WO2017159001A1 - Balloon catheter, chemical abrasion device for treating adrenal tumor and adrenal venous blood sampling device - Google Patents

Balloon catheter, chemical abrasion device for treating adrenal tumor and adrenal venous blood sampling device Download PDF

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Publication number
WO2017159001A1
WO2017159001A1 PCT/JP2017/000182 JP2017000182W WO2017159001A1 WO 2017159001 A1 WO2017159001 A1 WO 2017159001A1 JP 2017000182 W JP2017000182 W JP 2017000182W WO 2017159001 A1 WO2017159001 A1 WO 2017159001A1
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WIPO (PCT)
Prior art keywords
hardness
balloon catheter
adrenal
balloon
distal end
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PCT/JP2017/000182
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French (fr)
Japanese (ja)
Inventor
圭 高瀬
和将 清治
謙二 森
倫彦 光宗
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日本ライフライン株式会社
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Publication of WO2017159001A1 publication Critical patent/WO2017159001A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon catheter, an adrenal tumor chemical ablation treatment device, and an adrenal vein blood collection device, and more particularly, introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of an adrenal tumor.
  • the present invention relates to an over-the-wire balloon catheter, and a chemical ablation treatment apparatus and an adrenal vein blood collection apparatus provided with such a balloon catheter.
  • Primary aldosteronism is a hypertensive disease that develops because an adrenal gland (tumor) that oversecretes aldosterone, a blood pressure increasing hormone, is formed in the adrenal gland.
  • an adrenal gland tumor
  • aldosterone a blood pressure increasing hormone
  • To treat primary aldosteronism if excessive secretion of aldosterone is observed from one side of the adrenal gland, the adrenal gland with a tumor is removed. On the other hand, if excessive secretion of aldosterone is observed in both adrenal glands, the patients need to continue to take antihypertensive agents because they cannot be removed.
  • a method for treating primary aldosteronism in which aldosterone is excessively secreted blood is collected from the adrenal vein using a catheter (adrenal vein blood collection), and an abnormal adrenal gland is identified.
  • a method has been introduced in which a tumor is cauterized by accurately grasping from an image or the like and puncturing a bipolar RF (high frequency) needle from the back of a patient.
  • the treatment method as described above is less invasive than the adrenalectomy, but the burden on the patient is still heavy. Also, since the left adrenal gland is close to the pancreas and intestinal tract, it is difficult to anatomically perform a technique of puncturing a bipolar RF needle from the back against a tumor in the left adrenal gland.
  • the terminal side of the adrenal vein is branched into three branches (inner ascending branch, outer ascending branch, outer arc-shaped branch). For this reason, when performing chemical ablation treatment of adrenal tumors, it is desirable to collect blood for each branch and treat only the tumor of the branch where abnormalities (excessive secretion of aldosterone) are observed.
  • conventionally known balloon catheters used for PTCA and the like have a shaft diameter larger than the diameter of the branch (the outer diameter of the outer tube), and have a balloon length longer than the length of the branch. Therefore, it is impossible to insert into any one branch and close the branch with a balloon. Therefore, chemical ablation (contact with ethanol) is also applied to the branch where no abnormality is observed. Will be done.
  • the present invention has been made based on the above situation.
  • the object of the present invention can be used for intravenous chemical ablation treatment, which is a novel treatment method for primary aldosteronism, and in particular, it is possible to treat only a tumor of a branch vein in which an abnormality is observed.
  • An object of the present invention is to provide a balloon catheter that can be used.
  • Another object of the present invention is a chemical ablation treatment apparatus which can be used for intravenous ablation treatment for primary aldosteronism, and in particular, can treat only a tumor of a branch vein in which an abnormality is observed. Is to provide.
  • Still another object of the present invention is to provide an adrenal venous blood collection device capable of collecting adrenal venous blood before and after treatment for each branch.
  • the balloon catheter of the present invention is an over-the-wire balloon catheter that is introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of an adrenal tumor,
  • An inner tube having a guide wire lumen; an outer tube disposed outside the inner tube to form an expansion lumen; a balloon mounted on a distal end of the outer tube and disposed outside the inner tube; and the guide A guide wire port communicating with the wire lumen and a connector having an expansion port communicating with the expansion lumen;
  • the outer tube is composed of a proximal-side high hardness portion having a hardness of 72D or more and a distal-side low hardness portion having a hardness of 25D or more and less than 72D,
  • the outer diameter of the outer tube is 0.70 to 1.20 mm;
  • the balloon has a length of 0.5 to 5 mm.
  • a less invasive transvenous ablation treatment can be performed for primary aldosteronism.
  • the distal-side low hardness part of the outer tube has flexibility due to its low hardness, so that the distal-side low hardness part can follow (pass through the blood vessel) the complex blood vessel shape that reaches the adrenal gland,
  • the balloon attached to the tip can reach the target site of the adrenal gland.
  • the balloon catheter according to the present invention does not need to be inserted through a stenosis or the like unlike a conventionally known balloon catheter used for PTCA, so that the low hardness portion on the distal end side of the outer tube has a low hardness (25D or more and less than 72D). ) Is no problem.
  • the outer diameter of the outer tube is smaller than the shaft diameter of the conventionally known balloon catheter used in PTCA or the like (the outer diameter of the outer tube). A balloon catheter can be inserted.
  • the length of the balloon is shorter than the length of the balloon of a conventionally known balloon catheter used for PTCA or the like, so that the branch in which the balloon catheter of the present invention is inserted can be reliably occluded ( Can be occluded).
  • the length of the distal-side low hardness portion is preferably 20 to 150 mm, and particularly the length of the distal-side low hardness portion of the balloon catheter for the left adrenal gland is 100 to It is preferably 150 mm, and the length of the distal-side low hardness portion in the balloon catheter for the right adrenal gland is preferably 50 to 100 mm.
  • the distal-side low-hardness portion has a portion whose hardness decreases in an inclined or stepwise manner toward the distal direction.
  • the rigidity of the distal-side low-hardness portion can be continuously or intermittently reduced (improved in flexibility) toward the distal direction, whereby the balloon catheter can be reduced to the adrenal gland.
  • the operability at the time of introduction into can be further improved.
  • the distal-side low-hardness portion is located on the distal end side of the hardness inclined portion, the hardness inclined portion in which the hardness is gradually decreased toward the distal direction, and the distal end It is preferable that it consists of the most advanced part having the lowest constant hardness in the side low hardness part.
  • the proximal end is provided with the hardness inclined portion of the distal-side low-hardness portion between the proximal-side high-hardness portion and the distal-end portion of the distal-side low-hardness portion. Since the hardness does not change abruptly at the boundary between the side high hardness portion and the tip side low hardness portion, no kink or the like occurs at the boundary. As a result, the operability when introducing the balloon catheter of the present invention into the adrenal gland can be made particularly excellent.
  • the hardness of the inner tube is 40D or less at least in a portion located on the distal side of the outer tube.
  • the inner tube has a two-layer structure of an inner layer and an outer layer, and the inner layer is made of an ethanol-resistant resin.
  • the resin of the inner tube is eroded and swollen by ethanol, thereby preventing the movement of the guide wire and blocking the ethanol flow path. Can do.
  • the chemical ablation treatment apparatus of the present invention includes the balloon catheter of the present invention, Ethanol supply means connected to the guide wire port of the connector; And a guiding catheter for guiding the distal end portion of the balloon catheter to the adrenal gland.
  • the adrenal vein blood collection device of the present invention comprises the balloon catheter of the present invention, Blood suction means connected to the guide wire port of the connector; And a guiding catheter for guiding the distal end portion of the balloon catheter to the adrenal gland.
  • a transvenous chemical ablation treatment that is a novel treatment method for primary aldosteronism can be reliably performed.
  • adrenal vein blood collection before and after treatment can be performed for each branch.
  • transvenous ablation treatment for primary aldosteronism can be reliably performed.
  • it is possible to treat only a tumor of a branch that has an abnormality, and it is possible to avoid ablation of a site related to another branch that has no abnormality.
  • adrenal vein blood collection before and after treatment can be performed for each branch.
  • FIG. 2 is a partially enlarged view (part II detail view) of FIG. 1.
  • FIG. 3 is a cross-sectional view taken along the line III-III in FIG.
  • FIG. 4 is a partially enlarged sectional view (IV-IV sectional view) of FIG. 1.
  • It is explanatory drawing which shows the hardness change of the outer tube of the balloon catheter shown in FIG.
  • It is explanatory drawing which shows typically the structure of the chemical ablation treatment apparatus of this invention.
  • the balloon catheter 100 of this embodiment shown in FIG. 1 (FIGS. 1A and 1B) to FIG. 4 is an over-the-wire type that is introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of adrenal tumors. This is a balloon catheter.
  • the balloon catheter 100 of this embodiment includes an inner tube 10 having a guide wire lumen 21, an outer tube 30 disposed outside the inner tube 10 to form an expansion lumen 23, and an inner tube attached to the distal end of the outer tube 30.
  • a balloon 50 disposed outside the tube 10, a Y-connector 70 having a guide wire port 71 communicating with the guide wire lumen 21 and an expansion port 73 communicating with the expansion lumen 23, and the outer tube 30 has hardness Is composed of a proximal-side high hardness portion 301 having a hardness of 72D or more and a distal-side low hardness portion 302 having a hardness of 25D or more and less than 72D, and the outer diameter of the outer tube 30 is 0.70 to 1.20 mm.
  • the length 50 (L50) is 0.5 to 5 mm.
  • the inner tube 10 constituting the balloon catheter 100 has a guide wire lumen 21 having an inner diameter through which a guide wire (not shown) can be inserted.
  • the guide wire lumen 21 serves as a guide wire insertion passage and a flow path for ethanol, which is a chemical solution for ablation.
  • a contrast marker 40 is attached to the outer periphery of the inner tube 10 inside the balloon 50.
  • the inner tube 10 is constituted by a resin tube having a two-layer structure of an inner layer 11 and an outer layer 13.
  • the inner layer 11 constituting the inner tube 10 is formed of an ethanol resistant resin.
  • the “ethanol-resistant resin” refers to a resin that is insoluble in ethanol and hardly causes swelling or alteration when brought into contact with ethanol.
  • Specific examples of such a resin include polyimide, fluorine resin such as PTFE and PFA, rubber resin, polyethylene, and the like. Among these, PTFE is preferable.
  • the inner layer 11 of the inner tube 10 is formed of an ethanol-resistant resin, the constituent resins (the inner layer 11 and the outer layer 13) of the inner tube 10 are not eroded and swollen by ethanol, and the balloon catheter 100 Thus, it is possible to reliably prevent the guide wire from moving during use and the ethanol flow path from being blocked.
  • the thickness of the inner layer 11 of the inner tube 10 is preferably 0.01 to 0.05 mm, and 0.01 mm is a suitable example.
  • a resin constituting the inner tube of a conventionally known balloon catheter can be used as a resin for forming the outer layer 13 constituting the inner tube 10.
  • a resin constituting the inner tube of a conventionally known balloon catheter can be used.
  • the thickness of the outer layer 13 of the inner tube 10 is preferably 0.05 to 0.15 mm, and 0.06 mm as a suitable example.
  • the hardness of the inner tube 10 (the hardness of the resin constituting the outer layer 13) is preferably 40D or less, and is 25D if a suitable example is shown. In this embodiment, the hardness of the inner tube 10 is the same over the entire length (the outer layer 13 of the inner tube 10 is formed of the same hardness resin), but resins having different hardness along the length direction are used. Then, an inner tube (an outer layer in the case of a two-layer structure) may be formed.
  • the hardness of the inner tube at least in a portion located on the distal side from the distal end of the outer tube 30 is 40 D or less, and thereby the balloon 50 is delivered to the adrenal vein tributary which is a branched small blood vessel. It becomes possible to do.
  • the outer diameter of the inner tube 10 is preferably 0.55 to 0.70 mm, and a preferred example is 0.57 mm.
  • the inner diameter of the inner tube 10 is preferably 0.40 to 0.55 mm, and is 0.45 mm as a suitable example.
  • a tip 15 is attached to the tip of the inner tube 10.
  • the tip chip 15 is composed of, for example, a single layer resin tube.
  • tip 15 the resin same as the constituent resin of the outer layer 13 of the inner tube 10 can be mentioned, for example, Of these, PEBAX is preferable.
  • the hardness of the tip 15 (the hardness of the constituent resin) is preferably 55D or less, and is 40D if a suitable example is shown.
  • the outer diameter and inner diameter of the distal tip 15 are the same as the outer diameter and inner diameter of the inner tube 10.
  • the length (L15) of the tip 15 is preferably 0.3 to 3.0 mm, and is 1 mm as a suitable example.
  • the outer tube 30 constituting the balloon catheter 100 forms an expansion lumen 23 serving as a fluid flow path for expanding the balloon 50 outside the inner tube 10.
