Dressing for puncture site, especially for arteriovenous fistula

Abstract

Dressing (1) for a puncture or infusion point, comprising a first sheet (2) of micro-perforated polymer material, a first face (3) of this first sheet being covered with a pressure-sensitive adhesive and being intended to be fixed to the skin by covering a puncture or infusion point, the opposite face of this first sheet being non-adhesive, the dressing comprising a second sheet (10) carrying a strip of compress-forming material (5), the second sheet extending in a longitudinal direction (L) and comprising two end portions in this longitudinal direction, the first end portion (13) being fixed to the non-adhesive face of the first sheet, the second sheet being deformable by manual gripping of the second end portion (15) and manual traction in the longitudinal direction, the second sheet comprising a rear face (11) provided with an adhesive. Figure 1

Description

Title of the invention: Dressing for puncture site, in particular for arteriovenous fistula

[0001] The invention relates to the medical or veterinary field.

[0002] The invention relates more particularly to a dressing for a puncture point or an infusion point.

[0003] By "puncture" is meant here the operation by which a substance, generally liquid, is evacuated from a part of the body of a man or an animal, by introduction of a pointed and hollow instrument, through the skin, for exploratory, diagnostic or therapeutic purposes.

[0004] An example of puncture is blood sampling, a routine treatment allowing laboratory tests on a blood sample taken by venous, capillary or arterial puncture. The hypodermic needle used for blood sampling is often connected to vacuum tubes (for example Vacutainer®, marketed by the company Becton Dickinson).

[0005] By "infusion" is meant here the operation by which a substance, generally liquid, is introduced into a cavity or into the vessels of the body of a man or an animal, by a pointed and hollow instrument, through the skin, for exploratory, diagnostic or therapeutic purposes.

[0006] An example of infusion is intravenous infusion, a common parenteral infusion technique allowing the drop-by-drop administration of medications, liquids or blood products into the veins, generally a peripheral vein of the upper limb. Intravenous infusion allows in particular the administration of volume correction solutions.

[0007] By "puncture point or infusion point" is meant here an area of ​​skin of the body of a human or animal through which a puncture or infusion device (in particular a needle, a catheter, a cannula) passes. By "skin" we mean the outer covering of the human or animal body, formed by the epidermis and the dermis.

[0008] By "dressing of a puncture or infusion point" is meant here a device covering the wound formed by the puncture or infusion point, in particular to protect the wound and promote healing.

[0009] The invention relates more particularly to the medical or veterinary use of a vascular puncture or infusion point, for example needle or catheter infusions or short intravenous devices of the cathlon® type (PTFE cannulas).

[0010] The invention relates more particularly to the field of hemodialysis.

[0011] It is common practice to withdraw or inject fluids or administer medications to a patient or animal, via a tube attached to a needle or catheter. It is estimated that approximately 80% of hospitalized patients receive treatment administered via an intravenous catheter.

[0012] For puncture or infusion, a device is inserted through the skin (hypodermic needle, catheter, cannula). For example, winged needles are used for transfusions, blood sampling in particular. Examples of winged needles can be found in the following US patents issued under the following numbers: 2725058, 3064648, 3640275, 4194504, 4300553, 4627842, 5108376, 5149328, 6270480.

[0013] For some patients, peripheral catheters are used chronically. This is particularly the case for patients suffering from acute or chronic renal failure and treated by hemodialysis, or extra-renal purification.

[0014] Three types of vascular access predominate for hemodialysis: arteriovenous fistulas (AVF), arteriovenous prostheses or grafts, and central venous catheters (CVC).

[0015] 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 brachial artery and its homonymous vein. This anastomosis increases blood flow within said vein.

[0016] The needle bringing the patient's blood to the dialysis machine is called an artery, the one returning the blood to the patient being called a vein.

[0017] When the needle is removed from a blood vessel or a dialysis fistula, several risks must be taken into account: risk of hemorrhage, risk of blood projection, risk of contamination of the healthcare personnel (bacterial or viral contamination).

[0018] After disconnecting the patient, there is a risk of persistent bleeding.

[0019] The risk of hemorrhage is very high for certain patients suffering from acute or chronic renal failure and treated by hemodialysis. During hemodialysis, an anticoagulant is often used to limit the risks of clogging of the capillary lumens by thrombosis, the anticoagulant used often being heparin (low molecular weight heparin LMWH, unfractionated heparin UFH). In addition, elderly dialysis patients frequently present with cardiac complications (ischemia, valvulopathy, arrhythmia) and, where appropriate, vascular complications (atheromatosis, arteritis) which require the prescription of an antiplatelet agent or an anticoagulant.

[0020] At the end of the dialysis session, any hemorrhage from the puncture site can prove fatal for the patient.

[0021] The risks of blood projection and contamination are significant, the spread of AIDS and hepatitis, among other blood-borne contagious diseases, having only made this risk more dreaded.

