WEARABLE DEVICE WITH VESSEL IMAGING, LOCAL HEAT AND VIBRATION MODULE FOR VENOUS ACCESS IN NEONATES.

Abstract

The invention relates to a wearable device (1) that can be attached to the extremity of a newborn undergoing venous access. The wearable device (1) comprises a carrier structure (2), an open venous access area (3) on the carrier structure (2), a light-based vein identification module (4), a local heat module (5), a vibration module (6), a control unit (7), a fixation element (8), and a power supply (9). The vein identification module (4) is positioned to enhance the distinguishability of subcutaneous veins in the venous access area (3). The local heat module (5) transmits controlled local heat to the venous access area (3); the vibration module (6) transmits mechanical vibration to the surrounding area. The control unit (7) enables the vein identification module (4), the local heat module (5), and the vibration module (6) to be operated individually or simultaneously. The fixation element (8) maintains the position of the carrier structure (2) on the extremity of the newborn.

Description

1 TARIFF VESSEL IMAGINATION FOR VENOUS ACCESS IN NEONATES, WEARABLE DEVICE WITH LOCAL HEAT AND VIBRATION MODULE TECHNICAL AREA 5 The invention is a medical device used in venous interventions performed on newborns. The invention relates to the technical field of apparatus. Specifically, the invention concerns venous access in newborns. a device that can be attached to the extremity to be treated; it targets the blood vessels under the skin. a vascular enhancement module for highlighting the vascular features of the extremity a local heat module that transfers controlled local heat and mechanical vibration to the extremity 10 It relates to a wearable device that includes a vibration module that transmits signals. STATE OF THE ART Intravenous catheter placement in newborns, peripheral vascular access. Venous procedures such as opening the vein, taking blood samples, and administering medication 15 This is being carried out. The small diameter of the peripheral vessels in newborns, insufficient visualization of blood vessels close to the skin surface and intervention on the vessels The fact that it can easily collapse during the procedure, and the identification of a suitable intervention area. This can make things difficult. This situation requires multiple attempts and processes. This can cause the duration to be extended. 20 In the current state of the technique, to facilitate intravenous access. Heating the area where the venous access will be administered, transillumination with visible light, Vascular imaging using near-infrared light and ultrasound-assisted vascular imaging Applications such as imaging are utilized. In local heat applications, heat is applied to the area where the venous access will be administered. by applying a compress or external heat source to the blood vessels in the area The aim is to increase its prominence. However, with a hot compress... In the implemented applications, the homogeneity of the heat transferred to the region and the application process... The continuity of its temperature depends on the user and application conditions. It can vary. Due to the heat-sensitive nature of newborn skin, the 30 applied... Maintaining the temperature within a safe range is also important. In transillumination systems, visible light is directed at the extremity. the appearance of blood vessels different from the surrounding tissue during their passage through the tissue This is provided. In near-infrared vascular imaging systems, blood and 2 by taking advantage of differences in light absorption between the skin and the surrounding tissue An image is created to determine the location of the blood vessels. In ultrasound-assisted systems, the vascular structure is visualized via ultrasonic imaging. The aim is to detect it. These imaging systems... some are handheld devices or devices positioned separately from the venous access site 5 This is the situation where the healthcare professional uses the imaging device. positioning and performing venous access within the same procedure flow This can make its execution more difficult. Furthermore, these systems are primarily vascular. It focuses on determining its structure and what occurs during venous access. It does not provide a direct mechanical stimulus for pain. 10 In the current state of the technique, during venous access in neonates Administering sucrose and using a pacifier are methods to reduce the resulting pain. such as breastfeeding, kangaroo care, and sensory stimulation. Non-pharmacological methods are used. Mechanical vibration is applied. pain based on generating sensory stimuli around the intervention area 15 It is one of the control approaches. However, the pain control in question... applications to make veins visible or to the venous access area It does not include a structure designed for controlled heat transfer. Current practices include vein enhancement, local heat application, and Mechanical vibration generation processes using separate tools or independent 20 performed through applications, before and during venous access preparing multiple pieces of equipment and sequentially performing different applications This may require the implementation of separate tools. the area they occupy in the region, their positioning by the user, and Use 25 for proper fixation to the newborn's extremity. This can create difficulties. In conclusion, in the current state of the technique, venous access in newborns a carrier structure that can be attached to the limb to be treated, enlargement, controlled local heat transfer, and mechanical vibration generation. 