JP3623002B2 - Intraperitoneal indwelling catheter - Google Patents

Description

[0001]
[Industrial application fields]
The present invention mainly relates to an intraperitoneal indwelling catheter used for injecting and discharging dialysate by placing it in the abdominal cavity in peritoneal dialysis.
[0002]
[Prior art]
Dialysis therapy is performed mainly for the purpose of removing uremic substances such as water, urea, and creatinine accumulated in the body on behalf of a part of renal function. In many cases, treatment by hemodialysis is performed. However, since the treatment is performed under the supervision of a special device, the patient is forced to visit two or three times a week. The burden on the patient or their family is ˜5 hours, which is a great hindrance to the patient's return to society.
[0003]
On the other hand, peritoneal dialysis therapy is a treatment that reduces time constraints on patients and enables social rehabilitation, so the number of patients is increasing. In this peritoneal dialysis therapy, a procedure is performed in which a dialysate (dialysis perfusate) is injected into the peritoneum, and after a predetermined time has elapsed, the dialysate drainage is discharged outside the abdominal cavity. And such injection | pouring of a dialysate and discharge | emission of drainage are performed by the intraperitoneal indwelling catheter indwelled in the abdominal cavity, and the dialysate exchange system connected to this catheter.
[0004]
Conventionally, an intraperitoneal indwelling catheter includes an indwelling portion that is placed in the abdominal cavity, an extending portion that extends outside the abdominal wall, an intermediate portion between the indwelling portion and the extending portion, A cuff member made of a Dacron nonwoven fabric or the like was provided at two places on the detained portion side and the extended portion side of the intermediate portion. Then, the first cuff provided on the indwelling part side of the intermediate part is sutured and fixed to the peritoneum, and 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. In this case, in order to prevent moisture containing bacteria such as sweat and bacteria from entering from the percutaneous portion of the catheter at the inlet and outlet of the catheter extension and the abdominal wall, It was necessary to transplant the catheter to the patient with the liquid inlet / outlet facing downward.
[0005]
However, since the above-mentioned catheter was formed in a straight line, it was difficult to place the catheter with the dialysate injection / discharge port facing downward due to the recovery force of the catheter. This also makes it difficult to grow biological tissue in the cuff member and fix the catheter. Further, when a catheter is implanted in a patient, the living tissue recognizes the catheter as a foreign body, and the living tissue does not adhere to the catheter, so that the epidermis enters inside along the catheter, so-called down growth occurs. was there. When downgrowth becomes deeper, disinfection becomes unsatisfactory and a bacterial infection route is formed, which may cause skin inflammation and eventually peritonitis.
[0006]
Therefore, a swan neck type catheter (“Swan Neck” is a registered trademark of ACCURATE SURGICAL INSTRUMENT Inc.) in which an intermediate portion (subcutaneous tunnel portion) of the catheter is bent in an inverted U shape in advance has been developed and is widely used. This intraperitoneal indwelling catheter can be implanted into a patient with the dialysate injection / exhaust port of the extension portion facing downward. However, this catheter also uses a cuff member made of Dacron non-woven fabric or the like as the second cuff, and is placed a predetermined distance away from the percutaneous portion of the catheter when the catheter is implanted in a patient. For this reason, it is difficult to concentrate biological tissues near the percutaneous portion of the catheter around the catheter, and there is a risk that the downgrowth will become deeper. For this reason, it has been difficult to completely prevent bacteria from entering the body from the percutaneous portion of the catheter in the abdominal wall.
[0007]
Here, a conventional intraperitoneal catheter is provided with a percutaneous element made of porous ceramics, and a cuff member made of a silicon foam to which an amino acid-based biocompatible substance is attached. Have been proposed. However, when a transdermal device made of porous ceramics is provided, the percutaneous device is hard and is provided transcutaneously, so that when the dialysate is injected or drained, the abdomen is removed. With the movement, it is difficult for the tissue near the percutaneous portion of the catheter to follow, and there is a possibility that the living tissue may fall off from the percutaneous element. Further, the one provided with the cuff member made of silicon foam is superior to the one provided with the cuff member made of Dacron nonwoven fabric in that the living tissue is proliferated in the cuff member. It is difficult to concentrate biological tissue near the catheter around the catheter, and the cuff member is difficult to follow when the catheter extension moves as the abdomen moves, so the biological tissue falls off the cuff member. there is a possibility. For this reason, in any of the above catheters, there is a risk that bacteria may enter the body from the percutaneous portion of the catheter.
