Dressing for a puncture point, in particular for an arterio-venous fistula

Abstract

Dressing (1) for a puncture or infusion point, comprising a first sheet (2) made 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 material forming a compress (5), the second sheet extending in a longitudinal direction (L) and comprising two end portions along this longitudinal direction, the first end portion (13) being fixed on the non-adhesive face of the first sheet, the second sheet being deformable by manual gripping of the second end portion (15) and manual pulling in the longitudinal direction, the second sheet comprising a rear face (11) provided with an adhesive.

Description

[0001] Dressing for puncture site, especially for arteriovenous fistula

[0002] The invention relates to the medical or veterinary field.

[0003] The invention relates more particularly to a dressing for a puncture point or an infusion point.

[0004] By "puncture" we mean the operation by which a substance, generally liquid, is evacuated from a part of the body of a man or an animal, by introducing a pointed and hollow instrument through the skin, for exploratory, diagnostic or therapeutic purposes.

[0005] An example of puncture is blood sampling, a routine procedure that allows laboratory tests to be performed 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).

[0006] By "infusion" we mean 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.

[0007] An example of an infusion is intravenous infusion, a common parenteral infusion technique that allows the administration of medications, fluids, or blood products drop by drop into the veins, usually a peripheral vein in the upper limb. Intravenous infusion allows, in particular, the administration of fluids to correct blood volume.

[0008] By "puncture point or infusion point" is meant here an area of ​​skin on 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" is meant here the outer covering of the human or animal body, formed by the epidermis and the dermis. 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 in order to protect the wound and promote its healing. 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).

[0009] The invention relates more particularly to the field of hemodialysis.

[0010] It is common to withdraw or inject fluids or administer medications to a patient or animal through a tube attached to a needle or catheter. It is estimated that approximately 80% of hospitalized patients receive treatment administered through an intravenous catheter.

[0011] For puncture or infusion, a device is inserted through the skin (hypodermic needle, catheter, cannula). For example, butterfly needles are used for transfusions, blood sampling, etc. Examples of butterfly needles can be found in the following US patents issued under the following numbers: 2725058, 3064648, 3640275, 4194504, 4300553, 4627842, 51 08376, 5149328, 6270480.

[0012] For some patients, peripheral catheters are used chronically. This is particularly the case for patients suffering from acute or chronic renal failure and treated with hemodialysis or extrarenal purification.

[0013] Three types of vascular access predominate for hemodialysis: arteriovenous fistulas (AVFs), arteriovenous prostheses or grafts, and central venous catheters (CVCs).

[0014] AVFs are surgically created anastomoses to connect a patient's artery and vein, commonly in the forearm or upper arm, most often between a radial or brachial artery and its namesake vein. This anastomosis increases blood flow within the vein.

[0015] The needle bringing blood from the patient to the dialysis machine is called an artery, the one returning blood to the patient is called a vein.

[0016] When the needle is removed from a blood vessel or 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). After disconnecting the patient, there is a risk of persistent bleeding.

[0017] The risk of bleeding is very high for some patients suffering from acute or chronic renal failure and treated by hemodialysis. During hemodialysis, an anticoagulant is often used to limit the risk of clogging of the capillary lumens by thrombosis, the anticoagulant used often being heparin (low molecular weight heparin LMWH, unfractionated heparin HN F). 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.

[0018] At the end of the dialysis session, any bleeding from the puncture site can be fatal for the patient.

[0019] The risks of blood splashes and contamination are significant, with the spread of AIDS and hepatitis, among other blood-borne contagious diseases, only making this risk more dreaded.

[0020] 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."

[0021] According to the AES-Raisin network report for monitoring accidents with exposure to blood in French healthcare establishments, for the years 2013-2014, the rate of BSE per 100 beds is approximately 6%, and BSEs result in 20% of cases from a projection, particularly when withdrawing a needle through a patient's skin. In a 2005 study, Tarantola et al. estimate that 25% of blood exposure accidents in hemodialysis are blood projections (Blood Exposure Accidents and Caregivers 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).

[0022] 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 transmission of HIV after exposure to the blood of a patient carrying HIV is estimated at an average of 0.32%. The risk of transmission of HBV 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).

[0023] For hemodialysis sessions on AVFs, the most likely time for contamination by blood splashes is during compression, mainly when withdrawing the needle. Indeed, the hemostatic compress may be imperfectly positioned on the puncture site, particularly for AVFs with high flow or aneurysmal areas.

[0024] At the end of a dialysis session, when disconnecting the dialysis unit, 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.

[0025] 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). Hemostasis can sometimes take a long time to achieve, with the means implemented in the state of the art.

