JP2000084091A - Medical valve element - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical valve element suitable for use at a very restricted part, excellent in sealing function thereto in the presence or non- presence of a filament member such as a guide wire and a tube. SOLUTION: Regarding a medical valve element 60 having a contact hole 65 through in an axial direction, the peripheral maximum outer diameter D2 thereof is larger than the inner diameter D1 of a cylindrical part 102 used for mounting the valve body 60 in a state before the mounting of the valve element 60. The valve element 60 is mounted in a state of compression-deformed toward the internal side of the cylindrical part 102 with the contact hole 5 closed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical valve element used for medical instruments such as a balloon catheter, a drug injection catheter, an occlusion catheter, a contrast catheter, and a guiding catheter, and more particularly to an extremely narrow portion. The present invention relates to a medical valve element suitable for use.

[0002]

2. Description of the Related Art Intra-aortic balloon pumping (IABP), for example, involves inserting a balloon catheter into the aorta for treatment when cardiac function is reduced due to heart failure or the like. This is a treatment method for assisting the heart function by expanding and deflating the balloon portion in accordance with the heart beat. Various balloon catheters have been proposed for use in such an IABP method (JP-A-63-20).
No. 6255, Japanese Unexamined Patent Publication No. Sho 62-114565).

In such a balloon catheter,
A so-called double-lumen balloon catheter is known which can insert a balloon catheter into a blood vessel along a guide wire and guide the balloon portion to a predetermined position near the heart in an arterial blood vessel. In this balloon catheter, an inner tube is disposed inside an outer tube constituting a catheter tube. The lumen inside the outer tube provides a path for shuttle gas to expand or contract the balloon portion, and the lumen in the inner tube provides a guide wire passageway for guiding the balloon portion to a predetermined position near the heart in the arterial blood vessel. Becomes

However, the balloon catheter having the inner tube has the following problems.
That is, since the outer tube constituting the catheter tube is inserted into the arterial blood vessel of the patient, the outer diameter of the outer tube is determined by taking into account the burden on the patient, particularly the blood circulation to the tissue on the peripheral side further from the insertion portion. Smaller is more preferable.

However, if the outer diameter of the outer tube is small,
The cross section of the flow passage of the lumen formed therein becomes smaller. An inner tube is also disposed inside the outer tube, thereby narrowing a substantial flow passage cross-sectional area for gas flow. In order to increase the substantial cross-sectional area of the lumen of the outer tube, the outer diameter of the inner tube is preferably small. However, since the guide wire is inserted through the lumen of the inner tube, there is a limit in reducing the outer diameter of the inner tube.

Gas for expanding or contracting the balloon portion flows through the lumen of the outer tube except for the cross section of the inner tube. When the outer diameter of the outer tube is reduced, the flow path cross-sectional area of the lumen becomes smaller, the flow path resistance increases, the response of expansion and contraction of the balloon portion driven by gas becomes worse, and the expansion and contraction There is a possibility that the timing is shifted, and the assisting action of the heart may not be effectively exhibited.

[0007] The cycle of expansion and contraction of the balloon portion is, for example, 0.6 seconds when the heartbeat is 100 beats / minute, and the gas reciprocates in the lumen of the outer tube in a shorter time than this cycle. The smaller the flow path resistance, the better.

However, as described above, the inner tube is disposed inside the lumen of the outer tube, and there is a limit in reducing the outer diameter of the inner tube, and further, the outer diameter of the outer tube is reduced. Also had limitations.

Conventionally, therefore, the outer diameter of the outer tube constituting the catheter tube has to be set as large as possible without significantly increasing the burden on the patient.
In order to obtain a responsiveness of the expansion and contraction of the balloon portion at a satisfactory level, the burden on the patient has inevitably increased to some extent.

[0010]

SUMMARY OF THE INVENTION In order to solve such a conventional problem, the present applicant has reduced the outer diameter of an outer tube constituting a catheter tube so as to reduce the burden on a patient. Nevertheless, there has been proposed an epoch-making balloon catheter that can improve the responsiveness of expansion and contraction of the balloon portion. The balloon catheter has an outer tube having a first lumen therein, and a proximal end of a balloon portion joined to a distal end of the outer tube so as to form a balloon space therein. A distal end of the portion is joined to a cylindrical distal tip portion, and by introducing and leading a pressure fluid through the first lumen of the outer tube into the balloon space,
A balloon portion that is in an expanded state and a contracted state, and extends in the first lumen of the outer tube movably in the axial direction, protrudes toward the distal end side from the distal end portion of the outer tube, and And an inner tube which is detachably mounted and has a second lumen inside.

However, in order to keep the distal end of the inner tube detachably attached to the distal tip portion and to maintain the sealing inside the balloon portion even after the inner tube is removed, it is necessary to use the distal tip portion. Inside the part, a valve body having excellent sealing performance is required both in the presence and absence of the inner tube. The inside diameter of the tip is extremely small, and in such a narrow area,
Having good sealing performance both in the presence and absence of the inner tube has been quite difficult to achieve with previously known valve bodies.

In addition to such balloon catheters, other medical devices such as a drug injection catheter, an occlusion catheter, a contrast catheter, and a guiding catheter have an outer diameter and an inner diameter from the viewpoint of reducing the burden on the patient. It is required to be smaller. In addition, as a valve element used in such a narrow portion, a valve element having excellent sealing performance is required both when a linear member such as a guide wire is present and when it is not present.

The present invention has been made in view of such circumstances, and is a medical valve element suitable for use in an extremely narrow portion. The present invention is applicable to both cases where a linear member such as a guide wire or a tube is present and where it is not present. The object of the present invention is to provide a medical valve body having excellent sealing performance.

[0014]

In order to achieve the above object, a medical valve element according to the present invention is a medical valve element having an axially penetrating contact hole formed therein. Before the body is mounted, the maximum outer diameter of the outer peripheral portion of the valve body is larger than the inner diameter of the cylindrical portion to which the valve body is mounted, and the valve body is located inside the cylindrical portion. Compressed and deformed,
It is characterized in that it is mounted with the contact hole closed.

The Shore A hardness of the medical valve body is preferably 30 or less, more preferably 20 or less, particularly preferably 15 or less, and may be 5 or less. Shore A hardness is
It is measured based on JIS K6253. When the Shore A hardness of the medical valve body is larger than 30, depending on the outer diameter of the linear member, the contact hole cannot be completely closed in a state where the linear member is removed, and the sealing property is incomplete. Tends to be. Also, the insertion of the linear member tends to tear the contact hole.

The breaking elongation of the medical valve is preferably 300 to 1000%, more preferably 500 to 800.
%. The elongation at break is measured based on JIS K 7311. When the breaking elongation of the valve body is smaller than 300%,
Although depending on the outer diameter of the linear member, the insertion of the linear member tends to tear the contact hole. Breaking elongation 1000%
If it is larger, the valve element is likely to be plastically deformed, and although it depends on the outer diameter of the linear member, after the linear member is pulled out, the contact hole is not completely closed and the hemostatic property tends to be insufficient. .

