JP5052904B2 - Body access port - Google Patents

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.

  Conventionally, typical examples of the body access port include a gastrostomy catheter (PEG catheter) and an esophageal fistula catheter used for nutritional supplementation, for example. These body access ports have means for fixing to the inside and outside of the body so as not to fall out of the body after being attached to the body.

  As a fixing means inside the body, for example, there is a balloon type. As an example of this balloon type, for example, a balloon or the like that retains the expanded form of the balloon by preliminarily sealing the balloon with a fluid such as air or water is used, or the balloon is inserted into the body. Thereafter, a balloon is inflated by supplying fluid from a passage that communicates with the outside, and the balloon is inflated, and the passage is sealed to maintain the balloon inflated form (for example, Patent Document 1). , 2).

  As another example of the balloon type, for example, there is a shape memory type balloon that is automatically contracted by removing pressure from a pressurized state and can be folded around a catheter into a scroll shape before pressure inflation ( For example, see Patent Document 3).

  Further, as another example of the balloon type, for example, there is a shape-retaining type balloon that can be temporarily crushed only when being inserted into and removed from the body to eliminate the bulge and return to the original bulged state naturally ( For example, see Patent Document 4).

  The conventional body access port described in Patent Document 4 includes two catheters including a catheter tip and a catheter base, a balloon, and a long cap for pouring an infusion solution flowing out from the lumen of the catheter into the body. It is comprised by the four structural members which consist of a slit-shaped formation part. In this conventional body access port, two catheters are connected in series, and the balloon is fixed to each outer surface of the catheter tip and the catheter base via an adhesive in a state of surrounding the connecting part. . A slit forming portion is fitted and fixed in series with the balloon at the distal end portion of the catheter. In addition, this patent document 4 was previously proposed by the present applicant.

On the other hand, for example, two types of tube-type and button-type are known as examples of fixing means outside the body (see, for example, Patent Document 5).
JP 11-192310 A Japanese translation of PCT publication No. 2002-542840 JP 2003-62080 A JP 2005-13710 A JP 2001-346887 A

  By the way, the conventional body access port described in the above-mentioned patent documents 1 to 3 is configured to be inflated by supplying a fluid into a balloon as an escape preventing means made of a thin material excellent in stretchability. However, it is necessary to perform maintenance such as replenishment of air or liquid so that the balloon does not shrink due to air leakage or liquid leakage. In addition, it is necessary to provide an outlet or passage for supplying air or the like in the balloon along the catheter. In the passage, a stopper (a pin or a check valve) is required to hold the balloon bulge, and there are various problems that the structure of the body access port is complicated.

  Moreover, the conventional balloon described in the said patent document 3 is formed in the form folded by the scroll shape. Therefore, in forming the balloon, there is a problem that a complicated molding die is required and the manufacturing cost increases.

  On the other hand, the conventional body access port described in Patent Document 4 is configured such that the balloon can be naturally inflated and deflated, so that it is not necessary to perform maintenance such as replenishment of fluid. However, this conventional body access port includes two catheters, a balloon provided so as to surround the catheter connecting portion, and a long cap-shaped slit forming portion provided in series with the balloon on the outer surface of the distal end portion of the catheter. It has four constituent members. For this reason, the number of assembly parts increases, and a long time is required for the assembly work.

  In addition, in this conventional body access port, it is important to design the tip of the body access port as short as possible in order to make it difficult to come into contact with living tissue or the like. However, this conventional body access port is provided with a slit forming portion in series with the balloon on the outer surface of the distal end portion of the catheter. For this reason, the distal end portion of the body access port has a dimension obtained by adding the length of the slit forming portion to the length of the balloon, and the length in the distal end direction of the body access port inevitably increases. Accordingly, it is necessary to perform processing so that the tip of the slit forming portion does not come into contact with a living tissue or the like in a portion where the indwelling space is narrow.

  The present invention has been made to solve the above-described conventional problems, has a simple structure with a small number of parts, and can be manufactured efficiently and inexpensively without requiring a complicated mold. In addition, an object of the present invention is to provide a body access port that is easy to assemble, does not require maintenance, and does not need to consider contact with a living tissue or the like even in a portion where the indwelling space is narrow.

The present invention, inlet of injection liquid, a catheter having an outlet passage and said injection liquid of the infusion, there is a percutaneously insertable capable temporarily reduced during somatic insertion, body insert after automatically inflated by having a recoverable shape-retaining ability, and balloon the infusate to form a spout for pouring into the body flowing out of the outlet, have a, wherein the catheter, one The balloon is integrally formed by a shape-maintaining balloon body having a shape-retaining ability that can be restored, and a hollow balloon tip that opens on the balloon body side. The body access port is provided so as to cover a distal end portion of the catheter having the outflow port .

  As a preferred example of the present invention, a balloon is integrally formed by a shape-maintaining balloon body having a shape-retaining ability that can be restored and a hollow balloon tip that opens on the balloon body side. The outlet is preferably formed at the tip of the balloon. The outlet of the catheter is disposed at the opening end of the balloon tip, and the opening end has an annular engagement step portion that contacts and engages with the peripheral portion of the opening on the outlet side of the catheter. Is preferred. The balloon spout is preferably formed in a slit shape, but the present invention is not limited to this, and the balloon spout may be formed in a hole shape. In this case, it is important to provide a backflow prevention means for preventing the infusion from flowing back to the catheter side in the balloon. It is preferable that the wall portion constituting the spout is set to have a thickness that is thinner than other wall portions that do not have the spout.

  As another preferred example of the present invention, the balloon has a tip-side wall portion and a base-side wall portion opposite to the tip-side wall portion, and the tip-side wall portion. However, it has an inclined surface shape that spreads linearly at an angle of 20 to 50 degrees with respect to the catheter, and the wall portion on the base side is curved with an angle larger than the angle of the wall portion on the distal end side with respect to the catheter. It preferably has a curved shape. It is preferable that the wall on the base side further has a planar shape perpendicular to the axis of the catheter at the peripheral edge of the curved shape, and has two outer peripheral surfaces having a curved shape and a planar shape. It is.

