WO2003049800A1

WO2003049800A1 - Catheter kit for gastric ulcer

Info

Publication number: WO2003049800A1
Application number: PCT/JP2002/012578
Authority: WO
Inventors: Jiro Kanie
Original assignee: Jiro Kanie
Priority date: 2001-12-13
Filing date: 2002-12-02
Publication date: 2003-06-19
Also published as: JP2003180841A; JP3347315B1; AU2002349670A1

Abstract

A catheter kit for gastric ulcer capable of eliminating, while enjoying such a conventional advantage by an introducer method that the possibility of contagion of a wound part by bacteria is small, such a defect caused thereby that an extraction prevention function that must be performed by an in-stomach fixing device is impaired due to damage to the in-stomach fixing device, wherein a rod (14) for extending a non-balloon type in-stomach fixing device (12) fitted to a tube (10) is made hollow, and a passage (44) allowing a passage (40) in the rod to communicate with a space in a stomach with the rod engaged with the in-stomach fixing device is provided in the in-stomach fixing device, whereby a continuous guide wire (20) can be inserted into the rod and the in-stomach fixing device, and when the assembly of the tube, in-stomach fixing device, and the rod is inserted into the stomach by the introducer method, the assembly can be accurately guided into the stomach by the guide wire.

Description

Specification

Gastrostomy catheter / kit Technical field

The present invention relates to a catheter 'kit used in connection with a gastrostoma of a living body. Background art

Enteral nutrition has already been used for patients who have difficulty or cannot swallow food. As a technique for realizing such administration, there is a technique for injecting an enteral nutritional agent from outside the body into the stomach through a gastrostomy made in the abdominal wall and stomach wall of the patient. This is called gastrostomy nutritional management.

In order to perform this nutritional management of the gastrostomy, it is necessary to construct a gastrostomy on the patient's abdominal wall and stomach wall. This gastrostomy can be created by laparotomy, but in recent years, percutaneous endoscopic gastrostomy has the advantage of shortening the operation time and recovering the postoperative patient early. Implementation of Endoscopic Gastrostomy (PEG) is becoming widespread.

A catheter kit is used to perform this PEG. It is used to create a gastrostomy that penetrates the patient's abdominal wall and stomach wall, and is used to introduce nutrients from outside the body into the stomach when implanted in the stomach .

In addition, there is a type of catheter / kit that can be used for nutrient introduction but cannot be used for gastrostomy. Regardless of the intended use, the reality is that tubing is not designed to withstand long-term use. Is being replaced. The catheter kit, including the replacement tube, can be used for nutrient delivery but not for gastrostomy.

In consideration of these circumstances, the type that can be used not only for nutrition introduction but also for gastrostomy is called the gastrostomy catheter 'kit', whereas the type that can be used only for nutrition introduction, The type intended for tube replacement is distinguished by the type of gastrostomy nutritional management catheter, kit and rat.

However, nutrient introduction is feasible in both types, so if it is sufficient to discuss both types assuming the function of nutrient introduction, the meaning of distinguishing both types is important. There is no. Both types are collectively referred to as gastrostomy catheter kits.

In general, a gastrostomy catheter kit includes: (a) a tube having a nutrient passage for introducing nutrients from outside the body into the stomach; and (b) the tube in the stomach in the implanted state. And a gastric fixation device for fixing the tube to the stomach wall so that the tube is not removed from the patient.

Whether sold as part of the gastrostomy catheter kit or not, the tube is used not only with intragastric fixation but also with extracorporeal fixation. This extracorporeal fixation device is provided in a portion of the tube that is to be located outside the body in the above-mentioned implanted state, and fixes the tube to the abdominal wall so that the tube is not buried in the stomach. The cooperative action of the extracorporeal fixation device and the intragastric fixation device makes it possible to position the tube relatively to the abdominal wall and the stomach wall.

After the tube has been inserted into the abdominal wall and the stomach wall and the gastrostomy is not completed at the insertion site, the stomach wall and the abdominal wall are mutually connected at the gastrostomy site. It is important that it be maintained in close contact with the object. If the stomach wall and the abdominal wall separate from each other at the site of gastrostomy, for example, acute peritonitis may be caused.

The aforementioned PEG is roughly classified into two. The first technique is to introduce a tube into the stomach through the patient's abdominal wall and stomach wall, which is called the introducer method. The second method is the pull method and the push method. In the second method, a guide wire is inserted into the stomach through the patient's abdominal wall and stomach wall, whether pulled or pushed, and then inserted into the stomach from the oral cavity and then out of the oral cavity into the stomach. The guide wire is pulled by the endoscope pulled out, so that the guide wire is pulled out of the oral cavity together with the endoscope. Thereafter, a tube is inserted into the stomach from the oral cavity using the guide wire.

However, the insertion of the tube into the stomach is performed by pulling the tube into the stomach by the guider in the pull method, whereas the tube is inserted in the stomach by the push method. By pushing it into the stomach. When the above-mentioned int-oral transducer is performed, the intragastric fixation tube can be inserted into the stomach from outside the body via a narrow fistula in the gastrostoma. It must be.

Conventionally, the gastric fixation device includes a balloon which is formed of a thin shell and can be inflated and deflated, and the fluid is supplied to and discharged from the balloon (eg, sterile distilled water). It was generally configured as a balloon type that selectively realizes inflation and deflation of the stomach 內 fixation device.