The compression elastic modulus of the medical valve body is preferably
Is 0.01 to 0.30 kg / cm² And more preferably
0.05-0.15kg / cm²is there. Compression modulus
Is measured based on JIS K 7208. Medical
The compression modulus of the valve is 0.30 kg / cm²Larger than
Therefore, the resistance when the linear member is inserted tends to increase.
Compression modulus is 0.01kg / cm²Less than
The valve body tends to be plastically deformed and hemostasis tends to be insufficient
is there.

With the distal end of a linear member such as an inner tube or a guide wire inserted into the contact hole of the valve body, the contact hole expands, and the valve body is elastically deformed in the axial direction. Is preferably formed inside the cylindrical portion.

In order to provide a margin inside the cylindrical portion, a stopper member is provided inside the cylindrical portion, which is located on both axial sides of the valve body and allows the linear member to pass therethrough. It is preferred that

It is preferable that the cylindrical member is formed of a member that can be elastically deformed radially outward.

[0021]

The contact hole formed in the medical valve element according to the present invention is not particularly limited, but may be a through hole having a simple circular cross section. This through hole can be easily formed with a tool such as a needle. Immediately after being formed by the tool, the through-hole is almost completely closed by deformation at a stage before being mounted inside the cylindrical portion.

Since the medical valve element is mounted by being compressed and deformed inside the cylindrical portion, in this state, the contact hole is completely closed, and no fluid flows through the contact hole, and the sealing property is excellent. ing. When the linear member is inserted into the contact hole, the contact hole is satisfactorily expanded by elastic deformation.
The close contact hole is satisfactorily adhered to the outer periphery of the linear member, and the sealing property is good even in this state. To widen the contact hole, the valve
Deforms to spread axially or radially. After the linear member is pulled out of the contact hole, the contact hole is closed again and a good sealing state is achieved.

[0023]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below based on embodiments shown in the drawings. 1A is a schematic cross-sectional view of a balloon catheter using a medical valve according to one embodiment of the present invention, FIG. 1B is a cross-sectional view along IB-IB shown in FIG. 1A, and FIG. FIG. 3A is a cross-sectional view of a main part of the medical valve body showing a state where an inner tube is removed, and FIG. 3B is a cross-sectional view of the main part of the medical valve body before being attached to a distal tip portion. FIG. 4C is a cross-sectional view of the medical valve body, and FIG. 4C is a perspective view of the medical valve body before it is attached to the distal end tip portion.
Is a schematic view showing a state in which a balloon catheter is inserted into a blood vessel, FIG. 5 is a schematic view showing a state after a balloon catheter is inserted into a blood vessel, and FIG. 6 is a medical valve element according to another embodiment of the present invention. 7 (A) and 7 (B) are cross-sectional views of a main part showing a use state of a valve element mounted on the medical injection catheter shown in FIG. 6, and FIGS.
(C) is a sectional view of a main part of the valve body shown in FIGS. 7A and 7B, FIG. 8 is a perspective view of a valve body according to another embodiment of the present invention,
FIGS. 9A to 9D are perspective views each showing another example of the valve element.

(First Embodiment) As shown in FIG. 1, a medical valve body 60 according to the present embodiment
Is mounted inside the distal end tip portion 20. Medical valve 6
Before describing 0 in detail, the balloon catheter 2 will be described first.

This balloon catheter 2 is used for IABP, and has a balloon portion 4 which expands and contracts in accordance with the heartbeat. The balloon 4 is preferably formed of a cylindrical balloon film 22 having a thickness of 50 to 150 μm, and has a balloon space formed therein. If the film thickness is 50 μm or less, the strength is inferior, and if it is 150 μm or more, the expansion may not be performed smoothly. In the present embodiment, the shape of the balloon membrane 22 in the expanded state is a cylindrical shape. However, the present invention is not limited to this.
The shape may be a polygonal cylinder.

The IABP balloon membrane 22 is preferably made of a material having excellent bending fatigue resistance, and is formed of, for example, a material such as polyurethane, silicone, soft polyethylene, soft polyamide, or soft polyester, and particularly formed of polyurethane. Has a high ability to suppress the occurrence of thrombus,
It is suitable because it has high wear resistance. The outer diameter and length of the balloon membrane 22 are determined according to the inner volume of the balloon membrane 22, which greatly affects the assisting effect of the heart function, the inner diameter of the arterial blood vessel, and the like. For example, the inner volume of the balloon portion 4 is 25 to 6
5 cc, and the outer diameter D of the balloon portion 4 when expanded is preferably 10 to 30 mm, more preferably 15 to 25 m.
m and the length L of the balloon portion 4 (see FIG. 1A)
But preferably 90 to 300 mm, more preferably 1 to 300 mm.
10 to 250 mm. The length L of the balloon section 4 is a length from the joint with the distal end of the catheter tube 6 to the joint with the distal end of the distal tip section 20.

The method of manufacturing the balloon film 22 according to the present embodiment is not particularly limited. For example, a mold for forming the balloon film is immersed in a molding solution to form a resin film on the outer peripheral surface of the mold. A method of drying and demolding (dipping molding method) can be exemplified. There is also a method of forming a balloon film by blow molding a parison (blow molding method).

A tapered distal end portion 24 is formed at the distal end of the balloon membrane 22, and the most distal end 7 of the balloon membrane 22 is heat-sealed or adhered to the outer periphery of the distal end of the tip portion 20. It is attached by the means of. The detailed structure of the tip unit 20 will be described later.

At the proximal end of the balloon membrane 22, a tapered proximal end side taper portion 26 is formed, and the proximal end 5 thereof is
The outer tube 8 constituting the catheter tube 6 is joined to the distal end. The catheter tube 6 has a double tube structure including an outer tube 8 and an inner tube 10, and a first lumen 12 is formed in a gap between the outer tube 8 and the inner tube 10. 10
Is formed inside the balloon membrane 22 and a second lumen 14 that is not communicated with the first lumen 12 formed in the catheter tube 6.

Through the first lumen 12 formed inside the double catheter tube 6, the balloon membrane 22
The pressure fluid is introduced or led out, and the balloon membrane 22 expands or contracts. The bonding between the balloon film 22 and the outer tube 8 is performed by heat fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The distal end of the inner tube 10 projects farther than the distal end of the outer tube 8. The inner tube 10 is inserted through the inside of the balloon membrane 22 and the outer tube 8 movably in the axial direction. The proximal end of the inner tube 10 is detachably attached to a connector 40 described below.

The inner tube 10 of the catheter tube 6
Is used to guide the balloon portion 4 to a predetermined position in the artery when the balloon catheter 2 is inserted into the artery by inserting a guide wire into the second lumen 14 as described later. Can be When inserting the balloon catheter 2 into a body cavity such as a blood vessel, the balloon portion 4
Is folded and wound around the outer circumferences of the inner tube 10 and the support wire 42. Support wire 4
Details of 2 will be described later.

The inner tube 10 shown in FIG. 1 may be made of the same material as the outer tube 8, for example, a synthetic resin tube of polyurethane, polyvinyl chloride, polyethylene, polyamide, polyimide, or the like, or a metal spring reinforced tube, stainless steel. It is composed of a thin tube and the like. Note that a stainless wire, a nickel / titanium alloy wire, or the like may be used as a reinforcing material.

