JPH04132563A - Balloon catheter in aorta - Google Patents

Abstract

PURPOSE:To prevent the development of a complication with schemia of lower limbs while facilitating the insertion and withdrawal of a catheter by arranging an internal tubular body to be made of a hard resin as forming component having a tip and a base end. CONSTITUTION:A balloon catheter 1 has an external tubular body 2 and an internal tubular body 4 which is inserted through the external tubular body 2 with a tip of a balloon 3 fastened at the tip thereof. Moreover. the internal tubular body 4 has a second lumen 11 inside. The lumen 11 may be used as a path to insert a guide wire or a passage to dose a necessary drug. Then, a forming material herein usable for the internal tubular body 4 is a hard resin such as polyimide, polyethylene, polypropyrene, polyester, polyamide, polyvinylidene fluoride or ethylene-ethylene tetrafluoride copolymer, only if it can be formed into a tube. Especially, when it is made of polyimide, the thickness of the internal tubular body can be made as less as possible.

Description

[Detailed Description of the Invention] <Industrial Application Field> The present invention relates to an intra-aortic balloon catheter used for intra-aortic balloon pumping, which is one of the auxiliary circulation methods;
In particular, it relates to a double-lumen intra-aortic balloon catheter primarily for percutaneous insertion.

<Prior art> In recent years, IABP (intra-aortic balloon pumping) has been
It is gradually becoming popular as an auxiliary circulation method for octogenic shock symptoms due to pump failure, cases in which extracorporeal circulation is difficult to wean, heart failure after cardiac surgery, and low cardiac output syndrome.

Conventional IARP has generally used a surgical insertion method in which the blood vessel is exposed and inserted, but in recent years, IABP that can be inserted percutaneously has been considered. With the advent of IABP that can be inserted percutaneously, it has become possible for non-surgeons, such as internists and anesthesiologists, to quickly insert IABP, so JABP is now being used prophylactically. It has become increasingly popular in recent years.

However, while the application of IABP is expanding, complications associated with the use of IABP are also emerging. Complications that are considered problematic include vascular complications, ischemic diseases, and organ failure, and their manifestations include not only those caused by the patient, but also the type of catheter, insertion method, removal method, etc. Some are caused by the medical side.

On the other hand, the main components of the catheter used in IABP as described above include a flexible outer tubular body made of relatively soft plastic, and a distal end protruding from the outer tubular body by a predetermined length. an inner tubular body that is inserted through the inner tubular body, a balloon whose distal end and proximal end are fixed to the inner tubular body and the outer tubular body, respectively, and which can be repeatedly expanded and deflated; A branch shaft is included that is held integrally at the proximal end and has a boat for guiding fluid to the balloon and a boat for connecting a pressure quadrature transducer for measuring aortic pressure.

In such a catheter, in order to prevent the aforementioned complications due to the structure of the catheter, the smaller the outer diameter of the catheter, the better. In addition, this makes it easier to handle when inserting and removing the catheter.

However, gases such as helium or carbon dioxide are mainly used as the fluid to drive the expansion and contraction of the balloon, and the flow path resistance of these gases is reduced as much as possible.
In order to improve the drive responsiveness of the balloon, a sufficient cross-sectional area of the flow path between the outer tubular member and the inner tubular body must be ensured. As described above, conventionally, there has been a certain degree of difficulty in reducing the outer diameter of a catheter.

Furthermore, both the outer tubular members and the inner tubular member are made of a material with so-called low compliance so that the outer tubular member and the inner tubular member are not deformed in the diametrical direction due to pressure fluctuations in the flow path and blood pressure caused by the inflow and outflow of the driving gas.

In actual treatment procedures, the lumen within the inner tubular body is filled with heparinized saline, etc., and the aortic pressure fluctuations (pressure waves) are faithfully transmitted to the pressure quadrature transducer outside the body in order to measure them. A sufficient internal diameter (0.8-1.0+am for commercially available intra-aortic balloon catheters) is required. For the above reasons, in conventional intra-aortic balloon catheters, the inner tubular body has an outer diameter of 1.5 to
It was made from 2.0mm stainless steel tube. Therefore, the outer diameter of the catheter (=the outer diameter of the outer tubular body) has a limitation in making it thinner and has the drawback of being easily bent ("Auxiliary Circulation Method J, 1988, No. 62-63m, Metal Publishing)".

