• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    balloon ablation catheter the present invention aims to provide a balloon ablation catheter, which together achieves a decrease in balloon diameter in the time of balloon contraction and increases the reliability of a thermocouple temperature sensor and, simultaneously, it is resistant to being affected by a heating liquid supplied into the balloon and is capable of controlling the surface temperature of the balloon with high precision. The present invention is a balloon ablation catheter which is provided with a shaft having a lumen, a balloon so that the lumen is in communication with the interior of the balloon, and a high frequency current supply electrode which is formed by winding a high-frequency power supply binding wire in a coil around the shaft, while sandwiching a temperature sensor binding wire between the high-frequency power supply binding wire and the shaft, of so that the temperature sensor connecting wire is fixed along the direction of the long axis of the axis. a thermocouple temperature sensor is formed at a point where the HF power supply lead wire and the temperature sensor lead wire, which configure the HF current supply electrode, first come into tactile contact, as seen from the extreme rear side in the direction of the long axis.
    公开号:BR112013030398B1
    申请号:R112013030398-0
    申请日:2012-06-08
    公开日:2021-07-27
    发明作者:Hiroyuki Harada；Motoki Takaoka；Akinori Matsukuma；Takahiro Yagi
    申请人:Toray Industries, Inc；
    IPC主号:
    专利说明:

    TECHNICAL FIELD
    [0001] The present invention relates to a balloon ablation catheter. FUNDAMENTALS OF THE INVENTION
    Cautery ablation is a method of treating arrhythmia by inserting an ablation catheter into the cardiac chamber and cauterizing cardiac muscle tissue with an electrode attached to the anterior end of the catheter.
    [0003] A newly developed balloon ablation catheter is used by percutaneously introducing a balloon attached to the extreme anterior side of the catheter into the inferior vena cava and then supplying it via the right atrium and then the interatrial septum of the heart to the atrium left, where the balloon is inflated and heated with high-frequency energy to cauterize cardiac muscle tissue (Patent Documents 1 and 2). This catheter has now become the ultimate goal of catheter ablation.
    [0004] In use of a balloon ablation catheter, a balloon attached to the anterior end of the catheter is inflated with a heating liquid and a high-frequency current is applied between an electrode counterplate outside the patient's body and an electrode. application of high frequency current disposed inside the balloon, to heat the heating liquid. Therefore, the entire cardiac muscle tissue that is in contact with the balloon surface is cauterized. The surface temperature of the balloon is controlled by a temperature sensor disposed inside the balloon and the heating liquid inside the balloon is made uniform by agitation with an oscillator or the like.
    [0005] As a temperature sensor for the balloon ablation catheter, a thermocouple temperature sensor is often used, in which a metallic wire, which supplies high-frequency energy to the electrode applying high-frequency current, is dotted to a different type of metallic wire. It is said that, in such a case, arrangement of the thermocouple near the rear end and on the surface of the high-frequency current application electrode allows for safe positioning of the thermocouple within the balloon, resulting in increased reliability of the detected temperature (Document of Patent 3). However, at the same time, since the thermocouple temperature sensor is positioned close to the lumen that communicates with the inner side of the balloon, the sensor is likely to be directly influenced by cooling with the heating liquid discharged for agitation within the balloon, so there is an instability problem of temperature control of the balloon surface.
    [0006] On the other hand, in order to suppress the influence of cooling with the heating liquid discharged into the balloon, an attempt was made to arrange the thermocouple temperature sensor inside the front end of the current applying electrode. high frequency (Patent Document 4). PRIOR TECHNIQUE DOCUMENTS
    [0007] [Patent Documents] [Patent Document 1] JP 2002-78809 A [Patent Document 2] JP 4062935 B [Patent Document 3] JP 4226040 B [Patent Document 4] JP 4122152B SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION
    [0008] However, if the thermocouple temperature sensor is arranged on the anterior extreme side of the electrode applying high frequency current, the different type of metallic wire needs to be more extended to the anterior extreme side of the balloon. In this case, the flexibility of the catheter in the part where the different type of metallic wire is extended is deteriorated and the diameter of the balloon in contraction close to the electrode applying high frequency current increases, resulting in difficulty in introducing the ablation catheter with balloon inside the patient's body and disadvantages in terms of catheter operation and patient load.
