JP3483088B2 - catheter - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter having a balloon at its tip, and more particularly to a rapid exchange type balloon catheter.

[0002]

2. Description of the Related Art PTCA (Percutaneous Translumina)
l Coronary Angioplasty: A catheter used for percutaneous coronary angioplasty (hereinafter referred to as "PTCA catheter"), which is a balloon catheter for vascular insertion, in addition to a balloon lumen for dilating a balloon. , The guide wire lumen for inserting the guide wire is formed over the entire length of the catheter, and the guide wire is inserted into the guide wire inserting lumen before insertion of the catheter into the blood vessel so that the tip of the guide wire precedes. Then, the distal end of the guide wire together with the catheter is guided to the target site (near the blood vessel stenosis).

A wide variety of PTCA catheters are available, suitable for cases such as the size of the stenosis and the diameter of the blood vessel, or different balloon sizes for the gradual expansion of the stenosis. However, there is a case where it is necessary to replace the PTCA catheter after inserting the blood vessel. In addition, even when a plurality of indwelling devices called stents for securing the inner diameter of the blood vessel are installed, the catheter may be removed / inserted from the blood vessel several times.

It is preferable to replace the catheter with the guide wire left in the blood vessel in order to reduce the burden on the patient, the operation time and labor, the prevention of infection and the like.

However, in the conventional catheter, as described above, the lumen for inserting the guide wire is formed over the entire length of the catheter, so that the guide wire is left indwelling in the blood vessel from the external end side of the guide wire. In order to replace the catheter, the extracorporeal end of the guide wire has to be protruded from the proximal end of the catheter by a length not less than the entire length of the catheter, and there is a problem that the long protruding guide wire deteriorates operability.

[0006] Therefore, a lumen for inserting a guide wire is formed only at the distal end of the catheter, that is, a rapid-exchange type catheter, that is, a distal end opening of the catheter and a number from the distal end opening to the proximal side. There is proposed a catheter which is formed so as to communicate with a side hole provided at a position separated by about cm, and which is configured so that the short lumen and the guide wire are engaged with each other (Japanese Patent Publication No. 4-9548). In this catheter, the catheter can be exchanged while the guide wire is left in the blood vessel without the extracorporeal end of the guide wire protruding from the proximal end of the catheter.

[0007]

However, in the above-mentioned conventional rapid exchange type catheter,
No matter which manufacturing method is used to form the balloon lumen and the guide wire lumen at desired positions, the manufacturing is not easy, and there is a drawback that the diameter of the catheter cannot be sufficiently reduced. is there.

[0008] That is, as a first method of manufacturing the catheter, the catheter from the proximal end to the distal end is constituted by a shaft having a double pipe structure of an inner pipe and an outer pipe, and the inner pipe is fused midway. And the like, and a side hole is formed in the vicinity of the distal end side of the sealing portion to form a guide wire lumen. In this method, a portion closer to the base end side than the side hole (the base end of the guide wire lumen) is Also, since there is an unnecessary inner tube, the catheter becomes thick at that portion.

As a second method of manufacturing the catheter, a guide wire is prepared by adhering inner tube shafts of a required length in parallel to each other on the distal end portion of the outer tube shaft which constitutes the base end to the distal end of the catheter. Although a lumen is formed, in this method, the catheter becomes thick at the portion where the inner tube shaft is present (the tip of the catheter).

In any of the above methods, the strength of the shaft is reduced near the base end (near the side hole) of the guide wire lumen, and a kink (bending) is likely to occur, and this kink blocks each lumen. There is a problem.

Further, in this type of catheter, the strength at the proximal end side of the catheter is sufficiently secured to improve the torque transmission property, pushability (pushability) and kink resistance, while at the distal end side of the catheter. However, it is preferable to improve flexibility, but in the conventional catheter, it is not possible to select and use different constituent materials for the proximal side and the distal side of the catheter. Can not.

The present invention has been made in view of the above-mentioned drawbacks of the prior art, and an object of the present invention is to provide a catheter which is capable of reducing the diameter of each catheter portion while ensuring sufficient strength and which is easy to manufacture. To provide.

[0013]

These objects are achieved by the present invention described in (1) to (7) below.

