WO2009153973A1

WO2009153973A1 - Rectal catheter and penetration-enhancing system for enema drug

Info

Publication number: WO2009153973A1
Application number: PCT/JP2009/002731
Authority: WO
Inventors: 久米恵一郎
Original assignee: 学校法人産業医科大学
Priority date: 2008-06-19
Filing date: 2009-06-16
Publication date: 2009-12-23

Abstract

Provided is a penetration-enhancing system for an enema drug whereby an enema drug can be conveniently infused into the intestine and diffused and penetrated throughout the target lesion site. A rectal catheter comprising a catheter body (2), an extraanal balloon (3), an intraanal balloon (4) and an intestinal balloon (20) each provided on the side face of the body (2), wherein air-inlet/outlet channels (8, 9, 21) and a drug injection channel (5) are formed within the body (2). An inflatable vibrating balloon (19) is located between the intraanal balloon (4) and the intestinal balloon (20). Within the body (2), a vibrating air-channel (17), through which air that is capable of loading a dynamic air pressure change on the vibrating balloon (19) and thus allowing the vibration of the vibrating balloon (19) passes, is formed. Owing to the vibration of the vibrating balloon (19), the enema drug is allowed to penetrate the intestinal wall.

Description

Rectal catheter and enema penetration promotion system

The present invention is intended to promote penetration of an enema into the intestine by injecting a drug to be injected transanally (hereinafter referred to as “enema”) into the rectum and applying mechanical stimulation. The present invention relates to a rectal catheter and an enema penetration promotion system.

Among chronic intestinal diseases based on ulcerative colitis, there are intractable diseases that repeat relapse and remission. These enteric diseases are maintained in remission by applying or combining nutritional therapy, oral drugs, injections, and enemas alone.

Among these, an enema that exerts its effect by directly contacting and infiltrating the rectum or large intestine is affected by the application effect depending on the contact area, contact pressure, and contact time between the drug and the affected area. If bowel therapy, which is a local treatment using an enema, succeeds in intestinal diseases, it becomes possible to treat intestinal diseases without using systemic oral drugs or injections. Naturally, local treatments have significantly fewer side effects than systemic medications, so it is beneficial for patients to be successful only with local treatments.

However, when an enema is injected into the rectum, an anal canal reflex that results in physiological discharge of feces, gas, etc. occurs. Therefore, in enema therapy with an enema, there is a problem that the enema cannot stay in the intestinal tract for a long time after enema due to the anal canal reflex. Further, in order to bring the enema into contact with the affected area, it is necessary to adjust the position of the patient so that the enema reaches the target site. However, there is a problem that when the body position cannot be changed well, the medicine cannot be widely distributed.

Therefore, in enema therapy, how to keep the enema for a long time in the intestinal tract and spread the medicine over a wide area is an important issue.

Conventionally, a rectal catheter has been used as a medical device for transanally injecting a drug into the rectum (see Non-Patent Document 1, for example). There are two types of rectal catheters used for injecting medicinal solution and those used for assisting defecation. The former is related to the present invention.

As rectal catheters used for medicinal solution injection, those described in Non-Patent Document 1 and Patent Documents 1-5 are known. These rectal catheters pass a lumen for injecting medicinal solution (hereinafter referred to as “infusion lumen”), a lumen for excreting excrement such as feces (hereinafter referred to as “excretion lumen”), and air. And a catheter tube 2 which is a multi-lumen tube having a lumen (hereinafter referred to as “ventilation lumen”) for the purpose. This catheter tube 2 is flexible so that the entire tube is bendable and does not damage the patient when the tube is inserted into the patient. Therefore, a flexible polystyrene elastomer resin is coated with a silicone emulsion or fluororesin. Used. In the catheter tube 2, the end to be inserted into the patient is referred to as “distal end”, and the opposite end is referred to as “proximal end”.

FIG. 22 is a view showing the rectal catheter 100 described in Non-Patent Document 1 and Patent Documents 2-5. These rectal catheters 100 are mainly used for injecting a contrast medium such as barium liquid or a drug solution into the rectum.

Near the central part of the catheter tube 2 or on the distal end side of the central part, an expandable / contractible rubber external anal balloon 3 is provided around the catheter tube 2, and close to the external anal balloon 3 of the catheter tube 2. An intraanal balloon 4 made of rubber that can be expanded and contracted is provided around the distal end side of the anus balloon 3 at a predetermined interval. Further, as shown in FIG. 22 (b), lumens of an injection lumen 5, a discharge lumen 6, a ventilation lumen 7, and balloon injection /

exhaust lumens

8 and 9 are formed in the catheter tube 2. A hollow frustum-shaped tip cap 10 is attached to the tip of the catheter tube 2. Two

side holes

10a and 10b are formed in the side surface of the tip cap 10 so as to face each other (see Patent Document 5 and FIG. 1). An air injection tube 11, a chemical solution injection tube 12, an excretion tube 13, and

balloon inflation tubes

14 and 15 are connected to the proximal end of the catheter tube 2.

The injection lumen 5 is a lumen for injecting a contrast medium into the intestine, and one end opens to the distal end face in the distal end cap 10 at the distal end of the catheter tube 2 (see Patent Document 5 and FIG. 1). ), And the other end communicates with the drug solution injection tube 12 provided at the proximal end of the catheter tube 2. The excretory lumen 6 is a lumen for excreting extra excretion in the intestine such as contrast medium and intestinal contents, and one end is opened at the distal end face in the tip cap 10 at the distal end of the catheter tube 2. However, the other end communicates with the excretion tube 13 provided at the proximal end of the catheter tube 2. The ventilation lumen 7 is a lumen for injecting air into the intestine, and one end opens to the distal end face in the distal end cap 10 at the distal end of the catheter tube 2 (see Patent Document 5 and FIG. 1). The other end communicates with the excretion tube 13 provided at the proximal end of the catheter tube 2. The balloon injecting and

exhausting lumens

8 and 9 are lumens for injecting and exhausting air for inflating and deflating the extra-anal balloon 3 and the intra-anal balloon 4, respectively, and one end is respectively an

extra-anal balloon

3, 3. It opens to the side of the catheter tube 2 in the intraanal balloon 4 (

openings

8a, 9a), and the other ends communicate with

balloon inflation tubes

14, 15 connected to the proximal end of the catheter tube 2, respectively. .

When the rectal catheter 100 is inserted into the rectum from the anus, first, a lubricant such as xylocaine jelly or olive oil is applied as a lubricant to a portion to be inserted into the rectum such as the tip cap 10. Next, with the test subject in the lateral position, the catheter tube 2 is inserted into the anus about 5 cm from the distal end. Next, after confirming that the intraanal balloon 4 has been completely inserted into the anus, about 30 cc of air is injected from the balloon inflation tube 15 into the intraanal balloon 4 to inflate the intraanal balloon 4. After the intraanal balloon 4 is inflated, about 20 cc of air is injected from the balloon inflation tube 14 into the external anus balloon 3 to inflate the external anus balloon 3. As a result, the catheter tube 2 is fixed in the anal canal of the subject, the insertion of the catheter tube 2 is prevented, and the anus where the catheter tube 2 is inserted is sealed.

Next, the intestinal contents remaining in the intestine are aspirated and excreted from the excretory tube 13. Next, the operation of injecting an appropriate amount of contrast medium or drug into the intestine from the drug solution injection tube 12 and injecting the appropriate amount of air from the air injection tube 11 into the intestine is repeated several times while changing the posture of the subject, and the contrast medium or drug is injected. Spread enough in the intestines. Finally, after the chemical solution injection tube 12 is blocked with a slide clip or the like, excretion in which excess contrast medium or the like and intestinal contents are mixed is aspirated and excreted from the excretion tube 13. In this way, the drug solution can be injected into the intestine.

On the other hand, Patent Document 1 describes a rectal catheter 101 in which an intestinal balloon 20 for fixing the catheter tube 2 in the rectum is provided around the distal end of the catheter tube 2. FIG. 23 is a view showing a rectal catheter 101 described in Patent Document 1. As shown in FIG.