  As still another preferred example of the present invention, the balloon has a maximum outer peripheral dimension portion between the distal end side wall portion and the base side wall portion, and the inner angle of the maximum outer peripheral dimension portion is 75 to 110 degrees. Preferably it is. As the balloon, it is preferable that the tip side wall portion is set to be longer than the base side wall portion.

  As yet another preferred example of the present invention, it is preferable that the balloon is shaped to be extendable in the length direction of the catheter when inserted into the body. The balloon is shaped so that one or more of the maximum outer peripheral dimensions are folded inward along the length of the catheter when stretched in the length direction of the catheter when inserted into the body. It is preferable.

  As yet another preferred example of the present invention, the catheter passage is preferably an air passage to the balloon. It is desirable that the catheter passage or the hollow portion of the balloon tip is formed eccentrically with respect to the central axis.

  As another preferred example of the present invention, the body access port is further provided at a base portion having a catheter inlet, and has a catheter base as a fixing means outside the body, and the catheter base communicates with the inlet. It is preferable to have a bush portion having an injection port and a stopper for sealing the injection port, and to have a recess around the bush portion on the side in contact with the body surface. The stopper is preferably formed integrally with the catheter base. The body access port of the present invention is not particularly limited, but has a predetermined length and diameter suitable as a cecal access port, and is suitable for percutaneously inserting a balloon into the cecum. It can be formed with length and diameter.

  According to the present invention, a balloon that can be automatically inflated and deflated is provided with a spout for pouring an infusion solution flowing out from the outflow port of the catheter into the body, whereby one catheter can be used as the balloon. Thus, it is possible to eliminate the configuration in which the distal end portion of the catheter extends from the balloon to the outside. As a result, the distal end of the body access port can be formed with a smooth outer shape from the balloon toward the distal end side, and the distal end of the body access port can be set as short as possible. Because the tip of the body access port can be shortened, the tip of the body access port is less likely to come into contact with living tissue, etc., even if the placement space is narrow, and the range in which the body access port is placed is expanded. Is possible.

  According to the present invention, the shape-retaining balloon inflated in the natural state is temporarily contracted only when inserted into and removed from the body, and is naturally restored to the original state after insertion into the body. Therefore, the maintenance of the balloon becomes unnecessary, and there is no need to provide a stopper for holding the balloon bulge or an outlet or a passage for supplying air or the like into the balloon. The structure of the body access port can be simplified, and it can be manufactured efficiently and inexpensively without requiring a complicated mold.

  In the present invention, as in the conventional body access port described in Patent Document 4, a special member having an injection solution outlet is provided at the distal end of the catheter protruding from the balloon body toward the distal end. This is no longer necessary and the number of parts can be reduced. Combined with this, the assembly is simple, the manufacturing cost can be reduced, and the parts can be easily managed.

  Furthermore, in the present invention, it can be effectively used as a body access port dedicated to the cecum suitable for cecal port surgery. It is possible to reduce the labor and labor of equipment procurement, and it is possible to reduce the cost, reduce the labor of the surgeon, and improve the patient's QOL.

  Preferred embodiments of the present invention will be specifically described below with reference to the accompanying drawings.

[First Embodiment]
1 is a partially sectional side view schematically showing a body access port according to a first embodiment of the present invention, FIG. 2 is a partially enlarged sectional view schematically showing a balloon main body of FIG. (A) is the elements on larger scale which show the balloon front-end | tip part of FIG. 1 schematically, FIG.3 (b) is the III-III arrow directional cross-sectional view of Fig.3 (a).

(Composition of body access port)
In FIG. 1, the code | symbol 1 has shown the whole structure of the body access port. As shown in FIG. 1, the basic structure of the body access port 1 is a button-type catheter base 2 having an injection port 22 for an injection solution such as a nutrient solution or an enema solution, an injection solution passage 31 and an injection solution. Three members are provided: a catheter 3 having an outflow port 32 and a shape-retaining balloon 4 that is a means for preventing the catheter 3 from being pulled out. As a material of the body access port 1, for example, a silicon resin material can be used. As the hardness of the catheter 3, for example, rubber hardness (durometer A) 70 is suitable, and as the hardness of the balloon 4, for example, rubber hardness (durometer A) 30 is suitable. The material of the body access port 1 is not limited to the silicone resin material. For example, all components are highly flexible, and various materials having high biocompatibility, such as thermoplastics such as polyethylene, polyamide, and fluororesin. An elastomer can be used.

(Configuration of catheter)
As shown in FIG. 1, the catheter 3 is composed of a single flexible circular tube member, and a balloon 4 is provided in a liquid-tight manner so as to cover the distal end side of the catheter 3. The outflow port 32 of the catheter 3 is preferably in full contact with the balloon 4 when the balloon 4 is in an inflated state. The passage 31 of the catheter 3 may be formed eccentric with respect to the central axis.

(Composition of balloon)
Each of FIG. 2 and FIG. 3 schematically shows a part of a shape-retaining balloon. The balloon 4 is configured as a fixing means for preventing the body access port 1 from being pulled out after being inserted into the body. The balloon 4 is made of a flexible material, such as a silicon resin material, and can be manufactured using a conventional manufacturing technique.

  As shown in FIGS. 2 and 3, the typical structure of the balloon 4 includes a balloon body 41 and a short hollow rod-shaped balloon tip 44. The balloon body 41 includes a cylindrical portion 42 having an insertion port for the catheter 3 and a bulging cylindrical portion 43 bulging outward. The balloon tip portion 44 is integrally formed on the opposite side of the cylindrical portion 42 with the bulging tube portion 43 of the balloon main body 41 interposed therebetween.

