JP2003117002A - Balloon, balloon catheter and method of manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon, a balloon catheter having the balloon, and a method of manufacturing the same, having a thinness enough for being folded in small to secure the sufficient operability and safety of the balloon catheter in contraction, and having sufficient pressure resistance against pressure applied in expansion. SOLUTION: This balloon has a balloon part provided with a balloon inner layer part and a balloon outer layer part formed on a surface of the balloon inner layer part by vapor deposition polymerization method. The balloon is used in the balloon catheter, and a method of manufacturing the same is provided.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon, a balloon catheter, and a method for manufacturing them, and more specifically, can be used in percutaneous transluminal coronary angioplasty (PTCA) for treating heart diseases and the like. TECHNICAL FIELD The present invention relates to a balloon having a high strength even though it is a thin film, a balloon catheter, and a manufacturing method thereof.

[0002]

Balloon catheters are mainly used for angioplasty treatment of narrowed or occluded blood vessels.

A balloon catheter is generally a balloon catheter main body, a balloon provided at one end of the balloon catheter main body, and a balloon provided at an end of the balloon catheter main body opposite to the end thereof. It is composed of a catheter operating unit.

[0004] A balloon catheter is inserted into a blood vessel from a predetermined portion of the human body with the balloon at the front, and the balloon portion reaches the narrowed portion or the closed portion of the blood vessel to be treated. A pressure fluid is pressed into the body of the balloon catheter from the balloon catheter operating portion, and the balloon is expanded by the pressure of the pressure fluid. By expanding the balloon, the narrowed portion of the blood vessel in which the balloon is inserted is expanded. In such a state, the treatment for the narrowed portion or the like is performed.

Since the balloon catheter is used in this manner, it is desired that the balloon has sufficient mechanical strength so that it will not rupture when pressure is applied to the balloon. When the balloon bursts,
This is because not only the treatment cannot be performed, but also the pressure fluid may be mixed into the blood vessel and cause serious harm to the human body.

On the other hand, considering the operability of the balloon catheter and the influence on the human body, the large diameter portion of the balloon can be folded as small as possible when it is inserted into the body, and even after it is once expanded, it is the same as before expansion. It is desirable to be able to fold it down again. In order to make the balloon smaller and easier to fold, it is necessary to reduce the thickness of the balloon.

Therefore, the balloon of the balloon catheter is required to be as thin as possible and have high mechanical strength.

However, in the conventional balloon catheter, when a balloon having a thickness satisfying the above-mentioned operability requirements is manufactured by using a material having good workability represented by thermoplastic resins such as polyethylene and polyester, The strength of the balloon is reduced, the mechanical strength required for the balloon cannot be secured, and the balloon is likely to burst during treatment.

If a material having a higher strength than the thermoplastic resin is used to increase the strength of the balloon, there is a problem that it is difficult to form a balloon having a small film thickness.

[0010]

SUMMARY OF THE INVENTION The present invention has such a thinness that it can be folded small so as to ensure sufficient maneuverability and safety of the balloon catheter when it is deflated, and is added when it is expanded. An object of the present invention is to provide a balloon having sufficient pressure resistance against a given pressure, a balloon catheter equipped with such a balloon, and a method for manufacturing these.

[0011]

The present invention for achieving the above object has a balloon portion having a balloon inner layer portion and a balloon outer layer portion formed on the surface of the balloon inner layer portion by a vapor deposition polymerization method. In a preferred embodiment of the balloon, the balloon inner layer portion has a thickness of 5 to 40 μm, and the balloon outer layer portion has a thickness of 3 to 40 μm. The portion has a tensile elastic modulus that is at least three times the tensile elastic modulus of the balloon inner layer portion, and the balloon portion has a fold line that allows folding in the circumferential direction when in a contracted state, The balloon part has a functional group present on the surface of the balloon outer layer part and a hydrophilic substance bonded thereto.

Another invention for achieving the above object is a balloon catheter having the balloon.

Another invention for attaining the above object is characterized in that the balloon inner layer portion is formed, and the balloon outer layer portion is formed on the surface of the balloon inner layer portion by a vapor deposition polymerization method to form the balloon portion. A method of manufacturing a balloon, wherein a balloon inner layer portion is formed, and a fold line is formed on the balloon inner layer portion such that the balloon inner layer portion can be folded in the circumferential direction when the balloon inner layer portion is in a contracted state. After being folded in the circumferential direction, a method for producing a balloon, characterized in that the balloon portion is created by forming a balloon outer layer portion by a vapor deposition polymerization method on the surface of the balloon inner layer portion. In a preferred embodiment, the balloon inner layer portion is formed to have a thickness of 5 to 40 μm, and the balloon outer layer portion has a thickness of 3 μm. Create to be 40 [mu] m, the balloon outer layer is more than three times the tensile modulus of the tensile modulus the balloon inner layer portion.