  • a physiological saline can be exemplified as the fluid supplied to the expansion lumen 23.
  • the outer tube 30 includes a proximal end side high hardness portion 301 and a distal end side low hardness portion 302.
  • the outer tube 30 is a resin tube having a two-layer structure including an inner layer 31 and an outer layer 33 formed on the outer periphery of the inner layer 31.
  • Examples of the resin constituting the inner layer 31 of the outer tube 30 include polytetrafluoroethylene (PTFE), polyvinylidene fluoride and polyether ether ketone (PEEK), PFA, fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene ( PP), polyamide (PA), polyamide elastomer (PAE) and the like can be mentioned, and among these, PTFE is preferable.
  • PTFE polytetrafluoroethylene
  • PEEK polyether ether ketone
  • FEP fluorinated ethylene propylene
  • PE polyethylene
  • PP polypropylene
  • PA polyamide
  • PAE polyamide elastomer
  • the thickness of the inner layer 31 of the outer tube 30 is preferably 0.01 to 0.05 mm, and 0.03 mm if a suitable example is shown.
  • the outer layer 33 of the outer tube 30 is a braided tube (blade tube) in which a braid 35 is embedded in a resin.
  • Examples of the resin constituting the outer layer 33 of the outer tube 30 include the resins exemplified as those constituting the outer layer 13 of the inner tube 10, and among them, PEBAX is preferable.
  • the braid 35 embedded in the resin constituting the outer layer 33 is formed by braiding a metal wire such as stainless steel, and is arranged over the entire length of the outer tube 30.
  • the thickness of the outer layer 33 of the outer tube 30 is preferably 0.05 to 0.30 mm, and 0.08 mm as a suitable example.
  • the effective length (L100) of the balloon catheter 100 is preferably 800 to 1500 mm, and 950 mm as a suitable example.
  • the length (L30) of the outer tube 30 is preferably 750 to 1490 mm, and is 940 mm as a suitable example.
  • the length (L301) of the base end side high hardness portion 301 of the outer tube 30 is preferably 600 to 1450 mm, and is 800 mm if a suitable example is shown.
  • the hardness of the base end side high hardness portion 301 (the hardness of the resin constituting the outer layer of the portion) is 72D or more, and 72D is shown as a suitable example. Note that the hardness of the base-side high hardness portion 301 may be the same over the entire length or may change in the length direction.
  • the hardness of the tip-side low hardness portion 302 is 25D or more and less than 72D.
  • the distal-side low-hardness portion 302 of the outer tube 30 is positioned on the distal end side of the hardness-gradient portion 304, the hardness-gradient portion 304 whose hardness decreases in the direction of the distal end, and the distal-side low-hardness portion 302. It consists of the most advanced portion 306 having the lowest constant hardness.
  • An example of the hardness of the most advanced portion 306 (the hardness of the resin constituting the outer layer of the portion) is 25D.
  • the hardness of the proximal-side high hardness portion 301 is 72D and the hardness of the most distal portion 306 of the distal-side low hardness portion 302 is 25D
  • the hardness of the hardness inclined portion 304 (the portion concerned)
  • the hardness of the resin constituting the outer layer of the outer layer is inclined from 72D to 25D in the direction of the tip.
  • the method of decreasing the hardness of the hardness inclined portion 304 is not particularly limited.
  • a resin material having a high hardness for example, 72D
  • a resin material having a low hardness for example, 25D
  • a method of changing the blending ratio of the two along the length direction can be mentioned when extrusion molding is performed.
  • Such a distal-side low hardness portion 302 has flexibility due to the low hardness of the most distal portion 306, and can follow a complicated blood vessel shape (including a sharp curve shape) that reaches the adrenal gland. Further, the hardness inclined portion 304 of the distal end side low hardness portion 302 is interposed between the proximal end side high hardness portion 301 and the distal end portion 306 of the distal end side low hardness portion 302, whereby the proximal end side high hardness portion Since the hardness does not change abruptly at the boundary between 301 and the tip-side low hardness portion 302, no kink or the like occurs at the boundary. As a result, the operability when introducing the balloon catheter 100 of this embodiment into the adrenal gland can be made particularly excellent.
  • the length (L302) of the distal-side low hardness portion 302 of the outer tube 30 is preferably 20 to 150 mm. In particular, it is preferably 100 to 150 mm when a balloon catheter for the left adrenal gland is configured, and 130 mm is a suitable example for the left adrenal gland. In the case of constructing a balloon catheter for the right adrenal gland, it is preferably 50 to 100 mm, and 80 mm is shown as a suitable example for the right adrenal gland.
  • the length (L304) of the hardness inclined portion 304 of the distal-side low-hardness portion 302 is preferably 90 to 120 mm when a left adrenal balloon catheter is constructed, and is 100 mm if a suitable example is shown. . In the case of constructing a balloon catheter for the right adrenal gland, it is preferably 20 to 90 mm, and 60 mm is a preferable example.
  • the length (L306) of the most distal end portion 306 of the tip-side low hardness portion 302 is preferably 10 to 30 mm, and 20 mm is a preferable example.
  • the outer diameter of the outer tube 30 is 0.70 to 1.20 mm, preferably 0.80 to 1.00 mm, and 0.85 mm if a suitable example is shown.
  • the inner diameter of the outer tube 30 is preferably 0.60 to 0.80 mm, and a suitable example is 0.69 mm.
  • the balloon catheter 100 of the present embodiment configured by the outer tube 30 having a small outer diameter as described above, it can be inserted into each of the three branches in the adrenal vein.
  • the outer diameter of the outer tube 30 exceeds 1.20 mm, it becomes impossible or extremely difficult to insert into the branch of the adrenal vein. On the other hand, when the outer diameter of the outer tube 30 is less than 0.70 mm, it is impossible to secure a sufficient flow path for the lumen for balloon expansion.
  • the balloon 50 constituting the balloon catheter 100 is mounted on the distal end of the outer tube 30 and is disposed outside the inner tube 10 extending from the distal end of the outer tube 30.
  • the constituent material of the balloon 50 constituting the balloon catheter 100 the same material as that of the conventionally known balloon catheter can be used, and PEBAX can be cited as a suitable material.
  • the hardness of the balloon 50 (the hardness of the constituent resin) is preferably 40D to 70D, and 70D is shown as a suitable example.
  • the diameter of the balloon 50 at the time of expansion is preferably 1 to 3 mm, and a suitable example is 2.5 mm.
  • the length (L50) of the balloon 50 is 0.5 to 5 mm, preferably 0.5 to 3.0 mm, and 1.0 mm if a suitable example is shown.
  • the branch in which the balloon catheter 100 of this embodiment is inserted can be reliably occluded.
  • the balloon retracts to a position just before (branch side) where the balloon branches to the branch.
  • the adrenal vein is occluded, and it is not possible to perform treatment only for the tumor of the branch vein where blood is collected or abnormalities are observed for each branch.
  • some balloons with a length of less than 0.5 mm may be misaligned because the contact area between the outer wall of the balloon and the inner wall of the blood vessel cannot be sufficiently secured even if the balloon is inserted into the branch and expanded.
  • the adrenal vein cannot be reliably occluded.
  • the Y-shaped connector 70 constituting the balloon catheter 100 has a guide wire port 71 that communicates with the guide wire lumen 21 and an expansion port 73 that communicates with the expansion lumen 23.
  • 75 is a strain relief.
  • a guide wire is inserted into the guide wire lumen 21 from the guide wire port 71 of the Y-shaped connector 70.
  • the ethanol supply means is connected to the guide wire port 71 to supply the guide wire lumen 21 with ethanol, which is a chemical solution for ablation.
  • the supplied ethanol is jetted from the tip opening of the tip 15 toward the target site.
  • blood suction means to the guide wire port 71, blood can be collected from the distal end opening of the distal tip 15 and the collected blood circulates through the guide wire lumen 21 to form a Y-shaped connector.
  • the blood is collected from 70 guide wire ports 71 to blood suction means.
  • an ethanol supply means is connected to the guide wire port 71 and mounted on a chemical ablation treatment apparatus to be described later, so that transvenous chemical ablation treatment for primary aldosteronism can be performed. It can be done reliably.
  • the distal-side low-hardness portion 302 (particularly the most advanced portion 306) of the outer tube 30 has flexibility, so that complex blood vessels (the inferior vena cava and adrenal vein (the left adrenal vein) of the left adrenal gland) are reached.
  • the distal-side low-hardness portion 302 can follow the shape of the inferior vena cava, renal vein, and adrenal vein)). Therefore, the operability when introducing the balloon catheter 100 into the adrenal gland can be made particularly excellent.
  • the balloon catheter 100 can be inserted into each branch of the adrenal vein.
  • the branch can be reliably occluded.
  • adrenal vein blood collection before and after chemical ablation treatment can be performed for each branch.
  • the chemical ablation treatment apparatus 1000 shown in FIG. 6 includes the balloon catheter 100 of the above embodiment, the ethanol supply means 200 connected to the guide wire port 71 of the Y connector 70 constituting the balloon catheter 100, and the balloon catheter 100.
  • the ethanol supply means 200 is connected to the guide wire port 71 of the balloon catheter 100.
  • the ethanol supply means 200 is composed of, for example, a syringe containing ethanol.
  • the injected ethanol flows through the guide wire lumen 21 and is jetted from the distal end opening of the distal tip 15 toward the target site (adrenal tumor). This gives chemical ablation therapy for adrenal tumors.
  • the guiding catheter 300 constituting the chemical ablation treatment apparatus 1000 is inserted in advance so that the distal end is positioned at the entrance of the adrenal vein.
  • the guiding catheter 300 schematically shown in FIG. 6 has different shapes for the right adrenal gland and for the left adrenal gland due to the difference in blood vessel shape leading to the adrenal gland.
  • the balloon expansion means 400 is connected to the expansion port 73 of the balloon catheter 100.
  • the balloon expanding means 400 is made of, for example, a syringe containing physiological saline.
  • FIG. 8A shows the shape of the distal end portion of guiding catheter 300R for the right adrenal gland.
  • FIG. 8B shows the shape of the distal end portion of the guiding catheter 300L for the left adrenal gland.
  • a guiding catheter 300R shown in FIG. 8A has a first bending portion 301R and a second bending portion 302R
  • a guiding catheter 300L shown in FIG. 8B has a first bending portion 301L and a second bending portion. 302L.
  • the branch is occluded by the balloon 50 pushed out from the distal end opening of the guiding catheter 300R or 300L, the distal end of the hardness inclined portion of the lower hardness portion of the outer tube 30 (the base of the most distal portion). It is desirable that the end) is located in the lumen of the guiding catheter, that is, the outer tube 30 protruding from the distal end opening of the guiding catheter is only the most distal end portion of the distal-side low hardness portion. Thereby, the followability to the complicated blood vessel shape from the entrance of the adrenal vein to the branch can be further improved.
  • the guiding catheter 300R for the right adrenal gland shown in FIG. 8A is inserted through the inferior vena cava IVC so that its tip is located at the entrance of the right adrenal vein.
  • the guiding catheter 300L for the left adrenal gland shown in FIG. 8B is inserted through the inferior vena cava IVC and the left renal vein LRV so that the tip is located at the entrance of the left adrenal vein.
  • RK is the right kidney
  • LK is the left kidney
  • RAG is the right adrenal gland
  • LAG is the left adrenal gland.
  • the outer diameter of guiding catheter 300 (300R, 300L) is, for example, 1.35 to 2.35 mm, and preferably 1.65 to 2.00 mm.
  • the inner diameter of the guiding catheter 300 is, for example, 0.80 to 2.00 mm, and preferably 1.00 to 1.65 mm.
  • the length of the guiding catheter 300R for the right adrenal gland is, for example, 500 to 1000 mm, and preferably 600 to 800 mm.
  • the length of the guiding catheter 300L for the left adrenal gland is, for example, 500 to 1000 mm, and preferably 600 to 800 mm.
  • ethanol from the ethanol supply means 200 is ejected from the distal end opening of the distal end tip 15 of the balloon catheter 100 and brought into contact with the tumor tissue, thereby preventing primary aldosteronism.
  • Intravenous chemical ablation treatment minimum necessary treatment for a tumor of a branch artery with an abnormality
  • the adrenal venous blood collection device 2000 shown in FIG. 7 includes the balloon catheter 100 of the above embodiment, blood suction means 600 connected to the guide wire port 71 of the Y-shaped connector 70 constituting the balloon catheter 100, and the balloon catheter 100.
  • a blood suction means (syringe) 600 is connected to the guide wire port 71 provided in the Y-shaped connector 70 of the balloon catheter 100.
  • the guiding catheter 300 constituting the adrenal venous blood collection device 2000 has the same configuration as the guiding catheter 300 constituting the chemical ablation treatment device 1000 shown in FIGS. 6 and 8 (FIGS. 8A and 8B).