On the other hand, attempts to reduce the wall thickness of the outer tubular body are effective in securing a space between the outer tubular body and the inner tubular body, but they require adequate longitudinal flexibility (flexibility) and durability. Due to bendability, low compliance in the diameter direction, and blood compatibility of the outer surface, it is recommended to use thermoplastic polyurethane, double-layer tubes with polyethylene as the outer layer, or reinforcing braids (braiding) inside these tubes.
Therefore, there is a limit to reducing the wall thickness, and there is a limit to reducing the diameter by this.

<Problems to be Solved by the Invention> The present invention was made in view of the conventional problems such as difficulty in reducing the outer diameter of the catheter and ease of bending. By providing a rigid intra-aortic balloon catheter, the catheter can be inserted and removed more easily and complications such as lower limb ischemia can be prevented.

<Means for Solving the Problems> Two objects are achieved by the following present inventions (1) to (6).

(1) an outer tubular body; an inner tubular body having a protrusion that passes through the outer tubular body and projects a predetermined length from the distal end of the outer tubular body; and an internal lumen; a distal end portion and a proximal end portion; a catheter having a distal end fixed to the inner tubular body and an expandable and deflated balloon fixed to the proximal end fixed to the outer tubular body, the inner tubular body having a hard plastic as a forming component; An intra-aortic balloon catheter characterized by:

(2) The aorta according to (1) above, wherein the inner tubular body has an outer diameter of about 0.5 to 1.5 mff1 and a wall thickness of about 0.1 mm or less at least at a portion inserted into the outer tubular body. Internal balloon catheter.

(3) The hard plastic has a tensile modulus of approximately 10 k.
The intra-aortic balloon catheter according to (1) or (2) above, which is made of plastic with a g/am2 or more.

(4) The intra-aortic balloon catheter according to any one of (1) to (3) above, wherein the inner tubular body is made of polyimide.

(5) The intra-aortic balloon catheter according to any one of (1) to (4) above, wherein a reinforcing member is attached to the protrusion of the inner tubular body.

(6) The intra-aortic balloon catheter as set forth in (5) above, wherein the reinforcing member is a linear body that forms a spiral and is sheathed on the protrusion of the inner tubular body.

<Specific Configuration> The balloon catheter of the present invention, which is an embodiment shown in FIG. 1, will be described.

FIG. 1 is a schematic partial cross-sectional view of a balloon catheter according to an embodiment of the present invention.

The balloon catheter 1 of this embodiment includes an outer tubular body 2,
It is composed of a balloon 3, an inner tubular body 4, and a branch hub 10.

Specifically, the balloon catheter 1 of the embodiment shown in FIG. 1 includes an outer tubular body 2, an inner tubular body 4 which is inserted through the outer tubular body 2, and has a distal end portion of a balloon 3 fixed to its distal end. A first hub 6 is fixed to the base end of the outer tubular body 2, a second hub 7 is fixed to the base end of the inner tubular body 4, and the first hub 6 is fixed to the base end of the inner tubular body 4. A branch hub 10 is formed by fitting the second hub 7 into the rear end portion.

Further, a tip member 5 is attached to the tip of the inner tubular body 4, the tip of the balloon 3 is fixed to the tip member 5, and the proximal end of the balloon 3 is attached to the tip of the outer tubular body 2. is fixed to. Furthermore, the balloon 3 is cylindrical.

The outer tubular body 2 preferably has a certain degree of flexibility, such as polyolefin (e.g., polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.), polyvinyl chloride, polyamide. Thermoplastic resins such as elastomers and polyurethanes, silicone rubbers, latex rubbers, etc. can be used, preferably the above-mentioned thermoplastic resins, and more preferably polyolefins.

The length of the outer tubular body 2 is 200 to 600+a+
++ degree, more preferably about 450 to 525 μm, inner diameter is about 1.5 to 3.7 μl, more preferably 2.0 μm
- about 2.8 m-, the outer diameter is about 2.0-4.01 mm, more preferably about 2.3-3.2 mm, and the wall thickness is 0.
Approximately 15 to 0.40 button m, more preferably 0.20 to
It is about 0.25mm+.

The inner tubular body 4 inserted into the outer tubular body 2 has a balloon 3 between the inner wall surface of the outer tubular body 2 and the inner tubular body 4.
A first lumen 9 is formed through which a driving fluid flows.