(1) The first shaft on the base end side, the second shaft on the front end side, the first shaft and the second shaft
A third shaft for connecting to the shaft of the third shaft, and an expandable / contractible balloon provided on the distal end side of the third shaft, between the distal end of the catheter and the side portion of the third shaft. A catheter having a guide wire lumen for inserting a guide wire therethrough, comprising:
The shaft has a plurality of balloon lumens that communicate with the inside of the balloon and are partitioned by partition walls, and the second shaft is inserted and connected inside the third shaft. catheter.

(2) The first shaft on the base end side, the second shaft on the front end side, the first shaft and the second shaft
A third shaft connecting the shaft of the second shaft, an expandable / contractible balloon installed in the vicinity of the tip of the second shaft, and an inner lumen of the second shaft. A catheter having an inner tube forming a guide wire lumen for inserting a guide wire,
The third shaft has an opening forming deformable portion and a plurality of balloon lumens that communicate with the inside of the balloon and are partitioned by partition walls, and the tip of the inner tube is larger than the tip of the second shaft. The base end of the inner tube protrudes by a predetermined length, and the proximal end of the inner tube is located at or near the opening-forming deformation portion, and the balloon is located between the distal end portion of the inner tube and the distal end portion of the second shaft. And the second shaft is inserted into and connected to the inside of the third shaft.

(3) The catheter according to (2), wherein the inner tube has a proximal end open, and the proximal opening is located at the opening-forming deformable portion.

(4) The inner tube is closed at its base end,
Further, the catheter according to (2) above, in which an opening is formed in a side portion near the closed end, and the opening is located in the opening-forming deformed portion.

(5) The catheter according to any one of (2) to (4), wherein the opening-forming deformed portion is formed by denting the outer peripheral portion of the third shaft.

(6) The catheter according to any one of (1) to (5), wherein a reinforcing member is inserted into at least one of the plurality of balloon lumens.

(7) The second shaft is the first shaft.
The catheter according to any one of (1) to (6) above, which is more flexible than the shaft described in 1.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION The catheter of the present invention will be described below in detail with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a perspective view showing an embodiment of a catheter assembly when the catheter of the present invention is applied to a catheter for PTCA, and FIG. 2 is a structure near the tip of the catheter in the catheter assembly shown in FIG. Is a perspective view, FIG. 3 is a sectional view taken along line III-III in FIG. 2, and FIG.
FIG. 5 is a cross-sectional view taken along line IV-IV in FIG. 2, and FIG. 5 is a cross-sectional view taken along line VI-VI in FIG. For convenience of description, the right side in FIGS. 1 and 2 is referred to as a “base end”, and the left side is referred to as a “tip”.

As shown in FIG. 1, the catheter assembly 10
0 is the catheter 1 of the present invention and the guide wire 110.
And a guiding catheter 120 that passes through these
And a hub 130 attached to the proximal end of the catheter 1 and a hub 1 attached to the proximal end of the guiding catheter 120.
40 and a Y connector 150 connected to the hub 140.

The guide wire 110 is a flexible wire, and its constituent material is not particularly limited.
Various plastics and various metal materials such as superelastic alloys (eg, Ni—Ti alloys) can be used.

Further, the tip of the guide wire 110 is
It is preferable that taper processing is performed according to characteristics such as contact resistance and bending resistance, and the outer diameter thereof is gradually reduced toward the tip. Thereby, when the guide wire 110 is inserted into the blood vessel from the distal end side and reaches a target site (coronary artery or the like), the guide wire 110 flexibly copes with complicated blood vessel shape such as curve or branch of the blood vessel, and the guide wire 110 is inserted. The removal operation can be performed easily and safely.

Next, based on FIGS. 2 to 6, the catheter 1
The configuration of will be described. The catheter 1 is a rapid exchange type balloon catheter, and mainly
Of the first shaft 2 on the base end side, the second shaft 3 on the front end side, the third shaft 4 connecting the first shaft 2 and the second shaft 3, and at least the second shaft 3 Consists of an inner tube 5 installed so as to pass through the inside, a contrast marker 52 adhered to the inner tube, and an expandable / contractible balloon (expandable body) 6 installed near the tip of the second shaft 3. Has been done.

The first shaft 2 occupies most of the entire length of the catheter 1 (about 70 to 90%).

On the first shaft 2, there is formed a balloon lumen 70 which constitutes a flow path for supplying a working fluid for expanding and contracting the balloon 6 to the inner space of the balloon 6, and a guide wire 110 is formed. The guide wire lumen to be inserted is not formed. This makes the first
The diameter of the shaft 2 can be reduced.

