JP3797699B2 - Balloon catheter - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a balloon catheter used by being inserted into a blood vessel.
[0002]
[Prior art]
Conventionally, IABP (intra-aortic balloon pumping) has been widely used as a simple auxiliary circulation method for the reduction of left heart function due to acute myocardial infarction, heart failure after cardiac surgery, low cardiac output syndrome, and the like. This IABP assists the cardiac function by inserting a balloon catheter into the aorta and deflating and expanding (pumping) the balloon provided on the distal end side thereof. A method is employed in which helium gas is sent from outside the body into the balloon through the catheter shaft to expand the balloon, and conversely, the balloon is deflated by sucking the helium gas in the balloon through the catheter shaft.
[0003]
[Problems to be solved by the invention]
By the way, balloon explosion can be mentioned as the biggest complication in IABP. If the balloon ruptures for some reason during IABP, helium gas will flow into the aorta, causing problems such as gas embolization that blocks the thin blood vessels. And in the worst case, it can lead to the death of the patient. For this reason, research has been conducted on the film thickness and materials of balloons, which are less prone to rupture, and they have been adopted.
[0004]
However, balloon rupture has not yet been completely prevented, especially in patients with calcification in the aorta, where the surface of the calcified part is not always smooth and has a sharp pointed state. In many cases, the risk of balloon rupture is high, and further improvement of the balloon catheter has been desired in the medical field.
[0005]
In order to cope with such a demand, the present inventor conducted a detailed investigation on a case where balloon rupture actually occurred. As a result, balloon rupture is mostly caused by local contact wounds, and balloon rupture does not occur immediately after IABP (within 2 days empirically). It has been found that it tends to occur when a period of about one week has passed. And as estimated from these facts, the contact damage of the ruptured balloon is caused by the long contact between the calcified portion protruding sharply in the blood vessel and the balloon local portion, and avoids the contact for a long time. If possible, it was expected that the continuous service life of the balloon would be extended more than ever.
[0006]
The present invention has been completed on the basis of the above findings, and the purpose thereof is a balloon that is less likely to cause balloon rupture for a relatively long period of time and can be applied to a patient having a severe calcified portion in a blood vessel. It is to provide a catheter.
[0007]
[Means for Solving the Problems]
In order to achieve the above object, the balloon catheter according to claim 1 comprises:
A long, tube-like, flexible, bendable catheter shaft, a balloon provided on the distal end side of the catheter shaft, which is expanded / contracted by gas supplied and discharged through the lumen of the catheter shaft, In a balloon catheter provided with a connector provided on the proximal end side of the catheter shaft, for connection with the gas supply device, etc.,
A mounting part that is relatively immovable to the human body;
A rotating part that is rotatably provided in the attachment part, and the catheter shaft or the connector is fixed, and rotates the balloon as it rotates,
A fixed screw that fixes the rotating portion with respect to the mounting portion at all times and releases the fixing as necessary to rotate freely.
The rotary part has a fixed position of the plural kinds which are set in advance, is configured to be displaced to the locking position each time rotates by a predetermined angle, moreover, the fixing screw, the rotating portion of the plurality Street The rotating part can be fixed when displaced to any one of the fixed positions.
[0009]
The balloon catheter of claim 2 wherein the
A long, tube-like, flexible, bendable catheter shaft, a balloon provided on the distal end side of the catheter shaft, which is expanded / contracted by gas supplied and discharged through the lumen of the catheter shaft, In a balloon catheter provided with a connector provided on the proximal end side of the catheter shaft, for connection with the gas supply device, etc.,
A mounting part that is relatively immovable to the human body;
A rotating part that is rotatably provided in the attachment part, and the catheter shaft or the connector is fixed, and rotates the balloon as it rotates,
Rotating part driving means for rotating the rotating part continuously or intermittently by a predetermined angle as time elapses is provided.
