• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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  • 优先权
    • 专利摘要:
    catheter for measuring electrical potential, and, a balloon-tipped ablation catheter system is provided with a catheter for reliably measuring electrical potential, which can be inserted into a cardiac chamber, in combination with a balloon-tipped ablation catheter, and which can prevent abnormal heat generation by an electrode to measure electrical potential, even if a high frequency current passes through it. the catheter for measuring electrical potential is provided with: a rod comprising an electrode for measuring electrical potential, a metal section having a length of at least 2 mm and a lumen passing through the distal end of the proximal end, a metal section having a length of at least 2 mm and a lumen passing through the distal end of the proximal end in a longitudinal direction; and a metallic wire which passes through the aforementioned lumen and is connected to the aforementioned metallic section.
    公开号:BR112012030685B1
    申请号:R112012030685-5
    申请日:2011-06-06
    公开日:2021-06-15
    发明作者:Hiroyuki Harada；Motoki Takaoka
    申请人:Toray Industries, Inc.；
    IPC主号:
    专利说明:

    TECHNICAL FIELD
    [001] The present invention relates to a catheter for measuring electrical potential. FUNDAMENTALS OF THE INVENTION
    [002] Catheter ablation is a method of treating arrhythmia by inserting an ablation catheter into a cardiac chamber and cauterizing cardiac muscle tissue with electrodes attached to the distal end of the catheter. In this method, it is common to perform an electrophysiological examination using a catheter to measure the electrical potential, in order to determine the site of cauterization and confirm the therapeutic effects. Catheters for measuring electrical potential consist of a plurality of electrical potential measuring electrodes, electrical potential measuring electrode wires connected to the electrical potential measuring electrodes and an electrical potential measuring apparatus connector, and a measurement of electrical potential of cardiac muscle tissue allows confirmation of the cauterized site and the cauterization site.
    [003] In recent years, a balloon-tip ablation catheter has been developed, in which a balloon attached to the distal side of a catheter is percutaneously introduced into the inferior vena cava to reach the right atrium of the heart and the left atrium through the septum. atrial and cardiac muscle tissue is cauterized by heating the inflated balloon there with a high-frequency current (Patent Documents 1 and 2) and becomes the primary goal of catheter ablation. Even in treatment using a balloon-tipped ablation catheter, an electrophysiological examination using a catheter to measure electrical potential is still necessary to determine the site of cauterization and confirm therapeutic effects, and thus a tip ablation catheter balloon, also having an electrophysiological examination function, has also been reported (Patent Document 3). DOCUMENTS OF THE PREVIOUS TECHNIQUE PATENT DOCUMENTS
    [004] Patent Document 1: JP 2002-78809 A
    [005] Patent Document 2: Japanese Patent No. 4062935
    [006] Patent Document 3: Japanese Patent No. 4417052 SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION
    [007] However, the previously reported conventional balloon tip ablation catheters also have an electrophysiological examination function proven to be of high risk of causing, for example, thrombosis, excessive cauterization and tissue perforation in an affected area because, when a balloon is heated by distributing high-frequency current between a return electrode outside the patient's body and a high-frequency current distributing electrode inside the balloon, the high-frequency current is also distributed between the return electrode and the electrical potential measuring electrodes, causing an abnormal slack generation phenomenon in the electrical potential measuring electrodes.
    [008] On the other hand, when treatment is performed with a catheter to measure electrical potential separately provided by a balloon tip ablation catheter, in order to ensure patient safety, it is necessary to immediately evulsion of the balloon tip ablation catheter. balloon a patient and then reinserting the catheter to measure electrical potential in a cardiac chamber to perform an electrophysiological examination, and a prolonged procedure time and associated increased load in physicians and patients are currently unavoidable.
    [009] Thus, an objective of the present invention is to provide a highly safe catheter for measuring electrical potential, which can be inserted into a cardiac chamber, together with a balloon tip ablation catheter and be able to prevent abnormal heat generation in electrodes measuring electrical potential, even when high frequency current is distributed. MEANS TO SOLVE PROBLEMS
    [010] The present inventors studied intensively to solve the problems described above, to discover the inventions (1) to (8) below.
    [011] (1) A catheter for measuring electrical potential, comprising: a rod having electrical potential measuring electrodes, a metal part with a length of 2 mm or more and a lumen passing through it from a proximal end to a distal end in the longitudinal direction; and a metallic wire inserted through the lumen and connected with the metallic part.
