JPH0385177A - Digestive tract cannula - Google Patents

Abstract

PURPOSE:To obtain a digestive tract cannula not damaging the epithelial tissue of a patient, causing no pain even at the time of long-time mounting and not detached even when external force is applied by constituting said cannula of the soft cylindrical part inserted in the epithelial tissue and a flange part integrally formed to the body insertion part of the cylindrical part from a material having hardness larger than that of the cylindrical part. CONSTITUTION:A digestive tract cannula 1 consists of a cylindrical part 2, the doughnut plate-shaped flange part integrally formed to one end part of the cylindrical part 2. The digestive tract cannula 1 is inserted in epithelial tissue 13 by a ring 14 opened to said tissue 13 in such a state that the flange part 3 and the cylindrical part 2 are folded so that the flange part 3 is positioned on the side of a lumen 16. The flange part 3 and the cylindrical part 2 are restored to the original shape and said cannula is not detached even when external force is applied because the flange part 3 harder than the cylindrical part 2 is stayed in the lumen 16. The cannula 1 is fixed by a female ring 5. Since the cylindrical part 2 coming into contact with the epithelial tissue 13 is composed of a soft material, the epithelial tissue 3 can be prevented from damage and, since the cannula extends and contracts corresponding to the movement of a patient, the cannula causes no pain even when it is inserted for a long time.

Description

[Detailed Description of the Invention] [Field of Industrial Application] The present invention relates to a gastrointestinal cannula for medical use or animal experiments, and more specifically to a gastrointestinal cannula with improved biocompatibility by combining the materials of the cannula. Regarding canyule.

[Conventional technology]

A cannula is an instrument that is inserted into a part of an animal's body, such as the digestive tract, cut, blood vessel, or trachea, to inject or extract fluids.

Materials of construction of such cannulae include metals (e.g., U.S. Pat. No. 4,096,860), plastics (such as U.S. Pat. No. 4,096,860),
For example, JP-A-54-142888, t(arla
nA.

Thyfault, J., Dairy 5cienc.
s, 58 (12) 1899° (1975), etc.)
, polyvinyl chloride or silicone rubber (for example, JP-A-63-150066), polyethylene terephthalate or polyfluoroethylene, metal cannula coated with a synthetic material (JP-A-55-47867), polyester. Polyurethane is fixed to a tube made of woven fibers (Japanese Patent Laid-Open No. 62-5354), and polyurethane is soaked in epoxy resin and cured (R, J, Omarck).

J, Animal 5science, 53 (3)
790 (1981)) or silicone resin (R, W
. Dougherty, et al, Canada
-ian J, Animal 5science, 6
8.561 (198g)) are known.

However, cannulae made of these materials do not simultaneously satisfy the requirements of biocompatibility, ease of molding, ease of insertion into a living body, and retention after insertion.

For example, if a hard substance such as metal is used as the material for the cannula, it may be suitable for temporary puncture or insertion, but if the cannula is kept in the body for a long period of time, the movement of the patient or animal must be restrained. In addition, when inserting a cannula made of hard material into the body, the surgical incision must be made larger, and sufficient attention must be paid to suturing and postoperative management after insertion. There are problems such as. On the other hand, if a soft material such as silicone rubber is used as the material for the cannula, the cannula can be inserted easily even if the incision is small, and the cannula can expand and contract to some extent in response to the body's movements, so it can be easily inserted into the cannula. The pain will be less.

However, they have the disadvantage that they tend to separate when external force is applied, and the liquid tends to leak. In addition, attempts to change the physical properties of the canyule by compositing its constituent materials are difficult to manufacture, and it requires advanced technology to eliminate variations in quality. There are many, but there are few that have different physical properties for each part.

Incidentally, gastrointestinal cannulae are often worn for long periods of time, and in addition, they must have a larger diameter than vascular cannulae in order to administer drugs or collect contents.

As an example of a gastrointestinal cannula, the conventional technology of a rumen cannula inserted into the rumen of a ruminant has the following drawbacks.

(7) Komack's lumen cannula is hard as a whole, so in order to insert it, the incision must be made larger as mentioned above, and a lot of effort is required for suturing after insertion and post-operative management.

(b) The lumen cannula made by Thyfault is made of hardened liquid plastic, but this is not desirable because the frozen cannula comes into direct contact with the surgical site.

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

A gastrointestinal cannula that fully satisfies these conditions has not yet been developed.