A reinforcing wire (reinforcing member) 8 is inserted in the balloon lumen 70. Reinforcing wire 8
The proximal end of is positioned inside the hub 130 and is fixed, or is fixed (bonded to the inner surface of the lumen, etc.) using one of the split balloon lumens 72. The tip of the reinforcing wire 8 can be installed in the vicinity of the tip of the split balloon lumen 72 described below or at an arbitrary position of the balloon lumen 71.

The reinforcing wire 8 is made of, for example, stainless steel, superelastic alloy, copper or copper alloy, titanium or its alloy, noble metal, hard resin such as polyimide, polyamide, polyethylene terephthalate and polyphenylene sulfide. There are things.

The second shaft 3 is formed with a balloon lumen 71 which constitutes a flow path for supplying a working fluid for expanding and contracting the balloon 6 to the internal space of the balloon 6, and inside the balloon lumen 71. The inner tube 5 is inserted through the. Therefore, the outer diameter of the inner tube 5 is set to be less than the inner diameter of the balloon lumen 71.

The third shaft 4 connecting the first shaft 2 and the second shaft 3 has an opening forming deformation portion 41 in the middle of the longitudinal direction (particularly in the center). The opening forming deformable portion 41 has a semi-circular cut 42 formed in the outer peripheral wall of the third shaft 4, and the outer peripheral wall portion on the base end side of the notch 42 in the central axis direction of the third shaft 4. It is formed by being depressed, and forms a base end opening (side hole) of a guide wire lumen 73 described later.

Deformation portion 4 for forming an opening due to such depression
1 has the advantage that its formation is easy.

On the base end side of the opening forming deformable portion 41, an inclined portion 45 and a guide groove 46 which function as a guide surface for guiding the guide wire 110 are formed.
By installing the inclined portion 45, abrupt bending of the guide wire 110 from the outer surface side of the first and third shafts 2 and 4 to the base end opening of the inner tube 5 can be suppressed, and the guide wire 1
Smooth loading and unloading of 10.

Further, by installing the guide groove 46, since the guide wire 110 is well guided along the groove 46 from the outside of the third shaft 4 to the lumen of the inner tube 5, the guide wire 110 can be smoothly taken in and out. become.

The base end portion of the inner pipe 5 is located in the opening forming deformation portion 41 through the notch 42. In this case, the vicinity of the base end of the inner pipe 5 is installed substantially parallel to the third shaft 4, and the base end face 50 of the inner pipe 5 is substantially parallel to the cross section of the third shaft 4. As a result, the guide wire 110 is attached to the inclined portion 45 of the opening forming deformation portion 41.
Via the base end opening of the inner tube 5 through the guide wire lumen 73.

The tip portion of the inner pipe 5 projects a predetermined length from the tip of the second shaft 3 toward the tip side. The inner lumen of the inner tube 5 constitutes a guide wire lumen 73 through which the guide wire 110 is inserted. In the catheter 1, since the guide wire lumen 73 through which the guide wire 110 is inserted is formed only near the distal end portion of the catheter 1, the catheter 1 can be replaced with a simple operation while the guide wire 110 is left in the body. be able to.

Although the total length of the guide wire lumen 73 is not particularly limited, it is preferably about 150 to 350 mm, and more preferably about 200 to 300 mm in consideration of operability in the operation of exchanging the catheter. More preferable.

A plurality of (five in the figure) split balloon lumens 72 partitioned by partition walls 43 are formed in the portion of the third shaft 4 corresponding to the opening forming deformable portion 41. The base end of each split balloon lumen 72 is
It communicates with the balloon lumen 70 of the first shaft 2, and the tip of each divided balloon lumen 72 has a second shaft 3
It communicates with the balloon lumen 71.

In the present invention, in the opening forming deformation portion 41 of the third shaft 4, one balloon lumen is not formed in an annular shape so as to surround the inner tube 5, but a plurality of divided balloon lumens 72 are formed. Since the divided balloon lumens 72 are formed via the partition wall 43 and surround the inner tube 5, the strength can be increased without increasing the outer diameter of the third shaft 4. It is possible to prevent kinks in the opening forming deformed portion 41 of the shaft 4 and the vicinity thereof.

The reinforcing wire 8 described above is inserted into one of the divided balloon lumens 72. The tip of the reinforcing wire 8 is
It is preferably located near the tip of the split balloon lumen 72. With such a structure, the strength of the third shaft 4 is further increased, and the kink prevention effect is further improved. When the reinforcing wire 8 is made of a material having an X-ray contrast property, the X-ray contrast property of the catheter 1 can be obtained without separately installing a member having the X-ray contrast property.