[0022] According to the circular of the General Delegation of Health, dated April 20, 1998 (DGS / DH / 98 / 249), relating to the prevention of the transmission of infectious agents carried by blood or biological fluids during care in health establishments, a "blood exposure accident" (AES) is defined as "any contact with blood or a biological fluid containing blood and involving either a break in the skin or a projection onto a mucous membrane (eye) or onto damaged skin."

[0023] According to the report of the AES-Raisin network for monitoring accidents with exposure to blood in French health establishments, for the years 2013-2014, the rate of AES per 100 beds is approximately 6%, and AES result in 20% of cases from a projection, in particular when withdrawing a needle through a patient's skin.

[0024] In a 2005 study, Tarantola et al. estimated that 25% of blood exposure accidents in hemodialysis are blood splashes (Accidents exposing caregivers to blood in hemodialysis: epidemiological data and prevention in France, Nephrology and Therapeutics, vol. 1, no. 3, 2005). A similar percentage was observed in a 2016 cross-sectional study (Amri et al. Archives of occupational and environmental diseases, vol. 77, June 2016).

[0025] The risk of transmission of infectious diseases during AES in hemodialysis is currently dominated by the hepatitis C virus, due to its high prevalence in hemodialysis patients. The risk of HIV transmission after exposure to the blood of an HIV-positive patient is estimated at an average of 0.32%. The risk of HBV transmission from an infected patient is very high: between 2% and 40%. This high contagiousness is linked to the very large quantity of virus present in blood and biological fluids (between 1 million and 1 billion viral particles per ml).

[0026] For hemodialysis sessions on AVFs, the most likely moment for contamination by blood projection is that of compression, mainly at the time of needle withdrawal. Indeed, the hemostatic compress may be imperfectly positioned on the puncture point, in particular for AVFs with a high flow rate or aneurysmal areas.

[0027] At the end of the dialysis session, when disconnecting, there is a risk of bacterial contamination, generally staphylococcal. This risk is high when compressing the puncture points or when bleeding recurs some time after the dialysis session.

[0028] Post-dialysis bleeding (distant bleeding) is also a source of anxiety. Some patients remain at risk, even after thirty minutes of manual compression (Perera et al. A novel use of 2-Octyl-cyanocrylate: Controlling post-hemodialysis Site Hemorrhage, The Journal of Emergency Medicine, 44 vol 2, pp. 467-468, 2013).

[0029] Hemostasis is sometimes long to obtain, with the means implemented in the state of the art.

[0030] According to an extremely common technique for obtaining hemostasis on an AVF, a compress, a tampon or cotton is placed at the puncture point, and manual pressure is applied to this compress or cotton, one or more adhesive strips holding the compress or cotton in place after releasing the manual pressure.

[0031] Conventionally, manual pressure with two fingers is applied to the compress, to obtain hemostasis, at the level of the external (skin) and internal (vascular wall) orifice left by the oblique path of the dialysis needle.

[0032] For a compression time of 10 minutes, manual compression represents more than two hours per day for a nurse, and approximately 780 hours per year.

[0033] A compression time of 10 minutes is not exceptional. According to Schwab et al., hemostasis is achieved within a variable time frame: in the order of 15 to 20 minutes (Prevention of hemodialysis fistula thrombosis. Early detection of venons stenosis, Kidney International, 36, pp. 707-711, 1989). Sallée et al., in a study of 1538 nurses working in 150 dialysis centers, mention compression times of more than 10 minutes as a median value (Clinical Kidney Journal, vol 14, pp 1261-1268, 2021).

[0034] In dialysis patients with a high blood flow AVF, the effect of anticoagulants is such that the bleeding time, at the puncture point, can be up to thirty minutes after the dialysis session (WO2004 / 060245 page 1, 3rd paragraph, WO03 / 099143, page 1 lines 11-20).

[0035] The flow rate of the AVF, as well as the presence of hyperpressure due to stenosis of the vascular access, can contribute to prolonging the compression time.

[0036] In dialysis patients with a high blood flow AVF, the effect of anticoagulants is such that the bleeding time at the puncture site can be up to forty-five minutes after the dialysis session. Maintaining pressure on the AVF for such a long time is tedious and tiring.

[0037] People suffering from neurodegenerative diseases (Parkinson's, Parkinsonian syndrome, Alzheimer's) may not be able to maintain manual pressure at the puncture site. The same is true for patients who are agitated, depressed, epileptic, or suffering from chorea, or who suffer from convulsions for various reasons.

[0038] It is then the nursing staff who ensure the compression of the puncture points at the end of dialysis (nursing staff, beneficiary attendants).

[0039] It is also necessary to regularly check that the bleeding has stopped at the puncture or infusion point, which requires removing the compress or cotton. This control can cause blood to be projected, with a risk of contamination of the nursing staff, or even hemorrhage, particularly when the patient is agitated or for dialysis patients who must compress both the venous and arterial access of the AVF. Bleeding can occur when compressing the puncture site, requiring a change of compress, as the presence of blood obscures the puncture site. Regular verification that the bleeding has stopped by partial or total removal of the compress can cause the hemostatic compress to adhere or not to the puncture site, with a risk of detachment of the platelet plug.