[0008]
[Problems to be solved by the invention]
An object of the present invention is to enable a living tissue near the percutaneous portion of the catheter to follow the movement of the catheter, thereby preventing bacteria from entering the body from the percutaneous portion of the catheter. It is to provide an indwelling catheter.
[0009]
[Means for Solving the Problems]
Such an object is achieved by the intraperitoneal indwelling catheter of the present invention.
[0010]
That is, the intraperitoneal indwelling catheter of the present invention is a catheter body comprising an indwelling part that is placed in the abdominal cavity, an extending part that extends outside the abdominal wall, and an intermediate part between the indwelling part and the extending part. And an intraperitoneal indwelling catheter having a passage provided in the catheter body, on the outer surface of the intermediate portionA collagen porous body is provided, and the collagen porous body is movably provided along the outer surface of the catheter body.It is characterized by that.
[0011]
The collagenPorous tubular bodyIs preferably provided on the extended portion side of the intermediate portion.
[0012]
Furthermore, the collagenPorous tubular bodyIs preferably formed of a collagen porous body composed of fibrotic collagen and denatured collagen.
[0015]
Moreover, it is preferable that a first cuff for fixing the catheter body is provided on the indwelling portion side of the intermediate portion.
[0016]
Further, it is preferable that the intermediate portion is formed in a loop shape and a second cuff for fixing the catheter body is provided in the vicinity of the loop apex of the intermediate portion.
[0017]
[Action]
According to the intraperitoneal indwelling catheter of the present invention,A collagen porous body is provided, and the collagen porous body is movable along the outer surface of the catheter body.Because it is provided, collagenPorous materialIs located in the abdominal wall, collagenPorous materialIs replaced with living tissue, and the living tissue near the percutaneous part of the catheter is collagen.Porous materialGet into the collagenButGenerated. Thereby, the living tissue around the catheter is concentrated around the catheter.Further, since the collagen porous body is movably provided along the outer surface of the catheter body, the position of the collagen porous body can be adjusted when the catheter is implanted in a patient. .
[0018]
Also collagenPorous tubular bodyIs provided on the extended part side of the intermediate part,Porous materialIs placed under the epidermis, and the living tissue near the percutaneous portion of the catheter is concentrated around the catheter, thereby preventing the downgrowth from deepening.
[0019]
Here, when the depth of the downgrowth is about 5.0 mm or less, the downgrowth becomes an appropriate cushion against the movement of the abdomen when injecting dialysate and discharging the drainage, etc. The catheter is easy to follow, and disinfection does not cause skin irritation, but when the downgrowth depth is about 5.0 mm or more, disinfection reaches the depth even after disinfection. First, bacteria may enter the body, which can cause skin irritation and even peritonitis.
[0020]
Also collagenPorous tubular bodyIs formed of a porous collagen body composed of fibrotic collagen and denatured collagen, so that biological tissues are densely packed in the catheter body at an early stage.
[0021]
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 portion within the abdominal cavity. In addition, the middle part is formed in a loop shape, and a second cuff for fixing the catheter body is provided near the top of the loop in the middle part so that the dialysate injection / discharge port faces downward. Thus, it is easy to fix the intermediate part to the living tissue.
[0022]
【Example】
Hereinafter, an intra-abdominal indwelling catheter according to a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings. 1 is an overall side view of an intra-abdominal indwelling catheter according to an embodiment of the present invention, and FIG. 2 is a cross-sectional view taken along line AA in FIG.
[0023]
In the peritoneal dialysis method, the intraperitoneal indwelling catheter 1 of the present invention is a method for injecting dialysate into the abdominal cavity and discharging the dialysate to the outside of the abdominal cavity after a certain time has elapsed. Used as an exchange channel. That is, the distal end portion of the intraperitoneal indwelling catheter 1 is inserted into the abdominal cavity of the patient through the abdominal wall, and the distal end portion of the intraperitoneal indwelling catheter 1 is placed in the abdominal cavity. While maintaining the state where the part is extended outside the abdominal wall, the patient lives daily and exchanges the dialysate through the intraperitoneal indwelling catheter 1 at regular intervals.
