BREATHABLE SLEEVE FOR PROTECTIVELY COVERING A MEDICAL DEVICE IMPLANT SITE, AND MANUFACTURING METHOD

Abstract

A breathable protective sleeve (10) for the installation site of an external part of a medical device on a patient's limb comprises a knitted piece (12) forming a tubular body (18) including two open annular end portions (20), the knitted piece (12) having two end edges (14) each located at one of the two end portions (22). The knitted piece (12) has two seam edges (16) extending from one of the two end edges (14) to the other in a seam line area (22). The sleeve (10) includes a joint film (24) permanently applied to a first joint surface (26) of the knitted piece (18) located in the parting line area (22) along one of the two joint edges (16) and to a second joint surface (26) of the knitted piece (12) located in the parting line area (22) along a second of the two joint edges (16). (Shortcut Figure: 4)

Description

Title of the invention: BREATHABLE SLEEVE FOR PROTECTING AN IMPLANTATION SITE OF A MEDICAL DEVICE, AND METHOD OF MANUFACTURING TECHNICAL FIELD OF THE INVENTION

[0001] The invention relates to a breathable sleeve for protecting an installation site of an external part of a medical device on an upper or lower limb of a patient, for example a catheter, a blood glucose sensor or a dressing, on the forearm or lower arm or on the leg of a patient. STATE OF THE PRIOR ART

[0002] Some medium-term medical treatments require regular intravenous treatments. To avoid repeated injections, it is known to insert a catheter, most often in the patient's forearm or forearm, the catheter being able to be connected to a bag containing the prescribed treatment. In this way, it is possible to administer different intravenous treatments adapted to the evolution of the patient's state of health. When the catheter is not in use, it is closed with a cap to prevent any penetration of bacteria into the patient's body. However, the skin around the catheter remains exposed to bacteria and risks becoming infected if it is not protected.

[0003] Document WO 2010 / 013020 A2 describes a sleeve for holding a medical device installed on a patient's limb. This sleeve is composed of a tubular body knitted with elastomeric threads. Margins are formed at the ends of the tube body to prevent the tube from rolling on itself. The sleeve can be manufactured by a tubular knitting process. The manufacture of such a sleeve is complex and expensive since no assembly is provided and each knit must be directly shaped to the desired dimensions. Furthermore, in use, the sleeve does not always stay in place and can slip on the patient's limb. Disclosure of the invention

[0004] The invention aims to remedy the drawbacks of the state of the art and to propose a protective sleeve for a site of installation of a medical device on a limb of a patient, the mass production of which is simplified.

[0005] To this end, the invention proposes a breathable sleeve for protecting an installation site of an external part of a medical device on an upper or lower limb of a patient, the sleeve comprising a knitted piece forming a tubular body comprising two open annular end portions, the knitted piece having two end edges each located at one of the two portions end. The knitted piece has two joint edges extending from one of the two end edges to the other in a joint line area. The sleeve comprises a set of one or more adhesive films permanently applied to corresponding surfaces of the knitted piece, comprising at least one joint film permanently applied to a first joint surface of the knitted piece located in the joint line area along a first of the two joint edges and to a second joint surface of the knitted piece located in the joint line area along a second of the two joint edges.

[0006] The choice of a knit to constitute the tubular body of the sleeve makes it possible to ensure the breathability of the sleeve, that is to say its permeability to air, and its capacity to be stretched elastically.

[0007] The two joint edges are preferably cut, and, if necessary, some of the stitches of the knitted fabric may be incomplete at these cut edges. Thus, the knitted piece may have been cut from a large roll of knitted fabric, which makes it possible to envisage very high-yield flat knitting. The knitted fabric may in particular be a weft knit or a warp knit.

[0008] The sealing film allows the tubular body of the sleeve to be closed on itself, while avoiding wear, or even fraying, at the cut edges.

[0009] It is possible to envisage that the same face of the sealing film is applied permanently to the first and second sealing surfaces, the opposite face of the film not being covered.

[0010] Alternatively, and according to a preferred embodiment, the first joint surface of the knitted piece and the second joint surface of the knitted piece are superimposed, the joint film having a first face permanently applied to the first joint surface of the knitted piece and a second face, opposite the first face, permanently applied to the second joint surface of the knitted piece. The joint line area is then identical on the front and back. The first face of the joint film is preferably entirely covered by the first joint surface of the knitted piece, and the second face of the joint film is preferably entirely covered by the second joint surface of the knitted piece.Thus, the surface condition of the joint line area is that of the knitted piece, and the user can put on the sleeve with the same ease as if it were obtained by a tubular knitting process.

