy resin or the like.
  • the casing should be a relatively rigid material, including metal woven polyurethane, ABS, PEEK, PEBAX, etc.
  • FIG. 6 and 7 are schematic views of an internal structure of still another annular end portion of a catheter according to an embodiment of the present invention.
  • a piezoelectric film sensor (see Fig. 7) is placed on the inner surface of the electrode 61 to sense the contact force of the electrode with the tissue or blood vessel wall.
  • a piezoelectric film sensor is attached to the inner surface of the front side of each electrode (the direction in front of the front side as described above) and the inner surface of the outer side (the direction away from the center of the annular end portion), so that it can be calculated that n Two electrodes require 2n piezoelectric film sensors.
  • Fig. 7 shows a cross-sectional view taken along line B-B of Fig. 6, in which piezoelectric film sensors 711, 712 are shown, which are located on the inner surface and the outer inner surface of the front side of the electrode 72, respectively.
  • the piezoelectric film sensor is first applied to the stainless steel substrate with glue or epoxy resin, and then, in each of the electrodes, the piezoelectric film sensor is further adhered to the inner wall of the electrode by using glue or epoxy resin.
  • the role of the stainless steel substrate is to give the piezoelectric film sensor sufficient support force when the electrode is stressed.
  • the force sensor enables the catheter operator to grasp the adherence between the annular end and the blood vessel or organ, and to help control the contact force between the annular catheter and the vessel wall or the surface of the organ, which can be improved when applied to ablation surgery.
  • the quality of ablation surgery reduces the risk of surgery.

Abstract

A medical catheter (31) and a radio frequency treatment system (10) having said catheter (31). The catheter (31) is provided with an annular end portion (32) having a plurality of electrodes (33). The annular end portion (32) is further provided with a force sensor (34). The force sensor (34) is used to measure the contact force between the annular end portion (32) and other objects, and assists in controlling contact between the annular end portion (32) and vascular walls or organ surfaces.

Description

一种医疗导管和射频治疗系统Medical catheter and radiofrequency treatment system 技术领域Technical field
本发明涉及一种医疗导管和射频治疗系统。The present invention relates to a medical catheter and radiofrequency treatment system.
背景技术Background technique
射频消融术是一种发展较为迅速的微创手术,其通过高频电磁波产生的射频电流热效应,使组织凝固性坏死,达到治疗的效果。目前,射频消融已在临床上应用于心律失常,前列腺增生,各类实质性肿瘤等治疗中。射频消融术中包括消融导管和消融设备;以治疗心房纤颤为例,消融导管经静脉进入体内,到达消融灶,导管上的电极通电后,与体外的弥散电极形成回路,体内电极周围组织中的带电荷离子受电流影响而发生振荡,产生生物热,凝固具有异常电信号的心脏组织。Radiofrequency ablation is a rapid development of minimally invasive surgery, which uses the radio frequency current thermal effect generated by high-frequency electromagnetic waves to make tissue coagulative necrosis and achieve therapeutic effects. At present, radiofrequency ablation has been clinically applied in the treatment of arrhythmia, benign prostatic hyperplasia, various types of substantial tumors. Radiofrequency ablation includes ablation catheters and ablation devices; for the treatment of atrial fibrillation, the ablation catheter enters the body via the vein and reaches the ablation chamber. After the electrode on the catheter is energized, it forms a circuit with the diffused electrode in vitro, and the tissue around the electrode is in the tissue. The charged ions are oscillated by the current, generating bioheat, and solidifying the heart tissue with abnormal electrical signals.
环状导管是消融导管中的一种,电极均匀分布于环上,在消融过程中能形成互连的环状消融伤口,省去了进行多次点消融,节约手术时间并且减少了手术的风险。The annular catheter is one of the ablation catheters. The electrodes are evenly distributed on the ring, which can form an interconnected annular ablation wound during ablation, eliminating multiple point ablation, saving operation time and reducing the risk of surgery. .
