• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
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  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Device that allows to reproduce clinical applications of electrolysis using needles, effectively separating the cathodic (therapeutic) effects from those produced at the anode. The device has a needle-holder frame that slides with respect to a base which includes receptacles with ceramic filters and with a thread in its lower part to screw in a metal screw. The device allows controlled tests on different microorganisms, cells or tissues, simulating specific clinical conditions with the use of different types of needles. Its use not only facilitates the investigation of the properties and the mechanisms of action of this type of currents, but also its development as a therapeutic alternative to common health problems in other fields such as oncology (in tumors such as melanoma), dermatology (hidradenitis suppurativa), aesthetic medicine (scars and wrinkles) and nursing (wounds). (Machine-translation by Google Translate, not legally binding)
    公开号:ES2793098A1
    申请号:ES202031032
    申请日:2020-10-13
    公开日:2020-11-12
    发明作者:Vidal José Antonio García；Mirapeix Francesc Medina；Reina María Pilar Escolar；Mestre Juan De Dios Berná
    申请人:Universidad de Murcia；
    IPC主号:
    专利说明:

    [0004] TECHNICAL SECTOR
    [0006] The present invention is framed in the field of health and health, more specifically in the field of medical technologies intended for in vitro investigation of the effects of galvanic currents applied to human beings.
    [0008] BACKGROUND OF THE INVENTION
    [0010] Percutaneous electrolysis consists of the application of a high intensity galvanic direct current through a needle. This current produces a local non-thermal electrolytic ablation (Sanchez-Ibañez JM., 2013) by cathodic flow (the needle acts as a negative pole or cathode). This reaction causes a dissociation of the constituent elements of the molecules of Water (H2O) and Sodium Chloride (NaCl), migrating to the cathode the Na + ion, which will react with the H2O, forming sodium hydroxide (NaOH) and H +. These caustic products generate a change in local pH (alkaline medium), being one of those responsible for its germicidal and bactericidal effect (Valera F., 2013).
    [0012] This technique, created and currently used by physiotherapists, has demonstrated its effectiveness in pathologies that present with chronic inflammation, such as patellar tendinopathy (Abat F. et al, 2014) achylic tendinopathy (Sánchez-Ibáñez JM. Et al, 2015), subacromial syndrome and epicondylalgia (Valera-Garrido F. et al, 2013).
    [0014] Although its therapeutic effectiveness has been demonstrated, questions remain about the mechanisms of action of this type of currents since many of them remain theoretical and extrapolated from physics. Thus, more basic research is needed in environments that simulate clinical settings. The technical difficulties generated by the application of galvanic current in classic culture wells has impeded the advancement of research in this field, basically due to its dimensions and the anode and cathode have been placed in the same medium. As a consequence, it has not yet been possible to demonstrate basic issues such as its bactericidal effect, its ability to produce changes in the pH of the medium, the radius of action that each application reaches due to the “peak effect” or if the effect depends on the dimensions or the amount of needle inserted.
    [0016] An "in vitro" model is necessary to reproduce clinical conditions and allow the development of this technique and new applications related to it.
    [0018] DESCRIPTION OF THE INVENTION
    [0020] The invention consists of a device whose objective is to replicate the clinical conditions of application of electrolysis using needles in vitro, effectively separating the cathodic (therapeutic) effects from those produced at the anode. It allows to carry out controlled tests on different microorganisms, cells or tissues, simulating specific clinical conditions with the use of different types of needles.
    [0022] The device is composed of two main elements: a needle holder frame and a base. Both have one or more cylindrical through holes, so that the cylindrical holes in the base appear as receptacles. Thus, the cylindrical holes of the needle-holder frame and the receptacles of the base are through, each cylindrical hole being positioned on the same axis as each receptacle, being equidistant from each other and each hole and receptacle being positioned on the same axis. The number and diameter of the holes may vary depending on the nature of the experiments to be carried out and the type of needles to be used.
