JPH08206193A - Endoceliac indwelling catheter - Google Patents

Abstract

PURPOSE: To provide an endoceliac indwelling catheter which enables preventing of bacteria from infiltrating in vivo from an endermic part of a catheter. CONSTITUTION: A first cuff 6 provided on the indwelling part side of an intermediate part 3 is sutured securely on a peritonium 101 and a second cuff 7 provided at a loop top of the intermediate part 3 is sutured securely on an abdominal rectus muscle fascia 1. A member 5 comprising a collagen porous body provided on the side of an extending part of the intermediate part 3 is positioned under a skin 105. An organic tissue near an endermic part of a catheter enters into the member 5 comprising the collagen porous body to generate collagen while the member 5 comprising the collagen porous body is replaced with an organic tissue thereby enabling the massing of the organic tissue near the endermic part of the catheter.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention mainly relates to an intraperitoneal indwelling catheter used for peritoneal dialysis, which is placed in the abdominal cavity to inject and discharge a dialysate.

[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 since the treatment is performed under the supervision of a special device, it is necessary to visit the patient 2-3 times a week, and one treatment is 4 times. It takes about 5 hours and the burden on the patient or his / her family is large, which hinders 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 reduces the time constraint on the patients and enables the reintegration into society. In this peritoneal dialysis therapy, a procedure is performed in which a dialysate (dialysis perfusate) is injected into the peritoneum and, after a certain period of time, the dialysate drainage is discharged to the outside of the abdominal cavity. And injection of such dialysate,
The drainage of the drainage fluid is performed by an intraperitoneal indwelling catheter placed in the abdominal cavity and a dialysate exchange system connected to the catheter.

Conventionally, an intraperitoneal indwelling catheter has a catheter body including an indwelling part to be left in the abdominal cavity, an extending part extending out from the abdominal wall, and an intermediate part between the indwelling part and the extending part. A cuff member made of Dacron non-woven fabric or the like was provided in two places on the side of the indwelling portion and on the side of the extending portion, which consist of the passage of the catheter body. Then, the first cuff provided on the indwelling part side of the intermediate part is sutured and fixed to the peritoneum, the second cuff provided on the extension part side is positioned in the subcutaneous tissue, and the catheter is implanted in the patient. It was At this time, in order to prevent moisture containing bacteria such as sweat and bacteria from entering through the dialysate injection / exhaust port of the catheter extension and the percutaneous portion of the catheter in the abdominal wall, dialysis of the extension is performed. It was necessary to implant the catheter in the patient with the liquid injection / exhaust port facing downward.

However, since the above-mentioned catheter is formed in a linear shape, the recovery force of the catheter causes
It was difficult to indwell the catheter with the dialysate injection / exhaust port facing downward. Further, this makes it difficult to grow the living tissue in the cuff member and fix the catheter. Furthermore, when a catheter is transplanted to a patient, the living tissue recognizes the catheter as a foreign substance and the living tissue does not adhere to the catheter, so that the epidermis enters inside along the catheter.
There was a problem that wth) occurred. When the down-growth becomes deep, disinfection is poor, and a bacterial infection route is formed, which may cause skin irritation and eventually even peritonitis, which is a problem.

[0006] Therefore, a swan neck type catheter ("Swan Neck", in which the middle portion (subcutaneous tunnel portion) of the catheter is bent and formed in an inverted U shape in advance, is an ACCURATE SURGICAL INSTR
UMENT registered trademark) was developed and is widely used.
This intraperitoneal indwelling catheter made it possible to implant it in a patient with the dialysate injection / exhaust port of the extension part facing downward.
However, also in this catheter, the cuff member made of Dacron non-woven fabric or the like is used as the second cuff,
When the catheter was implanted in a patient, it was placed a predetermined distance from the percutaneous portion of the catheter. Therefore, it is difficult to densely collect the living tissue near the percutaneous portion of the catheter around the catheter, and there is a possibility that the downgrowth may become deep. Therefore, it has been difficult to completely prevent bacteria from entering the body through the percutaneous portion of the catheter on the abdominal wall.

