JP6984589B2 - Eccentric balloon catheter manufacturing equipment and eccentric balloon catheter manufacturing method - Google Patents

Description

The present invention relates to an eccentric balloon catheter manufacturing apparatus and a method for manufacturing an eccentric balloon catheter in which a balloon is eccentric and inflates with respect to the axis of the catheter tube.

In endoscopic procedures, for example, a balloon catheter may be used to remove stones (gallstones) generated in the bile duct from the body. Further, as such a balloon catheter, an eccentric balloon catheter in which the balloon inflates concentrically with respect to the catheter tube and an eccentric balloon catheter in which the balloon eccentrically inflates with respect to the axial center of the catheter tube has been proposed. An eccentric balloon catheter can efficiently scrape out stones as compared with a balloon that inflates concentrically, and is preferably used for removing stones.

As such an eccentric balloon catheter, a catheter tube is proposed in which a member that regulates partial expansion of the balloon in the circumferential direction, such as a tape for fixing, is fixed to the catheter tube.

Japanese Unexamined Patent Publication No. 2006-340914 Japanese Unexamined Patent Publication No. 2008-194166

However, as long as the eccentric balloon catheter of the type in which the expansion regulating member that regulates the expansion of the balloon is attached from above the balloon is manufactured by the conventional manufacturing method, the bonding strength of the expansion regulating member tends to vary, and the non-defective rate. Has the problem that it is difficult to increase. Further, in order to keep the bonding strength of the expansion regulating member in the finished product within a predetermined range, it is necessary to strictly control the coating position and the coating amount of the binder such as an adhesive, or the adhesive in the bonded portion. Since it is necessary to strictly check the spread of the product, there is a problem that the manufacturing work is difficult and efficient production is difficult.

The present invention has been made in view of such an actual situation, and an object thereof is an eccentric balloon catheter manufacturing apparatus capable of manufacturing an eccentric balloon catheter in which the joint strength of an expansion regulating member that regulates the expansion of the balloon is stable, and an apparatus thereof. It is to provide a method of manufacturing such an eccentric balloon catheter.

In order to achieve the above object, the eccentric balloon catheter manufacturing apparatus according to the present invention is used.
An eccentric balloon catheter manufacturing device in which the balloon is eccentric to the axis of the catheter tube and inflates.
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the balloon are arranged on the catheter tube and the balloon so that at least a part thereof overlaps the balloon, and when the balloon is inflated, the balloon An expansion restricting member that restricts a part of the circumferential direction from separating from the catheter tube, a clamp base formed with a groove for accommodating the expansion restricting member, and a clamp base.
A pressing portion that is relatively movable from the opening side of the groove portion so as to be close to and separated from the groove portion and presses the expansion restricting member toward the catheter tube.
It has a detection unit for detecting the pressing force by the pressing unit.

Since the eccentric balloon catheter manufacturing apparatus according to the present invention has a detection unit for detecting the pressing force when the expansion restricting member arranged on the clamp base is pressed toward the catheter tube, the manufactured eccentric balloon is manufactured. It is possible to stabilize the joint strength of the expansion restricting member in the catheter. That is, according to such a manufacturing apparatus, the width of the gap formed between the expansion regulating member and the balloon or catheter to be joined is determined by adjusting the pressing force to an appropriate range based on the detection result. Since it is possible to stabilize the spread of the connecting portion formed between the expansion regulating member and the joining target, it is possible to stabilize the joining strength of the expansion regulating member in the manufactured eccentric balloon catheter. Further, since the pressing force is detected by the detection unit, it is possible to appropriately adjust the pressing force when pressing the expansion restricting member toward the catheter tube even if the operator is not an expert. Efficient manufacturing is possible by using such an eccentric balloon catheter manufacturing apparatus.

Further, for example, the pressing portions are arranged at predetermined intervals along the extending direction of the groove portion, and the expansion restricting member is pressed toward the catheter tube on the distal end side from the balloon. It may have one pressing portion and a second pressing portion that presses the expansion restricting member toward the catheter tube on the proximal end side of the balloon.

Since the pressing portion has the first pressing portion and the second pressing portion, the expansion restricting member can be efficiently joined to the catheter tube at two points straddling the balloon in the axial direction. That is, according to such a manufacturing apparatus, the expansion restricting member can be reliably joined to the catheter tube, and the two points can be pressed at the same time, so that the workability is good.

Further, for example, the detection unit is arranged between the pressing unit and the pressing pressure transmitting unit that transmits the pressing force to the pressing unit, and the pressing unit is relative to the pressing unit according to the reaction force transmitted from the pressing unit. It may have a deformed portion that deforms in the moving direction and a display unit that displays the pressing force of the pressing portion corresponding to the deformation amount of the deformed portion.

A manufacturing apparatus having a deformed portion that deforms in the relative movement direction of the pressing portion and a display unit that displays the pressing force of the pressing portion makes it easier for the manufacturing operator to adjust the pressing force against the expansion restricting member within an appropriate range. Therefore, the joint strength of the expansion restricting member in the manufactured eccentric balloon catheter can be further stabilized.

