WO2018180491A1 - Parison production method and parison production apparatus - Google Patents

Abstract

[Problem] To produce a balloon having a symmetrical shape between one end side thereof and the other end side thereof. [Solution] The present invention pertains to a method for producing a parison which is used to produce a balloon used for a balloon catheter and which has an extension part at both ends of a straight barrel part thereof. This method comprises: a fixation step (A) for fixing, by means of a fixation mechanism 60, a portion of the part of a straight-pipe parison tube 1 that is to be formed into the straight barrel part; a heating step (B) for simultaneously heating a portion on one end side beyond the part of the parison tube 1 to be formed into the straight barrel part and a portion on the other end side beyond the part of the parison tube 1 to be formed into the straight barrel part; and a stretching step (C) for simultaneously stretching, by applying a tensional force to both ends of the parison tube 1, the portions of the parison tube 1 that have been heated in the heating step.

Description

PARISON MANUFACTURING METHOD AND PARISON MANUFACTURING DEVICE

The present invention relates to a parison manufacturing method for manufacturing a balloon included in a balloon catheter used for IABP (intra-aortic balloon pumping) and the like, and a parison manufacturing apparatus suitable for carrying out the manufacturing method.

IABP (intra-aortic balloon pumping) is performed as a treatment for lowering cardiac function, in which a balloon catheter is inserted into the aorta and the balloon is expanded and contracted in accordance with the pulsation of the heart to assist the cardiac function. An IABP balloon catheter used for IABP is inserted from the femoral artery or the like, and is used in a state where the balloon is placed in the descending aorta of the chest.

The balloon used for such an IABP balloon catheter has a cone portion (shoulder portion) formed in a tapered shape at both ends of the straight barrel portion, and a straight barrel neck portion at the tip of each cone portion. Each has an arranged shape. The balloon is mounted by attaching the neck portion to the outer surface of the catheter sheath.

Such a balloon is manufactured by biaxial stretch blow molding of a parison (tube) formed into a tubular shape by extrusion molding. As a manufacturing technique of the parison for that purpose, although it relates to a balloon catheter for PTCA (angioplasty), not a balloon catheter for IABP, the one described in Patent Document 1 is known.

In this technique, in order to improve the uniformity of the film thickness of the balloon, as a parison used for blow molding, a both-ends different diameter (thin diameter) tube whose both end parts are made thinner than the straight body part is used. . According to Patent Document 1, in the case of extrusion molding, both ends have different diameters by appropriately changing and controlling the extrusion conditions by the extruder, the take-up conditions by the take-up machine, and the like by alternately forming thin portions and thick portions. Manufactured.

As another method of manufacturing such a both-end deformed tube, a method in which portions near the both ends of a tube formed into a straight tube shape by extrusion molding are heated and stretched is put into practical use. In this method, a part of one end side of a tube formed in a straight tube shape is heated with a heating mold, tension is applied to both ends of the tube, the heated part on one end side is stretched, and then cooled. Subsequently, a part on the other end side of the tube is similarly heated with a heating mold, and tension is applied to both ends of the tube to extend the heated part on the other end side, and then the tube is cooled.

Thus, conventionally, after performing the first stretching for heating, stretching and cooling a part of one end side of the tube, the second stretching for heating, stretching and cooling a part of the other end side is performed by the first stretching. The stretching is performed under substantially the same conditions as the setting conditions (heating temperature, heating time, stretching speed, stretching length, cooling time, etc.) during stretching. Here, it is preferable that one end side and the other end side in the longitudinal direction of the balloon are symmetrical to each other, and therefore, the parison is also preferably symmetrical.

However, when the one end side and the other end side are sequentially stretched as in the prior art, at the time of the second stretching, there is an influence of the portion stretched by the first stretching, and the environmental conditions (atmosphere over time) It is difficult to make the actual stretching conditions the same in the first stretching and the second stretching, so that each stretched portion (stretched portion) does not have a symmetrical shape with each other. There was a case. Although it is theoretically possible to make the setting conditions for the second stretching different from the setting conditions for the first stretching (adjusted appropriately) so that they are symmetrical with each other, In order to influence each other, in practice, obtaining the optimum conditions requires a very complicated operation and is not practical.

JP 2001-321444 A

The present invention has been made in view of such a situation, and the object thereof is suitable for carrying out a method for manufacturing a parison capable of manufacturing a balloon having a symmetrical shape on one end side and the other end side thereof and the method. Is to provide a simple parison manufacturing apparatus.

The parison manufacturing method according to the first aspect of the present invention includes:
A method for producing a parison having stretched portions at both ends of a straight body portion for producing a balloon used for a balloon catheter,
A fixing step of fixing a part of the straight barrel portion of the straight tubular parison tube;
A heating step of simultaneously heating a part on one end side and a part on the other end side than the part to be the straight body part of the parison tube;
A stretching step in which tension is applied to both ends of the parison tube to simultaneously stretch the portion heated in the heating step of the parison tube.

In the parison manufacturing method according to the first aspect of the present invention, since a part of the straight body portion of the parison tube is fixed and heated and stretched, one stretched portion is stretched to the other. Can be prevented from being affected, and is not affected by environmental changes over time. For this reason, the symmetry of the shape of one extending portion and the other extending portion can be improved. Therefore, it is possible to manufacture a parison with good quality and, consequently, a balloon without requiring complicated work. Moreover, by heating and extending | stretching simultaneously, compared with the case where it performs sequentially, the time which manufacture requires can be shortened and productivity can also be improved.

