JPH07184995A - Intraperitoneal remaining catheter - Google Patents

Abstract

PURPOSE:To easily and surely obtain an intraperitoneal remaining catheter at a low cost capable of easily inserting and extracting the catheter to and from the peritoneal cavity and exchanging the dialysis liquid by providing a projected part projected outside from the side hole forming surface of a detention part and formed is succession along the axis direction. CONSTITUTION:An intraperitoneal remaining catheter 1 is provided with a catheter 10 having a detention part 2 in the peritoneal cavity at the tip, projected rib 3 in a detention part 2, the 1st cuff 4, and the 2nd cuff 5. An intraperitoneal opening 21 is formed towards the axis direction of the catheter 10 at the end of the detention part 2. Plural side pores connecting the intraperitoneal part and the outside surface are formed on the peripheral surface of the part 2. Further, the rib 3 is formed on the part 2. The rib 3 is formed parallel with the axis line of the catheter 10 and all over the detention part 2. At the base side of the rib 3, an inclination part 32 whose height of the rib 3 is reduced gradually is formed towards the base direction.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intraperitoneal indwelling catheter which is used by being placed in the abdominal cavity mainly in the peritoneal dialysis method.

[0002]

2. Description of the Related Art Dialysis therapy is mainly carried out for the purpose of removing uremic substances such as water, urea and creatinine accumulated in the body by acting as a part of renal function. In most cases, treatment by hemodialysis therapy is performed, but the treatment is performed under the supervision of a special device, so that the patient is required to visit the hospital twice or three times a week, and the treatment time for one treatment is 4 to 5 times. The time, the burden on the patient and their families were large, and it was a great obstacle to the patient's return to society.

On the other hand, the number of patients is increasing because the peritoneal dialysis therapy is a treatment method that alleviates the time constraint on the patients and enables rehabilitation to society. In the above-mentioned peritoneal dialysis therapy, a procedure is performed in which a dialysate (dialysis perfusate) is injected into the abdominal cavity, and after a certain period of time, the dialysate drainage is discharged to the outside of the abdominal cavity. Injecting dialysate and draining drainage fluid
It is performed by an intraperitoneal indwelling catheter placed in the abdominal cavity and a dialysate exchange system connected to this catheter.

A plurality of side holes are formed in the intraperitoneal indwelling portion of the intraperitoneal indwelling catheter so that dialysate and its drainage fluid (hereinafter collectively referred to as "dialysis fluid") can easily flow. This intraperitoneal indwelling part is inserted and placed in the lowest Douglas stalk in the abdominal cavity.

The conventional indwelling catheter in the abdominal cavity has a problem that when the dialysate is discharged, the inner wall of the abdominal cavity adheres to the side hole and the side hole is blocked, so that the dialysate cannot be discharged sufficiently. Further, when the dialysate in the abdominal cavity is sucked and discharged by a dialysate exchange system, etc., the inner wall of the abdominal cavity easily adheres to the side hole, and further, the inner wall is drawn into the side hole, which damages the inner wall of the abdominal cavity. was there.

Further, the indwelling catheter in the abdominal cavity moves in the abdominal cavity and deviates from the Douglas taka, which also causes a problem that the dialysate cannot be discharged sufficiently.

Here, the conventional indwelling catheter in the abdominal cavity is
In addition to fixing the catheter in the abdominal cavity, a disk is provided at the proximal and distal ends of the indwelling part to prevent adhesion and suction of the inner wall. Those that can be opened are proposed.

[0008] Further, in the case where the tip has a spherical shape or is provided with a disc, or a shape memory material is used, when the catheter is inserted into or removed from the abdominal cavity of the patient, a large incision is made in the abdominal wall. It is difficult to insert and remove, and the chances of infection increase,
The burden on the patient is heavy.

In particular, the one using the shape memory material has a problem that it is necessary to perform a positioning operation for fixing it in the abdominal cavity, and it is difficult to mount it without damaging the inner wall of the abdominal cavity. Further, in any of the above cases, there is a drawback that the initial cost becomes high because the structure becomes complicated.

[0010]

DISCLOSURE OF THE INVENTION An object of the present invention is to provide an intraperitoneal indwelling catheter which can be easily inserted into and extracted from the abdominal cavity, can exchange dialysate reliably and easily, and can be manufactured at low cost. Especially.

