阅读说明：本技术 用于人类患者和动物患者中的血液凝结和溃疡治疗及其他皮肤损伤治疗的电医疗设备 (Electro-medical device for blood coagulation and ulcer treatment and other skin lesion treatment in human and animal patients ) 是由 奥斯瓦尔多·丹尼尔·科塔萨尔·皮尔兹 安娜·玛丽亚·麦加·马卡斯 于 2019-07-02 设计创作，主要内容包括：所提出的发明涉及一种在大气压处产生用于人类患者和动物患者中的血液凝结以及溃疡治疗和其他皮肤损伤治疗的冷等离子体的电医疗设备。主要权利要求涉及使用借助于冷却和除湿进行预处理的气体,以及放电电极的新颖形状结合在其出口通道中的等离子体膨胀室系统。这些创新的结果是,使用本发明产生的等离子体比现有技术中的那些等离子体具有较低的温度,从而在血液凝结以及皮肤损伤的消毒和治疗中保持了较大的有效性,而不会对患者的健康组织导致损害。该设备可以用于治疗人类患者和动物患者,以在临床治疗和外科手术治疗期间大大加速血液凝结而不会损害健康组织。由于其消毒特性,本发明也可用于治疗溃疡和其他皮肤损伤,而不会损害健康组织。(The proposed invention relates to an electro-medical device for generating cold plasma at atmospheric pressure for blood coagulation and ulcer treatment and other skin lesion treatment in human and animal patients. The main claim relates to the use of a plasma expansion chamber system with gas pre-treated by means of cooling and dehumidification, and a novel shape of the discharge electrode incorporated in its outlet channel. As a result of these innovations, the plasma generated using the present invention has a lower temperature than those of the prior art, thereby maintaining greater effectiveness in blood coagulation and disinfection and treatment of skin lesions without causing damage to the healthy tissue of the patient. The device can be used to treat human and animal patients to greatly accelerate blood clotting without damaging healthy tissue during clinical and surgical treatments. Because of its disinfectant properties, the present invention can also be used to treat ulcers and other skin lesions without damaging healthy tissue.)

1. An electro-medical device for blood coagulation, ulcer treatment and other dermatological lesion treatment in human and animal patients, comprising: an electronic system called a high-frequency electric power generating unit (1); a gas injection system (2); an air compressor system (3); an inert gas bottle or tank (4); gas and electric energy transport hoses (5); a manual applicator (6); a gas cooling system (7); a gas dehumidification system (8); a universal digital control system (9); a user controls the touch screen (10) and the cold, non-thermal plasma jet (11) at atmospheric pressure.

2. Electro-medical device for blood coagulation, ulcer treatment and other dermatological disease treatments in human and animal patients according to claim 1, characterized in that a non-hot, cold atmospheric plasma is used, which does not transfer thermal energy to the patient in an amount sufficient to cause damage to healthy tissue and which is created from gases previously treated by means of a cooling system (7) and a dehumidification system (8).

3. Electro-medical device for blood coagulation, ulcer treatment and other dermatological disease treatments in human and animal patients according to claim 1, characterized in that air or inert gas cooled below ambient temperature by a system (7) designed for this purpose is used.

4. The electromedical apparatus for the treatment of blood coagulation, ulcers and other dermatological diseases in human and animal patients according to claim 1, characterized in that it uses air or an inert gas with maximum absolute moisture content controlled by a system (8) designed for this purpose.

5. Electro-medical device for blood coagulation, ulcer treatment and other dermatological disease treatment in human and animal patients according to claim 1, characterized by the fact that: the gas used to generate the plasma flows through the hole formed in the center of the positive frustoconical electrode (12), passes through the recess (15) in which the plasma is formed and drives it through the center hole of the flat ground electrode (13).

6. The electromedical apparatus for blood coagulation, ulcer treatment and other dermatological disease treatments in human and animal patients according to claim 1, characterized by the use of an expansion and plasma cooling chamber system (20) preceding the plasma outlet orifice (19) in said manual applicator (6), consisting of an alternating sequence of axially perforated circular disks with two different coaxial diameters, so that when the plasma passes through the above mentioned structure, where it expands and cools, it encounters a volume corresponding to the disk of larger diameter.