  • adrenal vein blood collection device 2000 of this embodiment adrenal vein blood collection before and after chemical ablation treatment can be performed for each branch.
  • the adrenal vein blood is collected by the balloon catheter 100 (adrenal vein blood collecting device 2000) of the present embodiment, and based on the result, chemical ablation treatment of the adrenal tumor is performed by the balloon catheter 100 (chemical ablation treatment device 1000).
  • chemical ablation treatment of the adrenal tumor is performed by the balloon catheter 100 (chemical ablation treatment device 1000). An example of the method will be described.
  • the guiding catheter 300 is inserted into the body from the femoral vein, and the distal end of the guiding catheter 300 reaches the entrance of the adrenal vein via the inferior vena cava.
  • the guiding catheter for the right adrenal gland is inserted directly into the entrance of the right adrenal vein from the inferior vena cava, while the guiding catheter for the left adrenal gland is inserted into the left adrenal gland from the inferior vena cava through the left renal vein. Inserted into the vein entrance.
  • a guide wire is inserted in advance to the middle of the lumen of the balloon catheter 100 in the long axis direction.
  • the balloon catheter 100 with the guide wire set in this manner is inserted into the lumen of the guiding catheter 300.
  • the guide wire is extended from the distal end of the balloon catheter 100, and the distal end portion of the guide wire protruding from the distal end of the guiding catheter 300 is connected to the adrenal vein 3. Insert into one of the book branches.
  • a blood suction means 600 is connected to the guide wire port 71 of the balloon catheter 100 to form an adrenal vein blood collection device 2000, and blood is collected (adrenal vein blood collection) at the branch.
  • the ethanol supply means 200 is connected to the guide wire port 71 of the balloon catheter 100 to form the chemical ablation treatment apparatus 1000, and the ethanol supply means 2 Chemical ablation treatment is performed by injecting ethanol from 00 through the distal end opening of the distal end tip 15 of the balloon catheter 100.
  • blood collection (adrenal vein blood collection) of the branch is performed in the same manner as (2) to (4) above. Measure the secretion again to confirm the therapeutic effect.

Abstract

The purpose of the present invention is to provide a balloon catheter which is usable in intravenous chemical abrasion for treating primary aldosteronism and which enables, in particular, exclusive treatment of tumor in a branch diagnosed as abnormal. The balloon catheter according to the present invention, which is to be used in chemical abrasion for treating adrenal tumor via an intravenous approach, comprises an inner tube (10), an outer tube (30), a balloon (50) and a connector (70), said connector (70) comprising a guide wire port (71) and an inflation port (73), wherein: the outer tube (30) comprises a high-hardness part (301) on the proximal end side having a hardness of 72D or higher and a low-hardness part (302) on the distal end side having a hardness of 25D or higher and lower than 72D; the outer diameter of the outer tube (30) is 0.70-1.20 mm; and the length of the balloon (50) is 0.5-5 mm.

Description

バルーンカテーテル、副腎腫瘍のケミカルアブレーション治療装置および副腎静脈採血装置Balloon catheter, adrenal tumor chemical ablation treatment device and adrenal vein blood collection device
　本発明は、バルーンカテーテル、副腎腫瘍のケミカルアブレーション治療装置および副腎静脈採血装置に関し、更に詳しくは、経静脈的アプローチにより副腎に導入されて、副腎静脈採血または副腎腫瘍のケミカルアブレーション治療に使用されるオーバーザワイヤ型のバルーンカテーテル、並びに、そのようなバルーンカテーテルを備えたケミカルアブレーション治療装置および副腎静脈採血装置に関する。 The present invention relates to a balloon catheter, an adrenal tumor chemical ablation treatment device, and an adrenal vein blood collection device, and more particularly, introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of an adrenal tumor. The present invention relates to an over-the-wire balloon catheter, and a chemical ablation treatment apparatus and an adrenal vein blood collection apparatus provided with such a balloon catheter.
　原発性アルドステロン症は、血圧上昇ホルモンであるアルドステロンを過剰分泌させる腺腫（腫瘍）が副腎にできることから発症する高血圧疾患である。
　原発性アルドステロン症の治療としては、アルドステロンの過剰分泌が片側の副腎から認められる場合には腫瘍のある副腎を摘出する。
　一方、アルドステロンの過剰分泌が両側の副腎から認められる場合には、両側の副腎を摘出することができないため、患者は降圧剤を服用し続ける必要がある。 Primary aldosteronism is a hypertensive disease that develops because an adrenal gland (tumor) that oversecretes aldosterone, a blood pressure increasing hormone, is formed in the adrenal gland.
To treat primary aldosteronism, if excessive secretion of aldosterone is observed from one side of the adrenal gland, the adrenal gland with a tumor is removed.
On the other hand, if excessive secretion of aldosterone is observed in both adrenal glands, the patients need to continue to take antihypertensive agents because they cannot be removed.
　最近、アルドステロンが過剰に分泌される原発性アルドステロン症の治療方法として、カテーテルを用いて副腎静脈から血液採取（副腎静脈採血）して異常のある副腎を特定した後、当該副腎の位置をＸ線画像などにより正確に把握し、患者の背中から、バイポーラＲＦ（高周波）針を穿刺して腫瘍を焼灼する方法が紹介されている。 Recently, as a method for treating primary aldosteronism in which aldosterone is excessively secreted, blood is collected from the adrenal vein using a catheter (adrenal vein blood collection), and an abnormal adrenal gland is identified. A method has been introduced in which a tumor is cauterized by accurately grasping from an image or the like and puncturing a bipolar RF (high frequency) needle from the back of a patient.
　しかしながら、上記のような治療方法は副腎の摘出手術と比較すれば侵襲の程度は低いものの、患者への負担は依然として重い。
　また、左副腎は膵臓や腸管に近いため、左副腎における腫瘍に対して背中からバイポーラＲＦ針を穿刺する手技は解剖学的に困難である。 However, the treatment method as described above is less invasive than the adrenalectomy, but the burden on the patient is still heavy.
Also, since the left adrenal gland is close to the pancreas and intestinal tract, it is difficult to anatomically perform a technique of puncturing a bipolar RF needle from the back against a tumor in the left adrenal gland.
　このような問題を解決するために、バルーンカテーテルを経静脈的なアプローチにより副腎に導入し、エタノール噴射による副腎腫瘍のケミカルアブレーション治療を行うことが考えられる。 In order to solve such a problem, it is conceivable to introduce a balloon catheter into the adrenal gland by a intravenous approach and perform chemical ablation treatment of adrenal tumor by ethanol injection.
　しかしながら、ＰＴＣＡなどに使用されている従来公知のバルーンカテーテルは、シャフトの剛性が高くて柔軟性に劣るために複雑な血管形状に追従することができず、副腎に導入する操作はきわめて困難である。 However, conventionally known balloon catheters used for PTCA and the like have a high shaft rigidity and are not flexible enough to follow a complicated blood vessel shape, and are difficult to introduce into the adrenal gland. .
　ところで、副腎静脈の末端側は３本の支脈（内側上行支、外側上行支、外側弧状支）に分岐している。このため、副腎腫瘍のケミカルアブレーション治療を行う場合には、支脈ごとに採血し、異常（アルドステロンの過剰分泌）が認められた支脈の腫瘍に対してのみ治療を行うことが望ましい。
　しかしながら、ＰＴＣＡなどに使用されている従来公知のバルーンカテーテルは、支脈の径より大きなシャフト径（アウターチューブの外径）を有しており、また、支脈の長さよりも長いバルーン長を有しているために、何れか１つの支脈に挿入して当該支脈をバル
ーンにより閉塞させることは不可能であり、従って、異常が認めらない支脈の部位に対してもケミカルアブレーション（エタノールとの接触）が行われてしまう。 By the way, the terminal side of the adrenal vein is branched into three branches (inner ascending branch, outer ascending branch, outer arc-shaped branch). For this reason, when performing chemical ablation treatment of adrenal tumors, it is desirable to collect blood for each branch and treat only the tumor of the branch where abnormalities (excessive secretion of aldosterone) are observed.
However, conventionally known balloon catheters used for PTCA and the like have a shaft diameter larger than the diameter of the branch (the outer diameter of the outer tube), and have a balloon length longer than the length of the branch. Therefore, it is impossible to insert into any one branch and close the branch with a balloon. Therefore, chemical ablation (contact with ethanol) is also applied to the branch where no abnormality is observed. Will be done.
　本発明は以上のような事情に基いてなされたものである。
　本発明の目的は、原発性アルドステロン症に対する新規な治療法である経静脈的なケミカルアブレーション治療に使用することができ、特に、異常が認められた支脈の腫瘍に対してのみ治療を行うことのできるバルーンカテーテルを提供することにある。
　本発明の他の目的は、原発性アルドステロン症に対する経静脈的なアブレーション治療に使用することができ、特に、異常が認められた支脈の腫瘍に対してのみ治療を行うことのできるケミカルアブレーション治療装置を提供することにある。
　本発明の更に他の目的は、治療前後における副腎静脈採血を支脈ごとに行うことができる副腎静脈採血装置を提供することにある。 The present invention has been made based on the above situation.
The object of the present invention can be used for intravenous chemical ablation treatment, which is a novel treatment method for primary aldosteronism, and in particular, it is possible to treat only a tumor of a branch vein in which an abnormality is observed. An object of the present invention is to provide a balloon catheter that can be used.
Another object of the present invention is a chemical ablation treatment apparatus which can be used for intravenous ablation treatment for primary aldosteronism, and in particular, can treat only a tumor of a branch vein in which an abnormality is observed. Is to provide.
Still another object of the present invention is to provide an adrenal venous blood collection device capable of collecting adrenal venous blood before and after treatment for each branch.
（１）本発明のバルーンカテーテルは、経静脈的アプローチにより副腎に導入されて副腎静脈採血または副腎腫瘍のケミカルアブレーション治療に使用されるオーバーザワイヤ型のバルーンカテーテルであって、
　ガイドワイヤルーメンを有するインナーチューブと、前記インナーチューブの外側に配置されて拡張ルーメンを形成するアウターチューブと、前記アウターチューブの先端に装着されて前記インナーチューブの外側に配置されたバルーンと、前記ガイドワイヤルーメンに連通するガイドワイヤポートおよび前記拡張ルーメンに連通する拡張ポートを有するコネクタとを有し、
　前記アウターチューブは、硬度が７２Ｄ以上である基端側高硬度部分と、硬度が２５Ｄ以上７２Ｄ未満である先端側低硬度部分とからなり、
　前記アウターチューブの外径が０．７０～１．２０ｍｍであり、
　前記バルーンの長さが０．５～５ｍｍであることを特徴とする。 (1) The balloon catheter of the present invention is an over-the-wire balloon catheter that is introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of an adrenal tumor,
An inner tube having a guide wire lumen; an outer tube disposed outside the inner tube to form an expansion lumen; a balloon mounted on a distal end of the outer tube and disposed outside the inner tube; and the guide A guide wire port communicating with the wire lumen and a connector having an expansion port communicating with the expansion lumen;
The outer tube is composed of a proximal-side high hardness portion having a hardness of 72D or more and a distal-side low hardness portion having a hardness of 25D or more and less than 72D,
The outer diameter of the outer tube is 0.70 to 1.20 mm;
The balloon has a length of 0.5 to 5 mm.
　このような構成のバルーンカテーテルによれば、原発性アルドステロン症に対して侵襲性の低い経静脈的なアブレーション治療を行うことができる。 According to the balloon catheter having such a configuration, a less invasive transvenous ablation treatment can be performed for primary aldosteronism.
　また、アウターチューブの先端側低硬度部分は、硬度が低いことにより柔軟性を有するので、この先端側低硬度部分を副腎に至る複雑な血管形状に追従（血管内を通過）させることができ、その先端に装着されたバルーンを副腎の目的部位に到達させることができる。
　なお、本発明のバルーンカテーテルは、ＰＴＣＡに使用される従来公知のバルーンカテーテルとは異なり、狭窄部などを挿通させる必要はないので、アウターチューブの先端側低硬度部分が低硬度（２５Ｄ以上７２Ｄ未満）であっても問題はない。 In addition, the distal-side low hardness part of the outer tube has flexibility due to its low hardness, so that the distal-side low hardness part can follow (pass through the blood vessel) the complex blood vessel shape that reaches the adrenal gland, The balloon attached to the tip can reach the target site of the adrenal gland.
The balloon catheter according to the present invention does not need to be inserted through a stenosis or the like unlike a conventionally known balloon catheter used for PTCA, so that the low hardness portion on the distal end side of the outer tube has a low hardness (25D or more and less than 72D). ) Is no problem.