The second shaft 3 and the third shaft 4 are connected by inserting the base end of the second shaft 3 inside the tip of the third shaft 4. This allows
The outer diameter of the second shaft 3 can be set to be equal to or less than the outer diameter of the third shaft 4, and the second shaft 3 can be made thinner.

Similarly, the connection between the first shaft 2 and the third shaft 4 is such that the tip of the first shaft 2 is the third.
It is preferable that the shaft 4 is inserted and connected inside the proximal end of the shaft 4. As a result, the outer diameter of the first shaft 2 can be made equal to or smaller than the outer diameter of the third shaft 4, and the first shaft 2 can be made thinner.

The total length of the third shaft 4 is not particularly limited, but is preferably about 3 to 350 mm, and 10 to 300 mm.
The degree is more preferable. The length of the opening forming deformable portion 41 is preferably about 3 to 20 mm, and 6 to 10 mm.
It is more preferable that the degree is. With such dimensions, the insertability of the guide wire 110, the difficulty of kinking of the opening forming deformable portion 41, and the first shaft 2
There is an advantage that the balance of the adhesion (fusion) cost with is improved.

As the constituent materials of the first, second and third shafts 2, 3, 4 and the inner tube 5 as described above, a flexible polymer material is preferable, and for example, polyethylene (low Density to high density), polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer and other polyolefins, polyethylene terephthalate, polyester such as polybutylene terephthalate, polyvinyl chloride, Polystyrene, polyurethane, polyamide, polyimide,
Examples thereof include various resins such as polyoxymethylene, polyvinyl alcohol, polytetrafluoroethylene, polyvinylidene fluoride, and other fluorine-based resins, thermoplastic elastomers such as polyamide elastomer and polyester elastomer, and various rubbers such as silicone rubber and latex rubber. In the present invention, the first, second and third shafts 2,
Since 3 and 4 are separate members, their constituent materials can be appropriately selected and used in combination.

The first shaft 2 on the base end side is made of, for example, a composite material obtained by coating a pipe made of a superelastic alloy or stainless steel with a resin such as polyethylene, or the like.
You may comprise using the said metallic material independent.

For example, as a constituent material of the first shaft 2, a material having a high rigidity (bending rigidity, torsional rigidity) (eg N
A pipe made of i-Ti alloy, stainless steel, or polyimide is selected, and a material having higher flexibility than the first shaft 2 as a constituent material of the second shaft 3 (eg, made of polyamide elastomer, polyester elastomer, polypropylene). By selecting (pipe), the catheter 1 as a whole is improved in torque transmissibility, pushability, and kink resistance, while the flexible tip portion can prevent damage to living tissue and the like, thus ensuring safety. It is possible to provide a high catheter.

The total length (total length) of the first to third shafts 2 to 4 is not particularly limited, but is 1200 to 1500 mm.
It is preferably about 1300 mm to 1400 mm.

The balloon 6 is composed of a tubular membrane member,
Both ends thereof are air-tightly or liquid-tightly fixed (adhered or fused) to the outer peripheral surface of the distal end portion of the inner tube 5 and the outer peripheral surface of the distal end portion of the second shaft 3, respectively.

The constituent material of the balloon 6 is preferably one having a certain degree of flexibility and tensile strength, and examples thereof include polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and crosslinked ethylene-. Polyolefin such as vinyl acetate copolymer, polyester, polyvinyl chloride, polyurethane, polyamide, polyamide elastomer, polyethylene terephthalate (PET), thermoplastic resin such as polyarylene sulfide such as polyphenylene sulfide, silicone rubber, latex rubber, etc. Is mentioned. From the viewpoint of improving the strength of the balloon 6, a material that can be stretched and oriented is preferable.

The contrast marker 52 is provided so that the position of the balloon 6 can be confirmed under fluoroscopy. For example, gold, platinum, tungsten or their alloys, or a silver-palladium alloy or the like can be used as the X-ray marker. It is made of a permeable material, and is wound and fixed to the outer peripheral surface of the inner tube 5 in a coil shape.

Further, it is preferable that a layer (not shown) made of a hydrophilic polymer substance having lubricity in a wet state is formed on the outer peripheral surface of the catheter 1. Thereby, when inserting the catheter 1, friction is reduced, the insertion can be performed smoothly, and operability and safety are improved.