[0011]

This object is achieved by the present invention (1) described below, and further (2) to (1)
0) is preferable.

(1) Intraperitoneal indwelling catheter having a catheter body having an indwelling portion to be placed in the abdominal cavity and a plurality of side holes provided in the indwelling portion and communicating the inner cavity of the catheter body with the outer surface An indwelling catheter in the abdominal cavity, wherein the indwelling catheter has a convex portion that projects at least outward from the side hole forming surface of the indwelling portion and that is formed continuously along the axial direction.

(2) The indwelling catheter in the abdominal cavity according to (1), wherein the convex portion is linearly formed.

(3) The intraabdominal indwelling catheter according to (1), wherein the convex portion is formed in a spiral shape.

(4) The abdominal indwelling device according to any one of the above (1) to (3), wherein the tip of the convex portion on the indwelling portion side projects from the tip of the indwelling portion in the axial direction of the catheter body. catheter.

(5) The intraperitoneal indwelling catheter according to any one of (1) to (4) above, wherein the catheter body is made of a thermoplastic fluororesin.

(6) The intraabdominal indwelling catheter according to any one of (1) to (5), wherein the convex portion is integrally formed with the catheter body.

(7) Intra-abdominal indwelling catheter having a catheter body having an indwelling portion to be placed in the abdominal cavity and a plurality of side holes provided in the indwelling portion and communicating the inner cavity of the catheter body with the outer surface In addition, the intraperitoneal indwelling catheter is characterized in that a groove is formed on an outer peripheral surface of the indwelling portion along an axial direction, and the side hole is formed in a bottom portion of the groove.

(8) The intraperitoneal indwelling catheter according to (6) or (7), which is molded by extrusion molding.

(9) The intraperitoneal indwelling catheter according to any one of (1) to (7), which has a plurality of convex portions, and connecting portions are provided between the convex portions at predetermined intervals.

(10) The abdominal indwelling catheter according to any one of the above (1) to (9), wherein at least the indwelling portion and the convex portion are subjected to a hydrophilic treatment.

[0022]

The preferred embodiments of the catheter for indwelling the abdominal cavity of the present invention will be described below in detail with reference to the accompanying drawings. FIG. 1 is an overall side view of the intraperitoneal indwelling catheter 1, and FIG.
FIG. 6 is a sectional view taken along line AA in FIG.

In the peritoneal dialysis method, the indwelling intraperitoneal catheter 1 of the present invention exchanges the dialysate when performing a procedure of injecting the dialysate into the abdominal cavity and discharging the dialysate out of the abdominal cavity after a certain period of time. Used as a flow path. That is, the tip portion of the intraperitoneal indwelling catheter 1 is inserted into the patient's abdominal cavity by penetrating the abdominal wall, and the intraperitoneal indwelling catheter 1 is inserted.
The patient has a daily life while maintaining the state in which the distal end portion of the abdominal cavity is left in the abdominal cavity, and the dialysate is exchanged through the intraabdominal indwelling catheter 1 at regular intervals.

Such an intraperitoneal indwelling catheter 1 has a catheter main body 10 having an indwelling portion 2 placed in the abdominal cavity at the tip, a rib 3 as a convex portion provided on the indwelling portion 2, and a first It has a cuff 4 and a second cuff 5.

The catheter body 10 is a tubular body,
The tip side to be inserted into the abdominal cavity is the indwelling section 2, the first cuff 4 is fixed to the proximal end of the indwelling section 2, and the second cuff 5 is further fixed to the proximal side. There is. These cuffs 4 and 5 are members for fixing the catheter body 10 to the abdominal wall. In addition, a peritoneal dialysis system in which a dialysate bag, a drainage bag and the like are connected by a tube is connected to the base end portion 6 of the catheter body 10 via a joint (not shown) or the like.

