JP5651257B2 - Catheter-type therapeutic / diagnostic instrument with stylet and catheter tube using stylet - Google Patents

Description

  The present invention relates to a catheter-type therapeutic instrument or diagnostic instrument that is formed by attaching a balloon or the like to the distal end of a catheter tube and is used for the treatment of valve stenosis by being inserted into a cardiovascular vessel.

  It has been reported that treatment using a balloon catheter is effective for aortic stenosis. For example, in Non-Patent Document 1, an antegrade approach is used to guide a guide wire passed through the right atrium, left atrium, left ventricle, aortic valve, and aorta in that order, and advance the Inoue balloon to the aortic valve position, where the valve Full dilation as well as valve formation has been described.

  However, this procedure is difficult to operate the catheter and guide wire and requires skill. For example, the guide wire must be looped 360 degrees or more in the heart, but the operation is extremely difficult. Also, it is not easy to insert the catheter tube along the looped guide wire. In particular, the left ventricle is relatively small, and the guide wire curves abruptly, and the catheter tube may not be able to advance there. In addition, when the guide wire or catheter tube is pulled out, the catheter tube is looped 360 °, so that the loop can only be reduced to a knot and the tip cannot move. At that time, the valve may be damaged.

www.ikegamihosp.jp/bumon/shinryou/pdf/PTAV.pdf

  The present invention has been made in view of such a problem, and when the catheter tube has to be inserted so as to be looped like a cardiovascular device, the operation can be easily and reliably performed more safely. The main objective of the present invention is to provide a catheter-type therapeutic / diagnostic instrument that can be used.

  That is, the treatment / diagnosis instrument according to the present invention includes a catheter tube inserted into the body, and a first formed wire and a second formed wire having predetermined bending elasticity that can be simultaneously inserted into the catheter tube. The first forming wire has a first curved portion that is curved in a natural state, and when inserted into the catheter tube, the first curved portion causes the catheter tube to be curved accordingly. The second forming wire has a second curved portion that is curved in a natural state, and when inserted into the catheter tube, the second curved wire portion bends the catheter tube accordingly. It is characterized by being.

  If this is the case, the catheter tube can be bent at two desired locations by advancing and retracting the two formed wires, so that the catheter can pass through each valve in the cardiovascular without the assistance of a guide wire, for example. Since the tube can be looped and the operability at that time is greatly improved, the treatment can be performed easily and reliably.

  In addition, since the bent shape of the catheter tube can be controlled by the formed wire, the catheter tube can be easily pulled out along substantially the same trajectory. Therefore, even if the catheter tube is looped, it is possible to reliably prevent a situation in which the loop diameter becomes small and the valve or the like is damaged when the catheter tube is pulled out.

In order to further improve the operability of the catheter tube, it is preferable that the formed wire is configured such that the bending degree of the first curved portion and the second curved portion are different.
Specific embodiments in which the effects of the present invention are more remarkable include those that are inserted into the cardiovascular and used for the treatment of heart diseases.
As a preferred embodiment, a balloon catheter in which a balloon is attached to the tip of the catheter tube can be mentioned.

  In order to insert two formed wires simultaneously into the catheter tube and to make both of them smoothly advance and retract, for example, the catheter tube has an outer tube and an inner tube for inserting a guide wire. It is desirable to have a double tube structure, and to be configured to insert the second forming wire into the inner tube and insert the first forming wire between the outer tube and the inner tube. .

  In order to reliably prevent the first forming wire from protruding from the catheter tube, a wire rod insertion tube with a sealed tip is disposed between the outer tube and the inner tube, and the wire rod insertion What is comprised so that a 1st formation wire may be inserted in a pipe | tube is suitable.

  In order to improve the operability in the cardiovascular system, it is preferable that the catheter tube is configured to be able to bend about 270 ° to 360 ° by the first and second curved portions.