[0040] The wound formed during each dialysis session has specific characteristics.

[0041] First, this wound occurs in a small area, repeatedly, with large-diameter needles. A hemodialysis session lasts approximately four hours and must be performed three times a week. The needles used to puncture the AVFs are large-caliber, with an internal diameter typically varying between 1.6 and 2 mm. In a known technique (rope-laddef), the entry point of the needle is offset by a few centimeters compared to the previous session, in order to use the entire length of the fistula. In another technique, called the buttonhole technique, the needle is introduced at the same point, with the same angle (Van Loon et al., Nephrol Dia Transplant 225-230, 2010).

[0042] Secondly, the skin surrounding the puncture or infusion site in the AVF is in principle non-exudative and non-secreting, only blood being able to be present.

[0043] Thirdly, the wound occurs in a deformed area. The creation of an AVF significantly modifies the appearance of the patient's forearm, by creating aneurysmal areas.

[0044] It is also common for dialysis patients to be elderly, with the resulting consequences for the sensitivity of the skin to dressings.

[0045] Skin lesions are common in patients with renal failure.

[0046] AVFs are often short, so that the two artery and vein needles must be placed close to each other. The use of fixation bands can cause repeated irritation of the skin, promoting excoriations which are sources of bacterial contamination, the AVFs being kept active for many years.

[0047] Apart from conventional manual compression, the means for achieving hemostasis on an AVF can be classified into three categories: - mechanical devices; - pads comprising a compress loaded with a hemostatic agent; - bandages and dressings providing compression.

[0048] The mechanical devices include clamps or tourniquets. The document CN203169258 describes a mechanical device comprising a spring mechanism. Reference may also be made to documents CN215349238, CN102166128.

[0049] Mechanical compression devices have several disadvantages.

[0050] First, these devices cannot be used on immature native AVFs or unestablished synthetic AVFs. Second, these mechanical compression devices are expensive. The unit price of a clamp is around 18 euros. In addition, these mechanical compression devices are either discarded after a single use or reused, in which case it is necessary to clean and disinfect them between each use, with the resulting costs and labor time. Furthermore, these mechanical compression devices can lead to the application of too much or too prolonged pressure, which can lead to complications such as stenoses or thromboses. The pressure applied by these devices could lead to total occlusion of the vascular access.

[0051] A wide variety of pads containing hemostatic agents have been proposed (gelatin, collagen, chitosan, cellulose oxide, kaolin, zeolite), see for example document US2006 / 0155235.

[0052] According to Varizi, hemostasis could be reduced to about 3 minutes by the local administration of thrombin (Topical thrombin and control of bleeding from the fistula puncture sites in dialyzed patients, Nephron 24, pp. 254-256, 1979). The use of poly-[3-1 —>4-N-acetylglucosamine would allow compression times of the order of one to fourteen minutes (US8992453, col. 4 lines 44-54).

[0053] Bachtell et al. (Treatment of dialysis access puncture wound bleeding with chitosan dressings, Dialysis & Transplantation, November 2006) describe the use of a hemostatic dressing marketed by the company HemCon, this dressing making it possible to reduce the compression time on the AVFs to achieve hemostasis to a few minutes. The dressings proposed by the company HemCon have been widely used in emergency contexts. These dressings, for example marketed under the name Hemcon Chito-Flex ®, contain hemostatic agents (chitosan derivative).

[0054] Pads have several disadvantages.

[0055] First, the pads obscure the puncture site, which cannot be visually monitored while compressing the skin bleeding point.

[0056] Secondly, according to some authors, hemostatic agents such as calcium alginate only act on the external skin orifice, and can mask the presence of internal bleeding which can cause complications.

[0057] There are a large number of patents and patent applications for compression dressings, in an attempt to reduce bleeding times (see for example WO2007 / 044647, US 3490448, US 6316686).

[0058] Document US 2004 / 0092999 describes an elastic latex bracelet on which a hemispherical piece of rubber or latex is glued, this bracelet being able to serve as a tourniquet before venous puncture, and facilitating hemostasis after puncture, the piece of rubber compressing the puncture point through a compress. The piece of rubber described in this prior document makes it possible to avoid the application of manual pressure to the puncture point. But the use of this bracelet does not make it possible to avoid the risks of blood projection or hemorrhage, when the compression piece is removed to check the puncture point. The dressings described in documents WO99 / 08723, US2005 / 0256438, WO03 / 099143 have the same drawbacks. The same applies to dressings that swell on contact with liquid, such as those sold under the brand name Sureseal®.

[0059] Document US 5891074 describes a compression dressing comprising an absorbent polymer foam placed opposite the puncture or infusion point. The absorbent polymer foam is, for example, a polyurethane foam marketed by the company Avitar under the brand name Hydrasorb®. Alternatively, a piece made of spring steel or a polymer material such as polycarbonate, polyethylene, polyurethane is placed in direct contact with the skin. The dressing described in document US 5891074 is complex and expensive to manufacture.