　また、アウターチューブの外径が、ＰＴＣＡなどに使用されている従来公知のバルーンカテーテルのシャフト径（アウターチューブの外径）と比較して小さく、これにより、３本の支脈の各々に本発明のバルーンカテーテルを挿入することが可能となる。 Further, the outer diameter of the outer tube is smaller than the shaft diameter of the conventionally known balloon catheter used in PTCA or the like (the outer diameter of the outer tube). A balloon catheter can be inserted.
　また、バルーンの長さが、ＰＴＣＡなどに使用される従来公知のバルーンカテーテルのバルーンの長さと比較して短く、これにより、本発明のバルーンカテーテルが挿入されている支脈を確実にオクリュージョン（閉塞）することができる。 Further, the length of the balloon is shorter than the length of the balloon of a conventionally known balloon catheter used for PTCA or the like, so that the branch in which the balloon catheter of the present invention is inserted can be reliably occluded ( Can be occluded).
（２）本発明のバルーンカテーテルにおいて、前記先端側低硬度部分の長さが２０～１５０ｍｍであることが好ましく、特に、左副腎用のバルーンカテーテルにおける前記先端側低硬度部分の長さが１００～１５０ｍｍであり、右副腎用のバルーンカテーテルにおける前記先端側低硬度部分の長さが５０～１００ｍｍであることが好ましい。 (2) In the balloon catheter of the present invention, the length of the distal-side low hardness portion is preferably 20 to 150 mm, and particularly the length of the distal-side low hardness portion of the balloon catheter for the left adrenal gland is 100 to It is preferably 150 mm, and the length of the distal-side low hardness portion in the balloon catheter for the right adrenal gland is preferably 50 to 100 mm.
（３）本発明のバルーンカテーテルにおいて、前記先端側低硬度部分は、先端方向に向かって傾斜的または段階的に硬度が低下している部分を有していることが好ましい。 (3) In the balloon catheter of the present invention, it is preferable that the distal-side low-hardness portion has a portion whose hardness decreases in an inclined or stepwise manner toward the distal direction.
　このような構成のバルーンカテーテルによれば、先端側低硬度部分の剛性を先端方向に向かって連続的または断続的に低下させる（柔軟性を向上させる）ことができ、これにより、バルーンカテーテルを副腎へ導入する際の操作性を更に優れたものとすることができる。 According to the balloon catheter having such a configuration, the rigidity of the distal-side low-hardness portion can be continuously or intermittently reduced (improved in flexibility) toward the distal direction, whereby the balloon catheter can be reduced to the adrenal gland. The operability at the time of introduction into can be further improved.
（４）本発明のバルーンカテーテルにおいて、前記先端側低硬度部分は、先端方向に向かって傾斜的に硬度が低下している硬度傾斜部と、前記硬度傾斜部の先端側に位置し、前記先端側低硬度部分の中で最も低い一定の硬度を有する最先端部とからなることが好ましい。 (4) In the balloon catheter of the present invention, the distal-side low-hardness portion is located on the distal end side of the hardness inclined portion, the hardness inclined portion in which the hardness is gradually decreased toward the distal direction, and the distal end It is preferable that it consists of the most advanced part having the lowest constant hardness in the side low hardness part.
　このような構成のバルーンカテーテルによれば、基端側高硬度部分と、先端側低硬度部分の最先端部との間に、先端側低硬度部分の硬度傾斜部が介在することにより、基端側高硬度部分と先端側低硬度部分との境界で硬度が急激に変化することはないので、当該境界においてキンクなどが発生しない。この結果、本発明のバルーンカテーテルを副腎へ導入する際の操作性を特に優れたものとすることができる。 According to the balloon catheter having such a configuration, the proximal end is provided with the hardness inclined portion of the distal-side low-hardness portion between the proximal-side high-hardness portion and the distal-end portion of the distal-side low-hardness portion. Since the hardness does not change abruptly at the boundary between the side high hardness portion and the tip side low hardness portion, no kink or the like occurs at the boundary. As a result, the operability when introducing the balloon catheter of the present invention into the adrenal gland can be made particularly excellent.
（５）本発明のバルーンカテーテルにおいて、少なくとも前記アウターチューブの先端よりも先端側に位置する部分における前記インナーチューブの硬度が４０Ｄ以下であることが好ましい。 (5) In the balloon catheter of the present invention, it is preferable that the hardness of the inner tube is 40D or less at least in a portion located on the distal side of the outer tube.
（６）本発明のバルーンカテーテルにおいて、前記インナーチューブは、内層と外層との二層構成であり、前記内層が耐エタノール性の樹脂により構成されていることが好ましい。 (6) In the balloon catheter of the present invention, it is preferable that the inner tube has a two-layer structure of an inner layer and an outer layer, and the inner layer is made of an ethanol-resistant resin.
　このような構成のバルーンカテーテルによれば、インナーチューブの構成樹脂がエタノールに浸食されて膨潤することによりガイドワイヤの移動が困難となったり、エタノールの流路が閉塞されたりすることを防止することができる。 According to the balloon catheter having such a configuration, the resin of the inner tube is eroded and swollen by ethanol, thereby preventing the movement of the guide wire and blocking the ethanol flow path. Can do.
（７）本発明のケミカルアブレーション治療装置は、本発明のバルーンカテーテルと、
　前記コネクタのガイドワイヤポートに接続されたエタノールの供給手段と、
　前記バルーンカテーテルの先端部を副腎に案内するためのガイディングカテーテルと
　を備えてなることを特徴とする。 (7) The chemical ablation treatment apparatus of the present invention includes the balloon catheter of the present invention,
Ethanol supply means connected to the guide wire port of the connector;
And a guiding catheter for guiding the distal end portion of the balloon catheter to the adrenal gland.
（８）本発明の副腎静脈採血装置は、本発明のバルーンカテーテルと、
　前記コネクタのガイドワイヤポートに接続された血液の吸引手段と、
　前記バルーンカテーテルの先端部を副腎に案内するためのガイディングカテーテルと
　を備えてなることを特徴とする。 (8) The adrenal vein blood collection device of the present invention comprises the balloon catheter of the present invention,
Blood suction means connected to the guide wire port of the connector;
And a guiding catheter for guiding the distal end portion of the balloon catheter to the adrenal gland.
　本発明のバルーンカテーテルを使用することにより、原発性アルドステロン症に対する新規な治療法である経静脈的なケミカルアブレーション治療を確実に行うことができる。
　特に、異常が認められた支脈の腫瘍に対してのみ治療することができ、異常が認められない他の支脈に係る部位に対してアブレーションすることを回避することができる。
　また、本発明のバルーンカテーテルを使用することにより、治療前後における副腎静脈採血を支脈ごとに行うことができる。 By using the balloon catheter of the present invention, a transvenous chemical ablation treatment that is a novel treatment method for primary aldosteronism can be reliably performed.
In particular, it is possible to treat only a tumor of a branch that has an abnormality, and it is possible to avoid ablation of a site related to another branch that has no abnormality.
In addition, by using the balloon catheter of the present invention, adrenal vein blood collection before and after treatment can be performed for each branch.
　本発明のケミカルアブレーション治療装置によれば、原発性アルドステロン症に対する経静脈的なアブレーション治療を確実に行うことができる。
　特に、異常が認められた支脈の腫瘍に対してのみ治療することができ、異常が認められない他の支脈に係る部位に対してアブレーションすることを回避することができる。 According to the chemical ablation treatment apparatus of the present invention, transvenous ablation treatment for primary aldosteronism can be reliably performed.
In particular, it is possible to treat only a tumor of a branch that has an abnormality, and it is possible to avoid ablation of a site related to another branch that has no abnormality.
　本発明の副腎静脈採血装置によれば、治療前後における副腎静脈採血を支脈ごとに行うことができる。 According to the adrenal vein blood collection device of the present invention, adrenal vein blood collection before and after treatment can be performed for each branch.
本発明の第１実施形態に係るバルーンカテーテルを示す側面図である。It is a side view which shows the balloon catheter which concerns on 1st Embodiment of this invention. 本発明の第１実施形態に係るバルーンカテーテルを示す側面図（寸法を説明するための図）である。It is a side view (figure for explaining a size) which shows a balloon catheter concerning a 1st embodiment of the present invention. 図１の部分拡大図（II部詳細図）である。FIG. 2 is a partially enlarged view (part II detail view) of FIG. 1. 図２の III－III 断面図である。FIG. 3 is a cross-sectional view taken along the line III-III in FIG. 図１の部分拡大断面図（IV－IV断面図）である。FIG. 4 is a partially enlarged sectional view (IV-IV sectional view) of FIG. 1. 図１に示したバルーンカテーテルのアウターチューブの硬度変化を示す説明図である。It is explanatory drawing which shows the hardness change of the outer tube of the balloon catheter shown in FIG. 本発明のケミカルアブレーション治療装置の構成を模式的に示す説明図である。It is explanatory drawing which shows typically the structure of the chemical ablation treatment apparatus of this invention. 本発明の副腎静脈採血装置の構成を模式的に示す説明図である。It is explanatory drawing which shows typically the structure of the adrenal vein blood collection apparatus of this invention. 本発明のケミカルアブレーション治療装置または副腎静脈採血装置を構成する右副腎用のガイディングカテーテルの形状を示す説明図である。It is explanatory drawing which shows the shape of the guiding catheter for right adrenals which comprises the chemical ablation treatment apparatus or adrenal vein blood-collecting apparatus of this invention. 本発明のケミカルアブレーション治療装置または副腎静脈採血装置を構成する左副腎用のガイディングカテーテルの形状を示す説明図である。It is explanatory drawing which shows the shape of the guiding catheter for left adrenals which comprises the chemical ablation treatment apparatus or adrenal vein blood-collecting apparatus of this invention. 図８Ａに示すガイディングカテーテルの先端を右副腎に到達させた状態を示す説明図である。It is explanatory drawing which shows the state which made the front-end | tip of the guiding catheter shown to FIG. 8A reach the right adrenal gland. 図８Ｂに示すガイディングカテーテルの先端を左副腎に到達させた状態を示す説明図である。It is explanatory drawing which shows the state which made the front end of the guiding catheter shown to FIG. 8B reach the left adrenal gland.
＜バルーンカテーテル＞
　図１（図１Ａ，図１Ｂ）～図４に示すこの実施形態のバルーンカテーテル１００は、経静脈的アプローチにより副腎に導入されて副腎静脈採血または副腎腫瘍のケミカルアブレーション治療に使用されるオーバーザワイヤ型のバルーンカテーテルである。 <Balloon catheter>
The balloon catheter 100 of this embodiment shown in FIG. 1 (FIGS. 1A and 1B) to FIG. 4 is an over-the-wire type that is introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of adrenal tumors. This is a balloon catheter.
　この実施形態のバルーンカテーテル１００は、ガイドワイヤルーメン２１を有するインナーチューブ１０と、インナーチューブ１０の外側に配置されて拡張ルーメン２３を形成するアウターチューブ３０と、アウターチューブ３０の先端に装着されてインナーチューブ１０の外側に配置されたバルーン５０と、ガイドワイヤルーメン２１に連通するガイドワイヤポート７１および拡張ルーメン２３に連通する拡張ポート７３を有するＹ字コネクタ７０とを有し、アウターチューブ３０は、硬度が７２Ｄ以上である基端側高硬度部分３０１と、硬度が２５Ｄ以上７２Ｄ未満である先端側低硬度部分３０２とからなり、アウターチューブ３０の外径が０．７０～１．２０ｍｍであり、バルーン５０の長さ（Ｌ５０）が０．５～５ｍｍである。 The balloon catheter 100 of this embodiment includes an inner tube 10 having a guide wire lumen 21, an outer tube 30 disposed outside the inner tube 10 to form an expansion lumen 23, and an inner tube attached to the distal end of the outer tube 30. A balloon 50 disposed outside the tube 10, a Y-connector 70 having a guide wire port 71 communicating with the guide wire lumen 21 and an expansion port 73 communicating with the expansion lumen 23, and the outer tube 30 has hardness Is composed of a proximal-side high hardness portion 301 having a hardness of 72D or more and a distal-side low hardness portion 302 having a hardness of 25D or more and less than 72D, and the outer diameter of the outer tube 30 is 0.70 to 1.20 mm. The length 50 (L50) is 0.5 to 5 mm.
　バルーンカテーテル１００を構成するインナーチューブ１０は、ガイドワイヤ（図示省略）を挿通可能な内径のガイドワイヤルーメン２１を有している。
　このガイドワイヤルーメン２１は、ガイドワイヤの挿通路となるとともに、アブレーション用の薬液であるエタノールの流路となる。 The inner tube 10 constituting the balloon catheter 100 has a guide wire lumen 21 having an inner diameter through which a guide wire (not shown) can be inserted.
The guide wire lumen 21 serves as a guide wire insertion passage and a flow path for ethanol, which is a chemical solution for ablation.