In contrast, when the above-described pull method or push method is performed, unlike the above-described introducer method, the intragastric fixation device and tube are externally passed through a narrow fistula. It is not necessary to insert it into the stomach Absent. Therefore, in this case, the intragastric fixation device is generally configured as a non-balloon type having a larger size and higher rigidity than the above-mentioned balloon.

If the intragastric fixation device is of a non-balloon type, the possibility of unintended deformation of the intragastric fixation device is small. Thus, it is unlikely that the stomach wall and abdominal wall will separate from each other at a time when it is important that the stomach wall and the abdominal wall adhere to each other at the site of gastrostomy.

On the other hand, if the gastric fixation device is of the balloon type, it may collapse unexpectedly due to damage such as rupture. If the intragastric fixation becomes deflated, it will be difficult to keep the stomach wall and abdominal wall in close contact, and complications such as acute peritonitis due to unplanned dissection of the stomach wall and abdominal wall will occur. May be triggered.

In other words, when the pull method or the push method is adopted, due to the high rigidity of the intragastric fixation, there is a small possibility that an unscheduled separation between the stomach wall and the abdominal wall may cause a complication such as acute peritonitis. There is an advantage.

However, implementing the pull method or push method has the following disadvantages. In the pull and push methods, the tube passes through the mouth and esophagus during gastrostomy. Since the oral cavity and the esophagus are culture media of the bacterial flora, if the pull method or the push method is performed, the tube is likely to be contaminated with bacteria when passing through the oral cavity and the esophagus. As a result, there is a high possibility that the gastrostomy site, or wound, of the patient will become infected with bacteria.

In contrast, when the introducer method described above is used, the wound does not have to pass through the medium of the oral and esophageal flora, and the wound may be infected with bacteria. small.

In other words, when performing the introducer method, the wound is susceptible to bacteria. The advantage is that the possibility of dyeing is small.

When performing the pull method or the push method, after the tube is implanted in the stomach, it is necessary to insert the endoscope into the stomach again from the oral cavity and confirm the position of the implanted tube. May be necessary. Therefore, when the pull method or the push method is performed, there are disadvantages that the procedure is complicated and the burden on the patient is large.

On the other hand, when the introducer method is performed, it is possible to confirm the insertion position when confirming the insertion of the tube with the endoscope. There is no need to reinsert the endoscope.

As is clear from the above description, there is a relationship between the pull method and the push method and the introducer method, in which one advantage is regarded as the other disadvantage, and PEG having no disadvantage is employed. There is still room to suggest.

U.S. Pat.Nos. 4,863,438, 4,944,732 and 5,248,302 disclose elastic deformation by external force. A possible non-balloon type intragastric fixation device, which is in a free state and protrudes radially outward from the tube, but in an external force acting state where an external force is applied. However, there is disclosed a device in which a projection area obtained by projecting the intragastric fixation coaxially with a tube is smaller than a projected state.

Specifically, according to the descriptions in these U.S. Patent Publications, when a tube is to be inserted into the stomach from outside the body via a gastrostoma, a rod-shaped obturator is placed inside or outside the tube. The tube is inserted until it reaches the gastric fixation device located at the distal end of the tube, and the obturator is further pushed in so that the gastric fixation device is coaxial with the tube. It is stretched elastically. Due to this stretching, the projected area of the intragastric fixation device is reduced.

Further, according to the prior art described in these US patent publications, the projection surface With the volume reduced, the tube is inserted into the stomach from outside the body via the gastrostoma together with the intragastric fixation device. After the insertion, the obturator is withdrawn from the tube, and accordingly, the intragastric fixture is restored to the overhang state, and as a result, the tube is prevented from being removed from the gastrostoma.

In the prior art, since the intragastric fixation device is non-balloon type, after the tube is implanted in the stomach, unlike the case of the balloon type, the intended function, namely, gastrostomy of the tube, is not achieved. There is no great possibility that the removal prevention function of preventing removal from the room will be impaired. Disclosure of the invention

However, all of these U.S. Patent Publications disclose techniques for inserting the above-mentioned tube and gastric fixation device from outside the body into the stomach through a gastrostomy already constructed in the patient. It does not disclose a technique for creating a gastrostoma in a patient using a tube and an intragastric fixation device.

That is, none of these U.S. Patents disclose the use of these tubes and intragastric fixation devices in accordance with the above-described int mouth ductor method.

It is proposed that the introducer method be performed simply using the tubes and intragastric fixation devices described in those patents. However, the proposal suggests that it is extremely difficult to properly construct a gastrostoma in a patient. Hereinafter, the reason is specifically described.

When a gastrostomy is to be constructed by the introducer method, a needle or the like is generally inserted into the abdominal wall and stomach wall of the patient at the tube insertion site where the tube should be inserted, at the start of the construction. Thus, a through-hole is formed through the abdominal wall and the stomach wall, and the stomach wall is fixed to the abdominal wall so that the stomach wall does not move with respect to the abdominal wall. In this state, the tube and the gastric fixation device are inserted into the stomach from outside the body via the above-mentioned through-hole, but it is actually difficult to completely fix the stomach wall to the abdominal wall. The stomach wall may move during surgery.

Therefore, if the insertion path of the tubes and the gastric fixation device is not appropriate in relation to the actual relative positions of the abdominal wall and the stomach wall, the tubes and the gastric fixation device are properly inserted into the stomach. I can't do that. As a result, gastrostomy cannot be properly constructed.