The inner diameter of the inner tube 10 is not particularly limited as long as it allows a guide wire to pass therethrough.
It is 5 to 1.5 mm, preferably 0.5 to 1 mm. The thickness of the inner tube 10 is preferably 0.1 to 0.4 mm. If it is 0.1 mm or less, the strength is inferior, and if it is 0.4 mm or more, the outer diameter of the inner tube 10 becomes too large, which is not preferable. The outer diameter of the inner tube 10 is preferably 0.3 to
It is 2.5 mm, particularly preferably 0.5 to 1.5 mm. The total length of the inner tube 10 is determined according to the axial length of the balloon catheter 2 inserted into the blood vessel, and the like.
Although not particularly limited, for example, 500 to 1200 mm,
It is preferably about 700 to 1000 mm.

Outer tube 8 of double catheter tube 6
Is preferably made of a material having a certain degree of flexibility, for example, polyethylene, polyethylene terephthalate, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polyvinyl chloride (PVC), crosslinked type Ethylene-vinyl acetate copolymer, polyurethane, polyamide, polyamide elastomer, polyimide, polyimide elastomer, silicone rubber,
Natural rubber or the like can be used, preferably polyurethane,
It is composed of polyethylene, polyamide and polyimide.
The outer diameter of the outer tube 8 of the catheter tube 6 may be uniform in the axial direction. However, the outer diameter of the outer tube 8 is small near the balloon membrane 22 and large at other portions (proximal end side). May be formed. 1st lumen 1
By enlarging the cross section of the flow path 2
Responsiveness for expanding and contracting can be improved. The inner diameter of the outer tube 8 of the catheter tube 6 is preferably 1.0 to 3.0 mm, particularly preferably 1.5 to 3.0 mm.
2.6 mm. The thickness of the outer tube 8 is preferably 0.05 to 0.4 mm. If the thickness is less than 0.05 mm, the strength is inferior. Further, the outer diameter of the outer tube 8 is preferably 1.3 to 3.3 mm, particularly preferably 1.8 to 3.0 mm, and the outer diameter of the inner tube 10 inserted into the first lumen of the outer tube 8. The gap with the diameter may be close to zero. First lumen 1 of outer tube 8
This is because the inner tube 10 has been removed and a sufficient flow path cross-section has been secured when the pressure fluid is introduced and led out of the balloon portion 4 through the inner portion 2. In the present embodiment, the length of the outer tube 8 is preferably 300 to
It is about 800 mm.

Outer tube 8 of double catheter tube 6
Is connected to a connector 40 located outside the patient's body. The connector 40 is formed separately from the outer tube 8 of the catheter tube 6, and is fixed by means such as heat fusion or adhesion. The connector 40 has a first lumen 12 in the catheter tube 6, a port 16 for introducing or extracting a pressurized fluid into the balloon membrane 22, and a terminal extraction portion 18. The ports 16 are linearly arranged inside the connector 40 along the longitudinal direction. This connector 40 is, for example, polycarbonate,
It is formed of a thermoplastic resin such as polyamide, polysulfone, polyacrylate, methacrylate-butylene-styrene copolymer.

A luer male connection portion 44 is formed on the outer periphery of the flange of the port 16. The lure male connection 44
A luer female connection portion 48 of the cap 46 is detachably mounted. The cap 46 is made of, for example, the same material as the connector 40.

At the center of the cap 46, the inner tube 1
The proximal end of the inner tube 10 is heat-sealed or glued so that the proximal end of the second lumen 14 is open. A negative pressure inlet 50 is formed in the cap 46. A negative pressure generator can be connected to the negative pressure inlet 50 via a check valve. Before introducing the balloon catheter 2 into the blood vessel, a negative pressure is introduced from the negative pressure inlet 50, and the inside of the balloon portion 4 is made to have a negative pressure through the port 16 and the first lumen 12, whereby the balloon membrane 22 is formed. It is folded and wound around the inner tube 10 and the support wire 42 to reduce the outer diameter near the balloon portion 4.

In this embodiment, as shown in FIG. 2, a valve body 60 for sealing the balloon space inside the balloon portion 4 and the outside of the balloon portion 4 is mounted inside the distal tip portion 20. is there. The distal end of the inner tube 10 is detachably mounted so as to penetrate the close contact hole 65 of the valve body 60. 1 and 2, the second lumen 14 of the inner tube 10 communicates through the distal end opening of the inner tube 10 into the blood vessel.

The tip section 20 of this embodiment has a sensor block 100 for holding the pressure sensor 70, a tip tube (tubular member) 102, and a cap 104. A first cylindrical recess 101 is formed on the outer peripheral surface of the sensor block 100 at the proximal end in the axial direction, and the farthest end 7 of the balloon portion 4 is heat-sealed or bonded thereto. A distal end of a tubular support wire 42 is joined to the end face of the sensor block 100 at the proximal end in the axial direction, and a wire 71 from a pressure sensor 70 mounted on the outer periphery of the sensor block 100 is supported. The inside of the wire 42 extends in the axial direction. The pressure sensor 70 measures the blood pressure in a blood vessel located on the outer periphery of the distal end tip portion 20a, and outputs the output signal to a wiring 71.
It can be output to the outside via.

The supporting wire 42 is for supporting the balloon catheter 2 after the inner tube 10 is pulled out, in particular, the balloon portion 4 in the longitudinal direction, and is made of a metal tube such as a nickel alloy, a titanium alloy or stainless steel. It is. The outer diameter of the support wire 42 is
0, sufficiently smaller than the outer diameter, preferably 0.2 to
It is 0.8 mm, more preferably 0.4 to 0.6 mm. When the support wire 42 has a tubular shape, the inner diameter of the tube is preferably 0.1 to 0.6 mm, particularly preferably 0.2 to 0.4 mm.

As shown in FIG. 1, the proximal end of the support wire 42 is fixed near the terminal extraction portion 18 of the connector 40. The wiring for the pressure sensor 70 inserted through the internal through hole of the support wire 42 is the terminal extraction portion 1 of the connector 40.
8, it is drawn out of the connector and is connected to a terminal 72 for electrical connection with another device.

A second cylindrical recess 103 is formed on the outer peripheral surface of the sensor block 100 shown in FIG. 2 at the distal end in the axial direction, and the proximal end of the tip tube 102 is heat-sealed or bonded thereto. I have. An axial through-hole 105 is formed at a position slightly eccentric from the center axis of the sensor block 100, and the distal end of the inner tube 10 is loosely inserted into the through-hole 105. The inner diameter of the through-hole 105 is preferably 0.9 to 0.9 in comparison with the outer diameter D5 of the inner tube 10.
It is about 1.2 times.

The distal end of the tip tube 102 is heat-sealed or bonded to a third cylindrical recess 107 formed on the back side of the cap 104. The outer diameter and inner diameter of the tip tube 102 are not particularly limited, but the outer diameter is 1.0
About 3.0 mm is preferable, and the inner diameter thereof is 0.5 to
It is preferably about 2.5 mm.

