JP3282831B2 - Catheter tube - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a catheter tube mainly used to be inserted into a blood vessel and performing a medical treatment from an extracorporeal position to a blood vessel or a lumen.

[0002]

2. Description of the Related Art Conventionally, as a device for dilating and treating a stenotic portion of a blood vessel, for example, a device in which an expandable body is disposed at a distal end portion of a catheter is known.

For example, when dilating a stenosis in a blood vessel, a treatment is performed by placing an expander of the catheter at the stenosis, expanding the dilator, and tearing the stenosis.

However, when such a treatment is performed, vascular endothelial cells are damaged, and platelet adhesion and agglutination occur at the damaged site.

[0005] That is, at this time, platelets release a number of substances out of the cell, for example, ADP, calcium, serotonin, etc., promote the growth of aggregates, and platelet factors
Promotes blood clotting and leads to the formation of blood clots. In addition, platelet-derived cell growth factor released from the platelets increases the intimal thickness as a repair mechanism of the living body.

[0006] Such an action of platelets may promote restenosis in a treatment part of a blood vessel, so that a sufficient therapeutic effect may not be obtained by dehiscence treatment of a stenosis part using a catheter with an expandable body. The problem was pointed out.

On the other hand, the catheter tube is used in addition to the above-described dilation treatment, for example, when injecting a drug near a lesion and directly treating the lesion, for example, when treating cancer. You. In such cases, the injected drug acts on the lesions and is carried by the blood to various parts of the body,
It can cause many side effects, and because the drug is diluted by blood, it is necessary to use a thick drug in order to obtain a sufficient therapeutic effect, rather it causes side effects There were also problems.

Further, when the inside of a blood vessel at a target site such as an enlarged stenosis portion is filled with a drug solution, it is difficult to remove blood, and it is difficult to fill only the target site with a drug solution that cannot be diluted.

[0009]

SUMMARY OF THE INVENTION An object of the present invention is to solve the above-mentioned drawbacks of the prior art and to more effectively perform endoluminal treatment and dilation treatment of stenosis in blood vessels. The object is to provide a catheter tube that can be obtained.

[0010]

This and other objects are achieved by the present invention which is defined below as (1) to (4).

(1) A catheter tube used by being inserted into a body cavity, comprising: a tube main body; a first expandable and contractible expandable body provided around a tube outer peripheral wall near a distal end of the tube main body; An expandable and contractible second expandable member installed around the outer peripheral wall of the tube at a predetermined distance from the first expandable member at a base end side, and means for expanding and contracting the first expandable member and the second expandable member A first lumen for injecting a fluid into a body cavity through a first opening provided between the first expansion body and the second expansion body; and the first expansion body and the second expansion body A second lumen for discharging fluid in the body cavity through a second opening provided between
One of the first opening or the second opening is provided in the vicinity of the first expansion body, and the other is provided in the vicinity of the second expansion body and on the opposite peripheral wall of the tube main body, The tube main body is provided with a third lumen through which a guide wire having an open distal end is inserted, and a third opening communicating with the third lumen is provided on a proximal end side of the second expansion body. A catheter tube, wherein the lumen is also used as a bypass lumen.

(2) The means for inflating and contracting the first expansion body and the second expansion body comprises a lumen communicating with each of the first expansion body and the second expansion body. The catheter tube according to 1).

(3) The catheter tube according to (1) or (2), wherein a cross-sectional area of the second lumen is larger than a cross-sectional area of the first lumen.

(4) The catheter tube according to (1) or (2), wherein the cross-sectional area of the first lumen is larger than the cross-sectional area of the second lumen.

[0015]

[Specific Configuration] A specific configuration of the present invention will be described below. FIG. 1 is a side view showing a configuration example of a catheter tube 1 of the present invention, FIG. 2 is a longitudinal sectional view thereof, and FIG.
FIG. 3 is a sectional view taken along line III-III in FIG.

