WO2003039383A1

WO2003039383A1 - Obturator for a catheter, length probe for determining the length of the stoma and set for enteral feeding

Info

Publication number: WO2003039383A1
Application number: PCT/EP2002/011991
Authority: WO
Inventors: Barbara Breuer-Thal; Bernd Wigginghaus; Arno Dormann
Original assignee: Fresenius Kabi Deutschland Gmbh
Priority date: 2001-11-08
Filing date: 2002-10-26
Publication date: 2003-05-15
Also published as: DE10154864A1

Abstract

The invention relates to an obturator (2) for a catheter (40), in particular a gastrostomy probe, comprising an upper piece (4) and a rod-like lower piece (6), which can be introduced into the catheter (40). The invention further relates to a length probe for determining the length of a stoma tract. Obturator (2) and length probe (16) are characterized in comprising a longitudinal channel (8). The longitudinal channel permits insertion of the catheter by means of the obturator or length probe on a guide wire introduced into the stoma tract, which gives a defined path for the introduction of the catheter or length probe, such that the gastrostomy probe may be securely positioned without injury, even with a non-ideally shaped stoma tract. Furthermore, The invention relates to a set comprising said obturator and length probe.

Description

Stylet for a catheter, length meter for determining the stoma length and

Set for enteral nutrition

The present invention relates to a stylet for a catheter, a length meter for measuring the stoma length and a set for enteral nutrition.

Different devices and sets for enteral nutrition are known from the prior art. These include, for example, the well-known PEG probes.

To insert a PEG probe, an endoscope or gastroscope is inserted into the patient's stomach and the stomach is unfolded by air insufiation. A cannula is then pushed through the abdominal wall and stomach wall into the stomach lumen. A guide thread is inserted through the cannula into the gastric lumen, grasped with the endoscope or gastroscope and pulled out again through the patient's esophagus and mouth. With the help of the guide thread laid in this way, the probe is then guided to the inside of the stomach and from there to the outside via the cannula. This procedure is also known as percutaneous endoscopically controlled gastrostomy (PEG).

After the stoma channel has been completely formed, the PEG probe is replaced by a gastrostomy probe, which is also referred to as a “button”.

EP 0 853 937 AI describes a gastrostomy probe for enteral nutrition, which has a support body that can be placed on the abdominal wall, from which a catheter tube with a supply channel for the nutrient solution can be found extends. To support the inner wall of the stomach, the catheter tube has a balloon that can be filled with liquid at its distal end. The catheter tube is inserted into the patient's stomach through the so-called stoma, an opening in the abdominal wall, until the support body rests on the abdominal wall, and the balloon is filled with liquid.

The company Fresenius AG, Bad Homburg, Germany, has launched the so-called Freka®-Button-Gastrostomy-Set. The known set comprises a stylet with an upper part which is designed as a handle part and a rod-shaped lower part which can be inserted into the catheter tube. Before the button is placed, the rod-shaped lower part of the stylet is inserted into the catheter tube to stiffen it, which considerably simplifies handling. The rod-shaped lower part has a crescent-shaped cross section, which corresponds to the inner cross section of the feed channel.

Before the catheter tube is inserted into the stoma canal, the stoma length must be measured. For this purpose, the known set comprises a length meter with a rod-shaped part which is provided with length markings. An expandable body is provided at the distal end of the rod-shaped part, with which the rod-shaped part can be supported on the inner wall of the stomach in the expanded state.

The set described above has proven itself in practice. The placement of the button proves to be difficult if the stoma canal is not ideal, which is the case with some patients. In addition, there is a risk that the ostomy canal will spontaneously close when the button is placed after the PEG probe has been removed by moving the abdominal wall layers.

The present invention is therefore based on the object of facilitating the installation of a gastrostomy probe even when the stoma channel is not ideally designed. This object is achieved with the features of claims 1, 4 and 6. Advantageous embodiments of the invention are the subject of the dependent claims.

