法国专利FR3027524A1 DEVICE FOR ATTACHING AN ELONGATED MEMBER TO THE BODY OF A PATIENT, TREATMENT NEED, AND ASSOCIATED ME

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专利摘要:
The device comprises a retaining support (6) of the elongated element (2), comprising at least one bottom wall and an adhesive strip (8) carrying the retaining support (6), and intended to be applied to the skin of the patient, the adhesive tape (8) defining at least one region of the fastening device (4) offset relative to the bottom wall. A region of the fixing device (4) located under the lower wall along an axis (A-A ') of insertion of the elongated element (2) into the retaining support (6) is intended to be non-adherent to the The retaining support (6) comprises a gripping flap adapted to be operated relative to the lower wall between an open position and a gripping position of the elongated element (2), wherein elongated element (2) is intended to be held between the bottom wall and the clasp flap.
公开号:FR3027524A1
申请号:FR1460355
申请日:2014-10-28
公开日:2016-04-29
发明作者:Benjamin Lahoucine Jaouani
申请人:Perouse Medical SAS；
IPC主号:

专利说明:

[0001] The present invention relates to a device for attaching an elongated element to the body of a patient, the elongated element being intended for to be partially inserted into the human body, the device comprising: a support for retaining the elongated element, comprising at least one bottom wall intended to be placed between the elongated element and the body of the patient; an adhesive strip carrying the retaining support, and intended to be applied to the skin of the patient, the adhesive tape defining at least one region of the attachment device offset relative to the lower wall intended to adhere to the skin of the patient. Certain elongated elements intended to be inserted into the body of a patient make it possible to introduce or withdraw liquids into the human body, for example via the blood network. This is particularly the case of catheters, or more especially "PICC", that is to say, central catheters inserted peripherally according to the acronym. Thus, a first end of the elongated member is introduced into the human body, while a second end is held outside the human body, to be connected to one or more supply pipes for the passage of fluid.
[0002] The elongated member is inserted into the human body from an exit point located on the patient's skin, for example at an arm. The first end of the catheter is placed in a precise injection or sampling site, for example in the vicinity of a heart valve. The position of the first end must be maintained accurately to ensure adequate distribution or collection of the product, while avoiding the risk of complications (eg thrombosis in case of poor placement in the bloodstream). When the catheter is not in use, it must be held in position to allow the patient to move freely without the risk of moving the first end. Similarly, when the catheter is used, the position of the first end must be maintained, to ensure for example the effectiveness of the treatment or to avoid complications. There are two methods for attaching the second end of the elongate member. The first method is to suture the end of the catheter to the skin. This ensures that the fixation is effective, but constitutes a traumatic step presenting risks of infection for the patient and the carer (in particular, risk of stinging with the suture needle).
[0003] A second method is to make a fixation without sutures, for example with a simple dressing. Dressing-based devices have been developed to limit the risk of mobilization of the elongated element.
[0004] Elongated elements, such as PICCs, are generally used for long periods of time, and often outside the hospital in mobile patients. It is therefore necessary to regularly change the dressings that hold the second end of the elongated element to the skin of the patient. To reduce the risk of infection, dressings must remain at most eight days on the patient.
[0005] The removal of the existing dressing and the introduction of a new dressing are likely to mobilize the elongated element, which can be harmful depending on where the first end of the elongated element is inserted. For example, the first end of the elongate member may be inserted into the superior vena cava. Axial displacement of the elongate member may then affect the heart or cause thromboses. In addition, a displacement of the catheter can perforate the vein in which it is located, which can lead to complications and pain. Moreover, simply turning the second end of the catheter outside the patient for the placement of the dressing or removal may be unpleasant for the patient.
[0006] To overcome this problem, it is known to provide elongated elements having, at their second end, fins which are fixed on a support by two valves, each associated with a fin. The elongated element is thus maintained in all directions, and the assembly is fixed on an adhesive tape. A kit of this type is described in WO 02/11786 A2.
[0007] Such a necessity does not give complete satisfaction. Indeed, during the change of dressing, it is necessary to lift the valves holding the elongated member, to eccentric or / and fold the elongate member and remove the dressing to disinfect the area around the exit point. This maneuver mobilizes significantly the elongated element.
[0008] In addition, the aforementioned device lacks simplicity, because both hands are required to proceed with the installation and removal of the device. In addition, the socket that allows the opening of the valves on the lower edge is not clearly identified, and the decision at another place on the upper edge or in the middle of the valve, makes it difficult to open the valve .