    [012] (2) The catheter for measuring electrical potential according to (1) above, wherein the electrodes for measuring electrical potential described above are fixed on a distal side in the longitudinal direction of the rod described above and the metallic part above described is located distal to the position of the electrodes for measuring electrical potential described above in the longitudinal direction of the rod described above.
    [013] (3) The catheter for measuring electrical potential according to (1) or (2) above, wherein the length of the metal part described above is 2 to 50 mm.
    [014] (4) The catheter for measuring electrical potential according to any one of (1) to (3) above, wherein the metal wire described above is electrically insulated.
    [015] (5) A catheter for measuring electrical potential, comprising a metal rod having electrical potential measuring electrodes and a lumen extending in the longitudinal direction.
    [016] (6) The catheter for measuring electrical potential according to (5) above, in which the metal rod described above is obtained by molding a metal wire into a spiral shape.
    [017] (7) The catheter for measuring the electrical potential according to (5) or (6) above, in which the metal rod described above is electrically insulated.
    [018] (8) A balloon tip ablation catheter system, comprising the catheter for measuring electrical potential according to any one of (1) to (7) above and a balloon tip ablation catheter comprising a lumen passing through it from a proximal end to a distal end in the longitudinal direction, wherein the above-described catheter for measuring electrical potential is inserted through the lumen of the above-described balloon tip ablation catheter. EFFECTS OF THE INVENTION
    [019] According to the present invention, abnormal heat generation in the electrical potential measuring electrodes of a catheter for measuring electrical potential can be avoided even when high frequency current is distributed and excessive cauterization of cardiac muscle tissue can be avoided . Furthermore, in accordance with the present invention, a catheter for measuring electrical potential can be inserted into a cardiac chamber simultaneously with a balloon tip ablation catheter and therefore the burden on physicians and patients can be significantly reduced. BRIEF DESCRIPTION OF THE DRAWINGS
    [020] Figure 1 is a schematic view of the catheter for measuring electrical potential according to the first embodiment of the present invention;
    [021] Figure 2 is a schematic view illustrating a vertical cross section to the longitudinal direction of the catheter for measuring electrical potential according to the first embodiment of the present invention;
    [022] Figure 3 is a schematic view of a balloon tip ablation catheter system, wherein the catheter for measuring electrical potential according to the first embodiment of the present invention is inserted through a lumen of a balloon tip ablation catheter; and
    [023] Figure 4 illustrates a test system to measure the temperature of the electrodes measuring electrical potential and a distal metallic part. BEST WAY TO CARRY OUT THE INVENTION
    [024] Preferred embodiments of the present invention will now be described in detail with reference to the drawings, however the present invention is not limited to these embodiments. Like numbers refer to like elements and repetitive descriptions will be omitted. The scale of the drawings does not necessarily correspond to those of the description. It should be understood that "length", as used herein, represents length in the longitudinal direction.
    [025] The catheter for measuring the electrical potential of the present invention is characterized by comprising: a rod having electrodes for measuring electrical potential, a metallic part with a length of 2 mm or more and a lumen passing through it from a proximal end to a distal end in the longitudinal direction; and a metallic wire inserted through the lumen and connected to the metallic part.
    [026] Figure 1 is a schematic view of the catheter for measuring electrical potential according to the first embodiment of the present invention.
    [027] A catheter for measuring electrical potential 1 shown in Figure 1 comprises a plurality of electrical potential measuring electrodes 2, a distal metallic part 5, a rod 3 and an electrical potential measuring apparatus connector 4.
    [028] The number of electrical potential measuring electrodes 2, attached to rod 3, is preferably 1 to 16 and more preferably 4 to 10. As a material of the electrical potential measuring electrodes 2, a highly conductive metal is preferred and examples of it include silver, gold, platinum, copper and SUS. The electrical potential measuring electrodes 2 are preferably fixed on the distal side in the longitudinal direction of the rod 3, as shown in Figure 1.
    [029] As shown in Figure 1, when the electrical potential measurement electrodes 2 are fixed to the surface of the rod 3, the shape of the electrical potential measurement electrodes 2 is preferably cylindrical. The length of the cylinder 2 shaped electrical potential measuring electrodes is preferably 0.5 to 2.0 mm and more preferably 1.0 to 2.0 mm.
