The present invention relates to an oblique inflation type balloon catheter and a balloon base, and more specifically relates to a balloon catheter, which is indwelled mainly in a blood vessel, capable of preventing a blood flow from directly hitting against a blood vessel wall by allowing a balloon provided at a distal end of a catheter body to obliquely inflate even in a curved blood vessel and capable of suppressing occurrence of a wrinkle in a balloon deflated state, and a balloon base for attaching the balloon.
In general, the balloon provided on the balloon catheter is adapted to inflate concentrically with respect to the catheter body. Therefore, in the case of a linear blood vessel, since the balloon is positioned at a right angle to the blood vessel, indwelling fixation is excellent, and a catheter lumen faces a center of the blood vessel against the blood vessel, so that it is possible to smoothly send blood or deliver liquid.
For example, the balloon catheter described above is used for a mass administration system of an anticancer drug to a liver cancer patient known as percutaneous hepatic perfusion chemotherapy (PIHP: Percutaneous Isolated Hepatic Perfusion). This system selectively removes an anticancer drug largely administered in a hepatic artery from a hepatic vein together with blood, adsorbs and removes the anticancer drug using an activated carbon column, etc., and then sends the blood to a patient again. For this reason, in the system, as illustrated in
Incidentally, in the PIHP therapy, it is necessary to indwell a distal end balloon in a short curved blood vessel portion between the heart and three hepatic vein holes (a right hepatic vein opening, a middle hepatic vein opening, and a left hepatic vein opening) to completely block a blood flow in the inferior vena cava following a right atrium of the heart using the balloon catheter 101. When the balloon catheter is inserted into and indwelled in the curved blood vessel, as illustrated in
According to investigation by the applicant, a prior art document for solving such problems is not present. However, JP 5679813 B2 (Patent Literature 1) discloses a balloon used for a tracheostomy tube inserted into a tracheal lumen.
Registered Japanese Patent No. JP 5679813 B2 relates to a tracheostomy tube device and is an invention having a balloon below according to description in claim 1,
However, since the balloon 175 is a balloon formed by preliminary shaping in a configuration described above with respect to a catheter body, a wrinkle is formed in a deflated state, and unevenness due to the balloon is generated on a surface of the catheter body, so that adhesion to the surface is not allowed. For this reason, when the catheter having the balloon with unevenness formed on the surface due to the wrinkle is inserted into the blood vessel as the above-mentioned mass administration system, there is concern that an inner wall of the blood vessel may be damaged by unevenness due to the wrinkle of the balloon. Besides, similarly to the conventionally known balloon described above, the problem that the balloon easily slips may not be solved.
In this regard, an object of the present invention to provide an oblique inflation type balloon catheter in which a balloon may be obliquely inflated to tilt with respect to a catheter body without a central axis of a blood vessel being shifted from a central axis of a catheter body even when the blood vessel is curved, and rarely slips without a contact area with respect to the blood vessel decreasing and a wrinkle being formed on the balloon in a deflated state, and a balloon base by solving the conventional problems described above.
To solve the above-mentioned problems, the invention described in claim 1 is a balloon catheter in which a balloon is provided at a front end of a tubular catheter body having a predetermined length, wherein a balloon base having a larger diameter than an outer diameter of the catheter body is integrally provided in a cylindrical shape at the front end of the catheter body, the balloon base is formed such that an outer peripheral surface thereof in an axis direction is inclined at a predetermined angle with respect to a central axis of the catheter body, and the balloon is provided on the outer peripheral surface to obliquely inflate with respect to the central axis of the catheter body during inflation.
The invention described in claim 2 is a balloon catheter in which a balloon is provided at a front end of a tubular catheter body having a predetermined length, wherein a balloon base is provided at the front end of the catheter body, the balloon base includes a balloon and a base and includes a cylindrical base having a larger diameter than an outer diameter of the catheter body, a lumen having substantially the same diameter as the outer diameter of the catheter body is formed on the base over an entire length with both ends opened, a central axis of the lumen is inclined at a predetermined angle with respect to a central axis of the base concentric with a central axis of the catheter body, an outer peripheral surface in an axis direction is formed in parallel with the central axis of the base, and the balloon is provided on the outer peripheral surface of the parallel base to obliquely inflate with respect to the central axis of the catheter body during inflation.
