1. Introduction to injection pen
Pen syringe, referred to as injection pen, is a product that "combines drugs and syringes into one". It looks like a pen and mainly consists of a pen cap, refill, syringe barrel and needle. The drug is stored in the refill, which is generally used with a specific injection pen. Refills from different manufacturers are not compatible. When using, remove the pen cap, install the injection needle and exhaust it, adjust the required dose and drive the injection button to achieve and complete drug delivery.
Injection pens generally have the following characteristics: 1) Self-injection operation is simple, convenient and safe; 2) Reduce drug waste and the dose is adjustable; 3) Automatically return to zero after injection (set the zero return prompt sound); 4) The scale window is enlarged, The injection resistance is reduced, the pain is relieved, and the user experience is improved. The use of injection pens for injection not only enhances patient dependence and reduces economic burden, but also alleviates the social pressure of "fewer doctors and more patients".
Currently, injection pen manufacturers commonly used in the domestic market include Novo, Eli Lilly, Sanofi, Bayer, Tonghua Dongbao and other medical device companies. Most of their products are imported or commissioned to be designed and manufactured abroad. They are widely used in medicines including diabetes, insulin, and growth. Self-management in various chronic disease areas including hormones, osteoporosis treatments, multiple sclerosis treatments, anemia treatments, and rheumatoid arthritis.
2. Development History of Injection Pens
The injection pen is a new type of self-injection device derived from the traditional disposable syringe. Its development and birth have gone through the traditional syringe (bottle + syringe), durable injection system (refill + durable injection pen), and prefilled injection The system (refill and injection pen combined into one) has three stages.
The first stage of traditional syringes first appeared abroad. In the early 1980s, they gradually evolved from glass to plastic. In the late 1980s, China also began to introduce disposable plastic syringe technology and gradually replaced glass syringes. Disposable syringes require Professional nursing staff inject drugs into patients, and the treatment has certain limitations. However, due to its advantages of simple structure, convenient operation, and low cost, it is still widely used in drug injection, liquid transfer, scientific research experiments and other fields; Chapter 1 The second-stage medium-durable injection system began in 1985. Novo developed the first convenient reusable injection device, the Novo pen. Products launched at the same time also included injection pen needles and pens used in conjunction with it. Refills and other products; in the late 1980s, Novo developed a new generation of injection devices - pre-filled injection pens. The injection devices have entered a new stage. The pre-filled injection pens are an injection pen and a refill. This product is anti-vandal and anti-counterfeiting. It is a disposable medical device product, so it is also called a disposable injection pen. Its most prominent advantage is "one drug, one device, special drug, special amount, and throw away after use."
3. Development status of injection pens
Compared with the injection method of traditional syringes, the injection pen has many advantages such as simple operation, convenience, accurate dosage, and light pain. Its injection method meets the needs of self-management in the field of chronic disease development. Since the birth of the injection pen, various pharmaceutical giants and designers Companies are committed to researching drug self-injection devices, innovating on the basis of the first-generation injection pens, and have developed a series of new products. The improvement and optimization of injection pens are mainly reflected in the pen refill chamber and injection adjustment mechanism: the improvement direction of the pen refill chamber is to make the refill replacement more convenient and the drug storage and release more convenient; the improvement direction of the adjustment mechanism is reflected in improving the injection In terms of accuracy, simplified structure, and convenience for patient operation, the essential purpose of all improvements is to make patient operation easier, avoid the adverse effects of misoperation, and improve user experience.
At present, existing injection pen products on the market can be classified in two ways. They are divided into reusable injection pens and disposable injection pens according to whether the drugs can be replaced; they are divided into mechanical injection pens according to their different structural principles (energy transfer methods). Pens and electronic smart injection pens.
In the first category, the body of the reusable injection pen and the medicine compartment are generally connected by threads or buckles. After the medicine is used up, a new refill can be replaced for reuse, but the push rod needs to be returned before replacing the refill. It can be used again, so its structural design is more complex than disposable injection pens, with a larger number of parts and complex assembly. Only by rigorous cooperation of each part can an accurate transmission relationship be achieved. Disposable injection pens are "drug-instrument-in-one" products. The pen body and drug compartment are combined into one and cannot be disassembled. However, the structure and function can be designed according to the characteristics, usage method and injection dose of the filled drugs to achieve customized innovative products. Currently, it has Various types of disposable injection pens have been developed, including adjustable, quantitative and freeze-dried drug premixed injection pens, and their development prospects are worth looking forward to.
In the second category, mechanical injection pens are the first technical principle adopted in the field of injection pens. In view of the fact that the technology in this field has reached a stable development, injection pen products with this type of technology are gradually taking a dominant position in the market. For example, Novo's 1st to 5th generation products developed by Novo, Eli Lilly's Youban series injection pens, and the Type II adjustable injection pen developed by Chengji Pharmaceutical in recent years and the micro-adjustable injection pen under development are all mechanical. The representative product of injection pens; the electronic smart injection pen is a new product that uses motor drive principles to achieve the same functions as mechanical injection pens. Its one-touch button operation enables dose setting and automatic injection, making the injection process simpler. At present, various injection pen products have been developed at home and abroad using this technology, such as SmartPlus designed and manufactured by Diamesco Co., Ltd. in South Korea and the Deful electronic injection pen series of Jiangsu Delphi in China, each of which has digital display, memory, Bluetooth and voice. Injection pen with prompt function.
4. The future and development of injection pens
Since the historical development of injection devices, large foreign pharmaceutical companies have studied the interaction between products, users and the environment through artificial factor engineering and global sharing of various products on the market. The results prove that the ease of operation of chronic disease self-management equipment is the most important factor for patients. The primary issue to consider is that the operating technology of injection pens that meet patient needs will receive more and more attention and use in the medical field. At present, foreign injection pen technology has transitioned from mature mechanical technology to the stage of intelligent injection technology. However, there are only a handful of domestic companies involved in the field of injection pens. Therefore, as one of the few domestic companies that independently develops injection pen products, We need to further adapt to the global design control process on the premise of complying with the country's specific regulatory requirements, forge ahead on the development path of the commercialization model of product collaborative design, strive to achieve the goal of "domestic production replacing imports", and move towards the goal of high-tech enterprises. forward.
