JP2004026844A - Perenteric nutrient and method for producing the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To obtain a perenteric nutrient easily suppressed in regurgitation of the perenteric nutrient from the stomach of a patient to the esophagus, wherein the perenteric nutrient is administrated to the patient by tube feeding. <P>SOLUTION: The perenteric nutrient 130 is formed as a semisolid material, common to solid materials by having a naturally unchangeable shape i.e. shape preservability and containing nutrient components at higher concentrations than liquid or fluid, but common to liquid materials and fluid materials by, having easier shape-changeable property than that of solids when forced externally. The shape preservability is kept throughout before and after its administration to the patient body, and when the perenteric nutrient 130 is accumulated in the patient body, the nutrient 130 is not liquified at a patient body temperature and keeps the shape preservability. <P>COPYRIGHT: (C)2004,JPO

Description

The present invention relates to an enteral nutrient that is administered to a patient by gavage and used for nutritional supplementation, and in particular, the enteral nutrition that is administered to a patient is directed from the patient's stomach to the esophagus. The present invention relates to an improvement in technology for suppressing reflux of gastroesophageal reflux.

い く つ か There are already several nutritional supplements that provide nutrition to patients.

Nutritional supplementation is classified into enteral nutrition and parenteral nutrition according to differences in the parts or organs of the human body to which nutrition is administered. Enteral feeding is a method of feeding nutrition to the intestine, while parenteral feeding is a method of feeding nutrients to blood flowing through a central vein or a peripheral vein.

Enteral feeding is classified into oral feeding and tube feeding because of the different routes of feeding nutrition from outside to inside the body.

Oral nutrition supplementation is administered to patients who can swallow food, and allows the patient to ingest food orally.

On the other hand, the tube feeding method is performed for patients who have difficulty in swallowing food, and is a method of injecting a nutritional supplement into a patient's stomach or intestine through a feeding tube. A nutritional supplement administered to a patient under this tube feeding method is defined as an enteral nutritional supplement. This tube feeding method is a method of administering enteral nutrition to patients by tube feeding, and is classified into nasogastric tube feeding method, gastrostomy feeding method, and enterostomy feeding method. You.

The nasogastric tube feeding method is a method in which a feeding tube is inserted into the esophagus with one end opened in the mouth or nose of a patient, and an enteral nutrient is injected into the stomach or intestine via the feeding tube.

In contrast, the transgastric fistula feeding method inserts a feeding tube into the fistula of a gastrostomy constructed over the abdominal wall and stomach wall of the patient, and enters the feeding tube from outside the body into the stomach through the feeding tube. The enteral fistula feeding method is to insert a feeding tube into the fistula of the enterostomy constructed across the abdominal wall and intestinal wall of the patient, and from outside the body through the feeding tube. This is a method of injecting an enteral nutrient into the intestine.

Patent Document 1 discloses that a liquid diet is administered as an enteral nutrition as a conventional technique for administering an enteral nutrition to a patient transnasally or transdermally.

The re-published patent publication with International Publication No. WO 00/13529 discloses that a liquid diet as an enteral nutrient may be administered to a patient scheduled to be administered by tube before or after administering the liquid diet. Or, at the same time, it is disclosed in the prior art to administer an emetic prophylactic food, which is a solution containing a thickener, by tube administration.
JP 2000-152975 A

す べ き As a matter to be noted when administering an enteral nutrient to a patient, there is a phenomenon in which the enteral nutrient administered into the stomach flows back toward the esophagus, that is, suppresses gastroesophageal reflux. This is because gastroesophageal reflux causes reflux esophagitis and swallowing pneumonia in patients. Reflux esophagitis is esophagitis caused by the stimulation of gastric acid of reflux from the stomach, whereas swallowing pneumonia is pneumonia due to the reflux of the reflux into the trachea.

噴 The stomach has a cardia that functions as a lid to prevent the contents of the stomach from flowing back toward the esophagus. Elderly patients who require enteral nutrition generally have a reduced function of the cardia, but even if the function is normal, gastroesophageal reflux may occur. high. Therefore, there is a strong demand for suppressing gastroesophageal reflux, especially when it is necessary to administer enteral nutrition to elderly patients.

However, in the case of using a liquid as an enteral nutrient, it is possible to sufficiently reduce gastroesophageal reflux even if a fluid is used in accordance with the disclosure of Patent Document 1. could not. Therefore, the burden of the caregiver on the patient was large.

FIG. 5 is a model showing that when a liquid or fluid enteral nutrition is administered to a patient by tube, the enteral nutrition has a strong tendency to reflux from the stomach toward the esophagus. I have. In the figure, reference numeral 10 denotes a patient's head, 12 denotes a foot, 14 denotes an abdomen, 16 denotes a back, 18 denotes a mouth, 20 denotes a stomach, 22 denotes an esophagus, and 24 denotes a liquid or fluid enteral nutritional supplement. Is shown.

Further, if the prior art disclosed in the above-mentioned reissued patent publication whose international publication number is WO00 / 13529 is carried out, a liquid diet as an enteral nutrition and a thickener are mixed in the stomach of a patient. After the appropriate reaction has occurred, gastroesophageal reflux is likely to be suppressed after the viscosity of the gastric contents has increased.

However, before the reaction between the liquid food and the thickener, the viscosity of both the liquid food and the thickener is low. Since there is a period during which the low-viscosity liquid diet and the thickener are stored in the body of the patient, there is a high possibility that gastroesophageal reflux occurs.

