JP2900419B2 - Digestive tract cannula - Google Patents

Description

Description: FIELD OF THE INVENTION The present invention relates to a digestive tract cannula for medical or animal experiments, and more particularly to a digestive tract having improved biocompatibility by compounding cannula materials. About the cannula.

[Conventional technology]

Cannulae are parts of the body, digestive tract, cuts, blood vessels,
It is an instrument that is inserted into the trachea and other parts and used for liquid injection and extraction.

Such cannula materials include metals (for example, U.S. Pat. No. 4,096,860) and plastics (for example, JP-A-54-142888, Harlan A. Thyfault, J. Dairy S.).
cience, 58 (12) 1899, (1975)), polyvinyl chloride or silicone rubber (for example, JP-A-63-150066), polyethylene terephthalate or polyfluorinated ethylene, and a metal cannula coated with a synthetic substance. (Japanese Patent Application Laid-Open No. 55-47867), a polyurethane fiber woven tube fixed with polyurethane (Japanese Patent Application Laid-Open
No. -5354), a product obtained by dipping and curing an epoxy resin in polyurethane (RJ Komarck, J. Animal Science, 53
(3) 790 (1981) or silicone resin (RWDougher
ty, et al., Canadian J. Animal Science, 68 , 561 (198
8)) are known.

However, a cannula made of these materials does not simultaneously satisfy biocompatibility, ease of molding, ease of insertion into a living body, or retention after insertion.

For example, if a hard material such as metal is used as a material for the cannula, it is suitable for temporary puncture insertion, but if it is kept in the body for a long period of time, the movement of the patient or animal must be sealed, so extra It will give you pain. Furthermore, when inserting a cannula made of a hard substance into the body, there is a problem that it is necessary to make a large incision by surgery, and that it is necessary to pay sufficient attention to suturing after insertion and postoperative management. . On the other hand, if a soft substance such as silicone rubber is used as the material of the cannula, the cutout for attaching the cannula can be inserted even if it is small, and it expands and contracts to some extent according to the movement of the body. The pain is less. However, they have the disadvantage that they are easily detached when an external force is applied, and that the liquid is apt to leak.
Also, it is difficult to make an attempt to change the physical properties by compounding the constituent materials of the cannula, so advanced techniques are required to eliminate quality variations, and further attempts to change the physical properties of the entire cannula have been made. Many of them have different physical properties for each part.

By the way, the digestive tract cannula is often worn for a long time, and further, it must be larger in diameter than a vascular cannula or the like in order to administer a drug or collect contents.

As an example of a gastrointestinal cannula, there are the following drawbacks in the prior art of a rumen cannula inserted into the rumen of a ruminant animal.

(A) Komack's lumen cannula is hard
As described above, the incision must be made large for insertion, and much labor is required for suturing after insertion and postoperative management.

(A) The lumen cannula created by Thyfault is a hardened liquid plastic, but is not preferred because the frozen cannula directly contacts the surgical site.

(C) Dougherty creates a lumen cannula using flexible silicone resin alone, but it is necessary to use a surgical mesh or the like to prevent leakage.

A digestive tract cannula that satisfies various conditions in this way
Not yet developed.

[Problems to be solved by the invention]

An object of the present invention is to solve the above problems without damaging the epithelial tissue of a fistula into which a gastrointestinal cannula is inserted, causing no pain even when worn for a long time, and removing the force even when an external force is applied. Without releasing, it can be easily inserted from a small fistula, and it is large enough to easily take out digested contents,
An object of the present invention is to provide a digestive tract cannula that does not cause digestion contents to stagnate and that can be easily manufactured.

[Means for solving the problem]

 The present invention is the following digestive tract cannula.

(1) A soft cylindrical portion to be inserted into a fistula, and a flange portion integrally formed on the body insertion side of the cylindrical portion with a material having a higher hardness than the cylindrical portion.
The hardness measured by K 6301 is 20 to 60, the hardness of the flange portion measured by JIS K 6301 is 40 to 85, and the difference from the hardness of the material of the cylindrical portion is 10 or more. Gastrointestinal cannula featuring.

(2) The digestive tract cannula according to the above (1), further comprising a soft stopper detachably attached to an inner peripheral portion of the cylindrical portion.