As shown in FIG. 3, the distal end of the indwelling portion 2 has a lumen 11 directed in the axial direction of the catheter body 10.
The opening 21 is formed, and a plurality of side holes 22 that communicate the inner cavity 11 and the outer surface are formed in the peripheral surface of the indwelling portion 2. As shown in FIG. 2, four side holes 22 are provided at equal intervals in the circumferential direction in the cross-sectional view, and are arranged at equal intervals on a straight line parallel to the axis of the catheter body 10. ing. The dialysate is exchanged through this opening 21 and the side holes 22.

Further, the detaining portion 2 is provided with ribs 3. The rib 3 of the present embodiment is provided parallel to the axis of the catheter body 10 and over substantially the entire length of the indwelling portion 2, and is integrally formed with the catheter body 10 by, for example, extrusion molding that pushes out in the axial direction. The conditions for extrusion molding are, for example, that the temperature at the resin inlet is 1
About 60 to 190 ° C, the temperature at the middle part (screw part) is about 190 to 250 ° C, and the temperature at the outlet part is 220 to
It is preferable that the temperature is about 250 ° C. and the discharge speed is about 20 to 50 rpm.

Further, as shown in the cross-sectional view of FIG. 2, four ribs 3 are provided, and each rib 3 is provided upright between the side holes 22 in a direction perpendicular to the peripheral surface. The four ribs 3 are formed in the same shape. The tip portion 31 of the rib 3 projects from the tip of the indwelling portion 2,
Its tip is formed in an arc shape and has a shape that does not damage the inner wall of the abdominal cavity by contacting it.

Further, on the base end side of the rib 3, there is formed an inclined portion 32 in which the height of the rib 3 gradually decreases toward the base end direction. The inclined portion 32 is formed from the base end portion of the region where the side hole 22 is formed to the region where the side hole 22 is not formed. By providing the inclined portion 32, when the catheter body 10 is pulled out from the abdominal cavity, the rib 3 can be smoothly pulled out without being hooked on the abdominal wall.

The catheter body 10 configured as described above is made of, for example, thermoplastic fluororesin, polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polystyrene, silicone, etc., and is made of a flexible material. It is preferably configured. In particular, it is preferable to use a thermoplastic fluororesin because it is easy to process.

The surface may be coated with a material having good biocompatibility. Examples of biocompatible materials include:
Polyurethane elastomer, polyamide elastomer,
Examples include silicone rubber and non-plasticized vinyl chloride resin.

It is preferable that at least the indwelling portion 2 of the catheter body 10 be embedded with a marker 12 made of a radiopaque material or attached to the inner and outer surfaces thereof. This allows the position of the catheter body 10 to be visually recognized under fluoroscopy when the catheter is inserted. The marker 12 may be provided in a linear shape as shown in the indwelling section 2 or over the entire length of the catheter body 10, and may be scattered at predetermined positions in the indwelling section 2. Good. Examples of the X-ray opaque material forming the marker 12 include gold, platinum, and alloys thereof.

The size of the indwelling part 2 varies depending on the case, but the inner diameter d is about 2 to 4 mm, and the total length is 20 to 20 mm.
It is preferably about 200 mm. The height H of the rib 3 is about 0.1 to 20 mm, preferably about 1 to 10 mm. The protruding length (L) of the tip of the rib 3 is 1 to
It is about 20 mm, preferably about 1 to 10 mm.

The distance p between the side holes 22 in the axial direction of the catheter body 10 is about 0.5 to 10 mm, and about 0.5 to ² per 1 cm ² of the peripheral surface of the indwelling portion 2. Is preferred.

Here, the number of ribs 3 is not limited to four, and 1
It may be three to five or five or more. Furthermore, when the number of ribs 3 installed is increased, in response to this,
It is also possible to set the height H of the rib 3 to be low. Further, in order to further increase the strength, connecting portions 33 that connect the ribs 3 at predetermined intervals may be formed between the ribs 3.

In the embodiment in which the rib 3 described above is provided,
As shown in FIG. 4, further catheter body 10
The rib 8 may be formed on the inner surface of the inner cavity 11. With such a configuration, the kink resistance of the catheter body 10 can be further improved.

FIG. 5 is a side view of the indwelling portion 2 of the catheter body 10 showing another embodiment. In this embodiment, the rib 7 is spirally formed on the peripheral surface of the indwelling portion 2. Four ribs 7 are formed, and the entire length of the indwelling portion 2 is substantially equal to the pitch P of the spiral. Then, the tip 71 of the rib 7
Protrudes from the tip of the indwelling unit 2. In the case of the spiral shape as described above, for example, as shown in FIG. 6, the pitch P of the spiral can be reduced to reduce the number of ribs without lowering the strength.

