JP2005013710A - Body access port - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a body access port reducing a risk of breaking a balloon, eliminating any possibility of being fallen off, dispensing with maintenance of the balloon, simplifying the structure and smoothly inserted into the body, and to provide a body access port dedicated for a caecum port suited to a caecum port operation and used simply. <P>SOLUTION: The body access port 1 comprises a catheter base 4 having a liquid filler inlet 7 and functioned as a fixing means of an extracorporeal part, a catheter 2 being a passage of the liquid filler and having a liquid filler outlet 6, a shape retaining balloon 3 functioned as a pull-out prevention means of an internal part, and a plug 5 sealing the liquid filler outlet 6. The caecum access port 41 has an optimized length and suited to the caecum port operation. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a body access port, and more particularly to a body access port that can directly access the stomach, esophagus, cecum, bladder, or the like, and a body access port dedicated to the cecum port.

Typical examples of conventional body access ports include gastrostomy catheters (PEG catheters) and esophageal fistula catheters used for nutritional supplementation.
These body access ports have means for fixing to the inside and outside of the body so that they will not fall out after wearing, and the form of fixing means on the outside of the body is of two types: tube type and button type As a means for preventing the body from coming off, a type having a balloon is generally used. The balloon as a means for preventing the removal is used by pre-filling a fluid such as air or water at the time of assembly, or the balloon part of the body access port is inserted into the body and then air or water is used. The fluid is inflated by injecting the fluid from the passage leading to the outside, and then the passage is sealed to maintain its form (see Patent Documents 1 to 4).
Also, there is a balloon catheter that is devised with respect to the shape of the balloon so that it can be folded into a scroll shape (see Patent Document 5).

On the other hand, cecal port surgery for spinal cord injury patients who cannot control defecation has recently attracted attention. A sputum (passage) is formed between the cecum and the outside of the body, and enema fluid is injected from a catheter (cecal port) placed in the sputum, thereby excreting feces stored in the colon. As a result, incontinence can be prevented for 24 to 48 hours until the stool is re-reserved in the colon, it is possible to go out without a diaper, and the quality of life (QOL) of the patient can be dramatically improved.
JP 11-192310 A US Pat. No. 5,125,897 JP 2001-346887 A Japanese translation of PCT publication No. 2002-542840 JP 2003-62080 A

  However, in the case of the conventional body access port as shown in Patent Documents 1 to 4 above, since the balloon as the removal preventing means is inflated using a thin material rich in stretchability, There is a risk that the balloon wall may rupture due to frictional damage or wearing. In addition, since the balloon may be contracted due to air leakage, liquid leakage, etc., there is a concern that the body access port may come off and there is a need for maintenance such as replenishment of air or liquid. Furthermore, it is necessary to provide an injection port and passage for injecting air etc. into the balloon along the catheter, and a passage stopper (pin or check valve) is necessary to hold the balloon bulge. The complexity of the structure is inevitable.

  Further, in the case of a balloon catheter as shown in Patent Document 5, since the shape of the balloon is a scroll shape, it requires a complicated mold for molding, and can be smoothly inserted even when folded into the body. Is hard to say.

  On the other hand, a body access port is an indispensable tool even in cecal port surgery, but there is no dedicated body access port at present, and the use of a substitute is forced, so the cecum to solve such an inconvenient situation The emergence of a dedicated body access port was strongly desired.

  Accordingly, it is an object of the present invention to provide a body access port that does not require balloon maintenance and that is less likely to cause damage to the balloon and does not cause the body access port to come off. A further object is to provide a body access port with a simplified structure and smooth insertion into the body.

  Another object of the present invention is to provide a body access port dedicated to the cecum port that can be used conveniently and suitable for cecal port surgery.

  In order to achieve the above object, the present invention has a catheter base which has an injection port for an infusion solution and serves as a fixing means outside the body, a catheter having a passage for the infusion solution and an outlet for the infusion solution, In the body access port consisting of a means for preventing omission and a stopper that seals the injection liquid inlet, the means for preventing omission is formed in a bulging state, and the outer diameter can be temporarily reduced during insertion into the body. There is provided a body access port which is a shape-retaining type balloon which can be inserted and can be returned to a state in which air is automatically inflated after being inserted through an air passage connected to the outside of the body.

  According to the present invention, since the shape maintaining type balloon inflated in the natural state is used, the structure naturally returns to the original state after insertion. Therefore, the structure can be simplified, and there is a concern that the balloon may be broken or come off after mounting. Absent. Thereby, the maintenance of the balloon becomes unnecessary, and the manufacturing cost can be reduced and the usability can be improved.

  Further, in order to achieve the above object, the present invention has a catheter base having an injection port for an injection solution and serving as a fixing means outside the body, a catheter having a passage for the injection solution and an outlet for the injection solution, In a body access port comprising a means for preventing removal from inside the body and a plug for sealing an infusion solution inlet, the catheter has a predetermined length and diameter suitable as a cecal access port, and the distal end of the catheter and the removal The preventive means provides a body access port characterized by a length and diameter suitable for percutaneous insertion into the cecum.

