WO2020232562A1

WO2020232562A1 - Human vasodilation device for effectively finding a patient's blood vessels

Info

Publication number: WO2020232562A1
Application number: PCT/CL2019/050042
Authority: WO
Inventors: Nicolás JARA DONOSO; Tomás Ignacio BARAÑAO DÍAZ; Francisco José MORALES UNDURRAGA
Original assignee: Jara Donoso Nicolas; Baranao Diaz Tomas Ignacio; Morales Undurraga Francisco Jose
Priority date: 2019-05-20
Filing date: 2019-05-20
Publication date: 2020-11-26

Abstract

The invention relates to a human vasodilation device that allows a patient's blood vessels to be found more effectively and provides better access to the puncture point, the device comprising: a protective case (1) containing an electric power source connected to one or more heating elements (2) located on a conductive plate (14) on the bottom face of the protective case (1); and a fastening component comprising a fastening strap (3) and a fastening means (9), the protective case (1) comprising, on a portion of the bottom face, a coupling element (11), and the fastening component further comprises a fastening plate (10) connected to the fastening strap (3), which in turn comprises a coupling element (12) configured to removably connect to the coupling element (11) of the protective case (1).

Description

HUMAN ODILAT ATION VAS DEVICE FOR EFFECTIVE FINDING OF THE BLOOD VESSELS OF A PATIENT DESCRIPTIVE MEMORY

SCOPE

The present application is directed to a human vasodilation device that operates based on the increase in temperature and pressure for the correct detection of blood vessels in humans, with applications in the medical area. Specifically, it is aimed at a device that fulfills the function of dilating veins, arteries and capillaries to facilitate the puncture of patients in the area of blood samples, intravenous application of serum and drugs, blood donation, catheter installation, among other procedures. intravenous punctures are applied.

BACKGROUND OF THE INVENTION

There is a large number of patients who have difficult venous access, either because they have very small diameter veins, as are mostly pediatric patients and older adults. Also due to anatomical characteristics of the patient, such as having a thick layer of muscle tissue as in the case of overweight patients. There are also patients with chemical treatments, as is the case with chemotherapy, who are not exempt from this problem. These chemicals produce negative side effects, such as the contraction of the vessels and increase the stiffness of these, which makes the veins difficult to detect when puncturing, so it is common that the puncture is not the first attempt. Hospitalized patients are one of the groups that suffer the most from multi-function, due to the constant admission of drugs that, due to the effects mentioned above, cause them to have to be punctured several times a day. Due to this, the limbs are damaged and the cups are left with multiple holes, which makes these cups more rigid. This accumulated damage makes future punctures even more difficult.

In addition, it is extremely common for patients to have difficult venous access at the time of the puncture due to nervousness and emotional state during the procedure, such as fear, insecurity, panic, among others. These psychological reactions cause the patient to contract his veins and be more difficult to detect, which makes the failure of the puncture more likely. This is more common in pediatric patients who have to undergo punctures. There are multiple causes that make it difficult to detect blood vessels when performing intravenous punctures, which is why there is a need to mitigate the complications associated with the procedure, in order to improve the technique with which the punctures are performed and reduce multipuncture.

At present, nurses, phlebotomists and doctors who require to apply intravenous punctures, either for the extract of blood tissue or for the application of serum and medications, perform them through pressure application methods, making a tourniquet in the limb, for which latex garters and / or elastic bands are used, in order to compress the blood vessel. These rubber bands are tied to the arm to apply pressure at a certain point, which generates an increase in pressure in the blood vessels. In case of not having them, the use of sterile gloves that fit around the arm, or the place where the puncture will be made, is adopted, which fulfill the same function as latex garters to exert pressure and compress the vessel. In patients with difficult-to-access veins, these measures are insufficient, since they do not effectively help the vein to be visible and palpable for the nurse, thus requiring repeated attempts to find it.

The use of infrared lights is also known which, when projected on the limbs of patients, show the location of the blood vessels under the skin, which helps to visualize them. However, most of the time this technique is not improves the detection condition through touch. In this sense, it is usually more effective to detect the intravenous route through touch than by vision. Therefore, it is important to mention that the visualization of the venous map under the skin does not contribute to the detection of these.