[0011] According to one embodiment, the set of adhesive films comprising two end films, each associated with one of the end portions and permanently applied to an annular end surface of the knitted piece, located in the associated end portion. The edges of the knitted piece are preferably rectilinear, to limit waste. The knitted piece is therefore preferably a qua quadrilateral, whose two end edges and two joining edges form the four sides and are all cut, in the sense that they are cut from a larger piece of knitted fabric. Since the two joining edges are the same length, the quadrilateral can be an isosceles trapezoid (whose two end edges are not the same size), or a rectangle, or even a square.

[0012] According to one embodiment, it is ensured that at each end portion, the piece of knitwear forms a hem folded over the tubular body. This arrangement contributes to better mechanical strength of the end portions, on which the user is likely to pull to put on or take off the sleeve. The end film can then play not only a role in holding the yarns of the knitwear at the end cut edge, but also a role in holding the hem.

[0013] According to a first variant, it is ensured that at each end portion, the associated end film has a face permanently applied to the hem and to an adjacent surface of the tubular body. In this case, the opposite face of the end film can be left uncovered, which allows it to play an anti-slip role. The film is then multifunctional.

[0014] According to another variant, it is ensured that at each end portion, the associated end film has a face permanently applied to a surface of the hem and an opposite face permanently applied to the tubular body. Where appropriate, the width of the end film may be greater than that of the hem so that a portion of the face of the end film facing the hem is not covered by the latter and can play an anti-slip role. Alternatively, both faces of the end film are entirely covered by the knitted piece.In this hypothesis, it can be provided, to fulfill this anti-slip function, that the set of adhesive films comprises at least one anti-slip film having a first face applied permanently to the piece of knitwear at one of the two end portions, and a second opposite the first face, at least partially uncovered, and having a rough surface condition.

[0015] According to various embodiments, each film of the set of one or more adhesive films: • comprises a thermoplastic polymer, and / or • does not contain silicone, and / or • has a weight less than or equal to 400 g / m2, and / or • has a thickness less than or equal to 400pm, and / or • has an elastic modulus of between 0.1 and 100Pa, and / or • has a melting temperature of less than 200°C, and / or • is bonded, preferably hot, to the corresponding surface of the part knitting.

[0016] By hot bonding is meant here the result of a hot application, for example at a temperature between 150°C and 180°C, and preferably by applying a pressing pressure, which in particular allows the film material to conform to the asperities and hollows on the surface of the knit, or even to surround at least some of the yarns of the knit, so as to maximize the contact interface and to promote physicochemical adhesion between the materials.

[0017] Preferably, all the films in the set of one or more adhesive films have the same composition. It is indeed advantageous to limit the number of different materials, so that the behavior of the sleeve is uniform, in particular with regard to its mechanical properties and its resistance to aging or washing.

[0018] According to one embodiment, the knitted piece comprises a localized zone at a distance from the annular end portions, preferably having a longitudinal dimension greater than 3 cm and a transverse dimension greater than 3 cm, the localized zone forming a recess relative to the inner face of the tubular body. This recess makes it possible to accommodate a projecting medical device, for example the external part of a catheter. Preferably, the localized zone is plastically deformed. The plastic deformation can be obtained hot. Advantageously, a lining piece with the dimensions of the localized zone can be provided, fixed to the knitted piece at the localized zone, in order to reinforce the sleeve in this zone. According to various manufacturing methods, the lining piece is made of knitwear, and preferably of the same material as the knitted piece.

[0019] Where appropriate, the lining piece is bonded to the knitted piece by a set of point areas of adhesive, the set of point areas of adhesive preferably occupying an area less than 20% of the area of ​​the lining piece, the set of point areas of adhesive preferably comprising at least ten point areas of adhesive. Alternatively, a layer of stabilizing fabric may be provided between the lining piece and the knitted piece.The lining piece is preferably adhered to the stabilizer fabric layer by a first set of adhesive spot areas, and the stabilizer layer is preferably adhered to the knit piece by a second set of adhesive spot areas, each of the first and second sets of adhesive spot areas preferably occupying an area of ​​less than 20% of the area of ​​the lining piece, the set of adhesive spot areas preferably comprising at least ten adhesive spot areas.