[0007] Here, in a conventional intraperitoneal indwelling catheter, a catheter provided with a percutaneous element made of porous ceramics and a cuff member made of silicone foam to which an amino acid-based biocompatible substance is attached are provided in an intermediate portion (subcutaneous). Tunnel section)
Have been proposed. However, the transdermal element made of porous ceramics has a hard transcutaneous element and is provided percutaneously, so that when the dialysate is infused or the drainage is discharged, Since it is difficult for the tissue in the vicinity of the percutaneous portion of the catheter to follow along with the movement, there is a possibility that biological tissue may fall off from the transdermal element. In addition, the one provided with the cuff member made of silicone foam is superior in that it proliferates the biological tissue in the cuff member, as compared with the one provided with the cuff member made of Dacron non-woven fabric, but the percutaneous catheter. It is difficult to close the body tissue around the catheter around the catheter and the cuff member is difficult to follow when the extension of the catheter moves along with the movement of the abdomen, so the body tissue falls off from the cuff member. there is a possibility. Therefore, in any of the above catheters, there is a risk that bacteria may enter the body through the percutaneous portion of the catheter.

[0008]

SUMMARY OF THE INVENTION An object of the present invention is to enable living tissue near the percutaneous portion of a catheter to follow the movement of the catheter, so that bacteria enter the body from the percutaneous portion of the catheter. An object of the present invention is to provide an intraperitoneal indwelling catheter capable of preventing the above-mentioned problem.

[0009]

Such objects are achieved by the intraperitoneal indwelling catheter of the present invention.

That is, the catheter for indwelling the abdominal cavity of the present invention comprises an indwelling part to be left in the abdominal cavity, an extending part extending out of the abdominal wall, and an intermediate part between the indwelling part and the extending part. An intra-abdominal indwelling catheter having the following catheter body and a passage provided in the catheter body, characterized in that a member containing collagen as a main material is provided on the outer surface of the intermediate portion.

Further, it is preferable that the member containing collagen as a main material is provided on the extension side of the intermediate portion.

Further, it is preferable that the member containing collagen as a main material is formed of a collagen porous material composed of fibrotic collagen and denatured collagen.

Further, it is preferable that the member mainly made of collagen is covered with a protective member formed in a mesh shape.

Further, it is preferable that the member mainly composed of collagen is provided so as to be movable along the outer surface of the catheter body.

It is preferable that a first cuff for fixing the catheter body is provided on the indwelling portion side of the intermediate portion.

Further, it is preferable that the intermediate portion is formed to be curved in a loop shape, and a second cuff for fixing the catheter body is provided near the loop apex of the intermediate portion.

[0017]

According to the catheter for indwelling the abdominal cavity of the present invention, since the member containing collagen as the main material is provided in the intermediate portion, the member containing collagen as the main material is located in the abdominal wall, and collagen is used as the main material. The living body tissue in the vicinity of the percutaneous portion of the catheter enters the member containing collagen as a main material, and collagen is produced while the member to be replaced is replaced with living body tissue. As a result, the living tissue around the catheter is concentrated around the catheter.

Further, since the member containing collagen as the main material is provided on the extension side of the intermediate portion, the member containing collagen as the main material is located under the epidermis, and the living body near the percutaneous portion of the catheter. Tissue is clustered around the catheter to prevent deep downgrowth.

Here, the depth of down growth is 5.0 mm.
When the level is below a certain level, the downgrowth provides an appropriate cushion for the movement of the abdomen when injecting dialysate and draining the drainage, etc., and the catheter easily follows along with the movement of the abdomen, and disinfection is performed. This does not cause skin irritation, but the depth of downgrowth is 5.
If it is about 0 mm or more, even if the disinfection is performed, the disinfection does not reach the deep part, bacteria may enter the body, and skin inflammation and eventually peritonitis may occur.

Further, since the member containing collagen as a main material is formed of a collagen porous body composed of fibrotic collagen and denatured collagen, the living tissue is densely gathered in the catheter body at an early stage. Further, since the member containing collagen as a main material is covered with the protective member formed in a mesh shape, it is possible to prevent the member containing collagen as a main material from falling off from the catheter body. Further, since the member containing collagen as a main material is provided so as to be movable along the outer surface of the catheter body, the position of the member containing collagen as a main material can be adjusted when the catheter is implanted in a patient. It is possible.

