Device for subsurface ablation of cutaneous and mucosal lesions via micro-needle mediated targeted steam injection

Abstract

A minimally invasive therapeutic device for single-session ablation of cutaneous and mucosal lesions up to 1 cm in diameter is disclosed. The apparatus comprises an ultra-fine (0.2 mm) titanium micro-needle, guided by integrated impedance sensors to ensure accurate penetration depth, and a compact pulsed steam generator that delivers controllable steam (100–150 °C, 1–3 bar) directly into the lesion base. A built-in microsurgical camera provides real-time visualization of lesion borders, enabling precise alignment and confirmation of complete ablation. Modular tips permit safe access to both skin and cervical mucosa, while an ergonomic needle-height adjustment mechanism ensures targeted treatment of deep-seated tissue without harming surrounding healthy areas. This system overcomes the limitations of cryotherapy, laser ablation, and surgical excision by achieving full thermal desiccation and ashing of abnormal tissue in one session, reducing patient discomfort, lowering recurrence rates, and shortening recovery time.

Description

Device for Subsurface Ablation of Cutaneous and Mucosal Lesions via Micro-Needle Mediated Targeted Steam Injection

[0001] The present invention relates to the field of advanced medical devices and surgical instruments, particularly to minimally invasive surgical instruments. In detail, this device has been carefully designed to treat aberrant Cutaneous and Mucosal lesions such as HPV-related genital warts, benign lesions and premalignant cervical lesions (CIN II / III) with a maximum size of up to 1 cm. It features an ultra-fine micro-needle tip, coupled with a controlled steam generation unit. This ensures that the penetration depth, tissue characteristics and steam temperature parameters can be adjusted dynamically in real time using embedded sensors. As a result, the device can effectively and precisely ablate the lesion as well as its components that are deeper seated in a single treatment session. This could be an effective technology, not only in dermatology, but also gynecology and other abnormal lesions.

[0002] Current therapies for cervical warts, benign cervical lesions, and premalignant cervical lesions (CIN II / III) include cryotherapy, laser therapy, and surgical excision, but all have their limitations and challenges. As an example, cryotherapy can quickly kill cells by freezing them, but it has been noted to create a burning sensation, damage surrounding tissues, and may require multiple sessions as the roots of a lesion are not always removed in one go. Just like in laser therapy that uses high heat to target abnormal cells, one of the challenges with it is achieving a high degree of control over the depth of thermal penetration to avoid superficial burns and damage to surrounding healthy tissues. While for surgical excision the lesion itself can be physically removed, challenges such as precisely identifying the lesion’s edges, the chance of residual abnormal cells being left behind, post-operative infections and longer recovery times can be problematic. Clinical studies and empirical data demonstrate that these traditional methods have not achieved the best results for deeper and more complex lesions, showing that the improvement of the treatment effectiveness, the reduction of side effect and the quality of life of patients need to be enhanced. The mechanism of the present device is comparable to The patent titled "System and Method for Prostate Treatment" (WO 2022 / 067309 A1), which utilizes controlled steam injection to induce targeted tissue ablation. This similarity underscores the proven efficacy of steam-based ablation methods, while our device uniquely integrates micro-needle delivery for enhanced precision in subsurface ablation of cutaneous and mucosal lesions. These current shortcomings are strong indicators of the immediate need for new and improved technologies capable of precisely and completely ablating lesions in a single session.

[0003] This patent relates to a new therapeutic device that can cure Cutaneous and Mucosal lesions such as HPV-related genital warts, benign lesions and premalignant cervical lesions (CIN II / III) with a maximum size of up to 1 cm in a single session. Its precision micro-needle tip is made of titanium with a diameter of 0.2mm, painlessly and accurately penetrating into the deep part of the lesion, guided by impedance sensors which access the root of the lesion. Directly upon needle insertion, a high-performance pulsed steam generator pumps controllable adjustable steam (100–150°C at pressure of 1–3bar) directly into base of the lesion, rapidly desiccating and ashing tissue, to ensure complete ablation. A mounted surgical imaging camera, aligned with the axis of the needle, allows the physician to accurately visualize the lesion borders to confirm complete resection. Additionally, the device comes with an ergonomic, purposebuilt tip for safe insertion into the cervix canal to deliver steam precisely into the cervical lesions with increased efficacy compared to traditional surgical approaches. This technology, along with other innovations, allows complete lesion ablation in a single session, which leads to fewer treatments, reduced pain, and risk of infection while lowering the overall costs of treatment.