Furthermore, the inner tubular body 4 has a second lumen 11 therein, as shown in FIG. This lumen 11 serves as a passage through which the guide wire is inserted.
Alternatively, it may be used as a channel for administration of necessary drugs.

As the material for forming the inner tubular body 4, hard plastic is used. For example, to give a specific example,
Polyimide, polyethylene, polypropylene, polyester, polyamide, polyvinylidene fluoride, ethylene-
Any hard plastic such as polytetrafluoroethylene copolymer that can be formed into a tubular shape can be used, but especially when it is made of polyimide, the wall thickness of the inner tubular body should be made thinner. In addition, it is difficult to deform due to pressure waves, and it is easy to restore the inner hole from blockage caused by bending. In the present invention, “hard plastic” refers to a tensile modulus of approximately 10 kg/n+++” or more (J I
5K6760.23℃) is defined as a plastic. By using such a material, the inner tubular body 4 has macroscopic flexibility, but does not deform in response to pressure in the radial direction when formed with a small diameter.

Further, the upper limit of the tensile modulus of the above-mentioned "hard plastic" is about 5000 kg/m+a2, more preferably about 2000 kg/me''.

Since the inner tubular body is formed of such a material, the wall thickness of the tube can be made thin (and the outer diameter can be made thinner, and the outer diameter is about 0.5 to 1.51 m111, more preferably 0.5 m111). Approximately .65~1.2m+a, inner diameter is 0.4~1.
About 45+ua, more preferably 0.6 to 1.0+++
o, the wall thickness may be approximately 0.025 to 0.10+mm, more preferably approximately 0.03 to 0.08+++m, and the length of the inner tubular body 4 may be approximately 700 to 1000 mm, more preferably 750 to Approximately 850mm is sufficient.
In this way, the outer diameter of the outer tubular body 2 can be made smaller while maintaining a sufficient cross-sectional area of the second lumen 9 formed between the inner wall surface of the outer tubular body 2 and the outer wall surface of the inner tubular body 4. can.

The tip member 5 fixed to the tip of the inner tubular body 4 functions as a guiding portion of the balloon catheter 1, and
The distal end of the balloon catheter 1 is provided to prevent damage to the blood vessel wall during insertion into the blood vessel.
For this reason, the tip of the tip member 5 may be formed into a bullet-shaped or hemispherical curved surface. The material for forming the tip member 5 is preferably one having a certain degree of flexibility, such as polyolefin (e.g. , polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.), thermoplastic resins such as polyvinyl chloride, polyamide elastomer, polyurethane, silicone rubber, latex rubber, etc. can be used, and preferably the above-mentioned It is a thermoplastic resin.

Furthermore, it is preferable that the material has adhesive properties with the material for forming the balloon 3. Furthermore, since the tip member 5 is also the tip of the balloon catheter 1, it is preferable that its position can be easily confirmed under X-ray fluoroscopy. Therefore, inside the tip member 5, pt, pt gold alloy W, W alloy, Ag, A
It is also possible to embed a metal member made of g-alloy or the like, or to mix metal powder.

The balloon 3 can be inflated and deflated, and is configured so that it can be wrapped around the outer circumference of the inner tubular body 4.

The material of the balloon 3 is preferably one having a certain degree of plasticity and hardness enough to transport blood, such as polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyesters such as polyethylene terephthalate, and polyvinyl chloride. , ethylene-vinyl acetate copolymer, crosslinked ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer, silicone rubber, latex rubber, etc. can be used.

The distal end of the balloon 3 is fluid-tightly fixed, for example, by adhesive, to a distal end member 5 fixed to the distal end of the inner tubular body 4, and the proximal end of the balloon 3 is fixed to the distal end of the outer tubular body 2. , for example, are also fixed in a liquid-tight manner by adhesive. Further, the inside of the balloon 3 communicates with a lumen 9 formed between the outer tubular body 2 and the inner tubular body 4 via a first opening 91 at the tip of the outer tubular body 2. Inflation fluid can flow into the interior.

The size of the balloon 3 is such that the outer diameter of the cylindrical portion when inflated is 12 to 17 mm, preferably 15 to 16 mm.
I11, and the entire length of balloon 3 is 200 to 27
0 mm, preferably 230 to 240 mm. Note that the shape of the balloon 3 may be such that the diameter decreases in the axial direction.

