JP6420266B2 - Ablation catheter evaluation instrument - Google Patents

Ablation catheter evaluation instrument Download PDF

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JP6420266B2
JP6420266B2 JP2016025671A JP2016025671A JP6420266B2 JP 6420266 B2 JP6420266 B2 JP 6420266B2 JP 2016025671 A JP2016025671 A JP 2016025671A JP 2016025671 A JP2016025671 A JP 2016025671A JP 6420266 B2 JP6420266 B2 JP 6420266B2
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container
ablation
object
liquid
example
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JP2017143875A (en
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拓也 桝田
拓也 桝田
久生 宮本
久生 宮本
倫彦 光宗
倫彦 光宗
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日本ライフライン株式会社
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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
    • 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

Description

  The present invention relates to an ablation catheter evaluation instrument used when evaluating ablation using an ablation catheter.

  An ablation catheter is inserted into a body (for example, the inside of a heart) through a blood vessel and used for treatment of arrhythmia or the like (for example, see Patent Document 1). In such an ablation catheter, generally, the shape near the tip (distal end) of the catheter tube inserted into the body is attached to the proximal end (proximal end, rear end, hand side) disposed outside the body. Depending on the operation of the part, it changes (deflects, curves, bends) in one direction or both directions.

JP 2002-119519 A

  By the way, in order to evaluate the state of cauterization using such an ablation catheter, a dedicated evaluation instrument is used. By using such an evaluation instrument, for example, it is possible to evaluate in advance (such as the ablation catheter product development stage) the temperature distribution during cauterization, the degree of cauterization in the cauterization region, and the like.

  In general, such an evaluation instrument is required to be easily evaluated and manufactured. Therefore, it is desirable to propose an evaluation instrument that allows simple evaluation and manufacturing.

  The present invention has been made in view of such problems, and an object thereof is to provide an ablation catheter evaluation instrument that enables simple evaluation and manufacturing.

  The ablation catheter evaluation instrument of the present invention is an instrument for evaluating ablation using an ablation catheter, and contains a counter electrode and a liquid disposed on the counter electrode and used for evaluating the ablation. In addition, a container made of a conductive resin and an ablation object as a sample when evaluating the ablation are disposed in the container. The ablation object includes a thermochromic material and a conductive material.

  In the evaluation instrument for an ablation catheter of the present invention, an ablation object as a sample when evaluating ablation using an ablation catheter includes a thermochromic material and a conductive material. This eliminates the need for a dedicated element (for example, a temperature sensor such as a thermocouple) for measuring the temperature during the cauterization (temperature in the cauterization object), and depending on the discoloration situation in the cauterization object, The temperature can be grasped (visible) at a glance. In addition, since the container for storing the liquid used when evaluating shochu is composed of a conductive resin, the container can be simplified as compared with, for example, a container obtained using a special material or manufacturing method. Be able to get.

  In the evaluation instrument for an ablation catheter of the present invention, it is desirable that a recess for inserting and arranging the ablation object is formed on the bottom surface of the container and that the recess is not penetrated to the counter electrode plate. In such a case, the cauterization object is cauterized in a state of being inserted and disposed in the depression, so that the occurrence of a short-circuit current during cauterization is prevented regardless of the concentration of the liquid contained in the container. As a result, the accuracy of shochu evaluation (measurement accuracy during evaluation) is improved. In addition, since this recess is not penetrating to the counter electrode plate, a container is interposed between the ablation object inserted and disposed in the recess and the counter electrode plate, so that the environment is closer to the actual treatment (more Impedance values can be obtained in an environment that accurately simulates a human body. As a result, for example, compared with the case where the dent penetrates to the counter electrode plate (when the through hole is formed instead of the dent), cauterization in an environment closer to the actual treatment is realized. The evaluation accuracy can be improved.

  In this case, it is desirable that the recess has a non-tapered side wall. In this case, for example, when using a cautery object having water absorption, the recess has a tapered side wall (a tapered side wall whose diameter gradually decreases toward the counter electrode plate) and Is different and looks like this: That is, the possibility that the ablation object jumps out of the depression due to the liquid absorbing and swelling is reduced or avoided. As a result, convenience in evaluating shochu is improved.

  Moreover, in the ablation catheter evaluation instrument of the present invention, it is desirable to further provide an inflow mechanism for allowing liquid to flow into the container using a pump. In this case, the liquid will flow in the container, so cauterization can be achieved in an environment that is closer to the actual treatment (environment where the blood is flowing) (an environment that more accurately simulates the human body). As a result, the evaluation accuracy can be further improved.

