Device for protecting the proximal part of a catheter

Abstract

Device (1) for protecting the proximal part of a catheter, in particular a dialysis catheter comprising at least one tube, said device (1) comprising a first part (A) provided with adhesive means intended to face the site at which the catheter comes out, the device (1) comprising a second part (B) forming a pouch (2) for containing the proximal part of the catheter, characterised in that the adhesive means have a force of adhesion to the tube of the catheter of less than 0.5 N / cm.

Description

[0001] DEVICE FOR PROTECTING THE PROXIMAL PORTION OF A CATHETER

[0002] The invention relates to a device for protecting a catheter, during medical or veterinary use.

[0003] The invention relates in particular to devices for protecting a deep catheter or a central venous catheter.

[0004] By "catheter" is meant here a device comprising a flexible tubular section, a first end part, called distal, of this tubular section being intended to be inserted into a cavity of a human or animal body; a second end 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 part and the distal part; the tubular section defining, when seen in cross-section, at least one lumen; the distal part of the tubular section comprising an extreme distal orifice and optionally at least one lateral orifice; the proximal part of the tubular section comprising a proximal orifice.

[0005] By "flexible tubular section" we mean here the capacity of the tubular section to be bent manually, without kinking, this capacity being linked to the materials used for the manufacture of this flexible tubular section, and to the shape of this section.

[0006] As examples, the catheters considered here are made of materials with good biocompatibility such as silicones, polyurethanes, polyurethane polymer (carbothane®) or polytetrafluoroethylenes.

[0007] By "cavity of the human or animal body" is meant here the 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.

[0008] The invention relates more particularly to 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 emergence site of a central venous dialysis catheter.

[0009] Permanent catheters should be distinguished from temporary medical devices comprising a tubular section (drains, bladder catheters, peripheral venous catheter, peripheral arterial catheter). Permanent catheters should also be distinguished from single-use intermittent medical devices. Central venous catheters for hemodialysis are conventionally formed by two separate catheters assembled together (double Canaud catheters, see also US57761 1 1 Tésio), or by catheters with two lumens, a first lumen ensuring the passage to the patient of the blood treated by the dialysis machine, the second lumen ensuring the passage of the blood to be treated from the patient to the dialysis machine.These two-lumen catheters can be of double D section (for example catheters marketed under the names VasCath, Opti-Flow, Palindrome, Mahurkar catheters, Schon catheters), or of double O section (catheters marketed under the name PermCath).

[0010] Central venous catheters are tunneled, with the exit sites of these catheters being distant from the central vein puncture point. For example, the jugular vein puncture point is located in the neck, while the exit sites are located six centimeters in the ipsilateral chest, after being passed through a subcutaneous tunnel.

[0011] Catheter fixation dressings conventionally comprise an absorbent pad made of stretchy, hydrophobic non-woven polyester coated with a hypoallergenic acrylic adhesive. These dressings only provide protection to the catheter entry site, as do transparent, semi-permeable films attached directly over the catheter entry site (e.g., those marketed under the names Opsite, Tegaderm, Bioclusive, Mefilm, Mepore). The proximal portion of the catheter is not protected.

[0012] There are several problems that arise for people with a catheter, particularly a venous dialysis catheter.

[0013] The first problem is discomfort. On the proximal part there are clamps that press on the skin, causing discomfort in certain positions, for example when the person moves during sleep.

[0014] A second problem is that people with a permanent catheter, for example dialysis patients and those undergoing chemotherapy, cannot easily wash themselves (bathe, shower) and also want the presence of the catheter to be as discreet as possible. Central venous catheters are also invasive devices and their presence is accompanied by risks of infection. In the event of infection, changing a central catheter is certainly possible, but often proves difficult, due to local stenoses or adhesions, this change also requiring a visit to the operating room, with at least locoregional anesthesia.

[0015] Infectious risks are potentially present during each dialysis session, the hemodialysis session lasting approximately four hours, and having to be carried out three times a week.

[0016] Infectious risks are also present between each dialysis, particularly following washing, as highlighted in a meta-analysis presented in 2022 by Maia et al. Moisture in hemodialysis catheter dressings and the risk of infection: an integrative review.

[0017] The main sources of infection are Staphilococcus aureus, Staphilococcus epidermidis, Pseudomonas aeruginosa, and Enterococcus faecalis, which are very common in our immediate environment. Yeasts such as Candida albicans can also contaminate catheters.

[0018] Taking into account infectious risks requires constant attention, particularly from healthcare staff, which is all the more delicate when patients are fragile, because they are agitated, or depressed, epileptic, or suffer from chorea, a neurodegenerative disease such as Parkinson's, Parkinson's syndrome, or suffer from convulsions for various reasons.

[0019] The infectious risks of central dialysis catheters can spread to the endocardium, or even to the entire body, by sometimes multi-resistant nosocomial germs. Minor infection can 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 carried by the entry orifice to the tunnel, or be internal to the catheter, an endoluminal infection being favored by the appearance of a biofilm or a fibrin sheath. The infection can also be combined with thrombosis.