[0060] Document EP2331038 describes a dressing for a fusion or puncture point, comprising a first adhesive part and a second part provided with a compress, the first part being adhesive on one of its faces and being intended to be fixed to the skin at the puncture or infusion point, the dressing comprising a third adhesive part on one of its faces and capable of receiving the first part, the second part then being placed between the first part and the third part of the dressing.

[0061] A dressing of the type described in document EP2331038 was evaluated in 64 patients, the use of the dressing being associated with a lower proportion of patients presenting persistent bleeding at three minutes, both at the venous puncture site and at the arterial puncture site (Boulanger et al., Evaluation of post-puncture bleeding time of arterialvenous fistulas with Iris® bandage, J Vase Access 2014 pp. 102-107).

[0062] Document EP3295909 describes a dressing for a puncture or infusion point, comprising a micro-perforated sheet of polymer material, a first face of this sheet being covered with a pressure-sensitive adhesive, the opposite face of this sheet being non-adhesive, the dressing comprising a strip of material fixed on this non-adhesive face, the strip of material being compressible and impermeable and forming a frame, the micro-perforated sheet of polymer material being provided with per- drillings with a diameter of less than 0.5 mm.

[0063] A dressing of the type described in document EP3295909 was evaluated in 12 patients, with an estimated time saving of seven minutes per dialysis session, or 18 hours per year per patient (Guerraoui et al., Evaluation of compression of the arteriovenous fistula by a Mozaik® dressing in two hemodialysis units: prospective study, Nephrology & Therapeutics, vol 13, 2017).

[0064] A wide variety of compression methods have been proposed in the prior art, for AVFs at the end of a hemodialysis session (manual compression, mechanical compression devices, compression dressings), and the means implemented in hemodialysis units to limit the risks of AES and hemorrhage are not standardized.

[0065] The disconnection protocols are not uniform in particular, several parameters being taken into account: autonomy of the patients, physical capacity of the patients allowing them to be more or less involved in their care, fragility of the skin of patients who are mostly elderly, existence or not of aneurysmal zones, taking anticoagulant medications such as acetylsalicylic acid, anti vitamin K or anti-inflammatory drugs.

[0066] The compression dressings proposed in the prior art do not make it possible to resolve the problems posed by the arterial and venous routes of the AVFs, in particular the risks of hemorrhage, the risks of AES and the high bleeding times.

[0067] The applicant noted in particular that certain patients still had prolonged post-dialysis bleeding times, despite the use of the best available techniques. Prolonged post-dialysis bleeding is a frequent and severe complication, which affects the quality of life of patients and lengthens the duration of dialysis sessions, with medical staff being particularly busy at the end of the dialysis session.

[0068] The invention aims to provide a solution to the problems presented above.

[0069] According to a first aspect, there is provided a dressing for a puncture or infusion point, comprising a first sheet of micro-perforated polymer material, a first face of this first sheet being covered with a pressure-sensitive adhesive and being intended to be fixed to the skin by covering a puncture or infusion point, the opposite face of this first sheet being non-adhesive. The dressing comprises a second sheet carrying a strip of compress-forming material, the second sheet extending in a longitudinal direction and comprising two end portions in this longitudinal direction. The first end portion is fixed to the non-adhesive face of the first sheet, the second sheet being deformable by manual gripping of the second end portion and manual traction. along the longitudinal direction, the second sheet comprising a rear face provided with an adhesive.

[0070] By “sheet” is meant here a strip of material in the form of a thin film, for example a few tens of microns.

[0071] A pressure-sensitive adhesive is, for example, based on acrylic, acrylate, polyurethane, silicone, natural rubber, hydrogel, ethylene and vinyl acetate copolymer or block copolymer of the poly(styrene-isoprene-styrene) type.

[0072] The pressure-sensitive adhesive is advantageously hypoallergenic.

[0073] By "sheet deformable by manual traction" is meant here a strip of material in the form of a thin film, this film being able to be stretched by manual traction.

[0074] In some implementations, manual pulling of the film leads to its elastic stretching.

[0075] In other implementations, manual traction of the film leads to its permanent deformation.

[0076] According to various embodiments, the second sheet is made of openwork textile material, possibly woven, made from wool fibers, silk fibers, cotton fibers, linen fibers, polyethylene fibers, polypropylene, polyester or polyamide.

[0077] In some implementations, a peelable tab is disposed on the back side of the second sheet, in the second end portion of the second sheet.

[0078] In particular implementations, the peelable tab is formed by a strip of material extending substantially parallel to the second sheet.

[0079] In other particular implementations, the peelable tab is formed by a strip of material folded back on itself and extending substantially parallel to the second sheet.

[0080] Advantageously, the second sheet is made of non-woven material.

[0081] According to various implementations, the first sheet is a film of a material selected from the group comprising films of polyethylene, polypropylene, polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins, polyvinyl fluoride, films of copolymer of polyether-polyester, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, films of triblock or diblock copolymers of styrene and olefin and films of polyether block amides.

