WO2006126311A1

WO2006126311A1 - Balloon and balloon catheter

Info

Publication number: WO2006126311A1
Application number: PCT/JP2006/302385
Authority: WO
Inventors: Mitsuharu Korogi
Original assignee: Kaneka Corporation
Priority date: 2005-05-27
Filing date: 2006-02-10
Publication date: 2006-11-30
Also published as: TW200702004A

Abstract

A balloon for catheters for medical use which is made of polyamide elastomers. This balloon comprises a base layer which is made of a polyamide elastomer and an inner layer which is provided within the base layer and made of another polyamide elastomer having a lower elastic modulus and a larger elongation at break or a lower Shore hardness each than the base layer. Thus, it is possible to provide a balloon for catheters which can be thinned while sustaining sufficient compression strength and dimensional stability and has such flexibility as facilitating the insertion into a curved and narrow part.

Description

Nolane and Nolane Force Tetenore

Technical field

TECHNICAL FIELD [0001] The present invention relates to a medical balloon and a balloon catheter including the balloon.

Conventionally, when stenosis or occlusion occurs in a blood vessel such as a blood vessel, angioplasty PTA is performed to improve the blood flow on the peripheral side of the blood vessel by expanding the stenosis or occlusion site of the blood vessel. Percutaneous Transluminal Angioplasty ^ PTCA: Percutaneous Transluminal Coronary Angioplasty, etc.) has many surgical cases in many medical institutions, and it is a common procedure for this type of case.

[0003] Balloon catheters are mainly used as a set of guide catheter and guide wire to dilate a stenotic site in a coronary artery. In angioplasty using this balloon catheter, the guide catheter is first inserted into the femoral artery, the tip is positioned at the entrance of the coronary artery via the aorta, and then the guide wire penetrating the balloon catheter is coronated. Advance beyond the stenosis site of the artery, then advance the balloon catheter along the guidewire, inflate with the balloon positioned at the stenosis site and dilate the stenosis site, and deflate the balloon It is removed outside the body. However, the neuron catheter is not limited to treating arterial stenosis but is useful for many medical applications including insertion into blood vessels as well as insertion into various body cavities.

[0004] Norane provided at the distal portion of the catheter shaft is required to have various characteristics due to its role of expanding the stenosis in the blood vessel. High pressure strength is required to expand the calcified hard stenosis. In addition, a high degree of flexibility is required in order to be positioned at a bent stenosis site. In addition, in order to be located at a stenosis site having a very high stenosis degree of 99%, not only flexibility but also a sufficiently thin balloon is required. Taking these characteristics together, balloons are required to be thin and have high membrane strength and high flexibility. A number of methods have been disclosed so far regarding balloon thinning, high strength, and dimensional stabilization during expansion.

[0005] For example, JP-A 63-183070 discloses a balloon made of polyethylene terephthalate (PET). This noren is thin, has high strength and has excellent dimensional stability. However, the lack of flexibility and pinhole destruction occur as disadvantages. In particular, pinhole destruction is not preferable because a high stress is locally applied to the blood vessel wall when the balloon breaks in the blood vessel, and the risk of causing damage to the blood vessel wall is extremely high.

[0006] JP-T-09-509860 discloses a balloon made of a block copolymer elastomer. This balloon has moderate elasticity and flexibility, but when trying to achieve sufficient dimensional stability, the balloon film thickness must be increased, and as a result, the passage through the constriction is impaired. .

[0007] Japanese Patent Application Laid-Open No. 09-164191 discloses a catheter nolon comprising a cylindrical portion and a catheter joint, wherein the balloon is made of a high-strength polymer, and the base layer A balloon having a coating layer which is close to the high-strength polymer formed on at least one surface of the material and has a flexible polymer force close to elongation at break and has a wall thickness of 25 m or less is disclosed. Yes. However, it is disclosed that the ratio of the Shore hardness of the polyamide elastomer forming the inner layer to the Shore hardness of the polyamide elastomer forming the base layer is 0.70 or more and 0.993 or less.