た め Therefore, even if the above-mentioned conventional technology is practiced, it is difficult to satisfactorily suppress gastroesophageal reflux throughout the entire period from the initial stage to the end stage of the liquid food and thickener administration steps.

Against this background, the present invention provides an enteral nutritional agent that can easily prevent an enteral nutritional agent administered to a patient by gavage from flowing back from the patient's stomach toward the esophagus. It was done with the task of doing.

各 The following aspects are obtained by the present invention. Each aspect is divided into sections, each section is numbered, and if necessary, described in a form in which the numbers of other sections are cited. This is to facilitate understanding of some of the technical features described in the present specification and some of the combinations thereof, and the technical features and the combinations thereof described in the present specification have the following aspects. It should not be construed as limited.

(1) An enteral nutrient administered by pressurizing the container from a container connected outside the patient to a feeding tube inserted into the patient through the feeding tube and into the stomach or intestine of the patient. hand,
It is common to solids in that it has a form retention property that retains its form without spontaneous change and that it can contain nutrients at a higher concentration than liquids and fluids, but changes in form due to forced external force Is formed as a semi-solid in common with liquids and fluids in that it is easier than a solid,
The form retention is maintained before and after administration of the enteral nutritional supplement to the patient's body, and in a state where the enteral nutritional supplement is stored in the patient's body, the enteral nutritional supplement depends on the body temperature of the patient. An enteral nutritional supplement in which the form retention is maintained so that the nutritional supplement does not liquefy.

This enteral nutritional agent has both properties as a liquid and a fluid and properties as a solid. As a result, while the enteral nutritional supplement has a form retention property in which the form is retained without being naturally changed, the form is more easily changed by a forced external force than a solid substance.

Further, according to this enteral nutritional supplement, since it is manufactured as a semi-solid material different from liquids and fluids in that it has a form retention property in which the form is retained without being naturally changed, the liquid and fluid It is easier to increase the viscosity or hardness than the body.

、 Here, “morphological retention” can be defined as a property that attempts to maintain its initial form against gravity and atmospheric pressure that naturally act on enteral nutrition from the outside.

Therefore, according to the enteral nutrition according to this section, the enteral nutrition 130 administered to the patient and stored in the stomach 20 flows back toward the esophagus 22 as schematically shown in FIG. Esophageal reflux can be easily suppressed.

胃 If gastroesophageal reflux of enteral nutrition is suppressed, it is not essential to maintain the patient's position in a sitting position, for example, during administration of enteral nutrition. As a result, for the patient himself, the possibility of pressure ulcers occurring on the buttocks and back with high contact pressure during administration of the enteral nutritional supplement is reduced.

If the use of an enteral nutrient is likely to cause gastroesophageal reflux in the patient, and thus the patient is likely to vomit, caregivers who care for the patient should During administration of enteral nutrition, the patient must be constantly monitored closely so that if the patient vomits and the condition changes suddenly, it can be immediately detected. Therefore, a heavy monitoring burden is imposed on the caregiver.

However, if the likelihood of gastroesophageal reflux for enteral nutritional products administered to the patient is reduced, the burden of caregiver monitoring on the patient is reduced.

As described above, when the prior art disclosed in the reissued patent publication whose international publication number is WO00 / 13529 is carried out, as described above, during the administration of the liquid food and the thickener, the flow rate of the thickener is increased. Because there is no increase in the viscosity of the food, there is a viscosity insufficiency period in which the viscosity of the gastric contents is lower than the viscosity at which gastroesophageal reflux does not easily occur, and there is a high possibility that gastroesophageal reflux occurs during the viscosity insufficiency period .

In contrast, according to the enteral nutrition according to this section, its form retention is maintained before and after administration of the enteral nutrition to the patient's body, and as a result, Since the above-mentioned period of insufficient viscosity does not exist during administration, it is easy to suppress gastroesophageal reflux over the entire administration period of the enteral nutritional supplement.

Further, when practicing the prior art disclosed in the above-mentioned re-published patent publication whose international publication number is WO00 / 13529, when the liquid diet and the thickener to be ultimately administered to the patient are to be administered. It is likely that the volume is greater than the total volume of the semi-solid enteral nutrition. As described above, the thickener is in a liquid state, and as a result, the mixture of the thickener and the liquid food contains a larger amount of water than the semisolid enteral nutrition.

In contrast, the enteral nutritional according to this section is formed as a semi-solid in common with a solid in that it can contain nutritional components at a higher concentration than liquids and fluids.

Accordingly, this enteral nutrient makes it possible to easily reduce the total volume of the substance to be finally administered to the patient, and consequently to shorten the administration time. If the administration time is shortened, the burden on the patient and the caregiver is reduced, and the tendency for bacteria to enter the enteral nutritional supplement from the outside and the tendency for the bacteria to multiply are reduced, thereby reducing the patient's It is easy to increase the cleanliness of the enteral nutrient administered to the patient.

腸 This enteral nutritional agent mainly changes its overall form by its own division by forced external force. On the other hand, the enteral nutritional supplement is broken by the forced external force acting from the feeding tube while passing through the feeding tube, changes its overall form, and is then administered to the patient. Therefore, this enteral nutritional supplement is present in the patient's body in a divided state. However, since each part of the enteral nutritional product resulting from its fragmentation still has form retention, the enteral nutritional product in a divided state as a whole will show stronger form retention than liquids and fluids.

That is, in this enteral nutritional supplement, the form retention is maintained before and after administration to the patient's body via the feeding tube.

Furthermore, in this enteral nutrition, when stored in the patient's body, the form retention is maintained so that the enteral nutrition does not liquefy depending on the patient's body temperature.

