Compression cuff for hemodialysis treatment

Abstract

The invention relates to a compression cuff for an arteriovenous fistula, the compression cuff comprising a rigid support element (5) traversed by an opening (12), a flexible band (2) connected to one end (10) of the support element and a closure device (3) for closing or opening the cuff, the support element and the band defining an enclosure having a rounded shape when the cuff is in the closed position, the cuff also comprising a rod (13) that is mounted slidably in translation in the opening of the rigid support element, without being able to rotate relative to the element, the rod having two opposite ends, an upper end located outside the enclosure and a lower end located inside the enclosure, the cuff also comprising a compression pad connected to the lower end of the rod and means for locking the translational movement of the rod.

Description

Compression cuff for hemodialysis treatment.

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

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

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

[0004] Indeed, it is important to remember that arterial puncture 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] This is why compression devices, designed for arteries to limit the risk of bleeding, are unsuitable for use during hemodialysis. However, many such devices are available.

[0006] Examples include document CN201814618, which describes a hemostatic compression device for a femoral artery, and document WO2021 / 019221, which describes a compression device for an abdominal artery.

[0007] Thus, in the context of hemodialysis, a central venous catheter is generally placed in the jugular vein. It is inserted and removed surgically, and the risk of bleeding is controlled during this procedure.

[0008] An arteriovenous bypass or fistula is usually performed in the arm and requires the introduction of needles for the hemodialysis session.

[0009] At the end of a hemodialysis session, the needles are removed and the nursing staff then manage a significant risk of bleeding.

[0010] The main way to stop post-puncture bleeding is manual compression by the nurse.

[0011] In this regard, it is worth remembering that a fistula is generally created by connecting an artery and a vein in the arm. It is therefore fragile, and compression tailored to each patient and carefully monitored must be applied to avoid the need for further intervention.

[0012] Post-dialysis hemostasis can be lengthy and can have a significant impact on the patient's quality of life. Indeed, the average compression time for an arteriovenous fistula is 5 to 10 minutes.

[0013] This duration can also, by disrupting the quality of care and the logistical organization of the service, alter the caregiver-patient relationship.

[0014] Prolonged compression can also promote stenosis, aneurysms, and thrombosis.

[0015] All these constraints mean that the patient and the healthcare staff perceive compression as a critical and stressful moment.

[0016] Various methods have already been developed to help healthcare staff with this task.

[0017] 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.

[0018] Dressings of this type are marketed, for example, by the company Nephrokit, under the trade name Iris.

[0019] We also know of a hemostatic bracelet that includes a compressible pad designed to come into contact with the puncture site. One example of such a bracelet is manufactured by the company Copenhagen MedLab and marketed under the name Diastop.

[0020] 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, making it difficult to fine-tune for each patient.

[0021] Another example is a compression clamp manufactured by the company SA.GE srl.

[0022] It has the advantage of being reusable after sterilization. However, the compression is applied using a calibrated spring and cannot be adjusted for each patient.

[0023] There is therefore a need for a device promoting hemostasis, particularly at the level of an arteriovenous fistula made in the arm of a patient, 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.

[0024] The invention thus relates to a compression cuff for an arteriovenous fistula created in a patient's arm, comprising a rigid support element through an orifice, 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 within 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.

[0025] In specific and / or advantageous modes, this device may include one or both of the following characteristics:

[0026] The rod has a rack over at least part of its height, and the locking means include a locking / unlocking system cooperating with the rack.

[0027] The locking / unlocking system includes a bar with a lug designed to be inserted into the rack in the rod's locking position and held in this position by the action of a spring, the rod being moved to the unlocked position by applying pressure to the bar.

[0028] The compression pad is removably connected to the lower end of the stem.

[0029] A push button is attached to the upper end of the stem.

[0030] The flexible band is non-stretchable.

[0031] The compression cuff includes means for centering the compression pad.

[0032] The centering means consist of protruding parts extending from the support element towards the interior of the enclosure.

[0033] The protruding parts extend towards the center of the enclosure.

[0034] The closure means include a protrusion located on the band and designed to fit into an opening in the support element.

[0035] 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.