Against the background described above, the present invention provides a stomach that can be used to overcome the disadvantages of the conventional introducer method while enjoying the advantages of the conventional introducer method. The task was to provide a fistula catheter kit.

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

(1) A catheter / kit for gastrostoma used to introduce nutrients from outside the body into the stomach in an implanted state embedded in the stomach of a living body, wherein the nutrient passage introduces the nutrients from outside the body into the stomach. Is provided in a tube formed therein, and a portion of the tube that is to be located in the stomach in the above-mentioned implanted state, and the tube is fixed to the stomach wall so that the tube is not removed from the living body. An elastically deformable non-balloon type intragastric fixation device, which is in a protruding state in which the tube protrudes radially outward from the tube in a free state, but an external force in which an external force is applied. In the operating state, the projection surface area obtained by projecting the gastric fixation device coaxially with the tube is the overhang. And a hollow for transmitting the external force from outside the body to the intragastric fixture in the embedded state in the engaged state. A mouth pad having a passage in the mouth therein, and wherein the intragastric fixture connects the passage in the mouth to the space in the stomach in the engaged state. Gastrostomy catheter kit with a communication channel to allow

The catheter kit can be used for gastrostomy applications. As mentioned above, it is important for the gastrostomy to optimize the insertion path when inserting the tube and the gastric fixation device from outside the body into the stomach. Specifically, it is important that the holes formed in the skin, abdominal wall, and stomach wall of the living body are matched with each other before the tube is inserted, and the tube is inserted in that state.

On the other hand, in the catheter kit according to this section, a hollow rod is used to temporarily reduce the projected area of the intragastric fixation device, and a rod is provided inside the hollow rod. An internal passage is provided. In connection with this passage in the rod, a communication passage for connecting the passage in the mouth to the space in the stomach when the hollow rod is engaged with the intragastric fixation device is provided in the stomach. It is provided on the fixture.

Therefore, in the catheter kit according to this section, when the hollow rod and the intragastric fixture are engaged, that is, when the projected area of the intragastric fixture is reduced, the hollow rod and the intragastric fixation are used. It is possible to pass a continuous wire through the tool.

On the other hand, the wire can be configured as a guide wire. The guide wire is used by passing through a through-hole formed so as to penetrate the abdominal wall and the stomach wall with the start of gastrostoma construction. This guide * wire is used while being passed through the hollow rod and By guiding the empty rod, the tube is guided to be inserted into the stomach from outside the body through the through hole.

When the guide wire is passed through the through hole, a force is applied from the guide wire to the abdominal wall and stomach wall in a tangential direction (lateral direction) of the surface of the skin of the living body. The force causes the holes formed in the skin, abdominal wall, and stomach wall of the living body to line up along the guide wire before the tube is introduced into the stomach. The stabilization will be at the same time as the introduction route of the vehicle is optimized.

As is clear from the above description, in the catheter kit according to this section, a rod is provided for reducing the projected area of the intragastric fixation device by the operation of an operator located outside the body. When the rod is hollowed, a communication passage is provided in the intragastric fixation device, whereby the assembly of the tube, the intragastric fixation device, and the hollow rod is guided. It can be guided by the wire and inserted into the stomach from outside the body.

Furthermore, in the catheter kit according to this section, the intragastric fixation device is of a non-balloon type, so that the removal prevention function is not hindered by damage such as rupture. You.

Therefore, according to the catheter / kit according to this section, the advantage of the conventional mouth-ducer method, that is, the possibility that the wound is less likely to be infected with bacteria than the pull method and the push method is obtained. However, the disadvantage of the conventional introducer method, that is, the function of the gastric fixation device that originally prevents removal, is said to be impaired due to damage to the gastric fixation device. It is easier to overcome the disadvantages.

The catheter / kit according to this section can be used for the purpose of replacing the tube currently used with a new one after the gastrostoma is completed. In this application, the tube currently used is After removal, the tube is inserted into the stomach via a gastrostomy with a new catheter / kit, using a hollow rod to reduce the projected area of the intragastric fixture. At the time of this insertion, the use of the aforementioned guide wire is generally omitted.

In this section, “living body” can be defined to include humans, but can also be defined to include animals other than humans.

(2) In addition, the tube is provided in a portion of the tube that is to be located outside the body in the implanted state, and the tube is fixed to the abdominal wall so that the tube is not buried in the stomach. The gastrostoma according to (1), including a fixing device, and positioning the tube relative to the abdominal wall and the stomach wall by a cooperative action of the extracorporeal fixing device and the intragastric fixing device. Catheter kit.

According to the catheter kit, both an intragastric fixation device and an extracorporeal fixation device that cooperate with each other to position the tube with respect to the living body are provided.

(3) Further, a guide 'wire used through a through-hole formed so as to penetrate the abdominal wall and stomach wall of the living body with the start of gastrostoma construction in the living body. And is used while being passed through the passage in the rod and the communication passage, and in this state, the assembly of the tube, the gastric fixation device, and the hollow rod is passed through the passage. A guide that guides the assembly to be inserted into the stomach from outside the body via the through-hole by being guided. << Including the wire The gastrostomy described in (1) or (2) above Catheter 'kit.