30 functions arranged together; these functions are controlled separately through a control unit. The need for a wearable device that can be operated separately or simultaneously. It continues. 3 THE TECHNICAL PROBLEM WE AIM TO SOLVE In venous interventions performed on newborns, peripheral vessels Its small diameter and the fact that the veins under the skin are not sufficiently prominent make it unsuitable. This can make it difficult to identify the area of ​​interference. Interference of vessels The fact that it can easily collapse during the procedure also means that multiple 5 vascular access procedures are required. This can cause the process to be repeated multiple times and prolong the processing time. In the known state of the technique, the enhancement of veins is an intervention. local heat application to the area and mechanical vibration during the process. creation, mostly independent tools or applications This is accomplished by using multiple pieces of equipment. This situation requires 10 pieces of equipment. preparation, separate positioning and operation of different systems during the process It may require checking. The vein is held in the hand. Imaging devices also allow the healthcare professional to examine the venous access site. This can make it difficult to access and keep the device in a stable position. In addition, existing systems for vein enhancement, venous 15 It does not provide a mechanical stimulus to reduce pain during the procedure; Non-pharmacological methods used in pain control include intravenous (IV) treatments. a structure that increases visibility or transfers controlled local heat to the intervention area It does not include. The technical problem that is intended to be solved within this scope is; newborn's 20 a structure that can be attached to the extremity where the venous access will be performed Vascular enhancement, controlled local heat transfer, and mechanical vibration. The simultaneous presentation of creation functions; these functions being under the same control It can be operated separately or simultaneously through its structure and 25 venous access site accessible to healthcare professionals It is to be abandoned. A BRIEF DESCRIPTION OF THE INVENTION The invention is a device that can be attached to the extremity of a newborn where venous access will be performed. It is a wearable device. The device consists of a carrier structure worn on the extremity, skin 30 a vein enhancement technique aimed at making the veins underneath more prominent a local heat module that transfers local heat to the extremity, mechanically to the extremity a vibration module that transmits vibrations and a control system connected to those modules. It includes the unit. 4 The wearable nature of the device allows the modules to be worn by the newborn. maintaining their position relative to the extremity and the procedure at the venous access site This allows the vessel to remain accessible during the procedure. The functions of enhancing, controlled local heating, and mechanical vibration are all in a single apparatus. are brought together within its structure. 5 In this context, the advantages provided by the invention are listed below:  It helps to increase the visibility of blood vessels under the skin.  It helps to make the blood vessels in the intervention area more prominent.  It helps reduce the perception of pain during venous access.  A single wearable device combines vein enhancement, localized heat, and vibration functions. It assembles them on the apparatus.  It allows modules to be run individually or simultaneously.  Thanks to its wearable design, the device can be placed on the newborn's extremity. It ensures the preservation of its position.  By reducing the need for a separate handheld device, it saves healthcare professionals 15 This allows him to use his hands for the venous access procedure.  Leaves the venous access site open to the healthcare professional.  The probability of completing the vascular access procedure on the first attempt It contributes to its increase.  Reducing the need for repeated venous interventions and the associated procedure time. 20 supports.  Separate use of vascular imaging, local heat, and vibration devices processing load resulting from preparation and positioning It reduces.  In neonatal intensive care units, neonatal wards, children 25 It can be used in clinics and other healthcare facilities.  Pain, stress, and discomfort experienced by newborns during venous access It helps to reduce discomfort. LIST OF FIGURES 30 Figure 1. Vessel visualization and local heat application for venous access in neonates. and a general view of the wearable device with vibration module. The Definitions of the Numbers in the Figures 1. Wearable device 2. Load-bearing structure 3. Venous access site 4. Vein enhancement module 5 5. Local heat module 6. Vibration module 7. Control unit 8. Fastening element 9. Power supply 10 DETAILED DESCRIPTION OF THE INVENTION The invention is used during venous interventions performed on newborns. highlighting the veins, controlled local heat transfer to the intervention area, and 15 that combine the functions of applying mechanical vibration on a single structure It relates to a wearable device (1). The invention is a wearable device (1); carrier structure (2), venous access area (3), vessel enhancement module (4), local heat module (5), vibration module (6), It includes a control unit (7), a mounting element (8) and a power supply (9). The supporting structure (2) is placed on the hand or foot of the newborn where venous access will be applied. or is designed to be attached to another extremity. The supporting structure. (2), an inner surface that comes into contact with the newborn’s skin and opposite the inner surface It has an external surface. The supporting structure (2) has at least one extremity. surrounding the part or placed on at least one surface of the extremity It is in the form of a wearable torso. 