  In this case, it is desirable to further provide a discharge mechanism for discharging the liquid contained in the container to the outside. In such a case, the risk of the liquid leaking out of the container due to the inflow of the liquid by the inflow mechanism is avoided, and the liquid is discharged so that the liquid flows more in the container. It will be done effectively. Therefore, convenience in evaluation is improved, and cauterization in an environment that simulates a human body is realized more accurately. As a result, evaluation accuracy is further improved.

  In the evaluation instrument for an ablation catheter of the present invention, it is desirable that the impedance of the container is substantially equal to the impedance of the ablation object. In this case, cauterization in an environment closer to that during actual treatment can be realized, and the evaluation accuracy can be further improved.

  Examples of the liquid include physiological saline, low-concentration saline, blood, and the like.

  According to the evaluation instrument for an ablation catheter of the present invention, the ablation object includes the thermochromic material and the conductive material, and the container formed of the conductive resin is provided. The temperature can be grasped at a glance, and the container can be easily obtained. Therefore, it becomes possible to easily evaluate the ablation using the ablation catheter, and to easily manufacture the ablation catheter evaluation instrument.

It is a mimetic diagram showing an example of schematic composition of an ablation catheter evaluation instrument etc. concerning one embodiment of the present invention. It is a model perspective view for demonstrating an example of the thermochromic property in the cauterization target object shown in FIG. It is a schematic diagram showing the example of schematic structures, such as an ablation catheter evaluation instrument which concerns on the comparative example 1. FIG. 10 is a schematic diagram illustrating a schematic configuration example of an ablation catheter evaluation instrument and the like according to Comparative Example 2. FIG. It is a schematic diagram showing the example of schematic structures, such as an ablation catheter evaluation instrument which concerns on the comparative example 3. FIG.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The description will be given in the following order.
1. Embodiment (an example of an evaluation instrument having a liquid inflow mechanism / outflow mechanism and a depression)
2. Modified example

<1. Embodiment>
[Constitution]
FIG. 1 schematically shows an example of a schematic configuration of an ablation catheter evaluation instrument (evaluation instrument 1) according to an embodiment of the present invention. The evaluation instrument 1 is an instrument for evaluating ablation using the ablation catheter 3. As shown in FIG. 1, the evaluation instrument 1 includes a container 11, a counter electrode plate 12, an ablation object (sample) 13, an inflow path 14, a pump 15, and a discharge path 16. In FIG. 1 (and also in FIGS. 3 to 5 described later), for convenience of explanation, the container 11, the counter electrode plate 12, and the ablation object 13 in the evaluation instrument 1 are shown in a cross-sectional view, and the ablation catheter 3 is shown. Is shown in a side view. In addition, the inflow path 14, the pump 15, and the discharge path 16 are shown in a schematic diagram.

(Ablation catheter 3)
The ablation catheter 3 used for the evaluation of such ablation is a catheter (electrode catheter) used for the treatment of arrhythmia and the like, and treatment is performed by cauterizing the affected area. In this example, as shown in FIG. 1, such an ablation catheter 3 includes a catheter tube 30 having one or more (three in this example) ring-shaped electrode 31 and tip electrode 32, and an operation unit (not shown) Catheter handle).

  The catheter tube 30 is a portion where the distal end side is inserted into a patient's body through blood vessels when used for actual treatment or the like. However, when used for the evaluation of cauterization as in the present embodiment, for example, as shown in FIG. 1, the distal end side of the catheter tube 30 is in the container 11 in the evaluation instrument 1 (in the liquid 2 described later). To be inserted.

  The catheter tube 30 is made of a flexible tubular structure (tubular member) and has a shape extending along its own axial direction (longitudinal direction). The catheter tube 30 is also formed with a so-called single lumen structure in which one lumen (pore, through-hole) is formed so as to extend along the axial direction of the catheter tube 30 or a plurality of (for example, four) lumens. So-called multi-lumen structure. In the catheter tube 30, both a region having a single lumen structure and a region having a multi-lumen structure may be provided. Various kinds of thin wires (not shown) (one or a plurality of conducting wires, operation wires, etc.) are inserted through such a lumen while being electrically insulated from each other.

  Such a catheter tube 30 is made of, for example, a synthetic resin such as polyolefin, polyamide, polyether polyamide, or polyurethane. The axial length of the catheter tube 30 is, for example, about 500 to 1200 mm (for example, 1170 mm), and the outer diameter of the catheter tube 30 is, for example, about 0.6 to 3 mm (for example, 2.0 mm). It is.