  As a conventional balloon, a balloon body having a thickness of about 0.5 mm is in a deflated state when it is in a normal natural state, and is generally inflated by supplying a fluid into the balloon body. On the other hand, the balloon 4 of this embodiment is formed in an inflated state, and can be inserted percutaneously that can be temporarily crushed and reduced in diameter when inserted into the body. The balloon 4 can be restored to the inflated state automatically by the elastic restoring force of the balloon 4.

  The balloon 4 of this embodiment can be formed in a bulging state by setting the wall thickness to be thicker than that of a conventional balloon. As the balloon 4, for example, a balloon set to a thickness dimension T1 of around 1.0 mm can be used. However, the outline shape, size, thickness, hardness, and the like of the balloon 4 can be changed according to the purpose of use of the body access port 1 and can be adjusted as appropriate. As the balloon 4, for example, a shape memory resin material can be used. The balloon 4 made of a shape memory resin material is preferable because it can be smoothly inserted into the body.

(Structure of the balloon body)
As shown in FIG. 2, the bulging tube portion 43 of the balloon 4 is composed of a wall portion 43a on the distal end side and a wall portion 43b on the base side opposite to the wall portion 43a, and these wall portions 43a. , 43b has a maximum outer peripheral dimension portion. The distal end side wall 43a has, for example, an inclined surface shape that extends linearly toward the base with an inclination angle θ1 with respect to the catheter 3. One base-side wall 43b has a curved shape that is curved with respect to the catheter 3 with an inclination angle θ2 that is larger than the inclination angle θ1 of the distal-end side wall 43a. In a state where the balloon body 41 is inflated, the length L21 of the distal end side wall 43a is set to be longer than the length L22 of the base side wall 43b.

(Configuration of balloon tip)
As shown in FIGS. 3 (a) and 3 (b), the balloon tip 44 of the balloon 4 has a cylindrical body 45 formed in a hollow shape opening on the surface of the balloon 4 on the side of the bulging cylinder 43, and its cylinder. The body 45 includes a solid taper portion 46 whose diameter decreases from one end to the tip, and a substantially hemispherical solid head 47 formed at the tip of the taper portion 46. The cylindrical body 45 is formed to have a diameter larger than the diameter of the catheter 3, and has a diameter-reduced inclined surface that gradually decreases in a stepwise or continuous manner from the tapered portion 46 toward the head 47. Even if the outer shape, size, thickness, hardness, etc. of the balloon tip 44 are changed, it can be changed depending on the purpose of use of the body access port 1. As the balloon tip portion 44, for example, it is preferable to have a reduced diameter inclined surface that gradually decreases in diameter stepwise or continuously from the cylindrical body portion 45 toward the head portion 47 without having a stepped portion. . By adopting this configuration, insertion into the body can be performed smoothly and easily.

  As shown in FIG. 3B, a circular hollow space (hollow part) 45a is formed inside the cylindrical body 45 of the balloon tip 44. As shown in FIG. The entrance of the hollow space 45a has a circular opening 45b having a smaller diameter than the circular opening of the hollow space 45a. The opening end portion of the small-diameter circular opening 45b has an annular engagement step portion 45c that comes into contact with and engages with the peripheral portion of the opening of the outflow port 32 of the catheter 3. The engaging step portion 45 c coincides with the inner peripheral surface of the bulging tube portion 43 of the balloon body 41. The outflow port 32 of the catheter 3 is liquid-tightly arranged in the engagement step portion 45c.

  As shown in FIGS. 3 (a) and 3 (b), the cylindrical body 45 of the balloon tip 44 has a slit 48 that serves as a pouring outlet for the injection solution. In order to give the spout a function as a backflow prevention means, it is preferable to have a slit shape. The slit 48 is formed so as to penetrate in a vertical direction at a position corresponding to the hollow space 45 a of the cylindrical body 45. As shown in FIG. 3 (b), the slit 48 is set so that the wall thickness constituting the slit is thinner than other wall portions other than the slit 48 portion, and the balloon tip 44 is hollow. The space 45a is formed eccentrically with respect to the central axis.

  The slit 48 of the balloon tip 44 is preferably provided with a cut parallel to the axis of the catheter 3 from the viewpoints of function and durability. At the time of pouring out the infusion solution, the relationship of internal pressure at the infusion port of the infusion solution> pressure for opening the slit 48 (for example, air pressure)> external pressure (for example, cecal pressure) is satisfied. At the time of pouring out the infusion, the internal pressure at the infusion port of the infusion is sufficiently higher than the pressure at which the slit 48 is opened, and the infusion can be smoothly and easily poured out from the slit 48 into the body. On the other hand, in a normal time, the pressure relationship of the pressure for opening the slit 48 from the outside> external pressure> internal pressure is satisfied. In normal times, the slit 48 is configured to withstand external pressure, and thus can function as a valve body that does not allow body fluid to flow backward.

  The shape, length, arrangement position, and the like of the slit 48 of the balloon tip 44 are not limited to the illustrated example. As a shape of a slit, it can be set as arbitrary shapes, such as a linear shape and a waveform, for example. The slit length can be set to a length shorter than the slit length in the illustrated example, for example, and the slit 48 is preferably disposed near the head 47 of the balloon tip 44, for example. By using the slit 48 as a spout, it is possible to reliably prevent the backflow of enema fluid or the like while having a simple structure. In addition, according to the example of illustration, although the injection hole of the injection liquid is formed in the slit shape, it is needless to say that it is not limited to this.

  By the way, depending on the thickness and size of the shape-retaining balloon 4, the pressure discharged from the slit 48 may be higher than the inflation pressure of the balloon 4. May swell, and the injection liquid may not be poured out from the slit 48 in some cases. When the internal pressure P is applied to the thin bulging cylinder portion 43 (radius R), the tearing force F acting in the tangential direction of the bulging cylinder portion 43 is obtained by F = R × P. When the same pressure P is applied, the tearing force F increases as the radius R increases. Therefore, as described above, the diameter of the balloon tip 44 is made larger than the diameter of the catheter 3, and the thickness of the portion where the slit 48 is formed is reduced within a range in which the prevention of the backflow of the infusion is sufficiently performed. The pressure for flowing out from the slit 48 can be set low. The balloon 4 has a diameter as small as possible within a range that maintains the retaining function and ease of insertion, and by setting the thickness to be thick, the pressure at which the balloon 4 inflates is set to be higher than the pressure poured out from the slit 48. It is important. With these configurations, it is possible to pour the infusion from the slit 48 into the body with a pressure lower than the pressure with which the balloon 4 inflates.

