WO2015166157A1

WO2015166157A1 - Device for protecting a catheter

Info

Publication number: WO2015166157A1
Application number: PCT/FR2015/050967
Authority: WO
Inventors: Mokhtar Chawki
Original assignee: Nephrokit
Priority date: 2014-04-30
Filing date: 2015-04-10
Publication date: 2015-11-05
Also published as: FR3020574A1; FR3020574B1

Abstract

Device for protecting the proximal part of a catheter, in particular a dialysis catheter, this device comprising a substantially planar first part (1) provided with a through-hole for the catheter next to its exit site, a flexible tubular second part (30) forming a pouch intended to contain the proximal part of the catheter, this second part (30) comprising an upper transverse mouth (32), characterized in that the second part (30) comprises a lower transverse mouth and means for reversibly closing this lower transverse mouth, the first part (1) comprising, on one of its faces referred to as the front, an adhesive zone for securing it to the skin of a patient, the first part (1) being provided, on its opposite face referred to as the back, with an adhesive zone for securing the second part (30) to the first part (1).

Description

DEVICE FOR PROTECTING A CATHETER

The invention relates to a device for protecting a catheter during medical or veterinary use, in particular a deep catheter or a central venous catheter.

By "catheter" is meant here a device comprising a flexible tubular section, a first end portion, said distal, of this tubular section being intended to be inserted into a cavity of a human or animal body; a second extreme part, called proximal, of this tubular section being intended to be placed outside the human or animal body; the tubular section comprising at least one conduit in fluid connection with the proximal portion and the distal portion; the tubular section defining, when viewed in cross section, at least one light; the distal portion of the tubular section comprising an extreme distal orifice and optionally at least one lateral orifice; the proximal portion of the tubular section comprising a proximal orifice.

The term "flexible tubular section" here designates the capacity of the tubular section to be bent manually, without plication, this capacity being related to the materials used for the manufacture of this flexible tubular section, and to the shape of this section. As examples, the catheters contemplated herein are made of materials having good bio-accounting such as silicones, polyurethanes, or polytetrafluoroethylenes.

By "cavity of the human or animal body" is meant here voids occupied by liquids in the human or animal body, and in particular the blood vessels, the peritoneal cavity, the pericardial cavity, the atria and ventricles of the heart.

The invention more particularly aims at the protection of the entry site and the protection of permanent or long-term catheters, in particular for hemodialysis or chemotherapy, for example the protection of the site of emergence of a central venous catheter of dialysis. Permanent catheters are distinguished from temporary medical devices comprising a tubular section (drains, vesical probes, peripheral venous catheter, peripheral arterial catheter). Permanent catheters are also distinguished from intermittent medical devices for single use.

Three types of vascular access predominate for hemodialysis: FAV arteriovenous fistulas, arteriovenous or graft prostheses, and CVC central venous catheters.

AVFs are surgically created anastomoses to connect an artery and a vein of the patient, commonly in the forearm, or arm, most often between a radial or humeral artery and its homonymous vein. This anastomosis makes it possible to increase the blood flow within said vein. The creation of an AVF strongly changes the appearance of the patient's forearm, creating aneurysmal areas. Arteriovenous prostheses are inserted under the skin of the forearm or the thigh, and are conventionally made of polytetrafluoroethylene or are homografts.

Central venous catheters for hemodialysis are conventionally formed by two separate catheters assembled (double catheters of Canaud, see also US5776111 TESIO), or by catheters with two lumens, a first lumen ensuring the passage to the patient of the blood treated by the machine. dialysis, the second light ensuring the passage of blood to treat the patient to the dialysis machine. These dual-lumen catheters may be of double-D section (for example catheters sold under the names VasCath, Opti-Flow, Palindrome, Mahurkar or Schon catheters), or of double O section (catheters sold under the name PermCath). . A very large number of forms have been proposed for the distal ends of dialysis catheters (for example catheters disseminated under the names Hemosplit, Cannon, Split Cath, Duo Split, by Quinton, Bard, Medcomp, Covidien), see for example Atherikul et al., Nephrol Dial Transplant 1998, 13, pp. 745-749; Ash, Advanced in tunneled central venous Catheters for Dialysis: Design and Performance, Seminars in Dialysis 2008.