    [0009] In addition, if the thermocouple temperature sensor is disposed on the surface of the electrode applying high frequency current, the spot bonding of the different type of metallic wire needs firm adhesion by soldering or similar and this adhesion is a of the factors that increase the diameter of the balloon in the contraction of the balloon. Furthermore, since the resistance of the thermal pair prepared by point bonding of the different type of metallic wire cannot be fully reliable, developing measures to suppress the risk of wire breakage and the like is an urgent task and improving the reliability of the thermocouple temperature sensor has been required.
    [0010] In view of this, the present invention aims to provide a balloon ablation catheter that achieves balloon diameter reduction in balloon contraction and increased reliability of the thermocouple temperature sensor, balloon ablation catheter being less likely to be influenced by the heating liquid discharged into the balloon and capable of controlling the temperature of the balloon surface with high precision. MEANS TO SOLVE PROBLEMS
    [0011] In order to solve the problems described above, the present inventors have intensively studied to discover the inventions (1) to (4) below. (1) A balloon ablation catheter comprising: an axis in which a lumen penetrates in the longitudinal direction; a balloon attached to the shaft, where the lumen communicates with the inner side of the balloon; and a high-frequency current-applying electrode disposed within the balloon, the electrode being formed by winding around the axis a high-frequency power supply connecting wire, which supplies high-frequency power through the supply means. of power, while interspersing, between the high-frequency power supply connecting wire and the shaft, a temperature sensor connecting wire that supplies a measured signal to the power supply medium, so that the sensor connecting wire temperature is fixed along the longitudinal direction of the axis; wherein a term thermocouple sensor is formed at the point where the high frequency power supply connecting wire and the temperature sensor connecting wire constituting the high frequency current applying electrode contact each other for the first time. turn, as seen from the extreme posterior side in the longitudinal direction. (2) The balloon ablation catheter according to (1), comprising an oscillator which oscillates a heating liquid within the balloon, repeating the suction and discharge of the heating liquid from the lumen. (3) Balloon ablation catheter according to (1) or (2), wherein the thermocouple temperature sensor is formed at the extreme rear of the high frequency current applying electrode. (4) Balloon ablation catheter according to any one of (1) to (3), wherein the temperature sensor lead wire reaches the front end of the high frequency current applying electrode. EFFECT OF THE INVENTION
    [0012] With the Balloon Ablation Catheter of the present invention, the balloon diameter in balloon contraction can be further reduced and the burden on the patient in introducing the balloon ablation catheter into the body can be reduced. Furthermore, the thermocouple temperature sensor of the balloon ablation catheter of the present invention is less likely to be influenced by the heating liquid discharged into the balloon and has a low risk of wire breakage and the like, so the surface temperature of the balloon can be controlled with high precision. BRIEF DESCRIPTION OF THE DRAWINGS
    Fig. 1 is a schematic diagram illustrating the balloon ablation catheter of the first embodiment of the present invention.
    [0014] Fig. 2 is a schematic diagram illustrating the cross section along line A-A' of the axis portion of the balloon ablation catheter of the first embodiment of the present invention.
    [0015] Fig. 3 is a schematic diagram illustrating the outward appearance in the vicinity of the front end of the balloon ablation catheter of the first embodiment of the present invention.
    [0016] Fig. 4 is a schematic diagram illustrating a cross section horizontal to the longitudinal direction near the high frequency current applying electrode of the balloon ablation catheter of the first embodiment of the present invention.
    [0017] Fig. 5 is a schematic diagram illustrating the outward appearance in the vicinity of the anterior end of the balloon ablation catheter of Comparative Example 1.
    [0018] Fig. 6 is a schematic diagram illustrating a cross section horizontal to the longitudinal direction near the high-frequency current application electrode of the balloon ablation catheter of Comparative Example 1.
    [0019] Fig. 7 is a schematic diagram illustrating the outward appearance in the vicinity of the anterior end of the balloon ablation catheter of Comparative Example 2.
    [0020] Fig. 8 is a schematic diagram illustrating a cross section horizontal to the longitudinal direction near the high-frequency current application electrode of the balloon ablation catheter of Comparative Example 2.