在实现本发明的过程中,发明人发现,环状导管与血管壁或组织表面的贴壁情况十分重要,不均匀的贴壁甚至是虚贴会导致消融深度的不均匀,使医生不得不进行多次反复的消融,增加了手术的风险。另外,导管电极对血管壁或器官的贴壁力也十分重要,通过控制导管电极贴壁力的大小,能使消融效果达到最佳。In the process of implementing the present invention, the inventors have found that the adherence of the annular catheter to the surface of the blood vessel wall or tissue is very important, and uneven adherence or even a virtual paste may result in uneven ablation depth, which makes the doctor have to carry out. Repeated ablation has increased the risk of surgery. In addition, the adhesion force of the catheter electrode to the blood vessel wall or the organ is also very important, and the ablation effect can be optimized by controlling the adhesion force of the catheter electrode.
发明内容Summary of the invention
有鉴于此,本发明提供一种医疗导管和射频治疗系统,有助于控制环状导管与血管壁或器官表面的接触力。In view of this, the present invention provides a medical catheter and radiofrequency treatment system that facilitates control of the contact force of the annular catheter with the vessel wall or organ surface.
为实现上述目的,根据本发明的一个方面,提供了一种医疗导管。 To achieve the above object, according to one aspect of the present invention, a medical catheter is provided.
本发明的医疗导管具有环状端部,所述环状端部上有多个电极;所述环状端部还设置有一个或多个力传感器,所述力传感器用于感测所述环状端部与其他物体的接触力。The medical catheter of the present invention has an annular end with a plurality of electrodes thereon; the annular end is further provided with one or more force sensors for sensing the ring The contact force of the end portion with other objects.
可选地,所述力传感器位于相邻的所述电极之间,或者位于所述电极内侧。Optionally, the force sensor is located between adjacent ones of the electrodes or inside the electrodes.
可选地,所述电极的数目为4至10个。Optionally, the number of the electrodes is 4 to 10.
可选地,所述环状端部为多腔管或单腔管,连接所述电极的导线、连接所述力传感器的导线、以及定型丝分布在所述多腔管中或位于所述单腔管中。Optionally, the annular end is a multi-lumen tube or a single lumen tube, a wire connecting the electrode, a wire connecting the force sensor, and a shaping wire distributed in the multi-lumen tube or located in the single In the lumen.
可选地,所述多腔管为两腔管,包括一第一管腔用于放置连接所述电极的导线和连接所述力传感器的导线,以及一第二管腔用于放置定型丝。Optionally, the multi-lumen tube is a two-chamber tube, comprising a first lumen for placing a wire connecting the electrode and a wire connecting the force sensor, and a second lumen for placing a shaping wire.
可选地,所述多腔管包括多个管腔,且其中的一个管腔内具有可调丝。Optionally, the multi-lumen tube comprises a plurality of lumens, and one of the lumens has an adjustable filament.
可选地,所述多腔管包括多个管腔,且其中的一个管腔内具有盐水管。Optionally, the multi-lumen tube comprises a plurality of lumens, and one of the lumens has a saline tube therein.
可选地,所述医疗导管包括3个力传感器,分别设置于相邻的所述电极之间,所述的3个力传感器沿所述环状端部的周向分布。Optionally, the medical catheter comprises three force sensors respectively disposed between adjacent ones of the electrodes, and the three force sensors are distributed along the circumferential direction of the annular end.
可选地,所述3个力传感器之间的周向间隙距离为0.1MM至0.4MM;Optionally, the circumferential gap distance between the three force sensors is 0.1 MM to 0.4 MM;
可选地,所述医疗导管包括2个力传感器,分别设置于相邻的所述电极之间,所述2个力传感器分别沿周向覆盖环状端部的外侧面和正前方。Optionally, the medical catheter comprises two force sensors respectively disposed between adjacent ones of the electrodes, the two force sensors respectively covering the outer side and the front side of the annular end portion in the circumferential direction.
可选地,所述2个力传感器之间的周向间隙距离为0.05MM至0.2MM。Optionally, the circumferential gap distance between the two force sensors is 0.05 MM to 0.2 MM.
可选地,所述医疗导管包括1个力传感器设置于相邻的所述电极之间。Optionally, the medical catheter includes a force sensor disposed between adjacent ones of the electrodes.
可选地,所述力传感器为压电薄膜传感器。Optionally, the force sensor is a piezoelectric film sensor.
