Electroporation therapeutic apparatus

Abstract

The utility model provides an electroporation therapeutic instrument, which relates to the technical field of medical instruments and comprises a driving component and an electroporation component connected with the driving component. Wherein the electroporation assembly comprises a base and an electrode needle array; the electrode needle array is connected with the driving assembly through the base; the electrode needle array comprises electrode needles; the electrode needle is a hollow needle; a medicine channel communicated with the electrode needle array is arranged in the base; and a Luer taper communicated with the medicine channel is arranged on the base. According to the electroporation therapeutic apparatus provided by the utility model, the electrode needle is of a hollow structure, and the base is provided with the medicine channel and the Luer taper which are communicated with the electrode needle, so that medicine delivery can be realized while electroporation therapy is carried out, the two steps are combined into one step, the operation steps are simplified, and the cost is reduced. And the accuracy of a medicine conveying position and an electric penetration treatment position can be ensured, and the treatment effect is improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment, in particular to an electroporation therapeutic apparatus. Background Art

[0002] When a high-amplitude, short-duration pulsed electric field acts on cells and tissues, the permeability of cell membranes and tissues increases. This increase in permeability is interpreted as the temporary appearance of water pores in the cell membrane, a phenomenon known as electroporation. Depending on whether the cell membrane can recover after opening, electroporation can be divided into irreversible electroporation and reversible electroporation. Among them, reversible electroporation refers to the ability to recover after the cell membrane is opened. Electroporation temporarily increases the permeability of the cell membrane, which helps molecules that could only pass through the cell membrane in small quantities to penetrate more efficiently. Based on this principle, reversible electroporation is often combined with drug therapy to improve the efficiency of drug delivery.

[0003] With the evolution of the times and the increasing pursuit of beauty, people often feel anxious about wrinkles and signs of aging on their skin, and the demand for cosmetic skin rejuvenation is gradually increasing. In addition, some skin diseases such as keloids and melanoma also cause troubles for patients. The continuous development of electroporation technology has gradually matured its application on the skin. Because the skin has a barrier function, it only allows substances with a small molecular weight (<500Da), which have balanced lipophilicity and are soluble in oil and water, to penetrate from the epidermis into the dermis, which limits the skin's absorption and utilization of whitening and anti-aging substances. Based on the principle of electroporation, reversible electroporation is an effective active energy-driven method that helps to improve the effect of transdermal drug delivery.

[0004] At present, when electroporation is applied on the skin, reversible electroporation is more often used in combination with drug therapy to assist the skin in absorbing drugs. In the electroporation currently used for skin treatment, it is usually necessary to first inject the drug into the corresponding position of the skin through a syringe, and then use the electroporation treatment device to perform electroporation on the skin at the injection site, which is cumbersome. Utility Model Content

[0005] In order to solve the problem of complicated operation of electroporation therapeutic apparatus in the prior art, the utility model provides an electroporation therapeutic apparatus. The electroporation therapeutic apparatus introduces a hollow electrode needle array and a drug channel connected to the hollow electrode needle array, so that the electroporation therapeutic apparatus can achieve drug delivery while performing electroporation, thereby simplifying the operation process of the electroporation therapeutic apparatus and solving the problem of complicated operation of electroporation therapeutic apparatus in the prior art.

[0006] The technical solution adopted by the utility model to solve its technical problems is:

[0007] An electroporation therapeutic apparatus comprises a driving component and an electroporation component connected to the driving component; wherein:

[0008] The electroporation assembly includes a base and an electrode needle array;

[0009] The electrode needle array is connected to the driving assembly through the base;

[0010] The electrode needle array comprises electrode needles;

[0011] The electrode needle is a hollow needle;

[0012] The base is provided with a drug channel communicating with the electrode needle array;

[0013] The base is provided with a Luer connector which is in communication with the drug channel.

[0014] Optionally, the top end of the electrode needle has a beveled structure.

[0015] Optionally, the angle of the beveled structure is 15°-40°.

[0016] Optionally, the electroporation assembly further comprises an outer baffle; the outer baffle is provided with at least two mounting grooves of different heights; and the base is provided with fixing buckles matched with the mounting grooves.

[0017] Optionally, the drive assembly includes a pulse generator electrically connected to the electroporation assembly.

[0018] Optionally, the pulse generator is a piezoelectric body.

[0019] Optionally, the driving component also includes a pressing component electrically connected to the pulse generator.

[0020] Optionally, the pressing assembly includes a shell and a pressing device arranged in the shell.

[0021] Optionally, the pressing device is an automatic pressing device.

[0022] Optionally, an operation hole is provided on the shell.