[0009] An object of the invention is to provide a device for fixing an elongate element, which further limits the risks of mobilization of the elongate element, while being simple to use both for the introduction and for the removal of the device. For this purpose, the subject of the invention is a device of the aforementioned type, characterized in that at least one region of the fixing device located under the bottom wall along an axis of insertion of the elongate element in the retaining support. is intended to be non-adherent to the patient's skin when the fixation device is attached to the patient's skin, the retaining support comprising a clasp flap adapted to be operated relative to the lower wall between an open position and a clamping position of the elongate member, wherein the elongate member is adapted to be held between the bottom wall and the clasp. The device according to the invention may comprise one or more of the following characteristics, taken separately or in any technically possible combination: the clasp flap is more rigid in flexion than the adhesive strip. - The retaining support comprises a fastening flap, adapted to fall back on the clasp to maintain the position of the clasp. - The fastening flap is stiffer in bending than the adhesive tape. - The device comprises a selective attachment assembly of the fastening flap on the clasp. - The retaining support comprises at least one set of wedging of the elongate element, intended to be interposed between the bottom wall and the clasp flap in the clamping position. - The wedging assembly comprises at least one element of an elastically deformable material projecting from the clasp and / or the bottom wall. - The wedging assembly comprises a first set of pins protruding from the clasp and a second set of pins protruding from the bottom wall. the adhesive strip has at least one adhesive external region intended to come into contact with the body of the patient, the or each adhesive outer region being offset relative to the holding support and advantageously with respect to an exit point of the elongated element out of the patient. the adhesive strip comprises at least two external adhesive regions situated on either side of the retaining support with respect to the insertion axis. the adhesive strip comprises a lower surface and an upper surface, the retaining support being fixed on the upper surface, advantageously by gluing. the adhesive strip comprises a lower surface and an upper surface, at least one central region of the adhesive strip being fixed on an upper surface of the lower wall, the central region overlapping the lower wall. at least one non-sliding contact element is fixed on the lower surface of the lower wall. - The retaining support comprises a folding flap, the flap is applied to the central region of the adhesive strip. the adhesive strip comprises at least three disjoint adhesive outer regions, advantageously at least four disjoint adhesive outer regions, the adhesive outer regions being distributed around the retaining support, on either side with respect to the insertion axis.
[0010] The subject of the invention is also a treatment kit comprising a device as defined above and an elongated element intended to be partially inserted into the body of the patient, the elongate element being advantageously chosen from a catheter, in particular an insertion central catheter. peripheral, a central venous catheter, a dialysis catheter, a urinary catheter, a nasogastric tube, a peritoneal catheter, a Foley catheter, a drainage catheter, a biliary tube, a nephrostomy tube, a gastrostomy tube, a catheter epidural, an arterial catheter, a pyelostomy tube, a peri-nerve catheter and / or tubing or the body of a Huber needle. The kit according to the invention may comprise one or more of the following characteristics, taken alone or in any technically possible combination: an upper dressing intended to cover the device, the upper dressing comprising a base sheet capping the device; device and a retaining flap adapted to fall back on the base sheet and defining an immobilization space of one end of the elongated element. The invention also relates to a method for attaching an elongated element to the body of a patient, implemented after the partial insertion of the elongated element into the body of the patient, the method comprising the following steps: - provision of a device as defined above; placing the clasp flap in its open position and inserting the elongated element on the lower wall by sliding the lower wall under the elongated element, without turning over the elongated element; - Passage of the clasp in its clasping position; - Fixing at least one outer region of the adhesive strip on the skin of the patient, at least one region of the device located under the bottom wall along an axis of insertion of the elongate member in the support being non-adherent to the skin of the patient. The method according to the invention may comprise one or more of the following characteristics, taken alone or in any technically possible combination: - take off of each external region away from the patient's skin, while maintaining the shutter entanglement in its clasping position; - Opening of the clasp to move to its open position; - Extracting the device away from the patient by sliding the non-adherent region of the device located under the lower wall between the skin of the patient and the elongate member, without returning the elongate member. The invention also relates to a device for fixing an elongated element to the body of a patient, the elongated element being intended to be partially inserted into the body of the patient, the device comprising: a support for retaining the elongated member having at least one bottom wall to be placed between the elongate member and the patient's body; an adhesive strip carrying the retaining support, and intended to be applied to the skin of the patient, the adhesive tape defining at least one region of the attachment device offset relative to the lower wall intended to adhere to the skin of the patient; characterized in that the adhesive strip comprises at least three disjoint adhesive outer regions, advantageously at least four disjoint adhesive outer regions, the adhesive outer regions being distributed around the retaining support, on either side with respect to the insertion, the retaining support comprising a gripping flap adapted to be operated with respect to the lower wall between an open position and a gripping position of the elongate member, wherein the elongate member is intended to be maintained between the lower wall and the clasp. In this case, the device does not necessarily have the characteristic that at least one region of the fixing device located under the bottom wall along an axis of insertion of the elongate element in the retaining support is intended to be non-adherent to the patient's skin when the fixation device is attached to the patient's skin. The region of the fixation device located under the bottom wall may be intended to be adherent to the skin of the patient when the fixation device is attached to the skin of the patient. In this case, the elongated element is preferably a Huber needle. The device according to the invention may then include one or more of the previously mentioned features, taken alone or in any combination technically possible.