The stylet according to the invention for a catheter for enteral nutrition, in particular a gastrostomy probe, has an upper part and a lower part. The upper part can be designed, for example, as a grip part which has a larger circumference than the lower part, so that the upper part also forms a stop element. The lower part is rod-shaped so that it can be inserted into the probe tube of the catheter. A longitudinal channel is formed in the upper and lower part, into which a guide wire is inserted, which is also referred to as a Seldinger wire. The stylet thus allows the gastrostomy tube to be installed using the well-known Seldinger technique. This means that the gastrostomy tube can be placed even if the stoma is uneven. If the catheter tube stiffened with the stylet is pulled over the Seidinger wire, there is no risk of the probe tip penetrating between the abdominal wall layers. Since the Seidinger wire prevents the abdominal wall layers from shifting towards each other, there is no risk of spontaneous occlusion of the stoma canal.

In a preferred embodiment, the rod-shaped lower part of the stylet has a section on the insertion side with a U-shaped cross section. The section on the insertion side means the section of the lower part facing away from the upper part. The longitudinal channel of the stylet is arranged between the legs of the U-shaped cross section. This embodiment is intended, for example, for those catheters whose probe tube has a filling channel in addition to the supply channel, the supply channel not having a circular cross section but a crescent-shaped cross section. This is the case, for example, with gastrostomy probes, which are balloon-like Have expansion body, which is filled with a fluid via a filling channel.

In a particularly preferred embodiment, the rod-shaped lower part of the stylet has a section facing the upper part with an annular cross section surrounding the longitudinal channel. This embodiment is intended for a catheter, the supply channel of which is closed at its proximal end by means of a valve, which can consist, for example, of two sealing lips that abut one another. These valves are also called duck bill valves. The section of the lower part facing the upper part, which holds the valve open, protects the valve against damage by the guide wire.

The length meter according to the invention for measuring the stoma length has a rod-shaped part with length markings, on which an expandable expansion body is provided, which can be supported on the inner wall of the stomach in the expanded state. Like the stylet according to the invention, the length meter has a longitudinal channel through which a guide wire can be passed, which facilitates the insertion of the length meter into the stoma channel and prevents the tip of the length meter from being inserted between the abdominal wall layers and thereby preventing tissue damage. Spontaneous occlusion of the stoma by the guidewire can also be avoided when measuring length.

In a further preferred embodiment of the length meter according to the invention, the rod-shaped part has a tubular rod, which surrounds the longitudinal channel and is slidably arranged in an outer tube which is connected to the distal end of the tubular rod. The outer tube has longitudinal slots distributed around the circumference, the length markings being provided on the outer tube. In this embodiment, the expansion body is formed by the regions of the outer tube lying between the longitudinal slots, which are located at bulging the rod radially outwards relative to the outer tube.

The set for percutaneous enteral nutrition comprises the stylet according to the invention and a guide wire, preferably a Seldinger wire.

A preferred embodiment of the set according to the invention further comprises the length meter according to the invention.

In a particularly preferred embodiment of the set according to the invention, a catheter is also provided which has a support body which can be placed on the abdominal wall, a catheter tube extending from the support body with a supply channel for supplying a nutrient solution and an expandable expansion body which is provided on the catheter tube and which is located in the catheter tube can support the expanded state on the inner wall of the stomach. The stylet can be inserted into the delivery channel of the catheter, the guide wire being able to be passed through the longitudinal channel of the stylet inserted into the delivery channel.

A valve is preferably provided in the supply channel of the catheter, which prevents leakage of the stomach contents.

In a particularly preferred embodiment of the set according to the invention, the valve in the supply channel can be opened by inserting the stylet. When the stylet is inserted, the valve is preferably held in the open position by the upper-part section with the annular cross section of the stylet.