As the hydrophilic polymer substance, a natural polymer substance type (eg, starch type, cellulose type, tannin / nignin type, polysaccharide type, protein) and synthetic polymer type substance (PVA type) are used. , Polyethylene oxide type,
Acrylic acid type, maleic anhydride type, phthalic acid type, water soluble polyester, ketone aldehyde resin, (meth) acrylamide type, vinyl heterocyclic ring type, polyamine type, polyelectrolyte, water soluble nylon type, glycidyl acrylate type) There is.

Among these, in particular, a cellulosic polymer material (for example, hydroxypropyl cellulose),
Polyethylene oxide-based polymer (polyethylene glycol), maleic anhydride-based polymer (eg, maleic anhydride copolymer such as methyl vinyl ether maleic anhydride copolymer), acrylamide-based polymer (eg, polydimethyl) Acrylamide), water-soluble nylon (for example, AQ-Nylon P-70 manufactured by Toray Industries, Inc.)
Alternatively, derivatives thereof are preferable because a low coefficient of friction can be stably obtained. For details of these, Japanese Patent Application No. 7
-270519.

As shown in FIG. 1, a hub 130 is attached to the proximal end of the catheter 1. The lumen of the hub 130 communicates with the proximal end of the balloon lumen 70 formed on the first shaft 2, and supplies the working fluid to the balloon lumens 70 to 72 via the hub 130, or operates. The fluid is extracted and the balloon 6 is expanded / contracted.

The guide wire 110 and the catheter 1 as described above are inserted into the guiding catheter 120 for use.

The guiding catheter 120 is a tubular member having an inner diameter that is greater than the maximum outer diameter of the catheter 1, and the guiding catheter 120 has the above-described first to third shafts 2.
It is composed of the same materials as those listed in 4 to 4.

A Y connector 150 is attached to the proximal end of the guiding catheter 120 via a hub 140. Inside the hub 140 and the Y connector 150, a lumen is formed along their longitudinal direction, the lumen communicates with the lumen of the guiding catheter 120, and the guide wire 110 and the catheter 1 are , The guiding catheter 120, the hub 140, and the lumen of the Y connector 150, and protrudes from the proximal end of the Y connector 150.

Further, the Y connector 150 is formed with a tubular branch portion 151. The branch part 151 is, for example,
It is used for injecting an X-ray contrast agent into a blood vessel (target site). The X-ray contrast medium injected from the branch portion 71 is
It is discharged from the tip opening of the guiding catheter 120 through the 0 lumen and the guiding catheter 120 lumen.

Next, an example of a method of manufacturing the catheter 1 will be described with reference to FIGS. 7 and 8.

7 and 8 are a sectional view taken along the line IV-IV and a sectional view taken along the line VV of the catheter 1 shown in FIG. 2 in a state before the opening-forming deformed portion 41 is formed, respectively.

[1] Raw materials for the first shaft 2, the second shaft 3, the third shaft 4 and the inner pipe 5 are prepared and cut into desired lengths. All of these are tubular members (tubes) made of the resin as described above. The dimensions and the like of each tubular member can be set as follows, for example.

Outer diameter of the first shaft 2: 0.80 mm Inner diameter of the first shaft 2: 0.60 mm Total length of the first shaft 2: 1140 mm Material of the first shaft 2: Ni-Ti alloy or polyimide

Outer diameter of the second shaft 3: 0.80 mm Inner diameter of the second shaft 3: 0.65 mm Second shaft 3 total length: 210 mm Material forming the second shaft 3: Polyamide elastomer

Outer diameter of the third shaft 4: 1.05 mm Inner diameter of the third shaft 4: 0.85 mm Total length of the third shaft 4: 20 mm Material of construction of third shaft 4: high-density polyethylene

Outer diameter of inner tube 5: 0.55 mm Inner diameter of inner tube 5: 0.4 mm Total length of inner tube 5: 250 mm Material of the inner tube 5: High density polyethylene

[2] Next, the third shaft 4 is processed as follows. First, at a predetermined position in the middle of the third shaft 4, a notch 42 having a half circumference is obliquely formed, and a portion on the proximal end side of the notch 42 is recessed in the central axis direction of the third shaft 4 (see FIG. 7). ).

