Radial-artery compression device

Abstract

The present invention relates to a conditioned and sterilised radial-artery compression device, used to exert pressure and control bleeding following procedures with radial access, which comprises: a cylindrical core (1) formed by a siliconised portion (2) surrounded by a tubular dressing (3), intended to be positioned on the area immediately above the area where the patient has been punctured; an adhesive elastic dressing (4) to which the core (1) is attached and which extends transversely on both sides of the core (1), the adhesive elastic dressing being intended to adhere to the patient's skin; and an adhesive reinforcing strap (8) formed by two adhesive strips (4) of elastic dressing that are positioned in the form of cross and are intended to adhere to the patient's skin after being placed on the core (1).

Description

[0001] Radial artery compression device

[0002] DESCRIPTION

[0003] OBJECT OF THE INVENTION

[0004] The present invention relates to a conditioned and sterilized device with a compression function that is used to apply pressure and control bleeding after performing an invasive procedure accessed through the radial artery.

[0005] This device, manufactured at a low cost for the hospital unit, facilitates the compression procedure for the nursing staff in charge of this task, with a very short learning curve for its placement.

[0006] BACKGROUND OF THE INVENTION

[0007] Hemodynamics and Interventional Cardiology has evolved significantly since its founding in 1929 by Dr. Werner Forssmann, to the present day; from the time when Dr. Kiemeneij began performing radial artery catheterizations in 1992, where the equipment used has become increasingly smaller and more manageable, as well as perfectly designed for its different functions.

[0008] From the very beginning, there has been a need for proper hemostasis after the procedure. Hemostasis is a physiological process to promote coagulation. In the case of catheterization, it is facilitated by mechanical compression, which has been developed with the advancement of hemodynamics. In the case of radial access, the best system available to date, and the most widely used, is the one developed by Dr. Kiemeneij, the father of transradial procedures. It consists of a device based on gauze rolled by hand at the time of catheterization.

[0009] Performing this manual technique entails a series of problems, such as: variability in the manual manufacture of the device; the need for sterilized material; having to "manufacture" it before the procedure; and the time required to create the device. In recent years, commercial devices for radial artery compression have been introduced to the market. Chapter XIII of the Manual of Nursing Procedures in Catheterization and Interventional Cardiology (ISBN 978-84-697-0208-6) recognizes manual compression as the gold standard technique and compression bandaging as the most commonly used. Among the devices we can find are the following:

[0010] -TR Band®. Terumo Interventional System: This is a clear plastic wristband-like device with a one-way valve and two balloons that are inflated using a unique 20cc syringe connector.

[0011] -SealOne®. Peurose Medical: This is a pneumatic cuff that uses a rotating dial to adjust inflation pressure. Contraindicated in patients with multiple punctures.

[0012] - Finale®. Merit Medical: This device features a rotating dial, similar to the Seal One, but in this case, the strap is a Velcro strap and has a rotating pressure adjustment dial.

[0013] -Radstat®. Merit Medical: Incorporates an immobilization splint, three Velcro straps, and a pad over the radial puncture site.

[0014] The high cost of these devices, which generate high healthcare costs, and the fact that they do not offer solutions to the most common complications, such as radial artery occlusion (RAO), means that these solutions do not meet the existing needs in this field.

[0015] DESCRIPTION OF THE INVENTION

[0016] The radial artery compression device that constitutes the object of the present invention is essentially formed by a cylindrical core, preferably formed by a silicone portion wrapped by a tubular bandage, and an adhesive elastic bandage to which the core is adhered, which extends transversely on both sides of the core, where said adhesive elastic bandage is configured by an outer textile and elastic layer, an intermediate adhesive contact layer and a removable protective inner layer that covers the intermediate layer in the non-operative situation of the device.

[0017] The device is applied with the core facing the area immediately above the puncture site, and the adhesive bandage is then fixed to the patient. To do this, the protective inner layer must first be removed, leaving the adhesive layer that is linked to the textile layer adhered to the patient's skin.

[0018] In addition, the device incorporates an adhesive reinforcement strip consisting of two strips of elastic adhesive bandage arranged in a cross shape that adhere to the patient, providing reinforcement to ensure the core is fixed.

[0019] The purpose of this product is to compress the radial artery after an invasive procedure with said access. Therefore, it is intended for patients who have undergone a diagnostic or therapeutic procedure with radial access or patients with invasive blood pressure measurement, among others.

[0020] The device will be supplied sterilized by ethylene oxide.