Further, since the first cuff for fixing the catheter body is provided on the indwelling portion side of the intermediate portion,
It is easy to fix the indwelling part in the abdominal cavity. In addition, the intermediate portion is formed in a curved shape in a loop, and the second cuff for fixing the catheter main body is provided near the loop apex of the intermediate portion, so that the dialysate injection / exhaust port is directed downward. Thus, it is easy to fix the intermediate portion to the living tissue.

[0022]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An intraperitoneal indwelling catheter according to a preferred embodiment of the present invention will be specifically described below with reference to the accompanying drawings.
1 is an overall side view of an intraperitoneal indwelling catheter according to an embodiment of the present invention, and FIG. 2 is A-A in FIG.
It is a line sectional view.

The intraperitoneal indwelling catheter 1 of the present invention is used in the peritoneal dialysis method when performing a procedure of injecting dialysate into the abdominal cavity and discharging the dialysate drainage out of the abdominal cavity after a certain period of time. It is used as an exchange channel for dialysate.
That is, the distal end of the intra-abdominal indwelling catheter 1 is inserted into the abdominal wall of a patient by penetrating the abdominal wall, the distal end of the intra-abdominal indwelling catheter 1 is indwelled in the abdominal cavity, and the proximal end of the intra-abdominal indwelling catheter 1 is inserted. While maintaining the state in which the region is extended outside the abdominal wall, the patient has a daily life, and the dialysate is exchanged through the intraperitoneal indwelling catheter 1 at regular intervals.

This intraperitoneal indwelling catheter 1 has an indwelling portion 2 placed in the abdominal cavity and an extending portion 4 extending outside the abdominal wall.
And a passageway 11 provided in the catheter body 10 and a catheter body 10 consisting of an intermediate portion 3 between the indwelling portion 2 and the extension portion 4, and collagen is a main material on the outer surface of the intermediate portion 3. The member 5 is provided. The member 5 having collagen as a main material is provided on the extending portion 4 side of the intermediate portion 3.

The catheter body 10 is a tubular body,
The distal end side that is inserted into the abdominal cavity is the indwelling portion 2, and the proximal end side that extends outside the abdominal wall is the extension portion 4. Further, between the indwelling part 2 and the extending part 4 is an intermediate part 3 provided with a member 5 whose main material is collagen. The intermediate portion 3 forms a subcutaneous tunnel between the inside of the abdominal cavity and the outside of the abdominal wall by the passage of the catheter body 10.

An opening 21 of the passage 11 is formed at the distal end of the indwelling portion 2 in the axial direction of the catheter body 10, and a groove 23 along the axial direction is formed on the outer surface of the indwelling portion 2. The side hole 22 is formed at the bottom of the groove 23. 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. . The dialysate is exchanged through the opening 21 and the side holes 22.

Further, due to the formation of the groove 23, the space between the groove 23 and the groove 23 becomes thick and the convex portion 9 is formed. Since the plurality of convex portions 9 formed in this manner have a large area of contact with the inner wall of the abdominal cavity, the pressure exerted when contacting the inner wall of the abdominal cavity is dispersed, and the influence on the body is small. Also,
The tip 92 of the convex portion 9 projects from the tip of the indwelling portion 2, and the tip 92 is formed in an arc shape so as to be in contact with the inner wall of the abdominal cavity and the Douglas stalk and not to be damaged. By providing this tip 92,
A passage (hereinafter, also referred to as “lumen”) when the indwelling part 2 comes into contact with the Douglas stake, which is located at the lowest point in the abdominal cavity.
The opening 21 is secured without being blocked.

As a method of forming such a thick and wide convex portion 9, for example, a method of forming a thick tube body by extrusion and then cutting the outer surface to form the groove 23. Alternatively, there is a method of using a die for forming the convex portion 9 at the time of extrusion molding. When forming the protrusions 9 by a method of using a die that forms the protrusions 9 at the time of extrusion molding, after forming a tube in which the protrusions 9 are formed over the entire length, the protrusions are formed by a predetermined length. The groove 23 formed by forming the groove 9 is buried, or the protrusion 9 is formed by a predetermined length.
There is a way to scrape off. Further, even when the convex portion 9 is formed by any method, it is possible to improve the strength by providing the connecting portion 91 formed by filling the groove 23 at a predetermined interval and connecting the adjacent convex portions 9. You can

Although the detention part 2 (or the tip of the detention part 2) may be formed independently and connected to the intermediate part 3 and the extension part 4, the detention part 2, the intermediate part 3 and the extension part 4 may be formed. May be integrally formed as the catheter body 10.