In the invention described in claim 3, the lumen of the catheter body is partitioned into a blood removing lumen for removing blood from a blood vessel and a blood feeding lumen for sending blood to the blood vessel, and an opening area of the blood removing lumen is larger than an opening area of the blood feeding lumen in claim 1 or 2.
In the invention described in claim 4, a second balloon is provided in the catheter body at a predetermined length behind the balloon, and a side hole for taking blood into the blood removing lumen is provided in the catheter body between the second balloon and the balloon in any one of claims 1 to 3.
In the invention described in claim 5, the predetermined angle is in a range of 3° to 10° in any one of claims 1 to 4.
The invention described in claim 6 is a balloon base provided at the front end of the catheter body in the oblique inflation type balloon catheter according to any one of claims 1 to 5, wherein the base includes a cylindrical base having a larger diameter than an outer diameter of the catheter body, a lumen having substantially the same diameter as the outer diameter of the catheter body is formed on the base over an entire length with both ends opened, a central axis of the lumen is inclined at a predetermined angle with respect to a central axis of the base, and an outer peripheral surface in an axis direction is formed in parallel with the central axis of the base.
In the invention described in claim 7, the predetermined angle is in a range of 3° to 10° in claim 6.
In the invention described in claim 8, the outer peripheral surface includes an outer peripheral surface of a balloon attachment central portion parallel to the central axis of the base and an outer peripheral surface of both ends curved to have a diameter gradually decreasing from the portion in claim 6 or 7.
In the invention described in claim 9, a communication passage allowing communication between the inside of the balloon and a balloon lumen provided on a peripheral wall of the catheter body is formed in the balloon base in any one of claims 6 to 8.
The invention is as described above. According to the invention described in claim 1, a balloon base having a larger diameter than an outer diameter of the catheter body is integrally provided in a cylindrical shape at the front end of the catheter body, the balloon base is formed such that an outer peripheral surface thereof in an axis direction is inclined at a predetermined angle with respect to a central axis of the catheter body, and the balloon is provided on the outer peripheral surface to obliquely inflate with respect to the central axis of the catheter body during inflation. In addition, according to the invention described in claim 2, a balloon base is provided at the front end of the catheter body, the balloon base includes a substantially tubular shaped-base having a larger diameter than an outer diameter of the catheter body, a lumen having substantially the same diameter as the outer diameter of the catheter body is formed on the base over an entire length with both ends opened, a central axis of the lumen is inclined at a predetermined angle with respect to a central axis of the base concentric with a central axis of the catheter body, an outer peripheral surface is formed in parallel with the central axis of the base, and the balloon is provided on the outer peripheral surface of the parallel base to obliquely inflate with respect to the central axis of the catheter body during inflation. Thus, in either case, the balloon may obliquely inflate with respect to the catheter body. For this reason, even in a curved blood vessel, a central axis thereof does not shift from the central axis of the catheter body. Therefore, unlike the conventional one, the central axis of the lumen of the curved blood vessel does not shift from the central axis of the catheter, and the blood flow does not directly hit the blood vessel wall to damage the blood vessel wall due to the rigidity of the catheter. In addition, at the same time, a contact area of the balloon with respect to the blood vessel does not decrease, and adhesion to the outer peripheral surface of the base is allowed since the balloon is not shaped and a wrinkle is not formed even in a balloon deflated state. Therefore, the balloon does not slip due to pressure during blood feeding, and there is an effect that indwelling and fixing may be firmly performed. Further, there are effects that an oblique inflation direction of the balloon may be adjusted by rotating a catheter central axis according to an anatomical individual difference such as a curved shape or a position of a hepatic vein ostium in a short blood vessel lumen between the heart and the liver during use, and the balloon on the distal end side may be appropriately indwelled and fixed. On the other hand, in a conventional balloon incapable of inflating in an oblique direction, a contact position between a balloon and a blood vessel lumen may not be changed even when a central axis of a catheter is rotated.
According to the invention described in claim 3, since the lumen of the catheter body is partitioned into a blood removing lumen for removing blood from a blood vessel and a blood feeding lumen for sending blood to the blood vessel, and an opening area of the blood removing lumen is larger than an opening area of the blood feeding lumen, it is possible to rapidly, surely, and efficiently remove blood.
