Ultrasonic suction integrated device with disposable waveguide assembly

Abstract

The application relates to the technical field of medical devices, and particularly discloses an ultrasonic suction integrated device with a disposable wave guide assembly, which comprises a reusable solid ultrasonic probe rod and a disposable consumable sheath assembly. The consumable sheath assembly is in a double-cavity structure in an up-down side-by-side mode, and comprises an upper suction pipeline which is through in front and back and a lower probe isolation sleeve (blind pipe) which is closed at the front end. The solid ultrasonic probe rod is inserted into the blind pipe to realize complete physical isolation. The application realizes the synchronous performance of large-diameter operation field unobstructed cleaning, Doppler blood flow and high-frequency nerve imaging; can accurately detect the running of blood vessels and nerves in tumors and the anatomical distance between the blood vessels and nerves and tumor substance. The blind pipe isolation mechanism completely eliminates the dead angle of cleaning at the front end of the instrument, the cross-infection risk and the high maintenance cost, greatly improves the total resection rate of complex tumors and significantly reduces the injury rate.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an integrated ultrasonic aspiration device with a disposable waveguide assembly. Background Technology

[0002] Neurosurgery is one of the most technically demanding and high-risk surgical procedures in the medical field. This is especially true during the resection of intracranial lesions (such as skull base tumors, brainstem tumors, aneurysms, and arteriovenous malformations), where the vascular distribution in the surgical area is exceptionally complex, and the anatomical structures are delicate and highly susceptible to damage. Accidental damage to critical blood vessels during surgery can lead to catastrophic consequences, such as massive hemorrhage, ischemic stroke, neurological deficits, or even patient death. Therefore, accurately identifying and protecting vital vascular structures during surgery remains a key focus for clinicians and researchers in the field of neurosurgery.

[0003] In traditional neurosurgical practice, surgical field cleaning and vascular identification typically require the use of multiple different instruments. Intraoperative suction is essential for removing blood, tissue fluid, and debris from the surgical area, ensuring a clear view and allowing the surgeon to more accurately observe anatomical structures and operational details. However, while surgeons can observe the surgical field using microscopes or endoscopes, it is difficult to fully identify important blood vessels hidden deep within tissues or tumors with the naked eye alone. If the surgeon overlooks the location of hidden vessels, the risk of intraoperative bleeding or injury increases dramatically, seriously threatening surgical safety and the patient's quality of life.

[0004] To overcome this technological bottleneck, Doppler ultrasound detection technology has been gradually introduced into neurosurgery in recent years. Miniature Doppler ultrasound probes utilize the Doppler effect of ultrasound waves to monitor the blood flow status of arteries or veins in the surgical area in real time, providing feedback to the surgeon in the form of sound or images. This has, to some extent, solved the problem of difficult intraoperative vessel identification. Clinical research and practice have proven that the use of miniature Doppler ultrasound detection technology during surgery can significantly improve the surgeon's accuracy in determining the location of blood vessels, helping them to identify and protect important vessels in a timely manner, and greatly reducing the risk of vascular injury during surgery.

[0005] For example, in intracranial aneurysm clipping surgery, Doppler ultrasound probes have become an important auxiliary tool for assessing the effectiveness of aneurysm clipping and the patency of blood flow in related vessels during the operation. Surgeons can use the probes to evaluate arterial blood flow in real time before and after aneurysm clipping, ensuring that the clipping procedure does not accidentally block normal arterial blood flow, thereby improving the safety and success rate of aneurysm surgery. Furthermore, in brainstem tumor resection surgery, micro-Doppler ultrasound probes are also used to monitor the location of important brainstem perforating arteries or veins in real time during the operation, avoiding serious consequences caused by accidental damage to critical vessels.

[0006] Despite the widespread acceptance and application of Doppler ultrasound technology in neurosurgery, several challenges remain in clinical practice. One of the most significant issues is that currently widely used intraoperative Doppler probes are typically separate instruments, used independently from conventional suction devices. Therefore, surgeons must frequently switch between suctioning the surgical field and Doppler probing of vessels. This frequent instrument switching not only disrupts the continuity of the surgical procedure but also easily leads to surgeon distraction, increasing operational errors and surgical time. Especially in confined and challenging surgical areas, frequent instrument changes may increase the risk of accidental tissue damage.

[0007] To address these issues, the industry has gradually begun exploring the integration of suction devices and Doppler ultrasound probes into a single design. The initial intention behind this design concept is to allow surgeons to simultaneously perform surgical field cleaning and blood flow monitoring using only a single instrument during surgery, significantly improving surgical efficiency and accuracy while reducing surgical risks. However, existing integrated suction-ultrasound probe devices have not yet been widely adopted because current technologies still face several unresolved technical bottlenecks and practical application obstacles in clinical practice.

[0008] First, existing integrated suction-Doppler devices face significant bottlenecks in postoperative sterilization and maintenance. Because the device's tip comes into direct contact with the patient's blood and tissue fluid, it must undergo rigorous high-temperature, high-pressure sterilization procedures post-operatively to ensure safety. This frequent sterilization process severely impairs the sensitivity and stability of the ultrasound components, often leading to signal attenuation, performance instability, or even failure after prolonged use. Furthermore, repeated sterilization can cause wear and even damage to probe components, increasing the cost and difficulty of equipment maintenance and severely limiting the clinical adoption and frequency of use of such devices.

[0009] Secondly, infection control remains a significant challenge that current technologies cannot effectively overcome. Even with standard sterilization procedures, repeatedly used ultrasound probes often retain microbial residues on their surfaces or inside the instruments. This increases the risk of postoperative infection for patients, forcing hospitals to invest substantial resources in additional instrument testing, maintenance, and quality control. This significantly increases hospital operating costs and limits the widespread adoption of new integrated surgical devices.

[0010] Furthermore, existing integrated devices are typically designed as a single, fixed structure, failing to offer flexible replacement or customized probe shapes and sizes for different surgical scenarios. The anatomical structures and spatial constraints of different neurosurgical operating areas vary; for example, brainstem surgery may require a long, thin suction head, while skull base tumor resection may require a curved probe to better adapt to anatomical angles. However, fixed probe structures cannot meet the needs for rapid intraoperative adjustment or replacement, severely limiting their clinical applicability and practical effectiveness.

