Compression cuff for hemodialysis treatment.

Abstract

The invention relates to a compression cuff for an arteriovenous fistula comprising a rigid support element (5) through which an orifice (12) passes, a flexible band (2) connected to one end (10) of the support element, and a closure device (3) for opening or closing the cuff. The support element and the band define a rounded enclosure when the cuff is in the closed position. The cuff also includes a stem (13) mounted to slide in translation within the orifice of the rigid support element, without being able to rotate relative to said element. The stem has two opposite ends, an upper end located outside the enclosure and a lower end located inside the enclosure. The cuff further includes a compression pad connected to the lower end of the stem and means for locking the translational movement of the stem. Figure for the abstract: Fig. 2

Description

Title of the invention: Compression cuff for hemodialysis treatment.

[0001] The present invention relates to a compression cuff intended to be used at the end of a hemodialysis session to prevent bleeding.

[0002] Hemodialysis is a known, iterative treatment whose main purpose is to remove toxic, or uremic, molecules from the blood, to remove excess water, and to regulate the patient's electrolyte levels and blood pH. The physical principle of hemodialysis consists of removing blood from a patient's body to "clean" it.

[0003] The exit and return of blood are achieved through a vascular access specially created in the patient, in particular by means of an arteriovenous fistula, a bypass or a central venous catheter.

[0004] Indeed, it should be noted that puncture of an artery is not an option because it is traumatic for the patient and requires very long coagulation times. These constraints are incompatible with a treatment such as hemodialysis, which must be repeated several times a week.

[0005] A central venous catheter is generally placed in the jugular vein. It is inserted and removed surgically, and the risks of bleeding are controlled during this procedure.

[0006] An arteriovenous bypass or fistula is generally performed at the level of an arm and requires the introduction of needles for the hemodialysis session.

[0007] At the end of a hemodialysis session, the needles are removed and the nursing staff then manage a significant risk of bleeding.

[0008] The main means to stop post-puncture bleeding is manual compression by the nurse.

[0009] In this regard, it should be noted that a fistula is generally created by connecting an artery and a vein in the arm. It is therefore fragile, and compression adapted to each patient and carefully controlled must be applied to avoid subsequent intervention.

[0010] Post-dialysis hemostasis can be lengthy and can have a significant impact on the patient's quality of life. Indeed, the average compression time on an arteriovenous fistula is 5 to 10 minutes.

[0011] This duration can also, by disrupting the quality of care and the logistical organization of the service, alter the caregiver-patient relationship.

[0012] Prolonged compression can also promote stenoses, aneurysms and thromboses.

[0013] All these constraints mean that the patient and the care staff perceive compression as a critical and stressful moment.

[0014] Various means have already been developed to assist healthcare staff in this task.

[0015] One example is hemostatic dressings or compresses which accelerate hemostasis at the puncture site. However, they are relatively expensive and, of course, single-use, which generates significant waste.

[0016] Dressings of this type are marketed, for example, by the company Néphrokit, under the trade name Iris.

[0017] A hemostatic bracelet comprising a compressible pad designed to come into contact with the puncture site is also known. An example of such a bracelet is manufactured by the company Copenhagen MedLab and marketed under the name Diastop.

[0018] This bracelet is designed to apply pressure to the puncture site using a mechanical system. The entire bracelet is single-use, which generates significant waste. Furthermore, the adjustment is made in increments, which proves difficult to fine-tune for each patient.

[0019] Another example is a compression clamp manufactured by the company SA.GE srl.

[0020] It has the advantage of being reusable after sterilization. However, the compression is applied by using a calibrated spring and it cannot be adapted to each patient.

[0021] There is therefore a need for a device promoting hemostasis, particularly at the level of an arteriovenous fistula, which is effective, reusable and of a cost compatible with the treatment of a chronic disease, while allowing precise adjustment of the compression to avoid any risk of degradation of the fistula.

[0022] The invention thus relates to a compression cuff for an arteriovenous fistula comprising a rigid support element through which an orifice passes, a flexible band connected to one end of the support element and a closure device to ensure the closure or opening of the cuff, the support element and the band defining a rounded enclosure when the cuff is in the closed position, the cuff also comprising a rod mounted to slide in translation in the orifice of the support element, without being able to rotate relative to said element, the rod having two opposite ends, an upper end located outside the enclosure and a lower end located inside the enclosure, the cuff further comprising a compression pad connected to the lower end of the rod and means for locking the translational movement of the rod.

[0023] In particular and / or advantageous modes, this device may include one or both of the following characteristics:

[0024] The rod has a rack over at least part of its height, and the locking means comprise a locking / unlocking system cooperating with the rack.

[0025] The locking / unlocking system includes a bar having a lug designed to be inserted into the rack in the locking position of the rod and held in this position under the action of a spring, the transition to the unlocked position of the rod being obtained by exerting pressure on the bar.