The parison manufacturing apparatus according to the second aspect of the present invention is:
A device for manufacturing a parison having extended portions at both ends of a straight body portion for manufacturing a balloon used for a balloon catheter,
A pair of first fixing mechanisms for releasably fixing both ends of a straight tubular parison tube;
A pair of second fixing mechanisms for releasably fixing a part on one end side and a part on the other end side of the portion to be the straight body part of the parison tube;
A part of a portion between the first fixing mechanism and the second fixing mechanism fixed to one end side of the parison tube, and the first fixing mechanism and the second fixing mechanism fixed to the other end side are fixed. A pair of heating molds that simultaneously heat each part of the part between the parts in a non-contact manner;
A stretching mechanism for simultaneously stretching the pair of first fixing mechanisms so as to separate each other and stretching the parison tube.

The parison manufacturing apparatus according to the second aspect of the present invention provides a parison manufacturing apparatus that can suitably implement the parison manufacturing method according to the first aspect of the present invention.

FIG. 1 is a front view of a parison tube as a base material for producing a parison according to an embodiment of the present invention. FIG. 2 is a front view of a parison manufactured by heating and stretching the parison tube shown in FIG. FIG. 3 is a front view of an IABP balloon manufactured by biaxial stretch blow molding of the parison shown in FIG. FIG. 4 is a cross-sectional view of an IABP balloon catheter manufactured using the IABP balloon shown in FIG. FIG. 5 is a diagram showing a process for manufacturing a parison according to an embodiment of the present invention. FIG. 6A is a front view illustrating a schematic configuration of a parison manufacturing apparatus suitable for performing the parison manufacturing process illustrated in FIG. 5. FIG. 6B is a front view showing the parison manufacturing apparatus shown in FIG. 6A during heating and stretching. FIG. 7A is a diagram illustrating a configuration of a chuck mechanism that configures the parison manufacturing apparatus illustrated in FIG. 6A. FIG. 7B is a diagram showing a state in the middle of fixing one end of the parison tube to the chuck mechanism shown in FIG. 7A. FIG. 7C is a diagram showing a state where one end of the parison tube is fixed to the chuck mechanism shown in FIG. 7A. FIG. 7D is a view showing a modification of the chuck mechanism shown in FIG. 7A. FIG. 8A is a front view showing a configuration in a state where heating blocks of a heating mold constituting the parison manufacturing apparatus shown in FIG. 6A are separated. FIG. 8B is a side view of the heating mold shown in FIG. 8A. FIG. 8C is a bottom view of the heating block above the heating mold shown in FIG. 8A or a plan view of the lower heating block. FIG. 8D is a front view showing a state in which the heating block of the heating mold shown in FIG. 8A is brought into contact. FIG. 8E is a side view of the heating mold shown in FIG. 8D. FIG. 9A is a side view showing a configuration in a case where the straight body fixing mechanism constituting the parison manufacturing apparatus shown in FIG. 6A is in the raised position. FIG. 9B is a side view showing a state where the fixing arm is separated at the lowered position of the straight body fixing mechanism shown in FIG. 9A. 9C is a side view showing a state in which the fixing arm of the straight body fixing mechanism shown in FIG. 9B is brought close to each other. FIG. 10 is a block diagram showing a configuration of a control system of the parison manufacturing apparatus shown in FIG. 6A.

Hereinafter, as an embodiment of the present invention, a case where a balloon included in a balloon catheter used for IABP (intra-aortic balloon pumping) is manufactured will be described as an example with reference to the drawings.

First, the parison tube 1 as a base material for manufacturing the parison according to the present embodiment will be described. As shown in FIG. 1, the parison tube 1 is a straight tube having a diameter that is substantially constant in the axial direction from one end to the other end.

As the material of the tube 1 for parison, a thermoplastic resin is used, and it is preferable that it is a material excellent in the bending fatigue resistance of the IABP balloon finally produced using this, for example, polyurethane, polyethylene, polyamide Polyamide elastomers, polyesters, and the like can be used, and those made of polyurethane are particularly preferable because they have a high ability to inhibit thrombus generation and high wear resistance.

Although the manufacturing method of the tube 1 for parison is not specifically limited, what was manufactured by extrusion molding can be used. The parison tube 1 has an axial dimension of about 50 to 400 mm, an outer diameter of about φ1 to 8 mm, and a wall thickness of about 0.1 to 1.0 mm.

As shown in FIG. 2, the parison (balloon parison) 2 is manufactured by heating and stretching the vicinity of both ends of the above-described parison tube as a base material, and the diameter thereof is substantially constant in the axial direction. It is a double-end stretched tube in which stretched portions (stretch portions) are disposed at both ends of a large diameter straight body portion (unstretched portion) 2a. The extending portions at both ends respectively have a transition portion 2b whose diameter gradually decreases and a small-diameter straight body portion 2c whose diameter hardly changes.

The axial dimension of the large diameter straight body 2a of the parison 2 is about 20 to 200 mm, and the axial dimension of the transition part 2b is about 2 to 50 mm. The outer diameter of the large diameter straight body portion 2a is about the same as the outer diameter of the parison tube 1, and the outer diameter of the small diameter straight body portion 2c is about φ0.2 to 3.0 mm.