[0011] Therefore, developing an innovative integrated neurosurgical device that combines suction and Doppler ultrasound detection while overcoming the aforementioned problems has become a significant technological need and research hotspot in this field. This novel device must not only perform exceptionally well clinically but also possess multiple advantages in practical operation, including high efficiency, reliability, safety, and cost-effectiveness. In particular, through structural design and material innovation, it is crucial to completely resolve issues related to infection control and maintenance costs, thereby truly meeting the refined, precise, and efficient clinical needs of modern neurosurgery and driving the development of neurosurgical techniques towards greater safety, efficiency, and economy.

[0012] Furthermore, conventional intraoperative Doppler ultrasound is mainly used to detect blood vessels and blood flow. Because nerve tissue is extremely small and has weak echoes, ordinary Doppler probes have insufficient resolution and are generally unable to directly visualize the nerve itself during surgery; only the structures surrounding the nerve can be seen. In many complex surgeries, nerves and blood vessels are intertwined, and surgeons urgently need an integrated instrument that can both identify blood vessels and accurately detect nerves. Summary of the Invention

[0013] The purpose of this invention is to provide an integrated ultrasonic aspiration device with a disposable waveguide assembly. The core concept of this device is to innovatively incorporate a detachable, disposable ultrasonic waveguide assembly, namely the waveguide head, into the existing integrated design of the aspirator and Doppler ultrasound probe. Through this structural innovation, this device not only retains the integrated functional advantages of traditional aspirators and ultrasound probes but also completely solves the problems of incomplete sterilization of the instrument tip, susceptibility to cross-infection, and high maintenance costs, significantly improving the clinical practicality and market value of such devices.

[0014] Technical Objectives of the Invention The primary technical objective of this invention is to design and implement a multifunctional surgical device for use in neurosurgery. This device can simultaneously perform two core functions: intraoperative negative pressure suction and ultrasonic Doppler vascular detection, completely eliminating the need for surgeons to frequently change different surgical instruments. This multifunctional device can greatly improve the continuity and efficiency of surgical procedures, and reduce the risk of intraoperative errors and tissue damage.

[0015] The second technical objective of this invention is to overcome significant shortcomings of existing similar devices in clinical use through a structural innovation using disposable waveguide components. These shortcomings include difficulties in postoperative cleaning, high risk of cross-infection, insufficient instrument performance stability, and excessively high equipment maintenance costs. This disposable waveguide component can be easily installed at the front end of the device body and is discarded after use, eliminating the need for repeated sterilization. This design ensures both instrument safety and performance stability while significantly reducing equipment maintenance and management costs in hospitals, meeting the demands of modern medical institutions for efficient, economical, and safe surgical instruments.

[0016] The third technical objective of this invention is to standardize and modularize the waveguide head, enabling it to have diverse forms and specifications to meet the needs of different types of neurosurgical procedures. Specifically, the waveguide head assembly can be designed with different lengths, diameters, and curvatures to suit different anatomical locations and surgical types (such as skull base tumor resection, brainstem tumor surgery, aneurysm clipping, arteriovenous malformation resection, etc.). Surgeons can quickly change to a suitable waveguide head according to the surgical situation, improving the applicability and surgical precision of this device.

[0017] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: This invention provides an integrated ultrasonic attraction device with a disposable waveguide assembly, comprising a solid ultrasonic probe and a consumable sheath assembly that is plugged into the solid ultrasonic probe; The consumable sheath assembly includes a suction tube and a probe isolation sleeve arranged side by side with the suction tube; One end of the suction tube is connected to the negative pressure drainage end, and the other end is provided with a liquid suction end; the probe isolation sleeve is a blind tube structure.

[0018] In this embodiment, the end of the solid ultrasonic probe is equipped with an ultrasonic transducer unit, and the other end is electrically connected to the main unit's detection end. The ultrasound transducer unit can be one of an ultrasound transducer, a Doppler ultrasound transducer, or a high-frequency ultrasound transducer. Specifically, depending on the surgical needs, a solid-state ultrasound probe with the required function can be selected. For example, a Doppler ultrasound transducer can be used to detect blood flow and blood vessels, while a specialized high-frequency ultrasound / musculoskeletal ultrasound transducer (such as a high-frequency linear array probe element) can be used. By switching between different frequency probe components on the same ultrasound host, and utilizing the high resolution of high-frequency ultrasound, the doctor can clearly display the morphology, thickness, presence of edema, compression, tearing, or tumor invasion of peripheral and deep fine nerves (such as the median nerve, ulnar nerve, radial nerve, sciatic nerve, common peroneal nerve, facial nerve, and auditory nerve), thereby achieving precise dual detection of both "blood vessels" and "nerves" under the same suction device.

[0019] Furthermore in this embodiment, the solid ultrasonic probe is a solid cylinder, and an operating handle is provided on its other end.

[0020] Furthermore in this embodiment, the suction tube and the probe isolation sleeve are integrally formed.

[0021] Furthermore in this embodiment, the suction tube is a hollow tube, one end of which is connected to a negative pressure source through the negative pressure drainage end, and the other end is the front end of the suction tube, which is connected to the liquid suction end through the liquid suction tube.

[0022] Furthermore in this embodiment, one end of the probe isolation sleeve is provided with a closed end, and the other end is provided with an anti-retraction buckle structure to fasten onto the handle.

[0023] In a further embodiment, the anti-retraction buckle structure includes an annular seat coaxially connected to the end of the probe isolation sleeve, and a plurality of breakable arc-shaped pieces integrally disposed on the annular seat; wherein, a one-way thread is pre-formed on the inner wall of the breakable arc-shaped pieces.

[0024] In a further embodiment, the anti-retraction buckle structure includes an integrally formed elastic cantilever that extends rearward, and the end of the elastic cantilever is provided with an inwardly buckling one-way buckle; an annular groove is provided on the root housing surface of the host detection component or the solid ultrasonic probe to lock in conjunction with the one-way buckle. To prevent irreversible damage during reuse, a V-shaped easy-break groove with reduced wall thickness is provided at the root of the elastic cantilever. When the consumable sleeve assembly is forcibly pulled out along the axial direction, the one-way chuck is blocked and restricted by the annular groove, and the stress is concentrated at the V-shaped easy-break groove, causing the elastic cantilever to undergo irreversible brittle fracture.

