Device for protecting a limb of the human body, in particular a limb which has an arteriovenous fistula

Abstract

The invention relates to a device (40) for protecting a limb of the human body, in particular a limb which has an arteriovenous fistula, comprising a sleeve (30) made of a first flexible and substantially resilient material (10), which can be slipped onto the limb receiving the arteriovenous fistula, a part (31) for protecting against cuts, said part being made of a second material (20) and covering at least 40% of the circumference of the sleeve, and means (111, 121, 211, 221) for holding or fixing the part (20, 31) for protecting against cuts onto the sleeve.

Description

Device for protecting a limb of the human body, in particular a limb with an arteriovenous fistula

[0001] The present invention relates to a device for protecting a limb of the human body, in particular a limb bearing an arteriovenous fistula, and a method for manufacturing such a protection device. Background

[0002] The kidneys perform a vital function for the body: the elimination of waste products from the bloodstream through urine. In cases of end-stage renal failure, the kidneys can no longer perform this function, and dialysis is necessary. For dialysis to be possible and effective, good blood flow is required. The flow of blood from the veins is too low. The flow of blood from the arteries is adequate, but blood cannot be drawn repeatedly from the arteries. Under anesthesia, the surgeon therefore creates a blood bypass from the radial artery into a superficial vein in the arm, forearm, or thigh—a connection between an artery and a vein. This vein will enlarge and form an arteriovenous fistula, allowing the patient to then undergo hemodialysis.The arteriovenous fistula significantly increases blood flow in a superficial vein, making it easier to puncture and obtain a sufficient quantity of blood for the dialyzer.

[0003] However, an arteriovenous fistula is very sensitive and fragile, so the patient must follow certain rules of "good conduct". The patient must not sleep on the side with the fistula (risk of ischemia), wear a watch or bracelet, wear sleeves that are too tight, carry heavy loads, take their blood pressure, have blood tests, or use pressure dressings. They must monitor any redness, discharge, or increased heat, which are a precursor to infection, and ensure increased monitoring of any bleeding. The major complications are the risk of infection and stenosis at the puncture site (narrowing of the blood channel), which can lead to a risk of thrombosis (obstruction of a vein by a clot).

[0004] Patients with an arteriovenous fistula, however, want to lead normal lives outside of hemodialysis periods. Some play sports, others garden, do DIY, cook, etc. During these activities, the risk of damage to the arteriovenous fistula is increased. Accidents can occur, such as a cut to the forearm at the fistula, a blow to the arteriovenous fistula, significant friction with an object, or other damage to the fistula that could endanger the patient's life.

[0005] It is therefore desirable to provide a means of protecting people with an arteriovenous fistula against such attacks, in order to make their lives more pleasant and safer.

[0006] Various protective devices are already known which do not meet the above-mentioned need. In particular, CN202960842U (2013 06 05) discloses a protective device used after arteriovenous fistulization. The protective device is intended for clinical use in a hospital and comprises a protective cylinder, a flexible sleeve disposed in the protective cylinder and a support frame connected to the protective cylinder, used to support the protective cylinder.

[0007] Various forearm or leg protection sleeves are also known, marketed under the brand names McDavid ("HEX Forearm Protection"), Adidas ("Terrex Primeblue Trail Sleeves"), Uvex ("Uvex C500 Forearm Protection Sleeve"), and Nike ("Nike Breaking2 Running Sleeves"). None of these sleeves are suitable for a person with an arteriovenous fistula. Summary

[0008] Thus, the present invention relates to a device for protecting a limb of the human body, in particular a limb carrying an arteriovenous fistula, comprising a sleeve made of a first flexible and substantially elastic material, capable of being slipped onto the limb, a cut protection piece made of a second material and covering at least 40% of the circumference of the sleeve, and means for holding or fixing the cut protection piece to the sleeve.

[0009] According to one embodiment, the cut protection piece comprises a proximal side edge fixed to the sleeve and a free or partially free distal side edge which can be folded over the sleeve.

[0010] According to one embodiment, the first material is an antibacterial and hypoallergenic material, substantially elastic, in particular a medical fabric, and the second material is a material having high mechanical resistance to cuts, in particular a tear-resistant fabric.

[0011] According to one embodiment, the device further comprises a shock protection part, and means for holding the shock protection part on the sleeve.

[0012] According to one embodiment, the shock protection part is a flexible plate or layer made from a shock-absorbing material, or a part of a substantially semi-cylindrical shape adapted to the morphology of the limb to be protected.

[0013] According to one embodiment, the impact protection part is removable and the means for holding the impact protection part on the sleeve comprise a housing extending between the sleeve and the cut protection part.