A convex curved surface is formed on the distal end surface of the cap 104 to reduce the resistance at the time of inserting the balloon catheter, reduce the burden, and improve the operability at the time of insertion. Similarly to the through hole 105 of the sensor block 100, the cap 104 has an axial through hole 106 eccentric with respect to the central axis. The distal end of the inner tube 10 is loosely inserted into the through hole 106. The axis of the through hole 106 is substantially the same as the axis of the through hole 105, and has the same inner diameter.

The valve body 60 according to the present embodiment is shown in FIG.
As shown in FIG. 5, before the mounting, the whole is disk-shaped, and is slightly eccentric from its axis to form a contact hole 65 having a substantially circular cross section. As shown in FIGS. 3A and 3B, before the medical valve body 60 is mounted inside the distal tube 102, the outer diameter D2 of the valve body 60 is equal to the internal diameter of the distal tube 102. It is larger than D1. As shown in FIG. 3A, the valve body 60 is compressed and deformed inside the distal end tube 102, and is mounted with the close contact hole 65 closed.

The contact hole 65 is provided so that the valve body 60
It is preferably formed in a state before being mounted inside the inner tube 02, but may be formed after being mounted inside the distal tube 102. In any case, as shown in FIG. 3A, when the valve body 60 is mounted inside the distal end tube 102, the contact hole 65 is closed, and the inside of the balloon portion 4 is sealed. . The contact hole 65 may be integrally formed when the valve body 60 is formed, or may be formed by processing with a tool such as a needle after the valve body 60 is formed. Since the inner tube 10 is inserted into the contact hole 65 as shown in FIG. 2, a lubricant such as silicone oil may be applied to the contact hole 65.

Note that in FIGS. 3B and 3C,
Before the valve body 60 is mounted inside the distal end tube 102, the contact hole 65 formed in the valve body 60 is clearly shown, but actually, the polymer constituting the valve body 60 is formed. Since the hardness of the material is considerably low, the contact hole 65 is almost completely closed by deformation. The outer diameter D3 of a tool such as a needle for forming the contact hole 65 is D5 × 0.3 to D5 × 1.0 when the outer diameter of the inner tube 10 is D5.
The outer diameter is about twice as large. Close contact hole 65 formed by tool
Immediately after that, at the stage before being mounted inside the distal end tube 102, it is almost completely closed by deformation.

As shown in FIG. 3B, before the valve body 60 is mounted inside the distal end tube 102, the valve body 6
The outer diameter D2 of 0 is larger than the inner diameter D1 of the distal end tube 102, and preferably at most about 2.0 times. By making the outer diameter D2 larger than the inner diameter D1 in such a range, the valve body 60 is satisfactorily compressed and deformed, is mounted inside the distal end tube 102, and completely closes the contact hole 65.

As shown in FIG. 3A, the valve body 60 of the present embodiment is mounted by being compressed and deformed inside the distal end tube 102. Further, as shown in FIG. Is inserted. Therefore, this valve element 6
0 is preferably made of a material having low hardness, large elongation at break, and low compression modulus.

The Shore A hardness of the valve body 60 is JIS K
Based on 6253, it is preferably 30 or less, more preferably 20 or less, particularly preferably 15 or less, and may be 5 or less. When the Shore A hardness of the valve body 60 is larger than 30, the contact hole 65 is not completely closed in the state shown in FIG. In addition, in the state shown in FIG.
The contact hole 65 is easily torn.

The elongation at break of the valve body 60 is preferably 300 to 1000%, more preferably 500 to 800%.
%. The elongation at break is measured based on JIS K 7311. When the breaking elongation of the valve body 60 is smaller than 300%, the insertion of the inner tube 10 in the state shown in FIG.
The contact hole 65 is easily torn. If the elongation at break is greater than 1000%, the valve body tends to undergo plastic deformation, and the hemostatic property tends to be insufficient.

The compression modulus of the valve body 60 is preferably
Is 0.01 to 0.30 kg / cm² And more preferably
0.05-0.15kg / cm²is there. Compression modulus
Is measured based on JIS K 7208. Valve 6
The compression modulus of 0 is 0.30 kg / cm²Greater than
And the resistance when the inner tube 10 is inserted in the state shown in FIG.
Tend to be higher. Compression modulus is 0.01kg / c
m²If it is smaller than this value, the valve will tend to plastically deform,
Tends to be insufficient.

Specific examples of the material of the valve body 60 having such physical properties include silicone, polyurethane, polyacrylic acid, and polyacrylamide. Polyurethane and silicone are preferable, and silicone is particularly preferable. Silicone has excellent properties such as heat resistance, water absorption resistance, sliding properties with a guide wire, and resilience (small stress relaxation). Examples of the silicone include a release silicone, a one-pack silicone, and an addition two-pack silicone, and the addition two-pack silicone is preferable. This is because the addition type two-part mixed type silicone has little precipitation of low molecular weight components, is relatively easy to produce, and is particularly preferable for medical use.

When silicone, polyurethane, or the like is used as the material forming the valve body 60, the hardness is adjusted by adjusting the weight ratio of the curing agent to the main component, the heating temperature and the heating time during molding, and the like. And the above-mentioned range. When a polyacrylic acid resin, a polyacrylamide resin, or the like is used as the material forming the valve body 60, the hardness is adjusted to the above-described range according to crosslinking conditions.

The valve body 60 is preferably sterilized before or after mounting on the balloon catheter.
Examples of the sterilization include gas sterilization and electron beam sterilization.

The eccentric shaft center of the contact hole 65 formed in the valve body 60 of this embodiment substantially matches the shaft center of the through holes 105 and 106. The eccentricity of the shaft center of the contact hole 65 is determined by the relationship with the support wire 42 in the inner pipe 10.
This is because it is difficult to dispose them along the central axis of the tip portion 20.

The valve body 60 according to the present embodiment is inserted into the distal end tube 102 after being compressed and deformed. Accordingly, in a state where the distal end of the inner tube 10 is pulled out from the distal end tip portion 20, as shown in FIG. 3, the contact hole 65 is crushed and closed, so that the inside of the balloon portion 4 is sealed from the outside. I have.

In the present embodiment, the sensor block 100 and the cap 104 constituting the tip unit 20 are
It also serves as a stopper member, and allows the inner tube 10 to be inserted into the contact hole 65 of the valve body 60 on both axial sides of the valve body 60, thereby allowing the valve body 60 to expand and deform in the axial direction. Extra spaces 94 and 96 are formed. The stopper member is for preventing the valve body 60 from protruding from the inside of the distal end tip portion 20 to the outside along the axial direction, and in the present embodiment, the sensor block 100 and the Cap part 104,
Also functions as a stopper member.