    [0021] Fig. 9 is a schematic diagram illustrating a test system for measuring the balloon surface temperature of a balloon ablation catheter. BEST WAY TO CARRY OUT THE INVENTION
    [0022] Embodiments of the present invention are described below in detail with reference to the drawings, however the present invention is not limited to these embodiments. Each identical factor is represented using an identical symbol and redundant explanations are omitted. The relationships used in the drawings are not necessarily the same as those in the description.
    [0023] The balloon ablation catheter of the present invention is characterized in that it comprises: an axis in which a lumen penetrates in the longitudinal direction; a balloon attached to the shaft, where the lumen communicates with the inner side of the balloon; and a high-frequency current-applying electrode disposed within the balloon, which electrode is formed by coiling, around the axis, a connecting wire that supplies high-frequency energy from the power supply means, while sandwiching between the wire. frequency power supply linkage and the axis, a temperature sensor linkage supplying a measured signal to the power supply medium, so that the temperature sensor linkage is fixed along the longitudinal direction of the axle; and so that a thermocouple thermosensor is formed at the point where the high frequency power supply connecting wire and the temperature sensor connecting wire constituting the high frequency current applying electrode are first contacted. turn, as seen from the extreme posterior side in the longitudinal direction.
    [0024] Figure 1 is a schematic diagram illustrating the balloon ablation catheter of the first embodiment of the present invention. Fig. 2 is a schematic diagram illustrating the cross section along line A-A' of the pivot portion of the balloon ablation catheter of the first embodiment of the present invention.
    The balloon ablation catheter 1 illustrated in Fig. 1 comprises: a balloon 2 on the extreme anterior side, which can be inflated and contracted; a high frequency current applying electrode 3 and a thermocouple temperature sensor inside balloon 2; a double cylindrical shaft, composed of an inner cylinder shaft 6, inserted into the lumen of an outer cylindrical shaft 5; and a high frequency power generator connector 7 at the rear end. Furthermore, the space between the outer cylindrical shaft 5 and the inner cylindrical shaft 6 illustrated in Figure 2, i.e. the lumen, communicates with the inner side of the balloon 2 and a high frequency power supply connecting wire 8 and a temperature sensor connecting wire 9 are inserted through this space.
    [0026] The shape of balloon 2 is not limited as long as the balloon fits the blood vessel. For example, a spherical shape, having a diameter of 20 to 40 mm, is preferred. The wall thickness of balloon 2 is preferably 20 to 120 µm, more preferably 20 to 50 µm.
    [0027] The balloon material 2 is preferably an elastic material excellent in antithrombogenicity, more preferably a polyurethane polymer material. Examples of the polyurethane polymer material include thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether resin polyurethane urea and polyether amide polyurethane urea.
    [0028] The "shaft on which a lumen penetrates in the longitudinal direction" is preferably a double cylindrical shaft comprising an inner cylinder shaft 6 inserted into the lumen of an outer cylindrical shaft 5, as shown in Figure 1.
    [0029] The method for attaching the balloon 2 to the outer cylindrical shaft 5 or to the inner cylinder shaft 6 is preferably welding. Here, as shown in Fig. 1, in cases where the extreme anterior part of the balloon 2 is fixed to the extreme anterior part in the longitudinal direction of the inner cylindrical axis 6 and the extreme posterior part of the balloon 2 is fixed to the extreme anterior part in the direction longitudinally of the outer cylinder axis 5, the longitudinal length of the balloon 2 can be changed by sliding between the inner cylindrical axis 6 and the outer cylindrical axis 5, whichever is preferred. Alternatively, both ends of balloon 2 can only be attached to one of the inner cylindrical shaft 6 and the outer cylindrical shaft 5.
    [0030] The length of each of the outer cylindrical shaft 5 and the inner cylindrical shaft 6 is preferably 500 to 1700 mm, more preferably 600 to 1200 mm. The material of each of the outer cylindrical shaft 5 and the inner cylindrical shaft 6 is preferably a flexible material excellent in antithrombogenicity and examples of the material include fluorocarbon resins, polyamide resins, polyurethane resins and polyimide resins. The outer cylindrical shaft 5 preferably has an outer diameter of 3.0 to 4.0 mm and an inner diameter of 2.5 to 3.5 mm. The inner cylindrical shaft 6 preferably has an outer diameter of 1.5 to 1.7 mm and an inner diameter of 1.2 to 1.3 mm. The outer cylindrical shaft 5 may have a multilayer structure.