[0020] Various means have been proposed in the prior art to limit the risk of infection. The use of permanent stoppers (Q-Syte, Tego) or specific locking solutions for the preventive treatment of infections (for example, marketed under the names Taurolock, Duralock, Citralock, Minoc-EDTA) only allows a partial reduction of the risk of infection.

[0021] Prevention of bacterial or fungal infections related to central catheters is based on strict hygiene rules and recommendations on the handling of catheter tips, as well as the preparation of dressings before and after dialysis procedures.Usually, the catheter dressing is performed before each start of dialysis according to a protocol of the following type: cleaning centered on the area of ​​emergence of the extracutaneous ends is carried out with a compress impregnated with alcohol or a disinfectant, then the free ends of the catheter and the skin area opposite are disinfected; in a second step, a gauze is placed around the ends of the catheter at its site of emergence, then a transparent polyurethane adhesive dressing is applied, this dressing being waterproof and breathable; the proximal part of the catheter, usually carrying the clamps, is surrounded by a gauze or a tubular bandage (for example marketed under the name 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 the clamps.

[0022] At the end of the dialysis session, the external tips of the catheter are disinfected and locked, and several compresses are placed over them, the whole being fixed by transparent polyurethane adhesive dressings.

[0023] To reduce the risk of infection, it has also been proposed that the materials forming the catheters be modified, particularly on the surface, with anti-adhesive products (e.g. polysaccharides, polyethylene glycol), bactericidal agents or anticoagulants.

[0024] Several devices have been devised in the prior art to attempt to improve patient comfort and reduce the risk of infection.

[0025] Several catheter protection devices have been or are still commercially available, for example under the names Diapouch (Nordic Medcom company), CathGuard (RPC company, Tucson), Protecath (LKN Medical company), Idelio (Hemodia company), Cath Dry (Dabel, Cath Dry Inc.), Exit-Pocket WP (Emodial), Solukat (Gergonne).

[0026] Reference may also be made, as an illustration of the prior art, to documents WO2021 1 62695 (Dabel), WO20151661 57 (Nephrokit), W0201 21 01265 (Prosys), CN 1 065121 79 (Wu), US2021308426 (Bushy), US2014323967 (Mancino), US20140046263 (Salazar), US20080077064 (Bockol), US2008208145 (McCulloch), US200801 67626 (Beery), US20070282271 (Kaplan), US200521 1 590 (McClure) , US2004074501 (Altman), US2003221693 (Altman), US2003056794 (Altman), US5605546 (Wolzinger), Sanford Altman Showering with central venous catheters experience using the CD-1000 composite dressing, Dialysis & Transplantation, 2006, pp. 1 -4.

[0027] Some prior art devices are presented below, with their drawbacks.

[0028] Document FR 2748661 (Vogel) proposes a device presented as a hermetic protection for the tips of deep catheters, this device comprising a transparent waterproof polyethylene bag, this bag being cut to access the tips and connect them to the dialysis machine. The polyethylene bag has a window at the top, a non-woven compress being placed in line with this window, this compress comprising two parallel slits for the passage of the catheter tips. An adhesive tape peripheral to the window ensures the attachment of the bag to the patient's skin.

[0029] The device described in document FR 2748661 and operated under the name Idélio has many disadvantages. Firstly, taking a bath or shower is not possible, due to the entry of water into the bag, the non-woven compress being absorbent and releasing its water inside the bag, increasing the internal humidity in the bag, with the resulting risks of maceration and congestion, and the resulting risks of infection. Furthermore, the need to cut the bag to access the catheter tips leads to risks of damage to the tips or the walls of the catheter, any cut in the wall of the catheter creating a relief conducive to the appearance of a biofilm, promoting the development of pathogenic germs.This risk is further aggravated by the possible use of catheters with an antibacterial surface treatment, a surface treatment which risks being degraded by contact with a sharp tool when cutting the bag. A cut in the catheter wall can constitute an initiation of rupture, this risk of rupture by fatigue being all the higher as the catheters are worn for very long periods, sometimes several years, with manipulations several times a week, at each dialysis session.

[0030] WO 201 1058397 (Pillai) proposes a device claimed to protect a catheter from infection. This device comprises a pouch with a lower opening and a side window. After removal of a peelable seal, an adhesive placed around the window of the pouch allows the pouch to be fixed around the catheter entry point. A suction valve is provided for suctioning air from the pouch.

[0031] The device described in document WO 201 1 058397 has many disadvantages. Firstly, its installation is delicate, the operator having to pass the entire external part of the catheter inside the bag before sticking the bag against the patient's skin, this operation having to be carried out without exerting traction on the catheter and without accidentally sticking the bag to the operator's gloves or to the catheter or the patient's skin. Furthermore, the depression of the bag complicates its opening for dialysis and requires the availability of technical suction means when installing the device.

[0032] US 20080208145 (Mc Culloch) describes a device claimed to allow dialysis patients with a central venous catheter to take showers. This single-use device forms a pocket around a sheath surrounding the proximal end of the catheter, with a dressing also covering the catheter entry point. A desiccant is placed inside the pocket.

[0033] The device described in US 200802081445 has many disadvantages. The presence of a desiccant poses a risk of burning the patient's skin, a risk that is all the greater since the patient will be reluctant, in the event of discomfort, to quickly remove the device for fear of damaging the catheter. The device is large and is not discreet to wear.

