JP2003000718A - Balloon-pressurizing device and medical apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a balloon-pressurizing device which gives less damage on a lesional site and which causes hardly a restenosis after a therapy or a delayed thrombosis in the therapy using a balloon catheter. SOLUTION: The balloon-pressurizing device 1 comprises a connector 2 capable of connecting a base end opening of a balloon lumen connecting with a balloon 130 of the balloon catheter 100, a reservoir 3 for storing an operating fluid, a means 4 for pressurizing to a predetermined pressure in the reservoir 3, a circulating passage 5 of the fluid formed via the reservoir 3, and a pressure change means 6 provided on the way of the passage 5 to generate a pulsation flow. The balloon 130 is pressurized by the means 4 and the means 6 so as to periodically change the pressure. Thus, the balloon 130 is vibrated in an enlarged state, and enlarges the lesional site while imparting a vibration to the site.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a balloon pressurizing device for pressurizing the inside of a balloon of a balloon catheter.

[0002]

2. Description of the Related Art A balloon catheter having an expandable / contractible balloon is used for treating a vascular lesion such as arteriosclerosis.

Such a balloon catheter is used by being inserted into the blood vessel from outside the body, and after the balloon reaches the lesion site, pressure is applied (pressurized) to expand the balloon.

As a result, the narrowed portion of the blood vessel is expanded and expanded to improve blood flow, and the aneurysm portion and the dissociated portion are stabilized.

However, the conventional treatment using a balloon catheter has a problem that the restenosis, delayed thrombosis and the like have a high incidence after the treatment. In addition, when the expansion of the vascular tissue due to the expansion of the balloon is locally concentrated, there is a problem that a minute tear or the like may occur in the vascular tissue and the lesion site may be damaged.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide balloon pressurization which causes less damage to a lesion site in treatment using a balloon catheter and is less likely to cause restenosis or delayed thrombosis after treatment. To provide a device.

[0007]

The above objects are achieved by the present invention described in (1) to (13) below.

(1) A connection part capable of connecting a proximal end opening part of the balloon lumen of a balloon catheter having a balloon expandable and contractible by a working fluid and a balloon lumen communicating with the inside of the balloon, and the connection part. And a pressurizing means for pressurizing the inside of the balloon of the balloon catheter via the working fluid, and the pressure in the balloon cyclically fluctuates by the pressurizing means when the balloon is expanded. A balloon pressurizing device which pressurizes the inside of the balloon as described above.

(2) The balloon pressurizing device according to (1), which has a circulation path through which the working fluid circulates.

(3) The pressurizing means has a pressure increasing means for pressurizing the inside of the balloon to a constant pressure, and a pressure changing means for generating a periodic pressure change from the constant pressure obtained by the pressure increasing means. The balloon pressurizing device according to (1) or (2).

(4) The balloon pressurizing device according to the above (3), wherein the inside of the balloon is pressurized to 6 to 20 atm by the pressurizing means.

(5) The balloon pressurizing device according to any one of (1) to (4) above, wherein the cycle of pressure fluctuation acting on the balloon is 10 to 100 Hz.

(6) The cycle of pressure fluctuation acting on the balloon can be set in multiples of 10 Hz.
The balloon pressurizing device according to.

(7) The difference between the maximum pressure and the minimum pressure in the periodic pressure fluctuation acting in the balloon is 1 to 5a.
The balloon pressurizing device according to any one of (1) to (6) above, which is tm.

(8) The balloon pressurizing device according to any one of (1) to (7) above, which has a pressure monitoring means for monitoring the pressure of the working fluid.

(9) A storage section for storing the working fluid, a pressure increasing means for pressurizing the inside of the storage section, a circulation path for the working fluid formed via the storage section, and a midway portion of the circulation path. The balloon pressurizing device according to any one of the above (1) to (8), which is provided and has a pressure fluctuation means for generating a pressure fluctuation of the working fluid.

(10) The balloon pressurizing device according to the above (9), which has flow rate adjusting means for adjusting the flow rate of the working fluid in the middle of the circulation path.