[0010]
Further, the balloon catheter of claim 3, wherein, in the balloon catheter of claim 1 or claim 2,
A twist detection marker that is formed of a radiopaque material on one or both of the balloon and the catheter shaft and that can detect the twist of the balloon or the catheter shaft according to a displacement state when the rotating portion is rotated. It is characterized by having.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
In the balloon catheter of the present invention, the balloon portion is inserted into the body in the same manner as the conventional one, and the attachment portion is attached so as not to move relative to the human body outside the body near the insertion site of the balloon catheter. The attaching portion is provided with the rotating portion, and a catheter shaft or a connector is fixed to the rotating portion. When the rotating part is rotated in this state, the catheter shaft or connector fixed to the rotating part is also rotated at the same time, and this rotation is transmitted to the balloon via the catheter shaft.
[0012]
Therefore, before the specific part of the balloon and the specific part in the blood vessel are kept in contact for an excessively long time (for example, two days or more), the balloon is rotated in the body, so that the balloon is locally loaded. Can be moved to another rotational position to avoid excessive fatigue in the local area. As a result, even if this balloon catheter is applied to a patient who has a sharp calcified portion in the blood vessel, the fatigue point of the balloon can be released to another position before the balloon ruptures. As compared with the case where the balloon is used as it is, the balloon can be prevented from bursting for a longer period.
[0013]
In this balloon catheter, the attachment portion is attached so as not to move relative to the human body. For example, it can be directly sutured to the skin surface of the human body or can be attached to the human body relatively immovably. A method of attaching to a member can be employed.
[0014]
In addition, a catheter shaft or a connector is fixed to the rotating portion. In the case of the catheter shaft, the catheter shaft is fixed to a portion exposed to the outside when inserted into the body.
By the way, If you rotate the balloon to a specific angle, or return to the original rotation angle against the will, it should be so as not or rotating in the rotation angle unexpected.
[0015]
In this respect, since the balloon catheter according to claim 1 includes the fixing screw as described above, the fixing of the rotating portion by the fixing screw is released as necessary, and the rotating portion is placed in any of a plurality of fixing positions. The rotating portion can be fixed to the mounting portion at the fixed position. If Sonaere such fixing screws, it is possible to fix the rotational portion mounting portion, although inadvertently fixed to be never released, be a structure that can be released freely fixed by a simple operation I can .
[0016]
According to the second aspect of the present invention , the rotating unit driving means rotates the rotating unit by a predetermined angle with time. The rotating position of the rotating part is not necessary to be changed to an unspecified angle due to disturbance factors such as patient movement, but the rotating position displaced by the rotating part driving means is a fixed amount of displacement per unit time, so there is no problem. There is no. The rotation of the rotating part may be continuously rotated or intermittently rotated at a predetermined angle by a predetermined angle.
[0017]
To rotate continuously, use a motor or the like as the drive source, reduce the rotation speed by a combination of gears, etc., and make one rotation (360 degrees) over the period of use of this balloon catheter (for example, one week). Move at a rotating speed. The rotation speed is not necessarily limited to one rotation. For example, it is considered that the load applied to the local area is dispersed even when the number of rotations is two or more, and prevention of balloon bursting can be expected. However, in view of the fact that there is no meaning of rotating too quickly, and that there is a possibility that an extra burden is placed on the patient, it is desirable not to increase the rotation speed excessively. In addition, for example, even when only an angle of less than 360 degrees is rotated, the load applied to the local area is considered to be correspondingly distributed as compared to a case where the angle is not rotated at all, and prevention of balloon bursting can be expected. However, in order to disperse the load applied to the local area over the entire circumference as much as possible, it is advantageous to rotate it one or more times.
[0018]
In order to rotate intermittently, a stepping motor or the like is used as a drive source, and the rotating part is rotated by a predetermined angle at a predetermined timing (for example, every hour or every day). Good.