(3) The gastrointestinal cannula according to (1) or (2), wherein the stopper has an opening and a valve body made of a flexible material covering the opening.

The tube inserted into the fistula is made of a soft material that does not damage the epithelium of the fistula. JIS K for the material of the cylindrical part
Use the one whose hardness measured by 6301 is 20-60,
Hardness 25 to 50, tensile strength of 20~60kgf / cm ^2, preferably 3
0-55 kgf / cm ² , tear strength 3-20 kgf / cm ² , preferably 1
It is preferable to use one having 0 to 17 kgf / cm ² .

Examples of the material of such a tubular portion include a soft rubber obtained by curing TSE 3454, a silicone rubber manufactured by Toshiba Silicone Co., Ltd., with TSE 3454B, a curing agent manufactured by the company (both are trade names). be able to.

The flange portion formed integrally with the cylindrical portion has a hardness higher than the material constituting the cylindrical portion, and has a hardness such that the digestive tract cannula does not detach even when external force is applied, and at the time of insertion It is made of a material that is flexible enough to be folded small. As the material of the flange portion, a material having a hardness of 40 to 85 measured according to JIS K 6301 is used, but the hardness is 45 to 70, the tensile strength is 40 to 80 kgf / cm ² ,
Preferably 45~60kgf / cm ^2, tear strength 10~23kgf / cm ^2,
Preferably, a material having a hardness of 12 to ²⁰ kgf / cm ² is used, and a material having a difference in hardness from the material of the cylindrical portion of 10 or more is selected.

As a material of such a flange portion, for example, TSE 3402 RTV which is a silicone rubber manufactured by Toshiba Silicone Co., Ltd.
And soft rubber cured with the company's curing agent TSE 3402 RTV (B).

The stopper is also made of a soft material, and it is preferable to use, for example, polyethylene.

Examples of the flexible material of the valve body that covers the opening of the stopper include silicone rubber.

[Operation] The gastrointestinal tract cannula of the present invention is used by inserting a tubular portion into a gastrointestinal fistula and mounting it so that the flange portion is inserted into the body. At this time, when inserting the digestive tract cannula, the cylindrical portion and the flange portion are inserted into the small folded portion. The tube and plug inserted into the fistula are flexible enough not to damage the epithelium of the fistula. The flange formed integrally with the tubular portion is made of a material harder than the tubular portion and stays in the gastrointestinal tract to prevent detachment of the gastrointestinal cannula, but does not cause stagnation of the contents of the gastrointestinal tract. Since the inner diameter of the cylindrical portion is large enough to collect a large amount of the contents of the digestive tract, injection of a sample or the like and collection of the contents are performed through the cylindrical portion.

By attaching a stopper to the inner peripheral portion of the cylindrical portion, the inside of the digestive tract and the outside of the body are completely separated, so that it is normally blocked by the stopper, and injection and collection can be performed only when necessary.
On the other hand, by providing the stopper with an opening and a flexible valve covering the opening, a small amount of sampling and drug administration can be easily performed.

〔Example〕

Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is an exploded plan view showing a part of a digestive tract cannula of an embodiment applied to a rumen rumen, and FIG. 2 is a sectional view showing a mounted state thereof.

In the figure, 1 is a digestive tract cannula, 2 is a cylindrical portion, 3
Is a flange portion formed integrally with the tubular portion 2, 4 is a stopper attached to the inner peripheral portion of the tubular portion 2, and 5 is a female ring for fixing the digestive tract cannula 1 from outside the body. .
The digestive tract cannula 1 comprises a cylindrical tubular portion 2 and a donut plate-like flange portion 3 integrally formed at one end of the tubular portion 2, and a rib 6 and a rib 6 are provided on the outer surface of the tubular portion 2. A flat part 7 is formed. The flat portion 7 is provided with a pin hole 8a for fixing the stopper 4.

The plug 4 has a shape which is in close contact with the inner peripheral portion of the cylindrical portion 2 when attached to the hollow portion of the cylindrical portion 2, and has a closing surface 9 at one end for closing the hollow portion of the cylindrical portion 2. An opening 10 for collecting a small amount of sample or administering a medicine is formed in the closing surface 9, and the opening 10 is closed from the outside of the stopper 4 by a valve body 11 made of a flexible material. ing. Valve 11 is a pull-out pin
It is attached to the closing surface 9 by 12. Further, the stopper 4 is provided with a pin hole 8b for fixing to the cylindrical portion 2. With the gastrointestinal cannula 1 attached to the fistula 14 of the epithelial tissue 13, the stopper 4 is fixed by inserting the fixing pin 15 into the pin holes 8a and 8b.