[0082] The dressing has the following arrangements, according to various embodiments, these arrangements being combined where appropriate: - the first sheet is provided with perforations with a diameter of less than 0.5 mm; - the first sheet is made of polyethylene with an acrylic adhesive; - the perforation density of the first sheet is of the order of one hundred per square centimeter.

[0083] Other objects and advantages of the invention will appear in the light of the description of an embodiment, given below with reference to the appended drawings in which:

[0084] [Fig-1] is a perspective view of a dressing, according to a first embodiment, the elements of the dressing being shown in exploded view;

[0085] [Fig.2] is a side view of the dressing shown in [Fig.l];

[0086] [Fig.3] is a perspective view of the dressing shown in Figures 1 and 2, according to a another angle of view;

[0087] [Fig.4] is a perspective view of a dressing, according to a second embodiment, the elements of the dressing being shown in exploded view;

[0088] [Fig.5] is a side view of the dressing shown in [Fig.4];

[0089] [Fig.6] is a perspective view of the dressing shown in Figures 4 and 5, according to a another angle of view.

[0090] In the following description, the same reference numerals are used to designate identical or similar elements.

[0091] We first refer to Figures 1 to 3.

[0092] The dressing 1 comprises a first sheet 2 made of polymer material.

[0093] This first sheet 2 of polymer material comprises a first adhesive face 3.

[0094] In an advantageous implementation, the first adhesive face 3 is provided with a pressure-sensitive adhesive.

[0095] The first face 3 is intended to cover a puncture or infusion point, in particular the entry point of a needle into a hemodialysis vascular access such as an arteriovenous fistula, at the end of a dialysis session.

[0096] The first sheet 2 has a second face 4, opposite the first face 3.

[0097] In an advantageous implementation, this second face 4 is devoid of adhesive.

[0098] Advantageously, the first sheet 2 is transparent, semi-transparent, or translucent. By "translucent" is meant here the capacity of a material to let light rays pass through, without it being possible, however, to perfectly distinguish the contours of the objects located under the material.

[0099] Advantageously, the first sheet 2 is micro-perforated.

[0100] In certain implementations, the first sheet 2 is provided with perforations with a diameter of less than 0.5 mm, and advantageously less than 0.3 mm.

[0101] In some implementations, the perforations are arranged in a square mesh pattern, 1 to 2 mm on each side. By these arrangements, the first sheet 2 has a high density of micro-perforations. In some implementations, the density of micro-perforations is in the order of 50 to 100 micro-perforations per square centimeter.

[0102] The perforation is advantageously carried out by implementing a method comprising the following steps: - depositing glue on side 3 of a film to be made adhesive; - application of a liner covering the glued face; - perforation of the film; - removal of the protective film and installation of a peelable strip.

[0103] The deposit of glue is for example carried out on a first sheet 2 formed by a polyethylene film, in particular a low density polyethylene, the thickness of the first sheet 2 being for example 30 to 60 microns.

[0104] The adhesive is for example acrylic-based, and is deposited to a thickness for example of approximately 20 to 50 microns.

[0105] In other embodiments, the adhesive is a silicone gel.

[0106] The perforation of the film forming the first sheet 2 is for example carried out by needling, advantageously hot. The needling can be carried out in one or more passes. The pattern of the perforations is for example a square or diamond mesh.

[0107] Perforation by needling leads to the formation of micro-perforations without removing material. The material constituting the film is pushed back by the needles.

[0108] In one implementation, the first face 3 carrying the adhesive is the one through which the needles are introduced, so that the first sheet 2 has reliefs, on the second face 4, these reliefs resulting from the pushing back of the constituent material of the first sheet 2, during the micro-perforation.

[0109] The dressing comprises a compress 5, arranged opposite the second face 4 of the first sheet 2. This compress 5 is intended to be kept pressed against the first sheet 2.

[0110] As the applicant was able to observe, when the first sheet 2 covers the puncture point of an arteriovenous fistula, the blood leaving the puncture point does not flow under the first sheet 2 and remains confined.

[0111] This confinement phase is of variable duration depending on the state of hydration of the whole blood: the more hyperhydrated the patient is, the longer this first phase is. The duration of this first phase is increased by taking anti-vitamin K or in the presence of a platelet abnormality. The duration of this first phase is also increased when the AVF is the site of a stenosis or when the AVF puncture is performed on an aneurysmal area or close to the anastomosis. The duration of this first phase can be reduced by exerting gentle pressure on the anastomosis for approximately two minutes.

[0112] In a second phase, shorter than the first, the blood is sieved by its passage through the first sheet 2, permeable to the liquid, and the serum is absorbed by the compress 5. The concentration of formed elements increases in the blood present at the puncture point, due to this sieving and absorption of the serum. The viscosity of the blood present at the puncture point increases. The perforations of the first sheet 2 are gradually obstructed by viscous blood.

[0113] Covering the puncture or infusion site of an AVF with the first sheet 2 makes it possible to significantly reduce the risks of resumption of bleeding.

[0114] It follows from the applicant's experience that the mechanisms leading to this reduction in the risk of resumption of bleeding could be the following.