[0026] In an extremely common technique for achieving hemostasis on an AVF, a compress, pad, or cotton is placed at the puncture site, and manual pressure is applied to this compress or cotton, with one or more adhesive strips holding the compress or cotton in place after the manual pressure is released.

[0027] 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.

[0028] For a 10-minute compression time, manual compression represents more than two hours per day for a nurse, and approximately 780 hours per year.

[0029] 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 venous stenosis, Kidney International, 36, pp. 707-71 1, 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).

[0030] 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 thirty minutes after the dialysis session (W02004 / 060245 page 1, 3 ème paragraph, W003 / 099143, page 1 lines 1 1 -20).

[0031] 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.

[0032] In dialysis patients with a high-flow AVF, the effect of anticoagulants is such that 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.

[0033] 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 have seizures for various reasons.

[0034] It is then the nursing staff who ensure the compression of the puncture points at the end of dialysis (nursing staff, beneficiary attendants).

[0035] It is also necessary to regularly check that the bleeding has stopped at the puncture or infusion site, which requires removing the compress or cotton. This check can cause blood to be sprayed, with a risk of contamination of the nursing staff, or even hemorrhage, particularly when the patient is agitated or for dialysis patients who have to compress both the venous and arterial access of the AVF. Bleeding can occur when compressing the puncture site, requiring the compress to be changed, as the presence of blood obscures the puncture site. Regularly checking 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.

[0036] The wound formed during each dialysis session has specific characteristics.

[0037] 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-ladder), 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, the needle is introduced at the same point, with the same angle (Van Loon et al., Nephrol Dia Transplant 225-230, 2010).

[0038] Second, the skin surrounding the puncture or infusion site in the AVF is in principle non-exudative and non-secreting, only blood may be present.

[0039] 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.

[0040] It is also common for dialysis patients to be elderly, with the resulting consequences for skin sensitivity to dressings.

[0041] Skin lesions are common in patients with renal failure.

[0042] AVFs are often short, so the two artery and vein needles must be placed close together. The use of fixation bands can cause repeated skin irritation, promoting excoriations that are a source of bacterial contamination, as the AVFs are kept active for many years.

[0043] Apart from conventional manual compression, the means of achieving hemostasis on an AVF can be classified into three categories:

[0044] - mechanical devices;

[0045] - pads comprising a compress loaded with a hemostatic agent;

[0046] - bandages and dressings providing compression.

[0047] Mechanical devices include clamps or tourniquets. Document CN203169258 describes a mechanical device comprising a spring mechanism. Reference may also be made to documents CN215349238 and CN 1 021 661 28.

[0048] Mechanical compression devices have several disadvantages.

[0049] 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 1.8 euros. In addition, these mechanical compression devices are either discarded after 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 excessive or prolonged pressure, which can lead to complications such as stenosis or thrombosis. The pressure applied by these devices could lead to total occlusion of the vascular access.

[0050] A wide variety of pads containing hemostatic agents have been proposed (gelatin, collagen, chitosan, cellulose oxide, kaolin, zeolite), see for example document US2006 / 01 55235.

[0051] According to Varizi, hemostasis could be reduced to about 3 minutes by local administration of thrombin ( Topical thrombin and control of bleeding from the fistula puncture sites in dialysis patients, Nephron 24, pp. 254-256, 1979). The use of poly-p- 1 — >4-N-acetylglucosamine would allow compression times of the order of one to fourteen minutes (US8992453, col. 4 lines 44-54). 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 a few minutes to obtain hemostasis. 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).

[0052] Pads have several disadvantages.

[0053] First, the pads obscure the puncture site, which cannot be visually monitored while compressing the skin bleeding point.

[0054] 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.

[0055] There are a large number of patents and patent applications for compression dressings, in an attempt to reduce bleeding times (see for example W02007 / 044647, US 3490448, US 6316686).

[0056] 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 venipuncture, 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, W003 / 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®.

[0057] 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.

[0058] 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.

[0059] A dressing of the type described in EP2331 038 was evaluated in 64 patients, with use of the dressing being associated with a lower proportion of patients with 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).

[0060] 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 perforations with a diameter of less than 0.5 mm.

[0061] 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 arteriovenous fistula compression using a Mozaik® dressing in two hemodialysis units: prospective study, Nephrology & Therapeutics, vol 13, 2017). 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.

[0062] Disconnection protocols are not uniform in particular, with several parameters being taken into account: patient autonomy, physical capacity of 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 areas, taking anticoagulant medications such as acetylsalicylic acid, anti-vitamin K or anti-inflammatory drugs.

[0063] The compression dressings proposed in the prior art do not solve 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.

