A shock absorption technique to reduce pain from microneedle use

Abstract

The present application relates to the field of medical devices, and discloses a medical device using microneedles as skin-breaking, stimulating and carrier functions, and a shock-absorbing and buffering technology for reducing the pain of patients during implementation. The present application uses a material with good elasticity and low elastic modulus as a shock-absorbing and buffering layer. The elastic material is adhered to the back of the microneedle. When the microneedle is pressurized, the mechanical transmission of the elastic material can buffer the pressure, so that the skin-breaking and stimulating functions are not reduced, and the drug carrying function is not affected. And / or, a flexible transition section is added between one end of the microneedle and the operating handle to achieve the purpose of shock absorption and pain reduction. The present application is not limited by the form of the microneedle device, and different elastic modulus shock-absorbing and buffering materials and / or flexible transition sections can be matched according to the use function of the microneedle product. During pressurization, the present application ensures the safety of the shock-absorbing and buffering layer material, the shock-absorbing and buffering layer and the microneedle layer have sufficient adhesive strength and do not fall off, and / or the addition of the flexible transition section does not affect the safety and flexibility of the original medical device, so as to achieve the purpose of reducing the pain of patients.

Description

Technical Field

[0001] This invention patent relates to the field of medical devices, and in particular to a shock-absorbing technology that can reduce pain during microneedling. Background Technology

[0002] Microneedles (MN) are a novel physical transdermal technology. An array of hundreds of micron-sized needle tips, applied under pressure, can penetrate the stratum corneum of the skin, thus achieving the goal of crossing the skin's stratum corneum barrier. Since Alan Richard Wagner first proposed the concept of intradermal microneedle injection in 1958, microneedling technology has undergone nearly 65 years of technological iteration, encompassing three main categories: silicone / silicone oxide microneedles, metal microneedles, and dissolvable microneedles.

[0003] In 2005, Miyano developed the first soluble microneedle. Unlike silicon / silica microneedles and metal microneedles, soluble microneedles are made from water-soluble materials. By incorporating drugs with various therapeutic effects into the hydrolyzable material, the unique efficacy of transdermal drug delivery can be achieved. This unique feature quickly stimulated the potential market in the medical and aesthetic fields. By 2015, the United States and Europe had begun to apply microneedles in the medical field, while Japan and South Korea mainly used them in the aesthetic field. In November 2020, microneedle drug delivery technology was ranked first among the top ten emerging technologies that are expected to change the world in 2020, as selected by the authoritative American science magazine Scientific American. To date, microneedle technology has been widely used and researched in areas such as blood glucose regulation, vaccine delivery, tissue fluid extraction, cancer treatment, and skin repair. In contrast, my country's microneedle products started relatively late. Microneedle devices, represented by microneedle patches and microneedle rollers, have only emerged in China in the past year. The products are limited in variety, lack technological sophistication, and have not yet formed a sufficient scale or industrial cluster.

[0004] Taking domestically produced pressurized soluble microneedle products as an example, the microneedle material is hydrolyzable and drug-loaded as needed. The microneedle base is made of the same material as the microneedle tip and is very thin, typically on the order of hundreds of micrometers. To ensure the necessary strength for transdermal penetration, the non-working surface of the microneedle layer is directly adhered to a rigid material, relying on this material to rigidly transmit pressure. For users, this rigid pressure transmission results in intense pain, which is highly detrimental to the application and promotion of microneedles in pain-sensitive individuals and certain pain-sensitive areas.

[0005] To address the aforementioned issues, this invention aims to reduce patient pain by adhering an elastic layer with shock-absorbing and buffering functions to the non-working surface of the flexible microneedle layer, and / or by adding a flexible transition section between one end of the microneedle and the operating handle. Summary of the Invention

[0006] The purpose of this invention is to provide a shock-absorbing technique that reduces patient pain during microneedling while ensuring that the function of the microneedling procedure is not affected in any way. To address the shortcomings of existing technologies, the technical solution provided by this invention is: A shock-absorbing technique to reduce pain during microneedling is proposed. The shock-absorbing and cushioning solution involves using a selected elastic material adhered to the back of the microneedle. This allows for pressure cushioning through the mechanical transmission of the elastic material during microneedling without reducing skin irritation or affecting drug delivery. Alternatively, a flexible transition section can be added between one end of the microneedle and the operating handle to achieve shock absorption and reduce pain.