On the other hand, the inner tubular body 4 protrudes from the tip of the outer tubular body 2 within the balloon 3, and the protruding portion 41 is covered with a reinforcing member 13. The protruding length corresponds to the length of the balloon 3 described above.

In the illustrated example, the reinforcing member 13 is a linear body that is deformed into a spiral shape to form a cylindrical shape, and is sheathed outside the protrusion within the balloon 3. When formed into a cylindrical shape, the inner diameter needs to be the same as or larger than the outer diameter of the inner tubular body 4, and it is desirable that the outer diameter is smaller than the outer diameter of the outer tubular body 2. This is to prevent the outer diameter of the contracted balloon 3 when folded (wrapped) from becoming larger than the outer diameter of the outer tubular body 2 in order to facilitate insertion into the guide lumen.

Specifically, the diameter of the linear body is about 0.01 to 1.0 mm,
More preferably, the outer diameter is about 0.05 to 0.2 a+m, and in the case of a cylindrical shape, the outer diameter is about 0.55 to 2.51, more preferably 0.55 to 2.51, as long as it is not thicker than the outer diameter of the outer tubular body 2.
75~], about 4cm, the inner diameter is about 0.5~1.5mm according to the outer diameter of the inner tubular body 4, more preferably 0.65~
Approximately 1.2 mm is sufficient.

Since the reinforcing member 13 is arranged at a position corresponding to the mounting position of the balloon 3, the balloon 3 is attached within one body.
X Il! that allows you to check the location of Preferably, it is made of a material that has contrast properties.

Furthermore, as described above, by spirally deforming into a cylindrical shape, the reinforcing member 13 itself has flexibility and restorability,
It can be bent freely and has good ability to follow the meandering of the blood vessel within the blood vessel, reducing the trouble of damaging the inside of the blood vessel during insertion or removal. In particular, reinforcing member 1
The material in step 3 may be, for example, stainless steel, precious metals, so-called elastic alloys, or plastics with a certain degree of elasticity.
Particularly preferably, a superelastic alloy is used.

The branch hub 10 includes a first hub 6 and a second hub 7. The first hub 6 is fluid-tightly secured to the proximal end of the outer tubular body 2 and has a second opening 8 communicating with the lumen 9 of the outer tubular body 2. 8 acts as a fluid inlet for balloon inflation. As the material for the first hub 6, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyacrylate, and methacrylate-butylene-styrene copolymer are used.

A second hub 7 is fluid-tightly secured to the rear end of the inner tubular body 4, and a third opening 12 is provided at the rear end to communicate with the lumen 11 inside the inner tubular body 4. .
For example, a pressure transducer is connected to the third opening 12.

The second hub 7 and the first hub 6 may be fixed together, but the second hub 7 may be configured to be rotatable while maintaining a fluid-tight state between them. By rotating the second hub 7, the inner tubular body 4 also follows and rotates, so that the balloon 3 can be easily wrapped around the outer circumference of the inner tubular body 4.

<Operation> According to a preferred embodiment of the invention, the inner tubular body 4 is made of polyimide which is flexible in the longitudinal direction but has low compliance in the diametrical direction.

This polyimide has a thinner outer wall than a conventional inner tubular body made of, for example, a stainless steel tube, and exhibits superior flexibility than conventional tubular members.

For example, conventional adult intra-aortic balloon catheter l
The inner tubular body has an outer diameter of 1.2~1.5cm-1 and an inner diameter of 0.7~
1.0 mm, and the cross-sectional area of the inner tubular body occupying the inner space of the outer tubular body is approximately 1.1 to 1.8 mm.In comparison, according to the present invention, the inner tubular body 4 So, even if you want to maintain the same inner diameter as before, the maximum outer diameter will be about 1.0
~1.2■, and the cross-sectional area is approximately 0.8~1.1m
m", and the cross-sectional area of the space between the outer tubular body 2 and the inner tubular body 4 can be improved. If the outer diameter of the outer tubular body 2 (that is, the catheter outer diameter) is approximately 3 m" as in the conventional case, .16+nm (9.5Fr), inner diameter 2.76m
In the case of a standard intra-aortic balloon catheter 1 with a diameter of 1.5 mm and an inner diameter of the inner tubular body 4 of 0.8 mm (outer diameter 1.2+aw+), the cross-sectional area of the space is about 4.85 mm.
becomes. Even if the outer diameter of the inner tubular body 4 is set to approximately 1.0 mm while maintaining the same cross-sectional area, the inner diameter of the outer tubular body 2 will be 2.68 mm. Therefore, the outer diameter of the outer tubular body 2 with a standard wall thickness, like the conventional one, is about 3.
08mm (9Fr), which allows for slimming.