As shown in FIG. 1, the catheter tube 1
Has a tube main body 2, and a hollow first extension body 3 is installed around the outer peripheral wall of the tube near the distal end (left side in the figure), and is located on the proximal side (right side in the figure) of the first extension body 3. A second hollow body 4 which is also hollow is installed around the outer peripheral wall of the tube at a position separated by a predetermined distance. The first expansion body 3 and the second expansion body 4 need to be attached to the tube body 2 in an air-tight or liquid-tight manner. As an attachment method, a separate member (preliminarily formed in an annular shape or a bag shape) is used. Any method capable of maintaining the air-tightness or liquid-tightness of the expansion body is possible, such as a method of bonding members or the like) with an adhesive or heat fusion, or a method of binding with a thread.

The first and second expansion members 3 and 4 are preferably formed of a material having some flexibility, such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and the like. Polyolefins such as cross-linked ethylene-vinyl acetate copolymers,
Thermoplastic resins such as polyvinyl chloride, polyurethane and polyamide elastomers, silicone rubber, latex rubber and the like can be used, preferably the above-mentioned thermoplastic resins, and more preferably a crosslinked ethylene-vinyl acetate copolymer.

The material for forming the tube body 2 is as follows.
Those having a certain degree of flexibility are preferred, for example, polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane , A thermoplastic resin such as a polyamide elastomer, a silicone rubber or the like can be used, preferably the above-mentioned thermoplastic resin, and more preferably a polyolefin.

Various lumens having different uses and functions as described below are formed in the tube main body 2.

The first lumen 5 communicates with a first opening 51 formed in the outer peripheral wall 21 of the tube between the first expansion body 3 and the second expansion body 4. For injecting fluid into Specifically, the lumen 5 is used to administer a drug or the like into a blood vessel into which the catheter tube 1 has been inserted and placed.

The second lumen 6 communicates with a second opening 61 formed in the tube outer peripheral wall 21 between the first expansion body 3 and the second expansion body 4. The second lumen 6 is the first lumen 6
It is used to discharge a drug or the like injected from the lumen 5 from inside the blood vessel partitioned by the expansion bodies 3 and 4.

The first opening 51 and the second opening 61
Are formed at positions close to the two expansion bodies 3 and 4, respectively, and are provided on the peripheral wall of the tube body 2 on the opposite side. This is because when the fluid is injected and discharged, the fluid exchange efficiency in the blood vessel partitioned by the expansion bodies 3 and 4 is improved.

As shown in FIG. 3, when the cross-sectional area of the second lumen 6 is larger than the cross-sectional area of the first lumen 5, it is easy to discharge medicines and the like using the second lumen 6. . A first lumen 5 for injecting a fluid into the body cavity;
When the cross-sectional area of the second lumen 6 is larger than the cross-sectional area of the second lumen 6, when injecting a fluid such as a medicine, it is difficult for the second lumen 6 to be clogged by foreign substances and the like. It will not be transmitted to the blood vessel through the lumen 6.

As shown in FIG. 2, the fourth lumen 7 communicates with the first extension body 3 and the second extension body 4, and flows into the first extension body 3 and the second extension body 4 with a fluid (gas or liquid). May be
Liquids are preferred in consideration of safety when inserted into blood vessels.

For example, an angiographic agent and the like can be mentioned. ) To inflate the first expansion body 3 and the second expansion body 4 at the same time, or to discharge the fluid and contract these expansion bodies 3 and 4 at the same time. Alternatively, a lumen may be provided for each of the expansion bodies 3 and 4, and each lumen may be communicated with the expansion bodies 3 and 4, and the expansion bodies 3 and 4 may be separately expanded and contracted.

The means for inflating and contracting the first and second expansion bodies does not necessarily have to be a lumen formed in the tube body 2, but instead of these means, each expansion body may be provided outside the tube body 2. An air supply or liquid supply tube communicating with 3 and 4 may be separately provided.