As shown in FIG. 3, the balloon (IABP balloon) 3 manufactured using the above-described parison 2 gradually increases in diameter at both ends of the straight body portion 3a whose diameter is substantially constant in the axial direction. A cone portion (shoulder portion) 3b that decreases to a minimum and a neck portion 3c having a diameter that is substantially constant in the axial direction and smaller than that of the straight body portion 3a are arranged. The balloon 3 is manufactured by biaxial stretch blow molding. The straight barrel portion 3a of the balloon 3 is in the large diameter straight barrel portion 2a of the parison 2, the cone portion 3b of the balloon 3 is in the transition portion 2b of the parison 2, and the neck portion 3c of the balloon 3 is in the small diameter straight barrel portion 2c of the parison 2. It roughly corresponds.

IABP balloon catheter 4 as a final product manufactured using the above-described balloon 3 is configured as shown in FIG. The balloon 3 of the IABP balloon catheter 4 expands and contracts in accordance with the heart beat. The balloon 3 is formed of a cylindrical balloon film having a film thickness of about 20 to 200 μm. In the present embodiment, the shape of the balloon membrane in the expanded state is a cylindrical shape, but is not limited thereto, and may be a polygonal cylindrical shape.

The outer diameter and length of the balloon 3 for IABP are set according to the inner volume of the balloon 3, which has a great influence on the assist effect of the cardiac function, the inner diameter of the arterial blood vessel, and the like. The balloon 3 usually has an inner volume of 5 to 50 cc, an outer diameter when expanded of 8 to 20 mm, and a length of 80 to 270 mm.

The distal end of the balloon 3 is attached to the outer periphery of the distal end of the inner tube 42 through a short tube 41 or directly by heat fusion or adhesion. The proximal end of the balloon 3 is joined to the distal end of the catheter tube 44 via a contrast marker 43 made of a metal tube or the like or directly. Through the first lumen formed inside the catheter tube 44, the pressure fluid is introduced into or extracted from the balloon 3, and the balloon 3 is expanded or contracted. The balloon 3 and the catheter tube 44 are joined by heat fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The distal end of the inner tube 42 projects farther from the distal end of the catheter tube 44. The inner tube 42 is inserted in the balloon 3 and the catheter tube 44 in the axial direction. The proximal end of the inner tube 42 is communicated with the second port 46 of the branch portion 45. A second lumen that does not communicate with the first lumen formed inside the balloon 3 and the catheter tube 44 is formed inside the inner tube 42.

When inserting the balloon catheter 4 into the artery, the second lumen of the inner tube 42 located in the balloon 3 is also used as a guide wire insertion lumen for conveniently inserting the balloon 3 into the artery. When the balloon catheter 4 is inserted into a body cavity such as a blood vessel, the balloon 3 is folded and wound around the outer periphery of the inner tube 42. The inner tube 42 is made of the same material as the catheter tube 44, for example.

The inner diameter of the inner tube 42 may be any diameter that allows the guide wire to be inserted, and is, for example, 0.15 to 1.5 mm, preferably 0.5 to 1 mm. The wall thickness of the inner tube 42 is preferably 0.1 to 0.4 mm. The total length of the inner tube 42 is determined according to the axial length of the balloon catheter 4 inserted into the blood vessel and is not particularly limited, but is, for example, about 500 to 1200 mm, preferably about 700 to 1000 mm.

The catheter tube 44 is preferably made of a material having a certain degree of flexibility. The inner diameter of the catheter tube 44 is preferably 1.5 to 4.0 mm, and the wall thickness of the catheter tube 44 is preferably 0.05 to 0.4 mm. The length of the catheter tube 44 is preferably about 300 to 800 mm.

The branch end 45 installed outside the patient's body is connected to the proximal end of the catheter tube 44. The branch portion 45 is formed separately from the catheter tube 44 and is fixed by means such as heat fusion or adhesion. The branch 45 includes a first port 48 for introducing or derivatizing pressure fluid to and from the first lumen in the catheter tube 44 and the balloon 3, and a second port 46 communicating with the second lumen of the inner tube 42. Is formed.

The first port 48 is connected to an unillustrated expansion / contraction drive device, and fluid pressure is supplied by the drive device so that the balloon 3 expands or contracts. The second port 46 is connected to a blood pressure fluctuation measuring device (not shown), and can measure a blood pressure fluctuation in the artery taken from the opening end 47 at the distal end of the balloon 3. Based on the blood pressure fluctuation measured by the blood pressure fluctuation measuring device, the driving device is controlled according to the heartbeat, and the balloon 3 is expanded and contracted in a short cycle of 0.4 to 1 second. .

Next, the manufacturing process of the parison 2 will be described with reference to FIG. First, as shown in FIG. 5 (A), as a fixing step, a part of a portion to be a straight body portion (see reference numeral 2a in FIG. 2) of the parison tube 1 is fixed. The fixing part is not particularly limited as long as it is a part to be a straight body part, but when fixing one place, the center part of the part to be a straight body part is preferable. In the present embodiment, two portions of a part on one end side and a part on the other end side of a portion to be a straight body part are fixed by a pair of straight body part fixing mechanisms (second fixing mechanisms) 60 and 60, respectively. .

Thereafter, as shown in FIG. 5 (B), in the vicinity of one end side and the other end of the parison tube 1 (the end side portions corresponding to the straight body fixing mechanisms 60 and 60, respectively), The heating molds 51 and 51 are arranged, and the heating process of heating the corresponding part by the heating molds 51 and 51 is performed. The heating dies 51, 51 are not particularly limited, but non-contact type having a substantially cylindrical heating space (heating surface) having a larger diameter than the parison tube 1 can be used.