[0115] The confinement and sieving of the blood flowing from the puncture point leads to the creation of small scabs. When the compress 5 is removed, the risk of these scabs detaching is thus reduced.

[0116] In some implementations, the first sheet 2 comprises two types of perforations: - a first series of perforations, intended for sieving the blood at the puncture point, this first series of perforations being for example random or diamond-shaped, - a second series of perforations, intended to facilitate, if necessary, the manual cutting of the first sheet 2, this second series of perforations having a square or rectangular pattern for example.

[0117] Advantageously, the perforations intended for screening are micro-perforations obtained without removing material, for example by needling.

[0118] The first sterile semi-permeable sheet 2 protects the vascular puncture site and is advantageously transparent, leaving the puncture site visible at all times, without risk of blood projection or direct sticking of the compress 5 to the puncture point.

[0119] In one implementation, the first sheet 2 carries at least one hemostatic compound, for example mixed with the adhesive present on the first face 3.

[0120] The first sheet 2 is advantageously flexible. By “flexible” is meant here the possibility of this first sheet 2 to follow the contours of a deformed area of ​​the skin, in particular an aneurysmal area of ​​an arteriovenous fistula.

[0121] The flexibility of the first sheet 2 results from its low thickness. The thickness of the first sheet 2 is between 2 microns and 2000 microns, preferably between 5 microns and 500 microns, and more preferably between 10 microns and 200 microns, even more preferably between 10 microns and 70 microns and is advantageously of the order of a few tens of microns, for example close to 60 microns.

[0122] The first sheet thus forms a thin film which can be chosen from films of polyethylene, polypropylene, polyurethane, polyester, polyamide, polyether, poly- vinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins (such as polyethylenes and polypropylenes), polyvinyl fluoride or among polyether-polyester, polyester-polyurethane, polyether-polyurethane, polyether-polyamide copolymer films, as well as triblock or diblock copolymer films of styrene and olefin (for example styrene / butadiene) and polyether block amide films.

[0123] The flexibility of the first sheet 2 also results from the material used. The first sheet 2 is for example made of low density polyethylene.

[0124] In other implementations, the first sheet 2 is made of coated fabric.

[0125] In advantageous implementations, the material forming the first sheet 2 is extensible. By "extensible" is meant here the possibility of deforming the first sheet 2 by manual traction. The first sheet 2 can be extensible along the main longitudinal direction L of the dressing 1. In certain implementations, the first sheet 2 is extensible along the longitudinal direction and along the transverse direction, perpendicular to the longitudinal direction. These arrangements make it possible to adapt the sheet 2 to the curvatures of the patient's body.

[0126] Advantageously, the first sheet 2 is elastic and the perforation of the first sheet is carried out with tension on the first sheet 2, so that the micro-perforations are substantially closed after the tension on the first sheet 2 is released. When applying the dressing, manual stretching of the first sheet 2 causes these micro-perforations to open.

[0127] The dressing 1 comprises at least one protector formed by a peelable strip, covering the first face 3 of the first sheet 2, before use of the dressing 1.

[0128] In advantageous embodiments, the dressing 1 comprises two peelable strips 6, 7, each of the two strips being provided with a gripping tab 8, 9, one of the two gripping tabs partially covering the other gripping tab.

[0129] The user of the dressing 1 can thus remove the peelable strips 6, 7, without touching with his fingers the adhesive layer carried by the first sheet 2.

[0130] The user can thus grasp, for example between the thumb and index finger, the first tab 8 to peel off a first peelable strip 6, before grasping the second tab 9 to peel off the second peelable strip 7.

[0131] In certain implementations, the peelable strips 6, 7 are based on silicone or fluoro-silicon polyester.

[0132] The thickness of the peelable strips 6, 7 is low, for example of the order of 0.05 mm.

[0133] The dressing 1 comprises a compress 5. In one implementation, the compress 5 is made of cellulosic material. In other implementations, the compress 5 is a polyurethane foam. In other implementations, the compress 5 is made of non- woven, for example from viscose, or cellulose, cotton.

[0134] Advantageously, this compress 5 is fixed to a second sheet 10.

[0135] In one implementation, the second sheet 10 comprises a rear face 11 against which the compress 5 is fixed. The second sheet 10 comprises a front face 12, opposite the rear face, this front face 12 being advantageously free of adhesive.

[0136] The terms “front”, “back” are used here in reference to an observer of a dressing 1 fixed on the patient's skin.

[0137] The second sheet 10 and the first sheet 2 are secured to a first end portion 13 of the second sheet 10.

[0138] In certain implementations, the two sheets 2, 10 are joined by gluing. For this purpose, the rear face 11 of the second sheet 10 is provided with an adhesive.

[0139] The dressing 1 is provided with a pull tab or strip 14. This pull strip 14 is peelable and is placed against the rear face 11 of the second sheet 10. In the longitudinal direction L of the dressing 1, the pull strip 14 is arranged at the second end part 15 of the second sheet 10.