Another aspect to consider is that many of these infrared light devices commonly used in medical centers do not allow their use while the puncture is being performed. In other words, it is extremely difficult for a person to use the device to illuminate the veins and at the same time perform the puncture, so most of the time they prefer not to use it, since it is preferable to use both hands to puncture.

In addition, this infrared light technology can be extremely expensive for clinics and hospitals, which affects the level of use in certain countries. A final factor to consider is that it does not help the veins to expand or decrease their rigidity, which makes it non-functional in patients with smaller diameter or rigid veins.

On the other hand, to improve the detection of veins through touch through vasodilation, latex gloves with hot water inside are also used, especially when the ambient temperature is low. This irregular mechanism of vein dilation is achieved through the glove that acts as a heat source, which helps the blood vessels to dilate due to the increase in temperature. However, the method is extremely risky, as it can cause injury to the patient, specifically the skin, resulting from burns in the event that latex gloves, or other similar artifact, break. Document US7825356B2 discloses a vasodilator device composed of an adjustable sleeve that can be put on the arm or other limb, it contains heating elements that are connected to a power source. This device is used by wrapping around the limb and connecting it to the power source, then allowing the device to deliver heat to the patient. However, the device disclosed in said document has the disadvantage that the device does not have a dedicated system for exerting pressure, since its function is only vasodilation, through the use of heat. In addition, it has the drawback that, as it has a large surface of heating elements, it requires a greater amount of energy supplied by the power source, which makes its autonomy and versatility in use very difficult, since it has to be permanently connected. to an electrical outlet. This device works exclusively on the arm, so it is not possible to produce vasodilation in any other part of the body. In addition, it does not have an interface that displays the temperature in order to control the application of heat.

To face some of these drawbacks, document CN202637031 discloses a vasodilator device composed of an elastic rubber hose that contains inside a wire-type heat conductor, enclosed in a heat-resistant layer and an insulating layer. A power cord is arranged at the front end of the heat conduction device and a ring is arranged on the hose to be hooked with a hook located at the end of the hose.

The device disclosed by said document has the disadvantage that since the skin contact element is a narrow hose with a single wire inside, the contact surface is very small, which does not allow providing sufficient heat for vasodilation. . This drawback is caused by the compact design of the device, where the pressure and temperature element is the same, thus covering a reduced area of the patient's arm. Furthermore, it has the drawback that the hose is not easily removable, which makes the cleaning process of the device difficult.

Another similar design of a vasodilator device is disclosed in document CN201939425. Said vasodilator device comprises a rubber tube attached to an electric heating blanket and a magnifying glass at the front end of the electric heating blanket. However, the previous document also has the drawback of making the device cleaning process difficult, as well as not providing adequate means for efficient heat transfer to the patient's arm, being necessary to use additional means for the detection of blood vessels such as a magnifying glass.

US4834802A discloses a disposable tourniquet having a plastic strap with a pair of liquid storage tanks mutually separated by a breakable wall. The rupture of the breakable wall causes the heating of the liquid by exothermic reaction, which causes vasodilation for subsequent puncture through a window in the strap.

This device has the drawback of providing a reduced heating surface. Furthermore, there is the risk that when the reservoir containing the liquid breaks, it may come into contact with the skin of the patient, thereby causing burns.

A common disadvantage present in the solutions of the state of the art has to do with the inability to regulate the heat emitted by the device depending on the type of user or according to the temperature conditions of the environment where it is located. For example, it could be that in winter a higher temperature is required than in summer to obtain the same results, or depending on the area of the body in which the device is placed, since there could be areas more sensitive to temperature than others.

To face the disadvantages of the state of the art identified above, the inventors of the present application developed a vasodilator device described in the Chilean Utility Model patent No. 512, which is made up of a power cable connected at one end to a power source and at the other end connected to one or more heating elements contained within a conductive plate and connected to a regulator. Both said heating elements and the conductive plate are arranged within a material insulator, and these components are coupled to a clamping means that contains a clamping band responsible for carrying out the pressure.

Although said device allows efficient vasodilation of a patient by means of a correct application of the heat and pressure technique to the puncture area, it has the disadvantage that, due to the large size of the heating elements, it is difficult and uncomfortable to access the correct puncture site. This drawback cannot be overcome simply by removing or moving the heating device aside as it could affect the operation of the clamping band, which is fixed to the heating elements.