In the rectal catheter 101, the catheter tube 2, the extraanal balloon 3, the intraanal balloon 4, the injection lumen 5, the ventilation lumen 7, the balloon injection / exhaust lumen 8, the tip cap 10, the

side holes

10a and 10b, the air injection tube 11, the drug solution The injection tube 12 and the

balloon inflation tubes

14 and 15 are the same as in FIG. The rectal catheter 101 is further provided with a rubber intestine balloon 20 that can be expanded and contracted around the distal end of the catheter tube 2 to fix the catheter tube 2 in the rectum. In addition to the liquid injection lumen 5, the ventilation lumen 7, and the balloon injection /

exhaust lumens

8, 9, a balloon injection / exhaust lumen 21 and two

excretory lumens

6a, 6b are formed in the catheter tube 2. Further, at the proximal end of the catheter tube 2,

excretion tubes

13 a and 13 b communicating with the

respective excretion lumens

6 a and 6 b and a balloon inflation tube 22 communicating with the balloon injecting and exhausting lumen 21 are connected.

The

excretory lumens

6a and 6b are lumens for excreting extra intestinal contrast media and excrement such as intestinal contents. The excretion lumen 6a is provided in the distal end cap 10 at the distal end of the catheter tube 2. The excretory lumen 6b is opened on the side surface of the catheter tube 2 between the intraanal balloon 4 and the intestinal balloon 20. The injection lumen 5 is also opened on the side surface of the catheter tube 2 between the intraanal balloon 4 and the intestinal balloon 20.

The balloon injecting / exhausting lumen 21 is a lumen for injecting / extracting air for inflating and deflating the intestinal balloon 20, and one end opens on the side of the catheter tube 2 in the intestinal balloon 20, The other end communicates with a balloon inflation tube 15 provided at the proximal end of the catheter tube 2.

Thus, by providing the intestinal balloon 20, by inserting the catheter tube 2 into the rectum and inflating and fixing the external anus balloon 3 and the intraanal balloon 4 and then inflating the intestinal balloon 20, The distal end of the catheter tube 2 can be fixed in the intestine.

Patent Document 6 proposes an ultrasonic coating penetration enhancer that vibrates the sponge member with ultrasonic waves in order to promote the penetration of the coating agent that directly applies the sponge member to the affected area in the region of the coating agent on the skin. Has been.

Further, Patent Document 7 proposes a palisater-type washing machine for washing clothes by rotating a rotating blade provided at the bottom of a water tank.

Further, Patent Document 8 proposes a magnetic stirrer that can stir a sample by rotating a magnetic stirrer in a laboratory instrument such as a beaker.

Further, Patent Document 9 proposes a catheter with a balloon that is devised so that the contrast medium to be injected is not discharged during the X-ray examination of the rectum / large intestine with a contrast medium such as barium.

JP-A-10-179750 JP 2005-143519 A JP 2004-357846 A JP 2003-190298 A JP 2002-153564 A JP 2005-215923 A Japanese Patent Laid-Open No. 2007-50059 JP 2008-68229 A JP 2005-143519 A

By the way, in the case of an enema applied to a chronic intestinal disease such as ulcerative colitis, the patient needs to inject the enema regularly into the rectum. In this case, the patient himself needs to enemate using a rectal catheter. However, when using a conventional rectal catheter, there are the following problems.

(1) After enema is injected into the rectum, it is necessary to spread the enema over the entire lesion in the intestine. Therefore, in order to spread the enema from the rectum to the entire surface of the lower part of the large intestine, the patient must change the position while the rectal catheter is inserted into the rectum. This is painful for the patient. Moreover, if the body position is not changed well, the enema cannot be distributed throughout the lesion site.

(2) After the enema is injected into the rectum, the enema is effective by sufficiently penetrating the intestinal lesion site. However, when a conventional rectal catheter is used, the means for penetrating the enema is performed by changing the patient's body position, and the enema does not sufficiently penetrate the lesion site. Therefore, sufficient efficacy of enema is not obtained.

Therefore, an object of the present invention is to allow the patient to easily enema the enema, easily spread the enema over the entire lesion site, and sufficiently penetrate the enema into the lesion site. It is an object to provide a rectal catheter and an enema penetration promoting system.

A first configuration of a rectal catheter according to the present invention is a rectal catheter for injecting an enema into the intestine,
A catheter body in which a drug solution injection path is formed;
An inflatable and expandable external anus balloon disposed at a site on the side of the catheter body;
An inflatable and inflatable anal balloon disposed in the vicinity of the extra-anal balloon in a portion of the side of the catheter body on the distal end side of the external anus balloon;
Inside the catheter body, there is formed a balloon injecting / exhausting passage for injecting / extracting air for inflation / deflation to each of the balloon outside the anus and the balloon inside the anus.
A stirring and exciting mechanism for stirring or shaking the liquid outside the side surface of the catheter body is provided on the distal end side of the catheter body on the distal side of the intraanus balloon.

According to this configuration, when a drug solution is locally administered to a lesion site in the intestine, the catheter body is inserted into the rectum from the anus, and the catheter is inflated by supplying air to the intraanal balloon and the anus balloon as necessary. Fix the body. Next, the drug solution is injected into the intestine from the drug solution injection path, and the drug solution is filled in the intestinal tract near the lesion site. In this state, the agitating / vibrating mechanism is used to stir or vibrate the drug solution outside the side of the catheter body ahead of the intraanal balloon (back side of the intestinal tract). Thereby, the pressure and osmotic force at which the drug solution directly contacts the mucous membrane in the intestine can be increased. In addition, since the anal canal can be sealed by the intraanal balloon and the external anus balloon, the discharge of the drug solution by the anal canal reflex is prevented. In addition, since the drug solution is vibrated and stirred in the intestinal tract by the stirring and shaking mechanism, the patient can reliably distribute the drug solution throughout the lesion site without changing the position with the rectal catheter inserted into the rectum. Can do.

A second configuration of a rectal catheter according to the present invention includes an inflatable and inflatable enteric balloon disposed in one part of a side surface near the distal end of the catheter body in the first configuration,
Inside the catheter body, the balloon injection / exhaust passage for injecting / extracting air for inflation / deflation to each of the extra-anal balloon, the intra-anal balloon, and the intestinal balloon is formed,
One end of the medicinal solution injection path is open on the side of the catheter body in the middle between the intraanal balloon and the intestinal balloon,
The stirring / vibrating mechanism stirs or vibrates the liquid outside the side surface of the catheter main body between the intraanal balloon and the intestinal balloon.

According to this configuration, the catheter body is fixed by inflating by supplying air to the intraanal balloon and the external balloon, and further, the distal end of the catheter body is also in the intestinal tract by inflating by supplying air to the intestinal balloon. Can be fixed. Then, in the state where the drug solution is injected into the intestine from the drug solution injection path and the drug solution is filled in the intestinal tract near the lesion site, the side wall of the catheter main body between the intraanal balloon and the enteral balloon is used by using a stirring and shaking mechanism. By stirring or shaking the outer chemical solution, it is possible to locally press and infiltrate the chemical solution into the lesion site of the rectum.

A third configuration of the rectal catheter according to the present invention is the first or second configuration, wherein the stirring and exciting mechanism is
An inflatable / deflatorable excitation balloon disposed at a site on the distal end side of the intra-anal balloon on the side surface of the catheter body;
And an excitation air passage formed inside the catheter body, through which air for dynamically changing air pressure on the excitation balloon and air-vibrating the excitation balloon flows.

According to this configuration, when a drug solution is locally administered to a lesion site in the intestine, the catheter body is inserted into the rectum from the anus, and the catheter is inflated by supplying air to the intraanal balloon and the anus balloon as necessary. Fix the body. Next, the drug solution is injected into the intestinal tract from the drug solution injection path, and the drug solution is filled in the intestinal tract near the lesion site. In this state, the vibration balloon is pneumatically vibrated from the vibration air path. Thereby, the chemical | medical solution with which the intestinal tract was filled is vibrated, and the pressure and osmotic force which a chemical | medical solution directly contacts the mucous membrane in an intestinal tract can be improved. Moreover, since the structure of the stirring and vibrating mechanism is simple, it can be manufactured easily and inexpensively, and handling is also simple. In addition, since the drug solution is shaken and agitated in the intestinal tract by the expansion and contraction of the vibration balloon, the patient can reliably spread the drug solution to the entire lesion site without changing the position with the rectal catheter inserted into the rectum. Can be made.