  According to the present invention, since it is possible to provide a cecal-specific body access port suitable for cecal port surgery, it is possible to reduce the labor and cost of procuring equipment, reduce the labor of the surgeon, and improve the patient's QOL.

According to the preferable aspect of this invention, it has the following characteristics.
(1) The catheter includes two parts, a distal end portion and a base portion, and each of the distal end portion and the base portion is fluid-tightly connected to the shape-retaining balloon.
(2) The catheter is characterized in that the distal end portion and the lumen of the base portion further have an inner core portion of the lumen.
(3) The catheter is characterized in that the lumen serves as the air passage to the shape-retaining balloon.
(4) The body access port according to claim 1, wherein the catheter has a slit forming portion having a diameter larger than that of the catheter at a distal end thereof.
(5) The shape-retaining balloon is characterized in that there is no opening that leads to the outside of the body in the wall portion of the shape-retaining balloon.
(6) The shape-retaining balloon has a shape in which the distal end side extends linearly at an angle of 20 to 50 degrees with respect to the catheter, and the base side is more than the angle on the distal end side with respect to the catheter. Is a curved surface curved at a large angle.
(7) The shape-retaining balloon has an inner angle of 75 ° to 110 ° configured from the distal end side and the base side at the maximum outer diameter portion of the balloon, and the maximum outer diameter portion from the connecting portion with the catheter. The length of the balloon up to is characterized in that the length on the distal end side is longer than the length on the base side.
(8) The shape-retaining balloon is extended in the longitudinal direction of the catheter when inserted into the body.
(9) The shape-retaining balloon is characterized in that when the balloon is stretched, one or two or more of the maximum outer diameter portions are folded inward along the longitudinal direction.
(10) The injection solution outlet is a slit having a backflow prevention function.
(11) The catheter or the slit forming portion is characterized in that a lumen thereof is eccentric and a thickness of the slit forming portion is reduced.
(12) The catheter base is on the side in contact with the body surface and has a depression around a connection portion with the catheter.
(13) The stopper is integrated with the catheter base.

  According to the body access port of the present invention, since the shape-retaining balloon is used, the body access that can be safely and securely mounted without worrying about the damage of the balloon or being smoothly inserted into the body and coming off after wearing. Can provide a port. In addition, there is no need to provide a stopper for holding the balloon bulge or an injection port or passage for injecting air into the balloon, thus simplifying the structure and reducing the manufacturing cost. Can provide. In addition, there is no need to refill the balloon with air or liquid after insertion, making it unnecessary to maintain the balloon. By using a slit valve as the outlet, the backflow of enema fluid, etc. is ensured with a simple structure. Can be stopped.

  Further, according to the body access port of the present invention, it is possible to provide a body access port dedicated to the cecum port suitable for cecal port surgery, so that the QOL of the patient can be dramatically improved. Become.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
<First Embodiment>
FIG. 1 shows a partial cross-sectional side view of a first embodiment of a body access port according to the present invention. 2 is a side view of the first embodiment, FIG. 3 is a perspective view, and FIG. 4 is a bottom view.

  The body access port 1 according to the first embodiment includes a configuration of a catheter 2, a shape-retaining balloon 3, a catheter base 4, a stopper 5, and a slit 6.

  The catheter 2 has a passage for an infusion solution such as nutrient solution or enema solution, and is divided into a distal end portion 2a and a base portion 2b, and a shape-retaining balloon 3 is provided so as to cover the divided portion. The part 2a and the base part 2b are liquid-tightly connected to the shape-retaining balloon 3 so as not to leak.

  As shown in FIG. 1, the distal end portion 2a and the base portion 2b of the catheter 2 are brought into full contact with the respective cutting portions 8a and 8b in the balloon 3 in a normal state (when the balloon 3 is in a normal state, that is, in an expanded state). Although it is preferable, it may be separated. Moreover, although it is preferable that the front-end | tip part 2a and the base 2b are the same thickness, each is different thickness, and one (for example, thin base 2b) fits into the other (for example, the thick front-end | tip part 2a). It may be in a state.

  The distal end portion 2a of the catheter 2 has a hemispherical shape with the distal end closed, and a slit 6 serving as an outlet of an infusion solution (nutrient solution, enema solution, etc.) is provided on the side surface. The outlet may not be slit-shaped, but is preferably slit-shaped in that it also functions as a backflow prevention means.

  The slit 6 is a mere notch, but it can flow out of the slit during injection because the pressure inside the port is high, and normally it can work as a valve without backflow because there is little difference in pressure inside and outside. . The slit 6 is preferably provided with a cut in the longitudinal direction parallel to the catheter 2 from the viewpoint of function, durability, and the like.

  FIG. 5 is an enlarged view of the slit 6 portion of the distal end portion 2 a of the catheter 2. The length and position of the slit are not limited to the length and position shown in FIG. 1 and FIG. 5, and can be appropriately shortened or provided at the tip. When an outlet that does not function as a backflow prevention means is used instead of a slit, it is preferable to separately provide a backflow prevention means in the tip portion 2a or the like.

