JP3446353B2 - Drainage equipment - Google Patents

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a drainage tool,
More specifically, the present invention relates to a retrograde percutaneous transhepatic biliary drainage device capable of significantly shortening the number of hospital stays of patients after surgery for extrabiliary fistula.

[0002]

2. Description of the Related Art In the liver, biliary tracts connecting to the common bile duct are stretched in a mesh pattern. The common bile duct sends the bile secreted by the gallbladder to the intestine. A pancreatic duct that sends pancreatic juice secreted by the pancreas to the intestine extends from the pancreas and joins the common bile duct before reaching the intestine. Therefore, the gallbladder and pancreas are connected via the common bile duct and pancreatic duct. As the operation for bile duct obstruction or pancreatic duct obstruction such as common bile duct stone disease, the gallbladder or pancreas is removed, the common bile duct or pancreatic duct is incised, and a lithotomy stone,
After stone removal, a tube or catheter is placed in the bile duct or pancreatic duct to expel bile or pancreatic juice from the body.
As a means for discharging bile (pancreatic juice), a tube with a puncture needle attached to the tip is passed from the incision of the common bile duct (pancreatic duct) through the lumen of the common bile duct (pancreatic duct), and retrogradely guided to the bile duct in the liver to After penetrating the liver from the middle and percutaneously guiding it to the outside of the body, the common bile duct (pancreatic duct) incision is sutured with the tube rear end contained in the common bile duct (pancreatic duct), and the puncture needle is removed from the tube tip, Percutaneous transhepatic drainage of bile (pancreatic juice) in the biliary tract has been performed. As a tube with a puncture needle attached to its tip used for this percutaneous transhepatic drainage method, a tube having a puncture needle with a conical tip formed of a metal pipe having a barrel shape has been proposed (actually, Kaisho 60-182061
Issue). However, since the tube with the puncture needle cannot be inserted into the periphery of the intrahepatic biliary tract, a method of percutaneously passing the tube through the liver tissue from the thick part of the intrahepatic biliary tract is adopted. Therefore, the liver tissue is seriously damaged, and it takes about 2 weeks after the operation to remove the tube. The puncture needle can be thinned to insert the tube to the distal part of the intrahepatic biliary tract, but simply thinning it will weaken the waist of the puncture needle and tend to damage the biliary tract wall. Insertion operation becomes difficult.

[0003]

DISCLOSURE OF THE INVENTION The object of the present invention is to provide a retrograde treatment which causes less damage to the liver, has a high life safety, and can significantly shorten the number of hospital stays of patients after surgery for extrabiliary fistula. PROBLEM TO BE SOLVED: To provide a percutaneous transhepatic biliary drainage device. The inventors of the present invention have conducted extensive studies to achieve the above-mentioned object, and by using a tube having a puncture needle formed at the tip with an outer diameter smaller than that of the rear end at the tip, It was found that it is possible to significantly shorten the number of hospital stays of patients after fistula surgery, and the present invention has been completed based on this finding.

[0004]

Thus, according to the present invention, (1) a drainage tool for connecting a puncture needle and a drainage tube for insertion into a living body tube or penetrating a living tissue, wherein the puncture needle comprises: The front end and the rear end each have a front end formed of a long body, a rear end formed of a long body having an outer diameter larger than that of the front end, and a connector for connecting the rear end with a drainage tube. The connector part and the connector part are connected in this order to form one elongated body.The drainage tube is a flexible tube, and the puncture needle and the drainage tube can be connected via the connector part. A featured drainage tool is provided.

Further, the following are provided as preferred embodiments of the present invention. (2) The drainage tool according to (1), wherein the tip of the puncture needle is formed in a dome shape or a spherical shape. (3) The outer diameter of the tip of the puncture needle is 5 to 8 of the outer diameter of the rear end.
It is 0%, The drainage tool of said (1) characterized by the above-mentioned. (4) The drainage tool according to (1) above, wherein the puncture needle is a hollow elongated body.

(5) The average bending strength of the puncture needle is 0.1 to
It is 10 kgf, The drainage tool of said (1) characterized by the above-mentioned.

(6) The drainage tool according to (1) above, wherein the tip of the puncture needle is made of stainless steel and the back end is made of aluminum. (7) The above-mentioned (1), characterized in that a pressure-relief side hole is provided at the end of the drainage tube which is connected to the puncture needle
Drainage tools. (8) A drainage tool according to the above (1), characterized in that a tapered portion whose diameter gradually increases from the outer diameter of the front end to the outer diameter of the rear end is provided between the front end and the rear end of the puncture needle. . The drainage tool of the present invention may have a structure in which the features described in (2) to (8) above are appropriately combined.