[Problem to be solved by the invention]

The purpose of the present invention is to solve the above problems,
The gastrointestinal cannula is inserted without damaging the epithelial tissue of the lump.
It does not cause pain even when worn for a long time, and does not fall off even when external force is applied; it can be easily inserted through a small lump, and is large enough to easily remove digestive contents. To provide a gastrointestinal cannula that does not cause stagnation and can be easily manufactured.

[Means to solve the problem]

The present invention is the following gastrointestinal cannula.

(1) A fire extinguisher characterized by comprising a soft cylindrical part inserted into the cylindrical part 11, and a flange part integrally formed on the body insertion side of the cylindrical part made of a material harder than the cylindrical part. Tube cannula.

(2) The gastrointestinal cannula according to (1) above, characterized by having a soft plug removably attached to the inner circumferential portion of the cylindrical portion.

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

The cylindrical part inserted into the aneurysm is made of a soft material that does not damage the epithelial tissue of the aneurysm. The material for the cylindrical part is JIS
Hardness measured by K 6301 is 20 to 60°, preferably 25 to 50, tensile strength is 20 to 60 kgf/aJ,
Preferably 30-55 kgf/j, tear strength 3-20
kgf/d.

Preferably, it is preferable to use 10 to 17 kgf/c*i.

An example of a material for such a cylindrical part is a soft rubber obtained by curing silicone rubber TSE 3454 manufactured by Toshiba Silicone Co., Ltd. with TSE 3454B (all trade names) manufactured by the same company. be able to.

The flange portion integrally formed with the cylindrical portion has a hardness greater than the material constituting the cylindrical portion, and is hard enough to prevent the gastrointestinal cannula from detaching even if external force is applied.
It is constructed from a material that is flexible enough to be folded into a small size during insertion. The material for the flange part has a hardness of 40 to 85 as measured by JIS K 6301.
, preferably 45-70, tensile strength 40-80 kgf
/aI, preferably 45-60 kgf/d, tear strength 10-23 kgf/aJ, preferably 12-2゜kgf
/aJ is preferably used, and it is preferable to select a material that has a hardness difference of 10 or more with the material of the cylindrical portion.

As a material for such a flange portion, for example, TSE 340, which is a silicone rubber manufactured by Toshiba Silicone Co., Ltd.
2. RTV was treated with the company's hardening agent TSE 3402 RT.
Examples include soft rubber cured with V(B).

The stopper is also preferably made of a soft material, such as polyethylene.

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

[For production]

The gastrointestinal cannula of the present invention is used by inserting the cylindrical portion into the aneurysm of the gastrointestinal tract so that the flange portion is inserted into the body. At this time, when inserting the gastrointestinal cannula, the cylindrical portion and flange portion are folded into a small size before insertion. The cylindrical part and the plug inserted into 11 are flexible enough not to damage the epithelial tissue of the scar.

The flange part integrally formed with the cylindrical part is made of a harder material than the cylindrical part, and stays in the gastrointestinal cannula to prevent the gastrointestinal cannula from dislodging, but does not cause stagnation of the contents of the gastrointestinal cannula. Since the inner diameter of the cylindrical portion is large enough to collect a large amount of the contents of the digestive tract, a sample or the like is injected or the contents are collected through this cylindrical portion.

By attaching a stopper to the inner periphery of the cylindrical part, the inside of the digestive tract and the outside of the body are completely separated.
Injection and collection can be performed only when necessary. On the other hand, by providing the stopper with an opening and a flexible valve body that covers the opening, sampling and drug administration of a small amount can be easily performed.

〔Example〕

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is an exploded plan view showing, in cross section, a part of the gastrointestinal cannula of the embodiment applied to the rumen of a ruminant.

FIG. 2 is a sectional view showing the installed state.

In the figure, 1 is a gastrointestinal cannula, 2 is a cylindrical portion, 3 is a flange portion integrally formed with the cylindrical portion 2, 4 is a stopper attached to the inner circumference of the cylindrical portion 2, and 5 is a gastrointestinal cannula. canyule 1
This is a female ring that is used to secure the body from the outside. The gastrointestinal cannula 1 includes a cylindrical tubular part 2 and a tubular part 2.
It consists of a donut plate-shaped flange portion 3 integrally formed at one end thereof, and ribs 6 and a flat portion 7 are formed on the outer surface of the cylindrical portion 2 . The flat part 7 is provided with a bottle hole 8a for fixing the stopper 4.