可选地,所述压电薄膜传感器的厚度为0.05MM至0.5MM。Optionally, the piezoelectric film sensor has a thickness of 0.05 MM to 0.5 MM.
根据本发明的另一方面,提供了一种射频治疗系统。According to another aspect of the invention, a radio frequency treatment system is provided.
本发明的射频治疗系统,包括射频消融仪,还包括本发明中的医疗导管,与所述射频消融仪相连接。The radiofrequency treatment system of the present invention, including a radio frequency ablation instrument, further includes a medical catheter of the present invention coupled to the radiofrequency ablation instrument.
根据本发明的技术方案,通过在医疗导管的环状端部的电极之间或者电极内侧加装力传感器,使导管操作人员能够掌握环状端部与血管或器官之间 的贴壁情况,有助于控制环状导管与血管壁或器官表面的接触力,在应用于消融手术时,能够提高消融手术的质量,降低手术风险。According to the technical solution of the present invention, the catheter operator can grasp the relationship between the annular end portion and the blood vessel or the organ by adding a force sensor between the electrodes of the annular end of the medical catheter or the inner side of the electrode. The adherence condition helps to control the contact force between the annular catheter and the vessel wall or organ surface. When applied to ablation surgery, it can improve the quality of ablation surgery and reduce the risk of surgery.
附图说明DRAWINGS
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:The drawings are intended to provide a better understanding of the invention and are not intended to limit the invention. among them:
图1是根据本发明实施例的射频治疗系统的示意图;1 is a schematic diagram of a radio frequency treatment system in accordance with an embodiment of the present invention;
图2是根据本发明实施例的环状导管在血管内进行标测或消融的示意图;2 is a schematic illustration of a circular catheter for mapping or ablation within a blood vessel in accordance with an embodiment of the present invention;
图3是根据本发明实施例的导管的环状端部的结构的示意图;3 is a schematic view showing the structure of an annular end portion of a catheter according to an embodiment of the present invention;
图4是根据本发明实施例的一种导管环状端部的内部结构的示意图;4 is a schematic view showing the internal structure of an annular end portion of a catheter according to an embodiment of the present invention;
图5是根据本发明实施例的另一种导管环状端部的内部结构的示意图;Figure 5 is a schematic illustration of the internal structure of another annular end of a catheter in accordance with an embodiment of the present invention;
图6和图7是根据本发明实施例的又一种导管环状端部的内部结构的示意图。6 and 7 are schematic views of an internal structure of still another annular end portion of a catheter according to an embodiment of the present invention.
具体实施方式detailed description
以下结合附图对本发明的示范性实施例做出说明,其中包括本发明实施例的各种细节以助于理解,应当将它们认为仅仅是示范性的。因此,本领域普通技术人员应当认识到,可以对这里描述的实施例做出各种改变和修改而不会背离本发明的范围和精神。同样,为了清楚和简明,以下的描述中省略了对公知功能和结构的描述。The exemplary embodiments of the present invention are described with reference to the accompanying drawings, and are in the Accordingly, it will be appreciated by those skilled in the art that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.
图1是根据本发明实施例的射频治疗系统的示意图。如图1所示,射频治疗系统10主要包括射频消融仪11和导管12。导管12具有近端和远端,其近端121连接至控制手柄124,其远端具有可偏转中间段122,和环状端部123。多个感测电极(图1中未示出)被均匀组装于导管的环状端部,优选的电极数为4-10个,能兼顾制造的可行性和测量的准确性。所述的电极具有标测或标测和消融功能,可对如心脏等组织的电信号进行采取,也可对指定的组织部位进行消融。控制手柄124通过连接导线13与射频消融仪11相连,用来 控制中间段122的偏转以及调节环状端部123的直径大小。在环状端部123的表面,位于上述的电极之间的位置安装有力传感器(图1中未示出),用于感测环状端部123与其他物体例如与血管壁或者器官的内/外表面的接触力。上述力传感器将感测信号通过导线13传回射频消融仪11,射频消融仪11中含有力感测处理系统,从而能够在控制面板141上指示环状端部123与其他物体的接触情况。1 is a schematic diagram of a radio frequency treatment system in accordance with an embodiment of the present invention. As shown in FIG. 1, the radiofrequency treatment system 10 primarily includes a radio frequency ablation device 11 and a catheter 12. The catheter 12 has a proximal end and a distal end, a proximal end 121 coupled to the control handle 124, a distal end having a deflectable intermediate section 122, and an annular end 123. A plurality of sensing electrodes (not shown in Fig. 1) are uniformly assembled to the annular end portion of the catheter, and the preferred number of electrodes is 4-10, which can balance manufacturing feasibility and measurement accuracy. The electrode has a mapping or mapping and ablation function, which can take electrical signals of tissues such as the heart, and can also ablate the designated tissue sites. The control handle 124 is connected to the radio frequency ablator 11 through a connecting wire 13 for The deflection of the intermediate section 122 is controlled and the diameter of the annular end 123 is adjusted. At the surface of the annular end portion 123, a force sensor (not shown in Fig. 1) is mounted at a position between the above-mentioned electrodes for sensing the end portion of the annular end portion 123 and other objects such as the blood vessel wall or the organ/ Contact force on the outer surface. The force sensor transmits the sensing signal back to the radio frequency ablation device 11 through the wire 13. The radio frequency ablation device 11 includes a force sensing processing system to indicate the contact of the annular end portion 123 with other objects on the control panel 141.
