Device for attaching a catheter

A medical device for fixing a catheter to a patient is disclosed. It includes a base having a planar main development, a first face configured to be glued to a patient's skin, a second face, opposite to the first face, adapted to receive a catheter according to an axis of insertion of the catheter, and at least two pegs which rise substantially perpendicular to the second face. Each peg has a stem which rises from the second face and has a cross section suitable to freely pass through a through hole of a fin of a catheter. The peg also has an enlarged free terminal end having a cross section greater than the cross section of the stem so that it cannot freely pass through the through hole. The enlarged terminal end is able to pass through the through hole only by elastically widening the through hole.

The present invention relates to the field of medical devices and in particular relates to an anchoring system for catheters to the body of a patient.

The use of catheters is a common practice in the treatment of patients who require the introduction of fluids, for example intravenous treatments, or the withdrawal of fluids as in the case of bladder catheterization. It is often necessary to use fixation methods that allow the catheter to be kept correctly positioned for the duration of long patient treatments. The most common method involves using medical patches, or adhesive tapes, to cover a portion of the catheter and tighten it to the patient's body.

However, the use of adhesive patches on the patient traditionally involves some drawbacks. Removal can also cause unwanted movement of the catheter over the patient causing pain. Furthermore, repeated application of adhesives to the catheter can lead to the formation of residues on the external surface of the catheter. These residues facilitate accumulation of contaminants that adhere to the catheter itself, increasing likelihood of infection at the insertion site. Another consequence is that the residues can make the catheter more difficult for healthcare professionals to be managed.

The object of the present invention is to provide a fastening device that allows a catheter to be held in the correct position for prolonged times without causing the above mentioned inconveniences.

Another object is to provide a device which is constructively simple and which therefore is economical to use, facilitating its diffusion in health facilities.

These objects are achieved with the catheter fixing device whose essential characteristics are defined by the first appended claim. Other important accessory characteristics are the subject of the dependent claims.

With reference toFIG.1, the fixing device fora catheter according to the present description comprises a base1. Said base1comprises a first face1aconfigured to be glued to the skin of a patient by means of the use of adhesive substances applied to the patient's skin and/or to the surface of said first face1a. Preferably, this first face1ais coated with an adhesive substance covered by a protective film to preserve its effectiveness. When the base1has to be fixed on a patient's skin, the protective film is removed and the base1is glued like a common plaster.

According to one aspect, the base1has a planar main development.

The base1also comprises a second face1b, facing in the opposite direction to the first face1a, suitable for receiving and housing a catheter A, shown inFIG.2and not part of the invention. The catheter is arranged on the second face1bdefining a first catheter axis X. By way of example only, a catheter shown inFIG.2usable with the fixation device of this disclosure can be a central or peripheral venous catheter. Typically, it comprises a needle C adapted to be inserted into the patient's vein and two fins B commonly used to be attached by plasters to the skin of a patient in order to keep the catheter in a correct position. These fins B generally comprise one or more through holes Bb, for each fin, generally used for the application of suture threads. The fins B are generally positioned in a mirror image with respect to the catheter.

The fixing device also comprises two pegs4connected to the base1which have a main development perpendicular to the second face1band are turned outwards with respect to the patient. Furthermore, they are preferably arranged, in a substantially specular way, astride a portion of the second face1bin order to intercept the fins B of a catheter A. The position from which the pegs4rise defines a positioning axis of the pegs Y, perpendicular to the catheter axis X. The pegs4comprise a stem41.

According to one aspect, each stem41has a circular cross section with a diameter smaller than the diameter of circular holes Bb of the fins B.

Each peg also comprises an enlarged free terminal end40having a cross section greater than the cross section of the respective stem41which is in turn configured to be able to be forced to penetrate into the holes Bb of the fins, deforming them elastically. By placing a hole Bb in correspondence with this free end, a user can elastically deform the hole Bb by pressing it against the free end of a peg to allow the insertion of the peg4inside the hole. Once the free end has completely crossed the hole Bb, the latter springs back elastically to its original shape around the stem41. The peg4will not be able to spontaneously come out of the hole Bb because the force necessary to make the pegs4come out from holes Bb is greater than the forces to which catheters implanted on patients are generally subjected. This feature ensures that the fins B of a catheter, once secured to the pegs4, are stably associated with the catheter fixation device according to the present description.