Further, the tube main body 2 has a third lumen 9 having a fourth opening 91 at the distal end of the tube main body 2. The third lumen 9 is a lumen for inserting a guide wire.

At the base end side of the second expansion body 4, a third opening 92 communicating with the third lumen 9 is formed in the outer peripheral wall 21 of the tube.
Are formed. Therefore, the third opening 92 and the fourth opening 91 communicate with each other via the third lumen 9, and the blood in the blood vessel on the distal side from the first expansion body 3 and the blood on the proximal side from the second expansion body 4. Blood can be circulated.

As described above, by using the third lumen 9 as a bypass lumen, the two expansion bodies 3,
In order to prevent ischemia on the peripheral side when dilating 4 in the blood vessel, the blood can flow to the distal side from the fourth opening 91 at the distal end through the bypass lumen. By also using the third lumen 9, the number of lumens can be reduced, and the diameter of the tube body 2 can be relatively reduced. The outer diameter of the tube body 2 and the inner diameter of each of the lumens 5, 6, 7, 9 may be appropriately determined according to the inner diameter of the body cavity (lumen such as a blood vessel or urethra) to be inserted. Has an outer diameter of about 1.0 to 8.0 mm, preferably about 1.2 to 6 mm, and an inner diameter of the first lumen 5 of about 0.4 to 0.9 mm, preferably 0.5 to 0.8 mm.
mm, the inner diameter of the second lumen 6 is about 0.4 to 0.9 mm, preferably about 0.5 to 0.8 mm.
Has an inner diameter of about 0.4 to 1.1 mm, preferably 0.5 to 1.1 mm.
About 1.0 mm, the inner diameter of the fourth lumen 7 is 0.4 to 1.1
mm, preferably about 0.5 to 1.0 mm, and the outer diameter of the first expansion body 3 is about 1.5 to 12 mm, preferably 2 to 1 mm.
The outer diameter of the second expansion body 4 is about 2 to 14 mm, preferably about 2.5 to 12 mm, and the gap distance S between the first expansion body 3 and the second expansion body 4 is 5 to 100 mm. Degree, preferably about 10 to 80 mm. However, the cross-sectional shape of each of the lumens does not necessarily have to be circular, and the gap distance S may be enlarged or reduced in accordance with the size of each constriction. The above-mentioned lumen diameters are values obtained by converting the sectional area into a circle.

The first expansion body 3 and the second expansion body 4 come into close contact with the inner wall surface of the blood vessel to be inserted at the time of inflation.
The role of fixing the catheter tube 1 to the blood vessel,
It has a role of blocking the inflow of blood between the first expansion body 3 and the second expansion body 4.

It is preferable that the first expansion body 3 and the second expansion body 4 expand radially from the center of the tube body 2 when expanded.

The cross-sectional shape of the first expansion body 3 and the second expansion body 4 can be a circle, an ellipse, or other similar shapes. However, it is assumed that the cross-sectional shape approximates the cross-sectional shape of the body cavity to be inserted and placed. This is preferable because the adhesion to the body cavity is improved. In particular, the diameter (minimum diameter) Dmin of the portion where the diameter of each of the first expansion body 3 and the second expansion body 4 at the time of expansion is minimum, and the diameter of the inner wall of the body cavity where the insertion and placement are performed (when the body cavity contracts) are maximum. The relationship with the diameter (maximum diameter) dmax of the part is Dmin ≧ dm
It is preferable to set it to ax because the two expansion bodies 3 and 4 surely adhere to the body cavity.

A marker 8 is provided on the outer peripheral surface of the tube body 2 surrounded by the expansion bodies 3 and 4. The marker 8 is preferably made of a radiopaque material (for example, gold, platinum, or an alloy thereof). This is for making it easier to confirm the positions of the expansion bodies 3 and 4 under fluoroscopy.