The heating temperature in the heating step is about 180 to 200 ° C., for example, when polyurethane is used as the base material of the parison tube 1, and the heating time is about 20 to 150 seconds. The heating range by the heating molds 51, 51 (dimension in the axial direction of the parison tube 1 on the heating surface) b1 is about 5 to 100 mm, and the portion to be the straight body portion (large diameter straight body portion 2a) of the parison 2 It is desirable to heat locally so as not to be heated as much as possible.

Next, as shown in FIG. 5C, by pulling both ends of the parison tube 1 as indicated by arrows a2 and a3 in the same figure, tension is applied to the parison tube 1, and the parison tube The extending | stretching process of extending | stretching the part heated at the said 1 heating process is implemented. The tension in the stretching process is about 2 to 20 N, and the stretching dimension b2 is about 5 to 200 mm.

In this embodiment, when the stretching process is performed, the heating by the heating molds 51 and 51 is stopped, but may be performed while continuing the heating.

When the stretching step is completed, a cooling step is then performed to fix the shape of the heated and stretched portion of the parison tube 1 as shown in FIG. 5 (D). The cooling step may be natural cooling in a state where heating by the heating dies 51, 51 is stopped or the heating dies 51, 51 and the parison tube 1 are separated from each other, or inside the parison tube 1. Alternatively, forced cooling may be performed by blowing a cooling gas to the outside. The cooling time is about 30 to 300 seconds when the internal temperature is 15 to 35 ° C. in the case of natural cooling.

In the present embodiment, the fixing of the portion to be the straight body portion by the straight body fixing mechanisms 60, 60 is continued even during the cooling process. By continuing to fix the portion to be the straight body portion even during cooling, it is possible to suppress the deformation of the heated and stretched portion of the parison tube 1 due to the action of gravity during cooling. However, the fixing may be released after the stretching step and before the cooling step.

Finally, the fixing of the portion to be the straight body portion by the straight body fixing mechanisms 60, 60 is released, and the fixing (supporting) of both ends of the parison tube 1 extending in the vicinity of both ends thereof is released and the drawing is extended. The parison (balloon parison) 2 as a completed body shown in FIG. 2 can be obtained by cutting at appropriate portions (position indicated by reference numeral c1 in FIG. .

Next, a manufacturing apparatus for performing the above-described manufacturing process of the parison 2 will be described with reference to FIG. 6A. The parison manufacturing apparatus 5 includes a pair of chuck mechanisms (first fixing mechanisms) 50, 50, a pair of heating dies 51, 51, a pair of stretching mechanisms 53, 53, and a pair of straight body fixing mechanisms (second fixing mechanisms). Mechanism) 60, 60. In addition, the parison manufacturing apparatus 5 includes a tension detection sensor (tension detection means) 54, a support base 55, a casing 56, a pair of fans 57 and 57, a temperature detection sensor 58 in the casing, a control device 59, and the like. Yes.

The pair of chuck mechanisms 50 and 50 are means for supporting and fixing both ends of the parison tube 1 so as to be releasable in a state in which the parison tube 1 extends substantially horizontally. Since the chuck mechanisms 50 are substantially the same except that they are arranged symmetrically, only one chuck mechanism 50 (left side in FIG. 6A) will be described.

As shown in FIGS. 7A to 7C, the chuck mechanism 50 includes a substantially cylindrical positioning member having a positioning contact surface (contact portion) 50a, a substantially cylindrical pin member (pin portion) 50b, and a pair of pairs. A chuck member (chuck part) 50c is roughly provided.

A pin member 50b is erected on the contact surface 50a of the positioning member so as to be substantially perpendicular to the corresponding contact surface 50a and substantially coaxial with the positioning member. The pin member 50b is a member that is inserted into the lumen 1a at the end of the parison tube 1, and is slightly larger in diameter as long as it is substantially equal to the inner diameter of the lumen 1a of the parison tube 1 or does not hinder insertion. Is formed. Although not shown in the figure, the distal end portion of the pin member 50b is tapered or rounded at a portion on the distal end side so that the insertion into the lumen 1a of the parison tube 1 can be performed smoothly. It is preferable to have a tinged shape.

The abutting surface 50a of the positioning member is a surface with which the end surface of the parison tube 1 inserted into the inner cavity 1a of the pin member 50b abuts, and a stretching mechanism 53 described later is at a predetermined initial position. In the set state, the end surface of the parison tube 1 is brought into contact with the corresponding contact surface 50a, whereby the parison tube 1 can be positioned in the extending direction (left-right direction in FIG. 6A). ing.

The chuck members 50c and 50c are portions in which the pin member 50b is inserted into the inner lumen 1a of the end portion thereof, and the pin member 50b of the parison tube 1 in which the end surface thereof is in contact with the contact surface 50a of the positioning member. It is a member for fixing the end part of the tube 1 for parison by being pressed and clamped from the outside.

The chuck members 50c, 50c have a plurality of claw portions that are erected on the opposing portions in order to securely fix the parison tube 1. Further, in the present embodiment, the chuck members 50c and 50c are arranged at positions facing each other by 180 degrees, and although not illustrated, they are supported so as to be symmetrically close to and separated from each other, such as an air cylinder or the like. These driving means are configured to be close to or away from each other. The operation or stop of the chuck mechanisms 50, 50 (operation or stop of the driving means) is controlled by a control device 59, which will be described later, in accordance with an operator instruction.