图2是根据本发明实施例的环状导管在血管内进行标测或消融的示意图。导管的环状端部21由导引鞘22导引,进入静脉或动脉23,到达指定位置后,在定形丝的作用下恢复成环形;操作者调节环状端部21,使其与血管壁接触,此时消融仪上显示出相应的读数,操作者可参考该读数调节环径,使环状端部21上的电极211(图中的多个黑色块为多个电极)与血管壁有最佳接触力,并执行标测或消融。图2中的箭头为各电极211的受力方向示意图,该受力方向通常与环状端部21在静脉或动脉23中的前进方向相反,即从环状端部21的正前方指向环状端部21的正后方。环状端部21直径调节范围可以是10MM至50MM。环状导管21既可在血管内,也可在血管入口处进行标测、消融。2 is a schematic illustration of a circular catheter for mapping or ablation within a blood vessel in accordance with an embodiment of the present invention. The annular end portion 21 of the catheter is guided by the guiding sheath 22, enters the vein or artery 23, and reaches the designated position, and then returns to a ring shape under the action of the shaped wire; the operator adjusts the annular end portion 21 to the blood vessel wall. Contact, at this time the corresponding reading is displayed on the ablator, the operator can refer to the reading to adjust the ring diameter, so that the electrode 211 on the annular end portion 21 (the plurality of black blocks in the figure are a plurality of electrodes) and the blood vessel wall have Optimal contact force and perform mapping or ablation. The arrow in Fig. 2 is a schematic view of the force direction of each electrode 211, which is generally opposite to the advancing direction of the annular end portion 21 in the vein or artery 23, that is, directed from the front of the annular end portion 21 to the ring shape. Immediately behind the end portion 21. The annular end portion 21 can be adjusted in diameter from 10 mm to 50 mm. The annular catheter 21 can be mapped or ablated either in the blood vessel or at the entrance of the blood vessel.
图3是根据本发明实施例的导管的环状端部的结构的示意图。如图3所示,导管31的环状端部32上有多个电极33,相邻的电极33之间有压电薄膜传感器。图3中示出了去除外层套管之后露出的压电薄膜传感器34。环状端部32内具有连接电极的导线(具体包括环电极导线、温度传感器导线等)、连接力传感器的导线、以及定型丝。定型丝用来维持导管远端的环形,其材料为镍钛合金、不锈钢等具有形状记忆的金属材料,优选地可以采用镍钛诺;也可以是具有形状记忆特性的高分子材料。环状端部32可以是单腔管或多腔管,如果为多腔管,上述的导线和定型丝分布在该多腔管中,例如两腔管的情形,则可以是连接电极的导线和连接力传感器的导线位于第一管腔内,定型丝位于第二管腔内。 3 is a schematic illustration of the structure of an annular end of a catheter in accordance with an embodiment of the present invention. As shown in Fig. 3, the annular end portion 32 of the duct 31 has a plurality of electrodes 33, and a piezoelectric film sensor is interposed between the adjacent electrodes 33. A piezoelectric film sensor 34 exposed after removal of the outer sleeve is shown in FIG. The annular end portion 32 has a wire connecting the electrodes (specifically, a ring electrode wire, a temperature sensor wire, etc.), a wire connecting the force sensor, and a shaping wire. The shaping wire is used to maintain the annular shape of the distal end of the catheter, and the material thereof is a metal material having shape memory such as nickel-titanium alloy or stainless steel, preferably Nitinol; or a polymer material having shape memory properties. The annular end portion 32 may be a single lumen tube or a multi-lumen tube. If it is a multi-lumen tube, the above-mentioned wire and shaping wire are distributed in the multi-lumen tube, for example, in the case of a two-chamber tube, it may be a wire connecting the electrodes and The wire connecting the force sensor is located in the first lumen, and the shaping wire is located in the second lumen.