[0026] The compression pad is removably connected to the lower end of the rod.

[0027] A push button is fixed to the upper end of the rod.

[0028] The flexible band is non-stretchable.

[0029] The compression cuff includes means for centering the compression pad.

[0030] The centering means consist of protruding parts extending from the support element towards the interior of the enclosure.

[0031] The protruding parts extend towards the center of the enclosure.

[0032] The closing means include a protrusion located on the strip and designed to fit into an opening in the support element.

[0033] The support element includes a gripping part and the band also includes a gripping part to facilitate handling of the band and the closing means.

[0034] The invention will be better understood and other objects, advantages and features thereof will become more apparent upon reading the following description, which is made with reference to the accompanying drawings, in which:

[0035] [Fig-1] is a perspective view of an armband according to the invention in position open;

[0036] [Fig.2] is a perspective view of an armband according to the invention in closed position;

[0037] [Fig.3] is a plan view of an armband according to the invention in the closed position; with the stem in the raised position;

[0038] [Fig. 4] is a right side view of the cuff according to the invention in the closed position illustrated in [Fig.3];

[0039] [Fig. 5] is a left side view of the cuff according to the invention in the closed position illustrated in [Fig.3];

[0040] [Fig. 6] is a top view of the cuff according to the invention in the closed position, illustrated to [Fig.3];

[0041] [Fig.7] is a detail of the cross-sectional view along BB of [Fig.5] illustrating the cuff closure device;

[0042] [Fig.8] is a cross-sectional view along AA of [Fig.3] illustrating the cuff stem locking system, in the locked position, with the stem in the raised position;

[0043] [Fig.9] is a cross-sectional view along AA of [Fig.3] illustrating the cuff stem locking system, in the unlocked position, with the stem in the raised position, and

[0044] [Fig. 10] is a plan view of an armband according to the invention in the closed position; with the stem in the lower position.

[0045] The elements common to the different figures are designated by the same references.

[0046] As illustrated in Figures 1 and 2, the armband includes a rigid support element 5 defining substantially an arc of a circle, comprising a plate 1 and a tab 4 extending the plate 1.

[0047] The term rigid is understood here as non-deformable under conditions of use.

[0048] This support element can for example be made of a plastic material, preferably transparent, such as transparent polyamide PA 12.

[0049] The transparent nature of the support element makes it easier to position the cuff at the puncture point and to monitor for any bleeding.

[0050] As shown in [Fig. 6] in this embodiment, the plate 1 has a rectangular shape in plan view, while being slightly curved, as shown in [Fig. 3]. Furthermore, [Fig. 3] shows that the tab 4 also has a slightly curved shape to define a rounded enclosure when the closing device is in the closed position.

[0051] The cuff also includes a flexible band 2 and a band closure device 3, by means of which the cuff can be fixed to a patient's arm.

[0052] Here, a flexible band is understood to be a band that can be easily curved or folded so as to adapt to the morphology of a patient. In all cases, this band is more deformable than the support element 5.

[0053] This band 2 is preferably non-extensible.

[0054] It can be made of a silicone material or of a thermoplastic elastomer such as TPE-S. In the embodiment illustrated in the figures, the strip 2 is one piece.

[0055] It is fixed by a first end 20 to the end 10 of the plate 1 which is free and corresponds to one of the two short sides of the rectangle formed by the plate.

[0056] For this purpose, the plate includes, for example, a notch 18 at the end 10, into which a protrusion 25 present at the first end 20 of the strip 2 can be inserted. This is shown in figures 1, 3 and 10.

[0057] The invention is of course not limited to this embodiment and other means of attachment could be provided, such as for example a clip.

[0058] Furthermore, this fixing at the end 10 of the plate can be removable or permanent. It is preferably removable, in particular to allow for changing the strip 2.

[0059] The band 2 comprises, at a second end 21, opposite its first end 20, a first part 30 of a closure device 3.

[0060] Indeed, the closure device 3 is made in two parts and, in this embodiment, the first part 30 is carried by the band 2, while the second part 31 is carried by the tab 4 of the support element 5.

[0061] The first part 30 of the closure device, carried by the band 2, consists here of a protrusion 300, while the second part 31, carried by the tab 4, consists of a series of openings 310 spaced apart from each other and extending along the tab 4. The dimensions of these openings are chosen so as to be able to receive the protrusion and retain it after insertion.

[0062] In practice, it is necessary to provide at least one opening and preferably a plurality of openings (here 7 openings) to allow precise adjustment of the cuff on a patient.

[0063] Figures 2, 3, 7 and 10 show that the protrusion 300 is inserted into one of the openings 310 to close the cuff and position it on a patient's arm. The support element 5 and the band then define a rounded enclosure so as to conform to the general shape of a patient's arm.