(11) The balloon pressurizing device according to (9) or (10), wherein the pressure changing means is a pump capable of forming a pulsating flow.

(12) The balloon pressurizing device according to any one of the above (9) to (11), wherein a flow path of the working fluid to the connecting portion is provided so as to be branched from the circulation path.

(13) A medical device comprising the balloon pressurizing device according to any one of (1) to (12) above and a balloon catheter connected thereto.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a balloon pressurizing device and a medical device of the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a general view showing an embodiment of a balloon pressurizing device and a medical device of the present invention, FIG. 2 is a general view showing an example of a balloon catheter, and FIG. 3 is a balloon in the balloon catheter shown in FIG. 4 is a vertical sectional view of
It is a graph which shows the pressure which acts in a balloon. In addition,
In the following description, the left side in FIGS. 2 and 3 is the “base end”,
The right side is called the "tip".

The balloon pressurizing device 1 shown in FIG. 1 is for expanding the balloon by pressurizing the inside of a balloon catheter having a balloon which can be expanded and contracted by a working fluid.

Before describing the balloon pressurizing device 1, first, an example of a balloon catheter will be described with reference to FIGS. 2 and 3.

The balloon catheter 100 shown in FIGS. 2 and 3 is an over-the-wire type balloon catheter, and includes an outer tube 110, an inner tube 120 inserted into the outer tube 110, the outer tube 110 and the inner tube 120. It has a balloon 130 installed on the outer periphery of the distal end portion of the tube 120, and a branch hub 140 provided on the proximal end side of the outer tube 110 and the inner tube 120.

The outer tube 110 and the inner tube 120 have desired flexibility, and the constituent materials thereof are, for example, various types of heat such as polyolefin resin, polyamide resin, urethane resin and polyimide resin. A plastic resin or a thermosetting resin can be used. Specifically, for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EV
Polyolefin such as A) and the like, polyvinyl chloride, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyurethane, polyamide, polyimide, polystyrene resin, fluorine resin, styrene resin, polyolefin resin, polyvinyl chloride resin , Polyurethane type, polyester type, polyamide type,
Examples include various thermoplastic elastomers such as polybutadiene type and fluororubber type.

The outer tube 110 and the inner tube 120 may each have a multi-layer laminated structure made of a plurality of kinds of materials.

A lumen 121 for inserting a guide wire (not shown) is formed in the inner tube 120, and the tip of the lumen 121 is open to the outside at a tip opening 122.

A lumen (balloon lumen) 111 is provided between the inner surface of the outer tube 110 and the outer surface of the inner tube 120, which serves as a flow path of a working fluid for expanding and contracting the balloon 130.
Are formed. The tip of the outer pipe 110 is the inner pipe 1
It is located slightly closer to the base end side than the tip end of 20.

The dimensions (length, outer diameter, etc.) of the outer tube 110 and the inner tube 120 are not particularly limited, and are appropriately determined depending on the application of the balloon catheter 100, the case, etc. Usually, the length of the outer tube 110 and the inner tube 120 is 50 to 15
About 0 cm is preferable. The outer diameter of the outer tube 110 is
The outer diameter of the inner tube 120 is preferably about 0.5 to 3 mm.
About 0.3 to 1.5 mm is preferable.

The inner and outer diameters of the outer tube 110 and the inner tube 120 may change along the longitudinal direction thereof. Further, the outer tube 110 and the inner tube 120 may each be configured by connecting a plurality of tubular members.

As shown in FIG. 3, the balloons 130 installed at the tips of the outer tube 110 and the inner tube 120 are made of a tubular film. This balloon 130
Is adhered to the inside of a stenosis site, aneurysm site, a dissection site, etc. (hereinafter collectively referred to as “lesion site”) of a lumen such as a blood vessel (hereinafter represented by “blood vessel”) and pressurized. It has a function of expanding / extending the lesion site.

The base end of the balloon 130 is fixed to the tip of the outer tube 110 in an airtight or liquid-tight manner, and the tip of the balloon 130 is airtight or liquid-tight to the tip of the inner tube 120. Is stuck to. The proximal end portion and the distal end portion of the balloon 130 and the distal end portions of the outer tube 110 and the inner tube 120 are fixed to each other by, for example, fusion bonding or adhesive bonding.

