JP2001522664A - Fixing device for fixing percutaneously laid tubes - Google Patents

Abstract

(57) [Summary] The fixation device (10) is laid in the percutaneous endoscopic gastrostomy (PEG) so as to penetrate the abdominal wall (14) or percutaneously at another place. It serves to fix the tube (10) or another catheter in place. For this purpose, a mounting plate (18) is provided, which has a support wall (20) on which the tube (10) is mounted. Is done. The fixing is performed by folding and turning the turning bracket (23), and the turning bracket (23) is locked in the closed position. At this time, the tube protruding from the abdominal wall is bent by 90 ° without changing the tube cross section.

Description

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a fixing device for fixing a percutaneously laid tube to the skin, wherein a mounting plate is provided, and the mounting plate has a hole for penetrating the tube. And adapted to deflect the tube exiting the skin by about 90 °.

A fixing device of this type is known from WO 94/08648. Such fixation devices are primarily used for percutaneous endoscopic gastrostomy (
percutan. endoskopisch kontrolliert. G
Astrostomie (PEG) and serves to fix the transdermal probe. In percutaneous endoscopic gastrostomy, for example as described in German Utility Model 91 12 338, a tube is drawn into the gastric lumen through the cardia through a hole in the abdominal wall and then The retaining member provided on the tube comes into contact with the inner wall of the stomach, and the tube is percutaneously advanced from the stomach. The tube acts as a sonde for enteral feeding, for example. This tube requires a position fixation outside the abdominal wall to avoid any unintended consequences.

[0003] An anchoring device such as is known from WO 94/08648 has a mounting plate, which is provided with a hole for the passage of a tube and which is provided with a patient. It is applied to the abdominal wall. A support wall protrudes from the mounting plate, and the support wall is provided with an open groove having a semicircular cross section at a peripheral edge thereof. The groove has a first area extending perpendicularly to the mounting plate and the first area.
And a second area extending in parallel with the mounting plate and continuing in an arc in the area. It is thus achieved that the tube first exits the patient body vertically, but is then deflected parallel to the skin surface.

[0004] The mounting plate in both areas is provided with a firmly integrated presser which closes the circumference of the groove and forms an eyelet with the groove.
The tube must be threaded through this eyelet. This known locking device has the disadvantage that the cross section of the tube is changed after the tube has been inserted into the locking device.

It is an object of the present invention to enable a simple introduction of the tubes and an easy movement of the tubes in order to adapt to the individually given conditions, but nevertheless to guide the tubes at right angles without crushing or bending. An object of the present invention is to provide a fixing device that can be fixed to a vehicle.

This object is achieved by the features of the characterizing part of claim 1.

In the fixing device according to the invention, the presser for pushing the tube into the groove in the support wall consists of a pivot bracket, which is pivotally connected to the mounting plate and about a specific axis. Can be turned. A hole for penetrating the tube is provided between the pivot bracket axis and the support wall. Therefore,
The pivot bracket can be pivoted in the longitudinal direction of the tube. With the pivot bracket pivoted upwards, the tube passes straight through the mounting plate. When the pivot bracket is pivoted downward, the tube is gripped by the pivot bracket and bent along the periphery of the support wall. Therefore, the mounting plate can be easily moved in the longitudinal direction of the tube while the turning bracket is open,
The position can be adjusted. However, when the turning bracket is turned downward, the position of the tube is fixed. Since this position fixation is based exclusively on the stress in the tube material, the cross section of the fixed tube is not changed. In particular, no bending or crushing takes place. This is an important prerequisite for obtaining an optimal flow rate of the food supplied through the tube.

Another advantage of the present invention is that the fixation device allows for one-handed operation. This is because the mounting plate can be easily moved with the pivot bracket opened, and the pivot bracket can be pushed down with one hand and locked.

In an advantageous embodiment of the invention, the mounting plate is made of a soft-elastic material, whereas the pivot bracket is made of a rigid material. The soft-elastic material of the mounting plate allows a “skin-friendly” contact of the mounting plate with the skin, while at the same time it can be used as a locking device for holding the pivot bracket.