[0034] Document EP 671 1 82 (Jerlôw) describes a device presented as allowing patients with a peritoneal dialysis or hemodialysis catheter to take a shower or practice swimming. The device comprises a bag made of waterproof and transparent polymer material, provided with an opening surrounded by an adhesive and breathable disc, this adhesive disc allowing the bag to be fixed around the point of emergence of the catheter. The bag also comprises a lower opening provided with zip-type closing means, allowing access to the connectors. A desiccant is placed in the bag, for example silica gel.

[0035] The device described in document EP 671 182 is presented as inspired by the structure of colostomy bags and has several drawbacks. Unlike colostomy bags conventionally placed on a support or skin protector, the bag described in document EP 671 182 integrates its fixing support and is therefore not easily put in place. It is not easy to pass the proximal part of the catheter through the rear opening of the bag, especially since the proximal end of the catheter comprises two flexible tubular sections beyond the emergence point, each section carrying a clamp and a tip that are more or less bulky depending on the catheter models. Furthermore, the device has a significant thickness, at the catheter emergence zone. The desiccant, placed in the upper part of the bag, is also likely to leak and cause irritation to the patient's skin.Finally, when a person washes, there is a risk of water stagnating between the bag and its support, in the upper part of the device.

[0036] GB 2477042 (Steer) describes a device claimed to enable a person with a central venous catheter to shower. The device comprises two elements made of an impermeable polymer material, for example polyethylene, the two elements being separate or not. A first element is a bag with a side opening, which opening is surrounded by an adhesive strip. The second element is a strip with a U-shaped adhesive edge, the second element being stuck to the patient's skin above the first element.

[0037] The device described in GB 2477042 has several drawbacks. It is not easy to pass the proximal part 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 emergence point, each section carrying a clamp and a tip that are more or less bulky depending on the catheter model. The superposition of two adhesive films opposite the emergence zone of the catheters increases the risk of allergic reaction and reduces the visibility of the catheter emergence zone.

[0038] Document CA 2741926 (Pecorari) describes a device presented as reducing the risks of infection of central venous catheters. The device uses dressings whose fibers are coated with aluminum or silver, this arrangement being said to promote hemostasis and prevent infection. The device comprises a pocket provided with an upper opening and a tab made of non-adhesive non-woven material, this tab being provided with a notch for the passage of a catheter, the opening of the pocket and the tab being covered by an adhesive strip. The notch is of such a shape and dimensions that the entirety of the skin surrounding the catheter emergence site is covered by the non-woven tab.

[0039] The device described in document CA 2741 926 has several disadvantages. If the notch made in the non-adhesive non-woven tab is smaller than that of the catheter, positioning this tab around the catheter is difficult and the catheter emergence zone is masked by the non-woven tab. Conversely, if the notch made in the non-adhesive non-woven tab is larger than that of the catheter, it cannot be ensured that this tab is held in position around the catheter emergence point.

[0040] The catheter protection devices proposed in the prior art have several disadvantages.

[0041] Firstly, most of these protective devices do not prevent the presence of moisture on the catheter when showering, with the resulting risk of infection. This risk is such that the French National Authority for Health recommends temporarily protecting the catheter dressing with a waterproof material when showering or when exposed to water (HAS, 2005), and recommendations for patients with a central venous catheter most often include a ban on showering, with an impact on quality of life. Secondly, removing these protective devices is often painful, even traumatic, with risks of ulceration or injury to the skin, even though patients' skin is often fragile. This is particularly the case for dialysis patients who are most often elderly, with nearly 40% of dialysis patients in France being over 75 years old.In addition, the skin of dialysis patients may undergo a premature aging process, with the appearance of pruritus and xerosis, and a reduction in the number of sweat glands.

[0042] Third, prior art protective devices are often adherent to the catheter, with the resulting risks of traction on the catheter or alteration of the catheter surface upon removal of the device. This disadvantage is aggravated when the protective device obscures the catheter entry point through the skin. Traction on the catheter upon removal of the protective device may be painful or even cause the catheter to dislodge. Alteration of the catheter surface may degrade its protection against bacteria.

[0043] Furthermore, the prior art protection devices are sometimes made up of several parts, which must be put in place successively, in a particular order, with the resulting difficulties for a person who wishes to fit the device alone. The invention aims to provide a product providing numerous advantages making it possible to largely alleviate the difficulties mentioned.

[0044] The invention aims in particular to provide a device for protecting a catheter which significantly reduces the risks of contamination, while improving patient comfort, in particular when inserting or removing the device.

[0045] For these purposes, the invention relates, according to a first aspect, to a device for protecting the proximal part of a catheter, in particular a dialysis catheter, comprising at least one tube, this device comprising a first part provided with adhesive means intended to come opposite the emergence site of the catheter, the device comprising a second part forming a pocket for containing the proximal part of the catheter, the adhesive means having an adhesion force to the tube of the catheter of less than 0.5N / cm.

[0046] The risks of alteration of the catheter surface are thus reduced.