    [0031] Fig. 3 is a schematic diagram illustrating the outward appearance in the vicinity of the front end of the balloon ablation catheter of the first embodiment of the present invention. Fig. 4 is a schematic diagram illustrating a cross section horizontal to the longitudinal direction near the high-frequency current delivering electrode of the balloon ablation catheter of the first embodiment of the present invention.
    [0032] The high-frequency current application electrode 3 is disposed inside the balloon 2 and, in cases where the "axis where a lumen penetrates in the longitudinal direction", is a double cylindrical axis as shown in Fig. 1, the high frequency current applying electrode 3 is preferably formed by winding the high frequency power supply lead wire 8 around the inner cylindrical shaft 6 as shown in Fig. 4. The high power supply lead wire frequency 8 forming the high frequency current applying electrode 3 has a diameter of preferably 0.1 to 1 mm, more preferably 0.2 to 0.5 mm. Examples of the HF power supply 8 conductive wire material include highly conductive metals such as copper, silver, gold, platinum, tungsten and alloys and it is preferred, in order to avoid short circuits, to apply an electrically insulating protective coating with a fluorocarbon resin or similar in the wire, except for the part where the high frequency current applying electrode 3 is formed.
    [0033] The thermocouple temperature sensor 4a is a thermocouple temperature sensor formed at the point where the high frequency power supply lead wire 8 and the temperature sensor lead wire 9 contact for the first time, as seen from the side rear end in the longitudinal direction, when the electrode is formed by winding the high frequency power supply lead wire 8 around the inner cylindrical axis 6, while sandwiching the temperature sensor lead wire 9 between the power supply lead wire of high frequency 8 and the inner cylindrical shaft 6.
    [0034] Once the thermocouple temperature sensor 4a is formed, while the temperature sensor lead wire 9 is sandwiched between the high frequency power supply lead wire 8 and the inner cylindrical shaft 6, the thermocouple temperature sensor 4a is consequently disposed between the high frequency current applying electrode 3 and the inner cylindrical shaft 6, i.e. on the inner surface of the high frequency current applying electrode 3.
    [0035] The balloon ablation catheter of the present invention preferably comprises an oscillator that provides oscillation to the heating liquid within the balloon by repeating the suction and discharge of the heating liquid from the lumen that communicates with the inner side of the balloon.
    [0036] Examples of the oscillator that provides oscillation to the heating liquid inside the balloon include devices comprising a roller pump, diaphragm pump, bellows pump, vane pump, centrifugal pump or a pump comprising a combination of a piston and a cylinder .
    [0037] Since, in a high-frequency current-applying electrode, high-frequency energy is more likely to be concentrated at the ends of the electrode, the thermocouple temperature sensor of the balloon ablation catheter of the present invention is preferably formed in an extreme part of the high frequency current applying electrode, preferably formed in the rear extreme part of the high frequency current applying electrode.
    [0038] Here, in cases where the balloon ablation catheter 1 has the oscillator and, in addition, the thermocouple temperature sensor 4a is formed at the rear end part of the high frequency current applying electrode 3, as illustrated in Fig. 4, the thermocouple temperature sensor 4a is consequently positioned close to the lumen that communicates with the inner side of balloon 2. However, since the thermocouple temperature sensor 4a is disposed on the inner surface of the current-applying electrode of high frequency current 3, rather than on the outer surface of the high frequency current applying electrode 3, the thermocouple temperature sensor 4a is less likely to be influenced by cooling with the heating liquid discharged for agitation inside the balloon 2 while being greatly influenced by heat condition of the high frequency current applying electrode 3. As a result, stable high frequency energy is supplied to the steel electrode. application of high frequency current 3 so that the surface temperature of balloon 2 can be remarkably stabilized.