[0004] Conventional treatment methods for abnormal cutaneous and mucosal lesions, such as genital warts and cervical precancerous lesions (CIN II / III), rely predominantly on cryotherapy, laser ablation, and surgical excision. These techniques, however, exhibit several significant deficiencies: they often require multiple treatment sessions due to the inability to fully ablate deep-seated lesion components; they may inflict collateral damage on surrounding healthy tissues, resulting in pain, scarring, and extended recovery periods; and they frequently suffer from high recurrence rates, which diminish long-term treatment efficacy. Furthermore, existing methods lack the precision required for effective lesion targeting, leading to inconsistent clinical outcomes. This technical problem thus calls for a more reliable, single-session treatment approach that minimizes patient discomfort and adverse effects while ensuring complete and precise removal of both superficial and deep lesion tissues.

[0005] The present invention resolves these challenges by introducing an advanced therapeutic device that combines a precision micro-needle system with a controlled pulsed steam generator and a real-time imaging module. In one embodiment, an ultra-fine titanium micro-needle (with a diameter of 0.2 mm) is employed to achieve controlled penetration into the lesion, guided by integrated impedance sensors that ensure accurate depth measurement and proper positioning. Simultaneously, the pulsed steam generator delivers steam at an optimally controlled temperature and pressure, which ensures rapid dehydration and complete thermal ablation of the target tissue without damaging adjacent healthy areas. The inclusion of an imaging module, such as a microsurgical camera, provides real-time visualization of the lesion, enabling precise delineation of its boundaries and fine-tuning of needle penetration. Additionally, the device is designed with modular components tailored for both cutaneous and mucosal lesions, including specialized configurations for cervical applications. This comprehensive solution not only achieves complete lesion eradication in a single treatment session but also reduces treatment duration, minimizes pain and side effects, lowers the risk of recurrence, and ultimately improves overall patient outcomes and quality of life.

[0006] The present invention offers significant improvements over conventional treatments for abnormal cutaneous and mucosal lesions. It enables complete ablation of both superficial and deep-seated lesions, such as genital warts and cervical precancerous lesions (CIN II / III) with a maximum size of up to 1 cm, in a single treatment session, thereby reducing the overall number of treatments required and significantly lowering treatment time and costs. The precision micro-needle system, in combination with a controlled pulsed steam generator, delivers steam at an optimal temperature and pressure, ensuring ensuring rapid dehydration and complete thermal ablation of the target tissue while sparing surrounding healthy tissue. Moreover, the integration of a real-time imaging module facilitates accurate delineation of lesion boundaries and dynamic adjustment of needle penetration, thus enhancing treatment precision and safety. The device’s adaptive control system further personalizes therapy by adjusting treatment parameters according to lesion size, tissue density, and location. Additionally, its modular design allows for the future integration of supplementary therapeutic or diagnostic functionalities, making it a versatile solution across various medical applications.

[0007] . Schematic of the system illustrates:

[0008] [NO. 1] Shows the Dedicated Water Inlet, which is A specific inlet provided for supplying water to the system.

[0009] [NO. 2] Shows the Generator Assembly, which is The section where the generator is installed to convert water into steam.

[0010] [NO.3] Shows the Water Tank, which is The reservoir where water is stored.

[0011] [NO. 4] Shows the Flexible Metal Corrugated Hose, which is A metal hose designed in a corrugated pattern that transfers steam from the generator to the device.

[0012] [NO. 5] Shows the Hose Connection Point, which is The designated area where the hose is connected to the system.

[0013] [NO. 6] Shows the Switching Station, which is A dedicated section for altering the device’s operating mode, wherein the current series is disconnected and linked to an alternative converter.

[0014] [NO. 7] Shows the Steam Output Intensity Control, which is A pressure button that regulates the intensity of the steam output.

[0015] [NO. 8] Shows the Needle Height Adjustment Mechanism, which A mechanism designed to adjust the needle height for improved penetration into the lesion.

[0016] [NO. 9] Shows Needle Installation Area, which is The location where disposable needles are mounted; these needles are replaced after each procedure.

[0017] [NO. 10] Shows Disposable Needles, which is The one-time use needles employed in the treatment process.

[0018] [NO. 11] Shows Device Support Base, which is The structural base that securely supports and stabilizes the device during operation, ensuring safety and ease of use.

[0019] . Schematic of the device illustrates:

[0020] [NO. 1] Shows the Dedicated Cervical Converter Connection Point, which is The specific interface where the dedicated cervical series is connected to the main device.

[0021] [NO. 2] Shows the Steam Outlet and Output Intensity Regulator, which is The component that discharges water vapor and adjusts its output intensity.

[0022] [NO. 3] Shows the Dedicated Needle, which is A needle specifically designed for cervical applications.

[0023] [NO. 4] Shows the Camera, which is An integrated imaging module for real-time monitoring of the treatment area.