Central venous catheters are tunnelled, the sites of emergence of these catheters being distant from the point of puncture of the central vein. For example, the point of puncture of the jugular vein is located in the neck, while emergence sites are six centimeters in the ipsilateral thorax after being passed through a subcutaneous tunnel.

The catheter fixation dressings conventionally comprise an absorbent pad of hydrophobic, expandable, nonwoven polyester coated with a hypoallergenic acrylic adhesive. These dressings provide only a protection of the catheter entry site and the same applies to semi-permeable transparent films fixed directly above the catheter inlet site (for example sold under the names Opsite, Tegaderm, Bioclusive, Mefilm, Mepore). The proximal portion of the catheter is not protected.

On the proximal part are clamps pressing against the skin, causing discomfort in certain positions, for example during the movements of the person during sleep.

People with permanent catheters, such as dialysis patients and people on chemotherapy, can not easily wash (bath, shower) and want the catheter to be as unobtrusive as possible.

Central venous catheters are also invasive devices and their presence is accompanied by infectious risks.

These infectious risks are potentially present during each dialysis, the hemodialysis session lasting about four hours, and to be performed three times a week. Consideration of infectious risks during dialysis requires attention medical staff, all the more delicate because patients are fragile, because they are depressed, depressed, epileptic, or suffering from chorea, a neurodegenerative disease such as Parkinson's, Parkinson's syndrome, or convulsions for various reasons . During dialysis sessions, the proximal ends of the catheter remain exposed to the air, which increases the risk of infection and especially as the manipulation of these ends is common. For example, in the event of malfunction of a dialysis catheter, it is necessary to inject products (for example urokinase) or to reverse the arterial and venous lines, or to reposition or reattach the external tips. These manipulations are source of germs. Among the most dangerous germs, providers of sepsis, there is a high percentage of staphylococcus aureus infections that can significantly reduce the vital prognosis of infected patients.

These infectious risks are also constantly present in the daily life of dialysis patients.

The infectious risks of central dialysis catheters can spread to the endocardium, or even to the whole organism, by sometimes nosocomial multi-resistant organisms. Minor infection may be manifest as inflammation of the orifices. Severe complications that may require immediate or rapid removal of the catheter are rare but severe (tunnelitis with or without fever, sepsis, endocarditis, spondylodiscitis). The infection can be conveyed through the inlet to the tunnel, or be internal to the catheter, an endoluminal infection being favored by the appearance of a biofilm or fibrin sheath. The infection can also be combined with thrombosis.

The use of permanent stoppers (Q-Syte, Tego) or specific lock solutions for preventive treatment of infections (for example marketed under the names Taurolock, Duralock, Ctralock, Cathloc, Minoc-EDTA) allows only a partial reduction of infectious risks. The prevention of bacterial or fungal infections related to central catheters is based on draconian hygiene rules and recommendations on the handling of catheter tips, as well as the preparation of dressings in pre and post dialysis procedures.

Usually, the catheter dressing is performed before each beginning of dialysis according to a protocol of the following type:

before each dialysis, a cleaning centered on the zone of emergence of the extra-cutaneous extremities is carried out with a compress impregnated with alcohol or with a disinfectant, then the free ends of the catheter and the cutaneous zone opposite are disinfected;

in a second step, a gauze is placed around the ends of the catheter at its emergence site, then a transparent polyurethane adhesive bandage is applied, this dressing being impervious to water and breathable;

the proximal portion of the catheter, usually carrying the clamps, is surrounded by a gauze or tubular bandage (eg, marketed as Tubifast) and passed through a hole in a sterile field;

the caps of the catheter tips are removed and the blood lines of the hemodialyzer are connected after opening of the clamps.

At the end of the dialysis session, the external tips of the catheter are disinfected and locked, and several compresses are arranged over the whole, the assembly being fixed by adhesive transparent dressings in polyurethane.