    [030] As a material of the distal metallic part 5, ie “the metallic part”, a highly conductive metal is preferred and examples of it include silver, gold, platinum, copper and SUS. "The metal part" is preferably attached to the distal side in the longitudinal direction of the rod 3, more preferably located distally to the position of the electrical potential measuring electrodes 2, in the longitudinal direction of the rod 3, like the distal metal part 5 shown in Figure 1 and even more preferably attached to the distal end of rod 3.
    [031] To avoid abnormal heat generation around the distal metal part 5 and the electrical potential measuring electrodes 2, the length of the distal metal part 5 is preferably 2 mm or more and more preferably 5 mm or more. In view of the risk, for example, of reduced operability, perforation of the heart wall, or vascular injury, the length of the distal metallic part 5 is preferably not more than 50 mm and more preferably not more than 25 mm .
    [032] "The metal part", whose shape is not particularly restricted, can be formed by inserting a rod made of highly conductive metal or the like through a lumen of rod 3 and removing a part of rod 3 to expose the highly conductive metal or the like, or it can be formed by removing a portion of the stem coating 3, which is made of highly conductive metal or the like, coated with other materials, to expose the highly conductive metal or the like. Also, a portion of the rod made of highly conductive metal or similar, which has been exposed at the distal end of rod 3 as a result of inserting a rod made of highly conductive metal or similar, which is longer than rod 3, through of a lumen of stem 3, can be defined as the distal metallic part 5.
    [033] Because the catheter for measuring electrical potential is used inserted through a lumen of a balloon tip ablation catheter, the length of rod 3 is preferably greater than the entire length of the balloon tip ablation catheter. balloon, more preferably 600 to 1800 mm and more preferably 700 to 1300 mm. Furthermore, because the catheter for measuring electrical potential is used inserted through a lumen of a balloon tip ablation catheter, the outer diameter of rod 3 is preferably 0.6 to 1.2 mm and more preferably from 0.8 to 1.2 mm.
    [034] As a stem 3 material, materials having low conductivity, excellent antithrombogenicity and flexibility are preferred and examples of them include fluororesins, polyamide resins, polyurethane resins and polyimide resins. For example, when rod 3 is made of highly conductive metal or the like, coated with other materials as described above, it is preferable to use as "other material" fluororesins or the like, described above.
    [035] The shape of the rod 3, in the region where a plurality of electrodes measuring electrical potential 2 is fixed, may not only be linear as shown in Figure 1, but also in loop or similar. On rod 3, the length of the region in which a plurality of electrical potential measuring electrodes 2 is attached is preferably from 20 to 100 mm and more preferably from 30 to 80 mm. Furthermore, the intervals between the electrical potential measuring electrodes 2, in the case where three or more electrical potential measuring electrodes 2 are fixed, are preferably equal, irrespective of the shape of the rod.
    [036] As shown in Figure 1, when the distal metallic part 5 is located distally to the position of the electrical potential measuring electrodes 2 in the longitudinal direction of the rod 3, the interval between the electrical potential measuring electrodes 2, fixed on the most distal side, and the distal metallic part 5 is preferably from 5 to 50 mm and more preferably from 10 to 40 mm.
    [037] Figure 2 is a schematic view illustrating a vertical cross-section to the longitudinal direction of the catheter, to measure the electrical potential, according to the embodiment of the present invention.
    [038] In the catheter for measuring electrical potential 1 shown in Figure 2, the rod has a lumen passing through it from a proximal end to a distal end in the longitudinal direction, and a metallic wire 6 and a plurality of electrode wires of 7 electrical potential measurement is entered through the lumen. The distal end of the metallic wire 6 is connected to the distal metallic part 5 and the distal end of the electrical potential measuring electrode wires 7 is connected to the electrical potential measuring electrodes 2 respectively. Examples of the connection method include but are not limited to soldering, oxygen soldering, and caulking connections. Alternatively, the metallic wire 6 and the distal metallic part 5 can be formed integrally of the same material in advance.
    [039] The diameters of the metallic wire 6 and of the electrode wires measuring electrical potential 7 are preferably from 0.1 to 1 mm and more preferably from 0.2 to 0.5 mm. Examples of the material of the metallic wire 6 and the electrical potential measuring electrode wires 7 include highly conductive metals such as copper, silver, gold, platinum, tungsten and alloy, and the electrical potential measuring electrode wires 7 are preferably coated with an electrically insulating protective coating, such as a fluororesin, to prevent a short circuit.