In a fourth configuration of the rectal catheter according to the present invention, in the second configuration, the stirring and exciting mechanism is
An inflatable / deflatorable excitation balloon disposed at a site on the distal end side of the intra-anal balloon on the side surface of the catheter body;
An excitation air passage formed inside the catheter body, through which air for dynamically exchanging air pressure is exerted on the excitation balloon and air for exciting the excitation balloon flows,
The vibration balloon is characterized in that the maximum diameter when inflated is smaller than the maximum diameter when the intraanal balloon and the intestinal balloon are inflated.

This configuration prevents the vibration balloon from coming into direct contact with the inner wall of the intestine and prevents damage to the intestinal mucosa.

The fifth configuration of the rectal catheter according to the present invention is characterized in that, in the first or second configuration, the stirring and agitating mechanism is an ultrasonic transducer attached to a distal end of the catheter body.

According to this configuration, when a drug solution is locally administered to a lesion site in the intestine, the catheter body is first inserted from the anus into the rectum, and the drug solution is injected into the intestinal tract from the drug solution injection path. In this state, the ultrasonic vibrator is vibrated, and the vibration is transmitted to the drug solution filled in the intestinal tract. Thereby, the pressure and osmotic force at which the drug solution directly contacts the mucous membrane in the intestine can be increased.

According to a sixth configuration of the rectal catheter according to the present invention, in the first or second configuration, the stirring and exciting mechanism is provided at a distal end side of the catheter body near the intraanus balloon or on a distal end of the catheter body. It is a ring-shaped stirring blade that is rotatably mounted and driven to rotate by an external force.

According to this configuration, when a drug solution is locally administered to a lesion site in the intestine, the catheter body is first inserted from the anus into the rectum, and the drug solution is injected into the intestinal tract from the drug solution injection path. In this state, by rotating the stirring blade, the drug solution filled in the intestinal tract is agitated, and the pressure / osmotic force at which the drug solution directly contacts the mucous membrane in the intestine can be increased.

Here, “rotation driven by an external force” means driving by a driving force by a motor or a magnetic force by a rotating magnetic field, for example.

A seventh configuration of a rectal catheter according to the present invention is characterized in that, in the sixth configuration, an annular motor is mounted on the catheter body and rotationally drives the stirring blade.

The eighth configuration of the rectal catheter according to the present invention is characterized in that, in the sixth configuration, the stirring blade is a magnetic stirring bar and can be driven to rotate by a magnetic stirrer.

According to a ninth configuration of the rectal catheter according to the present invention, in any one of the first to eighth configurations, the side of the catheter main body on the distal end side of the intraanal balloon communicates with the drug solution injection path. A plurality of side holes are formed.

With this configuration, the chemical solution spreads from the plurality of side holes into the intestinal tract and can be diffused over a wide range when the chemical solution is injected.

According to a tenth configuration of the rectal catheter of the present invention, in the ninth configuration, the catheter body can be freely inserted into and removed from a hollow tubular catheter sheath whose distal end is a blind end, and a tube of the catheter sheath. A hollow tube attached to the catheter tube, and the inside of the tube is constituted by the catheter tube serving as the drug solution injection path,
The plurality of side holes penetrating the side surface of the catheter sheath;
Each side hole is blocked by the catheter tube by moving the catheter tube into and out of the catheter sheath.

In this case, in the state where the distal end of the catheter sheath is a blind end, a plurality of side holes are penetrated through the side of the catheter sheath, and the catheter tube is inserted into the catheter sheath to the maximum, all the side holes are blocked, Each side hole can be closed / opened by moving the catheter tube in and out. Thereby, by adjusting the length of the catheter tube inserted into the catheter sheath, the opening and closing of the distal end of the drug solution injection path can be freely adjusted.

The eleventh configuration of the rectal catheter according to the present invention is characterized in that, in any one of the first to ninth configurations, the catheter body is composed of a catheter tube formed by molding a flexible member.

Thus, handling is facilitated by configuring the catheter body with an integral catheter tube.

The twelfth configuration of the rectal catheter according to the present invention is characterized in that, in the tenth or eleventh configuration, a medicinal capsule enclosing a medicinal solution is formed at the proximal end of the catheter tube.

Thereby, the rectal catheter can be made completely disposable (disposable), and a rectal catheter that can be used easily and hygienically at home can be provided.

Here, as the “medicinal sac”, an ampoule container that can be expanded and contracted by a ball protector, a bellows, and an ampoule container capable of extruding a chemical solution such as a syringe can be used.

A first configuration of the enema penetration promoting system according to the present invention includes a rectal catheter having the third or fourth configuration,
An exciting air tube having one end connected to the proximal end side of the rectal catheter in communication with the exciting air path;
Pneumatic excitation that is connected to the other end of the excitation air tube and that dynamically changes the air pressure on the excitation balloon through the excitation air tube and the excitation air passage, thereby exciting the excitation balloon pneumatically. And a device.

A second configuration of the enema penetration promoting system according to the present invention includes the rectal catheter of the eighth configuration,
And a rotating magnetic field generator for generating a rotating magnetic field for generating a rotational driving force in the magnetic stirrer.

The third configuration of the enema penetration promotion system according to the present invention is an enema penetration promotion system that injects an enema into the intestine and promotes the penetration of the enema into the intestine.
A catheter body with a chemical solution injection path formed inside,
An expandable / collapseable anus balloon disposed on one side of the side of the catheter body,
And an intra-anally expandable / collapseable anal balloon disposed in the vicinity of the extra-anal balloon at a portion of the side of the catheter main body on the distal end side of the extra-anal balloon,
In the inside of the catheter body, a rectal catheter in which a balloon injecting / extracting passage for inflating and inflating air for inflation / deflation is formed in each of the external balloon and the intraanal balloon;
And an ultrasonic transducer that can be inserted into and removed from the catheter body and can be inserted to the vicinity of the distal end of the catheter body.

According to this configuration, when a drug solution is locally administered to a lesion site in the intestine, the catheter body is first inserted from the anus into the rectum, and the drug solution is injected into the intestinal tract from the drug solution injection path. In this state, the ultrasonic transducer is inserted into the catheter body and installed near the distal end of the catheter body. And an ultrasonic transducer | vibrator is vibrated and the vibration is transmitted to the chemical | medical solution with which the intestinal tract was filled through the tube wall of a catheter main body. Thereby, the pressure and osmotic force at which the drug solution directly contacts the mucous membrane in the intestine can be increased.

As described above, according to the rectal catheter and the enema penetration promotion system of the present invention, the drug solution filled in the intestinal tract is vibrated by pneumatically exciting the vibration balloon, and the drug solution is applied to the mucous membrane in the intestinal tract. The direct contact pressure and osmotic force can be increased. This makes it possible to sufficiently increase the utility of the chemical solution.

In addition, since the drug solution is shaken and agitated in the intestinal tract by the expansion and contraction of the vibration balloon, the patient can reliably spread the drug solution to the entire lesion site without changing the position with the rectal catheter inserted into the rectum. Can be made.

As a result, it is possible to treat diseases such as ulcerative colitis by reducing or stopping the use of oral drugs or injections with strong side effects, or by not using them due to the increased effect of enema.

It is the front view (a) of the rectal catheter 1 which concerns on Example 1 of this invention, AA arrow sectional drawing (b), and the front view (c) of

connector

14a, 15a, 22a. FIG. 3 is a diagram for explaining how to use the rectal catheter 1 according to the first embodiment. FIG. 3 is a diagram for explaining how to use the rectal catheter 1 according to the first embodiment. FIG. 3 is a diagram for explaining how to use the rectal catheter 1 according to the first embodiment. FIG. 3 is a diagram for explaining how to use the rectal catheter 1 according to the first embodiment. FIG. 3 is a front view (a) of a rectal catheter 1 according to Embodiment 2 of the present invention, a front view (b) of a catheter tube 2, and a cross-sectional view taken along line AA (c). FIG. 6 is a diagram for explaining how to use the rectal catheter 1 according to the second embodiment. FIG. 6 is a diagram for explaining how to use the rectal catheter 1 according to the second embodiment. FIG. 6 is a diagram for explaining how to use the rectal catheter 1 according to the second embodiment. FIG. 6 is a diagram for explaining how to use the rectal catheter 1 according to the second embodiment. It is the front view (a) of the rectal catheter 1 which concerns on Example 3 of this invention, and the perspective view (b) of a stirring vibration excitation mechanism. It is the front view (a) of the rectal catheter 1 which concerns on Example 4 of this invention, and the perspective view (b) of a stirring vibration excitation mechanism. It is a figure explaining the usage method of the rectal catheter 1 which concerns on Example 4. FIG. They are the front view (a) of the rectal catheter 1 of the enema penetration promotion system concerning Example 5 of this invention, the front view (b) of the catheter tube 2, and the front view (c) of the ultrasonic vibration apparatus 65. FIG. 10 is a diagram for explaining how to use the rectal catheter 1 according to Example 5; It is the front view (a) of the rectal catheter 1 which concerns on Example 6 of this invention, the front view (b) of the catheter tube 2, and AA arrow directional cross-sectional view (c). It is a figure showing the use condition of the rectal catheter 1 used with the enema penetration promotion system concerning Example 7 of the present invention. It is a figure showing the ultrasonic vibration apparatus 18 used with the enema penetration promotion system concerning Example 7 of the present invention. It is a figure showing the structure of the rectal catheter 1 which concerns on Example 8 of this invention. It is a figure showing the structure of the enema penetration promotion system which concerns on Example 9 of this invention. It is a figure showing the structure of the rectal catheter 1 which concerns on Example 10 of this invention. 1 is a view showing a rectal catheter 100 described in Non-Patent Document 1 and Patent Documents 2-5. 1 is a view showing a rectal catheter 101 described in Patent Document 1. FIG.