  As shown in FIG. 1, each of the ring-shaped electrode 31 and the distal electrode 32 is disposed at a predetermined interval in the vicinity of the distal end of the catheter tube 30. The ring-shaped electrode 31 is fixedly disposed on the outer peripheral surface of the catheter tube 30, while the tip electrode 32 is fixedly disposed at the forefront of the catheter tube 30. These electrodes are electrically connected to an operation unit described later via a plurality of conductive wires (not shown) inserted into the lumen of the catheter tube 30 described above.

  Each of the ring electrode 31 and the tip electrode 32 has good electrical conductivity, such as aluminum (Al), copper (Cu), stainless steel (SUS), gold (Au), platinum (Pt), and the like. It is made of a metal material. In addition, in order to make the contrast property with respect to X-rays favorable at the time of use of the ablation catheter 3, it is preferable to be comprised with platinum or its alloy.

  The above-described operation unit is mounted on the proximal end side of the catheter tube 30 and includes, for example, a grip unit (handle body) and a rotating plate (not shown).

  The grasping portion is a portion grasped (gripped) by an operator (doctor) when the ablation catheter 3 is used. Various fine wires described above extend from the inside of the catheter tube 30 inside the gripping portion.

  The rotating plate is a member for performing a deflection movement operation (swing operation), which is an operation for deflecting (curving) the vicinity of the distal end of the catheter tube 30. Specifically, for example, the vicinity of the distal end of such a catheter tube 30 can be deflected in both directions by being operated by an operator so that the rotating plate rotates.

(Evaluation instrument 1)
The aforementioned counter electrode plate 12 in the evaluation instrument 1 is, for example, a flat electrode. Although details will be described later, when cauterization using the ablation catheter 3 is performed, high-frequency energization is performed between the counter electrode plate 12 and the tip electrode 32 described above in the ablation catheter 3. Incidentally, such a counter electrode 12 is used in a state of being mounted on the patient's body surface during actual treatment or the like.

  As shown in FIG. 1, the container 11 is a container that stores the liquid 2 used when evaluating ablation using the ablation catheter 3, and is arranged on the counter electrode plate 12 in this example. In this example, the container 11 has a bowl-like shape, and the size of the outer surface is, for example, about (100 mm × 140 mm) × 75 mm (height), and the size of the inner surface is, for example, (80 mm × 120 mm) × 40 mm (height).

  Here, examples of the liquid 2 include physiological saline, low-concentration saline, blood, and the like. The concentration in the physiological saline and the low-concentration saline is, for example, about 0.45% or about 0.90%. In consideration of the electrical characteristics of blood in the actual human body, it can be said that this concentration is preferably about 0.45% rather than about 0.90%. This is because human blood can be simulated more faithfully.

  Further, as shown in FIG. 1, a recess 110 that is not penetrating to the counter electrode plate 12 is formed near the center of the bottom surface S <b> 1 of the container 11. As shown in FIG. 1, the depression 110 is an opening (insertion hole on which the ablation object 13 is placed) for inserting and arranging the ablation object 13 when evaluating ablation using the ablation catheter 3. For example, it is a cylindrical opening. Therefore, in this example, the container 11 is interposed between the ablation object 13 inserted and disposed in the depression 110 and the counter electrode plate 12. Further, in this example, the depression 110 has a non-tapered side surface (side wall) S2 having a constant diameter from the bottom surface S1 side to the counter electrode plate 12 side of the container 11. In other words, the side surface S2 of the depression 110 is a non-inclined surface (vertical surface). The diameter of such a depression 110 is, for example, about 20 mm to 23 mm.

  Such a container 11 is made of a conductive resin. Examples of the conductive resin include conductive silicone rubber and conductive plastic. Moreover, it is preferable that the impedance (Z11) of the container 11 is substantially equal (desirably equal) to the impedance (Z13) of the ablation object 13 described above. In addition, as a value of these impedances Z11 and Z13, about 100-120 (ohm) is mentioned, for example.

  The above-described ablation object 13 is arranged in the container 11 when evaluating ablation using the ablation catheter 3 (in this example, it is inserted and arranged in the above-described depression 110). It functions as a sample (sample) when this shochu is evaluated. The ablation object 13 is configured using an artificial material (composition such as a conductive material) made of a predetermined material. Examples of the conductive material include a conductive resin such as conductive silicone rubber and conductive plastic, and a gel prepared using a water-soluble polymer such as PVA (PolyVinyl Alcohol).