By the way, in foods that are taken orally by patients for nutritional supplements, it is necessary to liquefy to some extent when the foods are taken into the patient's mouth in order to promote swallowing by patients. is there. However, this liquefaction rather increases the possibility of causing gastroesophageal reflux.

On the other hand, enteral nutrition is not a food that is taken orally, so it is not necessary to manufacture it to be liquefied after administration.

に Based on such findings, the enteral nutritional according to this section is formed as a semi-solid material having shape retention so as not to be liquefied by the patient's body temperature in the body of the patient.

Therefore, according to this enteral nutritional agent, gastroesophageal reflux can be easily suppressed without inhibiting administration to patients.

Generally, the stronger the enteral nutrition shows its shape retention, the more it loses its fluidity, that is, its free deformability, which may be a factor inhibiting the enteral nutrition from passing through the feeding tube.

However, the enteral nutritional product according to this section is passed through a feeding tube inserted into a patient's body, and then into a patient's stomach or intestine from a container connected to a portion of the feeding tube located outside the patient's body. Is administered using the pressurizing action of the container.

Accordingly, this enteral nutrient facilitates smooth passage through the feeding tube, even though it shows a stronger form retention than liquids and fluids.

The “enteral nutritional supplement” according to this section may be used under the aforementioned nasogastric tube feeding method, used under the aforementioned gastrostomy tube feeding method, It can be used under nutritional supplements.

In addition, in order to produce the “enteral nutritional supplement” as a semisolid substance, for example, a semisolidifying agent can be added to the liquefied nutritional supplement. In this case, as the semi-solidifying agent, egg white of a chicken egg can be selected, agar can be selected, gelatin can be selected, other semi-solidifying agents can be selected, or an appropriate combination thereof can be selected. It is possible.

In this section, the "predetermined semi-solidification treatment" can be defined as, for example, a heat treatment for a liquefied nutrient in a container, or can be defined as an aging treatment in which the liquefied nutrient is simply left alone. .

Further, in this section, the “container” has a function of accommodating the semi-solidified enteral nutrition and a function of injecting the enteral nutrition contained in the container into the nutrition tube by pressurizing. Any physical form is acceptable.

Accordingly, the “container” can be a syringe in which the plunger is airtightly and slidably fitted in the cylinder, or a flexible bag. The bag can be made of, for example, a film such as an aluminum film or a synthetic resin film, or can be made as a closed type for preventing invasion of various bacteria.

Further, the “container” may be a first type in which the enteral nutrition is mainly stored only during the administration, or the actual administration timing of the enteral nutrition may be considered. Regardless, it is possible to have a second form in which the enteral nutrition is stored prior to its actual administration and also during its administration.

Here, in the case of adopting the first form, prior to administration of the enteral nutritional supplement, the enteral nutritional supplement is transferred from the container exclusively storing the enteral nutritional supplement to the “container”, and then the enteral nutritional supplement is transferred. The nutrient will be administered to the patient from the “container”.

(2) The liquefied nutrient is filled in the same or a different container from the above-described container, and in the filled state, a predetermined semi-solidification treatment is performed on the liquefied nutrient in the same container or another container. The enteral nutrition according to item (1), which is produced by applying the composition to an enteral nutrition.

This enteral nutritional agent shows shape retention not only after administration to the patient's body but also before administration. If such a semi-solid enteral nutritional supplement is to be filled into a container, the form retention of the enteral nutritional supplement, that is, the nature of the semi-solid substance, causes the filling to fail. It may not be smooth.

On the other hand, the enteral nutritional according to this section is in a liquefied state before filling into a container, and shifts to a semi-solidified state only after filling into the container. Therefore, according to this enteral nutrition, it is easy to smoothly fill the container.

Here, the “container” is the same as the container in the above item (1), that is, the same as the container having the function of injecting the enteral nutritional agent into the nutrition tube while connected to the nutrition tube, and May be different.

場合 The case where the “container” is the same as the container in the above item (1) corresponds to the case where the above-mentioned first or second type is adopted. On the other hand, when the “container” is different from the container in the above item (1), the “container” may be used for enteral nutrition prior to its actual administration regardless of the actual administration timing of the enteral nutritional supplement. This corresponds to the case where the agent is stored but not stored during the administration, and is a container exclusively for storage.

(3) an addition step of adding a semi-solidifying agent to the liquefied nutrient, a filling step of filling the liquefied nutrient added with the semi-solidified agent into the same container or another container, A process in which the predetermined semi-solidification process is performed on the liquefied nutrient in the same container or another container in a filled state. Enteral nutrition.

(4) The enteral nutrition according to (3), wherein the semi-solidifying agent contains at least egg white of egg yolk and egg white of chicken eggs.

の 一 An example of “at least egg white” in this section is a whole egg containing both egg yolk and egg white of a chicken egg.

(5) The enteral nutritional according to (4), wherein the treatment step includes a heating step of heating the liquefied nutrient in the same container or another container as the predetermined semi-solidification treatment. .

「The“ heating step ”in this section can include, for example, a step of steaming or roasting a mixture of at least egg white and a liquefied nutrient (including a liquid nutrient).

Here, the cooking method of "steaming" can be defined as a cooking method in which heat is applied to the material through steam, whereas the cooking method of "steaming" applies heat to the material through steam. In parallel with the addition, it can be defined as a cooking method in which heat is applied directly to the same ingredient and baked.

(6) The enteral nutritional as described in (3), wherein the semi-solidifying agent contains agar.