Hereinafter, the best mode for carrying out the present invention will be described with reference to the drawings.

FIG. 1 is a front view (a) of a rectal catheter 1 according to Example 1 of the present invention, a cross-sectional view taken along line AA (b), and a front view (c) of

connectors

14a, 15a, 22a.

The main body of the rectal catheter 1 of this embodiment is constituted by a catheter tube 2 which is a multi-lumen tube. This catheter tube 2 is made of an elastomer resin such as polystyrene, polypropylene, polyacetal, polyethylene, polyester, polycarbonate, polyurethane, polyamide, polyvinyl chloride or the like, or a silicone emulsion, fluororesin (PTFE (polyethylene). Tetrafluoroethylene (tetrafluoroethylene), PFA (tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer), FEP (tetrafluoroethylene / hexafluoropropylene copolymer (4.6 fluoride)), etc.) The material used is used as a material and is flexible.

The outer anus balloon 3 is disposed so as to surround the side surface part at one site near the central part or the distal end of the side surface of the catheter tube 2. An intraanal balloon 4 is disposed at one site on the side of the catheter tube 2 on the distal end side of the outer anus balloon 3 so as to be adjacent to the anus balloon 3 and surround the side surface. In addition, an intestinal balloon 20 is disposed at one part of the side surface near the distal end of the catheter tube 2 so as to surround the side surface part. Further, an excitation balloon 19 is disposed at one site between the intraanal balloon 4 and the intestinal balloon 20 on the side of the catheter tube 2 so as to surround the side surface. The extra-anal balloon 3, the intra-anal balloon 4, the excitation balloon 19, and the intestinal balloon 20 are configured to be freely inflatable and contractible by an elastic film such as natural rubber. Further, as shown in FIG. 1A, the vibration balloon 19 is formed such that the maximum diameter when inflated is smaller than the maximum diameter when the intraanal balloon 4 and the intestinal balloon 20 are inflated. .

As shown in FIG. 1 (b), an injection lumen 5, a discharge lumen 6, a waste fluid lumen 23, balloon injection /

exhaust lumens

8, 9, 21, and an excitation air lumen 17 are formed inside the catheter tube 2. Has been. A hollow frustum-shaped tip cap 10 is attached to the distal end of the catheter tube 2. Two

side holes

10a and 10b are formed in the side surface of the tip cap 10 so as to face each other. Further, a waste liquid tube 24, a chemical solution injection tube 12, an excretion tube 13, and

balloon inflation tubes

14 and 15 are connected to the proximal end of the catheter tube 2, and a balloon is disposed near the proximal end on the side of the catheter tube 2. The inflation tube 22 and the vibration air tube 18 are branched.

The infusion lumen 5 is a medicinal solution injecting path for injecting medicinal solution, and the distal end side is branched into a plurality of openings, each opening on the side of the catheter tube 2 between the intraanal balloon 4 and the intestinal balloon 20. . The opening 5 a of the injection lumen 5 is arranged at a predetermined interval over the entire circumference of the side surface of the catheter tube 2 and the entire length from the intraanal balloon 4 to the intestinal balloon 20. As a result, the medicinal solution is uniformly poured into the section from the intraanal balloon 4 to the intestinal balloon 20. The proximal end side of the liquid injection lumen 5 communicates with the chemical liquid injection tube 12.

Excretion lumen 6 is a discharge path for discharging excrement such as intestinal contents remaining in the intestinal tract. One end of the excretory lumen 6 is open to the end face in the distal end cap 10 at the distal end of the catheter tube 2. The other end of the excretion lumen 6 communicates with the excretion tube 13.

The waste liquid lumen 23 is a waste liquid path for discharging excess chemical liquid from the intestine after enema administration of the chemical liquid. One end of the waste liquid lumen 23 is opened on the side of the catheter tube 2 between the intraanal balloon 4 and the intestinal balloon 20.

Balloon injection /

exhaust lumens

8, 9, 21 are balloon injection / exhaust passages for injecting / exhausting air for inflating / deflating into the external anus balloon 3, the intraanal balloon 4, and the intestinal balloon 20, respectively. One end of each of the balloon injecting and

exhausting lumens

8, 9, and 21 is open to the side of the catheter tube 2 in the extra-anal balloon 3, the intra-anal balloon 4, and the intestinal balloon 20. Further, the other ends of the balloon injecting / exhausting

lumens

8, 9, and 21 communicate with the

balloon inflation tubes

14, 15, and 22, respectively.

The excitation air lumen 17 is an excitation air passage through which air for dynamically changing the air pressure to the vibration balloon 19 and air for exciting the vibration balloon 19 flows.

Connectors

12a, 13a, and 24a with check valves are provided at the tips of the chemical injection tube 12, the excretion tube 13, and the waste liquid tube 24, respectively. The connector 12a is a one-way valve that flows in the inflow direction, and the

connectors

13a and 24a are one-way valves that flow in the outflow direction. Further,

connectors

14a, 15a and 22a with check valves are also provided at the tips of the

balloon inflation tubes

14, 15 and 22, respectively. The

connectors

14a, 15a and 22a are all one-way valves in the inflow direction. These

connectors

14a, 15a, and 22a include a pilot balloon 30, a syringe connection port 31, and a spring check valve 32, as shown in FIG. The pilot balloon 30 is composed of a balloon body that can be expanded and contracted, and is provided so that the air pressure injected into the balloon can be visually observed. The syringe connection port 31 is a port for connecting an air syringe 34 for injecting air into the balloon. The check valve 32 with a spring is a valve configured to open when an air syringe 34 is connected to the syringe connection port 31 and to close with a spring when the air syringe 34 is removed. A connector 18 a for connecting a pneumatic vibration device 35 described later is provided at the tip of the vibration air tube 18. The connector 18a is not provided with a valve.

The usage of the rectal catheter 1 configured as described above will be described below with reference to FIGS.

When the enema fluid is instilled into the rectum 41, first, as shown in FIG. 2, each balloon of the catheter tube 2 is evacuated, and an intermediate portion between the outer anus balloon 3 and the intraanus balloon 4 of the catheter tube 2 is placed. The catheter tube 2 is inserted until it is located near the anal canal 40. At this time, the distal end side of the catheter tube 2 is located in the lumen from the anal canal 40 to the rectum 41.

At this time, excrement such as intestinal contents remaining in the intestinal tract is sucked and discharged from the excretion tube 13.

Next, as shown in FIG. 3, an air syringe 34 is sequentially connected to the

connectors

14a, 15a, and 22a, and the external anus balloon 3, the intraanal balloon 4, and the intestinal balloon 20 are inflated by inflation. The extra-anal balloon 3 and the intra-anal balloon 4 are appropriately inflated so that the anal canal 40 is hermetically sealed. Further, the intestinal balloon 20 is inflated to such an extent that the rectum 41 is substantially occluded. Thereby, the catheter tube 2 is fixed so as to be approximately in the center of the rectum 41 during the pouring operation, and the vibrating balloon 19 is prevented from coming into contact with the rectal wall. It is to be noted that these air-injecting operations can be easily performed by inflating air with the pilot balloon 30 while observing the air pressure of the balloon.