[0064] The plaintiff noted in particular that some patients still experienced prolonged post-dialysis bleeding times, despite using the best available techniques. Prolonged post-dialysis bleeding is a common and severe complication, which affects patients' quality of life and lengthens the duration of dialysis sessions, with medical staff being particularly busy at the end of the dialysis session.

[0065] The invention aims to provide a solution to the problems presented above.

[0066] 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 in the longitudinal direction, the second sheet comprising a rear face provided with an adhesive.

[0067] By "sheet" we mean here a strip of material in the form of a thin film, for example a few tens of microns.

[0068] A pressure-sensitive adhesive is, for example, based on acrylic, acrylate, polyurethane, silicone, natural rubber, hydrogel, ethylene vinyl acetate copolymer or block copolymer of the poly(styrene-isoprene-styrene) type.

[0069] The pressure-sensitive adhesive is advantageously hypoallergenic. By "manually deformable sheet" is meant here a strip of material in the form of a thin film, this film being able to be stretched by manual traction.

[0070] In some implementations, manual pulling of the film leads to its elastic stretching.

[0071] In other applications, manual traction of the film leads to its permanent deformation.

[0072] 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.

[0073] In some implementations, a peel tab is disposed on the back side of the second sheet, in the second end portion of the second sheet.

[0074] In particular implementations, the peelable tab is formed by a strip of material extending substantially parallel to the second sheet.

[0075] 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.

[0076] Advantageously, the second sheet is made of non-woven fabric.

[0077] 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 polyether-polyester copolymer, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, films of triblock or diblock copolymers of styrene and olefin and films of polyether block amides.

[0078] The dressing has the following provisions, according to various embodiments, these provisions being combined where appropriate:

[0079] - the first sheet is provided with perforations with a diameter of less than 0.5 mm;

[0080] - the first sheet is made of polyethylene with an acrylic adhesive;

[0081] - the perforation density of the first sheet is of the order of one hundred per square centimeter.

[0082] 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:

[0083] - figure 1 is a perspective view of a dressing, according to a first embodiment, the elements of the dressing being shown in exploded view;

[0084] - Figure 2 is a side view of the dressing shown in Figure 1;

[0085] - figure 3 is a perspective view of the dressing shown in figures 1 and 2, from another angle;

[0086] - figure 4 is a perspective view of a dressing, according to a second embodiment, the elements of the dressing being shown in exploded view;

[0087] - Figure 5 is a side view of the dressing shown in Figure 4;

[0088] - figure 6 is a perspective view of the dressing shown in figures 4 and 5, from another angle.

[0089] In the following description, the same reference numerals are used to designate identical or similar elements.

[0090] We first refer to Figures 1 to 3.

[0091] The dressing 1 comprises a first sheet 2 of polymer material. This first sheet 2 of polymer material comprises a first adhesive face 3.

[0092] In an advantageous implementation, the first adhesive face 3 is provided with a pressure-sensitive adhesive. 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.

[0093] The first sheet 2 has a second face 4, opposite the first face 3.

[0094] In an advantageous implementation, this second face 4 is devoid of adhesive.

[0095] 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.

[0096] Advantageously, the first sheet 2 is micro-perforated.

[0097] 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.

[0098] 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 of the order of 50 to 100 micro-perforations per square centimeter.

[0099] The perforation is advantageously carried out by implementing a method comprising the following steps:

[0100] - depositing glue on side 3 of a film to be made adhesive;

[0101] - application of a liner covering the glued face;

[0102] - perforation of the film;

[0103] - removal of the protective film and installation of a peelable strip.

[0104] The glue is deposited, for example, 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.

[0105] The adhesive is, for example, acrylic-based, and is applied to a thickness of, for example, approximately 20 to 50 microns.

[0106] In other embodiments, the adhesive is a silicone gel. 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] Needle punching results in the formation of micro-perforations without removing any 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 hydration status 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 platelet abnormalities. 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 this absorption of the serum. The viscosity of the blood present at the puncture point increases. The perforations of the first sheet 2 are progressively obstructed by viscous blood. Covering the puncture or infusion site of an AVF with the first sheet 2 makes it possible to greatly reduce the risks of resumption of bleeding.

[0113] It follows from the applicant's experience that the mechanisms leading to this reduction in the risk of re-bleeding could be the following.

[0114] The containment and sieving of blood flowing from the puncture site leads to the creation of small scabs. When the compress 5 is removed, the risk of these scabs detaching is thus reduced.

[0115] In some implementations, the first sheet 2 includes two types of perforations:

[0116] - 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,

[0117] - 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.

[0118] Advantageously, the perforations intended for screening are micro-perforations obtained without removing material, for example by needling.