    [0039] Once the thermocouple temperature sensor 4a is fixed by winding the high frequency power supply lead wire 8 around the inner cylindrical shaft 6, while sandwiching the temperature sensor lead wire 9 between the power supply lead wire 8 high frequency power 8 and the inner cylindrical axis 6, so that the temperature sensor lead wire 9 is fixed along the longitudinal direction of the inner cylindrical axis 6, the thermocouple temperature sensor 4a does not need to be connected by welding or the like in absolute, different from the thermocouple of the prior art. As a result, the balloon diameter at the contraction of balloon 2 can be reduced so that balloon ablation catheter 1 can be easily introduced into the patient's body.
    [0040] The thermocouple temperature sensor 4a is fixed by winding the high frequency power supply lead wire 8 around the inner cylindrical shaft 6, while sandwiching the temperature sensor lead wire 9 between the power supply lead wire 8 high frequency energy 8 and the inner cylindrical axis 6, so that the temperature sensing lead wire 9 is fixed along the longitudinal direction of the inner cylindrical axis 6. Therefore, the temperature sensing lead wire 9 is inserted between the cylindrical axis inner 6 and the high frequency power supply lead wire 8 and extends to the front end side in the longitudinal direction, as seen from the position of the thermocouple temperature sensor 4a. Here, the temperature sensing lead wire 9 is preferably in contact at a plurality of points with the high frequency power supply lead wire 8, forming the high frequency current applying electrode 3. Furthermore, as illustrated in Fig. 4, the temperature sensing lead wire 9 is most preferably in contact with the high frequency power supply lead 8 along the entire length of the high frequency current applying electrode. That is, the temperature sensing lead 9 most preferably reaches the front end of the high frequency current applying electrode 3.
    [0041] Being inserted between the inner cylindrical shaft 6 and the high frequency power supply lead wire 8, the temperature sensor lead wire 9 is fixed to the inner cylindrical shaft 6 by the high frequency power supply lead wire 8. Therefore, the fixation of thermocouple temperature sensor 4a on balloon ablation catheter 1 in this case is stronger than in a case where welding or the like is performed. As a result, the resistance of the thermocouple temperature sensor increases remarkably and the risk of wire breakage, losing connection and the like can be suppressed, so that reliability increases remarkably.
    [0042] In addition, since the temperature sensor lead wire 9 is compactly housed within the small space between the inner cylindrical shaft 6 and the high frequency power supply lead wire 8, the deflection or similar of the sensor lead wire of temperature 9 never occurs. As a result, when compared to cases where the temperature-sensing lead 9 is extended into the space inside balloon 2, the balloon diameter at the contraction of balloon 2 can be reduced and the flexibility of the catheter is not deteriorated.
    [0043] The diameter of the temperature sensing lead wire 9 is preferably 0.1 to 0.6 mm, more preferably 0.1 to 0.3 mm. Examples of the material of the temperature sensor lead wire 9 include CONSTANTAN and, in order to avoid short circuit, an electrically insulating protective coating, with a fluorocarbon resin or similar, is preferably applied to the back to the position where the temperature sensor 4 It is formed.
    [0044] The trailing end of each of the high frequency power supply lead wire 8 and the temperature sensing lead wire 9, inserted through the space between the outer cylindrical shaft 5 and the inner cylindrical shaft 6, shown in Fig. 2, is further inserted through a Y-shaped connector 13 and connected to the high frequency power generator connector 7.
    [0045] The material of the Y-shaped connector 13 is preferably an electrically insulating material, such as a polycarbonate or ABS resin.
    [0046] The high frequency power generator connector 7 comprises a highly conductive metal pin. Examples of highly conductive metallic pin material include copper, silver, gold, platinum, tungsten and alloys. The surface of the highly conductive metal pin is protected with an electrically insulating and chemically resistant material. Examples of the material include polysulfone, polyurethane, polypropylene and polyvinyl chloride. EXAMPLES
    [0047] A specific example of the balloon ablation catheter of the present invention is described below with reference to the drawings. The term “length” here means the length in the longitudinal direction. (Example)
    [0048] While a polyurethane tube was drawn, air was injected into the tube's lumen to perform blow molding. In this way, a polyurethane balloon 2, having a diameter of 30 mm and a thickness of 20 µm, was prepared.