Furthermore, since it has a spiral shape, by rotating it, it is possible to further suppress damage to the abdominal wall during insertion and removal of the intraperitoneal indwelling catheter 1. Further, in the case of a spiral rib, the number of ribs can be reduced, and if this is rotated and inserted into the abdominal cavity, the hole formed in the abdominal wall can be made smaller, It can reduce the burden on the patient and further reduce the risk of infection.

A catheter body having such a spiral rib can also be manufactured by extrusion molding as described above. In this case, a method of forming a catheter main body having a linear rib by extrusion and twisting it by a predetermined angle under heating, a method of applying a twist while pushing out, and the like can be mentioned.

In addition to the above-described structure, the rib may have any shape as long as it is provided along the axial direction of the catheter body 10. For example, the rib is not linear or spiral, but has a meandering shape in the axial direction, or a rib. The shape or the like may be such that the width or height of the element changes at a constant cycle.

The catheter body and the rib may be made of different materials. In this case, it can be integrally formed by two-color extrusion molding. 7 to 9 show still another embodiment. Figure 7
FIG. 8 is a side view of the entire catheter for placement in the abdominal cavity, FIG. 8 is a sectional view taken along line BB in FIG. 7, and FIG. 9 shows another embodiment of the section.

In the embodiment shown in FIG. 7, the groove 2 along the axial direction is formed on the outer surface of the indwelling portion 2 of the catheter body 10.
3 and a side hole 22 formed at the bottom of the groove 23. By forming the groove 23, the space between the groove 23 and the groove 23 becomes thicker, and the convex portion 9 is formed. Since the area of contact with the inner wall of the abdominal cavity is wide, the convex portion 9 having such a configuration disperses the pressure applied to the inner wall when contacting the inner wall, which is particularly preferable because it has little influence on the body.

As a method of forming such a thick and wide convex portion 9, a method of forming a groove 23 by cutting the outer surface after forming a thick tube body, and a method of extruding
There is a method of using a die for forming the convex portion 9. According to the former method, the cross-sectional shape of the groove 23 becomes rectangular as shown in FIG. 8, and according to the latter method, the cross-sectional shape of the groove 23 becomes open side as shown in FIG. The width gradually widens toward. The strength can be improved by providing the connecting portion 91 formed by filling the groove 23 at a predetermined interval and connecting the adjacent convex portions 9.

The surface of the indwelling portion 2 of the above described intraperitoneal indwelling catheter is preferably subjected to hydrophilic treatment. Examples of the hydrophilic treatment include hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. And the like.

As a specific example of such hydrophilization treatment, thermoplastic fluororesin Daier T-530 (manufactured by Daikin) is used as a fluorocarbon resin surface treatment agent containing sodium metal (specifically, Tetra Etch registered trademark by Junkosha Co., Ltd.). A, Tetra Etch B or NORTON registered trademark CHEMGR
A surface treatment is performed with an IP Treating Agent or the like) to introduce a hydroxyl group on the substrate surface. Subsequently, 4.4'methylenediphenyl diisocyanate was reacted to introduce an isocyanate group, and when the surface was coated with a hydrophilic polymer, methyl vinyl ether / maleic anhydride copolymer half ethyl ester, the surface was lubricated with water or body fluid. Sex can be expressed.

When such a treatment is performed, the insertion resistance when inserting the catheter into the abdominal cavity can be reduced, and the patient's pain at the time of insertion can be reduced. In addition, the mucous membrane is less damaged and the tissue adhesion is suppressed, and even if the constituent material contains a biologically inconvenient substance, the outflow of such a substance can be prevented.

<Example>

Specific examples of the present invention will be described below.

[Example 1]

1 kg of a thermoplastic fluororesin was put into an extrusion molding machine, and a tube was molded at a resin inlet portion of 180 ° C., an intermediate portion (screw portion) of 250 ° C., an outlet portion of 250 ° C., and a discharge speed of 35 rpm.