　図２および図３に示すように、バルーン５０の内部におけるインナーチューブ１０の外周には造影マーカー４０が装着されている。 2 and 3, a contrast marker 40 is attached to the outer periphery of the inner tube 10 inside the balloon 50.
　図４に示すように、インナーチューブ１０は、内層１１と外層１３との二層構成の樹脂チューブにより構成されている。 As shown in FIG. 4, the inner tube 10 is constituted by a resin tube having a two-layer structure of an inner layer 11 and an outer layer 13.
　インナーチューブ１０を構成する内層１１は耐エタノール性の樹脂によって形成されている。ここに、「耐エタノール性の樹脂」とは、エタノールに不溶で、エタノールと接触させたときに膨潤や変質などを起こしにくい樹脂をいう。
　そのような樹脂の具体例としては、ポリイミド、ＰＴＦＥやＰＦＡのようなフッ素樹脂、ゴム系樹脂、ポリエチレンなどを挙げることができ、これらのうちＰＴＦＥが好ましい。 The inner layer 11 constituting the inner tube 10 is formed of an ethanol resistant resin. Here, the “ethanol-resistant resin” refers to a resin that is insoluble in ethanol and hardly causes swelling or alteration when brought into contact with ethanol.
Specific examples of such a resin include polyimide, fluorine resin such as PTFE and PFA, rubber resin, polyethylene, and the like. Among these, PTFE is preferable.
　インナーチューブ１０の内層１１が耐エタノール性の樹脂によって形成されていることにより、インナーチューブ１０の構成樹脂（内層１１および外層１３）がエタノールに浸食されて膨潤するようなことはなく、バルーンカテーテル１００の使用中にガイドワイヤの移動が困難となったり、エタノールの流路が閉塞されたりすることを確実に防止することができる。 Since the inner layer 11 of the inner tube 10 is formed of an ethanol-resistant resin, the constituent resins (the inner layer 11 and the outer layer 13) of the inner tube 10 are not eroded and swollen by ethanol, and the balloon catheter 100 Thus, it is possible to reliably prevent the guide wire from moving during use and the ethanol flow path from being blocked.
　インナーチューブ１０の内層１１の厚さは０．０１～０．０５ｍｍであることが好ましく、好適な一例を示せば０．０１ｍｍである。 The thickness of the inner layer 11 of the inner tube 10 is preferably 0.01 to 0.05 mm, and 0.01 mm is a suitable example.
　インナーチューブ１０を構成する外層１３を形成する樹脂としては、従来公知のバルーンカテーテルのインナーチューブを構成する樹脂を使用することができ、例えば、ポリオレフィン、ポリアミド、ポリエーテルポリアミド、ポリウレタン、ナイロン、ＰＥＢＡＸ（登録商標）（ポリエーテルブロックアミド共重合体）などの合成樹脂を挙げることができ、これらのうち、ＰＥＢＡＸが好ましい。 As a resin for forming the outer layer 13 constituting the inner tube 10, a resin constituting the inner tube of a conventionally known balloon catheter can be used. For example, polyolefin, polyamide, polyether polyamide, polyurethane, nylon, PEBAX ( (Registered trademark) (polyether block amide copolymer) and the like, and among these, PEBAX is preferable.
　インナーチューブ１０の外層１３の厚さは０．０５～０．１５ｍｍであることが好ましく、好適な一例を示せば０．０６ｍｍである。 The thickness of the outer layer 13 of the inner tube 10 is preferably 0.05 to 0.15 mm, and 0.06 mm as a suitable example.
　インナーチューブ１０の硬度（外層１３を構成する樹脂の硬度）は４０Ｄ以下であることが好ましく、好適な一例を示せば２５Ｄとされる。
　なお、本実施形態では、インナーチューブ１０の硬度は全長にわたり同じである（同じ硬度の樹脂でインナーチューブ１０の外層１３が形成されている）が、長さ方向に沿って硬度の異なる樹脂を使用してインナーチューブ（二層構成の場合には外層）を形成してもよい。 The hardness of the inner tube 10 (the hardness of the resin constituting the outer layer 13) is preferably 40D or less, and is 25D if a suitable example is shown.
In this embodiment, the hardness of the inner tube 10 is the same over the entire length (the outer layer 13 of the inner tube 10 is formed of the same hardness resin), but resins having different hardness along the length direction are used. Then, an inner tube (an outer layer in the case of a two-layer structure) may be formed.
　何れの場合においても、少なくともアウターチューブ３０の先端より先端側に位置する部分におけるインナーチューブの硬度は４０Ｄ以下であることが好ましく、これにより、分岐した細血管である副腎静脈支流までバルーン５０を送達することが可能になる。 In any case, it is preferable that the hardness of the inner tube at least in a portion located on the distal side from the distal end of the outer tube 30 is 40 D or less, and thereby the balloon 50 is delivered to the adrenal vein tributary which is a branched small blood vessel. It becomes possible to do.
　インナーチューブ１０の外径としては０．５５～０．７０ｍｍであることが好ましく、好適な一例を示せば０．５７ｍｍである。
　インナーチューブ１０の内径としては０．４０～０．５５ｍｍであることが好ましく、好適な一例を示せば０．４５ｍｍである。 The outer diameter of the inner tube 10 is preferably 0.55 to 0.70 mm, and a preferred example is 0.57 mm.
The inner diameter of the inner tube 10 is preferably 0.40 to 0.55 mm, and is 0.45 mm as a suitable example.
　インナーチューブ１０の先端には、先端チップ１５が装着されている。
　先端チップ１５は、例えば、単層の樹脂チューブから構成されている。　　　　　　　
　先端チップ１５を形成する樹脂としては、例えば、インナーチューブ１０の外層１３の
構成樹脂と同一の樹脂を挙げることができ、それらのうち、ＰＥＢＡＸが好ましい。 A tip 15 is attached to the tip of the inner tube 10.
The tip chip 15 is composed of, for example, a single layer resin tube.
As resin which forms the front-end | tip chip | tip 15, the resin same as the constituent resin of the outer layer 13 of the inner tube 10 can be mentioned, for example, Of these, PEBAX is preferable.
　先端チップ１５の硬度（構成する樹脂の硬度）は５５Ｄ以下であることが好ましく、好適な一例を示せば４０Ｄとされる。
　先端チップ１５の外径および内径は、インナーチューブ１０の外径および内径と同一である。先端チップ１５の長さ（Ｌ１５）は０．３～３．０ｍｍであることが好ましく、好適な一例を示せば１ｍｍである。 The hardness of the tip 15 (the hardness of the constituent resin) is preferably 55D or less, and is 40D if a suitable example is shown.
The outer diameter and inner diameter of the distal tip 15 are the same as the outer diameter and inner diameter of the inner tube 10. The length (L15) of the tip 15 is preferably 0.3 to 3.0 mm, and is 1 mm as a suitable example.
　バルーンカテーテル１００を構成するアウターチューブ３０は、インナーチューブ１０の外側に、バルーン５０を拡張させるための流体流路となる拡張ルーメン２３を形成する。ここに、拡張ルーメン２３に供給される流体としては生理食塩水を例示することができる。 The outer tube 30 constituting the balloon catheter 100 forms an expansion lumen 23 serving as a fluid flow path for expanding the balloon 50 outside the inner tube 10. Here, a physiological saline can be exemplified as the fluid supplied to the expansion lumen 23.
　図１に示すように、アウターチューブ３０は、基端側高硬度部分３０１と、先端側低硬度部分３０２とからなる。
　また、図４に示すように、アウターチューブ３０は、内層３１と、内層３１の外周に積層形成された外層３３との二層構成の樹脂チューブである。 As shown in FIG. 1, the outer tube 30 includes a proximal end side high hardness portion 301 and a distal end side low hardness portion 302.
As shown in FIG. 4, the outer tube 30 is a resin tube having a two-layer structure including an inner layer 31 and an outer layer 33 formed on the outer periphery of the inner layer 31.
　アウターチューブ３０の内層３１を構成する樹脂としては、ポリテトラフルオロエチレン（ＰＴＦＥ）、ポリフッ化ビニリデンおよびポリエーテルエーテルケトン（ＰＥＥＫ）、ＰＦＡ、フッ化エチレンプロピレン（ＦＥＰ）、ポリエチレン（ＰＥ）、ポリプロピレン（ＰＰ）、ポリアミド（ＰＡ）、ポリアミドエラストマー（ＰＡＥ）などを挙げることができ、これらのうち、ＰＴＦＥが好ましい。 Examples of the resin constituting the inner layer 31 of the outer tube 30 include polytetrafluoroethylene (PTFE), polyvinylidene fluoride and polyether ether ketone (PEEK), PFA, fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene ( PP), polyamide (PA), polyamide elastomer (PAE) and the like can be mentioned, and among these, PTFE is preferable.
　アウターチューブ３０の内層３１の厚さは０．０１～０．０５ｍｍであることが好ましく、好適な一例を示せば０．０３ｍｍである。 The thickness of the inner layer 31 of the outer tube 30 is preferably 0.01 to 0.05 mm, and 0.03 mm if a suitable example is shown.
　アウターチューブ３０の外層３３は、樹脂の内部に編組３５が埋設されてなる編組チューブ（ブレードチューブ）である。 The outer layer 33 of the outer tube 30 is a braided tube (blade tube) in which a braid 35 is embedded in a resin.
　アウターチューブ３０の外層３３を構成する樹脂としては、インナーチューブ１０の外層１３を構成するものとして例示した樹脂を挙げることができ、それらのうちＰＥＢＡＸが好ましい。 Examples of the resin constituting the outer layer 33 of the outer tube 30 include the resins exemplified as those constituting the outer layer 13 of the inner tube 10, and among them, PEBAX is preferable.
　外層３３を構成する樹脂中に埋設された編組３５は、ステンレスなどの金属素線を編み込むことにより形成され、アウターチューブ３０の全長にわたり配置されている。 The braid 35 embedded in the resin constituting the outer layer 33 is formed by braiding a metal wire such as stainless steel, and is arranged over the entire length of the outer tube 30.
　アウターチューブ３０の外層３３の厚さは０．０５～０．３０ｍｍであることが好ましく、好適な一例を示せば０．０８ｍｍである。 The thickness of the outer layer 33 of the outer tube 30 is preferably 0.05 to 0.30 mm, and 0.08 mm as a suitable example.
　バルーンカテーテル１００の有効長（Ｌ１００）としては８００～１５００ｍｍであることが好ましく、好適な一例を示せば９５０ｍｍである。
　アウターチューブ３０の長さ（Ｌ３０）としては７５０～１４９０ｍｍであることが好ましく、好適な一例を示せば９４０ｍｍである。 The effective length (L100) of the balloon catheter 100 is preferably 800 to 1500 mm, and 950 mm as a suitable example.
The length (L30) of the outer tube 30 is preferably 750 to 1490 mm, and is 940 mm as a suitable example.
　アウターチューブ３０の基端側高硬度部分３０１の長さ（Ｌ３０１）としては６００～１４５０ｍｍであることが好ましく、好適な一例を示せば８００ｍｍである。 The length (L301) of the base end side high hardness portion 301 of the outer tube 30 is preferably 600 to 1450 mm, and is 800 mm if a suitable example is shown.
　基端側高硬度部分３０１の硬度（当該部分の外層を構成する樹脂の硬度）は７２Ｄ以上とされ、好適な一例を示せば７２Ｄとされる。
　なお、基端側高硬度部分３０１の硬度は、ぞの全長にわたり同一であっても、長さ方向に変化していてもよい。 The hardness of the base end side high hardness portion 301 (the hardness of the resin constituting the outer layer of the portion) is 72D or more, and 72D is shown as a suitable example.
Note that the hardness of the base-side high hardness portion 301 may be the same over the entire length or may change in the length direction.
　先端側低硬度部分３０２の硬度は２５Ｄ以上７２Ｄ未満である。
　アウターチューブ３０の先端側低硬度部分３０２は、先端方向に向かって傾斜的に硬度が低下している硬度傾斜部３０４と、硬度傾斜部３０４の先端側に位置し、先端側低硬度部分３０２の中で最も低い一定の硬度を有する最先端部３０６とからなる。
　最先端部３０６の硬度（当該部分の外層を構成する樹脂の硬度）の一例を示せば２５Ｄである。 The hardness of the tip-side low hardness portion 302 is 25D or more and less than 72D.
The distal-side low-hardness portion 302 of the outer tube 30 is positioned on the distal end side of the hardness-gradient portion 304, the hardness-gradient portion 304 whose hardness decreases in the direction of the distal end, and the distal-side low-hardness portion 302. It consists of the most advanced portion 306 having the lowest constant hardness.
An example of the hardness of the most advanced portion 306 (the hardness of the resin constituting the outer layer of the portion) is 25D.