Further, the deformed portion may have a compression spring, a pneumatic spring, or a hydraulic spring.

The deformed portion is not particularly limited as long as it deforms according to the reaction force transmitted from the pressing portion, but may have, for example, a compression spring, a pneumatic spring, a hydraulic spring, or the like, and is expanded by such a deformed portion. The pressing force on the regulating member can be adjusted more accurately.

The method for manufacturing an eccentric balloon catheter according to the present invention is a method for manufacturing an eccentric balloon catheter in which the balloon is eccentric and inflates with respect to the axial center of the catheter tube.
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the balloon are arranged on the catheter tube and the balloon so that at least a part thereof overlaps the balloon, and when the balloon is inflated, the balloon A step of arranging an expansion restricting member that regulates a part of the circumferential direction from separating from the catheter tube in a groove formed in a clamp base, and
The step of applying an adhesive between the expansion restricting member and the catheter tube, and
A step of pressing the expansion restricting member toward the catheter tube by a pressing portion that can move relative to the groove portion of the clamp base from the opening side of the groove portion so as to be close to and separated from the groove portion.
The process in which the detection unit detects the pressing force by the pressing unit, and
The present invention includes a step of adjusting the pressing force by the pressing unit based on the detection result by the detecting unit.

According to the method for manufacturing an eccentric balloon catheter according to the present invention, it is possible to manufacture an eccentric balloon catheter having an expansion regulating member bonded with a stable adhesive strength.

FIG. 1 is a schematic view showing an example of an eccentric balloon catheter manufactured by the manufacturing apparatus according to the embodiment of the present invention. FIG. 2 is a schematic cross-sectional view of the eccentric balloon catheter shown in FIG. FIG. 3 is a schematic cross-sectional view of an eccentric balloon catheter along line III-III shown in FIG. FIG. 4 is a schematic perspective view showing an eccentric balloon catheter manufacturing apparatus according to an embodiment of the present invention. FIG. 5 is a partially enlarged view of the manufacturing apparatus shown in FIG. FIG. 6 is a perspective view of a clamp table included in the manufacturing apparatus shown in FIG. FIG. 7 is a schematic plan view showing a catheter tube, a balloon, and an expansion control member installed on a clamp table in the manufacturing apparatus shown in FIG. FIG. 8 is a conceptual diagram showing a method of manufacturing an eccentric balloon catheter by the manufacturing apparatus shown in FIG. FIG. 9 is a flowchart showing an example of a manufacturing process of an eccentric balloon catheter by the manufacturing apparatus shown in FIG. FIG. 10 is a graph showing the result (level 1) of the peeling test in the example. FIG. 11 is a graph showing the result (level 2) of the peeling test in the example. FIG. 12 is a graph showing the result (level 3) of the peeling test in the example.

Hereinafter, the present invention will be described based on the embodiments shown in the drawings.

FIG. 1 is a schematic view showing an example of an eccentric balloon catheter 1 manufactured by the manufacturing apparatus according to the embodiment of the present invention. The eccentric balloon catheter 1 has a catheter tube 5, a balloon 2, and a band-shaped body 20 as an expansion restricting member. As shown in FIG. 1, in the eccentric balloon catheter 1, the balloon 2 is eccentric with respect to the axial center of the catheter tube 5 and inflates.

The catheter tube 5 is a tube made of a flexible material, and has a distal end 7 of the tube, which is the end on the side to be inserted into the body, and a proximal end located on the other end (not shown). ) And. The outer diameter d1 of the catheter tube 5 is, for example, about 1 to 3 mm, and the total length can be about 500 to 2500 mm, but is not particularly limited, and the size of the catheter tube 5 depends on the use of the eccentric balloon catheter 1 and the like. Will be changed as appropriate. The material of the catheter tube 5 is not particularly limited as long as it is a flexible material, but a polymer material is preferable, and a polyamide resin or a polyamide-based elastomer is particularly preferable.

As shown in FIG. 2, a balloon lumen 8, a contrast medium lumen 9, and a guide wire lumen 10 are formed inside the catheter tube 5. The balloon lumen 8 is a lumen that serves as a flow path for sending a fluid such as air used for inflating the balloon 2 to the internal space 24 of the balloon 2. The balloon lumen 8 extends from the proximal end of the catheter tube 5 to the middle of the tube distal end 7 which is the distal end of the catheter tube 5, and is provided so as to open into the internal space 24 of the balloon 2. It is conductive with the fluid outlet 11.

The contrast medium lumen 9 is a lumen used as a flow path of the contrast medium when performing X-ray imaging in the body for the purpose of confirming the position of a stone. The contrast agent lumen 9 penetrates from the proximal end of the catheter tube 5 to the spout 12 of the tube distal end 7 of the catheter tube 5. The spout 12 is an opening provided so as to be located on the proximal end side of the balloon 2. The spout may be an opening provided so as to be located on the distal end side of the balloon 2.