  The ablation object 13 includes a predetermined thermochromic material in addition to the above-described conductive material, for example, as shown in FIGS. 2 (A) and 2 (B). That is, as shown in FIG. 2A, the cauterization object 13 is in an environment where the temperature is relatively low and in an environment where the temperature is relatively high as shown in FIG. It is comprised so that the color to show may change. In other words, the thermochromic material described above has a characteristic (thermochromic characteristic) that changes color according to a change in temperature (amount of heat applied from the outside). As this thermochromic property, it is desirable to exhibit irreversible discoloration. Although the details will be described later, the temperature condition during the shochu can be visually recognized more appropriately. Examples of such a thermochromic material include heat-sensitive decoloring ink containing a leuco dye, a developer, and a decoloring agent. Further, the discoloration temperature in the thermochromic material is not particularly limited, but is preferably within a temperature range (for example, about 40 to 60 ° C.) during general shochu.

  As shown in FIG. 1, the inflow path 14 is a path (flow path) when the liquid Lin is introduced (injected) into the container 11 from the outside. That is, the liquid Lin flows into the container 11 from the outside via the inflow path 14. Note that the liquid Lin is merely different from the liquid 2 for convenience of explanation, and is the same as the liquid 2 described above (such as physiological saline, low-concentration saline or blood).

  The pump 15 is a pump that operates so that the liquid Lin flows into the container 11 via the inflow path 14. As such a pump 15, various types of pumps can be used.

  Here, the inflow path 14 and the pump 15 correspond to a specific example of the “inflow mechanism” in the present invention.

  As shown in FIG. 1, the discharge path 16 is a portion that becomes a path (flow path) for discharging (outflowing) a part of the liquid 2 contained in the container 11 to the outside as the liquid Lout. That is, a part of the liquid 2 accommodated in the container 11 is discharged to the outside as the liquid Lout through the discharge path 16. The liquid Lout is also different from the liquid 2 for convenience of explanation, and is the same as the liquid 2 described above (such as physiological saline, low-concentration saline or blood).

  Here, such a discharge path 16 corresponds to a specific example of the “discharge mechanism” in the present invention.

[Action / Effect]
(A. Basic operation)
The evaluation instrument 1 is used in the following manner when evaluating ablation using the ablation catheter 3.

  That is, first, as shown in FIG. 1, the above-described cauterization object 13 is inserted and disposed in the depression 110 in the container 11, and the liquid 2 used for evaluating the cauterization is injected into the container 11. Is done.

  Next, as shown in FIG. 1, the vicinity of the distal end of the catheter tube 30 (the ring electrode 31 and the distal electrode 32) in the ablation catheter 3 is inserted into the liquid 2 accommodated in the container 11. Then, by supplying predetermined power to the ablation catheter 3 from a power supply device (high frequency generator) (not shown), high frequency current is supplied between the distal electrode 32 in the catheter tube 30 and the counter electrode plate 12 in the evaluation instrument 1. Made. As a result, a predetermined current flows between the electrode and the counter electrode plate 12, and cauterization of the cauterization object 13 is performed.

  And after such a cauterization, the cauterization condition etc. in the cauterization area | region in the cauterization target object 13 are confirmed by visual observation etc., for example.

  By using the evaluation instrument 1 in this way, the ablation status of the ablation object 13 (for example, the temperature distribution during the ablation and the ablation condition in the ablation region) is preliminarily (product development stage of the ablation catheter 3, etc.) ) Can be evaluated.

(B. Action in the evaluation instrument 1)
Then, the effect | action in the evaluation instrument 1 used for evaluation of such a shochu is demonstrated in detail, comparing with a comparative example (comparative examples 1-3).

(B-1. This embodiment)
First, the evaluation instrument 1 of the present embodiment is as follows, unlike Comparative Examples 1 to 3 described later.

  That is, first, in this evaluation instrument 1, as shown in FIG. 1, the ablation object 13 as a sample when evaluating ablation using the ablation catheter 3 is added to the above-described conductive material in addition to the above-described thermal material. It is configured to include a color changing material. In other words, for example, as shown in FIGS. 2 (A) and 2 (B), the ablation object 13 exhibits thermochromic properties. Thus, in this embodiment, unlike Comparative Examples 1 to 3 described later, a dedicated element (for example, a temperature sensor such as a thermocouple) for measuring the temperature during the cauterization (the temperature in the cauterized object 13) is unnecessary. Thus, depending on the discoloration state of the cautery object 13, the temperature during cauterization can be grasped at a glance (visible). In other words, the evaluation instrument 1 can evaluate the ablation status of the ablation object 13 without using a temperature sensor such as a thermocouple.

  Moreover, in this evaluation instrument 1, the container 11 which accommodates the liquid 2 used when evaluating a shochu is comprised with conductive resin as mentioned above. Thereby, in this Embodiment, compared with the case of the container etc. which are obtained using a special raw material and a manufacturing method like the comparative example 3 mentioned later, the container 11 can be simply obtained now. In addition, unlike the container 301 in Comparative Example 3 to be described later, this container 11 does not cause problems such as restriction on use time and heat resistance described later.