In the balloon catheter 2 of the present embodiment,
The sensor block 100, the distal tube 102, and the cap 104 that constitute the distal tip portion 20 may be made of a hard material such as a metal. It is desirable to lower the value compared to That is, by increasing the flexibility of the distal end tube 102 and the cap portion 104 as compared with the sensor block 100, the operability of inserting the balloon catheter is improved. In addition, the burden on the patient when inserting the balloon catheter into the blood vessel can be reduced. From such a viewpoint, it is preferable that the distal end tube 102 and the cap portion 104 are made of a synthetic resin such as polyurethane having a Shore A hardness of preferably 70 to 98, more preferably 80 to 95. In contrast, the sensor block 100
Is preferably made of stainless steel, ceramic or the like having a Shore D hardness of preferably 70 or more. Also,
The distal tube 102 can follow the radially outward expansion and deformation of the valve body 60, and
From the viewpoint of reducing the insertion resistance, it is preferable that the elastic member be formed of a member that can be elastically deformed radially outward. From such a viewpoint, it is preferable that the distal end tube 102 is made of a synthetic resin or the like having the above hardness range, rather than a metal pipe.

In the balloon catheter 2 using the medical valve body 60 according to the present embodiment, as shown in FIG.
With the inner tube 10 pulled out, the tip 2
0 is closed, and the internal through hole is sealed. That is, leakage of the fluid to the outside is prevented when the pressure fluid is introduced into the balloon portion 4, and the through-hole of the distal end tip portion 20 is formed while the pressure fluid is led out from the inside of the balloon portion 4. To prevent the blood from entering the inside of the balloon portion 4 through the inside. Further, as shown in FIG. 2, the distal end of the inner tube 10 can be detachably attached so as to penetrate the eccentric contact hole 65 of the valve body 20. Even in the state shown, the internal space of the balloon portion 4 is sealed from the outside.

To perform treatment by IABP using the balloon catheter 2 according to the present embodiment, first, the balloon catheter 2 in the state shown in FIG. 1 is prepared. That is, the cap 46 is attached to the port 16 of the connector 40 before IABP driving. And
Before introducing the balloon catheter 2 into the blood vessel, a negative pressure is introduced from the negative pressure introduction port 50 of the connector 40 and the port 16 is introduced.
By applying a negative pressure to the inside of the balloon portion 4 through the first lumen 12 and the
And, it is folded and wound around the support wire 42 to reduce the outer diameter near the balloon portion 4.

Next, as shown in FIG.
From above, a puncture needle composed of an outer trocar (cannula) and an inner trocar (not shown) is pierced, and the tip is positioned in the blood vessel 32. Next, the inner trocar is extracted while leaving the outer trocar (cannula), and the guide wire 34 is inserted into the blood vessel 32 from the hole from which the inner trocar has been extracted.

The guide wire used usually has an outer diameter of 0.2 to 1.2 mm, preferably 0.4 to 0.9 mm.
And a length of 700 to 2000 mm, preferably 1000
1600 mm, made of stainless steel, nickel-titanium alloy, and coated with a fluorine resin or a urethane resin as necessary.

Next, the trocar is withdrawn along the inserted guide wire 34, and then the guide wire 34 is passed through the dilator, and the introducer 35 and the dilator (not shown) are moved along the guide wire 34. The distal end of the integrated catheter tube insertion tool is
Plug in.

As shown in FIG. 4, the distal end of the catheter tube insertion tool including the integrated introducer 36 and the dilator is inserted into the insertion port 36 of the blood vessel, and the tapered distal end formed at the distal end of the dilator is formed. The part pushes open the insertion port 36 of the blood vessel. Further, if the tip of the catheter tube insertion tool is pushed in, the tip of the introducer 35 also
2 is inserted.

Thereafter, the dilator is withdrawn from the introducer 35 and, instead, the proximal end of the guide wire 34 is inserted into the second lumen 14 of the inner tube 10 from the balloon portion 4 side of the balloon catheter 2 shown in FIG. When the balloon catheter 2 is inserted into the introducer 35 and the balloon catheter 2 is
Along 4, it is conveniently inserted into blood vessel 32. Then, as shown in FIG.
First, the guide wire 34 shown in FIG. 4 is pulled out from the inside of the blood vessel 32, and then the cap 4 is removed from the port 16 of the connector 40 located outside the body.
6, the inner tube 10 is pulled out along the longitudinal direction, and the connection between the valve body 60 of the distal end tip portion 20 and the distal end of the inner tube 10 is released. The valve body 60 includes the inner tube 1
Even if 0 is pulled out, the inside of the balloon portion 4 is kept sealed. Further, by pulling the cap 46, the inner tube 10 can be pulled out along the first lumen 12 of the outer tube 8. As a result, the inner tube 10 can be completely pulled out from the port 16, and the inner tube 10 does not exist inside the balloon portion 4 and the outer tube 8.

In this state, a pump device 28 shown in FIG. 5 is connected to the port 16 of the connector 40 shown in FIG. 1, and the shuttle device supplies the shuttle gas to the port 16 and the inner tube 10 shown in FIG. First lumen 1 that does not exist
2 and is introduced or led out into the balloon membrane 22.
The shuttle gas to be introduced is not particularly limited, but helium gas or the like having a small viscosity and mass is used so that the balloon membrane 22 expands or contracts quickly according to the driving of the pump device 28. Further, as the pump device 28, for example, a device as shown in Japanese Patent Publication No. 2-39265 is used.

The terminal 72 drawn from the connector 40 shown in FIG. 1 is connected to the blood pressure fluctuation measuring device 29 shown in FIG. 5, and can measure the blood pressure fluctuation in the artery detected by the pressure sensor 70 shown in FIG. Has become. This blood pressure measuring device 29
The pump device 28 is controlled in accordance with the pulsation of the heart 1 shown in FIG. 5 based on the fluctuation of the blood pressure measured in the step (a), and the balloon unit 4 is expanded and deflated in a short cycle of 0.4 to 1 second. Perform 1 adjuvant treatment.

In the balloon catheter 2 according to the present embodiment, when the balloon catheter 2 is inserted into the blood vessel 32 of the patient, the inner tube 10 is attached inside the balloon portion 4 and the outer tube 8 along the axial direction. Since the guide wire 34 is passed through the second lumen 14 of the inner tube 10, the balloon portion 4 of the balloon catheter 2 can be conveniently guided to a predetermined position in the blood vessel 32.

As shown in FIG. 5, the balloon portion 4 is
After being positioned at a predetermined position near the heart 1 in the inner tube 2, the inner tube 10 is pulled out from the proximal end side of the connector 40 positioned outside the body of the balloon catheter 2, thereby forming the outer tube constituting the catheter tube 6. 8, the inner tube 10 does not exist. Before and after that, guide wire 3
4 is also withdrawn from the proximal end side of the connector 40.

In the present embodiment, the flow passage cross-sectional area of the first lumen 12 of the outer tube 8 constituting the catheter tube 6 is increased by the absence of the inner tube 10. as a result,
By driving the pump system 28 shown in FIG. 5, the cross section of the flow path for sending the shuttle gas into the inside of the balloon portion 4 is increased, and the responsiveness for expanding and contracting the balloon portion 4 is significantly improved. This means that even if the outer diameter of the outer tube 8 constituting the catheter tube 6 is made smaller than that of the conventional balloon catheter, a response characteristic of the expansion / contraction of the balloon portion 4 which is equal to or higher than that of the conventional balloon catheter can be obtained. Means that If the outer diameter of the outer tube 8 constituting the catheter tube 6 can be reduced, the burden on the patient can be reduced.