[0024]
This intraperitoneal indwelling catheter 1 is a catheter body comprising an indwelling part 2 placed in the abdominal cavity, an extending part 4 extending outside the abdominal wall, and an intermediate part 3 between the indwelling part 2 and the extending part 4. 10 and a passage 11 provided in the catheter body 10, and on the outer surface of the intermediate part 3Tubular body of collagen porous body5 is provided. And collagenPorous tubular body5 is provided on the extended portion 4 side of the intermediate portion 3.
[0025]
The catheter body 10 is a tubular body, the distal end side inserted into the abdominal cavity is an indwelling portion 2, and the proximal end side that extends outside the abdominal wall is an extended portion 4. Between the indwelling part 2 and the extension part 4 is collagen.Porous tubular bodyThe intermediate portion 3 having 5 is provided. The intermediate portion 3 forms a subcutaneous tunnel between the abdominal cavity and the abdominal wall by the passage of the catheter body 10.
[0026]
And the opening 21 of the channel | path 11 is formed in the front-end | tip of the indwelling part 2 toward the axial direction of the catheter main body 10, Moreover, the groove | channel 23 along the axial direction on the outer surface of the indwelling part 2, and the groove | channel 23 It has a side hole 22 drilled in the bottom. 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 on a straight line parallel to the axis of the catheter body 10 at equal intervals. . The dialysate is exchanged through the opening 21 and the plurality of side holes 22.
[0027]
Further, the formation of the groove 23 results in a thick wall between the groove 23 and the convex portion 9. The plurality of convex portions 9 formed in this way has a large area in contact with the inner wall of the abdominal cavity, so that the pressure applied when contacting the inner wall of the abdominal cavity is dispersed, and the influence on the body is small. Further, the tip 92 of the convex portion 9 protrudes from the tip of the indwelling portion 2, and the tip 92 is formed in an arc shape so that it does not come into contact with the inner wall of the abdominal cavity or the Douglas flaw. Yes. By providing the tip 92, the opening 21 of the passage (hereinafter also referred to as “lumen”) 11 is blocked when the indwelling portion 2 comes into contact with the Douglas fistula located at the lowest position in the abdominal cavity. Secured.
[0028]
In addition, 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 molding and then shaving the outer surface to form the groove 23, or extrusion There is a method of using a die for forming the convex portion 9 at the time of molding. When forming the convex portion 9 by a method using a die for forming the convex portion 9 at the time of extrusion molding, after forming a tube in which the convex portion 9 is formed over the entire length, the convex portion has a predetermined length. There is a method of burying the groove 23 formed by the formation of 9 or scraping the convex portion 9 by a predetermined length. Moreover, even if the convex part 9 is formed by any method, the strength is improved by providing the connecting part 91 formed by filling the groove 23 at a predetermined interval and connecting the adjacent convex parts 9. Can do.
[0029]
The indwelling part 2 (or the tip of the indwelling part 2) may be formed independently and connected to the intermediate part 3 and the extension part 4, but the indwelling part 2, the intermediate part 3 and the extension part 4 are integrated. Alternatively, the catheter body 10 may be formed.
[0030]
On the other hand, a connector (not shown) or the like is provided at the proximal end of the extension portion 4, and a peritoneal dialysis system formed by connecting a dialysate bag, a drainage bag, or the like with a tube via the connector or the like. Etc. are connected.
[0031]
The intermediate portion (hereinafter also referred to as “subcutaneous tunnel portion”) 3 is formed in a loop shape and has a U shape (swan neck shape). A first cuff 6 is fixed to the indwelling portion 2 side of the subcutaneous tunnel portion 3, and a second cuff 7 is fixed to the vicinity of the top of the loop with a silicone adhesive or the like. A member (hereinafter also referred to as “cuff member”) 5 made of a collagen porous body is provided on the protruding portion 4 side so as to be movable along the outer surface of the catheter body 10.
[0032]
The first cuff 6 and the second cuff 7 are formed in a tubular shape from a Dacron nonwoven fabric, and the cuffs 6 and 7 are sutured and fixed to the living tissue, so that the fibroblasts as the living tissue are cuff 6 and 6. 7, the catheter body 10 is placed in a fixed position. Further, since the cuff member 5 is formed in a tubular shape by a collagen porous body made of fibrotic collagen and modified collagen, fibroblasts enter the cuff member 5 to generate collagen, and the cuff member 5 is fibroblast. It will be replaced by cells. For this reason, fibroblasts concentrate around the catheter body 10 and the catheter body 10 is fixed. Further, since the cuff member 5 is positioned under the dermis, an appropriate depth of downgrowth is maintained, and deepening of the downgrowth is prevented.