    [0049] A polyurethane tube, having an outer diameter of 4 mm, inner diameter of 3 mm and an overall length of 1000 mm was used as the outer cylindrical shaft 5. A 13-Y-shaped connector was inserted and fitted into a clasp luer 12, fitted at one end of the tube, and secured by connection. A polyimide tube, having an outer diameter of 1.8 mm, inner diameter of 1.4 mm and an overall length of 1100 mm, was used as the inner cylindrical shaft 6.
    [0050] A copper wire having a diameter of 0.03 mm, with an electrically insulating protective coating, was used as the lead wire for the high frequency power supply 8 and a constantan wire having a diameter of 0.1 mm with an electrically insulating protective coating was used as the temperature sensor lead 9.
    [0051] A part of the electrically insulating protective coating, applied to each of the high-frequency power supply lead wire 8 and the temperature sensor lead wire 9 has been removed and, from the position 20 mm away from the front end of the inner cylindrical shaft 6, the high frequency power supply lead wire 8 was wound around the inner cylindrical shaft 6, while the temperature sensor lead wire 9 was sandwiched between the high frequency power supply lead wire 8 and the inner cylindrical shaft 6 to form a spiral shaped high frequency current applying electrode 3 having a length of 13 mm and a thermocouple temperature sensor 4a disposed at the rear end portion of the high frequency current applying electrode 3.
    [0052] The front end and the rear end of the high frequency current applying electrode 3 were fixed to the inner cylindrical shaft 6 by welding with a polyurethane tube.
    [0053] The inner cylindrical shaft 6 was inserted into the outer cylindrical shaft 5. The extreme anterior part of the balloon 2 was fixed by welding at the position 10 mm away from the anterior end of the inner cylindrical shaft 6 and the extreme posterior part of the balloon 2 was fixed by welding on the extreme anterior part of the external cylindrical shaft 5.
    [0054] The high frequency power supply lead wire 8 and the temperature sensor lead wire 9 were inserted through the space between the outer cylindrical shaft 5 and the inner cylindrical shaft 6 and through the Y-shaped connector 13. A The posterior end of each wire was connected to a high frequency power generating connector 7 to complete the balloon ablation catheter of the present invention (hereinafter referred to as the "Example Catheter"). (Comparative Example 1)
    [0055] A balloon ablation catheter (hereinafter referred to as the "Comparative Example 1 catheter") was completed in the same manner as in the Example, except for the method for forming the high-frequency current delivering electrode and sensor of thermocouple temperature. Fig. 5 is a schematic diagram illustrating the outward appearance in the vicinity of the anterior end of the catheter of Comparative Example 1. Fig. 6 is a schematic diagram illustrating a horizontal cross section in the longitudinal direction near the high frequency current applying electrode of the catheter of Comparative Example 1.
    [0056] The high frequency current applying electrode 3 and the thermocouple temperature sensor 4b of the catheter of Comparative Example 1 were formed as follows. First, a part of the electrically insulating protective coating, applied to each of the high-frequency power supply lead wire 8 and the temperature sensor lead wire 9 was removed and, from the position 20 mm away from the front end of the shaft inner cylindrical 6, the high frequency power supply lead wire 8 was wound around the inner cylindrical shaft 6 to form a coil shaped high frequency current applying electrode 3 having a length of 10 mm. Then, the front end of a constantan wire 9, having a diameter of 0.1 mm, was spot-bonded by soldering on the surface of the high-frequency power supply conductor wire 8 at the position 2 mm away from the rear end of the high frequency current applying electrode 3 to form a thermocouple temperature sensor 4b. The front end and rear end of the formed high-frequency current applying electrode 3 were fixed to the inner cylindrical shaft 6 using a heat-shrink tube. (Comparative Example 2)
    [0057] A balloon ablation catheter (hereinafter referred to as the "Comparative Example 2 catheter") was completed in the same manner as in the Example, except for the method for forming the high frequency current delivering electrode and sensor of thermocouple temperature. Fig. 7 is a schematic diagram illustrating the outward appearance in the vicinity of the anterior end of the catheter of Comparative Example 2. Fig. 8 is a schematic diagram illustrating a horizontal cross section in the longitudinal direction near the high frequency current applying electrode of the catheter of Comparative Example 2.