  Furthermore, in this evaluation instrument 1, as shown in FIG. 1, a depression 110 for inserting and arranging the cauterization object 13 is formed on the bottom surface S1 of the container 11. In the present embodiment, the cauterization target 13 is cauterized while being inserted and disposed in the recess 110, and in this embodiment, the liquid 2 passes between the ablation catheter 3 and the counter electrode plate 12, as shown in FIG. A short circuit path will not be formed. Therefore, unlike the comparative examples 1 and 2, which will be described later, in the present embodiment, the occurrence of the short-circuit current Is during the cauterization is avoided (see the “x” marks shown in FIG. 1). In other words, in the present embodiment, the occurrence of the short-circuit current Is during cauterization is prevented regardless of the concentration of the liquid 2 accommodated in the container 11 or the like.

  Further, as shown in FIG. 1, since the recess 110 is not penetrating to the counter electrode plate 12, the container 11 is interposed between the cauterization object 13 inserted into the recess 110 and the counter electrode plate 12. Intervene. As a result, in the present embodiment, an impedance value can be obtained in an environment closer to that during actual treatment (an environment that more accurately simulates a human body). As a result, for example, compared to a case where the dent penetrates to the counter electrode plate 12 (a case where a through hole is formed instead of the dent 110), a decrease in impedance value is prevented, and during actual treatment. Shochu in a closer environment is realized. This is because organs, muscles, skin, and the like exist in addition to the myocardium corresponding to the ablation object 13 between the electrode (tip electrode 32) and the counter electrode 12 in the ablation catheter 3 during actual treatment. is there. Moreover, in this evaluation instrument 1, since a temperature sensor such as a thermocouple is not necessary as described above, for example, a lead wire (lead wire) or the like in the thermocouple is pulled out from the evaluation instrument 1 to the outside (measurement instrument or the like). Since there is no need, the depression 110 can be formed instead of the through-hole for drawing out.

  Here, in the evaluation instrument 1, as shown in FIG. 1, the recess 110 has a non-tapered side surface (side wall) S2. Thereby, in this Embodiment, when using the cauterization target 13 which has water absorption, for example, the hollow 110 becomes a tapered side wall (a tapered side wall whose diameter gradually decreases toward the counter electrode plate 12 side). Unlike the case of having), it is as follows. That is, the risk that the cauterized object 13 jumps out of the depression 110 due to the liquid 2 absorbing water and swelling is reduced or avoided.

  In addition, in this evaluation instrument 1, when the impedance (Z11) of the container 11 is substantially equal (preferably equal) to the impedance (Z13) of the cauterization object 13, the following is performed. become. That is, ablation in an environment closer to that during actual treatment (an environment that more accurately simulates a human body) is realized.

  Here, with respect to such an evaluation instrument 1 of the present embodiment, the following problems may occur in Comparative Examples 1 to 3. The problems of Comparative Examples 1 to 3 will be described in detail below.

(B-2. Comparative Example 1)
FIG. 3 schematically illustrates an example of a schematic configuration of an ablation catheter evaluation instrument (evaluation instrument 100) according to Comparative Example 1. As shown in FIG. 3, the evaluation instrument 100 of Comparative Example 1 includes a container 101, a counter electrode plate 12, an ablation object 109, and a thermocouple. In FIG. 3, for the sake of convenience, illustration of the thermocouple is omitted.

  In the evaluation instrument 100 of the embodiment, the container 101 and the cauterization object 109 are provided in place of the container 11 and the cauterization object 13, respectively, and the arrangement of the counter electrode plate 12 is different. The other configurations are basically the same.

  The container 101 has a bowl-like shape like the container 11 and is made of, for example, a material such as polypropylene or acrylic. However, unlike the container 11, the bottom of the container 101 is not formed with a recess 110 for inserting and arranging the cauterization object 109. Further, unlike the evaluation instrument 1, the counter electrode plate 12 is disposed inside the container 101 (on the bottom surface). An ablation object 109 is placed on the counter electrode plate 12. That is, in Comparative Example 1, the counter electrode plate 12 and the cauterization object 109 are each immersed in the liquid 2 in the container 101.

  Moreover, unlike the cauterization object 13 in the evaluation instrument 1, the cauterization object 109 in the evaluation instrument 100 does not include a thermochromic material. In other words, the ablation object 109 is different from the ablation object 13 in that it does not exhibit thermal discoloration.