25 The supporting structure (2) is a flexible structure that adapts to the extremity of the newborn. It can be made of material. In an alternative application, the load-bearing structure (2) is flexible. sections with vessel enhancement module (4), local heat module (5), vibration the shape guard carrying the module (6), control unit (7) and power supply (9) It can include sections together. 30 The dimensions of the carrier structure (2) vary depending on the gestational weeks and different body sizes. It can be modified to accommodate newborns of different weights. Carrier The surface of the structure (2) that comes into contact with the newborn's skin, limiting skin irritation and 6 It can be made from a material suitable for medical use. The surface in question is single. It is reusable, replaceable, cleanable, or disinfectable. Venous access site (3), on the supporting structure (2) of the healthcare professional It is designed to be accessible to the newborn's extremity. Venous access region (3), through an opening in the form of a window on the load-bearing structure (2) or 5 a supporting structure (2) left open so as not to obstruct venous access It may consist of parts. Thanks to the venous access area (3) being left open, the wearable device (1) intravenous catheter while attached to the extremity of the newborn insertion, establishment of peripheral venous access, or blood sampling procedures 10 can be performed. Venous access area (3), vessel enhancement module (4) will be located in the area of ​​influence of the local heat module (5) and the vibration module (6). It is positioned on the supporting structure (2) in this way. Vein enhancement module (4), subcutaneous tissue in the venous access area (3) a light-based structure that increases the distinguishability of vessels from surrounding tissue 15 It has. The vein enhancement module (4) is venous on the carrier structure (2). directing light to the interference zone (3) or to the surrounding area of ​​this zone It is located. The vein enhancement module (4) contains at least one light source. The subject is a light source, a near-infrared light-emitting light source, LED-based 20 from a light source or suitable for highlighting the veins under the skin It may originate from another light source. In one application, the vein enhancement module (4), the light by passing the blood vessels through the extremity tissue, the vessels differ from those in the surrounding tissue. It is a form of transillumination scheme that makes it visible. Another 25 application form of vascular enhancement module (4), near infrared light based on the fact that it is absorbed at different rates by the blood vessels and surrounding tissue It is in the form of an arrangement. The vessel enhancement module (4) on the carrier structure (2) its presence, with the attachment of the wearable device (1) to the extremity, vascular 30 position of the clarification module (4) relative to the venous access area (3) It ensures the protection of the vein enhancement module (4). venous without the need for holding by a healthcare professional The intervention zone (3) can be illuminated. 7 Local heat module (5), on the carrier structure (2) to the venous access area (3) It is located in a neighboring location. The local heat module (5), when activated over the surface of the carrier structure (2) that contacts the newborn’s skin It contains at least one heating element that transfers local heat to the extremity. Local heat module (5), without closing the venous access area (3) to this area 5 or is positioned to transfer heat to the surrounding area. Local heat Heat transferred by module (5) to the vessels in the venous access area widening and making the blood vessels under the skin more visible It supports. The local heat module (5) ensures that the heat transferred to the newborn's skin is within a safe range of 10°C. It may include a temperature control structure to maintain the temperature within a specified range. In practice, the local heat module (5) measures the temperature transferred to the venous access area. It may be connected to at least one temperature sensor that enables its detection. The temperature information is transmitted to the control unit (7) and the operation of the local heat module (5) is activated. It can be adjusted. Thus, the local heat module (5) can be adjusted to a predetermined temperature of 15 Heat transfer is restricted outside of this range. Vibration module (6) on the carrier structure (2) to the venous access area (3) It is located in a neighboring location. The vibration module (6), when activated the mechanical vibration created by the carrier structure (2) through the newborn It contains at least one vibrating element that transmits the vibration to the extremity. 