Another aspect of the present invention for attaining the above object is to provide a balloon manufactured by the method for manufacturing a balloon described above with a catheter body, and to provide a catheter operating portion on the catheter body. Is.

[0015]

BEST MODE FOR CARRYING OUT THE INVENTION 1. Balloon A balloon 1 which is a specific example of the balloon according to the present invention is shown in FIGS. FIG. 1 shows a front view of the balloon 1 in a state where the balloon 1 is contracted and further folded. FIG. 2 shows a left side view of the balloon 1 in a state where the balloon 1 is contracted and further folded. FIG. 3 shows a front view of the balloon 1 in a state where the balloon 1 is expanded. FIG. 4 shows a left side view of the balloon 1 in a state where the balloon 1 is expanded. FIG. 5 shows a cross-sectional view taken along the line AA of the balloon 1 in a state where the balloon 1 is expanded.

The balloon 1 includes a balloon portion 2 and a connecting pipe portion 3.
And an end tube portion 4.

The balloon portion 2 has a function of expanding when pressure is applied inside the balloon catheter and contracting when pressure is removed. The balloon part 2 is
It is sent to the stenosis part in the blood vessel in a contracted state, and expands there to push the stenosis part.

The expanded state of the balloon portion 2 is shown in FIGS. 3 and 4, and the contracted state of the balloon portion 2 is shown in FIGS.

In the expanded state, the balloon portion 2 has a substantially circular cross section and a tubular shape with both ends narrowed. still,
The reason why it is described as a substantially circular shape is that since the balloon portion 2 has a bending line, it is not a perfect circle and has a substantially circular cross section. The balloon portion 2 has a tapered portion 6 continuous with the connecting pipe portion 3, a tapered portion 7 continuous with the end pipe portion 4, and a tubular body portion 5 sandwiched between the tapered portion 6 and the tapered portion 7.
Have and.

The balloon portion 2 is provided with a plurality of bending lines 10 along the extending direction thereof. The plurality of bending lines 10 are provided with the same number of mountain-folding bending lines and valley-folding bending lines alternately provided in parallel at regular intervals.

The balloon portion 2 can be bent along the bending line 10 when it is deflated. Therefore, when the balloon portion 2 is deflated, the balloon portion 2 is folded in a mountain fold and a valley fold along the folding line 10 to form a fold, and can be folded in the circumferential direction as shown in FIGS. 1 and 2. In this way, the balloon portion 2 can be folded compactly when it is deflated and has a compact shape.
Can smoothly move in the blood vessel when the balloon portion 2 is deflated.

The length of the balloon portion 2 is not particularly limited as long as the above-mentioned function of the balloon portion 2 can be ensured, and can be made to be approximately the same as the length of the balloon portion in the conventional balloon catheter, for example, 5 to 5. It can be 100 mm.

The diameter of the tubular body portion 5 when the balloon portion 2 is expanded can be made approximately the same as the diameter of the tubular body portion when the conventional balloon catheter is expanded, for example, 1.5 to 4 mm. can do.

The pressure required for the balloon portion 2 to burst (hereinafter referred to as "burst pressure") when pressurized from the inside depends on the use of the balloon, but is actually 7.84532. 10 ^{5 to} 14.709975 × 10 ⁵
Since a pressure of Pa (8 to 15 kg / cm ² ) is applied, safety is expected to be 14.709975 × 10 ^{5 to} 29.41.
The thickness of the balloon portion 2 which is preferably 95 × 10 ⁵ Pa (15 to 30 kg / cm ² ) is preferably 8 to 80 μm. When the thickness of the balloon portion 2 is within the above range, the balloon 2 can be folded compactly so as to ensure good operability of the balloon catheter in the blood vessel.

As shown in FIG. 5, the balloon portion 2 is formed of two layers, a balloon inner layer portion 8 and a balloon outer layer portion 9.

Of the portions represented by the end faces in the sectional view and the end view in the drawings attached to this specification, the portion relating to the balloon and the balloon catheter is drawn to have a larger thickness than the actual portion. Has been.

The balloon inner layer portion 8 is made of synthetic resin,
It is formed integrally with the connecting pipe portion 3 and the end pipe portion 4.

The thickness of the balloon inner layer portion 8 is such that the balloon portion 2 obtained by forming the balloon outer layer portion 9 on the balloon inner layer portion 8 can smoothly move through the blood vessel when folded as described above. The size is determined to be a size that can be achieved, and can be, for example, 5 to 40 μm.

The material of the balloon inner layer portion 8 can be blow-molded and can be formed to the thickness as described above, and the balloon outer layer portion can be formed on the surface thereof. There is no particular limitation as long as it is a synthetic resin capable of ensuring the physical properties and safety, and examples thereof include thermoplastic resins such as nylon, polyurethane, polyethylene and polyester. Also, the material of the balloon inner layer portion 8 is the balloon outer layer portion 9
Since it is preferable that the material of the balloon outer layer portion 9 has a high affinity with the above material, for example, if the material of the balloon outer layer portion 9 is polyamide, the material of the balloon inner layer portion 8 is nylon such as polyamide. Is desirable.