(7) the adding step includes a heating step of heating a mixture of the liquefied nutrient and the agar to dissolve the agar in the liquefied nutrient;
The enteral nutrition according to item (6), wherein the treatment step includes an endothermic step of performing endothermic treatment of the liquefied nutrient in the same container or another container as the predetermined semi-solidification treatment.

(8) The feeding tube is used by being inserted into a fistula laid across the abdominal wall and the stomach wall or the intestinal wall of the patient, and the stomach is passed through the patient's mouth or nose through the patient's esophagus. The enteral nutrition according to any one of (1) to (7), which has a larger inner diameter and a shorter inner diameter than the feeding tube used by being inserted into the nut.

When the enteral nutrition according to any one of the above (1) to (7) is used under the above-mentioned feeding method for gastrostomy or feeding method for enterostomy, the above-mentioned nasogastric tube is used. The feeding tube through which the enteral nutrients pass, ie, the administration route, is shorter than when used under the nutritional supplementation method.

Therefore, when the enteral nutrition according to any one of the above items (1) to (7) is used under the aforementioned gastrostomy nutritional supplementation method or enteral nutritional supplementation method, the enteral nutritional supplement is used. Is not a liquid, but a thicker than a liquid, so that it is a semi-solid material that can contain the same amount of nutrients and can be easily reduced in volume, and therefore, the administration time required to administer a dose of enteral nutritional supplement. Can be easily shortened.

Furthermore, the shorter administration route of the enteral nutrient means that the high viscosity of the enteral nutrient makes it easier for the enteral nutrient to become clogged and remain in the feeding tube during tube administration. It leads to things that can be avoided.

Furthermore, a feeding tube used by being inserted into a fistula laid across the abdominal wall of the patient and the stomach or intestinal wall is generally inserted into the stomach from the patient's mouth or nose through the patient's esophagus. It is shorter than the feeding tube used and has a larger inner diameter.

And, when the enteral nutrition is administered to the patient by tube, if it depends on the shortening of the administration route and the diameter of the enteral nutrition, the administration time can be shortened easily. The avoidance of enteral nutrition in the feeding tube is also facilitated.

Based on such findings, the enteral nutritional product according to this section is to enter the stomach or intestine from outside the body via a feeding tube inserted into a fistula built across the patient's abdominal wall and stomach wall or intestinal wall. It is an enteral nutritional product to be administered and used. That is, this enteral nutritional supplement is used under the above-mentioned gastrostomy fistula feeding method or enteral fistula feeding method.

When an enteral nutritional supplement is administered to a patient via a gastrostomy, which is a fistula formed between the abdominal wall and the stomach wall of a patient, a feeding tube extending from the gastrostomy to the intestine (hereinafter referred to as a “gastric fistula jejunum”) If no feeding tube is used, the enteral nutrient will be administered into the stomach and then delivered into the intestine by gastric peristalsis. On the other hand, if a gastrostomy jejunal feeding tube is used, the enteral nutrient is immediately administered to the intestine without being administered to the stomach. Such nutritional supplementation can be referred to as transgastric fistula jejunal nutritional supplementation.

経 The enteral nutritional product according to this section can be used under the gastrostomy fistula jejunal feeding method.

In general, when a certain restriction is imposed between the degree of form retention of the enteral nutritional supplement and the inner diameter of the nutritional tube from the viewpoint of satisfying the desire to allow the enteral nutritional supplement to smoothly pass through the nutritional tube. There is. The restriction is that the inner diameter of the feeding tube must be increased in order to increase the degree of freedom of the enteral feeding agent in the feeding tube as the enteral feeding agent exhibits a shape retaining property.

In contrast, the enteral nutritional product according to this section is to be administered to the patient's body via a feeding tube used under the gastrostomy feeding method or the enterostomy feeding method. The feeding tube has a larger inner diameter than the feeding tube used under the nasogastric tube feeding method.

Accordingly, according to this enteral nutrition, it is easy to smoothly administer to a patient through a large-diameter nutrition tube despite having stronger form retention than liquids and fluids.

(9) An enteral nutritional supplement with a container, wherein the enteral nutritional supplement to be administered by tube into a patient is contained in a container,
Although the enteral nutritional supplement is common to solids in that it has a form-retaining property in which the form is retained without being naturally changed and that it can contain nutritional components at a higher concentration than liquids and fluids. Formed as a semi-solid in common with liquids and fluids in that changes in form due to forced external forces are easier than solids,
The form retention is maintained before and after administration of the enteral nutrient into the patient's body, and in a state where the enteral nutrient is stored in the patient's body, the enteral nutrition is dependent on the patient's body temperature. The form retention is maintained so that the nutrient does not liquefy,
A container in which the enteral nutrition is manufactured by filling the container with a liquefied nutrient and applying a predetermined semi-solidification treatment to the liquefied nutrition in the container in the filled state. With enteral nutrition.

According to the enteral nutritional supplement with container, the same action and effect can be realized according to the same principle as the enteral nutritional supplement according to the above item (1).

When comparing the same enteral nutritional supplement in the same container in the liquefied state and the case of trying to fill in the semi-solid state, the case of trying to fill in the semi-solid state is better, Due to the form-retaining property of the enteral nutrient, that is, the property as a semi-solid, it may not be possible to efficiently fill the container. This possibility increases, for example, as the form retention of the enteral nutrition is stronger and as the opening of the container is narrower.

On the other hand, the enteral nutritional supplement with container according to this section is in a liquefied state before filling into the container, and shifts to a semi-solidified state only after filling into the container. Therefore, according to the enteral nutritional supplement with a container, it is easy to efficiently fill the container.