[3] Next, the cored bar 75 is inserted into the inner cavity of the inner tube 5, the inner tube 5 is inserted into the third shaft 4 from the distal end side, and the base end of the inner tube 5 is cut. It is made to project toward the base end side from 42 and is positioned on the recessed portion 44 (see FIG. 7).
Further, the cored bar 75 is projected from the third shaft 4 toward the base end side. As a result, during thermal processing, the above-mentioned inclined portion 4
5 and the guide groove 46 are formed. The core metal 75 used here is made of, for example, stainless steel or Ni-Ti.
It is made of alloy and its outer diameter is 0.39-0.40.
It is about mm.

[4] Recessed portion 44 of the third shaft 4
7, the divided balloon lumen 7 is provided in the lower lumen.
A plurality of cored bars 76 for forming 2 are inserted and arranged in a predetermined arrangement (see FIGS. 7 and 8).

Each core metal 76 used here is, for example,
Made of stainless steel or Ni-Ti alloy,
The outer diameter is about 0.20 to 0.22 mm. In addition, each core metal 76 is long enough so that both ends thereof protrude from both ends of the third shaft 4. Further, one of the core bars 76 may be replaced with the reinforcing wire 8.

[5] Conditions under which a heat-shrinkable tube (made of silicone) is covered on the outer periphery of at least the opening forming deformable portion 41 of the third shaft 4 so that the constituent material of the third shaft 4 can be melted ( For example, 130-140 ℃, 2
Heat for 0 seconds to heat-shrink the heat-shrink tube. As a result, the constituent material of the third shaft 4 is in a molten state, and the third shaft 4 that has been in the state shown in FIGS. 7 and 8 is in the states shown in FIGS. 4 and 5, respectively.

At this time, there is a recessed portion 44 near the center of the third shaft 4 (the cut portion), and this recessed portion 44 is melted together with the lower outer wall of the third shaft 4 to be adjacent to it. Since the space is filled between the cored bars 76, the partition wall 43 and the split balloon lumen 72 defined by the partition wall 43 are formed without significantly reducing the outer diameter.

The third shaft 4 itself may be made of a heat shrink tube. In this case, the third shaft 4 is heat-treated under the above conditions without covering the heat shrink tube separately. You can give it. Alternatively, the opening forming deformable portion 41 may be formed by simply heating and melting the third shaft 4 without using such a heat-shrinkable tube.

[6] Each core metal 7 from the third shaft 4
5 and 76 are pulled out and the heat shrink tube is peeled off,
Remove. As a result, the proximal end portion of the inner tube 5 having the guide wire lumen 73 is fused and fixed (embedded), and
The third shaft 4 in which the two split balloon lumens 72 are formed is completed.

[7] Next, the tip of the first shaft 2 is inserted into the base end of the third shaft 4, and these are fused (heat fusion, high frequency fusion, ultrasonic fusion, etc.) or bonded. Glue
Fix it. At this time, the portion on the distal end side of the reinforcing wire 8 inserted through the first shaft 2 is inserted into the predetermined split balloon lumen 72 by a predetermined depth.

[8] The base end of the second shaft 3 is inserted into the tip of the third shaft 4, and these are fused (heat fusion, high frequency fusion, ultrasonic fusion, etc.) or bonded with an adhesive. , Fix it. Further, an X-ray contrast marker (platinum coil, gold coil) 52 is set and adhered to a predetermined length portion of the inner tube 5 protruding from the second shaft 3.

[9] Both ends of the balloon 6 are fused to the outer peripheral surface of the distal end portion of the inner tube 5 and the outer peripheral surface of the distal end portion of the second shaft 3 (heat fusion, high frequency fusion, ultrasonic fusion, etc.). Alternatively, it is adhered with an adhesive and fixed in a liquid-tight or airtight manner.

[10] The hub 1 is attached to the base end of the first shaft 2.
Wear 30. The catheter 1 of the present invention is completed as described above.

In the catheter 1 of the present invention, the first shaft 2, the second shaft 3 and the third shaft 4 are respectively formed of different members, and these are assembled to form the catheter 1
Therefore, it is possible to reduce the diameter of each shaft by forming the minimum necessary lumen with the minimum necessary size, and to independently perform the above-described processing on the third shaft 4. Since the completed and completed third shaft 4 is connected to the first shaft 2 and the second shaft 3, manufacturing and assembly can be easily performed.