[0011] The invention will be better understood on reading the description which follows, given solely by way of example, and with reference to the appended drawings, in which: FIG. 1 is a view from above of a first necessary treatment device according to the invention comprising an elongated element, a device for fixing the elongate element and an upper dressing intended to cover the assembly; - Figure 2 is a top view of the necessary after its introduction; FIG. 3 is a side view of the retaining support in the fixing device of FIG. 1, comprising in this example a bottom wall, a clasp flap and a fastening flap; - Figure 4 is a top view of the holding bracket of Figure 3 when in its unfolded position; - Figure 5 is a side view of the selective attachment mechanism of the fastening flap on the clasp of the holding bracket of Figure 3; - Figure 6 is a perspective view of a second fixing device according to the invention during its assembly; FIG. 7 is a side view of an alternative fastening system of the elongate element for a fixing device comprising pins; - Figure 8 is a schematic representation of the adhesive tape according to a second embodiment; FIG. 9 is a side view of a nonslip contact element fixed against the lower wall; FIG. 10 is a view from above of the retaining support in unfolded position, in the presence of a second selective fixing mechanism according to the invention, and FIG. 11 is a view from above of the kit after it has been put in place, wherein the upper dressing comprises a flap for holding one end of the elongate member.
[0012] A first treatment kit 1 according to the invention is shown in FIG. 1. The kit 1 comprises an elongated element 2, intended to be introduced at least partially into the body of a patient, and a first device 4 for fixing the patient. elongated element 2 on the body of the patient.
[0013] The device 4 comprises, according to the invention, a retaining support 6, and an adhesive strip 8 carrying the retaining support 6 to fix it on a body surface of the patient. The kit 1 also advantageously comprises an upper dressing 10. The elongated element 2 comprises in this example a flexible hose 12, and a handling base 14. The flexible hose 12 extends between a first end intended to be introduced into the patient's body, for example in a vein, and a second end intended to be held outside the patient's body and to be received in the retaining support 6 of the device 4.
[0014] The length of the hose 12 is for example between 5 cm and 60 cm, and its inner diameter is for example between 0.30 mm and 8 mm. The handling base 14 projects outside the flexible pipe 12 in the vicinity of the second end. It is kept permanently outside the body of the patient.
[0015] The hose 12 has, at its second end, at least one connector 16 for fluid connection of the elongated element 2 to at least one fluid transfer assembly from outside the body of the patient to the inside of the patient's body. (Or vice versa). The first end of the hose 12 is advantageously introduced into the patient's body via an exit point 17 in the patient's skin (visible in FIG. 2). It is brought to an injection site and / or fluid sampling in the patient, preferably through its circulatory system. The assembly formed by the flexible hose 12 and the handling base 14 constitutes in particular a peripheral catheter type catheter inserted by peripheral route or "PICC".
[0016] As indicated above, the device 4 comprises the retaining support 6 fixed on the adhesive strip 8. FIG. 3 represents a side view of the retaining support 6. The retaining support 6 is intended to reversibly maintain a portion of the elongate member 2 protruding from the patient's body from the exit point 17.
[0017] The retaining support 6 is formed by a clamp which comprises a bottom wall 18 fixed on the adhesive strip 8, a clasp 20 movable relative to the bottom wall 18 between an open position and a clasping position of the elongated element 2, and advantageously a fastening flap 22 movable relative to the clasp flap 20 between a rest position and a holding position of the clasp flap 20 in the gripping position of the elongated element 2.
[0018] The retaining support 6 further comprises a wedging assembly 24 of the elongated element 2, interposed between the bottom wall 18 and the clasp flap 20 in the clasping position, and an adjustable fastening assembly 26 of the flap 22. fixing in its holding position. The bottom wall 18 of the retaining support 6 is for example of rectangular shape. The lower wall 18 advantageously comprises one or two notches opposite to each other, included on the longitudinal edges of the bottom wall 18, to allow the use of an antimicrobial dressing and / or hemostasis. This type of dressing is described, for example, in US Pat. No. 8,579,863 B2. It extends transversely with respect to an axis AA 'for introducing and holding the elongated element 2 in the retaining support 6. The lower wall 18 is rigid in flexion, in the sense that it is more rigid in flexion That is, preferably, when the side edges of the bottom wall 18 are grasped between the fingers of a user, they can not be flexed toward each other manually, or they can be flexed. one towards the other, without being able to come into contact with each other without irreversible deformation of the lower wall 18. The bottom wall 18 is for example made of a thermoplastic material such as PE, ABS, MABS, PU, silicone, fluoropolymer, TPE, PP or PC.
[0019] The lower wall 18 has a lower surface fixed in part or in full on a central portion of the adhesive strip 8. The lower surface of the bottom wall 18 is non-sticky and atraumatic. As a variant visible in FIG. 9, a nonslip contact element 27 is fixed on the lower surface of the lower wall 18. The nonslip contact element 27 is for example a foam or a plate made of silicone, PU or in TPE. In the example shown in FIG. 9, the nonslip contact element 27 comprises a plurality of strips arranged parallel to one another perpendicular to the axis A-A '. The strips define between them channels allowing the circulation of air, which improves the breathing of the skin when the device 4 is installed on the skin of the patient. Advantageously, the strips are foam.