[0008]

The drainage tool of the present invention has a puncture needle having an outer diameter of the distal end portion smaller than that of the rear end portion, so that it can be inserted into the distal portion of the intrahepatic biliary tract. However, there is less damage when penetrating the liver. Further, since the puncture needle is provided with a rear end portion having an outer diameter larger than that of the front end portion, the hip of the puncture needle is moderately strong, so that the insertion operation is easy and the biliary wall is accidentally punctured and scratched. There are few things. Therefore, the recovery of biliary tract and liver damage is accelerated, and the number of hospital stays can be shortened. In addition, if a taper part that gradually increases in diameter from the outer diameter of the tip to the outer diameter of the rear end is provided between the front end and the rear end, the peripheral biliary tract and liver tissue can be comfortably spread out, so the liver Can be easily inserted without puncturing the biliary wall without damaging the biliary wall if the tip of the puncture needle is formed into a dome shape or a spherical shape. It is possible to

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the drainage tool of the present invention will be described with reference to the drawings. FIG. 1 is an overall view showing one embodiment of the drainage tool of the present invention. FIG. 2 is a view showing an aspect of the tip of the puncture needle of the drainage tool of the present invention. FIG. 3 is a view showing an aspect of the connector portion of the puncture needle of the drainage tool of the present invention.
FIG. 4 is a cross-sectional view showing an aspect of a puncture needle of the drainage tool of the present invention.

The drainage tool of the present invention has a puncture needle 10 and a drainage tube 7. The puncture needle used in the present invention is an elongated body that can pass through a body cavity or penetrate biological tissue. The puncture needle has a tip portion 2 formed of a long body, a rear end portion 4 formed of a long body having an outer diameter larger than that of the tip portion, and a connector portion 5 for connecting the rear end portion to a drainage tube. Then, the front end portion, the rear end portion, and the connector portion are connected in this order to form one elongated body. The outer diameter of the tip portion 2 of the puncture needle is smaller than that of the rear end portion 4. The outer diameter of the front end portion is usually 5 to 80%, preferably 10 to 75% of the outer diameter of the rear end portion. By making the outer diameter of the front end portion smaller than the outer diameter of the rear end portion, it becomes possible to insert the drainage tool into the distal portion of the intrahepatic biliary tract without damaging the biliary tract wall. The outer diameter of the tip is usually 0.5 to 1.8 mm, preferably 0.7 to
It is 1.5 mm. The larger outer diameter of the tip makes it difficult to insert a drainage tool without damaging the biliary tract. On the contrary, when the outer diameter of the tip portion becomes small, the waist of the puncture needle becomes weak and it becomes difficult to insert the needle. The outer diameter of the rear end is usually 1.5
It is -10 mm, preferably 1.8-9 mm. When the outer diameter of the rear end portion becomes small, the waist of the puncture needle becomes weak and it becomes difficult to insert the needle. On the contrary, when the outer diameter of the rear end portion becomes large, the rigidity becomes high and it becomes impossible to follow the bending of the biliary tract.

The length of the tip of the puncture needle is usually 50 to 2
50 mm, preferably 100 to 200 mm, and the length of the rear end is usually 30 to 180 mm, preferably 50.
~ 150 mm.

The puncture needle used in the present invention may be one in which the distal end portion and the rear end portion are directly connected to each other to form one elongated body, but the distal portion of the biliary tract and the liver tissue are pushed and spread without difficulty. In order to reduce damage to the biliary tract and liver, it is preferable to provide a taper portion between the front end portion and the rear end portion that gradually increases in diameter from the front end outer diameter to the rear end outer diameter. The inclination angle of the tapered portion is usually 10 to 60 degrees, preferably 15 to 50 degrees with respect to the long axis of the puncture needle.

At the rear end of the puncture needle, there is a connector portion 5 for connecting the rear end portion to the drainage tube. The connector portion 5 is usually a long body having an outer diameter substantially equal to the inner diameter of the drainage tube, and the peripheral surface of the long body is provided with unevenness as shown in FIG. 3 (a), (b) or (d). It may be provided. The length of the connector part is usually 5 to
It is 20 mm.

The tip 1 of the puncture needle has a conical shape (FIG. 2 (c)), a dome shape (FIG. 2 (a)), or a spherical shape (FIG. 2).
(B)), columns (FIG. 2 (d)), and the like. Domes or spheres are preferred to facilitate insertion into the intrahepatic biliary tract and prevent damage to the biliary tract wall.

The puncture needle may be a solid elongated body or a hollow elongated body. If the outer diameter of the rear end or the tip of the puncture needle increases, the puncture needle becomes stiffer and it becomes difficult to insert it following the bending of the biliary tract. It is preferable to use the one having a shape (FIG. 4).

The puncture needle used in the present invention has an average bending strength of usually 0.1 to 10 kgf, preferably 0.
It is 3 to 6 kgf. If the average bending strength is small, the waist of the puncture needle becomes weak and it becomes difficult to insert it. High mean bending strength makes it difficult to insert a drainage device without damaging the biliary tract. The average bending strength was determined by placing a puncture needle horizontally at two fulcrums of a triangle 40 mm apart and pushing the middle position of the fulcrums vertically with the force gauge 12 (Fig. 5 (a)). The values indicated by the force gauge when the angle reaches 120 degrees (FIG. 5B) are obtained by arithmetically averaging the calculated values for the front end and the rear end.