  The shape-retaining balloon 3 is a means for preventing the body access port 1 from being pulled out after being inserted into the body, and the conventional balloon having a thickness of about 0.5 t is deflated in a normal state (natural state). The balloon of the present invention is normally inflated (permanent balloon) and is crushed only when inserted into the body, or a stylet is used. Thus, the bulge is eliminated or reduced, and after insertion, air enters and returns to its original shape. The wall is thicker than a conventional balloon and is molded in an inflated state, but it can be inserted after being deformed using a stylet, etc. If there is something, it can be used. For example, a balloon having a rubber hardness (durometer A) of 30 and a wall thickness of about 1.0 t can be suitably used. The size, thickness and hardness of the balloon depend on the purpose of use of the body access port. Etc. are adjusted accordingly. As long as the above conditions are satisfied, a shape memory resin or the like may be used as a material. The shape-retaining balloon 3 is preferably configured to be stretched in the longitudinal direction of the catheter 2 when inserted into the body, from the viewpoint that it can be smoothly inserted into the body.

  The shape of the balloon is not particularly limited as long as it can be prevented from coming off, but as shown in FIG. 1, the cross section in the axial direction of the shaft of the catheter is shaped like a rhombus, and the balloon on the catheter tip 2a side is relatively loose. Specifically, the balloon on the distal end portion 2a side has a shape that expands linearly at an angle of 20 to 50 degrees, preferably 25 to 45 degrees, more preferably 30 to 40 degrees with respect to the catheter distal end portion 2a. The balloon on the catheter base 2b side is formed at an angle larger than the angle of the balloon on the distal end 2a side. Specifically, the balloon on the base 2b side is preferably 40 degrees to 80 degrees, more preferably with respect to the catheter base 2b. It is preferable that the curved shape is curved at an angle of 45 to 80 degrees, more preferably 55 to 80 degrees.

  Further, as shown in FIG. 6, the inner angle formed by the balloon wall on the distal end side and the balloon wall on the base side in the maximum outer diameter portion of the balloon is preferably 75 degrees to 110 degrees, and 80 degrees to 110 degrees is more preferable, and 85 degrees to 105 degrees is even more preferable. At this time, it is preferable that the length (A) on the distal end portion 2a side is longer than the length (B) on the base portion 2b side in the length of the balloon wall from the connecting portion with the catheter to the maximum outer diameter portion.

  When the shape-retaining balloon 3 has such a shape, the inclined portion of the cross section on the distal end portion 2a side becomes linear, and when inserted, the balloon tends to become straight (flat) when the balloon is deflated and extended, There is an effect that it can be smoothly inserted into the human body without the protrusion of the balloon, and by curving the base 2b side, it is harder to come out than when it is attached and fixed inside the body such as the stomach wall and cecal wall.

  Since the shape holding balloon 3 after insertion cannot return to its original shape in a sealed state, a means capable of communicating with the outside serving as an air passage is necessary for the catheter so that it can return to its original shape. In Embodiment 1, the inner side of the balloon communicates with the lumen of the catheter 2 through the distal end portion 2a and the cutting portions 8a and 8b of the base portion 2b, and the infusion solution passage in the base portion 2b of the catheter plays its role, and thus is provided separately. There is no need.

  The catheter base 4 is attached to the catheter base 2b and is positioned outside the body to hold the body access port 1 in the fistula with the shape-retaining balloon 3 as a means for preventing the body from coming off and sandwiching the abdominal wall and organ wall of the human body. And has an inlet 7 for a nutrient solution or the like. The catheter base 4 and the catheter base 2b may be integrally molded. The catheter base 4 may have any shape as long as it functions as a fixing means. In particular, since the human body contact portion is preferably soft and less uneven with less irritation, such shape and material (preferably silicon resin) is used. It is formed.

  In order to allow injection solution (nutrient solution, enema solution, etc.) to be injected using a general-purpose medical syringe or connector, the injection port 7 has a luer taper shape as shown in FIG. It is preferable. The catheter base 4 has a stopper 5 that serves as a stopper for closing the injection port 7. The stopper 5 may be independent of the catheter base 4, but an integrated shape is preferable because there is no risk of loss. Moreover, it is preferable to make it a shape which becomes flat when the stopper 5 is closed so as not to obstruct the human body in consideration of long wearing.

  It is preferable to use a material that is flexible and highly biocompatible as the material of the body access port 1, and it is desirable that all the components are made of silicon resin, but the material is not limited to this.

<Second Embodiment>
FIG. 7 shows a side view of the second embodiment of the body access port according to the present invention as a partial cross-section. FIG. 7a shows the shape at the time of normal operation, and FIG. ing.

  The body access port 11 according to the second embodiment includes a catheter 12, a shape-retaining balloon 13, a catheter base 14, a stopper 15, and a slit 16. The basic configuration is the same as that of the first embodiment, but is different in the following points.

  That is, the catheter 12 is composed of three portions, that is, a distal end portion 12a, a base portion 12b, and a central core portion 12c, and the distal end portion 12a and the base portion 12b do not leak with the shape-retaining balloon 30 located in the middle portion thereof. It is connected so as to be liquid-tight.