As shown in FIG. 7A, the operator places one end portion of the parison tube 1 in the vicinity of one chuck member 50c, and as shown in FIG. 7B, the operator inserts a pin member into the lumen 1a on one end side of the parison tube 1. 50b is inserted, and the one end surface of the parison tube 1 is brought into contact with the contact surface 50a of the positioning member. In this state, by operating the drive means of the chuck members 50c, 50c, one end of the parison tube 1 can be fixed as shown in FIG. 7C. By performing the same operation on the other end portion of the parison tube 1, the parison tube 1 extends between the pair of chuck mechanisms 50 and 50 in a substantially horizontal direction and is fixedly disposed. be able to.

Since the parison tube 1 is sandwiched between the pin member 50b inserted into the lumen 1a and the chuck members 50c and 50c having a plurality of claws pressed against the pin member 50b, the lumen 1a of the parison tube 1 is crushed. Is difficult to occur, and it is possible to realize a strong fixation. For this reason, even when a high tensile load is applied, it is possible to withstand this. In addition, since the parison tube 1 can be accurately positioned, variation in quality between lots can be reduced.

In addition, although the number of chuck members 50c is two in the present embodiment, the number of chuck members 50c may be three or more, and they may be arranged radially at equal angular intervals. Although not essential, as shown in FIG. 7D, a gas passage 50d opened at the tip of the pin member 50b is formed, and nitrogen is introduced into the lumen 1a of the parison tube 1 through the gas passage 50d. It is preferable that an inert gas such as a gas can be supplied so as to suppress oxidation accompanying heating inside the parison tube 1.

Returning to FIG. 6A, the chuck mechanisms 50 and 50 are supported and fixed to the stretching mechanisms 53 and 53, respectively. The stretching mechanisms 53, 53 move or urge one of the pair of chuck mechanisms 50, 50 so as to be separated from the other, respectively, to the parison tube 1 whose both ends are fixed to the chuck mechanisms 50, 50. Means for applying tension. Since the extending mechanisms 53 and 53 are substantially the same except that they are arranged symmetrically, only one extending mechanism 53 (left side in FIG. 6A) will be described.

Although not shown in detail in the drawing mechanism 53, the movable member 53a and the movable member 53a are supported so as to be movable (slidable) in the left-right direction (see arrow a16) in the drawing, and the movable member 53a is linearly supported. The linear drive mechanism 53b etc. to be moved is provided.

The chuck mechanism 50 described above is supported and fixed to the movable member 53a, and the linear drive mechanism 53b of the stretching mechanism 53 is supported and fixed to the support base 55. The linear drive mechanism 53b includes a drive motor (such as a servo motor) and a ball screw mechanism that converts the rotational motion of the drive motor into linear motion. The linear drive mechanism 53b is not limited to such a configuration, and may be a rack and pinion mechanism, a linear motor, or the like. The linear drive mechanism 53b is controlled in its operation, stop, moving speed, moving direction, and the like by a control device 59 described later.

With the stretching mechanisms 53 and 53 set to predetermined initial positions, both ends of the parison tube 1 are fixed to the chuck mechanisms 50 and 50, and the stretching mechanisms 53 and 53 are operated, whereby the movable members 53a and 53a are moved. Both move synchronously (or try to move) in directions away from each other, and a desired tension can be applied to the parison tube 1.

Each stretching mechanism 53, 53 has a tension detection sensor (tension detection means) 54 for detecting the tension generated in the parison tube 1. For example, a load cell can be used as the tension detection sensor 54. In the present embodiment, a power transmission member 53c is provided in parallel to be separated from the movable member 53a in the moving direction, and a coil spring (not shown) and a tension detection sensor 54 are provided between the movable member 53a and the power transmission member 53c. The driving force of the linear drive mechanism 53b is transmitted to the movable member 53a via the power transmission member 53c. The detection value of the tension detection sensor 54 is input to the control device 59, and the thrust by the linear drive mechanism 53b is controlled by the control device 59 so that an appropriate preset tension is applied.

The heating dies 51, 51 have a part on one end side (a part to be an extension part) and a part on the other end side (an extension part) This is a means for heating the portion to be formed in a non-contact manner. The heating dies 51, 51 are disposed between the chuck mechanisms 50, 50 and spaced apart from each other in the left-right direction (the direction in which the parison tube 1 extends) in FIG. Since these heating molds 51 and 51 have substantially the same configuration, only one heating mold 51 (left side in FIG. 6A) will be described.

As shown in FIGS. 8A to 8E, the heating mold 51 has a pair of upper and lower heating blocks 51a and 51b each made of a metal material such as beryllium copper. The heating blocks 51a and 51b are moved up and down synchronously so as to be close to and away from each other in the vertical direction (see arrow a11 in FIG. 6A) by the lifting mechanism 51c.

Although not shown in detail, the elevating mechanism 51c includes a slide mechanism that holds the heating blocks 51a and 51b so that the heating blocks 51a and 51b can be slid upward and downward, a servo motor for moving the heating blocks 51a and 51b up and down, a ball screw, and the like. Drive mechanism. In the present embodiment, the heating blocks 51a and 51b are configured so that both move symmetrically and are separated from each other, but one (for example, the lower heating block 51b) is fixed, Only the other (for example, the upper heating block 51a) may be configured to move up and down, or vice versa.