The first to third shafts 2 to 4 and the inner pipe 5 can be made of materials suitable for the required characteristics and conditions, and their shapes and
Since the dimensions and the like can be set to be suitable for each, sufficient rigidity (bending rigidity) is provided near the proximal end side of the catheter 1 and the proximal end of the guide wire lumen 73 (the opening forming deforming portion 41). , Torsional rigidity) and flexibility can be improved at the distal end side of the catheter 1. As a result, operability and safety during insertion of the catheter 1 into the body are significantly improved.

FIG. 9 is a perspective view showing another embodiment of the catheter of the present invention, and FIG. 10 is a sectional view taken along line XX in FIG. Hereinafter, the configuration of the catheter 1'will be described based on these drawings, but the description of the same items as those of the catheter 1 will be omitted.

The catheter 1'is a rapid exchange type balloon catheter, and in the same manner as above, the first shaft 2, the second shaft 3, the first shaft 2 and the second shaft 3 are connected. Third shaft 4 to connect
An inner tube 5, an X-ray contrast marker 52, and an expandable / contractible balloon 6 installed near the tip of the second shaft 3.
It consists of and.

In this catheter 1 ', the notch 42 is not formed on the third shaft, and the deforming portion 4 for forming an opening is formed.
The difference is that the third shaft 4 is located outside the inner tube 5 over the entire length of 1.

The base end of the inner pipe 5 is sealed (closed), preferably by fusion bonding, and the inner pipe 5 and the third shaft 4 at the upper side in the figure are provided on the side portion near the closed end 51. A side hole (opening) 74 penetrating a portion where and overlap is formed. The side hole 74 is located in the opening forming deformable portion 41.

Also in the catheter 1'having such a configuration, the same operation / effect as the operation / effect of the catheter 1 described above is performed.
The effect is demonstrated.

Next, an example of a method for manufacturing the catheter 1'will be described. The manufacturing method of the catheter 1'is the same as the manufacturing method of the catheter 1 described above, except for the following points.

Instead of performing the step [2], instead of the step [3], the base end of the inner tube 5 is fused (heat fusion, high frequency fusion, ultrasonic fusion, etc.) or an adhesive prior to the step [3]. Seal with adhesive.

In the step [3], the inner pipe 5 having the cored bar inserted therein is inserted into the third shaft 4 from the tip side thereof, and the base end of the inner pipe 5 is inserted in the middle of the third shaft 4. Position it.

In the step [4], the third shaft 4
The cored bar 76 is inserted and arranged in the inner cavity below the inner tube 5 in the figure.

After the step [5], a side hole 74 penetrating the inner tube 5 and the third shaft 4 is formed in the upper joining (fusion) portion in the figure. The formation of the side hole 74 can be performed by, for example, fusing with heat or mechanical cutting (cutting).

Although the catheter of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this.

For example, the connecting portion between the first shaft 2 and the third shaft 4 has a structure in which the base end of the third shaft 4 is inserted inside the tip end of the first shaft 2, the first shaft 2. The structure may be such that the end surfaces of the shaft 2 and the third shaft 4 are adhered or fused to each other.

The number of split balloon lumens 72 is
The number is not limited to 5, and may be 4, 3, 2, or 6 or more. Similarly, the number of the reinforcing wires 8 can be increased or decreased according to the number of the split balloon lumens 72 or the like.

Further, the catheter 1 may be formed with one or more other lumens such as a liquid ejecting lumen (flash lumen) for the purpose of injecting a contrast medium or a specific medicine. .

The catheter of the present invention is not limited to the case of being applied to a PTCA catheter, and may be, for example, OTCA.
It can also be applied to an OTCA catheter used in (intraoperative coronary angioplasty), a stent insertion / delivery device, an endoscope, a pacemaker, and the like.

[0096]

As described above, according to the catheter of the present invention, the diameter of each part of the catheter can be reduced. In particular, since the first to third shafts that are manufactured separately are assembled, it is possible to form the minimum necessary lumen in each shaft with the minimum necessary size, and also to form the second shaft into the third shaft. Since it is inserted and connected inside the shaft,
It is extremely advantageous for reducing the diameter.

Further, since each shaft 4 is manufactured separately and assembled, the degree of freedom in designing in terms of shape, structure, dimensions, etc. is wide, and there are few restrictions in the order of assembly, etc., so that manufacturing and assembly are facilitated. It can be carried out.