The above digestive tract cannula 1 is, as shown in FIG.
The flange portion 3 and the cylindrical portion 2 are folded and inserted and attached so that the flange portion 3 is located on the lumen 16 side from the fistula 14 opened in the epithelial tissue 13 by surgical means. In this state, the flange portion 3 and the cylindrical portion 2 are restored to their original shapes,
Since the harder flange portion 3 is retained in the lumen 16, it does not detach even when an external force is applied. The inserted digestive tract cannula 1 is fixed by the female ring 5. Even when the digestive tract cannula 1 is inserted, the tubular portion 2 in contact with the epithelial tissue 13 is made of a soft material, so that the epithelial tissue 13 can be prevented from being damaged, and expands and contracts in response to the movement of the patient or animal. It does not cause any pain even if inserted for a long time.

The stopper 4 is attached to the gastrointestinal cannula 1 with the obstructing surface 9 facing the lumen 16, and the pin hole 8 a of the gastrointestinal cannula 1 is aligned with the pin hole 8 b of the stopper 4, and fixed with the fixing pin 15. The stopper 4 is attached so that the outer periphery of the stopper 4 is in close contact with the inner periphery of the digestive tract cannula 1 so that the liquid does not leak from the lumen 16.

When collecting a small amount of sample from the lumen 16, a sampling device such as a kogame pipette is inserted through the opening 10 and collected. In this case, when the valve element 11 closing the opening 10 at the tip of the sampling instrument is pushed into the lumen 16, the valve element 11 is opened with the extraction pin 12 as a fulcrum, and the opening 10 is opened and the sampling instrument can be inserted. . When administering a drug, the opening 10
Can be administered from When no force is applied to the valve body 11 from the outside, the valve body 11 is pressed against the closing surface 9 by the pressure in the lumen 16, so that there is no leakage of liquid or the like from the opening 10. When collecting a large amount of sample from the lumen 16,
After removing the fixing pin 15, the extraction pin 12 is pinched with a finger, pulled out of the body, and the stopper 4 is removed and collected.

To insert the gastrointestinal cannula 1 into the lumen 16 from a fistula 14 opened in the epithelial tissue 13 by surgical means, the tubular portion 2
Can be inserted by crushing the hollow of the tubular portion 2 and the flange portion 3 in a small folded state, so that the size of the fistula 14 opened in the epithelial tissue 13 for inserting the digestive tract cannula 1 may be small, As a result, suturing and postoperative management can be reduced. Surgical means for inserting the digestive tract cannula 1 can be performed by a usual method.

To manufacture the digestive tract cannula 1, first, a mold for the cylindrical portion 2 is made of polypropylene chloride or the like, and a mold for the flange portion 3 made of another thermoplastic resin or the like is fixed to this mold, A mold for the cannula 1 is prepared. Then Hardness 40 degree was measured by JIS K 6301 in the mold, the tensile strength of 53kgf / cm ² or so, tear strength 11 kgf / cm ² approximately silicone rubber (e.g., TSE 3454, Toshiba Silicone Co., Ltd., After mixing 9: 1 (v / v) of a curing agent (for example, TSE 3454B, trade name, manufactured by Toshiba Silicone Co., Ltd., trade name) and degassing, the mixture is formed into a cylindrical portion. Then, the mixture is heated at 60 ° C. for 30 minutes and cured to form the cylindrical portion 2. Then, hardness 60 degree was measured with JIS K 6301, tensile strength 55 kgf / cm ² or so, tear strength 17kgf
/ cm ² silicone rubber (for example, TSE 3402 RTV, manufactured by Toshiba Silicone Co., Ltd., trade name) and a curing agent (for example, TS
E 3402 RTV (B), manufactured by Toshiba Silicone Co., Ltd., trade name)
And 9: 1 (v / v), and after degassing, pour into this flange forming mold, heat at 60 ° C. for 6 hours to cure, and integrate the flange 3 It is formed. After cooling, remove the molding from the mold and remove the burr,
The digestive tract cannula 1 in which the cylindrical portion 2 and the flange portion 3 are integrally formed is obtained.