FIG. 4 shows the proximal end of the catheter tube. As shown, a manifold 22 is connected to the proximal end of the tube main body 2, and the manifold 2 is connected to the manifold 22.
Each of the lumens is branched through the second lumen. The first lumen 5, the second lumen 6, and the fourth lumen 7 branched from the manifold 22 are branched pipes 52, 62, 7 respectively.
Cocks 53, 6 for opening and closing the flow paths of the respective branch pipes via
3, 73. The third lumen 9 is connected to a hub 94 via a branch pipe 93. The cocks 53, 63, and 73 respectively have a syringe A,
B and C are connected to operate injection and extraction of a drug and expansion and contraction of an expansion body. The guide wire 10 is connected to the hub 94.
Is inserted.

In the catheter tube of the present invention, the outer surface of the catheter body 2 and the outer surfaces of the expansion bodies 3 and 4 are provided with lubricity with blood and the like to facilitate insertion into a blood vessel and further into a guide catheter. For this purpose, it is preferable to perform a hydrophilic treatment. Examples of such a hydrophilic treatment include, for example, hydrophilic treatments such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether, maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. And a method of coating a conductive polymer.

[0036]

The operation of the catheter tube 1 according to the present invention will be described below.

FIGS. 5, 6 and 7 are partial cross-sectional side views showing the use state of the catheter tube 1 of the present invention.

As shown in FIG. 5, the catheter tube 1
Is inserted into the blood vessel 12 and placed at the stenosis site. When the fluid is sent from the fourth lumen 7 into the first and second expansion bodies 3 and 4 to expand the first and second expansion bodies 3 and 4, as shown in FIG. 6, the stenosis site is expanded, Good blood flow.

Next, as shown in FIG. 7, the tube main body 2 is moved so that the expansion site is located between the first and second expansion bodies 3 and 4, and the fluid is again passed through the fourth lumen 7. The inflation causes the first and second expansion bodies 3, 4 to expand.

The first and second expansion bodies 3 and 4
The catheter tube 1 is brought into close contact with the inner wall surface 13 of the
2 while blocking the flow of blood 14 in the blood vessel 12 (possible in either direction, left or right in the figure).

In this state, as shown in FIG. 7, for example, a medicine 15 for suppressing intimal thickening is injected from a first opening 51 provided in the vicinity of the second expansion body 4 through the first lumen 5, and Blood is easily sucked out and removed from the second opening 61 provided in the vicinity of the first expansion body 3 on the opposite peripheral wall of the tube main body 2, and the first and second expansion bodies 3,
The inside of the blood vessel between 4 is filled with the drug 15 around the dilation site.

The drug 15 suppresses intimal hyperplasia and suppresses restenosis. In addition, since the medicines 15 can be sequentially replenished, a new medicine 15 can be constantly sent to the entire circumference of the stenotic dilation portion to act thereon, and the therapeutic effect can be enhanced.

On the other hand, the blood 14 on the distal end side of the first expansion body 3 and the blood 14 on the proximal end side of the second expansion body 4 can mutually flow through the third lumen 9 for bypass. For example, if blood flows in the direction of arrow 16 in FIG. 7, the blood 14 on the proximal end side of the second expansion body 4 enters through the third opening 92 and flows through the third lumen 9 used as a bypass. It flows out and comes out of the fourth opening 91 to the distal end side of the first expansion body 3. As described above, even during the treatment, the circulation of the blood in the blood vessel 12 is ensured, so that ischemia on the peripheral side is prevented, and the treatment can be performed for a long time.

The treatment part in the blood vessel is the inner wall surface 1 of the blood vessel.
In the range defined by the first expansion body 3 and the second expansion body 4 that are in close contact with the third expansion body 3, the medicine filled between the two expansion bodies can be directly applied to the affected part without being diluted. And a sufficient therapeutic effect can be obtained with a small amount of drug.