[0025] Furthermore, in this embodiment, a disposable ultrasonic coupling gel capsule or acoustic pad is pre-installed on the inner wall of the probe isolation sleeve near the closed end.

[0026] Furthermore, in this embodiment, the consumable sheath assembly also includes a series of sleeves with straight heads, different pre-bending angles, and different length specifications.

[0027] Innovation and advantages of this invention The innovation of this invention is reflected in the following aspects: This invention is the first to propose a disposable ultrasound waveguide head structure: Through the innovative design of the disposable waveguide head, the performance degradation, cross-infection risk and high maintenance cost caused by repeated disinfection of ultrasound probes in existing technologies are completely avoided, which greatly improves the clinical safety and ease of use of the device.

[0028] Standardized modular design: The connection between the waveguide head and the main device adopts standardized specifications, which can realize the quick replacement of waveguide heads of various specifications and shapes, significantly improving the applicability and flexibility of this device to different neurosurgical scenarios.

[0029] Highly efficient dual-function integration: This device simultaneously achieves negative pressure suction and ultrasound Doppler vascular monitoring, eliminating the need for frequent instrument changes during operation and greatly improving surgical efficiency and accuracy.

[0030] The main advantages of this invention include: Significant advantages in infection control: The disposable waveguide design avoids the risk of intraoperative infection, improves patient safety, and reduces the incidence of hospital-acquired infections.

[0031] Exceptional instrument reliability: No need for repeated sterilization, significantly extended lifespan of main device electronic components, stable and reliable performance, ensuring continuous blood flow monitoring during surgery.

[0032] Significant economic benefits and commercial potential: Standardized waveguides are easy to mass-produce, inexpensive, and have great market potential. Both manufacturers and hospitals can benefit from the continued use of disposable consumables.

[0033] In summary, this invention provides a neurosurgical instrument with significant clinical value and commercial potential through innovative structural design and functional integration.

[0034] Implementation Scenarios and Scope of the Invention The neurosurgical suction-Doppler ultrasound probe device of this invention fully considers the complexity and diversity of clinical surgery in its design and application, and particularly emphasizes its wide applicability and flexibility in practical scenarios. Its disposable ultrasound waveguide assembly structure is designed with the specific needs of different surgical types and anatomical locations in mind, making the device widely applicable to almost all important surgical types in the field of neurosurgery, especially offering significant advantages in highly complex surgeries with extremely high requirements for surgical safety, precision, and real-time performance.

[0035] Specifically, this invention is particularly applicable to the following typical clinical surgical scenarios: 1. Used for neuroprotection during acoustic neuroma surgery in neurosurgery. In neurosurgical resection of acoustic neuromas, the tumor is often tightly adhered to the facial and auditory nerves, making it difficult to discern the nerve pathways with the naked eye. The surgeon uses this device equipped with a high-frequency ultrasound transducer to simultaneously aspirate fluid and tumor debris from the surgical area while performing real-time, high-definition scanning through a disposable isolation sheath. High-frequency ultrasound clearly displays the precise pathways and boundaries of the facial and auditory nerves, helping surgeons perfectly protect these nerves during tumor removal, which has significant intraoperative clinical value.

[0036] 2. Applications in plastic and cosmetic surgery and peripheral nerve entrapment surgery The high-frequency ultrasound aspiration integrated device proposed in this application also has significant interdisciplinary application value. In complex plastic and cosmetic procedures (such as facelifts, facial liposuction, maxillofacial surgery, and deep injections), the facial nerve network and peripheral nerve branches are densely packed and highly susceptible to damage. Using the high-frequency neuro-ultrasound mode of this integrated device, doctors can track the location of minute nerves in real time and precisely avoid critical nerve plexuses. This completely avoids the most dreaded complication of facial nerve injury and disfigurement during cosmetic surgery; it can also be used in nerve decompression procedures such as carpal tunnel syndrome, greatly increasing the device's application scenarios and commercial value.

[0037] 3. Skull base tumor surgery (especially when the tumor surrounds the internal carotid artery) In skull base tumor surgery, especially complex tumor lesions located in the sella region, petrous apex region, cavernous sinus region, or clivus region of the skull base, the surgical area has an extremely complex anatomical structure and a narrow space, surrounded by a large number of important blood vessels and nerve tissues. Accidental damage to any key structure during surgery may lead to serious sequelae or fatal complications.

[0038] The suction-Doppler ultrasound probe device of this invention monitors blood flow signals in real time via a waveguide, enabling clear identification of vascular structures surrounding tumors, particularly vascular branches or small perforating arteries that are difficult to visualize on preoperative imaging. In clinical practice, especially when the tumor surrounds the internal carotid artery, the surgeon can use this device to accurately assess the relationship between the tumor and the internal carotid artery, avoiding accidental damage to important arteries during surgery and preventing serious complications. Therefore, this application scenario is one of the greatest highlights of this invention and is explicitly described first in the embodiments.

[0039] 4. Intracranial aneurysm clipping and intraoperative blood flow monitoring In aneurysm clipping surgery, determining whether the aneurysm clip has been successfully applied without affecting surrounding normal blood vessels is crucial to the success of the procedure. Traditionally, surgeons need to use a separate micro-Doppler probe for blood flow monitoring, which not only requires interrupting the surgical procedure but also carries the risk of surgical field contamination or operational errors due to probe replacement.

[0040] The device provided by this invention integrates suction and Doppler functions into a single unit, allowing the surgeon to monitor the clipping effect in real time without frequent instrument switching during the procedure. The disposable waveguide assembly enables real-time assessment of arterial blood flow, allowing the surgeon to quickly detect abnormalities and adjust the clip position promptly. This real-time feedback mechanism significantly improves the safety and efficiency of aneurysm clipping surgery and substantially reduces surgical risks.