[0033]
Here, as a method of generating the collagen porous body constituting the cuff member 5, for example, a collagen solution is mixed with an equilibrium salt solution such as a phosphate buffer and incubated at 37 ° C. for about 4 hours. Fibrosis collagen. On the other hand, the collagen solution is heat denatured by heating and denatured. In addition, since heat 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 preferred heat denaturation treatment is at 60 ° C. for 30 minutes. After mixing the fiberized collagen solution thus obtained and the denatured collagen solution, freeze drying in a tubular container, and performing thermal dehydration crosslinking, the cuff member 5 made of a collagen porous body is obtained. can get. Fibrotic collagen and heat-denatured collagen are crosslinked by thermal dehydration for 30 minutes to 12 hours, preferably 1 to 6 hours, and suitable thermal dehydration crosslinking is at 110 ° C. for 2 hours.
[0034]
Further, the outer surface and the inner surface of the tubular body (cuff member 5) made of a collagen porous body are covered with a Dacron protective member 51 formed in a mesh shape, whereby the collagen porous body is made into fibroblasts. At this time, there is no risk of dropping from the catheter body 10. Alternatively, a Dacron nonwoven fabric is fixed to the catheter body 10 with a predetermined thickness with an adhesive or the like, and the cuff member 5 made of a collagen porous body is placed on the nonwoven fabric. There is no risk of 5 dropping out.
[0035]
Further, 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 in a state where the catheter body 10 is extended and the outer diameter of the catheter body 10 is reduced. Also by installing the member 5 at a predetermined position, the cuff member 5 comes into close contact with the catheter main body 10, and there is no possibility that the cuff member 5 falls off the catheter main body 10.
[0036]
The catheter body 10 configured as described above is made of, for example, silicone rubber, thermoplastic fluororesin, polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polystyrene, polyurethane, and the like. It is preferable that it is comprised by. In particular, it is preferable to use a silicone rubber because of its excellent biocompatibility, and it is also preferable to use a thermoplastic fluororesin because of its easy processability. In order to improve biocompatibility, the surface may be coated with, for example, polyurethane elastomer, polyamide elastomer, unplasticized vinyl chloride resin, silicone rubber, or the like.
[0037]
Moreover, it is preferable that a marker 12 made of a radiopaque material is embedded or attached to the inner and outer surfaces at least in the indwelling portion 2 of the catheter body 10. Thereby, the position of the catheter main body 10 can be confirmed under fluoroscopy at the time of catheter implantation. The shape of the marker 12 may be provided as a linear shape from the indwelling portion 2 to the subcutaneous tunnel portion 3 as illustrated, or may be provided over the entire length of the catheter body 10. Further, the indwelling portion 2 and the subcutaneous tunnel portion 3 may be provided at predetermined positions. Examples of the radiopaque material constituting the marker 12 include tungsten, barium sulfate, gold, platinum, or alloys thereof.
[0038]
In addition, 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, the abdominal wall is implanted in the abdominal cavity or abdominal wall at the time of catheter transplantation or dialysate exchange. It is possible to prevent the lumen 11 from being crushed and blocked in the abdominal cavity.
[0039]
Here, although the full length of the catheter main body 10 changes with cases, it is about 250-600 mm, Preferably it is about 300-550 mm, More preferably, it is about 350-500 mm, Among these, the indwelling part 2 is about 150-200 mm. The subcutaneous tunnel portion 3 is preferably about 100 to 150 mm, and the extended portion 4 is preferably about 100 to 150 mm. Furthermore, the convex part 9 formation part of the indwelling part 2 is about 110-60 mm, and the cuff member 5 located in the subcutaneous tunnel part 3 is about 3.0-50 mm, Preferably it is about 5.0-50 mm, 1st. The second cuffs 6 and 7 are preferably about 5.0 to 15 mm. Moreover, the protrusion length of the front-end | tip 92 of a convex part is about 1.0-20 mm, Preferably it is about 2.0-10 mm.