The plug 4 has a shape that comes into close contact with the inner periphery of the cylindrical part 2 when attached to the cavity of the cylindrical part 2, and has a closing surface 9 at one end that closes the cavity of the cylindrical part 2. An opening 10 is formed in the closing surface 9 for collecting a small amount of sample or administering a drug, and this opening 10 is formed with a valve body 1 made of a flexible material.
1 closes the stopper 4 from the outside. The valve body 11 is attached to the closing surface 9 by means of a pull-out pin 12 . Furthermore, stopper 4
A bottle hole 8b for fixing to the cylindrical portion 2 is provided in the cylindrical portion 2. The plug 4 connects the gastrointestinal cannula 1 to the epithelial tissue 13 at 1114.
The fixing bottle 15 is inserted into the bottle holes 8a and 8b and fixed in place.

As shown in FIG. 2, the above-mentioned gastrointestinal cannula 1 is constructed such that the flange portion 3 is located on the lumen 16 side from the aneurysm 14 made in the epithelial tissue 13 by surgical means.
Then, the cylindrical part 2 is folded and inserted and installed. In this state, the flange part 3 and the cylindrical part 2 are restored to their original shapes, and the flange part 3, which is harder than the cylindrical part 2, is retained in the lumen 16, so that the inserted gastrointestinal cannula will not come off even if an external force is applied. l is fixed by a female ring 5. Even when the gastrointestinal cannula 1 is inserted, the cylindrical part 2 in contact with the epithelial tissue 13 is made of a soft material, so damage to the epithelial tissue 13 can be prevented, and it also expands and contracts in response to the movement of the patient or animal. Therefore, it does not cause any pain even if it is inserted for a long time.

The plug 4 is attached to the gastrointestinal cannula 1 with the obstructing surface 9 facing the lumen 16, and the pin hole 8a of the gastrointestinal cannula I and the bottle hole 8b of the plug 4 are aligned and fixed with a fixing pin 15. The plug 4 is attached so that the outer periphery of the plug 4 is in close contact with the inner periphery of the gastrointestinal cannula 1 to prevent fluid from leaking from the lumen 16.

When collecting a small amount of sample from the lumen 16, a sampling device such as a pivet is inserted through the opening IO to collect the sample. In this case, when the valve body 11 blocking the opening 10 is pushed into the lumen 16 with the tip of the collection instrument, the valve body 11 opens using the pull-out pin 12 as a fulcrum.

The opening 10 is opened and a collection instrument can be inserted. When administering a drug, it can be administered from the opening 10 in the same manner. Note that 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 inside the lumen 16, so there is no leakage of liquid from the opening 10, and a large amount of liquid does not leak from the lumen 16. When collecting a sample, use fixing pin 1
5 is removed, the extraction pin 12 is picked up with fingers and pulled out to the outside of the body, and the stopper 4 is removed and collected.

In order to insert the upper part of the gastrointestinal cannula into the lumen 16 through the aperture 14 made in the epithelial tissue 13 by surgical means, the cavity of the cylindrical part 2 is crushed and the cylindrical part 2 and the flange part 3 are folded into a small size. [11] Since the gastrointestinal cannula 1 can be inserted into the epithelial tissue 13,
The size of 4 may be small, which in turn can reduce sutures, post-operative management, etc. Incidentally, the surgical means for inserting the gastrointestinal cannula I can be performed in a conventional manner.

To manufacture the gastrointestinal cannula 1, first, a mold for the cylindrical portion 2 is made of polypropylene chloride, etc., and a mold for the flange portion 3 made of another thermoplastic resin is fixed to this mold. Creating a mold for tube cannula 1 6
Next, this mold has a hardness of 4 as measured by JISK 6301.
about 0, tensile strength about 53 kgf/cd, tear strength l1
kgf/cd silicone rubber (for example, TSE
3454, Toshiba Silicone Co., Ltd. 1!1, trade name) and a curing agent (for example, TSE 3454B, Toshiba Silicone (trade name)
Co., Ltd., trade name) at a ratio of 9:1 (v/v).