According to one aspect, the cross section of the enlarged end40of the peg4can be about 1.1 to 1.5 times larger than the cross section of the stem41. According to one aspect, the enlarged end preferably comprises a recess40a, adapted to facilitate the plastic deformation of hole Bb. The recess40acomprises a tapering of the terminal portion of the enlarged end40. Each enlarged end40also comprises a joint surface40bopposite the recess40a, preferably of an angle substantially of 90°, which connects the end40to the stem41. This joining surface further increases the force necessary to make the pegs4come out of the hole Bb.

According to one aspect, the pegs have a substantially circular cross section.

The base1has elastically deformable portions3on which the pegs4are directly fixed. These elastically deformable portions3move the pegs along the positioning axis of the pegs Y in response to a stress by the user. The elastically deformable portions3mentioned above preferably comprise a connecting segment3a, thin enough to be flexible.

According to one aspect, a first end of this segment is rigidly connected to a body of the base1, while a peg4is rigidly connected to a second end.

The fact that the pegs are on the elastically deformable portions3, allows, during the assembly phase of the catheter fins, to first insert only one of the two pegs4into a fin of the catheter, after which it is possible to exert a traction, or a push, along the positioning axis of the pegs Y on the fin to bring the peg already inserted at a distance such as to allow the insertion of the second peg4inside the second hole Bb on the second fin B. In this way, the fixing device according to the present description can be adapted to the various types of fins B for catheters available on the market, which typically have the holes defined at different mutual distances.

According to one aspect, the base1comprises a central portion1carranged along the catheter axis X. Two further stabilizing portions1dare rigidly connected perpendicularly to the ends of this portion, one at each end of the central portion1c, preferably arranged parallel to the positioning axis of the Y pegs.

According to an aspect illustrated in the figures but not essential for the realization of the device of this disclosure, the three portions are arranged so as to form an “H” shape. However, other embodiments are possible in which the three portions are arranged according to a different geometry.

The first face1ais defined by the lower face, i.e. the surfaces that come into contact with the patient's skin, of each of the three portions introduced above. Similarly, the second face is defined by the upper faces of the three portions, one central1cand two stabilizing1d. Each connection segment3ais preferably cantilevered connected to a respective stabilization portion1d, has a development parallel to the catheter axis X and is comprised between said stabilization portions1d, and is flanked by the central portion1e. Even more preferably, the connection segment3acomprises a U-shaped folding on itself so as to increase the possible excursion of the position of the peg along the positioning axis of the pegs Y.

The fastening device is preferably made of flexible plastic material. Even more preferably, the device is a single piece obtained by injection molding or thermoforming.

The procedure to be followed for applying the catheter to a patient's skin by means of the fastener of this disclosure is as follows:1. Inserting the tip of the catheter into the desired route;2. Holding the base and the fin, making one of the pegs of the device penetrate into a hole in one of the catheter fins;3. If necessary, exerting a traction or a push on the fin so as to make a hole in the second fin coincide with the second peg of the device, proceed to make the second peg also penetrate into the hole in the second fin;4. Preparing the skin for the positioning of the base; and5. Removing the protective film from the first face of the base, exposing the adhesive substance, and place the first face on the patient's skin.

The fastening device according to the present description has the advantage of allowing the fins of a catheter to be fixed in a stable and safe manner without having to resort to adhesive plasters or tapes. In particular, the enlarged end of the pegs allows a secure coupling between the fins of a catheter and the fixing device.

Thanks to the elastic connection means it is advantageously possible to use the fastening device described in the description with various types of fins available on the market.

Another advantage of the device consists in being extremely simple in construction, since it can be made in a single piece by molding plastic material, while having all the safety and practicality features already described.

The present invention has been described up to now with reference to its preferred embodiments. It is to be understood that other embodiments may exist which pertain to the same inventive core, all falling within the scope of protection of the claims hereinbelow.