[0047] Comfort during device removal is increased. When removing the device, the risks of catheter movement, or even tearing of the catheter, are greatly reduced.

[0048] Advantageously, the adhesive means comprise a silicone gel. The adhesion force to the skin is thus reduced, the removal of the device being atraumatic.

[0049] Advantageously, the device is a single unit.

[0050] This makes it easier to install and remove the device, especially for a single person.

[0051] Advantageously, the adhesive means have an adhesion force to the skin of less than 0.2N / cm and preferably of the order of 0.06N / cm.

[0052] Advantageously, the second part forms a flexible pocket that is impermeable to fluids.

[0053] Advantageously, the second part forms a pocket permeable to water vapor.

[0054] In certain implementations, the pocket is formed by assembling two strips of film made from a material chosen from the group comprising polyurethanes, polyetherurethanes, polyetheramides, polyetheresters.

[0055] For example, silicone gel adhesive is coated on film strips.

[0056] Advantageously, the pouch is formed by assembling two strips of film, a ribbon of absorbent material being fixed inside the pouch on each of the two strips of film, one ribbon extending into the first part of the device.

[0057] In some implementations, the tape comprises a nonwoven provided with absorbent fibers selected from the group comprising cellulose fibers, rayon fibers or viscose fibers.

[0058] In certain particular implementations, the tape is made of a complex comprising a non-woven fabric covered with a polymer film such as polyethylene.

[0059] The invention relates, according to a second aspect, to a catheter dressing kit comprising a device as presented above.

[0060] The invention relates, according to a third aspect, to a dialysis kit, in particular hemodialysis, comprising a dialysis catheter and a device as presented above. Other objects and advantages of the invention will appear in the light of the description of embodiments, given below with reference to the appended drawings in which:

[0061] - Figure 1 is a front view of a catheter protection device, according to one embodiment;

[0062] - Figure 2 is a schematic sectional view illustrating the assembly of the elements of a catheter protection device, according to one embodiment;

[0063] - Figure 3 is an exploded perspective view illustrating the elements of a catheter protection device, according to one embodiment.

[0064] In the remainder of this description, the term device will be used, for the sake of simplicity, to designate a device for protecting a deep catheter or a central venous catheter, such as, for example, a dialysis catheter or a chemotherapy catheter.

[0065] In the remainder of this description, the horizontal direction and the vertical direction refer to a device laid flat, as shown in Figure 1, the term width being used in relation to the horizontal direction and the term height being used in relation to the vertical direction, without the use of these terms imposing an orientation on the device during its use.

[0066] In the remainder of this description, the expression emergence site will be used to designate the site of insertion of a catheter through the skin, this site being unique for certain catheters (for example marketed under the names Vascath, Permcath, Hemosplit, Pristine), two neighboring insertion sites being necessary for catheters with two independent channels (Canaud catheter, for example marketed under the name Duet).

[0067] The device 1 is advantageously monobloc, that is to say a single piece, and is obtained by assembling several elements. An embodiment of the different elements forming this assembly is shown diagrammatically in Figure 2.

[0068] The device 1 comprises a part A provided with means for fixing to the skin, opposite and around the emergence site, and a part B defining an impermeable and flexible pocket 2, capable of containing the proximal end part of a catheter, in particular the flexible tubular sections of the catheter and the tips. The catheter is in particular a two-way hemodialysis catheter, comprising a tubular section for the venous route and a tubular section for the arterial route, each of the two tubular sections carrying a clamp and an end cap, for example of the “Luer-lock” type.

[0069] In the embodiment shown in Figure 1, part B of the device 1 is rectangular and of substantially constant width over its entire height. For information purposes, the width of part B is 70 mm and its height is 155 mm.

[0070] In the embodiment shown in Figure 1, part A of the device 1 is rectangular and its width is substantially constant over its entire height. For information purposes, the width of part A is 95 mm and its height is 60 mm.

[0071] By pocket we mean here an elongated cavity, open at one end, forming a case, sheath, sock or protective sheath for the catheter.

[0072] For information purposes, pocket 2 is roughly rectangular in outline and has a length of 195 mm and a width of 50 mm.

[0073] The length of the pouch is adapted to the length of the proximal part of the catheter to be protected. This length is advantageously such that the distal end of the catheter can be fully housed in the pouch, without bending. The risks of kinking and damage to the catheter are thus avoided.

[0074] The width of the pocket is adapted to the shape of the proximal part of the catheter to be protected. For example, some catheters have three separate channels, with the proximal part of the catheter comprising three tubes and being wider than that of a two-channel catheter.

[0075] By waterproof pocket, we mean the property of the pocket not to let fluids pass through, and in particular water.

[0076] By flexible here is meant the ability to be folded by hand. The flexibility of the bag 2 allows it to be opened and the manual insertion into the bag 2 of the proximal end part of the catheter, with its tips, clamps and end caps. The flexibility of the bag 2 also allows it to be comfortably applied to the skin, for example against the thorax of a patient wearing a central venous catheter. Advantageously, the bag 2 is formed by assembling two strips of film 3, 4 which are impermeable to fluids and pathogenic microorganisms and permeable to water vapor.