[0140] The compress 5 is arranged between the two end parts 13, 15 of the second sheet 10.

[0141] When the user grasps the traction strip 14 and exerts a force in the longitudinal direction L, the traction strip 14 is detached from the second sheet 10, and a deformation of the second sheet 10, in the longitudinal direction L, is advantageously obtained.

[0142] In certain implementations, the second sheet 10 is a non-woven fabric having low mechanical resistance to stretching, along the longitudinal direction L of the dressing 1.

[0143] In certain implementations, the second sheet 10 is made of openwork textile material, possibly woven, made with plant, animal, synthetic or mineral materials. The second sheet 10 is advantageously an openwork textile made from wool fibers, silk fibers, cotton fibers, linen fibers, polyethylene, polypropylene, polyester or polyamide fibers.

[0144] The dressing 1 as shown in Figures 1 to 3 is advantageously used in the following manner.

[0145] In a first step, the first peelable strip 6 is removed, by grasping the tab 8. At the end of this first step, the first adhesive face 3 of the first sheet 2 is uncovered, on the surface corresponding to the first peelable strip 6.

[0146] In a second step, this adhesive surface of the dressing 1 is placed on the patient's skin. The second peelable strip 7 is then removed, the entire first face 3 of the first sheet 2 then being stuck to the patient's skin and covering the puncture or infusion point, in particular the site used for the arterial needle or venous needle of a dialysis machine, for a patient with an arteriovenous fistula or an arteriovenous prosthesis.

[0147] In a third step, the assembly formed by the compress 5, the second sheet 10 and the traction strip 14 is placed on the second face 4 of the first sheet 2.

[0148] The compress 5 is then placed between the first sheet 2 and the second sheet 10. The compress 5 can then absorb the residual blood or serum which would pass through the micro-perforations of the first sheet 2.

[0149] If necessary, manual pressure can be applied to the compress 5, directly with a finger or, if necessary, with an external compress.

[0150] The hemostasis check can be carried out visually, easily, by lifting the assembly formed by the compress 5, the second sheet 10, and the traction strip 14.

[0151] When hemostasis is obtained, the dressing 1 can be closed. The dressing 1 is closed by removing the peelable traction strip 14, and gluing the adhesive part of the second sheet 10 to the second face 4 of the first sheet 2, in the second end part 15.

[0152] During this closure, a traction exerted in the longitudinal direction L makes it possible to deform the second sheet 10. This traction followed by the bonding of the second sheet 10 to the first sheet 2 causes compression of the patient's skin, allowing compression to be maintained at the puncture point.

[0153] The traction advantageously allows an elongation of the second sheet 10, so that its adhesive part can be located beyond the first sheet 2, in the longitudinal direction L, the second sheet 10 then being stuck to the patient's skin.

[0154] These arrangements allow, where appropriate, the formation of a fold at the level of the patient's skin, participating in the compression of the puncture point.

[0155] The removal of the dressing 1 is carried out by peeling off the assembly formed by the compress 5 and the second sheet 10, a pull on the dressing 1 then allowing the peeling off of the first sheet 2.

[0156] We now refer to Figures 4 to 6 which illustrate an alternative embodiment.

[0157] The points in common with the first embodiment shown in figures 1 to 3 are not repeated here, the elements bearing the same numerical references in the figures being identical or similar.

[0158] The second embodiment differs from the first embodiment by the structure of the traction tab.

[0159] In the second embodiment, the pull tab is formed by a peelable strip 14 folded into a U. This arrangement makes it possible to reduce the forces required to peel off the peelable strip 14.

[0160] For information purposes, the dressing 1 is, when viewed in plan, of substantially rectangular outline with rounded edges, of length (measured in the longitudinal direction L) equal to approximately 72 mm and of width equal to approximately 25 mm.

[0161] In other embodiments, the dressing 1 is oval or square in outline.

[0162] The second sheet 10 is for example of substantially rectangular shape, with a length (measured in the longitudinal direction) of the order of 45 mm, the width of the second sheet 10 being equal to that of the first sheet 2, of the order of 25 mm.

[0163] The compress 5 is for example square or rectangular in outline, when seen in plan, and its longitudinal dimension is for example 22 mm.

[0164] The first end portion 13, on which the first sheet 2 and the second sheet 10 are fixed, extends for example over a length, measured in the longitudinal direction L, of the order of 10 to 25 mm.

[0165] The second end part 15, on which the traction tab 14 is placed, extends for example over a length, measured in the longitudinal direction L, of the order of 10 to 25 mm.

[0166] To facilitate the use of the dressing 1, indications such as arrows are advantageously printed on the peelable strips 6, 7 and on the tab or the pull strip 14, numbers being printed where appropriate to show the sequence of steps to be implemented to place the dressing 1 on the patient's skin.

[0167] Tests were carried out, allowing the comparison of the performance of a dressing according to the invention with that of a dressing marketed under the brand name Iris, by the company Nephrokit.

[0168] A presentation of the Iris bandage can be found in the document Boulanger et al (Evaluation of post-puncture bleeding time of arteriovenous fistulas with Iris® bandage, J Vase Access 2014 pp. 102-107).