[0020] As will be seen below, according to the invention, the retaining support 6 is non-adherent to the skin of the patient facing at least one region of the lower wall 18, located in the axis A-A ', advantageously facing the entire lower wall 18. The clasp 20 is also flexural rigid, as defined above. It has a length substantially equal to that of the bottom wall 18, as can be seen in FIG. 4. The clasp flap 20 is hinged on a first lateral edge of the bottom wall 18, around an articulation axis BB ' substantially parallel to the insertion and holding axis A-A '.
[0021] It is adapted to fall back on the lower wall 18, by pivoting about the axis BB 'between the open position, visible in FIG. 4, and the clasping position of the elongated element 2, visible in FIG. In the open position, the clasp 20 is laterally offset relative to the bottom wall 18. The elongate member 2 is adapted to be inserted without pivoting around the exit point 17, by inserting the bottom wall 18 under the elongated member 2 in a transverse movement relative to the axis A-A ', or in axial movement with respect to the axis A-A'. In the clasping position, the clasp 20 has been pivoted about the axis B-B ', to place it facing the lower wall 18, above it.
[0022] The elongated element 2 is adapted to be wedged between the clasp 20 and the bottom wall 18 in this position. The fastening flap 22 is hinged to the bottom wall 18 along a second lateral edge of the bottom wall 18 about a pivot axis CC 'parallel to the axis AA' and to the axis B-B ' , and opposed to the first edge.
[0023] It has a length substantially identical to that of the clasp 20 and that of the bottom wall 18. It is adapted to fall back on the clasp in its clasping position, by pivoting about the axis CC between the open position, visible in FIG. 4, and the holding position of the clasp flap, visible in FIG.
[0024] As illustrated in FIG. 5, an end region of the fastening flap 22 is able to attach itself selectively in length to the clasp flap 20 via the fastening assembly 26. The fastening flap 22 is also rigid in flexion, as defined above.
[0025] With reference to FIG. 5, the fixing assembly 26 comprises, for example, crenellations 28 formed in an upper surface of the clasp flap 20, and a hooking projection 30 formed in a lower surface of the fastening flap 22. crenellations 28 are spaced transversely with respect to the axis A-A ', along the clasp 20. They define a plurality of gripping projection attachment zones 30 spaced transversely with respect to the axis A -AT'. The selective attachment of the attachment projection 30 in one of the slots 28 adapts the tightening of the elongated element 2 according to its size or its shape, and constitutes, with the clasp 20, an additional support 2. Advantageously, the fixing assembly 26 further comprises a reversible fastening element 32 of the clasp flap on the bottom wall, and a receiving member 34 of the reversible fastener element 32. L reversible fastening element 32 is for example formed by a hook projecting transversely to the free end of the clasp 20. The receiving element 34 is constituted by a receiving housing of the hook formed in the bottom wall 18 to the neighborhood of the axis C-C '. In a first variant, the fastening assembly 26 comprises a first velcro band (not shown) and a second velcro band (not shown). The first velcro strip is fixed on an upper surface of the clasp 20. The second velcro strip is fixed on a lower surface of the fastening flap 22. In a variant, a combination of hook and velcro strip form fixing assembly. In a second variant shown in FIG. 10, the fixing assembly 26 comprises a groove 35 passing through the fastening flap 22, into which the reversible fastening element 32 can engage. The groove 35 extends along an axis longitudinal of the fastening flap 22, here perpendicular to the axis A-A '. The width of the groove 35 is greater than the width of the reversible fastener 32. According to one embodiment, the width of the groove 35 is constant over the entire length of the groove 35. According to another embodiment, the width of the groove 35 decreases as it approaches the axis C-C '.
[0026] In the open position, the reversible fastener 32 is adapted to be inserted into the groove 35 at one end of the groove. It is adapted to slide towards an opposite end of the groove when passing into the gripping position. The wedging assembly 24 is intended, when the clasp 20 occupies its clasping position, to hold in place the elongated element 2 between the bottom wall 18 and the clasp 20. The timing assembly 24 comprises for example elements of elastically deformable material, for example blocks of foam, as shown in Figure 3, or pins, as shown in Figure 7.
[0027] In a variant, the wedging assembly 24 is advantageously made from relatively thick hard foam, which is less hard than the clasp 20, and comprises a universal cutout making it possible to place any handling base 14. wedging 24 reinforces the holding of the elongated element 2 thanks to its height and the shape of the cut.
[0028] In the example shown in FIG. 3 and in FIG. 4, the wedging assembly 24 comprises at least a first deformable material element 36 carried by an upper surface of the bottom wall 18, and at least a second element of material deformable 38, carried by a lower surface of the clasp 20. The adhesive strip 8 is intended to fix the retaining support 6 on the skin of the patient. It defines a lower surface 40 intended to come into contact with the skin of the patient and an upper surface 42 carrying the retaining support 6. In this example, the support 6 is fixed on the upper surface. In the example shown in FIG. 2, the adhesive strip 8 comprises a central region located facing the retaining support 6 and at least one external region 44 projecting laterally with respect to the central region and relative to the retaining support 6. In the central region, the lower surface 40 is at least partially non-adhesive, and preferably completely non-adhesive. Thus, when the fixing device 4 is withdrawn, the central region carrying the retaining support 6 is able to be removed by sliding on the skin, without having to lift the elongated element 2 significantly, and in any case without have to return it. In addition, there is no risk of detachment of the dressing 8 relative to the support 6 in case of perspiration or oozing. Preferably, the adhesive strip 8 comprises at least two opposite outer regions 44, located on either side of the axis A-A ', delimiting between them, along the axis A-A', the region Central.