On the other hand, a connector (not shown) or the like is provided at the proximal end of the extending portion 4, and a dialysate bag, a drainage bag or the like is connected by a tube via this connector or the like. A peritoneal dialysis system or the like is connected.

The intermediate portion (hereinafter, also referred to as "subcutaneous tunnel portion") 3 is curved and formed in a loop shape, and has a U shape (swan neck shape). A first cuff 6 is fixed to the subcutaneous tunnel portion 3 on the side of the indwelling portion 2 and a second cuff 7 is fixed to the vicinity of the loop apex with a silicone adhesive or the like. A member (hereinafter, also referred to as a “cuff member”) 5 made of a collagen porous material is provided on the side of the projecting portion 4 of the catheter body 10.
Movably along the outer surface of the.

Then, the first cuff 6 and the second cuff 7
Is made of Dacron non-woven fabric in a tubular shape. By suturing and fixing the cuffs 6 and 7 to the living tissue, the fibroblasts which are the living tissue proliferate in the cuffs 6 and 7, and the catheter body 10 is fixed. Be placed in position. Further, since the cuff member 5 is formed into a tubular shape by a collagen porous body composed of fibrotic collagen and denatured collagen, fibroblasts enter the cuff member 5 to generate collagen, and at the same time, the cuff member 5 undergoes fibroblast formation. The cells are replaced. For this reason, the fibroblasts are concentrated around the catheter body 10, and the catheter body 10 is fixed. Further, since the cuff member 5 is located under the dermis, the downgrowth of an appropriate depth is maintained and the downgrowth is prevented from becoming deep.

Here, as a method for producing the collagen porous material constituting the cuff member 5, for example, a collagen solution is mixed with a balanced salt solution such as a phosphate buffer solution,
By incubating at 7 ° C. for about 4 hours, the collagen is fibrillated. On the other hand, the collagen solution is heat-denatured by heating to be subjected to a denaturing treatment. In addition,
Since the thermal denaturation of collagen occurs at around 37 ° C, it is denatured in the range of 40 to 100 ° C, preferably 60 to 80 ° C. A suitable heat denaturation treatment is 6
30 minutes at 0 ° C. The fibrotic collagen solution thus obtained and the denatured collagen solution are mixed, lyophilized in a tubular container, and then thermally dehydrated and crosslinked to obtain a cuff member 5 composed of a collagen porous body. can get. Fibrotic collagen and heat-denatured collagen are crosslinked by heat dehydration for 30 minutes to 12 hours, preferably 1 to 6 hours.
2 hours at 10 ° C.

Further, by covering the outer surface and the inner surface of the tubular body (cuff member 5) made of a collagen porous body with a Dacron protective member 51 formed in a mesh shape, the collagen porous body becomes a fibroblast. There is no risk of falling off the catheter body 10 when it is converted. Further, by fixing a non-woven fabric made of Dacron with a predetermined thickness to the catheter body 10 with an adhesive or the like, and installing a cuff member 5 made of a collagen porous body on the non-woven fabric, the cuff member can be removed from the catheter body 10. There is no fear that 5 will fall out.

When installing the cuff member 5 on the catheter body 10, the cuff member 5 is moved along the outer surface of the catheter body while the catheter body 10 is expanded and the outer diameter of the catheter body 10 is reduced. However, even if the cuff member 5 is installed at a predetermined position, the cuff member 5 is brought into close contact with the catheter body 10 and the catheter body 10
There is no risk that the cuff member 5 will fall out from.

The catheter body 10 constructed as described above is made of, for example, silicone rubber, thermoplastic fluororesin, polyethylene, polypropylene, polyvinyl chloride,
Polyethylene terephthalate, polystyrene, polyurethane, or the like is used, and is preferably composed of a flexible constituent material. In particular, it is preferable to use silicone rubber because it is excellent in biocompatibility, and it is also preferable to use thermoplastic fluororesin because it is easy to process. In order to improve biocompatibility, the surface may be coated with, for example, polyurethane elastomer, polyamide elastomer, non-plasticized vinyl chloride resin, silicone rubber or the like.