[0169] The trials were carried out for two groups of hemodialysis patients, patients having an arteriovenous fistula as vascular access route, each group comprising 45 patients.

[0170] For a first group of patients, at the end of the dialysis session, the Iris dressing was used for the arterial and venous entry. Two Iris dressings were used for each patient.

[0171] For the second group of patients, at the end of the dialysis session, a dressing according to the invention was used, for the arterial inlet and the venous inlet. Two dressings according to the invention were used for each patient.

[0172] During manual compression, post-puncture bleeding time is assessed by the percentage of patients with persistent bleeding beyond three minutes.

[0173] For the second group of patients, manual traction on the second sheet of the dressing was carried out, this traction followed by the gluing of the second sheet 10 on the first sheet 2 ensuring compression of the patient's skin, allowing compression to be maintained at the puncture point.

[0174] For the first group of patients, which is the control group, the mean time to stop bleeding was 6.56 minutes, with a standard deviation of 2.26, and the rate of stopping bleeding after 3 minutes of dressing application was 89.5%. These results confirm the good performance of Iris dressings, already mentioned in the literature.

[0175] For the second group of patients, the mean time to stop bleeding was 5.51 minutes, with a standard deviation of 2.01, and the rate of stopping bleeding after 3 minutes of dressing application was 93.7%.

[0176] The performance obtained by a dressing according to the invention is thus higher than that made possible by Iris dressings, currently considered to be the best available technique. The dressing has numerous advantages.

[0177] At the end of dialysis, stopping bleeding at the puncture points determines the patient's discharge and comfort.

[0178] Reducing bleeding times allows for a reduction in compression times and greater availability of healthcare personnel.

[0179] The risks of hemorrhage and hemostasis times are reduced, in particular by the blood confinement and sieving mechanisms. Compression times at the AVF puncture points are thus reduced, and brought down to a few tens of seconds.

[0180] The risks of bacterial or viral contamination are reduced, the user being able to quickly and visually check whether hemostasis has been achieved, without the risk of blood being splashed.

[0181] The first sheet 2 is placed between the compress 5 and the patient's skin and does not have to be removed, the puncture point remaining covered during the visual check of hemostasis. The risks of bleeding linked to removal of the platelet plug are reduced.

[0182] The risks of accidents due to exposure to AES blood are greatly reduced when the venous and arterial lines are disconnected at the end of the dialysis session.

[0183] The flexibility of the dressing 1 makes it possible to follow the contours of the skin, in particular in the vicinity of the aneurysmal areas of the AVFs.

Claims

Claims

1. Dressing (1) for a puncture or infusion point, comprising a first sheet (2) of micro-perforated polymer material, a first face (3) of this first sheet (2) being covered with a pressure-sensitive adhesive and being intended to be fixed to the skin by covering a puncture or infusion point, the opposite face (4) of this first sheet (2) being non-adhesive, the dressing (1) comprising a second sheet (10) carrying a strip of compress-forming material (5), the second sheet (10) extending in a longitudinal direction (L) and comprising two end portions (13, 15) in this longitudinal direction (L), the first end portion (13) being fixed to the non-adhesive face (4) of the first sheet (2), characterized in that the second sheet (10) is deformable by manual gripping of the second end portion (15) and manual traction in the longitudinal direction (L),the second sheet (10) comprising a rear face (11) provided with an adhesive.,

2. Dressing (1) according to claim 1, characterized in that it comprises a peelable tab (14) arranged on the rear face (11), in the second end part (15) of the second sheet (10).

3. Dressing (1) according to claim 2, characterized in that the peelable tab (14) is formed by a strip of material extending substantially parallel to the second sheet (10).

4. Dressing (1) according to claim 2, characterized in that the peelable tab (14) is formed by a strip of material folded back on itself and extending substantially parallel to the second sheet (10).

5. Dressing (1) according to any one of claims 1 to 4, characterized in that the second sheet (10) is made of non-woven material.

6. Dressing (1) according to any one of claims 1 to 5, characterized in that the second sheet (10) is made of openwork textile material, made from wool fibers, silk fibers, cotton fibers, linen fibers, polyethylene fibers, polypropylene, polyester or polyamide.

7. Dressing (1) according to any one of claims 1 to 6, characterized in that the first sheet (2) is provided with perforations with a diameter of less than 0.5 mm.

8. Dressing (1) according to any one of claims 1 to 7, ca- characterized in that the first sheet (2) is a film of a material selected from the group comprising films of polyethylene, polypropylene, polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins, polyvinyl fluoride, films of copolymer of polyether-polyester, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, films of triblock or diblock copolymers of styrene and olefin and films of polyether block amides.

9. Dressing (1) according to any one of claims 1 to 8, characterized in that the first sheet (2) is made of polyethylene provided with an acrylic adhesive.

10. Dressing (1) according to any one of claims 7 to 9, characterized in that the density of perforations of the first sheet (2) is of the order of one hundred per square centimeter.

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