Patent Document 1: JP-A 63-183070

Patent Document 2: No. 09-509860

Patent Document 3: Japanese Patent Laid-Open No. 09-164191

Disclosure of the invention

Problems to be solved by the invention

[0008] Therefore, an object of the present invention is to provide a medical balloon that has the same film thickness but has sufficient pressure resistance and dimensional stability when compared with balloons of other configurations.

Means for solving the problem

[0009] The present invention solves the above-described problems and includes the following configuration. Snow The

(1) A balloon for a medical catheter that has the strength of a polyamide elastomer. The balloon has a base material layer made of a polyamide elastomer and has a lower bending elastic modulus than the base material layer inside the base material layer. A balloon characterized by having an inner layer made of a polyamide elastomer having a large breaking elongation.

(2) The balloon for medical catheter according to (1), wherein the ratio of the cross-sectional area of the inner layer to the cross-sectional area of the entire balloon is 0.01 force and 0.25.

(3) A balloon for a medical catheter that has the power of a polyamide elastomer, the balloon comprising a base material layer made of a polyamide elastomer, and a polyamide elastomer having a Shore hardness lower than that of the base material layer inside the base material layer. There is an inner layer which can be used as a force, and the ratio of the polyamide elastomer forming the inner layer to the Shore hardness of the polyamide elastomer forming the base material layer is from 0.70 to 0.93. Characteristic balloon.

(4) The polyamide elastomer strength of the inner layer is selected from a polyetheramide elastomer and a polyetheresteramide elastomer, and the polyamide elastomer of the outer layer is selected from a polyetheramide elastomer and a polyetheresteramide elastomer. 3) The balloon.

(5) The balloon according to (3) or (4), wherein the base layer of the balloon has a Shore hardness of 60D or more and 78D or less.

(6) The ratio of the cross-sectional area of the inner layer to the total cross-sectional area of the balloon is 0.01 to 0.25. (3) No (5) V-shaped balloon.

(7) Furthermore, there is an outer layer on the outside of the base material layer where the flexural modulus is lower than 300 MPa and the elongation at break is greater than 380%. (1) Yes (6) V No nolane.

(8) A balloon for a medical catheter comprising a polyether ester amide elastomer, wherein the balloon has a base layer also comprising a polyether ester amide elastomer, and has a Shore hardness inside the base layer than the base layer. There is an inner layer consisting of a low polyether ester amide elastomer marker, where the hard segment weight ratio of the polyether ester amide elastomer that forms the base layer is X, and the polyether ester that forms the inner layer A balloon characterized in that the ratio of 62 X y + 14 to 62 Χ χ + 14 is from 0.70 to 0.93, where y is the hard segment weight ratio of the amide elastomer.

(9) A balloon catheter provided with a foldable balloon used for medical treatment for the purpose of expansion operation, characterized in that it has a balloon described in (1) N A balloon catheter.

The invention's effect

[0010] According to the present invention, there is provided a medical balloon having sufficient pressure resistance and dimensional stability when compared to a balloon having the same film thickness but having another configuration.

Brief Description of Drawings

FIG. 1 is a graph showing the relationship between balloon film thickness and breaking pressure.

FIG. 2 is a graph showing the relationship between the balloon film thickness and the diameter expansion rate.

FIG. 3 is a graph showing the relationship between balloon film thickness and breaking pressure.

FIG. 4 is a graph showing the relationship between balloon film thickness and diameter expansion rate.

BEST MODE FOR CARRYING OUT THE INVENTION

[0012] In one aspect of the present invention, there is provided a catheter for medical use having a polyamide elastomer force, the balloon comprising a base material layer made of a polyamide elastomer, and a base material layer on the inner side of the base material layer than the base material layer. There is provided a balloon characterized by having an inner layer having a low bending elastic modulus and a polyamide elastomer having a large elongation at break and a great strength.