[0036] 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:

[0037] is a perspective view of an armband according to the invention in the open position;

[0038] is a view is a perspective view of an armband according to the invention in the closed position;

[0039] is a plan view of an armband according to the invention in the closed position; with the stem in the raised position;

[0040] is a right side view of the cuff according to the invention in the closed position illustrated in the;

[0041] is a left side view of the cuff according to the invention in the closed position illustrated in the;

[0042] is a top view of the cuff according to the invention in the closed position illustrated in the;

[0043] is a detail of the cross-sectional view according to BB illustrating the cuff closure device;

[0044] is a cross-sectional view along AA illustrating the cuff stem locking system, in the locked position, with the stem in the raised position;

[0045] is a cross-sectional view along AA illustrating the cuff stem locking system, in the unlocked position, with the stem in the raised position, and

[0046] is a plan view of an armband according to the invention in the closed position; with the stem in the lower position.

[0047] The elements common to the different figures are designated by the same references.

[0048] 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 from the plate 1.

[0049] The term rigid is understood here as non-deformable under conditions of use.

[0050] This support element can, for example, be made of a plastic material, preferably transparent, such as transparent PA12 polyamide.

[0051] The transparent nature of the support element makes it easier to position the cuff at the puncture point and to monitor for any bleeding.

[0052] As shown in this example, plate 1, viewed from above, has a rectangular shape, while being slightly curved, as shown in the figure. Furthermore, the figure shows that tab 4 also has a slightly curved shape to define a rounded enclosure when the closing mechanism is in the closed position.

[0053] 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.

[0054] Here, a flexible band is defined as a band that can be easily curved or folded to adapt to a patient's body shape. In all cases, this band is more deformable than the support element 5.

[0055] This band 2 is preferably non-stretchable.

[0056] It can be made of silicone material or thermoplastic elastomer such as TPE-S. In the example shown in the figures, strip 2 is a single piece.

[0057] 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.

[0058] 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.

[0059] The invention is of course not limited to this embodiment and other means of attachment could be provided, such as a clip.

[0060] Furthermore, this fixing at end 10 of the plate can be removable or permanent. It is preferably removable, particularly to allow for changing strip 2.

[0061] The band 2 has, at a second end 21, opposite its first end 20, a first part 30 of a closing device 3.

[0062] 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.

[0063] 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.

[0064] In practice, it is advisable 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.

[0065] 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 to conform to the general shape of a patient's arm.

[0066] 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 inside 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.

[0067] Furthermore, to secure the closure of the cuff, magnetic means can be provided both on band 2 and on tab 4.

[0068] 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 housings 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.

[0069] These magnetic devices facilitate both the installation and adjustment of the cuff on a patient's arm.

[0070] The invention is not limited to this embodiment of the cuff closure device.

[0071] 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 leg 4.

[0072] The cuff could also be closed using two hook-and-loop fasteners placed on the second outer face 23 of the band, spaced apart. 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 ending with the second end 21 of the band, and the two hook-and-loop fasteners are then brought into contact to secure the cuff.

[0073] It is also possible to provide a support element consisting only of the plate 1, the second end 21 of the strip being inserted into an opening (not illustrated) made at the level of the end 11 of the plate, opposite the end 10.

[0074] A closure device such as the one described in document EP3638069 can also be considered.

[0075] 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.

[0076] 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.

[0077] Plate 1 will now be described in more detail.

[0078] The figures show that plate 1 has an opening 12 through it and that a rod 13 is mounted to slide in translation within the opening of the plate. Therefore, no intermediate part, such as a housing for the rod, is provided between the rod and the opening.

[0079] This translational movement is the only possible movement of this rod 13, the latter being, by design, fixed in rotation relative to the plate. This fixation is therefore present in all operating modes of the cuff according to the invention.

[0080] For example, the rod 13 is cylindrical and has a flat section along most of its length. This flat section receives the rack of the locking device. Furthermore, the orifice 12 is also cylindrical and has a flat section slightly larger than the rod. Thus, the rod and the orifice can only cooperate in translation; no rotational movement is possible between these two parts.

[0081] 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.

[0082] A compression pad 14 is directly connected to the lower end 131 of the stem. It is intended to come into contact with the patient's arm.

[0083] This pad is preferably attached in a removable way to the stem so that it can be replaced after each use of the cuff.

[0084] As illustrated in the figures, this buffer is located inside the enclosure formed by the closed armband.

[0085] A snap fastener 133 is attached to the upper end 130 of the stem 13 and rigidly connected to this upper end. The user uses this snap fastener 133 to press on the stem 13 to force it into a translational movement within the enclosure when the cuff is closed.

[0086] It should be noted that in the embodiment illustrated in the figures, the stem 13 is hollow, allowing it to receive the lower base of the button 133 in its cavity 134. This stem could also be solid. This is irrelevant because the stem does not contain any means for adjusting the pressure exerted on the fistula, such as a fine-tuning mechanism. Indeed, as will be detailed later, the compression mechanism according to the invention is designed so that an operator can adjust the compression as they would with their fingers. Thus, the stem is the only element of the cuff designed to control the movement of the pad.