Several devices have been devised, to try to improve the comfort of patients and reduce the risk of infection.

The document FR 2748661 (Vogel) proposes a device presented as a hermetic protection for deep catheter tips, this device comprising a transparent impervious bag made of polyethylene, this pocket being cut to access the end pieces and connect them to the dialysis machine. The polyethylene bag has a window at the top, a nonwoven compress being placed in line with this window, this compress comprising two parallel slots for passage of the tips of the catheter. A peripheral adhesive tape at the window secures the pocket to the patient's skin. The device described in document FR 2748661 and used under the name Idélio has many disadvantages. In the first place, the taking of a bath or a shower is not possible, because of the entry of water into the pocket, the nonwoven compress being absorbent and releasing its water inside the pocket, increasing the internal moisture in the pocket, with the risks of maceration and congestion that result, and the risk of infection that result. Furthermore, the need to cut the bag to access the catheter tips leads to the risk of damage to the tips or walls of the catheter, any cut in the wall of the catheter creating a terrain conducive to the appearance of a biofilm, promoting the development of pathogenic germs. This risk is further aggravated by the possible use of catheters provided with an antibacterial surface treatment, surface treatment that may be degraded by contact with a cutting tool during cutting of the pocket. A cut in the wall of the catheter can constitute a beginning of rupture, this risk of rupture by fatigue is even higher than the catheters are worn over very long periods, sometimes several years, with manipulations several times a week, to every dialysis session. The change of a central catheter is certainly possible, but is often difficult, due to local stenosis or adhesions, this change also implying a passage to the operating room, with an at least regional anesthesia.

WO 2011058397 (Pillai) proposes a device presented as protecting a catheter from infections. This device comprises a pocket provided with a lower opening and provided with a side window. After removal of a peelable seal, an adhesive placed around the pocket window allows attachment of this pouch around the entry point of the catheter. A suction valve is intended for the aspiration of the air contained in the pocket. The device described in WO 2011058397 has many disadvantages. In the first place, its installation is delicate, the operator having to pass the entire external portion of the catheter inside the pocket before sticking the pocket against the skin of the patient, this operation to be performed without exerting traction on the catheter and without inadvertent sticking of the pocket on the operator's gloves or on the patient's catheter or skin. Moreover, the depression of the pocket complicates its opening for dialysis and involves having technical means of aspiration during the installation of the device.

Document US 20080208145 (Me Culloch) describes a device presented as allowing dialysis patients carrying a central venous catheter to hang showers. This disposable device forms a pocket around a sheath surrounding the proximal end of the catheter, a dressing also covering the entry point of the catheter. A desiccant is placed inside the pocket. The device described in US 200802081445 has many disadvantages. The presence of a desiccant is a risk of burns for the skin of the patient, the risk is even higher that the patient will hesitate, in case of discomfort, to tear the device quickly for fear of damaging the catheter. The device has a large volume and its port is not discrete.

EP 671 182 (Jerlow) describes a device disclosed for allowing patients with a peritoneal dialysis catheter or hemodialysis to shower or swim. The device comprises a bag made of impermeable and transparent polymeric material, provided with an opening surrounded by an adhesive and breathable disc, this adhesive disc allowing the attachment of the bag around the point of emergence of the catheter. The bag further comprises a lower opening provided with closure means of zip type, allowing access to the connectors. A desiccant is placed in the bag, for example a silica gel. The device described in EP 671 182 is presented as inspired by the structure of colostomy bags and has several disadvantages. Unlike colostomy bags conventionally placed on a support or skin protector, the pocket described in EP 671 182 integrates its mounting bracket and is thus not easily implemented. It is not easy to pass the proximal portion of the catheter through the rear opening of the pocket, especially since the proximal end of the catheter comprises two flexible tubular sections beyond the point of emergence. each section carrying a clamp and a tip more or less bulky depending on the catheter models. Furthermore, the device has a significant thickness, right of the emergence zone of the catheter. The desiccant, placed in the upper part of the pocket, is also likely to leak and cause irritation on the skin of the patient. Finally, when a person performs his toilet, there is a risk of water stagnation between the pocket and its support, in the upper part of the device.