  In the shape maintaining type balloon 4 configured as described above, the wall 43a on the distal end side has a smooth inclined surface shape that extends linearly toward the base side, so that it can be inserted into the body. When the balloon 4 is deflated and stretched, it tends to become flat. Therefore, since the protruding part of the balloon 4 is eliminated, there is an advantage that it can be smoothly inserted into the human body. On the other hand, since the wall 43b on the base side has a curved surface shape, there is an advantage that it is less likely to come out than when it is attached to a body such as a stomach wall or a cecal wall.

  By adopting this shape-retaining type balloon 4, it becomes possible to increase the degree of freedom in design, and one catheter 3 can be internally fitted and fixed to the balloon body 41, and the body access port 1 The tip can be set to a short dimension. By shortening the distal end of the body access port 1, the balloon distal end portion 44 is less likely to come into contact with a living tissue or the like even in a region where the placement space is narrow, and the reliability of the body access port 1 can be improved. .

(Configuration of catheter base)
As shown in FIG. 1, the catheter base 2 has a truncated conical cylindrical bush portion 21 integrally projecting at the center of the disc body, and an annular recess 23 is formed on the outer surface portion thereof. ing. The bush portion 21 is formed with an injection port 22 for an infusion solution such as a nutrient solution or an enema solution, and close to the distal end portion of the flexible belt-shaped member integrally extended from the outer peripheral portion of the disc body. A substantially cylindrical plug 24 that closes the injection port 22 is projected.

  As shown in FIG. 1, the bush portion 21 of the catheter base 2 is fitted and fixed to the base side of the catheter 3 in a liquid-tight manner. The catheter base 2 is a fixing means located outside the body that holds the body access port 1 in the fistula with the balloon 4 serving as a means for preventing the body from falling out and sandwiching the abdominal wall, organ wall, etc. of the human body. In the illustrated example, the catheter base 2 is fixed to the catheter base side with an adhesive. However, the present invention is not limited to this. For example, the catheter base 2 and the catheter 3 can be integrally formed. The catheter base 2 can be formed into various forms as long as it functions as a fixing means outside the body. In particular, the human body contact portion of the catheter base 2 is preferably a flat shape which is rich in flexibility with little irritation and has no irregularities on the surface. As a material for the catheter base 2, for example, a silicon resin material is preferably used.

  As shown in FIG. 1, the injection port 22 of the catheter base 2 has a Luer taper shape so that the injection solution can be injected using a general-purpose medical syringe or connector. The inlet 22 is not limited to the illustrated example, and may have a shape other than the Luer taper shape, for example, from the viewpoint of preventing erroneous connection to the infusion line. In this case, the injection port 22 has a shape to which an adapter dedicated to the body access port can be connected. The plug 24 of the catheter base 2 may be formed separately from the catheter base 2, but a configuration integrated with the catheter base 2 is preferable in that there is no fear of loss or the like. In consideration of being left in the human body for a long time, it is preferable to form the catheter base 2 in a flat shape so that it does not get in the way when the injection port 22 of the catheter base 2 is closed with the stopper 24. As the catheter base 2, it is preferable to use a button type from the viewpoints of simplicity and prevention of pulling.

  According to the body access port 1 according to this embodiment, there is no need to refill the balloon 4 with air or liquid after insertion into the body, and a stopper for holding the balloon 4 inflating or air in the balloon 4. There is no need to provide a special outlet or passage for supplying the gas. For this reason, a structure can be simplified and the body access port 1 which can suppress a manufacturing cost is obtained. Moreover, although the structure of the body access port 1 is simplified, it does not inadvertently escape from the body, and further maintenance can be eliminated.

(Example of using the body access port)
Hereinafter, a usage example of the body access port according to the first embodiment will be described with reference to FIGS. 1, 2, and 4 to 6.

  4 is a side view of the body access port prior to operation showing the catheter base inlet of the body access port of FIG. 1, and FIG. 5 is a perspective view of the body access port of FIG. These are explanatory drawings which show typically the state which mounted | wore the cecal wall with the body access port of FIG.

  The body access port 1 according to the first embodiment configured as described above can be effectively used for, for example, the stomach, esophagus, cecum, or bladder. In this usage example, a case where the body access port 1 is used exclusively for the cecum port (hereinafter referred to as “cecal access port 1”) will be described.

  The total length of the catheter 3 of the cecal access port 1 is preferably about 30 to 150 mm as shown in FIG. The length L1 of the body fixing portion of the catheter 3 is preferably designed to be approximately equal to the total thickness of the abdominal wall H4, muscle layer H3, and cecal wall H1 shown in FIG. 6, for example, about 25 to 120 mm. Designed to. The outer diameter D2 of the catheter 3 is 10 to 20 Fr. It is preferable that it is about (about 3.3-6.6 mm).

  As shown in FIG. 1, the diameter D3 of the maximum outer peripheral dimension portion of the balloon body 41 is preferably about 10 to 20 mm, particularly preferably about 12 to 18 mm. The length L4 of the cylindrical portion 42 of the balloon body 41 is preferably about 5 mm. As length L2 of the bulging cylinder part 43 of the balloon main body 41, about 7-15 mm is suitable. Preferably, about 10 mm is suitable. As described above, it is preferable that the length L21 of the distal end side wall 43a and the length L22 of the base side wall 43b of the balloon 4 have a dimensional relationship of L21> L22 (FIG. 2). The length L3 of the balloon tip 44 is preferably about 12 mm.