[0014] According to one embodiment, an edge of the sleeve comprises an elastic band for holding the sleeve on a limb onto which it is capable of being put on.

[0015] According to one embodiment, an internal face of the sleeve comprises a blood flow measurement sensor, arranged on the internal face of the sleeve.

[0016] Embodiments also relate to a method for manufacturing a device for protecting a limb of the human body, in particular a limb bearing an arteriovenous fistula, comprising the steps of providing a first part made of an antibacterial and hypoallergenic material, which is substantially elastic, providing a second part made of a material having high mechanical resistance to cuts, of an average length at least equal to half an average length of the first part, assembling, by sewing, gluing or welding, a first lateral edge of the first part with a second lateral edge so as to obtain a sleeve made from the first part, assembling, by sewing, gluing or welding, a proximal lateral edge of the second part with the first part, so as to obtain a cut protection part attached to the sleeve made from the second part,the cut protection piece covering at least 40% of the circumference of the sleeve, and providing means for holding or fixing on the sleeve a distal lateral edge of the second cut protection piece.,

[0017] According to one embodiment, the method comprises the step of equipping the device with at least one of the following two additional protection means: an impact protection part, designed to be housed between the sleeve and the cut protection part or integral with the cut protection part, a blood flow measurement sensor, arranged on the inner face of the sleeve.

[0018] The invention also relates to a method for protecting a person having an arteriovenous fistula, comprising the step of arranging the device described above on the limb of the person having the arteriovenous fistula.

[0019] Summary description of the drawings

[0020] Examples of embodiments of a protection device according to the invention will be described below without limitation in relation to the attached figures, among which:

[0021] The display of the inner faces of two parts used in the manufacture of a protection device according to the invention,

[0022] The watch of the outer faces of the pieces of the,

[0023] Lamontre a step of a method of manufacturing a protection device according to the invention,

[0024] Lamontre another step of a method of manufacturing a protection device according to the invention,

[0025] The protective device obtained at the end of the steps in figures 3 and 4 is shown,

[0026] Lamontre also shows the protective device obtained,

[0027] Shows a characteristic of an embodiment of the protection device according to the invention,

[0028] Lamontre another embodiment of the protection device according to the invention, in an open position,

[0029] The watch the protection device in a closed position,

[0030] Lamontre shows yet another embodiment of the protection device according to the invention.

[0031] Lamontre shows a variant of an element of the embodiment of the,

[0032] The watch shows a person equipped with a protective device according to the invention. Detailed description

[0033] Figures 1 to 4 show an embodiment of a method of manufacturing a device according to the invention intended in particular to protect a person with an arteriovenous fistula. The device is here made from two pieces 10, 20 made of fabric or other flexible material, shown flat in Figures 1 and 2, for example placed on a work surface. L shows the inner faces of the pieces 10, 20 and l shows their outer faces.

[0034] The piece 10 is of substantially trapezoidal shape and has an upper longitudinal edge 11 of a length d11, and a lower longitudinal edge 12 of a length d12, the length d11 being greater than the length d12. The edges 11, 12 may be very slightly arcuate, the edge 11 having a curvature oriented towards the outside of the surface of the piece 10 and the edge 12 a curvature oriented towards the inside of the surface of the piece. The piece 10 also has two lateral edges 13, 14 of substantially equal lengths l13, l14. The edges 11, 12 may each be provided with a border or bias 110, 120, of a width of 1 to 2 cm for example. A bias is conventionally a strip cut diagonally from a fabric relative to the straight grain. Once folded and sewn onto the edge of a work, it replaces the traditional hem and provides a practical and decorative finish, which protects the edges of the work.

[0035] Optionally, the edge 11 also comprises an elastic band 15, for example made of silicone, which adheres substantially to the skin, and which is here glued or sewn onto the bias 110. The elastic band 15 is preferably of a length less than the length d11 of the edge 11, for example half of its length, to avoid a tourniquet effect preventing good circulation of the blood, as will be understood later.

[0036] The part 20 is roughly parallelepipedal in shape and here has an upper longitudinal edge 21 of length d21, a lower longitudinal edge 22 of length d22, a proximal lateral edge 23 of a length l23 substantially equal to the lengths l13, l14 of the lateral edges 13, 14 of the part 10, and a distal lateral edge 24 of length l24 substantially less than the length l23.

[0037] The length d21 of the edge 21 is preferably equal to or greater than half the length d11 of the edge 11 of the part 10. The length d22 of the edge 22 is preferably equal to or greater than half the length d12 of the edge 12 of the part 10.