[0077] Depending on the materials used for the film strips 3, 4, the assembly of these two strips can be carried out by gluing or welding, in particular by high-frequency welding or ultrasonic welding.

[0078] In certain implementations, the film strips 3, 4 are made of a material chosen from the group comprising polyurethanes, polyetherurethanes, polyetheramides, polyetheresters.

[0079] Advantageously, the film strips 3, 4 are made of biocompatible medical polyurethane.

[0080] Advantageously, the film strips 3, 4 are manufactured in a clean room and the elements constituting the device 1 are assembled in a clean room.

[0081] In some implementations, the film strips 3, 4 are thin, with a thickness of between 5 and 200 microns, preferably between 10 and 75 microns.

[0082] In certain implementations, the film strips 3, 4 are transparent or translucent, in particular with a matte finish.

[0083] In other implementations, the film strips 3, 4 are flesh-colored, for greater discretion of the device 1.

[0084] For information, the two strips of film 3, 4 are assembled at their periphery over a width of approximately 10 mm.

[0085] The horizontal dashes 5, 6 and the vertical dashes 7, 8 in Figure 1 delimit the edges of the pocket 2. As will appear in the remainder of this description, the horizontal dashes 5, 6 correspond, in certain implementations, to the top and bottom edges of an absorbent tape fixed to each of the two strips of film 3, 4, inside the pocket 2.

[0086] In the embodiment shown in figure 1, the pocket 2 is closed in the lower part of the device 1, and open in the upper part of the device 1, allowing the entry into the pocket 2 of the proximal end part of a catheter.

[0087] In other embodiments, not shown, the pocket 2 is provided with closing means in the lower part, for example of the self-gripping strip type or zipper type. In the embodiment shown in Figure 2, the film strips 3, 4 are adhesively bonded on a single face, internal to the pocket 2, in particular by an acrylic adhesive. This adhesive layer 9, 10 is shown diagrammatically by crosses in Figure 2.

[0088] The presence of this adhesive layer 9, 10 allows the fixing, inside the pocket 2, on each strip of film 3, 4, of a ribbon 11, 12 made of absorbent material.

[0089] The acrylic adhesive 9, 10 ensures strong adhesion of each of the two tapes 11, 12 to a strip of film 3, 4.

[0090] The tapes 11, 12 are for example made of non-woven fabric, for example gauze or foam. The non-woven fabric may comprise absorbent fibers such as cellulose fibers, rayon or viscose fibers.

[0091] Nonwovens are, for example, produced using the dry-process manufacturing method known as "airlaid" or aerodynamic process. Bonding can be achieved by latex spray coating, or by incorporating thermo-adhesive fibers or powders followed by heat treatment, or by compressing the fibers.

[0092] In certain implementations, the ribbons 11, 12 are made of a complex comprising a non-woven fabric covered with a polymer film such as polyethylene.

[0093] In some implementations, the ribbons 11, 12 contain an active ingredient, for example an antibacterial such as a silver salt, an antiseptic.

[0094] The ribbons 11, 12 provide protection for the end of the catheter located in the pocket 2, in particular against shocks and friction.

[0095] Advantageously, the ribbons 11, 12 have a width substantially equal to the width of the pocket 2. For information, the ribbons 11, 12 have a width of 50 mm.

[0096] In the embodiments shown in figures 2 and 3, the two ribbons 11, 12 are not of identical heights, a first ribbon 11 extending over a height less than that of the second ribbon 12.

[0097] The upper edge 12a of the second ribbon 12 appears in dashes in figure 1, the upper edge 11a of the first ribbon 11 being substantially coincident with the upper edge 6 of the pocket 2. In the embodiment shown in figure 2, the lower edges 11b, 12b of the two ribbons 11, 12 are substantially arranged at the lower edge of the pocket 2.

[0098] For information, the first ribbon 1 1 extends over a height of 165 mm, from the lower edge of the pocket 2, and the second ribbon 1 2 extends over a height of 1 95 mm from the lower edge of the pocket 2.

[0099] The device 1 can be attached to the skin in two orientations.

[0100] In a first orientation, it is the film strip 4 on which the second ribbon 1 2 is fixed which is placed against the skin, and it is the film strip 3 which covers the emergence site. When the film strip 3 is translucent or transparent, it is thus possible to see the emergence point of the catheter. This arrangement advantageously makes it possible to see, for example, the Dacron® sleeve of a tunneled dialysis catheter, and to detect the presence of redness or purulent discharge at the point of entry of the catheter into the skin, which are signs of a possible infection.

[0101] In a second possible orientation of the device 1, it is the film strip 3 on which the first ribbon 11 is fixed which is placed against the skin, and it is the film strip 4 which covers the emergence site, which is then hidden from view. This configuration for placing the device 1 may be preferred by the patient, for his visual comfort.

[0102] The arrangement of two ribbons 1 1 , 1 2 of different heights thus makes it possible to choose whether or not to leave the catheter emergence site visible, depending on the preferences of the patient and the medical staff.

[0103] In the embodiment shown in Figure 2, the first ribbon 11 extends over the entire height of the pocket 2.

[0104] In the embodiment shown in Figure 2, the second ribbon 12 extends over the entire height of the pocket 2 and also extends over substantially half the height of the part A of the device 1.