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 confirmed under fluoroscopy during catheter implantation. The shape of the marker 12 is linear as shown in the drawing, and the detention portion 2
To the subcutaneous tunnel portion 3, or may be provided over the entire length of the catheter body 10. Furthermore, it may be provided so as to be scattered at a predetermined position from the indwelling portion 2 to the subcutaneous tunnel portion 3. Examples of the X-ray opaque material forming the marker 12 include tungsten, barium sulfate, gold, platinum, or alloys thereof.

Further, by providing a plurality of fins in the lumen 11 of the catheter body 10 at least from the indwelling portion 2 to the subcutaneous tunnel portion 3, at the time of catheter implantation in the abdominal cavity or abdominal wall or exchange of dialysate. Occasionally, it is possible to prevent the lumen 11 from being crushed and blocked in the abdominal wall or abdominal cavity.

Here, the total length of the catheter body 10 varies depending on the case, but is about 250 to 600 mm, preferably about 300 to 550 mm, more preferably 350 to 50 mm.
It is about 0 mm, of which the indwelling part 2 is 150 to 200
mm, and the subcutaneous tunnel portion 3 is 100 to 150 mm
The extent of the extension 4 is preferably about 100 to 150 mm. Furthermore, the convex portion 9 forming portion of the indwelling portion 2 is
It is about 110 to 60 mm, and the cuff member 5 located in the subcutaneous tunnel portion 3 is about 3.0 to 50 mm, preferably 5.
0 ~ 50mm, the first and second cuff 6,7 is 5.0
It is preferably about 15 mm. The protruding length of the tip 92 of the convex portion is about 1.0 to 20 mm, preferably 2.
It is about 0 to 10 mm.

In the cuff member 5, if the total length is 3.0 mm or less, it is difficult to densely collect the living tissue around the catheter body 10, and it is difficult to maintain downgrowth appropriately, and the total length is 50 mm or more. Therefore, it is necessary to change the position where the second cuff 7 is installed. The second cuff 7 is installed at a subcutaneous tunnel formed in a loop shape in order to fix the catheter body 10 to the abdominal wall with the dialysate injection / exhaust port of the catheter 1 facing downward. It is preferably near the loop apex of the part 3. Also, the cuff member 5 may be positioned at any length between the base end side and the installation position of the second cuff as long as the distal end side is positioned near the percutaneous portion of the catheter 1, and the total length is 3 ．
Plural pieces having a size of 0 to 25 mm may be adjacently used, or may be arranged in a row at a predetermined interval. The wall thickness of the cuff portion 5 is about 1.0 to 4.0 mm, preferably 1.
If the wall thickness is about 5 to 2.5 mm and the wall thickness is 1.0 mm or less, it is difficult to densely collect the biological tissue around the catheter body 10, and it is difficult to maintain downgrowth appropriately, and the wall thickness is When it is 4.0 mm or more, damage to the abdominal wall when a catheter is implanted in a patient becomes large, and it may take time to form downgrowth.

The inner diameter of the catheter body 10 is
The thickness of the catheter body 10 is about 1.0 to 3.5 mm, preferably about 2.0 to 3.0 mm, and only the indwelling portion 2 or only the protruding portion 9 forming portion of the indwelling portion 2 is formed thick. The thickness may be the same over the entire length, but specifically, it is about 1.0 to 3.0 mm, preferably about 2.0 to 2.5 mm in the thick portion. The height of the convex portion 9 (depth of the groove 23) formed in the indwelling portion 2 is 0.5 to
It is about 1.5 mm, preferably about 1.0 to 1.3 mm.

The number of the convex portions 9 or the grooves 23 is not limited to four, but may be one to three or five or more, and is determined according to the outer diameter of the catheter body 10 and the like.
It is preferable to set the height of the convex portions 9 according to the number of the convex portions 9. Further, the connecting portion 91 may be provided as necessary depending on the material forming the catheter body 10, the thickness, and the like. The number of the side holes 22 depends on the number of the grooves 23, but it depends on the number of the grooves 2.
About 6 to 20 pieces, preferably 8 to 1 pieces per number 3
It is about 6 pieces.

