WO2020257897A1

WO2020257897A1 - Electroporation application tip for electrochemotherapy procedure

Info

Publication number: WO2020257897A1
Application number: PCT/BR2020/050198
Authority: WO
Inventors: Carlos Henrique MACIEL BRUNNER
Original assignee: Eqt Equipamentos E Tecnologia Ltda.
Priority date: 2019-06-28
Filing date: 2020-06-03
Publication date: 2020-12-30
Also published as: BR102019013578A2

Abstract

The present invention refers to an electroporation applicator tip (16) that comprises at least two sets (F1, F2) electroporation needles (162), each set (F1, F2) containing at least two electroporation needles (162) that delimit a geometric area of application of electrical pulses, in which each set (F1, F2) of at least two electroporation needles (162) is mounted on an electrical connector (C1, C2), the at least two sets (F1, F2) having opposite polarities, the applicator tip (16) of the present invention delimiting a geometric treatment area for electroporation action, preventing electrical pulses from affecting areas adjacent to the area bounded by electroporation needles (162), avoiding the waste of energy load in areas that do not require treatment and that should not be subjected to any influence of electrical fields.

Description

Specification of the Patent of Invention for "ELECTROPORATION APPLICATION TIP FOR ELECTROCHEMOTHERAPY PROCEDURE".

[001 ] The present invention refers to an electroporation applicator tip particularly used with electroporation application equipment for electrochemotherapy procedures.

Description of the State of The Art

[002] As is known from the state of the art, the effectiveness of an electrochemotherapy procedure occurs through the electroporation of living tissues, through the application of electrical pulses at the site, together with the availability of as many molecules as possible in the chemotherapy drug at the same site.

[003] Currently, the procedure in question occurs such that the drug is injected at the site to be treated intratumorally or applied by sys- temic venous route, using a hypodermic syringe before, during or after electroporation. The electrical pulses required for electroporation are calibrated in a console, manually, and applied to all tissues, whether of different electrical resistances or not, thus receiving the same energy load. In this case, there is a reduction in the effectiveness of the drug, requiring higher injection volumes, requiring a measurement of the tumor and calculation of its volume in order to calculate the volume of drug to be injected.

[004] To exemplify the state of the art, it is possible to cite document PI0312459-2 which presents a device for injecting substances into tissues and, preferably, to application by electroporation, that is, the procedure of introducing substances into cells during or after the application of an electrical field.

[005] The device disclosed in document PI0312459-2 comprises means for applying an electrical voltage to a needle, allowing the needle to be used not only for drug injection, but also as an electrode during electroporation, the electrical field being applied in the same area of the injected substance. In this sense, both the volume of injected substance and the size of the electrical field can be reduced, while a satisfactory adjustment between the electrical field and the substance is achieved.

[006] Although the device of document PI0312459-2 describes the possibility of injecting a drug during the application of an electrical field, it is observed that the device in question is not able to delimit a treatment area for electroporation action, such that electrical pulses affect areas adjacent to the treated area, wasting energy load in areas that do not require treatment and that, in theory, should not be subjected to any influence of electrical fields.

Objectives of the Invention

[007] The objective of the present invention is to provide an electroporation application tip endowed with at least two pairs of needles for the application of electrical pulses, delimiting a geometric area of action of the electrical field for electrochemotherapy treatment. The delimitation of the area of operation of the electrical field enables greater effectiveness of electroporation to be achieved, consequently, making it possible to reduce the amount of drug used, due to the high efficiency of the application of electrical pulses.

[008] The present invention is intended to perform electroporation in specifically designated and delimited areas, whether for medical or aesthetic or veterinary use, designed to reduce the risk of contamination of the hospital environment by chemotherapy drugs, since it reduces the volume of drug needed for treatment, reducing the chances of systemic adverse effects and enabling the electrochemotherapy procedure to be performed in a laboratory environment.

Brief Description of invention

[009] The objectives of the present invention are achieved by an electroporation application tip comprising at least two sets of electroporation needles, each set containing at least two electroporation needles that delimit a geometric area of application of electrical pulses, in which each set of at least two electroporation needles is mounted on an electrical connector, the at least two sets having opposite polarities, the at least two electroporation needles provided in each set being arranged in a row, the sets being parallel aligned delimiting a rectangular geometric area of application of electrical pulses, a central spacing being provided between the sets of at least 1 mm, the central spacing ranging between 2 mm and 20 mm.

[0010] The objectives of the present invention are also achieved by an applicator tip endowed with at least six electroporation needles provided in at least two sets containing three electroporation needles in each set, the sets being parallel aligned delimiting a rectangular geometric area of application of electrical pulses.