By the way, the balloon catheter of the present invention rotates the part exposed to the outside of the body and transmits the rotation to the balloon. The characteristic that torque can be satisfactorily transmitted to the balloon is required. In order to improve such torque transmission characteristics, the catheter shaft itself is replaced with a relatively soft material (for example, polyurethane, nylon, etc.), and a relatively hard material (for example, metal, polyimide, fluororesin, etc.). ), A method in which a resin tube reinforced with a metal mesh or metal spring is used for the catheter shaft, or a special jig that resists twisting is inserted into the guide wire lumen when rotating. A method of temporarily fixing both ends of the balloon catheter, rotating the balloon catheter integrally, and then pulling out the jig may be employed. The degree of rigidity required for torsion depends on various factors such as the difference in contact state due to the relationship between the balloon diameter and the blood vessel diameter, and the difference in the curved state of the catheter shaft due to the meandering blood vessel. However, it is necessary to select or combine the most suitable means appropriately depending on the patient.
[0019]
Whether or not the balloon catheter is rotating without twisting is convenient because it can be determined by observing the displacement state of the twist detection marker with X-rays by configuring as described in claim 3 . The twist detection marker may be of any specific shape as long as it satisfies the intended function. For example, the twist detection marker may be axially formed by a radiopaque material on the outer periphery from the catheter shaft to the balloon. It is possible to determine the occurrence of torsion by drawing a straight line extending in a straight line and observing how the straight line bends. Also, the same function can be achieved by arranging points at equal intervals instead of a straight line or drawing some pattern.
[0020]
[Concrete example]
Next, in order to further clarify the embodiment of the present invention, a specific example of the balloon catheter of the present invention will be described based on the drawings. The specific examples described below are merely examples of the embodiments of the present invention, and the embodiments of the present invention are not limited to the specific examples illustrated below.
[0021]
As shown in FIG. 1A, the balloon catheter 1 includes a tip 2, a balloon 3, an inner tube 4, an outer tube 5, a Y connector 6, a balloon position detection marker 7, and the like. A first lumen that penetrates to the distal end of the distal tip 2 through the lumen of the tube 4 and the inside serves as an insertion path for a guide wire (not shown), the inner tube 4 and the outer tube 5 from the inflation port 9 Is a well-known double lumen type that includes a second lumen that communicates with the interior of the balloon 3 through a gap between the second lumen and the inside of the balloon 3.
[0022]
Further, as a characteristic configuration of the balloon catheter 1, the proximal end side of the outer tube 5 is attached to an attachment portion 11 that is sewn to the skin and attached relatively immovably to the human body, and rotates to the attachment portion 11. The rotating part 13 to which the outer tube 5 is fixed and the fixing screw 15 that can be screwed into the mounting part 11 and can maintain the rotation angle of the rotating part 13 at a specific angle are provided. A twist detection marker 17 formed by drawing a straight line with a radiopaque material is provided on the outer periphery of the balloon 3 and the outer tube 5.
[0023]
Among these, the attachment part 11 has a thread hole 11b for passing a suture thread through the wing parts 11a on both sides, and as shown in FIGS. 1B and 1C, the rotating part 11b. 13 has a bearing hole 11c into which the screw 13 is inserted, and a screw hole 11d into which the fixing screw 15 is screwed. The rotating portion 13 includes a shaft portion 13a fitted into the bearing hole 11c and an operation portion 13b with a scale. The shaft portion 13a has a fixing screw 15 at a position corresponding to the scale of the operation portion 13b. A recess 13c into which the tip 15a is fitted is formed. In this specific example, the recesses 13c are formed at eight positions on the entire circumference every 45 degrees, and the scales corresponding to the recesses 13c are marked with numerical values 1 to 8 to identify the rotation position of the rotation unit 13. It can be done. In addition, a through hole 13d is formed in the rotating portion 13, and the outer tube 5 is passed through the through hole 13d, and the outer tube 5 and the rotating portion 13 are fixed by an adhesive.