[0020] The knit is preferably synthetic. According to one embodiment, the knitted piece is composed of yarns comprising polyamide, preferably in proportions greater than 60%, and preferably greater than 70%, and where appropriate elastane, preferably in proportions less than 40%, and preferably less than 30%.

[0021] Preferably, the knitted piece has a weight of less than 200 g / m2, and preferably less than 150 g / m2, for example between 100 and 130 g / m2.

[0022] According to another aspect of the invention, it relates to a method of manufacturing a breathable sleeve according to any one of the preceding claims, characterized in that the knitted piece is cut from a piece of larger dimensions, the joint edges, and where appropriate the end edges, being cut edges. BRIEF DESCRIPTION OF THE FIGURES

[0023] Other characteristics and advantages of the invention will emerge on reading the description which follows, with reference to the following appended figures.

[0024] [Fig.l] is a perspective view of a breathable sleeve according to one embodiment of the invention.

[0025] [Fig.2] is a front view of a piece of knitting intended to form a body of the sleeve of [Fig.l], according to one embodiment.

[0026] [Fig. 3] is a front view of a piece of knitting intended to form a body of the sleeve of [Fig. 1], according to another embodiment.

[0027] [Fig.4] is a cross-section of the sleeve of [Fig.l].

[0028] [Fig.5] is a detail D of [Fig.4].

[0029] [Fig.6] is an axial section of an end portion of the sleeve of [Fig.l], following a first variant.

[0030] [Fig.7] is an axial section of an end portion of the sleeve of [Fig.l], according to a second variant.

[0031] [Fig.8] is an axial section of an end portion of the sleeve of [Fig.l], according to a third variant.

[0032] For clarity, identical or similar elements are identified by identical reference signs throughout the figures. DETAILED description of embodiments

[0033] In [Fig.l] is illustrated a breathable sleeve 10 for protecting an installation site of an external part of a medical device on an upper or lower limb of a patient. The medical device in question may be, for example, a catheter, a blood glucose sensor or a dressing. The purpose of the breathable protective sleeve 10 is to protect the installation site against mechanical aggression, with a view to improving the patient's comfort. In particular, the aim is to prevent the medical device from interfering with the patient's clothing, in particular when dressing or undressing, and to prevent any movement of the medical device relative to the patient's body when the latter moves. The sleeve 10 is said to be breathable in the sense that it is permeable to air.

[0034] For this purpose, the sleeve 10 comprises a knitted piece 12 which, before assembly, has the shape of an isosceles trapezoid ([Fig.2]) or a rectangle ([Fig.3]), or even a square, with four rectilinear sides forming four edges 14, 16 of the knitted piece. The knitted piece 12 is composed of yarns comprising polyamide, preferably in proportions greater than 60%, and preferably greater than 70%, and where appropriate elastane, preferably in proportions less than 40%, and preferably less than 30%. The tightness of the stitches ensures good air permeability of the knitted piece 12. The knitted piece 12 is preferably light, preferably with a weight of less than 200 g / m2, and preferably less than 150 g / m2, for example between 100 and 130 g / m2.

[0035] This piece is intended to be obtained by cutting from a larger piece, for example from a roll with a length of several tens of meters and a width greater than one meter, knitted flat. Cutting the knitted piece 12 from a larger piece has the effect that the edges 14, 16 are cut.

[0036] After assembly, the knitted piece 12 forms a tubular body 18, frustoconical or cylindrical. Two of the four edges are end edges 14 each located in an end portion 20 of the tubular body 18, in one of the configurations illustrated in FIGS. 3 to 5. The other two edges are called joint edges 16, in the sense that, after the sleeve has been made, they are positioned in a common joint zone 22 which extends from one end edge 14 to the other, as illustrated in [Fig. 2].

[0037] At the common joint area illustrated in Figures 4 and 5, an adhesive film, called joint film 24, is hot-bonded to a first joint surface 26 of the knitted piece 12, located in the joint line area 22 along one of the two joint edges 16 and to a second joint surface 28 of the knitted piece 12 located in the joint line area 22 along the other joint edge 16. More specifically, the first joint surface 26 and the second joint surface 26 are superimposed, the joint film 24 having a first face permanently applied to the first joint surface 24 of the knitted piece and a second face, opposite the first face, permanently applied to the second joint surface 24 of the knitted piece. The joint film is entirely covered by the knitted piece.

