Shanxi Medical University to Transfer Cardiovascular Puncture Assistance Device Patent for RMB 500,000

Recently, Shanxi Medical University regarding its held utility model patent“A Cardiovascular Puncture Assistance Device”Proposed to be500,000 yuanThe full rights of this patent are transferred to Taiyuan Shuangding Technology Co., Ltd. for RMB. The inventor of this patent isWang Yuyao and Her Team。

Image from the official website of Shanxi Medical University

The core of the present invention lies inIntegrated Synchronous Sterilization and Anti-Kinking Guidance Function:By incorporating a built-in three-way stopcock structure with a disinfectant sponge, the device automatically disinfects the surface as the trocar passes through. Meanwhile, its guide ring system, equipped with guide balls and a conical shield, effectively prevents catheter kinking caused by thrust force, ensuring smooth operation. This device addresses clinical pain points associated with existing puncture assistance devices, such as the inability to perform simultaneous disinfection and insufficient anterior support leading to catheter deformation, thereby significantly enhancing the safety, precision, and efficiency of cardiovascular puncture procedures.

In current clinical practice,Cardiovascular Puncture (Including Arterial and Central Venous Puncture)As a fundamental component of critical medical procedures such as intensive care, perioperative management, interventional diagnosis and treatment, and hemodynamic monitoring, its safety and success rate directly impact patient prognosis and healthcare quality. Although the widespread adoption of imaging technologies, such as ultrasound guidance, has significantly improved puncture accuracy, the mechanical manipulation during the puncture process remains highly dependent on supportive devices. However, existing puncture assistance devices still exhibit numerous limitations in structural design, functional integration, and clinical applicability, failing to meet the comprehensive requirements of modern precise, safe, and efficient puncture procedures.

First,Disconnection between disinfection and puncture procedures, with inadequate aseptic assurance.Current standard operating procedures require chemical disinfection of the skin (e.g., with povidone-iodine or chlorhexidine) prior to puncture, with the procedure performed only after the antiseptic has dried. However, this “two-step method” creates operational gaps in both time and space: after disinfection is complete, the needle, catheter, or operator’s gloves may come into contact again with the peripheral skin areas that are not fully isolated, posing a risk of potential microbial contamination.

Particularly in high-burden settings such as emergency departments and intensive care units (ICUs), the rapid pace of procedures and complex environments predispose to cross-contamination, thereby increasing the risk of local infections and even catheter-related bloodstream infections (CRBSI). Currently, the vast majority of puncture-assist devices available on the market do not integrate real-time disinfection capabilities, failing to achieve simultaneous surface sterilization at the moment instruments penetrate the skin barrier. This results in a “technical loophole” in aseptic technique at critical junctures.

Secondly,The guiding structure design is simplistic and lacks effective mechanical support for the catheter/needle body.Most existing assistive devices offer only static angular guidance and cannot dynamically adapt to changes in tissue resistance. During procedures involving long puncture paths (such as femoral artery puncture in obese patients) or deep-seated vessels (such as the internal jugular vein), the needle or guidewire is prone to bending, deviation, or even buckling due to lateral resistance from heterogeneous tissues, including subcutaneous fascia and adipose layers, during advancement.

Once the distal tip of the catheter loses its linearity, it not only reduces the first-attempt puncture success rate but may also cause mechanical complications such as intimal tear, pseudoaneurysm, and hematoma formation. More seriously, some low-cost or disposable auxiliary devices made of materials with insufficient rigidity may deform under stress, further exacerbating guidance failure.

Third,Absence of anterior support, resulting in poor puncture stability.Existing devices mostly provide initial angular constraints on the skin surface, but lack a continuous support mechanism for the mid-to-distal path of the needle after it enters the subcutaneous tissue. Once the needle tip passes through the epidermis, the procedure reverts to a “freehand” state, relying entirely on the operator’s tactile feedback and experience to control the insertion trajectory.

This structural flaw, characterized by “anterior stability and posterior instability,” is particularly pronounced in complex scenarios such as vascular anatomical variations, hypotension-induced vascular collapse, or patient agitation. It significantly increases the rate of procedural failure and the number of repeat punctures, thereby prolonging procedure time, exacerbating patient discomfort, and elevating the risk of complications.

Fourth,Limited functionality and lack of system integration.Puncture-assistance products currently available on the market exhibit a “fragmented” landscape: some are designed solely to fix the puncture angle, others serve merely as guidewire channels, and still others rely on external disinfection procedures. Few devices organically integrate core functionalities—such as disinfection, guidance, kink resistance, and stable advancement—into a single structure. This functional fragmentation not only increases procedural steps and consumable usage but also raises the technical proficiency required of operators, hindering standardized adoption. These limitations are particularly pronounced in primary healthcare institutions and emergency rescue settings.

Finally,There is a significant application gap between high-end and low-end products.On one hand, high-end puncture systems based on electromagnetic navigation, robotic assistance, or augmented reality (AR) offer advantages in precision and intelligence but are hindered by high costs, bulky sizes, and complex operations, making them difficult to popularize in routine clinical settings. On the other hand, simple plastic puncture guides, while low-cost, suffer from limited functionality and insufficient reliability, failing to meet the demands of complex puncture procedures. This status quo of “high-end being inaccessible and low-end being unreliable” highlights an urgent clinical need for a mid-range, integrated puncture assistance device that combines high performance, low cost, ease of use, and broad applicability.