[0024]
The fixing screw 15 is screwed into the screw hole 11 d of the mounting portion 11, the tip 15 a protrudes into the bearing hole 11 c, and the tip 15 a is fitted into the recess 13 c of the rotating portion 13. As a result, the fixing screw 15 plays a role of preventing the rotation of the rotating portion 13 and preventing the rotating portion 13 from coming off the mounting portion 11.
[0025]
Next, the usage method of this balloon catheter 1 is demonstrated.
First, the inside of the balloon 3 is set to a negative pressure by sucking with a syringe or the like through the inflation port 9 of the balloon catheter 1. Then, a blood vessel (for example, a femoral artery) is punctured using the puncture needle, a guide wire is inserted into the blood vessel through the lumen of the puncture needle, and the puncture needle is pulled out. Next, a dilator is inserted along the guide wire, the punctured hole is sufficiently widened, and the dilator is pulled out. Here, in the case of an insertion method without using a sheath, the balloon catheter 1 is inserted into the blood vessel along the guide wire, and the balloon catheter 1 is pushed to a target position (for example, in the aorta). In the case of an insertion method using a sheath, the dilator and the sheath are inserted as a set, and when the sheath is inserted to a predetermined position, the dilator is pulled out and the balloon catheter 1 is inserted into the sheath. Push forward to the position. When the balloon catheter 1 reaches the target position in this way, the attachment portion 11 is sutured and fixed to the patient's skin. Then, a known air driving device or the like is connected to the inflation port 9 of the balloon catheter 1, and IABP is performed.
[0026]
Now, when 24 hours have passed since the start of the IABP, the fixing screw 15 is loosened, the rotating part 13 is rotated by one scale (that is, 45 degrees), and the fixing screw 15 is tightened again. As a result, the entire balloon catheter 1 rotates 45 degrees, and even if a part of the balloon 3 is in contact with the sharp calcified portion, the contact position is shifted and comes into contact with another portion. Whether or not the entire balloon catheter 1 has been successfully rotated can be determined by confirming the bending state of the torsion detection marker 17 with an X-ray image. If it does not rotate well, a wire-like jig is inserted from the guide wire port 8 and the twist is eliminated by applying a rotational torque also from the inner side of the inner tube 4.
[0027]
Thus, if the rotating part 13 is rotated every 24 hours, the specific part of the balloon 3 and the specific part in the blood vessel move to another rotational position before continuing to contact for 24 hours or more. Even if this balloon catheter 1 is applied to a patient having a sharp calcified portion in a blood vessel, the fatigue point of the balloon 3 can be relieved to another position before the balloon ruptures. The balloon is not ruptured as compared with the case where the lens is not rotated.
[0028]
Incidentally, in the case of this balloon catheter 1, it is rotated once in 8 days by a rotating operation once a day. Usually, since IABP is frequently used for about 3 to 7 days, the balloon catheter 1 can be used in many cases. When used for a longer period of time, even if the present balloon catheter 1 is rotated beyond 360 degrees, it is less likely to cause balloon rupture than the conventional balloon catheter.
[0029]
Although specific examples of the present invention have been described above, various specific configurations of the present invention are possible in addition to the specific examples.
For example, in the above specific example, an example in which the rotating unit 13 is manually operated once a day to rotate is shown, but instead of the recess 13c of the rotating unit 13, a gear unit 13e is formed as shown in FIG. The rotational speed of the motor 21 is reduced by the gear box 23 containing a large number of gears, and the gear 25 fitted in the output shaft of the gear box 23 is engaged with the gear part 13e. It may be changed. In this case, the rotational angle displaced per unit time can be set in any way by the combination of the rotational speed of the motor 21 and the reduction ratio of the gear box 23. Normally, the rotational angle is 1 over the period of use of the balloon catheter. It is desirable to set it to rotate. 2 is provided with a stopper 27 for the rotating portion 13 so that an unnecessary load is not applied to the gear 25.