Therefore, it is an objective of the present invention to solve the drawbacks that state-of-the-art devices present by finding the patient's blood vessels more effectively and granting better access to the puncture site, in order to be able to perform them correctly. better and less traumatic way.

It is a specific objective of the present invention to provide a human vasodilator device that allows to regulate and monitor the temperature of the puncture site, that is reusable and that can operate as a compact, lightweight and hygienic portable device.

In this context, the incorporation of this human vasodilator device, which facilitates the detection of blood vessels to improve the development of the puncture protocol of a medical service, in an efficient and painless way, is of vital importance in the materialization of a new concept in work in which there is a constant need to puncture patients.

The advantages of the device lie in the fact that the factor of having a combination of two vasodilators, such as heat and pressure, makes it possible to increase the effectiveness of each intravenous puncture, in the same time frame, in a safe way. Both are natural vasodilators, which do not bring side effects in patients. This enables perform a greater number of medical examinations, due to the decrease in repetitions of each of these.

By decreasing the chance of a second or third puncture in patients with difficult to detect veins, nurses can do more punctures. This leads to greater efficiency in the time used by nurses when attending.

In addition, it is possible to reduce the number of puncture attempts, thus reducing the risks of injury, avoiding bruising and damage to the patients' veins.

SUMMARY OF THE INVENTION

The present invention consists of a human vasodilation device, which makes it possible to more effectively find the blood vessels of a patient and provide better access to the puncture site, said device comprising: a protective casing that contains a source of electrical supply connected to one or more heating elements located on a conductive plate on the underside of the protective casing; a fastening component comprising a fastening band and a fastening means.

The protective housing comprises on a portion of its lower face a coupling element and the clamping component further comprises a clamping plate connected to the clamping band, which in turn comprises a coupling element configured to removably connect with the coupling element of the protective housing.

According to a preferred embodiment, the coupling element of the clamping component is a male coupling element and because the coupling element of the protective housing is in a female coupling element, both coupling elements being configured for mechanical and / or coupling or magnetically.

In this way and advantageously, the protective casing containing the heating elements and the clamping component are two completely independent mechanisms, which can be mounted and disassemble from each other. This greatly facilitates puncture, as heat is applied to the puncture site first, and then the needle insertion space is cleared.

At the same time, the clamping band adjusted to the patient's limb exerts pressure, allowing the patient's blood vessels to be effectively dilated through the combination of these two techniques.

The technical effect previously described and achieved by the invention has not been proposed in any of the references of the state of the art mentioned above and therefore represents an advantage over it, by allowing the user to have a clear surface on the patient's limb that facilitates puncture.

Another effect is that it allows the user to decide whether to use only the headband, only the heating device or both simultaneously. On the other hand, the band can remain static applying pressure to the limb, while the heating device has the facility to apply heat to any point the user wishes, such as the palm or back of the hand, biceps muscle, or any another area of an extremity where a venous channel can be accessed. This is an important comparative advantage over the state of the art, as it broadens the range of utilities of the device.

On the other hand, the power source being a rechargeable battery allows the device not to have to be connected to the current through a wall socket. This contributes greatly to the autonomy, versatility and independence of operation of the device, as it is a portable unit. Furthermore, and according to preferred embodiments of the invention, the batteries can be charged wirelessly, without the need to connect cables to feed the power source. This advantage will be described later.

The fact of applying heat to a specific local area of the patient's limb saves a large amount of electrical energy, allowing the use of batteries as power sources and allowing the device to have greater autonomy during use. These and other advantages of the device are seen in greater detail from the figures described below.

BRIEF DESCRIPTION OF THE FIGURES

To better understand the essential characteristics of the human vasodilation device, based on the increase in temperature and pressure for the correct detection of blood vessels in the medical area, it is described according to the following figures that are an integral part of the invention , where: Fig. 1 shows a perspective view of all the components of the heating element, object of the present invention.

Fig. 2 shows a perspective view of all the components of the vasodilator object of the present invention.

Fig. 3 shows a plan view of the heating element, showing the heating component and the thermal propagation system, according to a preferred embodiment of the invention. Fig. 4 shows a side view of the heating element, object of the present invention.