The balloon outer layer portion 9 is provided on the outer peripheral surface of the balloon inner layer portion 8, that is, the entire outer surface of the tubular body portion 5, the tapered portion 6 and the tapered portion 7. Balloon outer layer 9
Is formed by a vapor deposition polymerization method. According to the vapor deposition polymerization method, it is possible to form an extremely thin outer layer portion of the balloon capable of imparting the mechanical strength required for the balloon portion 2 to the inner portion of the balloon. Further, according to vapor deposition polymerization, since the outer layer of the balloon has good throwing power with respect to the inner layer of the balloon, even when manufacturing a balloon part having a complicated shape, the outer layer of the balloon is difficult to form in the part such as gaps where the outer layer of the balloon is difficult to form. Since the forming material is supplied in the same manner as the other portions, it is possible to form the balloon outer layer portion having a uniform thickness.

The thickness of the balloon outer layer portion 9 is not particularly limited as long as the balloon portion 2 obtained by forming the balloon outer layer portion 9 on the balloon inner layer portion 8 satisfies the conditions regarding the above thickness and mechanical strength. It can be 40 μm. When the thickness of the balloon outer layer portion 9 is within the above range, the balloon catheter 1 can smoothly move through the blood vessel when the balloon portion 2 is deflated, and does not rupture due to the pressure received from the pressure fluid when the balloon portion 2 is expanded. It is possible to secure good mechanical strength.

In the present invention, the vapor deposition polymerization method used when forming the balloon outer layer portion 9 can be carried out in the same manner as the known vapor deposition polymerization method. For example, “Applied Physics” No. 6
Volume 6, No. 10 (1997), pages 1084 to 1087, or "Polymer Thesis Collection" Vol. 53, No. 5
(1996) pp. 317-321.

With respect to the raw material used for vapor deposition polymerization, the outer layer portion of the balloon obtained by vapor deposition polymerization using the same forms the balloon portion 2 satisfying the conditions relating to the thickness required for the balloon portion 2 and the mechanical strength. It is necessary to be able to do this, but if this is satisfied, there is no particular limitation. Examples of the raw material include (A) a combination of aromatic tetracarboxylic dianhydrides such as pyromellitic dianhydride and aromatic diamines such as 4,4′-diaminodiphenyl ether, and (B) 4,4′-diamino. A combination of aromatic diamines such as diphenylmethane and aromatic diisocyanates such as 4,4'-diphenylmethane diisocyanate, and (C) aromatic diamines such as paraphenylenediamine and aromatic dicarboxylic acids such as dichloride terephthalate Mention may be made of combinations with acid dichlorides.

When (A) is used as the starting material for vapor deposition polymerization, polyamic acid which gives polyimide when heated and dehydrated is obtained, and when (B) is used for vapor deposition polymerization, polyurea is obtained. An aromatic polyamide is obtained by vapor deposition polymerization using (C).

A preferred method for the vapor deposition polymerization method used in the present invention.
Suitable pressure is 1.33322 × 10 ^-1~ 1.3332
2 x 10^-3Pa (10^-3-10^-5Torr)
It Suitable Polymerization in the Vapor Deposition Polymerization Method Used in this Invention
The temperature is 10 to 100 ° C. Pressure and polymerization temperature before
Within the above range, the point that the vapor deposition polymerization reaction proceeds rapidly
Is preferred.

The preferred polymerization time in the vapor deposition polymerization method used in the present invention is 30 to 120 minutes. When the polymerization temperature is within the above range, the balloon outer layer portion 9 having the thickness required for the balloon outer layer portion 9 can be obtained, which is preferable.

The outer balloon layer portion 9 preferably has a tensile elastic modulus of 3 times or more that of the inner balloon layer portion 8. When the tensile elastic modulus of the balloon outer layer portion 9 is 3 times or more than the tensile elastic modulus of the balloon inner layer portion 8, the film thickness of the balloon outer layer portion 9 can be reduced in a practical range and has a large pressure resistance. The advantage is that it is easy to adjust the compliance of the balloon.

In the balloon catheter according to the present invention, the outer surface of the balloon outer layer portion can be subjected to hydrophilic lubrication treatment. For example, a functional group can be introduced into the outer surface of the outer layer of the balloon, and a hydrophilic substance can be bound to the functional group. Examples of the functional group include -NCO, -NH
2, -NH-, -SH-, -OH and the like can be mentioned, and as the hydrophilic substance, PEO, hyaluronic acid,
Examples thereof include polyvinyl alcohol. When the balloon catheter is subjected to the hydrophilic lubrication treatment as described above, the affinity between the balloon portion and blood is increased, so that the balloon catheter can be moved more smoothly in the blood vessel and the biocompatibility is improved.