With such a configuration, the lumen 111
Are open inside the balloon 130. That is, the lumen 111 communicates with the inside of the balloon 130. The balloon 130 is preferably installed concentrically with the outer tube 110 and the inner tube 120.

This balloon 130 is not expanded (when deflated).
Although it is collapsed and folded, it is expanded by supplying a working fluid to the inside 131 thereof.

The balloon 130 is made of various polymer materials (particularly, thermoplastic resin). In this case, it is preferable that the entire balloon 130 is made of a material having flexibility but relatively low elasticity (elongation rate).

Specific examples of the constituent material of the balloon 130 include polyester resins such as polyethylene terephthalate, polyethylene naphthalate, polybutylene terephthalate and polybutylene naphthalate, polyester elastomers containing the same, olefin resins such as polyethylene and polypropylene, or the like. Those that have been subjected to a cross-linking treatment (particularly those that have been cross-linked by electron beam irradiation), polyamide resins such as nylon 11, nylon 12, nylon 610, etc. or polyamide elastomers containing these, polyurethane resins, ethylene-vinyl acetate copolymers or Materials obtained by subjecting these to a cross-linking treatment, or materials such as polymer blends and polymer alloys containing at least one of these may be mentioned.

Further, the balloon 130 may be constituted by a laminated body in which a plurality of films made of these materials are laminated. In this case, for example, each layer is coextruded, or each layer is bonded,
The laminated body can be obtained by a method of joining by fusion or the like, or a method of forming another layer by coating on one layer. Further, a soft resin layer, a layer of a lubricating material, a layer of an antithrombotic material, or the like may be provided on the outside or inside of the layer made of the above material.

In the constituent material of the balloon 130,
For example, an antithrombotic material such as heparin, prostaglandin, urokinase, or arginine derivative, or an X-ray opaque material such as barium sulfate, barium carbonate, bismuth oxide, or tungsten that functions as a marker described below may be blended. .

The branch hub 140 attached to the base ends of the outer pipe 110 and the inner pipe 120 has a bifurcated shape, and the ports 141 and 1 are provided at the respective branch ends.
42 is formed. Port 141 is lumen 11
1 and the port 142 communicates with the lumen 121.

A guide wire is inserted through the port 142 and inserted through the lumen 121 so that the distal end portion of the guide wire is positioned near the distal end of the lumen 121.
The tip of the needle is guided when inserting 00 into the blood vessel (lumen).

A balloon pressurizing device 1 described later is connected to the port 141, and the working fluid is sent into the balloon 130 (inside 131) through the lumen 111, and the balloon 1
Perform 30 extended operations.

The constituent material of the branch hub 140 is not particularly limited, and examples thereof include polyvinyl chloride, polyethylene,
It can be made of a resin material such as polypropylene, polycarbonate, polymethylmethacrylate, acrylonitrile-styrene-butadiene copolymer, or various metal materials.

As shown in FIG. 3, the balloon 1 is provided on the outer peripheral surface of the inner tube 120 inside the balloon 130 under fluoroscopy.
At least one marker 150 for confirming the position of 30 in the body is provided. This marker 150
Is made of a metal such as platinum, gold, silver, titanium, or tungsten, or an X-ray opaque material such as an alloy thereof.

In this embodiment, the marker 150 is
Although it has a ring shape covering the outer peripheral surface of the inner tube 120, the shape is not limited to this, and may be, for example, a chip shape or a block shape.

It should be noted that such a marker is not limited to the one under fluoroscopy, but the balloon 1 is used in CT scan, MRI, etc.
The position of 30 may be confirmed.

Although an example of the balloon catheter has been described above, in the present invention, the type of balloon catheter,
Needless to say, the shape, structure, etc. are not particularly limited, and the balloon pressurizing device 1 of the present invention can be used in combination with other various balloon catheters.