[0040]
In the cuff member 5, if the total length is 3.0 mm or less, it is difficult to concentrate biological tissues around the catheter body 10, it is difficult to maintain downgrowth appropriately, and the total length is 50 mm or more. It is necessary to change the position where the second cuff 7 is installed. The second cuff 7 is installed at a position where the dialysate injection / discharge port of the catheter 1 faces downward, and in order to fix the catheter body 10 to the abdominal wall, a subcutaneous tunnel formed in a loop shape is formed. It is preferable to be near the loop apex of the part 3. Further, the cuff member 5 may be positioned at any length between the proximal end side and the installation position of the second cuff as long as the distal end side is positioned in the vicinity of the percutaneous portion of the catheter 1. A plurality of ones having a thickness of about 0 to 25 mm may be used adjacent to each other, or may be arranged at a predetermined interval. The wall thickness of the cuff portion 5 is about 1.0 to 4.0 mm, preferably about 1.5 to 2.5 mm. If the wall thickness is 1.0 mm or less, the living tissue is around the catheter body 10. It is difficult to condense, and it is difficult to maintain downgrowth moderately. When the wall thickness is 4.0 mm or more, damage to the abdominal wall is increased when a catheter is implanted in a patient, and downgrowth is formed. It may take time to do.
[0041]
And the internal diameter of the catheter main body 10 is about 1.0-3.5 mm, Preferably it is about 2.0-3.0 mm, The thickness of the catheter main body 10 is only the indwelling part 2 or the convex part of the indwelling part 2. Only the 9 forming part may be formed thick, and may be the same thickness over the entire length. Specifically, in the thick part, about 1.0 to 3.0 mm, preferably 2.0 to It is about 2.5 mm. And the height (depth of the groove | channel 23) of the convex part 9 formed in the indwelling part 2 is about 0.5-1.5 mm, Preferably it is about 1.0-1.3 mm.
[0042]
In addition, the number of the convex portions 9 or the grooves 23 is not limited to four, and may be one, three, five or more, and is determined according to the outer diameter of the catheter body 10. It is preferable to set the height of the convex portion 9 according to the number. Furthermore, the connecting portion 91 may be provided as necessary depending on the material forming the catheter body 10, the thickness, and the like. Further, the number of the side holes 22 is about 6 to 20, preferably about 8 to 16, per number of the grooves 23 although it depends on the number of the grooves 23.
[0043]
It is preferable that at least the outer surface of the intraperitoneal indwelling catheter 1 described above is subjected to hydrophilic treatment at least from the indwelling portion 2 to the subcutaneous tunnel portion 3, and as such hydrophilic treatment, for example, poly (2-hydroxy) Examples thereof include a method of coating a hydrophilic polymer such as ethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinyl pyrrolidone.
[0044]
When such a process is performed, the insertion resistance when the catheter is inserted into the abdominal cavity can be reduced, and the time for catheter transplantation operation can be shortened. The burden is reduced. It also has less mucosal damage and suppresses tissue adhesion.
[0045]
Next, the state when the intraperitoneal indwelling catheter 1 according to a preferred embodiment of the present invention is implanted in a patient will be specifically described. 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 patient's abdominal wall.
[0046]
As shown in FIG. 3, the subcutaneous tunnel portion 3 of the intraperitoneal indwelling catheter 1 is implanted through the abdominal wall 100, and is subcutaneously interposed between the intraperitoneal 120 and the outer abdominal wall 110 by the lumen 11 of the catheter body 10. A tunnel is formed. Dialysate is exchanged through this subcutaneous tunnel. Further, the distal end side of the subcutaneous tunnel portion 3 formed in a loop shape penetrates the peritoneum 101 and is placed in the abdominal cavity 120, and the proximal end side of the subcutaneous tunnel portion 3 penetrates the epidermis 105. The outside of the abdominal wall 110 is extended. The distal end of the indwelling portion 2 placed in the abdominal cavity 120 is positioned at a Douglas fistula, and a connector is connected to the proximal end of the extending portion 4 extending outside the abdominal wall 110.
[0047]
The first cuff 6 provided on the indwelling portion 2 side of the subcutaneous tunnel portion 3 is positioned at the bottom of the muscular layer tissue 102 and is fixed to the peritoneum 101 by stitching. 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. Further, 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.
[0048]
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 is secured to the rectus abdominis fascia 103 by stitching. By this second cuff 7, the subcutaneous tunnel portion 3 is fixed to the living tissue with the dialysate injection / discharge port facing downward.