  The middle core portion 12c is positioned in the inner cavity of the tip portion 12a, the base portion 12b, and the shape-retaining balloon 13, and the outer circumference of one end of the middle core portion 12c is bonded to the inner circumference of the tip portion 12a. Alternatively, the outer periphery of the other end of the core portion 12c may be bonded to the inner periphery of the base portion 12b without being bonded to the inner periphery of the distal end portion 12a, and both ends may be bonded. It is preferable that at least one end is not bonded from the viewpoints of air passage holding, structure simplification, and shape-retaining balloon 13 that are easy to extend in the longitudinal direction. It is particularly desirable from the same viewpoint that only the tip 12a side is bonded. The central core portion 12c uses a catheter that is slightly thinner than the catheter 12 (12a, 12b), and smoothly slides in the lumen of the catheter 12 (12a, 12b) when the shape-retaining balloon 13 is extended in the longitudinal direction. It is desirable to be configured as follows. Further, as shown in FIG. 7b, when the shape-retaining balloon 13 is fully extended by a stylet (not shown) or the like when inserted into the body, the core 12c does not fall into the shape-retaining balloon 13. The length of the middle core portion 12c needs to be adjusted.

  The middle core portion 12c has a lumen and serves as a passage for an infusion solution (nutrient solution, enema solution, etc.). Since the middle core portion 12c is less likely to bend, it is easier to insert the body access port 11 into the body than the body access port 1 according to the first embodiment.

  FIG. 8 shows a cross-sectional view of a portion of the catheter 12 of the body access port 11. Since the shape-retaining balloon 13 after insertion cannot return to its original shape in a sealed state, a means capable of communicating with the outside serving as an air passage is necessary so that it can return to its original shape. In the second embodiment, a small hole is provided in the center core portion 12c, or, as shown in FIG. 8, a gap leading to the outside is provided between the base portion 12b (or the tip portion 12a) and the center core portion 12c. As a result, the passage 18 is secured as an external communication means. The shape and size of the passage 18 are not limited as long as the passage 18 can be an air passage. Not only the gap based on the inner diameter / outer diameter difference, the shape of the core 12c may be an ellipse, or a small groove may be provided. Thereby, the balloon can be deflated and returned to its original shape. Note that the resistance of the catheter lumen is small, so it is difficult for the liquid to flow into the balloon. However, when injecting the infusion, the gap should be small to prevent the liquid from entering the balloon. preferable.

  The body access port 11 of the second embodiment is somewhat complicated in structure as compared with the first embodiment having a simplified configuration, but the structure is simplified as compared with the conventional product. Therefore, manufacturing is easy, cost is reduced, and handling is simplified.

<Third Embodiment>
9 shows a partial cross-sectional side view of a third embodiment of a body access port according to the present invention, FIG. 10 shows a side view of the third embodiment, and FIG. 11 shows a perspective view. Is shown.

  The body access port 21 according to the third embodiment differs from the body access port 1 according to the first embodiment shown in FIG. 1 mainly in the shapes of the shape-retaining balloon 23 and the catheter base 24, and The configuration is the same as that of the first embodiment except that a slit forming portion 29 is provided.

  FIG. 12 shows the shape of the shape-retaining balloon 23 of the body access port 21 according to the third embodiment and the shape of the slit forming part 29 in which the slit is formed. FIG. 13 shows the slit forming part. 29 shows the shape of 29 in more detail.

  Depending on the thickness of the catheter 22 and the thickness and size of the shape-retaining balloon 23 provided so as to cover the divided portion of the catheter 22, the pressure that flows out from the slit 26 rather than the pressure that the shape-retaining balloon 23 swells. In some cases, the shape retention type balloon 23 may be inflated even when pressure is applied, and the injection liquid may not be discharged from the slit 6. When the internal pressure p is applied to the thin cylinder (radius r), the tearing force T acting in the tangential direction of the cylinder is obtained by T = r × p. When the same pressure of p is applied, the larger r is, the more T Will grow. Therefore, the pressure for allowing the slit 26 to flow out from the slit 26 by making the diameter of the slit 26 larger than the diameter of the catheter 22 and further reducing the thickness of the portion where the slit 26 is formed within a range in which the backflow prevention functions sufficiently. Set low. The shape-maintaining balloon 23 is preferably set to have a diameter and a thickness that are as small as possible within a range that maintains the slip-off preventing function and insertion property, and the pressure at which the shape-maintaining balloon 23 inflates is set higher than the pressure that causes the slit to flow out from the slit. As a result, the injected liquid can be allowed to flow out from the slit 26 at a pressure lower than the pressure at which the shape maintaining balloon 23 is inflated. This embodiment will be specifically described below.