[0105] The upper part A of the device 1 comprises means for fixing to the skin.

[0106] Advantageously, these fixing means comprise an atraumatic adhesive, such as a silicone gel 13, 14, carried by one face of a support film 15, 16. This atraumatic adhesive is shown diagrammatically by circles in figure 2.

[0107] The opposite face of the support film 15, 16 is advantageously fixed to the internal face of the films 3, 4 carrying for example an acrylic adhesive. In certain implementations, the support film 15, 16 is made of a material chosen from the group comprising polyurethanes, polyetherurethanes, polyetheramides, polyetheresters.

[0108] Advantageously, the support film 1 5, 1 6 is made of medical, biocompatible polyurethane, for example identical to the material forming the film strips 3, 4.

[0109] In some implementations, the atraumatic adhesive, for example based on silicone gel, is coated on one side of each polyurethane support film 15, 16.

[0110] Before the first use of the device 1, the silicone gel 13, 14 is covered with a removable strip 17, 18 provided with a gripping tab 19, 20.

[0111] The removable strips 1 7, 1 8 form protection for the silicone gel and are made, for example, of polyethylene terephthalate (PET), in particular transparent PET.

[0112] Silicone gel here means a silicone compound in crosslinked form.

[0113] Silicone gel provides adhesion to the skin and low peel release force.

[0114] The silicone gel has such cohesion that it does not leave any residue on the skin when the device 1 is removed.

[0115] Silicone gel can be made from silicone precursors that crosslink after contact following a hydrosilylation or condensation reaction.

[0116] The silicone gel can be obtained from a mixture of a poly-di-organosiloxane resin and catalyst, for example in a weight ratio of these aforementioned compounds of 1:1, 3:1 or even 10:1, said mixture of poly-di-organosiloxane and catalyst being subjected to crosslinking.

[0117] For example, silicone gel is chosen from products marketed under the brands Silpuran (Wacker Chemie AG), Silbione (Elkem), MG7 (Dow Corining).

[0118] In the embodiment shown in Figure 2, the device 1 is provided, on each of the two opposite faces of its part A, with a carrier strip 21, 22 carrying a selvedge 23, 24.

[0119] The edge 23, 24 is advantageously colored and opaque, ensuring visual marking and attracting the user's attention, facilitating the use of the device 1, the other elements of the device being predominantly white (in particular the ribbons 11, 12 and the strips 17, 18), or predominantly gray and transparent or translucent (film strips 3, 4).

[0120] The edge 23, 24 visually highlights the boundary between part A and part B of the device 1.

[0121] The carrier strips 21, 22 and the strips 17, 18 form two articulation lines 25, 26 for the first part A of the device 1, relative to the second part B.

[0122] The selvedge 23, 24 is for example made of polypropylene and is fixed by an acrylic adhesive on each carrier strip 21, 22. This layer of acrylic adhesive is represented by crosses in figure 2.

[0123] For information purposes, each of the two edges 23, 24 has a height of the order of 20 mm and extends over the entire width of the first part A of the device 1.

[0124] In one embodiment, part A of the device 1 comprises, starting from a first external face of the device 1 and going towards the opposite external face, a selvedge 23, a layer of adhesive, for example acrylic, for fixing the selvedge 23 to a carrier strip 22, a film 4, for example polyurethane, a layer of adhesive, for example acrylic, for fixing a support film 16, a layer of atraumatic adhesive, for example silicone gel. Part A then comprises the upper part of the second tape 12 and a removable strip 18.

[0125] Starting from the opposite external face and returning towards the first external face, part A of the device 1 comprises a selvedge 24, a layer of adhesive, for example acrylic, for fixing the selvedge 24 to a carrier strip 21, a film 3, for example polyurethane, a layer of adhesive, for example acrylic, for fixing a support film 17, a layer of atraumatic adhesive, for example silicone gel. Part A then comprises a removable strip 17.

[0126] After removal of the strips 17, 18, part A is advantageously transparent or translucent.

[0127] In the embodiment shown in Figure 2, the device 1 has a plane of symmetry passing halfway between the two films 3, 4, with the sole exception of the greater height of the second ribbon 12 relative to the first ribbon 11.

[0128] The device 1 can thus be fixed to the patient's skin in two orientations, with the film 3 or the film 4 facing the patient's skin. These two orientations offer the same quality of protection for the proximal end of the catheter contained in the bag 2, in particular against shocks or friction. The end of the catheter contained in the bag 2 is also protected from contact with water or hands, reducing the risk of infection and facilitating washing, in particular showering.

[0129] Advantageously, part B of the device 1 is provided with means for fixing to the skin, for example in the form of at least one adhesive border 30 fixed for example by an acrylic adhesive on the film 4 and / or on the film 3. The acrylic adhesive for fixing the border 30 is shown diagrammatically by crosses in figure 2.

[0130] A protective tab 31 covers the adhesive border 30 before first use.

[0131] In the embodiment shown in Figure 2, only one adhesive border is provided.

[0132] In other embodiments, not shown, an adhesive border is arranged on each of the two opposite faces of the device 1.

