JP2738581B2 - Drainage tube insertion hole forming set - Google Patents

Description

The present invention relates to a set for forming a drainage tube insertion hole, and more particularly, to insert a drainage tube into a diseased part in the body when treating biliary tract disease, kidney disease, etc. The present invention relates to a drainage tube insertion hole forming set used for forming a hole for performing a treatment for removing bile, calculus, and the like.

[Conventional technology]

Conventionally, percutaneous treatment using a drainage tube has been performed for various diseases in the bile duct, gallbladder, renal pelvis, and ureter. That is, if a tube having an outer diameter of 5 to 6 mm required for insertion of a drainage tube is percutaneously inserted into a luminal organ such as a bile duct, a gallbladder, or a renal pelvis, which requires treatment, a living body is placed around the tube. Fibrosis as a foreign body reaction of
As a result, a fistula is formed, and the drainage tube is inserted and removed through the fistula.

By the way, in the conventional percutaneous treatment using a drainage tube, the tube of the finer suture is gradually replaced with a tube of the right meridian at intervals of several days to one week, and the drainage tube is inserted for about one month. Although the fistula is formed as long as possible, it takes too much time to form the fistula, and the pain given to the patient is very serious.

As a method of shortening the time required for such a surgical operation or treatment, Japanese Utility Model Laid-Open No. 62-78938 discloses a thin tube into which a guide wire can be inserted and a medium-diameter tube covering the outer periphery of the small-diameter tube. A bile duct drainage expansion set including a large-diameter tube having a larger outer diameter than the medium-diameter tube over the outer periphery of the small-diameter tube is introduced.

[Problems to be solved by the invention]

However, treatment using drainage tubes, such as the removal of crushed stones and polyps, and the collection of excised tissue, requires the drainage tube to be inserted and removed many times, which requires the surface between the chest wall and the liver or between the posterior abdominal wall and the kidney. It was necessary for the fistula to adhere firmly, and it was necessary to indwell a large-diameter tube with an outer diameter of 5 to 6 mm for 2 to 3 weeks to wait for completion of the fistula, and the pain given to the patient was great.

Furthermore, there is also a means of inserting the drainage tube into the hollow part of the large-diameter tube while leaving the large-diameter tube in the body, but the diaphragm at the border between the lung and the liver moves up and down with each breath, and in conjunction with it There is a problem that the position of the large-diameter tube moves because the liver also moves up and down. In addition, the part located at the border between the chest wall and the liver surface bends every time the lungs breathe,
There was a problem that the large-diameter tube was broken.

The present inventor has studied variously to solve these problems, using a tube having a tear line in the longitudinal direction as the largest diameter tube, tearing a part of the tear line and folding it, and suturing the folded part with the skin surface. The inventors have found that these problems can be solved by fixing the largest diameter tube, and have arrived at the present invention.

In addition, since the tear line of these tubes is conventionally formed by a knife cutter or a heat cutter, the tear line formed by the heat cutter is as shown in the vertical cross-sectional view of the thick portion of the tube in FIG. In addition, both edges 12 of the cut portion 14 of the tear line were overlaid by the heat of the heat cutter, and the surface of the thick portion contracted and deformed at that location, thereby damaging human tissue when inserting or removing the tube. Also, when the tube was manually opened outward from the proximal end of the tube, the tube was not necessarily opened along the tear plug. Further, if the knife cutter is not sufficiently sterilized, bacteria may adhere to the cut portion when cutting the tube, and there is a risk of contaminating luminal organs such as a subcutaneous tissue and a bile duct of a patient. In particular, it is difficult for these cutters to adjust the desired cutting length and cutting width in the cross-sectional direction of the thick part of the tube, and it is difficult to obtain a tube of a predetermined quality. As a result, the tube may be compressed by the pressure in the subcutaneous tissue, and the tear line may be broken in the subcutaneous tissue before the drainage tube is inserted to damage the cell tissue. Also, since the tear line of the tube formed by these cutters has a large cutting width, external bacteria adhere to the cut point of the tear line, and patients can be infected with pathogenic bacteria or human tissues can be damaged when inserting or removing the tube. I was hurt.