The swivel bracket has an integrally formed passage which, when the swivel bracket is closed, complements the groove provided in the support wall to form a circular tubular cross section. Advantageously. In this way, through the 90 ° deflection of the tube, a closed tubular cross section of the peripheral surface is formed, such a tubular cross section being molded around the entire tube. Thus, even if a tensile force is applied to the tube, bending of the tube is reliably avoided.

It is advantageous if the mounting plate has a substantially triangular shape and forms a triangular wing which projects laterally from the support wall. Advantageously, the penetration of the sonde is located near the base of this triangle. As a result, a very uniform pressure distribution is achieved, so that local surface pressures are avoided. Thereby, optimal wearing comfort is obtained. This is important. This is because the fixation device can also be used for tube sondes that work for enteral long-term nutrition, that is, tube sondes that are used for a relatively long time. Furthermore, plaster fixation is also possible.

The subject of the present invention is also a gastrostomy set comprising a tube having a retaining member and a fixation device. In the configuration of the present invention, the pivot bracket and the tube of the fixing device are coordinated with each other so that the tube is not crushed or bent or the cross section of the tube is not changed while the pivot bracket is closed. I have.

In the following, embodiments of the present invention will be described in detail with reference to the drawings.

In FIG. 1, a tube 10 is provided as an enteral feeding sonde. The tube 10 has a disc-shaped retaining member 11 at one end and a thread loop 13 at the other end 12. The tube 10 is introduced into the stomach through the esophagus, with the end 12 in front, and then a pre-perforated abdominal wall 14, anterior stomach wall 15 by a guide thread which is tied to a thread loop 13. Through the distal (dis
tal) so that the end 12 of the tube 10 can be pulled out of the patient's body. At this time, the retaining member 11 is applied to the inside of the anterior stomach wall 15.

In order to fix the position of the tube 10, a fixing device 16 works. This fixing device 1
6 is applied to the skin 17 of the patient from the outside.

The fixing device 16 has a mounting plate 18, which has a substantially equilateral triangular shape. In this case, each corner (apex) of the triangle is rounded. . The mounting plate 18 has a hole 19 through which the tube 10 passes. Through this hole 19, the end 12 of the tube 10 is first inserted,
The mounting plate 18 is then moved along the tube 10 until its lower surface contacts the skin 17.

A support wall 20 that stands up and protrudes is integrally formed with the mounting plate 18.
A groove 21 extending in the longitudinal direction is provided on the upper surface of the support wall 20. The groove 21 has a semicircular cross section and serves to accommodate one circumferential half of the tube 10. As shown in FIG. 3, the groove 21 is formed in the hole 1 while drawing an arc at the curved portion 22.
It extends to nine. The tube 10 that has advanced from the hole 19 is supported by the support wall 2 at the curved portion 22.
It is bent by 90 ° along the circumference of 0 and then extends in the groove 21 parallel to the mounting plate 18.

A turning bracket 23 is supported by the mounting plate 18 so as to be turnable about a shaft 24. The hole 19 is located between the shaft 24 and the support wall 20. Axis 2
Numeral 4 designates lateral attachments provided on the swivel bracket 23 which project into corresponding cutouts provided in the side portions 25 provided on the mounting plate 18. . The side portion 25 is a raised portion provided side by side on the support wall 20. In this case, between the support wall 20 and each ridge or side portion 25,
A groove 26 (FIG. 5) is provided.

The pivot bracket 23 has the shape of an elongated blade having two parallel side edges 27 and an arc-shaped curved central portion 28 joining the two side edges 27. The side edges 27 are each provided with laterally projecting locking elements 29 which, when the pivot bracket 23 is pressed into the closed position shown in FIG. Each of them protrudes into a notch provided in the side part 25 and is locked. The turning bracket 23 has a semicircular passage 30, which corresponds to the groove 21 provided in the support wall 20. The passage 30 is formed by the groove 21
To form a circular tubular cross-section for receiving the tube 10. Since this passage 30 also extends through the bend area of the pivot bracket 23 which is located opposite the bend 22, the tube 10 is formed so as to be entirely surrounded by a 90 ° bend. The tubular cross section formed from the molded cross section of the groove 21 and the molded cross section of the passage 30 exactly matches the outer cross section of the tube 10, so that the tube 10 is completely accommodated. The fixing of the position of the tube 10 is performed based on the bending of 90 ° and the friction generated at the bent portion.