环状端部32也可以是四腔管,并且其中还可以设置有可调丝,这种结构见图4,图4是根据本发明实施例的一种导管环状端部的内部结构的示意图。The annular end portion 32 may also be a four-chamber tube, and may also be provided with an adjustable wire. This structure is shown in FIG. 4. FIG. 4 is a schematic view showing the internal structure of the annular end portion of the catheter according to an embodiment of the present invention. .
图4示出了环状端部32上的电极之间的截面,即图3的A-A截面,如图4所示,环状端部32内部为多腔管结构,图中示出了四腔管47的结构;第一管腔41放置可调丝411,可调丝411用来调节环径大小,其材料为铜或镍铁合金;第二管腔42放置导线421,导线有多条,包括环电极导线、温度传感器导线等;当环状端部32具有消融功能时,每一个环电极中都放置了一个温度传感器,用来感测消融温度;第三管腔43放置定型丝431;第四管腔44放置力传感器导线441。图4中的多腔管的外径优选地不大于8F。图3中的力传感器34在图4中具体示为分布在四腔管47圆周上的力传感器341、342、343。4 shows a cross section between the electrodes on the annular end portion 32, that is, the AA cross section of FIG. 3. As shown in FIG. 4, the inside of the annular end portion 32 is a multi-lumen tube structure, and four chambers are shown. The structure of the tube 47; the first lumen 41 is provided with an adjustable wire 411, the adjustable wire 411 is used to adjust the diameter of the ring, the material is copper or nickel-iron alloy; the second lumen 42 is placed with the wire 421, and the wire has a plurality of wires, including a ring electrode lead, a temperature sensor lead, etc.; when the annular end portion 32 has an ablation function, a temperature sensor is placed in each of the ring electrodes for sensing the ablation temperature; and the third lumen 43 is placed with the shaping wire 431; The four lumens 44 place the force sensor wires 441. The outer diameter of the multi-lumen tube in Figure 4 is preferably no greater than 8F. The force sensor 34 of FIG. 3 is specifically illustrated in FIG. 4 as force sensors 341, 342, 343 distributed over the circumference of the four lumen 47.
另外环状端部32也可以是五腔管,其中还可以设置盐水管。这种结构见图5,图5是根据本发明实施例的另一种导管环状端部的内部结构的示意图。图5同样是截面图,导管的环状端部50内有多个腔室,分别放置可调丝、定型丝、电极导线、热电偶导线以及力传感器导线,与图4不同之处在于还有一个腔室用来放置盐水管。请一并参考图2,本领域技术人员容易理解,当环状端部在血管内移动,尤其是前进时,其内侧面(靠近环状端部的圆心的部分表面)以及正后方表面不易与其他物体接触,所以压电薄膜传感器511、512分别放置于环状端部的外侧面(远离环状端部的圆心的部分表面)及正前方(参考图2,箭头方向为从正前方指向正后方)。同样压电薄膜传感器采用粘结材料进行固定,再固定于套管之中。这里的粘结材料可以是胶和环氧树脂。这种带有环状端部的导管可以感测来自环状端部正前方和环外侧的接触力。Alternatively, the annular end portion 32 can be a five-chamber tube in which a saline tube can also be provided. This structure is shown in Fig. 5. Fig. 5 is a schematic view showing the internal structure of another annular end portion of a catheter according to an embodiment of the present invention. Figure 5 is also a cross-sectional view, the annular end portion 50 of the catheter has a plurality of chambers, respectively, which are provided with an adjustable wire, a shaped wire, an electrode wire, a thermocouple wire, and a force sensor wire. The difference from Figure 4 is that A chamber is used to place the saline tube. Referring to FIG. 2 together, it will be readily understood by those skilled in the art that when the annular end moves within the blood vessel, especially when advancing, the inner side surface (part of the surface near the center of the annular end portion) and the rear surface are not easily compatible. Since the other objects are in contact, the piezoelectric film sensors 511 and 512 are respectively placed on the outer side surface of the annular end portion (part of the surface away from the center of the annular end portion) and directly in front (refer to FIG. 2, the direction of the arrow points from the front to the front) rear). The piezoelectric film sensor is also fixed by a bonding material and then fixed in the sleeve. The bonding material here may be a glue and an epoxy resin. Such a catheter with an annular end can sense the contact force from the front of the annular end and the outside of the annulus.