In the present embodiment, the medical valve element 60 is used in a portion having an extremely small inner diameter, such as the distal end portion 20 of the balloon catheter 2.
It has excellent sealing performance both when 0 is present and when it is not present. In addition, the medical valve body 60 of the present embodiment has the above-described specific physical properties,
By changing manufacturing conditions such as cross-linking conditions, the polymer material can be manufactured very easily. Also,
The close contact hole 65 of the valve body 60 of the present embodiment is a simple through hole having a substantially circular cross section, and is easy to manufacture, and is less likely to be torn even when the inner tube 10 is inserted.
By the way, if a conventional valve body with a slit is to be mounted on a small inner diameter portion such as the tip portion 20 of the balloon catheter 2, it is difficult to manufacture the valve body, and there is a problem that it is easy to tear from the slit portion. I have.

(Second Embodiment) As shown in FIG. 6, a medical valve body 60a according to the present embodiment includes a drug injection catheter 2a.
Mounted within the distal end of the First, the drug injection catheter 2a will be described.

The drug-injection catheter 2a is for directly spraying and injecting a drug solution into a predetermined site in a patient's body cavity. The catheter tube 6a and the proximal end of the catheter tube 6a are bonded or fused. And a connector hub 40a attached thereto. The connector hub 40a is provided with a connection lure portion 44a for connecting a syringe or the like for injecting a chemical solution. The connector hub 40a
For example, it is made of the same material as the connector 40 shown in FIG.

The catheter tube 6a is made of the same material as the outer tube 8 of the catheter tube 6 shown in FIG. 1, has flexibility, an outer diameter of about 2.0 mm, and an inner diameter of about 2.0 mm. It is around 1.3 mm. The axial length of the catheter tube 6a is about 1 m.

An imaging ring 82 is mounted near an opening 81 formed at the distal end of the catheter tube 6a. The imaging ring 82 is connected to the catheter tube 6a.
Can be imaged with X-rays or the like when the distal end of the is inserted into a body cavity, and is made of, for example, a metal such as platinum.

The medical valve body 60a of this embodiment is mounted inside the catheter tube 6a located on the proximal end side of the contrast ring 82 together with the stopper members 100a and 104a. In the tube wall of the catheter tube 6a located on the proximal end side of the valve body 60a, a plurality (for example, about 10) of side holes 8 penetrating the inside and outside of the tube are provided.
0 are formed at predetermined intervals along the longitudinal direction of the tube. The inner diameter of each side hole 80 is, for example, 0.7 mm
About the distal end opening 8 of the catheter tube 6a.
The imaging ring 82, the valve body 60a, and the stopper members 100a and 104 are disposed in an axial range of about 1 to about 15 cm.
a and all the side holes 80 are located.

As shown in FIGS. 7A to 7C, stopper members 100a and 104a located on both axial sides of the valve body 60 are mounted inside the catheter tube 6a. The stopper members 100a and 104a are ring-shaped, respectively, and formed with through holes 105a and 106a that allow the guide wire 34 to pass therethrough. The stopper members 100a and 104a are for preventing the valve body 60a from protruding outside from the inside of the catheter tube 6a along the axial direction, respectively, and are made of a material harder than at least the valve body 60a. Members constituting the stopper members 100a and 104a are not particularly limited, and examples thereof include a polyurethane resin and an epoxy resin.

The stopper members 100a and 104a
The catheter tube 6a may be fixed inside the catheter tube 6a using an adhesive, but may be simply fitted so as not to move easily in the axial direction. In addition, these stopper members 10
As long as Oa and 104a can be integrally formed with the catheter tube 6a, they may be integrally formed.

As shown in FIG. 7A, the axial gap between the two stopper members 100a and 104a is such that marginal gaps 94a and 96a are formed between the two stopper members 100a and 104a and the valve body 60a located therebetween. Is determined. As shown in FIG. 7B, the clearance gaps 94a and 96a are widened when the distal end of the guide wire 34 is inserted into the clearance hole 65a of the valve body 60a, and the valve body 60a
Is a gap for allowing elastic deformation in the axial direction. If the clearances 94a and 96a are too small,
When the guide wire 34 is inserted into the contact hole 65a, the resistance tends to be too large, and the usability deteriorates. The width of these extra gaps 94a and 96a is
As shown in (B), with the distal end of the guide wire 34 inserted into the contact hole 65a of the valve body 60a,
a is determined based on the amount of elastic deformation in the axial direction.

In this embodiment, the catheter tube 6a
It is preferable that at least the distal end is formed of a member elastically deformable radially outward. Because Figure 7
As shown in (B), in the state where the distal end of the guide wire 34 is inserted into the contact hole 65a of the valve body 60a, the contact hole 6
This is because 5a spreads and the valve body 60a also tries to spread radially outward. Even if the distal end of the catheter tube 6a is made of a material that does not spread radially outward, the valve body 6
0a is not a problem because it is made of a material that is easily elastically deformed in the axial direction.

However, since the distal end of the catheter tube 6a is formed of a member that can be elastically deformed radially outward, the distal end of the guide wire 34 can be inserted into the contact hole 65a of the valve body 60a. Is further reduced, which is more preferable. From such a viewpoint, the catheter tube 6
The distal end is preferably made of a synthetic resin having a Shore A hardness of preferably about 40 to 95 measured according to JIS K 6253. Above all, it is preferable to be made of polyurethane having excellent durability and antithrombotic properties. The reason why the hardness of the distal end of the catheter tube 6a is set in the above range is that if the hardness is too low, the pushing characteristics of the catheter tube 6a tend to decrease. This is because elastic deformation tends to be small.

The medical valve body 60a of this embodiment is similar to the medical valve body 60a shown in FIG.
As shown in (C), the whole is disc-shaped, and an adhesion hole 65a composed of a through-hole having a substantially circular cross section is formed along the substantially central axis thereof.

As shown in FIG. 7 (C), before the valve body 60a is mounted inside the distal end of the catheter tube 6a, the outer diameter D2 of the valve body 60a is set at the distance from the catheter tube 6a. It is larger than the inner diameter D1 of the position end. FIG. 7 (A)
As shown in the figure, the valve body 60a is connected to the catheter tube 6a.
Is compressed and elastically deformed inside the distal end portion, and is mounted in a state where the contact hole 65a is completely closed.

[0086] The close contact hole 65a is preferably formed before the valve body 60a is mounted inside the distal end of the catheter tube 6a, but is preferably formed inside the distal end of the catheter tube 6a. It may be formed after mounting. In any case, as shown in FIG. 7A, when the valve body 60a is mounted inside the distal end of the catheter tube 6a, the close contact hole 65a is closed, and the inside of the balloon portion 4 is closed. Is sealed. The contact hole 65a may be integrally formed at the time of molding the valve body 60a, but after molding the valve body 60a,
It may be formed by processing with a tool such as a needle. Adhesion hole 65a
7B, the guide wire 34 is inserted as shown in FIG. 7B, so that a lubricant such as silicone oil may be applied to the contact hole 65a.