　図５に示すように、基端側高硬度部分３０１の硬度が７２Ｄであり、先端側低硬度部分３０２の最先端部３０６の硬度が２５Ｄである場合において、硬度傾斜部３０４の硬度（当該部分の外層を構成する樹脂の硬度）は、先端方向に向かって、７２Ｄから２５Ｄまで傾斜的に低下している。 As shown in FIG. 5, when the hardness of the proximal-side high hardness portion 301 is 72D and the hardness of the most distal portion 306 of the distal-side low hardness portion 302 is 25D, the hardness of the hardness inclined portion 304 (the portion concerned) The hardness of the resin constituting the outer layer of the outer layer is inclined from 72D to 25D in the direction of the tip.
　ここに、硬度傾斜部３０４の硬度を傾斜的に低下させる方法としては、特に限定されるものではないが、例えば、高硬度（例えば７２Ｄ）の樹脂材料と低硬度（例えば２５Ｄ）の樹脂材料とを使用して押出成形する際に、両者の配合比率を長さ方向に沿って変化させる方法を挙げることができる。 Here, the method of decreasing the hardness of the hardness inclined portion 304 is not particularly limited. For example, a resin material having a high hardness (for example, 72D) and a resin material having a low hardness (for example, 25D) can be used. A method of changing the blending ratio of the two along the length direction can be mentioned when extrusion molding is performed.
　このような先端側低硬度部分３０２は、最先端部３０６の硬度が低いことによって柔軟性を有し、副腎に至る複雑な血管形状（急なカーブ形状を含む）に追従させることができる。
　また、基端側高硬度部分３０１と、先端側低硬度部分３０２の最先端部３０６との間に、先端側低硬度部分３０２の硬度傾斜部３０４が介在することにより、基端側高硬度部分３０１と先端側低硬度部分３０２との境界で硬度が急激に変化するようなことはないので、当該境界においてキンクなどが発生しない。この結果、本実施形態のバルーンカテーテル１００を副腎へ導入する際の操作性を特に優れたものとすることができる。 Such a distal-side low hardness portion 302 has flexibility due to the low hardness of the most distal portion 306, and can follow a complicated blood vessel shape (including a sharp curve shape) that reaches the adrenal gland.
Further, the hardness inclined portion 304 of the distal end side low hardness portion 302 is interposed between the proximal end side high hardness portion 301 and the distal end portion 306 of the distal end side low hardness portion 302, whereby the proximal end side high hardness portion Since the hardness does not change abruptly at the boundary between 301 and the tip-side low hardness portion 302, no kink or the like occurs at the boundary. As a result, the operability when introducing the balloon catheter 100 of this embodiment into the adrenal gland can be made particularly excellent.
　アウターチューブ３０の先端側低硬度部分３０２の長さ（Ｌ３０２）としては２０～１５０ｍｍであることが好ましい。
　特に、左副腎用のバルーンカテーテルを構成する場合には１００～１５０ｍｍであることが好ましく、左副腎用である場合の好適な一例を示せば１３０ｍｍである。
　また、右副腎用のバルーンカテーテルを構成する場合には５０～１００ｍｍであることが好ましく、右副腎用である場合の好適な一例を示せば８０ｍｍである。 The length (L302) of the distal-side low hardness portion 302 of the outer tube 30 is preferably 20 to 150 mm.
In particular, it is preferably 100 to 150 mm when a balloon catheter for the left adrenal gland is configured, and 130 mm is a suitable example for the left adrenal gland.
In the case of constructing a balloon catheter for the right adrenal gland, it is preferably 50 to 100 mm, and 80 mm is shown as a suitable example for the right adrenal gland.
　先端側低硬度部分３０２の硬度傾斜部３０４の長さ（Ｌ３０４）としては、左副腎用のバルーンカテーテルを構成する場合には９０～１２０ｍｍであることが好ましく、好適な一例を示せば１００ｍｍである。また、右副腎用のバルーンカテーテルを構成する場合には２０～９０ｍｍであることが好ましく、好適な一例を示せば６０ｍｍである。 The length (L304) of the hardness inclined portion 304 of the distal-side low-hardness portion 302 is preferably 90 to 120 mm when a left adrenal balloon catheter is constructed, and is 100 mm if a suitable example is shown. . In the case of constructing a balloon catheter for the right adrenal gland, it is preferably 20 to 90 mm, and 60 mm is a preferable example.
　先端側低硬度部分３０２の最先端部３０６の長さ（Ｌ３０６）としては１０～３０ｍｍであることが好ましく、好適な一例を示せば２０ｍｍである。 The length (L306) of the most distal end portion 306 of the tip-side low hardness portion 302 is preferably 10 to 30 mm, and 20 mm is a preferable example.
　アウターチューブ３０の外径としては０．７０～１．２０ｍｍとされ、好ましくは０．８０～１．００ｍｍ、好適な一例を示せば０．８５ｍｍである。
　アウターチューブ３０の内径としては０．６０～０．８０ｍｍであることが好ましく、好適な一例を示せば０．６９ｍｍである。 The outer diameter of the outer tube 30 is 0.70 to 1.20 mm, preferably 0.80 to 1.00 mm, and 0.85 mm if a suitable example is shown.
The inner diameter of the outer tube 30 is preferably 0.60 to 0.80 mm, and a suitable example is 0.69 mm.
　上記のような小さい外径を有するアウターチューブ３０によって構成される本実施形態
のバルーンカテーテル１００によれば、副腎静脈における３本の支脈の各々に挿入することが可能となる。 According to the balloon catheter 100 of the present embodiment configured by the outer tube 30 having a small outer diameter as described above, it can be inserted into each of the three branches in the adrenal vein.
　アウターチューブ３０の外径が１．２０ｍｍを超えると、副腎静脈の支脈に挿入することが不可能またはきわめて困難となる。他方、アウターチューブ３０の外径が０．７０ｍｍ未満であると、バルーン拡張用のルーメンの流路を十分に確保できなくなる。 If the outer diameter of the outer tube 30 exceeds 1.20 mm, it becomes impossible or extremely difficult to insert into the branch of the adrenal vein. On the other hand, when the outer diameter of the outer tube 30 is less than 0.70 mm, it is impossible to secure a sufficient flow path for the lumen for balloon expansion.
　バルーンカテーテル１００を構成するバルーン５０は、アウターチューブ３０の先端に装着されて、アウターチューブ３０の先端から延び出ているインナーチューブ１０の外側に配置されている。 The balloon 50 constituting the balloon catheter 100 is mounted on the distal end of the outer tube 30 and is disposed outside the inner tube 10 extending from the distal end of the outer tube 30.
　バルーンカテーテル１００を構成するバルーン５０の構成材料としては、従来公知のバルーンカテーテルを構成するバルーンと同一のものを使用することができ、好適な材料としてＰＥＢＡＸを挙げることができる。 As the constituent material of the balloon 50 constituting the balloon catheter 100, the same material as that of the conventionally known balloon catheter can be used, and PEBAX can be cited as a suitable material.
　バルーン５０の硬度（構成する樹脂の硬度）は４０Ｄ～７０Ｄであることが好ましく、好適な一例を示せば７０Ｄとされる。 The hardness of the balloon 50 (the hardness of the constituent resin) is preferably 40D to 70D, and 70D is shown as a suitable example.
　バルーン５０の拡張時における直径としては１～３ｍｍであることが好ましく、好適な一例を示せば２．５ｍｍである。
　バルーン５０の長さ（Ｌ５０）としては０．５～５ｍｍとされ、好ましくは０．５～３．０ｍｍ、好適な一例を示せば１．０ｍｍとされる。 The diameter of the balloon 50 at the time of expansion is preferably 1 to 3 mm, and a suitable example is 2.5 mm.
The length (L50) of the balloon 50 is 0.5 to 5 mm, preferably 0.5 to 3.0 mm, and 1.0 mm if a suitable example is shown.
　このような短い長さ（Ｌ５０）を有するバルーン５０によれば、本実施形態のバルーンカテーテル１００が挿入されている支脈を確実にオクリュージョン（閉塞）することができる。 According to the balloon 50 having such a short length (L50), the branch in which the balloon catheter 100 of this embodiment is inserted can be reliably occluded.
　５ｍｍを超える長さのバルーンによっては、何れかの支脈に挿入させたとしても、これを拡張させる際に、当該バルーンが支脈に分岐する手前（基端側）の位置まで後退し、分岐前の副腎静脈をオクリュージョンすることになり、支脈ごとの副腎静脈採血や異常が認められた支脈の腫瘍に対してのみの治療を行うことができない。
　他方、０．５ｍｍ未満の長さのバルーンによっては、支脈に挿入して、これを拡張させても、バルーンの外壁と血管内壁の接触領域を十分に確保することができないために位置ずれが生じるなどのおそれがあり、副腎静脈を確実にオクリュージョンすることができない。 Depending on the length of the balloon exceeding 5 mm, even if it is inserted into any branch, when it is expanded, the balloon retracts to a position just before (branch side) where the balloon branches to the branch. The adrenal vein is occluded, and it is not possible to perform treatment only for the tumor of the branch vein where blood is collected or abnormalities are observed for each branch.
On the other hand, some balloons with a length of less than 0.5 mm may be misaligned because the contact area between the outer wall of the balloon and the inner wall of the blood vessel cannot be sufficiently secured even if the balloon is inserted into the branch and expanded. The adrenal vein cannot be reliably occluded.
　バルーンカテーテル１００を構成するＹ字コネクタ７０は、ガイドワイヤルーメン２１に連通するガイドワイヤポート７１と、拡張ルーメン２３に連通する拡張ポート７３とを有している。図１において、７５はストレインリリーフである。 The Y-shaped connector 70 constituting the balloon catheter 100 has a guide wire port 71 that communicates with the guide wire lumen 21 and an expansion port 73 that communicates with the expansion lumen 23. In FIG. 1, 75 is a strain relief.
　この実施形態のバルーンカテーテル１００を副腎に導入する際には、Ｙ字コネクタ７０のガイドワイヤポート７１からガイドワイヤルーメン２１にガイドワイヤを挿入する。
　また、バルーンカテーテル１００を副腎に導入してガイドワイヤを抜去した後において、ガイドワイヤポート７１にエタノールの供給手段を接続することにより、ガイドワイヤルーメン２１に、アブレーション用の薬液であるエタノールを供給することができ、供給されたエタノールは、先端チップ１５の先端開口から目的部位に向けて噴射される。
　また、ガイドワイヤポート７１に血液の吸引手段を接続することにより、先端チップ１５の先端開口から血液を採取することができ、採取された血液は、ガイドワイヤルーメン２１を流通して、Ｙ字コネクタ７０のガイドワイヤポート７１から血液の吸引手段に採取される。 When the balloon catheter 100 of this embodiment is introduced into the adrenal gland, a guide wire is inserted into the guide wire lumen 21 from the guide wire port 71 of the Y-shaped connector 70.
In addition, after introducing the balloon catheter 100 into the adrenal gland and removing the guide wire, the ethanol supply means is connected to the guide wire port 71 to supply the guide wire lumen 21 with ethanol, which is a chemical solution for ablation. The supplied ethanol is jetted from the tip opening of the tip 15 toward the target site.
Further, by connecting blood suction means to the guide wire port 71, blood can be collected from the distal end opening of the distal tip 15 and the collected blood circulates through the guide wire lumen 21 to form a Y-shaped connector. The blood is collected from 70 guide wire ports 71 to blood suction means.
　この実施形態のバルーンカテーテル１００によれば、ガイドワイヤポート７１にエタノールの供給手段を接続して、後述するケミカルアブレーション治療装置に搭載することにより、原発性アルドステロン症に対する経静脈的なケミカルアブレーション治療を確実に行うことができる。 According to the balloon catheter 100 of this embodiment, an ethanol supply means is connected to the guide wire port 71 and mounted on a chemical ablation treatment apparatus to be described later, so that transvenous chemical ablation treatment for primary aldosteronism can be performed. It can be done reliably.
　また、バルーンカテーテル１００は、アウターチューブ３０の先端側低硬度部分３０２（特に最先端部３０６）が柔軟性を有するので、副腎に至るまでの複雑な血管（下大静脈および副腎静脈（左副腎の場合には、下大静脈、腎静脈および副腎静脈））の形状に当該先端側低硬度部分３０２を追従させることができ、また、先端側低硬度部分３０２が硬度傾斜部３０４と最先端部３０６とからなることにより、バルーンカテーテル１００を副腎へ導入する際の操作性を特に優れたものとすることができる。 In the balloon catheter 100, the distal-side low-hardness portion 302 (particularly the most advanced portion 306) of the outer tube 30 has flexibility, so that complex blood vessels (the inferior vena cava and adrenal vein (the left adrenal vein) of the left adrenal gland) are reached. In this case, the distal-side low-hardness portion 302 can follow the shape of the inferior vena cava, renal vein, and adrenal vein)). Therefore, the operability when introducing the balloon catheter 100 into the adrenal gland can be made particularly excellent.