The connecting pipe portion 3 is a pipe having a constant outer shape and inner diameter. The connecting pipe portion 3 is provided at the end of the balloon portion 2 on the side where the diameter of the tapered portion 6 is small. The connecting pipe portion 3 is a portion connected to the balloon catheter body of the balloon catheter.

The outer diameter, inner diameter and length of the connecting pipe portion 3 are not particularly limited as long as the function of the balloon 1 can be secured, and are the same as the outer diameter, inner diameter and length of the connecting pipe portion 3 in the conventional balloon. It can be a degree.

The terminal tube portion 4 is a tube having a constant outer diameter and inner diameter. The terminal tube portion 4 is provided at the end of the balloon portion 2 on the side where the diameter of the tapered portion 7 is small. The terminal tube portion 4 is a portion that is inserted at the beginning when the balloon catheter is inserted into the blood vessel.

The outer diameter, inner diameter and length of the end tube portion 4 are not particularly limited as long as the function of the balloon 1 can be ensured, and are the same as the outer diameter, inner diameter and length of the end tube portion 4 of the conventional balloon. It can be a degree.

The balloon according to the present invention is not limited to the balloon 1, and the balloon 1 can be appropriately modified. 2. Balloon catheter A balloon catheter according to the present invention is a balloon catheter using the balloon. The structure other than the balloon in the balloon catheter according to the present invention is not particularly limited as long as the function of the balloon is not impaired, and may be the same as the structure other than the balloon in the conventional balloon catheter, for example.

FIG. 13 shows a balloon catheter 51 which is a specific example of the balloon catheter according to the present invention.
The balloon catheter 51 includes a balloon 1, a balloon catheter main body 52, a balloon catheter operating unit 53, and an inner tube 54. FIG. 14 shows a vertical sectional view of a portion of the balloon catheter 51 including the balloon 1.

The inner tube 54 is inserted into the balloon 1 from the side of the connecting pipe portion 3 and fitted into the end pipe portion 4. The balloon catheter main body portion 52 is mounted on the distal end pipe portion 4 of the balloon 1 in a state where the inner tube 54 protruding from the connection pipe portion 3 of the balloon 1 is housed inside. The balloon catheter operating portion 53 is provided at the end of the balloon catheter main body 52 opposite to the end where the balloon 1 is provided. 3. Action of Balloon and Balloon Catheter The action of the balloon 1 and balloon catheter 51 is as follows.

The method of using the balloon 1 and the balloon catheter 51 is the same as that of the conventional balloon and balloon catheter.

The balloon catheter 51 is shown in FIGS.
In the state where the balloon portion 2 is folded as shown in FIG. 3, the balloon 1 is inserted into a blood vessel from a predetermined portion of the human body with the balloon 1 at the head so that the balloon portion 2 reaches the narrowed portion or the closed portion of the blood vessel to be treated. .

Since the balloon portion 2 of the balloon 1 is thin as described above, the balloon portion 2 can be folded compactly. Therefore, the balloon catheter 51
When the balloon catheter 51 is moved in the blood vessel, the balloon portion 2 can smoothly pass through even a curved portion of the blood vessel, so that the operability is good, and the blood vessel is not damaged to the human body. Never give.

A pressure fluid is pressed into the balloon catheter body 52 from the balloon catheter operating portion 53 to expand the balloon portion 2 by the pressure of the pressure fluid. Due to the expansion of the balloon part 2, the stenosis part of the blood vessel is expanded,
Predetermined therapeutic treatment is performed.

Since the balloon portion 2 of the balloon 1 is thin, it can be rapidly expanded by the pressure of the pressure fluid. On the other hand, the balloon portion 2 of the balloon 1 is thin, but since it has the high-strength balloon outer layer portion 9 formed by vapor deposition polymerization as described above, it has sufficient pressure resistance against the pressure of the pressure fluid. is doing. Therefore, the balloon 1 does not rupture when expanded, and the ruptured balloon 1 does not damage the blood vessel or the pressure fluid mixes into the blood vessel. 4. Method of Manufacturing Balloon The balloon 1 can be manufactured, for example, as follows.

First, a balloon tube is prepared. The balloon tube is formed by inflating the portions other than the both end portions, so that the inflated portion becomes the balloon inner layer portion 8, one of the both end portions becomes the connecting pipe portion 3, and the other end portion becomes the end pipe portion 4. Is a member that constitutes the part.

Therefore, as the material of the balloon tube, the synthetic resin shown as the material of the balloon inner layer portion 8 in "1. Balloon" is used.

The outer diameter, inner diameter, and length of the balloon tube are such that when the predetermined portion of the balloon tube is inflated, the balloon inner layer portion 8 and the connecting tube have the predetermined size shown in "1. Balloon" above. Section 3 and end tube section 4
Is determined to be obtained.