本实施例中所采用的力传感器是压电薄膜传感器,其作用是使力传感器能够被安装到具有环形形状以及呈曲面的表面的导管端部。压电薄膜传感器基于薄膜压电原理,能灵敏地测出0至200g的力,灵敏度为±1g,其厚度为0.05MM至0.5MM。如果需要全方位测量施加于环状端部的力,可以在环状 端部的电极之间,采用3片力传感器均匀分布于管壁,由此,总的力传感器的数目为3(n-1),其中n为电极的数目。采用3片压电薄膜传感器的情形可参见图4,压电薄膜传感器342、343的间距D1(指此处圆周的弧长)可以是0.1MM至0.4MM。如果仅设置在环状端部的外侧面及正上方,参考图5,则压电薄膜传感器的间距D2(同样指此处圆周的弧长)可以是0.05MM至0.2MM。压电薄膜传感器之间具有间距有助于减少压电薄膜传感器的用量。但如果为了比较方便地将压电薄膜传感器设置在环状端部,上述的具有间距的2片或3片压电薄膜传感器可以由环绕环状端部的管体一周或者覆盖环状端部的外侧面至正上方的1片压电薄膜传感器来代替。The force sensor employed in this embodiment is a piezoelectric film sensor that functions to enable the force sensor to be mounted to the end of the catheter having a toroidal shape and a curved surface. Based on the piezoelectric principle of the film, the piezoelectric film sensor can sensitively measure a force of 0 to 200 g with a sensitivity of ±1 g and a thickness of 0.05 MM to 0.5 MM. If it is necessary to measure the force applied to the end of the ring in all directions, it can be in the ring. Between the electrodes at the ends, three force sensors are evenly distributed on the tube wall, whereby the total number of force sensors is 3 (n-1), where n is the number of electrodes. For the case of using three piezoelectric film sensors, see Fig. 4, the pitch D1 of the piezoelectric film sensors 342, 343 (referring to the arc length of the circumference here) may be 0.1 MM to 0.4 MM. If it is provided only on the outer side and the upper side of the annular end portion, referring to FIG. 5, the pitch D2 of the piezoelectric film sensor (also referred to as the arc length of the circumference here) may be 0.05 MM to 0.2 MM. The spacing between the piezoelectric film sensors helps to reduce the amount of piezoelectric film sensor. However, if the piezoelectric film sensor is disposed at the annular end portion for the sake of convenience, the above-mentioned two or three piezoelectric film sensors having a pitch may be surrounded by the tubular body surrounding the annular end or covered with the annular end portion. A piezoelectric film sensor from the outer side to the top is replaced.
压电薄膜传感器可以采用粘结材料黏附于单腔管或多腔管外壁,再固定于套管(参见图4中的套管48)之中。其中,单腔管或多腔管需要有足够的刚度,以提供压电薄膜传感器的止动,其材料可以选用聚醚醚酮(PEEK)或嵌段聚醚酰胺弹性体(PEBAX),但不限于这些;这里的粘结材料可以是胶或环氧树脂等。套管应为较为刚性的材料,包括金属编织聚氨酯,ABS,PEEK,PEBAX等。The piezoelectric film sensor can be adhered to the outer wall of the single-cavity tube or the multi-lumen tube by a bonding material, and then fixed to the sleeve (see the sleeve 48 in Fig. 4). Among them, single-cavity or multi-lumen tube needs to have sufficient rigidity to provide the stopper of the piezoelectric film sensor. The material can be selected from polyetheretherketone (PEEK) or block polyetheramide elastomer (PEBAX), but not Limited to these; the bonding material here may be a glue or an epoxy resin or the like. The casing should be a relatively rigid material, including metal woven polyurethane, ABS, PEEK, PEBAX, etc.