The stopper 4 of the gastrointestinal cannula 1 is obtained by cutting a bottomed cylindrical body such as a polyethylene bottle so as to fit the size of the gastrointestinal cannula 1 and attaching a valve 11 made of silicone rubber with a stainless steel pull-out pin 12. Can be manufactured.
Pin holes 8a and 8b for fixing the stopper 4 are formed by drilling after forming.

By the method as described above, TSE 3454 and TSE 3454B manufactured by Toshiba Silicone Co., Ltd. were used as the material of the cylindrical portion 2.
(Both are trade names and the mixing ratio is 9: 1 by weight)
The TSE 3402 RTV and TSE 3402 RTV (B) (both are trade names and the mixing ratio is 9: 1 by weight) manufactured by Toshiba Silicone Co., Ltd. are used as the material of the flange portion 3, and the inner diameter of the cylindrical portion 2 is 62 mm. , Outer diameter 68-78mm, length 60mm, outer diameter of flange 3
A digestive tract cannula 1 having a thickness of 125 mm and a thickness of 12 mm was produced. Also, a polyethylene stopper 4 having an inner diameter of 62 mm, an outer diameter of 64 mm and a length of 75 mm was manufactured.

As a result of surgical operation, the digestive tract cannula 1 having the stopper 4 was attached to 11 sheep, and as a result, the food intake of each sheep was restored to a normal level within one week. The sheep have survived for more than four years, during which time no abnormalities in the digestive tract cannula 1 or abnormal growth have occurred.

〔The invention's effect〕

As described above, the gastrointestinal tract cannula of the present invention includes a soft tubular portion inserted into a fistula, and a flange portion integrally formed on the body insertion side of the tubular portion with a material having a hardness greater than that of the tubular portion. The flexible tubular portion prevents damage to the epithelial tissue, and expands and contracts in response to the movement of the patient or animal, so that it does not cause any pain even when inserted for a long time. Further, since the flange portion is made of a material having a higher hardness than the cylindrical portion, it does not detach even when an external force is applied. Further, since the flange portion also has flexibility, the cylindrical portion and the flange portion can be folded and inserted into a small size. Therefore, it can be easily inserted into the epithelial tissue simply by opening a small fistula by surgical means. Further, since the flange portion inserted into the digestive tract is small, even if it stays in the digestive tract, the contents of the digestive tract do not stagnate.

Furthermore, when a soft stopper having an opening in the digestive tract cannula and a valve body made of a flexible material covering the opening is attached to the inner peripheral portion of the cylindrical portion, a small amount of sampling and drug administration can be performed from the opening. Insertion of the sampling device into the digestive tract can be easily performed, and large-volume sampling can be easily performed by removing the stopper.

Further, such a gastrointestinal cannula can be easily manufactured using readily available materials.

[Brief description of the drawings]

FIG. 1 is an exploded plan view of a gastrointestinal cannula of an embodiment, FIG.
The figure is a sectional view showing the mounted state. In the drawings, the same reference numerals denote the same parts, 1 is a digestive tract cannula, 2 is a cylindrical portion, 3 is a flange portion, 4 is a stopper, 5 is a female ring, 6 is a rib, 8a, 8b, and a pin hole. , 10 is the opening,
11 is a valve body, 13 is an epithelial tissue, and 14 is a fistula.

Claims (3)

(57) [Claims] 1. A tubular part comprising a soft tubular part to be inserted into a fistula and a flange part integrally formed on the body insertion side of the tubular part with a material having a higher hardness than the tubular part. The hardness measured by JIS K 6301 is 20 to 60, the hardness of the flange portion measured by JIS K 6301 is 40 to 85, and the difference from the hardness of the material of the cylindrical portion is 10 or more. A digestive tract cannula, which is characterized in that: 2. The gastrointestinal cannula according to claim 1, further comprising a soft plug detachably attached to an inner peripheral portion of the cylindrical portion. 3. The gastrointestinal cannula according to claim 1, wherein the stopper has an opening and a valve body made of a flexible material covering the opening.