An object of the present invention is to provide a tube for inserting a drainage tube capable of minimizing damage to human body tissue and performing percutaneous treatment using a drainage tube in a short time.

[Means for solving the problem]

That is, at least one synthetic resin tube formed so that the small-diameter tube can be inserted into the hollow portion of the large-diameter tube, and a guide wire and / or
Alternatively, in a set for forming a drainage tube insertion hole formed of a puncture needle, a flexible resin having at least one tear line in which a part of a cross section of a thick portion of a tube having a maximum diameter is cut substantially linearly in a longitudinal direction. It is a set for forming a drainage tube insertion hole, which is a tubular body consisting of:

The present invention is also the drainage tube insertion hole forming set, wherein the tear line of the tube having the largest diameter is formed by an ultrasonic cutter.

Furthermore, in the present invention, the cutting width of the thick portion of the tube having the maximum diameter is 0.
01-1.0mm, cut thickness is 20 for the thickness of the thick part of the tubular body
It is a set for forming a drainage tube insertion hole of up to 80%.

[Action]

The set for forming a drainage tube insertion hole of the present invention punctures a luminal organ such as a bile duct, a gallbladder, a renal pelvis, or a ureter requiring treatment with a puncture needle inserted in a minimum diameter tube, and inserts the tube into these tubes. The puncture needle is withdrawn while remaining in the luminal organ. Next, after expanding the fistula with the medium-diameter tube extrapolated to the tube, the small-diameter tube was removed, the diameter of the tube was sequentially increased, and the fistula was gradually expanded, and finally with a tube having a tear line. A fistula is formed, the tear line outside the body of the tube is torn, and the torn portion is folded back and sutured to the skin surface. Thereafter, a drainage tube is inserted into the hollow portion of the tube to perform treatment for removing bile, calculi, and the like. The rest of the tube inside the body passes through the subcutaneous tissue and the tip is inside the hollow organ, so that it is possible to suppress damage to human tissue due to frequent insertion or withdrawal of the drainage tube.

〔Example〕

Hereinafter, an example of the present invention in an embodiment will be described. FIG. 1 is a perspective view of a tube for inserting a drainage tube used in the present invention, FIGS. 2 to 6 are explanatory views showing an example of a method of using a set for forming a drainage tube insertion hole of the present invention, and FIG. 7 is a drainage. FIG. 8 is a sectional view of a tube for inserting a tube, and FIG. 8 is a sectional view of a tear line partially cut by a heat cutter. In the figure, 1 is a tube for inserting a drainage tube, 2
Is a puncture needle, 3 is a drainage tube, 4 is a drainage tube tip, 5 is a drainage tube side hole, 6 is a guide wire, 7 is a folded portion of a tube, 8 is a tearing portion, 9 is a cut portion, and 10 is a tube base end. Part, 11 is a tube tip, 12 is a cladding on both edges, 13 and 14 are cut parts, 15 is a small diameter tube, 16 is a medium diameter tube, 17 is a large diameter tube,
A indicates a liver, B indicates a bile duct, and C indicates a gall bladder.

FIG. 1 is a perspective view showing an example of a drainage tube insertion tube used in the present invention. The tube extends from a notch 9 at a tube base end 10 to a tube tip 11 on the outer surface of a tubular body made of a flexible resin. At least one substantially straight tear line 8 is formed in the longitudinal direction of the tube. The tear line 8 is formed by an ultrasonic cutter,
As shown in the sectional view of the thick part of the tube in FIG.
13 is half-cut to the thick portion thickness d with almost the same width W without forming the buildup on both edges of the thick portion surface. The cut thickness d of the thick part is 20 to 80%, preferably 35 to 70%, of the thickness D of the thick part. If it is less than 20%, the tube tends to be difficult to tear and it is difficult to tear along the tear line, and if it exceeds 80%, the tube tends to have low breaking strength, and the pressure in the subcutaneous tissue causes drainage. Before the tube is inserted, there is a danger that the tube will break along the tear line and that bodily fluids will enter the tube cavity.
In FIG. 1, the tear line 8 of the tube 1 extends from the proximal end 10 to the distal end 11 of the tube.
Is provided only in the part outside the body, and the body part may not have a tear line.