GB 2477042 (Steer) discloses a device disclosed as allowing a person wearing a central venous catheter to take a shower. The device comprises two elements made of impermeable polymer material, for example polyethylene, these two elements being separated or not. A first element is a bag provided with a lateral opening, an opening surrounded by an adhesive strip. The second element is a band provided with a U-shaped adhesive edge, the second element being adhered to the skin of the patient above the first element. The device described in GB 2477042 has several disadvantages. It is not easy to pass the proximal portion of the catheter through the rear opening of the first element, especially since the proximal end of the catheter comprises two flexible tubular sections beyond the point of emergence. each section carrying a clamp and a tip more or less bulky depending on the catheter models. The superposition of two adhesive films opposite the zone of emergence of the catheters increases on the one hand the risks of allergic reaction and on the other hand reduces the visibility of the zone of emergence of the catheter.

CA 2741926 (Pecorari) describes a device presented as reducing the risk of infection of central venous catheters. The device uses dressings whose fibers are coated with aluminum or silver, this provision being given as promoting hemostasis and preventing infection. The device comprises a bag having an upper opening and a non-woven non-woven material tab, which tab is provided with a notch for the passage of a catheter, the opening of the bag and the tab being covered by a band-Aid. The cut is of shape and dimensions such that all of the skin surrounding the emergence site of the catheter is covered by the nonwoven leg. The device described in CA 2741926 has several disadvantages. If the notch in the non-woven non-woven lug is smaller than that of the catheter, placement of the lug around the catheter is difficult and the emergence zone of the catheter is obscured by the nonwoven tab. Conversely, if the notch in the non-woven non-woven tab is larger than that of the catheter, maintaining this tab in position around the point of emergence of the catheter can not be assured. Moreover, this device does not allow access to the catheter tips during dialysis sessions.

Other impervious dressings are currently available, for example under the name Diapouch. Reference may also be made, by way of illustration of the prior art, to the documents US6540724 (Harris), US20140046263 (Salazar), US5605546 (Wolzinger), US20070282271 (Kaplan), US20080077064 (Bockol), US20080167626 (Beery), US2003221693 (Altman), US2004074501 (Altman), US2003056794 (Altman), Sanford Altman Showering with central venous catheters experiment using the CD Composite Composite 1000, Dialysis & Transplantation, 2006, pp. 1-4.

After a thorough study of the problems presented above, the present inventor has devised a product bringing many advantages that will largely mitigate the difficulties mentioned.

The invention aims in particular to provide a device for protecting a catheter significantly reducing the risk of contamination, while improving the comfort of the patient. The invention also aims to provide a device for protecting a catheter significantly reducing the time spent by caregivers during care.

For these purposes, the invention relates, in a first aspect, to a device for protecting the proximal part of a catheter, in particular a dialysis catheter, this device comprising a first substantially flat portion provided with a through hole for the catheter facing its emergence site, a second flexible tubular portion forming a pocket intended to contain the proximal portion of the catheter, this second portion comprising an upper transverse mouth, the second portion comprising a lower transverse mouth and closure means reversible of this lower transverse mouth, the first part comprising, on one of its so-called recto faces, an adhesive zone for its attachment to the skin of a patient, the first part being provided, on its opposite face, said face, an adhesive zone for fixing the second part to the first part.

By these provisions, the insertion of the proximal portion of the catheter into the tubular portion of the device is easy: the upper transverse mouth of the tubular portion can form a wide opening, for example 60 mm. It is not necessary to bend the catheter to introduce it into the tubular part of the device. The proximal portion of the catheter, including its tips and clamps, is fully housed in the tubular portion forming a pocket and thus protected. Access to the ends of the catheter, including tips and clamps, can be made without touching these tips, by manipulating them through the second flexible tubular portion. The lower transverse mouth of the tubular portion may form a wide opening, for example 60 mm, allowing easy access to the end pieces. The reversible closure means makes it possible to keep the lower transverse mouth closed as long as access to the proximal portion of the catheter is not required, and to temporarily open this lower transverse mouth when access to the catheter is desired.

