RU200410U1 - NEW DEVICE FOR VISUALIZATION OF SURFACE SUBCUTANEOUS VINES - Google Patents

Abstract

This utility model relates to medical technology and medical equipment, namely to a new device for imaging superficial saphenous veins, and can be used to detect saphenous veins to facilitate manipulations (blood sampling, intravenous injections, intravenous catheter placement, sclerotherapy, etc.) on superficial veins, for manipulation in patients with problematic, damaged or deep veins, for example, in children, the elderly, people with a high body mass index, cancer patients, as well as for use in conditions of emergency medical care. 3 h. p. f-ly, 7 ill.

Description

This utility model relates to medical technology and medical equipment, namely a new device for imaging superficial saphenous veins, and can be used to detect the saphenous veins to facilitate manipulations (blood sampling, intravenous injections, intravenous catheter placement, sclerotherapy, etc.) on superficial veins, for manipulation in patients with problematic, damaged or deep veins, for example, in children, the elderly, people with high body mass index, cancer patients, as well as for use in conditions of emergency medical care.

Devices for imaging and searching for superficial veins are used in medicine to perform manipulations on superficial veins, such as venipuncture, intravenous infusion, blood sampling from a vein for testing or from donors, sclerotherapy of spider veins, etc. Such devices are especially useful in cases where it is really difficult to detect a vein - when taking blood from patients with dark and dark skin, with a significant layer of subcutaneous fat, with damaged veins, as well as in burns, infectious and oncological patients, children and old people.

Studies by E.A. Cummings et al. Have shown that vein manipulation is one of the most common causes of childhood pain [Е.А. Cummings et al, Prevalence and source of pain in pediatric inpatients, Pain, Volume 68, Issue 1, November 1996, Pages 25-31.]. Often, when taking blood or intravenous injection to a child, a nurse is forced to puncture several times in a row due to the fact that the veins of the child are in most cases difficult to detect in the absence of special devices. It is difficult to find veins not only in children, but also in all categories of patients listed above. The use of a vein imaging device allows non-invasive and painless detection of a suitable vein for manipulation, thereby speeding up and facilitating the procedure for the patient. However, this is not the only advantage that this device provides - repeated repeated injections force the nurse to use several sets of needles for one blood collection, which leads to an increase in the cost of consumables.

с соавт. показали, что в США фиксируется порядка 250000 случаев КАИ ежегодно, а смертность от КАИ составляет от 12 до 25% [NP

et al, Guidelines for the Prevention of Intravascular Catheter-related Infections, The Centers for Disease Control, August 9, 2002, Vol. 51, No. RR10, Pages 1-26]. Каждая катетер-ассоциированная инфекция влечет за собой необходимость проведения лечения антибиотиками, а также зачастую симптоматического лечения и проведения пациентом дополнительного времени в стационаре, что влечет за собой значительные дополнительные расходы для медицинского учреждения. RP Shannon с соавт. в своей статье заявляют, что ликвидация подобных ситуаций позволит как улучшить результаты лечения пациентов, так и обеспечит значительную выгоду для медицинских учреждений [RP Shannonet et al, Economics of central line-associated bloodstream infections, American Journal of Medical Quality, 2006. Vol. 21, No. 6 suppl, Pages 7S-16S]. Использование устройств для визуализации вен дает возможность произвести установку катетера с минимальными повреждениями, а также следить за состоянием вены во время нахождения катетера в ней. Все это позволяет снизить число случаев КАИ и как следствие повысить выживаемость пациентов и понизить затраты на лечение.Another problem associated with manipulation of veins is catheter-associated infections (CIA). NP

et al. showed that in the USA about 250,000 cases of CAI are recorded annually, and mortality from CAI is from 12 to 25% [NP

et al, Guidelines for the Prevention of Intravascular Catheter-related Infections, The Centers for Disease Control, August 9, 2002, Vol. 51, No. RR10, Pages 1-26]. Each catheter-associated infection entails the need for antibiotic treatment, as well as often symptomatic treatment and additional hospital time for the patient, which entails significant additional costs for the medical institution. RP Shannon et al. in their article claim that the elimination of such situations will both improve patient outcomes and provide significant benefits for medical institutions [RP Shannonet et al, Economics of central line-associated bloodstream infections, American Journal of Medical Quality, 2006. Vol. 21, No. 6 suppl, Pages 7S-16S]. The use of vein imaging devices makes it possible to insert the catheter with minimal damage, as well as monitor the condition of the vein while the catheter is in it. All this makes it possible to reduce the number of cases of CAI and, as a consequence, to increase the survival rate of patients and reduce the cost of treatment.

Known devices for non-invasive imaging of the saphenous veins can be divided into two groups:

1) Contact;

2) Contactless.

Contact devices for non-invasive visualization of the saphenous veins are characterized by the fact that for visualization of the vein, the working area of the device must be in direct contact with the working surface (above the area where the vein is located on the surface of the human skin). An example of existing devices of this type is the VeinLite vein imager from TransLite (Fig. 1).