By putting a hand under the attached portion 31 protruding from the end of the turning bracket 23, the closed turning bracket 23 can be turned upward toward the open position. Due to such an opening force, the locking elements 29 are pushed out of the notches accommodating these locking elements 29. On the other hand, swivel bracket 2
The swivel bracket 23 can be locked to the mounting plate 18 simply by pressing down the 3.

The mounting plate 18 is advantageously made of a soft elastic material. On the other hand, it is advantageous if the pivot bracket 23 is made of hard plastic or viscoelastic plastic.

As can be seen from FIG. 4, the mounting plate 18 has a triangular basic contour shape. On both sides of the swing bracket 23, triangular wings 33 project. In these wings 33, the mounting plate 18 is formed very thin and is therefore also flexible. These wings 33 can be adhered to the patient's skin using plaster. In the area of the wings 33, sharp corners are avoided, so that a uniform pressure distribution is obtained without the danger of sharp indentations. The hole 19 is located between the center point of the mounting plate 18 and the base opposite the bent tube 10, ie the hole 19 is offset towards this base.

After the tube 10 has been laid as described with reference to FIG.
6 is passed along the tube 10 and applied to the skin 17. By moving the locking device 16 along the tube 10, an appropriate distance between the locking device 16 and the retaining member 11 can be adjusted. For this purpose, the tube 10 is provided with a length marking (not shown). Thereafter, the fixing device 16 is fixed by turning the turning bracket 23 downward. Finally, the fixation device 16 is fixed to the patient's body using a bandage. If necessary, the pivoting bracket 23 can be reopened and the care and / or post-adjustment of the fixation device 16 can be performed.

[Brief description of the drawings]

FIG. 1 is a perspective view showing a fixing device before it is fixed to a tube that percutaneously penetrates an abdominal wall.

FIG. 2 is a diagram viewed from the direction of arrow II in FIG.

FIG. 3 is a cross-sectional view of the fixing device taken along a line III-III in FIG. 2 in a state in which a swing bracket is closed;

FIG. 4 is a plan view of a fixing device.

5 is an end view of the fixing device seen from the direction of arrow VV in FIG. 3;

[Explanation of symbols]

10 tube, 11 retaining member, 12 end, 13 thread loop,
14 abdominal wall, 15 anterior stomach wall, 16 fixation device, 17 skin, 18 mounting plate, 19 holes, 20 support wall, 21 groove, 22 curved part, 2
3 swing bracket, 24 axle, 25 side part, 26 groove, 27 side edge, 28 central part, 29 locking element, 30 passage, 31 attachment part, 33 airfoil

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] October 15, 1999 (1999.10.15)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Name of invention

[Correction method] Change

[Correction contents]

Patent application title: Gastrostomy set for percutaneous endoscopic gastrostomy

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] 0001

[Correction method] Change

[Correction contents]

The present invention relates to a gastrostomy set for percutaneous endoscopic gastrostomy, which comprises a tube having a retaining member and a tube for fixing the percutaneously laid tube to the skin. A fixing device and a mounting plate are provided, and the mounting plate has a hole for penetrating the tube, and a support wall provided subsequent to the hole, and the support wall has A groove for accommodating a part of the tube circumference and bending the tube substantially parallel to the mounting plate, and further provided with a retainer, which retains the tube in the groove. The presser foot comprises a pivot bracket, the pivot bracket being pivotable about a transversely extending axis perpendicular to the support wall, and wherein the hole is formed between the pivot bracket axis and the support bracket. Located between the wall Regarding the format.

