Release date: 2006-10-08 Analysis of the future trend of medical machinery technology-------------------------------------------- ------------------------------------ X-Ray Products,X-Ray Protective Products,X-Ray Machine Product,X-Ray Protective Ningbo Cland Medical Instruments Co., Ltd. , https://www.ruipumedical.com
In 1998, the Center for Instruments and Radiology (CDRH) of the US Food and Drug Administration (FDA) published a research report titled "Future Trends in Medical Instrument Technology," which predicts medical technologies that will be significantly developed by 2007. . The report summarizes these technologies into six categories, including computer-related technology, molecular medicine technology, family and self-health, minimally invasive technology, device and drug combinations, and device replacement and auxiliary devices, and subdivides them into 21 technologies. There are 36 specific products with promising prospects. To date, the actual development of medical devices is basically in line with the content of the report.
In 2005, the MDDI editorial department of the American professional journal pointed out that there are ten important medical instrument technologies that are affecting patient diagnosis, clinical practice, product development and medical machinery industry. They are: implantable coated instruments, carotid stents. , cardiac assist devices, artificial bone and skin grafts, artificial orthopedic disks, nucleic acid-based IVD (in vitro diagnostic) devices, medical lasers, medical imaging technology, wireless technology, computer-assisted surgery.
Although this report is based on the situation of the United States and other developed countries, it may not be fully applicable to China, but its analysis is very useful. Because the United States is the world's largest producer and user of medical devices in the world, and the value of medical devices sold to foreign markets each year is between $4 billion and $5 billion. The analysis and predictions represent, to some extent, international medical devices. The most cutting-edge perspectives and trends in the industry. In the recently issued "Eleventh Five-Year Development Guidance for the Pharmaceutical Industry", China has also clearly stated that the development goal in the field of medical devices is to add 10 to 20 digital, non-invasive or minimally invasive medical equipment and medical materials into the industry. Turn. This coincides with the prediction of the future direction of medical devices by American experts.
Implantable coated devices: not only for heart disease Since 2003, it has been impossible to discuss the development of the medical machinery industry without studying drug-coated stents. For patients, doctors, medical companies and investors, the enormous benefits of drug-coated stents are rare in the field of medical devices. Two drug-coated stents approved by the FDA, Cypher of J&J and Taxus of Boston, are the first products to be introduced to the market. Industry insiders predict that with the development of new generation products and the application of coating principles to other technologies, their huge impact will continue in the future.
Coronary atherosclerotic heart disease is one of the leading causes of death in humans. It was first treated with bypass surgery, followed by percutaneous coronary angioplasty (PTCA), but the rate of restenosis remains high. After the use of vascular stents, compared with the angioplasty, can reduce the rate of postoperative restenosis by about 30%, but because the stent is mostly made of metal, it can cause inflammation, and its long-term traction on blood vessels will lead to blood vessels. Intimal hyperplasia causes restenosis of the blood vessels, so in-stent restenosis remains a problem; today, drugs that inhibit inflammatory response and intimal growth in vascular stent coating can inhibit the occurrence of restenosis in the stent.
More than one-third of patients who are placed in uncoated metal stents will experience re-occlusion of the artery. The clinical advantage of drug-eluting stents is to reduce the rate of restenosis and to reduce the inflammatory response caused by stent compression of the artery. Complications were reduced by the same procedure, and patients and doctors quickly accepted the new device. This clinical advantage has caused major changes in the market in a very short period of time. Four or five companies selling uncoated metal stents have been replaced by two companies that sell drug-coated stents. The Cypher stents that entered the market in 2003 and 2004 The Taxus stent entering the market immediately occupied 80% of the market. At present, more than 90% of stents implanted in US patients are drug-coated stents. It is predicted that by the end of 2006, the US market will see more than $6 billion in drug-coated stents.
The development of such products is inseparable from the study of stent coating materials. The stent coating materials are usually divided into inorganic materials, polymers and gelatin proteins.