[0064] These figures show that the protrusion 300 is located on a first inner face 22 of the band 2 and that it extends from this inner face towards the interior of the enclosure when the closure device is in the closed position. The band 2 partially covers the tab 4 to ensure the closure of the cuff.

[0065] Furthermore, to secure the closure of the cuff, magnetic means can be provided both on the band 2 and on the tab 4.

[0066] These means may consist, for example, of two button-shaped magnets (not shown) located on the band 2, on either side of the protrusion 300, and of two magnetic rods 311, for example made of magnetic stainless steel, extending on either side of the series of openings 310. These rods may, in particular, be fixed in recesses provided on the tab 4. Once the second end 21 of the band is placed on the tab 4 and the protrusion 300 is inserted into an opening 310, the magnets cooperate with the rods by magnetic attraction to secure the closure of the cuff.

[0067] These magnetic means facilitate both the installation and adjustment of the cuff on a patient's arm.

[0068] The invention is not limited to this embodiment of the cuff closure device.

[0069] Thus, each of the two magnetic rods could be replaced by a series of several independent magnets, arranged along a line parallel to an edge of the leg 4.

[0070] The cuff could also be closed using two hook-and-loop fasteners placed on the second outer face 23 of the band, spaced apart from each other. The second end 21 of the band is inserted into an opening (not shown) made at the free end 43 of the tab 4, so as to form a loop terminating with the second end 21 of the band, and the two hook-and-loop fasteners are then brought into contact to secure the cuff.

[0071] A support element can also be provided comprising only the plate 1, the second end 21 of the strip being inserted into an opening (not illustrated) made at the end 11 of the plate, opposite the end 10.

[0072] A closure device such as that described in document EP3638069 can also be considered.

[0073] Figures 1, 3, 7 and 10 also show that the band 2 preferably includes a gripping part 24, located substantially opposite the protrusion 300 but on the second (external) face 23 of the band, opposite the first face 22. It makes it easier to handle the band and the closure device.

[0074] Similarly, for the same purpose, the support element 5 preferably includes a gripping part 41, located on a first (external) face 42 of the leg 4 and which extends outwards from the rounded enclosure defined by the support element 5 and the band in the closed position.

[0075] Plate 1 will now be described in more detail.

[0076] The figures show that the plate 1 is traversed by an orifice 12 and that a rod 13 is mounted to slide in translation in the orifice of the plate.

[0077] This translational movement is the only possible movement of this rod 13, the latter being blocked in rotation relative to the plate.

[0078] The rod 13 has two opposite ends, an upper end 130 located outside the enclosure and a lower end 131 located inside the enclosure formed when the cuff is closed.

[0079] A compression pad 14 is connected to the lower end 131 of the stem. It is intended to come into contact with the patient's arm.

[0080] This pad is preferably removably connected to the stem so that it can be replaced after each use of the cuff.

[0081] As illustrated in the figures, this buffer is located inside the enclosure formed by the closed armband.

[0082] A snap button 133 is fixed to the upper end 130 of the rod 13. The user uses this button 133 to press on the rod 13 in order to force it into a translational movement inside the enclosure when the cuff is closed.

[0083] Furthermore, means are provided for locking the translational movement of the rod 13.

[0084] Thus, the rod 13 has, over at least part of its length, a rack formed by a series of notches 132, spaced apart from each other.

[0085] Plate 1 has a locking / unlocking system 15 for the rod 13. It comprises a bar 150 which is partially inserted into a cavity 180 provided in plate 1. As shown in Figures 8 and 9, this cavity extends transversely to plate 1 or substantially parallel to one of its short sides. This cavity is closed by a base 181.

[0086] A first end 152 of the bar 150 is thus located outside the cavity 180, while the second end 153, opposite the first, is located inside the cavity 180. On the first end 152, a push button 155 is fixed.

[0087] A spring 154 is provided between the bottom 181 of the cavity 180 and the second end 153.

[0088] The barrel50 also includes a projecting part or lug 156 having a complementary shape to a notch 132 of the rack provided on the rod 13.

[0089] Fig. 8 illustrates the locked position of the rod 13, in which the protruding part 156 is inserted between two notches 132 and held in this position by the restoring force exerted by the spring 154 on the bar 150.

[0090] In this locked position, the rod 13 is blocked in translation.

[0091] The rod is unlocked by applying pressure to the push button 155, according to arrow F. This causes the bar 150 to move towards the bottom of the cavity 180, which disengages the protruding part 156 of the rack by compressing the spring 154. The rod is then in the unlocked position and can move laterally.

[0092] The invention is not limited to this embodiment of the locking / unlocking system of the rod 13 and other embodiments may be provided.

[0093] Figures 1, 2 and 3 in particular show that the plate 1 also supports means for centering the compression pad 14. As will be explained in the Following the description, these means help to ensure precise positioning of the cuff on a patient's arm.