The guide wire lumen 10 is a lumen through which the guide wire is inserted when the eccentric balloon catheter 1 is inserted into the body along the guide wire, and penetrates from the proximal end of the catheter tube 5 to the distal end opening 10a. There is. It should be noted that the contrast agent lumen and the guide wire lumen 10 do not necessarily have to be provided in the catheter tube 5, and other lumens having a function other than the above-mentioned functions may be formed.

The cross-sectional shapes of the balloon lumen 8, the contrast agent lumen 9, and the guide wire lumen 10 are not limited, and each of them may be a shape that can be efficiently arranged in the catheter tube 5. However, the guide wire lumen 10 preferably has a circular cross-sectional shape. The cross-sectional area of the balloon lumen 8 is, for example, 0.03 to 0.3 mm2, the cross-sectional area of the contrast medium lumen 9 is, for example, 0.08 to 0.8 mm2, and the cross-sectional area of the guide wire lumen 10 is, for example, 0.5 to 1. Although it can be set to 0 mm2, the cross-sectional area of each lumen is not particularly limited and may be appropriately changed according to the outer diameter of the catheter tube and the like.

The balloon 2 of the eccentric balloon catheter 1 is attached near the distal end 7 of the catheter tube 5 so as to cover the fluid outlet 11 formed in the catheter tube 5. The balloon 2 is made of an elastic material and is expanded by introducing a fluid into the internal space 24 via the balloon lumen 8 of the catheter tube 5. The inflated balloon 2 can scrape or push out the calculus 50 as shown in FIG. 2 to remove the calculus in the body.

As the elastic material forming the balloon 2, 100% modulus (value measured according to JIS K 6251) is preferably 0.1 to 10 Mpa, and particularly preferably 1 to 5 Mpa. If the 100% modulus is too small, the strength of the balloon 2 may be insufficient, and if it is too large, the balloon 2 may not be able to be inflated to a sufficient size. Further, specific examples of the elastic material suitable for forming the balloon 2 include natural rubber, silicone rubber, polyurethane elastomer and the like.

As shown in FIGS. 1 to 3, the balloon 2 has a cylindrical shape as a whole, and the catheter tube 5 is inserted therein, and joint portions 4a and 4b joined to the outer peripheral surface of the catheter tube 5 are formed at both ends thereof. It is formed. The shape of the joint portions 4a and 4b located on both ends of the inflatable portion 3 of the balloon 2 is not particularly limited as long as it can be joined to the outer peripheral surface of the catheter tube 5, but is preferably cylindrical.

When the joint portions 4a and 4b of the balloon 2 are cylindrical, the inner diameter thereof is preferably substantially equal to the outer diameter of the catheter tube 5, and the length thereof is preferably 0.5 to 5 mm. Further, the wall thickness of the joint portions 4a and 4b of the balloon 2 is not particularly limited, and may be substantially equal to, for example, the expansion portion 3. The method of joining the joining portions 4a and 4b of the balloon 2 to the outer peripheral surface of the catheter tube 5 is not particularly limited, and examples thereof include adhesion with an adhesive, heat fusion, welding with a solvent, and ultrasonic welding. be able to.

In the balloon 2, an expansion portion 3 that expands when a fluid is introduced into the internal space 24 is formed between the joint portions 4a and 4b. 1 to 3 show an inflated balloon 2. It is preferable that the maximum outer diameter of the inflated portion 3 of the balloon 2 in the inflated state is 110 to 200% of the minimum outer diameter in the inflated state. If this ratio is too small, the balloon 2 may not expand to a sufficient size, and if it is too large, the balloon 2 may interfere with the insertion of the eccentric balloon catheter 1 into the body. The length of the inflatable portion 3 (the length along the axial direction of the catheter tube 5) in the balloon 2 is preferably 5 to 20 mm, and the wall thickness is preferably 0.10 to 0.50 mm. The wall thickness of the balloon 2 is preferably uniform along the circumferential direction.

The method for producing the balloon 2 having the above-mentioned shape is not particularly limited, and a known method may be used as a film forming method for the stretchable material, but it is preferable to use a dipping molding method. In the dipping molding method, a stretchable material and various additives are dissolved in a solvent to form a solution or suspension, and a mold having an outer shape substantially equal to the desired balloon shape is formed in this solution (suspension). Immerse and apply a solution (suspension) to the surface of the mold and evaporate the solvent to form a film on the surface of the mold. By repeating this dipping and drying, a balloon having a desired wall thickness can be formed. Depending on the type of elastic material, if necessary, cross-linking is performed after film formation.