[0041] 5. Surgery for brainstem tumors or vascular malformations Brainstem surgery demands extremely high skill from the surgeon. Due to its unique anatomical location, even the slightest mistake can lead to severe neurological dysfunction or death. Therefore, real-time and accurate identification of important perforating arteries or veins around the brainstem is of paramount importance.

[0042] Using the device of this invention, surgeons can accurately locate important blood vessels during brainstem surgery by utilizing real-time ultrasound blood flow feedback signals, reducing the risk of accidental damage to critical structures. The slender design of the waveguide is also particularly suitable for accessing deep brainstem regions, effectively solving the problem that traditional ultrasound probes are too large to penetrate into minimally invasive channels.

[0043] 6. Other complex intracranial tumors and vascular malformations surgery In addition to the specific implementation scenarios described above, the device of this invention is also widely applicable to various high-risk intracranial surgeries with complex anatomical structures, such as acoustic neuroma resection, arteriovenous malformation (AVM) resection, and moyamoya disease bypass surgery. The waveguide assembly's various morphological designs, such as straight, curved, or with side holes, can quickly adapt to different surgical needs, meeting the stringent clinical requirements for flexibility and precision.

[0044] Commercialization Prospects and Economic Benefits Analysis The disposable ultrasonic waveguide assembly design concept adopted in this invention greatly enhances the commercial potential of the device. Trends in the medical device industry indicate that disposable consumables are gradually becoming a major procurement focus for medical institutions. This is not only due to stringent requirements for hospital infection control but also to hospitals' urgent need for cost control and simplified equipment maintenance. This invention, through its disposable consumable model, eliminates the need for hospitals to invest significant resources in the daily maintenance and sterilization of equipment, thereby substantially reducing hospital management costs.

[0045] From a manufacturer's perspective, the disposable waveguide assembly structure proposed in this invention is simple in design, inexpensive in materials, and easy to scale up production and standardize quality control. Manufacturers can obtain stable market sales revenue and establish a stable business model through continuous production and supply of waveguide assemblies. Compared to the traditional single-device sales model, the sales model of disposable waveguide heads is more sustainable and has greater profit potential, and it is also more in line with current market trends in the medical industry.

[0046] Furthermore, the compatibility of this invention with existing Doppler host systems enhances its market acceptance. Hospitals can enjoy the innovative functions of this invention without replacing or upgrading their existing ultrasound equipment, which significantly reduces the technology adoption costs and facilitates rapid acceptance and widespread use.

[0047] Compared with the prior art, the beneficial technical effects of the present invention are as follows: 1) Precise distance assessment greatly improves the complete resection rate of complex tumors: The main solution is to enable surgeons to precisely detect the course of blood vessels within tumors and the "precise anatomical distance between blood vessels and tumor parenchyma" during the surgical removal of complex tumors surrounding important blood vessels. This greatly increases the possibility of completely removing the tumor while perfectly preserving the blood vessels.

[0048] 2) Continuous operation without interruption, improving efficiency and ensuring thorough control: Intraoperative real-time detection eliminates the need for frequent suction device replacements, significantly improving surgical efficiency. Furthermore, the use of disposable waveguide components completely resolves the problems of incomplete sterilization of the tip of traditional instruments, susceptibility to cross-infection, and high maintenance costs, significantly enhancing the clinical usability and market value of this device.

[0049] 3) Cross-disciplinary neural detection has extremely significant clinical implications: It breaks through the limitation of traditional Doppler which can only visualize blood flow, and enables simultaneous surgical field cleaning and "intraoperative nerve imaging", which greatly avoids compression and accidental damage to fragile nerves in complex surgeries.

[0050] 4) This application utilizes an integrally molded upper and lower parallel double cavity structure to achieve physical isolation between fluid and electronic components, completely eliminating the risk of cross-infection; wherein, the cross-section of the upper and lower parallel double cavity structure is in the shape of an "8", and its large-diameter straight pipe with round hole avoids blockage during drainage.

[0051] 5) The ultrasonic transducer of this application does not need to undergo high temperature and high pressure sterilization, its lifespan is extended by 3-5 times, and its signal stability is significantly improved.

[0052] 6) This application, through the irreversible damage design of the anti-return buckle structure, eliminates iatrogenic infection caused by the reuse of consumables from a physical mechanism. Attached Figure Description

[0053] The invention will be further described below with reference to the accompanying drawings. Figure 1 A schematic diagram showing the use of an integrated ultrasonic aspiration device with a disposable waveguide assembly; Figure 2 A schematic diagram of an integrated ultrasonic attraction device with a disposable waveguide assembly; Figure 3 for Figure 2 External schematic diagram; Figure 4 This is a schematic diagram of the structure of Example 3 with the anti-retraction buckle structure; Figure 5 This is a schematic diagram of the structure of Example 4 with an anti-retraction buckle structure.

[0054] Explanation of reference numerals in the attached figures: 10. Main unit probe end; 11. Handle; 12. Solid-state ultrasonic probe rod; 13. Ultrasonic transducer; 20. Consumable sheath assembly; 21. Suction tubing; 211. Suction tubing tip; 22. Probe isolation sleeve; 221. Closed end; 23. Anti-retraction buckle structure; 231. Breakable arc-shaped piece; 232. One-way thread; 233. Elastic cantilever; 234. V-shaped easy-break groove; 235. One-way clamp; 130. Negative pressure drainage end; 40. Liquid suction end. Detailed Implementation

[0055] The overall structure of the device of the present invention includes the following key parts: handle (operating end), suction tube body (negative pressure suction channel), ultrasonic probe assembly (ultrasonic transducer element), and disposable ultrasonic waveguide assembly (replaceable waveguide head).

[0056] 1) The handle is ergonomically designed to ensure a stable grip and precise control for operators during prolonged procedures. Its shape is designed for slip resistance, fatigue prevention, and ease of operation, and it is made of lightweight yet robust medical-grade plastic or metal. The handle integrates the Doppler ultrasound transducer's drive and signal receiving modules, and a standard interface for connecting to existing hospital negative pressure suction devices and ultrasound main unit is provided at the tail. The control buttons or toggle switches on the handle are simple and intuitive, allowing operators to quickly activate and deactivate the ultrasound detection function.