    [040] The proximal end of the electrical potential measuring apparatus 7 electrode wires is connected to the electrical potential measuring apparatus connector 4 shown in Figure 1. Examples of the material of a shielding of the electrical potential measuring apparatus connector 4 include polysulfones, polycarbonates and low conductivity vinyl chloride resins. A plurality of metal pins are disposed within the connector of the electric potential measuring apparatus and the electric potential measuring electrode wires are connected to the metal pins. Examples of the connection method include but are not limited to weak soldering, oxygen soldering, and caulking connections.
    [041] The proximal end of the metallic wire 6 is preferably electrically insulated in order to inhibit the distribution of high frequency current between a return electrode and the electrical potential measuring electrodes and to avoid abnormal heat generation in the distal metallic part 5. “Electrically insulated” here refers to a state where the proximal end of metallic wire 6 has no electrical connection, including grounding (grounding). Examples of the case where the proximal end of metallic wire 6 is “electrically insulated” include a state where the proximal end of metallic wire 6 is not connected to or contacted with anything as shown in Figure 2. If not an electrical connection, the contact of the proximal end of the metallic wire 6 with, for example, the connector of the electrical potential measuring apparatus 4 also provides the same effect.
    [042] To avoid abnormal heat generation due to high-frequency current concentration in metallic wire 6, the length of metallic wire 6 is preferably 300 mm or more and more preferably 500 mm or more.
    [043] The catheter for measuring electrical potential according to the second embodiment of the present invention is characterized by comprising a metal rod having electrical potential measuring electrodes in a lumen extending in the longitudinal direction.
    [044] The catheter for measuring electrical potential, according to the second embodiment, is capable of providing the same effect as that of the catheter for measuring electrical potential, according to the first embodiment of the present invention, having the distal metallic part 5, using an all-metal rod. Examples of the metallic catheter shaft material for measuring electrical potential according to the second embodiment include highly conductive metals such as copper, silver, gold, platinum, tungsten and alloy. In the catheter for measuring electrical potential according to the second embodiment, to improve the accuracy of electrical potential measurement of cardiac muscle tissue, it is preferred that a low conductivity material such as a fluororesin, a polyamide resin, a polyurethane resin or a polyimide resin, is disposed between the electric potential measuring electrodes and the rod, ie the electric potential measuring electrodes and the rod are electrically insulated.
    [045] The metallic shaft of the catheter for measuring electrical potential according to the second embodiment is preferably one obtained by molding a metallic wire into a spiral shape, in order to ensure flexibility. “Spiral shape” here refers to a state in which a metallic wire is spirally wound into a cylindrical shape. The metallic shaft of the catheter for measuring electrical potential, according to the second embodiment, is preferably electrically insulated.
    [046] The diameter of a metallic wire that forms the metallic shaft of the catheter to measure the electrical potential, according to the second embodiment, is preferably from 0.1 to 0.3 mm and more preferably from 0. 2 to 0.3 mm.
    [047] The number, material, fixation position and the like of the electrodes for measuring the electrical potential of the catheter for measuring electrical potential according to the second embodiment are preferably the same as those of the catheter for measuring electrical potential 1, according to the first embodiment.
    [048] Figure 3 is a schematic view of a balloon tip ablation catheter system, wherein the catheter for measuring electrical potential according to the first embodiment of the present invention is inserted through a lumen of a catheter of balloon tip ablation.
    [049] The balloon tip ablation catheter system shown in Figure 3 is largely composed of the catheter for measuring electrical potential according to the first embodiment of the present invention and a balloon tip ablation catheter 8 and a high frequency power generator 15.
    [050] The balloon tip ablation catheter 8 comprises on its distal side a balloon 9, which is inflatable and contractable and further comprises a double cylinder-type rod, in which an inner tubular body 13 is inserted into a lumen of a outer tubular body 12, and inner tubular body 13 is capable of sliding in the longitudinal direction. The distal end of balloon 9 is attached near the distal end in the longitudinal direction of the inner tubular body 13 and the proximal end of the balloon 9 is attached near the distal end in the longitudinal direction of the outer tubular body 12. A high current distribution electrode frequency 10 and a temperature sensor 11 are arranged inside balloon 9.