In order to expand the scope of application to treatment and diagnosis of various locations and to further improve the operability, the first formed wire member is provided with a first curved portion that can change the degree of curvature by a hand operation. It is preferable to have it.
In this case, the first curved portion is not a fixed portion, but is preferably one that can be changed by a hand operation.

In order to bring the catheter tube to the aortic valve by the antegrade approach using such a therapeutic / diagnostic instrument, it is preferable to go through the following processes.
(1) The distal end portion of the catheter tube is passed from the right atrium to the left atrium through the atrial septum.
(2) The first formed wire and the second formed wire are inserted into the catheter tube, and a first bent portion is formed at a distal end portion of the catheter tube by the first curved portion, and the catheter is formed by the second curved portion. A second bent portion that is bent more gently than the first bent portion is formed on the base end side of the first bent portion of the tube.
(3) The catheter tube is advanced, the mitral valve is passed with the first bent portion as the head, and the distal end of the catheter tube reaches the left ventricle in a posture facing the aortic valve. In order to perform this operation easily, the second forming wire and the second curved portion accompanying it bend the catheter tube 180 degrees, and the catheter tube that advances from the inferior vena cava to the head side passes through the right atrium and enters the left atrium. Then, the mitral valve is passed through the operation of inserting and removing the catheter tube toward the mitral valve located in the caudal direction.
(4) The catheter tube is advanced, and the aortic valve is passed from the distal end thereof. In order to perform this operation easily, the first forming wire and the first curved portion associated therewith are placed in the vicinity of the left ventricular apex and the catheter tube is pushed forward to pass through the aortic valve.

In order to prevent unexpected movement of the catheter tube after insertion and to secure the catheter tube, the second formed wire is pulled out with the distal end portion of the catheter tube passing through the aortic valve. After the guide wire is inserted into the catheter tube and passed through the aortic valve, the distal end of the guide wire reaches the descending aorta.
In the step (1), it is also possible to insert the catheter tube into the body with at least one (preferably the first forming wire) inserted into the catheter tube.

  The medical instrument according to the present invention can be configured with a single formed wire. The formed wire in that case has a first curved portion that is curved in a natural state and a second curved portion that is curved with a degree of bending different from that of the first curved portion, and when inserted into the catheter tube, Desirably, the first and second curved portions bend the catheter tube at two locations accordingly.

  The catheter tube according to the present invention includes a guide wire insertion tube for inserting a guide wire, and a wire rod insertion tube for inserting the formed wire, and when the formed wire is inserted, the curve thereof Mention may be made of correspondingly curved parts. With such a configuration, the formed wire can be smoothly advanced and retracted by the wire insertion tube.

Further, as another embodiment, there may be mentioned one provided with an outer tube, an inner tube for inserting a guide wire, and a wire rod insertion tube disposed between the outer tube and the inner tube.
In addition, when there are a plurality of formed wire rods, a plurality of wire rod insertion pipes may be provided according to the number.

  According to the present invention configured as described above, the catheter tube can be bent at two desired locations by advancing and retracting the formed wire, so that the catheter can be passed through, for example, each valve in the cardiovascular without the assistance of a guide wire. Since the tube can be looped and the operability at that time is greatly improved, the treatment can be performed easily and reliably.

  In addition, since the bent shape of the catheter tube can be controlled by the formed wire, the catheter tube can be easily pulled out with substantially the same trajectory that has progressed. Therefore, even if the catheter tube is looped, it is possible to prevent a situation where the loop diameter becomes small and the valve or the like is damaged when the catheter tube is pulled out.

1 is an overall view showing a treatment / diagnosis instrument according to an embodiment of the present invention. The exploded view which shows the treatment / diagnostic instrument of the embodiment. The longitudinal cross-sectional view which shows the internal structure of the balloon and catheter tube in the embodiment. The cross-sectional view which shows the internal structure of the catheter tube in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. Method explanatory drawing which shows the insertion method to the heart of the treatment / diagnostic instrument in the embodiment. The cross-sectional view which shows the internal structure of the catheter tube in other embodiment of this invention. The figure which shows the stylet in further another embodiment of this invention. The figure which shows the stylet in further another embodiment of this invention.