In addition, it can be used for local administration of anticancer agents such as endoxane and immunosuppressants such as cyclosporin. In addition, even if a drug having a strong side effect or a drug with a high concentration is used, the drug can be recovered by sending a saline solution through the first opening 51 after locally acting with the catheter tube of the present invention. Therefore, there are advantages that side effects can be further reduced and a higher therapeutic effect can be obtained than before.

[0046]

EXAMPLE A catheter tube having the structure shown in FIGS. 1 and 2 was prepared. The conditions for this catheter tube are:
It is as follows.

<Tube body> Material: Polyvinyl chloride containing X-ray contrast agent Outer diameter: Approximately 1.5 mm Effective length: Approximately 135 cm Lumens: 4 lumens 1st (for liquid injection) 1 lumen, 2nd (fluid discharge) 1) Lumen, 3rd (for expansion of the 1st and 2nd expansion body) 1 lumen, 4th (for insertion of guide wire) (for bypass) 1 lumen (inner diameter 0.4mm) <1st expansion body> Material: Polyurethane Thickness: 20 μm Shape: Cylindrical Effective length: 15 mm Inflated diameter: 5 mm <Second extension> Material: Polyurethane Thickness: 20 μm Shape: Cylindrical Effective length: 15 mm Inflated diameter: 5 mm First extension The distance S between the catheter and the proximal end of the catheter lumen is shown in FIG. 4 at the proximal end of the fourth lumen and the proximal ends of the first and second lumens communicating with the first and second expansion bodies. Like that A cock having a luer taper receiving port is attached via each manifold 22, and syringes A, B, and C are connected to these to enable inflation fluid (angiographic agent) to be injected into the expansion body. The infusion and drainage of the therapeutic fluid into the blood vessel defined by the two dilators was enabled.

<Contents of Implementation> In the simulation test device 17 shown in FIG.
Is inserted into the simulated blood vessel 173 of the
The extension was detained. The simulated blood vessel 173 is made of vinyl chloride, and the pump 1 is located upstream of the stenosis equivalent part 174.
72 are provided. The pump 172 is connected to the liquid storage tank 17.
Pumping the simulated blood from 1 and sending it into the simulated blood vessel 173,
The simulated blood flowing through the simulated blood vessel 173 is stored in the storage tank 171.
Return to and circulate. In the stenosis equivalent part 174, the bypass tube 1
75 are provided side by side, and a valve 176 is provided. By adjusting the valve 176, the flow rate of the simulated blood in the stenosis equivalent part 174 is adjusted.

First, the syringe C is manually operated to expand the first and second expansion bodies, and the stenosis-equivalent portion 174 is obtained.
Was cleaved. Further, the first and second dilation bodies were contracted by operating the syringe C, and the catheter tube was moved to position the stenosis-equivalent portion 174 between the first and second dilation bodies.

The syringe C is operated again to expand the first and second expansion bodies, and the catheter tube is moved to the simulated blood vessel 1.
73 and the flow of the simulated blood was shut off.

Next, the syringes A and B are operated,
2 ml of physiological saline was injected into the blood vessel partitioned by the first and second dilators from the first opening while simulating blood was discharged from the second opening. This state was maintained for 5 minutes.

At this time, a sufficient simulated blood flow had occurred through the third lumen.

[0053]

According to the catheter tube of the present invention,
When performing medical treatment inside a blood vessel at a site partitioned by a first expansion body and a second expansion body in a blood vessel, injection and discharge of a drug or the like in the site becomes possible. Can be filled while allowing the permeating agent or the like to uniformly pass through the peripheral wall in the site, and for example, local treatment can be performed efficiently, such as suppressing restenosis after dilation treatment of a vascular stenosis, and a high therapeutic effect. Can be obtained.