    [051] The shape of balloon 9 can be any shape, as long as it fits the blood vessel, and examples of such shapes include globular shape or onion shape with a diameter of 20 to 40 mm. The film thickness of the balloon 9 is preferably 20 to 150 µm and more preferably 20 to 120 µm.
    [052] As a balloon material 9, stretchable materials having excellent antithrombogenicity are preferred and polymeric polyurethane materials are more preferred. Examples of polymeric polyurethane materials include thermoplastic polyether urethane, polyether polyurethane urea, fluorine polyether urethane urea, polyether polyurethane urea resins and polyether polyurethane urea amide.
    [053] The length of the outer tubular body 12 and the inner tubular body 13 is preferably 500 to 1700 mm and more preferably 600 to 1200 mm. For the outer diameter of the outer tubular body 12 and the inner tubular body 13, because of use with the catheter to measure electrical potential being inserted through the lumen of the balloon tip ablation catheter, the inner diameter of the inner tubular body 13 it is preferably not less than 1.0 mm and more preferably not less than 1.2 mm. As a material of the outer tubular body 12 and the inner tubular body 13, flexible materials having excellent antithrombogenicity are preferred and examples thereof include fluororesins, polyamide resins, polyurethane resins, polyimide resins and the like.
    [054] As a method for attaching balloon 9 to each of the outer tubular body 12 and the inner tubular body 13, welding is preferred. Alternatively, the ends of the balloon 9 can be attached only to the outer tubular body 12 or the inner tubular body 13.
    [055] The high-frequency current distribution electrode 10 is attached to the inner tubular body 13 and examples of the attachment method include caulking, adhesives, welding, and heat shrink tubing.
    [056] The shape of the high-frequency current distribution electrode 10 is preferably a spiral shape. The diameter of an electrical wire forming the spiral-shaped high-frequency current distribution electrode 10 and a high-frequency power supply wire is preferably 0.1 to 1 mm and more preferably 0.2 at 0.5 mm. As its material, a highly conductive metal is preferred and examples of it include copper, silver, gold, platinum, tungsten and alloy. In addition, to avoid short circuiting, parts other than spiral shaped parts of the electrical wire and the high frequency power supply wire are more preferably coated with an electrically insulating protective coating, such as a fluororesin.
    [057] The high-frequency power supply wire is connected to the high-frequency power generator 15, via a high-frequency power generator connector 14, to distribute high-frequency current to the current-distributing electrode high-frequency 10.
    [058] Examples of temperature sensor 11 attached to inner tubular body 13 include a thermocouple and a resistance thermometer.
    [059] A temperature sensor wire connected to the temperature sensor 11 is connected to the high frequency power generator 15 via the high frequency power generator connector 14 to transfer temperature signals measured with the temperature sensor 11 for the high-frequency power generator 15.
    [060] The diameter of the temperature sensor is preferably from 0.05 to 0.5 mm. As a wire material of the temperature sensor, when the temperature sensor 11 is a thermocouple, the same material as that of the thermocouple is preferred and example of it, in the case of a T-type thermocouple, includes copper and constantan. On the other hand, when temperature sensor 11 is a resistance thermometer, a highly conductive metal such as copper, silver, gold, platinum, tungsten or alloy is preferred. Also, to avoid a short circuit, it is more preferable to be coated with an electrically insulating protective coating, such as a fluororesin.
    [061] As described above, the high-frequency power generator 15 is connected to the high-frequency current distribution electrode 10 through the high-frequency power supply wire and to the temperature sensor 11 through the temperature sensor and the high-frequency power generator connector 14, and further connected to a return electrode 18 via a return electrode wire 19.
    [062] The balloon is heated by distributing high-frequency current between the high-frequency current distributing electrode 10 and the return electrode 18, fixed to the patient's body surface with the high-frequency power generator 15 .