[0057] 2) Suction Tube Body (Negative Pressure Suction Channel): The suction tube body is a slender tubular structure, typically 15-25 cm in length and 5-8 mm in diameter, to accommodate narrow neurosurgical access routes. The tube wall is made of medical-grade high-strength stainless steel or titanium alloy, combining lightweight and high strength, and can be repeatedly sterilized under high temperature and pressure without affecting its performance. The suction tube body has an internal cavity design, connected to the hospital's negative pressure system, used for intraoperative removal of blood, tissue fluid, and fine tissue debris. The front end of the suction tube has a standard connection interface for connecting a replaceable disposable ultrasonic waveguide assembly. The interface is specially designed with a sealing ring or O-ring structure to ensure a tight connection with the waveguide head without leakage.

[0058] 3) The ultrasound probe assembly is the core electronic component of this device, integrating a miniature, high-performance ultrasound transducer chip capable of emitting and receiving high-frequency ultrasound signals (typically in the 10MHz-20MHz range) for real-time blood flow detection and vessel localization. The transducer is cleverly embedded within the front end of the suction tube body near the waveguide head, and its surface undergoes a special waterproof encapsulation process, enabling it to operate stably in humid tissue environments for extended periods while avoiding damage from sterilization processes. The transducer is connected to the ultrasound drive module in the handle via a highly flexible, insulated miniature cable, which is concealed within a dedicated cable groove in the suction tube body wall to ensure it is not interfered with or damaged during operation.

[0059] Detailed Design of Disposable Ultrasonic Waveguide Assembly (Wavehead) The disposable ultrasonic waveguide assembly is a key innovation and realization method of this invention, and has the following detailed structural design: (1) Overall structure of waveguide The waveguide assembly is designed as a disposable, replaceable sleeve or tubular structure. Its front end features an open or closed acoustic diaphragm structure to ensure efficient ultrasonic wave transmission while providing sufficient structural strength to support the suction function. The rear end of the waveguide head has a standardized connection interface with a high-precision threaded or snap-fit ​​structure on the inner wall, which mates with the corresponding interface at the front end of the suction tube body for quick installation and secure connection.

[0060] (2) Optimization of ultrasonic waveguide materials and structures The waveguide head is constructed using medical-grade ultrasonic sound-transmitting materials, such as medical-grade polycarbonate (PC) or polyether ether ketone (PEEK). These materials have excellent acoustic properties (low attenuation, high sound transmission) and good biocompatibility, making them suitable for scenarios involving long-term contact with human tissues.

[0061] The waveguide head is designed with a coaxial double-layer structure. The outer layer is a high-strength solid acoustic medium, while the inner layer is a through negative pressure suction channel. The two are tightly bonded together with no gaps or gaps through a special molding technology, thereby achieving efficient propagation of ultrasonic waves and avoiding ultrasonic signal attenuation.

[0062] (3) Acoustic conduction enhancement technology To further enhance the waveguide efficiency and stability of ultrasound, the inner wall of the waveguide head can be pre-coated with a layer of medical coupling agent or filled with an appropriate amount of liquid ultrasound coupling medium. These coupling media are close to the acoustic impedance of tissue, which can further reduce signal loss during sound wave propagation and significantly improve the sensitivity and clarity of blood flow detection.

[0063] (3) Waveguide interface and quick replacement mechanism The interface design at the rear end of the waveguide assembly is standardized, featuring leak-proof sealing gaskets and a self-locking structure. During surgery, the operator only needs slight rotation or pushing to install the waveguide head, which remains securely connected to the main device after installation and will not loosen due to pulling or twisting during the procedure. After surgery, the waveguide head can be quickly removed by simply rotating it in the opposite direction or pressing the release button. The operation is convenient and rapid, completed within seconds, greatly improving the smoothness of the procedure.

[0064] Compatibility and adaptability optimization design This device is specifically designed for compatibility with mainstream Doppler ultrasound equipment on the market. The structural design of the ultrasound probe and waveguide head is fully compatible with existing medical equipment in terms of ultrasound frequency, energy output mode, and signal processing standards. For example, if the user already has mainstream intraoperative Doppler equipment such as the Smartdop 45, this device can be used directly plug-and-play without any modification or upgrade to the hospital's existing equipment, thus minimizing the hospital's technology introduction costs.

[0065] Sterilization and protection design optimization This invention features a modular design. The front waveguide is disposable and requires no sterilization. The rear main body is made of high-strength medical-grade materials, resistant to conventional high-temperature, high-pressure sterilization or low-temperature plasma sterilization. The internal electronic components of the handle are sealed, waterproof, and moisture-proof, allowing for routine surface disinfection without additional special sterilization processes. This tiered sterilization design not only ensures medical safety but also effectively extends the lifespan of the device and reduces maintenance costs.

[0066] Human-computer interaction and safety design considerations The ultrasound start / stop button on the device's handle is clearly visible and easy to operate, allowing the surgeon to easily switch the ultrasound function on and off with one hand during surgery. The device's suction channel features a quick-adjustment opening, allowing the surgeon to adjust the suction intensity in real time with simple fingertip movements on the handle, further improving the precision and comfort of the procedure.

[0067] refer to Figures 1 to 5 The present invention has the following design structure: Example 1 This embodiment discloses an integrated ultrasonic attraction device with a disposable waveguide assembly, including a solid ultrasonic probe 12 and a consumable sheath assembly 20 that is plugged into the solid ultrasonic probe 12.

[0068] The working principle of this example is as follows: During surgery, blood and tissue fluid are only suctioned away through the upper suction tube 21, and the fluid contact surface is only disposable plastic consumables. The ultrasonic transducer 13 inside the solid-state ultrasonic probe 12 emits ultrasonic waves, which are transmitted to human tissue through the extremely thin acoustically transparent plastic wall of the closed end of the probe isolation sleeve 22, and the echo signal is received. After the surgery, the solid-state ultrasonic probe 12 is removed, and the high-value main unit inside remains completely "blood-free" throughout the entire process, requiring only surface disinfection.