Next, the balloon pressurizing device 1 will be described. As shown in FIG. 1, a balloon pressurizing device 1 includes a connecting portion 2 capable of connecting a port 141 (a proximal end opening portion of a balloon lumen) of a balloon catheter 100, a storing portion 3 for storing a working fluid, and the storing portion. Pressure increasing means 4 for pressurizing the inside of the portion 3
And the working fluid circulation path 5 formed via the reservoir 3.
And a pressure fluctuation means 6 provided in the middle of the circulation path 5.

The connecting portion 2 has, for example, a lock connector, and the port 141 of the balloon catheter 100.
Can be detachably connected while ensuring air tightness or liquid tightness.

When the balloon catheter 100 is connected to the connecting portion 2, the inside 131 of the balloon 130, the lumen 111, and the flow path inside the balloon pressurizing device 1 are filled with a working fluid (priming state).

As the working fluid, reduction of pressure loss,
Also, from the viewpoint of safety in the event that the balloon 130 bursts, it is preferably a liquid. Among liquids, X
A liquid having a line contrast property is more preferable. For example, a liquid obtained by diluting an X-ray contrast agent such as an arterial contrast agent with physiological saline several times can be used.

The storage portion (reservoir) 3 is a closed space for storing such working fluid. This storage part 3
A pressure raising means 4 for pressurizing the inside of the storage portion 3 to a constant pressure is connected to the. The pressurizing means 4 is composed of, for example, a syringe 41 or the like, and preferably has a pressure gauge 42.
In the present embodiment, the pressure increasing means 4 is configured to pressurize the air in the storage section 3 to pressurize the inside of the storage section 3.

Also, one ends of the first flow path 51 and the second flow path 52 of the circulation path 5 are connected to the storage part 3, respectively, and the working fluid flows out of the storage part 3 into the first flow path 51. Then
The working fluid flows into the reservoir 3 from the second flow path 52.

The first flow path 51 and the second flow path 5 of the circulation path 5.
The other ends of 2 are connected to the pressure changing means 6, respectively.

The pressure changing means 6 has a function of generating a periodic pressure change from the constant pressure obtained by the pressure increasing means 4. Pressure fluctuation means 6 is a pulsating flow (unsteady flow)
Is preferably a pump capable of forming a roller, for example, a roller pump or a diaphragm pump.

The pressure varying means 6 as described above is provided in the first flow path 5
The working fluid is sucked from No. 1 and discharged to the second flow path 52. That is, the working fluid is sucked from the reservoir 3 through the first flow path 51 to the pressure fluctuation means 6, then discharged from the pressure fluctuation means 6, and returned to the storage part 3 through the second flow path 52.

In the present embodiment, the balloon catheter 1 connected to the connecting portion 2 by the pressurizing means 4 and the pressure varying means 6.
A pressing means for pressing the inside of the balloon 130 of No. 00 is configured.

From the downstream side of the pressure fluctuation means 6 in the circulation path 5 (second flow path 52), a flow path 11 to the connecting portion 2 is provided in a branched manner. The pressure generated by the pressurizing means acts in the balloon 130 via the working fluid in the flow path 11 and the lumen 111.

A pressure gauge (pressure monitor means) 7 is installed in the middle of the flow path 11 via a port 12. The pressure gauge 7 can monitor (detect) the pressure of the working fluid in the flow path 11 (pressure acting in the balloon 130). The pressure gauge 7 is preferably installed near the connecting portion 2. As a result, the pressure inside the balloon 130 can be detected almost accurately.

In the second flow path 52 downstream of the port 12, a valve 8 capable of adjusting the cross-sectional area of the flow path is installed as a flow rate adjusting means. The flow rate of the working fluid can be adjusted by increasing or decreasing the cross-sectional area of the flow path with the valve 8, and as a result, the pressure acting on the balloon 130 can be adjusted.

In the present embodiment, the pressure increasing means 4, the pressure changing means 6 and the pressure gauge 7 are electrically connected to the control means (controller) 10, respectively. This control means 10 operates the input unit 101 to
The initial pressure P ₁ , the pressure fluctuation width, the pressure fluctuation cycle, etc., which will be described later, can be input and set.
Based on the detection signals from the pressure gauge 7 and the pressure gauge 42,
Controls the operation of each part. For example, the balloon 130 is controlled so that the pressure detected by the pressure gauge 7 does not exceed a certain value.
Prevents over-expansion and rupture.