  The shape-retaining balloon 23 of the third embodiment differs from the shape-retaining balloon 3 of the first embodiment in the thickness of the balloon wall, the size and shape of the balloon, and the thickness of the balloon wall A little thicker. Specifically, a balloon having a wall thickness of 1.0 to 1.5 t and having a wall thickness from the connecting portion of the catheter to the maximum outer diameter portion can be suitably used. It is desirable that the thickness be 1.1 to 1.7 times the wall thickness of the parallel portion. For example, when used as a cecal port, when the thickness of the portion parallel to the balloon catheter is 1.0 t, the thickness near the maximum diameter of the balloon is 1.3 t to 1.7 t, particularly 1.4 t to 1.. 6t is preferable, and the wall thickness of the bulging portion other than the vicinity of the maximum diameter of the balloon is preferably 1.1t to 1.4t, and particularly preferably 1.2t to 1.3t. In addition, the size of the balloon is slightly smaller. Specifically, for example, when used as a cecal port, the maximum diameter of the balloon is 8 to 18 mm, more preferably 10 to 16 mm, and still more preferably 12 to 14 mm. Further, by increasing the angle between the balloon wall and the base portion 22b of the catheter 22, the angle formed by the balloon wall at the maximum diameter portion of the balloon is about 75 to 83 degrees. More preferably, it is about 77-80 degrees. At this time, it is desirable that the angle between the balloon wall and the base portion 22b of the catheter 22 is approximately 65 to 85 degrees. Thereby, it can be set as the structure which flows out injection liquid from the slit 26, maintaining a removal prevention function and insertion ease.

  Further, the catheter distal end portion 22a of the third embodiment has a slit forming portion 29 in which a slit 26 is provided. The slit forming part 29 is formed as a separate part and connected to the catheter tip 22a by adhesion, but may be formed integrally with the catheter.

  As shown in FIG. 13, the slit forming portion of the slit forming portion 29 is designed to be larger than the diameter of the catheter distal end portion 22 a, and the slit forming portion 29 has a thickness other than the portion where the slit 26 is provided. It is thinner than the part. That is, the slit inner cavity portion 26a is eccentric. Moreover, the diameter of the slit formation part 29 becomes small stepwise or continuously, so that it goes to the front end side. Thereby, the insertion into a body becomes smoother.

  FIG. 14 shows the shape of the catheter base 24. The catheter base 4 of the first embodiment is substantially circular, whereas the catheter base 24 of the fourth embodiment is shaped to have a circular left and right protrusion. Alternatively, it may be oval. Thereby, the area which hits a body surface is ensured and the operativity at the time of a surgery improves.

  The catheter base 24 shown in FIG. 14a includes a circular donut-shaped dent 24a similar to that of the first embodiment. However, the shape of the dent is not limited to this, and the circular shape as shown in FIG. 14b is used. It may be a shape (or an elliptical shape) having protrusions on the left and right, or may be a hollow shape formed of a plurality of circles. Due to the presence of such dents, when contacting the body surface at the time of wearing, air permeability is ensured by creating a gap without being completely adhered, reducing skin troubles such as rash on the body surface due to prolonged contact. be able to.

<Fourth embodiment>
FIGS. 15A and 15B are side views showing a partial cross section of the fourth embodiment of the body access port according to the present invention. FIG. 15A shows a shape at the time of normal operation, and FIG. ing.

  The basic configuration of the body access port according to the fourth embodiment is the same as that of the third embodiment, but is different in the following points.

  That is, as in the second embodiment, the catheter 22 is composed of three parts, that is, a distal end part 22a, a base part 22b, and a central core part 22c, and the distal end part 22a and the base part 22b are positioned at the intermediate part thereof. The holding type balloon 23 is liquid-tightly connected so as not to leak. The explanation of the core part 22c is the same as that of the core part 12c of the second embodiment. FIG. 15B is a diagram in which the shape-retaining balloon 23 is stretched by a stylet (not shown) or the like when inserted into the body, and the core portion 22c is prevented from falling into the shape-retaining balloon 23. The length is adjusted.

  The means that can communicate with the outside serving as an air passage is the same as in the second embodiment so that the shape-maintaining balloon 23 after insertion can return to its original shape.

<Fifth embodiment>
As a fifth embodiment, a case where the catheter is configured as one without being divided is also conceivable and is within the scope of the present invention. In this case, the structure is further simple and easy to manufacture. As a means for forming an air passage between the inside and outside of the balloon, in addition to providing a small hole in the catheter that also serves as a passage for the infusion solution, a separate passage may be provided along the catheter in order to eliminate the risk of the infusion solution flowing into the inside of the balloon. .

  The body access port of the present invention can be used by adjusting the size and shape of the stomach, esophagus, cecum, or bladder.

<How to use the body access port>
Next, the usage method of the body access port of this invention is demonstrated.
FIG. 16 is a cross-sectional view showing a state in which the stylet 30 is inserted into the body access port 31 of the present invention and the balloon 33 is extended in the longitudinal direction of the catheter. FIG. 16a is the first embodiment, and FIG. This shows the third embodiment.

  The stylet 30 is used to attach a body access port. The stylet 30 is a rod having a grip portion on a stainless steel or resin rod. The stylet 30 is inserted into the access port, and the catheter base of the access port is held by hand and pushed. Any shape can be used as long as the catheter is straightened as a whole and can be smoothly inserted into the eyelid opened in the human body. If the catheter is not divided and is configured as one (fifth embodiment), it can be inserted without using the stylet 30, but the stylet 30 is used for smoother insertion. It is preferable. In the first or third embodiment, it is particularly preferable to use the stylet 30 because it is bent at the time of insertion at the cut portion and is difficult to insert straight. On the other hand, in the second or fourth embodiment, there is no concern that the three portions overlap and bend during insertion, but it is preferable to use the stylet 30 in order to stretch the balloon and insert it more smoothly.