[0029] Advantageously, in the example shown in FIG. 1, the adhesive strip 8 has a four leaf clover shape, with four outer regions 44 angularly distributed around the central region, forming disjointed petals. Two outer regions 44 are located on one side of the A-A 'axis, and two other outer regions 44 are located on another side of the A-A' axis. The outer regions 44 located on either side of the axis AA 'delimit between them an intermediate space extending along the central axis AA' devoid of external region 44. Each outer region 44 is located away from the retaining support 6 and is therefore accessible to the user, without having to lift the support 6, in particular to take off the skin of the patient. In each outer region 44, the lower surface 40 is at least partially adhesive, preferably is fully adhesive. It is advantageously provided with a detachable protective tab 46 fixed below the adhesive part of the lower surface 40. Preferably, the protective tongue 46 projects partially outwards with respect to the adhesive strip 8, for allow the easy removal of the protection tab 46, in order to discover the adhesive part of the lower surface 40. The upper surface 42 carries the retaining support 6. The central region of the upper surface 42 holds the retaining support 6 by a adhesive, the other parts of the upper surface 42 being free of adhesive. The adhesive strip 8 is deformable. It is less rigid in flexion than the bottom wall 18. Thus, preferably, when the side edges of the adhesive strip 8 are gripped between the fingers of a user, they can be flexed towards each other manually, until to come into contact with each other in a reversible way. The upper dressing 10 serves to maintain the assembly constituted by the device 4 holding the elongated element 2, on the skin of the patient. It constitutes an additional means of fixing the elongate element 2. The upper dressing 10 is for example of rectangular shape (FIG. 1 and 2), with a V-shaped notch in the middle of one of its sides, so to have a better hold of the assembly consisting of the elongated element 2, the retaining support 6 and the adhesive strip 8. The V-shaped notch on the upper dressing 10 is located along the axis AA 'of the side opposite to the exit point 17. Thus, it is possible to visualize the exit point 17, even when the device 4 is installed on the skin of the patient.
[0030] In a variant shown in FIG. 11, the upper dressing 10 comprises a base sheet 49 intended to cover the device 4 and a holding flap 51 of the end 53 of the elongate element 2 articulated on the base sheet. 49 by a first edge 51A.
[0031] The inner surface of the base sheet 49 is at least partially adhesive to bond to the patient's skin. The outer surface of the base sheet is advantageously non-adhesive. The holding flap 51 is adapted to fall back on the upper dressing 10. The upper surface of the holding flap 51 is non-adhesive. The lower surface of the holding flap 51 is non-adhesive in a central zone 510 of the holding flap 51. It is adhesive along the first edge 51A and along a second edge 51B of the holding flap 51. The inner surface of the holding flap 51 and the outer surface of the sheet 49 defines between them an intermediate space of immobilization of the end 53 of the elongated element 2. Thus, whatever the length of the flexible pipe 12, it is possible to bring the end 53 of the hose 12 resting on the outer surface of the sheet 49, after placing the sheet 49 on the device 4, leaving the holding flap open. The end 53 is then fixed on the outer surface by folding the holding flap 51.
[0032] The operation of the attachment kit 1 will now be described. Initially, the elongate member 2 was placed in the patient's body. It has a first end located at an injection site, an inner section extending into the patient to the exit point 17, and an outer section projecting from the patient's body on the skin of the patient, until at a second end along an axis A-A '. A fixing kit 1 is then provided. The operator grasps the device 4 and places the clasp 20 in its open position, and the fastening flap 22 in its rest position. It then directs the retaining support 6 along an axis perpendicular to the axis A-A 'of the elongated element 2. The clasp 20 is in its open position. The retaining support 6 may be optionally placed in one direction or the other along the axis perpendicular to the axis A-A '. It then slides the adhesive strip 8 provided with the protective tabs 46 and the bottom wall 18 under the elongate element 2, either laterally or axially while keeping the elongated element 2 in position.
[0033] The lifting of the elongated element 2 is minimal, which limits its mobilization. In no case it is necessary to turn the elongated element 2 around the outlet point 17. The central region being free of adhesive, the support slides easily on the skin under the elongated element.
[0034] The clasp 20 is then pivoted about the axis BB 'to pass it in its clasping position, and transversely grasp the elongated element 2, in the wedging assembly 24. The reversible fastening element 32 located at the end of the clasp 20 is introduced into the receiving element 34 formed in the bottom wall 18.
[0035] Then, the fastening flap 22 is pivoted about the axis CC 'to be folded down on the clasp 20. As a function of the height of the elongated element 2 sandwiched between the clasp 20 and the lower wall 18, the operator introduces the attachment projection 30 in a slot 28 adapted. The elongated element 2 is then held in position in the retaining support 6.