  An embodiment of the present invention will be described with reference to the drawings.

  As shown in FIGS. 1 and 2, a catheter-type therapeutic instrument 100 according to this embodiment includes a catheter tube 10, a balloon 3 attached to the distal end of the catheter tube 10, and a base member attached to the proximal end of the catheter tube 10. 5 and two types of formed wire rods 1 and 2 (hereinafter also referred to as a first stylet 1 and a second stylet 2) inserted in the catheter tube 10 so as to be able to advance and retract.

  The catheter tube 10 basically has a double tube structure comprising an outer tube 11 and an inner tube 12 for inserting a guide wire 4, as shown in FIGS. In the form, two tubes are further inserted between the outer tube 11 and the inner tube 12. One is a drain pipe 14 for extracting air from the balloon 3, and the tip of the drain pipe 14 is disposed so as to open into the balloon 3. The other is a wire rod insertion tube 13 for inserting the first stylet 1, and its tip is sealed so that the stylets 1 and 2 inserted therein do not protrude.

  As shown in FIG. 3, the balloon 3 is mainly made of an elastic resin film (natural or synthetic resin) and is attached so as to cover the distal end portion of the outer tube 11. The inner tube 12 is provided so as to penetrate the balloon 3, and the balloon 3 is configured to expand in a bowl shape when an expansion liquid is pressed between the outer tube 11 and the inner tube 12. Note that the balloon 3 in this embodiment is a well-known balloon called the Inoue balloon 3, and a belt-like body (not shown) is provided in the middle part which is slightly less stretched than the other parts. When the inflation liquid is pressed into the Inoue balloon 3 by the action of the belt-like body, the first half first swells and then the second half swells into a bowl-like shape.

  As shown in FIG. 1 and the like, the base member 5 is formed of a hard resin material, and includes a base portion 51 connected to the catheter tube 10 and a plurality of branch portions 52 branched from the base portion 51. Yes. Each branch portion 52 is hollow, and is configured to communicate with the inner tube 12, the inner tube 12 and the outer tube 11, the drain tube 14, and the wire rod insertion tube 13.

  The stylets 1 and 2 are substantially inelastic in the length direction, and are made of, for example, Nitinol or stainless steel having a predetermined elastic restoring force against bending, as shown in FIG. As described above, curved portions 1a and 2a that are curved in a natural state are provided on the distal end side.

  The curved portion 1a of the first stylet 1 (hereinafter also referred to as the first curved portion 1a) and the curved portion 2a of the second stylet 2 (hereinafter also referred to as the second curved portion 2a) have different degrees of bending. . Here, the degree of bending of the first curved portion 1a is set to be tighter than the degree of bending of the second curved portion 2a.

  The rigidity of the stylets 1 and 2 with respect to bending is set to be stronger than that of the guide wire 4, and when these stylets 1 and 2 are inserted into the catheter tube 10, as shown in FIG. The portions corresponding to the curved portions 1a and 2a of the stylets 1 and 2, that is, the bent portions 10a and 10b are bent according to the degree of bending of the curved portions 1a and 2a, and the bent portions 10a and 10b are formed. It is configured to be.

More specifically, when the two stylets 1 and 2 are inserted into the catheter tube 10, the catheter tube 10 is bent by the first curved portion 1a and the second curved portion 2a as a whole by about 270 ° to 360 °. To do. In particular, the degree of bending of the catheter tube 10 by the first curved portion 1a is preferably about 150 ° to 180 ° facing the opposite direction, and may be set to be further bent to about 210 °.
Although not shown in the drawings, the tips of the stylets 1 and 2 are configured to be tapered and wound with a thin wire so that they are softer and easier to bend than other portions. This is to prevent damage to the inner wall of a blood vessel or the like. At the same time, the inside of the catheter tube can be moved smoothly.

  Next, an example of a method for treating, for example, aortic stenosis using the therapeutic instrument 100 having such a configuration will be described with reference to FIGS.