As a method for manufacturing a balloon tube,
There is no particular limitation as long as a balloon tube having a predetermined shape can be produced using the synthetic resin, and a known method can be appropriately used. Examples of such a method include an extrusion method. According to the extrusion method, a balloon tube having a predetermined shape can be easily manufactured at low cost. The specific operation in the extrusion processing method can be performed according to the conditions of the extrusion processing method usually performed.

The balloon tube is prepared by inflating the portions other than both ends of the balloon tube. The inflated portion becomes the balloon inner layer portion 8.

The inflatable portion of the balloon tube is the portion where the balloon inner layer portion 8 having the predetermined length shown in "1. Balloon" is obtained.

As a method of manufacturing a balloon tube,
There is no particular limitation as long as the balloon inner layer portion 8 having the predetermined shape shown in the above “1. Balloon” can be formed, but the blow molding method is preferable. According to the blow molding method, a balloon tube having a balloon inner layer portion having a predetermined shape can be easily manufactured at low cost.

The method for producing a balloon tube by the blow molding method is not particularly limited as long as a balloon tube having a predetermined shape can be produced, but concretely, for example, as shown in FIGS. 6 to 9. Two identical molds 11
The method using can be mentioned. 6 to 9 show vertical cross sections of the end surface of the mold 11 and the balloon tube 12 and the balloon tube 13.

The mold 11 includes a recess 14 for forming an end pipe portion, a recess 15 for forming a connecting pipe portion, and a recess 1 for forming a balloon inner layer portion.
Have six.

As shown in FIG. 6, two molds 11 are arranged with the recesses provided in the molds 11 facing each other, and a balloon tube 12 is inserted therebetween.

As shown in FIG. 7, the two molds 11 are brought into contact with each other. At this time, the tip portion 17 of the balloon tube 12
Comes into contact with the tip portion 18 of the recess 14 for forming the end tube portion, and the portion of the two molds 11 forming the recess 14 for forming the end pipe portion and the portion forming the recess 15 for forming the connecting pipe portion 12 make the balloon tube 12 The positional relationship between the two molds 11 and the balloon tube 12 is adjusted so that the two are sandwiched.

The mold 11 is heated so that the balloon tube 12 is softened and becomes a deformable temperature. As shown in FIG. 8, compressed air is blown into the balloon tube 12 to deform outwardly the portion of the balloon tube 12 located in the void formed by the balloon inner layer portion forming recess 16. The outer peripheral surface of that part,
Balloon inner layer forming recess 16 in two molds 11
It is pressure-bonded to the inner peripheral surface of the portion forming the. In this way, the balloon tube 12 is given a predetermined shape.

After cooling the two metal molds 11, the two metal molds 11 are separated from each other as shown in FIG. 9, and the balloon tube 13 molded by the above operation is taken out.

Next, as shown in FIG. 10, a plurality of bending lines 19 are formed in the balloon inner layer portion 8 of the balloon tube 13.
To form. The plurality of fold lines 19 are provided in parallel at regular intervals and the same number of mountain folds and valley folds are alternately provided. By forming the folding line 19, the balloon inner layer portion 8 is given a folding habit.

The folding line 19 can be formed by, for example, a method of pressing the balloon inner layer portion 8 and then pressing, a method of heating after folding, or a method of crosslinking after folding.

The balloon tube 13 on which the fold line 19 is formed is evacuated and folded, and then the opening 21 and the opening 22 are closed and sealed as necessary, and after depressurization, the outer layer portion is formed by vapor deposition polymerization. Form. FIG. 11 shows a vertical end view of the sealed balloon body 23.

In the method for producing a balloon according to the present invention, the balloon inner layer portion is not bent at this stage, the balloon outer layer portion is formed on the balloon inner layer portion to form the balloon portion, and then the balloon portion is formed. It is possible to attach a fold line, but it is easier to make the folding habit permanent if the fold line is attached to the balloon inner layer at this stage.
It is preferable because the rewrap property is improved.

The sealing balloon 24 has a terminal blind tube portion 25 and a connecting blind tube portion 26 at both ends thereof. FIG. 12 shows a vertical end view of the sealing balloon 24. The balloon inner layer portion 8 and the balloon outer layer portion 9 provided on the outer peripheral surface thereof form the balloon portion 2.

The outer balloon layer 9 is formed by vapor deposition polymerization. The vapor deposition polymerization method is as described in “1. Balloon” above.

The formation of the balloon outer layer portion 9 by this vapor deposition polymerization method is preferably carried out with the balloon inner layer portion 8 folded, and can be carried out even with the balloon inner layer portion 8 unfolded. . Even when the balloon inner layer portion 8 is not folded, the raw material evaporated and vaporized in the vapor deposition polymerization method can freely enter between the folds of the fold-folded balloon inner layer portion 8. The outer balloon layer 9 can be formed with a uniform thickness over the entire outer surface of the inner balloon layer 8.