According to the invention described in claim 4, since a second balloon is provided in the catheter body at a predetermined length behind the balloon, and a side hole for taking blood into the blood removing lumen is provided in the catheter body between the second balloon and the balloon, it is possible to effectively withdraw blood between the both balloons from the side hole to the blood removing lumen.
According to the invention described in claim 5, since the predetermined angle is in a range of 3° to 10°, it is possible to effectively deal with a curved blood vessel of a patient having some individual differences.
According to the invention described in claim 6, since the base includes a cylindrical base having a larger diameter than an outer diameter of the catheter body, a lumen having substantially the same diameter as the outer diameter of the catheter body is formed on the base over an entire length with both ends opened, a central axis of the lumen is inclined at a predetermined angle with respect to a central axis of the base, and an outer peripheral surface in an axis direction is formed in parallel with the central axis of the base, the balloon attached to the outer peripheral surface with the base interposed therebetween may be inflated to be inclined with respect to the catheter body.
According to the invention described in claim 7, since the predetermined angle is in a range of 3° to 10°, it is possible to effectively deal with a curved blood vessel of a patient having some individual differences.
According to the invention described in claim 8, since the outer peripheral surface includes an outer peripheral surface of a balloon attachment central portion parallel to the central axis of the base and an outer peripheral surface of both ends curved to have a diameter gradually decreasing from the portion, it is possible to smoothly attach the balloon to the outer peripheral surface of the central portion, and to prevent damage to the blood vessel wall by the outer peripheral surface of the curved both ends.
According to the invention described in claim 9, since a communication passage for communication between the inside of the balloon and a balloon lumen provided on a peripheral wall of the catheter body is formed in the balloon base, the balloon may be inflated and deflated through the communication passage even when the balloon is attached with the base interposed therebetween.
Hereinafter, an oblique inflation type balloon catheter according to an embodiment of the present invention will be described with reference to drawings.
In
In the catheter body 2, a lumen 6 having a substantially circular cross section is provided in an axis direction from a front end to a rear end thereof. A front end of the catheter body 2 is obliquely cut out. The lumen 6 is partitioned into a blood removing lumen 10 and a blood feeding lumen 11 by an integrally formed partition wall 7 extending in an axial direction. The blood removing lumen 10 is for removing blood from a blood vessel in a body, and the blood feeding lumen 11 is for sending blood to the blood vessel in reverse. In this example, an opening area of the blood removing lumen 10 on a surface orthogonal to the axial direction is slightly larger than that of the blood feeding lumen 11. A reason therefor is to carry out blood removal more rapidly, surely and efficiently. A ratio of the opening area of the blood removing lumen 10 to the opening area of the blood feeding lumen 11 is not particularly limited, and is preferably 6:4 ratio in terms of ratio. In this example, the blood removing lumen 10 and the blood feeding lumen 11 are partitioned by the partition wall 7. However, a small-diameter pipe may be concentrically arranged in the lumen 6 without partitioning by the partition wall 7, and an inside or an outside of the pipe may be used as either the blood removing lumen 10 or the blood feeding lumen 11.
As illustrated in
The balloon base 5 includes a component independently manufactured separately from the catheter body 2 and is provided at a front end of the catheter body 2. This balloon base 5 has of an eccentric type single lumen tube type. That is, as specifically illustrated in
When the base is provided at the front end of the catheter body 2, the lumen 16 on the base 15 is provided such that a central axis X thereof is inclined at a predetermined angle 0° with respect to a central axis Y of the base 15 which is concentric with the central axis of the catheter body 2. This angle of inclination is preferably in a range of 3° to 10°, particularly preferably 4° to 6°, and more particularly preferably 5° in this example. The angle of inclination is not limited to the angle in the range of 3° to 10°, and may be set to an arbitrary angle around the range, particularly in a range of an angle of 16° to 25° for a large angle as necessary since there is an individual difference in degree of curvature of a blood vessel depending on the patient. When the lumen 16 is inclined as described above, a front end opening thereof is located closer to an upper side of the base 15, and a rear end opening is located closer to a lower side of the base 15.
At a central portion of the base 15, two water passing holes 17 are provided as communication passages for communication between the inside of the balloon 3 and the balloon lumen 12 provided on a peripheral wall of the catheter body 2.