[0036] The protective tabs 46 of the outer regions 44 of the adhesive strip 8 are then removed. The adhesive tape 8 is firmly attached to the patient's skin. Then, the upper dressing 10 is placed on the device 4 to protect it. Upon removal of the device, the upper dressing 10 is first removed. The outer regions 44 of the adhesive strip 8 are then peeled off. The outer regions 44 are then advantageously glued on themselves to avoid getting stuck on the skin. The fastening flap 22 and the clasp 20 are ironed respectively in their rest position and in their open position. According to the invention, the central region of the adhesive strip 8 facing the retaining support 6 being non-adherent with the skin of the patient, the device 4 can again be slid under the elongated element 2 between the elongated element 2 and the skin of the patient, without having to lift the elongated element 2. Unlike the devices known from the state of the art, the introduction and withdrawal of the device 4 do not require significant lifting of the elongated element 2 , thanks to the use of a retaining support 6 formed of a clamp, and thanks to the non-adherence of the device 4 on the skin of the patient facing the retaining support 6. Thus, the device 4 can be put into operation. placed and withdrawn with minimal mobilization of the elongated element 2. When the fixing device 4 is withdrawn, one hand of the user holds the elongated element 2 and the other hand manipulates the fixing device 4.
[0037] When the removal of the fixing device 4 is carried out to install a new fixing device 4, it is not necessary to clean with alcohol the portion of the elongated element 2 previously held by the fixing device 4, since no portion of the fastening device 4 holding the elongated element 2 is sticky. In addition, the fixing device 4 is adapted to be used indifferently in an axial direction or in the other, which facilitates the work of the practitioner.
[0038] In a variant, the wedging assembly 24 of the elongate element 2 comprises two sets of opposing pins as shown in FIG. 7. A first set of pins 48 projects upwards from the upper surface of the lower wall. 18, and a second set of pins 50 protrudes downwardly from the lower surface of the clasp 20 to fit between the pins of the first set of pins 48 in the clipping position. Such a set of wedging 24 has the advantage of maintaining and adapting to any type of elongate element 2, whatever its shape or its diameter. FIG. 6 schematically represents a second fixing device 52 according to the invention. Unlike the first device 4, the adhesive strip 8 is in contact with the patient's skin at external regions 44, but not at its central region. The central region of the adhesive strip 8 overlaps the bottom wall 18, to attach thereto. The upper surface of the bottom wall 18 is applied to the lower surface 40 of the adhesive strip 8 at the central region.
[0039] The lower surface of the bottom wall 18 is applied against the skin of the patient. This lower surface is devoid of adhesive, and is non-adherent with the patient's skin. As described above, a nonslip contact element 27 is advantageously fixed on the lower surface of the bottom wall 18. Advantageously, the retaining support 6 has, in addition to the bottom wall 18, the clasp 20 and the fastening flap 22, a folding flap 54 on the central region of the adhesive strip 8. The folding flap 54 is of shorter length than that of the bottom wall 18. It is articulated on the bottom wall 18, along a longitudinal edge around an axis DD 'substantially perpendicular to the axis A-A'.
[0040] When mounting the device 6, the folding flap 54 is adapted to fold over the central portion of the adhesive strip 8 at the bottom wall 18, between an open position and a folded position, in which it covers the central region Advantageously, as illustrated in FIG. 6, the folding flap 54 has on its upper face a first set of pins 48.
[0041] The clasp 20 has on its underside a second set of pins 50, so that, by folding on the clasp 20, the two sets of previously defined pins are inserted into one another . When the folding flap 54 and the clasp 20 are in the folded position, the elongated element 2 is thus held between the two sets of pins 48 and 50. When mounting the device 6, the central region of the adhesive strip 8 is fixed on the retaining support 6. The folding flap 54 is held in its open position. The adhesive strip 8 is brought facing the bottom wall 18. The upper surface of the bottom wall 18 of the holding support 6 is then fixed by gluing to the central region of the lower surface 40 of the adhesive strip 8. Then, the folding flap 54 is placed in the folded position, by pivoting about the axis DD 'with a first set of pins 48 on its upper surface. When using the device 6, the elongated element 2 is then positioned on the folding flap 30, and is then held by the clasp 20 in the clasping position, as previously described. Advantageously, the bottom wall 18, the fastening flap 20, the fastening flap, the flap and the two sets of spikes are formed integrally by being made of material, for example based on a material thermoplastic such as PE, ABS, MABS, PU, silicone, fluoropolymer, TPE, PP, or PC. The second device according to the invention 6 is therefore particularly simple and inexpensive to manufacture. In a variant, illustrated in FIG. 8, the adhesive strip 8 has a U shape. It thus has parallel branches forming adhesive external regions connected to each other by a central branch. The retaining support 6 is fixed at each of its ends on the parallel branches of the U. The lower surface of the retaining support 6 disposed between the parallel branches of the adhesive strip 8 and is not adherent to the skin of the patient.
[0042] In another variant, the treatment kit 1 does not include an elongate element 2. In this case, the elongated element 2 is provided separately. Thanks to the invention which has just been described, it is possible to visualize the exit point 17 of the elongate element 2, even in the case of covering with an opaque upper dressing.
[0043] The fixing device 4, 52 can be used regardless of the externalized length of the elongated element 2.
[0044] The mobilization of the elongated element 2 is minimal during the installation and removal, and the device 4, 52 is neither invasive nor traumatic, in particular thanks to the presence of a bottom wall 18 at least partially non-adhesive. In a variant of the device of Figure 2, the region of the fixing device 4 located below the bottom wall 18 is intended to be adherent to the skin of the patient when the fixing device 4 is attached to the skin of the patient. In this case, the elongated element 2 is advantageously a Huber needle.