Unlike this structure, the operation of each part is
While visually confirming the measurement values of the pressure gauge 7 and the pressure gauge 42,
It may be controlled manually.

The medical device of the present invention has the balloon pressurizing device 1 and a balloon catheter such as the balloon catheter 100.

To pressurize the inside of the balloon 130 with such a balloon pressurizing device 1, first, the pressurizing means 4 is operated. As a result, the pressure inside the reservoir 3 is increased, and the pressure acting on the balloon 130 (pressure measured by the pressure gauge 7) is increased via the working fluid in the circulation path 5, the flow path 11 and the lumen 111. It rises to a constant pressure P ₀ (see FIG. 4).

By this pressurization, the balloon 130 is expanded, and the surface of the balloon 130 is brought into close contact with the inner surface of the lesion site. As a result, the vibration of the balloon 130 generated thereafter can be more reliably transmitted to the lesion site, and the lesion site can be expanded to some extent.

Initial pressure P before vibration of the balloon 130
_{Although 0} is not particularly limited, it is preferably 6 to 20 atm, and more preferably 8 to 16 atm.

When the initial pressure P ₀ is less than the lower limit value,
Depending on the conditions and cases of the balloon catheter 100,
The surface of the balloon 130 may not sufficiently adhere to the inner surface of the lesion site.

If the initial pressure P ₀ exceeds the upper limit value, the lesion site may be excessively expanded depending on the condition of the balloon catheter 100, the case, etc.

After pressurizing means 4 pressurizes the inside of reservoir 3 and balloon 130 in this way, pressure varying means 6 is operated. As a result, the pulsating flow (unsteady flow) generated by the pressure fluctuation means 6 causes a pulsed pressure to act in the balloon 130, and the pressure acting in the balloon 130 is maximum (maximum) pressure P ₁ and minimum (minimum). ) It periodically fluctuates with the pressure P ₂ (see FIG. 4).

In FIG. 4, the initial pressure P₀Is the maximum (pole
Large) Pressure P₁And minimum (minimum) pressure P _TwoTo the size between
Has become (P₁> P₀> P_Two) Is not limited to this, but P
₁= P₀Or P_Two= P₀May be

By pressurizing the inside of the balloon 130 in such a manner that the pressure inside the balloon 130 fluctuates periodically, the balloon 130 in the expanded state periodically undergoes relatively small expansion / contraction. repeat. In other words,
In the expanded state, the outer diameter of the balloon 130 periodically fluctuates between a relatively small outer diameter and a relatively large outer diameter. That is, the balloon 130 vibrates.

As described above, in the present invention, the balloon 130 is used.
Expands the lesion while vibrating. As a result, the following effects are obtained.

Reduction of Damage to Lesion Site due to Expansion by Balloon In the present invention, damage associated with expansion of the lesion site can be reduced. That is, it is possible to uniformly apply a mechanical stretch stimulus due to the expansion of the balloon 130 in the circumferential direction of the lesion site, and the mechanical stretch stimulus is concentrated (stress concentration) in a part of the lesion site in the circumferential direction. Since it does not occur, it is possible to prevent damage such as causing minute tears in the tissue at the lesion site.

Prevention of Restenosis, Delayed Thrombosis, etc. After Treatment In the present invention, unlike the normal dilatation method, since the entire circumference is uniformly loosened without degenerating the vascular tissue, the smooth muscle tissue constituting the blood vessel is Contributes to the rearrangement of (cells). As a result, it is possible to effectively prevent restenosis, delayed thrombosis, etc. due to hyperproliferation of vascular smooth muscle after treatment.

That is, at the stenosis site, as can be seen from the cross-sectional pathological image, the hyperproliferated vascular smooth muscle is not in the circularly running arrangement of normal smooth muscle tissue but in a disordered form. There is. This indicates a situation in which the smooth muscle running in a circle loses its elasticity due to arteriosclerosis and cannot repeat extension / contraction following the pulsating blood flow.