The die used had an in-die diameter of 4.5 mm, an out-die diameter of 8.6 mm, four out-die ribs, an out-die rib height of 2.2 mm and an out-die rib width of 2.0 mm.

The obtained tube has four ribs formed in the axial direction, and has an inner diameter of 2.38 mm and an outer diameter of 4.49 m.
m, rib height 1.45 mm, rib width 0.67 mm.
The rib tip portion 2 mm of this obtained tube was heated and melted at 200 ° C., and the rib tip portion was protruded from the tube by 1 mm and rounded.

A length of 435 mm is cut out from the tip of the catheter in which the tip of the rib is processed, and 260 is cut from the base end.
The rib of the portion other than the intraperitoneal indwelling portion was removed by scraping the rib of the mm portion and remolding at 200 ° C. to prepare an intraperitoneal indwelling catheter.

The side holes formed on the side surface have a diameter of 0.5 mm, and the number of holes is 1.3 per minute from the tip of the indwelling portion to 8.5 cm.
It was formed at a rate of cm ² .

[Embodiment 2]

In the catheter for indwelling the abdominal cavity of Example 1, the distal end and the proximal end of the portion where the rib was formed were kept relatively rotated by 360 degrees and placed in an oven for 2 hours at 150 ° C. An intraperitoneal indwelling catheter having a spirally formed portion was prepared. The number of side holes formed on the side surface is
Same as Example 1.

[Embodiment 3]

1 kg of a thermoplastic fluororesin was put into an extrusion molding machine, and a tube was formed at a resin inlet portion of 180 ° C., an intermediate portion (screw portion) of 250 ° C., an outlet portion of 250 ° C., and a discharge speed of 40 rpm.

The die has an in-die diameter of 4.5 mm, four in-die grooves, out-die diameter of 8.6 mm, out-die ribs of 4, out-die rib height of 2.2 mm, out-die rib width of 2.0 mm, in-die groove depth of 0.7 mm. , In-die groove width 1.
I used a 2 mm one.

The obtained tube has four ribs formed on the outer surface and the inner surface in the axial direction, and has an inner diameter of 2.3.
8 mm, outer diameter 4.49 mm, outer rib height 1.45 mm, rib width 1.15 mm, inner rib height 0.48 mm, rib width 0.67 mm.

The height of the rib formed on the inner peripheral surface is 0.
The width was 48 mm and the width was 0.67 mm. The rib tip portion 2 mm of this obtained tube was heated and melted at 200 ° C., and the rib tip portion was protruded from the tube by 1 mm and rounded.

A length of 435 mm was cut out from the tip of the catheter in which the tip of the rib was processed, and 260 was cut from the base end.
The rib of the portion other than the intraperitoneal indwelling portion was removed by scraping the rib of the mm portion and remolding at 200 ° C. to prepare an intraperitoneal indwelling catheter.

The side holes to be formed on the side surface have a diameter of 0.5 mm, and the number of holes is 1.3 per minute from the tip of the indwelling part to 8.5 cm.
It was formed at a rate of cm ² .

[Comparative Example 1]

As a comparative example, an indwelling catheter without ribs was prepared. That is, 1 kg of a thermoplastic fluororesin was put into an extrusion molding machine, and a tube was molded at a resin inlet portion of 180 ° C., an intermediate portion (screw portion) of 250 ° C., an outlet portion of 250 ° C., and a discharge speed of 35 rpm.

The die used had an in-die diameter of 4.5 mm and an out-die diameter of 8.6 mm, an inner diameter of 2.38 mm and an outer diameter of 4.49.
A mm indwelling catheter was obtained. The number of side holes formed on the side surface was the same as in Example 1.

(Experiment 1)

The strength of Examples 1, 3 and Comparative Example 1 was measured by a bending test. The intraperitoneal indwelling portion of each intraperitoneal indwelling catheter is supported by two fulcrums having an interval of 20 mm, and a load is applied to the central portion between the fulcrums so that the displacement of the position becomes 10 mm / min. The load applied when it became 2 mm was measured. The measurement was performed twice under the same conditions, and the average value was calculated. The measurement results are shown in Table 1.