The “container” in this section stores the enteral nutritional supplement mainly during the administration of the enteral nutritional supplement at the actual administration time of the enteral nutritional supplement, and stores the enteral nutritional supplement in a connected state with the nutrition tube. It is possible to use a form of injection into a feeding tube.

The “container” further stores the enteral nutritional supplement prior to its actual administration, regardless of the actual administration timing of the enteral nutritional supplement, and during the administration thereof, and is provided with a feeding tube. It is also possible to adopt a form in which the enteral nutrient is injected into the feeding tube in a connected state.

The "container" can also be in a form that stores the enteral nutrient prior to its actual administration but does not preserve it during its administration, regardless of when the enteral nutrition is actually administered. It is.

Further, the “container” has at least the former function of accommodating a semi-solid enteral agent in a semi-solid state and a function of injecting an enteral nutritional agent contained in the container into a nutrition tube by pressurization. The physical form is not limited as long as it has a function.

Accordingly, the “container” can be a syringe in which the plunger is airtightly and slidably fitted in the cylinder, or a flexible bag. The bag can be made of, for example, a film such as an aluminum film or a synthetic resin film, or can be made as a closed type for preventing invasion of various bacteria.

容器 The enteral nutrition with a container according to this section can be implemented in combination with the characteristic technique according to any of the above (2) to (8).

(10) In order to administer the enteral nutrition according to any of (1) to (8) to the patient, the enteral nutrition is filled and the filled enteral nutrition is added. A syringe that presses and ejects,
A syringe that functions as a container for storing the enteral nutrient prior to use of the syringe by commercializing the enteral nutrient in a pre-filled state together with the enteral nutrient.

When the enteral nutrition according to any one of the above (1) to (8) is administered to a patient using a feeding tube, the enteral nutrition is required to overcome the form retention or viscosity of the enteral nutrition. It is necessary to push the agent into the feeding tube. This indentation can be achieved by pressurizing the enteral nutrition with a syringe and administering it to the patient.

As described above, a technique of administering an enteral nutritional supplement to a patient using a syringe (forced administration in the sense of being distinguished from spontaneous administration in which a substance is naturally administered to a patient by utilizing the spontaneous fall of a substance). In general, when the parenteral nutritional supplement and the syringe are separately manufactured, the enteral nutritional supplement is traded in a state stored in a dedicated container.

When the enteral nutrient and the syringe are separately manufactured in this way, the enteral nutrient is aspirated from the dedicated container in which the enteral nutrient is stored with the syringe prior to administration of the enteral nutrient. The syringe is then filled into the chamber of the syringe, and then the plunger of the syringe is pressed into the cylinder, whereby the enteral nutritional supplement filled in the chamber is injected into the patient.

On the other hand, the syringe according to this item is produced as a single product together with the enteral nutritional supplement in a state in which the enteral nutritional supplement is pre-filled, so that the enteral nutritional supplement is administered before the use of the syringe. Functions as a container for storing nutrients. This syringe can be referred to as a prefilled type.

Therefore, according to this syringe, it is not necessary to transfer the enteral nutritional supplement from the dedicated container to the syringe prior to administration, thereby simplifying the operation required for administration and the time required for the administration. Can be easily shortened.

Hereinafter, some more specific embodiments of the present invention will be described in detail with reference to the drawings.

The enteral nutritional supplement according to the first embodiment of the present invention is used by being administered into the stomach through a gastrostomy constructed in a patient. That is, the enteral nutrition is used under the transgastric fistula supplementation method. As shown in FIG. 1, the gastrostoma 100 straddles the abdominal wall 102 and the stomach wall 104 of the patient, and is constructed so that the extracorporeal space 106 and the intragastric space 108 communicate with each other.

The gastrostoma 100 can be constructed by laparotomy, but can also be constructed percutaneously using an endoscope inserted into the stomach. The latter percutaneous endoscopic gastrostomy is specifically the process of inserting a tube from outside the body into the stomach using an endoscope and forming a fistula around the tube in the patient's abdominal and gastric walls. It is.

It is said that this percutaneous endoscopic gastrostomy is more advantageous than gastrostomy performed by laparotomy in that there are fewer complications induced by the patient during the operation.

In addition, when performing this percutaneous endoscopic gastrostomy, a feeding tube is inserted into the patient via the nose and esophagus to reach the stomach in order to perform nasogastric tube feeding. It is said that the pain given to the patient is less and the burden on the caregiver is also reduced as compared with the case where the patient does the treatment.

か ら For the two reasons explained above, this percutaneous endoscopic gastrostomy is rapidly spreading today.

When performing the transgastric fistula feeding method, a gastrostomy tube 110 as a feeding tube is inserted into the gastrostoma 100 as shown in FIG. The gastrostoma tube 110 is positioned with respect to the gastrostoma 100 by the extracorporeal fixation plate 112 and the intragastric fixation plate 114 attached thereto.

腸 Enteral nutrition is injected into the stomach from outside the body by passing through the gastrostomy tube 110. The gastrostomy tube 110 generally has a wider lumen (larger inner diameter) and a longer length than a nasogastric tube used as a feeding tube for performing the above-mentioned nasogastric tube feeding method. Is short. A general nasogastric tube has a narrow lumen (inner diameter is small) such as an inner diameter of 2 to 4 [mm] and a length as long as 60 [cm] or more.