权利要求:
Claims (18)
[0001]
1. A device (4; 52) for fixing an elongated element (2) on the body of a patient, the elongate element (2) being intended to be partially inserted into the body of the patient, the device comprising: - a retaining support (6) of the elongated element (2), comprising at least one bottom wall (18) intended to be placed between the elongated element (2) and the body of the patient - an adhesive tape (8) carrying the retaining support (6), and intended to be applied to the skin of the patient, the adhesive tape (8) defining at least one region of the attachment device (4) offset relative to the lower wall (18) for adhering to the skin of the patient characterized in that at least one region of the fixing device (4) located under the bottom wall (18) along an axis (A-A ') of insertion of the elongated element (2) in the retaining support (6) is intended to be non-adherent to the patient's skin when the device the fixation bracket (4) is attached to the skin of the patient, the retaining support (6) comprising a clasp (20) adapted to be operated relative to the bottom wall (18) between an open position and a position clamping the elongate member (2), wherein the elongated member (2) is adapted to be held between the bottom wall (18) and the clasp (20).
[0002]
2.- Device (4; 52) according to claim 1, characterized in that the clasp (20) is more rigid in flexion than the adhesive strip (8).
[0003]
3.- Device (4; 52) according to one of claims 1 or 2, characterized in that the retaining support (6) comprises a fastening flap (22), adapted to fall back on the clasp ( 20) to maintain in position the clasp (20).
[0004]
4.- Device (4; 52) according to claim 3, characterized in that the fastening flap (22) is more rigid in flexion than the adhesive strip (8).
[0005]
5.- Device (4; 52) according to any one of claims 3 or 4, characterized in that it comprises a fixing assembly (26) selectively the fastening flap (22) on the clasp flap (20). ).
[0006]
6.- Device (4; 52) according to any one of the preceding claims, characterized in that the retaining support (6) comprises at least one set of wedging (24) of the elongated element (2) intended for be interposed between the bottom wall (18) and the clasp (20) in the clasping position.
[0007]
7.- Device (4; 52) according to claim 6, characterized in that the wedging assembly (24) comprises at least one element of elastically deformable material (36) projecting from the clasp (20). ) and / or the bottom wall (18).
[0008]
8.- Device (4) according to any one of claims 6 or 7, characterized in that the wedging assembly (24) comprises a first set of pins (48) projecting from the clasp (20). and a second set of pins (50) projecting from the bottom wall (18).
[0009]
9.- Device (4; 52) according to any one of the preceding claims, characterized in that the adhesive strip (8) has at least one external region (44) adhesive intended to come into contact with the body of the patient, the or each adhesive outer region (44) being offset from the retaining holder (6) and preferably from an exit point (17) of the elongate member (2) from the patient.
[0010]
10.- Device (4; 52) according to any one of the preceding claims, characterized in that the adhesive strip (8) comprises at least two external adhesive regions (44) located on either side of the support ( 6) relative to the insertion axis.
[0011]
11.- Device (4) according to any one of the preceding claims, characterized in that the adhesive strip (8) has a lower surface (40) and an upper surface (42), the retaining support (6) being fixed on the upper surface (42), advantageously by gluing.
[0012]
12.- Device (52) according to any one of claims 1 to 10, characterized in that the adhesive strip (8) has a lower surface (40) and an upper surface (42), at least a central region of the an adhesive tape (8) being attached to an upper surface of the bottom wall (18), the central region overlapping the bottom wall (18).
[0013]
13.- Device (52) according to claim 12, characterized in that at least one nonslip contact element (27) is fixed on the lower surface of the bottom wall (18).
[0014]
14.- Device (52) according to any one of the preceding claims, characterized in that the support (6) comprises a folding flap (54), the folding flap (54) being applied to the central region of the adhesive tape (8).
[0015]
15. A treatment kit (1) comprising a device (4; 52) according to any one of the preceding claims and an elongated element (2) intended to be partially inserted into the body of the patient, the elongated element (2). being advantageously selected from a catheter, in particular a peripheral insertion central catheter, a central venous catheter, a dialysis catheter, a urinary catheter, a nasogastric tube, a peritoneal catheter, a Foley catheter, a drainage catheter, a biliary catheter, a nephrostomy tube, a gastrostomy tube, an epidural catheter, an arterial catheter, a pyelostomy tube, a peri-nerve catheter and / or tubing or the body of a Huber needle.
[0016]
16. Treatment kit (1) according to claim 15, characterized in that it further comprises an upper dressing (10) intended to cover the device (4; 52), the upper dressing (10) comprising a sheet of base (49) covering the device (4) and a holding flap (51) adapted to be folded on the base sheet (49) and defining an immobilization space of one end (53) of the elongated element ( 2).
[0017]
17. A method of fixing an elongated element (2) on the body of a patient, implemented after the partial insertion of the elongated element (2) in the body of the patient, the method comprising the following steps : - Providing a device (4; 52) according to claims 1 to 14; - placing the clasp (20) in its open position and insertion of the elongated member (2) on the bottom wall (18) by sliding the bottom wall (18) under the elongate member (2), without returning the elongated element (2); - Passage of the clasp (20) in its clamping position; - Fixing at least one outer region of the adhesive strip (8) on the skin of the patient, at least one region of the device (4; 52) located under the bottom wall (18) along an axis of insertion of the elongated element in the support being non-adherent to the skin of the patient.
[0018]
18. A method according to claim 17, characterized in that it comprises the following steps: - taking off each outer region (44) away from the skin of the patient, while maintaining the clasp (20) in his position of restraint; opening the clasp (20) to move it to its open position; - Extracting the device (4) away from the patient by sliding the non-adherent region of the device (4) located under the lower wall (18) between the patient's skin and the elongated element (2), without returning the elongated element (2).

