WO2020197519A1

WO2020197519A1 - Glove type tens device with a temperature tracking system

Info

Publication number: WO2020197519A1
Application number: PCT/TR2020/050044
Authority: WO
Inventors: Serdar AKGÜÇ; Beril DOĞAN; Ecem ACAR; Mert ÇERİ
Original assignee: Odtue Gelistirme Vakfi Egitim Hizmetleri AS
Current assignee: Odtue Gelistirme Vakfi Egitim Hizmetleri AS
Priority date: 2019-03-25
Filing date: 2020-01-21
Publication date: 2020-10-01
Anticipated expiration: 2021-09-25

Abstract

The invention is related to a "glove type tens device having a temperature tracking system" that has been designed to concurrently prevent the formation of neuropathies arising from chemotherapeutic agents.

Description

GLOVE TYPE TENS DEVICE WITH A TEMPERATURE TRACKING SYSTEM

Technical Field of the Invention

The invention is related to a“glove type tens device having a temperature tracking system” that has been designed to concurrently prevent the formation of neuropathies arising from chemotherapeutic agents.

Known State of the Art (Prior Art)

Colon cancers, breast cancers, and lung cancers are some of the most frequently observed cancer types. Nerve damage is called neuropathy. Neuropathies can emerge depending on several reasons. Neuropathy can progress at an acute (early) or a chronic (late, long term) stage. One of the reasons for neuropathy is some chemotherapy drugs that are used in treating cancer. The agents that cause the most frequent neuropathy from among the chemotherapeutic agents are platin, taxan and vinca alkaloids. Particularly cisplatin and oxaliplatin that are some of the platin compounds lead to neuropathy. The most frequently used chemotherapeutic agents in common cancers are oxaliplatin in colon cancers, cisplatin and taxan in lung cancer, again taxan in breast cancer. Platin compounds may damage the nerves in particularly the hands and feet and especially the sensory nerves (“glove-sock type neuropathy”). Oxaliplatin that is commonly used in colon cancers can especially cause sensory polyneuropathy (multiple nerve damage in especially hands and partially in feet). Polyneuropathy that develops depending on oxaliplatin, may intensify even more due to particularly being in contact with cold. Again taxan, and vinca alkaloids may also cause neuropathy to progress further. Polyneuropathy related to taxan, is in the form of sensory neuropathy that is especially notable in hands and feet, similar to polyneuropathy that may develop due to platin compounds. Nerve damage in the feet that are dependent on vinca alkaloids is typical.

As a result, especially during the treatment of agents that are significantly known to cause neuropathy, such as taxan and platin treatment (these agents are given intravascularly), the related chemotherapeutic agent, can cause damage to the nerves that neighbor the veins via blood (especially in the hands and feet) when said agent is given intravascularly. Chemotherapy can be applied at certain periods of time, as repeated doses. Chemotherapy graphs are available which show the efficient and safe doses, application routes, and the intervals at which and how chemotherapeutic agents can be applied for the cancer type, and the efficiencies of each chemotherapeutic regime has been proved by scientific studies. When repeated chemotherapy sessions are applied, the risk of neuropathy in the future is also increased, as expected. Neuropathy is frequently observed following the usage of chemotherapeutic agents such as platin and taxan. Polyneuropathy risk related to chemotherapy has been reported as 68% and this risk continues up to 6 months in 30% of the patients following the polyneuropathy treatment process. Additionally, it has been noted that CIPN (peripheral neuropathy associated with chemotherapy) had a negative effect on the life quality of patients. There are views that symptoms that are associated with CIPN may arise depending on the increase in the activation of the central nervous system or reduction in inhibition. As a result, symptoms such as pain and pins and needles can be observed.

Transcutaneous Electrical Nerve Stimulation (TENS) devices are more commonly used in the field of physical therapy during daily practices. The devices are used generally to provide symptomatic comfort for patients with conditions related to the muscles such as fibromyositis. In the prior art, a Tens device has been used in order to reduce the side effects of peripheral neuropathy that is caused by chemotherapeutic agents constituting high neuropathy risks such as oxaliplatin and taxan, that are given to cancer patients that are receiving chemotherapy treatment.

A TENS device that has been designed to reduce pain and to reduce pins and needles due to peripheral neuropathy caused by chemotherapy treatments of the prior art, has been designed for domestic usage and its effect has been examined.

All of these Transcutaneous Electrical Nerve Stimulation devices that are mentioned in the prior art are TENS devices that are used in treatment neuropathy after said neuropathy has developed in association with chemotherapy. It is a very difficult and tedious process to treat or completely eliminate the damage to the nerves after said damage has occurred. As a result, it is a necessity to design a device that prevents the development of neuropathy rather than treating it after it has developed.