The puncture needle is usually made of metal or resin. Specific examples thereof include metals such as stainless steel, aluminum, brass, copper, and Ni—Ti alloy; resins such as phenol resin, epoxy resin, silicone resin, polycarbonate, acetal resin, and polysulfone. Of these, the tip portion 2 of the puncture needle is preferably stainless steel, particularly soft stainless steel, and the rear end portion 4 of the puncture needle is preferably stainless steel, aluminum, particularly aluminum.

The puncture needle can be obtained by integrally molding the front end portion, the rear end portion and the connector portion (tapered portion if necessary), or after the respective portions are molded, they are assembled by means such as welding or fitting. You can also get it.

The drainage tube 7 is a flexible tube. The drainage tube 7 is flexible and strong so that it can penetrate biological tissue, and preferably,
It does not deteriorate due to body fluids such as bile and pancreatic juice. The drainage tube is usually made of resin. Specific examples of the resin include polyurethane, polyethylene, polypropylene, polyvinyl chloride, polyamide, polyester, silicone rubber, natural rubber, chloroprene rubber and butyl rubber. In order to confirm the location of the drainage tube by X-ray, an X-ray opaque substance (contrast agent) such as barium sulfate, titanium oxide, bismuth oxide or molybdenum sulfide is attached to the surface of the tube. It is also possible to use the one formed by kneading the resin forming the tube or the tube. The outer diameter of the drainage tube is approximately the same as the outer diameter of the rear end portion of the puncture needle, and is usually 1.5 to 10 mm, preferably 1.8 to 9 m.
m. The inner diameter of the drainage tube is usually 0.5
It is ~ 9.5 mm, preferably 1-8.5 mm.

The drainage tube has a drainage tube end that is not connected to the puncture needle and is usually provided with a terminal hole 9 or a side hole 8 that communicates with the lumen of the drainage tube. The diameter of the side or end holes is
Usually, it is 0.5 to 2 mm. The number of side holes is usually 2 to
It is 10 and the number of terminal holes is usually 1.

After the drainage tool is inserted through the common bile duct or pancreatic duct incision and percutaneously penetrated transhepatically, the puncture needle is left attached to the drainage tube, and the common bile duct or pancreatic duct incision is sutured. The bile duct or pancreatic duct may be filled with bile or pancreatic juice, and the pressure may increase to tear the sutured part. As a drainage tube to prevent tearing of the suture,
It is preferable that the pressure relief side hole 6 communicating with the lumen of the drainage tube is provided at the end portion on the side connected to the puncture needle. Since the bile or pancreatic juice in the common bile duct or pancreatic duct is discharged from the pressure-relieving side hole, the pressure in the common bile duct or pancreatic duct does not increase and the suture portion does not tear.

The puncture needle and the drainage tube can be connected via a connector portion. The connection between the puncture needle and the drainage tube is performed by inserting or inserting the connector portion into the lumen of the drainage tube, and then adhering or fusing.

[0023]

EFFECTS OF THE INVENTION The drainage device of the present invention is highly safe for life and is 7 to 10 days after surgery since it requires less damage to the liver when it is placed in a retrograde transdermal transhepatic manner. Since the drainage tube can be removed with, the number of hospital stays of the patient can be shortened.

[Brief description of drawings]

FIG. 1 is an overall view showing one embodiment of a drainage tool of the present invention.

FIG. 2 is a view showing a state of the most advanced puncture needle of the drainage tool of the present invention.

FIG. 3 is a view showing an aspect of a puncture needle connector portion of the drainage tool of the present invention.

FIG. 4 is a cross-sectional view showing an aspect of a puncture needle of the drainage tool of the present invention.

FIG. 5 is a diagram showing a measurement state of bending strength of a puncture needle.

[Explanation of symbols]

1 ... Cutting-edge needle 2 ... Tip side 3 ... Tapered part 4 ... rear end side 5 ... Connector part 6 ... Pressure release side hole 7 ... Drainage tube 8 ... Side hole 9 ... End hole 10 ... Puncture needle 11 ... Hollow part 12 ... Force gauge

─────────────────────────────────────────────────── ─── Continuation of the front page (58) Fields investigated (Int.Cl. ⁷ , DB name) A61M 1/00-1/38 A61M 25/00-27/00 A61B 17/34

Claims (2)

(57) [Claims] 1. A drainage tool for connecting a puncture needle and a drainage tube to be inserted into a living body tube or penetrated into a living tissue, wherein the puncture needle has a length of 50 to 250 mm and 0.5 to 1.8.
a tip portion made of a long body having an outer diameter of mm, and 30 to 1
80mm length and 1.5-10mm larger than the tip
Has a rear end portion formed of a long body having an outer diameter of, and a connector portion for connecting the rear end portion to the drainage tube, and the front end portion, the rear end portion, and the connector portion are connected in this order. The outer diameter of the front end portion is 5 to 80% of the outer diameter of the rear end portion.
Yes , the drainage tube is a flexible tube, and the puncture needle and the drainage tube can be connected via a connector portion. 2. The drainage tube of the puncture needle is
A contract characterized by having substantially the same outer diameter as the rear end
The drainage tool according to claim 1.