As shown in FIG. 1, the eccentric balloon catheter 1 has a band-shaped body 20 as an expansion regulating member. The band-shaped body 20 as an expansion restricting member is arranged on the catheter tube 5 and the balloon 2 so that at least a part thereof overlaps with the balloon 2, and when the balloon 2 is inflated, a part in the circumferential direction of the balloon 2 is formed. Restricts separation from the catheter tube 5. The band 20 extends along the axial direction of the catheter tube 5 so as to straddle the balloon 2, and the axial length of the band 20 is longer than the axial length of the balloon 2. The band-shaped proximal end 22b, which is the proximal end of the band 20, is fixed to the outer peripheral surface of the catheter tube 5 on the proximal end side of the balloon 2 and is the distal end of the band 20. The distal end 22a of the body is fixed to the outer peripheral surface of the catheter tube 5 on the distal end side of the balloon 2.

The material of the strip 20 is not particularly limited, and is made of, for example, a resin similar to the resin constituting the catheter tube 5. However, when the balloon 2 is inflated, the band 20 restricts the expansion of the balloon 2 so that the center of the inflated balloon 2 can be separated from the band 20 with respect to the center of the catheter tube 5. Is preferably made of a material having less elasticity than the balloon 2. Further, the joining method between the proximal end 22b of the band and the distal end 22a of the band and the catheter tube 5 to be joined thereof is not particularly limited, and examples thereof include adhesion, heat fusion, and high frequency fusion. be able to.

The width of the band 20 is a width of 1/2 or less of the circumferential length of the outer circumference of the catheter tube 5, preferably 1/3 to 1/5. If this width is too small, the function of restricting a part of the balloon 2 in the circumferential direction from the top of the balloon 2 from the catheter tube 5 becomes small, and if the width is too large, the balloon 2 is sufficiently inflated. Will be difficult.

In the eccentric balloon catheter 1, a band 20 that restricts a part of the circumferential direction of the balloon 2 from separating from the catheter tube 5 when the balloon 2 is inflated is joined to the catheter tube 5, and is therefore shown in FIG. As described above, the inflated portion 3 of the balloon 2 eccentrically inflates with respect to the axial center of the catheter tube 5. The eccentricity h1 of the expansion center of the expansion portion 3 with respect to the axial center of the catheter tube 5 is preferably 50 to 100%, more preferably 75 to 100%, with respect to the expansion radius R of the expansion portion 3. It should be noted that the balloon 2 does not have to expand completely in a circular shape in its cross section, and may inflate into an elliptical shape or other shape.

As shown in FIGS. 1 and 2, in the eccentric balloon catheter 1, contrast rings 26a and 26b are provided at two locations on the outer peripheral surface of the catheter tube 5. The contrast ring 26a is arranged in the internal space 24 of the balloon 2, and the contrast ring 26b is arranged at a position outside the balloon 2 and close to the junction 4b on the proximal end side of the balloon 2. However, the arrangement, shape and number of the contrast rings 26a and 26b are not particularly limited. The contrast rings 26a and 26b are manufactured by using a resin composition containing, for example, a metal such as gold, platinum, or a platinum iridium alloy which is an X-ray opaque material, or a powder of an X-ray contrast substance.

FIG. 4 is a schematic view showing a pressing device 60 for manufacturing an eccentric balloon catheter 1 and pressing a band-shaped body 20 which is an object arranged on a clamp base 61 against a catheter tube 5. The pressing device 60 has a pedestal 64, a support column 66 extending upward from the pedestal 64, and a beam 67 extending horizontally from the support column and being cantilevered and supported by the support column 66. Further, the pressing device 60 includes a clamp base 61 installed on the pedestal 64 below the beam 67, a pressing pressure transmitting member 68 connected to the beam 67 so as to be relatively movable, and a pressing pressure transmitting member 68. It is connected with the deformed portion 71 sandwiched between the two, and has a pressing portion 69 that can move relative to the groove portion 62 of the clamp base 61 so as to be close to and separated from the groove portion 62. Further, the pressing device 60 has a lever 65 for moving the pressing force transmitting member 68 and the pressing unit 69 in the vertical direction, and a detecting unit 70 for detecting the pressing force by the pressing unit 69.

In the pressing device 60, when the lever 65 is rotated toward the front side, the pressing pressure transmitting member 68 and the pressing portion 69 descend toward the clamp base 61, and when the lever 65 is rotated toward the back side, the pressing pressure transmitting member 68 and the pressing portion 69 are lowered. 69 is raised so as to be separated from the clamp base 61. As shown in FIG. 6, which is an enlarged view of the clamp base 61, the clamp base 61 is formed with a groove portion 62 that opens upward.

FIG. 7 is a conceptual diagram of the clamp base 61 and the catheter tube 5 and the like housed in the groove portion 62 of the clamp base 61 as viewed from above. The groove 62 of the clamp base 61 houses the vicinity of the distal end 7 of the catheter tube 5, the balloon 2 joined to the catheter tube 5, and the strip 20 before being joined to the catheter tube 5. Has been done. The band 20 is arranged above the catheter tube 5 and the balloon 2 so as to straddle the balloon 2 along the axial direction of the catheter tube 5.