Furthermore, in a preferred embodiment of the present invention, the polyimide inner tubular body 4 can be made and used with a very thin wall thickness of about 0.025 mm. In other words, the minimum outer diameter of the inner tubular body 4 necessary for accurately measuring aortic pressure can be reduced to approximately 0.551 mm by using the inner space, thereby reducing the cross-sectional area of the above-mentioned space. In order to ensure that
It is difficult to fabricate such a narrow diameter and thin walled inner tubular body made of conventional stainless steel, and even if it were possible to fabricate it, sufficient flexibility could not be obtained. .

In the case of an intra-aortic balloon catheter for percutaneous insertion, the balloon 3 is wrapped around the inner tubular body 4 during wrapping to facilitate insertion, so that its outer diameter is equal to the outer diameter of the outer tubular body 2.
Generally, the outer tubular body 2 is absent from the outer tubular body 2 so that the outer diameter of the balloon 3 is approximately equal to the outer diameter of the outer tubular body 2 . That is, in this part, the bending resistance cannot be left to the outer tubular body 2. Therefore, in the present invention, this part (from the distal end member 5 to the vicinity of the proximal end of the balloon 3) is closely attached to the inner tubular body 4. It is desirable to provide a reinforcing member 13 on the outside thereof. This reinforcing member 13 can be made of either metal or plastic. Furthermore, by spirally deforming, flexibility and restorability are further improved.

Although the above description has been made with respect to an intra-aortic balloon catheter for adults, it is even more beneficial to apply it to a pediatric catheter in that the outer diameter of the catheter can be reduced. The outer diameter of a pediatric catheter is 1 to 2.5 m.
m, more preferably about 1.5 to 2 m, and the outer diameter of the inner tubular body is about 0.5 to 1 m, more preferably about 0.5 to 0.7+*m. good.

<Effects of the Invention> As explained above, according to the balloon catheter of the present invention, compared to conventional catheters, it is possible to obtain a small-diameter catheter that does not reduce the lumen cross-sectional area (and has sufficient flexibility). Therefore, complications caused by the structure of the catheter during IABP can be reduced, and the catheter can be easily inserted and removed.

[Brief explanation of drawings]

FIG. 1 is an overall side view, partially cut away, of the balloon catheter of the present invention. FIG. 2 is a partially enlarged side sectional view of the distal end portion of the catheter. Explanation of symbols 1...Balloon catheter 2...Outer tubular body 3...Balloon 4...Inner tubular body 41...Protrusion 5...Tip member 6...First hub 7... -Second hub 8...Second opening 9...Lumen 91...First opening 10...Branch hub 11...Lumen 12...Third opening 13...Reinforcement member Patent Applicant Teru Sen Co., Ltd. Company Representative
People Patent Attorney Ishi Kyodo

Claims (6)

[Claims] (1) an outer tubular body; an inner tubular body having a protrusion that passes through the outer tubular body and projects a predetermined length from the distal end of the outer tubular body; and an internal lumen; a distal end portion and a proximal end portion; a catheter having a distal end fixed to the inner tubular body and an expandable and deflated balloon fixed to the proximal end fixed to the outer tubular body, the inner tubular body having a hard plastic as a forming component; An intra-aortic balloon catheter characterized by: (2) The inner tubular body has an outer diameter of about 0.5 to 1.5 mm and a wall thickness of about 0.1 mm or less at least at a portion inserted into the outer tubular body. Balloon catheter. (3) The hard plastic has a tensile modulus of approximately 10 kg.
Claim 1 or 2, wherein the plastic material has a diameter of /mm^2 or more.
The intra-aortic balloon catheter described in . (4) The intra-aortic balloon catheter according to any one of claims 1 to 3, wherein the inner tubular body is formed of polyimide. (5) The intra-aortic balloon catheter according to any one of claims 1 to 4, wherein a reinforcing member is attached to the protrusion of the inner tubular body. (6) The intra-aortic balloon catheter according to claim 5, wherein the reinforcing member is a linear body, forms a spiral, and is sheathed on the protrusion of the inner tubular body.