[0013] In another aspect of the present invention, the balloon and the balloon catheter of the present invention are medical catheter balloons made of a polyamide elastomer, the balloon comprising a base material layer also made of a polyamide elastomer and the base. There is an inner layer of polyamide elastomer that has a lower Shore hardness than the base material layer inside the material layer, and the ratio of the Shore hardness of the polyamide elastomer that forms the inner layer to the Shore hardness of the polyamide elastomer that forms the base layer Is 0.70 or more and 0.93 or less. The hardness of the polyamide elastomer is a force that can be used with any hardness depending on the flexibility required of the balloon. Preferably, it has a Shore D hardness of 25 to 72, and more preferably a Shore D hardness of 50 to 72. Is used.

In this aspect, the fracture pressure when compared at the same film thickness is the ratio of the Shore hardness of the polyamide elastomer that forms the inner layer of the norene of the present invention to the Shore hardness that forms the base material layer. If it is smaller than 0.70, the target cannot be achieved because the fracture pressure when compared at the same film thickness is small, and if it is larger than 0.93, all of them are formed only by the same base material layer. Compared to the lane, the improvement effect of high pressure strength and low expansion rate is insufficient.

[0015] The ratio of the Shore hardness of the polyamide elastomer forming the inner layer of the balloon of the present invention to the Shore hardness forming the base material layer is more preferably from 0.78 to 0.93.

From the viewpoint of being suitable for an angioplasty balloon that requires dimensional stability, the Shore hardness of the polyamide elastomer that forms the base layer of the balloon of the present invention is preferably 60D or more. From the viewpoint of flexibility and insertability into the lesion, the polyamide elastomer forming the base material layer preferably has a Shore hardness of 78D or less. In addition, the Shore hardness referred to in this specification means a value measured by IS0868.

[0016] In another aspect of the present invention, the present invention provides a balloon for a medical catheter that is also a polyetheresteramide elastomer, the balloon comprising a base material layer that also has a polyetheresteramide elastomer force, Inside the base material layer is an inner layer which is also a polyether ester amide elastomer having a lower Shore hardness than the base material layer. Here, the hard segment weight ratio of the polyether ester amide elastomer forming the base material layer is set to X When the hard segment weight ratio of the polyether ester amide elastomer forming the inner layer is y, it is a force of 62 Xy + 14 to 62 X X + 14 ^). 70 or more and 0.9 or less Provide a balloon to do. The weight ratio of the hard segment is determined by measuring the weight of the polyamide part and the weight of the polyether part by P ^ -NMR and calculating the weight ratio of the polyamide part.

[0017] The method for producing the balloon of the present invention is not particularly limited, but a tube having an inner layer having a Shore hardness lower than that of the base material layer on the inner side of the base material layer that also has a polyamide elastomer having a high elastic modulus (Parison) ) By extrusion molding, and the parison is biaxially stretch blow molded.

In any of the above aspects, examples of the polyamide elastomer include polyether ester amide elastomers and polyamide ether elastomers. Polyether ester amide elastomers are preferred from the viewpoint of better dimensional stability of balloons with higher yield strength. [0019] The polyamide elastomer of the inner layer is preferably a polyether ester amide elastomer from the viewpoint of better dimensional stability of the balloon.

[0020] The polyamide elastomer of the outer layer is preferably a polyether ester amide elastomer from the viewpoint of better dimensional stability of the balloon.

[0021] As the polyetheresteramide elastomer, a block copolymer comprising a hard segment and a soft segment is used. Preferably, a block copolymer using a hard segment made of polyamide and a soft segment also having a polyether strength is used. Further, as the polyamide constituting this hard segment, polyamide 6, 6-6, 6-10, 6-12, 11, 12 and the like can be used. Particularly, polyamide 12 is preferable. Furthermore, as the polyether constituting the soft segment, polyethylene glycol, polypropylene glycol, polytetramethylene glycol and the like can be used. Particularly, polytetramethylene glycol is preferable.

[0022] In any of the above aspects, from the viewpoint of dimensional stability, the ratio of the overall cross-sectional area of the cross-sectional area of the inner layer of the balloon of the present invention is preferably 0.01 to 0.25. Here, the cross-sectional area means the cross-sectional area when the balloon is cut into a ring perpendicular to the longitudinal direction of the balloon.