Between the proximal band 22b, which is the proximal end of the band 20, and the outer peripheral surface of the catheter tube 5, and between the distal end 22a of the band, which is the distal end of the band 20, and the catheter tube 5. An adhesive for joining the strip 20 to the catheter tube 5 is applied between the outer peripheral surfaces. As shown in FIG. 6, the clamp base 61 is informed that the catheter tube 5, the balloon 2 and the band-shaped body 20 are displaced or deviate from the groove portion 62 during the pressing operation in the pressing device 60 described later. A fixing plate 63 for prevention is provided.

As shown in FIG. 5, which is a partially enlarged view of the pressing device 60, the pressing portion 69 is placed at the lower tip of the pressing pressure transmitting member 68 that transmits the pressing force to the pressing portion 69, between the pressing portion 69 and the pressing force transmitting member 68. They are connected with the deformed portion 71 interposed therebetween. The deforming portion 71 is composed of a compression spring that elastically deforms in the vertical direction, which is the relative moving direction of the pressing portion 69, and urges the pressing portion 69 downward. The pressing portion 69 moves relative to the groove portion 62 in the clamp base 61 so as to be close to and separated from the opening side by the operator operating the lever 65 shown in FIG.

Further, the pressing portion 69 can move relative to the pressing pressure transmitting member 68 in the vertical direction, and when the pressing portion 68 receives a reaction force from the band-shaped body 20 or the like to be pressed, the deformed portion 71 contracts. As a result, the pressing portion 69 moves upward relative to the pressing pressure transmitting member 68.

The pressing portion 69 has a first pressing portion 69a and a second pressing portion 69b arranged at predetermined intervals along the extending direction of the groove portion 62 in the clamp base 61. The first pressing portion 69a arranged on the distal end side presses the band-shaped distal end portion 22a shown in FIG. 7 toward the catheter tube 5, and the second pressing portion 69b arranged on the proximal end side , The proximal end 22b of the band shown in FIG. 7 is pressed toward the catheter tube 5.

As shown in FIG. 5, the pressing device 60 has a detecting unit 70 that detects the pressing force by the pressing unit 69. The detection unit 70 is arranged between the pressing unit 69 and the pressing pressure transmitting member 68, and corresponds to the deformation unit 71 that deforms according to the reaction force transmitted from the pressing unit 69 and the deformation amount of the deformation unit 71. It has a scale 72 as a display unit for displaying the pressing force.

The scale 72 of the detection unit 70 is formed on the surface of the pressing unit 69, and the pressing unit 69 depends on the positional relationship between the lower end 68a of the pressing pressure transmitting member 68 and the scale 72, which move relative to each other according to the amount of deformation of the deforming unit 71. Pressing pressure by is displayed.

The material of each member included in the pressing device 60 is not particularly limited, but the pedestal 64, the column 66, the pressing force transmitting member 68, the pressing portion 69, and the like are made of metal such as iron or stainless steel from the viewpoint of durability and stability. It is preferably made of a material. The compression spring constituting the deformed portion 71 is made of a hard metal such as high carbon steel or stainless steel wire, but is not particularly limited. Further, the clamp base 61 can also be manufactured by using a material such as metal or resin, and the material is not particularly limited. However, for example, when the clamp base 61 is manufactured by PTFE, excess adhesive adheres to the clamp base 61. In some cases, this is preferable because it can be easily removed.

FIG. 9 is a flowchart showing an example of a manufacturing process of the eccentric balloon catheter 1 using the pressing device 60 shown in FIG. Hereinafter, the manufacturing process of the eccentric balloon catheter 1 will be described with reference to FIG. 9 and the like.

In step S001 shown in FIG. 9, the balloon 2 is joined to the vicinity of the tube distal end portion 7 of the catheter tube 5 shown in FIG. Specifically, the joint portions 4a and 4b of the balloon 2 are fixed to the outer peripheral surface of the catheter tube 5 with an adhesive or the like or by heat fusion. When the eccentric balloon catheter 1 has contrast rings 26a and 26b, the contrast rings 26a and 26b are fixed to predetermined positions of the catheter tube 5 with an adhesive or the like before and after step S001.

In step S002 shown in FIG. 9, the catheter tube 5 to which the balloon 2 is joined in step S001 and the band-shaped body 20 are set in the groove portion 62 of the clamp base 61. At this time, first, the catheter tube 5 to which the balloon 2 is joined is arranged in the groove portion 62 of the clamp base 61, and then the band-shaped body 20 is arranged so as to be overlapped on the balloon 2 as shown in FIG. At this time, the band-shaped body 20 is catheterized so that the band-shaped body distal end 22a and the band-shaped proximal end 22b, which are both ends of the band-shaped body 20, protrude to the distal end side and the proximal end side of the balloon 2. Arranged for tube 5. The catheter tube 5, the balloon 2, and the strip 20 arranged in the groove 62 are fixed to the groove 62 by using the fixing plate 63 shown in FIG.