[0087] Furthermore, means are provided for locking the translational movement of rod 13.

[0088] 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.

[0089] Plate 1 features a locking / unlocking system 15 for the rod 13. This system comprises a bar 150 that is partially inserted into a cavity 180 in plate 1. As shown in Figures 8 and 9, this cavity extends transversely across plate 1 or substantially parallel to one of its shorter sides. This cavity is closed by a base 181.

[0090] 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.

[0091] A spring 154 is provided between the bottom 181 of the cavity 180 and the second end 153.

[0092] The bar 150 also includes a projecting part or lug 156 having a complementary shape to a notch 132 of the rack provided on the rod 13.

[0093] Laillustrate 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.

[0094] In this locked position, rod 13 is blocked from translation.

[0095] The rod is unlocked by applying pressure to the push button 155, as indicated by 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 in translation.

[0096] The invention is not limited to this embodiment of the locking / unlocking system of the rod 13 and other embodiments may be provided.

[0097] Figures 1, 2 and 3 in particular show that plate 1 also supports means for centering the compression pad 14. As will be explained later in the description, these means help to ensure precise positioning of the cuff on a patient's arm.

[0098] In the example illustrated in the figures, these centering means consist of protruding parts 16, 17 extending from plate 1 towards the interior of the enclosure. These parts are therefore fixed to the inner face 18 of plate 1.

[0099] 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.

[0100] 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.

[0101] These centering devices are preferably made of a flexible material for better patient comfort.

[0102] The invention is not limited to this embodiment of the centering means.

[0103] The use of the armband according to the invention will now be described.

[0104] The nurse begins by securing the cuff to the patient's arm using the closure device described previously. They position it so that the stem 13 is roughly aligned with the fistula created on that arm. The stem 13 is then in the locked and raised position (see image), with most of the stem located outside the enclosure formed by the cuff.

[0105] The nurse then presses the push button 133 on the rod with his index finger and the push button 155 with his thumb, which causes the rod to move into the enclosure and towards the patient's arm, with the rod 13 being unlocked.

[0106] When the compression pad 14 is near the fistula, the nurse releases the pressure on the two buttons, which locks the rod, preventing it from moving. The rod is then in the lowered position illustrated in the figure.

[0107] He can then begin to remove the needle from the fistula, while adjusting the pressure exerted by the tampon on the puncture point, thanks to a new maneuver on the two buttons 133 and 155.

[0108] This final adjustment allows for precise adjustment of the pressure exerted at the puncture point, without causing any movement of the arm skin, as the rod is locked in rotation.

[0109] This is an important point in the context of the invention because an arteriovenous fistula is fragile and, moreover, is frequently stressed during dialysis.

[0110] It is understood that the cuff according to the invention allows a user to have the same sensations as when performing compression without any device, which allows him to easily make a fine adjustment of the compression.

[0111] Furthermore, the centering devices are an aid to properly position the compression pad 14 in relation to the fistula.

[0112] The cuff then remains in place on the patient until hemostasis is achieved, without the nurse being required to stay near the patient.

[0113] The cuff therefore offers the advantage of allowing precise centering of the compression pad without causing any rotational movement on the skin of the arm. This eliminates any risk of discomfort or even skin irritation.

[0114] 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 their finger placed on the pressure button.

[0115] 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 applying greater compression.

[0116] This cuff is reusable; only the compression pad is single-use. It is therefore perfectly suited to chronic conditions, such as chronic kidney disease.

[0117] Finally, this cuff is particularly suitable for an arteriovenous fistula but can also be used in the case of a bypass.

Claims

Compression cuff, for an arteriovenous fistula made in a patient's arm, 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) 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 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. Compression cuff according to claim 1, in which the rod (13) has a rack (132) over at least part of its height, the locking means comprising a locking / unlocking system cooperating with the rack. Compression cuff according to claim 2, in which 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. 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. Compression cuff according to any one of claims 1 to 4, comprising a push button (133) fixed to the upper end of the stem. Compression cuff according to any one of claims 1 to 5, wherein the band (2) is non-stretchable. Compression cuff according to any one of claims 1 to 6, comprising means for centering (16,17) the compression pad (14). 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. Compression cuff according to any one of claims 1 to 8, wherein the closure means include a protrusion (300) located on the band (2) designed to fit into an opening (310) in the support element (5). 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.

Images