  First, as shown in FIG. 5, for example, a catheter tube 10 with a balloon is inserted from the inferior vena cava, and the balloon 3 is penetrated from the right atrium to the atrial septum to reach the left atrium. Note that the transatrial septal puncture method is used for penetration of the catheter tube 10 into the atrial septum.

  Next, as shown in FIG. 6, the first stylet 1 is inserted into the wire insertion tube 13 of the catheter tube 10 and the second stylet 2 is inserted into the inner tube 12 of the catheter tube 10. To the left atrium. At this time, the first curved portion 1a having a small curvature (tight) is inserted deeper than the second curved portion 2a, and the first bent portion 10a of the catheter tube 10 formed by the first curved portion 1a is It operates so that it may be located in the front end side rather than the 2nd bending part 10b of the catheter tube 10 formed of the 2 curved part 2a.

  As shown in the figure, the distal end portion of the catheter tube is J-shaped in the left atrium, and the first bent portion 10a is positioned at the top.

  Next, as shown in FIG. 7, the catheter tube 10 is further advanced together with the first stylet 1 to pass the mitral valve from the first bent portion 10 a to bring the balloon 3 to the left ventricle. In FIG. 7 and subsequent figures, the illustrations of stylets 1 and 2 are omitted for the sake of complexity. As a result, as shown in FIG. 8, the distal end of the balloon 3 (the distal end of the catheter tube 10) is in a posture facing the aortic valve in the left ventricle.

  Next, the stylets 1 and 2 are not moved, and only the catheter tube 10 is further fed. As a result, the balloon 3 travels on the bloodstream so as to be sucked toward the aortic valve, and passes through the aortic valve as shown in FIG.

  From this state, the guide wire 4 is replaced with the second stylet 2 and inserted into the inner tube 12 to extend from the distal end of the balloon 3, and as shown in FIG. Lead to the aorta. This stabilizes the catheter tube 10.

  Next, as shown in FIG. 11, the first stylet 1 is fixed in place, and the balloon 3 is pulled down by slightly pulling the catheter tube 10 and positioned on the aortic valve. Alternatively, the balloon 3 can be pulled down by fixing the base portion of the catheter tube 10 in place and pushing the first stylet 1 slightly. In FIG. 11 and subsequent figures, the guide wire 4 in the catheter tube 10 is not shown.

  Then, as shown in FIG. 12, after inflating the inflation liquid, only the first half of the balloon 3 is inflated. Using this as an anchor, the balloon 3 is positioned more accurately, and then the inflation liquid is further infused. The latter half of the bulge is also inflated, pushing the stenosis of the aortic valve. At this time, the balloon 3 may not be inflated to the maximum diameter all at once, but the expansion diameter may be gradually increased while repeating expansion and contraction.

  After the treatment of the stenosis site is finished, the guide wire is pulled out after the balloon 3 is contracted. Then, only the catheter tube 10 is retracted without moving the first stylet 1. As a result, the balloon 3 leaves the aortic valve and returns to the left ventricle, resulting in the state shown in FIG.

Next, as shown in FIG. 14, the first stylet 1 is pulled out to release the first bent portion 10a, and then the catheter tube 10 is pulled out of the body.
In the above operation, it goes without saying that the catheter tube 10 and the stylets 1 and 2 may be moved slightly in order to correct the shift due to the movement of the heart.

  Thus, according to such a configuration, the balloon 3 can be easily brought to the aortic valve by bending the catheter tube 10 at a desired site only by operating the two stylets 1 and 2. In particular, instead of passing the mitral valve from the balloon 3, the point is that the mitral valve is passed with the first bent portion 10a bent in advance so that the balloon 3 faces the aortic valve. Thus, since the catheter tube 10 is not bent in the left ventricle having a relatively small volume, the treatment becomes extremely easy.

  In addition, the balloon 3 is stabilized by the guide wire 4 on the aortic valve, but this guide wire 4 is inserted by being guided by the catheter tube 10 contrary to the conventional case, so that the guide wire 4 is inserted into the heart. Thus, complicated and difficult operations such as looping 360 degrees are not required.