  FIG. 17 is a cross-sectional view taken along the line AA in a state where the balloon in FIG. 16 is extended. FIG. 17a shows a state in which the balloon is stretched without being bent, while in FIG. 17b, one of the maximum outer diameter portions is folded inward, and in FIG. 17c, two of the maximum outer diameter portions are folded inward. . In this way, when the balloon is stretched, forming the balloon so that one or more of the maximum outer diameter portions are folded inward along the longitudinal direction can reduce the diameter of the balloon and insert it smoothly. It is preferable at a point and it is especially preferable that a fold is 1 place or 2 places.

  For example, in the case of the body access port in the first embodiment, when the injection solution such as enema solution is injected, the injection solution enters the balloon from the cutting portions 8a and 8b, However, if the air is slightly injected after injecting the injection liquid, the liquid is replaced with air, so that the liquid is not left in the indwelling state.

  When it is necessary to replace the device with respect to the human body, for example, the body access port attached to the cecum is cut and the balloon portion of the present invention remaining inside the body is dropped into the cecum. It can be forced to be discharged with the stool. The stylet 30 can be used to stretch and pull the balloon.

<Caecal access port>
Next, an embodiment of a body access port dedicated to the cecum port (hereinafter referred to as “cecum access port”) will be described.

  FIG. 18 shows a side view of the cecal access port. The cecal access port is placed in the cecum for a long period of time, and is fixed so that the inside (inside the cecum) is prevented from coming out and the outside (body surface) is fixed by the fixing means. It is a device for injecting enema fluid directly into the intestine from the entrance and defecation. The configuration of the cecum access port includes, for example, a catheter 42, a balloon 43, a catheter base 44, a stopper 45, and a slit 46 as shown in FIG. 18a.

  The catheter 42 has a passage for enema fluid to be infused therein, and as described in the above body access port, even if the catheter 42 is divided into the distal end portion 42a and the base portion 42b, the distal end portion 42a, the base portion 42b, and the core Although it may be composed of three parts 42c (not shown) or one part, it is designed to have a length suitable as a cecal access port. The catheter 42 preferably has a total length of about 60 to 150 mm including the balloon connecting portion. The distal end portion 42a (here, referring to a portion having a length of 15 mm in FIG. 18a) is preferably about 10 to 20 mm, and more preferably about 10 to 15 mm. It is desirable to design as short as possible in order to avoid contact between the tip and the intestinal lining. The base 42b (here referring to a portion having a length of 44 to 120 mm in FIG. 18a) is desirably designed to be approximately equal to the total thickness of the abdominal wall, muscle layer, and cecum wall, About 35 to 130 mm is preferable, and about 44 to 120 mm is more preferable. In the case of insertion from the appendix (FIG. 19b), the length is designed in consideration of the length of the appendix. The length of the appendix can be adjusted by cutting the appendix in accordance with the length of the catheter base 42b. When the catheter 42 is inserted / mounted from the appendix (FIG. 19b), the thickness of the catheter 42 is 10-12 Fr. (About 3.3 to 4 mm) is preferable. In the case of the cecum (FIG. 19a), 10 to 20 Fr. It is preferably about (about 3.3 to 6 mm).

  The balloon 43 is a means for preventing the cecum access port 41 from coming out after being inserted into the body, and various conventional fixing means can be used in addition to the balloon. For example, any means other than the balloon-type removal prevention means may be used as long as it spreads inside the body cavity and becomes a removal prevention stopper, and a malecot-type removal prevention means can also be used. The malecot type is a type that is provided with a large number of slits in the vertical direction and opens and closes like a flower, and is excellent in that it can be linearly inserted and has a little hindrance to insertion when inserted percutaneously. Like the shape-retaining balloon of the present invention, it is formed in an open state in a natural state (normal time), and when inserted, the stylet is pushed in and extended, and automatically inserted into the original inflated state after insertion. Although a returning one may be used, in the case of a malecot type, it is generally necessary to provide an opening / closing mechanism.

  The diameter of the maximum outer diameter portion of the balloon 43 is preferably about 10 to 20 mm, and particularly preferably 12 to 18 mm. The length in the longitudinal direction (swelled portion) is preferably about 7 to 15 mm, particularly preferably around 10 mm.

  It is preferable to use the shape-retaining balloon of the present invention from the viewpoint that the structure of the cecal access port is simplified, the insertion of the access port is smooth and there is no fear that it will come off, and maintenance is not required. In the case of using a conventional balloon, an air or fluid inlet for the balloon, an injection passage, and its sealing means are required.

  On the side surface of the distal end portion 42a of the catheter 42, an enema fluid outlet is provided. Although various shapes can be used as the outlet, it is preferable to provide a slit 46 that also functions as the backflow prevention means of the present invention from the viewpoint of simplifying the structure. When an outlet that does not function as a backflow prevention means is used instead of the slit, it is preferable to separately provide a backflow prevention means within the outlet or the cecal access port.