[0049]
The cuff member 5 provided on the extending portion 4 side of the subcutaneous tunnel portion 3 is positioned below the skin 105. The cuff member 5 is a porous collagen body.Tubular bodyAnd is converted to fibroblasts. In addition, fibroblasts of the subcutaneous tissue 104 also enter the cuff member 5 to generate collagen. The cuff member 5 allows the living tissue in the vicinity of the percutaneous portion of the catheter 1 to follow the movement of the catheter 1 even when the extension portion 4 of the catheter 1 is moved in the vertical direction or the like when injecting or discharging dialysate. To do. For this reason, the downgrowth 150 having an appropriate depth is maintained, and the downgrowth 150 is prevented from deepening.
[0050]
[Example 1]
1 kg of silicone rubber was put into an extrusion molding machine, the discharge speed was 35 rpm, the temperatures of the inlet part, the middle part (screw part), and the outlet part were normal temperature, and the tube was molded. The die shape of the extrusion molding machine used was an in-die diameter of 2.7 mm, an out-die diameter of 5.0 mm, the number of 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 convex portions at equal intervals in the axial direction of the outer surface, an inner diameter of 2.5 mm, an outer diameter of 4.7 mm, a wall thickness of 1.1 mm, a convex portion height of 0.4 mm, and a convex portion. The width was 1.2 mm.
[0051]
Cut the length of 440 mm of the obtained tube, insert a stainless steel core into the lumen of the tube, fill it with a linear silicone rubber in a groove of 350 mm from the base end, and bury 90 mm from the tip Left convex. Next, about 100 mm, which is near 290 mm from about 190 mm from the tip of the tube, was bent in a loop shape. And in this state, it heated at the temperature of about 160 degreeC, and the tube was hardened.
[0052]
Next, the groove from the tip of the cured tube to 5.0 mm was scraped off to form a protrusion. And the front-end | tip of this protrusion part was processed into round. Next, nine side holes were formed in each groove per groove. The side hole has a diameter of 0.5 mm.
[0053]
A first cuff and a second cuff having a total length of 10 mm were placed at a position 180 mm and a position 250 mm from the tip of the obtained tube, and were fixed by adhesion with a silicone-based adhesive. The first and second cuffs are formed from a Dacron nonwoven fabric.
[0054]
[Example 2]
Production of fibrotic collagen: Atelocollagen powder (manufactured by Koken Co., Ltd.) was dissolved in dilute hydrochloric acid at pH 3.0 at a temperature of 4 ° C. to adjust to 0.3 to 0.4 (w / v)%. The solution was sterilized by filtration through two types of filters having pores with a diameter of 0.8 μm and 0.2 μm in order, and then a phosphate buffer solution of pH 7.0 was added while stirring at 4 ° C. The collagen solution was atelocollagen (30 mM disodium phosphate, 100 mM sodium chloride) having a final concentration of 0.1 to 0.15 (w / v)%.
[0055]
Subsequently, it was left to stand in a 37 degreeC thermostat for 4 hours, and the fibrotic atelocollagen (FC) solution was adjusted. The FC solution was concentrated by centrifugation under aseptic conditions to adjust the concentration to 4.0 (w / v)%.
[0056]
Production of denatured collagen: On the other hand, 0.3-0.4 (w / v)% atelocollagen solution sequentially passed through the above-mentioned filter was freeze-dried and again in sterile distilled water, 4.0 (w / v) It was redissolved to be%.
[0057]
This solution was left in a constant temperature bath at 60 ° C. for 30 minutes to cause heat denaturation to obtain a denatured atelocollagen (HAC) solution. The HAC solution was filtered through a filter having pores with a diameter of 0.45 μm at a temperature of 37 ° C.
[0058]
Production of collagen porous body: FC solution and HFC solution obtained in this way are mixed at a ratio of 9: 1, put into 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, and frozen. It dried and thermal dehydration bridge | crosslinking was performed at the temperature of 110 degreeC for 2 hours.
[0059]
The obtained porous collagenous tubular body was cut into a total 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. Next, the cuff member is moved along the outer surface of the catheter body in a state where the catheter produced in Example 1 is expanded and the outer diameter of the catheter body is reduced, and the proximal end side of the cuff member is set to the proximal end of the catheter. To 130 mm. And the cuff member was installed in the catheter of Example 1 by restoring the outer diameter of the catheter body.