[0038] The perimeter of the part 20 is optionally covered with a bias 200 with a width of 1 to 2 cm for example. The edge 21 is here substantially curved with a curvature directed towards the inside of the part 20. The edge 22 is itself substantially curved with a curvature also directed towards the inside of the part 20.

[0039] Table 1 below provides, by way of non-limiting example, examples of dimensions of the parts 10, 20 in the context of producing a device for protecting a person's arm. The overall lengths are measured along straight lines between the ends of each edge.

[0040] EdgesLengthmmUpper longitudinal edge 11 of part 10d11308Lower longitudinal edge 12 of part 10d12275Lateral edge 13 of part 10l13200Lateral edge 14 of part 10l14200Upper longitudinal edge 21 of part 20d21195Lower longitudinal edge 22 of part 20d22177Proximal lateral edge 23 of part 20l23200Distal lateral edge 24 of part 20l24180

[0041] On the, pieces 10 and 20 have been turned over together by a movement from left to right, to show their outer faces. The edge 13 of piece 10 which formed its right edge on the is therefore here to the left of it, and the edge 23 of piece 20 which formed its right edge is also to the left of it. Piece 20 is now placed to the right of piece 10.

[0042] The lower longitudinal edge 12 of the outer face of the part 10 is covered with a self-gripping strip 121 over approximately half of its length, the self-gripping strip 121 stopping close to the edge 14. The upper longitudinal edge 11 of the part 10 comprises, substantially at its mid-length, a section of self-gripping strip 111 of short length. The upper longitudinal edge 21 of the part 20 similarly comprises a section of self-gripping strip 211. The latter covers an area of ​​intersection of the edge 21 and the distal lateral edge 24. The lower longitudinal edge 22 of the part 20 is covered over practically its entire length with a self-gripping strip 221, this however not covering the bias 200 which covers the proximal lateral edge 23.

[0043] The hook-and-loop strips 121 and 221 are complementary, one being provided for example with loops and the other with hooks. Likewise the hook-and-loop strip sections 111 and 211 are complementary. The hook-and-loop strip section 111 and the hook-and-loop strip 121 are for example sewn or glued to the bias strips 110 and 120. The hook-and-loop strip section 211 and the hook-and-loop strip 221 are similarly sewn or glued to the bias strip 200.

[0044] In a step shown in the, the lateral edge 13 of the part 10 is folded over the lateral edge 14 of the same part, so as to form a sleeve 30 and so that the strips and the sections of self-gripping strip are located outside the sleeve. The two edges 13, 14 are then assembled by sewing, gluing or welding. The sleeve 30 has a large diameter corresponding substantially to the length d11 of the upper longitudinal edge 11 of the part 10, by which the sleeve 30 can be slipped onto the limb carrying an arteriovenous fistula, and a small diameter corresponding substantially to the length d12 of the lower longitudinal edge 12 of the part 10.

[0045] During a step shown in the, the proximal lateral edge 23 of the part 20 is assembled on the sleeve 30, by sewing, gluing or welding the edge 23 on the assembly zone of the lateral edges 13, 14 of the part 10.

[0046] In a variant not shown, the lateral edge 14 of the part 10 is assembled with the proximal lateral edge 23 of the part 20, by sewing, gluing or welding. The lateral edge 13 of the part 10 is then folded over the assembly zone of the edges 14, 23, then assembled with it by sewing, gluing or welding, preferably by ensuring that the proximal lateral edge 23 of the part 20 is interposed between the lateral edges 13 and 14.

[0047] In another variant not shown, the lateral edges 13, 14 of the part 10 and the proximal lateral edge 23 of the part 20 are all assembled together during the same sewing, gluing or welding step.

[0048] According to one aspect of the invention, the part 10 is composed of an antibacterial, antifungal and hypoallergenic material, preferably anti-odor with a soft, relatively elastic "feel" and providing no compression effect. The part 20 is made of a preferably hydrophobic material having a high mechanical resistance to cuts, for example ripstop, namely a fabric shaped into a mesh whose warp and weft threads are arranged to ensure its resistance and prevent the extension of a possible tear. In one embodiment, a medical-grade cut-resistant fabric is used for reasons of medical certification of the device, for example a reference fabric JT1380 from Jules Tournier (https: / www.jules-tournier.com).

[0049] The material used to make the part 10 preferably meets the LNE (National Metrology and Testing Laboratory) reference and must preferably be machine-cleanable, for example at 40°C. Preferably, this material meets the ISO 10993-10 standard (skin irritation and sensitization). In one embodiment, the material is a fabric, preferably meeting the OEKO-TEX standard 100 class 1 certification. The material is, for example, a fabric of the SMB brand and reference 0263. The material used to form the biases 110, 120, 200 is, for example, a fabric of the SMB brand and reference 0119, which is sewn onto the parts 10, 20.