  The catheter base 44 is a fixing means that is attached to the catheter and is located outside the body and holds the cecal access port 41 in the fistula across the abdominal wall and cecal wall of the human body together with the means for preventing the body from coming off. It has an inlet 47. The catheter base 44 may have any shape as long as it functions as a fixing means. In particular, since the human body contact portion is preferably soft and less uneven with less irritation, such shape and material (preferably silicon resin) is used. It is formed. The diameter of the circular shape is preferably about 15 to 30 mm, and particularly preferably 20 to 25 mm.

  In order to allow the enema fluid to be injected using a general-purpose medical syringe or connector, the injection port 47 preferably has a luer taper shape as shown in FIG. 18a. The catheter base 44 has a stopper 45 that serves as a stopper for closing the injection port 47. The stopper 45 may be independent of the catheter base 44, but an integrated shape is preferable in that there is no risk of loss. In view of long wearing on the human body, it is preferable that the plug 45 be flat when closed so as not to get in the way.

  The material of the cecal access port is preferably a flexible and highly biocompatible material, and it is desirable that all components be formed of silicone resin, but the material is not limited to this.

  FIG. 18b shows another embodiment of a cecal access port. 18c is similar to the cecal access port shown in FIG. 18a, except that the cecal access port of FIG. 18a is shaped according to the first embodiment of the body access port described above, whereas the cecal access port of FIG. 18b. Is different in that it has a shape according to the third embodiment. Further, due to the difference in shape, desirable dimensions (sizes) are different, and the diameter of the maximum outer diameter portion of the balloon 53 is preferably about 8 to 18 mm, and particularly preferably 10 to 16 mm. The length in the longitudinal direction of the balloon 53 (refers to the inflated portion, which is 8 mm in FIG. 18b) is preferably about 6 to 13 mm, preferably about 7 to 10 mm, and particularly preferably about 8 mm. About 15-25 mm is preferable and, as for the length of the slit formation part 59 (Here, the part made into length 20mm in FIG.18b) including the parallel part of the balloon 53 is about 15-20 mm. In addition, the length (major axis direction) of the catheter base 54 (referred to here as a portion having a length of 30 mm in FIG. 18b) is preferably about 22 to 38 mm, and particularly preferably 27 to 33 mm. The catheter base 54 has an elliptical shape, and the length in the minor axis direction is preferably about 13 to 25 mm, and particularly preferably 15 to 23 mm.

  FIG. 18c shows a cross-sectional side view of the balloon 53 in FIG. 18b. In the balloon 53, the thickness of the portion parallel to the catheter 53 is 1.0 t, the thickness near the maximum diameter of the balloon is 1.5 t, and the thickness of the bulging portion other than the vicinity of the maximum diameter of the balloon is around 1.2 t. is there. The angle formed by the balloon wall at the maximum diameter portion of the balloon 53 is 77 degrees, and the angle between the balloon wall and the base 52b of the catheter 52 is 71 degrees.

  FIGS. 19a and 19b are views of mounting the cecal access port 41 according to the present invention. The method of using the cecum access port 41 will be described in detail. As shown in FIG. As shown in FIG. 19b, it is preferable to attach the appendix so that the appendix is reversed from the appendix, since this also prevents leakage and prevention. Specifically, after mounting on an inverted appendix or varus colon by laparotomy, endoscopic surgery or colonoscopic access, it is used semipermanently as an injection port for enema fluid.

  In the above-described embodiment of the present invention, the shape of the catheter base which is a fixing means outside the body is described as a button type, but it can also be applied to a tube type. However, the button type is preferable from the viewpoint of simplicity and prevention of pulling.

It is a partial cross section side view of the body access port concerning a 1st embodiment of the present invention. It is a side view of the body access port which concerns on the 1st Embodiment of this invention. 1 is a perspective view of a body access port according to a first embodiment of the present invention. It is a bottom view of the body access port concerning the 1st embodiment of the present invention. It is an enlarged view of the catheter front-end | tip part 2a in which the slit 6 of the body access port which concerns on the 1st Embodiment of this invention was formed. It is a partial cross section side view of the front-end | tip part 2a of the body access port which concerns on the 1st Embodiment of this invention, and the shape retention type | mold balloon 3. FIG. (A) is the partial cross section side view (normal time) of the body access port which concerns on the 2nd Embodiment of this invention, (b) is the body access port which concerns on the 2nd Embodiment of this invention It is a partial cross section side view (at the time of expansion | extension). It is sectional drawing of the catheter 12 of the body access port which concerns on the 2nd Embodiment of this invention. It is a partial cross section side view of the body access port which concerns on the 3rd Embodiment of this invention. It is a side view of the body access port which concerns on the 3rd Embodiment of this invention. It is a perspective view of the body access port which concerns on the 3rd Embodiment of this invention. It is a partial cross section side view of shape maintenance type balloon 23 and slit formation part 29 of a body access port concerning a 3rd embodiment of the present invention. (A) is a side view of the slit forming part 29, (b) is a longitudinal sectional view of the slit forming part 29, and (c) is a transverse sectional view of the slit forming part 29. (A) is a bottom view of the catheter base 24, (b) is a bottom view of the catheter base 24 according to another embodiment. (A) is the partial cross section side view (normal time) of the body access port which concerns on the 4th Embodiment of this invention, (b) is the body access port which concerns on the 4th Embodiment of this invention It is a partial cross section side view (at the time of expansion | extension). (A) is a cross-sectional side view at the time of insertion (at the time of expansion | extension) of the body access port which concerns on the 1st Embodiment of this invention, (b) is the body access port which concerns on the 3rd Embodiment of this invention. It is a cross-sectional side view at the time of insertion (at the time of extension). (A)-(c) is AA sectional drawing in FIG. (A) is a side view of a cecal access port according to the present invention, (b) is a side view of a cecal access port according to another embodiment of the present invention, and (c) is a sectional side view of a balloon. is there. (A) And (b) is a wearing figure of the cecal access port concerning the present invention.