Advantageously, the device comprises a third part intended to cover the first part and the upper mouth of the second part, this third part comprising a non-adhesive window and an adhesive edge. The third part advantageously comprises a film impermeable to fluids and pathogenic microorganisms and permeable to water vapor, this film being in a material selected from the group comprising polyurethane, polyetherurethane, polyetheramide, polyetherester. The film is advantageously thin, with a thickness of between 5 and 200 microns, preferably between 10 and 75 microns.

According to various embodiments, the device has the following characters, if any combined:

the first part is made of non-woven fabric or foam;

the first part is carried out by the dry route, the bonding being carried out by latex spray coating, or by incorporation of fibers or thermo-binder powders and heat treatment, or by compression of fibers;

the first part contains an active ingredient selected from the group consisting of silver salts, antiseptics, painkillers; the second part comprises a tubular sheath of transparent or translucent polymer material;

the reversible closure means comprise a hook and loop tape, or an adhesive tape, or a zip;

the first portion has a solid lower section and an upper section provided with the through hole, the lower section being wider than the upper section; the passage hole is formed of a longitudinal upper slot and an oblong transverse opening;

the first part comprises two gripping tongues, on either side of the upper slot, each tongue carrying an adhesive strip on the back of the first part;

the first portion has a solid lower section and an upper section provided with the through hole, the lower section having, on the back, two side adhesive strips.

The invention relates, in a second aspect, to a catheter grooming kit comprising a device as presented above. The invention relates, in a third aspect, to a dialysis kit, including hemodialysis, comprising a dialysis catheter and a device as presented above.

Other objects and advantages of the invention will become apparent in the light of the description of an embodiment, given hereinafter with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a first part of the device, forming a compress, front side view, the peelable strips being shown spaced views;

Figure 2 is a perspective view of the first part of the device shown in Figure 1, side view, the peelable strips being viewed apart;

Figure 3 is a schematic front view of the first part of the device shown in Figures 1 and 2, front side view;

Figure 4 is a schematic front view of the first part of the device shown in Figures 1 to 3, side view back;

Figure 5 is a plan view of the proximal portion of a catheter, for example a subclavian implanted dialysis catheter;

Fig. 6 is a view of the first step of placing a catheter protection device on the catheter shown in Fig. 5;

Figure 7 is a perspective view of the first part of the device, in position on the skin of the patient;

Figure 8 is a schematic view of the subsequent steps of laying a catheter protection device;

Figure 9 is a perspective view of the last step of laying a catheter protection device;

Figure 10 is a perspective view of a catheter protection device after the last laying step.

In this description, the term "back" is used to denote the face of the device placed opposite the skin of the patient, the term "front" being used to designate the opposite side of the device. In the remainder of this description, the device will be presented in a context of protection of a catheter provided with two proximal branches, each branch carrying a tip and a clamp, this catheter being adapted to dialysis and for example subclavian or jugular . It is understood, however, that the device can be used for a single-lumen catheter.

The device has a slenderness along a so-called longitudinal direction. The length dimensions of the various parts of the device will be given with reference to this longitudinal direction. The width dimensions of the different parts of the device will be given with reference to a so-called transverse direction, perpendicular to the longitudinal direction. Finally, the thicknesses of the various parts of the device will be given with reference to a third direction forming a direct trihedron with the longitudinal and transverse directions.

The protective dressing comprises a first part 1, shown more particularly in FIGS. 1 to 4, this first part 1 comprising an orifice 2 allowing the passage of a catheter. The orifice 2 is formed of a longitudinal upper slot 3 and an oblong transverse opening 4. The upper slot 3 opens out at the upper transverse edge of the first portion 1. The upper slot 3 opens at mid-width of the oblong transverse opening 4.

The width and length of the oblong transverse opening 4 are adapted to those of the catheter at its emergence site. As an indication, the width of the opening 4 is 25 mm and its length is 10 mm.