  Furthermore, since the loop shape of the catheter tube 10 is maintained by the stylets 1 and 2, the catheter tube 10 can be easily and easily pulled out from the aortic valve.

  The present invention is not limited to the above embodiment.

For example, the fixing guide wire 4 is not always necessary.
Also, which stylet is inserted into which tube of the catheter tube can be variously changed. For example, in the above-described embodiment, the first stylet is inserted into the wire rod insertion tube. However, the first and second stylets may be inserted into the inner tube so that the inner tube also serves as the first stylet. Alternatively, two stylets may be inserted between the outer tube and the inner tube, and the inner tube may be a dedicated tube for inserting a guide wire. In that case, two wire rod insertion pipes may be provided to insert each stylet. This eliminates the need to pull out the stylet when inserting the guide wire.

The catheter tube is not limited to a double tube, and as illustrated in FIG. 15, for example, an expansion liquid introduction tube 16, a guide wire insertion tube 17, a wire rod insertion tube 13, and the like may be provided in parallel.
In order to insert the catheter tube 10 from the left ventricle into the aortic valve, there is a method of retracting the first stylet 1.
Three or more stylets may be used, or only one stylet having two or more curved portions 1a and 2a may be used as shown in FIG.
The branching angle and shape of the branch part 52 may be made looser or curved than in FIG. 1 in order to make the stylet move smoothly.

Further, for example, the first stylet 1 may be capable of changing the degree of bending by a hand operation. Specifically, for example, as shown in FIG. 17, the first stylet 1 is composed of a core material X1 and a flexible tube (such as a coil) X2 disposed around the core material X1. The thing joined to the front-end | tip of the flexible tube X2 can be mentioned. If it is such, it can curve according to the distance which the 1st stylet 1 pulled by pulling core material X1 by a hand. With such a configuration, it is possible to expand the scope of application to treatment and diagnosis at various locations and to further improve operability.
In this case, the first curved portion is not a fixed portion, but is preferably one that can be changed by a hand operation.

  Not only balloons but also artificial valves, stent grafts, stents, filters, and the like can be attached to the tip of the catheter tube. In order to replace the aortic valve with a prosthetic valve, conventionally, the femoral artery or the left ventricular apex has been approached and a prosthetic valve is implanted into the aorta via a catheter. It is also possible to perform treatment with the sexual approach.

  The advantages of the transvenous approach are described below. When the catheter tube for treatment (relatively thick and hard) is passed through the femoral artery and passes through the aortic arch to the aortic valve, sclerotic lesions and blood clots on the aortic wall peel off and flow into the cerebral blood vessels, causing cerebral infarction There is a risk of causing. On the other hand, the method of reaching the aortic valve via the femoral vein (via the inferior vena cava) has very little risk. At the same time, the method via the femoral artery requires an open surgical operation of the femoral artery for insertion of the catheter tube. However, in the method via the femoral vein, the catheter tube is inserted into the vein by the puncture method, that is, percutaneously catheterized. Insertion is possible, and open surgery is not necessary. If the catheter tube is relatively thin, it can be inserted into the femoral artery using a puncture technique even when it is via the femoral artery. In the case of pressure, a large amount of bleeding may occur. On the other hand, postoperative hemostasis after inserting the same catheter tube into the hip vein by puncture method is completed in a very short time. Therefore, the patient's pain, operation time, and rest time after operation are greatly reduced. In addition, in the elderly, the femoral artery is often accompanied by stenosis and bending due to arteriosclerotic lesions, and the catheter tube cannot be inserted, or complications such as vascular damage and occlusion are observed at the time of insertion. If it is via veins, there is no such annoying problem.