[0023] The beneficial effects of the utility model are:

[0024] The electroporation therapeutic apparatus provided by the utility model can realize drug delivery while performing electroporation treatment by setting the electrode needle as a hollow structure and arranging a drug channel and a Luer connector communicated with the electrode needle on the base, thereby combining the two steps into one. While simplifying the operating steps, it can also ensure the accuracy of the drug delivery position and the electroporation treatment position, thereby improving the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The utility model is further described below in conjunction with the accompanying drawings and embodiments.

[0026] Figure 1 This is a simplified structural diagram of the electroporation therapeutic apparatus in the utility model;

[0027] Figure 2 It is a simplified structural diagram of the electrode needle array in the utility model;

[0028] Figure 3 It is a schematic diagram of the bottom structure of the base in the utility model.

[0029] In the figure: 1-driving assembly; 11-pulse generator; 12-pressing assembly; 121-housing; 1211-operating hole; 122-pressing device; 2-electroporation assembly; 21-base; 211-drug channel; 212-Luer connector; 213-fixing buckle; 22-electrode needle array; 221-electrode needle; 23-outer baffle; 231-installation slot. DETAILED DESCRIPTION

[0030] The present utility model is now further described in detail. The embodiments described below are exemplary and intended to be used to explain the present utility model, but cannot be understood as limiting the present utility model. Based on the embodiments of the present utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present utility model.

[0031] In the description of the present utility model, it should be understood that the terms "first" and "second" are only used to simplify the description, and cannot be understood as indicating or implying relative importance, or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present utility model, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0032] In the present utility model, unless otherwise clearly stipulated and limited, a first feature being "above" or "below" the first feature may include that the first feature is in direct contact with the second feature, or may include that the first feature and the second feature are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" the second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" the second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0033] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0034] In order to solve the problem of complicated operation of electroporation therapeutic apparatus in the prior art, the utility model provides an electroporation therapeutic apparatus, see Figure 1 , Figure 2 As shown, the electroporation therapeutic apparatus includes a driving component 1, and an electroporation component 2 connected to the driving component 1; during operation, the driving component 1 drives the electroporation component 2 to perform electroporation therapy; wherein the electroporation component 2 includes a base 21 and an electrode needle array 22; the electrode needle array 22 is connected to the driving component 1 through the base 21; specifically, one end of the base 21 is connected to the driving component 1, and the other end is equipped with the electrode needle array 22; the electrode needle array 22 is used to contact the patient's skin to perform electroporation therapy, and the electrode needle array 22 includes an electrode needle 221, so as to facilitate electroporation therapy through the electrode needle 221; in order to simplify the operating steps of the electroporation therapy process, the utility model preferably uses the electrode needle 221 as a hollow needle; further, a drug channel 211 connected to the electrode needle array 22 is provided in the base 21; and a Luer connector 212 connected to the drug channel 211 is provided on the base 21.

[0035] During the operation of the electroporation therapeutic apparatus, the Luer connector 212 can be connected to the corresponding medical injection silicone tube, so that the drug can be delivered to the electrode needle array 22 through the Luer connector 212 and the drug channel 211, and then further delivered to the skin undergoing electroporation treatment through the hollow electrode needle 221, so that the electroporation therapeutic apparatus can achieve drug delivery while performing electroporation, thereby simplifying the operation process of the electroporation therapeutic apparatus and solving the problem of complicated operation of the electroporation therapeutic apparatus in the prior art.

[0036] The electroporation therapeutic apparatus provided by the utility model can realize drug delivery while performing electroporation treatment by setting the electrode needle 221 as a hollow structure and arranging a drug channel 211 and a Luer connector 212 which are communicated with the electrode needle 221 on the base 21, thereby combining the two steps into one. While simplifying the operation steps, it can also ensure the accuracy of the drug delivery position and the electroporation treatment position, thereby improving the treatment effect.

[0037] The electrode needle 221 of the utility model is preferably made of a biocompatible and conductive material, which is both an energy applicator for electroporation and a syringe for drugs. The utility model has no special restrictions on the length of the electrode needle 221. For example, the length of the electrode needle 221 of the present application can be 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20 cm, etc. When applied, those skilled in the art can change the length of the electrode needle according to user requirements or different skin application scenarios. The diameter of the electrode needle 221 of the utility model is preferably 4 mm, the diameter of the middle hollow cylinder is 2 mm, and the needle length is 1 cm, and the hollow structure in the middle assists drug delivery. In order to prevent the electrode needle 221 from causing tissue blockage during puncture to the greatest extent, the utility model preferably has a bevel structure at the top of the electrode needle 221, that is, the end of the electrode needle 221 away from the base 21, to prevent tissue accumulation near the needle tip, thereby ensuring that the drug can be successfully injected into the skin through the hollow electrode needle 221; specifically, the utility model preferably has an angle of the bevel structure of 15°-40°, and further preferably has an angle of 30°. This design not only performs well in preventing tissue blockage, but also due to the bevel structure, the needle tip of the electrode needle 221 is sharper, making it easier to penetrate the skin.