Since each

connector

14a, 15a, 22a is provided with a check valve 32 with a spring, each balloon is kept inflated even after the air syringe 34 is removed.

Next, as shown in FIG. 4, an irrigation syringe 36 filled with a chemical solution is connected to the connector 12 a, and the chemical solution is irrigated into the rectum 41 through the injection lumen 5. At this time, excess gas in the rectum 41 is discharged through the excretion tube 13.

In addition, since the check valve is provided in the connector 12a, the chemical solution does not flow backward even after the irrigation syringe 36 is removed.

Next, as shown in FIG. 5, the pneumatic vibration device 35 is connected to the connector 18 a of the vibration air tube 18. The pneumatic vibration device 35 includes a vibration air tube 35a and a switch 35b, and also includes a pneumatic vibrator (not shown) for generating dynamic air pressure fluctuations therein. By connecting the vibration air tube 35a to the connector 18a and turning on the switch 35b of the pneumatic vibration device 35, the pneumatic vibrator is activated. The air pressure fluctuation generated by the pneumatic vibrator is transmitted to the vibration balloon 19 through the vibration air passage, and the vibration balloon 19 repeatedly expands and contracts. Thereby, the chemical | medical solution 42 in the rectum 41 is pneumatically shaken, and is shaken and stirred in the intestinal tract. Therefore, the patient can reliably spread the drug solution throughout the lower part of the rectum 41 including the lesion site without changing the body position. In addition, the pressure / osmotic force at which the drug solution 42 directly contacts the mucous membrane in the rectum 41 can be increased by pneumatically exciting the drug solution 42. Thereby, the utility of the chemical solution 42 can be sufficiently enhanced.

After sufficiently infiltrating the medicinal solution 42 into the mucous membrane in the rectum 41, the air of each balloon is extracted and contracted, and the used medicinal solution 42 is drained from the waste liquid tube 24. Finally, the catheter tube 2 is extracted, and all the pouring operations are completed.

FIG. 6 is a front view (a) of the rectal catheter 1 according to the second embodiment of the present invention, a front view (b) of the catheter tube 2, and a cross-sectional view taken along line AA (c). In FIG. 6, the same reference numerals are given to configurations corresponding to those in the first embodiment.

In this embodiment, the rectal catheter 1 includes a hollow tubular catheter sheath 45 and a catheter tube 2 inserted into the tube of the catheter sheath 45. The catheter sheath 45 is a multi-lumen tube made of a soft member, the catheter tube 2 is a single lumen tube, and the cross section thereof is constructed as shown in FIG.

An injection lumen 5 for injecting a chemical solution is formed inside the catheter tube 2. In the catheter sheath 45, balloon injecting / exhausting

lumens

8, 9, and 21, an excitation air lumen 17, and a catheter tube insertion lumen 25 are formed. The

balloon inflation tubes

14, 15, 22 and the excitation air tube 18 are branched from the side surface near the proximal end of the catheter sheath 45, and the balloon injection /

exhaust lumens

8, 9, 21 and the excitation air lumen 17, respectively. Communicate. The extra-anal balloon 3, the intra-anal balloon 4, the vibration balloon 19, and the intestinal balloon 20 are respectively disposed at predetermined sites on the side surface on the distal end side of the catheter sheath 45.

The distal end of the catheter sheath 45 is blocked by a special filter 46. The special filter 46 is a gas-liquid separation filter through which gas (gas) passes but liquid does not pass. For example, the special filter 46 is a repellent material such as polyolefin such as polyethylene or polypropylene, or thermoplastic fluororesin such as PTFE (polytetrafluoroethylene). An aqueous resin porous membrane (porous Teflon (registered trademark)) or the like is used. By providing this special filter 46, only intestinal gas that has moved from the mouth side by rectal reflex or peristaltic movement is discharged through the special filter 46.

Further, a plurality of side holes 47 are provided in the side surface of the catheter sheath 45 between the intraanal balloon 4 and the intestinal balloon 20. A tightening screw cylinder 48 for fastening and fixing the catheter tube 2 is screwed to the proximal end of the catheter sheath 45.

On the other hand, the distal end side of the catheter tube 2 is an open end, and the injection lumen 5 is opened at the opening 5 a at the distal end of the catheter tube 2. A connector 2 a for connecting an irrigation syringe 36 is provided at the proximal end of the catheter tube 2. Further, a scale line 2b for indicating the length inserted into the catheter sheath 45 is marked on the side surface of the catheter tube 2.

As shown in FIG. 6C, when the catheter tube 2 is inserted into the catheter tube insertion lumen 25 of the catheter sheath 45, the outer surface of the catheter tube 2 and the inner surface of the catheter tube insertion lumen 25 are substantially in close contact with each other. The liquid does not leak from the gap between the inner and outer surfaces. In order to improve the adhesion and facilitate the insertion / extraction of the catheter tube 2, the outer surface of the catheter tube 2 is coated with a lubricating film such as a silicone emulsion or a fluororesin. Thereby, the side hole 47 at each position can be smoothly closed / opened while adjusting the insertion length of the catheter tube 2 using the scale line 2b as a mark. In the state where the catheter tube 2 is inserted into the catheter sheath 45 as much as possible, all the side holes 47 are closed, and no liquid can pass from the injection lumen 5 to the outside of the catheter sheath 45 through the side holes 47.

The usage of the rectal catheter 1 according to the present embodiment configured as described above will be described below with reference to FIGS.

First, as shown in FIG. 7, the rectal catheter 1 with the catheter tube 2 inserted into the catheter sheath 45 to the maximum is inserted into the rectum 41 from the anal canal 40 of the observer, and the extraanal balloon 3 and the intraanal balloon 4 are inserted. And intestinal balloon 20 is inflated and fixed. This operation is the same as in the first embodiment.

Next, as shown in FIG. 8, an irrigation syringe 36 filled with a chemical solution is connected to the connector 2 a of the catheter tube 2. Then, while referring to the scale line 2b of the catheter tube 2, the catheter tube 2 is moved from the catheter sheath 45 in the extubation direction, and the side holes 47 at each position of the catheter sheath 45 are conducted. Next, the plunger 36 a of the irrigation syringe 36 is pushed in, and the drug solution in the irrigation syringe 36 is irrigated into the rectum 41.

Next, as shown in FIG. 9, the catheter tube 2 is again inserted into the catheter sheath 45 as much as possible, and all the side holes 47 are made non-conductive. Thereby, the medicinal solution irrigated in the rectum 41 does not flow out of the intestine. Then, the vibration air tube 35a of the pneumatic vibration device 35 is connected to the connector 18a of the vibration air tube 18, and the switch 35b of the pneumatic vibration device 35 is turned on to start the pneumatic vibrator. Along with this, air pressure fluctuations generated by the pneumatic vibrator are transmitted to the vibration balloon 19 through the vibration air passage, and the vibration balloon 19 repeats expansion and contraction. Thereby, the chemical | medical solution 42 in the rectum 41 is pneumatically shaken, and is shaken and stirred in the intestinal tract. Therefore, the patient can reliably spread the drug solution throughout the lower part of the rectum 41 including the lesion site without changing the body position. In addition, the pressure / osmotic force at which the drug solution 42 directly contacts the mucous membrane in the rectum 41 can be increased by pneumatically exciting the drug solution 42. Thereby, the utility of the chemical solution 42 can be sufficiently enhanced.

When the medical solution 42 is sufficiently penetrated into the mucous membrane in the rectum 41 and the treatment is completed, the catheter tube 2 is extracted from the catheter sheath 45 as shown in FIG. As a result, the side holes 47 of the catheter sheath 45 become conductive, and the drug solution in the rectum 41 passes through the catheter sheath 45 and is naturally discharged outside the body. Finally, the catheter sheath 45 is extracted, and all the pouring operations are completed.

FIG. 11 is a front view (a) of a rectal catheter 1 according to Example 3 of the present invention and a perspective view (b) of a stirring and shaking mechanism. In FIG. 11, portions corresponding to the configuration of the first embodiment are denoted by the same reference numerals. The rectal catheter 1 of this embodiment includes an electric stirring device 50 instead of the vibration air lumen 17, the vibration air tube 18 and the vibration balloon 19 shown in FIG.