Explanation of symbols

1: Body access port 2: Catheter 2a: Tip 2b: Base 3: Shape retention type balloon 4: Catheter base 5: Stopper 6: Slit 7: Injection port 8a, 8b: Cutting part
11: Body access port 12: Catheter 12a: Tip
12b: Base portion 12c: Central core portion 13: Shape-retaining balloon
14: catheter base 15: stopper 16: slit 18: passage 21: body access port 22: catheter 22a: distal end
22b: Base portion 22c: Central core portion 23: Shape-retaining balloon
24: Catheter base 24a, 24b: Recess 25: Stopper
26: Slit 26a: Slit cavity portion 27: Injection port 28a, 28b: Cutting portion 29: Slit forming portion 31: Body access port 32a: Tip portion 32b: Base portion 33: Shape-retaining balloon 34: Catheter base 35: Plug 39 : Slit forming part 30: stylet 41: cecal access port 42: catheter 42a: tip part
42b: Base 43: Balloon 44: Catheter base 44a: Recess 45: Stopper 46: Slit 47: Injection port 51: Cecal access port 52: Catheter 52a: Tip
52b: Base 53: Balloon 54: Catheter base 54a: Recess
55: Plug 56: Slit 57: Injection port 59: Slit formation part

Claims (15)

A catheter base having an injection port for an infusion solution and serving as a fixing means outside the body; a catheter having a passage for the infusion solution and an outlet for the infusion solution; In the body access port consisting of a sealing plug,
The removal prevention means is formed in an inflated state and can be inserted percutaneously so that its outer diameter can be temporarily reduced when inserted into the body. After insertion, air enters through an air passage connected to the outside of the body and automatically enters. A body-access port characterized by being a shape-retaining balloon capable of returning to an inflated state.   The body access port according to claim 1, wherein the catheter is composed of two parts, a distal end portion and a base portion, and each of the distal end portion and the base portion is fluid-tightly connected to the shape-retaining balloon. .   The body access port according to claim 2, wherein the catheter further has a central portion of a lumen in the lumen of the distal end portion and the base portion.   The body access port according to claim 1, wherein the lumen of the catheter serves as the air passage to the shape-retaining balloon.   The body access port according to claim 1, wherein the catheter has a slit forming portion having a diameter larger than that of the catheter at a distal end thereof.   2. The body access port according to claim 1, wherein the shape-retaining balloon does not have an opening communicating with the outside of the body in a wall portion of the shape-retaining balloon.   The shape-retaining balloon has a shape in which the distal end side linearly expands at an angle of 20 to 50 degrees with respect to the catheter, and the base side has an angle larger than the angle on the distal end side with respect to the catheter. The body access port according to claim 2, wherein the body access port is curved.   The shape-retaining balloon has an inner angle of 75 ° to 110 ° formed from the distal end side and the base side at the maximum outer diameter portion of the balloon, and the balloon from the connecting portion with the catheter to the maximum outer diameter portion. The body access port according to claim 2, wherein a length on the distal end side is longer than a length on the base side.   The body access port according to claim 1, wherein the shape-retaining balloon is extended in a longitudinal direction of the catheter when inserted into the body.   The shape-retaining balloon is formed such that when the balloon is stretched, one or more of the maximum outer diameter portions are folded inward along the longitudinal direction. Body access port.   The body access port according to claim 1, wherein the infusate outlet is a slit having a backflow prevention function.   The body access port according to claim 1, wherein the lumen of the catheter or the slit forming portion is eccentric, and the thickness of the slit forming portion is thin. .   The body access port according to claim 1, wherein the catheter base has a depression on a side in contact with a body surface and around a connection portion with the catheter.   The body access port of claim 1, wherein the plug is integral with the catheter base. A catheter base having an injection port for an infusion solution and serving as a fixing means outside the body; a catheter having a passage for the infusion solution and an outlet for the infusion solution; In the body access port consisting of a sealing plug,
The catheter has a predetermined length and diameter suitable as a cecal access port, and the distal end of the catheter and the removal preventing means have a length and diameter suitable for being percutaneously inserted into the cecum. Body access port characterized by being.