Brief Description of the Drawings

[001 1] The present invention will now be described in more detail based on an example of execution represented in the drawings. The drawings show:

Figure 1 - a first view in a top perspective of the applicator tip of the present invention;

Figure 2 - a second view in a top perspective of the applicator tip of the present invention;

Figure 3 - a first view in a bottom perspective of the applicator tip of the present invention;

Figure 4 - a second view in a bottom perspective of the applicator tip of the present invention;

Figure 5 - a perspective cutaway view of the applicator tip of the present invention;

Figure 6 - a bottom perspective view of the end of an applicator device showing the assembly of the applicator tip of the present invention; and:

[0012] Figure 7 - a front perspective view of the tip of an applicator device showing the establishment of electrical contact between electrical terminals provided at the end of the applicator device and the electrical connectors provided in the body of the applicator tip of the present in- vention.

Detailed Description of Drawings

[0013] Figures 1 to 7 illustrate an example of execution of the object of the present invention. The applicator tip 16, as illustrated in figures 1 and 2, refers to a component for electroporation application in an elec- trochemotherapy procedure and which has, among other parts, a body 161 substantially trunk-conical in shape and which is endowed with multiple electroporation needles 162 that have the function of applying electrical pulses to the patient's living tissues. The body 161 can take on other formats, such as cubic, cylindrical, trapezoidal, without the body shape limiting in any way the protection of the applicator tip 16.

[0014] In a first example of execution of the present invention, the applicator tip 16 comprises at least two sets F1 , F2 containing at least two electroporation needles 162 in each set F1 , F2. The two electroporation needles 162 provided in each set F1 , F2 are arranged in a row, the sets F1 , F2 being parallel aligned to delimit a rectangular geometric area. It should be noted that at least two, or at least three, or at least four, or as many sets F1 , F2 of electroporation needles are required, the sets F1 , F2 always being arranged to form a geometric area of electrical field application, be it a rectangular, square, triangular, pentagonal, hex- agonal, or other desired geometric shape, provided that each set F1 , F2 contains at least two electroporation needles 162.

[0015] The two electroporation needles 162, provided in each of the sets F1 , F2, are joined by an electrical connector C1 , C2 that gives them the same polarity, such that the two sets F1 , F2 of electroporation nee- dies 162 have opposite polarities. The body 161 of the applicator tip 16 is injected with the electrical connectors C1 , C2 and the electroporation needles 162.

[0016] Additionally, a central spacing is provided between the sets F1 , F2 of two electroporation needles162, this spacing being at least 1 mm and ranging between 2 mm and 20 mm, or between 5 mm and 15 mm, preferably equal to 7 mm. The spacing between the sets F1 , F2 of electroporation needles 162 may vary according to design and need.

[0017] In an example of preferential execution of the present invention, the applicator tip 16 comprises at least two sets F , F2' containing at least three electroporation needles 162 in each set FT, F2'. The three electroporation needles 162 provided in each set FT, F2' are arranged in a row, the sets FT, F2' being parallel aligned to delimit a rectangular geometric area. It should be noted that at least two, or at least three, or at least four can be provided, or as many sets FT, F2' of electroporation needles as required, the sets FT, F2' always being arranged to form a geometric area of electrical field application, be it a rectangular, square, triangular, pentagonal, hexagonal area, or other desired geometric shape.

[0018] The three electroporation needles 162, provided in each of the sets FT, F2', are joined by an electrical connector CT, C2' which gives them the same polarity, such that the two sets FT, F2' of electroporation needles 162 have opposite polarities. The body 161 of the applicator tip 16 is injected with the electrical connectors CT, C2' and the electroporation needles 162.

[0019] Each of the 162 electroporation needles is solid, made of surgical grade stainless steel, with conical tip, 0.35 mm thick and 15 mm long. It should be noted that electroporation needles 162 can be made of other materials, with different thickness and length, such that the use of the applicator tip 16 is not limited to the parameters of shape and size of the electroporation needles 162.

[0020] The electroporation needles 162 are set on the body 161 of the applicator tip 16, such that they extend out of body 161 in a longitudinal direction.

[0021] As illustrated in figures 2 to 4, the body 161 is endowed with an opening 163 provided from the outer diameter to the center of the body 161 , in a crosswise direction, and extending along the entire length of the body 161 , in a longitudinal direction. The opening 163 is arranged in a central region between the two sets FT, F2' of electroporation needles 162 for fitting an injection needle 154. Thus, the applicator tip 16 can be fitted into a drug applicator and electroporation device on an injection needle 154, without interfering with the use of the desired injection needle 154. Figure 6 illustrates the applicator tip 16 associated with an applicator device, with the injection needle 154 arranged in the opening 163.