Brief Description of the Invention and its Aims

The foremost aim of the invention is to increase regional blood circulation by stimulating the nerves in said region by transmitting electrical stimulation at certain frequencies at certain intervals by means of a TENS device that can be specially customized for each patient and that is placed inside a glove, which shall provide stimulation concurrently with the application of the chemotherapeutic agents (particularly taxan, platin etc.) to the patient, that have high risk of causing neuropathy and as a result, to prevent the development of neuropathy in a patient concurrently with the application of chemotherapeutic agents to the patient.

By means of the invention, the feeding and oxygenating the nerves can be increased by increasing the blood circulation in the region, by stimulating the nerves in said region. Again, by means of the increased blood circulation, as the transient passage of the chemotherapeutic agent within the vein that neighbors the nerves, that is in circulation at that moment shall also be accelerated, the risk of damage to the neighboring nerves by the chemotherapeutic agent shall also be reduced or even prevented.

Again the infusion of the chemotherapeutic agent called oxaliplatin that is one of the platin compounds (intravascular infusion of the chemotherapeutic agent, presence of the agent within blood circulation) may cause polyneuropathy that can be aggravated (increased) with cold, during the acute (early) stage. In the acute stage, the patient feels this as paresthesia (a sensory disorder such as pins and needles) such as the feeling of an“electric shock” in hands and feet that may occur due to being subjected to cold temperatures. This can become more significant during chemotherapy and within the few days following chemotherapy. Due to this reason, it is advised for patients to keep away from the cold especially during these periods of time.

Another aim of the invention is to minimize both nerve damage by means of the tens device located inside the glove and also to minimize the risk of neuropathy which is the side effect of an agent used for cancer treatment by constantly tracking hand temperature (by means of the thermometer and resistance) and by keeping it constant a certain degree.

This device aims to provide electrical stimulation to the nerves and the resistance that has been placed inside glove increases the temperature up to 37 °C at the regions that carry neuropathy risk, and the resistance also keeps the temperature at a constant value and the thermometer inside the device tracks the temperature of the hands and in the event that there is a drop in temperature, the thermometer in the device subject to the invention, senses this drop of temperature immediately and temperature inside the glove is brought back to normal body temperatures (37 °C) by means of the resistance. Definition of the Figures of the Invention

Figure 1: Front perspective view of the glove type tens device having a temperature tracking system.

Figure 2: Rear perspective view of the glove type tens device having a temperature tracking system.

Figure 3: The sections on and inside the housing, of the glove type tens device having a temperature tracking system has been shown.

Figure 4: The other sections of the glove type tens device having a temperature tracking system has been shown.

Figure 5: The sections inside the glove type tens device having a temperature tracking system has been shown.

Figure 6: The voltage cable which is one of the components of the glove type tens device having a temperature tracking system has been shown.

Definitions of the parts/aspects/sections forming the invention

The parts/sections/aspects provided in the figures in order to further describe the device comprising a tens device that has been designed to prevent the creation of neuropathy arising from chemotherapeutic agents developed by means of the invention have each been numbered and the references of each number have been listed below.

1. Housing

2. Digital LCD Screen

3. Tens Pad Connection Socket

4. Resistance Hand Heating Connection Socket

5. Tens Pad Frequency Setting

6. Tens Frequency Modulation Setting

7. Tens Control Card

8. Voltage Adapter

9. Temperature Control Card

10. Tens Pad 11. Tens Probe

12. Tens Probe Cable Connection Socket

13. Device Connection Cables of Tens Pads

14. Glove

15. Resistance Hand Heating Pad

16. Heat Adjusted Resistance

17. Thermometer

18. Hand Heating Connection Socket

19. Voltage Cable

20. On/Off Power Switch

21. Connection Socket

Detailed Description of the Invention

The “Glove type tens device having a temperature tracking system” of the invention comprises a housing (1) carrying the components of an LCD screen (2), tens pad connection socket (3), resistance hand heating connection socket (4), tens pad frequency setting (5) and tens frequency modulation setting (6) thereon; and tens control card (7), voltage adapter (8), temperature control card (9); tens pad (10), pens probe (11), tens probe cable connection socket (12), device connection cables of tens pads (13), glove (14) positioned inside the housing and resistance hand heating pad (15), heat adjusted resistance (16), thermometer (17) and hand heating connection socket (18); voltage cable (19), on/off power switch (20) and 220v connection socket (21) located inside the glove (14).