  Such a configuration causes the following problems in Comparative Example 1, for example, as schematically shown in FIG. That is, first, during cauterization using the ablation catheter 3, not only the current I101 (current flowing through the ablation object 109) as shown in FIG. 3 but also the short-circuit current Is (liquid 2 flowing through the liquid 2). A current that flows through the short-circuit path that passes through. In addition, the short-circuit current Is is larger than the current I101 that should flow during cauterization. In the comparative example 1, the impedance (for example, about 60Ω) during the cauterization is too low compared with the impedance (about 100 to 120Ω) in the human body because a lot of such short circuit current Is is generated during the cauterization. Therefore, the evaluation accuracy of shochu (measurement accuracy at the time of evaluation) is lowered.

  Moreover, unlike the cauterization object 13, the cauterization object 109 does not exhibit thermochromic properties. Therefore, in Comparative Example 1, a thermocouple is required for evaluating the cauterization state of the cauterization object 109, as described above. Evaluation would be difficult.

(B-3. Comparative Example 2)
FIG. 4 schematically illustrates a schematic configuration example of an ablation catheter evaluation instrument (evaluation instrument 200) according to Comparative Example 2. As shown in FIG. 4, the evaluation instrument 200 of Comparative Example 2 includes a container 101, a counter electrode plate 12, an ablation object 109, and a thermocouple. In FIG. 4, for the sake of convenience, illustration of the thermocouple is omitted.

  This evaluation instrument 200 corresponds to the evaluation instrument 100 of Modification 1 described above, in which the liquid 202 is accommodated in the container 101 instead of the liquid 2, and the other configurations are basically the same. .

  The liquid 202 corresponds to a liquid whose concentration (for example, the concentration of salt) is lower than that of the liquid 2. Specifically, the concentration in the liquid 2 is, for example, about 0.45% or 0.90%, while the concentration in the liquid 202 is, for example, about 0.20%. Thereby, the impedance in the liquid 202 is set to be approximately the same as the impedance (about 100 to 120Ω) in the human body described above, and is set to be in an appropriate range as compared with the impedance in the liquid 2 (for example, about 60Ω as described above). It has become so.

  Therefore, in this comparative example 2, compared with the comparative example 1, the generation of the short circuit current Is during the cauterization is suppressed. Specifically, first, as schematically illustrated in FIG. 4, for example, in the comparative example 2 as well, only the current I201 (current flowing through the ablation object 109) is obtained during cauterization using the ablation catheter 3. Instead, a short circuit current Is flowing through the liquid 202 (current flowing through a short circuit path passing through the liquid 202) is generated. However, since the impedance in the liquid 202 is set in an appropriate range as described above, the short-circuit current Is is smaller than the current I201 that should flow in the cauterization. As described above, in Comparative Example 2, the generation of the short-circuit current Is during the cauterization is suppressed, so that the evaluation accuracy of the cautery is improved as compared with Comparative Example 1.

  However, for example, as shown in FIG. 4, during such cauterization, the irrigation liquid L (such as physiological saline) is ejected from the vicinity of the distal end of the distal electrode 32 in the ablation catheter 3 for evaluation. In such a case, the following problem may occur also in the comparative example 2. It should be noted that such a method of ejecting the irrigation liquid L during cauterization in actual treatment or the like causes damage due to excessive increase in the temperature of the treatment portion during the cauterization, or a thrombus is stuck in the treatment portion. It is used in order to avoid (or improve blood retention).

  That is, when such irrigation liquid L is ejected, the concentration of the liquid 202 contained in the container 101 fluctuates (becomes higher), so that the occurrence of the short-circuit current Is also increases. Also in this comparative example 2, the evaluation accuracy is lowered. That is, it can be said that the evaluation accuracy may be lowered depending on the concentration of the liquid 202 stored in the container 101.

  In Comparative Example 2 as well, since the ablation object 109 that does not exhibit thermochromic properties is used, a thermocouple is required to evaluate the ablation status of the ablation object 109 as in Comparative Example 1 described above. Thus, simple evaluation becomes difficult.

(B-4. Comparative Example 3)
FIG. 5 schematically illustrates a schematic configuration example of an ablation catheter evaluation instrument (evaluation instrument 300) according to Comparative Example 3. As shown in FIG. 5, the evaluation instrument 300 of Comparative Example 3 includes a container 301, a counter electrode plate 12, and a thermocouple. In FIG. 5, for the sake of convenience, the illustration of the thermocouple is omitted.

  This evaluation instrument 300 corresponds to the evaluation instrument 1 of the embodiment in which the container 301 is provided instead of the container 11 and the cauterization object 13, and the other configurations are basically the same.