In step S003 shown in FIG. 9, an adhesive for joining the strip 20 to the catheter tube 5 is applied. Specifically, after lifting the band-shaped distal end 22a of the band-shaped body 20 and applying an adhesive to the outer peripheral surface of the catheter tube 5 located below the band-shaped distal end 22a, the band-shaped distal end is applied. The portion 22a is overlaid on the coated adhesive. The same applies to the proximal band 22b as well as the distal band 22a. However, as shown in FIG. 7, since a part of the band-shaped proximal end 22b is located on the contrast ring 26b, a part of the adhesive for fixing the band-shaped proximal end 22b is not available. It is also applied on the contrast ring 26b.

FIG. 8 is a cross-sectional view showing the periphery of the distal strip 22a and the proximal strip 22b in FIG. 7. It is preferable that the adhesive 78b for fixing the band-shaped proximal end 22b to the catheter tube 5 is arranged at a predetermined distance from the balloon 2 so as not to come into contact with the balloon 2. This is to prevent the expansion of the balloon 2 from being restricted more than necessary, and to prevent the adhesive portion from peeling off due to the expansion of the balloon 2. The same applies to the adhesive 78a that fixes the distal end 22a of the band to the catheter tube 5.

In step S004 shown in FIG. 9, the band-shaped body 20 set in the groove 62 of the clamp base 61 is pressed toward the catheter tube 5. Specifically, as shown in FIG. 4, the clamp base 61 in which the catheter tube 5 coated with the adhesive is set in step S003 is fixed below the pressing portion 69 in the pressing device 60. Next, the operator of the pressing device 60 rotates the lever 65 shown in FIG. 4 toward the front side to lower the pressing force transmitting member 68 and the pressing portion 69 connected to the lower ends of the pressing force transmitting member 68. Move it. Along with this, the first pressing portion 69a and the second pressing portion 69b of the pressing portion 69 shown in FIG. 5 approach the groove portion 62 from the opening side of the groove portion 62. Further, as shown in FIG. 8, the first pressing portion 69a and the second pressing portion 69b come into contact with the band-shaped body distal end portion 22a and the band-shaped body proximal end portion 22b of the band-shaped body 20, respectively, thereby causing the band-shaped body. Pressing on 20 and the catheter tube 5 is initiated.

In step S005 shown in FIG. 9, the detection unit 70 of the pressing device 60 shown in FIG. 5 detects the pressing force, and the operator adjusts the pressing force while observing the detection result. When the pressing portion 69 starts pressing, the deforming portion 71 shown in FIG. 5 contracts in the vertical direction by transmitting the reaction force received by the pressing portion 69 to the deforming portion 71, and detects the pressing force by the pressing portion 69. do. Further, in the detection unit 70, the relative position between the lower end 68a of the pressing force transmitting unit 68 and the scale 72 changes due to the deformation of the deforming unit 71, and the pressing force by the pressing unit 69 is applied by the positional relationship between the lower end 68a and the scale 72. indicate.

The operator of the pressing device 60 operates the lever 65 of the pressing device 60 while observing the display content of the pressing pressure by the scale 72, so that the pressing portion 69 presses the band-shaped body 20 toward the catheter tube 5. To adjust. In step S004 or step S005, the state in which the pressing portion 69 presses the band-shaped body 20 toward the catheter tube 5 with a predetermined pressing force may be continued for a certain period of time. The time for maintaining the predetermined pressing force is appropriately adjusted according to the applied adhesive or the like.

In step S006 shown in FIG. 9, the adhesive for adhering the band 20 and the catheter tube 5 is cured. For example, when the adhesive applied in step S003 is a moisture-curable type or a solvent-volatile type, the catheter tube 5 and the band-shaped body 20 after the completion of step S005 are left in a predetermined environment such as a room for adhesion. Cure the agent. As described above, the eccentric balloon catheter 1 shown in FIGS. 1 to 3 can be obtained by a series of steps shown in FIG.

As described above, by manufacturing the eccentric balloon catheter 1 by using the pressing device 60 as shown in FIG. 4, the joint strength between the band-shaped body 20 and the catheter tube 5 can be stabilized, so that the strength and reliability are appropriate. An eccentric balloon catheter 1 having a property can be efficiently manufactured. That is, based on the detection result of the pressing force by the detection unit 70 of the pressing device 60, the pressing force in the joining step between the band-shaped body 20 and the catheter tube 5 is adjusted to an appropriate range to obtain the band-shaped body 20 and the catheter tube 5. Since it is possible to stabilize the width of the gap formed between the strips and the spread of the adhesive cured layer that joins the strip 20 and the catheter tube 5, the joining reliability between the strip 20 and the catheter tube 5 is improved. be able to.

Further, since the pressing device 60 can accurately adjust the pressing force, even when the pressing force is pressed at two locations simultaneously by the first pressing portion 69a and the second pressing portion 69b, the pressing force and the related bonding strength vary. Therefore, the eccentric balloon catheter 1 can be efficiently manufactured. Further, as shown in FIG. 8, the pressing device 60 may have a different shape depending on the presence or absence of the contrast ring 26b between the joint portion formed by the first pressing portion 69a and the joining portion formed by the second pressing portion 69b. Adhesives 78a and 78b can be appropriately interposed between the joining surfaces to improve the joining reliability of the band 20 in the eccentric balloon catheter 1.