[0069] refer to Figure 1 and Figure 2 The solid-state ultrasonic probe 12 can be made of medical-grade stainless steel and is a solid cylinder. Its front end is internally encapsulated with an ultrasonic transducer unit, and its other end is electrically connected to the main unit's detection end. The ultrasound transducer unit is one of an ultrasound transducer, a Doppler ultrasound transducer, or a high-frequency ultrasound transducer. Specifically, depending on the surgical requirements, different solid-state ultrasound probes 12 can be selected and equipped with different ultrasound transducer units. For example, a Doppler ultrasound transducer is used to detect blood flow and blood vessels, while a specialized high-frequency ultrasound / musculoskeletal ultrasound transducer (such as a high-frequency linear array probe element) can be used. By switching between different frequency probe assemblies on the same ultrasound host, the doctor can clearly display the morphology, thickness, presence of edema, compression, tearing, or tumor invasion of peripheral and deep fine nerves (such as the median nerve, ulnar nerve, radial nerve, sciatic nerve, common peroneal nerve, facial nerve, and auditory nerve) using the high resolution of high-frequency ultrasound. This allows for precise dual detection of both "blood vessels" and "nerves" under the same suction device. The rear end is connected to the host probe end 10, which includes operation buttons and a cable interface. The probe has a smooth, completely sealed outer wall without any suction or cleaning channels.

[0070] refer to Figure 2 The consumable sheath assembly 20 is integrally injection molded from medical-grade polycarbonate or polyetheretherketone material and is a disposable consumable. Its cross-section has a figure-eight-shaped side-by-side structure.

[0071] In this embodiment, a disposable ultrasonic coupling gel capsule or acoustically transparent pad is pre-installed on the inner wall of the probe isolation sleeve near the closed end; the medium used to conduct sound waves is designed to eliminate air and improve imaging quality; the coupling agent is mainly used to fill the tiny gaps between the probe and uneven tissue, while the acoustically transparent pad, while having a filling function, can also increase the distance between the probe and the target area. The consumable sheath assembly also includes a series of sleeves with straight heads, different pre-bending angles, and different length specifications.

[0072] The consumable sheath assembly 20 specifically includes a suction tube 21 and a probe isolation sheath 22; (See reference) Figure 1The suction tube 21 protrudes slightly forward from the sealed blind end 221 of the probe isolation sleeve 22, forming a stepped shape, so as to facilitate quick identification of the suction tube 21 and the probe isolation sleeve 22.

[0073] The suction tube 21 is located in the upper part and is a hollow tube that runs from front to back. The rear end is a negative pressure drainage end 30 connected to a negative pressure source, and the front end is a suction end 40, which is used for blood suction and irrigation during the operation.

[0074] The probe isolation sleeve 22 is located in the lower half and is a blind tube structure with an open rear end and a completely closed front end. Its frontmost end forms a closed end 221, where the plastic wall is extremely thin and has excellent sound transmission performance, serving as an ultrasonic sound transmission window.

[0075] The specific usage process of this device is as follows: Before the procedure, the nurse removes the individually packaged disposable consumable sheath assembly 20. The front end of the solid-state ultrasonic probe 12 is aligned with the rear opening of the probe isolation sleeve 22 and pushed in axially. During insertion, the anti-reverse locking structure 23 elastically engages, producing a "click" sound, indicating proper installation. At this point, the ultrasonic transducer 13 at the front end of the solid-state ultrasonic probe 12 is tightly abutted against the inner wall of the closed end 221, with no air gap between them, ensuring efficient transmission of ultrasonic waves.

[0076] During the procedure, the doctor holds handle 11 to perform the operation.

[0077] When the negative pressure source is activated, blood, irrigation fluid, and tissue debris in the surgical area enter the suction line 21 through the suction end 40 and are discharged through the negative pressure drainage end 30. The fluid only comes into contact with the wall of the disposable plastic tube.

[0078] When it is necessary to identify hidden blood vessels, the ultrasound switch is activated. The ultrasound transducer 13 inside the solid-state ultrasound probe 12 emits high-frequency sound waves. The sound waves pass through the plastic wall of the closed end 23 of the probe isolation sleeve 22 and enter the tissue. When they encounter flowing blood, they generate a Doppler frequency shift signal, and the echo is then transmitted back to the transducer through the plastic wall. Since the solid-state ultrasound probe 12 does not come into contact with contaminated liquid, the signal transmission is stable and there is no signal attenuation.

[0079] After the surgery, the medical staff used the handle 11 to pull out the solid-state ultrasonic probe 12.

[0080] Because the outer surface of the removed solid ultrasonic probe 12 was protected by a plastic sheath throughout the procedure, it was free of blood and tissue contamination. It only required low-level surface disinfection with alcohol-containing wipes before it could be used for the next surgery.

[0081] Example 2 In transsphenoidal skull base surgery, due to the deeper surgical channel, an extended consumable sheath assembly 20 can be used. The lengths of its suction tube 21 and probe isolation sleeve 22 are correspondingly increased to 15-20 cm, but the rear anti-retraction buckle structure remains completely identical to the standard type. The solid-state ultrasound probe 1 maintains universal specifications, adapting to consumables of different depths without requiring replacement of the main unit, significantly reducing hospital procurement costs. During use, the solid-state ultrasound probe 12 is slid into the blind tube of the probe isolation sleeve 22 of the consumable sheath assembly 20 until the probe end face is tightly against the inner wall of the closed end.

[0082] Example 3 Based on Embodiment 1, one end of the probe isolation sleeve 22 is designed as a closed end 221, and the other end is equipped with an anti-retraction buckle structure 23 to fasten onto the handle 11.

[0083] refer to Figure 4 The anti-retraction buckle structure 23 includes an annular seat coaxially connected to the end of the probe isolation sleeve 22, and three breakable arc-shaped pieces 231 integrally disposed on the annular seat; wherein, a one-way thread 232 is pre-formed on the inner wall of the breakable arc-shaped pieces 231. The handle 11 is provided with an external thread adapted to the one-way thread 232; the one-way thread 232 is used to prevent the handle 11 from being pulled upwards. The anti-reverse buckle structure 23 can be made of plastic. When the handle 11 needs to be pulled out, the breakable arc-shaped piece 231 can be directly twisted off to achieve separation, which also avoids damage to the consumable sheath assembly 20 and avoids secondary use.