In an advantageous embodiment, the expansion body of the catheter is designed as a fillable balloon, and a first connector part is also for Connection of a feed element, which is in flow connection with the supply duct, and a second connector part for connecting a filling element, which is in flow connection with the balloon via a filling duct, is provided. The feed element can be understood to mean, for example, the known transfer systems with hose lines and a container containing the nutrient solution. The filling element can be, for example, a plunger syringe through which a saline solution or the like is injected into the expansion body.

The invention is explained in more detail below with the aid of exemplary embodiments with reference to the attached figures.

Show it:

La to ld a side view of an embodiment of the set according to the invention for percutaneous enteral nutrition with the stylet according to the invention and the length meter according to the invention,

Fig. 2 is a side view of the catheter of the set according to the invention with an inserted stylet in a sectional view and

3 to 10 is a schematic representation of the procedure when applying the catheter.

The parts shown in FIGS. 1a to 1d together form an embodiment of the set for percutaneous enteral nutrition.

Fig. La shows the stylet 2 according to the invention for a gastrostomy probe (button). The stylet 2 has an upper part 4 and a lower part 6. The upper part 4 is designed as a grip part, so that it is easy to close with two fingers grab is. The lower part 6 is essentially rod-shaped, so that it can be inserted into the tube of the gastrostomy tube. A longitudinal channel 8 extends through the upper and lower part 4, 6, through which a guide wire (not shown), in particular a Seldinger wire, can be passed. The rod-shaped lower part 6 has a section 10 directly adjacent to the upper part 4, which has an annular cross section, as can be seen from the section along the section line AA in FIG. In the upper part 10, the longitudinal channel 8 is completely enclosed by the lower part 6 or formed within the same. The upper section 10 is followed by the insertion section 12, ie the section of the lower section 6 facing away from the upper section 4. The section 12 of the stylet 2 on the insertion side has a U-shaped cross section, as can be seen from the section along the section line BB in FIG. The longitudinal channel 8 is arranged between the two legs 14 of the U-shaped cross section.

1b shows the length measuring device 16 according to the invention for determining the stoma length. The length measuring device 16 has a first grip piece 18 and a second grip piece 20, the first grip piece 18 being arranged displaceably in a guide 22 of the second grip piece 20. A tubular rod 24 adjoins the first handle 18 and extends from the guide 22 through the second handle 20. An end piece 26 is arranged at the distal end of the tubular rod 24. The tubular rod 24 is surrounded by an elastic outer tube 28 which is fastened on the one hand to the end piece 26 and on the other hand to the second grip piece 20. The inner diameter of the outer tube 28 is selected such that the tubular rod 24 can be displaced in the longitudinal direction within the outer tube 28. In a lower section 30 of the outer tube 28, several longitudinal slots (not shown) are provided, so that the areas between the longitudinal slots bulge outwards when the first handle 18 together with the tubular rod 24 and the end piece 26 in the illustrated use position upwards is pulled. The areas between the longitudinal slots thus form the expansion body of the length meter 16.

The length meter 16 has a long channel 32 through which a guide wire can be passed. The longitudinal channel 32 is composed of several sections in the illustrated embodiment, i. H. it consists of a first channel 34 which extends through the first handle 18, a second channel 36 which is formed in the interior of the tubular rod 24, and a third channel 38 which extends through the end piece 26 at the distal end of the tubular rod 24 extends. The arrangement of the second channel 36 within the tubular rod 24 is particularly clear from the sectional view along the section line C-C in FIG. 1b.

1c shows the gastrostomy probe 40 (button) of the set according to the invention for percutaneous enteral nutrition. The catheter 40 has a support body 42 which can be placed on the abdominal wall of a patient (not shown) and from which a catheter tube 44 extends. A supply channel 46 for supplying nutrient solution is provided in the catheter tube 44 and in the support body 42. A first connector part 48 is provided in the end of the feed channel 46 on the support body, to which a feed element (not shown), such as a hose line coming from a bag with nutrient solution, can be connected. A valve is provided in the first connector part 48, which in the present embodiment is formed by two sealing lips 50, 52 which lie against one another in a sealing manner and which prevents the contents of the stomach from escaping. An expansion body 54 is provided on the catheter tube 44 and is shown in an expanded state in FIG. 1c. In the present embodiment, the expansion body 54 is designed as a fillable balloon.