Therefore, according to the method for manufacturing a balloon of the present invention, the balloon inner layer portion 8 is folded to reduce the volume of the entire balloon inner layer portion 8 and to increase the mechanical strength of the balloon outer layer portion. Since the formation of the outer balloon layer 9 can be performed, there is no concern that the inner balloon layer 8 of the sealed balloon body 23 will be caught by an instrument or bent during the operation of forming the outer balloon layer 9. The handling of the balloon tube 13 during operation becomes extremely easy.

A fold line 10 is formed on the balloon outer layer portion 9 provided on the balloon inner layer portion 8 at a position corresponding to the fold line 19 attached to the balloon tube 13. The folding line 19 and the folding line 10 give the balloon portion 2 a folding habit.

The closed ends of the distal blind tube portion 25 and the connecting blind tube portion 26 of the sealing balloon 24 are cut off. The cutting position is the end tube portion 4 having a predetermined length from the end blind tube portion 25.
Is formed, and the connecting pipe part 3 having a predetermined length is formed from the connecting blind pipe part 26.

The balloon 1 is completed as described above.

In the balloon catheter according to the present invention, the outer surface of the balloon outer layer portion can be subjected to hydrophilic lubrication treatment. Regarding the hydrophilic lubrication treatment,
As described in “1. Balloon”.

The above balloon manufacturing method can be appropriately changed depending on the shape and structure of the balloon to be manufactured. 5. Method for Producing Balloon Catheter The balloon catheter according to the present invention can be produced by a known method using the balloon produced by "4. Method for producing balloon".

For example, the balloon catheter 51 shown in FIGS. 13 and 14 can be manufactured as follows.

The inner tube 54 is inserted into the balloon 1 manufactured by the above-mentioned “4. Method for manufacturing balloon” from the opening on the side of the connecting tube portion 3, and the tip of the inner tube 54 on the inserted side is inserted into the balloon 1. It is aligned with the open end on the side of the end tube portion 4. The balloon catheter body 52,
With the inner tube 54 protruding from the connecting tube portion 3 of the balloon 1 accommodated therein, the end tube portion 4 of the balloon 1
Attach to. The balloon catheter operating unit 53 is attached to the end of the balloon catheter main body 52 opposite to the end where the balloon 1 is provided.

[0079]

[Examples] (1) Example 1 Using nylon 6 as a raw material, a known extrusion process was performed.
A balloon tube having an outer diameter of 0.7 mm and a wall thickness of 40 μm was prepared.

A balloon tube having a length of 20 cm was attached to a tubular body of 20 mm, a taper portion of 3 mm, and a length of 3.2 m.
Using a mold having a void corresponding to the diameter of the balloon part of m, blow molding under conditions of 110 ° C. and 20 atm,
A balloon tube having an outer diameter of 3 mm and a balloon inner layer having a wall thickness of 15 μm was obtained.

This balloon tube was folded into a cap-shaped roll, inserted into a Teflon (registered trademark) tube having an inner diameter of 1 mm, and heated at 100 ° C. for 30 minutes to give the balloon tube a folding habit.

Both openings of the balloon tube having this folding tendency were melted and sealed to prepare a sealed balloon body.

This sealed balloon body was put into a vapor deposition polymerization tank after depressurization, and phthalic acid chloride and phenylenediamine were used as raw materials at a temperature of 30 ° C. and a pressure of 1.33322 × 10 7.
^-2 Pa (10 ^-4 Torr) was vapor-deposited and polymerized to form a balloon outer layer portion on the outer surface of the balloon inner layer portion of the sealed balloon body to prepare a sealed balloon. The outer layer of the balloon had a thickness of 5 μm.

The melt-sealed part was also cut to 100 mm so that an end tube having a length of 3 mm was obtained.
It was cut and removed so as to obtain a connecting pipe portion having a length of. The balloon was created by the above.

An inner tube with a length of about 110 mm was inserted into the balloon from the opening on the side of the connecting tube,
The tip of the inner tube on the inserted side was inserted on the end tube side of the balloon. The outer diameter of the tip 20 cm is 0.8
mm and the other part has an outer diameter of 1.0 mm, the inner tube protruding from the connecting tube portion of the balloon is housed in the balloon catheter main body portion, and the balloon catheter main body portion is connected to the end tube portion of the balloon. Attach to. A balloon catheter operating unit is attached to the end of the balloon catheter body opposite to the end where the balloon is provided. The balloon catheter was produced as described above. (2) Example 2 After the step of Example 1, the functional group such as —NH— existing on the surface of the outer layer of the balloon is reacted with PEO in a blocked isocyanate to make the surface of the balloon hydrophilic. It was