    [0024] Each hole in the frame is intended to support a needle, each one acting as a cathode in the in vitro needle electrolysis process. The frame can move perpendicularly on the base through its vertical movement, making use of both guide rods, preferably metallic. The displacement of the frame through the guide rods is achieved thanks to two connection elements, preferably metallic, which are inserted in the sides of the frame in two holes made to accommodate them and into which the guide rods are inserted. which are removable from the entire device. These connecting elements move along the guide rods, thus achieving the displacement of the frame on the base. This movement of the frame on the base can be braked or released at any point along the path by mechanically tightening or loosening the respective fixing means, preferably made up of metal stud bolts, located on both sides of the frame, with which it is also possible to control the length of the needle inserted into the receptacles containing the samples to be analyzed. The metallic character of the fixing means allows a better tightening against the guide rods without causing damage. As an alternative to the grub screws, any other mechanical system could be used that allows activating or slowing the movement of the frame on the base. The upper part of the base has connection elements on each of its sides, preferably another inserted bushing, having the task of accommodating the guide rods, ensuring that they remain anchored to the needle-holder frame, tightening the fixing means. thus avoiding any type of oscillation.
    [0026] In this invention, both the guide rods and the connection elements are preferably made of metal to achieve a sliding fit between them that guarantees concentricity and that it is not lost with the wear caused by the use of another softer material.
    [0028] The main function of the holes as receptacles in the base is to allow an independent space, destined to house inside a liquid culture medium for cells, microorganisms or tissues to be analyzed. The receptacles are capable of isolating the cathodic effects of the galvanic current applied and have a narrowing in their intermediate part that allows the coupling of a ceramic filter. Each receptacle has in its lower part a thread to mechanically screw in a metal screw with an O-ring made of flexible material to guarantee the tightness between the screw and the base. Achieving this tightness is essential to prevent the liquid medium contained in the receptacles between the screw and the base from leaking out. These metal screws are connected to an external electrolysis equipment (galvanic current generator with European conformity marker) and act as an anode in the in vitro galvanic electrolysis procedure.
    [0030] Once the needles have been arranged in the frame and the culture medium prepared in the receptacles, the frame is lowered so that the needles, connected in turn by a metal handle to the needle-holder handle of an external electrolysis equipment that generates the galvanic current, penetrate the receptacles of the base for the desired length without touching the ceramic filter, to then pass a galvanic current of intensity and determined duration between the cathode (needle) and the corresponding anode (coated screw), through the liquid medium.
    [0032] Once the test is carried out, the culture medium is extracted and analyzed to see the results of the current on it.
    [0034] This device provides several advantages over the state of the art. First of all, it allows the tests to be carried out in a reduced space, taking advantage of the possibility of having several receptacles. Second, both the metal screws and the ceramic filter allow the cathodic effects (negative pole) to be efficiently isolated in the same medium from the anodic effects (positive pole). This avoids contamination by the Red-Ox effect, as occurs in therapeutic applications in patients. Furthermore, it allows studying the "peak effect" of the application of galvanic current with a needle, under the control of variables such as the amount of needle inserted and its width.
    [0036] BRIEF DESCRIPTION OF THE DRAWINGS
    [0038] To complement the description that is going to be made below and in order to help a better understanding of the characteristics of the invention, according to a preferred example of a practical embodiment thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:
    [0040] Figure 1 shows an assembly view of the device for the in vitro application of electrolysis using needles carried out according to a preferred embodiment of the object of the present invention.
    [0042] Figure 2 shows a front view of the device of the invention represented in the previous figure, including a detailed view of some elements that make up the device.
    [0043] Figure 3 shows a perspective representation of the device according to the preferred embodiment of the invention, where the needle-holder frame is positioned away from the base, a needle being represented.
    [0045] Figure 4 shows a perspective representation of the device according to the preferred embodiment of the invention, where the needle-holder frame is positioned close to the base, the needle being inserted into a receptacle of the base.
    [0047] REFERENCES
    [0049] 1. Needle holder frame.
    [0050] 2. Connection element.
    [0051] 3. Fixing means.
    [0052] 4. Guide rod.
    [0053] 5. Base.
    [0054] 6. Connection element.
    [0055] 7. Ceramic filter.
    [0056] 8. O-ring.
    [0057] 9. Metal screw.
    [0058] 10. Receptacle.
    [0059] 10 '. Receptacle narrowing
    [0060] 10 ''. Receptacle thread
    [0061] 11. Holes in the needle holder frame.
    [0062] 12. Needle
    [0064] PREFERRED EMBODIMENT OF THE INVENTION
    [0066] According to the figures outlined, the device of the invention is integrated according to the preferred embodiment of the invention the following elements:
    [0068] - A needle-holder frame (1), which has a plurality of cylindrical holes (11) to receive a needle (12) in each one, the needle-holder frame (1) being provided on each of its sides with an element connection (2).