According to this catheter 'kit', the presence of a guide 'wire through which the hollow rod passageway and the gastric fixation passageway together allow the intragastric passage Although the fixing device is a non-balloon type, it is easy to properly construct a gastrostoma in a living body by the introducer method. (4) The hollow rod is disposed on the outer side of the tube in the engaged state, and at the same time, applies a compressive force in a direction generally parallel to the gastric fixation device in the gastric space. And the intragastric fixation is elastically stretched coaxially by the transmitted compressive force, whereby the projection area is reduced (1) or (3). Catheter kit for gastrostoma according to [1].

(5) The hollow rod is disposed on the inner side of the tube in the engaged state, and at the same time, applies a compressive force in a direction generally parallel to the gastric fixation device in the gastric region. And the intragastric fixation is elastically stretched coaxially by the transmitted compressive force, thereby reducing the projection area. (1) to (3) A catheter kit for gastrostoma according to claim 1.

(6) The gastric fixation device has a hollow structure, and in the engaged state, the hollow gasket uses the transmitted compressive force of the gastric fixation device. The gastrostoma catheter 'kit according to (4) or (5), wherein the gastric anchor is engaged with a portion where the intragastric fixation device is to be stretched.

(7) The catheter kit for gastrostoma according to (6), wherein the site is a site facing the distal end of the hollow rod in the intragastric fixture.

(8) The intragastric fixation device includes an engaging portion to be engaged with a distal end portion of the hollow rod, and the communication passage is connected to the engaging portion. (1) ) The gastrostoma catheter 'kit according to any of the above items.

(9) The engaging portion includes a bottomed hole that receives the front end of the hollow port in abutting state, and the communication passage has a bottom surface at one end thereof and a bottom end at the other end thereof. The gastrostoma according to (8), wherein each of the gastric fistulas is opened on a surface of the gastric fixation device that comes into contact with the space in the stomach in the implanted state. Catheter and kit.

(10) A catheter for gastrostoma, wherein the catheter kit for gastrostoma according to any one of (1) to (9) is used for the purpose of constructing a gastrostoma in the living body. A method for using a kit, comprising: a guide to be passed through a through-hole formed so as to penetrate an abdominal wall and a stomach wall of the living body; A first step of communicating with the gasket, and applying the external force to the intragastric fixture by the hollow rod to reduce the projection area of the intragastric fixture. While the assembly of the tube, the intragastric fixation device, and the hollow rod is guided to the stomach wire, the assembly is inserted into the stomach from outside the body through the through hole, whereby the tube is inserted into the stomach. A second step of burying the hollow rod in the stomach fixture after the burying. Withdrawal, thereby restoring the intragastric fixture elastically to the overstretched state, and a third step of withdrawing the guide * wire out of the body. How to use catheters and kits.

According to this method, it is easy to appropriately construct a gastrostoma in a living body by the introducer method while the intragastric fixation device is a non-balloon type.

Therefore, according to this method, while enjoying the advantages of the conventional introducer method, that is, the possibility that the wound is infected with bacteria is smaller than that of the pull method and the push method, The drawback of the conventional introducer method is that the gastric fixation device's essential removal protection is impaired due to unexpected deformation of the gastric fixation device. It will be easier to overcome.

To perform this method, the combination of tube and intragastric fixation used to perform this method must be sold as a single gastrostomy catheter kit. Is not essential.

(11) The catheter for gastrostoma according to any of (1) to (9) A method for using a gastrostomy catheter kit for using the kit for nutritional supplementation to the living body, wherein the hollow force allows the external force to act on the intragastric fixture. In a state where the projected area of the intragastric fixture is reduced, the assembly of the tube, the intragastric fixture, and the hollow rod is inserted into the stomach from outside the body, and a gastrostoma previously constructed in the living body is inserted. A first step of burying the tube in the stomach, and after the burial, removing the hollow rod from the stomach fixture, whereby the stomach fixture is removed. And a second step of elastically restoring the protruded state to the overhang state.

According to this method, it is possible to perform tube replacement using a force catheter that can be used for both gastrostoma construction and tube replacement.

Therefore, according to this method, unlike the case where the tube is replaced by using a force catheter that can be used only for tube replacement, the parts of the catheter kit can be easily shared. For some reason, it is possible to replace tubes with a cheap power catheter kit. For the same reason, according to the method according to the above (10), inexpensive power kits can be used because the components of the cat kit can be easily shared. This makes it possible to construct a gastrostoma using

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view showing an assembled state of a catheter / kit for a gastrostoma according to a first embodiment of the present invention.

FIG. 2 is a front sectional view showing a part of the kit for gastrostoma catheter shown in FIG.

FIG. 3 is a perspective view for conceptually explaining a method of constructing a gastrostoma using the gastrostoma catheter kit shown in FIG. Figure 4 is a flowchart showing the gastrostomy procedure.

FIG. 5 is a front cross-sectional view for explaining how the guide wire 20 is inserted into the stomach during the implementation of the gastrostomy method of FIG.

FIG. 6 is a front sectional view showing a part of the gastrostoma catheter 'kit according to the second embodiment of the present invention in an assembled state and in a free state.

7 is a front sectional view showing the gastrostoma catheter 'kit' in FIG. 6 in an assembled state and in an externally acting state.

