WO2017159001A1 - Cathéter à ballonnet, dispositif d'abrasion chimique pour traiter une tumeur surrénale et dispositif d'échantillonnage de sang veineux surrénal - Google Patents

Cathéter à ballonnet, dispositif d'abrasion chimique pour traiter une tumeur surrénale et dispositif d'échantillonnage de sang veineux surrénal 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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Prior art keywords
hardness
balloon catheter
adrenal
balloon
distal end
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PCT/JP2017/000182
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English (en)
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/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon 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.

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Abstract

La présente invention a pour objet un cathéter à ballonnet qui peut être utilisé dans une abrasion chimique intraveineuse pour traiter un aldostéronisme primaire et qui permet, en particulier, le traitement exclusif d'une tumeur dans une branche diagnostiquée comme étant anormale. Le cathéter à ballonnet selon la présente invention, qui doit être utilisé dans l'abrasion chimique pour traiter une tumeur surrénale par une approche intraveineuse, comprend un tube interne (10), un tube externe (30), un ballonnet (50) et un raccord (70), ledit raccord (70) comprenant un orifice de fil de guidage (71) et un orifice de gonflage (73), où : le tube externe (30) comprend une partie de dureté élevée (301) sur le côté d'extrémité proximale ayant une dureté de 72D ou plus et une partie de faible dureté (302) sur le côté d'extrémité distale ayant une dureté de 25D ou plus et inférieure à 72D; le diamètre externe du tube externe (30) est de 0,70 à 1,20 mm; et la longueur du ballonnet (50) est de 0,5 à 5 mm.
PCT/JP2017/000182 2016-03-16 2017-01-05 Cathéter à ballonnet, dispositif d'abrasion chimique pour traiter une tumeur surrénale et dispositif d'échantillonnage de sang veineux surrénal WO2017159001A1 (fr)

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JP2016-052745 2016-03-16
JP2016052745A JP2017164310A (ja) 2016-03-16 2016-03-16 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

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Citations (2)

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JP2010264024A (ja) * 2009-05-13 2010-11-25 Hi-Lex Corporation 血液等採取用のカテーテル
WO2014122760A1 (fr) * 2013-02-07 2014-08-14 テルモ・クリニカルサプライ株式会社 Cathéter à ballon

Family Cites Families (1)

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JP2002291900A (ja) * 2001-03-29 2002-10-08 Nippon Zeon Co Ltd 医療器具およびその製造方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010264024A (ja) * 2009-05-13 2010-11-25 Hi-Lex Corporation 血液等採取用のカテーテル
WO2014122760A1 (fr) * 2013-02-07 2014-08-14 テルモ・クリニカルサプライ株式会社 Cathéter à ballon

Non-Patent Citations (1)

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KOZO MAKITA: "Genpatsusei Aldosterone-sho ni Okeru Fukujin Jomyaku Saiketsu -Fukujin Jomyaku Sampling Shugi o Seiko saseru Tameno Kotsu", THE OFFICIAL JOURNAL OF THE JAPANESE SOCIETY OF INTERVENTIONAL RADIOLOGY, vol. 28, no. 2, 2013, pages 204 - 210, ISSN: 2185-6451 *

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