A substantially semi-cylindrical inner wall surface (heating surface 51d) is formed on the lower surface of the upper heating block 51a and the upper surface of the lower heating block 51b, and the lower surface of the upper heating block 51a and the lower heating block 51b When the upper surface comes into contact, the semi-cylindrical heating surfaces 51d and 51d cause the left and right direction (the direction in which the parison tube 1 whose both ends are supported and fixed to the chuck mechanisms 50 and 50 extend). , The central axis extends, and a substantially cylindrical heating space opened at both ends thereof is defined.

Although not shown, each heating block 51a, 51b incorporates a heater that generates heat when energized and a mold temperature detection sensor (for example, a thermocouple) that detects the temperature of the heating block 51a, 51b. The control device 59 controls energization to the heater based on the detection value by the mold temperature detection sensor (see reference numeral 59c in FIG. 11), and is a substantially circle defined by the heating surfaces 51d and 51d of the heating blocks 51a and 51b. The columnar heating space is heated so as to have an appropriate temperature. The number of heaters and mold temperature detection sensors provided in each of the heating blocks 51a and 51b may be single or plural, but a plurality is more preferable because the temperature distribution on the heating surfaces 51d and 51d can be made more uniform. .

The inner diameter of the substantially cylindrical heating space defined by the heating surfaces 51d and 51d of the heating blocks 51a and 51b is separated from the outer periphery of the parison tube 1 disposed through the inside by a predetermined dimension. The diameter is set larger than the outer diameter of the parison tube 1 so that it can be heated without contact. Specifically, the inner diameter of the substantially cylindrical heating space defined by the heating surfaces 51d and 51d of the heating blocks 51a and 51b is set to about 2 to 12 mm.

When both ends of the parison tube 1 are supported and fixed to the pair of chuck mechanisms 50, 50, as shown in FIGS. 8A and 8B, the upper heating block 51a is set upward (see arrow a12) and the lower heating block is set. 51b is moved downward (see arrow a13) to be spaced apart from each other and open. When the portions near both ends of the parison tube 1 are heated, as shown in FIGS. 8D and 8E, the upper heating block 51a is downward (see arrow a13) and the lower heating block 51b is upward (arrow a12). And the lower surface of the upper heating block 51a and the upper surface of the lower heating block 51b are brought into contact with each other to be in a closed state. When removing the parison tube 1 from the chuck mechanisms 50, 50, as shown in FIGS. 8A and 8B, the upper heating block 51a is moved upward (see arrow a12) and the lower heating block 51b is moved downward (see This can be done by moving to the arrow a13) and making it open.

Returning to FIG. 6A, the straight body fixing mechanisms 60, 60 are one ends of a portion (refer to reference numeral 2 a in FIG. 2) that should be the straight body of the parison tube 1 whose both ends are supported and fixed to the chuck mechanisms 50, 50. It is means for supporting and fixing a part on the side and a part on the other end side. In this embodiment, two straight body fixing mechanisms are provided so as to support and fix the two portions in the vicinity of both end portions of the portion to be the straight body portion. One may be provided so as to support and fix one part (preferably, the central part).

The straight body fixing mechanisms 60, 60 are disposed between the heating dies 51, 51 and are spaced apart from each other in the left-right direction (direction in which the parison tube 1 extends) in FIG. 6A. Since these straight body fixing mechanisms 60 and 60 have substantially the same configuration, only one of the straight body fixing mechanisms 60 (left side in FIG. 6A) will be described.

As shown in FIGS. 9A to 9C, the straight body fixing mechanism 60 includes a pair of fixing arms 60a and 60a, a gripping mechanism 60c, and a lifting mechanism 60d. Fixing portions 60b and 60b, which are substantially half-shaped notches, are formed in the vicinity of the lower ends of the fixing arms 60a and 60a so as to face each other. The inner diameters of the fixing portions 60a and 60a are set to be slightly smaller than the outer diameter of the parison tube 1 so that the parison tube 1 can be reliably fixed while suppressing deformation thereof. The shape of the fixing portions 60a and 60a is not limited to a substantially semicircular shape as long as the parison tube 1 can be reliably fixed while suppressing deformation and damage to the outer periphery as much as possible.

The upper ends of the pair of fixed arms 60, 60 are supported by the gripping mechanism 60c. Although not shown in detail in the gripping mechanism 60c, each of the fixed arms 60a and 60a is slidably held in the direction of the arrow a19 in FIG. 9A (the front-rear direction in FIG. 6A) and the fixed arms 60a and 60a. And a drive mechanism having a servo motor and a ball screw for movement. The fixed arms 60a and 60a are moved and opened synchronously in a direction away from each other as shown in FIG. 9A or 9B by the gripping mechanism 60c, and in a direction close to each other as shown in FIG. 9C ( Two states can be taken: a closed state by moving synchronously in the direction of arrow a20 in FIG. 9C.

The gripping mechanism 60c is supported by the lifting mechanism 60d. Although not shown in detail, the elevating mechanism 60d includes a slide mechanism that slidably holds the gripping mechanism 60c up and down (see arrow a17 in FIG. 9A), a servo motor for driving the elevating mechanism 60c, a ball screw, and the like. And a drive mechanism having The gripping mechanism 60c is moved by the elevating mechanism 60d to the upper initial position as shown in FIG. 9A and downward (in the direction of arrow a18) as shown in FIG. The tube 1 can be in two states: a state where the tube 1 can be held and fixed.

When the gripping mechanism 60c is set at the lower position by the elevating mechanism 60d, the pair of fixed arms 60a and 60a are brought close to each other by the gripping mechanism 60c, and as shown in FIG. The parison tube 1 is clamped and fixed by 60b.