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法律状态:
2015-10-22| PLFP| Fee payment|Year of fee payment: 2 |

2016-04-29| PLSC| Publication of the preliminary search report|Effective date: 20160429 |

2016-10-10| PLFP| Fee payment|Year of fee payment: 3 |

2017-09-21| PLFP| Fee payment|Year of fee payment: 4 |

2018-09-21| PLFP| Fee payment|Year of fee payment: 5 |

2019-10-07| PLFP| Fee payment|Year of fee payment: 6 |

2020-09-14| PLFP| Fee payment|Year of fee payment: 7 |

2021-09-10| PLFP| Fee payment|Year of fee payment: 8 |

优先权:

申请号 | 申请日 | 专利标题

FR1460355A|FR3027524B1|2014-10-28|2014-10-28|DEVICE FOR ATTACHING AN ELONGATED MEMBER TO THE BODY OF A PATIENT, TREATMENT NEED, AND ASSOCIATED METHOD|FR1460355A| FR3027524B1|2014-10-28|2014-10-28|DEVICE FOR ATTACHING AN ELONGATED MEMBER TO THE BODY OF A PATIENT, TREATMENT NEED, AND ASSOCIATED METHOD|

EP15191935.4A| EP3015129B1|2014-10-28|2015-10-28|Device for securing an elongate member to the body of a patient, treatment kit and associated method|

US14/925,840| US10695538B2|2014-10-28|2015-10-28|Device for securing an elongated element on the body of a patient, treatment kit and associated method|

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