[0050] As best seen in Figures 5 and 6, the protective device 40 thus produced comprises a sleeve 30 produced from the part 10, and a tear-proof flap 31 formed by the part 20, which covers at least 40% of the circumference of the sleeve. The flap 31 ensures the protection of an arteriovenous fistula against accidental cuts which could lead to risks of ischemia or hemorrhage, and thus makes it possible to limit surgical interventions. When the flap 31 is folded over the sleeve 30, it is held pressed against the sleeve by the self-gripping strip section 211 which cooperates with the self-gripping strip section 111, as well as by the self-gripping strip 221 (not visible in figures 5, 6) which cooperates with the self-gripping strip 121. The elastic band 15 shown transparently on the also ensures that the sleeve is held on the limb without a tourniquet effect.

[0051] In an alternative embodiment, the edge 22 of the part 20 is fixed to the edge 12 of the part 10 by sewing, gluing or welding. In this case the hook-and-loop strips 121, 221 are no longer necessary. Only the edge 21 of the flap 31 comprising the hook-and-loop strip section 211 must be folded over the sleeve 30, to attach to the hook-and-loop strip section 111.

[0052] In an embodiment shown in the, the distal lateral edge 24 of the part 20 further comprises a whalebone 41 which is arranged inside the bias 200, to stiffen the end of the flap 31.

[0053] In an advantageous embodiment of the protective device 40, the latter is further equipped with an impact protection part, and comprises means for holding this part on the sleeve. In an exemplary embodiment shown in FIGS. 8 and 9, the impact protection part is a plate 50 made of a malleable material, such as memory foam or a thermoformable material. The holding means comprise a housing extending between the sleeve 30 and the part 20 when the latter is folded over the sleeve and is held against it by means of the hook-and-loop strip sections.

[0054] In another embodiment shown in the, the impact protection part is a part 51 of semi-cylindrical shape adapted to the morphology of the member to be protected, made of a flexible or semi-rigid material, for example a thermoformable material, and optionally having a wavy relief reinforcing its impact resistance. The part 51 is, like the part 50, arranged between the sleeve 30 and the part 20.

[0055] In yet another embodiment, the impact protection part is made of a viscoelastic material and takes, for example, the form of a layer or plate of silicone gel capable of absorbing shocks. This layer or plate of viscoelastic gel may, instead of being inserted into the housing extending between the sleeve 30 and the flap 31, be arranged in a closed pocket made in the part 20 forming the flap 31.

[0056] In an embodiment shown in the, the protection device 40 further comprises a sensor 60 for measuring the blood flow. The sensor 60 is arranged on the internal face of the part 10, i.e. inside the sleeve 30, close to the anastomosis zone but not directly opposite the arteriovenous fistula, so as not to damage it. It is positioned so as to be substantially flush with the skin and configured to take measurements in the capillary surface layer of the skin.

[0057] The sensor 60 is for example a sensor operating by Doppler effect marketed by the company Kyocera under the name “LDF Sensor”, comprising a vertical laser and a brightness sensor. The sensor is associated with an electronic system for controlling and amplifying the signals provided by the sensor, with low power consumption, compatible with “IoT” (Internet of Things), offering a wireless connection and capable of communicating to a remote server, via the Internet of Things, the data that it collects, for increased monitoring of the patient. Alternatively, the electronic system is connected by Bluetooth or Wi-Fi to a mobile phone equipped with a blood flow monitoring application, which is configured to issue an alert if an anomaly is detected. The alert may consist of the emission of a ringtone, the sending of a short message, an email, or the calling of a special number, etc.The electronic system for controlling and amplifying the signals is preferably produced on a semiconductor microchip of the SOC type (System On Chip) equipped with an electric battery. It can be arranged on the external face of the sleeve 30, in a region opposite that receiving the flap 31 (not visible on the), and connected to the sensor by means of very fine wires which do not degrade the comfort of the sleeve. The electronic system executes a blood flow calculation algorithm by means of a microcontroller, the parameters of which are accessible and modifiable according to the patient during a calibration step. In one embodiment, the sensor is associated with an accelerometer making it possible to detect body movements, so that the microcontroller can correct measurement errors linked to such movements.

[0058] The blood flow measurement sensor may also be of a type other than a Doppler sensor, for example a sensor configured to detect variations in colorimetry or changes in the size of blood vessels.