    [0058] The high frequency current applying electrode 3 and the thermocouple temperature sensor 4c of the catheter of Comparative Example 2 were formed as follows. First, a part of the electrically insulating protective coating, applied to each of the high-frequency power supply lead wire 8 and the temperature sensor lead wire 9 was removed and, from the position 20 mm away from the front end of the cylindrical shaft inner 6, the high frequency power supply lead wire 8 has been wound around the inner cylindrical shaft 6 to form a coil shaped high frequency current applying electrode 3 having a length of 12 mm. Then, the leading end of a constantan wire 9, having a diameter of 0.1 mm, was spot-welded onto the leading end surface of the high-frequency current applying electrode 3 to form a thermocouple temperature sensor. 4c. The front end and the rear end of the high frequency current applying electrode 3 were fixed to the inner cylindrical shaft 6 using a heat-shrink tube. (Measurement of the Balloon Surface Temperature)
    [0059] Fig. 9 is a schematic diagram showing an evaluation system for measuring the balloon surface temperature of the balloon ablation catheter.
    Balloon 2 of the catheter of the Example was expanded with a diluted contrast medium (2-fold diluted with physiological saline) to a balloon diameter of 28 mm. By sliding between the inner cylindrical axis 6 and the outer cylindrical axis 5, the length of the balloon 2 (hereinafter referred to as the "balloon length") was adjusted to 30 mm.
    [0061] Balloon 2 was soaked in a tank filled with physiological saline solution and balloon 2 was inserted into a pulmonary vein 14 artificially prepared using an acrylic polymeric material. A thermocouple 15 for measuring the temperature of the balloon surface was placed in contact with the upper and lower surfaces of the balloon 2.
    [0062] An electrode backplate 16 to apply a high-frequency current was soaked in a tank and the high-frequency power generator connector 7 and the electrode backplate 16 of the catheter of the Example were connected to a high-frequency power generator 17. Through the inner cylindrical shaft 6 of the Example catheter, a guidewire 18 was inserted.
    [0063] A high frequency energy (frequency, 1.8 MHz; maximum energy, 150 W; preset temperature, 70o C) was applied to the catheter. The balloon surface temperature, during energy application, was recorded by a thermocouple data logger 19 and the high frequency output and the temperature inside the balloon measured by the thermocouple temperature sensor 4a were recorded on the thermocouple power generator. high frequency 17.
    [0064] In the same manner as described above, except that the balloon length was 25 mm (this makes the thermocouple temperature sensor 4a more likely to be influenced by cooling by the heating liquid discharged into the balloon), the surface temperature of the balloon, during the application of high frequency energy, was recorded.
    [0065] The catheter of Comparative Example 1 and the catheter of Comparative Example 2 were also tested in the same manner as described above for the cases of a balloon length of 30 mm and a balloon length of 25 mm, and the surface temperature balloon during the application of high frequency energy was recorded.
    [0066] The maximum balloon surface temperature, during the application of high frequency energy, observed for each of the Example catheter, Comparative Example 1 catheter and Comparative Example 2 catheter is shown in Table 1. In the Example catheter and in the catheter of Comparative Example 2, the maximum balloon surface temperature was hardly influenced by the change in balloon length. However, only in the catheter of Comparative Example 1 the maximum balloon surface temperature, in the case of a balloon length of 25 mm, was 66.1°C, which was about 4°C higher than that of the one-length case. of 30 mm balloon. Furthermore, this maximum temperature was higher than 65°C, which is a warming temperature that can cause pulmonary vein stenosis.