There is a patent application No. 2017137086, which essentially describes an analogue of the Veinlite LED + model of the TransLite brand, namely, a vein transilluminator containing a flat-shaped body, a power supply for LEDs with a control device located in a part of the body that functionally is a transilluminator handle, an illuminator a part at the other end of the body in the form of an arc with free outer ends surrounding a round through window of the body intended for viewing the circular area of the patient's body surface; a row of LEDs are placed on the arc in a circle, which are arranged to emit light outward from the lower surface of the body, while LEDs provide the emission of at least orange and red light provided by the choice of the appropriate radiation wavelength, characterized in that the LEDs are connected to the printed circuit board aligned with the arc to ensure that the radiation is focused in the circular viewing area below the bottom surface of the housing ca by 0.5-15 mm by inclined placement of LEDs on the board, also along the perimeter of the lower edge of the round window, a relief with a height of 1-3 mm is made, while the height h of the body, at least in the lighting part, and the diameter of the round window d are made in the ratio h / d = 1 / 3.2 ÷ 3.5, in addition, the LEDs are arranged symmetrically in the "one red-three orange" sequence and are connected to a microcontroller-based control device, which provides machine-readable commands to control the LED power supply by means of two push-button switches, separately for red and orange LEDs, while the control includes the following steps of giving commands, executed sequentially by means of one switch: switching on a group of LEDs at 100% brightness - reducing the radiation brightness to 50% - reducing the radiation brightness to 25% - turning on LEDs at 100% brightness - turning off a group of LEDs, the microcontroller also contains machine-readable commands from the software demonstration of the battery charge outside the operating mode of the transilluminator by means of a command to control the LED power supply, set by the operator by simultaneously pressing two pushbutton switches, and ensuring that the LEDs are turned on in an amount corresponding to the charge level (where the LEDs provide at least orange and red light emission, provided by choosing the appropriate radiation wavelength).

Non-contact devices for non-invasive imaging of the saphenous veins are characterized by the fact that when using them, there is no need for direct contact of the devices with the working surface. In this case, the vein visualizer is installed at a distance from the surface of the human skin over the area where the vein is located, and the image of the saphenous veins is projected onto the working area. An example of existing devices of this type is the AccuVein vein imager [US patents, for example, US 7904138, US 8073531, US 8150500, US 8295904, US 8478386, US 8712498, US 8818493, US 9042966, US 9044207, US 9125629] (in Fig 2 shows the device in operation) and the Christie VeinViewer.

Known devices for non-invasive imaging of the veins of the company TransLite, related to medical technology and which can be used for non-invasive imaging of superficial saphenous veins. Any device for non-invasive imaging of veins of the TransLite company includes a body with a round cut, which is a working area, an on / off button for the device, as well as a light source and a battery located inside the case.

The TransLite line of devices includes 5 varieties: VeinLite LED +, VeinLite LED, VeinLite PEDI (devices for visualizing veins in children), VeinLite EMS PRO, VeinLite EMS, which differ from each other in size and number of LEDs in the light source (Fig. 3 ).

Known patent No. 176530, which describes a fundamentally new design and location of the shape of the working area (the shape of the working area is made U-shaped and located along the short side of the body).

The disadvantages of the known devices for imaging the saphenous veins are the small number of LEDs, as well as, in general, insufficient elaboration of the characteristics of the light source.

The TransLite Vein Imager is distinguished by the fact that the light source is a maximum of 28 LEDs arranged in one row, there is no special protective visor to improve the imaging quality.

The authors of this utility model have created a new device for imaging superficial saphenous veins, the advantages of which are:

1) A large number of LEDs (at least 32);

2) The use of ultra-bright small size LEDs with a wide beam angle of at least 110 degrees;

3) The location of the light source board at an angle of 10-20 degrees to the surface;

4) Large size of the light source at least 25 mm wide and 45-55 mm long;

5) Double-row arrangement of LEDs with a tape width of at least 5 mm;

6) The presence of a special protective visor, which improves the quality of visualization.

The aim (object) of the present invention is to provide a new device for imaging the superficial saphenous veins.

This goal is achieved by a new prototype for visualizing superficial saphenous veins (Fig. 4), consisting of a body (1), a special protective visor (2), an on / off button (3), a special light source (4), and placed inside the body power circuit, battery, and characterized in that the light source is made in the form of a connected group of at least 32 SMD-LEDs with a wavelength of 600-640 nm, with a wide angle of the light beam of at least 110 degrees, the light source board is located at an angle 10-20 degrees to the surface, measuring at least 25 mm wide and 45-55 mm long, and the LEDs are arranged in a two-row way, with a tape width of at least 5 mm and a special protective visor.

A schematic diagram of the device is shown in Fig. 5 where

5 - USB connector;

6 - charger;

7 - storage battery;

8 - microcontroller;

9 - voltage stabilizer;

10 - light source.

The task to which the claimed technical solution is directed is to increase the size of the light source to at least 25 mm wide and 45-55 mm long with the location of the light source board at an angle of 10-20 degrees to the surface with a tape width of at least 5 mm, which is achieved the use of a special flexible printed circuit board and the use of ultra-bright small-sized LEDs with a wide beam angle of at least 110 degrees, as well as an increase in the number of LEDs in the light source to at least 32, their two-row arrangement, and the addition of a special protective visor.