The inorganic coating reduces the metal stent and blood contact and improves the biocompatibility of the stent. Its research has evolved from diamond-like, semiconductor SiC to ceramic materials. Animal experiments have confirmed that ceramics have good biocompatibility, and the stent used as a coating carries the immunosuppressant tacrolimus, which can significantly inhibit the intimal hyperplasia of rabbit arteries.
Polymer coating materials are generally classified into two types: biodegradable and non-degradable. The biodegradable polymer is used as a coating to increase the biocompatibility of the stent and as a drug carrier, and the drug is released as the material is degraded. However, studies have shown that a variety of biodegradable polymers can cause inflammation and intimal hyperplasia in animals, so the material is currently not used to improve the blood compatibility of the stent, but because it can carry drugs to reduce restenosis. rate. Phosphocholine and polyurethane are two of the most promising polymers in non-degradable polymers. Phosphocholine has good blood compatibility and has been used as a sustained release carrier for various drugs, and it has a good prospect for use as a stent coating. Polyurethane can cause inflammatory reactions in animals, but it does not cause intimal hyperplasia, so it is also very concerned.
The use of parylene, or Parylene, as a coating, or an important influence on the development of drug-coated stents. For the medical device industry, Parylene is not a new material, but just a new use - Palin has been widely used in medical instruments to eliminate microporous biocompatibility and biological fluids for nearly 30 years. Various problems related to corrosion. For arterial stents, Parylene is used in a variety of applications: as a binder or tie layer, Parylene coating is used between metal stents and drug or drug carrier polymers; as a drug release control agent, Parylene is used. On the drug coated stent. The Cypher scaffold of Sirolimus carrying the immunological preparation is coated with modified Parylene.
The stent coating is divided into passive coating and active coating. The so-called passive coating is to apply a material with good biocompatibility to the surface of the stent as a barrier to reduce the adverse effects of the stent. The active coating is a stent coating with a drug that directly inhibits endocardial hyperplasia. Active coatings are further divided into chemical coupling and adsorption depending on the mode of action of the drug and the coating material. Chemical coupling means that the drug is chemically attached to the surface of the coated stent, and the adsorption is to direct the coating material to encapsulate the drug therein by sponge or method.
By adjusting the geometry of the stent and the synthetic material, increasing the elasticity of the stent and reducing its rigidity, it can reduce the damage to the vessel wall, and fundamentally inhibit the proliferation of the intima; and enhance the blood of the stent by synthesizing a new coating material. Compatibility, drug loading, and effectiveness minimize the incidence of restenosis. This is the development direction of drug-coated stents. In addition, the combination of stent coating technology and transfer technology will also become an effective method for treating restenosis.
The success of drug-coated stent technology will have a huge impact on the medical industry. It marks the beginning of a new development period for devices and drug combinations. Because of the combination of instruments and drugs, it is not only the gospel of heart patients, but also good news for other patients. Many medical and pharmaceutical companies and pharmaceutical companies will work together to develop a wide range of medical products, such as:
·Neural Stimulating Device · Dental Implants · Vascular Stitching Devices · Chest Implants · Hearing Aids · Prostate Treatment Devices · Contraceptive Obstruction Devices · Pacemakers and Electrical Stimulation Wires · Spinal Repair Devices · Joint Replacement Devices · Diabetes Treatment Devices · Neurostimulation Devices In summary, drug-eluting stent technology has created one of the most important market opportunities in the history of the medical industry. Its success is due to its ability to treat diseases effectively, while avoiding patients undergoing surgery for restenosis, helping to reduce health care costs. Parylene plays an important role in this process, and with the development and application of a new biocompatible modified Parylene, this technology will be extended to other medical applications.
Carotid Stent: A Major Progress in Preventing Strokes Just as cardiovascular stents have fundamentally changed the treatment of coronary artery disease, carotid stents may revolutionize the current state of stroke prevention. Guidant's Acculink neck stent device and Accunet embolization device approved by the US FDA in 2004 gave doctors the opportunity to verify. Clinical trials have shown that the Guidant device can reduce the likelihood of a stroke causing a stroke in the US dollar compared to traditional surgery. If these effects are confirmed in clinical practice, it is possible to change the various ways to prevent the stroke of the dollar. In theory, cervical stents can replace carotid endarterectomy in patients with a risk of stroke. But in practice, it is still necessary to continue research.