Further, in the catheter of the present invention, the constituent materials and dimensions of various parts of the catheter can be selected and set as appropriate, so that, for example, on the proximal end side of the catheter, sufficient rigidity can be secured, Sufficient flexibility can be ensured on the distal end side of the catheter. In particular, since the partition wall that cuts off each balloon lumen is formed on the third shaft, the rigidity thereof, particularly the rigidity in the vicinity of the proximal end opening of the guide wire lumen, can be increased, and the kink in the third shaft can be increased. And twist can be prevented.

As described above, it is possible to improve the torque transmission property, push-in property, and kink resistance of the catheter, and the catheter is excellent in operability.

The catheter of the present invention is also excellent in the operability of the guide wire when inserting or replacing the guide wire or the catheter.

From the above, it is effective to apply to a catheter used by being inserted into a peripheral blood vessel such as a PTCA catheter for which there is a strong demand for reduction in diameter and improvement in operability. It contributes to the improvement of operability in insertion and replacement of the patient and the reduction of the burden on the patient.

[Brief description of drawings]

FIG. 1 is a perspective view showing an embodiment of a catheter assembly when the catheter of the present invention is applied to a PTCA catheter.

FIG. 2 is a perspective view showing a structure in the vicinity of a distal end portion of a catheter in the catheter assembly shown in FIG.

3 is a sectional view taken along line III-III in FIG.

4 is a sectional view taken along line IV-IV in FIG.

5 is a sectional view taken along line VV in FIG.

6 is a sectional view taken along line VI-VI in FIG.

7 is a cross-sectional view taken along the line IV-IV of the catheter shown in FIG. 2 before forming a deformed portion for forming an opening.

8 is a cross-sectional view taken along the line VV of the catheter shown in FIG. 2 in a state before forming an opening forming deformed portion.

FIG. 9 is a perspective view showing another embodiment of the catheter of the present invention.

10 is a sectional view taken along line XX in FIG.

[Explanation of symbols]

1,1 'catheter 2 First shaft 3 Second shaft 4 Third shaft 41 Deformation part for opening formation 42 notches 43 partitions 44 recessed part 45 slope 46 Guide groove 5 inner tube 50 base end face 51 closed end 52 X-ray contrast marker 6 balloons 70,71 Balloon lumen 72 split balloon lumens 73 guide wire lumen 74 side hole 75, 76 core 8 Reinforcing wire 100 catheter assembly 110 guide wire 120 guiding catheter 130 hub 140 hub 150 Y connector 151 branch

Front page continuation (58) Fields surveyed (Int.Cl. ⁷ , DB name) A61M 25/00-25/18 A61M 29/00-29/02

Claims (7)

(57) [Claims] 1. A first shaft on the base end side, a second shaft on the front end side, a third shaft connecting the first shaft and the second shaft, and a third shaft. A catheter having an expandable / contractible balloon installed closer to the distal end side, and having a guidewire lumen formed between the distal end of the catheter and the side portion of the third shaft. The third shaft has a plurality of balloon lumens that communicate with the inside of the balloon and are partitioned by partition walls, and the second shaft is inserted into and connected to the inside of the third shaft. A catheter characterized by: 2. A first shaft on the base end side, a second shaft on the front end side, a third shaft connecting the first shaft and the second shaft, and a second shaft. An expandable / contractible balloon installed near the tip of, and installed so as to pass through the inside of the second shaft,
A catheter having an inner tube that has an inner tube that forms a guide wire lumen for inserting a guide wire, wherein the third shaft communicates with the opening-forming deformable portion and inside the balloon, and is partitioned by a partition wall. A plurality of balloon lumens, the distal end of the inner tube projects a predetermined length from the distal end of the second shaft, and the proximal end of the inner tube is located at or near the opening-forming deformable portion. The balloon is installed between the distal end of the inner tube and the distal end of the second shaft, and the second shaft is inserted and connected inside the third shaft. A catheter characterized by the following. 3. The inner tube has an open base end,
The catheter according to claim 2, wherein the base end opening is located at the opening forming deformable portion. 4. The inner tube is closed at its base end, and an opening is formed in a side portion near the closed end, and the opening is located in the opening forming deformable portion. Catheter. 5. The catheter according to claim 2, wherein the opening-forming deformed portion is formed by recessing an outer peripheral portion of the third shaft. 6. The catheter according to claim 1, wherein a reinforcing member is inserted into at least one of the plurality of balloon lumens. 7. The catheter according to claim 1, wherein the second shaft is more flexible than the first shaft.