WO2021124238A1

WO2021124238A1 - Probe, method and system for administration of substances through skin

Info

Publication number: WO2021124238A1
Application number: PCT/IB2020/062170
Authority: WO
Inventors: Gerhard MIKOLAICZIK
Original assignee: Mikolaiczik Gerhard
Priority date: 2019-12-19
Filing date: 2020-12-18
Publication date: 2021-06-24
Also published as: PL432327A1; WO2021124238A4; EP4076617A1

Abstract

A probe for administration of pharmaceutical and/or cosmetic substances through the skin comprises a housing, external and/or internal source of electric power (1), a dosing pump connected with a source of a pharmaceutical and/or cosmetic substance and at least one applicator applying the substance on the skin (8) equipped with at least one coil (8c) generating alternating electromagnetic field. The object of the invention is also a method and a system for administration of pharmaceutical and/or cosmetic substances through the skin.

Description

PROBE, METHOD AND SYSTEM FOR

ADMINISTRATION OF SUBSTANCES THROUGH SKIN

TECHNICAL FIELD

The object of the present invention is a probe, a method and a system for administration of pharmaceutical and/or cosmetic substances through the skin.

BACKGROUND ART

Transdermal non-invasive application of pharmaceutical and/or cosmetic substances found its place in therapy of many diseases, and also is commonly used in cosmetology.

Modem methods of drugs absorption through skin consist inter alia of use of ultrasounds or electricity.

Patent application KR101022201 discloses an ultrasonic device for transdermal dmg delivery comprising a drug storage unit, a dmg infusing unit, which injects the dmg stored in the dmg storage unit, and an ultrasonic wave generator.

Patent application US2018243544 discloses a medical device comprising a piezoelectric element for generating ultrasonic waves for effectively transferring a functional material into a human body and an electrical stimulation signal for treatment effects.

Patent application US2006276741 discloses an intradermal drug delivery device comprising an iontophoresis electrode

Patent application US2002040203 discloses a method for transdermal delivery of molecules comprising electroporating the skin concurrently or sequentially in relation to the application of the molecules and a liposomal composition comprising negatively charged liposomal.

Patent application US2004230224 discloses a portable device generating magnetic field used for human and animal therapeutic applications.

In the solutions used so far, ultrasounds or electric current of high frequency and short duration of pulses causes a certain permeability of skin, however not to such extent that a pharmaceutical or cosmetic substance could actually permeate under the skin. Unexpectedly, it turned out, that it is possible to develop a method, a device and a system that allow for non-invasive administration of pharmaceutical and/or cosmetic substances through the skin. DISCLOSURE OF THE INVENTION

A probe for administration of pharmaceutical and/or cosmetic substances through the skin according to the invention is characterized in that it comprises a housing, external and/or internal source of electric power, a dosing pump connected with a source of a pharmaceutical and/or cosmetic substance and at least one applicator applying the substance on the skin equipped with at least one coil generating alternating electric field. The dosing pump can be placed inside the probe or outside if the substance is supplied from an external tank.

The source of the substance is a tank placed inside the housing.

The source of the substance is an external tank, and the substance is supplied to the probe through a pipe

The dosing pump is powered by a stepper motor.

The applicator is equipped with vibrating and/or ultrasounds generating elements. Ultrasounds generating elements may be turned on and off individually, in groups, or all at once. The ultrasounds generating element is connected to the generator.

The coil generates electromagnetic field of frequency of 1-5 MHz. Preferably the power is up to 65 Watts. The generator powering the coil can feed the coil with a different signal (sine, square, saw). The purpose of the coil is to stimulate the skin with an electromagnetic field to increase its permeability to the administered substances.

The source of electric power is an accumulator placed inside the housing and/or at least one battery. The probe may be also powered by electricity network.

The probe is equipped with a control system, which is equipped with a computer program controlling generation of electromagnetic field, and dosing, and administration of the substance. The control system may be placed inside the probe or outside it.

The computer program controls also generation of vibrations and/or ultrasounds.

The dosing module of the applicator is equipped with a radially shaped recess enabling symmetrical and even distribution of the remains of the administered substance over the entire contact surface with the skin. The edges of the recesses are rounded so that their entire surface remain in contact with the skin. The task of this module is also to transfer the ultrasonic wave and vibrations to the skin surface. The recess creates a pattern similar in shape to a multi-pointed star.

The probe is equipped with a temperature sensor. The temperature of the patient's skin is thus regularly monitored by the control system. This parameter can be used by the artificial intelligence of the control system to optimize the transport of substances through the skin and/or to prevent the skin from overheating in long-term use, such as e.g. during filling larger wrinkles.

A method of administration of pharmaceutical and/or cosmetic substance through the skin according to the invention is characterized in that, electromagnetic field is generated on the skin surface, and then a pharmaceutical and/or cosmetic substance is administered on the skin.

The electromagnetic field has frequency of 1-5 MHz. Preferably its power is equal to 65 Watts.