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] 0002

[Correction method] Change

[Correction contents]

[0002] Fixing devices of the type described above are generally known from WO 94/08648. Such fixation devices are firstly known as percutaneous endoscopic gastrostomy (percutan. Endoskopisch control).
iert. Used in Gastrostomie (PEG) to help position the transdermal probe. For example, German Utility Model 91123
In the percutaneous endoscopic gastrostomy procedure described in document 38, a tube is drawn into the gastric lumen through the cardia through a hole in the abdominal wall, and then a detent provided on the tube. The member contacts the stomach lining and the tube percutaneously exits the stomach. The tube acts as a sonde for enteral feeding, for example. This tube requires a position fixation outside the abdominal wall to avoid any unintended consequences.

[Procedure amendment 5]

[Document name to be amended] Statement

[Correction target item name] 0003

[Correction method] Change

[Correction contents]

[0003] An anchoring device such as is known from WO 94/08648 has a mounting plate, which is provided with a hole for the passage of a tube and which is provided with a patient. It is applied to the abdominal wall. A support wall protrudes from the mounting plate, and the support wall is provided with an open groove having a semicircular cross section at a peripheral edge thereof. The groove has a first area extending perpendicularly to the mounting plate and the first area.
And a second area extending in parallel with the mounting plate and continuing in an arc in the area. It is thus achieved that the tube first exits the patient body vertically, but is then deflected parallel to the skin surface.

[Procedure amendment 6]

[Document name to be amended] Statement

[Correction target item name] 0004

[Correction method] Change

[Correction contents]

[0004] The mounting plate in both areas is provided with a firmly integrated presser which closes the circumference of the groove and forms an eyelet with the groove.
The tube must be threaded through this eyelet. This known locking device has the disadvantage that the cross section of the tube is changed after the tube has been inserted into the locking device. In addition, catheter clamping devices are known (GB 2288542). This known catheter clamping device comprises a mounting and holding plate for accommodating a catheter tube and a presser formed as a pivot bracket. The tube can be fixed in position by using the presser. The pivot bracket is pivotable about a unique axis, with the tube extending between the axis and the mounting plate. In this case, the pivot bracket is pivotable about said axis such that the tube is clamped by the pivot bracket while the pivot bracket is pivoted inward. However, a failure-free use of the tube is not guaranteed, since this may reduce the cross-section of the tube at the clamping point. Furthermore, plaster bandages for fixing drainage tubes are known (WO 97/21459).
. The plaster bandage has a flat bandage part, which is provided with a receiving part for receiving and guiding the drainage tube. The drainage tube is secured to the retaining portion and the flat bandage by adhesive tape.
In the simplest case, the receiving part is formed by two guide strips provided on a flat bandage part which are spaced from one another. The drainage tube can be accommodated between the two guide strips. In another embodiment, the retaining part is formed by a separate molded part, which is fixed to a flat bandage. A disadvantage of this known plaster dressing is that the drainage tube must be secured to the flat dressing section by a separate adhesive tape.
This cannot be said to be a secure position fixation. Further, in a known liquid drainage device (U.S. Pat. No. 4,659,329), a groove-shaped catheter tube accommodating passage is built in a container that can be closed using a cover. The catheter tube accommodating passage accommodates the drainage tube supplied from the lower side of the container, and turns the drainage tube from a vertical position to a horizontal position. For this purpose, the guideway has a tube turning portion, by which the position of the tube is turned by approximately 90 °. Then, the catheter tube is fixed to the tube turning portion by the closed swiveling of the cover. Apart from the relatively high construction effort which is caused in this connection, furthermore, the fixing of the tubes in the tube turning section takes place only in the area of the cover's application to the tube turning section. In other areas, the catheter tube is not properly guided. Therefore, the known device is not suitable for use for percutaneous endoscopic gastrostomy.

[Procedure amendment 7]

[Document name to be amended] Statement

[Correction target item name] 0005

[Correction method] Change

[Correction contents]

[0005] Furthermore, holding devices for the intravenous administration of drugs are already known (US Pat.
No. 5,179,971). In this known holding device, a holding plate is provided with guide rings spaced apart from one another. A drug tube can be wound around these guide rings, which can then be fixed in position by a cover attached to the holding plate. The tube then extends at an acute angle to the holding plate. The holding plate holds an adhesive tape on its lower surface, with which the holding plate can be fixed to the patient's skin. This known device is also not suitable for percutaneous endoscopic gastrostomy.