[0023] As a method of measuring the cross-sectional area ratio of the inner layer, when a parison formed by extrusion molding is produced by biaxial stretch blow molding, a cross section of the parison before biaxial stretch blow molding is cut with a microscope. Magnified observation, measure the inner diameter of the parison, the outer diameter, and the intermediate diameter formed by the interface between the outer layer and the inner layer, and assume that the inner circle, outer circle, and middle circle are true circles, respectively. There is a method of calculating the ratio by calculating the inner diameter, outer diameter, and intermediate diameter force for each cross-sectional area, and using this as the cross-sectional area ratio of the inner layer of the balloon.

[0024] As another measurement method, the inner layer and the outer layer may be measured in the same manner as the method of measuring the cross section of the parison by observing the balloon by cutting it into a ring perpendicular to the longitudinal axis direction and magnifying with a microscope. There is a method of calculating the ratio by calculating the cross-sectional area.

[0025] If the cross-sectional area ratio of the inner layer is smaller than 0.01, the effect of reducing the film thickness while maintaining high fracture pressure and high dimensional stability is poor. Point force that reduces dimensional stability is not preferable. The cross-sectional area ratio of the inner layer is more preferably 0.02 force to 0.20, and still more preferably 0.03 force to 0.15. [0026] In any of the above aspects, in the balloon and balloon catheter of the present invention, from the viewpoint of increasing flexibility, an outer layer that is one of the most powerful polyamide elastomers on the outside of the base material layer has low elastic modulus and high elongation at break. It exists, but ...

In any of the above aspects, in the norene of the present invention, preferably, from the viewpoint of increasing flexibility, a polyamide elastomer having a bending elastic modulus lower than 300 MPa and a breaking elongation larger than 380% is provided outside the base material layer. There may be an outer layer that can be as powerful as possible. In this case, an inner layer that is a polyamide elastomer marker having a Shore hardness lower than that of the base material layer is provided inside the base material layer, and the base material layer of the polyamide elastomer that forms the inner layer has a Shore hardness. In order to obtain the effects of the present invention, it is essential that the ratio of the polyamide elastomer that forms the Shore hardness is 0.70 or more and 0.93 or less. Examples of the polyamide elastomer having a low flexural modulus and a large breaking elongation include polyether ester amide elastomer and polyether amide elastomer. From the viewpoint of better dimensional stability of the balloon, a polyester ester amide elastomer is preferred as the polyamide elastomer having a low elastic modulus and a large elongation at break.

[0027] An outer layer that has the strength of a polyamide elastomer that has a low elastic modulus and a large breaking elongation exists outside the base material layer, and a balloon that does not have an inner layer inside the base material layer has the same film thickness when compared. Because the pressure resistance is inferior!

The flexural modulus referred to in this specification is a value measured by IS0178. The elongation at break referred to in this specification is a value measured by ASTM D638.

Example

[0028] (Example 1)

A parison with a base layer strength of PEBAX7233 (manufactured by Elfachem) and an inner layer of PEBAX6333 with a ratio of 0.09 to the total cross-sectional area of the inner layer was formed by extrusion. PEBAX7233 has a flexural modulus of 730 MPa and an elongation at break of 360%. PEBAX6333 has a flexural modulus of 290 MPa and an elongation at break of 440%. A biaxial stretch blow molding was performed under various molding conditions to obtain a balloon having a thickness of 20 m to 23 m. Here, the film thickness of the balloon was measured with a micrometer, and the average of the thicknesses at the center, right side, and left side of the straight tube portion of the balloon was taken as the film thickness. These balloons were placed in a water bath filled with 37 ° C physiological saline, and the pressure was increased by 0.2 atm using physiological saline. The outer diameter was measured by holding for 1 second at each pressure. The pressure was continuously increased until the balloon was broken, and the breaking pressure of the balloon was measured. The diameter expansion rate was calculated when the pressure was increased from 12 atm to 22 atm. Table 1 shows the measured values. Figure 1 shows the relationship between film thickness and burst pressure, and Figure 2 shows the relationship between film thickness and diameter expansion rate. The diameter expansion rate was calculated using the following formula.