It is preferable that at least the outer surface of at least the indwelling portion 2 of the intraperitoneal indwelling catheter 1 extending from the indwelling portion 2 to the subcutaneous tunnel portion 3 be subjected to a hydrophilic treatment. 2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone,
Examples of the method include coating with a hydrophilic polymer such as.

When such a treatment is performed, the insertion resistance when inserting the catheter into the abdominal cavity can be reduced, and the time for catheter implantation surgery can be shortened.
The burden on the patient is reduced when implanting the catheter in the patient. In addition, it also has the effect of suppressing damage to the mucous membrane and suppressing tissue adhesion.

Next, the state when the intraperitoneal indwelling catheter 1 according to the preferred embodiment of the present invention is transplanted to a patient will be specifically described. 3 is a partial cross-sectional view showing a state in which the intraperitoneal indwelling catheter according to the embodiment of the present invention is transplanted to the abdominal wall of a patient.

As shown in FIG. 3, the subcutaneous tunnel portion 3 of the intra-abdominal indwelling catheter 1 is implanted through the abdominal wall 100, and the inner cavity 11 of the catheter body 10 connects the intra-abdominal cavity 120 and the abdominal wall outside 110. A subcutaneous tunnel is formed between them. The dialysate is exchanged via this subcutaneous tunnel. Further, the distal end side of the subcutaneous tunnel portion 3 formed in a loop shape is penetrated through the peritoneum 101 and left in the abdominal cavity 120, and the proximal end side of the subcutaneous tunnel portion 3 is the epidermis 1
It extends through 05 to the outside 110 of the abdominal wall. The tip of the indwelling part 2 placed in the abdominal cavity 120 is located in the Douglas stilt, and a connector is connected to the base end of the extension part 4 extended to the outside 110 of the abdominal wall.

The first cuff 6 provided on the indwelling portion 2 side of the subcutaneous tunnel portion 3 is located at the bottom of the muscular tissue 102,
It is fixed to the peritoneum 101 by suture. The catheter body 10 is fixed to the abdominal wall 100 by the first cuff 6, and the indwelling portion 2 is indwelled at a fixed position. In addition, the first cuff 6 prevents the dialysate from leaking out of the abdominal cavity 120 when the dialysate is injected into the abdominal cavity 120.

The second cuff 7 provided near the loop apex of the subcutaneous tunnel portion 3 is located at the bottom of the subcutaneous tissue 104 and fixed to the rectus fasciae 103 by suture. This second
With the cuff 7 of, the dialysate inlet / outlet is turned downwards,
The subcutaneous tunnel portion 3 is fixed to the living tissue.

The cuff member 5 provided on the extension 4 side of the subcutaneous tunnel portion 3 is located below the epidermis 105. The cuff member 5 is made of a collagen porous material and converted into fibroblasts. Further, the fibroblasts of the subcutaneous tissue 104 also enter the cuff member 5 to generate collagen. With this cuff member 5, even if the extending portion 4 of the catheter 1 is moved in the vertical direction when injecting and discharging the dialysate, the movement of the catheter 1 is followed by the biological tissue near the percutaneous portion of the catheter 1. To do. Therefore, down growth 1 of moderate depth
50 is maintained and the downgrowth 150 is prevented from becoming deeper. Further, if the cuff member 5 is covered with a protective member formed in a mesh shape in advance, the cuff member 5 is removed from the catheter body 10 when the collagen porous body (cuff member 5) is replaced with fibroblasts. There is no such thing as falling off.

Example 1 1 kg of silicone rubber was put into an extrusion molding machine, the discharge speed was 35 rpm, and the temperatures of the inlet portion, the intermediate portion (screw portion) and the outlet portion were normal temperature.
The tube was molded. The extrusion die used had an in-die diameter of 2.7 mm, an out-die diameter of 5.0 mm, four out-die protrusions, an out-die protrusion height of 1.3 mm, and an out-die protrusion width of 0.4 mm. The obtained tube has four protrusions at equal intervals in the axial direction on the outer surface, and has an inner diameter of 2.5 mm, an outer diameter of 4.7 mm, a wall thickness of 1.1 mm, a protrusion height of 0.4 mm, and a protrusion. The width was 1.2 mm.