FIG. 8 is a flow chart showing a method of exchanging the tube 10 using the gastrostomy catheter kit shown in FIG. BEST MODE FOR CARRYING OUT THE INVENTION

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

FIG. 1 shows an assembled state of all the components of a gastrostomy catheter 'kit according to a first embodiment of the present invention, except for the hollow port and the extracorporeal fixing device. This gastrostomy catheter kit can be used to create a gastrostomy with the int-oral transducer in a patient as a living body, and to supply nutrition to the patient directly from outside the body into the stomach. Used for ぅ applications.

The gastrostomy catheter kit includes a tube 10, a non-balloon type intragastric fixture 12, a hollow rod 14 shown in a cross-sectional view in FIG. 2, and an extracorporeal fixture 16. It is configured to include the guide 'wire 20' shown in FIG. The tube 10 is, as is well known, used to introduce nutrients from outside the body into the stomach in an implanted state in the patient's stomach. Therefore, the tube 10 has a nutrition passage 11 therein.

The gastric fixation device 12 is provided in a portion of the tube 10 that is to be located in the stomach in the above-mentioned embedded state. In this embodiment The gastric fixation device 12 has the gastric fixation device 12 attached to the tip of the tube 10 _{c. The} gastric fixation device 12 has the tube 10 attached to the stomach wall so that the tube 10 is not removed from the human body. Performs a pull-out prevention function of fixing to

The gastric fixation device 12 is made of an elastically deformable material. As a result, the intragastric fixation device 12 is in a protruding state in which the tube 10 protrudes radially outward from the tube 10 in the free state, but is in the stomach in the external force acting state in which an external force is applied. The projected area obtained by projecting the fixture 12 coaxially with the tube 10 is reduced from the overhang state.

In the present embodiment, as shown in FIG. 2, the intragastric fixture 12 has a hollow structure that is open on the side opposite to the side where the tube 10 is mounted. Specifically, the intragastric fixation device 12 mainly has a thin-walled structure and a mushroom shape.

The intragastric fixation device 12 has a mounting structure with the tube 10, and the distal end portion of the tube 10 is substantially airtight and pulled out from an engagement portion 24 formed coaxially with the gastric fixation device 12. It has a structure that makes it impossible to fit.

An external force acting position at which the external force is to be applied is set in a portion of the intragastric fixture 12 facing the outside of the body in the implanted state. When a compressive force is applied as an external force to the tube 10 at the position where the external force acts in the direction from the rear end to the distal end of the tube 10, the intragastric fixture 12 becomes, as shown in FIG. It can be elastically deformed into a slender shape than the free shape.

Due to this elastic deformation, the projected area obtained by projecting the intragastric fixture 12 coaxially with the tube 10 is reduced, and as a result, the diameter of the hole through which the intragastric fixture 12 can pass is reduced. .

In contrast, the hollow rod 14 is removably engaged with its intragastric fixture 12 therefrom. The hollow rod 14 is in its engaged state In the implanted state, it functions to transmit the compressive force from outside the body to the intragastric fixation device 12.

As shown in FIG. 2, in the present embodiment, the hollow rod 14 is designed so as to be engaged with the intragastric fixation device 12 while being arranged outside the tube 10. Have been. Specifically, the hollow rod 14 is arranged at a position offset from the axis of the intragastric fixation device 12 coaxial with the tube 10 radially outward of the tube.

As shown in FIG. 2, an engagement portion 30 is formed in the intragastric fixture 12 at the position where the external force acts. The gastric fixation device 12 is engaged with the hollow rod 14 at the engagement portion 30. In the present embodiment, the engaging portion 30 is formed so as to have an engaging hole 32 that opens on the side of the hollow rod 14. The engagement hole 32 has a bottom portion 34.

The hollow rod 14 is fitted coaxially into the engagement hole 32 until the tip of the hollow rod 14 abuts against the bottom portion 34, whereby the engagement with the intragastric fixation device 12 is established. Is achieved. In this engaged state, a compressive force as an external force is transmitted to the bottom portion 34 of the intragastric fixture 12 via the hollow rod 14, and as a result, as shown in FIG. The intragastric fixture 12 is coaxially stretched.

On the other hand, when the hollow rod 14 is removed from the stomach fastener 12 and the engagement between them is released, a compressive force is applied to the intragastric fastener 12. The gastric fixation device 12 is restored to a free state by its own elasticity.

In addition, in the present embodiment, in the present embodiment, the free state of the intragastric fixture 12 and the projected area reduced state (that is, the elastic deformation state) are selectively realized by the elasticity of the intragastric fixture 12 itself. A plurality of structural members having no elasticity, and an elastic connecting mechanism for elastically connecting the plurality of members to each other (for example, a mechanism having a connecting function and an elastic force applying function) It is possible to implement the present invention by configuring the intragastric fixation device 12 so as to include the following. Such an intragastric fixture 12 can be referred to as a mechanical type.

As shown in FIG. 2, the hollow rod 14 has a rod passage 40 therein. Correspondingly, the intragastric fixture 12 has a communication passage 44.

The communication passage 44 is opened at a surface facing the hollow rod 14 and a surface facing the opposite side of the both surfaces of the bottom portion 34. As a result, when the hollow rod 14 is engaged with the intragastric fixture 12, the hollow rod 14 communicates from the extracorporeal space and the intragastric space through the intrarod passage 40. A continuous space extending to the passageway 4 4 is formed. The guide wire 20 passes through the continuous space.

At the rear end of the hollow rod 14, an operation unit 48 is provided. In the present embodiment, the operation portion 48 is formed as a projecting portion projecting radially outward from the hollow rod 14. The operation unit 48 is provided so that an operator can easily handle the hollow rod 14.