  The container 301 has a bowl-like shape like the container 11. However, unlike the container 11, the bottom surface S301 of the container 301 is not formed with a recess 110 for inserting and arranging the ablation object 109. In Comparative Example 3, the container 301 (the portion on the bottom surface S301 side) also functions as the ablation object 109. Such a container 301 is made of a predetermined material (for example, PVA-H (PolyVinyl Alcohol-Hydrogel)) having an impedance relatively close to the impedance (about 100 to 120Ω) in the human body described above.

  With such a configuration, unlike Comparative Examples 1 and 2, in Comparative Example 3, generation of a short-circuit current Is during cauterization is avoided (see “x (X)” marks shown in FIG. 5). As described above, since a part of the container 301 containing the liquid 2 also functions as the ablation object 109, a short-circuit path that passes the liquid 2 is formed between the ablation catheter 3 and the counter electrode plate 12. Is due to not being. Specifically, for example, as schematically shown in FIG. 5, during cauterization using the ablation catheter 3, currents I <b> 301 and I <b> 302 (current flowing in the cauterization object 109) are generated while the liquid 2 The generation of the short-circuit current Is flowing through is avoided. In this way, in Comparative Example 3, the occurrence of the short-circuit current Is during cauterization is avoided. As a result, the evaluation accuracy of the cautery is improved as compared with Comparative Examples 1 and 2.

  However, the container 301 described above is manufactured using a special manufacturing method. Specifically, for example, a heating process of about several hours at about 100 ° C. or a cooling process of about one day at a low temperature (about −30 ° C.) with the PVA solution poured into the jig is required. Yes. That is, in Comparative Example 3, it can be said that it is difficult to easily manufacture the evaluation instrument 300, although the accuracy of evaluating the shochu is improved.

  In addition, since the container 301 of this comparative example 3 is produced through a cooling process as described above, it can only be used for several hours (there is a limitation on the use time) and has low heat resistance (80 Therefore, there is also a problem that it gradually breaks during shochu.

  Also in Comparative Example 3, since the container 301 that also functions as the ablation object 109 that does not exhibit thermochromic property is used, the container 301 (ablation object) as in Comparative Examples 1 and 2 described above. 109), a thermocouple is required for the evaluation of the ablation status, and a simple evaluation becomes difficult.

(C. Effect in the evaluation instrument 1)
As described above, in the present embodiment, the cauterization object 13 includes the thermochromic material and the conductive material, and the container 11 made of the conductive resin is provided. The container 11 can be easily obtained while the temperature can be grasped at a glance. Therefore, it is possible to easily evaluate the ablation using the ablation catheter 3, and it is possible to easily manufacture such an evaluation instrument 1.

  Further, since the depression 110 for inserting and arranging the cauterization object 13 is formed on the bottom surface S1 of the container 11, a short circuit during cauterization is performed regardless of the concentration of the liquid 2 accommodated in the container 11. Generation of the current Is can be prevented. Therefore, it becomes possible to improve the evaluation accuracy at the time of cauterization using the ablation catheter 3.

  Further, since the depression 110 is not penetrated up to the counter electrode plate 12, an impedance value can be obtained in an environment closer to that during actual treatment (an environment more accurately simulating a human body). Become. As a result, it is possible to prevent the impedance value from being lowered, to achieve cauterization in an environment closer to that during actual treatment, and to further improve the evaluation accuracy at the time of cauterization.

  In addition, since the depression 110 has a non-tapered side surface (side wall) S2, for example, when the cauterization object 13 having water absorption is used, the depression 110 has a tapered side wall. Unlike the case of having, it is as follows. That is, the risk that the cauterized object 13 jumps out of the depression 110 due to the liquid 2 absorbing water and swelling is reduced or avoided. Therefore, it is possible to improve convenience when evaluating shochu.

  In addition, when the impedances Z11 and Z13 are substantially equal to each other (preferably equal), as described above, ablation in an environment closer to that during actual treatment is realized. Become so. Therefore, in this respect, it is possible to further improve the evaluation accuracy.

  Furthermore, since an inflow mechanism for allowing the liquid Lin to flow into the container 11 using the pump 15 is provided, the liquid 2 flows in the container 11. Therefore, cauterization in an environment closer to the actual treatment (environment in which blood flows) (an environment that more accurately simulates the human body) is realized, and as a result, the evaluation accuracy can be further improved. Become.

  In addition, by using such an inflow mechanism, for example, it is possible to appropriately adjust (control) the temperature, concentration, etc. of the inflowing liquid Lin, so that it is possible to realize cauterization in a more appropriate environment. It becomes possible.