After cutting a length of 440 mm of the obtained tube and inserting a stainless steel core into the inner cavity of the tube, the groove of 350 mm from the base end was filled with a linear silicone rubber and embedded, and the tip was inserted. A convex portion was left on the 90 mm portion. Then, from the tip of the tube, near 190 mm,
Around 100 mm around 0 mm was curved into a loop. Then, in this state, the tube was heated at a temperature of about 160 ° C. to cure the tube.

Then, the groove up to 5.0 mm from the tip of this cured tube was cut off to form a protrusion. Then, the tip of this protruding portion was rounded. Next, nine side holes were formed in each groove per groove.
The size of the side hole is 0.5 mm in diameter.

180 mm from the end of the obtained tube
10mm in total length including the tip at the position of and 250mm
The first cuff and the second cuff of No. 1 were set, and they were adhesively fixed with a silicone adhesive. In addition, the first and second
The cuff is made of Dacron non-woven fabric.

[Example 2] Production of fibrillated collagen: Atelocollagen powder (manufactured by Koken Co., Ltd.) was dissolved in dilute hydrochloric acid having a pH of 3.0 at a temperature of 4 ° C to obtain 0.3 to 0.4 (w / v). ) Adjusted to%. The solution was sequentially sterilized by filtration through two kinds of filters having pores with diameters of 0.8 μm and 0.2 μm, and then a phosphate buffer of pH 7.0 was added while stirring at 4 ° C. The final concentration was 0.1 to 0.15 (w / v)% atelocollagen (30 mM disodium phosphate, 100 mM sodium chloride).

Then, the fibrotic atelocollagen (FC) solution was prepared by leaving it in a constant temperature bath at 37 ° C. for 4 hours.
Then, this FC solution was concentrated by centrifugation under aseptic conditions to adjust the concentration to 4.0 (w / v)%.

Production of denatured collagen: On the other hand, a 0.3 to 0.4 (w / v)% atelocollagen solution which was successively passed through the above-mentioned filter was freeze-dried and then re-dissolved in sterile distilled water at 4.0 (w). / v) redissolved so that it became%.

This solution was allowed to stand in a constant temperature bath at 60 ° C. for 30 minutes to cause heat denaturation so that denatured atelocollagen (HA
C) A solution was prepared. Then, this HAC solution was filtered at a temperature of 37 ° C. through a filter having pores with a diameter of 0.45 μm.

Formation of porous collagen body: The FC solution and the HFC solution thus obtained were mixed at a ratio of 9: 1 and placed in a tubular container having a total length of 50 mm, an inner diameter of 4.3 mm and an outer diameter of 8.0 mm. Then, it was lyophilized and subjected to thermal dehydration crosslinking at a temperature of 110 ° C. for 2 hours.

The obtained collagen porous tubular body was cut into a length of 20 mm to obtain a cuff member having an inner diameter of 4.3 mm and a wall thickness of 2.0 mm. Then, with the catheter produced according to Example 1 stretched and the outer diameter of the catheter body reduced, this cuff member is moved along the outer surface of the catheter body so that the proximal end side of the cuff member is the proximal end of the catheter. To 130
It was located at mm. Then, by restoring the outer diameter of the catheter body, the cuff member was installed in the catheter of Example 1.

[Experimental Example] Two tubes prepared by cutting the tube prepared in Example 1 to a length of 65 mm were prepared, and one tube among them had a total length of 2 prepared in Example 2.
Two 0 mm cuff members were installed so that their ends were located 10 mm from the tip and 10 mm from the base. Then, an evaluation experiment was conducted using the tube provided with the cuff member and the tube not provided with the cuff member.

A scalpel was placed on the back of the rat so that the two cuff members were positioned under the epidermis, and both ends of the tube were adjusted to about 10 mm.
mm was extended outside the abdominal wall and a tube provided with a cuff member was implanted. Further, the tube without the cuff member was tandemly arranged with the tube with the cuff member and transplanted in the same manner.