As shown in FIG. 1, the extracorporeal fixing device 16 is provided in a portion of the tube 10 that will be located outside the body in the embedded state. The position of the extracorporeal fixing device 16 in the axial direction with respect to the tube 10 is adjustable. The external fixture 16 serves to fix the tube 10 to the abdominal wall so that the tube 10 is not buried in the stomach. The tube 10 is then moved relative to the patient's abdominal wall 50 and stomach wall 52 (see FIG. 3) by the cooperative action of the extracorporeal fixture 16 and the intragastric fixture 12. The function of positioning is realized.

As shown in Fig. 3, the guide wire 20 is connected with the start of gastrostoma construction. It is used by penetrating through holes 54 formed so as to penetrate abdominal wall 50 and stomach wall 52.

This guide wire 20 is used while being passed through the intra-rod passage 40 of the hollow rod 14 and the communication passage 44 of the intragastric fixture 12 together. By guiding the assembly of the tube 10, the stomach fixing device 12, and the hollow rod 14 in the through state, the tube 10 can be inserted into the stomach from outside the body through the through hole 54. It has the function of guiding the insertion through the plug.

The structure of the gastrostomy catheter / kit has been described in detail above. Next, how to use the catheter will be described in detail. This gastrostomy catheter / kit is used for the purpose of gastrostomy in the present embodiment.

FIG. 4 is a flow chart showing a method of constructing a gastrostoma using a gastrostoma catheter kit.

In this method, first, in step S 1 (hereinafter simply referred to as “S 1”. The same applies to other steps), the worker is placed in the supine position. An endoscope is introduced into the stomach through the patient's mouth. In this state, the worker sends air through the lumen of the endoscope into the patient's stomach. Due to this air supply, the patient's stomach expands, and the abdominal wall 50 and the stomach wall 52 come into close contact with each other. In this S1, the worker further observes the transmitted light emitted from the inserted endoscope and transmitted through the stomach wall 52 and the abdominal wall 50, and by palpating the worker. Identify the tube insertion site in the abdominal skin where tube 10 should be inserted. This tube insertion site is a site where a patient's skin is locally incised, and is also a site where a gastrostoma is finally constructed.

Next, in S2, the worker disinfects the patient's skin, the identified tube insertion site and its surroundings. Subsequently, in S 3, the operator performs local anesthesia on the tube insertion site. Thereafter, in S4, the operator fixes the stomach wall 52 to the abdominal wall 50 in order to prevent the relative position of the stomach wall 52 from the abdominal wall 50 from being shifted due to peristaltic motion of the stomach. This fixation can be performed, for example, by suturing the stomach wall 52 and the abdominal wall 50 with a suture near the tube insertion site. This gastric wall fixation is released when it is no longer needed.

In the present embodiment, as described above, a gastrostoma is constructed by an introducer method using a gastrostoma catheter 'kit having a non-balloon-type intragastric fixture 12. A non-balloon type intragastric fixation device 12 is usually larger than a conventional balloon type intragastric fixation device.

Therefore, a gastrostomy catheter having an intragastric fixation device 12 that is not a balloon type is a balloon type when a gastrostomy is to be constructed by the introducer method using a kit. The tube 10 and the gastric fixation device 1 2 are different from the case where the gastrostoma is constructed by the introducer method using a gastrostomy catheter with a conventional gastric fixation device. It is important to be as cautious as possible.

That is, prior to insertion, the holes formed at the tube insertion site in the patient's skin, abdominal wall 50, and stomach wall 52 were made to coincide with each other, and the tube 10 and intragastric fixation device 1 were passed through the holes. It is important to introduce 2 into the stomach to optimize and stabilize the introduction path of tube 10.

In consideration of such circumstances, in the present embodiment, prior to the insertion of the assembly of the tube 10 and the gastrointestinal fixation device 12 into the stomach, the stomach wall 52 in S 4 is It is fixed to the abdominal wall 50.

Further, in this embodiment, as described later, prior to insertion of the tube 10 into the stomach, the patient's skin, abdominal wall 50 and stomach wall 52 are connected to the tube. In this case, guide wires 20 are passed through the holes formed respectively.

By this communication, a force is applied from the guide * wire 20 to the abdominal wall 50 and the stomach wall 52 in the tangential direction (lateral direction) of the surface of the patient's skin. Due to the force, the holes formed in the patient's skin and the abdominal wall 50 and the stomach wall 52 in line with the guide wire 20 before the tube 10 was introduced into the stomach. The holes are aligned so that the holes are aligned with each other prior to insertion of tube 10 into the stomach.

Thereafter, an assembly of the tube 10, the intragastric fixture 12, and the hollow rod 14 is inserted into the stomach through the holes while being guided by the guide wire 20.

As described above, in the present embodiment, deep consideration is given to the appropriateness and stabilization of the insertion path of the tube 10.

Thereafter, in S5, the operator locally incises the skin at the tube insertion site, and as a result, an opening is formed in the skin at the tube insertion site. In S5, the worker further inserts a hollow needle into the formed opening so as to penetrate the abdominal wall 50 and the stomach wall 52 in order. Thereby, a through hole 54 penetrating the abdominal wall 50 and the stomach wall 52 is formed. Subsequently, in S 6, the worker inserts the guide * wire 20 into the stomach via the lumen of the needle inserted into the formed through hole 54. The part of the guide * wire 20 outside the body is passed through the communication passage 44 of the intragastric fixture 12 and the passage 40 of the hollow rod 14. This can be done after the guide wire 20 has been inserted into the stomach or before it can be inserted, or in theory it can be done during the insertion. Noh.