20 Vibration module (6), mechanical without closing the venous access area (3). It is positioned to transmit the vibration to the surrounding area. The vibration module (6) will generate low frequency mechanical vibration. It can be adjusted. Vibration operating time and vibration level control unit (7) It can be adjusted via. 25 The mechanical vibration generated by the vibration module (6) causes the venous system of the newborn to vibrate. venous access by generating sensory stimulation around the access area (3) It helps to reduce the perception of pain that occurs during vibration. module (6), before venous access, during venous access or at both times It can be operated within the range of 30. Control unit (7), vein enhancement module (4), local heat module (5) and is electrically connected to the vibration module (6). The control unit (7) is connected to the vessel. the highlighting module (4), the local heat module (5) and the vibration module (6) 8 to enable them to be operated separately or simultaneously It has been arranged. Control unit (7); vessel enhancement module (4), local heat module (5) and switching the vibration module (6) on and off and its operating status It includes at least one control element that enables its determination. The control element is: opening-5 power switch, module selection switch or module operating level It can be in the form of a setting element that determines. The control unit (7) is activated. a visual that informs the user of the operating status of the module or wearable device (1) and / or may also include an auditory notification element. In one application, the local heat module (5) is 10 before venous access. It is operated via the control unit (7). The vein enhancement module (4) is local after heat application or simultaneously with local heat application It can be operated. The vibration module (6) can be operated before or during venous access. They can be run during the process. The order and duration of module operation are monitored by health regulations. It can be determined by the professional via the control unit (7). 15 The fixing element (8) is attached to the extremity of the newborn of the carrier structure (2). It is connected to the supporting structure (2) in such a way as to maintain its position on it. The fixing element (8) has different perimeter dimensions of the supporting structure (2). It may have an adjustable structure that allows it to be adapted to the extremities. Fastening element (8); interlocking surfaces, snap connection 20 from its elements, an elastic connection section or of the load-bearing structure (2) from another connecting structure that allows it to wrap around the extremity It may occur. The fixing element (8) is the extremity of the supporting structure (2). while maintaining its position on it, leaving the venous access site (3) open It is located. 25 Power supply (9), to the vessel enhancement module (4), to the local heat module (5) provides electrical energy to the vibration module (6) and the control unit (7). The power source (9) is a battery or rechargeable battery carried on the carrier structure (2). It can be in the form of an energy storage unit. Wearable 30 in the application where a rechargeable power source (9) is used. The device (1) enables the power supply (9) to be connected to an external power source. It may include a charging connection. The power supply (9) is placed on the extremity of the newborn. will limit the transferred weight and access to the venous access area (3) It is positioned on the supporting structure (2) in such a way as not to obstruct. 9 In one application, the vascular enhancement module (4), local heat module (5), vibration module (6), control unit (7) and power supply (9), carrier structure (2) It can be organized in an integrated manner. In another form of implementation, it is mentioned... At least one of the components can be attached to the carrier structure (2) in a detachable manner. Thus, the electronic components are separated from the carrier structure (2) and the carrier structure (2) 5 It can be made possible to clean, disinfect or replace them. During the use of the wearable device (1), the carrier structure (2), venous access area (3) In the hand of the newborn, in a way that corresponds to the targeted vascular region, It is placed on the foot or other suitable extremity. The support structure (2), fixation It is fixed on the extremity via element (8). 10 By activating the local heat module (5) via the control unit (7) Controlled local heat transfer is applied to the venous access area (3). Vein enhancement With the activation of module (4), the venous access area (3) is illuminated with light and The visibility of blood vessels under the skin from surrounding tissue is increased. Vibration. By activating module (6), mechanical vibration venous intervention region (3) 15 It is transferred to its surroundings. Leaving the venous access area (3) open on the supporting structure (2) thanks to the wearable device (1) while attached on the extremity, health The professional's access to the identified vein is preserved. With this structure... Vascular enhancement, controlled local heat transfer, and mechanical vibration generation 20 their functions are located on the same carrier structure (2) and the same control unit (7) It is assembled in a wearable device (1) that is operated via. 30