After generation of electric field, during administration of the substance on the skin, vibrations and/or ultrasounds are generated.

A system for administration of pharmaceutical and/or cosmetic substances through the skin according to the method described above in accordance with the invention is characterized in that it comprises at least one probe for the substance administration on the skin, a source of substances connected with a pump dosing the substance and source of electric power, while the probe is equipped with at least one coil generating electromagnetic field on the skin surface. The probe described above may be used in the system. The probe additionally generates ultrasounds and/or vibrations. Ultrasounds increase the permeability of the skin, and the vibrations of the applicator surface cause the substances supplied by the applicator on the skin to pass inside the skin due to the generated acoustic pressure.

The control system is equipped with a computer program controlling generation of electromagnetic field, and dosing, and administration of substances. The control system may be placed inside the probe or may be connected with it by a wire and or wirelessly and may be placed outside.

The computer program controls also generation of vibrations and/or ultrasounds.

The control system is connected with a temperature sensor placed in the probe and retrieves data from the sensor - the temperature of patient’s skin, and the computer program uses these data to control the system operation. The temperature of patient’s skin is used by the artificial intelligence of the control system to optimize the transport of substances through the skin and to prevent the skin from overheating in long-term use, such as e.g. during filling larger wrinkles.

The probes are mounted on a hand or a leg of the patient by means of a strap. The probe according to the invention should be sized such that it can be grasped freely with one hand, and that it can also be attached by a strap to a body part such as leg or arm. The dispensing module of the applicator has openings through which a pharmaceutical or cosmetic substance is administered. It may also include a membrane through which the administration of the substance occurs. The probe or several probes can be attached to the patient's arm or leg with a strap.

The alternating electromagnetic field used in the invention facilitates the passage of the material particles through the skin barrier making the skin permeable. The probe sends the appropriate number of droplets of the substance onto the skin "prepared" in this way, "shooting" them under the skin at an appropriate speed. Examples of substances used in the invention are: hyaluronic acid, collagen peptides, nutrients or other cosmetic substances. They can also be pharmaceutical substances such as insulin or methylcobalamin. The use of a stepper motor in the dosing system allows for precise dosing of substances. The use of substance tanks, in turn, allows for dosing a specific amount of substance. Therefore, the invention also allows for the administration of pharmaceutical substances having a therapeutic effect. The method of administration of the substance according to the invention does not damage the skin, so there is no risk of infections and related complications.

The probe acts as a 3D printer head, "printing" under the skin a structure from the substance used.

The probe comprises a tank for the substance, or the substance is supplied from outside.

The system works as follows:

1^st phase preparation - the probe is placed precisely on the surface of the skin and creates electromagnetic field on the surface, while heating it;

2^nd phase transport - the probe administers droplets of the substance at a defined speed, owing to the contact, the appropriate speed of administration and the permeability of the skin, increased thanks to the electromagnetic field and ultrasounds, the substance (pharmaceutical or cosmetic) passes through the skin;

3^rd ultrasonic frequency vibrations of the probe cause the substance remaining on the skin to be absorbed, the vibrations are generated by piezoelectric vibrating elements placed in the probe.

The ultrasonic elements are controlled individually and can be turned on separately, which makes it possible to turn them on in specific sequences, e.g. clockwise, in groups symmetrically in relation to the axis of the applicator or pulsating. Such a method greatly expands the applicability and optimization of transdermal transport. The single, successive turning on the ultrasonic elements significantly improves the effect of the operation of the ultrasonic section. The radially shaped recess in the probe causes the rest of the substance to be distributed symmetrically on the skin. During this time, the electromagnetic field is turned off.

The generated electromagnetic field in combination with the ultrasonic wave causes the skin to "unseal" due to the reversible weakening of the so-called tight junctions, i.e. proteins that bind adjacent cells together.

The object of the invention is disclosed at the drawings, where fig. 1 illustrates a probe schematic diagram, fig. 2 illustrates an ultrasonic module 8b, fig. 3 - a coil 8c, fig. 4 - an applicator administering the substance on the skin 8d, fig. 5 - a system equipped with the probe administering the substance on the face, fig. 6 - the probe having shape of a strap, fig. 7 - the system administering the substance on the leg skin, fig. 8 illustrates a simplified scheme of connection of generators powering the coil and the ultrasonic element (Gl, G2), as well as a controller of a stepper motor (SI).