[0030]
In the above specific example, the rotating portion 13 is fixed to the outer tube 5, but as shown in FIG. 3, the mounting portion 31, the rotating portion 33, and the fixing screw 35 that are used by fixing the Y connector 6, The intended purpose can be achieved.
Further, in the above-described specific example, the rotating unit 13 is fixed by rotating 45 degrees. However, various divisions of the rotation angle can be set. For example, if the rotating part 13 is fixed by rotating 10 degrees, 36 fixed positions are possible. The position can be obtained, and it can be used for 36 days with a rotation operation once a day, or 6 days with a rotation operation 6 times a day.
[0031]
In the above specific example, a double lumen type balloon catheter has been described as an example. However, even a single lumen type has the same effect in preventing balloon rupture.
[0032]
【The invention's effect】
As described above, according to the balloon catheter of the present invention, since balloon rupture is less likely to occur for a relatively long period of time, it is safer than before and can be applied to a patient having a severe calcification portion in a blood vessel. it can.
[Brief description of the drawings]
FIG. 1 shows a balloon catheter of a specific example, in which (a) is a front view thereof, (b) is a cross-sectional view taken along line AA, and (c) is a cross-sectional view taken along line BB.
FIG. 2 is a cross-sectional view showing a main part of a balloon catheter as another specific example.
FIG. 3 shows a main part of a balloon catheter as still another specific example, in which (a) is a longitudinal sectional view thereof, and (b) is a sectional view taken along the line CC.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 ... Balloon catheter, 2 ... Tip, 3 ... Balloon, 4 ... Inner tube, 5 ... Outer tube, 6 ... Y connector, 7 ... Balloon position detection marker, 8 ... Guide wire port, 9 ... Inflation port, 11 ... Mounting part, 11a ... Wing part, 11b ... Yarn hole, 11c ... Bearing hole, 11d ... Screw Hole, 13 ... Rotating part, 13a ... Shaft part, 13b ... Operation part, 13c ... Recessed part, 13d ... Through hole, 15 ... Fixing screw, 15a ... Tip, 17 ... Twist detection marker.

Claims (3)

A long, tube-like, flexible, bendable catheter shaft, a balloon provided on the distal end side of the catheter shaft, which expands / contracts with a gas supplied / exhausted through the lumen of the catheter shaft, In a balloon catheter provided with a connector provided on the proximal end side of the catheter shaft, for connection with the gas supply device, etc.,
A mounting part that is relatively immovable to the human body;
A rotating part that is rotatably provided in the attachment part, and the catheter shaft or the connector is fixed, and rotates the balloon as it rotates,
A fixed screw that fixes the rotating portion with respect to the mounting portion at all times and releases the fixing as necessary to rotate freely.
The rotating unit has a plurality of preset fixed positions, and is configured to be displaced to the fixed position every time the rotating unit rotates by a certain angle. In addition, the fixing screw includes the plurality of rotating units. A balloon catheter configured to be able to fix the rotating portion when displaced to any one of the fixed positions. A long, tube-like, flexible, bendable catheter shaft, a balloon provided on the distal end side of the catheter shaft, which expands / contracts with a gas supplied / exhausted through the lumen of the catheter shaft, In a balloon catheter provided with a connector provided on the proximal end side of the catheter shaft, for connection with the gas supply device, etc.,
A mounting part that is relatively immovable to the human body;
A rotating part that is rotatably provided in the attachment part, and the catheter shaft or the connector is fixed, and rotates the balloon as it rotates,
A balloon catheter, comprising: a rotating part driving means for rotating the rotating part continuously or intermittently by a predetermined angle as time elapses. The balloon catheter according to claim 1 or 2,
A twist detection marker that is formed of a radiopaque material on one or both of the balloon and the catheter shaft and that can detect the twist of the balloon or the catheter shaft according to a displacement state when the rotating portion is rotated. A balloon catheter comprising:

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