This electric stirrer 50 has a ring shape and is mounted on the distal end side of the intraanus balloon 4 of the catheter tube 2. As shown in FIG. 11B, the electric stirrer 50 includes an annular motor 51 and a stirring blade 52 that is rotationally driven by the annular motor 51. As the annular motor 51, for example, an ultrasonic motor or the like is used. The stirring blade 52 includes a rotating ring 52a that is coaxially attached to the annular motor 51, and

blades

52b and 52b that protrude outside the rotating ring 52a. The material of the stirring blade 52 is a fluororesin or the like.

In addition, a power supply line 53 for supplying electric power to the electric stirrer 50 is embedded in the catheter tube 2, and this power supply line 53 branches off from the tube on the proximal end side of the catheter tube 2. It is connected to the power feeder 54. By turning on the switch 54a of the power feeder 54, power is supplied to the annular motor 51, and the stirring blade 52 is rotationally driven.

Further, the distal end side of the portion of the catheter tube 2 where the electric stirrer 50 is mounted is configured such that the outer diameter smoothly increases toward the electric stirrer 50. The outer diameter of the portion in contact with the stirring device 50 is molded so as to be approximately equal to the diameter of the stirring blade 52. Similarly, the distal end side of the portion of the catheter tube 2 around which the electric stirrer 50 is mounted is configured so that the outer diameter smoothly increases toward the electric stirrer 50. The outer diameter of the portion in contact with the stirring device 50 is molded so as to be approximately equal to the diameter of the stirring blade 52. This prevents the electric stirrer 50 from becoming an obstacle when the catheter tube 2 is inserted into and removed from the anal canal 40.

In addition, about the usage method of the rectal catheter 1 of a present Example, it is the same as that of Example 1 except performing a vibration and stirring of a chemical | medical solution with the electric stirring apparatus 50, Therefore It abbreviate | omits description.

FIG. 12 is a front view (a) of a rectal catheter 1 according to Example 4 of the present invention and a perspective view (b) of a stirring and shaking mechanism. In FIG. 12, the same reference numerals are given to portions corresponding to the configuration of the first embodiment. The rectal catheter 1 of this embodiment includes a magnetic stirrer 55 instead of the vibration air lumen 17, the vibration air tube 18 and the vibration balloon 19 shown in FIG.

As shown in FIG. 12B, the magnetic stir bar 55 includes a rotating cylinder 55a and a blade 55b. As these materials, fluorine resin or the like is used. A permanent magnet (not shown) is embedded in the magnetic stirring bar 55. The magnetic stirring bar 55 is rotatably mounted on the distal end side of the intraanal balloon 4 of the catheter tube 2.

The usage of the rectal catheter 1 of the present embodiment is the same as that of the first embodiment, but the chemical solution is shaken and stirred by the magnetic stirrer 56. This is shown in FIG. When the drug solution in the rectum 41 is agitated and shaken, the patient sits on the pedestal 57 of the magnetic stirrer 56 with the rectal catheter 1 inserted, as shown in FIG. A concave portion 57a is formed on the upper surface of the pedestal 57 so as to prevent a portion protruding from the anal canal 40 of the rectal catheter 1 from the lower portion of the anal portion to the rear.

In the body of the magnetic stirrer 56, a rotating magnetic field generator 58 is installed. The rotating magnetic field generator 58 includes a motor 59 that generates a rotational driving force, a rotating disk 60 that is coaxial with the rotating shaft 59a of the motor 59 and pivoted on the rotating shaft 59a, and the vicinity of the periphery of the rotating disk 60 on the plate. Drive

magnets

61 and 61 arranged symmetrically. When the rotary disk 60 is rotationally driven by the motor 59, the

drive magnets

61 and 61 rotate on a circular orbit centering on the rotary shaft 59a, and a rotating magnetic field is generated. By this rotating magnetic field, the magnetic stirrer 55 is rotationally driven, and the chemical solution 42 in the rectum 41 is stirred and shaken.

FIG. 14: is the front view (a) of the rectal catheter 1 and the front view (b) of the catheter tube 2 and the front view (c) of the ultrasonic vibration device 65 of the enema penetration promoting system according to the fifth embodiment of the present invention. ). In FIG. 14, portions corresponding to the configuration of the second embodiment are denoted by the same reference numerals. The rectal catheter 1 of this embodiment is different from the embodiment 2 in that it does not include the vibration air lumen 17, the vibration air tube 18, and the vibration balloon 19, and the other portions are the same. Moreover, the enema penetration promotion system of the present embodiment includes an ultrasonic vibration device 65 as a stirring vibration mechanism.

The ultrasonic vibration device 65 includes an ultrasonic vibrator 66, a power supply line 67, and a power supply device 68. The ultrasonic transducer 66 is an element that vibrates to generate ultrasonic waves, and has an outer diameter smaller than the injection lumen 5 (see FIG. 6) of the catheter tube 2. The power supply line 67 is a line that supplies driving power to the ultrasonic transducer 66. The power supply device 68 is a device that generates power to be supplied to the ultrasonic transducer 66 through the power supply line 67.

The usage of the rectal catheter 1 of this embodiment is the same as that of the second embodiment, except that the chemical solution is vibrated and stirred by the ultrasonic vibration device 65. This is shown in FIG.

The operation until the drug solution is irrigated in the rectum 41 is the same as that in Example 2. After the drug solution is irrigated into the rectum 41, the catheter tube 2 is inserted into the catheter sheath 45 as much as possible, and all the side holes 47 are made non-conductive. In this state, the irrigation syringe 36 is removed from the connector 2a, and then the ultrasonic transducer 66 is inserted into the injection lumen 5 of the catheter tube 2 from the connector 2a. At this time, the ultrasonic transducer 66 is inserted until the position in the rectum 41 is near the lesion site. Then, the switch 68 a of the power supply device 68 is turned on to vibrate the ultrasonic transducer 66. This vibration is transmitted to the drug solution 42 in the rectum 41, and the intestinal tract wall in contact with the drug solution 42 is also vibrated by ultrasonic waves. Thereby, the utility of the chemical solution 42 can be sufficiently enhanced.

FIG. 16 is a front view (a) of a rectal catheter 1 according to Example 6 of the present invention, a front view (b) of a catheter tube 2, and a cross-sectional view taken along line AA (c). Since the configuration of the rectal catheter 1 of the present embodiment is basically the same as that described in FIG. 6 of Embodiment 2, the corresponding components are denoted by the same reference numerals and description thereof is omitted.

In the rectal catheter 1 of the present embodiment, the connector 2a (see FIG. 6) for connecting the irrigation syringe 36 to the proximal end of the catheter tube 2 is not provided. Instead, the proximal end of the catheter tube 2 is provided. The medicine bag 70 is integrally formed. The distal end of the catheter tube 2 is fitted with a cap 71 for preventing the drug solution from leaking out, and the cap 71 is removed during use. The medicinal bag 70 is a narrow fruitless ampoule container made of an elastic member, and a medicinal solution is enclosed therein. The medicinal solution 70 can be injected into the intestine from the distal end of the catheter tube 2 by holding and holding the medicinal capsule 70 with a finger.

Thus, by forming the medicinal capsule 70 integrally with the proximal end of the catheter tube 2, the rectal catheter 1 can be made completely disposable (disposable).

In this embodiment, the complete disposable type of the rectal catheter of the type of Example 2 is exemplified. However, the rectal catheters of Example 1 and Example 3-5 can be similarly set to the complete disposable type.

In addition, the form of the medicine bag 70 can be configured in a bellows shape or a syringe shape.

FIG. 17 is a view showing a use state of the rectal catheter 1 used in the enema penetration promoting system according to Example 7 of the present invention. Moreover, FIG. 18 is a figure showing the ultrasonic vibration apparatus 18 used with the enema penetration promotion system which concerns on Example 7 of this invention. The enema penetration promoting system of the present embodiment is constituted by the rectal catheter 1 and the ultrasonic vibration device 18.

In FIG. 17, the rectal catheter 1 of this embodiment includes a catheter tube 2, a connector 2a, an extraanal balloon 3, an intraanal balloon 4,

balloon inflation tubes

14 and 15,

connectors

14a and 15a, a catheter sheath 45, a special filter 46, And side holes 47, which are the same as those in FIG. Further, the rectal catheter 1 of this embodiment is different from that of FIG. 6 in that it does not include the vibration balloon 19, the intestinal balloon 20, the vibration air tube 18, the balloon inflation tube 22, and the

connectors

18a and 22a. Different.