    [063] The catheter for measuring electrical potential is inserted through a lumen of the inner tubular body 13 of the balloon tip ablation catheter 8. EXAMPLES
    [064] Specific examples of the catheter for measuring the electrical potential of the present invention will now be described with reference to the Figures. It is to be understood that "length" as used herein represents length in the longitudinal direction. (Example 1)
    [065] A medical tubing apparatus was used to prepare a polyurethane tube with an outer diameter of 1.2 mm, an inner diameter of 0.9 mm and a length of 1200 mm. Starting from the 50 mm position from the distal end of the polyurethane tube, eight holes with a diameter of 1 mm, for the passage of electrode wires for measuring electrical potential, were produced at 5 mm intervals, to produce a shaft 3 of a catheter for measuring electrical potential.
    [066] Using a silver-coated copper tube with an outer diameter of 1.2 mm and a length of 1 mm as an electrical potential measuring electrode 2 and copper wires with a diameter of 0.1 mm as electric potential measuring electrode wires 7, electric potential measuring electrodes 2 and electric potential measuring electrode wires 7 have been soldered together. The electric potential measuring electrode wires 7 have been coated with a fluororesin electrically insulating protective cover. Eight parts connecting the electrical potential measuring electrodes 2 to the electrical potential measuring electrode wires 7 were produced.
    [067] The electrical potential measurement electrode wires 7, of the parts described above, were each inserted into eight holes of the rod 3 and the electrical potential measurement electrodes 2 and the holes were fixed by caulking.
    [068] In the region where eight electrical potential measuring electrodes 2 are fixed in a row, shape memory alloy wires, with a diameter of 1 mm and a length of 80 mm, were fixed within the lumen of the rod 3 to form the region described above into a loop shape.
    [069] Employing a stainless wire with an outer diameter of 1.2 mm and a length of 10 mm as a distal metal part 5, a metal wire 6 with an outer diameter of 0.4 mm and a length of 900 mm, was connected to it by soldering.
    [070] The metallic wire 6 was inserted through the distal side of the rod 3 and the proximal end of the distal metallic part 5 and the distal end of the rod 3 were joined by fixation with an adhesive. The metallic wire 6, inserted inside the rod 3, was not connected to the connector of the electrical potential measuring device 4, in order to be electrically isolated on the proximal side of the rod 3.
    [071] Each of the electrical potential measuring electrode wires 7 was removed from the proximal end of the rod 3 and all were connected to the connector of the electrical potential measuring device 4, after which the proximal end of the rod 3 and the connector of the electrical potential measuring apparatus 4 were fixed with an adhesive and a heat-shrinkable tube to prepare a catheter for measuring electrical potential (hereinafter referred to as "the electrical potential measuring catheter of Example 1"). (Example 2)
    [072] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 9 mm as the distal metallic part 5 (hereinafter referred to as “the catheter for measuring electrical potential in Example 2”). (Example 3)
    [073] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 8 mm as the distal metallic part 5 (a hereafter referred to as “the catheter for measuring electrical potential of Example 3”). (Example 4) A catheter for measuring electrical potential was prepared in the same way as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 7 mm as the distal metallic part 5 ( hereinafter referred to as "the catheter for measuring electrical potential of Example 4"). (Example 5)
    [074] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 6 mm as the distal metallic part 5 (a hereafter referred to as "the catheter for measuring electrical potential of Example 5"). (Example 6)
    [075] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 5 mm as the distal metallic part 5 (a hereafter referred to as "the electrical potential measuring catheter of Example 6"). (Example 7)
    [076] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 4 mm as the distal metallic part 5 (a hereafter referred to as "the electrical potential measuring catheter of Example 7"). (Example 8)
    [077] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 3 mm as the distal metallic part 5 (a hereafter referred to as “the catheter for measuring electrical potential of Example 8”). (Example 9)
    [078] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 2 mm as the distal metallic part 5 (a hereafter referred to as "the catheter for measuring electrical potential in Example 9") (Comparative Example 1)
    [079] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except using a stainless wire with an outer diameter of 1.2 mm and a length of 1 mm as the distal metallic part 5 (a hereafter referred to as “the catheter for measuring electrical potential of Example 1”). (Comparative Example 2)
    [080] A catheter for measuring electrical potential was prepared in the same manner as in Example 1, except that the distal metallic part 5 and metallic wire 6 were not attached (hereinafter referred to as “the catheter for measuring electrical potential in Example Comparative 2”). (Preparation of balloon tip ablation catheter)
    [081] A balloon tip ablation catheter 8, through whose lumen the catheter for measuring the electrical potential of the present invention is inserted, was prepared by the following procedure.