  As shown in FIG. 2, the inclination angle θ1 of the distal end side wall 43a of the balloon main body 41 is preferably, for example, 20 degrees to 50 degrees with respect to the catheter 3, more preferably 25 degrees to 45 degrees. A tilt angle of 30 to 40 degrees is more preferable. The inclination angle θ2 of the one base side wall 43b is preferably, for example, 40 to 80 degrees, more preferably 45 to 80 degrees, and further preferably 55 to 80 degrees with respect to the catheter 3. . In this usage example, the inclination angle θ2 of the base side wall 43b is set to 71 degrees, for example. The inner angle θ3 formed by the distal end side wall 43a and the base side wall 43b in the inflated state of the balloon main body 41 is preferably set within a range of 75 ° to 110 °, and preferably 80 ° to 110 °. More preferably, it is 85 to 105 degrees.

  The catheter base 2 has a disk shape as shown in FIGS. 4 to 6, and the diameter D1 of the catheter base 2 is preferably about 15 to 30 mm, for example, as shown in FIG. Particularly preferred.

  As shown in FIG. 6, the cecal access port 1 has a balloon 4 placed in the cecum for a long period of time, and the cecum and body surface are fixed so as to sandwich the abdominal wall H4, muscle layer H3, and cecal wall H1 of the human body. It is a device for injecting enema fluid directly from the injection port 22 of the catheter base 2 through the slit 48 of the balloon tip 44 into the intestine for defecation. The catheter 3 of the cecal access port 1 is designed to be as short as possible in order to avoid contact between the balloon tip 44 and the intestinal lining. According to the illustrated example, the distal end of the catheter 3 can be temporarily separated from the engagement step 45c of the balloon body 41 during insertion into the body, and the diameter of the balloon body 41 can be reduced. After the cecum access port 1 is mounted on the varus of the colon by laparotomy, endoscopic surgery or colonoscopic access, it can be used semipermanently as an injection port for enema fluid.

  As a usage mode of the cecal access port 1 after being attached to the human body, for example, when enema fluid is being injected, the enema fluid is in contact with the engagement step 45 c at the opening end of the balloon tip 44 and the outlet 32 of the catheter 3. It is conceivable that the air enters the balloon body 41 from the boundary between them and the air in the balloon body 41 is replaced with the enema liquid. However, if the air is slightly supplied after the enema liquid is injected, the enema liquid is replaced with the air. It is also possible to prevent the enema fluid from remaining in place. When it is necessary to replace the cecal access port 1 attached to the body, for example, the cecal access port 1 attached to the cecum is cut and the balloon body 41 remaining in the body is dropped into the cecum. Can be discharged together with feces. Note that the stylet 5 shown in FIG. 7 can be used to stretch the balloon 4 and pull it out of the cecum.

  Although the body access port 1 according to the first embodiment can be inserted into the body without using a stylet, the stylet 5 shown in FIG. 7 is used to smoothly insert the body access port 1 into the body. It is good. As an example of the balloon 4, for example, by inserting the stylet 5 into the catheter 3, the distal end of the catheter 3 is temporarily separated from the engagement step portion 45 c of the balloon body 41, and the bulging tube portion of the balloon body 41 is 43 can be deformed by extending in the longitudinal direction of the catheter or by reducing the diameter, and after insertion into the body, air enters the balloon body 41 through the outlet 32 of the catheter 3, and the balloon body 41 remains at the predetermined time. It may return to the original outer shape, and may have a hardness that does not easily escape from the body.

  FIG. 7 is a cross-sectional view of the body access port schematically showing a state where the balloon is extended in the longitudinal direction of the catheter.

  In the same figure, the code | symbol 5 has shown the stylet for extending and pulling out the balloon main body 41 typically. As shown in FIG. 7, the stylet 5 is configured to have a grip portion 52 at the end of a rod 51 made of stainless steel or a resin material. As the stylet 5, the balloon body 41 is inserted into the access port 1, and the proximal side of the catheter 3 of the access port 1 is gripped and pushed by hand, and the balloon body 41 is extended, thereby reducing the swelling of the balloon body 41. Various shapes can be used as long as they can be smoothly inserted into a heel opened in a human body in a straight state.

  8 is an end view taken along the line VII-VII in FIG. 7 and schematically shows a state in which the balloon 4 of the body access port 1 is extended. FIG. 8A shows a state in which the balloon main body 41 extends without being bent. FIG. 8B shows a state in which one portion of the maximum outer peripheral dimension of the balloon main body 41 is bent inward along the catheter length direction. FIG. 8C illustrates the state in which two portions of the maximum outer peripheral dimension portion of the balloon main body 41 are folded inward along the catheter length direction. As shown in the illustrated example, the balloon body 41 is formed by forming the balloon body 41 so that when the balloon body 41 is stretched, one or more of the maximum outer peripheral dimension portions are folded inward along the catheter longitudinal direction. This is preferable in that it can be contracted to a smaller diameter and can be smoothly inserted into the body.

[Second Embodiment]
FIG. 9 is a side view of the body access port showing a state where the catheter base inlet of the body access port according to the second embodiment of the present invention is closed, and FIG. 10 is a view of the body access port of FIG. FIG. In these drawings, the thickness dimension of the balloon wall, the size of the balloon, and the outer shape of the balloon are different from those of the first embodiment. In these drawings, substantially the same members as those in the first embodiment are given the same member names and symbols. Therefore, the detailed description regarding these members is omitted.

  Table 1 below summarizes the dimensions of the body access port according to the first and second embodiments.

  As is clear from Table 1, the total length of the catheter, the length L1 of the body fixing portion, the length L3 of the balloon tip portion, and the length L4 of the balloon cylindrical portion are the body access port according to the first embodiment. There is no difference from 1.

(Configuration of catheter)
In the second embodiment, the outer diameter D2 of the catheter 3 is, for example, 10 to 12 Fr. It is preferable that it is about (about 3.3-4 mm).