[0038] Specifically, the electrode needle array 22 in the utility model is composed of a positive electrode needle array and a negative electrode needle array, and preferably adopts a scheme of alternating power supply of a row of positive electrode needle arrays and a row of negative electrode needle arrays in sequence, based on which the electrode needles 221 in the same row are tightly connected through the base 21 to form an electrode strip with a stable structure. This electrode strip design is not only conducive to the centralized installation of the electrode needles 221 on the base 21, but also makes the power supply and lead-in between the electrode needles 221 more convenient.

[0039] Correspondingly, the drug channel 211 is divided into a positive drug channel and a negative drug channel that are independent of each other and not connected; and there are two Luer connectors 212, which are respectively connected to the positive drug channel and the negative drug channel; when the drug solution enters the base 21 through the Luer connector 212, the positive and negative drug solutions are distinguished through the positive drug flow channel and the negative drug flow channel and injected into the skin through the electrode needle array 22.

[0040] The base 21 of the utility model is made of insulating material, and has two Luer connectors 212 at the upper end, which are used to transport the positive and negative liquids respectively. When injecting medicine, the two Luer connectors 212 are connected to the medical injection silicone tube, which ensures the sealing and performs the infusion work simply and efficiently. Figure 3As shown, the preferred base 21 of the utility model is provided with grooves adapted to the electrode needle array, and the number of the grooves is determined according to the total number of the positive electrode needle array and the negative electrode needle array; the preferred electrode needle array 22 of the utility model includes 14 rows of positive and negative electrode needle arrays, therefore, 14 grooves are provided at the bottom end of the base 21 for installing the electrode needle array; and three flow channels are provided at each groove, that is, each groove is provided with a corresponding drug channel 211, and correspondingly, each row of the electrode needle array is also provided with a corresponding flow channel, and after the electrode needle array 22 is installed in the groove of the base 21, the corresponding flow channels together constitute a drug channel 211 which is connected to the Luer connector 212 at one end and connected to the electrode needle array 22 at the other end, so as to realize drug delivery. It should be noted that the present application preferably has three flow channels of the same electrode polarity in each groove and each row of electrode needle array, that is, the three flow channels in the same groove and each row of electrode needle array can all be flow channels for positive electrode drugs, or can all be flow channels for negative electrode drugs, depending on the specific needs. The present utility model preferably has an inner diameter of 1 mm; the distribution path of the flow channels in the base 21 can be set according to the needs.

[0041] In the current market, solving the insulation problem of hollow electrode needles when injecting drugs is a challenge. Therefore, the utility model solves this problem simply and effectively by designing flow channels at the bottom of the groove. The design of these flow channels helps to isolate the drug solution injected into the positive and negative electrodes. Since the drug solution will fill the gap in the hollow electrode needle during electroporation, the flow channel design helps to prevent the positive and negative electrodes from being confused during electroporation.

[0042] In order to expand the use scope of the electroporation therapeutic apparatus, the utility model preferably includes the electroporation component 2 further comprising an outer baffle plate 23; the outer baffle plate 23 is provided with at least two mounting grooves 231 of different heights; the base 21 is provided with a fixing buckle 213 adapted to the mounting groove 231; the height of the mounting groove 231 in the utility model specifically refers to the distance between the mounting groove 231 and one end of the outer baffle plate 23 close to the electrode needle array 22; during the assembly process, the exposed length of the electrode needle 221 is adjusted according to the treatment requirements by connecting the fixing buckle 213 with the mounting grooves 231 at different heights.

[0043] The utility model has no special restrictions on the adjustment position of the outer baffle plate 23, that is, the distance between adjacent mounting grooves 231. Preferably, the exposed length of the electrode needle 221 changes by 1 to 10 mm, more preferably 3 mm, when the position is changed. When applying, those skilled in the art can select a suitable adjustment position of the outer baffle plate 23 according to actual conditions.