The rectal catheter 1 inserted from the anal canal 40 is a double tube comprising a flexible catheter sheath 45 and a catheter tube 2 inserted into the tube. In the vicinity of the distal end of the catheter sheath 45, a large number of side holes 47 are provided. The distal end of the catheter sheath 45 is closed with a special filter 46.

The special filter 46 is desirable if there is a material that allows gas (gas) to pass through but does not pass through the liquid. However, if the material cannot be procured, the special filter 46 is blinded with a material equivalent to the catheter sheath 45. If there is a material through which gas (gas) passes but does not pass through the liquid, only the intestinal gas that has moved from the mouth side due to rectal reflex or peristaltic movement is discharged through the special filter 46, which is effective.

The side hole 47 of the catheter sheath 45 is closed by the catheter tube 2 by moving the catheter tube 2 in and out of the catheter sheath 45. Therefore, by adjusting the insertion length of the catheter tube 2, the passage / non-passage of the substance from the side hole 47 can be adjusted.

Inside the catheter sheath 45, balloon injecting and

exhausting lumens

8 and 9 are formed in the same manner as in FIG. 6 (c). The proximal anal side communicates with the

balloon inflation tubes

14 and 15, respectively. Therefore, the extra-anal balloon 3 and the intra-anal balloon 4 can be inflated by injecting air with a syringe or the like from the connectors 14a and 14b at the tips of the

balloon inflation tubes

14 and 15, respectively. Moreover, the connectors 14a and 14b are the same as those shown in FIG. 1C, and have a check valve function capable of maintaining the inflated state of the external balloon 3 and the internal balloon 4.

In FIG. 18, the ultrasonic vibration device 65 includes an ultrasonic vibrator 66, a power supply line 67, and a power supply device 68, which are the same as those in FIG. 14c. The power supply device 68 includes a frequency variable knob 68 b that adjusts the vibration frequency of the ultrasonic transducer 66.

Next, how to use the enema penetration promoting system of the present embodiment will be described.

First, the rectal catheter 1 composed of a double tube of the catheter sheath 45 and the catheter tube 2 is inserted into the rectum 41 or the large intestine (sigmoid colon) 43 through the anal canal 40. Then, if necessary, the extra-anal balloon 3 and the intra-anal balloon 4 are inflated to fix the rectal catheter 1 to the anal canal 40 and close the anal canal 40.

Then, the insertion length of the catheter tube 2 is adjusted to open the side hole 47 to allow passage of the drug solution (enema), and in this state, a necessary amount of enema is obtained from the connector 2a at the proximal end of the catheter tube 2. Inject drugs. After the injection, the insertion length of the catheter tube 2 is adjusted to close the side hole 47 so that the drug solution does not pass.

Next, the ultrasonic transducer 66 attached to the tip of the power supply line 67 of the ultrasonic vibration device 65 is inserted and fixed to the appropriate treatment site between the deepest part of the catheter tube 2 and the rectum 41. Then, the ultrasonic vibration device 65 is operated with the frequency variable knob 68b set to an appropriate frequency. When the ultrasonic vibrator 66 vibrates, the ultrasonic vibration is transmitted to the drug solution stored in the intestinal tract via the catheter tube 2 and the catheter sheath 45, and the drug solution is directly applied to the rectum / large intestine mucosa by the ultrasonic vibration. Increases contact pressure and penetration.

After sufficient treatment, the ultrasonic transducer 66 is removed from the catheter tube 2, the air inside the extra-anal balloon 3 and the intra-anal balloon 4 is deflated, and the rectal catheter 1 is extracted from the anal canal 40 to enter the intestinal tract. Naturally drain the enema.

In this embodiment, the enema penetration promotion system constituted by the rectal catheter 1 and the ultrasonic vibration device 18 has been described. However, the rectal catheter 1 is first placed near the distal end of the flexible catheter sheath 45. From the above, it is assumed that the ultrasonic vibrator 66 is attached, and the same effect can be obtained.

FIG. 19 is a diagram showing the configuration of the rectal catheter 1 according to Example 8 of the present invention. In FIG. 19, the rectal catheter 1 of this embodiment includes a catheter tube 2, a connector 2a, an extraanal balloon 3, an intraanal balloon 4,

balloon inflation tubes

14 and 15,

connectors

14a and 15a, a catheter sheath 45, a special filter 46, And side holes 47, which are the same as those in FIG. Further, the rectal catheter 1 of this embodiment is different from that shown in FIG. 6 in that it does not include the vibration balloon 19, the intestinal balloon 20, the vibration air tube 18, the balloon inflation tube 22, and the

connectors

18a and 22a. Different.

Furthermore, in the rectal catheter 1 of the present embodiment, a stirring blade 52 is rotatably mounted on the distal end side in the vicinity of the intraanal balloon 4. The stirring blade 52 is the same as that shown in FIG. 11B and also includes an annular motor 51 serving as a power source for the stirring blade 52.

The mounting position of the annular motor 51 and the stirring blade 52 is not limited to the vicinity of the intraanal balloon 4, and may be disposed at the distal end of the catheter sheath 45 instead of the special filter 46, for example. In this case, the blades of the stirring blade 52 are oriented perpendicular to the rectal catheter 1 so as to prevent injury even if the tip is in contact with the mucous membrane, and a blind end is provided.

In addition, the rectal catheter 1 of this embodiment includes a power supply line 53 that supplies power to the annular motor 51 and a motor connector 53a provided at the base end of the power supply line 53. The motor connector 53a is used as an appropriate power supply unit. By connecting, the annular motor 51 is fed.

In addition, the method of the medical solution treatment using the rectal catheter 1 of the present embodiment is the same as that of the seventh embodiment except that the stirring of the chemical solution is changed to the stirring by the stirring blade 52 instead of the ultrasonic vibration. It is.

FIG. 20 is a diagram showing a configuration of an enema penetration promoting system according to Example 9 of the present invention. In FIG. 20, the rectal catheter 1 of this embodiment includes a catheter tube 2, a connector 2a, an extraanal balloon 3, an intraanal balloon 4,

balloon inflation tubes

14 and 15,

connectors

18a and 22a. Different.

In the rectal catheter 1 of this embodiment, a magnetic stirrer 55 is rotatably mounted on a catheter sheath 45 on the distal end side in the vicinity of the intraanal balloon 4. The magnetic stirrer 55 can be the same as that shown in FIG. 12B, but in the present embodiment, the magnetic stirrer 55 separated from the catheter sheath 45 is used.

Also, the enema penetration promotion system of the present embodiment includes a magnetic stirrer 56 that is a rotating magnetic field generator that generates a rotating magnetic field for generating a rotational driving force in the magnetic stirrer 55. The magnetic stirrer 56 includes a motor 59, a rotating shaft 59a, a rotating disk 60, and driving

magnets

61 and 61 inside a pedestal 57, which are the same as those described in the fourth embodiment. The magnetic stirrer 56 can drive the motor 59 to generate a rotating magnetic field, thereby rotating the magnetic stirrer 55. One end of the magnetic stirring bar 55 is an N pole and the other end is an S pole. One of the

drive magnets

61, 61 mounted on the rotating disk 60 is arranged so that the N pole faces the upper surface and the other has the S pole facing the upper surface, so that the rotating disk 60 is rotated by the motor 59. The magnetic stirrer 55 pulled by the magnetic force also rotates.

In the case of performing chemical treatment using the enema penetration promoting system of the present embodiment, first, the magnetic stirrer 55 is inserted into the rectum 41, and then a double catheter sheath 45 and a catheter tube 2 are formed. The rectal catheter 1, which is a tube, is inserted into the anal canal 41.

Next, an enema is injected into the rectum 41. The procedure for injecting the enema into the rectum 41 is the same as in Example 7, and will not be described.

Thereafter, the patient sits on the magnetic stirrer 56 or the magnetic stirrer 56 is positioned on the back side or the abdominal side of the patient's buttocks 44 so that the magnetic stirrer 55 is magnetized. Then, the motor 59 of the magnetic stirrer 56 is activated to rotate the magnetic stirrer 55 and stir the enema in the rectum 41.

Then, the enema in the rectum 41 is discharged and the treatment is completed. Since the procedure for discharging the enema is the same as in Example 7, the description thereof is omitted.