  In addition, since the discharge mechanism (discharge path 16) for discharging the liquid 2 stored in the container 11 to the outside is provided, the following effects can be obtained. That is, the risk of the liquid 2 leaking out of the container 11 due to the inflow of the liquid Lin by the inflow mechanism described above is avoided, and the liquid Lout is discharged, so that the liquid 2 in the container 11 is discharged. The flow becomes more effective. Therefore, it is possible to improve the convenience during the evaluation of the shochu, and it is possible to realize the shochu in an environment that simulates the human body more accurately and to further improve the evaluation accuracy. Become.

<2. Modification>
While the present invention has been described with reference to the embodiment, the present invention is not limited to this embodiment, and various modifications can be made.

  For example, the configuration (shape, arrangement position, material, etc.) of each member described in the above embodiment is not limited, and other shapes, arrangement positions, materials, etc. may be used. Specifically, for example, the shape of the recess 110 is not limited to the shape described in the above embodiment (the non-penetrating shape having the non-tapered side surface S2), and may be another shape. In some cases, the depression 110 may not be formed (for example, the bottom surface S1 of the container 11 may be formed in a shape surrounding the cauterization object 13). Furthermore, the shape, arrangement position, and material (material such as conductive resin and thermochromic material) of the ablation object 13 are not limited to those described in the above embodiment, but other shapes and arrangement positions, It may be a material.

  Further, the configuration of the electrodes in the catheter tube 30 (arrangement, shape, number, etc. of the ring-shaped electrode 31 and the tip electrode 32) is not limited to those described in the above embodiment, and other configurations may be used.

  Further, the liquid inflow mechanism (pump 15 and inflow path 14) and the discharge mechanism (discharge path 16) may not be provided in some cases.

  In addition, in the said embodiment, although the example in the case where the impedance of a container was substantially equal (desirably equal) with the impedance of a cauterization target was given and demonstrated, it is not restricted to this. That is, for example, the present invention can also be applied to the case where the impedance of the container and the impedance of the ablation object are different from each other (one of these has a larger or smaller impedance than the other). .

  Further, the shape of the shape near the distal end of the catheter tube 30 is not limited to that described in the above embodiment. Specifically, in the above-described embodiment, the ablation catheter 3 of the type in which the shape in the vicinity of the distal end of the catheter tube changes in both directions according to the operation to the operation unit (bidirectional type) has been described as an example. This is not a limitation. That is, the present invention can be applied to, for example, an ablation catheter of a type (single direction type) in which the shape near the distal end of the catheter tube changes in one direction in accordance with an operation on the operation unit.

  DESCRIPTION OF SYMBOLS 1 ... Evaluation instrument, 11 ... Container, 110 ... Indentation, 12 ... Counter electrode plate, 13 ... Ablation object, 14 ... Inflow path, 15 ... Pump, 16 ... Discharge path (discharge mechanism), 2 ... Liquid, 3 ... Ablation catheter , 30 ... catheter tube, 31 ... ring electrode, 32 ... tip electrode, I1, I2 ... current, Is ... short circuit current, S1 ... bottom surface, S2 ... side surface (side wall), Lin, Lout ... liquid.

Claims (6)

  1. An instrument for evaluating ablation using an ablation catheter,
    A counter electrode plate,
    A container that is disposed on the counter electrode plate and contains a liquid used when evaluating the shochu, and is made of a conductive resin;
    A cautery object as a sample when the cautery is evaluated, disposed in the container,
    The ablation object is configured to include a thermochromic material and a conductive material.
  2. A depression for inserting and arranging the ablation object is formed in the bottom surface of the container,
    The ablation catheter evaluation instrument according to claim 1, wherein the depression is non-penetrating to the counter electrode plate.
  3. The ablation catheter evaluation instrument according to claim 2, wherein the recess has a non-tapered side wall.
  4. The evaluation instrument for an ablation catheter according to any one of claims 1 to 3, further comprising an inflow mechanism for allowing the liquid to flow into the container using a pump.
  5. The evaluation instrument for an ablation catheter according to claim 4, further comprising a discharge mechanism that discharges the liquid contained in the container to the outside.
  6. The ablation catheter evaluation instrument according to any one of claims 1 to 5, wherein the impedance of the container is substantially equal to the impedance of the ablation object.
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EP1709924B1 (en) * 2004-01-27 2018-10-31 Japan Lifeline Co., Ltd Ablation catheter
JP5272888B2 (en) * 2009-05-19 2013-08-28 東レ株式会社 Ablation catheter system with guide wire and balloon
US9468492B2 (en) * 2010-06-03 2016-10-18 Covidien Lp Specific absorption rate measurement and energy-delivery device characterization using image analysis
US8984969B2 (en) * 2012-01-27 2015-03-24 Medtronic Ablation Frontiers Llc Thermochromic polyacrylamide tissue phantom and its use for evaluation of ablation therapies
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