[0133] In certain embodiments, the adhesive border 30 comprises a double-sided adhesive, a first face, for example made of acrylic, being arranged on the side of the film strip 4, the second face of the border 30, advantageously made of silicone gel, being arranged on the skin side. These arrangements make it possible to reduce the risks of irritation, when fixing the part B of the device to the skin.

[0134] The device 1 is advantageously delivered sterile. Sterilization is carried out, for example, using ethylene oxide.

[0135] The use of polyurethane films 3, 4 ensures a bacterial barrier, water impermeability and gas permeability. The device 1 is advantageously placed at the end of a dialysis or chemotherapy session, and can remain in place for several days and ensure effective protection of the catheter exit point, until the next dialysis or chemotherapy session.

[0136] The device 1 can be placed on the skin, at the emergence site of a catheter to be protected, in the following manner.

[0137] In a first step, it is chosen to place the device 1 while keeping or not keeping the catheter emergence site visible, according to the patient's wishes or the requests of the nursing staff. The bag 2 is then opened and the two flaps of part A are articulated in relation to part B, around lines 25, 26.

[0138] A first part of part A, comprising all the elements between the edge 24 and the strip 17, pivots around the line

[0139] 25 and comes opposite film 3, the person placing device 1 having a hand slipped between this first panel and film 3.

[0140] The second part of part A, comprising all the elements between the edge 23 and the strip 18, pivots around the line

[0141] 26 and comes opposite film 4, the person placing device 1 having his other hand slipped between this second panel and film 4.

[0142] The proximal end of the catheter is manually slid into pocket 2, moving device 1 up towards the catheter's emergence point.

[0143] Then, one of the two strips 17, 18 is peeled off and one of the two flaps of part A of the device 1 is fixed to the skin, opposite the catheter emergence site, the surface of this flap carrying an atraumatic adhesive such as a silicone gel for fixing to the skin.

[0144] In one implementation, it is the first flap of part A which is fixed to the skin, and the emergence point of the catheter is then covered by the film 1 5. The emergence point is thus advantageously left visible, through the two films 3, 1 5.

[0145] In another alternative implementation, it is the second part of part A which is fixed to the skin, and the emergence point is then hidden from view, but protected from shocks, by the presence of the second tape 1 2.

[0146] When the first flap of part A is attached to the patient's skin, part B of the device 1 is lifted and the strip 18 is manually removed, the second flap of part A then being attached to the patient's skin. In this placement, the emergence site is left visible.

[0147] Alternatively, when the second flap of part A is secured to the patient's skin, part B of the device is lifted and the strip 17 is manually removed, the first flap of part A then being secured to the patient's skin. In this placement, the emergence site is covered by the tape 12.

[0148] When the device is placed, the two marking strips are used to locate the emergence site. When the two flaps are attached to the patient's skin, the two marking strips 23, 24 are removed.

[0149] If necessary, the edge 30 of part B of the device 1 is then fixed to the patient's skin.

[0150] The device 1 thus fixed is comfortable and discreet.

[0151] The opening of the pocket 2, through which the proximal end of the catheter passes, is surrounded by a continuous surface of atraumatic adhesive, advantageously based on silicone gel, and advantageously over a large width.

[0152] This provides a secure and waterproof attachment to the skin, making washing easier, especially showering.

[0153] The use of an adhesive having an adhesion force to the catheter tube of less than 0.5N / cm is advantageous in combination with the presence of two ribbons 1 1 , 12 of unequal heights.

[0154] In other embodiments, not shown, the two ribbons 11, 12 are of identical heights and extend into part A of the device 1.

[0155] Device 1 has many advantages.

[0156] Device 1 protects the skin against friction from the catheter, the proximal part of which is housed in pocket 2. This protection is all the more important when the skin is fragile, when the person is elderly or on dialysis.

[0157] Device 1 protects the proximal part of the catheter against friction, particularly from clothing, and against impacts. This protection is all the more useful since the catheter is intended to be worn for a long period, several years for dialysis patients.

[0158] Device 1 protects the catheter entry site and the entire proximal portion of the catheter from water and hand contact. This makes washing easier, especially showering. The risk of infection is reduced.

[0159] Device 1 allows the catheter exit site to be kept under visual control and signs of infection or tunnelitis to be detected.

[0160] The device 1 can be placed with or without the catheter exit site visible, depending on the risk of infection and the user's preferences. The use of an atraumatic adhesive such as silicone gel allows the first part A of the device to be directly fixed to and opposite the catheter exit point, maintaining good comfort when removing the device, the adhesion force to the skin being low.

[0161] Device 1 is a single-piece device, making it easy to install and remove by one person.

[0162] The pocket 2 is advantageously waterproof and permeable to water vapor, allowing the evacuation of any moisture formed in the pocket 2.

[0163] The device advantageously does not contain latex, does not contain carcinogenic, mutagenic or toxic chemical agents for reproduction (CMR cat 1 A or 1 B), endocrine disrupting substances, does not contain phthalates.

[0164] All adhesive surfaces of the device are protected before first use.

[0165] The adhesive force of the protective device 1 on the catheter is reduced, compared to the devices known in the prior art, which use acrylic-type adhesive materials.