(Composition of balloon)
Even in the shape maintaining type balloon 4 according to the second embodiment, as shown in FIGS. 9 and 10, the shape is a mountain shape outward from the cylindrical portion 42 having the insertion port of the catheter 3. A balloon main body 41 having a bulging tubular portion 43 that bulges and a short rod-shaped balloon tip portion 44 that is integrally formed on the opposite side of the cylindrical portion 42 with the bulging tubular portion 43 interposed therebetween. . The distal end side wall 43a of the balloon main body 41 has an inclined surface shape that extends linearly toward the base side with an inclination angle θ1 with respect to the catheter 3. One base side wall 43b has a curved shape portion curved with an inclination angle θ2 larger than the inclination angle θ1 of the distal end side wall portion 43a with respect to the catheter 3 and a straight straight portion 43c smoothly and continuously. It is comprised by two outer peripheral surfaces which consist of curved surface shape and planar shape. The straight portion 43c stands upright with respect to the axial center of the catheter 3 in the inflated state of the balloon body 41, becomes a wall surface facing the in-vivo contact portion side, and functions as a retaining means for preventing the body from coming out of the body. Can be done.

  As for the thickness dimension of the balloon 4, the thickness T1 of the balloon 4 is 1.0 to 1.7 mm, and the thickness gradually increases from the cylindrical part 42 or the balloon tip part 44 parallel to the catheter 3 to the maximum outer peripheral dimension part. The balloon main body 41 can be used preferably. It is desirable that the wall thickness T1 of the bulging tube portion 43 of the balloon body 41 is 1.1 to 1.7 times the wall thickness T2 of the cylindrical portion 42 parallel to the catheter 3 or the wall thickness T2 of the balloon tip portion 44. .

  In the illustrated example, when the thickness T2 of the cylindrical portion 42 or the balloon tip portion 44 parallel to the catheter 3 is 1.0 mm, the thickness T3 near the maximum outer peripheral dimension portion of the balloon body 41 is, for example, 1 3 to 1.6 mm is preferable, and 1.4 to 1.5 mm is particularly desirable. On the other hand, as the wall thickness T1 other than the vicinity of the maximum outer peripheral dimension portion of the balloon body 41, for example, 1.2 to 1.4 mm is preferable, and 1.3 mm is particularly desirable.

  As shown in FIGS. 9 and 10, the balloon 4 has a thicker balloon wall and a smaller diameter of the balloon body 41 compared to the shape-retaining balloon according to the first embodiment. It is set to be compact. According to the illustrated example, in a state where the balloon body 41 is inflated, the diameter D3 of the maximum outer peripheral dimension portion of the balloon body 41 is preferably about 8 to 18 mm, and particularly preferably about 10 to 16 mm. More preferably, the thickness is about 12 to 14 mm. The length L2 of the bulging tube portion 43, which is the inflated portion of the balloon body 41, is preferably about 6 to 13 mm in the inflated state of the balloon body 41. Preferably, about 7-10 mm is suitable, and around 8 mm is particularly desirable. The length L3 of the balloon tip 44 is preferably about 12 mm. In the inflated state of the balloon main body 41, the length L21 of the distal end side wall portion 43a and the length L22 of the base side wall portion 43b have a dimensional relationship of L21> L22.

  As shown in FIG. 10, the balloon 4 has an inner angle θ3 of the maximum outer peripheral dimension formed by the distal end side wall portion 43a and the base side wall portion 43b in a state where the balloon body 41 is inflated to be about 75 to 83 degrees. Is formed. More preferably, the inner angle θ3 of the maximum outer peripheral dimension portion is about 77 to 80 degrees. At this time, the angle θ2 formed by the base side wall 43a of the balloon body 41 and the catheter 3 is preferably, for example, 65 degrees to 85 degrees. By adopting such a configuration, the injection solution from the slit 48 of the balloon distal end portion 44 can be smoothly poured out while maintaining the removal prevention function and the ease of insertion.

(Configuration of catheter base)
11 is a perspective view of the body access port before operation showing a state where the catheter base inlet of the body access port of FIG. 9 is opened, and FIG. 12 is a configuration example of the catheter base viewed from the human body contact portion side. It is a schematic plan view.

  In the first embodiment, a truncated cone-shaped bush portion 21 is integrally projected at the center of the disc body of the catheter base 2, and the outer surface portion of the bush portion 21 has a width. A narrow annular recess 23 is formed. On the other hand, the catheter base 2 in the second embodiment has a protruding piece 25 in which the catheter base 2 is integrally projected from the rear part of the disc body, as shown in FIGS. 11 and 12A. In addition, the second embodiment is different from the first embodiment in that a wide annular recess 23 is provided on the outer surface of the truncated conical bush portion 21.

  As shown in FIGS. 11 and 12A, the catheter base 2 has an elliptical shape, and the diameter of the catheter base 2 in the major axis direction is preferably about 22 to 38 mm, particularly 27 to 33 mm. preferable. The diameter of the catheter base 2 in the minor axis direction is preferably about 13 to 25 mm, and particularly preferably 15 to 23 mm.

(Modification of catheter base)
As another example of the catheter base 2, as shown in FIG.12 (b), a pair of notch recessed part 23a notched outward from the annular recessed part 23 can be formed facing. As another example of the annular recess 23, for example, an uneven shape having a plurality of annular recesses 23,..., 23 formed on the same circumference centering on the annular recess 23, etc. Good. With this configuration, when the catheter 3 is mounted in the body, the catheter base 2 is not completely brought into close contact with the body surface, so that a gap is generated, thereby ensuring air permeability. Combined with this, even when the catheter base 2 is in contact with the body surface for a long time, skin troubles such as rash on the body surface can be reduced. The outer shape of the catheter base 2 may be an elliptical shape in plan view, for example, instead of the disc body. With this configuration, it is possible to secure an area corresponding to the body surface and improve operability during surgery.