7. The electromedical apparatus for the treatment of blood coagulations, ulcers and other dermatological diseases in human and animal patients according to claim 1, characterized by the fact that at the end of said applicator (6) a removable metal sheath (26) is used, which makes it possible to sterilize it in order to avoid accidental cross-contamination during the clinical and surgical use of the invention.

Technical Field

A61B18/10.medical, veterinary and hygiene. Diagnosis, Surgery and identification (A61B18/10.Medical Science, Veterinary and Science, diagnostics, Surgery, and identification.).

A61D1/00. An instrument, device, tool or veterinary method. Veterinary instruments (A61D1/00.Medical Science, Veterinary and hylene instruments, devices, tools, or Veterinary methods).

Background

In physics, a plasma is defined as a fourth state of matter. Plasma is obtained by delivering sufficient energy to a gas such that a significant portion of its molecules or atoms are ionized. There are many examples of plasma in nature, ranging from electrical discharges in arctic light and storm water to stars whose coronas (corona, suns, moon) are in this state. In addition, there are also technical examples such as plasma in a fluorescent lamp tube and a plasma screen. Thermal plasmas are those that are in thermodynamic equilibrium and are capable of transferring heat to any object in contact therewith. Thermal plasma generated by electrical discharge at atmospheric pressure has been widely used to treat tissues of human and animal patients. A device known as an "electroscalknife" uses this type of plasma and has been used in operating rooms for decades. However, they cause extensive damage to the patient's tissue, triggering blood coagulation by cauterization, with consequent cell tissue death due to the high temperature and heat transferred thereto. A negative consequence of the described method is that the recovery time of the patient is increased, since dead cells have to be eliminated by the body and replaced by healthy cells as part of the healing process. The need to implement methods to produce rapid coagulation without damaging healthy tissue has led to a series of developments based on the use of non-thermal plasma at atmospheric pressure, such as those proposed by Ximpii Lu in US 20090188626A1, Eckhard Kindel in US 20120187841A1, Gregory Konesky in US 2018085155A1, and Greg Watson in US 2016181069A1, among others. All of these inventions use low heat transfer of non-thermal plasma with other materials because they do not have thermodynamic equilibrium state as their main feature. These Plasmas are also referred to as "Cold Atmospheric Plasmas" (Cold Atmospheric Plasmas) or the acronym CAP. In addition, these non-thermal plasmas have important properties for killing bacteria and fungi, while hardly affecting the healthy tissue of the patient. This is due to differences in the cellular structure of these organisms from mammals, particularly their outer membranes. High concentrations of ions and free radicals are responsible for this selective effect, which is one of the principles that make these plasmas an emerging tool of great value in combating antibiotic-resistant bacteria. In addition to the blood coagulation described above, the second aspect of the present application opens up the field of application of non-thermal plasmas in the treatment of dermatological lesions, in particular those that convert resistant bacteria into ulcers that are present for a long period of time and therefore do not heal, due to their colonization.

The invention proposed here is an innovative device for generating cold plasma at atmospheric pressure to be used for blood coagulation, ulcer treatment and other dermatological lesion treatments. The innovations detailed in the claims are completely original and allow the proposed invention to produce a plasma with lower temperatures than the ones corresponding to the state of the art, while maintaining a great effectiveness both in blood coagulation and in the disinfection and treatment of dermatological lesions.

Disclosure of Invention

The present invention relates to an electro-medical device for blood coagulation, ulcer treatment and other dermatological lesion treatment. The key to the invention is the use of a non-thermal cold plasma of air or other gas at atmospheric pressure, which is generated by the apparatus using the original method of proving the requirements set forth herein. The present invention produces a plasma at atmospheric pressure that is not in thermodynamic equilibrium, meaning that the plasma does not transmit heat to the patient's skin, but the ions and reactive radicals present in the plasma have sufficient energy to accelerate blood coagulation, destroying the natural mechanisms of bacteria and fungi, without damaging the patient's healthy tissue.