[0007] The aforementioned shock-absorbing technology, which can reduce pain during microneedling, features an elastic shock-absorbing buffer layer whose material can be appropriately matched to the function of the microneedling device; the thickness of the elastic shock-absorbing buffer layer can be selected and matched according to the shape of the microneedling device; and the elastic shock-absorbing buffer layer and the microneedle layer are bonded together through a special adhesion process to ensure sufficient bonding strength and flexible mechanical conduction properties. The aforementioned shock-absorbing technology, which can reduce pain during microneedling, uses materials for the flexible transition section that include, but are not limited to, slow-rebound, fully elastic, and other materials that can provide flexible connections; the form of the flexible transition section includes, but is not limited to, mechanical rods, springs, and other mechanical structures that can achieve flexible connections. The aforementioned shock-absorbing technology, which can reduce pain during microneedling, involves the implementation of an elastic shock-absorbing buffer layer and / or a flexible transition section. This allows excessive local stress to be released within the shock-absorbing buffer layer and / or the flexible transition section through mechanical transmission, thereby reducing the patient's pain. The shock-absorbing technology described herein can reduce pain during microneedling use. Through the implementation of this invention, the functionality and operational flexibility of existing microneedling products remain unaffected.

[0008] The implementation of this invention is not limited to the category of microneedle products, including but not limited to the materials and structural designs involved in this invention. Any invention that can achieve shock absorption and cushioning of microneedle products and reduce patient pain is within the scope of protection of this invention. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the structure of the patch-type shock absorption and buffer layer / patch-type microneedle working section of this invention (left, planar; right, curved). Figure 2 This is a schematic diagram of the shock-absorbing buffer layer / roller-shaped microneedle working section structure of the roller-type microneedle product of this invention patent; Figure 3 This is a schematic diagram of the working section structure of the flexible transition device / patch-type microneedle of this invention patent; Figure 4This is a schematic diagram of the working section structure of the flexible transition device / roller-shaped microneedle of this invention patent; Detailed Implementation

[0010] The above solution will be further explained below with reference to specific embodiments. It should be stated that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Any invention based on this patent that aims to reduce pain during the use of microneedling products through physical methods such as shock absorption and cushioning should fall within the scope of protection of this patent.

[0011] Example 1 (Shock-absorbing buffer layer / / patch-type microneedles): Specifically, this implementation employs a shock-absorbing technology to reduce pain during microneedling. The patch microneedles are metal microneedles with a tip length of 220 micrometers, applied to scar treatment on the skin surface. The shock-absorbing buffer layer is made of slow-rebound sponge with a thickness of 5 millimeters. (See schematic diagram for the combined structure.) Figure 1 During treatment, pressure is transmitted from the shock-absorbing layer to the metal microneedle layer by pressing with the fingers, ultimately acting on the treatment surface. This is suitable for treatment surfaces of various curved shapes. Figure 1 The pressure applied (on the right) is also indirectly transmitted through the shock-absorbing buffer layer. Because of the buffer layer, the pressure difference between treatment surfaces with different radii of curvature is smaller due to this indirect pressure transmission method. This not only reduces pain but also makes the pressure more uniform, which is beneficial to improving the treatment effect.