    [0069] - A base (5), which has a plurality of cylindrical holes as receptacles (10) to receive the sample to be analyzed, the base (5) being provided on each of its sides with a connection element (6).
    [0070] - Two guide rods (4), which are coupled at one end to the connection elements (2) of the base (5) and which are coupled to the connection elements (2) of the needle-holder frame at the other end (1).
    [0071] - Fixing means (3) located on the sides of the needle holder frame (1) to brake and / or release the movement of the needle holder frame (1) along the guide rods (4),
    [0073] Preferably, the number of receptacles (10) of the base (5) is the same as the number of cylindrical holes (11) of the needle-holder frame (1), so that each needle (12) is inserted into a hole ( 11) of the needle-holder frame (1) and faces a receptacle (10) of the base (5) fully aligned with it.
    [0075] In the base (5) the connection elements (6) are pressed, preferably made up of bushings and on these, also under pressure, the guide rods (4) to achieve their fixation.
    [0077] As can be seen in the detail of figure 2, each receptacle (10) of the base (5) has a thread (10 '') in its lower part and a narrowing (10 ') in its intermediate part. Thus, in each receptacle (10) a ceramic filter (7) is inserted through the upper part, remaining engaged by the narrowing (10 ') of the receptacle, that is, the ceramic filter moves along the receptacle (10) until it meets its narrowing (10 '). Preferably, the ceramic filter (7) is fixed and fitted by pressure on the constriction (10 ') of the receptacle (10).
    [0079] On the other hand, each receptacle (10) has a thread (10 '') in its lower part, into which a metal screw (9) is mechanically screwed, associated with an O-ring (8) to ensure tightness.
    [0081] On the other hand, some connection means (2), preferably bushings, are pressed into the needle-holder frame (1) and the fixing means (3), preferably set screws, are screwed into the two side holes of the frame needle holder (1), as seen in figures 1 and 2.
    [0082] Next, the needle-holder frame (1) is inserted through the connection means (2) in the guide rods (4) and the device of the invention is ready to start the test, which will be carried out carried out by applying the following steps:
    [0084] a) Sterilization of the assembly at a temperature below 50 ° C.
    [0085] b) Filling each receptacle (10) of the base (5) with a sample of corresponding cells, microorganisms or tissues. As many receptacles (10) as samples to be tested will be filled.
    [0086] c) Placing each needle (12) on the hole (11) of the needle-holder frame (1). As many needles (12) as receptacles (10) filled with samples to be tested will be used.
    [0087] d) Movement of the needle-holder frame (1) on the base (5) until each needle (12) penetrates the receptacles (10) to the desired length as shown in Figures 3 and 4.
    [0088] e) Anchoring the needle-holder frame (1) on the guide rods (4), by means of the fixing means (3), preferably by tightening some set screws. f) Connection of the cathode of an electrolysis equipment to one of the needles (12). g) Connection of the anode of the electrolysis equipment to the corresponding metal screw (9) of the base (5).
    [0089] h) Supply of galvanic current of intensity and duration determined by the electrolysis equipment between the cathode and the anode through the sample in liquid medium.
    [0090] i) Repeat steps f), g) and h) for all receptacles (10).
    [0091] j) Extraction of the samples from the upper part of the receptacles (10) of the base (5) and their analysis to determine the effects produced by the galvanic current applied.
    [0093] The two main elements that make up the device, the needle-holder frame (1) and the base (5), are 3D printed in a biocompatible material, preferably in a biocompatible plastic material. The chosen material will be certified to be in contact with the skin for up to 30 days and with mucous membranes for up to 24 hours without interruption, which will not alter the cell or tissue samples at all; It is non-conductive and transparent, so it will not interfere with the transmission of galvanic current through the culture medium and will also allow the naked eye to see any significant change in color and / or color. state of the samples during the experiment.
    [0095] The only drawback of the biocompatible plastic material is that it can deform above 50 ° C, so sterilization of the device before each experiment must be carried out at low temperatures, recommending a system that uses hydrogen peroxide plasma.
    [0097] Precisely for the latter, the rest of the metal components such as the connection elements (2), (6), the fixing means (3), the metal screws (9) and the guide rods (4) are preferably made of stainless steel. to avoid deterioration that could cause contamination of the samples by the action of hydrogen peroxide.