The other operations were the same as in Example 1,
Balloons and balloon catheters were created. (3) Comparative Example 1 In the process of Example 1, the outer diameter is 0.7 mm and the wall thickness is 50.
Same as Example 1 except that a balloon tube having a diameter of 3 μm was prepared, and a balloon tube having an inner layer of 3 μm in outer diameter and a wall thickness of 20 μm was prepared in the step of Example 1 and the subsequent steps were not performed. The procedure described above was performed to prepare a balloon and a balloon catheter each having a single balloon portion. (4) Balloon Pressure Test Regarding the balloons obtained in Example 1, Example 2 and Comparative Example 1, a pressure test device “hydraulic burst-leak” of “Crescent Design Co.”
The following pressure test was performed using "tester-model 1000".

One end of the balloon is tightly plugged, and from the other end,
Inject physiological saline at 37 ° C. with a water pressure of 19.6133 × 10 ⁴ Pa (2 kg / cm ² ) and gradually increase the water pressure by 9.80665 × 10 ⁴ Pa (1 kg / cm ² ) every 30 seconds. The balloon pressure was increased and the burst pressure of the balloon was measured.

The burst pressure of the balloon of Example 1 was 30 × 10.
⁵Pa, the burst pressure of the balloon of Example 2 is 29 × 1.
0⁵Pa, the burst pressure of the balloon of Comparative Example 1 is 15 ×
10 ⁵It was Pa.

This test revealed that the balloon according to the present invention is less likely to burst when pressurized from the inside, as compared with the conventional balloon having a balloon portion consisting of only one layer. (5) Insertability Test An insertability test was conducted on the balloon catheters obtained in Example 1, Example 2 and Comparative Example 1. The insertability test was performed as follows.

Made of polyethylene with a diameter of 3 mm and a total length of 1 m
The tube 55 has three curves as shown in FIG.
It was molded into a shape. R₁= 50 mm, R_Two= 20m
m, R _Three= 10 mm. The length of each curve is different
It was set to 1/3 of the circumference. At 25 ° C
A saline solution was injected into the tube 55. In tube 55
Guide wire (Product name "Athlete" (Japan Lifeline
Manufactured by K.K.) was inserted. Each of the balloon catheters
The tube 55 along the guide wire.
It was inserted from 56 into the tube 55. Each of the above at this time
Ease of passage of balloon catheter through tube 55
(Passability) was evaluated according to the following criteria. ○: Easy to pass, △: Difficult to pass, ×: Passed
Can't let After acting once, reduce the pressure to 50 mmH and repeat the same as above.
An insertability test was performed.

The results of this test are shown in Table 1.

This test revealed that the hydrophilically lubricated balloon catheter according to the present invention has better insertability than conventional balloon catheters. (6) Repeated pressurization / depressurization test The balloon catheters obtained in Example 1, Example 2 and Comparative Example 1 were subjected to the following pressurization / depressurization repeat test.
These balloon catheters in saline at 37 ° C
Pressurization to 15 × 10 ⁵ Pa and depressurization to 50 mmHg were repeated 5 times, and the appearance of the wing of each balloon under the pressure of 80 mmHg was evaluated according to the following criteria.

◯: Wing does not appear, Δ: Wing appears, X: Wing appears significantly. The results are shown in Table 1.

The balloon catheters of Examples 1 and 2 had no wing, whereas the balloon catheters of Comparative Example 1 had collapsed bending habit.

[0095]

[Table 1]

[0096]

The balloon and balloon catheter according to the present invention have a balloon portion composed of a balloon inner layer portion and a balloon outer layer portion formed by a vapor deposition polymerization method, which is thin and has high pressure resistance. From
It can be folded compactly during contraction, and sufficient operability and safety of the balloon catheter in the blood vessel can be ensured, and there is no risk of rupture even if pressure is applied by the pressure medium during expansion.

The balloon and the balloon catheter according to the present invention can be improved in operability and biocompatibility by applying hydrophilic lubrication to the balloon portion.
Hydrophilic lubrication can be imparted by introducing a functional group into the outer layer of the balloon and reacting it with a hydrophilic substance, so that it is stably maintained for a long period of time.

In the method for manufacturing a balloon and the method for manufacturing a balloon catheter according to the present invention, since the balloon outer layer portion is formed after the balloon inner layer portion is provided with the folding habit, the balloon portion has a permanent folding habit and the rewrap property is improved. To do.

In the method of manufacturing a balloon and the method of manufacturing a balloon catheter according to the present invention, since the outer layer of the balloon bears strength, the balloon tube to be ballooned has good moldability and can be manufactured from an inexpensive material. it can. Therefore, the method for manufacturing a balloon and the method for manufacturing a balloon catheter according to the present invention have few restrictions on moldability and are highly economical.