[0119] 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 the risk of blood projection or direct sticking of the compress 5 to the puncture point.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] The first sheet thus forms a thin film which can be chosen from films of polyethylene, polypropylene, polyurethane, polyester, polyamide, polyether, polyvinyl chloride, polyvinylidene chloride, polyvinyl alcohols, polyvinyl acetate, polystyrene, polyolefins (such as polyethylenes and polypropylenes), polyvinyl fluoride or from films of copolymer of polyether-polyester, polyester-polyurethane, polyether-polyurethane, polyether-polyamide, as well as films of triblock or diblock copolymers of styrene and olefin (for example styrene / butadiene) and films of polyether block amides.

[0124] 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.

[0125] In other implementations, the first sheet 2 is made of coated fabric. 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 embodiment, the compress 5 is made of cellulosic material. In other embodiments, the compress 5 is a polyurethane foam. In other embodiments, the compress 5 is made of non-woven material, for example based on 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 portion 15 of the second sheet 10.

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

[0141] 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.

[0142] 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.

[0143] The dressing 1 as shown in Figures 1 to 3 is advantageously used in the following manner.

[0144] 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.

[0145] 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 the venous needle of a dialysis machine, for a patient with an arteriovenous fistula or an arteriovenous prosthesis.

[0146] 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.

[0147] The compress 5 is then placed between the first sheet 2 and the second sheet 10. The compress 5 can then absorb any residual blood or serum that passes through the micro-perforations of the first sheet 2. If necessary, manual pressure can be applied to the compress 5, directly with a finger or, if necessary, with an external compress.

[0148] 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 band 14.

[0149] When hemostasis is achieved, the dressing 1 can be closed. The dressing 1 is closed by removing the peelable traction strip 14, and sticking the adhesive part of the second sheet 10 to the second face 4 of the first sheet 2, in the second end part 15.

[0150] 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 gluing of the second sheet 10 onto the first sheet 2 causes compression of the patient's skin, allowing compression to be maintained at the puncture point.

[0151] 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.

[0152] These provisions allow, where appropriate, the formation of a fold in the patient's skin, contributing to the compression of the puncture point.

[0153] 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. We now refer to figures 4 to 6 which illustrate an alternative embodiment.

[0154] 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.

[0155] The second embodiment differs from the first embodiment by the structure of the traction tab.

[0156] 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. For information purposes, the dressing 1 is, when seen 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.

[0157] In other embodiments, the dressing 1 is oval or square in outline.

[0158] 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.

[0159] The compress 5 is for example square or rectangular in outline, when seen in plan, and its longitudinal dimension is for example 22 mm.

[0160] 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. The second end portion 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.

[0161] 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.

[0162] 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. A presentation of the Iris dressing 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).

[0163] The trials were conducted for two groups of hemodialysis patients, patients with an arteriovenous fistula as vascular access route, each group comprising 45 patients.

[0164] For a first group of patients, at the end of the dialysis session, the Iris dressing was used for the arterial and venous inlets. Two Iris dressings were used for each patient. For the second group of patients, at the end of the dialysis session, a dressing according to the invention was used for the arterial and venous inlets. Two dressings according to the invention were used for each patient.

[0165] During manual compression, post-puncture bleeding time is assessed by the percentage of patients with persistent bleeding beyond three minutes.

[0166] 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 1 0 on the first sheet 2 ensuring compression of the patient's skin, allowing compression to be maintained at the puncture point.

[0167] 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.

[0168] 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%.

[0169] The performance achieved by a dressing according to the invention is thus higher than that made possible by Iris dressings, currently considered the best available technique. The dressing has many advantages.

[0170] At the end of dialysis, stopping bleeding at the puncture points determines the patient's discharge and comfort.

[0171] Reducing bleeding times allows for reduced compression times and greater availability of healthcare personnel.

[0172] The risks of bleeding and hemostasis times are reduced, in particular by the blood containment and sieving mechanisms. Compression times at the AVF puncture points are thus reduced to a few tens of seconds. The risks of bacterial or viral contamination are reduced, as the user can quickly and visually check whether hemostasis has been achieved, without the risk of blood splashing.

[0173] The first sheet 2 is placed between the compress 5 and the patient's skin and does not have to be removed, the puncture site remaining covered during visual inspection of hemostasis. The risks of bleeding linked to removal of the platelet plug are reduced.

[0174] 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.

[0175] The flexibility of dressing 1 allows it to follow the contours of the skin, particularly in the vicinity of the aneurysmal areas of the AVFs.

Claims

Claims 1 . Dressing (1) for 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 parts (13, 15) in this longitudinal direction (L), the first end part (13) being fixed on 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 part (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, fibers of cotton, 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, characterized in that the first sheet (2) is a film of a material chosen 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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