(Other usage examples of body access port)
Hereinafter, a more specific embodiment of the cecal access port of the present invention will be described with reference to FIGS. FIG. 13 schematically shows a state in which the body access port according to the second embodiment is attached to the appendix.

  As an example of use of the cecal access port 1, as shown in FIG. 6, it is common to provide the cecal access port 1 in a thick part of the cecal wall H1, but as shown in FIG. It is preferable to attach it so that it is reversed because it also prevents leakage and prevention. According to the illustrated example, it can be used semipermanently as an injection port for enema fluid after being attached to the inverted appendix H2 by laparotomy, endoscopic surgery, or access by a colonoscope. In FIG. 13, symbol H3 indicates a muscle layer and symbol H4 indicates an abdominal wall.

  As shown in FIG. 13, when the catheter 3 is inserted from the appendix H2, the catheter 3 is designed to be longer in consideration of the length of the appendix H2. According to the length of the catheter 3, the length of the appendix H2 is adjusted by cutting the appendix H2. The outer diameter D2 of the catheter 3 is 10-12 Fr. from the size of the appendix H2 when inserted and placed from the appendix H2. It is preferable that it is about (about 3.3-4 mm).

  The balloon 4 shown in FIG. 13 has a thickness T2 of the cylindrical portion 42 or balloon tip 44 parallel to the catheter 3 of 1.0 mm, a thickness of the balloon body 41 near the maximum outer peripheral dimension portion T3 of 1.5 mm, The wall thickness T1 of the bulging portion other than the vicinity of the maximum outer peripheral dimension portion 41 is set to about 1.3 mm. Further, in this balloon 4, in the state where the balloon body 41 is inflated, the inner angle θ3 of the maximum outer peripheral dimension formed by the distal end side wall 43a and the base side wall 43b is 77 degrees, and the base side wall 43b and the catheter 3 Is 71 degrees.

(Third embodiment)
FIG. 14 schematically shows a balloon of a body access port according to the third embodiment. 14A is an enlarged view of the balloon, and FIG. 14B is a cross-sectional view taken along the line XIV-XIV in FIG. 14A. In these drawings, the substantially same members as those in the above embodiments are given the same member names and reference numerals. Therefore, the detailed description regarding these members is omitted.

(Composition of balloon)
In these drawings, the balloon 4 according to the third embodiment is such that the hollow space 45a of the balloon tip 44 is formed on the same axis as the central axis of the catheter 3, and the injection port for the injected solution is a hole. It differs from the above embodiments in that it is formed in a shape and a backflow prevention means is provided in the balloon 4.

  In order to give the injection outlet a function as a backflow prevention means, it is preferable that the injection outlet has a slit shape, but it does not function as a backflow prevention means in place of the slit 48 which is the injection outlet. A spout can be used. In the third embodiment, as shown in FIG. 14A, a circular hole 48a serving as a spout is formed at a position corresponding to the hollow space 45a of the cylindrical body 45 of the balloon tip 44. It is formed to penetrate in the vertical direction. The spout is not limited to a circular shape, and may be, for example, an elliptical hole or a rectangular hole shape such as a rhombus or a square.

  In each of the embodiments described above, the wall thickness of the wall portion that forms the slit 48 serving as the injection port for the injection solution is set to be thinner than other wall portions other than the slit 48 portion. On the other hand, in the third embodiment, as shown in FIG. 14B, the wall portion constituting the pouring port for the injected solution and the other wall portion other than the slit 48 portion have the same wall thickness. Can be set to

  When a spout that does not function as a backflow prevention means is used, a backflow prevention means can be provided in the spout or body access port 1. According to the third embodiment, as shown in FIG. 14B, a check valve 49 having a duckbill shape is provided at the entrance of the hollow space 45a of the balloon tip 44. The check valve 49 is made of, for example, a silicon resin material. The check valve 49 is not limited to the illustrated example, and for example, the size, shape, material, and the like of the valve can be appropriately set.

  The check valve 49 shown in FIG. 14B is not particularly limited, but can be attached to an annular peripheral wall surface forming the inlet of the hollow space 45a via an adhesive, for example. In providing the check valve 49 in the hollow space 45a, an adhesive is applied in advance to the peripheral wall surface of the inlet of the hollow space 45a through the circular hole 48a, and the check valve 49 is installed through the circular hole 48a. By inserting it into the hollow space 45a, the check valve 49 can be bonded and fixed to the peripheral wall surface of the inlet of the hollow space 45a. Even when the diameter of the circular hole 48a serving as the spout is formed smaller than the check valve 49, the check valve 49 can be folded and inserted into the hollow space 45a.

  The check valve 49 can function as a valve that does not allow the injection liquid to flow backward because the pressure difference inside and outside the injection outlet of the injection liquid is small at normal times. The pressure discharged from the check valve 49 is set lower than the pressure at which the balloon 4 is inflated. At the time of pouring out the infusate, the infusate can be freely flowed into the body through the check valve 49, and backflow can be suppressed under a differential pressure in the reverse direction. When the balloon 4 is inserted into the body, as described above, the balloon 4 can be easily and smoothly inserted into the body by extending the balloon 4 using the stylet 5 shown in FIG. The dimensions of the body access port 1 according to the third embodiment are not different from the dimensions of the components of the body access port according to the second embodiment shown in Table 1 above.

  As is clear from the above description, in each of the above-described embodiments, the shape of the catheter base, which is a structure having the circular hollow space 45a in the cylindrical body 45 of the balloon tip 44, is a fixing means outside the body. Is constituted by a button type. However, the present invention is not limited to this. For example, the tapered portion 46 and the head 47 of the balloon tip 44 are eliminated, or the cylindrical body 45 of the balloon tip 44 is made as short as possible. You may form in a dimension. In addition, the balloon tip 44 can be eliminated to form an injection port for the injection solution at the tip of the balloon body 41, and the shape of the catheter base 2 can of course be a tube type. It is possible to sufficiently achieve the initial objectives. Therefore, the present invention is not limited to the above embodiments and modifications, and various design changes can be made within the scope described in each claim.