[0038] The function of the joint film 24 is to secure the two joint edges 16 of the knitted piece to each other to form the tubular body 18, and to prevent fraying of the threads of the knitted piece 12 at the two cut joint edges 16.

[0039] Similarly, adhesive films, called end films 30, are applied to the two end portions 20 of the knitted piece 12, as illustrated in FIGS. 3 to 5, at least to prevent fraying of the threads of the knitted piece 12 at level of the end edges 14, which we recall are also cut.

[0040] Preferably, and as illustrated in each of the variants of figures 6 to 8, the knitted piece 12 forms, at each end portion 20, a hem 32 folded over the tubular body 18.

[0041] According to [Fig. 3], the end film 30 has a face 34 straddling the hem 32 and an adjacent surface of the tubular body 18, and bonded both to the hem 32 and to the adjacent surface of the tubular body 18. The opposite face 36 of the end film 30 is not covered, and may, if necessary, by its surface condition, constitute a non-slip device facilitating the holding in place of the sleeve 10 on the patient's body. It is thus possible to combine three functions at the level of the end film 30.

[0042] According to Figures 7 and 8, the end film 30 has a face 34 permanently applied to the hem 32 and an opposite face 36 permanently applied to the tubular body 18. According to [Fig.7], the end film 30 is not entirely covered by the hem 32, so that the face 34 extends beyond the hem 32 without being covered, and can then constitute an anti-slip device. According to the variant of [Fig.5], the end film 30 is entirely covered by the hem 32. It is then possible to provide an added anti-slip device, by applying an adhesive film 40 to a free face of the end portion of the knitted piece 12.

[0043] The adhesive films 24, 30, 40 affixed to the knitted piece preferably all have the same composition. The material constituting the film preferably comprises a thermoplastic polymer. The films 24, 30, 40 may be welded, but are preferably bonded, in particular hot-bonded, to the corresponding surface of the knitted piece 12. Here, hot-bonding is understood to mean the result of hot-applying the film by applying sufficient pressure to maximize the area of ​​the contact interface and obtain physicochemical adhesion at this interface. During this hot operation, the film becomes pasty, or even liquid, and is inserted between the fibers of the knitted piece. Preferably, the material constituting the film does not contain silicone, which is favorable in terms of biocompatibility and skin allergies. The thickness of the film is preferably less than or equal to 400 pm, and its weight less than or equal to 400 g / m2.Its elastic modulus is preferably between 0.1 and 100 Pa.

[0044] Optionally, the knitted piece may comprise a localized zone 50, at a distance from the end portions, having a longitudinal dimension greater than 7 cm and a transverse dimension greater than 5 cm, the localized zone forming a recess 52 relative to the inner face of the tubular body 18. A lining piece 54 with the dimensions of the localized zone may be fixed to the knitted piece 12 at the localized zone 50. Preferably, the lining piece 54 is made of knitwear, made of the same material as the knitted piece 12 forming the tubular body 18. The liner piece 54 may be adhered to the knit piece 12 by a set of adhesive spot areas 56, the set of adhesive spot areas preferably occupying an area less than 20% of the area of ​​the liner piece 54, the set of adhesive spot areas 56 preferably comprising at least 10 adhesive spot areas. The localized area 50 is plastically deformed under heat to provide the desired recess 52, which provides a housing for a bulky medical device such as a catheter.

[0045] Naturally, the examples shown in the figures and discussed above are given for illustrative purposes only and are not limiting. It is explicitly provided that the different embodiments illustrated can be combined with each other to propose others.

Claims

Claims

1. A breathable sleeve (10) for protecting an installation site of an external part of a medical device on an upper or lower limb of a patient, the sleeve (10) comprising a knitted piece (12) forming a tubular body (18) comprising two open annular end portions (20), the knitted piece (12) having two end edges (14) each located at one of the two end portions (22), characterized in that the knitted piece (12) has two joint edges (16) extending from one of the two end edges (14) to the other in a joint line area (22), and in that the sleeve (10) comprises a set of one or more adhesive films (24, 30, 40) permanently applied to corresponding surfaces of the knitted piece (12),comprising at least one seal film (24) permanently applied to a first seal surface (26) of the knitted piece (18) located in the seal line area (22) along a first of the two seal edges (16) and to a second seal surface (26) of the knitted piece (12) located in the seal line area (22) along a second of the two seal edges (16).,

2. Breathable sleeve (10) according to claim 1, characterized in that the first joint surface (26) of the knitted piece (12) and the second joint surface (26) of the knitted piece (12) are superimposed, the joint film (24) having a first face permanently applied to the first joint surface (26) of the knitted piece (12) and a second face, opposite the first face, permanently applied to the second joint surface (26) of the knitted piece (12).