The positioning of the cutting thickness d of the tube can be performed by moving the cutter in a swinging manner without changing the relative dimension between the cutting edge of the ultrasonic cutter and the roll surface, or by keeping the relative dimension between the cutting edge of the ultrasonic cutter and the tube table constant. The ultrasonic cutter is moved horizontally with respect to the tube table, or the size is adjusted with a laser measuring instrument capable of measuring up to 1 μm.
Thereby, the tube cutting thickness d can be arbitrarily determined. The tear line can be locally melted and solidified only at the cut portion by frictional heat generated by micro-vibration of the cutting edge of the ultrasonic cutter. The width W of the cutting portion 14 can be arbitrarily determined according to the purpose, but is usually 0.01 to 1.0 mm,
Preferably it is 0.01 to 0.6 mm. If the width W is less than 0.01 mm, the tube tends to be difficult to tear,
If it exceeds m, there is a risk that external bacteria may adhere to the cut portion 13 of the tear line, and also the tear line 8 of the tube tends to cleave in the body tissue. If the width W of the cut portion 13 is 0.2 mm or less, the position of the tear line is apparently indistinct, and it is preferable because the appearance of the drainage tube insertion tube is not spoiled.

As drainage tube insertion tube material, drainage tube material and fistula formation tube material,
Fluorine resin, polyurethane, silicone resin, polyvinyl chloride, polypropylene, polyethylene, ethylene propylene copolymer, poly (ethylene butylene) polystyrene block copolymer, polyamide, polyethylene terephthalate or a copolymer thereof, and a mixture thereof. Particularly, polyolefins such as polypropylene and polyethylene which are hard to be cut by a high frequency cutter are preferable. In general, a somewhat hard synthetic resin is more convenient for forming a fistula than a drainage tube insertion tube and a drainage tube. In FIG. 1, the tear line 8 extends from the tube proximal end 10 to the tube distal end 11,
Although it extends in a substantially straight line, when the tube is torn midway and folded, it may not be necessary to provide a tear line on the distal end side. The tube base end 10 is provided with a cut 9 and is open, but a cleavage plug for tearing a tear line may be provided at the base end.

At least one tear line 8 of the drainage tube insertion tube is provided in the longitudinal direction of the tube.
When there are two or more tearing lines, it is convenient to turn the tearing portion of the tube, and it is particularly preferable to provide two tearing lines at the tube facing position.

An example of a method of using the drainage tube insertion hole forming set of the present invention will be described with reference to FIGS. Small diameter tube
The puncture needle 2 is inserted into the hollow portion 15 with the distal end of the puncture needle exposed from the distal end of the tube 15. The distal end of the tube is preferably tapered so as to be in close contact with the side wall of the puncture needle 2 so that body fluids and the like do not enter the gap between the tube and the needle. The puncture needle 2 with the tube 16 extrapolated is punctured into the patient as shown in FIG. 2, and the distal end thereof is guided to the bile duct B through the subcutaneous tissue. At this time, a flexible guide wire 6 is inserted through the hollow portion of the puncture needle 2, and after the puncture needle 2 is removed, the guide wire 6 is inserted into the hollow portion of the tube to introduce the tube. It is convenient because it can be smoothly introduced. Continued medium-diameter tube 16 larger in diameter than the tube
Is externally inserted into the small-diameter tube 15 as shown in FIG. 3 to expand the fistula. After removing the small-diameter tube 15 to form a fistula, the large-diameter tube 17 is extrapolated to the medium-diameter tube 16 to sequentially enlarge the fistula.

Finally, the drainage tube insertion tube 1 is extrapolated into the large-diameter tube 17 in the body as shown in FIG. 4 to further expand the fistula, tear off the tear line outside the body, turn it over, and put the folded part on the skin. After suturing, the drainage tube insertion tube 1 is fixed as shown in FIG. In FIG. 5, the folded portion of the tube is sewn to the skin surface, but may be fixed to the skin with a fixture.

Thereafter, an endoscope is inserted into the hollow portion of the tube 1 as needed, and various bile duct diseases such as common bile duct stones, bile duct stenosis, gallbladder stones, and gallbladder polyps, or ureteral stenosis, ureter stones, and kidney disease are inserted through the endoscope. After the inspection, the endoscope is removed while the tube 1 is left in the body.