[0029] [ _Equation 1] Diameter when the pressure inside the _{vane is} 2 atm 1 Diameter when the pressure inside the _{vane is} 1 2 atm _{ν ι ηη}

No./"Inner pressure 2 2 atm diameter

[0030] (Example 2)

Base layer layer SPEBAX7233, outer layer force PEBAX6333, inner layer PEBAX6333 has a three-layer structure, the ratio of the inner layer cross-sectional area to the total cross-sectional area is 0.06, and the ratio of the outer layer cross-sectional area to the total cross-sectional area is 0.03. The parison was molded by extrusion. A biaxial stretch blow molding was performed under various molding conditions to obtain a balloon having a diameter of 3. Omm and a film thickness of 20 μm to 24 μm. The breaking pressure and the diameter expansion rate of the balloon were measured in the same manner as in Example 1. Table 1 shows the measured values. Fig. 1 shows the relationship between film thickness and burst pressure, and Fig. 2 shows the relationship between film thickness and diameter expansion rate.

[Example 3]

A double layer structure with PEBAX7233 as the base material layer and PEBAX6333 as the inner layer, and a ratio of the inner layer cross-sectional area to the total cross-sectional area of 0.05 was formed by extrusion molding. Biaxial stretch blow molding was performed under various conditions to obtain balloons having a diameter of 3. Omm and a thickness of 19 μm to 23 μm. The breaking pressure and the diameter expansion rate of the balloon were measured in the same manner as in Example 1. Table 1 shows the measured values. Figure 1 shows the relationship between film thickness and burst pressure, and Figure 2 shows the relationship between film thickness and diameter expansion rate.

[Example 4]

A parison having a two-layer structure with a base material layer of PEBAX7233 and an inner layer of PEBAX6333 and a ratio of the inner layer cross-sectional area to the total cross-sectional area of 0.20 was formed by extrusion molding. Balloon with diameter of 3. Omm and thickness of 21 μm to 24 μm by biaxial stretch blow molding under various conditions Got. The breaking pressure and expansion rate of the balloon were measured in the same manner as in Example 1. Table 1 shows the measured values. Figure 1 shows the relationship between film thickness and burst pressure, and Figure 2 shows the relationship between film thickness and expansion rate.

[table 1]

[0034] (Comparative Example 1)

A single layer structure of PEBAX7233 was formed by extrusion. Biaxial stretch blow molding was performed under various molding conditions to obtain balloons with a diameter of 3. Omm and a film thickness of 21 μm to 25 μm. The breaking pressure and the diameter expansion rate of the balloon were measured in the same manner as in Example 1. Table 2 shows the measured values. Fig. 1 shows the relationship between film thickness and burst pressure, and Fig. 2 shows the relationship between film thickness and diameter expansion rate.

[0035] (Comparative Example 2)

A parison having a two-layer structure consisting of a base material layer SPEBAX7233 and an outer layer force SPEBAX6333 and having an outer layer cross-sectional area ratio of 0.09 was formed by extrusion molding. Biaxial stretch blow molding was performed under various molding conditions to obtain balloons with a diameter of 3. Omm and a film thickness of 22 μm to 25 μm. The breaking pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 1. Table 2 shows the measured values. Figure 1 shows the relationship between film thickness and burst pressure, and Figure 2 shows the relationship between film thickness and expansion rate.

[0036] (Comparative Example 3)

A parison having a two-layer structure with a base material layer of PEBAX7233 and an inner layer of PEBAX6333 and a sectional area ratio of the inner layer of 0.40 was formed by extrusion molding. Balloons having a diameter of 3. Omm and a thickness of 19 μm to 23 μm were formed by biaxial stretch blow molding under various molding conditions. Balloon breaking pressure and expansion rate were measured in the same manner as in Example 1. Table 2 shows the measured values. Figure 1 shows the relationship between film thickness and burst pressure, and Figure 2 shows the relationship between film thickness and expansion rate.