    (Measurement of the Maximum Diameter of the Balloon)
    The maximum diameter of balloon 2 in contraction was measured for each of the Example catheter, Comparative Example 1 catheter and Comparative Example 2 catheter. As a result, the maximum balloon 2 diameter was 2.38 mm in the Example catheter. , 2.68 mm in the catheter of Comparative Example 1 and 2.64 mm in the catheter of Comparative Example 2. Thus. Thus, a diameter reduction of about 0.3 mm was obtained with the Example catheter, compared to the Comparative Example 1 catheter and the Comparative Example 2 catheter. INDUSTRIAL APPLICABILITY
    [0068] The present invention can be used as a balloon ablation catheter for treating arrhythmia such as atrial fibrillation; endometriosis; cancer cells; hypertension; and the like; in the medical field. DESCRIPTION OF SYMBOLS
    [0069] 1, Balloon Ablation Catheter (Example); 2, Balloon; 3, High frequency current application electrode; 4a, 4b, 4c, Thermocouple temperature sensor; 5, Outer cylindrical shaft; 6, Inner cylindrical shaft; 7, high frequency power generator connector; 8, High frequency power supply lead wire; 9, Temperature sensor lead wire; 12, Luer closure; 13, Y-shaped connector; 14, Artificial pulmonary vein; 15, Thermocouple for measuring the temperature of the balloon surface; 16, Against electrode plate; 17, High Frequency Power Generator; 18, Guide wire; 19, Thermocouple Data Chrono Recorder.
    权利要求:
    Claims (5)
    [0001]
    1. A balloon ablation catheter (1) comprising: an axis (5, 6) in which a lumen penetrates in the longitudinal direction; a balloon (2) attached to said axis, wherein said lumen communicates with the inner side of the balloon; and an electrode (3) for applying high-frequency current disposed inside said balloon (2), this electrode being formed by winding a wire (8) of high-frequency power supply that supplies high-frequency energy from the medium. of power supply (7) around said axis, a temperature sensor conductor wire (9), which supplies a measured signal to the power supply means which lies in the middle between the power supply conductor wire (8) high frequency and the axis, and is fixed along the longitudinal direction of the axis; characterized by the fact that a thermosensor (4a) thermocouple is formed at the point where said wire (8) conducting high-frequency power supply and said wire (9) conducting temperature sensor, constituting said electrode (3) for application of high frequency current, are contacted for the first time as seen from the rear end side in the longitudinal direction, and said temperature sensor conductor wire (9) is in contact at a plurality of points with said supply conductor wire (8) of high frequency energy.
    [0002]
    2. Balloon ablation catheter according to claim 1, characterized in that it comprises an oscillator that provides oscillation to a heating liquid within said balloon, repeating the suction and discharge of the heating liquid from said lumen.
    [0003]
    3. Balloon ablation catheter according to claim 1 or 2, characterized in that said thermosensor (4a) thermocouple is formed at the extreme rear of said electrode (3) for applying high frequency current.
    [0004]
    4. Balloon ablation catheter according to claim 1 to 3, characterized in that said temperature sensor conductor wire (9) reaches the extreme anterior part of said electrode (3) applying high frequency current.
    [0005]
    5. Balloon ablation catheter according to any one of claims 1 to 4, characterized in that said temperature sensor conductor wire (9) and said high frequency power supply conductor wire (8) are formed from a different kind of metal.
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    同族专利:
    公开号 | 公开日
    EP2719350B1|2017-09-27|
    ES2644245T3|2017-11-28|
    EP2719350A4|2014-10-22|
    CN103582464A|2014-02-12|
    DK2719350T3|2018-01-02|
    US9439725B2|2016-09-13|
    CA2837853A1|2012-12-13|
    CN103582464B|2016-07-06|
    KR20130140175A|2013-12-23|
    TWI586316B|2017-06-11|
    RU2013158645A|2015-07-20|
    TW201302151A|2013-01-16|
    BR112013030398A2|2016-12-13|
    WO2012169607A1|2012-12-13|
    AU2012267815A1|2014-01-16|
    JP2012254140A|2012-12-27|
    JP5853426B2|2016-02-09|
    US20140114306A1|2014-04-24|
    KR101637434B1|2016-07-07|
    RU2592781C2|2016-07-27|
    CA2837853C|2017-09-05|
    EP2719350A1|2014-04-16|
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-06-15| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 08/06/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    JP2011/128052|2011-06-08|
    JP2011128052A|JP5853426B2|2011-06-08|2011-06-08|Ablation catheter with balloon|
    PCT/JP2012/064752|WO2012169607A1|2011-06-08|2012-06-08|Ablation catheter with balloon|
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