[0059] It will be apparent to those skilled in the art that the protective device is susceptible to various other variations, embodiments and applications. In particular, the cut protection piece, instead of being foldable, could have its distal end permanently attached to the sleeve.

[0060] The protective device 40 is placed on the limb bearing an arteriovenous fistula, for example an arm as shown in the figure. It ensures good protection of the fistula as well as its monitoring if it is equipped with the sensor 60. It makes the life of patients more pleasant and safer, and leaves complete freedom to practice a sport, gardening, DIY, as well as other activities. It can be put in place easily, without risk of injury or compression. Contact with the skin is soft and without risk of allergy. The device adapts to different morphologies and can include a mark for the positioning of the impact protection plate, which can be offered to the public as an optional accessory, which can be easily separated and cleaned.

[0061] The protective device should preferably cover the entire arm or forearm, or thigh, depending on the positioning of the arteriovenous fistula. Several sizes may be available, as shown in Table 2 below, which concerns fistulas created by the surgeon on the forearm or arm (the most common case). To select the optimal size, the protective device should not hinder movement or create an “elastic return” effect when removed.

[0062] Examples of protection device lengthsPositioning of the arteriovenous fistulaSizesForearmArmSmall20 - 24 cm27 - 31 cmMedium24 - 28 cm31 - 34 cmLarge28 - 32 cm34 - 37 cmX-Large32 - 36 cm37 - 40 cmXX-Large36 - 39 cm40 - 46 cm

Claims

Device (40) for protecting a limb of the human body, in particular a limb bearing an arteriovenous fistula, characterized in that it comprises:- a sleeve (30) made of a first flexible and substantially elastic material (10), capable of being slipped onto the limb,- a cut protection piece (20, 31) made of a second material (20) and covering at least 40% of the circumference of the sleeve, and- means (111, 121, 211, 221) for holding or fixing the cut protection piece (20, 31) to the sleeve. Device according to claim 1, wherein the cut protection part (20, 31) comprises a proximal lateral edge (23) fixed to the sleeve and a free or partially free distal lateral edge (24) which can be folded over the sleeve. Device according to one of claims 1 and 2, in which:- the first material (10) is an antibacterial and hypoallergenic material, substantially elastic, in particular a medical fabric, and- the second material (20) is a material having high mechanical resistance to cuts, in particular a tear-resistant fabric. Protective device according to one of claims 1 to 3, further comprising a piece (50, 51) for protection against impacts, and means (31, 111, 121, 211, 221) for holding the piece (50) for protection against impacts on the sleeve. Device according to claim 4, in which the shock protection part is a flexible plate or layer (50) made of a shock-absorbing material, or a part (51) of substantially semi-cylindrical shape adapted to the morphology of the limb to be protected. Device according to one of claims 4 and 5, in which the impact protection part (50, 51) is removable and the means for holding the impact protection part on the sleeve comprise a housing extending between the sleeve (30) and the cut protection part (20, 31). Device according to one of claims 1 to 6, in which an edge (11) of the sleeve comprises an elastic band (15) for holding the sleeve on a limb onto which it is capable of being put on. Device according to one of claims 1 to 7, in which an internal face of the sleeve (30) comprises a sensor (60) for measuring blood flow, arranged on the internal face of the sleeve. A method of manufacturing a device (40) for protecting a limb of the human body, in particular a limb bearing an arteriovenous fistula, comprising the steps of:- providing a first part (10) made of an antibacterial and hypoallergenic material, substantially elastic,- providing a second part (20) made of a material having high mechanical resistance to cuts, of an average length (d21, d22) at least equal to half an average length (d11, d12) of the first part,- assembling, by sewing, gluing or welding, a first lateral edge (13) of the first part (10) with a second lateral edge (14) so ​​as to obtain a sleeve (30) made from the first part (10)- assembling, by sewing, gluing or welding, a proximal lateral edge (23) of the second part (20) with the first part (10), so as to obtain a cut protection part (31) attached to the sleeve made from the second part (20),the cut protection part (31) covering at least 40% of the circumference of the sleeve (30), and- providing means (111, 121, 211, 221) for holding or fixing on the sleeve a distal lateral edge (24) of the second cut protection part (20)., Method according to claim 9, comprising the step of equipping the device (40) with at least one of the following two additional protection means: - a piece (50, 51) for protection against impacts, designed to be housed between the sleeve (30) and the piece (20, 31) for protection against cuts or integral with the piece (20, 31) for protection against cuts, - a sensor (60) for measuring the blood flow, arranged on the inner face of the sleeve (30). Method for protecting a member of the human body, comprising the step of arranging the device according to one of claims 1 to 8 on the member to be protected.

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