[0037] [Table 2] Comparative Example Comparative Example Comparative Example

Film thickness Breaking pressure expansion rate Film thickness Breaking pressure expansion Film thickness Breaking pressure expansion rate

[Example 5]

A parison with a base layer of PEBAX7233 (manufactured by Elf Atchem) and an inner layer of PEBAX6333 with a ratio of the inner layer cross-sectional area to the total cross-sectional area of 0.09 was formed by extrusion molding. PEBAX7233 has a Shore hardness of 72D and PEBAX6333 has a Shore hardness of 63D. The ratio of the inner layer Shore hardness to the substrate layer Shore hardness is 0.88. Under various molding conditions, the temperature is in the range of 60 ° C and 110 ° C, the pressure is in the range of 3MPa, 5.5MPa, the inner diameter of the nozzle is 0.6mm, and the outer diameter of the nozzle is 1.5mm. To 2.0 mm, a balloon having a diameter of 6 mm and a thickness of 28 μm and 36 μm was obtained by biaxial stretch blow molding. Here, the film thickness of the balloon was measured with a micrometer, and the average thickness of the three points of the center, right side and left side of the straight tube portion of the balloon was taken as the film thickness.

These balloons were placed in a water bath filled with 37 ° C physiological saline, and the pressure was increased by 0.2 atm using physiological saline. The outer diameter was measured by holding for 1 second at each pressure. The pressure was continuously increased until the balloon was broken, and the breaking pressure of the balloon was measured. The diameter expansion rate was calculated when the pressure was increased from lOatm to 18atm. Table 3 shows the measured values.

[0039] [Table 3]

[0040] Fig. 3 shows the relationship between the film thickness and the burst pressure, and Fig. 4 shows the relationship between the film thickness and the diameter expansion rate. The diameter expansion rate was calculated using the following formula.

[0041] [Numerical equation 2] Diameter when pressure inside Peroon is 18 atm-Diameter when pressure inside Paroon is 10 atm.

Diameter expansion (%) = 100

Diameter when the internal pressure is 8 atm [Example 6]

A parison having a base layer of PEBAX7233 and an inner layer of PEBAX5533 and a ratio of the inner layer cross-sectional area to the total cross-sectional area of 0.06 was formed by extrusion molding. PEBAX5 533 has a Shore hardness of 55D. The ratio of the Shore hardness of the inner layer to the Shore hardness of the base material layer is 0.76. A biaxial stretch blow molding was performed under various molding conditions to obtain a balloon having a diameter of 6 mm and a film thickness of 32 to 36 m. The breaking pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 5. The measured values are shown in Table 3 above, the relationship between film thickness and breaking pressure is shown in Fig. 3, and the relationship between film thickness and diameter expansion rate is shown. This is shown in Fig. 4.

[0043] (Comparative Example 4)

A single layer structure of PEBAX7233 was formed by extrusion. A balun having a diameter of 6 mm and a film thickness of 44 μm to 48 μm was obtained by biaxial stretching blow molding under various molding conditions. The breaking pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 5. The measured values are shown in Table 24, the relationship between film thickness and breaking pressure is shown in Fig. 3, and the relationship between film thickness and diameter expansion rate is shown. Shown in 4.

[0044] [Table 4]

[0045] (Comparative Example 5)

A parison having a two-layer structure consisting of a base material layer SPEBAX7233 and an outer layer force SPEBAX4033 and having an outer layer cross-sectional area ratio of 0.09 was formed by extrusion molding. PEBAX2533 has a Shore hardness of 25D. The ratio of the Shore hardness of the inner layer to the Shore hardness of the base layer is 0.58. Biaxial stretch blow molding was performed under various molding conditions to obtain a balloon having a diameter of 6 mm and a film thickness of 35 μm to 43 μm. The fracture pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 5 (results are shown in Table 4 above), and the relationship between film thickness and fracture pressure is shown in Fig. 3, and the relationship between film thickness and expansion rate. This is shown in Fig. 4.