After degassing, this mixture is poured into a mold for forming a cylindrical portion, and in this state is heated at 60° C. for 30 minutes to harden, thereby forming the cylindrical portion 2. And JISK 630
Hardness measured in 1: about 60, tensile strength: 55 kgf/ci
Silicone rubber (e.g., TSE 3402 RTV, manufactured by Toshiba Silicone Corporation, trade name) with a tear strength of about 17 kgf/(d) and a curing agent (e.g., TSE 340
2 RTV (B), manufactured by Toshiba Silicone Corporation, product name)
were mixed at a ratio of 9:1 (V/V), degassed, poured into a mold for forming the flange portion, heated at 60° C. for 6 hours to harden, and the flange portion 3 was integrally formed. to form. After cooling, the molded product is removed from the mold and the paris is removed, thereby obtaining the gastrointestinal cannula 1 in which the cylindrical portion 2 and the flange portion 3 are integrally formed.

The plug 4 of the gastrointestinal cannula 1 is made of a cylindrical body with a bottom made from a polyethylene bottle, cut to match the size of the gastrointestinal cannula 1, and a valve body 11 made of silicone rubber is attached with a pull-out pin 12 made of stainless steel. It can be manufactured by Bottle holes 8a and 8b for fixing the stopper 4 are made using a molding machine drill or the like.

By the above method, TSE 3454 and TSE manufactured by Toshiba Silicone Co., Ltd. were used as the material for the cylindrical part 2.
3454B (both are product names, the mixing ratio is 9 by weight)
(7) TSE 3402 RTV and TSE3402 RTV (B) manufactured by Toshiba Silicone Corporation (both trade names, mixing ratio 9:1 by weight) as the material for the flange portion 3. Inner diameter 62a of cylindrical part 2
A gastrointestinal cannula 1 having an outer diameter of 68 to 78 nn, a length of 60 m, an outer diameter of the flange portion 3 of 125 round, and a thickness of 12 m was manufactured. Also, the inner diameter is 62mm, the outer diameter is 64am, and the length is 75ffI.
Eleven polyethylene plugs 4 were manufactured.

As a result of surgically equipping 11 sheep with the gastrointestinal cannula 1 having the plug 4, the food intake of all the sheep returned to normal levels within one week. The sheep lived for over 4 years, and no abnormalities in the gastrointestinal cannula 1 or growth abnormalities occurred during this period.

〔Effect of the invention〕

As described above, the gastrointestinal cannula of the present invention includes a soft cylindrical part to be inserted into the aneurysm, and a flange integrally formed on the side of the cylindrical part to be inserted into the body, made of a material with a harder hardness than the cylindrical part. The cylindrical part is flexible, which prevents damage to the epithelial tissue, and expands and contracts in response to the movement of the patient or animal, so it does not cause pain even when inserted for a long time. Since the flange portion is made of a harder material than the cylindrical portion, it will not come off even if external force is applied. Further, since the flange portion is also flexible, the cylindrical portion and the flange portion can be folded into a small size and inserted. Therefore, it can be easily inserted by simply making a small surgical incision in the epithelial tissue. Furthermore, since the flange portion inserted into the digestive tract is small, the contents of the digestive tract will not stagnate even if it remains within the digestive tract.

Furthermore, if the gastrointestinal cannula has an opening and a soft stopper with a valve body made of flexible material that covers this opening is attached to the inner circumference of the cylindrical part, small amounts of sampling and drug administration can be taken from the opening. This can be easily done by inserting an instrument into the gastrointestinal tract, and large amounts of sampling can be easily done by removing the stopper.

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

[Brief explanation of drawings]

The second engineering drawing is an exploded plan view of the gastrointestinal cannula of the example.
The figure is a sectional view showing the attached state. In each figure, the same reference numerals indicate the same parts, 1 is the gastrointestinal cannula, 2 is the cylindrical part, 3 is the flange part, 4 is the stopper, 5 is the female ring, 6 is the rib, 8a, 8b. 10 is a pin hole, 10 is an opening, 11 is a valve body, 13 is an epithelial tissue, and 14 is a lump.

Claims (3)

[Claims] (1) An extinguisher comprising a soft cylindrical part that is inserted thinly, and a flange part that is integrally formed on the body insertion side of the cylindrical part and made of a material harder than the cylindrical part. Tube cannula. (2) The gastrointestinal cannula according to claim (1), further comprising a soft plug removably attached to the inner periphery of the cylindrical portion. (3) The gastrointestinal cannula according to claim 1 or 2, wherein the stopper has an opening and a valve body made of a flexible material that covers the opening.