Returning to FIG. 6A, a pair of extending mechanisms 53 and 53 (linear drive mechanisms 53b and 53b) holding the chuck mechanism 50, a pair of heating dies 51 and 51 (elevating mechanisms 51c and 51c), and a pair of straight body fixing mechanisms. 60, 60 (elevating mechanisms 60 d, 60 d) are fixed on the support base 55, and all of these are accommodated in a housing 56. As the housing 56, a frame made of a metal or the like and a transparent panel (for example, an acrylic plate) attached thereto can be used. Although not shown, the casing 56 is provided with an openable / closable door for manually fixing or removing the parison tube 1 with respect to the chuck mechanisms 50, 50, or for other maintenance. Yes. A plurality of intake and exhaust (exhaust in this embodiment) fans 57 and 57 and an in-casing temperature detection sensor 58 for detecting the temperature in the casing 56 are attached to the casing 56.

Next, the control system of the above-described parison manufacturing apparatus will be described with reference to FIG. The control device 59 includes input means 59a and display means 59b. The input means 59a includes buttons for operating or releasing the chuck mechanisms 50, 50, an emergency stop button, other buttons, a keyboard for selecting functions and inputting various setting values, and the like. The display means 59b includes a liquid crystal monitor and various indicators.

When manufacturing the parison, first, the operator manually sets the unstretched parison tube 1 to the chuck mechanisms 50 and 50 at both ends thereof. At this time, as shown in FIG. 6A, the stretching mechanisms 53 and 53 are set at predetermined initial positions, and the heating dies 51 and 51 are in a state where the heating blocks 51a and 51b are separated (open). It has become. At this time, as shown in FIGS. 6A and 9A, the straight body fixing mechanisms 60 and 60 are set at the upper initial position, and the fixing arms 60a and 60a are separated (open). It has become. Next, the operation buttons of the chuck mechanisms 50 and 50 are pressed to support and fix both ends of the parison tube 1.

When it is confirmed that the ends of the parison tube 1 are fixed normally, the operator performs a predetermined operation (for example, presses a start button for heating and stretching), thereby performing a series of steps for manufacturing the parison. Operation starts. The control device 59 automatically controls each part in accordance with a control sequence previously selected by the operator. Note that this operation may be omitted, and a series of controls including the operation of fixing both ends of the above-described parison tube 1 may be started by pressing the operation buttons of the above-described chuck mechanisms 50 and 50.

An example of a control sequence by the control device 59 will be described. First, the stretching mechanisms 53 and 53 are driven so as to be separated from each other, whereby both ends thereof are supported and fixed to the chuck mechanisms 50 and 50 and become a straight body portion. A preset tension (initial tension) is applied to the parison tube 1 in which the vicinity of both ends of the power part is supported and fixed, and the state is maintained. The tension generated in the parison tube 1 is detected by a tension detection sensor 54. Based on the detected value, the stretching mechanisms 53 and 53 are controlled so as to have a preset initial tension, and the initial tension is set. After reaching, the feedback control is performed so that the tension becomes constant.

The initial tension is set to an appropriate value at which the slack of the parison tube 1 (the difference in height between the central portion in the axial direction of the tube and the fixed portions at both ends) is within an allowable range. If the initial tension is too small, the slack becomes large, and there are cases where the fixing by the straight body fixing mechanisms 60, 60 to be performed later cannot be performed properly. On the other hand, if the initial tension is too large, the slackness is reduced and the above problem can be solved. However, the heating portion of the parison tube 1 is unnecessarily stretched during the heating by the heating mold 51 and is manufactured. In addition, the unevenness of the transition part 2b of the parison 2 may not be uniform (the inclination becomes two steps), which may cause stretching unevenness. For this reason, the initial tension is set to an appropriate value that both of these allow. The initial tension can be about 1 to 10N. In this embodiment, since the tension generated in the parison tube 1 can be detected in real time by the tension detection sensor 54, the initial tension can be accurately maintained constant at a desired value, and the fluctuation of the initial tension can be maintained. It is possible to reduce the occurrence of stretching unevenness.

When the initial tension is applied, the straight body fixing mechanisms 60 and 60 are operated, and the fixing arms 60a and 60a are lowered from the initial position shown in FIG. 9A as shown in FIGS. 6B and 9B. As shown in FIG. 9C, the fixing arms 60a and 60a are closed close to each other, and the portion to be the straight body portion of the parison tube 1 is sandwiched and fixed by the fixing portions 60b and 60b of the fixing arms 60 and 60. The

Next, as shown in FIG. 6B, the elevating mechanisms 51c and 51c of the heating molds 51 and 51 are operated, the upper heating block 51a is lowered (see arrow a13 in the figure), and the lower heating block 51b is raised. Then (see arrow a12 in the figure), the portions to be stretched in the vicinity of both ends of the parison tube 1 are defined by the heating surfaces 51d and 51d of the heating blocks 51a and 51b. It arrange | positions in the heating space formed (refer also FIG. 8D and FIG. 8E).

Next, energization is performed to the heaters of the heating molds 51 and 51, and heat generation is started. The energization of the heaters of the heating molds 51 and 51 may be performed before the heating blocks 51a and 51b are closed. The temperatures of the heating molds 51 and 51 are detected by a mold temperature detection sensor 59c, and energization of the heater is controlled so as to be a predetermined temperature set in advance.