Two gripping tabs 6, 7 extend on either side of the upper slot 3. These tongues 6, 7 have dimensions allowing their capture between the fingers. As an indication, the width of these tongues 6, 7 is 25 mm and their length is 20 mm.

The first part 1 is substantially rectangular in outline when viewed in plan, and has a lower section 8 full width slightly larger than that of the upper section 9 provided with the orifice 2. The side edges 10, 11 of the first part 1 and include a hook 12, 13 placed substantially one third of the length of the first part 1. As a indicative, the width of the lower section 8 is 60 mm, the width of the upper section 9 is 55 mm. The unhooked 12, 13 ensure, as will appear later, a visual and tactile cue during installation of the device. As an indication, the length of the lower section 8 is 27 mm, and that of the upper section is 43 mm.

The reverse side of the first part 1 is now described with reference in particular to FIG.

The tongues 6, 7 carry an adhesive strip 14, 15 upper, each upper adhesive strip 14, 15 being covered, before use of the device, by a peelable film 16, 17. Advantageously, the dimension, for example the length and / or the width, peelable films 16, 17, is greater than that of the adhesive strips 14, 15, this arrangement to facilitate the manual removal of peelable films 16, 17 during installation of the device.

Advantageously, the upper adhesive strips 14, 15 have a length less than the length of the upper slot 3. This arrangement makes it possible to ensure that the adhesive strips 14, 15 remain placed away from the zone of emergence of the catheter, this emergence zone being situated substantially in line with the oblong opening 4 when the device is placed. As an indication, the length of the upper slot 3 is 20 mm, the length of the adhesive strips 8, 9 being 10 mm.

The lower section 8 carries two lateral adhesive strips 18, 19. Advantageously, these two lateral strips 18, 19 extend over a small width, indicatively 15 mm, from the lateral edge 10, 11. The two side strips 18, 19 extend over a length substantially equal to that of the lower section 8, from the lower transverse edge 20 of the first part 1, indicative 27 mm. The side adhesive strips 18, 19 are covered, before use, by a peelable film 21. In the embodiment shown, a single peelable film covers the two adhesive strips 18, 19. In other embodiments, not shown, each strip adhesive 18, 19 is covered with a peelable film. Advantageously, the dimension, for example the length and / or the width, of the peelable film 21 is greater than that of the adhesive strips 18, 19, this arrangement making it easier to remove the peelable film 21 manually during the laying of the device. .

We now describe the front face of the first part 1, with particular reference to Figure 1.

The first part 1 of the device is provided, on the front side, with an adhesive strip 22 covered, before use of the device, with a peelable film 23. Advantageously, the dimension, for example the length and / or the width, of the peelable film 23 is greater than that of the adhesive tape 22, this arrangement facilitating the manual removal of the peelable film 23 during installation of the device. The adhesive strip 22 advantageously extends between the lateral edges 10, 11 from the lower transverse edge 20 to a length slightly greater than that of the lower section 8. As an indication, the upper transverse edge 24 of the adhesive strip 22 is placed a few millimeters, for example 5 mm, beyond the unhooked 12, 13 and thus extends in part in the upper section 9.

Each peelable strip 16, 17, 21, 23 is advantageously provided with a gripping tab of a few millimeters in length, for example 5 millimeters, allowing its removal during installation of the device.

The first part is nonwoven, for example gauze, or foam. The nonwoven may comprise absorbent fibers such as cellulose, rayon or viscose fibers. The nonwoven is for example obtained by the dry manufacturing method known as the aerodynamic route or "airlaid". The binding can be carried out by coating latex spray, by incorporation of fibers or thermolysis powders and heat treatment, by combination of these two techniques, or by compression of the fibers.

In one embodiment, the first part 1 contains an active ingredient, for example an antibacterial such as a silver derivative such as silver salts, an antiseptic, or a painkiller.

The device thus comprises, in particular shown in FIG. 10, a second portion 30 intended to contain the proximal portion of the catheter, including the tips and clamps.