[0012] Example 2 (Shock-absorbing buffer layer / roller-shaped microneedles): Specifically, this implementation employs a shock-absorbing technology to reduce pain during microneedling, using soluble roller-shaped microneedles. The needle tip length is 400 micrometers, and the roller diameter is 25 millimeters, applied to facial pigmentation treatment. The shock-absorbing buffer layer is made of silicone and is 2.5 millimeters thick. See the schematic diagram of the combined structure for reference. Figure 2 During treatment, the operator holds the handle, and the microneedles on the roller are applied to the treatment surface. Because the microneedle layer is attached to the roller, this product achieves efficient treatment and more even pressure. Between the supporting roller and the microneedle layer is the elastic shock-absorbing buffer layer involved in this invention patent. Verification has shown that the addition of the buffer layer has resulted in no reports of unbearable pain in any test patients of any age group, demonstrating a significant pain-reducing function compared to roller products with microneedle layers directly mounted on a hard plastic or metal roller base.

[0013] Example 3 (Flexible Transition Device / Patch-type Microneedles): Specifically, this implementation employs a shock-absorbing technology to reduce pain during microneedling use. The patch microneedles are metal microneedles with a tip length of 1000 micrometers, used for vaccine delivery. The metal microneedles serve as the working end, connected to an operating rod via a flexible transition device. The operating rod has a diameter of 15 millimeters, and the flexible transition device is a spring mechanism. During implementation, the pressure of the operating rod is slowly transmitted to the treatment surface through the flexible transition section, giving the patient sufficient time to perceive pain and adjust the operating pressure accordingly. (See schematic diagram for reference.) Figure 3 .

[0014] Example 4 (Flexible Transition Device / Roller-Shaped Microneedle): Specifically, this implementation employs a shock-absorbing technique to reduce pain during microneedling, using soluble microneedles in its roller microneedles. The needle tip length is 380 micrometers, and the roller diameter is 28 millimeters. It is applied to hair regrowth or color-changing treatments on male and female genital areas. The soluble roller microneedles serve as the working end, connected to an operating rod via a flexible transition device. The operating rod has a diameter of 15 millimeters, and the flexible transition device is a spring (0.8mm*10mm*30mm) made primarily of 304 stainless steel. During application, the pressure from the operating rod is transmitted to the treatment surface through the flexible transition device, allowing the operator to control transdermal pressure over a wider range by adjusting the operating angle. (See schematic diagram for reference.) Figure 4 .

Claims

1. A shock-absorbing technology to reduce pain during microneedling, characterized in that... The pain-relieving microneedling technique involves adhering an elastic shock-absorbing material to the non-working surface of the microneedle of the microneedle device, and / or adding a flexible transition section between one end of the microneedle and the operating handle.

2. The shock absorption technology for reducing pain during microneedling use according to claim 1, characterized in that... The material selection for the elastic shock-absorbing buffer layer can be appropriately matched according to the function of the microneedle device.

3. The shock-absorbing technology for reducing pain during microneedling use according to claim 1, characterized in that... The thickness of the elastic shock-absorbing buffer layer can be selected to match the shape of the microneedle device.

4. The shock absorption technology for reducing pain during microneedling use according to claim 1, characterized in that... The elastic shock-absorbing buffer layer and the microneedle layer are bonded together by a special adhesion process to ensure sufficient bonding strength and flexible mechanical conduction properties.

5. The shock-absorbing technology for reducing pain during microneedling use according to claim 1, characterized in that... The addition of the flexible transition section will not affect the functionality and operational flexibility of the original microneedle device.

6. The shock-absorbing technology for reducing pain during microneedling use according to claim 1, characterized in that... The materials used in the flexible transition section include, but are not limited to, slow-rebound, fully elastic, and other materials that can provide a flexible connection.

7. The shock-absorbing technology for reducing pain during microneedling use according to claim 1, characterized in that... The form of the flexible transition section includes, but is not limited to, mechanical structures that can achieve flexible connection, such as mechanical rods and springs.

8. A shock-absorbing technology for reducing pain during microneedling use according to claim 1, characterized in that... The implementation of elastic shock-absorbing buffer layers and / or flexible transition sections can release excessive local stress within the shock-absorbing buffer layers and / or flexible transition sections through mechanical transmission, thereby reducing the patient's pain.

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