    [082] First, a glass balloon mold, having a mold surface corresponding to a desired balloon shape, was immersed in a polyurethane solution at a concentration of 13% by weight and a polyurethane balloon 9, with a diameter of 30 mm and a thickness of 120 µm, was prepared by the immersion method, in which a solvent (dimethylacetamide) is evaporated by heating at 70°C, to form a urethane polymer coating on the mold surface.
    [083] An outer tubular body 12, which was a polyurethane tube with an outer diameter of 4 mm, an inner diameter of 3 mm and an overall length of 1000 mm, was provided at its proximal end with a luer lock 16, and snap-fitted and adhesively secured to a 17 Y-shaped connector.
    [084] Starting from the 20 mm position from the distal end of an inner tubular body 13, which is a polyurethane tube with an outer diameter of 1.8 mm, an inner diameter of 1.4 mm and a length 1100 mm total, a 0.5 mm diameter high-frequency power supply wire, whose electrically insulating protective covering was partially peeled, was directly wound around the inner tubular body 13 to form a spiral shape. 10 mm long, which was used as a high-frequency current distribution electrode 10.
    [085] Using an ultra-thin thermocouple copper wire, coated with an electrically insulating protective coating as a temperature sensor wire and a thermocouple constantan wire coated with an electrically insulating protective coating as the other temperature sensor wire, the ends of the temperature sensor wires were soldered together and the joining tip was defined as a temperature sensor 11. The temperature sensor 11 was disposed at the 1 mm position from the proximal end of the high-frequency current distribution electrode 10.
    [086] The inner tubular body 13, to which the high-frequency current distribution electrode 10 and the temperature sensor 11 were attached, was inserted, from the proximal side of the Y-shaped connector 17, into the tubular body outer 12, and inner tubular body 13 and outer tubular body 12 were fixed on the proximal side.
    [087] The high-frequency current distribution wire and the temperature sensor wire were connected to the high-frequency power generator connector 14 through the space between the outer tubular body 12 and the inner tubular body 13 and through the connector Y-shaped connector 17 and the Y-shaped connector 17 was connected to the high-frequency power generator connector 14.
    [088] Finally, the distal end of balloon 9 was heat welded to the outer periphery 10 mm from the distal end of the inner tubular body 13 and the proximal end of balloon 9 was heat welded to the outer periphery near the distal end of the tubular body external 12, respectively, thereby completing the balloon tip ablation catheter 8. (Construction of balloon tip ablation catheter system)
    [089] Each of the catheters, for measuring electrical potential of Examples 1 to 9 and Comparative Examples 1 and 2 prepared, was inserted from the proximal end of the inner tubular body 13 of the balloon tip ablation catheter 8 through its lumen and the electrical potential measuring electrodes 2 were exposed near the distal end of balloon 9, to construct a balloon tip ablation catheter system for each catheter to measure electrical potential. (Temperature measurement of electrical potential measurement electrodes and metal part)
    [090] Figure 4 illustrates a test system to measure the temperature of the electrodes measuring electrical potential and a distal metallic part.
    [091] Balloon 9 of the balloon tip ablation catheter system was inflated with physiological saline, so that the largest dimension was 30 mm, and immersed in a water tank filled with physiological saline. In addition, the return electrode 18 for delivering high frequency current was immersed in the same water tank and then the high frequency power generator connector 14 and the return electrode wire 19 were connected to the power generator. high frequency.
    [092] High-frequency current (frequency: 1.8 MHz, maximum electrical power; 150 W, preset temperature: 70°C) was distributed between the return electrode and the high-frequency current distribution electrode for heating the balloon and each of the temperature of the electrical potential measuring electrode and the temperature of the distal metal part was measured with a T-type 20 thermocouple, connected to a temperature data logger 21. The temperature measurements were continued for 5 minutes from the beginning of the distribution of the high-frequency current and the maximum temperature of each was taken as the temperature of the electrical potential measuring electrode and the temperature of the distal metallic part. (Results of temperature measurement of electrical potential measuring electrodes and distal metal part).
    [093] Table 1 shows the results of measuring the temperature of the electrical potential measuring electrode and the temperature of the distal metal part of each balloon tip ablation catheter system through which the catheter to measure the electrical potential of the Examples 1 to 9 or Comparative Example 1 or 2 has been entered.