[0060]
[Experimental example]
Two tubes prepared by cutting the tube made in Example 1 into a length of 65 mm are prepared, and one of the tubes is provided with two cuff members having a total length of 20 mm created in Example 2 at the end from the tip. It installed so that it might be located in the place of 10 mm and 10 mm from a base end. And the evaluation experiment was performed using the tube which installed this cuff member, and the tube which has not installed the cuff member.
[0061]
A scalpel was placed on the back of the rat so that the two cuff members were positioned under the epidermis, and about 10 mm at both ends of the tube were extended outside the abdominal wall, and the tube provided with the cuff member was transplanted. Moreover, the tube which does not provide the cuff member was vertically aligned with the tube provided with the cuff member, and transplanted in the same manner.
[0062]
Four weeks after transplanting the tube, in the tube provided with the cuff member, the cuff member made of a collagen porous body is replaced with fibroblasts. The skin around the part followed and did not deepen the downgrowth. On the other hand, in the tube without the cuff member, a prominent downgrowth was observed, and redness reminiscent of bacteria entering from the percutaneous part of the tube was confirmed.
[0063]
From the above evaluation experiment, it was found that the cuff member of Example 2 can prevent bacteria from entering from the percutaneous portion of the tube. Further, it can be understood that the downgrowth can be prevented from being deepened because the tissue around the percutaneous portion of the tube can follow the movement of the tube.
[0064]
【The invention's effect】
As described above, according to the intraperitoneal indwelling catheter of the present invention, the indwelling portion placed in the abdominal cavity, the extending portion extending outside the abdominal wall, and the intermediate between the indwelling portion and the extending portion. An intraperitoneal indwelling catheter having a catheter body composed of a portion and a passage provided in the catheter body, wherein collagen is formed on the outer surface of the intermediate portionPorous tubular bodyWithThe collagen porous body is provided so as to be movable along the outer surface of the catheter body.As a result, the biological tissue can be concentrated in the catheter body at an early stage, so that bacteria do not enter the body from the percutaneous portion of the catheter. For this reason, the occurrence frequency of peritonitis can be reduced.Furthermore, since the position of the porous collagenous body can be adjusted when the catheter is implanted in the patient, the depth of the downgrowth formed can be adjusted to allow bacteria to enter the body from the percutaneous part of the catheter. Can be prevented.
[0065]
The collagenPorous tubular bodyIs provided on the extension portion side of the intermediate portion, so that the living tissue near the percutaneous portion of the catheter can be concentrated in the catheter body, and the living tissue near the percutaneous portion of the catheter is moved by the catheter. Can be followed. For this reason, since it is possible to prevent the downgrowth from becoming deep, bacteria do not enter the body from the percutaneous part of the catheter.
[0066]
Furthermore, the collagenPorous materialIs formed of a porous collagen body composed of fibrotic collagen and denatured collagen, so that it is possible to concentrate biological tissue in the catheter body at an early stage and prevent downgrowth from deepening. Bacteria do not enter the body through the skin.
[Brief description of the 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 cross-sectional view taken along line AA in FIG.
FIG. 3 is a partial cross-sectional view showing a state where an intra-abdominal indwelling catheter according to an embodiment of the present invention is implanted in a patient's abdominal wall.
[Explanation of symbols]
1 Intraperitoneal indwelling catheter
10 Catheter body
11 passage
12 Markers
2 detention section
21 opening
22 side holes
23 groove
3 subcutaneous tunnel
4 Extension part
5 CollagenPorous tubular body
6 First cuff
7 Second cuff
9 Convex
91 Connecting part
92 Tip of convex part
100 abdominal wall
101 Peritoneum
102 Muscle tissue
103 Rectus abdominis fascia
104 Subcutaneous tissue
110 Outside the abdominal wall
120 abdominal cavity
150 downgrowth

Claims (3)

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, an intermediate part between the indwelling part and the extending part, and a passage provided in the catheter body. An intraperitoneal indwelling catheter comprising a tubular body of a collagen porous body on the outer surface of the intermediate portion, the tubular body of the collagen porous body being provided movably along the outer surface of the catheter body intraperitoneal indwelling catheter, characterized in that there. The intraperitoneal indwelling catheter according to claim 1, wherein the collagen porous body is provided on the extension part side of the intermediate part. The intraperitoneal indwelling catheter according to claim 1, wherein the tubular body of the collagen porous body is formed of a collagen porous body composed of fibrotic collagen and denatured collagen.

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