Fig. 5 shows a perspective view of all the components of the clamping element, object of the present invention. Fig. 6 shows a front view of all the components of the clamping element, object of the present invention.

Fig. 7 shows a top view of all the components of the clamping element, object of the present invention.

Fig. 8 shows a top view of the mode of use of all the components of the vasodilator device, object of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with Figures 1 to 8, the invention consists of a vasodilator device that operates under the principle of increasing temperature and pressure for the correct detection of blood vessels in the medical area, being made up of a protective casing 1, which in its The interior contains an electrical power source connected to one or more heating elements 2 (Fig. 3), the latter located on a conductive plate 14 of the casing and whose function is to transmit heat towards the puncture site.

According to figure 1, the protective casing is made up of two portions, a lower portion preferably horizontal and which comprises the conductive plate 14, and an upper portion, the latter preferably forming an angle with the lower portion. Said upper portion comprises a light indicating the battery level of the device 4, a display interface 5 that can be a screen, for example a touch screen or user interaction infographic. In addition, it includes lights indicating the temperature level 6 in which the device is located, temperature regulation buttons 7, which can regulate said temperature at different levels and an on and off button 8. The electrical power supply included inside the protective casing (not illustrated) preferably corresponds to one or more rechargeable batteries, which provide electrical energy to the one or more heating elements 2. The voltage and current comply with the standards of IEC 60601-1 electro-medical device safety, while the power source power should vary between 5 to 20 [W]. According to a preferred embodiment, the batteries are wireless charging, said charging being produced by supporting or bringing the protective casing 1 containing the batteries closer to a wireless charging device. In other embodiments, the batteries can be charged through a cable and through a connector located in said casing.

The protective casing 1 is constructed of a resistant material capable of protecting the interior of the device from shocks, fluid spills and disengagement of the components of the heating device. In turn, it is hygienic and smooth enough to be washable. To achieve this, the protective casing 1 is constructed of resistant plastic material or a material of similar conditions with organic enamel. For its part, the one or more heating elements

2 can be electrical resistances, enameled cable or meshes made with metallic fibers designed to emit heat.

According to Figure 5, the device of the invention comprises a clamping component configured to be removably connected to the protective casing. Said clamping component is made up of a clamping plate 10 configured to be positioned on an extremity of the patient, which is traversed by a clamping band 3 through pins 13 arranged at the ends thereof. In turn, the clamping plate 10 contains on its upper face a first coupling element 12, preferably a male coupling element with a cylindrical shape, which has the function of engaging and disengaging from a second coupling element 11 of the protective casing. 1. The clamping band 3 can be made of an elastic material or nylon and has a clamping means 9, which allows to contain the tension that can be given to the clamping band 3 around the limb of the patient.

In figure 3 you can see the second coupling element 11, which consists of a hole-shaped female coupling, preferably located on the rear face of the upper portion of the protective casing and is designed to receive the first coupling element. 12 of the clamping component. According to a preferred embodiment of the invention, the first coupling element 12 and the second coupling element 11 consist of magnetic fasteners, which provide a simple, fast and intuitive coupling / uncoupling operation, so that to disassemble the casing protector 1 of the clamping plate 10, it is sufficient to lift the first with a minimum force that exceeds the magnetic attraction force between both coupling elements.

A second function of the second coupling element 11 is to allow connection to a wireless battery charger whose charging terminal is designed in the shape of the first coupling element 12.

On the other hand, the temperature regulating buttons 7 control the electrical current that feeds the one or more heating elements 2, so that the user can adjust the temperature that the vasodilator device emits to the patient's arm. To have knowledge about the temperature levels in which the user is, it is that the latter has the indicator lights of the temperature level 6 that show the first, second and third levels respectively. Additionally, the device includes inside a temperature sensor and a thermostat connected to a temperature regulator (not illustrated), in order to control the temperature emitted by the heating elements. According to a preferred embodiment of the invention, the temperature that the device is capable of reaching is up to 42 ° C. The on / off button 8 lights up when the device starts operating, and stays off when the device is unplugged.