    [094] The catheter for measuring the electrical potential of Comparative Example 2, which does not have a distal metallic part, had an electrical potential measuring electrode temperature of 65.7°C, exceeding 65°C, which is a temperature causing pulmonary vein stenosis.
    [095] On the other hand, although the catheters for measuring the electrical potential of Examples 1 to 9 and Comparative Example 1, which have a distal metallic part, did not cause abnormal heat generation exceeding 65°C in the electrical potential measuring electrodes, the catheter for measuring the electrical potential of Comparative Example 1 caused abnormal heat generation (76.7°C) in a distal metallic part.
    [096] From the results in Table 1 it is evident that the catheters for measuring the electrical potential of Examples 1 to 9, which have a length of the distal metallic part of 2 mm or more, did not cause an abnormal heat generation in the measuring electrodes. electrical potential or in a distal metallic part and that, in particular, the catheters for measuring the electrical potential of Examples 1 to 6, which have a length of the distal metallic part of 5 mm or more, can reduce heat generation in the electrodes. measurement of electrical potential and on a distal metallic part at 50°C or less. These results are presumably because the high-frequency current density, on a surface of the distal metal part, can be reduced to a low level, ensuring the length of the distal metal part of 2 mm. INDUSTRIAL APPLICABILITY
    [097] The present invention can be used in the medical field as a catheter to measure electrical potential, which can be used in combination with a balloon tip ablation catheter. DESCRIPTION OF SYMBOLS 1: Catheter for measuring electrical potential 2: Electrodes for measuring electrical potential 3: Stem 4: Connector for electrical potential measuring apparatus 5: Distal metal part 6: Metal wire 7: Wires for electrical potential measuring electrode 8: Balloon tip ablation catheter 9: Balloon 10: High-frequency current distribution electrode 11: Temperature sensor 12: Outer tube body 13: Inner tube body 14: High-frequency power generating connector 15: High-frequency power generator 16: Luer lock 17: Y-shaped connector 18: Return electrode 19: Return electrode wire 20: T-type thermocouple 21: Temperature data logger
    权利要求:
    Claims (4)
    [0001]
    1. Catheter for measuring electrical potential comprising: a rod (3) having electrical potential measuring electrodes (2) and a lumen passing through it from a proximal end to a distal end in the longitudinal direction, characterized in that said catheter comprises a metal part (5) with a length of 2 mm to 50 mm, and a metal wire (6) inserted through said lumen and connected to said metal part, in which the proximal end of the metal wire has no electrical connection, including grounding.
    [0002]
    2. Catheter for measuring electrical potential according to claim 1, characterized in that said electrodes for measuring electrical potential (2) are fixed on a distal side in the longitudinal direction of said rod (3), and said metallic part (5) is located distally with respect to the position of said electrical potential measuring electrodes in the longitudinal direction of said rod.
    [0003]
    3. Catheter to measure electrical potential according to claim 1 or 2, characterized in that said metallic wire (6) is electrically insulated.
    [0004]
    4. Balloon tip ablation catheter system, characterized in that it comprises: the catheter for measuring electrical potential as defined in any one of claims 1 to 3; and a balloon tip ablation catheter comprising a lumen passing therethrough from a proximal end to a distal end in the longitudinal direction, wherein said catheter for measuring electrical potential is inserted through the lumen of said balloon tip ablation catheter. .
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    同族专利:
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    RU2531439C2|2014-10-20|
    KR20130014592A|2013-02-07|
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    AU2011262989B2|2014-11-13|
    CA2798164A1|2011-12-15|
    US9131897B2|2015-09-15|
    TW201206393A|2012-02-16|
    AU2011262989A1|2012-12-20|
    TWI523635B|2016-03-01|
    KR101455746B1|2014-10-28|
    DK2581058T3|2016-06-06|
    EP2581058A1|2013-04-17|
    EP2581058B1|2016-03-23|
    JP5870694B2|2016-03-01|
    CN102917660A|2013-02-06|
    WO2011155424A1|2011-12-15|
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    法律状态:
    2018-12-26| 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]|
    2021-05-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-15| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/06/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF |
    优先权:
    申请号 | 申请日 | 专利标题
    JP2010130774|2010-06-08|
    JP2010-130774|2010-06-08|
    PCT/JP2011/062889|WO2011155424A1|2010-06-08|2011-06-06|Catheter for measuring electric potential|
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