The method for manufacturing the eccentric baru catheter 1 using the pressing device 60 and the pressing device 60 shown in FIGS. 4 to 6 is only one embodiment of the present invention, and the present invention includes many other embodiments. Needless to say. For example, in the method for manufacturing the eccentric balloon catheter 1 described above, the band-shaped body 20 is adhered to the outer peripheral surface of the catheter tube 5, but the joining method of the band-shaped body 20 is not limited to this, and a part or all of the band-shaped body 20 is formed. It may be joined to the balloon 2. Further, in the above-described embodiment, the expansion regulating member that regulates the expansion of the balloon 2 is the strip-shaped body 20, but the expansion-regulating member is not limited to the strip-shaped strip-shaped body 20, and has other shapes such as linear and tubular. It doesn't matter.

Further, the detection unit 70 of the pressing device 60 shown in the embodiment has a compression spring as the deformation unit 71, but the deformation unit 71 of the detection unit 70 is not limited to this, and is like a pneumatic spring or a hydraulic spring. Other springs can be adopted. Further, the display unit is not limited to the one having the scale 72 as shown in FIG. 2, and may be an electrical display means such as a lamp or a liquid crystal panel, or a mechanical display means such as a pressure gauge. good. The pressing device may employ a pressure sensor that converts a mechanical deformation amount into an electric signal as the deformation unit of the detection unit 70.

Further, the eccentric balloon catheter 1 manufactured by the pressing device 60 and the manufacturing method using the pressing device 60 is not limited to the eccentric balloon catheter for removing gallstones from the bile duct, and may move stones other than gallstones and the like. It may be an eccentric balloon catheter to be removed or another eccentric balloon catheter.

Hereinafter, the present invention will be described in more detail with reference to examples, but the technical scope of the present invention is not limited to these embodiments.

An eccentric balloon catheter 1 is produced according to the flowchart shown in FIG. 9 using the pressing device 60 shown in FIG. 4, and then a peeling test is performed in which the bonded strip 20 is peeled off from the catheter tube 5 to show variations in adhesive strength. investigated. The sample No. that was subjected to the peeling test. 1-No. Reference numeral 20 is the same regarding the materials and dimensions of the catheter tube 5, the balloon 2, and the band-shaped body 20, the type and amount of the adhesive for fixing the band-shaped body 20 to the catheter tube 5. The conditions common to all samples are shown below.

Catheter tube: Material Nylon-based elastomer, outer diameter 1.80 to 1.90 mm, length 1950 to 2150 mm
Balloon: Material Natural rubber latex, outer diameter when contracted 2.14 to 2.30 mm, length 10.5 to 11.5 mm, film thickness 0.17 to 0.25 mm
Band-shaped body: Material Nylon-based elastomer, length 13.5-14.5 mm, width 1.3-1.7 mm, thickness 0.15-0.25 mm
Adhesive: Type Cyanoacrylate adhesive, application amount 1-2 drops (per band distal end 22a or band proximal end 22b)

Sample No. prepared for the peeling test. 1-No. 20 was produced by changing the pressing force of the band 20 on the catheter tube 5 performed in step S005 in FIG. 9 at the three levels shown in Table 1. In the production of each sample, in step S005, after adjusting the pressing force to the level shown in Table 1, the pressing force was maintained for about 30 to 50 seconds.

In the peeling test, first, by cutting the strip 20 in the center, from one eccentric balloon catheter 1, the sample whose adhesion position is the distal end 22a of the strip and the adhesion position is the proximal end of the strip. Two samples of 22b were prepared. Further, the end of the cut strip 20 is fixed to the load cell, the catheter tube 5 is fixed to the movable table, and then the movable table is moved to pull the strip 20, and the relationship between the tension distance of the strip 20 and the weight is changed. It was measured. A rheometer (manufactured by Leotech Co., Ltd.) was used for the peeling test.

In FIG. 10, the sample No. 1 in which the pressing force by the pressing device 60 is level 1 (4.89N) is shown. 1-No. It is a graph which shows the result of the peeling test up to 6. At this level, in 1 of the 6 samples (Sample No. 1), the process of stretching the strip 20 before breaking was not observed, and poor joining was confirmed.

FIG. 11 shows the sample No. 1 in which the pressing force on the pressing device 60 is level 2 (6.94N). 7 to No. It is a graph which shows the result of the peeling test up to 12. At this level, no bonding failure was confirmed in any of the samples.

FIG. 12 shows the sample No. in which the pressing force by the pressing device 60 is level 3 (9.03N). 13 ~
No. It is a graph which shows the result of the peeling test up to 20. At this level, in 4 of the 8 samples (Samples No. 15, No. 18 to No. 20), the process of stretching the strip 20 before breaking was not observed, and poor joining was confirmed.