    [0099] Below the ceramic filter, an Oxidation-Reduction reaction occurs as the current passes through the metal screw (9) at the bottom of the base (5).
    [0101] Advantageously, to avoid contamination of the sample by the Red-Ox effect, a platinum coating has been applied to each metal screw (9) using the sputtering technique called "sputtering" that complements the action of the filter (7). Optionally, and for the same purpose, the metal screw (9) is made of platinum.
    权利要求:
    Claims (3)
    [1]
    1§.- Device for the in vitro application of electrolysis using needles comprising:
    - A needle-holder frame (1), which has one or more cylindrical holes (11) to receive a needle (12) in each one, the needle-holder frame (1) being provided on each of its sides with an element connection (2).
    - A base (5), which has one or more cylindrical holes as receptacles (10) to receive the sample to be analyzed, the base (5) being provided on each of its sides with a connection element (6).
    - Two guide rods (4), which are coupled at one end to the connection elements (2) of the base (5) and which are coupled to the connection elements (2) of the needle-holder frame at the other end (1).
    - Fixing means (3) located on the sides of the needle holder frame (1) to brake and / or release the movement of the needle holder frame (1) along the guide rods (4),
    Characterized because
    Each receptacle (10) has in its lower part a thread (10 '') into which a metal screw (9) with an O-ring (8) is mechanically screwed, while each receptacle has a narrowing (10 '), so that a ceramic filter (7) is coupled to the receptacle (10) of the base (5) by means of the narrowing (10').
    [2]
    2§.- Device for the in vitro application of electrolysis using needles according to claim 1, characterized in that the cylindrical holes (11) of the needle-holder frame (1) and the receptacles (10) of the base (5) are through, leaving each cylindrical hole (11) positioned on the same axis as each receptacle (10), being equidistant from each other and each hole and receptacle being positioned on the same axis.
    [3]
    3§.- Device for the in vitro application of electrolysis using needles according to claim 1, characterized in that the number of receptacles (10) of the base (5) is the same as the number of cylindrical holes (11) of the needle-holder frame (1).
    4- .- Device for the in vitro application of electrolysis using needles according to claim 1, characterized in that the metal screw (9) is made of platinum or is covered by a platinum coating.
    5- .- Device for the in vitro application of electrolysis by needles according to previous claims characterized in that the needle-holder frame (1) and the base (5) are made of a biocompatible material.
    6- .- Device for the in vitro application of electrolysis using needles according to claim 5, where the material is a biocompatible plastic material.
    7- .- Device for the in vitro application of electrolysis using needles according to claim 1 characterized in that the ceramic filter (7) is coupled by pressure on the narrowing (10 ') of the receptacle (10).
    8- .- Device for the in vitro application of electrolysis using needles according to claim 1 characterized in that the connection elements (2), (6), the fixing means (3) and the guide rods (4) are made of metal .
    9.- Device for the in vitro application of electrolysis using needles according to claim 7, characterized in that the metal of the connection elements (2), (6), the fixing means (3), the metal screws (9) and the guide rods (4) are stainless steel.
    10.- Device for the in vitro application of electrolysis using needles according to any of the preceding claims, characterized in that the fixing means (3) are made up of set screws.
    11.- Device for the in vitro application of electrolysis using needles according to any of the previous claims, characterized in that the connection elements (2), (6) are made up of bushings.
    12.- Procedure for the in vitro application of electrolysis by needles using the device of claims 1-11 characterized by being carried out according to the following steps:
    - Sterilization of the device at a temperature below 50 ° C.
    - Filling each receptacle (10) of the base (5) with a sample in liquid medium of cells, microorganisms or tissues to be analyzed.
    - Placing each needle (12) on the hole (11) of the needle holder frame (1).
    - Displacement of the needle holder frame (1) with respect to the base (5) on the guide rods (4) until each needle (12) penetrates the receptacle (10) in the desired length.
    - Locking the position of the needle-holder frame (1) on the guide rods (4) by means of the fixing elements (3).
    - Connection of the cathode of an electrolysis equipment to a needle (12).
    - Connection of the anode of the electrolysis equipment to the corresponding metal screw (9) of the base (5).
    - Supply of galvanic current by the electrolysis equipment between the cathode and the anode through the sample in liquid medium.
    - Extraction of the sample in liquid medium analyzed from the receptacle (10) of the base (5) and analysis to determine the effects produced by the galvanic current applied.
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    法律状态:
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