The invention is a“Glove type tens device having a temperature tracking system” comprising a at least a digital LCD screen (2) that is positioned on the housing (1) that shows the electrical current values produced by the device and that houses all of the components of the device in order to ensure said components are safe and complete, at least a tens pad connection socket (3) that enables the electrical current created by the device to be transferred onto the tens pads (10), a thermoactive resistance (16) that is placed inside the glove (14) in order to increase the hand temperature to equalize it with the body temperature that is 37°C and to keep the temperature constant having a thermometer located inside the glove (14) on the resistance hand heating pad (15) which is placed inside the resistance, which enables to keep the temperature at a constant value, where said thermometer transiently measures the temperature of the medium inside the glove and/or transmits a warning to the resistance in order to equalize the temperature with body temperature that is 37°C, when the temperature drops and/or increases, and also comprises a resistance hand heating connection socket (4) that enables the cable of the thermometer to be connected to the housing, at least a tens pad frequency adjuster (5) that enables to adjust the electric current produced for the tens pads (10) and at least a tens frequency modulation adjuster (6) that enables to customize the strength of and the duration of the electrical current that is produced by the device according to the patient, at least a tens control card (7) within the main board that enables to produce the energy required by the tens pads that have been positioned inside the housing (1), at least a voltage adaptor (8) that enables to convert 220 volts to 12 volts, at least a temperature control card (9) that enables to keep the temperature medium created for the thermoactive resistance, inside the glove (14) at a constant degree.

According to an embodiment of the invention, the voltage adapter (8) that is used is 220 volts. The invention is a "glove type tens device having a temperature tracking system" which enables the electrical current created by adhering inside/outside of the hand of the patient, which ensures that the current reaches the hands that are most frequently affected by neuropathy, thereby aiming to minimize/eliminate the nerve damage that can occur at the nerve endings that neighbor the veins in the hands due to the side effects of the drugs given during chemotherapy treatment, by means of increasing blood circulation in the hand veins via the effect of the current and by increasing oxygenation; wherein said device comprises at least a tens pad (10), at least a tens probe (11) that enables to transmit electrical current to said tens pads (10), a cable connection socket (12) belonging to the tens probe which enables to transfer the electrical current via the electrical cable to the tens device, at least a tens pad device connection cable (13) that enables to transfer the electrical current to the tens pads (10), and a double chambered glove (14) which at one side houses the tens pads that provide electrical current to the hands and at the other side houses the thermometer that measures the temperature medium of the hand, and the resistance hand heater, that ensures that the temperature medium of the hand is equalized with body temperature/is kept constant at said temperature.

According to an embodiment of the invention, the glove (14) that is used is a double layer velvet glove.

According to an embodiment of the invention, there are 2 main and 2 spare tens pads (10) adding up to a total of 4 pads.

The invention is a "gloved tens device having a temperature tracking system", wherein the glove (14) that is one of the components of the invention, comprises a thermoactive resistance (16) that is placed inside the glove and that increases the hand temperature to equalize it with the body temperature that is 37°C and in order to keep the temperature constant, a resistance hand heating pad (15) that ensures to keep the temperature constant, at least a thermometer (17) located on the resistance hand heating pad, which transiently measures the temperature of the medium inside the glove and/or transmits a warning to the resistance in order to equalize the temperature with body temperature that is 37°C, when the temperature drops and/or increases, and at least a hand heating connection socket (18) that enables the thermoactive resistance to receive the energy that is required for heating.

According to an embodiment of the invention, the voltage cable (19) that transfers electricity to the device is 220 volts.

According to an embodiment of the invention, the device comprises an on/off power switch (20) that enables to turn the device on and off.

According to an embodiment of the invention, the connection socket (21) that enables the device to receive electrical energy is 220 volts.

The platens that are taken received during chemotherapy may cause polyneuropathy that may be aggravated (increased) particularly with cold, during the acute (early) stage. When taking chemotherapy, it is important for the patients to keep their body temperature at the normal temperature which is 37 °C, in order to minimize the nerve damage that may occur in the hands due to neuropathy. Due to this reason, it has been aimed to increase this temperature to 37 °C and to keep the temperature constant at this value by means of the thermoactive resistance (16) and the thermometer (17) of the invention.