[0021] In general, nursing staff will handle the device according to the following phases:

[0022] 1. The core is applied to the area immediately above the puncture site and secured to the patient's skin with the adhesive elastic bandage.

[0023] 2. Next, the reinforcing strip is placed over the cylinder.

[0024] 3. The radial introducer is withdrawn, while pressing with the thumb on the cylinder.

[0025] 4. The reinforcement tape will then be fixed to the patient's forearm, first adhering one part of one of the cross-shaped strips to the medial side of the forearm and then the opposite side, then proceeding in the same way with the other strip.

[0026] 5. At this point you can release the finger that is applied to the core.

[0027] 6. The device's application time varies depending on the unit where it is used, the procedure performed, whether the patient is anticoagulated, and the size of the introducer used. It typically ranges from 2 to 4 hours. The greatest benefit of this device is its low cost and high comfort for the patient / user.

[0028] Unlike other devices, the device of the present invention does not contain plastic material to be applied to the wound, it does not close or immobilize the wrist, it can be applied after multiple punctures, it is small and unique in size, the learning time for its use is short or almost non-existent, and it is a more economical solution.

[0029] DESCRIPTION OF THE DRAWINGS

[0030] To complement the description being made and in order to help better understand the characteristics of the invention, in accordance with a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description, in which the following has been represented for illustrative and non-limiting purposes:

[0031] Figure 1.- Shows a perspective view of the radial compression device.

[0032] Figure 2.- Plan view of the core and the fixing strip.

[0033] Figure 3.- Plan view of the cross-shaped reinforcement strip.

[0034] Figure 4.- Perspective view of how the device is applied to a patient's arm (simulation): a) core and strip attached to the radial artery; b) back of the wrist with the device in place; c) device placed on the radial artery.

[0035] PREFERRED EMBODIMENT OF THE INVENTION

[0036] In view of the figures, a preferred embodiment of the radial artery compression device is described below.

[0037] As can be seen in Figure 1, the device basically comprises a cylindrical core (1) that is formed by a silicone portion (2) wrapped by a tubular bandage (3), and an adhesive elastic bandage (4) to which the core (1) is adhered, which extends transversely on both sides of the core (1), as can also be seen in Figure 2.

[0038] In addition, the device comprises an adhesive reinforcement tape (8), shown in Figure 3, formed by two strips of adhesive elastic bandage (4) placed in the shape of a cross that is applied over the core (1) and adheres to the patient's skin.

[0039] In figures 1, 2 and 3 it can be seen that the adhesive elastic bandage (4), both the one that is adhered to the core (1) and those that form part of the reinforcement tape (8) are configured by an outer layer (5) of elastic textile nature, an intermediate layer (6) of adhesive contact and a removable protective inner layer (7) that covers the intermediate layer (6) in the non-operative situation of the device.

[0040] In a specific embodiment of the device, the core (1) can have a diameter of 1.8 mm and a length of 3 cm, the adhesive elastic bandage (4) has a width of 3 cm, similar to the length of the core (1) and a length of 15 cm for the strip that is fixed to the core and 20 cm for each of the other two strips.

[0041] The elements described can be incorporated as a kit in a semi-transparent bag suitable for sterilization by ethylene oxide, duly identified, ready for use.

[0042] In figure 4c it can be seen that the radial artery compression device is used to apply pressure and control bleeding after performing a catheterization, observing in figure 4a that the core (1) is positioned on the area immediately above the patient's puncture area and the adhesive elastic bandage (4) adheres to the patient's skin, and additionally observed in figures 4b and 4c is the reinforcement tape (8) formed by the two strips of adhesive elastic bandage (4) that is then applied centered on the core (1).

Claims

CLAIMS 1.- Radial artery compression device, used to apply pressure and control bleeding after performing procedures with radial access, characterized in that it comprises: - a cylindrical core (1) consisting of a silicone portion (2) wrapped in a tubular bandage (3), which is intended to be positioned on the area immediately above the patient's puncture area, - an elastic adhesive bandage (4) to which the core (1) is adhered, which extends transversely on both sides of the core (1), intended to adhere to the patient's skin, and - an adhesive reinforcement tape (8) formed by two strips of adhesive elastic bandage (4) arranged in a cross shape, intended to adhere to the patient's skin after placing them on the core (1). 2.- The device of claim 1 wherein the adhesive elastic bandage (4) comprises an outer layer (5) of elastic textile nature, an intermediate adhesive contact layer (6) and a removable protective inner layer (7) that covers the intermediate layer (5) in the non-operative situation of the device.

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