LU84341A1 - IMPROVEMENT ON SURGICAL DEVICES - Google Patents

Description

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This invention relates to a guide device for insertion, especially for tunneling catheters.

The introduction of a tubular surgical device, such as cannulas or catheters in body cavities, always carries a high risk of infection at the point of entry or exit of the device from the tissue. A wound is created here that allows the bacteria direct access to the bloodstream. The risk increases if the device has to remain in situ for a long time, e.g. For weeks or months, as always happens when the patent needs constant treatment, for example in the context of leukemia or cancer therapy, in peritoneal dialysis, e.g. B.C.A.P.D. (continuous outpatient peritoneal dialysis), or with total parenteral nutrition.

If the catheter is placed intravascularly, it is inserted directly percutaneously into a vein (e.g., into the subclavian vein), after being exposed through an incision, because this minimizes unwanted movements of the device and can be easily attached to the patient . This creates long-term access to the central venous system. Here, however, there is the additional risk that air is inadvertently sucked in by the pumping movements of the heart and thus causes air embolism.

For these reasons, the so-called "tunneling technology" has been developed in recent years. With this technique, the free catheter is not allowed to end directly from the blood vessel or body cavity, e.g. the peritoneum, but a longer distance (e.g.

40 cm for the subclavian vein and approximately 6 - 12 cm for the peritoneal catheter) below the skin through an artificially created tunnel.

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In this way, an externally occurring infection cannot penetrate into the blood vessel or the body cavity. In fact, it has been clearly proven that the subcutaneous tissue is a natural barrier against infection and, as long as the catheter material can be tolerated by the tissue, the risk of infection is greatly reduced. One method is to insert the tube through a surgically prepared tunnel

Now the catheter or another device can be inserted into the tunnel in two ways: either you push it into the tunnel first and then guide it into the final position in the deep tissue, e.g. · a peritoneal body cavity (the so-called "one-way technique") ”), Or you first insert the distal end into the body cavity and then - as a second step - the free (or proximal) end is pulled backwards into the tunnel, ie in the second step you work - so to speak - from the center of the tube outwards. The latter method ("two-way technique") is particularly suitable for catheters with an integrated connection coupling. The end coupling of a catheter is usually larger in diameter than the catheter tube in order to facilitate the connection. The catheter coupling can either be removable, e.g. insertable, or it can be firmly attached to the catheter during manufacture.

However, both methods involve risks. When inserting a flexible tube into a tunnel, you need a hollow, rigid guide made of metal or plastic (such as a sharp tip or a trocar and an insertion cannula), and the problem arises of how to remove the guide, especially if the clutch, e.g. for connection to an infusion device, a 'l I.

»4» is an integrated part of the catheter and has a larger diameter than the latter. In the second method, the coupling must be removed from the catheter tube if the tube is to be pulled back through the tunnel, or it must be inserted into a capsule so that the coupling does not get caught in the tissue and cause injuries.

A removable (e.g. plug-in or screw-on) coupling presents other problems, including that of contamination. On the one hand there is a plug connection to trRnrmngHanfMlH g, on the other hand a thread in the very soft material of the tube would not hold enough. But also as an integrated tube part, the coupling is of course an obstacle when pushing the tube through the tunnel due to its diameter and can also easily cause injuries.

It is apparent from the above explanations that in practice the tunneling technique is generally carried out by surgeons who work without suitable equipment.

It is therefore the object of the invention to provide a guiding device which facilitates the insertion of a catheter or other tubular surgical device into a tunnel, while avoiding or reducing as far as possible the disadvantages mentioned above.

According to the present invention, there is provided a guiding device for facilitating the insertion of a catheter or other tubular device into a subcutaneous tunnel, which comprises a rod or tube with a handle at the proximal end and a removable tip at the distal end (for the purpose of smooth passage through the subcutaneous tissue) represents.

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The exercise device can e.g. made of metal or hard plastic material and the distal part came to be slightly curved, e.g. in the last third of its length. The :-? Device also came to be flexible or pliable to adapt to any given surgical situation. At the proximal end of this device we provide a handle which is expediently at least partially removable and is preferably elongated and rounded (for example cylindrical with a rounded end or in the form of an egg).

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The distal end is preferably provided with means for attaching the tip. Such means can consist, for example, of an internal screw thread or other cavity or a protruding pin with an external screw thread.

Several additional tips are assigned to this device, which are mainly required for the "two-way technique" described above and which, e.g. can be screwed into the mentioned distal end of the guide device by means of a plug which is threaded at the proximal end. These additional tips are explained in more detail below with regard to their various possible uses in the tunneling process.