The base 15 includes a central portion 18 which is an outer peripheral surface parallel to the central axis Y of the base 15 concentric with the central axis of the catheter body 2 as described above and both ends 19 and 20 which are outer peripheral surfaces curved in tapered shapes to have diameters gradually decreasing from the portion. Further, the balloon 3 is provided on the outer peripheral surface of the central portion 18 which is parallel. The both ends 19 and 20 have a large degree of curvature on a thicker side and a small degree of curvature on a thinner side. As is clear from
Due to the above-described shape, the balloon base 5 is viewed from the left side in a shape in which the front end opening of the lumen 16 faces upward to face the inside of the lumen as illustrated in
When dimensions of each component of the balloon base 5 are described for reference, the total length is 30 mm, the outer diameter is 11.7 mm, the diameter of the lumen 16 is 8 mm, the length of the central portion 18 is 17 mm, the length of both ends 19 is 8.6 mm, and the length of both ends 20 is 5.0 mm.
As described above, in the catheter body 2 between the balloon 4 and the balloon 3 in which the balloon base 5 provided with the balloon 3 is provided at the front end of the catheter body 2, as illustrated in
According to the configuration of the base 5, as is clear from
In
A method of using the balloon catheter 1 will be described. Basically, the method is similar to the content described in the conventional system for administering a large amount of anticancer drug to the patient with liver cancer illustrated in
In the operation of the system, the balloon 3 of the balloon catheter 1 obliquely inflates to incline with respect to the catheter body 2, and thus a central axis of a blood vessel does not shift from the central axis of the catheter body 2 even when the blood vessel is curved as illustrated in
In addition, in the shaped balloon 175 cited as the conventional art, a wrinkle is generated in the balloon in a deflated state, and unevenness of the balloon occurs on the surface of the catheter. Thus, when the catheter of the shaped balloon is inserted into the blood vessel, there is concern that the inner wall of the blood vessel may be damaged due to the wrinkle of the balloon. However, the balloon 3 of the balloon catheter 1 is a flat balloon that can adhere to the outer peripheral surface of the base 5 in the deflated state and does not cause unevenness. Thus, even when the catheter is inserted into the lumen, the inner wall of the blood vessel is not damaged.
In this embodiment, the catheter body 2, the balloon base 5, and the balloons 3 and 4 are made of a material suitable for a living body such as silicone rubber, and this material includes thermoplastic resins such as PP, PE, PU, and nylon. Further, a material used in medical devices may be used.
In more detail, the balloon base 5a is integrally provided in a cylindrical shape having a larger diameter than an outer diameter of the catheter body at a front end of the catheter body 2a. In the balloon base 5a, as is clear from the drawing, an outer peripheral surface in an axis direction, in other words, a central axial formed by the outer peripheral surface is formed to incline at a predetermined angle 0° with respect to a central axis of the catheter body 2a, and a balloon 3a is provided on the outer peripheral surface. The balloon 3a is a flat balloon mentioned above, and obliquely inflates with respect to the central axis of the catheter body 2a in an inflated state. As described above, the predetermined angle 0° is preferably in a range of 3° to 10°. In the figure, Z denotes an axis extending along the outer peripheral surface of the balloon base 5a and intersecting the central axis Y of the catheter body 2a, and Z and Y form the predetermined angle 0°.
The embodiment is merely a preferable example, and design of details, etc. of the present invention may be appropriately modified and corrected within a range described in claims. For example, the inclination angle of the lumen 16 of the balloon base 5, the shape of the outer peripheral surface of the both ends 19 and 20 of the base 15, etc. may be appropriately designed in practice. In addition, the balloon base 5 may not be a separate body as shown in the example of the embodiment, and may be formed integrally with the catheter body 2a as shown in the modification. In addition, even though the embodiment shows an example in which the balloon catheter 1 is used for the mass administration system of the anticancer drug for the liver cancer patient, it goes without saying that the balloon catheter 1 may be used for another purpose.
This is a U.S. national phase application under 35 U.S.C. § 371 of International Patent Application No. PCT/JP2016/060359, filed Mar. 30, 2016. The entire contents of these applications are hereby incorporated by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/JP2016/060359 | 3/30/2016 | WO | 00 |