Further, in the catheter tube of the present invention, when the tube main body is provided with a bypass lumen in which a guide wire lumen is used in combination, even during medical treatment inside a body cavity or the like, a blood vessel can be passed through the bypass lumen. A fluid (for example, blood in a blood vessel) on the distal side of the first expansion body and a fluid on the proximal side of the second expansion body can be circulated.

[0055] Therefore, a catheter tube that involves a blockage of blood flow in a blood vessel during a medical procedure cannot perform a medical procedure for a long time due to safety restrictions on the human body. Since the circulation is ensured, a catheter tube capable of performing medical treatment for a long time is provided, and there is an effect that a higher therapeutic effect is obtained.

[Brief description of the drawings]

FIG. 1 is a side view showing one configuration example of a catheter tube of the present invention.

FIG. 2 is a longitudinal sectional view of the catheter tube of the present invention.

FIG. 3 is a sectional view taken along line III-III in FIG. 2;

FIG. 4 is an enlarged view of a proximal end portion of a catheter tube.

FIG. 5 is a partial cross-sectional view of a blood vessel showing a state where a first expansion body is placed at a stenosis site.

FIG. 6 is a partial side sectional view of a blood vessel showing a state where a stenosis portion is expanded by expansion of a first expansion body.

FIG. 7 is a partial cross-sectional view of a blood vessel showing a state where a medical procedure is being performed on a dilated stenosis portion by flushing a medicine.

FIG. 8 is a schematic diagram showing an implementation state of the catheter tube of the present invention using a simulation test apparatus.

[Explanation of symbols]

 Reference Signs List 1 catheter tube 2 tube main body 21 tube outer peripheral wall 22 manifold 3 first expanded body 4 second expanded body 5 first lumen 51 first opening 52 branch pipe 53 cock 6 second lumen 61 second opening 62 branch pipe 63 cock 7 Fourth lumen 72 Branch pipe 73 Cock 8 Marker 9 Third lumen 91 Fourth opening 92 Third opening 93 Branch pipe 94 Hub 10 Guide wire 12 Blood vessel 13 Inner wall surface 14 Blood 15 Drug 16 Blood flow direction 17 Simulation experiment Apparatus 171 Reservoir 172 Pump 173 Simulated blood vessel 174 Stenosis equivalent part 175 Bypass tube 176 Valve

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-2-297380 (JP, A) JP-A-54-31985 (JP, A) JP-A-62-155868 (JP, A) JP-A 64-64 27564 (JP, A) JP-A-2-55064 (JP, A) JP-A-3-39171 (JP, A) JP-T-58-501983 (JP, A) JP-T 1-502484 (JP, A) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 25/00

Claims (4)

(57) [Claims] 1. A catheter tube used by being inserted into a body cavity, comprising: a tube main body; a first expandable and contractible expandable body disposed around a tube outer peripheral wall near a distal end portion of the tube main body; An expandable and contractible second expandable body installed around the outer peripheral wall of the tube at a predetermined distance from the first expandable body toward the base end side; and a means for expanding and contracting the first expandable body and the second expandable body. A first extension provided between the first extension and the second extension;
A first lumen for injecting a fluid into a body cavity through an opening; a second lumen provided between the first expansion body and the second expansion body
A second lumen for discharging a fluid in a body cavity through an opening, wherein one of the first opening and the second opening is provided near the first expansion body, and the other is the second expansion body And a third lumen for inserting a guide wire having an open distal end is provided in the tube body, and a proximal end side of the second expansion body is provided in the tube body. A third opening communicating with the third lumen, the third lumen also serving as a bypass lumen. 2. The means for expanding and contracting the first expansion body and the second expansion body comprises a lumen communicating with the inside of each of the first expansion body and the second expansion body. A catheter tube according to claim 1. 3. The catheter tube according to claim 1, wherein a cross-sectional area of the second lumen is larger than a cross-sectional area of the first lumen. 4. The catheter tube according to claim 1, wherein a cross-sectional area of the first lumen is larger than a cross-sectional area of the second lumen.