[0024] . Schematic of the system illustrates:

[0025] [NO. 1] Shows the Dedicated Water Inlet, which is A specific inlet provided for supplying water to the system.

[0026] [NO. 2] Shows the Generator Assembly, which is The section where the generator is installed to convert water into steam.

[0027] [NO.3] Shows the Water Tank, which is The reservoir where water is stored.

[0028] [NO. 4] Shows the Flexible Metal Corrugated Hose, which is A metal hose designed in a corrugated pattern that transfers steam from the generator to the device.

[0029] [NO. 5] Shows the Hose Connection Point, which is The designated area where the hose is connected to the system.

[0030] In one embodiment, the present device is configured to treat superficial skin lesions with a maximum size of up to 1 cm, such as genital warts, using a water vapor ablation mechanism. When a user intends to remove a lesion, the device is activated to generate controlled steam that ablates the target tissue. The device comprises two dedicated series. The first series is designed for treating cutaneous lesions and includes a nozzle equipped with a micro-needle tip that is similar in size and ergonomics to a pen. The physician holds this series and positions the needle nozzle directly over the lesion so that the disposable microneedle penetrates the lesion to a predetermined depth. The penetration depth is finely adjustable by a needle height adjustment mechanism (as shown in, element 8), enabling precise control over the depth of ablation.

[0031] In another embodiment, intended for mucosal lesions such as cervical lesions, the device utilizes a second dedicated series (depicted in). In this configuration, a specialized nozzle designed for cervical applications is provided along with an integrated imaging module. The imaging module, positioned adjacent to the micro-needle, enables real-time measurement and visualization of the lesion. This facilitates precise placement of the needle over the lesion, ensuring that the controlled steam, delivered at the optimal temperature and pressure, effectively ablates the abnormal tissue in the cervical region.

[0032] The present Patent is highly industrially applicable, being designed for mass production and commercial exploitation in diverse healthcare settings such as hospitals, specialized clinics, and treatment centers in dermatology and gynecology. Its modular and flexible design enables precise adjustment of therapeutic parameters and easy integration of supplementary diagnostic or treatment technologies. By providing complete lesion ablation in a single session, the device significantly reduces treatment duration and costs while enhancing patient outcomes and quality of life. Moreover, the manufacturing process is compatible with existing industrial production technologies, ensuring scalability and cost-effectiveness, which makes the invention a versatile platform for advanced medical and surgical applications.

Claims

A therapeutic device for ablating abnormal Cutaneous and Mucosal lesions with a maximum size of up to 1 cm, the device comprising: A monofilamentable micro-needle tip (0.2mm, titanium) is designed for controlled penetration into the Cutaneous and Mucosal lesion tissue; A sensing system (eg, impedance sensors) for characterization of tissue and ensuring proper placement of the needle; Pulsed Steam Generator: Compact and efficient steam generation unit, which is capable to produce steam at controlled temperature (100–150°C) and appropriate pressure (1–3bar); A delivery system configured to deliver the generated steam through the micro-needle tip to a depth of the Cutaneous and Mucosal lesion. The micro-needle tip for achieving a deep penetration target on the Cutaneous and Mucosal lesion as claimed in claim 1, that avoids an injury to adjacent healthy tissue.The device according to claim 1, comprising an additional dedicated surgical imaging module (microsurgical camera) configured to help delineate the lesion margins and confirm complete ablation.The device according to claim 1, wherein the steam generation unit is configured to generate steam with an optimal temperature and pressure for rapid desiccation of the Cutaneous and Mucosal lesion tissue and ashing thereof and that does not inflict significant damage to superficial tissue.The device as claimed in claim 1, further including a specific tip that can be inserted into the cervical canal and is specially shaped for treating cervical Cutaneous and Mucosal lesions, the tip configured for safely entering the cervical canal of the uterus and deliver steam according to lesion areas thereof.A treatment procedure for removing genital warts and cervical lesions using the device of claim 1, including the steps of: - Orienting the device on the lesion; - Penetrating the micro-needle into the lesion to a predetermined depth, based on sensor data and physician assessment; - Activation of the steam producing unit to supply regulated steam (120±5 °C at 2±0.5 bar) to the lesion for a defined duration; - Imaging monitoring the ablation process to confirm the absence of the lesion in a single session.The device and method of claims 1–6, wherein the intelligent control module is programmed with adaptive algorithms that dynamically modify the treatment parameters (e.g., lesion size, tissue density, location).The device and method of any of claims 1-7, wherein a modular design permits therapeutic or imaging capabilities captured by the imaginer to be subsequently integrated into the device, extending the applicability of the device and method to treatment of other types of abnormal lesions.

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