[Procedure amendment 8]

[Document name to be amended] Statement

[Correction target item name] 0006

[Correction method] Change

[Correction contents]

An object of the present invention is to enable a simple introduction of the tubes and an easy movement of the tubes in order to adapt to the individually given conditions, but nevertheless to guide the tubes at right angles without crushing or bending. The purpose of the present invention is to provide a gastrostomy set which can be fixed to a gastrostomy.

[Procedure amendment 9]

[Document name to be amended] Statement

[Correction target item name] 0007

[Correction method] Change

[Correction contents]

According to the present invention, in a gastrostomy set of the type described at the outset, the swivel bracket and the tube are arranged such that the cross section of the tube is not changed when the swivel bracket is closed. It is solved by being harmonized with each other.

[Procedure amendment 10]

[Document name to be amended] Statement

[Correction target item name] 0008

[Correction method] Change

[Correction contents]

[0008] In the gastrostomy set according to the present invention, the presser for pushing the tube into the groove of the support wall includes:
It consists of a pivot bracket, which is pivotally connected to the mounting plate and can be pivoted about its own axis. A hole for penetrating the tube is provided between the pivot bracket axis and the support wall. Therefore, the turning bracket can be turned in the longitudinal direction of the tube. With the pivot bracket pivoted upwards, the tube passes straight through the mounting plate. When the pivot bracket is pivoted downward, the tube is gripped by the pivot bracket and bent along the periphery of the support wall. Therefore, the mounting plate can be easily moved in the longitudinal direction of the tube to adjust the position while the turning bracket is open. However, when the turning bracket is turned downward, the position of the tube is fixed. Since this position fixation is based exclusively on the stress in the tube material, the cross section of the fixed tube is not changed. In particular, no bending or crushing takes place. This is an important prerequisite for obtaining an optimal flow rate of the food supplied through the tube.

[Procedure amendment 11]

[Document name to be amended] Statement

[Correction target item name] 0009

[Correction method] Change

[Correction contents]

Another advantage of the present invention is that the fixation device allows for one-handed operation. This is because the mounting plate can be easily moved with the pivot bracket opened, and the pivot bracket can be pushed down with one hand and locked.

[Procedure amendment 12]

[Document name to be amended] Statement

[Correction target item name] 0010

[Correction method] Change

[Correction contents]

In a preferred embodiment of the invention, the mounting plate is made of a soft elastic material, and the pivot bracket is made of a relatively rigid or viscoelastic plastic. The soft-elastic material of the mounting plate allows a “skin-friendly” contact of the mounting plate with the skin, while at the same time it can be used as a locking device for holding the pivot bracket.

[Procedure amendment 13]

[Document name to be amended] Statement

[Correction target item name] 0011

[Correction method] Change

[Correction contents]

The swivel bracket has an integrally formed passage which, when the swivel bracket is closed, complements the groove provided in the support wall to form a circular tubular cross section. Advantageously. In this way, through the 90 ° deflection of the tube, a closed tubular cross section of the peripheral surface is formed, such a tubular cross section being molded around the entire tube. Thus, even if a tensile force is applied to the tube, bending of the tube is reliably avoided.

[Procedure amendment 14]

[Document name to be amended] Statement

[Correction target item name] 0012

[Correction method] Change

[Correction contents]

Advantageously, the mounting plate has a substantially triangular shape and forms a triangular wing that projects laterally from the support wall. Advantageously, the penetration of the sonde is located near the base of this triangle. As a result, a very uniform pressure distribution is achieved, so that local surface pressures are avoided. Thereby, optimal wearing comfort is obtained. This is important. This is because the fixation device can also be used for tube sondes that work for enteral long-term nutrition, that is, tube sondes that are used for a relatively long time. Furthermore, plaster fixation is also possible.

[Procedure amendment 15]

[Document name to be amended] Statement

[Correction target item name] 0013

[Correction method] Change

[Correction contents]

In the following, embodiments of the present invention will be described in detail with reference to the drawings.