In S6, after the guide wire 20 has been inserted, the operator removes the needle from the patient while leaving the guide wire 20. Thereafter, in S7, the operator performs a process on the patient to expand the diameter of the formed through hole 54. In this expansion process, for example, the dilator is inserted into the through hole 54 to be expanded while the guide wire 20 is inserted through the inner cavity of the dilator. In this case, after the through-hole 54 has been expanded, the operator removes the dilator from the patient. At this time, as shown in FIG. 5, the patient is in a state where only the guide wire 20 is passed through the expanded through hole 54.

Subsequently, in S8, the worker enters the tube 10 into the stomach through the through hole 54 using the hollow rod 14 and the guide wire 20. In this embodiment, prior to insertion, the hollow mouth 14 is engaged with the intragastric fixture 12, and the compressive force is transmitted to the intragastric fixture 12 via the hollow rod 14. As a result, the gastric fixation device 12 is deformed to an elongated shape.

Therefore, according to the present embodiment, despite the fact that the intragastric fixation device 12 is not of a balloon type, the patient is not pressed strongly in the through-hole 54, and the gastric fixation device 12 is not squeezed. It passes through the hole 54 and is inserted into the stomach.

In the present embodiment, prior to the introduction of the tube 10 into the stomach, the worker accidentally pulls the guide wire 20 into the stomach and accidentally pulls the guide wire 20 during the subsequent work. Ensure that it is placed in the stomach long enough to allow it to be withdrawn. Therefore, the guide wire 20 is not inadvertently removed from the patient during a series of operations for gastrostomy, and this prevents the guide wire 20 from being removed. Thus, the guiding function of the tube 10 is guaranteed.

In this state, the worker揷入the assembly of the tube 1 0 and intragastric fixture 1 2 along the guide 'Wai ya ² 0 and hollow Rod 1 4 intragastrically. I Therefore, the path of the insertion is properly maintained by the cooperative action of the guide wire 20 and the hollow tube 10 and the intragastric fixture 12.

If the tube 10 is thus partially implanted in the stomach, then, at S9, the operator removes the guide wire 20 from the patient. Subsequently, in S 10, the worker removes the hollow rod 14 from the tube 10 in the buried state. As a result, the gastric fixation device 12 is restored to the free state, and the gastric fixation device 12 is brought into a state in which the above-described removal prevention function can be exhibited.

Thereafter, in S11, the operator adjusts the external fixation device 16 on the tube 10 to an appropriate position, thereby connecting the intragastric fixation device 12 and the external fixation device 16 with each other. The joint positions the tube 10 relatively to the abdominal wall 50 and the stomach wall 52.

Thus, a series of operations for constructing a gastrostoma has been completed.

As is apparent from the above description, in the present embodiment, S 6 in FIG. 4 constitutes an example of the “first step” in the above (10), and S9 and S10 cooperate with each other to form an example of the "second step" in the same paragraph. In addition, if it is necessary to remove the tube 10 from the patient for replacement or the like, for example, it is necessary to remove the intragastric fixture 12 without the aid of the hollow rod 14. The tube 10 can be pulled out of the patient using elastic deformation.

Next, a second embodiment of the present invention will be described. However, in the present embodiment, there are elements common to the first embodiment. Therefore, detailed description of common elements will be omitted by quoting using the same reference numerals, and only different elements will be described in detail. I do.

In the first embodiment, as shown in FIG. 2, the hollow rod 14 is a tube. Although it is arranged at a position offset with respect to the tube 10, in this embodiment, as shown in FIG. 6, the hollow rod 70 is substantially coaxial with the tube 10. And it is arranged in the nutrition passage 11 of the tube 10. In the present embodiment, as shown in FIG. 6, the non-balloon type intragastric fixation device 74 has a hollow structure and has a first and a second It has portions 80 and 82.

The first portion 80 is formed with an engaging portion 84 to which the distal end of the tube 10 is irremovably engaged. The engaging portion 84 has a bottomed hole 86 for receiving the front end of the tube 10 in abutting state. A through hole 88 is formed at the bottom of the bottomed hole 86, and a hollow rod 70 is passed through the through hole 88.

On the other hand, the second portion 82 has an engaging portion 92 with which the distal end of the hollow rod 70 is removably engaged. The engaging portion 92 has a bottomed hole 94 for accommodating the front end portion of the hollow opening 70 in an abutting state. A through hole 96 is also formed at the bottom of the bottomed hole 94.

Therefore, in this embodiment, it is possible to apply a compressive force to the intragastric fixture 74 from the hollow rod 70, and the intragastric force is applied by the applied compressive force. The fixture 74 is elastically stretched. FIG. 7 shows that the intragastric fixture 74 is stretched, thereby reducing its projected area.

The gastric fixation device 74 has a communication passage 100 for allowing the nutrition passage 11 in the tube 10 to communicate with the space in the stomach via the space in the gastric fixation device 74.