FIG. 7 (C) clearly shows the contact hole 65a formed in the valve body 60a before the valve body 60a is mounted inside the distal end portion of the catheter tube 6a. However, actually, since the hardness of the polymer material forming the valve body 60a is considerably low, the close contact hole 65a is almost completely closed by deformation. The outer diameter D3 of a tool such as a needle for forming the contact hole 65a is D4 × 0.3 times to D4 when the outer diameter of the guide wire 34 is D4.
The outer diameter is about × 1.0. Immediately after that, the contact hole 65a formed by the tool is almost completely closed by deformation at a stage before being mounted inside the distal end of the catheter tube 6a.

As shown in FIG. 7 (C), before the valve body 60a is mounted inside the distal end of the catheter tube 6a, the outer diameter D2 of the valve body 60a is different from that of the catheter tube 6a. It is preferable that the inner diameter is larger than the inner diameter D1 of the position end, and at most about 2.0 times. By making the outer diameter D2 larger than the inner diameter D1 within such a range, the valve body 60a is satisfactorily compressed and deformed, is mounted inside the distal end of the catheter tube 6a, and completely closes the contact hole 65a. Close to.

As shown in FIG. 7A, the valve body 60a of the present embodiment is mounted by being compressed and deformed inside the distal end of the catheter tube 6a, and as shown in FIG. 7B. The guide wire 34 is inserted through the contact hole 65a. Therefore, the valve body 60a is preferably made of a material having low hardness, a large elongation at break, and a low compression modulus, and is made of the same material as the valve body 60 shown in FIGS. Have similar physical properties.

In the drug injection catheter 2a having the valve body 60a according to the present embodiment inside the distal end of the catheter tube 6a, as shown in FIG. 7B, the inside of the distal end of the catheter tube 6a 7A, the interior of the balloon portion 4 is well sealed by the valve body 60a even when the guide wire 34 is not passing through, as shown in FIG. 7A.

Since the inside diameter D1 of the distal end of the catheter tube 6a is relatively small, it is practically impossible to mount a conventional slit valve body inside the distal end of the catheter tube 6a as it is. Is difficult. This is because, in the conventional valve body with a slit, it is easy to break from the slit portion and it is difficult to perform slit processing.
Since the valve body 60a of the present embodiment has only the close contact hole 65a having a simple through-hole shape, the valve body 60a is easy to manufacture even with a small size, and has reliable sealing performance.

In the drug injection catheter 2a according to the present embodiment, the distal end of the catheter tube 6a of the drug injection catheter 2a shown in FIG. 6 is moved along a guide wire 34 shown in FIG. Guide to the site. Thereafter, the guide wire 34 is pulled out from the connector hub 40a side, or the hub 4 is removed with the guide wire 34 remaining.
A chemical solution is injected from 0a. Then, the medicinal solution is injected into the body cavity from a plurality of side holes 80 formed at the distal end of the catheter tube 6a, and the medicinal solution is sprayed on a relatively wide affected area in the body cavity.

By the way, if the sealing performance of the valve body 60a is incomplete, the chemical is injected only from the distal end opening 81,
There is a risk that the drug solution will not be sprayed on the target affected area. Further, when the distal end of the catheter tube 6a of the drug injection catheter 2a is guided to a predetermined site inside the body cavity of the patient along the guide wire 34, if the sealing property of the valve body 60a is incomplete, the distal end The bodily fluid in the body cavity passes through the tube 6 through the opening.
a, it is not preferable because it leaks from the hub 40a to the outside. In the valve body 60a according to the present embodiment, FIG.
As shown in FIG. 7B, even when the guide wire 34 passes through the inside of the distal end of the catheter tube 6a, FIG.
As shown in (A), even when the guide wire 34 does not pass through, the inside of the catheter tube 6a holds the valve 6
0a provides better sealing.

(Other Embodiments) In the present invention,
Instead of the disc-shaped valve element 60 or 60a, a cylindrical valve element 60b shown in FIG. 8 or valve elements 60c to 60f having the shapes shown in FIGS. 9 (A) to 9 (D) may be used. The valve body 60b shown in FIG. 8 is a cylindrical valve body, and is the same as the valve body 60a shown in FIG. 7C except that the shape is different, and has a contact hole 65b similar to the contact hole 65a. . FIG. 9 (A)
The valve element 60c shown in FIG. 8 is a cylindrical valve element, a valve element having a shape in which both end surfaces of a cylinder are convex, and is the same as the valve element 60b shown in FIG. Contact hole 65
It has a close contact hole 65d similar to b. The valve element 60d shown in FIG. 9 (B) is a valve element having a shape in which both end surfaces of a cylinder are concave, and is similar to the valve element 60b shown in FIG. It has a similar contact hole 65d. The valve body 60e shown in FIG. 9C is a valve body having a shape in which the outer peripheral surface of a cylinder is convex, except that the shape is different.
It is the same as the valve body 60b shown in FIG. 8, and has a contact hole 65e similar to the contact hole 65b. The valve element 60 shown in FIG.
f is a valve body having a cylindrical shape in which the outer peripheral surface is concave, and is the same as the valve body 60b shown in FIG. 8 except that the shape is different, and has a contact hole 65f similar to the contact hole 65b.

The valve body used in the balloon catheter according to the present invention may be a valve body having the shape shown in FIGS. 8 and 9A to 9D, or a valve body combining these shapes.

The valve bodies 60 and 60a to 60f having the structure described above can be used also as a hemostatic valve for medical instruments other than the balloon catheter and the drug injection catheter.

The present invention is not limited to the above-described embodiment, but can be variously modified within the scope of the present invention.

[0098]

EXAMPLES Hereinafter, the present invention will be described based on more detailed examples, but the present invention is not limited to these examples.

Example 1 As shown in FIGS. 7A to 7C, a valve body 60a was attached to a distal end of a catheter tube 6a in which a side hole and the like were not formed. The catheter tube 6a has an inner diameter of 1.8 mm and an outer diameter of 2.3 m.
m catheter tube made of polyurethane was used. The Shore A hardness of the catheter tube was 90.

The valve body 60a was made of an addition-type two-component mixed type silicone. 6 parts by weight of a hardening agent composed of vinyl silicone is mixed well with 100 parts by weight of silicone as a main agent, and centrifugal removal is performed at 700 G for 4 minutes.
The mixture was filled in a mold for obtaining a disc-shaped valve body 60a as shown in FIG. 7 (C). 7 in the mold
After heat molding at 0 ° C. and 2 hours and curing, the valve 6
0a was taken out. The outer diameter of the valve body 60a was 2.0 mm, and its axial length was 2 mm. This valve 6
A needle having an outer diameter of D3 = 0.35 mm is passed through the center axis of 0a to open a contact hole 65a.
A lubricating oil consisting of silicone oil (viscosity 20 cps) was applied. After the needle processing, the contact hole 65a is almost completely closed by deformation of the silicone constituting the valve body 60a.

The Shore A hardness of the valve body 60a is determined according to JIS K
It was 5 or less when measured based on 6253.
Further, the breaking elongation of the valve body 60a is determined according to JIS K 7311.
It was 800% when measured based on. further,
The compression modulus of the valve body 60a was 0.01 kg / cm ² when measured based on JIS K 7208.