图6和图7是根据本发明实施例的又一种导管环状端部的内部结构的示意图。压电薄膜传感器(见图7)放于电极61内表面,来感测电极与组织或血管壁的接触力。每一个电极的正前方(与前文所述的正前方的方向一致)的内表面以及外侧(远离环状端部的圆心的方向)的内表面都贴有压电薄膜传感器,因此可以算出,n个电极则需要2n个压电薄膜传感器。图7示出了图6中的B-B截面图,其中示出了压电薄膜传感器711、712,分别位于电极72的正前方的内表面和外侧的内表面。6 and 7 are schematic views of an internal structure of still another annular end portion of a catheter according to an embodiment of the present invention. A piezoelectric film sensor (see Fig. 7) is placed on the inner surface of the electrode 61 to sense the contact force of the electrode with the tissue or blood vessel wall. A piezoelectric film sensor is attached to the inner surface of the front side of each electrode (the direction in front of the front side as described above) and the inner surface of the outer side (the direction away from the center of the annular end portion), so that it can be calculated that n Two electrodes require 2n piezoelectric film sensors. Fig. 7 shows a cross-sectional view taken along line B-B of Fig. 6, in which piezoelectric film sensors 711, 712 are shown, which are located on the inner surface and the outer inner surface of the front side of the electrode 72, respectively.
压电薄膜传感器首先用胶或环氧树脂贴敷于不锈钢衬底,之后,在每一个电极中,压电薄膜传感器再采用胶或环氧树脂类,紧贴于电极的内壁。其中不锈钢衬底的作用是当电极受力时,给予压电薄膜传感器足够的支撑力。The piezoelectric film sensor is first applied to the stainless steel substrate with glue or epoxy resin, and then, in each of the electrodes, the piezoelectric film sensor is further adhered to the inner wall of the electrode by using glue or epoxy resin. The role of the stainless steel substrate is to give the piezoelectric film sensor sufficient support force when the electrode is stressed.
根据本实施例的技术方案,通过在医疗导管的环状端部的电极之间加装 力传感器,使导管操作人员能够掌握环状端部与血管或器官之间的贴壁情况,有助于控制环状导管与血管壁或器官表面的接触力,在应用于消融手术时,能够提高消融手术的质量,降低手术风险。According to the technical solution of the embodiment, by installing between the electrodes of the annular end of the medical catheter The force sensor enables the catheter operator to grasp the adherence between the annular end and the blood vessel or organ, and to help control the contact force between the annular catheter and the vessel wall or the surface of the organ, which can be improved when applied to ablation surgery. The quality of ablation surgery reduces the risk of surgery.
上述具体实施方式,并不构成对本发明保护范围的限制。本领域技术人员应该明白的是,取决于设计要求和其他因素,可以发生各种各样的修改、组合、子组合和替代。任何在本发明的精神和原则之内所作的修改、等同替换和改进等,均应包含在本发明保护范围之内。 The above specific embodiments do not constitute a limitation of the scope of the present invention. Those skilled in the art will appreciate that a wide variety of modifications, combinations, sub-combinations and substitutions can occur depending on design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and scope of the invention are intended to be included within the scope of the invention.

Claims (15)

  1. 一种医疗导管,具有环状端部,所述环状端部上有多个电极;其特征在于,A medical catheter having an annular end with a plurality of electrodes on the annular end;
    所述环状端部还设置有一个或多个力传感器,所述力传感器用于感测所述环状端部与其他物体的接触力。The annular end portion is also provided with one or more force sensors for sensing the contact force of the annular end portion with other objects.
  2. 根据权利要求1所述的医疗导管,其特征在于,所述力传感器位于相邻的所述电极之间,或者位于所述电极内侧。The medical catheter of claim 1 wherein the force sensor is located between adjacent ones of the electrodes or inside the electrodes.