In view of the above-mentioned advantages, if this method is applied, the catheter tube can be easily and safely transvenously and antegradely inserted into the heart, the aortic valve, the coronary artery, the whole aorta, and the branching blood vessels, carotid artery, and brain. The catheter can be inserted into a blood vessel or the like, and accordingly, catheter treatment can be performed transvenously and antegradely in each region. This opens up new perspectives for future catheter treatment and is expected to make a significant contribution to its development.
Although the catheter type therapeutic instrument having the stylet has been described above, the present case can also be applied to a catheter type diagnostic instrument in which, for example, an endoscope or an ultrasonic device is attached to the distal end of the catheter tube. Moreover, it is an important diagnostic method to obtain the Inoue findings under fluoroscopy simply by injecting a contrast medium through the catheter through-hole.
Furthermore, the present invention is applicable not only to cardiovascular but also to other sites.
In addition, the present invention can be variously modified without departing from the spirit of the present invention.

100 ... Treatment device (treatment / diagnosis device)
DESCRIPTION OF SYMBOLS 10 ... Catheter tube 10a ... 1st bending part 10b ... 2nd bending part 11 ... Outer tube 12 ... Inner tube (wire material insertion tube)
13 ... Wire rod insertion tube 1 ... First formed wire rod (first stylet 1)
1a ... first curved portion 2 ... second formed wire (second stylet 2)
2a ... second curved portion 3 ... balloon 4 ... guide wire

Claims (9)

Inserted into the cardiovascular and used for the treatment or diagnosis of cardiovascular disease,
A catheter tube to be inserted into the body, and at least two formed wires having a predetermined bending elasticity;
Of these, the first forming wire has a first curved portion that is curved in a natural state, and when inserted into the catheter tube, the first curved portion is configured to bend the catheter tube accordingly.
The second formed wire has a second curved portion that is curved in a natural state, and when inserted into the catheter tube, the second curved portion causes the catheter tube to be curved accordingly.
The treatment / diagnosis instrument characterized in that the catheter tube can be bent at 270 ° or more by the first curved portion and the second curved portion .   The therapeutic / diagnostic instrument according to claim 1, wherein the first curved portion and the second curved portion are configured to have different bending degrees. The treatment / diagnosis instrument according to claim 1 or 2, which is a balloon catheter having a balloon attached to a tip of the catheter tube. The catheter tube has a double tube structure having an outer tube and an inner tube for inserting a guide wire, and the first forming wire is inserted between the outer tube and the inner tube, The treatment / diagnosis instrument according to any one of claims 1 to 3, wherein the second formed wire is configured to be inserted into the inner tube. Yes wire insertion tube sealed tip is disposed between the outer and inner tubes, 1 to claim are configured such that the first forming wire is inserted into該線member insertion tube 4. The therapeutic / diagnostic device according to any one of 4 . Inserted into the cardiovascular and used for the treatment or diagnosis of cardiovascular disease,
Comprising a catheter tube to be inserted into the body and at least two formed wires;
Of these, the first forming wire has a first curved portion that can change the degree of curvature by a hand operation, and when inserted into the catheter tube, the first curved wire causes the catheter tube to be deformed by the first curved portion. It is curved accordingly,
The second formed wire has a second bending portion that has a predetermined bending elasticity and is bent in a natural state, and when inserted into the catheter tube, the second bending portion causes the catheter tube to be bent accordingly. Is,
The treatment / diagnosis instrument characterized in that the catheter tube can be bent at 270 ° or more by the first curved portion and the second curved portion .   In a catheter tube inserted into a cardiovascular and used for treatment or diagnosis of a heart / vascular disease,
  A first formed wire having a first bending portion having a predetermined bending elasticity and bending in a natural state, and a second forming portion having a second bending portion having a predetermined bending elasticity and bending in a natural state. The forming wire is inserted,
  A catheter tube configured to be able to be bent at 270 ° or more by the first curved portion and the second curved portion. The catheter tube according to claim 7 , further comprising a guide wire insertion tube for inserting a guide wire, and a wire rod insertion tube for inserting the formed wire rod. The catheter tube according to claim 8, wherein the wire insertion tube has a sealed end.