Four weeks after the tube was transplanted, in the tube provided with the cuff member, the cuff member made of the collagen porous material was replaced with fibroblasts, and when the extension part of the tube was pinched and moved, The skin around the percutaneous portion of the tube followed and did not deepen the downgrowth. On the other hand, prominent down-growth was observed in the tube without the cuff member, and redness was confirmed, which was thought to be the entry of bacteria from the percutaneous portion of the tube.

From the above evaluation experiments, it was found that the cuff member of Example 2 was able to prevent bacteria from entering through the percutaneous portion of the tube. Further, it is understood that the downgrowth can be prevented from being deepened because the tissue around the percutaneous portion of the tube can be made to follow the movement of the tube.

[0064]

As described above, according to the catheter for indwelling the abdominal cavity of the present invention, the indwelling portion to be indwelled in the abdominal cavity,
An intra-abdominal indwelling catheter having an extension part extended to the outside of the abdominal wall, a catheter body consisting of the indwelling part and an intermediate part between the extension parts, and a passage provided in the catheter body, By providing the member whose main material is collagen on the outer surface of the intermediate portion, the biological tissue can be densely gathered in the catheter main body at an early stage, so that bacteria do not enter the body through the percutaneous portion of the catheter. For this reason,
The frequency of peritonitis can be reduced.

Further, since the member containing collagen as a main material is provided on the extension side of the intermediate portion,
The living tissue near the percutaneous portion of the catheter can be densely packed in the catheter body, and the living tissue near the percutaneous portion of the catheter can follow the movement of the catheter. For this reason, it is possible to prevent deep downgrowth, and thus bacteria do not enter the body through the percutaneous portion of the catheter.

Furthermore, since the member whose main material is collagen is formed of a collagen porous material composed of fibrotic collagen and denatured collagen, it becomes possible to densely condense living tissue on the catheter body at an early stage, Because it can prevent deep downgrowth,
Bacteria do not enter the body through the percutaneous part of the catheter.

Further, since the member mainly made of collagen is covered with the mesh-like protective member, it is possible to prevent the member mainly made of collagen from falling off the catheter body. So
It is possible to prevent the invasion of bacteria from the percutaneous part of the catheter into the body by making the biological tissue densely packed in the catheter body.

Further, the collagen-based member is provided so as to be movable along the outer surface of the catheter body, so that the position of the collagen-based member can be adjusted when the catheter is implanted in a patient. Since it can be adjusted, the depth of the downgrowth formed can be adjusted to prevent bacteria from entering the body through the percutaneous portion of the catheter.

[Brief description of drawings]

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

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

FIG. 3 is a partial cross-sectional view showing a state in which the intraperitoneal indwelling catheter according to the embodiment of the present invention is implanted in the abdominal wall of a patient.

[Explanation of Codes] 1 Intraperitoneal indwelling catheter 10 Catheter body 11 Passage 12 Marker 2 Indwelling part 21 Opening 22 Side hole 23 Groove 3 Subcutaneous tunnel part 4 Extension part 5 Member mainly made of collagen 6 First cuff 7 No. 2 Cuff 9 Convex part 91 Connection part 92 Convex tip 100 Abdominal wall 101 Peritoneum 102 Muscle layer tissue 103 Rectus fascia 104 Subcutaneous tissue 110 Outer abdominal wall 120 Abdominal cavity 150 Downgrowth

Claims (5)

[Claims] 1. A catheter body comprising an indwelling part to be placed in the abdominal cavity, an extending part extending to the outside of the abdominal wall, and an intermediate part between the indwelling part and the extending part, and to the catheter body. An intraperitoneal indwelling catheter having a passage provided therein, wherein the outer surface of the intermediate portion is provided with a member containing collagen as a main material. 2. The intraperitoneal indwelling catheter according to claim 1, wherein the member containing collagen as a main material is provided on the extension side of the intermediate portion. 3. The collagen-based member is formed of a collagen porous body composed of fibrotic collagen and denatured collagen.
Intraperitoneal indwelling catheter. 4. The intraperitoneal indwelling catheter according to claim 1, wherein the member containing collagen as a main material is covered with a protective member formed in a mesh shape. 5. The intraperitoneal indwelling catheter according to claim 1, wherein the member mainly composed of collagen is provided so as to be movable along the outer surface of the catheter body.