In the present invention, for such a stenotic site,
The vibration of the balloon 130 expands while applying a stretching / contracting stimulation (circumferential direction) in a ring-like manner, thereby assisting in-vivo repair force and arranging the vascular smooth muscles in an originally normal ring-like arrangement. Can promote rearrangement. In this way, it is clear from the rehabilitation treatment of muscle strength recovery that the ordered rearrangement of the tissue is promoted by applying the mechanical (mechanical) stimulation matched with the arrangement of the muscle tissue.

From the above, restenosis due to hyperproliferation of vascular smooth muscle, delayed thrombosis and the like are effectively prevented, and the muscular force for retaining the lumen at the lesion site is strengthened, so that the lumen of the blood vessel is almost It can be restored to a circular shape.

Improvement of Efficiency of Penetration of Substance into Lesion Site In the present invention, the local permeability of the lesion site is enhanced by vibration of the balloon 130, and substances such as drugs in blood penetrate the lesion site with high efficiency. And local treatment is possible.

Here, conventionally, a substance (medicine) to the lesion site
Built-in ultrasonic oscillator as a device to enhance the penetration effect,
There is a catheter that vibrates a lesion site by the ultrasonic waves generated by the ultrasonic oscillator (hereinafter referred to as "ultrasonic catheter"), but this catheter has the following drawbacks.

In the ultrasonic catheter, it is necessary to incorporate a relatively large ultrasonic oscillator for generating ultrasonic waves having a long wavelength in order to sufficiently vibrate the lesion site, and it is difficult to miniaturize it.

In the above-mentioned ultrasonic catheter, ultrasonic waves directly act on vascular smooth muscle cells to form micropores in the cell membrane to allow penetration of substances such as drugs, resulting in damage to cells (cells). Is large and stimulates smooth muscle. As a result, smooth muscle cells tend to proliferate and restenosis is likely to occur.

In the above ultrasonic catheter, a separate vascular dilatation catheter (balloon catheter) must be used for dilation treatment of a stenosis site, which requires complicated procedures, requires a long working time, and is a burden on the patient. Is also big.

On the other hand, according to the present invention, a high substance (drug) penetrating effect at the lesion site can be obtained without causing the problems of the ultrasonic catheter.

As a method of supplying the drug to the lesion site,
For example, as described in Japanese Patent Application Laid-Open No. 8-98893, a balloon carrying a drug or a balloon having a function of releasing a drug and having a balloon also having a function of expanding a lesion site It may be performed simultaneously with the expansion and vibration of the lesion site using a catheter,
It may be performed independently by using a drug delivery catheter that is separate from the lesion site expansion catheter.

The frequency of pressure fluctuation acting on the balloon 130 is not particularly limited, but is preferably 10 to 100 Hz, and more preferably 30 to 50 Hz.

When the frequency of the pressure fluctuation acting in the balloon 130 is in such a range, the smooth muscle cells (cells) have substantially no effect, and only the intercellular matrix expands and contracts, thereby The effects described above can be obtained while more reliably preventing the destruction and damage of the (cell).

If the frequency of the pressure fluctuation acting on the balloon 130 is less than the lower limit value, depending on other conditions,
The above-mentioned effects may not be sufficiently obtained.

If the frequency of pressure fluctuation acting on the balloon 130 exceeds the upper limit value, cells may be damaged depending on other conditions.

Further, it is preferable that the frequency of the pressure fluctuation acting on the balloon 130 can be set in a multiple of 10 Hz, such as 10 Hz, 20 Hz, 30 Hz .... In terms of neurophysiology, it is said that when a frequency that is a multiple of 10 Hz is applied to a nerve, the action exerted on nerve tissue is increased.

The difference (pressure fluctuation width) between the maximum (maximum) pressure P ₁ and the minimum (minimum) pressure P ₂ in the pressure fluctuation acting on the balloon 130 is not particularly limited, but is 1 to 5 at.
It is preferably m, and more preferably 2-3 atm.

The balloon pressurizing device and the medical device of the present invention have been described above with reference to the illustrated embodiments, but the present invention is not limited to this, and each part constituting the balloon pressurizing device and the medical device is , And can be replaced with an arbitrary structure that can exhibit the same function.