This second portion 30 comprises a sleeve 31 of flexible polymeric material, preferably transparent or translucent. This sleeve 31 defines an upper mouth 32 whose width is advantageously substantially equal to the width of the sleeve 31 and is substantially equal to the width of the lower section 8 of the first portion 1. As an indication, this width is 60 mm. The length of the sheath 31 is adapted to the length of the catheter. As an indication, this length is 160 mm. The sleeve 31 defines a lower mouth 33 whose width is advantageously substantially equal to the width of the sleeve 31. This lower mouth 33 can be closed by reversible closing means. In the embodiment shown, these means are formed of a transverse adhesive strip 34. In other embodiments, not shown, these means comprise a hook and loop tape, for example Velcro® type, a zipper, for example zip type.

The device advantageously comprises, as represented in particular in FIG. 10, a third part 40 intended to cover the first part 1 and the upper mouth 31 of the second part 30.

This third part 40 comprises a non-adhesive window 41. As an indication, this window 41 is elliptical, 90 mm wide and 60 mm long. Around this window 41, the third portion 40 has an adhesive edge 42. In the embodiment shown, the third portion 40 is of elliptical contour, its width being indicative of 140 mm and its length of 100 mm. A protective paper covers the front adhesive part of this third part 40. Advantageously, this protective paper is in two parts, each of the two parts carrying a lateral gripping tab.

The third portion is preferably impervious to external pathogenic fluids and microorganisms while providing water vapor permeability so as to avoid both contact of the emergence zone of the catheter with external fluids and bacteria and maceration of the wound.

The third portion 40 is preferably thin, so as to better fit the shape of the body and follow the movements without the risk of detaching, and is preferably conformable. Among the films that can be used, examples that may be mentioned include polyurethane, polyetherurethane, polyetheramide or polyetherester films.

The thickness of the film is for example between 5 and 200 microns, preferably between 10 and 75 microns, more preferably between 10 and 50 microns.

The installation of the device is now described.

The first part 1 of the device is glued to the patient's skin, around the emergence zone of the catheter. This bonding is provided by the side adhesive strips 18, 19 and by one or two adhesive strips 14, 15 higher. When the two upper adhesive strips 14, 15 are used, as shown in the figures, the catheter passes through the oblong transverse opening 4 and the upper slot 3 is advantageously closed by bringing the two tabs 6, 7 closer together. laying, one of the tabs 6, 7 is glued on top of the other, reproducing a fastening appearance said tie.

Then the proximal portion of the catheter is inserted into the sheath 31, until the upper mouth 32 is placed substantially at the height of the upper transverse edge 24 of the adhesive strip 22. peelable strip 23 is then removed and the second portion 30 is fixed on the adhesive strip 22, so that the mouth 32 is substantially above the upper transverse edge 24 of the adhesive strip 22.

Then the third part 40 of the device is placed so as to cover the first part and consequently close the upper mouth 32 of the sleeve 31.

Finally, the lower mouth 33 of the sleeve 31 is closed by means of the reversible closing means.

In an alternative embodiment, the device comprises a line of weakness facilitating the cutting of the sleeve 31 in an emergency, for example in case of oozing of the emergence point, or when an infusion must be performed. The risk of damaging the catheter during this cutting is acceptable in these cases of urgency, this risk being offset by the benefit of a rapid intervention without having to remove the entire device.

In an alternative embodiment, the sleeve houses a separator, for example a piece of Y-shaped polymer material, for placing the free ends of a catheter away from one another in the sheath.

In an alternative embodiment, the sheath comprises a longitudinal separation line and is provided with two lower transverse mouths, the sheath comprising two lower tubular parts each housing a tube of the catheter.

In an alternative embodiment, two or more sleeves are fixed on the first part of the device, each sleeve being able to house a proximal tubular end portion of a catheter.

The device has many advantages.

During the dialysis session, the clamps and the ends of the catheter can be manipulated through the sheath 31, advantageously transparent, according to a "no touch" technique, reducing the risk of infection.

At the end of the dialysis session, the catheter tips are protected by the caps without touching them directly.

In the absence of abnormalities in the zone of emergence of the catheter (redness, oozing), pain on palpation, the setting up of a new device is not necessary at each new dialysis session, with time savings for the patient and the nursing staff that result.