[0044] Specifically, this electroporation therapeutic device can be used for both cosmetic skin rejuvenation and skin disease treatment, and has diverse functions. In order to make this electroporation therapeutic device suitable for various treatment situations, an outer baffle 23 structure is designed to adjust the penetration depth of the electrode needle 221 into the skin. A fixing buckle 213 is designed on the side of the base 21 to fix and adjust the outer baffle 23. The preferred adjustment gear of this electroporation therapeutic device is 3mm. Each time the gear is adjusted, the relative exposure length of the electrode needle 221 (i.e., the penetration depth of the electrode needle 221 into the skin) changes by 3mm.

[0045] The electroporation therapeutic apparatus provided by the utility model has a driving component 1 which includes a pulse generator 11 electrically connected to an electroporation component 2, so as to drive an electrode needle array 22 to penetrate the skin for treatment through the pulse generator 11.

[0046] In the present invention, it is further preferred that the pulse generator 11 is a piezoelectric body.

[0047] The present invention has no special restrictions on the piezoelectric body. The piezoelectric body can preferably cause an electroporation effect in which, within the action range, the central area reaches the threshold of irreversible electroporation, and the surrounding area reaches the threshold of reversible electroporation. By combining the two treatment methods of reversible electroporation and irreversible electroporation, different piezoelectric body styles can be selected according to different electroporation requirements.

[0048] Since a piezoelectric body is used as the pulse generator 11, electroporation is triggered by pressing the piezoelectric body. Manual pressing will have the following disadvantages: one or a few electroporations cannot achieve the desired therapeutic effect, and may even require hundreds of presses. Referring to the pressing of a lighter, it can be seen that multiple continuous presses require a certain amount of force, and manual pressing is difficult. When the number of presses increases, it is also difficult to count manually. Therefore, the driving component 1 provided by the utility model also includes a pressing component 12 electrically connected to the pulse generator 11, so that the pressing of the piezoelectric body can be achieved through the pressing component 12, reducing the difficulty of operation.

[0049] Specifically, the pressing assembly 12 includes a shell 121 and a pressing device 122 disposed in the shell 121; further, the pressing device 122 is an automatic pressing device to further reduce the difficulty of operation and improve the accuracy of operation.

[0050] The present invention preferably includes a display and a button, and the display and the button are arranged at the handle of the pressing device 122. The display can be used to display the working state of the automatic pressing device, and the button can be used to control the stopping of the work or change the control state. There is a numeric keyboard on the handle, and the user can input the number of times to be pressed, and the control end will work according to the input instruction. An STM32 core control board is arranged inside to control the whole work, and the push-pull motor is used to complete the precise control of the number of presses.

[0051] For ease of operation, the utility model preferably provides an operating hole 1211 on the housing 121 , and assembles a numeric keypad, a display and buttons at the operating hole 1211 , so that the electroporation therapeutic apparatus can be controlled through the operating hole 1211 .

[0052] The piezoelectric body and the pressing device 122 in the present invention can select corresponding existing technologies according to actual use requirements.

[0053] In order to realize the assembly of the piezoelectric body, the preferred driving component 1 of the utility model may include a piezoelectric body chamber, which may be a cylindrical structure with two small holes under the cylinder for leading out the positive and negative electrodes connected to the positive electrode needle array and the negative electrode needle array respectively from the piezoelectric body.

[0054] At present, traditional electroporation pulse generators are usually expensive and not portable (usually weighing more than 5kg), which limits the application scenarios of electroporation technology, especially in poor areas or places with limited medical resources. The utility model solves the problem that traditional pulse generators are expensive and not portable by using the piezoelectric body in a lighter as an electroporation piezoelectric pulse generator; currently, among the irreversible electroporation electrode needle devices available on the market, there is no electroporation instrument that uses the piezoelectric body in a lighter as an electroporation pulse generator. This application innovatively combines the piezoelectric pulse generator and the hollow electrode needle array to design a low-cost and continuously released perfusion electroporation therapeutic device, which solves the problem that traditional pulse generators are expensive and not portable and the transdermal drug delivery treatment steps are complicated.

[0055] The present invention preferably designs the pressing assembly 12 as a handheld structure, and preferably the driving assembly 1 and the electroporation assembly 2 are detachably connected. When the piezoelectric pulse generator is scrapped due to excessive pressing times, only the piezoelectric body needs to be replaced, saving replacement costs. The connection of the piezoelectric body chamber is connected to the housing 121 through a threaded structure.

[0056] During electroporation therapy, irreversible electroporation causes cell death because the cell membrane cannot be restored and the ion balance inside and outside the cell is destroyed. Irreversible electroporation is an emerging minimally invasive tissue ablation procedure. During the treatment process, an externally applied pulsed electric field is used to ablate tumor cells while preserving tissue scaffolds, large blood vessels and other important tissue structures. This can effectively control the scope of damage to normal tissues. With the evolution of the times and the increasing pursuit of beauty, irreversible electroporation has also shown unique advantages in the treatment of some skin diseases due to its cell ablation characteristics, such as keloids and melanoma, which may cause trouble to the health and beauty of individuals.