Therefore, when the enteral nutrition is administered to the patient using a common nasogastric tube, the liquid form of the enteral nutrition is required to ensure the ease of the flow of the enteral nutrition. In contrast, when an enteral nutrition is administered to a patient using the gastrostomy tube 110, the dosage form of the enteral nutrition is a half that has a stronger form retention than liquid. Even if a solid is used, it is possible to ensure easy flow of the enteral nutrition.

位置 FIG. 2 is a partial side sectional view showing the positional relationship among the abdominal wall 102, the stomach wall 104, and the gastrostoma tube 110.

(3) The enteral nutrition is injected into the stomach 20 using a syringe 120 as shown in FIG. In the syringe 120, the plunger 122 is slidably fitted to the cylinder 122. A chamber 126 is formed between the cylinder 122 and the plunger 124 so as to communicate with an injection port (hidden and invisible in the figure). The chamber 126 is filled with an enteral nutrition 130 to be injected by the syringe 120. The injection port of the syringe 120 is generally larger in diameter than that of a general syringe.

The filled enteral nutrient 130 is injected into the gastrostomy tube 110 by pushing the plunger 124 deep into the cylinder 122, and is thereby forced into the stomach 20 via the gastrostomy tube 110 by a forced external force. Injected. Thus, the enteral nutritional supplement 130 is forcibly administered to the patient's body.

Enteral nutrition 130 is manufactured as follows.

First, 250 [ml] of a liquefied nutrient (ie, a liquid containing a nutrient component to be administered to a patient) is prepared in a container. Next, one whole raw egg is added to the liquefied nutrient and stirred. After that, a part of the mixture of the liquefied nutrient and the whole raw egg is sucked by the syringe 120 having a capacity of 100 [ml] and filled in the chamber 126.

Subsequently, the syringe 120 filled with the mixture is set in a predetermined cooker, and the mixture is steamed or roasted together with the syringe 12. Thus, the enteral nutritional supplement 130 is manufactured.

経 The enteral nutritional supplement 130 thus produced is formed as a semi-solid. Here, the term “semi-solid” refers to a solid substance in terms of having a form-retaining property in which the form is not naturally changed and containing a nutritional component at a higher concentration than liquids and fluids. However, it means a substance having properties common to liquids and fluids in that the form is easily changed by a forced external force compared to solids. The viscosity and hardness of the enteral nutrient 130 are on the order of pudding or chawanmushi.

Therefore, when the enteral nutritional supplement 130 is administered to a patient, it depends on the form retention of the enteral nutritional supplement 130 as shown in a model in FIG. Gastro-esophageal reflux, in which the enteral nutrition 130 flows back toward the esophagus 22, is suppressed.

Therefore, according to the present embodiment, it is not essential to maintain the patient in a sitting position during administration of the enteral nutritional supplement 130, and as shown in FIG. Administration of the agent 130 can be performed normally.

By the way, the whole egg that has been steamed or roasted functions as a material that suppresses liquefaction in the patient's body due to the patient's body temperature. Therefore, liquefaction of the enteral nutritional supplement 130 in the patient's body due to the patient's body temperature is suppressed.

As is clear from the above description, in the present embodiment, whole eggs are used to increase the viscosity of the liquefied nutrient, but the present invention may be implemented using agar, for example. However, cooking of the enteral nutritional supplement 130 is easier when using whole eggs than when using agar.

Further, in this embodiment, prior to steaming or roasting the mixture of whole eggs and liquefied nutrients, the mixture is sucked into the syringe 120 and filled into the syringe 120, and the mixture is injected into the syringe 120. 120 together or steamed.

That is, after the liquid mixture is filled into the syringe 120, the liquid mixture in the syringe 120 is heated, whereby the mixture is semi-solidified. Therefore, according to this embodiment, the process of filling the semi-solid enteral nutrient 130 into the syringe 120 having a narrow opening can be easily performed.

However, it is possible to implement the present invention by steaming or roasting the liquid mixture to produce the enteral nutritional supplement 130 and then filling it into the syringe 120.

Further, in this embodiment, the syringe 120 pre-filled with the enteral nutritional supplement 130 is manufactured and shipped as one product.

Therefore, according to the present embodiment, prior to administering the enteral nutritional supplement 130 to the patient, the operation of suctioning the enteral nutritional supplement 130 by the syringe 120 and filling the same into the syringe 120 is omitted, and as a result, The operation of administering the enteral nutritional supplement 130 is simplified and the administration time is shortened.

Next, a second embodiment of the present invention will be described.

The enteral nutritional product according to the present embodiment is also used by being administered into the stomach via a gastrostomy built in the patient, similarly to the enteral nutritional product 130 according to the first embodiment. That is, this enteral nutritional supplement is also used under the transgastric fistula supplementation method.

The enteral nutritional supplement 130 according to the first embodiment is manufactured using whole eggs as a semi-solidifying agent as described above, but the enteral nutritional supplement according to the present embodiment uses agar as a semi-solidifying agent. Manufactured using. Agar is in the form of a dry powder.

The reason for choosing agar as a semi-solidifying agent is
(A) that it is easy to obtain and cook;
(B) the degree of semisolidification of the enteral nutrient by agar, that is, the hardness is easily adjusted,
(C) the semisolid enteral nutrition does not dissolve (liquefy) in the patient's body due to its body temperature;
(D) low-calorie, high-fiber content that does not impair the patient's health;
(E) This is because attention has been paid to the point that the semisolid enteral nutritional supplement has a low consistency and is easily injected into the patient via the gastrostomy tube 110.