[0084] After the surgery, the solid ultrasonic probe 12 was pulled out. Due to the damage to the anti-retraction buckle 23 structure, the consumable sheath assembly 20 could not be reinstalled and used. The internal high-value host was "blood-free" throughout the process and only surface disinfection was required.

[0085] Example 4 Based on Embodiment 1, the anti-retraction buckle structure 23 of this embodiment is designed to include an integrally formed elastic cantilever 233 extending rearward, with a radially inwardly buckling one-way latch 235 at the end of the elastic cantilever 233; an annular groove 111 is provided on the root shell surface of the host detection assembly 5 or the solid ultrasonic probe 12 to lock in conjunction with the one-way latch 235; to achieve irreversible anti-reuse damage, a V-shaped easy-break groove 234 with reduced wall thickness is provided at the root of the elastic cantilever 233; when the consumable sheath assembly is forcibly pulled out axially, the one-way latch 235 is blocked and restricted by the annular groove 111, and the stress is concentrated at the V-shaped easy-break groove 234, causing the elastic cantilever 233 to undergo irreversible brittle fracture.

[0086] This application is particularly applicable to the following typical clinical application cases. Application Case 1 Neuroprotection during auditory neuroma surgery In neurosurgical resection of acoustic neuromas, the tumor is often tightly adhered to the facial and auditory nerves, making it difficult to discern the nerve pathways with the naked eye. The surgeon uses this device equipped with a high-frequency ultrasound transducer to simultaneously aspirate fluid and tumor debris from the surgical area while performing real-time, high-definition scanning through a disposable isolation sheath. High-frequency ultrasound clearly displays the precise pathways and boundaries of the facial and auditory nerves, helping surgeons perfectly protect these nerves during tumor removal, which has significant intraoperative clinical value.

[0087] Application Case 2 Applications in plastic and cosmetic surgery and peripheral nerve entrapment surgery The high-frequency ultrasound aspiration integrated device proposed in this application also has significant interdisciplinary application value. In complex plastic and cosmetic procedures (such as facelifts, facial liposuction, maxillofacial surgery, and deep injections), the facial nerve network and peripheral nerve branches are densely packed and highly susceptible to damage. Using the high-frequency neuro-ultrasound mode of this integrated device, doctors can track the location of minute nerves in real time and precisely avoid critical nerve plexuses. This completely avoids the most dreaded complication of facial nerve injury and disfigurement during cosmetic surgery; it can also be used in nerve decompression procedures such as carpal tunnel syndrome, greatly increasing the device's application scenarios and commercial value.

[0088] Application Case 3 Application in skull base tumors (tumor surrounding the internal carotid artery) Skull base tumor surgery is recognized as one of the most challenging neurosurgical procedures due to its complex anatomy, dense vascularity, and high risks. In particular, when the tumor surrounds or is adjacent to the internal carotid artery, safely separating the tumor tissue while protecting the internal carotid artery presents the greatest technical challenge for the surgeon.

[0089] The specific implementation steps during surgery using the ultrasonic aspiration integrated device with disposable waveguide components of the present invention are as follows: (1) Preoperative preparation: Based on preoperative imaging data (MRI or CT angiography), the surgeon assesses the relationship between the tumor and the internal carotid artery, preliminarily determines the surgical approach and strategy, and selects the appropriate waveguide head specifications (slender, straight, or curved).

[0090] (2) Waveguide head installation: Before the procedure, the assistant quickly retrieves the disposable waveguide assembly and rotates it onto the front end of the suction tube, completing the installation in just a few seconds. The ultrasound machine is then turned on, signal transmission is confirmed to be stable, and preparations are made for the surgery to begin.

[0091] (3) Intraoperative procedures: After exposing the tumor in the surgical field, the surgeon uses this device to penetrate the anatomical space between the tumor and the internal carotid artery. While using negative pressure suction to remove accumulated blood and debris from the surgical area and maintain a clear surgical field, the surgeon simultaneously monitors the blood flow signal in the anterior tissue using Doppler ultrasound. When the suction waveguide approaches the wall of the internal carotid artery, a clear Doppler signal indicates strong arterial blood flow, allowing the surgeon to immediately identify the anterior structure as an artery and avoid further advancement that could lead to accidental damage.

[0092] (4) Intraoperative fine dissection: With the help of real-time ultrasound feedback, the surgeon can safely and efficiently separate the adhesions and tumor tissue between the tumor and the internal carotid artery layer by layer. Once the waveguide head approaches the vessel wall, Doppler audio immediately provides a clear prompt, allowing the surgeon to accurately judge the distance between the surgical instruments and the vessel and adjust the operating path in real time, avoiding accidental damage to the vessel.

[0093] (5) Postoperative procedures and instrument retrieval: After the surgery, the assistant quickly removed the used waveguide head and disposed of it properly. The main body only needs routine surface wiping and disinfection before it can be used again. The overall operation is fast, hygienic and safe.

[0094] This embodiment demonstrates that, in complex surgical scenarios involving skull base tumors surrounding the internal carotid artery, the use of this device not only significantly improves surgical precision and safety but also saves surgical time and reduces the risk of intraoperative complications, showcasing the unique and outstanding clinical application value of this device.

[0095] Application Case 4 Application in intracranial aneurysm clipping surgery (intraoperative real-time blood flow monitoring) In intracranial aneurysm clipping surgery, the disposable waveguide of this device also demonstrates significant technical advantages. The specific implementation process is as follows: (1) Before the operation, select the appropriate waveguide head specification (usually a straight waveguide head) and complete the installation, and start the ultrasound Doppler host.

[0096] (2) Blood flow detection before aneurysm clipping during surgery: After the aneurysm is clearly exposed, the surgeon uses the Doppler function at the front end of the probe of this device to listen to the arterial blood flow in real time close to the neck area of ​​the aneurysm, accurately determine the location, width and direction of the surrounding normal blood vessels of the aneurysm neck, and assist the surgeon in determining the optimal position for placing the aneurysm clip.