In alternative embodiments of the invention, the vasodilator device includes additional means for monitoring and control of temperature parameters, where said means can be selected from the group that includes, for example: a microcontroller, Bluetooth transmitters and receivers, a transistor, a signal conditioner, among others.

EXAMPLE OF APPLICATION

According to one application of the vasodilator device of the invention, a person in charge of the medical area installs the clamping mechanism on the patient's forearm by adjusting the clamping band 3 that passes through the clamping plate 10 and is tightened with the clamping means 9. Coupling and uncoupling of the heating device with the clamping mechanism is shown in figure 8. In step 1 the clamping plate attached with the clamping band to the patient's arm is shown. In stage 2, the clamp band is adjusted by compressing the patient's limb and the clamping means (located in the example under the limb) is used. Then, in step 3, the heating device is arranged on the clamping plate, which must be joined by connecting the first coupling element of the clamping mechanism with the second coupling element of the housing.

It should be said that this is the traditional method of using the device. However, this could be used in any area of the body where the puncture will be performed, be it the forearm, hand, biceps, among others.

Once both parts have been coupled, the device is turned on with the on / off button and the device enters a passive state waiting for user interaction, as can be seen in stage 4. In this same stage, the temperature is regulated using the temperature adjustment buttons located under the temperature level indicator lights, which indicate the three temperature levels that the device can reach. Thus, the device allows the passage of current from the battery to the heating elements, so that they can increase the temperature locally in the patient's arm. These heating elements transmit heat in a controlled manner through the conductive plate.

Once the desired temperature is reached in the local area of the patient's arm, the heating device is uncoupled from the clamping plate, so that the puncture area is clear to insert the needle (step 5).

NUMERICAL REFERENCES

1. Protective shell 7. Temperature regulation buttons

2. Heating elements 20 8. On / off button

3. Fastening band 9. Fastening means

4. Battery level indicator light 10. Holding plate

device 11. Second coupling element

5. Display interface 12. First coupling element

6. Level 25 indicator lights 13. Pins

temperature 14. Conductive plate

Claims

1. Human vasodilation device, which allows the blood vessels of a patient to be found more effectively and provides better access to the puncture site, said device comprising:

a protective casing (1) that inside contains an electrical power supply connected to one or more heating elements (2) located on a conductive plate (14) on the underside of the protective casing (1);

a fastening component comprising a fastening band (3) and a fastening means (9);

CHARACTERIZED in that the protective casing (1) comprises in a portion of its lower face a coupling element (11) and in that the clamping component further comprises a clamping plate (10) connected with the clamping band (3), which in turn, it comprises a coupling element (12) configured to be removably connected to the coupling element (11) of the protective casing (1).

2. The human vasodilation device according to claim 1, CHARACTERIZED in that the coupling element (12) of the clamping component is a male coupling element and in that the coupling element (11) of the protective housing (1) is in a female coupling element.

3. The human vasodilation device according to claim 2, CHARACTERIZED in that both coupling elements (11, 12) are configured to engage mechanically and / or magnetically.

4. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the clamping band (3) is connected to the clamping plate (10) through pins (13).

5. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the heating element (s) (2) are selected from the group of: electrical resistances, enameled cable or meshes made with metallic fibers.

6. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the protective casing (1) is made up of two portions: a lower portion preferably horizontal and which comprises the conductive plate (14), and an upper portion forming an angle with the lower portion.

7. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the protective casing (1) comprises at least one device selected from:

- a light indicating the battery level of the device (4);

- a display interface (5);

- temperature level indicator lights (6);

- temperature regulation buttons (7);

- an on / off button (8).

8. The human vasodilation device according to claim 7, CHARACTERIZED in that the display interface (5) is selected from: a screen such as a touch screen or user interaction infographic.

The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the protective casing (1) further comprises means for monitoring and controlling the temperature parameters selected from the group of: a microcontroller, Bluetooth transmitters and receivers, a transistor , a signal conditioner, among others.

10. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the electrical power source is one or more rechargeable batteries.

11. The human vasodilation device according to claim 10, CHARACTERIZED in that the one or more batteries are wirelessly rechargeable.

12. The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the protective casing (1) is made of plastic material.

The human vasodilation device according to any of the preceding claims, CHARACTERIZED in that the fastening band (3) is made of an elastic material or nylon.