By using the gastrostomy catheter / kit according to the present embodiment, a gastrostomy can be created in a patient by a new introducer method similar to that in the first embodiment, or the gastrostomy can be prepared in advance. Nutrition from outside the patient through the gastrostomy It is possible to inject into.

In addition, although not shown, the intragastric fixture 74 has an introduction portion such as a passage for introducing the enteral nutritional agent from the nutrition passage 11 into the stomach, an opening, and the like.

FIG. 8 is a flow chart showing a method of replacing the tube 10 by using the gastrostomy catheter / kit according to the present embodiment.

According to this method, first, in S51, the operator removes the extracorporeal fixture 16 from the tube 10 currently in use. Next, in S52, the worker puts a new catheter 'kit' and inserts the hollow rod 70 into the tube 10.

Subsequently, in S53, the operator pushes the hollow rod 70 deep into the tube 10 and thereby stretches the intragastric fixture 74 by compressive force. Thereafter, in S54, the operator inserts the assembly of the tube 10, the intragastric fixture 74, and the hollow rod 70 into the stomach from outside the body via the existing gastrostoma. .

If the tube 10 is partially implanted in the stomach in this way, subsequently, at S55, the operator removes the hollow rod 70 from the tube 10 force. Thereby, the intragastric fixture 74 is restored to the overhang state. Thereafter, in S56, the worker attaches the extracorporeal fixation device 16 to the tube 10, thereby fixing the tube 10 in the stomach in cooperation with the intragastric fixation device 74.

Thus, a series of operations for replacing the tube 10 is completed.

In addition, when replacing the tube 10, it is not necessary to use the passage 40 in the rod or the communication passage 100.

As is clear from the above description, in the present embodiment, FIG. S54 forms an example of the “first step” in the above (11), and S55 forms an example of the “second step” in the above section.

In addition, when it is necessary to remove the tube 10 according to the present embodiment from the patient, the operation is performed, for example, in a procedure reverse to the procedure of inserting the tube 10 into the stomach. It is possible to do with. In this case, the gastrointestinal fixture 74 of the tube 10 to be replaced will be stretched with the aid of the hollow rod 70, and the tube 10 will be stretched without the support. It is easier to reduce the pain given to the patient than in the case where it is removed.

In particular, in the present embodiment, when trying to remove the tube 10 already attached to the gastrostoma, the hollow rod 70 is connected to the intragastric fixture 74 via the lumen of the tube 10. Will be reached. Therefore, unlike the case where the hollow rod 70 is disposed outside the tube 10, it is not necessary to use the annular gap between the gastrostoma and the tube 10.

Therefore, according to the present embodiment, the operation of removing the tube 10 can be easily simplified with the support of the hollow rod 70.

As described above, some of the embodiments of the present invention have been described in detail with reference to the drawings. However, these are merely examples, and various modifications and improvements can be made based on the knowledge of those skilled in the art without departing from the gist of the present invention. It is possible to implement the present invention in another form in which the method is applied.

Claims

The scope of the claims

1. A gastrostomy catheter / kit used to introduce nutrition from outside the body into the stomach in an implanted state embedded in the stomach of a living body,

A tube in which a nutrition passage for introducing the nutrition from outside the body into the stomach is formed;

An elastically deformable tube that is provided in a portion of the tube that is to be located in the stomach in the above-mentioned implanted state and that fixes the tube to the stomach wall so that the tube is not removed from the living body. This is a non-balloon type intragastric fixation device, which is in a protruding state in which the tube protrudes radially outward from the tube in a free state, but in an external force acting state in which an external force is applied, A projection area obtained by projecting the intragastric fixation coaxially with the tube is smaller than the overhang state,

A hollow rod that is removably engaged with the intragastric fixture, and in the engaged state, transmits the external force from outside the body to the intragastric fixture in the implanted state; With a passage in the mouth

And a gastrostoma catheter kit, wherein the intragastric fixation device has a communication passage for connecting the intra-rod passage to a space in the stomach in the engaged state.

2. An extracorporeal fixation that is provided in a portion of the tube that will be located outside the body in the implanted state, and that fixes the tube to the abdominal wall so that the tube is not buried in the stomach. 2. The stomach according to claim 1, wherein the stomach is positioned relative to the abdominal wall and the stomach wall by a cooperative action of the extracorporeal fixing device and the intragastric fixing device. Fistula catheter kit.

3. With the start of gastrostoma construction in the living body, the abdominal wall of the living body And a guide wire that is used to pass through a through hole formed so as to penetrate through the stomach wall and the stomach wall, when the wire is used by passing through the intra-rod passage and the communication passage. In addition, by guiding the assembly of the tube, the intragastric fixation device, and the hollow rod in the inserted state, the assembly is inserted into the stomach from outside the body via the through hole. The catheter kit for gastrostoma according to claim 1, including a guide wire for guiding the catheter.

4. The hollow rod is disposed outside the tube in the engaged state, and applies a compressive force to the gastric fixture in a direction generally parallel to the gastric fixture. Communicate,

The gastrostoma catheter according to claim 1, wherein the intragastric anchor is coaxially elastically stretched by the transmitted compressive force, thereby reducing the projected area. G.

5. The hollow rod is disposed inside the tube in the engaged state, and applies a compressive force to the gastric fixture in a direction generally parallel to the gastric fixture. Communicate,

2. The gastrostoma catheter according to claim 1, wherein the intragastric fixation device is coaxially stretched by the transmitted compressive force, thereby reducing the projected area. G.