[0097] (3) Real-time monitoring of the effect after aneurysm clip placement: After clipping the aneurysm neck, the operator immediately uses the probe of this device to re-clamp the distal and proximal arteries to assess in real time whether arterial blood flow is obstructed after clipping. If a clear and strong arterial pulsation signal is heard, it indicates that the clipping operation was successful and no normal blood vessel was mistakenly clipped; if an abnormality or no signal is detected, the operator can adjust the clip position immediately.

[0098] (4) After the operation is completed, quickly remove the waveguide head and discard it. The main device is kept in reserve.

[0099] This embodiment shows that the device of the present invention significantly improves the accuracy and safety of intraoperative aneurysm clipping, avoids the risk of serious complications caused by accidental clipping of arteries, and also shortens the operation delay caused by repeated probe changes during the operation.

[0100] Application Case 5 Applications in brainstem surgery (e.g., brainstem cavernous malformations). Brainstem surgery demands extremely high precision; even the slightest error can lead to catastrophic consequences. This example uses brainstem cavernous malformation surgery as a case study: (1) Select a slender waveguide and complete the installation to ensure that the front end of the probe is suitable for the narrow passage of brainstem surgery.

[0101] (2) Intraoperative fine suction and real-time blood flow detection: The surgeon slowly advances into the brainstem lesion area, aspirating blood and tissue fluid from the surgical field to maintain a clear view while monitoring blood flow signals along the path of advancement in real time. When the probe approaches a vital brainstem perforating artery, the ultrasound unit immediately emits a clear audio signal indicating blood flow, allowing the surgeon to immediately stop further advancement and instead bypass the area around the vessel, safely removing the lesion without damaging the blood vessel.

[0102] (3) The waveguide head can be quickly removed after the operation without complicated sterilization, which greatly improves the efficiency of hospital equipment management and infection control.

[0103] This embodiment highlights the crucial role of this device in high-risk brainstem surgery, demonstrating its safety, precision, and efficiency.

[0104] Application Case 6 Applications in other complex neurosurgical procedures In addition to the typical scenarios mentioned above, the multi-specification waveguide heads of this device can be widely used in other neurosurgical procedures, such as acoustic neuroma resection, intraventricular tumor resection, and intracerebral hematoma evacuation. Its clinical applications are extensive and flexible.

[0105] For example, in intraventricular tumor resection, the surgeon can quickly change to different sizes of waveguides to accurately locate the blood vessels around the tumor in the ventricle, while simultaneously cleaning the surgical field to ensure precise, safe and complete tumor removal.

[0106] Through the detailed description of the above-mentioned specific implementation cases, the neurosurgical suction-Doppler ultrasound probe device and its disposable ultrasound waveguide assembly provided by the present invention significantly improve the safety, accuracy and operational efficiency of complex neurosurgical operations, solve key problems that have long been difficult to solve effectively in clinical practice, and demonstrate great technological innovation and clinical application value.

[0107] The implementation examples of this device are not limited to the specific situations mentioned above. This invention can be applied to and leverage its advantages in any surgical scenario involving surgical field cleaning and real-time intraoperative vascular monitoring.

[0108] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. An integrated ultrasonic attraction device with a disposable waveguide assembly, characterized in that: Includes a solid ultrasonic probe (12) and a consumable sheath assembly (20) that is plugged into the solid ultrasonic probe (12). The consumable sheath assembly (20) includes a suction tube (21) and a probe isolation sheath (22) arranged side by side with the suction tube (21). One end of the suction tube (21) is connected to the negative pressure drainage end (3), and the other end is provided with a liquid suction end (40); the probe isolation sleeve (22) is a blind tube structure.

2. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 1, characterized in that: The solid ultrasonic probe (12) has an ultrasonic transducer built into its end, and its other end is electrically connected to the main unit probe (10). The ultrasound transducer unit is one of an ultrasound transducer (13), a Doppler ultrasound transducer, or a high-frequency ultrasound transducer. In use, by switching probe components of different frequencies on the same ultrasound host, the high resolution of high-frequency ultrasound can be used to clearly display the morphology, thickness, presence or absence of edema, compression, tearing or tumor invasion of peripheral and deep fine nerves, thereby achieving dual precise detection of "blood vessels" and "nerves" under the same suction device.

3. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 2, characterized in that: The solid ultrasonic probe (12) is a solid column, and an operating handle (11) is provided on its other end.

4. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 1, characterized in that: The suction tube (21) and the probe isolation sleeve (22) are integrally formed.

5. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 1, characterized in that: The suction tube (21) is a hollow tube, one end of which is connected to a negative pressure source through the negative pressure drainage end (3), and the other end is the front end (221) of the suction tube. The front end (221) of the suction tube is connected to the suction end (40) through the suction tube.

6. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 3, characterized in that: One end of the probe isolation sleeve (22) is provided with a closed end (221), and the other end is provided with an anti-retraction buckle structure (23) to fasten to the handle (11).

7. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 6, characterized in that: The anti-retraction buckle structure (23) includes an annular seat coaxially connected to the end of the probe isolation sleeve (22) and a plurality of breakable arc-shaped pieces (231) integrally disposed on the annular seat; wherein, a one-way thread (232) is pre-made on the inner wall of the breakable arc-shaped pieces (231).

8. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 6, characterized in that: The anti-reverse buckle structure (23) includes an integrally formed elastic cantilever (233) extending rearward, and the end of the elastic cantilever (233) is provided with an inwardly buckling one-way buckle (235); the root shell surface of the host detection component (5) or the solid ultrasonic probe (12) is provided with an annular buckle groove (111) that cooperates with and locks with the one-way buckle (235); a V-shaped easy-break groove (234) with reduced wall thickness is opened around the root of the elastic cantilever (233).

9. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 1, characterized in that: A disposable ultrasonic coupling gel capsule or acoustic pad is pre-installed on the inner wall of the probe isolation sleeve (22) near the closed end (221).

10. The ultrasonic attraction integrated device with disposable waveguide assembly according to claim 1, characterized in that: The consumable sheath assembly (2) also includes a series of sleeves with straight heads, different pre-bending angles, and different length specifications.

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