From the results of the peeling test shown in FIGS. 10 to 12, in the step of adhering the band 20 to the catheter tube 5, the pressing force is in a predetermined range (for example, around the level 2 or at the level) by using the pressing device 60. By manufacturing the eccentric balloon catheter 1 while controlling it so as to be in the range of 1 to 2), the bonding strength between the band 20 and the catheter tube 5 can be stabilized at a level that can secure sufficient strength. I was able to confirm. Further, by manufacturing the eccentric balloon catheter 1 while controlling the pushing pressure by using the pressing device 60, it is possible to suppress the generation of defective products due to the poor connection between the band-shaped body 20 and the catheter tube 5, and efficiently manufacture the eccentric balloon catheter 1. Is thought to be possible.

1 ... Eccentric balloon catheter 2 ... Balloon 3 ... Inflatable part 4a, 4b ... Joint part 5 ... Catheter tube 7 ... Tube distal end 20 ... Band 22a ... Band distal end 22b ... Band proximal end 24 ... Internal space 26a, 26b ... Contrast ring 50 ... Calculus 60 ... Pressing device 61 ... Clamp stand 62 ... Groove 63 ... Fixed plate 64 ... Pedestal 65 ... Lever 66 ... Support 67 ... Beam 68 ... Pushing pressure transmission part 69 ... Pressing part 69a ... 1st pressing part 69b ... 2nd pressing part 70 ... Detection part 71 ... Deformation part 72 ... Scale 78a, 78b ... Adhesive

Claims (6)

An eccentric balloon catheter manufacturing device in which the balloon is eccentric to the axis of the catheter tube and inflates.
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the balloon are arranged on the catheter tube and the balloon so that at least a part thereof overlaps the balloon, and when the balloon is inflated, the balloon An expansion restricting member that restricts a part of the circumferential direction from separating from the catheter tube, a clamp base formed with a groove for accommodating the expansion restricting member, and a clamp base.
A pressing portion that is relatively movable from the opening side of the groove portion so as to be close to and separated from the groove portion and presses the expansion restricting member toward the catheter tube.
Have a, a detector for detecting the pressing force by the pressing portion,
The pressing portions are arranged at predetermined intervals along the extending direction of the groove portion, and are arranged with a first pressing portion that presses the expansion restricting member toward the catheter tube on the distal end side of the balloon. A second pressing portion that presses the expansion restricting member toward the catheter tube on the proximal end side of the balloon.
At the predetermined interval, the first pressing portion presses the distal end portion of the expansion restricting member toward the catheter tube, and the second pressing portion presses the proximal end portion of the expansion regulating member toward the catheter tube. The first pressing portion and the second pressing portion are spaced so as to press the expansion restricting member toward the catheter tube at two points axially straddling the balloon. Eccentric balloon catheter manufacturing equipment. The detection unit is arranged between the pressing unit and the pressing pressure transmitting unit that transmits the pressing pressure to the pressing unit, and is deformed in the relative movement direction of the pressing unit according to the reaction force transmitted from the pressing unit. The eccentric balloon catheter manufacturing apparatus according to claim 1, further comprising a deformed portion and a display portion for displaying the pressing force of the pressing portion corresponding to the deformation amount of the deformed portion. The eccentric balloon catheter manufacturing apparatus according to claim 2 , wherein the deformed portion has a compression spring. The eccentric balloon catheter manufacturing apparatus according to claim 2 , wherein the deformed portion has a pneumatic spring. The eccentric balloon catheter manufacturing apparatus according to claim 2 , wherein the deformed portion has a hydraulic spring. A method for manufacturing an eccentric balloon catheter in which a balloon is eccentric to the axis of a catheter tube and inflates.
The catheter tube, the balloon through which the catheter tube is inserted and joined, and the balloon are arranged on the catheter tube and the balloon so that at least a part thereof overlaps the balloon, and when the balloon is inflated, the balloon A step of arranging an expansion restricting member that regulates a part of the circumferential direction from separating from the catheter tube in a groove formed in a clamp base, and
The step of applying an adhesive between the expansion restricting member and the catheter tube, and
A step of pressing the expansion restricting member toward the catheter tube by a pressing portion that can move relative to the groove portion of the clamp base from the opening side of the groove portion so as to be close to and separated from the groove portion.
The process in which the detection unit detects the pressing force by the pressing unit, and
Have a, and adjusting the pressing force by the pressing portion based on a detection result by the detector,
The pressing portions are arranged at predetermined intervals along the extending direction of the groove portion, and press the distal end portion of the expansion restricting member toward the catheter tube on the distal end side of the balloon. It has a first pressing portion and a second pressing portion that presses the proximal end of the expansion restricting member toward the catheter tube on the proximal end side of the balloon.
In the step of pressing the expansion restricting member toward the catheter tube by the pressing portion, the expansion regulating member is pressed at two points axially straddling the balloon by the first pressing portion and the second pressing portion. A method for manufacturing an eccentric balloon catheter that presses against a catheter tube.

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