[0022] Additionally, a central spacing is provided between the sets

FT, F2' of electroporation needles 162, the spacing being at least 1 mm and ranging between 2 mm and 20 mm, or between 5 mm and 15 mm, preferably equal to 7 mm. The spacing between sets FT, F2' of needles 162 may vary according to design and need.

[0023] Additionally, the applicator tip 16 comprises a protective cover 164 integrated into the body 161 , which protects the electroporation needles 162. The protective cover 164 belongs to the same plastic set for injection into the production mold. The protective cover 164 comprises a semi-cylindrical shape with flaps 164', 164" supporting sides that facilitate the removal of the protective cover 164 at the time of treatment application. Between the protective cover 164 and the body 161 , a small groove is provided to allow the breakage and removal of the cover 164, exposing the electroporation needles 162. In this sense, there is no risk of possible operation accident, because the professional is protected from the injection needle 154 by the protective cover 164 of the electroporation needles 162 during the entire preparation procedure of the applicator device.

[0024] As illustrated in Figure 7, the electrical connectors C1 \ C2' are associated with electrical terminals T1 , T2 provided in an applicator device, establishing electrical contact between the electroporation applicator tip 16 and the applicator device.

[0025] The applicator tip 16 works such that a drug applicator and electroporation device, whatever the device, emits an electrical pulse, previously calibrated and having known parameters, to a first set F1 of electroporation needles 162 and measures the energy captured by the second set F2 of electroporation needles, enabling the electrical impedance of the living tissue in the insertion region of the applicator tip 16 to be calculated.

[0026] The electroporation electrical field is generated in the central spacing between the two sets FT, F2' of electroporation needles 162, restricting an area of action of the electrical pulses.

[0027] As an example, imagining that one wishes to electropore a tumor 5 centimeters long by 2 centimeters wide, therefore, with 10 square centimeters (cm²) of area. Considering a central spacing be- tween the sets CT, C2' of 7 mm electroporation needles 162 (0.7 centimeter) with a length of each set CT, C2' of 3 centimeters, that is, the electroporation needles 162, when lined up, being evenly spaced with a distance of 3 centimeters measured between the electroporation needles 162 disposed at the ends of the row, such that a rectangular geo- metric area of electroporation of 2.1 cm² is formed. In this case, to cover the 10 cm² of tumor area, it will be necessary to apply in 5 distinct points of 2 cm² each, covering the entire tumor area. In this sense, the operator can insert the applicator tip 16 at different points to cover the entire tumor area by applying a drug simultaneously to electroporation.

[0028] Particularly in clinical use, the attention of the professional to the procedure is indispensable, beginning the application from an initial point and applying to the other points in a sequence to cover the entire area of interest. It is of paramount importance, however, that the application points do not overlap, because at the time of application there is no significant visual alteration of the tissue, which reinforces the need for the professional to be attentive.

[0029] Thus, the applicator tip 16 of the present invention delimits a geometric treatment area for electroporation action, preventing electrical pulses from affecting areas adjacent to the area bounded by electro- poration needles 162, avoiding the waste of energy load in areas that do not require treatment and should not be subjected to any influence of electrical fields.

[0030] Having described one example of a preferred embodiment, it should be understood that the scope of the present invention covers other possible variations, being limited only by the content of the accompanying claims, potential equivalents being included therein.

Claims

1. An electroporation applicator tip (16), characterized by the fact that it comprises at least two sets (F 1 , F2) of electroporation needles (162), each set (F1 , F2) containing at least two electroporation needles (162) that delimit a geometric area of application of electrical pulses, wherein each set (F1 , F2) of at least two electroporation needles (162) is mounted on an electrical connector (C1 , C2), at least two sets (F1 , F2) having opposite polarities.

2. The electroporation applicator tip (16) according to claim 1 , characterized by the fact that the at least two electroporation needles

(162) provided in each set (F1 , F2) are arranged in a row, the sets (F1 , F2) being parallel aligned delimiting a rectangular geometric area of application of electrical pulses.

3. The applicator tip (16) according to claim 2, characterized by the fact that a central spacing between the sets (F1 , F2) of at least 1 mm is provided.

4. The applicator tip (16) according to claim 2, characterized by the fact that a central spacing is provided between the sets (F1 , F2) varying between 2 mm and 20 mm.

5. The applicator tip (16) according to claim 1 , characterized by the fact that it is endowed with at least six electroporation needles (162) provided in at least two sets (FT, F2') containing three electroporation needles (162) in each set, the sets (FT, F2') being aligned in parallel, delimiting a rectangular geometric area of application of electri- cal pulses.