Claims

REQUESTS 1. A carrier device that can be attached to the extremity of a newborn where venous access will be performed. structure (2), venous access area (3), vessel enhancement module (4), local heat module (5), vibration module (6), control unit (7), fixing element 5 (1) is a wearable device containing (8) and power supply (9), and its feature is; - the carrier structure (2) has an inner surface that comes into contact with the newborn’s skin. and having an outer surface opposite the inner surface, of the extremity in the form of a wearable torso that surrounds at least one part of it being, 10 - venous access region (3), created on the supporting structure (2) having an opening in the shape of a window, - the vessel enhancement module (4), at least one light source including and on the carrier structure (2) venous access area (3) positioning it to direct the light, 15 - adjacent to the local heat module (5), venous access region (3) being in position and through the inner surface of the supporting structure (2) It must contain at least one heating element that transfers local heat to the extremity. - local heat module (5), transferred to the venous access area (3) temperature information regarding temperature sensing to the control unit (7) 20 It must be connected to at least one temperature sensor that transmits heat, - vibration module (6) located adjacent to the venous access area (3) the presence of and the mechanical vibration it creates in the carrier structure (2) It must contain at least one vibrating element that transmits the vibration to the extremity. - local heat module (5) and vibration module (6), venous access 25 It is related to positioning it in such a way as not to close the area (3), - control unit (7), vein enhancement module (4), local heat electrical and verbal with module (5) and vibration module (6) the subject is to run the modules separately or simultaneously regulated, 30 - The fixing element (8) is attached to the carrier structure (2) and is adjustable. being in a structure, - the power supply (9) is located on the carrier structure (2) and the vessel to the modulus of clarity (4), local heat modulus (5), vibration 11 by supplying electrical energy to the module (6) and the control unit (7) It is characteristic.

2. Wearable device (1) according to claim 1, and its feature is; control unit (7), vessel enhancement module (4), local heat module (5) and vibration Module selection button 5 which determines the operating status of module (6). It is characterized by its inclusion.

3. Wearable device (1) according to claim 1, and its feature is; control unit (7), A visual indicating the operating status of the wearable device (1) to the user. and / or is characterized by containing an auditory notification element.

4. Wearable device (1) according to claim 1, its feature is; vibration module (6) 10 generating low frequency mechanical vibration and vibration modulus (6) The working time and vibration level can be adjusted with the control unit (7). It is characterized by its being.

5. Wearable device (1) according to claim 1, its feature is; charging of the power supply (9). being a usable energy storage unit and wearable device (1), power 15 (9) includes a charging connector that connects its source to an external power source It is characterized by...

6. Wearable device (1) according to claim 1, its feature is; vein enhancement module (4), local heat module (5), vibration module (6), control unit (7) and by arranging the power supply (9) in an integrated manner with the carrier structure (2) 20 It is characteristic.

7. Wearable device (1) according to claim 1, its feature is that the carrier structure (2) is flexible. sections with vessel visibility module (4), local heat module (5), carrying the vibration module (6), control unit (7) and power supply (9) It is characterized by containing shape-preserving sections together. 25

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