In the present embodiment, a commercially available liquefied nutritional supplement (that is, a liquid containing a nutritional component to be administered to a patient) is used to produce an enteral nutritional supplement. This liquefied nutrient is a semi-digestive nutrient. This liquefied nutrient is mixed with a necessary amount of water (an example of a diluent) when dilution for reducing calorie intake is required. The mixture is then heated. In this state, powdery agar is added to the liquid mixture at a ratio of 1 [g] to 200 [ml] of water. Thereafter, the agar is stirred and dissolved in the mixture.

At this point, the mixture in which the agar is dissolved is in a liquefied state, and the liquefied mixture is sucked by the syringe 120 and filled in the syringe 120.

Thereafter, the syringe 120 containing the liquefied mixture is stored in a cold storage such as a refrigerator. This removes heat from the liquefied mixture, which consequently solidifies under the influence of agar. The mixture is semi-solidified under the influence of the agar, whereby the semi-solid enteral nutrition is completed in the syringe 120 in a pre-filled state. The hardness of the enteral nutrient is set to be as high as that of pudding.

The enteral nutrition is injected into the gastrostoma tube 110 using the syringe 120. In the present embodiment, it is possible to administer a single required dose of the enteral nutritional agent to the patient at once with the syringe 120, and the administration time is about several minutes.

(4) The present inventors conducted a clinical trial on several patients in order to confirm the gastroesophageal reflux prevention effect of the enteral nutritional supplement.

In this trial, the same patient is administered a semisolid enteral nutritional supplement and a liquefied enteral nutritional supplement, respectively, and in each case, it is evaluated whether gastroesophageal reflux has occurred. In each case in which gastroesophageal reflux occurred, the length of the reflux area where gastric contents refluxed to the esophagus (the maximum gastric content of refluxed gastric contents) was further determined based on images obtained by CT (computed tomography). The distance between the uppermost position and the lowermost position) and the distance from the cardia at the uppermost position of the stomach contents flowing back into the esophagus were measured.

In the CT, 30 minutes after administration of an enteral nutritional supplement containing a contrast agent to each patient, the chest of each patient is photographed by slices at intervals of 1 [cm]. On the captured image, the presence or absence of a contrast agent is determined in association with the CT value of each part in the esophagus (a value expressing the height position of each part in the esophagus by the number of slices), and gastroesophageal reflux is determined according to the presence or absence. Is determined.

Regarding the method for preparing an enteral nutrition containing a contrast agent, a water-soluble contrast agent is used in 5 [ml] per 100 [ml] of the enteral nutrition regardless of whether it is in a liquefied state or a semi-solid state. The semisolidified enteral nutritional agent was semisolidified after the contrast agent was mixed.

Regarding the administration method of the enteral nutrition, regardless of whether the liquid is in a liquefied state or a semi-solid state, the dose is set to 400 [ml], and the liquefied enteral nutrition is administered once. The administration was performed over about 15 minutes, while the semi-solid enteral nutrition was administered at once using a syringe 120 having a volume of 50 [ml].

FIG. 6 shows the results of this trial in tabular form. In the column showing the presence or absence of gastroesophageal reflux in the same figure, "-" indicates that gastroesophageal reflux was not observed, and "+" indicates that gastroesophageal reflux was observed. Further, both the length of the backflow range and the distance from the cardia are measured with reference to the CT value described above.

治 This trial was conducted on 17 patients. All of the patients were almost bedridden, but were medically stable. In FIG. 6, each patient is identified by an ID number, age and gender are described as attributes of each patient, and further, the name of the underlying disease of each patient is described.

結果 According to the results shown in FIG. 6, out of the 17 patients, gastroesophageal reflux was observed after administration of the liquefied enteral nutritional supplement in 10 (58.5%). In contrast, gastroesophageal reflux was observed in 4 (23.5%) patients after administration of the semisolid enteral nutrition.

Accordingly, it was confirmed that the enteral nutritional supplement according to the present embodiment prevented gastroesophageal reflux better than the liquefied enteral nutritional supplement.

The enteral nutrition according to the present embodiment is also advantageous in the following points as compared with the liquefied enteral nutrition.

症 例 There have been reports of an increased incidence of gastroesophageal reflux after gastrostomy in patients. The cause has not been clarified yet, but the following has been pointed out regarding the cause.

と When the stomach wall is fixed to the abdominal wall with the construction of a gastrostomy, the peristalsis of the stomach is suppressed and the excretory capacity of the stomach is reduced. It has already been pointed out that this decrease in excretion ability leads to an increase in the time during which the enteral nutrition is retained in the stomach, and as a result, the occurrence frequency of gastroesophageal reflux increases.

On the other hand, factors that promote and suppress gastric peristalsis related to the ability to excrete the stomach include, in addition to neurological factors, factors called humoral regulation depending on various gastrointestinal hormones. Among the various gastrointestinal hormones, gastrin is said to most strongly enhance gastric peristalsis, and its secretion is stimulated by elongation of the gastric wall.

When a liquefied enteral nutritional product is administered intranasally into the patient's stomach via nasogastric tube, the liquefied enteral nutritional supplement should generally be dripped at a slow rate to prevent vomiting of the patient during administration. Is recommended. However, at such a slow dropping rate, it is difficult to fill the stomach with the liquefied enteral nutrient, and thus the gastric elongation due to the administration of the liquefied enteral nutrient into the stomach is insufficient. . Therefore, the secretion of gastrin is not active, and the peristalsis of the stomach is not active, so that the excretion capacity of the stomach is reduced, and consequently the gastroesophageal reflux may be promoted.