[Procedure amendment 16]

[Document name to be amended] Statement

[Correction target item name] 0014

[Correction method] Change

[Correction contents]

In FIG. 1, a tube 10 is provided as an enteral feeding sonde. The tube 10 has a disc-shaped retaining member 11 at one end and a thread loop 13 at the other end 12. The tube 10 is introduced into the stomach through the esophagus, with the end 12 in front, and then a pre-perforated abdominal wall 14, anterior stomach wall 15 by a guide thread which is tied to a thread loop 13. Through the distal (dis
tal) so that the end 12 of the tube 10 can be pulled out of the patient's body. At this time, the retaining member 11 is applied to the inside of the anterior stomach wall 15.

[Procedure amendment 17]

[Document name to be amended] Statement

[Correction target item name] Brief description of drawings

[Correction method] Change

[Correction contents]

[Brief description of the drawings]

FIG. 1 is a perspective view showing a gastrostomy set including a fixing device in a state before the fixing device is fixed percutaneously to a tube penetrating an abdominal wall.

FIG. 2 is a diagram viewed from the direction of arrow II in FIG.

FIG. 3 is a cross-sectional view of the fixing device taken along a line III-III in FIG. 2 in a state in which a swing bracket is closed;

FIG. 4 is a plan view of a fixing device.

FIG. 5 is an end view of the fixing device as viewed from the direction of arrow VV in FIG. 3;

[Description of Signs] 10 tube, 11 retaining member, 12 end, 13 thread loop,
14 abdominal wall, 15 anterior stomach wall, 16 fixation device, 17 skin, 18 mounting plate, 19 holes, 20 support wall, 21 groove, 22 curved part, 2
3 swing bracket, 24 axle, 25 side part, 26 groove, 27 side edge, 28 central part, 29 locking element, 30 passage, 31 attachment part, 33 airfoil

Claims (7)

[Claims] 1. A fixing device for fixing a percutaneously laid tube (10) to a skin (17), comprising a mounting plate (18), wherein the mounting plate (18) is provided. ) Has a hole (19) for penetrating the tube (10) and a support wall (20) provided following the hole (19), and the support wall (20).
Has a groove (21) for accommodating a part of the tube circumference and bending the tube substantially parallel to the mounting plate (18), and further provided with a presser, which presses the tube. In the form of holding in a groove (21), the presser comprises a pivoting bracket (23), which extends in a transverse direction perpendicular to said support wall (20). It is pivotable about an axis (24), the hole (19) being arranged between the axis (24) of the pivot bracket (23) and the support wall (20). A fixing device for fixing a percutaneously laid tube. 2. The fixing device according to claim 1, wherein the mounting plate (18) is made of a soft elastic material, and the pivot bracket (23) is made of a rigid viscoelastic material. 3. The swivel bracket (23) has an integrally formed passage (30), and with the swivel bracket (23) closed, the passage (30) is
3. The fixing device according to claim 1, wherein the support wall (20) complements a groove (21) provided in the support wall (20) to form a circular tubular cross section. 4. The swivel bracket (23) has a locking element (29) which, with the swivel bracket (23) closed, holds the locking element (29).
4. The fixing device according to claim 1, wherein the locking device is adapted to engage a locking element provided on the mounting plate (18). 5. 5. A mounting plate (18) is provided on both sides of said support wall (20) with grooves (5).
26), and the side edge (27) of the swing bracket (23) is provided in the groove (26).
) Are adapted to engage, respectively. 6. A mounting plate (18) having a substantially triangular shape, forming a triangular wing (33) laterally projecting from said support wall (20), and said hole ( 19) is the center point of the mounting plate (18) and the mounting plate (18).
2, between the support wall (20) and a bottom side opposite to the support wall (20).
The fixing device according to any one of claims 1 to 5, wherein 7. Percutaneous endoscopic gastrostomy with a tube (10) having a retaining member (11) and a fixation device according to any one of claims 1 to 6. In the gastrostomy set of the present invention, the turning bracket (2) is kept so that the cross section of the tube (10) cannot be changed in a state where the turning bracket (23) is closed.
A gastrostomy set for percutaneous endoscopic gastrostomy, characterized in that 3) and the tube (10) are coordinated with each other.