[0166] This results in greater comfort for the patient when removing the device 1 , with reduced stress on the catheter tubing and reduced risk of catheter displacement.

[0167] Tests have been carried out, showing the importance of this advantage.

[0168] A strip of polyurethane (PU) material coated with an adhesive was placed in an adhesion measuring device on a dialysis catheter tube.

[0169] The measurement conditions are as follows: adhesion measurement at an angle of 180°, 10N measuring cell, 5 mm x 125 mm specimen, specimen glued to a catheter tube with application of pressure with two back and forth movements of a 2 kg FINAT roller, aging before testing for 72 hours at 23°C / 50% relative humidity, this duration of 72 hours corresponding to the maximum time between two dialysis sessions.

[0170] Three specimens were used for each configuration (catheter type and adhesive type).

[0171] Two types of adhesive were tested.

[0172] A first adhesive, from the state of the art, is acrylic. A product referenced M025 marketed by the applicant was used, this adhesive being acrylic, for medical use, with an adhesion force on the skin of the order of 0.5N / cm. The adhesive was placed on a polyurethane film 25 microns thick, with an adhesive quantity of 25g / m 2 .

[0173] A silicone gel adhesive was used for comparison with the state of the art. A product referenced M021 marketed by the applicant was used, this adhesive being a silicone gel, for medical use, with an adhesion force on the skin of the order of 0.06N / cm. The adhesive was placed on a 20 micron thick polyurethane film, with an adhesive quantity of 60 g / m 2 .

[0174] Multiple catheters were used.

[0175] Catheter 1 is marketed under the name “Symetrex long term hemodialysis catheter” by the company Medcomp and includes a double D section tube made of polyurethane.

[0176] Catheter 2 is marketed under the name “Tesio long term hemodialysis catheter” by the company Medcomp, and comprises two separate silicone tubes.

[0177] Catheter 3 is marketed under the name “Palindrome precision” by the company Covidien, and includes polyurethane tubes (carbothane®).

[0178] Catheter 4 is marketed under the name “Palindrome precision H-Heparin coated” by Covidien and includes polyurethane (carbothane®) tubes with a coating containing heparin.

[0179] The adhesion values ​​between the adhesive-coated PU film and the catheter tube are as follows:

[0180] The use of a silicone gel type adhesive allows for very low adhesion to the catheter tube, less than 0.5N / cm . Device 1 is easy to use, both for insertion and removal, as Device 1 is of the one-piece type (“all-in-one”) and has very low adhesion to the catheter tubing.

[0181] The surface of the catheters is therefore not altered when the device is removed. This advantage is all the more important since the surface of the catheters includes treatments intended to reduce the risks of bacterial colonization or infection. This advantage is all the more notable since the catheters are intended to be worn for long periods, several years for dialysis patients.

[0182] The risks of movement or even tearing of the catheter during removal of the device are reduced.

[0183] The use of atraumatic adhesive means, particularly silicone gel, allows for painless removal of the device.

Claims

Claims 1. Device (1) for protecting the proximal part of a catheter, in particular a dialysis catheter comprising at least one tube, this device (1) comprising a first part (A) provided with adhesive means intended to come opposite the emergence site of the catheter, the device (1) comprising a second part (B) forming a pocket (2) for containing the proximal part of the catheter, characterized in that the adhesive means have an adhesion force to the tube of the catheter of less than 0.5N / cm.

2. Device (1) according to claim 1, characterized in that the adhesive means comprise a silicone gel.

3. Device (1) according to any one of claims 1 or 2, characterized in that it is a single-piece device.

4. Device (1) according to any one of claims 1 to 3, characterized in that the adhesive means have an adhesion force to the skin of less than 0.2N / cm and preferably of the order of 0.06N / cm.

5. Device (1) according to any one of claims 1 to 4, characterized in that the second part (B) forms a pocket (2) which is flexible and impermeable to fluids.

6. Device (1) according to any one of claims 1 to 4, characterized in that the second part (B) forms a pocket (2) permeable to water vapor.

7. Device (1) according to any one of claims 1 to 6, characterized in that the pocket (2) is formed by assembling two strips of film (3, 4) made of a material chosen from the group comprising polyurethanes, polyetherurethanes, polyetheramides, polyetheresters.

8. Device (1) according to any one of claims 1 to 7, characterized in that the pocket (2) is formed by assembly of two strips of film (3, 4), a ribbon (11, 12) of absorbent material being fixed inside the pocket (2) on each of the two strips of film (3, 4), a ribbon (12) extending in the first part (A) of the device (1).

9. Device (1) according to claim 8, characterized in that the tape (11, 12) comprises a non-woven fabric provided with absorbent fibers chosen from the group comprising cellulose fibers, rayon or viscose fibers.

10. Device (1) according to claim 8 or 9, characterized in that the ribbon (11, 12) is made of a complex comprising a non-woven fabric covered with a polymer film such as polyethylene.

11. Catheter dressing kit comprising a device (1) according to any one of claims 1 to 10.

12. Dialysis kit, in particular hemodialysis, comprising a dialysis catheter and a device (1) according to any one of claims 1 to 10.

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