The device is advantageously dry, around the emergence zone of the catheter, to prevent any maceration.

The placement of the device can be performed without significant displacement of the catheter, particularly without risk of traction on the catheter and without bending the proximal ends of the catheter.

The external branches of the catheter remain visible through the sheath, as well as the emergence site, allow permanent visual control.

The insertion of the proximal portion of the catheter into the sheath of the device is easy: the upper transverse mouth can form a wide opening, for example 60 mm. It is not necessary to bend the catheter to introduce it into the tubular part of the device.

The proximal portion of the catheter, including its tips and clamps, is fully housed in the pouch pouch and thus protected.

The lower transverse mouth of the tubular portion may form a wide opening, for example 60 mm, allowing easy access to the end pieces. The reversible closure means makes it possible to keep the lower transverse mouth closed as long as access to the proximal portion of the catheter is not required, and to temporarily open this lower transverse mouth when access to the catheter is desired.

Claims

1. A device for protecting the proximal portion of a catheter, in particular a dialysis catheter, this device comprising a substantially flat first portion (1) provided with a passage hole for the catheter facing its emergence site, a second flexible tubular portion (30) forming a pocket for containing the proximal portion of the catheter, said second portion (30) comprising an upper transverse mouth (32), characterized in that the second portion (30) comprises a lower transverse mouth ( 33) and reversible closing means of this lower transverse mouth (33), the first part (1) comprising, on one of its faces called recto, an adhesive zone (18, 19) for its attachment to the skin of a patient, the first part (1) being provided, on its opposite side called back, an adhesive zone (22) for fixing the second portion (30) to the first part (1).

2. Device according to claim 1, characterized in that it comprises a third portion (40) intended to cover the first part (1) and the upper mouth (32) of the second part (30), this third part ( 40) comprising a non-adhesive window (41) and an adhesive edge (42).

3. Device according to claim 2, characterized in that the third part (40) comprises a film impermeable to fluids and pathogenic microorganisms and permeable to water vapor, this film being in a material selected from the group comprising polyurethane polyetherurethane, polyetheretheramide, polyetherester.

4. Device according to claims 2 or 3, characterized in that the film is of thickness between 5 and 200 microns, preferably between 10 and 75 microns.

5. Device according to any one of claims 1 to 4, characterized in that the first part (1) is made of non-woven fabric or foam.

6. Device according to claim 5, characterized in that the first part (1) is carried out dry, the bonding being carried out by latex spray coating, or by incorporation of fibers or thermo-binder powders then heat treatment, or by compression of fibers.

7. Device according to any one of claims 1 to 6, characterized in that the first part (1) contains an active ingredient selected from the group consisting of silver salts, antiseptics, painkillers.

8. Device according to any one of claims 1 to 7, characterized in that the second portion (30) comprises a tubular sheath (31) of transparent or translucent polymer material.

9. Device according to any one of claims 1 to 8, characterized in that the reversible closure means comprise a hook-and-loop tape, or an adhesive tape (34), or a zip.

10. Device according to any one of claims 1 to 9, characterized in that the first part (1) has a lower section (8) and a solid upper section (9) provided with the hole (2) passage, the section lower (8) being of greater width than the upper section (9).

11. Device according to any one of claims 1 to 10, characterized in that the hole (2) of passage is formed of a slot (3) longitudinal upper and an opening (4) oblong transverse.

12. Device according to claim 11, characterized in that the first portion (1) comprises two tongues (6, 7) for gripping, on either side of the slot (3) upper, each tongue (6, 7). carrying an adhesive tape (14, 15) on the back of the first part (1).

13. Device according to any one of claims 1 to 12, characterized in that the first portion (1) has a lower section (8) and a solid upper section (9) provided with the hole (2) passage, the section lower section (8) having, on the back side, two lateral adhesive strips (18, 19).

14. A catheter grooming kit comprising a device according to any one of claims 1 to 13.

15. Dialysis kit, in particular hemodialysis, comprising a dialysis catheter and a device according to any one of claims 1 to 13.