In contrast, according to the present embodiment, since the enteral nutrition is directly administered into the stomach via the gastrostoma, the enteral nutrition can be quickly injected into the stomach without worrying about vomiting. It becomes. Therefore, administration of an enteral nutritional agent into the stomach greatly expands the stomach, stimulates the secretion of gastrin, and can be expected to promote active gastric peristalsis. As a result, the excretory capacity of the stomach is improved, and the occurrence frequency of gastroesophageal reflux of the enteral nutritional agent is favorably reduced in combination with the semi-solidified enteral nutritional supplement.

後 に After a gastrostomy is created in a patient, the gastrostomy tends to increase in diameter over time, and as a result, the gap between the gastrostomy and the feeding tube inserted into the gastrostomy increases. This gap may be a path through which the enteral nutritional supplement injected into the patient's stomach via the feeding tube leaks out of the body due to intragastric pressure.

On the other hand, according to the present embodiment, the enteral nutritional supplement is in a semi-solid state, and has a stronger form retention than in the liquefied state, so that it passes through a gap of the same size. High resistance when doing. Therefore, according to the present embodiment, the problem of leakage of the enteral nutrient due to pressure in the stomach can be easily solved.

FIG. 7 shows that a patient (female, then 85 years old, admitted to a nursing care facility for the elderly) who had an endoscopic gastrostoma was administered a liquefied enteral nutritional supplement, The results of a clinical trial of administration of semisolid enteral nutrition according to the form are shown over time.

示 す As shown in the figure, in this clinical trial, a liquefied enteral nutritional supplement was administered to the patient by gastrostoma from the beginning of May 2000 to the middle of October. During this period, gastroesophageal reflux occurred frequently, and leakage of enteral nutrients and vomiting through the gap between the gastrostoma and the feeding tube were observed.

On the other hand, in the period after the middle of October of the same year, semisolidified nutritional supplements were administered to the same patients in place of liquefied enteral nutritional supplements. During this period, neither gastroesophageal reflux, leakage nor vomiting was observed at all, as shown in FIG.

Therefore, it is confirmed that the semisolid enteral nutrition according to the present embodiment is also advantageous in that leakage and vomiting of the enteral nutrition can be easily suppressed as compared with the liquefied enteral nutrition. Was.

As described above, some of the embodiments of the present invention have been described in detail with reference to the drawings. However, these embodiments are merely examples, and those skilled in the art, including the embodiments described in the section [Means for Solving the Problems] above, may be used. The present invention can be implemented in other forms in which various modifications and improvements are made based on knowledge.

1 is a partial cross-sectional side view showing a gastrostomy 100 and a gastrostomy tube 110 used to administer an enteral nutritional agent to a patient according to a first embodiment of the present invention. FIG. 2 is a partial side cross-sectional view showing the gastrostomy tube 110 in FIG. FIG. 3 is a perspective view showing a prefilled syringe 120 that is pre-filled with the enteral nutritional supplement 130 and commercialized according to the embodiment. FIG. 9 is a side cross-sectional view schematically showing a state in which gastroesophageal reflux is suppressed for enteral nutritional supplement 130 in a state in which enteral nutritional supplement 130 according to the above-described embodiment is administered to a patient in a supine position by tube feeding. . Side cross-sectional view schematically showing a state in which gastroesophageal reflux is likely to occur in enteral nutrition 24 when liquid or fluid conventional enteral nutrition 24 is administered to a patient in a supine position by tube. It is. It is a figure showing the result of the trial conducted in order to confirm the gastroesophageal reflux prevention effect by the enteral nutrition according to the second embodiment of the present invention in comparison with the liquefied enteral nutrition. Table 3 shows the results of trials conducted to confirm the gastroesophageal reflux prevention effect, leakage prevention effect, and vomiting prevention effect of the enteral nutritional product according to the second embodiment while comparing it with the liquefied enteral nutritional product. FIG.

Explanation of reference numerals

Reference Signs List 20 stomach 22 esophagus 100 gastrostoma 102 abdominal wall 104 stomach wall 100 gastrostoma 110 gastrostoma tube 120 syringe 130 enteral nutrition

Claims (2)

From a container connected outside the patient to a feeding tube inserted into a fistula constructed across the abdominal wall of the patient and the stomach or intestinal wall, the container is inserted into the patient's stomach or intestine via the feeding tube via the feeding tube. An enteral nutrient administered by pressure,
By adding powdered agar as a semi-solidifying agent to a liquefied nutrient at a ratio of 1 g to 200 ml of water, the form is retained without changing its form naturally, and it is retained from the outside. With respect to the point that it has the property of trying to maintain its initial form against gravity and atmospheric pressure that naturally acts on the enteral nutritional supplement, and that it can contain nutrients at higher concentrations than liquids and fluids Is common to solids, but is formed as a semi-solid in common with liquids and fluids in that changes in form due to forced external forces are easier than solids,
The form retention is maintained before and after administration of the enteral nutrient into the patient's body, and when the enteral nutrient is stored in the patient's stomach or intestine, the patient's body temperature causes Is an enteral nutritional supplement in which the form retention is maintained so that the enteral nutritional supplement does not liquefy. A method for producing an enteral nutritional supplement according to claim 1,
In the liquefied state, the mixture of the liquefied nutrient and the semi-solidifying agent is filled in the same or different container as the container, and in the filled state, in the same container or another container. A method for producing an enteral nutritional supplement, wherein the mixture is cooled together with its container to semisolidify the mixture to produce the enteral nutritional supplement.

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