The invention has the following features relating to its use:

a. the invention is applied to bleeding wounds, producing a very significant acceleration of the natural coagulation of the blood without damaging the healthy tissue of the patient.

b. The present invention is applied to the surface of ulcers and other dermatological lesions of a patient, eliminating a wide range of bacteria and fungi including resistant bacteria.

c. The ionized particles that are part of the plasma function without damaging healthy cells of the patient's tissue.

d. The active medium is a plasma of air or other partially ionized gas at atmospheric pressure, which is projected onto the tissue of the patient by means of a manual applicator designed for this purpose.

e. The present invention does not develop resistance in bacteria.

f. The invention has no side effect.

g. The invention does not generate waste.

h. The present invention does not use any drug.

The apparatus comprises: a high-frequency electric power generating unit; a gas injection system; an air compressor for generating a gas for plasma generation; an inert gas bottle used alone or in a mixture with air; a gas injector system; gas and electrical power transport hoses; a manual applicator for generating plasma; a gas cooling system; a gas dehumidification system; a general digital control system and a user controlled touch screen. It is noted at this point that the embodiment of the pre-treatment system for dehumidifying and cooling a gas is part of the innovation claimed herein with respect to the state of the art. In the case where air is used as the feed gas by means of an air compressor, humidity control is very important. This factor, although having a great effect, is not considered by other inventors due to the amount of oxygen contributing to the plasma from water vapor naturally contained in the air. With respect to the gas cooling system, its effect significantly changes the final temperature of the plasma jet performed by the gas injection system, whether it be air, an inert gas or a suitable mixture of the two. Both gas pretreatment systems produced very significant improvements in plasma generation repeatability, quality and stability. These factors help expand the scope of the present invention's usability and safety in both human and animal patients. Other important advances in the art are in the development of manual applicators. The system is formed by a frustoconical positive electrode which is axially perforated at its apex and faces a flat ground electrode which is also axially perforated. Between them, a high-frequency discharge is established with the energy supplied by the high-frequency generator unit to generate a gas plasma which flows between the two electrodes through the above-mentioned perforations. The positive electrode is connected to a metal flow exchanging portion whose function is to exchange the circulation of the gas flow and the electric current. In this way, the gas from the injection system is guided through the axial perforation of the positive electrode, increasing its velocity, passing through the plasma volume through its recess (sink) and exiting it through the aperture of the flat ground electrode, into an exit channel which is open to the outside and which will be described in detail later. This geometry is an innovation according to the prior art and is reflected in the claims. Other inventors have not used a truncated cone shaped hollow electrode having a hole on its axis through which gas flows at high velocity to form a plasma, but instead, other inventors used a solid electrode to establish a discharge and gas flows outside it. The advantage of this design is that a first stage of plasma cooling occurs as the gas passes through the plasma during plasma formation. Once the plasma is introduced into the hole of the flat ground electrode, the plasma begins its journey through the outlet channel to the outside. In this channel, a plasma expansion chamber system has been realized consisting of an alternating sequence of axially perforated circular disks with two different coaxial diameters. This configuration results in the diameter of the outlet channel of the manual applicator not having a constant diameter. Thus, the outlet channel alternately has two diameters: one smaller and the other larger, so that when the plasma passes through the above-mentioned passage, it encounters a volume corresponding to the disk of larger diameter where it expands, called the plasma expansion chamber. These expansion chambers produce very significant plasma cooling due to two physical effects; one of the two physical effects is its rapid expansion and the other is an increase in the guide surface relative to the constant diameter channel, which facilitates heat evacuation. The plasma expansion chamber system is a fundamental innovation that allows for a completely new second cooling stage in the prior art, significantly improving the performance of the invention as part of the claims over the prior art. The entire arrangement of the elements described above is maintained in a coaxial central position by means of a tube made of insulating material. In addition, the system is surrounded by a threaded metal housing and is fixed to the metal body of the grounded manual applicator. Finally, a removable metal sheath is achieved at the end of the applicator, which is fixed to the metal housing, making it easy to sterilize and making it replaceable for each patient, avoiding possible cross-contamination during clinical and surgical use. The metal housing, the metal body of the manual applicator and the removable metal cover all facilitate grounding, thereby ensuring safety of the operator and patient from electrical shock. Removable metal sleeves are also a recent innovation and are claimed as part of the claims.