For example, it is possible to unscrew or otherwise attach a sharp point, e.g. a metal tip or a so-called trocar or preferably a so-called dissector tip of flattened and rounded shape to the guide device in a simple manner to cut a tunnel and at the same time to bring the guide device into position for the purpose of attachment to the catheter ("one-way -Technik "), so that the construction of a tunnel by surgery is unnecessary.

Should the insertion of the catheter into the tunnel take place according to the second technique mentioned above, i.e. by pulling the catheter backwards s 6 s via an integrated coupling, the best way to do this is to push the catheter coupling into a housing which is open at the distal end and which, in turn, is threaded at its proximal end; said pin can be screwed into the distal end of the guide device which has already been pushed through the tunnel. The housing part should have a streamlined or rounded, elongated shape so that it can be easily pulled through the tunnel without its circumference causing any damage.If the catheter tubes do not have an integrated coupling device, the process of withdrawing through the tunnel can also be carried out by the guide device our invention can be facilitated.

For this purpose a coupling member is guided to the proximal end of a thickened middle part, e.g. a threaded pin that can be screwed into the distal end of the guide device and on its. distal end presents a suitable means for releasably attaching a flexible catheter tube, for example a peg equipped with means for increasing its frictional engagement within the cavity of a catheter, e.g. one or more circumferential ribs.

If the above-mentioned first tunneling method (n one-way method ”) is to be used, which consists in first inserting the catheter tube into the tunnel and then bringing it into a desired position (for example into a blood vessel), then this can be done with catheters without Couplings happen in a particularly simple and elegant manner with the aid of the guide device according to the invention, which is provided with a sharp tip (preferably made of metal) at the distal end.

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In one method, the catheter is pushed into the appropriately dimensioned cavity within the guide device and then - as described above - a sharp tip is screwed onto the distal end. The tip is preferably hollow and has an inner diameter which is sufficient for receiving the catheter tube so that the latter can be pushed in a little and protrudes from the distal end of the actual guide tube. Using the guide device prepared in this way, the tunnel can now be drilled directly through the tissue. The tip is then unscrewed and the catheter is pushed further, with its distal end free of the guide device. The end can then be held in place while the guide is withdrawn through the tunnel.

A disadvantage of this method is that both the tip and the tubular guide device have to be relatively wide, since the catheter must certainly fit into the hollow tip and this in turn has to fit into the guide tube.

This disadvantage is avoided if a tip with a fixed spigot is used and the catheter ends shortly before the spigot (and therefore close to the end of the tube of the guide device). In this case, the catheter must be advanced further after unscrewing the tip the guide device so that it can be held while the guide device is retracted.

On the other hand, however, a narrower guide tube and a slimmer or standard tip can be used.

Another variant of the "disposable technique" consists of pulling the (seamless) catheter over its entire length over the guide tube so that it lies inside. a In this case, a tip must be screwed on as a perforator 8, which is approximately the same thickness as the catheter wall than the guide device, so that the catheter is pushed through the tunnel in the opening defined by the tip can and does not get caught or roll up on the body tissue. Here, too, the tip is unscrewed, the catheter is held in place and the guide device is withdrawn through the tunnel.

* It is also possible to use the guide device after the

Form a gutter so that it is not closed all around, but has a gap through which the catheter tube can be peeled out after tunneling. The catheter is then placed in the guide device and then inserted into the tunnel together with the guide tube. After completion of the insertion process, both ends of the catheter are gripped and raised so that the catheter can be removed from the guide device through the slot and the guide device can be removed.

It is even possible to insert the catheter with an integrated attachment or coupling using the "disposable technique". For this purpose, the handle of the slotted guide tube device described above is constructed so that it can accommodate the catheter hub. In this embodiment, the handle can either be completely or partially removed (e.g. unscrewed) and / or it is provided with a slot in part of its length (e.g. a third) which forms a line with the slot in the guide around the To allow removal of the coupling from the guide. The technique of exposing the catheter and approach is performed as described in the above procedure.

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The guide device according to the invention is generally supplied in a sterilizable and reusable state, but it can also be in a hermetically sealed container or packaging, e.g. Plastic wrap, packaged, and sterilized in situ by heat, radiation, or chemical sterilization. ·· After first use, the device can be cleaned and resterilized, or in some cases treated as disposable.