EXAMPLE

Example 1

A probe for administration of pharmaceutical and/or cosmetic substances through the skin comprises a source of electric power 1, a control system 2. The probe may have also an alternative control system 2a having a display. The probe is equipped with a stepper motor 3 powering a dosing pump 6 and with a tank for the substance to be applied on the skin 4. It is also possible to supply the substance through a pipe 5 from a tank placed outside the probe. The dosing pump 6 supplies the substance through a pipe 7 to an applicator 8. The applicator 8 comprises an electromagnetic shield 8a, an ultrasonic module 8b, a coil 8c and a dosing module 8d spreading the substance over the skin surface. In the dosing module 8d a radially shaped recess having shape similar to a multi-pointed star is placed. The ultrasonic element 8b and the coil 8c are connected with a generator Gl, G2, and a controller SI controls the stepper motor 3. Example 2

A system for administration of pharmaceutical and/or cosmetic substances through the skin comprises a probe 1.1. A. The operation of the probe 1.1.A is controlled by the control system 1.2.B. The substance is supplied to the probe 1.1. A from the external tank I.3.C. With the help of the system, it is possible to e.g. fill in facial wrinkles.

Example 3

On the arm 2.1.A there is a strap 2.1.C fastening the probes 2.2. A, 2.2.B,

2.2. C and 2.2.D. The probes administer a medicinal substance, e.g. insulin, on the patient's skin.

Example 4

On the knee 3.1. A there is a strap 3.1.B fastening the probes 3.2. A,

3.2.B, 3.2.C and 3.2.D. The probes administer a medicinal substance on patient's skin. The operation of the probes is controlled by the control system 3.3. A, which controls the speed of substance administration, patient's body temperature, the power of ultrasounds and vibrations. In this case, four probes are used, fastened around the knee with an elastic strap. Applicators have internal tanks with the active substance. The active substance used is, for example, hyaluronic acid, anti- inflammatory or analgesic drugs. It is administered into a sore knee joint.

Example 5

The ultrasonic element 8b and the coil 8c are connected to the generator Gl, G2, and the controller SI controls the stepper motor 3.

Claims

PATENT CLAIMS

1. A probe for administration of pharmaceutical and/or cosmetic substances through the skin, characterized in that, it comprises a housing, external and/or internal source of electric power (1), a dosing pump connected with a source of a pharmaceutical and/or cosmetic substance and at least one applicator applying the substance on the skin (8) equipped with at least one coil (8c) generating alternating electromagnetic field.

2. The probe according to claim 1, characterized in that, the source of the substance is a tank placed inside the housing (4).

3. The probe according to claim 1, characterized in that, the source of the substance is an external tank, and the substance is supplied to the probe through a pipe (7).

4. The probe according to claim 1 or 2, characterized in that, the dosing pump is powered by a stepper motor (3).

5. The probe according to any of the preceding claims, characterized in that, the applicator (8) is equipped with vibrating and/or ultrasounds generating elements (8b).

6. The probe according to any of the preceding claims, characterized in that, the coil (8c) generates electromagnetic field of frequency of 1-5 MHz.

7. The probe according to any of the preceding claims, characterized in that, the source of electric power is an accumulator placed inside the housing and/or at least one battery.

8. The probe according to any of the preceding claims, characterized in that, it is equipped with a control system (2), which is equipped with a computer program controlling generation of electromagnetic field, and dosing, and administration of the substance.

9. The probe according to claim 8, characterized in that, the computer program controls generation of vibrations and/or ultrasounds.

10. The probe according to any of the preceding claims, characterized in that, the dosing module (8d) of the applicator is equipped with a radially shaped recess.

11. The probe according to any of the preceding claims, characterized in that, it is equipped with a temperature sensor.

12. A method of administration of pharmaceutical and/or cosmetic substance through the skin, characterized in that, electromagnetic field is generated on the skin surface, and then a pharmaceutical and/or cosmetic substance is administered on the skin.

13. The method according to claim 12, characterized in that, the electromagnetic field has frequency of 1-5 MHz.

14. The method according to claim 12 or 13, characterized in that, after generation of electric field, during administration of the substance on the skin, vibrations and/or ultrasounds are generated.

15. A system for administration of pharmaceutical and/or cosmetic substances through the skin according to the method described in claims from 12 to 14, characterized in that, it comprises at least one probe (1.1. A, 2.2, 3.2) for the substance administration on the skin, a source of substances connected with a pump dosing substance and a source of electric power, while the probe is equipped with at least one coil (8c) generating electromagnetic field on the skin surface.

16. The system according to claim 15, characterized in that, the probe (1.1. A, 2.2, 3.2) additionally generates ultrasounds and/or vibrations.

17. The system according to claim 15 or 16, characterized in that, it comprises a control system (1.2.B, 3.3. A), which is equipped with a computer program controlling generation of electromagnetic field, and dosing, and administration of substances.

18. The system according to claim 17, characterized in that, the computer program controls generation of vibrations and/or ultrasounds.

19. The system according to claim 17 or 18, characterized in that, the control system (1.2.B, 3.3. A) is connected with a temperature sensor placed in the probe and retrieves data from the sensor, and the computer program uses these data to control the system operation.

20. The system according to any of claims 15-19, characterized in that, the probes (2.2. A, 2.2.B, 2.2.C, 2.2.D, 3.2.A, 3.2.B, 3.2.C, 3.2.D) are mounted on a hand or a leg of the patient by means of a strap (2.1.C, 3.1. A).