The technical result of this technical solution is to improve the quality of vein visualization and its contrast by changing the design of the light source and adding a special protective visor.

The solution to this problem is achieved by a new device for visualization of superficial saphenous veins, consisting of a case, a special protective visor, an on / off button, a microUSB connector for connecting a charger, a special light source and power circuits located inside the case, a rechargeable battery, characterized in that the light source is made in the form of a connected group of at least 32 SMD-LEDs with a wavelength of 600-640 nm, with a wide angle of the light beam of at least 110 degrees, the light source board is located at an angle of 10-20 degrees to the surface, with a size of at least 25 mm wide and 45-55 mm long, and the LEDs are arranged in a two-row manner, with a tape width of at least 5 mm and a special protective visor.

The device for imaging veins includes a body with a U-shaped cut, which is a working area, with a special protective visor, on the body there is an on / off button for the device, a microUSB connector for connecting a charger.

A special light source, power circuit and battery are located inside the case.

The light source is at least 32 SMD-LEDs with a wavelength of 600-640 nm, with a wide beam angle of at least 110 degrees, the light source board is located at an angle of 10-20 degrees to the surface, measuring at least 25 mm wide and 45- 55 mm long, and the LEDs are arranged in a two-row manner, with a strip width of at least 5 mm (Fig. 6).

More preferable is a device characterized in that there are connectors on the body or a special magnetic mount for connecting the device with a harness for fixing the device to a limb, which allows a fixation harness to be attached to the body.

More preferable is a device characterized in that a special protective visor is located above the working area, which makes it possible to reduce the amount of external light falling on the working area and, as a consequence, improve the visualization quality.

A more preferred device is for intravenous injection, intravenous catheter placement, or blood collection.

More preferred is a device for conducting spider veins sclerotherapy.

The following are definitions of terms that are used in the description of the present invention.

1) SMD - surface mounted device (component, mounted on a surface);

2) KAI - catheter-associated infections;

3) Sclerotherapy - the introduction of a special drug into the lumen of the vessel, which causes the walls of the vessel to stick together and then dissolve them.

Also, the invention is illustrated by drawings.

FIG. 1. Vein Visualizer VeinLite from TransLite.

FIG. 2. The AccuVein Vein Visualizer at work.

FIG. 3. The line of vein visualizers from TransLite: VeinLite LED +, VeinLite LED, VeinLite PEDI, VeinLite EMS PRO, VeinLite EMS.

FIG. 4. A device for non-invasive visualization of superficial saphenous veins.

FIG. 5. Schematic diagram of the utility model.

FIG. 6. Special light source

FIG. 7 General view of the device in operation

The examples below illustrate but do not limit the utility model.

Example 1. To carry out intravenous injection / blood sampling from a vein on a previously prepared limb (the proposed injection area is freed from clothing, a tourniquet is applied above the injection area), the search area for the superficial saphenous vein is sterilized and a device for visualizing superficial saphenous veins is turned on (Fig. 4 ) using the on / off button (3), press the light source of the device (4) to the surface of the patient's skin in the place where the vein is to be detected, moving the device in the longitudinal and transverse directions detect the vein, position the device so that the detected vein is located along the U-shaped notch, then an injection is made into the detected vein located in the working area with a needle and the device is turned off using the on / off button (3).

Example 2. To carry out sclerotherapy of veins, the working area (the surface of the skin above the vessel to be sclerosed) is sterilized and the device for imaging the superficial saphenous veins is turned on the device (Fig. 4) using the on / off button (3), the light source of the device is pressed ( 4), located around the working area to the surface of the patient's skin at the location of the affected vessel, rotating and moving the device in the transverse and longitudinal directions, install the device so that the vessel to be sclerosed is visualized with maximum contrast, and the access for the needle is located as conveniently as possible for the user, then an injection is made, a sclerosant is injected, at the end of the procedure, the device is turned off using the on / off button (3).

The invention can be used in medicine, veterinary medicine to facilitate manipulations (blood sampling, intravenous injections, installation of an intravenous catheter, sclerotherapy, and so on) on superficial veins, for manipulations in patients with problematic, damaged or deep veins, for example, in children , the elderly, people with a high body mass index, cancer patients, as well as for use in conditions of need for emergency medical care.

Claims (4)

1. A device for visualizing superficial saphenous veins, consisting of a body, a protective visor, an on / off button, a microUSB connector for connecting a charger, a light source and power circuits located inside the body, a rechargeable battery, characterized in that the light source is made in the form connected group of not less than 32 SMD-LEDs, arranged in a two-row way, with a width of not less than 5 mm and the presence of a protective visor. 2. The device according to claim. 1, characterized in that the body has connectors or a magnetic mount for connecting the device with a harness for fixing the device to a limb, which allows you to attach a fixation harness to the body. 3. The device according to claim. 1, for intravenous injections, installation of an intravenous catheter or blood collection. 4. A device according to claim 1 for sclerotherapy of spider veins.

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