For example, the pressurizing means may not be divided into the boosting means and the pressure fluctuating means, and may have a function of boosting and a function of generating pressure fluctuation.

Further, for example, the arrangement of the working fluid circulation passage may be different, or the working fluid may not be provided.

Further, according to the present invention, the balloon is vibrated while the stent (the indwelling device for securing the inner diameter of the blood vessel) is placed on the balloon of the balloon catheter, and the lesion site is vibrated through the stent. It may be that.

[0095]

As described above, according to the present invention, the lesion site of the lumen can be expanded without damaging the lesion site, and restenosis after treatment, delayed thrombosis, etc. Can be prevented.

Further, the penetration efficiency of the substance (drug) into the lesion site can be improved, and the lesion site can be concentrated and treated.

[Brief description of drawings]

FIG. 1 is an overall view showing an embodiment of a balloon pressurizing device and a medical device of the present invention.

FIG. 2 is an overall view showing an example of a balloon catheter.

3 is a vertical cross-sectional view of a balloon in the balloon catheter shown in FIG.

FIG. 4 is a graph showing the pressure acting in the balloon.

[Explanation of symbols]

1 Balloon pressurizing device 11 flow paths 12 ports 2 connection 3 storage 4 boosting means 41 syringe 42 pressure gauge 5 circuit 51 First flow path 52 Second channel 6 Pressure fluctuation means 7 Pressure gauge 8 valves 10 Control means 100 balloon catheter 110 outer tube 111 lumens 120 inner tube 121 lumens 122 Tip opening 130 balloon 131 Inside 140 branch hub 141, 142 ports 150 markers

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Claims (13)

[Claims] 1. A connection part capable of connecting a proximal end opening part of the balloon lumen of a balloon catheter having a balloon expandable / contractible by a working fluid and a balloon lumen communicating with the inside of the balloon, and to the connection part. A pressurizing means for pressurizing the inside of the balloon of the connected balloon catheter via the working fluid, wherein the pressurizing means expands the balloon,
A balloon pressurizing device which pressurizes the inside of the balloon so that the pressure inside the balloon periodically changes. 2. The balloon pressurizing device according to claim 1, further comprising a circulation path through which the working fluid circulates. 3. The pressurizing means includes pressure increasing means for pressurizing the inside of the balloon to a constant pressure, and pressure changing means for generating a periodic pressure change from the constant pressure obtained by the pressure increasing means. 1. The balloon pressurizing device according to 1 or 2. 4. The inside of the balloon is set to 6 by the pressurizing means.
The balloon pressurizing device according to claim 3, which pressurizes to about 20 atm. 5. The balloon pressurizing device according to claim 1, wherein a cycle of pressure fluctuation acting on the balloon is 10 to 100 Hz. 6. The balloon pressurizing device according to claim 5, wherein the cycle of pressure fluctuations acting on the balloon can be set in multiples of 10 Hz. 7. The balloon pressurizing device according to claim 1, wherein the difference between the maximum pressure and the minimum pressure in the periodic pressure fluctuation acting on the balloon is 1 to 5 atm. 8. The balloon pressurizing device according to claim 1, further comprising a pressure monitor means for monitoring the pressure of the working fluid. 9. A storage part for storing the working fluid, a pressure increasing means for pressurizing the inside of the storage part, a circulation path of the working fluid formed via the storage part, and a midway of the circulation path. 9. The balloon pressurizing device according to claim 1, further comprising a pressure fluctuation means for generating a pressure fluctuation of the working fluid. 10. The balloon pressurizing device according to claim 9, further comprising flow rate adjusting means for adjusting the flow rate of the working fluid in the middle of the circulation path. 11. The balloon pressurizing device according to claim 9, wherein the pressure changing means is a pump capable of forming a pulsating flow. 12. The balloon pressurizing device according to claim 9, wherein a flow path of the working fluid to the connection portion is provided so as to be branched from the circulation path. 13. A medical device comprising the balloon pressurizing device according to claim 1 and a balloon catheter connected thereto.