When a predetermined time set in advance has elapsed from the start of heating (or after reaching a predetermined temperature), the heating is stopped and the stretching mechanisms 53 and 53 are moved away from each other (arrow a17). , A18), tension is applied to the portion between the chuck mechanism 50 and the straight barrel fixing mechanism 60 on one end side and the portion between the chuck mechanism 50 and the straight barrel fixing mechanism 60 on the other end side of the parison tube 1, respectively. Applied and stretched. The tension generated in the parison tube 1 is detected by a tension detection sensor 54, and the moving speed of the linear drive mechanisms 53b and 53b by the stretching mechanisms 53 and 53 is controlled based on the detected value. In addition, you may continue a heating during extending | stretching.

When the preset stretching length (stretch length) is reached, the movement of the linear drive mechanisms 53b, 53b of the stretching mechanisms 53, 53 is stopped, and this state is maintained for a preset predetermined time. The parison tube 1 is cooled. Thereby, the shape of the tube 1 for parison by which the vicinity part of the both ends was extended is fixed. If the cooling for a predetermined time is performed, the operator confirms that the series of operations has been completed after the fixing of the portion to be the straight body portion of the parison tube 1 by the straight body portion fixing mechanisms 60, 60 is released. To terminate the sequence. The end notification can be displayed on an indicator or the like of the display means 59b, or can be made with a buzzer or the like.

When a series of sequences is completed, the operator depresses the release buttons of the chuck mechanisms 50 and 50 to release the fixing of both ends of the parison tube 1 in which the portions near the both ends are extended. Remove this at work. Note that during these series of operations, the temperature in the casing 56 is detected by the temperature detection sensor 58 in the casing, and the fans 57 and 57 are activated or stopped based on the detected value, whereby the casing 56 is detected. The temperature in the body 56 is controlled to be constant. Further, the releasing operation of the chuck mechanisms 50, 50 may be omitted, and this operation may be included in a series of sequences.

Finally, the parison 2 as a completed body shown in FIG. 2 is obtained by manually cutting an appropriate portion of the stretched portion of the tube 1 for parison in which the vicinity of both ends is stretched and cutting off both ends. Obtainable.

According to the above-described embodiment, the portions near both ends of the portion to be the straight body portion of the parison tube 1 are fixed by the straight body portion fixing mechanisms 60 and 60, respectively, and heated and stretched. It is possible to prevent one of the stretched portions from affecting the other stretched portion and is not affected by the environmental change over time. For this reason, the symmetry of the shape of one extending portion and the other extending portion can be improved. Therefore, it is possible to manufacture a parison with good quality and, consequently, a balloon without requiring complicated work. Moreover, by heating and extending | stretching simultaneously, compared with the case where it performs sequentially, the time which manufacture requires can be shortened and productivity can also be improved.

Furthermore, since the tension | tensile_strength accompanying extending | stretching does not act on the part which should become the straight body part of the tube 1 for parison at the time of extending | stretching, it can also reduce that an adverse effect is exerted by applying unnecessary tension to the straight body part 2a. it can.

The embodiment described above is described for facilitating understanding of the present invention, and is not described for limiting the present invention. Therefore, each element disclosed in the above-described embodiment is intended to include all design changes and equivalents belonging to the technical scope of the present invention.

DESCRIPTION OF SYMBOLS 1 ... Tube for parison 2 ... Parison 2a ... Large diameter straight body part 2b ... Transition part 2c ... Small diameter straight body part 3 ... Balloon for IABP 3a ... Straight body part 3b ... Conical part 3c ... Neck part 4 ... Balloon catheter for IABP 5 ... Parison manufacturing equipment 50 ... Chuck mechanism (first fixing mechanism)
50a ... Contacting surface of positioning member 50b ... Pin member 50c ... Chuck member 51 ... Heating die 51a, 51b ... Heating block 51c ... Lifting mechanism 51d ... Heating surface 53 ... Stretching mechanism 53a ... Movable member 53b ... Linear drive mechanism 53c ... Power transmission member 54 ... Tension detection sensor 55 ... Support base 56 ... Case 57 ... Fan 58 ... In-case temperature detection sensor 59 ... Control device 59a ... Input means 59b ... Display means 59c ... Die temperature detection sensor 60 ... Straight body part Fixing mechanism (second fixing mechanism)
60a ... fixed arm 60b ... fixed portion 60c ... gripping mechanism 60d ... lifting mechanism

Claims (2)

A method for producing a parison having stretched portions at both ends of a straight body portion for producing a balloon used for a balloon catheter,
A fixing step of fixing a part of the straight barrel portion of the straight tubular parison tube;
A heating step of simultaneously heating a part on one end side and a part on the other end side than the part to be the straight body part of the parison tube;
And a stretching step of simultaneously stretching the portions heated in the heating step of the parison tube by applying tension to both ends of the parison tube. A device for manufacturing a parison having extended portions at both ends of a straight body portion for manufacturing a balloon used for a balloon catheter,
A pair of first fixing mechanisms for releasably fixing both ends of a straight tubular parison tube;
A pair of second fixing mechanisms for releasably fixing a part on one end side and a part on the other end side of the portion to be the straight body part of the parison tube;
A part of a portion between the first fixing mechanism and the second fixing mechanism fixed to one end side of the parison tube, and the first fixing mechanism and the second fixing mechanism fixed to the other end side are fixed. A pair of heating molds that simultaneously heat each part of the part between the parts in a non-contact manner;
A parison manufacturing apparatus comprising: a stretching mechanism that simultaneously biases the pair of first fixing mechanisms so as to be separated from each other and stretches the parison tube.

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