In the method for manufacturing a balloon and the method for manufacturing a balloon catheter according to the present invention, the adhesion between the balloon inner layer portion and the balloon outer layer portion is improved by appropriately selecting the materials for the balloon inner layer portion and the balloon outer layer portion. You can

[Brief description of drawings]

FIG. 1 is a front view of the balloon 1 in a state in which the balloon 1 is deflated and is further folded.

FIG. 2 is a left side view of the balloon 1 in a state where the balloon 1 is contracted and further folded.

FIG. 3 is a front view of the balloon 1 in a state where the balloon 1 is expanded.

FIG. 4 is a left side view of the balloon 1 in a state where the balloon 1 is expanded.

5 is a cross-sectional view of the balloon 1 taken along the line AA in a state where the balloon 1 is expanded. FIG.

FIG. 6 is a cross-sectional explanatory view showing a state in which a balloon tube 12 is inserted between two molds 11.

FIG. 7 is a cross-sectional explanatory view showing a state in which two metal molds 11 are in contact with each other with the balloon tube 12 sandwiched therebetween.

FIG. 8 is a cross-sectional explanatory view showing a state in which compressed air is blown into the balloon tube 12 to make the balloon tube 12 into a balloon.

FIG. 9 is a drawing showing two molds 11 separated from each other,
It is a section explanatory view showing the state where the balloon tube 13 was taken out.

FIG. 10 is a plan view of a balloon tube 13 having a plurality of fold lines 19.

FIG. 11 is a vertical end view of the sealed balloon body 23.

FIG. 12 is a vertical end view of the sealing balloon 24.

FIG. 13 is a plan view of the balloon catheter 51.

FIG. 14 is a longitudinal sectional view of a portion of the balloon catheter 51 including the balloon 1.

FIG. 15 shows a tube 5 used for insertability test.
It is explanatory drawing of 5.

[Explanation of symbols]

1 ... balloon 2 ... Balloon part, 3 ... Connection pipe part, 4 ... End tube part, 5 ... Tube body, 6 ... Tapered part, 7 ... Tapered part, 8 ... Balloon inner layer, 9 ... Balloon outer layer, 10 ... Bending line, 11 ... Mold, 12 ... Balloon tubes, 13..Balloonized tube, 14 ... Recess for forming end tube portion, 15 ... Recess for forming connecting pipe portion, 16 ... Recesses for forming inner layer of balloon, 17 ... 18 ... 19, folding lines, 21 ... Opening, 22 ... Opening, 23. Sealed balloon body, 24 ... Sealed balloons, 25 ··· Terminal blind tube part, 26 .. Connection blind pipe part, 51 ... Balloon catheter, 52 ... Balloon catheter body, 53 .. Balloon catheter operation unit, 54 ... Inner tube, 55 ... tube, 56..Opening

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Claims (11)

[Claims] 1. A balloon comprising a balloon inner layer portion and a balloon portion having a balloon outer layer portion formed on the surface of the balloon inner layer portion by a vapor deposition polymerization method. 2. The balloon inner layer portion has a thickness of 5 to 5.
40 μm, and the outer layer of the balloon has a thickness of 3
The balloon according to claim 1, which has a diameter of -40 μm. 3. The balloon according to claim 1, wherein the outer layer portion of the balloon has a tensile elastic modulus that is at least three times the tensile elastic modulus of the inner layer portion of the balloon. 4. The balloon according to claim 1, wherein the balloon portion has a fold line that can be folded in the circumferential direction when in a contracted state. 5. The balloon according to claim 1, wherein the balloon portion has a functional group present on the surface of the balloon outer layer portion and a hydrophilic substance bonded to the functional group. 6. A balloon catheter comprising the balloon according to any one of claims 1 to 5. 7. A method for producing a balloon, comprising forming a balloon inner layer portion and forming a balloon outer layer portion on the surface of the balloon inner layer portion by a vapor deposition polymerization method to form the balloon portion. 8. A balloon inner layer portion is formed, and a fold line is formed on the balloon inner layer portion such that the balloon inner layer portion can be folded in the circumferential direction when the balloon inner layer portion is in a contracted state. A method for producing a balloon, comprising forming the balloon portion by forming the balloon outer layer portion on the surface of the balloon inner layer portion by a vapor deposition polymerization method after being folded. 9. The balloon inner layer has a thickness of 5 to 5.
The balloon outer layer is made to have a thickness of 40 μm,
8. The thickness is 3 to 40 .mu.m.
Or the method for manufacturing a balloon according to item 8. 10. The method of manufacturing a balloon according to claim 7, wherein the tensile modulus of elasticity of the outer balloon layer is 3 times or more the tensile modulus of elasticity of the inner balloon layer. 11. A balloon catheter, characterized in that a balloon manufactured by the method for manufacturing a balloon according to claim 7 is provided with a catheter body, and the catheter body is provided with a catheter operating portion. Production method.