In the support body 42, a second connector part 56 is provided, to which a filling element (not shown) can be connected. The second connector part 56 stands above a filling channel 58 which extends through the support body 42 and extends the catheter tube 44 in fluid communication with the interior of the balloon-shaped expansion body 54. As can be seen from the sectional diagram D-D, the filling channel 58 is arranged in the illustrated embodiment in the wall of the catheter tube 44, but it is also possible, for example, to form the filling channel within a further tube lying in the supply channel 46. In any case, the filling channel 58 requires that the supply channel 46 is narrowed and thus has a substantially crescent-shaped cross section (see DD). A further valve 60 is provided in the second connector part 56, which prevents the filling material (not shown) from flowing back out of the balloon-shaped expansion body 54 as long as the valve 60 is not opened from the outside.

On the support body 42, an elastic tab 62 is also attached, on which a plug 64 is arranged. After the catheter 40 has been properly attached and the nutrient solution has been introduced, the tab 62 can be pressed onto the support body 42 through the supply channel 46, as a result of which the sealing plug 64 reaches the first connector part 48 and additionally seals the sealing lips 50, 52.

FIG. 1d shows a schematic illustration of a guide wire 66 (Seldinger wire) which, in the embodiment shown, consists of a spiral spring which is thinly coated with plastic and which is closed at its ends 68.

The procedure for placing the gastrostomy probe 40 with the aid of the stylet according to the invention and the length meter according to the invention is explained in more detail below with reference to FIGS. 2 to 10. This is done, for example, using the procedure for replacing an already existing PEG probe with the catheter of the set according to the invention for percutaneous enteral nutrition. 3 shows the abdominal wall 70 of a patient, which comprises a plurality of abdominal wall layers 72, 74. A stoma duct 76 is formed in the abdominal wall 70, in which a PEG probe 78, which is to be exchanged, is arranged. Before the PEG probe 78 is removed, the guide wire 66 of the set according to the invention must first be inserted into the stoma 76 through the feed channel of the PEG probe 78.

The PEG probe 78 can then be removed endoscopically, so that, as can be seen in FIG. 4, only the guide wire 66 lies in the stoma 76. The guide wire 66 lying in the stoma 72 prevents a spontaneous closure of the stoma 76 by shifting the abdominal wall layers 72, 74 against one another and specifies a defined path.

Thereafter, the length meter 16 according to the invention is pushed onto the guide wire 66 (FIG. 5), which is possible due to the longitudinal channel 36 within the length meter 16. The length measuring device 16 is pushed into the stoma 76 until its distal end reaches the patient's stomach. The guidewire 66 defines a defined path so that insertion of the distal end between the abdominal wall layers 72, 74 prevents it.

After insertion of the length meter 16, its expansion body is expanded, which is done by pulling the first handle 18 out of the second handle 20 (FIG. 1b). After expansion, the expansion body is pulled up to the inner wall of the stomach (FIG. 6). The length of the stoma 76 can now be read using a length marking (not shown), which is provided in an area 80 above the area 30 on the outer tube 28 (FIG. 1b). Then the expansion body is reduced again in order to remove the length measuring device 16 again (FIG. 7). The guide wire 66 remains in the stoma 76 and thereby further prevents the same from spontaneously occluding. Thereupon the catheter 40, which was selected according to the determined stoma length, must be prepared for the import. For this purpose, the stylet 2 according to the invention is inserted into the supply channel 46 of the catheter 40, as shown in FIG. 2. The insertion-side section 12 of the stylet 2 stiffens the catheter tube 44 of the catheter, so that insertion into the stoma 76 is simplified. The stylet 2, however, does not completely fill the crescent-shaped cross section of the feed channel 46, rather the longitudinal channel 8 remains, as can be seen from the sectional view EE in FIG. 2.