FIG. 21 is a diagram showing the configuration of the rectal catheter 1 according to Example 10 of the present invention. In FIG. 21, the rectal catheter 1 of this embodiment includes a catheter tube 2, a connector 2a, an extraanal balloon 3, an intraanal balloon 4,

balloon inflation tubes

14 and 15,

connectors

14a and 15a, an excitation air tube 18, and a connector 18a. The vibrating balloon 19, the catheter sheath 45, the special filter 46, and the side hole 47 are provided, which are the same as those in FIG. Further, the rectal catheter 1 of the present embodiment is different from that of FIG. 6 in that it does not include the intestinal balloon 20, the balloon inflation tube 22, and the connector 22a.

In the inside of the catheter sheath 45, balloon injecting and

exhausting lumens

8 and 9 and an excitation air lumen 17 are formed as in FIG. The distal end sides of the balloon injecting / exhausting

lumens

8 and 9 communicate with the sac of the extra-anal balloon 3 and the intraanal balloon 4, respectively, and the proximal end sides communicate with the

balloon inflation tubes

14 and 15, respectively. The distal end side of the excitation air lumen 17 communicates with the sac of the excitation balloon 19, and the proximal end side communicates with the excitation air tube 18. Unlike the

connectors

14a and 15a, the connector 18a at the tip of the vibration air tube 18 does not have a check valve function.

The vibration balloon 19 is inflated and contracted with a pneumatic ON-OFF pulse by a pneumatic vibration device 35 (see FIG. 5) connected to the vibration air tube 18. The maximum diameter of the vibrating balloon 19 when inflated is limited to an amount that does not rupture the rectum / large intestine. By the expansion and contraction of the vibration balloon 19 by the pulse, the penetration / contact force of the enema in the intestinal tract is increased as in the case of the first embodiment.

DESCRIPTION OF SYMBOLS 1 Rectal catheter 2 Catheter tube 2b Scale line 3 Ball outside the anus 4 Ball inside the anus 5 Injection fluid lumen 5a Opening part 6 Excretion lumen 7

Ventilation lumen

8, 9, 21 Balloon injection exhaust lumen 10

Tip cap

10a, 10b Side hole 11 Air injection Tube 12 Chemical solution injection tube 13

Excretion tube

2a, 12a, 13a, 14a, 15a, 18a, 22a,

24a Connector

14, 15, 22 Balloon inflation tube 16 Connector 17 Excitation air lumen 18 Excitation air tube 19 Excitation balloon 20 Intestinal balloon 23 Waste fluid lumen 24 Waste fluid tube 25 Catheter tube insertion lumen 30 Pilot balloon 31 Syringe connection port 32 Check valve with spring 34 Air syringe 35 Pneumatic vibration device 35a Excitation air tube 35b Switch 36 irrigation syringe 36a plunger 40 anal canal 41 rectum 42 chemical 43 colon (S-shaped colon)
44 collar 45 catheter sheath 46 special filter 47 side hole 48 tightening screw cylinder 50 electric stirrer 51 annular motor 52 stirring blade 52a rotating ring 52b blade 53 feeding line 53a motor connector 54 feeder 54a switch 55 magnetic stirring bar 55a rotating tube 55b Blade 56 Magnetic stirrer 57 Pedestal 57a Recessed portion 58 Rotating magnetic field generator 59 Motor 59a Rotating shaft 60 Rotating disk 61 Driving magnet 65 Ultrasonic vibrator 66 Ultrasonic vibrator 67 Feed line 68 Power supply 68a Switch 68b Frequency variable knob 70 Medicine bag 71 cap

Claims

A rectal catheter for injecting enema into the intestine,
A catheter body in which a drug solution injection path is formed;
An inflatable and expandable external anus balloon disposed at a site on the side of the catheter body;
An inflatable and inflatable anal balloon disposed in the vicinity of the extra-anal balloon in a portion of the side of the catheter body on the distal end side of the external anus balloon;
Inside the catheter body, there is formed a balloon injecting / exhausting passage for injecting / extracting air for inflation / deflation to each of the balloon outside the anus and the balloon inside the anus.
A rectal catheter comprising an agitation and agitation mechanism for agitating or agitating the liquid outside the side surface of the catheter body on a distal end side of the intraanal balloon of the catheter body.
Comprising an inflatable and inflatable intestinal balloon disposed at one site on the side surface near the distal end of the catheter body;
Inside the catheter body, the balloon injection / exhaust passage for injecting / extracting air for inflation / deflation to each of the extra-anal balloon, the intra-anal balloon, and the intestinal balloon is formed,
One end of the medicinal solution injection path is open on the side of the catheter body in the middle between the intraanal balloon and the intestinal balloon,
2. The rectum according to claim 1, wherein the agitating and agitating mechanism agitates or agitates a liquid outside the side surface of the catheter body intermediate between the intraanal balloon and the intestinal balloon. catheter.
The stirring and shaking mechanism is
An inflatable / deflatorable excitation balloon disposed at a site on the distal end side of the intra-anal balloon on the side surface of the catheter body;
And a vibration air passage formed inside the catheter body, through which air for dynamically changing air pressure to the vibration balloon and causing air to vibrate the vibration balloon circulates. Item 3. A rectal catheter according to item 1 or 2.
The stirring and shaking mechanism is
An inflatable / deflatorable excitation balloon disposed at a site on the distal end side of the intra-anal balloon on the side surface of the catheter body;
An excitation air passage formed inside the catheter body, through which air for dynamically exchanging air pressure is exerted on the excitation balloon and air for exciting the excitation balloon flows,
The rectal catheter according to claim 2, wherein the vibration balloon is formed such that a maximum diameter when inflated is smaller than a maximum diameter when the intraanal balloon and the intestinal balloon are inflated.
The stirring and shaking mechanism is
The rectal catheter according to claim 1, wherein the rectal catheter is an ultrasonic transducer attached to a distal end of the catheter body.
The stirring and shaking mechanism is
3. A ring-shaped stirring blade that is rotatably attached to a distal end side of the catheter body in the vicinity of the intraanal balloon or a tip of the catheter body and is driven to rotate by an external force. The rectal catheter as described.
The rectal catheter according to claim 6, further comprising an annular motor that is attached to the catheter body and rotationally drives the stirring blade.
The rectal catheter according to claim 6, wherein the stirring blade is a magnetic stirring bar and can be driven to rotate by a magnetic stirrer.
The side surface of the catheter main body on the distal end side of the intraanus balloon is formed with a plurality of side holes communicating with the drug solution injection path. Rectal catheter.
The catheter body is a hollow tubular catheter sheath whose distal end is a blind end, and a hollow tube that is detachably mounted in a tube of the catheter sheath, and the inside of the tube serves as the drug solution injection path A tube, and
The plurality of side holes penetrating the side surface of the catheter sheath;
10. The rectal catheter according to claim 9, wherein each side hole is closed by the catheter tube by moving the catheter tube into and out of the catheter sheath.
The rectal catheter according to any one of claims 1 to 9, wherein the catheter body is formed of a catheter tube formed by molding a flexible member.
The rectal catheter according to claim 10 or 11, wherein a medicinal capsule containing a medicinal solution is formed at a proximal end of the catheter tube.
Rectal catheter according to claim 3 or 4,
An exciting air tube having one end connected to the proximal end side of the rectal catheter in communication with the exciting air path;
Pneumatic excitation that is connected to the other end of the excitation air tube and that dynamically changes the air pressure on the excitation balloon through the excitation air tube and the excitation air passage, thereby exciting the excitation balloon pneumatically. And an enema penetration promotion system.
A rectal catheter according to claim 8;
And a rotating magnetic field generator for generating a rotating magnetic field for generating a rotational driving force for the magnetic stirrer.
An enema penetration promoting system for injecting an enema into the intestine to promote the penetration of the enema into the intestine,
A catheter body with a chemical solution injection path formed inside,
An expandable / collapseable anus balloon disposed on one side of the side of the catheter body,
And an intra-anally expandable / collapseable anal balloon disposed in the vicinity of the extra-anal balloon at a portion of the side of the catheter main body on the distal end side of the extra-anal balloon,
In the inside of the catheter body, a rectal catheter in which a balloon injecting / extracting passage for inflating and inflating air for inflation / deflation is formed in each of the external balloon and the intraanal balloon;
An enema penetration promoting system, comprising: an ultrasonic transducer that can be inserted into and removed from the catheter body and can be inserted to the vicinity of the distal end of the catheter body.