1 is a partial cross-sectional side view schematically showing a cutaway part of a body access port according to a first embodiment of the present invention. FIG. 2 is a partial cross-sectional enlarged view schematically showing a balloon body in the body access port of FIG. 1. (A) is the elements on larger scale which show schematically the balloon front-end | tip part in the body access port of FIG. 1, (b) is the III-III sectional view taken on the line of (a). FIG. 2 is a side view of the body access port before operation showing a state in which the catheter-based inlet of the body access port of FIG. 1 is opened. FIG. 5 is a perspective view of the body access port of FIG. 4. It is explanatory drawing which shows typically the state which mounted | wore the cecal wall with the body access port of FIG. It is sectional drawing of the body access port which shows the state by which the balloon was extended by the catheter longitudinal direction. (A) is an end view taken along line VII-VII in FIG. 7, (b) is an end view showing a modification of (a), and (c) is another modification of (a). FIG. It is a side view of the body access port which shows the state which the injection hole of the catheter base of the body access port which is the 2nd Embodiment concerning this invention closed. FIG. 10 is a partial cross-sectional enlarged view schematically showing a balloon of the body access port of FIG. 9. FIG. 10 is a perspective view of the body access port before operation showing a state in which the catheter-based inlet of the body access port of FIG. 9 is opened. It is the schematic plan view which looked at the structural example of the catheter base from the human body contact part side. It is explanatory drawing which shows typically the state which mounted | wore the appendix with the body access port which concerns on the said 2nd Embodiment. (A) is the enlarged view which shows schematically the balloon of the body access port which is 3rd Embodiment which concerns on this invention, (b) is a XIV-XIV arrow directional cross-sectional view of (a). is there.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Body access port 2 Catheter base 3 Catheter 4 Balloon 5 Stylet 21 Bush part 22 Inlet 23 Recess 23a Notch recessed part 24 Plug 25 Projection piece 31 Passage 32 Outlet 41 Balloon main body 42 Cylindrical part 43 Inflated cylinder part 43a, 43b Wall part 43c Straight part 44 Balloon tip part 45 Cylindrical body part 45a Hollow space 45b Circular opening 45c Engagement step part 46 Taper part 47 Head part 48 Slit 48a Circular hole 49 Check valve 51 Rod 52 Grain part H1 Cecal wall H2 Appendices H3 Muscle layer H4 Abdominal wall

Claims (17)

A catheter having an infusate inlet, an infusate passage and an infusate outlet;
Be those of percutaneously insertable capable temporarily reduced during somatic insertion, after insertion into the body, have a recoverable shape-retaining ability inflated automatically, the injection liquid flowing out of the outflow port A balloon that forms a spout to pour into the body,
I have a,
The catheter consists of one tube member,
The balloon is integrally formed by a shape-maintaining type balloon body having a shape-retaining ability capable of being restored, and a hollow balloon tip that opens on the balloon body side,
The body access port , wherein the balloon body is provided so as to cover a distal end portion having the outflow port of the catheter . The spout of the previous SL balloon body access port according to claim 1, characterized in that it is formed on the balloon tip. The outlet of the catheter is disposed at the open end of the balloon tip,
The open end, the body access port according to claim 1, characterized in that it has the flow outlet side of the opening peripheral portion and the engaging step portion of the contact with the annular engaging the catheter. The body access port according to claim 1 or 2, wherein the spout at the tip of the balloon is formed in a slit shape. The spout at the balloon tip is formed in a hole shape,
The body access port according to claim 1 or 2, wherein a backflow preventing means for preventing the infusion from flowing back to the catheter side is provided in the balloon tip . The wall portion constituting the spout at the tip of the balloon is set to have a thinner thickness than other wall portions not having the spout. Body access port according to any of the above. The balloon main body has a wall on the distal end side and a wall on the base side opposite to the wall on the distal end side,
The wall on the distal end side has an inclined surface shape that extends linearly at an angle of 20 to 50 degrees with respect to the catheter,
The body access according to claim 1 or 2, wherein the base-side wall has a curved shape that is curved with respect to the catheter at an angle larger than the angle of the distal-end-side wall. port.   The base-side wall portion further has a planar shape perpendicular to the axis of the catheter at the curved peripheral edge, and has two outer peripheral surfaces comprising the curved shape and the planar shape. 8. A body access port according to claim 7, wherein: The balloon body has a maximum outer peripheral dimension portion between the distal end side wall portion and the base side wall portion,
The body access port according to claim 7 or 8, wherein an inner angle of the maximum outer peripheral dimension portion is 75 to 110 degrees. The body access port according to any one of claims 7 to 9, wherein the balloon main body is set such that a wall portion on the distal end side is longer than a wall portion on the base side. The body access port according to any one of claims 1, 2, 7 to 10, wherein the balloon body is formed to be extendable in a length direction of the catheter when inserted into the body. The balloon body is shaped so that one or more of the maximum outer peripheral dimension portions are folded inward along the length direction of the catheter when the balloon body is extended in the length direction of the catheter when inserted into the body. The body access port according to claim 11, wherein the body access port is provided.   The body access port according to claim 1, wherein the passage of the catheter is an air passage to the balloon.   3. The body access port according to claim 1, wherein the hollow portion of the passage of the catheter or the distal end portion of the balloon is formed eccentrically with respect to a central axis. The body access port is further provided at a base portion having the inlet of the catheter, and has a catheter base serving as a fixing means outside the body,
The catheter base has a bush portion having an injection port communicating with the inflow port and a plug for sealing the injection port, and has a concave portion around the bush portion on the side in contact with the body surface. The body access port of claim 1, wherein 16. The body access port of claim 15 , wherein the plug is integrally formed with the catheter base. The body access port has a predetermined length and diameter suitable as a cecal access port;
The body access port of claim 1, wherein the balloon is of a length and diameter suitable for percutaneous insertion into the cecum.

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