The tens device of the invention starts to operate when the voltage cable (19) is plugged in and the on/off power switch (20) at the back of the device is switched on, and at the same time the resistance (16) inside the double-layered velvet glove (14) is also activated. The resistance glove (14) that is activated is heated up to 37 °C which is the normal body temperature of a person. The thermometer that is located inside the glove (14) transiently measures the temperature and checks if the desired temperature has been reached. After the desired temperature is reached, the resistance (16) stops operating. The thermometer (17) constantly takes measurements and sends commands to the resistance (16). The tens devices that are placed inside the gloves are adhered to the outside or inside of the hand of the patient (the region where the nerve damage is observed the most). By means of the ports on the product, the current transmission can be adjusted according to the requirements of the patient and the responses received from the patient. The current is provided to be continuous or at intervals and its percentage changes from a minimum 9% to a maximum 100% according to the body response of a patient. The duration of this current is determined by the doctors that are practicing the chemotherapy treatment. The chemotherapy session may change according to the patient and the tensopathy application time of each patient may be different according to the duration of the chemotherapy session. The time is as follows: 15 minutes of Tensopathy application, 30 minutes of resting, 15 minutes of repetition of Tensopathy application is suggested. After the tens pads are stuck to the hands, 350 Hz frequency current is transmitted to these areas where the pads are stuck to, and the nerves are stimulated and blood circulation is increased. During this time, in order to ensure that the hand temperature of the patient does not drop, the resistance (16) inside the glove continues to heat up the hand and the thermometer (17) continues to take measurements. These steps are repeated in every application. After the treatment session is ended, the glove and the tens pads are removed and the device is shut off by turning off the on/off switch (20) behind the device.

Claims

1. A glove type tens device having a temperature tracking system that concurrently prevents the formation of neuropathies arising from chemotherapeutic agents, characterized by comprising;

• A housing (1) which houses all of the components of the device;

• At least a digital LCD screen

(2) that is positioned on the housing (1) which shows the electrical current values produced by the device;

• At least a tens pad connection socket

(3) that enables the electrical current created by the device to be transferred onto the tens pads (10),

• A thermoactive resistance (16) that is placed inside the glove (14) in order to increase the hand temperature to equalize it with the body temperature and to keep the temperature constant having a thermometer located inside the glove (14) on the resistance hand heating pad (15) which is placed inside the resistance (16), which enables to keep the temperature at a constant value, where said thermometer transiently measures the temperature of the medium inside the glove and/or transmits a warning to the resistance in order to equalize the temperature with normal body temperature, when the temperature drops and/or increases, and also comprises a resistance hand heating connection socket

(4) that enables the cable of the thermometer to be connected to the housing,

• At least a tens pad frequency adjuster

(5) that enables to adjust the electric current produced for the tens pads (10);

• At least a tens frequency modulation adjuster

(6) that enables to customize the strength of and the duration of the electrical current that is produced by the device according to the patient;

• At least a tens control card

(7) within the mainboard that enables to produce the energy required by the tens pads that have been positioned inside the housing (1);

• At least a voltage adapter

(8);

• At least a temperature control card

(9) that enables to keep the temperature medium created for the thermoactive resistance, inside the glove (14) at a constant degree;

• At least a tens pad (10);

• At least a tens probe (11) that enables to transfer the electrical current to the tens pads

(10); • At least a tens probe connection socket (12) that enables to transfer the electricity by means of an electrical cable to the tens device;

• At least a connection cable (13) connecting the tens pads to the device that allows electricity to be delivered to the tens pads (10);

• A double-chambered glove (14) which at one side houses the tens pads (10) that provide electrical current to the hands and at the other side houses the thermometer (17) that measures the temperature medium of the hand, and the resistance hand heater, that ensures that the temperature medium of the hand is equalized with normal body temperature/is kept constant at said temperature.

• At least a resistance hand heating pad (15) located inside the thermoactive resistance (16) that is in turn, located inside the glove (14), that enables to increase the hand temperature up to normal body temperature and that keeps this temperature at a constant value;

• A thermoactive resistance (16) that is placed inside the glove (14) in order to increase the hand temperature to equalize it with normal body temperature and to keep the temperature constant;

• At least a thermometer (17) located on the resistance hand heating pad (15), that transiently measures the temperature of the medium inside the glove and/or transmits a warning to the resistance in order to equalize the temperature with normal body temperature, when the temperature drops and/or increases,

• At least a hand heater connection socket (18) enables to receive the energy required to heat the thermoactive resistance.

2. A glove type tens device having a temperature tracking system according to claim 1, characterized in that the voltage adapter (8) is (220) volts.

3. A glove type tens device having a temperature tracking system according to claim 1, characterized in that the glove (14) is a double-layered velvet glove.

4. A glove type tens device having a temperature tracking system according to claim 1, characterized in that there are 2 main and 2 spare tens pads (10) adding up to a total of 4 pads.

5. A glove type tens device having a temperature tracking system according to claim 1, characterized by comprising a 220-volt cable (19).

6. A glove type tens device having a temperature tracking system according to claim 1, characterized by comprising an on/off power switch (20) that enables to turn the device on and off.

7. A glove type tens device having a temperature tracking system according to claim 1, characterized by comprising a 220- volt connection socket (21).