The valve body 60a was compressed and deformed into a position about 2 mm from the distal end of the above-mentioned catheter tube 6a and packed. Next, at the tip end side of the mounting position of this valve element, FIG.
The stopper member 104a shown in (A) was formed of an epoxy resin. The inner diameter of the stopper member 104a is 1.2 m
m. Before the valve body 60a is packed into the distal end of the catheter tube, the stopper member 100a located on the left side of the valve body 60a in FIG. Formed by an epoxy resin. That is, the valve body 60a was mounted so as to have extra spaces 94a and 96a between the stopper members 100a and 104a. The total axial length of the extra spaces 94a and 96a was about 1.0 to 2.0 mm.

[0103] Inside the catheter tube 6a to which the valve body 60a is attached, an outer diameter of 0.81 mm lubricated with water.
When the resistance when passing through the close contact hole of the valve body was examined through a hydrophilic guide wire (GW), no resistance was felt as shown in Table 1. Further, the tip of the catheter tube to which the valve body 60a is attached is put in water,
The guide wire was pulled out while applying a pressure of 0.4 kgf / cm ² , and the hemostatic property was evaluated by measuring the air leakage. As shown in Table 1, there is no air leakage,
It was confirmed that the hemostatic property was excellent.

[0104]

[Table 1]

Example 2 By changing the weight ratio of the curing agent to the silicone main component, the Shore A hardness was 10, the elongation at break was 800%, and the compression modulus was 0.013 kg / cm.
No. ² valve body was manufactured, and the resistance and hemostasis of the guide wire were examined in the same manner as in Example 1 except that the valve body was pushed into the tip of the catheter tube. As shown in Table 1, it was confirmed that the resistance due to the insertion of the guide wire was small and the hemostasis was excellent.

Example 3 A valve body having a Shore A hardness of 15, a breaking elongation of 600% and a compression modulus of 0.2 kg / cm ² by changing the weight ratio of the curing agent to the silicone main component. Was manufactured, and the resistance and hemostatic property of the guide wire were examined in the same manner as in Example 1 except that the guide wire was pushed into the tip of the catheter tube. As shown in Table 1, it was confirmed that the resistance due to the insertion of the guide wire was small and the hemostasis was excellent.

Example 4 By changing the weight ratio of the curing agent to the silicone main component, the Shore A hardness was 30, the breaking elongation was 400%, and the compression modulus was 0.27 kg / cm ^2.
The resistance and hemostatic property of the guide wire were examined in the same manner as in Example 1 except that the valve body was manufactured and pushed into the tip of the catheter tube. As shown in Table 1, although there was slight resistance due to insertion of the guide wire, it was confirmed that the hemostasis was excellent.

Comparative Example 1 By changing the weight ratio of the curing agent to the silicone main component, the Shore A hardness was 5 or less, the elongation at break was 1300%, and the compression modulus was 0.01 kg / cm.
The resistance and hemostasis of the guide wire were examined in the same manner as in Example 1 except that ^two or less valve bodies were manufactured and pushed into the tip of the catheter tube. As shown in Table 1, although there was no resistance due to insertion of the guide wire, leakage was observed and hemostasis was not sufficient. However, even such a valve element can be used as a medical valve element that allows some leakage.

Comparative Example 2 By changing the weight ratio of the curing agent to the silicone main component, the Shore A hardness was 40, the breaking elongation was 200%, and the compression modulus was 0.37 kg / cm ^2.
The resistance and hemostatic property of the guide wire were examined in the same manner as in Example 1 except that the valve body was manufactured and pushed into the tip of the catheter tube. As shown in Table 1, since the guide wire was forcibly inserted, the valve body was broken, and hemostasis was impossible. However, even with such a valve body, there remains a possibility of being used as a medical valve body for use using a thinner guide wire.

Example 5 Polyurethane was used as the material constituting the valve body, the weight ratio of the curing agent to the main agent was 100: 30, the heating conditions were 80 ° C. and 6 hours in a mold, and the Shore A hardness was 1
5, a rupture elongation of 600% and a compression modulus of 0.20 kg / cm ² were manufactured and pushed into the distal end of the catheter tube in the same manner as in Example 1 except that a guide wire was formed. Resistance and hemostasis were examined. It was confirmed that the resistance due to the insertion of the guide wire was small and the hemostasis was excellent.

[0111]

As described above, according to the medical valve element of the present invention, even if it is used in an extremely narrow portion, it can be used when a linear member such as a guide wire or a tube exists or does not exist. Both have excellent sealing performance. Further, the resistance at the time of pulling out the linear member is small, and the operability is excellent.

[Brief description of the drawings]

FIG. 1A is a schematic sectional view of a balloon catheter using a medical valve according to one embodiment of the present invention, and FIG. 1B is a sectional view along IB-IB shown in FIG. 1A.

FIG. 2 is a cross-sectional view of a main part of the medical valve body showing a state where an inner tube is inserted.

FIG. 3 (A) is a cross-sectional view of a main part of the medical valve body showing a state in which an inner tube is removed, and FIG. 3 (B) is a cross-sectional view of the medical valve body before being attached to a distal tip portion; FIG. (C) is a perspective view of the medical valve body before being attached to the distal tip portion.

FIG. 4 is a schematic view showing a state where a balloon catheter is inserted into a blood vessel.

FIG. 5 is a schematic view showing a state after a balloon catheter has been inserted into a blood vessel.

FIG. 6 is a cross-sectional view of a main part of a drug injection catheter using a medical valve according to another embodiment of the present invention.

7 (A) and 7 (B) are cross-sectional views of a main part showing a use state of a valve attached to the drug injection catheter shown in FIG. 6, and FIG. 7 (C) is a sectional view of FIG. It is principal part sectional drawing of the valve body shown to (B).

FIG. 8 is a perspective view of a valve body according to another embodiment of the present invention.

9 (A) to 9 (D) are perspective views showing other examples of the valve element, respectively.

[Explanation of symbols]

 2 Balloon catheter 2a Drug injection catheter 4 Balloon section 6, 6a Catheter tube 8 Outer tube 10 Inner tube 12 First lumen 14 Second lumen 20 Tip tip 22 Balloon membrane 34 Guide wire 40 connector 40a connector hub 42 support wire 46 cap 60, 60a to 60f medical valve body 65, 65a to 65f adhesion hole 100 sensor block 100a, 104a stopper member 102 tip tube 104 cap

Claims (4)

[Claims] 1. A medical valve body having a contact hole penetrating in an axial direction, wherein a maximum outer diameter of an outer peripheral portion of the valve body before the medical valve body is mounted is: Medical use, wherein the valve body is larger than the inner diameter of the cylindrical portion to which the valve body is mounted, and the valve body is compressed and deformed inside the cylindrical portion, and is mounted with the close contact hole closed. Valve body. 2. The medical valve element according to claim 1, wherein the medical valve element has a Shore A hardness of 30 or less. 3. The breaking elongation of the medical valve body is 300-1.
The medical valve element according to claim 1, which is 000%. 4. A compression modulus of the medical valve body is 0.01.
The medical valve body according to claim 1 which is ~0.30kg / cm ^2.