[0094] In the example illustrated in the figures, these centering means consist of protruding parts 16, 17 extending from the plate 1 towards the interior of the enclosure. These parts are therefore fixed to the inner face 18 of the plate 1.

[0095] Figures 3 and 10 show that each of these parts 16,17 has a trapezoidal cross-section, the large base 160, 170 being fixed on the inner face 18 of the plate and the small base 161, 171 being positioned inside the enclosure when the armband is in the closed position.

[0096] They also show that the two centering parts 16 and 17 are arranged symmetrically with respect to the X-X' axis of the rod 13 and in the direction of this axis.

[0097] These centering means are preferably made of a flexible material for better patient comfort.

[0098] The invention is not limited to this embodiment of the centering means.

[0099] The use of the armband according to the invention will now be described.

[0100] The nurse begins by securing the cuff to the patient's arm using the closure device described previously. The nurse positions the cuff so that the stem 13 is approximately opposite the fistula created on that arm. The stem 13 is then in the locked and raised position (see [Fig. 3]), with most of the stem located outside the enclosure formed by the cuff.

[0101] The nurse then presses the pressure button 133 on the rod with his index finger and the push button 155 with his thumb, which causes a translational movement towards the inside of the enclosure and the patient's arm, the rod 13 being unlocked.

[0102] When the compression pad 14 is near the fistula, the nurse releases the pressure on the two buttons, which causes the rod to lock and is blocked in translation. The rod is then in the lower position illustrated in [Fig. 10].

[0103] He can then begin to withdraw the needle from the fistula, while adjusting the pressure exerted by the tampon on the puncture point, by means of a further maneuver on the two buttons 133 and 155.

[0104] This final adjustment allows the pressure exerted at the puncture point to be precisely adjusted without causing any movement of the skin of the arm, the rod being blocked in rotation.

[0105] Furthermore, the centering means are an aid to properly position the compression pad 14 in relation to the fistula.

[0106] The cuff then remains in place on the patient until hemostasis is achieved, without the nurse being required to remain near the patient.

[0107] The cuff therefore has the advantage of allowing the compression pad to be precisely centered without causing any rotational movement on the skin of the arm. Any risk of discomfort, or even skin damage, is thus avoided.

[0108] In addition, the height adjustment of the compression pad is done in two stages, the final adjustment being easily made, the user feeling any contact or resistance with his finger placed on the pressure button.

[0109] Furthermore, a non-stretch band helps to avoid the risk of deformation of the cuff, a deformation which would impair the accuracy of the support on the patient's arm and which would require greater compression to be applied.

[0110] This cuff is reusable, only the compression pad is single-use. It is therefore perfectly suited to chronic diseases, such as chronic kidney disease.

[0111] Finally, this cuff is particularly suitable for an arteriovenous fistula but can also be used in the case of a bypass.

Claims

Demands

1. Compression cuff for an arteriovenous fistula comprising a rigid support element (5) through an orifice (12), a flexible band (2) connected to one end (10) of the support element and a closure device (3) for ensuring the closure or opening of the cuff, the support element and the band defining a rounded enclosure when the cuff is in the closed position, the cuff also comprising a stem (13) mounted to slide in translation within the orifice of the rigid support element, without being able to rotate relative to said element, the stem having two opposite ends, an upper end (130) located outside the enclosure and a lower end (131) located inside the enclosure, the cuff further comprising a compression pad (14) connected to the lower end of the stem and means for locking the translational movement of the stem.

2. Compression cuff according to claim 1, wherein the stem (13) has a rack (132) over at least part of its height, the locking means comprising a locking / unlocking system cooperating with the rack.

3. Compression cuff according to claim 2, wherein the locking / unlocking system comprises a bar (150) having a lug designed to be inserted into the rack in the rod locking position and held in this position under the action of a spring (154), the transition to the unlocked position of the rod being obtained by exerting pressure on the bar.

4. Compression cuff according to any one of claims 1 to 3, wherein the compression pad (14) is removably connected to the lower end (131) of the stem.

5. Compression cuff according to any one of claims 1 to 4, comprising a push button (133) fixed to the upper end of the stem.

6. Compression cuff according to any one of claims 1 to 5, wherein the band (2) is non-stretchable.

7. Compression cuff according to any one of claims 1 to 6, comprising means for centering (16,17) the compression pad (14).

8. Compression cuff according to claim 7, wherein the centering means (16,17) consist of protruding parts extending from the support element (5) into the interior of the enclosure.

9. Compression cuff according to any one of claims 1 to 8, wherein the closure means comprise a protrusion (300) located on the band (2) designed to fit into an opening (310) in the support element (5).

10. Compression cuff according to any one of claims 1 to 9, wherein the support element includes a gripping part (41) and the band (2) also includes a gripping part (24) to facilitate handling of the band (2) and the closure means.

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