3. A breathable sleeve (10) according to any preceding claim, characterized in that the set of adhesive films (24, 30, 40) comprises two end films (30), each associated with one of the end portions (20) and permanently applied to an annular end surface of the knitted piece (12), located in the associated end portion (20).

4. Breathable sleeve according to claim 3, characterized in that at each end portion (20), the knitted piece (12) forms a hem (32) folded over the tubular body (18).

5. Breathable sleeve according to claim 4, characterized in that at each end portion (20), the associated end film (30) has a face (34) permanently applied to the hem (32) and on an adjacent surface of the tubular body (18).

6. A breathable sleeve according to claim 4, characterized in that at each end portion (20), the associated end film (30) has a face (36) permanently applied to a surface of the hem (32) and an opposite face (34) permanently applied to the tubular body (18).

7. Breathable sleeve according to claim 6, characterized in that the set of adhesive films comprises at least one non-slip film (30, 40) having a first face permanently applied to the knitted piece (12) at one of the two end portions (20), and a second opposite the first face, at least partially uncovered, and having a rough surface condition.

8. Breathable sleeve (10) according to any one of the preceding claims, characterized in that each film (24, 30, 40) of the set of one or more adhesive films - comprises a thermoplastic polymer, and / or - does not contain silicone, and / or - has a grammage less than or equal to 400 g / m2, and / or - has a thickness less than or equal to 400 pm, and / or - has an elastic modulus of between 0.1 and 100 Pa, and / or - has a melting temperature less than 200°C, and / or - is glued, and preferably hot, to the corresponding surface of the knitted piece.

9. A breathable sleeve (10) according to any preceding claim, characterized in that all the films (24, 30, 40) of the set of one or more adhesive films have the same composition.

10. Breathable sleeve (10) according to any one of the preceding claims, characterized in that the knitted piece (12) comprises a localized zone (50) at a distance from the annular end portions (20), preferably having a longitudinal dimension greater than 3 cm and a transverse dimension greater than 3 cm, the localized zone (50) forming a recess (52) relative to the inner face of the tubular body (18).

11. A breathable sleeve according to claim 10, characterized in that the localized area (50) is plastically deformed.

12. A breathable sleeve according to claim 10 or claim 11, ca- characterized in that it comprises a lining piece (54) with the dimensions of the localized area (50), fixed to the knitted piece (12) at the localized area (50).

13. Breathable sleeve according to claim 12, characterized in that the lining piece (54) is made of knit, preferably of the same material as the knit piece (12).

14. A breathable sleeve according to claim 12 or claim 13, characterized in that: - The lining piece (54) is bonded to the knitted piece (12) by a set of point areas of adhesive (56), the set of point areas of adhesive (56) preferably occupying an area of ​​less than 20% of the area of ​​the lining piece (54), the set of point areas of adhesive (56) preferably comprising at least ten point areas of adhesive (56), or - Between the lining piece and the knitted piece is arranged a layer of stabilizing fabric, the lining piece (54) being bonded to the layer of stabilizing fabric by a first set of point areas of adhesive (56), and the stabilizer layer being bonded to the knitted piece (12) by a second set of point areas of adhesive,each of the first and second sets of adhesive punctate areas (56) preferably occupying an area less than 20% of the area of ​​the liner piece (54), the set of adhesive punctate areas (56) preferably comprising at least ten adhesive punctate areas (56).,

15. Breathable sleeve (10) according to any one of the preceding claims, characterized in that the knitted piece (12) - is composed of yarns comprising polyamide, preferably in proportions greater than 60%, and preferably greater than 70%, and where appropriate elastane, preferably in proportions less than 40%, and preferably less than 30% and / or - has a weight less than 200 g / m2, and preferably less than 150 g / m2, for example between 100 and 130 g / m2.

16. A method of manufacturing a breathable sleeve according to any one of the preceding claims, characterized in that the knitted piece is cut from a piece of larger dimensions, the joint edges, and where appropriate the end edges, being cut edges.

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