In summary, existing puncture assistance devices inSterility Assurance, Mechanical Support, Structural Continuity, Functional Integration, and Clinical Accessibility...all exhibit systemic shortcomings, making it difficult to meet the comprehensive requirements of modern precision medicine for operational safety, efficiency, and standardization.

Therefore, there is an urgent need to deeply integrate engineering innovation with clinical demands to develop an integrated cardiovascular puncture assistance device capable of simultaneously achieving automatic disinfection, dynamic guidance, and anti-kink protection—this is the core issue that this patented technology aims to address.

The cardiovascular puncture assistance device proposed in this patent systematically addresses the inherent defects of existing puncture assistance devices in terms of sterile assurance, guidance stability, and operational convenience through structural innovation and functional integration, demonstrating significant technical advantages and clinical value. Its core innovations are mainly reflected in the following four aspects:

First, we pioneered an integrated “simultaneous disinfection-puncture” mechanism.The device integrates a three-way lumen containing a disinfectant-soaked sponge within its main structure. As the trocar advances, it automatically passes through this lumen, achieving immediate, closed-loop disinfection of the instrument’s outer surface prior to skin penetration. This design overcomes the temporal and spatial disconnect inherent in the traditional “disinfect first, puncture later” approach, effectively blocking pathways for secondary contamination during the procedure. By technically reinforcing the sterile barrier, it significantly reduces the risk of infection.

Second, construct a multi-level anti-kinking guidance system.The distal end of the device features a composite guidance structure composed of a guide ring, a conical shroud, and embedded ball bearings. The guide ring provides initial axial constraint, while the conical shroud forms a progressively narrowing channel to guide the needle into a centered trajectory. Meanwhile, the embedded ball bearings roll during catheter advancement to reduce friction and dynamically correct any deviation. This multi-level synergistic mechanism not only effectively prevents bending or kinking of the puncture needle or catheter due to tissue resistance but also enhances the linearity and controllability of the puncture path, making it particularly suitable for deep vascular access or patients with complex anatomical conditions.

Third, compact structure, easy operation, and controllable cost.The entire device adopts a modular design, with its main body injection-molded from disposable medical-grade polymer materials. It requires no external power supply or complex control systems, ensuring both biocompatibility and usage safety while significantly reducing manufacturing costs. During clinical use, the device simply needs to be adhered and fixed to the skin to achieve dual functions of disinfection and guidance, substantially simplifying the operational workflow and shortening the learning curve. This facilitates its promotion and application across medical institutions at all levels, particularly in primary care settings.

Fourth, strong adaptability, covering multiple puncture scenarios.This device is designed to meet the requirements of both arterial and venous puncture. It can be widely used for radial and femoral arterial blood gas sampling and invasive blood pressure monitoring, and is also suitable for central venous catheterization procedures such as internal jugular and femoral venous access. Its universal design eliminates the need for multiple specialized instruments for different vessel types, thereby improving equipment utilization and clinical practicality.

In summary, the patented technology of this invention achieves“Sterilization–Guidance–Anti-Kinking”The tripartite functional integration, while ensuring operational safety, significantly improves the first-attempt success rate, procedural efficiency, and standardization level of cardiovascular puncture. It fills the technological gap in existing mid-range puncture assistance devices and holds clear prospects for clinical translation and industrialization value.

Currently, products or technical solutions on the market with functions similar to those of the patent “A Cardiovascular Puncture Assistance Device” are mainly concentrated in several representative categories of devices and patented designs. Although each has its own focus, none has achieved an organic integration of the three core functions: sterilization, guidance, and anti-kinking.

Arrow (Teleflex)ofArterial/Central Venous Puncture KitIt is a classic product widely used in clinical practice. Its accompanying plastic guide frame provides only basic angle fixation, featuring a simple structure and low cost, and has achieved high penetration globally in the fields of critical care and anesthesia. In recent years, Arrow has enhanced ultrasound compatibility in its kits. Meanwhile, its central venous puncture kits, leveraging mature solutions and high cost-effectiveness, lead in market penetration within the global anesthesia and critical care sectors, boasting a solid market foundation.

3M CompanyLaunchedIoban™ Antimicrobial Incise Drapes and ChloraPrep™ Series Skin Prepping Systemsrepresents another technical pathway—Continuous antimicrobial activity at the puncture site achieved through adhesive films containing iodine or chlorhexidine.These products have clear evidence-based support for preventing catheter-related infections and have been included in the recommendations of multiple clinical guidelines. Currently, in China's hospital infection prevention and control market, 3M Ioban™ antimicrobial surgical drapes and the ChloraPrep™ skin preparation system, backed by robust evidence and explicit guideline recommendations, have achieved high penetration rates in key departments such as tertiary hospitals and ICUs, becoming essential supplies for the prevention and control of catheter-related infections.

Overall, the current market for puncture assistance devices exhibits a “polarized” landscape: at one end are traditional guide frames that are widely adopted but offer limited functionality; at the other are intelligent navigation systems that are precise and efficient yet costly and complex. Mid-range integrated products that balance safety, practicality, and cost-effectiveness remain scarce. As demands for medical quality rise, primary healthcare capacity building advances, and hospital infection prevention and control measures become increasingly stringent, clinical demand for puncture assistance tools that are “one-step, safe, reliable, and require no additional training” will continue to grow.