The apparatus can be used to treat human and animal patients to significantly accelerate blood clotting without damage to healthy tissue during clinical and surgical treatments. In addition, due to the disinfecting properties of the present invention, the present invention can also be used for ulcer treatment and other dermatological injury treatments without causing damage to healthy tissue.

Drawings

To complete the description and to assist in a better understanding of the characteristics of the invention, a set of drawings is attached as an integral part of the description, in which the following are shown by way of illustration and not of limitation:

fig. 1 shows a block diagram of the invention, in which the different conceptual parts constituting the invention and the way they are connected to each other can be understood. Arrows indicate the flow of matter, energy or information, as the case may be, electricity, gas and control signals.

Fig. 2 shows a cross-sectional view of the manual applicator, in which the different parts constituting the manual applicator can be seen. The whole system has cylindrical symmetry.

Detailed Description

An embodiment of the invention is described below with the aid of fig. 1 and 2.

The proposed apparatus comprises: a high-frequency electric power generating unit (1); a gas injection system (2); an air compressor (3); an inert gas bottle (4); a transport hose (5) for gas and electric power; a manual applicator (6); a gas cooling system (7); a gas dehumidification system (8); a universal digital control system (9); a touch screen (10) for user control and a jet (11) of cold, non-hot atmospheric plasma of the gas used.

Fig. 2 shows the structure of the manual applicator in detail in a cross-sectional view. In general, the arrangement (set: set) has cylindrical symmetry, wherein the different parts making up the arrangement are coaxial. The system is formed by a positive electrode (12) of frustoconical shape perforated axially at its vertex, facing a flat ground electrode (13) also perforated axially. Between them, a high-frequency discharge is established by means of the energy supplied by the generating unit (1) through the connecting cable (14), which high-frequency discharge produces a plasma in the region indicated by the dashed circle (15) in fig. 2. The positive electrode (12) is connected to a metal flow exchanger (16) whose function is to exchange the circulation of a gas flow (17) and an electrical flow (18). In this way, the gas is guided through the axial perforation of the positive electrode (12), increasing its speed, passing through the plasma volume through its recess and being discharged through the plasma outlet orifice (19), from which the plasma jet (11) to be used for the treatment is formed. In addition, between the plasma generating region (15) and the plasma outlet orifice (19), a plasma expansion chamber system (20) has been realized, which consists of an alternating sequence of axially perforated circular disks with two different coaxial diameters. This arrangement results in the diameter of the outlet passage which communicates the region (15) where the plasma is generated with its plasma outlet orifice (19) not having a constant diameter. Instead, the outlet channels alternately have two diameters: one smaller and one larger so that as the plasma passes through the passage, it encounters a volume corresponding to the larger diameter disk where it expands, referred to as the plasma expansion chamber. The entire arrangement of the elements described above is maintained in a coaxial central position by means of tubes (21), (22) and (23) made of insulating material. Furthermore, the system is surrounded by a metal housing (24) which is screwed and fixed to a metal body (25) of the grounded manual applicator. Finally, a removable metal cover (26) is achieved, which is fixed on the metal casing (24) so as to make it easy to sterilize and to be replaced for each patient, avoiding possible cross-contamination during clinical and surgical use. The metal housing (24), the metal body (25) of the manual applicator and the removable metal sleeve (26) are all conveniently connected to the ground, ensuring safety of the operator and the patient with respect to electric shocks.

Once the gas flow (17) from the gas injection system (2) is established, it is treated by the gas pre-treatment systems (7) and (8), entering the transport hose (5) and advancing towards the manual applicator (6). After a prescribed time to reach suitable humidity and temperature conditions in the gas, the high frequency electric energy generating unit (1) is activated, generating a plasma in the manual applicator (6) in a region (15) corresponding to the free volume between the axially perforated frusto-conical positive electrode (12) and the axially perforated flat ground electrode (13). The plasma is cooled and driven towards the outlet port (19) of the manual applicator (6) by a structure of alternating coaxial annuli of two different diameters forming a plasma expansion chamber system (20). As the plasma passes through this structure, it undergoes a second cooling, eventually emerging through the outlet orifice (19). From the moment when the plasma exit is observed at the end of the manual applicator (6), the operator can use the system by applying a plasma jet (11) on the surface of the lesion or wound to be treated.