Carotid endarterectomy is a highly invasive procedure in which a plaque is removed from the patient's carotid artery after an incision is made in the neck. In stent surgery, the stent is implanted into a small incision in the groin and then moved to a defined site. Because some patients are too dangerous to perform surgery, carotid stents have been developed for such patients.
However, there is still disagreement as to whether this minimally invasive method can be the best treatment. Because carotid endarterectomy is highly damaging, it is safe and effective with a success rate of 95%. Some people think that it is difficult to prove whether the stent surgery with less damage can do better than others. It is also believed that carotid stent surgery is more difficult to perform than coronary stent surgery. If the removed plaque enters the brain, it may be Causes permanent brain damage; detached plaques rarely cause permanent damage if they enter the heart. Studies have shown that when part of the heart loses function, quality of life is maintained, and when part of the brain is no longer functional, quality of life is severely affected. Therefore, it is critical to help prevent plaque from distal protection during surgery into the brain.
Difficulties in the design and manufacture of carotid stents differ from coronary stents. The carotid artery is smaller, and it is more difficult to manipulate the stent in it, and the ease of implantation and release is a major challenge for developers. The molecules must be attached to the surface of the catheter to allow the catheter to slide freely. The catheter is made of a plastic material with low friction and a hydrophilic coating.
Although there are doubts about carotid stenting technology, the development and application of this technology has never stopped. In the market, we can also see another product - the Neurolink (R) bracket device. Because fat deposits accumulate in intracranial blood vessels (atherosclerotic disease), some patients may have intracranial strokes of the dollar, and the Neurolink(R) device may be used when the drug treatment is ineffective. In 2003, the FDA approved this product from Guidant under the Humanitarian Instrument Exemption Program.
The medical instrument consists of a nerve connection stent and a delivery catheter and a neural connection balloon extension catheter. The nerve-jointed stent and delivery catheter have an expandable stainless steel stent that provides a structural scaffold to the blood vessel that helps open the blood vessels and keep the blood flowing.
The delivery catheter delivers the neural connection scaffold into the blood vessels in the brain through the circulatory system. The delivery catheter places the stent and expands the stent to a certain diameter at a specified pressure. Once the stent is properly placed, the extension catheter expands the inner diameter of the invaded vessel. Such devices can be used if the intracranial blood vessels (2.5 mm to 4.5 mm in diameter) are narrowed to 50% or more. The FDA quickly approved the device because it helps maintain the proper diameter of the blood vessels and allows the proper amount of blood to flow into the brain. However, patients who are highly sensitive to heparin, stainless steel, anesthetics, X-ray contrast agents, and those who cannot tolerate slow elimination of blood clots cannot use such devices.
Similar technology products include the Neuroform(TM) micro-transport holder. In 2003, the FDA also approved this micro-transport stent to prevent rupture of cerebral aneurysms with the Humanitarian Instrument Exemption Program. An abnormally thinned portion of the artery produces an aneurysm that stretches over time, forming a balloon-like bulge in the arterial wall; if left untreated, the thinned portion may rupture.
The Neuroform consists of a stent and a delivery system. The stent is a tubular small mesh that can be permanently placed in the opening of the aneurysm. The delivery system is essentially a soft catheter that is used to deliver the stent to the juxtaposition of the aneurysm. When the stent extension is aligned with the interior of the artery wall, the delivery catheter is withdrawn. Subsequently, another catheter is placed through one of the small holes in the stent mesh, and the small metal coil (referred to as the embolus coil) is slid into the aneurysm by the root catheter. This coil prevents blood from flowing into the aneurysm and prevents the aneurysm from rupturing, while the stent prevents the coil from slipping out of the aneurysm sac. There are many intracranial aneurysms in the neck. After the metal clip is placed on the neck of the aneurysm without treatment, the stent device can be used for treatment.
—— Information from: China Medical News