[0057] The electroporation therapeutic device provided by the utility model can be applied to the skin. When applied to beauty and skin rejuvenation, the electroporation therapeutic device assists in the efficient delivery of skin care products through reversible electroporation, and can also stimulate skin regeneration and renewal through electroporation. When applied to the treatment of skin diseases such as keloids, irreversible electroporation can directly ablate target cells, and reversible electroporation can assist in the delivery of therapeutic drugs. The same is true for other skin diseases.

[0058] In addition, when electroporation is currently applied to the skin, reversible electroporation is more often used in combination with drug therapy, and attempts to apply irreversible electroporation to the skin are relatively limited. In the electroporation currently used for skin treatment, most of the energy applicators used are solid electrode needles. Before electroporation, it is usually necessary to inject drugs through another syringe, which is cumbersome and complicated. The utility model designs the energy applicator for electroporation as a hollow electrode needle array, and designs the syringe and energy applicator into one body, thereby eliminating the cumbersomeness of replacing treatment instruments during treatment; by selecting a suitable lighter piezoelectric body, it is ensured that it can generate a sufficiently large field strength to reach the threshold of irreversible electroporation, and experiments are conducted to solve the problem of immature application of irreversible electroporation on the skin.

[0059] In summary, the electroporation therapeutic device provided by the utility model can be used on the skin (such as cosmetic skin rejuvenation, treatment of melanoma, keloid, etc.). The operation of the piezoelectric pulse generator is controlled by inputting the number of times the piezoelectric body is pressed into the automatic control end, and the hollow electrode needle is used as an energy applicator to form an electric field on the skin. The area where the field strength reaches the irreversible electroporation threshold can directly ablate the target cells, and the area where the field strength reaches the reversible electroporation threshold can improve the drug delivery efficiency; there is no need to use an additional syringe before electroporation, and the work of injecting drugs can be completed directly through this electroporation therapeutic device; if the user is a patient with keloid, the position of the outer baffle 23 can be adjusted according to the patient's severity of the disease, and the relative exposure length of the electrode needle 221 can be changed to make it suitable for patients in different conditions.

[0060] Based on the above ideal embodiments of the utility model, the relevant staff can make various changes and modifications without deviating from the technical concept of the utility model through the above description. The technical scope of the utility model is not limited to the content of the specification, and its technical scope must be determined according to the scope of the claims.

Claims

1. An electroporation therapeutic apparatus, characterized in that: It comprises a driving component (1), and an electroporation component (2) connected to the driving component (1); wherein: The electroporation assembly (2) comprises a base (21) and an electrode needle array (22); The electrode needle array (22) is connected to the driving component (1) via the base (21); The electrode needle array (22) comprises electrode needles (221); The electrode needle (221) is a hollow needle; The base (21) is provided with a drug channel (211) communicating with the electrode needle array (22); The base (21) is provided with a Luer connector (212) which is in communication with the drug channel (211).

2. The electroporation therapeutic apparatus according to claim 1, characterized in that: The top end of the electrode needle (221) has a beveled structure.

3. The electroporation therapeutic apparatus according to claim 2, characterized in that: The angle of the beveled structure is 15°-40°.

4. The electroporation therapeutic apparatus according to claim 1, characterized in that: The electroporation assembly (2) further comprises an outer baffle (23); the outer baffle (23) is provided with at least two mounting grooves (231) of different heights; and the base (21) is provided with a fixing buckle (213) adapted to the mounting groove (231).

5. The electroporation therapeutic apparatus according to any one of claims 1 to 4, characterized in that: The driving component (1) comprises a pulse generator (11) electrically connected to the electroporation component (2).

6. The electroporation therapeutic apparatus according to claim 5, characterized in that: The pulse generator (11) is a piezoelectric body.

7. The electroporation therapeutic apparatus according to claim 5, characterized in that: The driving component (1) further comprises a pressing component (12) electrically connected to the pulse generator (11).

8. The electroporation therapeutic apparatus according to claim 7, characterized in that: The pressing assembly (12) comprises a shell (121) and a pressing device (122) arranged in the shell (121).

9. The electroporation therapeutic apparatus according to claim 8, characterized in that: The pressing device (122) is an automatic pressing device.

10. The electroporation therapeutic apparatus according to claim 9, characterized in that: The housing (121) is provided with an operating hole (1211).

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