[Comparative Example 6]

A parison having a two-layer structure consisting of a base material layer SPEBAX7233 and an outer layer force SPEBAX2533 and having an outer layer cross-sectional area ratio of 0.09 was formed by extrusion molding. PEBAX2533 Shore hardness Is 25D. The ratio of the Shore hardness of the inner layer to the Shore hardness of the base layer is 0.35. Biaxial stretch blow molding was performed under various molding conditions to obtain balloons having a diameter of 6 mm and a film thickness of 29 μm to 39 μm. The fracture pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 5 (results are shown in Table 4 above), and the relationship between film thickness and fracture pressure is shown in Fig. 3, and the relationship between film thickness and expansion rate. This is shown in Fig. 4.

(Comparative Example 7)

A parison having a two-layer structure consisting of a base material layer SPEBAX7233 and an outer layer force SPEBAX7033 and having an outer layer cross-sectional area ratio of 0.08 was formed by extrusion molding. PEBAX7033 has a Shore hardness of 70D. The ratio of the Shore hardness of the inner layer to the Shore hardness of the base layer is 0.96. Biaxial stretch blow molding was performed under various molding conditions to obtain balloons having a diameter of 6 mm and a film thickness of 42 μm to 45 μm. The fracture pressure and diameter expansion rate of the balloon were measured in the same manner as in Example 5 (results are shown in Table 4 above), and the relationship between film thickness and fracture pressure is shown in Fig. 3, and the relationship between film thickness and expansion rate. This is shown in Fig. 4.

Claims

The scope of the claims

[1] A balloon for a medical catheter that also has the strength of a polyamide elastomer, which is a base material layer that also has the power of a polyamide elastomer, and a fracture that has a lower bending elastic modulus than the base material layer inside the base material layer Nonylene, characterized in that it has an inner layer made of a polyamide elastomer with high elongation.

2. The balloon for medical catheter according to claim 1, wherein the ratio of the cross-sectional area of the inner layer to the cross-sectional area of the entire balloon is 0.01 force or 0.25.

[3] A balloon for a medical catheter that also has the strength of a polyamide elastomer, the nolane comprising a base material layer that has the strength of a polyamide elastomer, and a polyamide elastomer that has a Shore hardness lower than that of the base material layer inside the base material layer. There is also an inner layer that has a force, wherein the ratio of the polyamide elastomer that forms the inner layer to the Shore hardness of the polyamide elastomer that forms the base layer is 0.70 or more and 0.93 or less. Nolane.

[4] A polyamide elastomer elastomer and a polyether ester amide elastomer selected from the polyamide elastomer of the inner layer, and a polyamide amide elastomer and a polyether ester amide elastomer of the outer layer are also selected. 3 Balloon described.

[5] The balloon according to claim 3 or 4, wherein the base material layer of the balloon has a Shore hardness of 60D or more and 78D or less.

6. The ratio of the cross-sectional area of the inner layer to the total cross-sectional area of the balloon is 0.01 to 0.25, and the balloon of any one of 51 and 51 /.

7. The nonylene according to any one of claims 1 to 6, further comprising an outer layer made of a polyamide elastomer having a bending elastic modulus lower than 300 MPa and a breaking elongation larger than 380% outside the base material layer.

[8] A polyether ester amide elastomer, which is a medical catheter lane, wherein the balloon has a base layer that also becomes a polyether ester amide elastomer, and a base layer on the inside of the base layer. There is an inner layer made of a polyether ester amide elastomer having a low Shore hardness, where the hard segment weight ratio of the polyether ester amide elastomer forming the base layer is X, and the polyether ester amide forming the inner layer D A lane characterized in that the ratio of 62 X y + 14 to 62 X x + 14 is from 0.70 to 0.93, where y is the hard segment weight ratio of the lastomer.

A balloon catheter having a foldable balloon used for medical treatment for an expansion operation, wherein the balloon catheter includes the balloon according to any one of claims 1 to 8.