　また、アウターチューブ３０の外径（いわゆるシャフト径）が小さくて、バルーン５０の長さ（Ｌ５０）も短いことから、副腎静脈の支脈の各々にバルーンカテーテル１００を挿入することができ、バルーン５０によって支脈を確実にオクリュージョン（閉塞）することができる。この結果、異常が認められた支脈の腫瘍に対してのみの治療（必要最小限の治療）することができ、異常が認められない他の支脈に係る部位に対してアブレーションすることを回避することができる。 Further, since the outer diameter of the outer tube 30 (so-called shaft diameter) is small and the length (L50) of the balloon 50 is short, the balloon catheter 100 can be inserted into each branch of the adrenal vein. The branch can be reliably occluded. As a result, it is possible to treat only the tumor of the branch that has an abnormality (minimum necessary treatment), and avoid ablation to the site related to another branch that has no abnormality. Can do.
　また、ガイドワイヤポート７１に血液の採取手段を接続して、後述する副腎静脈採血装置に搭載することにより、ケミカルアブレーション治療の前後における副腎静脈採血を支脈ごとに行うことができる。 Further, by connecting blood collecting means to the guide wire port 71 and mounting it on an adrenal vein blood collecting device described later, adrenal vein blood collection before and after chemical ablation treatment can be performed for each branch.
＜ケミカルアブレーション治療装置＞
　図６に示すケミカルアブレーション治療装置１０００は、上記実施形態のバルーンカテーテル１００と、このバルーンカテーテル１００を構成するＹ字コネクタ７０のガイドワイヤポート７１に接続されたエタノールの供給手段２００と、バルーンカテーテル１００の先端部を患者Ｐの副腎ＡＧに案内するためのガイディングカテーテル３００と、バルーンカテーテル１００を構成するＹ字コネクタ７０の拡張ポート７３に接続されたバルーンの拡張手段４００とを備えてなる。 <Chemical ablation treatment device>
The chemical ablation treatment apparatus 1000 shown in FIG. 6 includes the balloon catheter 100 of the above embodiment, the ethanol supply means 200 connected to the guide wire port 71 of the Y connector 70 constituting the balloon catheter 100, and the balloon catheter 100. A guiding catheter 300 for guiding the distal end of the catheter to the adrenal AG of the patient P and a balloon expansion means 400 connected to the expansion port 73 of the Y-shaped connector 70 constituting the balloon catheter 100.
　バルーンカテーテル１００のガイドワイヤポート７１には、エタノールの供給手段２００が接続されている。このエタノールの供給手段２００は、例えば、エタノールが収容されているシリンジからなる。 The ethanol supply means 200 is connected to the guide wire port 71 of the balloon catheter 100. The ethanol supply means 200 is composed of, for example, a syringe containing ethanol.
　エタノールの供給手段２００からガイドワイヤポート７１にエタノールを注入することにより、注入されたエタノールは、ガイドワイヤルーメン２１を流通して先端チップ１５の先端開口から目的部位（副腎腫瘍）に向けて噴射され、これにより、副腎腫瘍のケミカルアブレーション治療が施される。 By injecting ethanol from the ethanol supply means 200 into the guide wire port 71, the injected ethanol flows through the guide wire lumen 21 and is jetted from the distal end opening of the distal tip 15 toward the target site (adrenal tumor). This gives chemical ablation therapy for adrenal tumors.
　ケミカルアブレーション治療装置１０００を構成するガイディングカテーテル３００は、バルーンカテーテル１００の先端部を患者Ｐの副腎ＡＧに案内するために、その先端が副腎静脈の入口に位置するよう先行して挿入される。
　図６において模式的に示したガイディングカテーテル３００は、副腎に至る血管形状の相違により、右副腎用と左副腎用とでそれぞれの形状が異なる。 In order to guide the distal end portion of the balloon catheter 100 to the adrenal AG of the patient P, the guiding catheter 300 constituting the chemical ablation treatment apparatus 1000 is inserted in advance so that the distal end is positioned at the entrance of the adrenal vein.
The guiding catheter 300 schematically shown in FIG. 6 has different shapes for the right adrenal gland and for the left adrenal gland due to the difference in blood vessel shape leading to the adrenal gland.
　バルーンカテーテル１００の拡張ポート７３には、バルーンの拡張手段４００が接続されている。このバルーンの拡張手段４００は、例えば、生理食塩水が収容されているシリンジからなる。 The balloon expansion means 400 is connected to the expansion port 73 of the balloon catheter 100. The balloon expanding means 400 is made of, for example, a syringe containing physiological saline.
　図８Ａは、右副腎用のガイディングカテーテル３００Ｒの先端部分の形状を示している。他方、図８Ｂは、左副腎用のガイディングカテーテル３００Ｌの先端部分の形状を示している。
　図８Ａに示すガイディングカテーテル３００Ｒは第１の湾曲部３０１Ｒと第２の湾曲部３０２Ｒとを有しており、図８Ｂに示すガイディングカテーテル３００Ｌは第１の湾曲部３０１Ｌと第２の湾曲部３０２Ｌとを有している。
　なお、ガイディングカテーテル３００Ｒまたは３００Ｌの先端開口から、バルーン５０が押し出されているときに、アウターチューブ３０の先端側低硬度部分（硬度傾斜部）の基端は、当該ガイディングカテーテルの第２の湾曲部３０２Ｒまたは３０２Ｌの基端よりも更に基端側に位置していることが望ましい。これにより、操作性に特に優れたケミカルアブレーション治療装置とすることができる。
　また、ガイディングカテーテル３００Ｒまたは３００Ｌの先端開口から押し出されたバルーン５０によって支脈がオクリュージョンされているときに、アウターチューブ３０の先端側低硬度部分の硬度傾斜部の先端（最先端部の基端）が当該ガイディングカテーテルのルーメンに位置していること、すなわち、当該ガイディングカテーテルの先端開口から突出しているアウターチューブ３０は先端側低硬度部分の最先端部のみであることが望ましい。これにより、副腎静脈の入口から支脈に至る複雑な血管形状への追従性を更に向上させることができる。 FIG. 8A shows the shape of the distal end portion of guiding catheter 300R for the right adrenal gland. On the other hand, FIG. 8B shows the shape of the distal end portion of the guiding catheter 300L for the left adrenal gland.
A guiding catheter 300R shown in FIG. 8A has a first bending portion 301R and a second bending portion 302R, and a guiding catheter 300L shown in FIG. 8B has a first bending portion 301L and a second bending portion. 302L.
When the balloon 50 is pushed out from the distal end opening of the guiding catheter 300R or 300L, the proximal end of the distal side low hardness portion (hardness inclined portion) of the outer tube 30 is the second guiding catheter of the guiding catheter. It is desirable to be located further on the base end side than the base end of the curved portion 302R or 302L. Thereby, it can be set as the chemical ablation treatment apparatus especially excellent in operativity.
Further, when the branch is occluded by the balloon 50 pushed out from the distal end opening of the guiding catheter 300R or 300L, the distal end of the hardness inclined portion of the lower hardness portion of the outer tube 30 (the base of the most distal portion). It is desirable that the end) is located in the lumen of the guiding catheter, that is, the outer tube 30 protruding from the distal end opening of the guiding catheter is only the most distal end portion of the distal-side low hardness portion. Thereby, the followability to the complicated blood vessel shape from the entrance of the adrenal vein to the branch can be further improved.
　図８Ａに示す右副腎用のガイディングカテーテル３００Ｒは、図９Ａに示すように、下大静脈ＩＶＣを通って、その先端が右副腎静脈の入口に位置するように挿入される。また、図８Ｂに示す左副腎用のガイディングカテーテル３００Ｌは、図９Ｂに示すように、下大静脈ＩＶＣおよび左腎静脈ＬＲＶを通って、その先端が左副腎静脈の入口に位置するように挿入される。
　なお、図９Ａおよび図９Ｂにおいて、ＲＫは右腎、ＬＫは左腎、ＲＡＧは右副腎、ＬＡＧは左副腎である。 As shown in FIG. 9A, the guiding catheter 300R for the right adrenal gland shown in FIG. 8A is inserted through the inferior vena cava IVC so that its tip is located at the entrance of the right adrenal vein. Further, as shown in FIG. 9B, the guiding catheter 300L for the left adrenal gland shown in FIG. 8B is inserted through the inferior vena cava IVC and the left renal vein LRV so that the tip is located at the entrance of the left adrenal vein. Is done.
9A and 9B, RK is the right kidney, LK is the left kidney, RAG is the right adrenal gland, and LAG is the left adrenal gland.
　ガイディングカテーテル３００（３００Ｒ，３００Ｌ）の外径は、例えば１．３５～２．３５ｍｍとされ、好ましくは１．６５～２．００ｍｍとされる。
　ガイディングカテーテル３００の内径は、例えば０．８０～２．００ｍｍとされ、好ましくは１．００～１．６５ｍｍとされる。
　ガイディングカテーテル３００の長さとしては、右副腎用のガイディングカテーテル３００Ｒの長さが、例えば５００～１０００ｍｍとされ、好ましくは６００～８００ｍｍとされる。また、左副腎用のガイディングカテーテル３００Ｌの長さが、例えば５００～１０００ｍｍとされ、好ましくは６００～８００ｍｍとされる。 The outer diameter of guiding catheter 300 (300R, 300L) is, for example, 1.35 to 2.35 mm, and preferably 1.65 to 2.00 mm.
The inner diameter of the guiding catheter 300 is, for example, 0.80 to 2.00 mm, and preferably 1.00 to 1.65 mm.
Regarding the length of the guiding catheter 300, the length of the guiding catheter 300R for the right adrenal gland is, for example, 500 to 1000 mm, and preferably 600 to 800 mm. Further, the length of the guiding catheter 300L for the left adrenal gland is, for example, 500 to 1000 mm, and preferably 600 to 800 mm.
　この実施形態のケミカルアブレーション治療装置１０００によれば、エタノールの供給手段２００からのエタノールを、バルーンカテーテル１００の先端チップ１５の先端開口から噴射して腫瘍組織と接触させることにより、原発性アルドステロン症に対する経静脈的なケミカルアブレーション治療（異常が認められた支脈の腫瘍に対する必要最小限の治療）を確実に行うことができる。 According to the chemical ablation treatment apparatus 1000 of this embodiment, ethanol from the ethanol supply means 200 is ejected from the distal end opening of the distal end tip 15 of the balloon catheter 100 and brought into contact with the tumor tissue, thereby preventing primary aldosteronism. Intravenous chemical ablation treatment (minimum necessary treatment for a tumor of a branch artery with an abnormality) can be reliably performed.
＜副腎静脈採血装置＞
　図７に示す副腎静脈採血装置２０００は、上記実施形態のバルーンカテーテル１００と、このバルーンカテーテル１００を構成するＹ字コネクタ７０のガイドワイヤポート７１に接続された血液の吸引手段６００と、バルーンカテーテル１００の先端部を患者Ｐの副腎ＡＧに案内するためのガイディングカテーテル３００と、バルーンカテーテル１００を構成するＹ字コネクタ７０の拡張ポート７３に接続されたバルーン拡張手段４００とを備えてなる。 <Adrenal vein blood collection device>
The adrenal venous blood collection device 2000 shown in FIG. 7 includes the balloon catheter 100 of the above embodiment, blood suction means 600 connected to the guide wire port 71 of the Y-shaped connector 70 constituting the balloon catheter 100, and the balloon catheter 100. A guiding catheter 300 for guiding the distal end portion to the adrenal AG of the patient P, and a balloon expanding means 400 connected to the expansion port 73 of the Y-shaped connector 70 constituting the balloon catheter 100.
　バルーンカテーテル１００のＹ字コネクタ７０に設けられたガイドワイヤポート７１には、血液の吸引手段（シリンジ）６００が接続されている。
　なお、副腎静脈採血装置２０００を構成するガイディングカテーテル３００は、図６、図８（図８Ａおよび図８Ｂ）に示したケミカルアブレーション治療装置１０００を構成するガイディングカテーテル３００と同一の構成である。 A blood suction means (syringe) 600 is connected to the guide wire port 71 provided in the Y-shaped connector 70 of the balloon catheter 100.
The guiding catheter 300 constituting the adrenal venous blood collection device 2000 has the same configuration as the guiding catheter 300 constituting the chemical ablation treatment device 1000 shown in FIGS. 6 and 8 (FIGS. 8A and 8B).
　この実施形態の副腎静脈採血装置２０００によれば、ケミカルアブレーション治療の前後における副腎静脈採血を支脈ごとに行うことができる。 According to the adrenal vein blood collection device 2000 of this embodiment, adrenal vein blood collection before and after chemical ablation treatment can be performed for each branch.