Various embodiments of the invention will now be described with reference to the accompanying drawings:

Figure 1 shows a perspective view of a tubular guide device. Various accessories for attachment to the distal end are shown.

Figures 2 to 5 show top view, partly in cross section, of the distal end of the guide device according to the invention, which have a sharp tip mounted there and show a catheter inside or outside of said device;

Figure 6 is a top view, partially in cross-section, of a slotted guide device with a handle attached and a catheter within said device and handle.

We now come back to Figure 1. There is shown a tubular guide device 1 which is slightly curved in the distal third of its length, with an extended handle 2 at the near end and an internal screw thread 3 at the distal end.

The elements 4, 7 and 8 are accessories that can be attached to the guide tube by means of a pin 6 with an external screw / thread. * 10

The housing 4 (insert A) is open at the distal end for receiving a catheter coupling 5 which has Luer locking eyes 5 ′ and is provided with a threaded pin 6 at its proximal end. The housing has an interior. Thread 5 "to releasably anchor the coupling. A removable pin 6 * is shown which temporarily closes the end of the catheter.

Below this, at insert B, a removable, sharp metal tip 7 is shown, which serves as a perforator, which can also be attached to the guide device 1 by means of a threaded pin 6.

The tip is provided with two opposing concave handle surfaces 10.

However, the sharp tip is sometimes responsible for the occurrence of trauma and we therefore prefer the • dissector tip 15 (slot C) with a flattened and rounded end. The task of the dissector tip is to push the tissue apart rather than cut it, which is advantageous for the patient. At insert D, a coupling part 8 is also shown, which serves to connect the free end of a catheter without an end coupling to the guide device. The middle part 9 is thickened and has two opposite, concave grip surfaces 10. At one end it carries a pin 6 with an external thread, and at the other end a pin, two circumferential ribs for frictional engagement in the cavity of a catheter.

Figure 2 shows a tubular guide device 1 with a sharp tip 7, which is screwed on. The connecting pin 6 of the tip is hollow and contains the distal end of a simple catheter tube 11 which in this way protrudes from the distal end of the guide tube.

11 * Figure 3 shows an alternative construction, in which the connecting pin 6 of the tip is solid, and the catheter 11, which is inside the guide device, ends proximal to this pin.

Figure 4 shows an inner guide tube 1, onto which the catheter 11 is screwed. The tip 7 used is wider than the guide tube and forms a structure so that the walls of the catheter are kept clear during the tunneling procedure, i.e. don't get caught.

Figure 5 shows a guide device in the form of a split tube from which the inner catheter 11 can be lifted out after the tunneling process. Column 14 is shown more clearly by the cut used, which was taken along line A-B.

In Figure 6 the guide tube is split lengthways as in Figure 5 and as shown in the section along A-B. In addition, it is equipped with a handle 2, which is slit longitudinally along the distal third of its length and which has a cavity 12 for receiving a catheter coupling (or an attachment). The proximal part of the handle can be unscrewed on the screw thread 13 in order to expose the catheter end coupling 5 and to enable its removal from the guide device. It can be seen that the coupling 5 is too large in diameter to permit its passage through the longitudinal gaps.

Claims (10)

1. A guide device to facilitate the insertion of a catheter or other tubular surgical device in a subcutaneous tunnel, which is a rod or tube with a handle at the distal end and a removable tip at the distal end for a gentle. Has passage through the subcutaneous tissues. 2. An apparatus according to claim 1, wherein the distal portion of said rod or tube is longitudinally curved. 3. An apparatus according to claim 1, wherein said rod or tube is flexible to suit a particular surgical situation. 4. An apparatus according to any one of claims 1 to 3, wherein said removable tip is flattened and rounded to form a dissector tip. 4 »P_A_T_E_N ^ T A_N_S_P_R Ü_C_H_E_: 5. An apparatus according to any one of claims 1 to 3, wherein said removable tip is sharply pointed. 6. A device according to any one of claims 1 to 3> in which said removable tip has a housing open at the distal end for receiving a catheter coupling. A device according to any one of claims 1 to 3, characterized in that said removable tip has a pin for insertion into a catheter tube. A device according to any one of claims 1 to 5, wherein said tube is sized to receive a catheter inside. / K 'r 9 9. An apparatus according to claim 8, wherein said tube is provided with an elongated slot to enable said tube to be removed from the catheter. 10. An apparatus according to claim 9, wherein said handle is hollow so that it can receive a catheter coupling, and is wholly or partially removable and / or is provided with a slot to enable said coupling to be removed from the apparatus. »