Due to the longitudinal channel 8, the catheter 40 can be pushed onto the guide wire 66 (FIG. 8). The catheter 16 is advanced with the unexpanded expansion body 54 into the stoma 76 until its catheter tube 44 reaches the patient's stomach and the support body 42 rests on the abdominal wall 70. The guide wire 66 also defines a defined path during this insertion movement, so that insertion of the distal end of the stiffened catheter tube 44 between the abdominal wall layers 72, 74 is prevented.

Finally, the guide wire 66 (FIG. 9) and the stylet 2 can be removed (FIG. 10) and the expansion body 54 may be expanded by filling (FIG. 10), the latter serving to fasten the catheter 40. The sequence of the last-mentioned work steps is arbitrary, but it is advantageous to first fasten the catheter 40 before the stylet 2 and possibly also the guide wire 66 are removed.

Claims

claims

1. stylet for a catheter, in particular a gastrostomy probe, with an upper part (4) and a rod-shaped lower part (6) that can be inserted into the catheter, characterized in that a longitudinal channel (8) is formed by an upper and lower part (4, 6) extends through which a guide wire can be passed.

2. stylet according to claim 1, characterized in that the rod-shaped lower part (6) has an insertion-side section (12) with a U-shaped cross section.

3. stylet according to claim 2, characterized in that the rod-shaped lower part (6) has a section (10) facing the upper part (4) with an annular cross-section enclosing the longitudinal channel (8).

4. Length meter for measuring the length of an ostomy canal, which has a rod-shaped part with length markings, on which an expandable expansion body is provided which can be supported on the inner wall of the stomach in the expanded state, characterized in that the length meter has a longitudinal channel (32) which can be passed through a guide wire.

5. Length meter according to claim 4, characterized in that the rod-shaped part of the length meter has a tubular rod (24) which surrounds the longitudinal channel (32) and is slidably arranged in an outer tube (28) which is connected to the distal end of the tubular rod (24) is connected and has circumferentially distributed longitudinal slots, the length markings being provided on the outer tube (28).

6. Set for enteral nutrition with a stylet according to one of claims 1 to 3 and a guide wire (66), preferably a Seldinger wire.

7. Set for enteral nutrition according to claim 6, characterized in that the set further comprises a length meter (16) according to one of claims 4 or 5.

8. Set for enteral nutrition according to one of claims 6 to 7, characterized in that a catheter (40), in particular a gastrostomy probe, with

a support body (42) which can be placed on the abdominal wall,

a catheter tube (44) extending from the support body (42) with a supply channel (46) for supplying a nutrient solution, and

an expandable expansion body (54) provided on the catheter tube (44), which can be supported on the inner wall of the stomach in the expanded state,

The stylet (2) can be inserted into the feed channel (46) and the guide wire (66) can be guided through the longitudinal channel (8) of the stylet (2) inserted into the feed duct (46).

9. Set for enteral nutrition according to claim 8, characterized in that a valve (50, 52) is provided in the supply channel (46), which prevents leakage of the stomach contents.

10. Set for enteral nutrition according to claim 9, characterized in that the valve (50, 52) in the supply duct (46) by inserting the stylet (2) is evident.

11. Set for enteral nutrition according to one of claims 9 or 10, characterized in that the valve (50, 52) in the supply channel (46) with an inserted stylet (2) through the upper part section (10) with the annular cross section in the open Position is durable.

12. Set for enteral nutrition according to one of claims 8 to 11, characterized in that the expansion body (54) is designed as a fillable balloon and a first connector part (48) for connecting a supply member which is in flow connection with the supply channel (46) , and a second connector part (56) for connecting a filling element, which is in flow connection with the balloon via a filling channel (58), are provided.