＜副腎静脈採血およびケミカルアブレーション治療方法＞
　次に、本実施形態のバルーンカテーテル１００（副腎静脈採血装置２０００）によって副腎静脈採血を行い、その結果に基いて、このバルーンカテーテル１００（ケミカルアブレーション治療装置１０００）によって副腎腫瘍のケミカルアブレーション治療を行う方法の一例について説明する。 <Adrenal vein blood sampling and chemical ablation treatment method>
Next, the adrenal vein blood is collected by the balloon catheter 100 (adrenal vein blood collecting device 2000) of the present embodiment, and based on the result, chemical ablation treatment of the adrenal tumor is performed by the balloon catheter 100 (chemical ablation treatment device 1000). An example of the method will be described.
（１）ガイディングカテーテル３００を大腿静脈から体内に挿入し、下大静脈を経由して、ガイディングカテーテル３００の先端を副腎静脈の入口に到達させる。
　既述したように、右副腎用のガイディングカテーテルは、下大静脈から右副腎静脈の入口に直接挿入されるが、左副腎用のガイディングカテーテルは、下大静脈から左腎静脈を通して左副腎静脈の入口に挿入される。 (1) The guiding catheter 300 is inserted into the body from the femoral vein, and the distal end of the guiding catheter 300 reaches the entrance of the adrenal vein via the inferior vena cava.
As described above, the guiding catheter for the right adrenal gland is inserted directly into the entrance of the right adrenal vein from the inferior vena cava, while the guiding catheter for the left adrenal gland is inserted into the left adrenal gland from the inferior vena cava through the left renal vein. Inserted into the vein entrance.
（２）予め、ガイドワイヤをバルーンカテーテル１００のルーメンの長軸方向の中途まで挿入しておく。このようにしてガイドワイヤがセットされたバルーンカテーテル１００をガイディングカテーテル３００のルーメンに挿入する。ガイディングカテーテル３００の先端付近までバルーンカテーテル１００を進めた後、バルーンカテーテル１００の先端からガイドワイヤを延び出させ、ガイディングカテーテル３００の先端から突出させたガイドワイヤの先端部を、副腎静脈の３本の支脈の何れかに挿入する。 (2) A guide wire is inserted in advance to the middle of the lumen of the balloon catheter 100 in the long axis direction. The balloon catheter 100 with the guide wire set in this manner is inserted into the lumen of the guiding catheter 300. After the balloon catheter 100 is advanced to the vicinity of the distal end of the guiding catheter 300, the guide wire is extended from the distal end of the balloon catheter 100, and the distal end portion of the guide wire protruding from the distal end of the guiding catheter 300 is connected to the adrenal vein 3. Insert into one of the book branches.
（３）ガイドワイヤに沿って、バルーン５０を含むバルーンカテーテル１００の先端部を副腎静脈の支脈に挿入し、バルーン拡張手段４００から供給される生理食塩水によってバルーン５０を拡張させて当該支脈をオクリュージョンさせた後、ガイドワイヤを抜去する。 (3) The distal end portion of the balloon catheter 100 including the balloon 50 is inserted into the branch of the adrenal vein along the guide wire, and the balloon 50 is expanded by the physiological saline supplied from the balloon expansion means 400, thereby occupying the branch. After the illusion, the guide wire is removed.
（４）バルーンカテーテル１００のガイドワイヤポート７１に、血液の吸引手段６００を接続して副腎静脈採血装置２０００とし、当該支脈において採血（副腎静脈採血）を行う。 (4) A blood suction means 600 is connected to the guide wire port 71 of the balloon catheter 100 to form an adrenal vein blood collection device 2000, and blood is collected (adrenal vein blood collection) at the branch.
（５）残りの２つの支脈に対しても上記（２）～（４）の操作を行って支脈ごとの副腎静脈採血を実施した後、バルーンカテーテル１００およびガイディングカテーテル３００を抜去する。 (5) The operations of (2) to (4) are performed on the remaining two branches to collect blood from the adrenal vein for each branch, and then the balloon catheter 100 and the guiding catheter 300 are removed.
（６）支脈ごとに採取した血液をそれぞれ検査（アルドステロン分泌量を測定）した結果、３本の支脈の一部（１本または２本）の支脈で採取した血液に異常（アルドステロンの過剰分泌）が認められた場合に、上記（１）および（２）と同様にして、ガイドワイヤの先端部を異常が認められた支脈に挿入し、上記（３）と同様にして当該支脈をオクリュージョンさせた後、ガイドワイヤを抜去する。 (6) As a result of examination (measurement of aldosterone secretion amount) of each blood sample taken for each branch, abnormalities in blood collected from one or two of the three branches (one or two) (excess secretion of aldosterone) In the same manner as (1) and (2) above, the distal end portion of the guide wire is inserted into a branch in which an abnormality has been observed, and the branch is occluded in the same manner as (3) above. Then, remove the guide wire.
（７）バルーンカテーテル１００のガイドワイヤポート７１に、エタノールの供給手段２００を接続してケミカルアブレーション治療装置１０００とし、エタノールの供給手段２
００からのエタノールを、バルーンカテーテル１００の先端チップ１５の先端開口から噴射してケミカルアブレーション治療を行う。 (7) The ethanol supply means 200 is connected to the guide wire port 71 of the balloon catheter 100 to form the chemical ablation treatment apparatus 1000, and the ethanol supply means 2
Chemical ablation treatment is performed by injecting ethanol from 00 through the distal end opening of the distal end tip 15 of the balloon catheter 100.
（８）異常が認められた１本または２本の支脈の腫瘍に対するケミカルアブレーション治療終了後、上記（２）～（４）と同様にして、当該支脈の採血（副腎静脈採血）を行ってアルドステロン分泌量を再度測定して治療効果を確認する。 (8) After completion of the chemical ablation treatment for the tumor of one or two branches with abnormalities, blood collection (adrenal vein blood collection) of the branch is performed in the same manner as (2) to (4) above. Measure the secretion again to confirm the therapeutic effect.
１００　バルーンカテーテル
　１０　インナーチューブ
　１１　内層
　１３　外層
　１５　先端チップ
　２１　ガイドワイヤルーメン
　２３　拡張ルーメン
　３０　アウターチューブ
　３１　内層
　３３　外層
　３５　編組
　３０１　基端側高硬度部分
　３０２　先端側低硬度部分
　３０４　硬度傾斜部
　３０６　最先端部
　４０　造影マーカー
　５０　バルーン
　７０　Ｙ字コネクタ
　７１　ガイドワイヤポート
　７３　拡張ポート
　７５　ストレインリリーフ
１０００　ケミカルアブレーション治療装置
　２００　エタノールの供給手段
　３００　ガイディングカテーテル
　４００　バルーンの拡張手段
２０００　副腎静脈採血装置
　６００　血液の吸引手段 DESCRIPTION OF SYMBOLS 100 Balloon catheter 10 Inner tube 11 Inner layer 13 Outer layer 15 Tip tip 21 Guide wire lumen 23 Expansion lumen 30 Outer tube 31 Inner layer 33 Outer layer 35 Braid 301 Base end side high hardness portion 302 Tip end low hardness portion 304 Hardness inclined portion 306 Most advanced portion 40 Contrast marker 50 Balloon 70 Y-shaped connector 71 Guide wire port 73 Expansion port 75 Strain relief 1000 Chemical ablation treatment device 200 Ethanol supply means 300 Guiding catheter 400 Balloon dilation means 2000 Adrenal vein blood collection device 600 Blood suction means

Claims (8)

  1. 　経静脈的アプローチにより副腎に導入されて、副腎静脈採血または副腎腫瘍のケミカルアブレーション治療に使用されるオーバーザワイヤ型のバルーンカテーテルであって、
    　ガイドワイヤルーメンを有するインナーチューブと、前記インナーチューブの外側に配置されて拡張ルーメンを形成するアウターチューブと、前記アウターチューブの先端に装着されて前記インナーチューブの外側に配置されたバルーンと、前記ガイドワイヤルーメンに連通するガイドワイヤポートおよび前記拡張ルーメンに連通する拡張ポートを有するコネクタとを有し、
    　前記アウターチューブは、硬度が７２Ｄ以上である基端側高硬度部分と、硬度が２５Ｄ以上７２Ｄ未満である先端側低硬度部分とからなり、
    　前記アウターチューブの外径が０．７０～１．２０ｍｍであり、
    　前記バルーンの長さが０．５～５ｍｍであることを特徴とするバルーンカテーテル。     An over-the-wire balloon catheter introduced into the adrenal gland by a transvenous approach and used for adrenal vein blood collection or chemical ablation treatment of adrenal tumors,
    An inner tube having a guide wire lumen; an outer tube disposed outside the inner tube to form an expansion lumen; a balloon mounted on a distal end of the outer tube and disposed outside the inner tube; and the guide A guide wire port communicating with the wire lumen and a connector having an expansion port communicating with the expansion lumen;
    The outer tube is composed of a proximal-side high hardness portion having a hardness of 72D or more and a distal-side low hardness portion having a hardness of 25D or more and less than 72D,
    The outer diameter of the outer tube is 0.70 to 1.20 mm;
    A balloon catheter, wherein the balloon has a length of 0.5 to 5 mm.
  2. 　前記先端側低硬度部分の長さが２０～１５０ｍｍであることを特徴とする請求項１に記載のバルーンカテーテル。 The balloon catheter according to claim 1, wherein the length of the tip side low hardness portion is 20 to 150 mm.
  3. 　前記先端側低硬度部分は、先端方向に向かって傾斜的または段階的に硬度が低下している部分を有していることを特徴とする請求項１または請求項２に記載のバルーンカテーテル。 The balloon catheter according to claim 1 or 2, wherein the distal-side low hardness portion has a portion whose hardness decreases in an inclined or stepwise manner toward the distal direction.
  4. 　前記先端側低硬度部分は、先端方向に向かって傾斜的に硬度が低下している硬度傾斜部と、前記硬度傾斜部の先端側に位置し、前記先端側低硬度部分の中で最も低い一定の硬度を有する最先端部とからなることを請求項１または請求項２に記載のバルーンカテーテル。 The tip-side low-hardness portion is located on the tip-side of the hardness-tilt portion having a hardness that is inclined to the tip direction, and is the lowest constant among the tip-side low-hardness portions. The balloon catheter according to claim 1, wherein the balloon catheter comprises a foremost portion having a hardness of 3 mm.
  5. 　少なくとも前記アウターチューブの先端よりも先端側に位置する部分における前記インナーチューブの硬度が４０Ｄ以下であることを特徴とする請求項１～４の何れかに記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 4, wherein the hardness of the inner tube is 40D or less at least in a portion located on the distal end side of the distal end of the outer tube.
  6. 　前記インナーチューブは内層と外層との二層構成であり、前記内層が耐エタノール性の樹脂により構成されていることを特徴とする請求項１～５の何れかに記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 5, wherein the inner tube has a two-layer structure of an inner layer and an outer layer, and the inner layer is made of an ethanol-resistant resin.
  7. 　請求項１～６の何れかに記載のバルーンカテーテルと、
    　前記コネクタのガイドワイヤポートに接続されたエタノールの供給手段と、
    　前記バルーンカテーテルの先端部を副腎に案内するためのガイディングカテーテルと
    　を備えてなる副腎腫瘍のケミカルアブレーション治療装置。     A balloon catheter according to any one of claims 1 to 6;
    Ethanol supply means connected to the guide wire port of the connector;
    A chemical ablation treatment apparatus for an adrenal tumor, comprising: a guiding catheter for guiding a distal end portion of the balloon catheter to the adrenal gland.
  8. 　請求項１～６の何れかに記載のバルーンカテーテルと、
    　前記コネクタのガイドワイヤポートに接続された血液の吸引手段と、
    　前記バルーンカテーテルの先端部を副腎に案内するためのガイディングカテーテルと
    　を備えてなる副腎静脈採血装置。     A balloon catheter according to any one of claims 1 to 6;
    Blood suction means connected to the guide wire port of the connector;
    An adrenal venous blood collection device comprising: a guiding catheter for guiding the distal end portion of the balloon catheter to the adrenal gland.
PCT/JP2017/000182 2016-03-16 2017-01-05 Balloon catheter, chemical abrasion device for treating adrenal tumor and adrenal venous blood sampling device WO2017159001A1 (en)

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Citations (2)

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JP2010264024A (en) * 2009-05-13 2010-11-25 Hi-Lex Corporation Catheter for sampling blood or the like
WO2014122760A1 (en) * 2013-02-07 2014-08-14 テルモ・クリニカルサプライ株式会社 Balloon catheter

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JP2002291900A (en) * 2001-03-29 2002-10-08 Nippon Zeon Co Ltd Medical tool and method for manufacturing the same

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JP2010264024A (en) * 2009-05-13 2010-11-25 Hi-Lex Corporation Catheter for sampling blood or the like
WO2014122760A1 (en) * 2013-02-07 2014-08-14 テルモ・クリニカルサプライ株式会社 Balloon catheter

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