  3. 根据权利要求1所述的医疗导管,其特征在于,所述电极的数目为4至10个。The medical catheter of claim 1 wherein the number of electrodes is from 4 to 10.
  4. 根据权利要求1所述的医疗导管,其特征在于,所述环状端部为多腔管或单腔管,连接所述电极的导线、连接所述力传感器的导线、以及定型丝分布在所述多腔管中或位于所述单腔管中。The medical catheter of claim 1 wherein said annular end is a multi-lumen tube or a single lumen tube, a lead connecting said electrode, a lead connecting said force sensor, and a shaped wire are disposed in said In or in the multi-lumen tube.
  5. 根据权利要求4所述的医疗导管,其特征在于,所述多腔管为两腔管,包括一第一管腔用于放置连接所述电极的导线和连接所述力传感器的导线,以及一第二管腔用于放置定型丝。The medical catheter according to claim 4, wherein said multi-lumen tube is a two-chamber tube, comprising a first lumen for placing a wire connecting said electrode and a wire connecting said force sensor, and a The second lumen is used to place the shaped wire.
  6. 根据权利要求4所述的医疗导管,其特征在于,所述多腔管包括多个管腔,且其中的一个管腔内具有可调丝。The medical catheter of claim 4 wherein said multi-lumen tube comprises a plurality of lumens and one of said lumens has an adjustable filament.
  7. 根据权利要求4所述的医疗导管,其特征在于,所述多腔管包括多个管腔,且其中的一个管腔内具有盐水管。The medical catheter of claim 4 wherein said multi-lumen tube comprises a plurality of lumens and one of said lumens has a saline tube therein.
  8. 根据权利要求1所述的医疗导管,其特征在于,包括3个力传感器,分别设置于相邻的所述电极之间,所述的3个力传感器沿所述环状端部的周向分布。The medical catheter according to claim 1, comprising three force sensors respectively disposed between adjacent ones of said electrodes, said three force sensors being distributed along a circumferential direction of said annular end .
  9. 根据权利要求8所述的医疗导管,其特征在于,The medical catheter of claim 8 wherein:
    所述3个力传感器之间的周向间隙距离为0.1MM至0.4MM;The circumferential gap distance between the three force sensors is 0.1 MM to 0.4 MM;
  10. 根据权利要求1所述的医疗导管,其特征在于,包括2个力传感器, 分别设置于相邻的所述电极之间,所述2个力传感器分别沿周向覆盖环状端部的外侧面和正前方。The medical catheter of claim 1 including two force sensors, They are respectively disposed between adjacent electrodes, and the two force sensors respectively cover the outer side surface and the front side of the annular end portion in the circumferential direction.
  11. 根据权利要求10所述的医疗导管,其特征在于,The medical catheter of claim 10, wherein
    所述2个力传感器之间的周向间隙距离为0.05MM至0.2MM。The circumferential gap distance between the two force sensors is 0.05 MM to 0.2 MM.
  12. 根据权利要求1所述的医疗导管,其特征在于,包括1个力传感器设置于相邻的所述电极之间。The medical catheter of claim 1 including a force sensor disposed between adjacent ones of said electrodes.
  13. 根据权利要求1至12中任一项所述的医疗导管,其特征在于,所述力传感器为压电薄膜传感器。The medical catheter according to any one of claims 1 to 12, wherein the force sensor is a piezoelectric film sensor.
  14. 根据权利要求13所述的医疗导管,其特征在于,所述压电薄膜传感器的厚度为0.05MM至0.5MM。The medical catheter of claim 13 wherein said piezoelectric film sensor has a thickness of from 0.05 mm to 0.5 mm.
  15. 一种射频治疗系统,包括射频消融仪,其特征在于,还包括如权利要求1至14中任一项所述的医疗导管,与所述射频消融仪相连接。 A radio frequency treatment system comprising a radiofrequency ablation apparatus, further comprising a medical catheter according to any one of claims 1 to 14 coupled to the radio frequency ablation instrument.
PCT/CN2014/088568 2013-10-15 2014-10-14 Medical catheter and radio frequency treatment system WO2015055112A1 (en)

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