Then, as shown in FIG. 6, the drainage tube 3 is inserted into the lumen of the tube 1 placed in the body so that the tip reaches the diseased part, and bile is poured out to be used for reducing jaundice and the like. You. Tip 4 of drainage tube 3
May be tapered and have a circular opening cross section, but a circular closing cross section having a plurality of small holes 5 on the side can also be used. In addition, a catheter can be inserted into the lumen of the tube 1 indwelled in the body up to the diseased site, and a drug solution can be injected.

The drainage tube 3 is curled toward the distal end portion 4, and a mesh or coil-shaped wire made of stainless steel is embedded in a portion other than the distal end portion 4, and the distal end portion 4 has at least one side. It has a structure in which holes 5 are provided.

Hereinafter, an example of each component will be described. The guide wire 6 is for guiding the small-diameter tube 15 extrapolated to this to the drainage tube application site,
It is made of metal such as stainless steel, and the shape of the tip differs depending on the application site. For example, there is a J guide wire having a habit of having a tip portion elastically curved in a J-shape. Insert the J guidewire into the tube with its distal end straightened. When the distal end guide protrudes from the opening at the distal end of the tube, the distal end is bent in a J-shape and may damage the bile duct. There is no.

The small-diameter tube 15 has a length of about 1 mm, an outer diameter of 3.4 mm, and a total length of 50 cm so as to be adapted to the size of the guide wire 6. The small-diameter tube 16 has a high elasticity and is made of a somewhat hard synthetic resin, and a tip portion thereof is formed so as to be gradually tapered in a tapered shape.

The medium diameter tube 16 has an inner diameter of 3.4 mm, an outer diameter of 4.7 mm, and a total length of about 20 cm so that the medium diameter tube 16 can be extrapolated to the outer periphery of the small diameter tube 15. Like the small-diameter tube 16, the middle-diameter tube 17 is formed of a somewhat hard synthetic resin so that the outer diameter of the distal end portion is gradually tapered.

The medium-diameter tube has an inner diameter of 3.4 mm so that it can be extrapolated to the outer periphery of the small-diameter tube 15, the outer diameter is formed to be 5.3 mm larger than the medium-diameter tube 16, and the entire length is the medium-diameter tube 1.
It is the same as 6 and about 20cm.

The large-diameter tube 17 has an inner diameter of 3.4 mm so that it can be extrapolated to the outer periphery of the small-diameter tube 15, the outer diameter is formed to be 6.0 mm thicker than the medium-diameter tube, and the entire length is the medium-diameter tube 1.
It is the same as 6 and about 20cm. The material and the shape of the distal end of the large-diameter tube 17 are the same as those of the medium-diameter tube 16.

The drainage tube insertion tube 1 enables insertion and removal of the drainage tube 3, and has an inner diameter of 6.0 mm, an outer diameter of 6.3 mm, and a total length of about 20 cm. The tube 1 is preferably formed to be thin as long as it can maintain rigidity unlike the tubes 15 to 17.

After the drainage tube 3 is inspected with an endoscope if necessary,
It removes waste from the luminal organs, and is inserted into the hollow part of the drainage tube insertion tube 1 and has an inner diameter of 3.4 mm, an outer diameter of 6.0 mm, and a total length of about 33 cm. The drainage tube 3 is made of a soft synthetic resin and has high flexibility and elasticity. The distal end portion 4 is provided with a plurality of side holes 5 for drainage.

Example 1 Tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (Teflon manufactured by Mitsui Fluorochemicals, Inc.)
350-J) was melt extruded to form a tubular body having an inner diameter of 6.1 mm, an outer diameter of 6.6 mm, a thick portion of 0.25 mm, and a length of 90 mm. Two notches 9 shown in FIG. 1 are provided at one end of this tubular body at opposing positions, and an ultrasonic cutter (manufactured by Nippon Thermonics Co., Ltd., T-02) is provided from that position toward the other end of the tubular body 8. Thus, two substantially straight tear lines 8 were formed. Fix the width of the tear line 8 to 0.06mm and set the depth of the cut part in the cross-sectional direction to 1st.
The tube was manufactured by changing as shown in the table. Table 1 shows the tear strength of the tube from the cut 9. Tear strength was measured using a Shimadzu S-500D autograph measuring instrument at a distance between chucks of 50 mm and a crosshead speed of 200 mm / min.
The measurement was performed by opening in the 0 degree direction. Further, the occurrence of tears in the tear line when the tube was compressed in the cross-sectional direction connecting the two tear lines of the tube was tested for 100 tubes, and the defect rate was measured. Further, the tube is cleaved into a sheet, and the width is 12.7 mm and the MIT of ASTM-D-2157 is used.
The bending life was measured by the Folding Endurance method. Table 1 shows the results.