[0069]

[Table 1]

It is apparent that in Example 1, a larger load is applied and the kink resistance is improved by the time the same displacement is reached, as compared with Comparative Example 1. In particular, it was found that the kink resistance of Example 3 was extremely good.

(Experiment 2)

As a pseudo peritoneal cavity, 500 ml of a peritoneal dialysate was placed in a polyethylene bag having a thickness of 0.05 mm and a surface area of 1.5 m ² , and the intraperitoneal indwelling catheters of Example 1, Example 2 and Comparative Example 1 were used. An intraperitoneal indwelling part was placed. The mouth of the bag was sealed in a state where the air in the bag was evacuated, and the portion where the sealing portion and the catheter were overlapped and could not be sealed was closed with an adhesive to completely seal the bag.

The tip of the catheter in the bag was fixed so as to be the bottom of the bag. In this state, the dialysate in the bag is discharged from the proximal end of the catheter with an electric aspirator,
The residual amount of dialysate in the bag when the liquid could not be drained was confirmed. The confirmation results are shown in Table 2.

[0074]

[Table 2]

In the case of Comparative Example 1, when polyethylene bags were brought into close contact with some side holes at the same time as suction, the drainage rate was reduced and the amount of dialysate in the bags was reduced. The flexible polyethylene bag stuck to the side hole and the opening of the tip of the catheter, and the drainage became impossible.

In Examples 1 and 2, the ribs provided a gap between the bag and the side surface of the catheter to prevent the side holes and openings from being blocked, and the dialysate could be almost completely discharged.

[0077]

As described above, according to the indwelling catheter of the present invention, the catheter can be easily inserted into the abdominal cavity, the inner wall of the abdominal cavity is prevented from adhering to the side hole, and the dialysate can be exchanged reliably and easily. This reduces the burden on the patient. Moreover, it can be manufactured at low cost.

When this is molded by extrusion molding, the manufacturing cost is further reduced. Since the rigidity is increased by forming the ribs, the tip of the catheter can be reliably placed in the Douglas stalk and maintained.

In particular, when the rib shape is spiral,
By rotating the catheter for insertion and extraction, the incision for inserting the catheter through the abdominal wall can be made smaller, further reducing the burden on the patient.

Further, when the rib is projected from the tip of the indwelling part, the opening of the tip is prevented from being closed, so that the exchange of the dialysate is further ensured. When the catheter body is formed by extrusion and the rib and the catheter body are integrally formed, the rigidity of the catheter is further improved.

[Brief description of drawings]

FIG. 1 is an overall side view of an intraperitoneal indwelling catheter of the present invention.

FIG. 2 is a sectional view taken along line AA in FIG.

FIG. 3 is a partially enlarged side view of a detention unit.

FIG. 4 is an AA in FIG. 1 when a lumen rib is formed.
It is a line sectional view.

FIG. 5 is a side view of an indwelling portion in which four ribs are spirally formed.

FIG. 6 is a side view of an indwelling portion in which one rib is spirally formed.

FIG. 7 is an overall side view of the intraperitoneal indwelling catheter of the embodiment in which a groove is formed on the outer peripheral surface of the indwelling portion.

8 is a sectional view taken along line BB in FIG.

FIG. 9 is a cross-sectional view of the indwelling portion when formed by another forming method.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Intraperitoneal indwelling catheter 11 Lumen 12 Marker 2 Indwelling part 21 Opening 22 Side hole 23 Groove 3 Rib (convex part) 31 Tip 32 Sloping part 33 Connecting part 4 First cuff 5 Second cuff 6 Base end 7 Rib 71 tip 8 rib 9 convex 91 connection

 ─────────────────────────────────────────────────── ─── Continued Front Page (72) Inventor Hideki Watanabe 1500 Inoguchi, Nakai-cho, Ashigarakami-gun, Kanagawa Terumo Corporation

Claims (1)

[Claims] 1. An intraperitoneal indwelling catheter having a catheter body having an indwelling portion to be placed in the abdominal cavity, and a plurality of side holes provided in the indwelling portion and communicating between the lumen of the catheter body and the outer surface thereof. There, protruding at least outside from the side hole forming surface of the detention unit,
An intraperitoneal indwelling catheter having a convex portion continuously formed along the axial direction.