As is apparent from Table 1, as the ratio of the depth d of the cut portion of the tear line to the sheet thickness D increases, the tear strength from the cut portion decreases, and the tear line when the sheath is compressed is reduced. The rate of occurrence of cracks is increased, and the bending life is shortened.

〔effect〕

By using the tube for inserting a drainage tube of the present invention, the destruction of tissue is small, and the drainage tube can be introduced to a diseased site in a short time. Moreover, since the tube is used as a substitute for the fistula, a period for forming the fistula is not required, the pain of the patient is greatly reduced, and the drainage tube can be smoothly taken in and out.

In addition, if the drainage tube insertion hole forming set of the present invention is used, destruction of tissue can be reduced, and the drainage tube insertion tube can be safely installed in the body in a short time. Further, since the tube is fixed by being sutured on the skin surface, it does not move due to respiration or pressure in the body. Further, since the width of the tear line of the tube is small, external bacteria do not attach to the cut portion of the tear line and infect the body. In addition, when the distal end of the drainage tube is guided into a luminal organ such as a bile duct, or when the drainage tube is led out of the body, the tear line of the tube is not compressed by the subcutaneous tissue and does not rupture to damage the cell tissue. .

Furthermore, the tear line of the tube can be cut to a desired cutting depth with a narrow width by an ultrasonic cutter, and there is no build-up that occurs when cutting with a heat cutter on both edges of the tube, and the tube opens outward from the cut portion. Then, the tube can be opened smoothly along the tear line. For this reason, the tube can be torn to a necessary portion when desired, and thus, it is possible to suppress damage to human body tissue due to frequent introduction or detachment of the drainage tube.
In addition, since bleeding is prevented, treatment during surgery is easy, and recovery after treatment can be accelerated.

[Brief description of the drawings]

FIG. 1 is a perspective view of a tube for inserting a drainage tube used in the present invention, FIGS. 2 to 6 are explanatory views showing an example of a method of using a set for forming a drainage tube insertion hole of the present invention, and FIG. 7 is a drainage. FIG. 8 is a cross-sectional view of a tear line temporarily cut by a heat cutter, in which FIG. 1 is a tube for inserting a drainage tube, 2 is a puncture needle, 3 is a drainage tube, 4 is a tip of the drainage tube. Part, 5 is a drainage tube side hole,
6 is a guide wire, 7 is a folded portion of a tube, 8 is a tear line, 9 is a cut portion, 10 is a base end portion of a tube, 11 is a tip portion of a tube, 12 is a built-up portion on both edges, and 13 and 14 are cut portions. , 15 is a small tube, 16 is a medium tube, 17 is a large tube, A is a liver, B is a bile duct, and C is a gallbladder.

Claims (3)

(57) [Claims] At least one synthetic resin tube formed so that a small-diameter tube can be inserted into a hollow portion of a large-diameter tube, and a guide wire and / or a guide wire.
Alternatively, in a set for forming a drainage tube insertion hole formed of a puncture needle, a flexible resin having at least one tear line in which a part of a cross section of a thick portion of a tube having a maximum diameter is cut substantially linearly in a longitudinal direction. A set for forming a drainage tube insertion hole, which is a tubular body composed of: 2. The set for forming a drainage tube insertion hole according to claim 1, wherein the tear line of the tube having the largest diameter is formed by an ultrasonic cutter. 3. The cutting width of a thick part of a tube having a maximum diameter is 0.01.
~ 1.0mm, cutting thickness is 20 ~ 8 with respect to the thickness of the thick part of the tubular body
The set for forming a drainage tube insertion hole according to claim 2, which is 0%.