Zhejiang Tongli Modified Engineering Plastic Co., Ltd.
What is PEEK's future in the medical field?
Polyetheretherketones (PEEK), Chinese name called polyether ether ketone, is made up of hydroquinone and 4, 4 '- two fluorine diphenyl ketone through multiple step polycondensation reaction of a high performance polymer.
Polyether ether ketone can stand out among many medical raw materials because of its own characteristics.
Biocompatibility is the most basic requirement for whether a material is suitable for an implant. The implanted material must be cytotoxic, mutagenic, carcinogenic and non-allergenic.
Evonik (Evonik) company VESTAKEEP ® embedded polyether ether ketone, independent testing agency (GLP laboratory) abroad not only strictly in accordance with the requirements of the ISO10993 biocompatibility tests, but in China, directly under the CFDA surgical implants with polyether ether ketone whole project inspection qualification and orthopedic medical devices all project qualification of testing institutions, strictly follow the requirements of Chinese national standard GB16886 complete biological compatibility test.
Domestic and international test reports indicate that Evonik VESTAKEEP® implant grade POLYEtherketone has excellent biocompatibility without any side effects.
X ray penetrability
Compared to metals, VESTAKEEP® implant grade POLYEtherketone can be penetrated by X-rays with good visibility: 1. Avoid creating artifacts on X-ray film; 2. The operation can be carried out with the assistance of CT scan or MRI to help doctors adjust the position of the implant during the operation and easily track the healing process after the operation, so as to realize good monitoring of bone growth and healing.
The modulus of elasticity is closer to cortical bone
VESTAKEEP® implant grade polyetherketone is rigid and flexible, and the elastic modulus is closer to the bone, which can effectively alleviate the stress masking effect. The stress on the bone is not fully borne by the implant, making the bone healthier and longer.
Since its inception, PEEK has been active in various fields of medical devices. If a patient has a degenerative spine condition, doctors usually recommend removing the affected disc and replacing it with a prosthetic implant called a "fusion cage." The fusion cage is thought to provide an osseous connection between adjacent vertebrae. The central hole of the fusion cage can be filled with calcium phosphate or the patient's own bone. Intervertebral fusions are mostly anatomic, and their serrated surfaces provide a high degree of "initial firmness," a steadiness that is achieved only by the clamping effect of the implant.
In addition to the intervertebral fusion cage, the researchers also developed innovative applications of PEEK in the spinal field, including the lumbar transpedicular screw dynamic fixation system, the lumbar intervertebral process implant system, artificial intervertebral discs and artificial nucleus pulposus.
PEEK suture rivets are widely used in sports medicine, most commonly to treat rotator cuff or ligament tears or other intra-articular injuries. Metal suture rivets are prone to complications such as loosening, pulling out and cartilage damage. The presence of high-strength stitches increases the load at the joint of the stitching rivet, thus increasing the risk of cutting at the joint. PEEK stitching rivets can avoid these problems; PEEK also has higher strength than absorbable rivets.
Whether it's a birth defect or a skull injury caused by an accident or disease, a skull implant is designed to protect a patient's fragile brain. Thanks to 3D scanning technology, the skull's three-dimensional structure is accurately reconstructed on a computer, and then a personalized skull implant is produced using A CNC cutting process.
For patients, they prefer ultra-low thermal conductivity materials: when the ambient temperature of patients changes drastically, for example, in winter when patients move from warm indoors to cold outdoors, the excellent thermal conductivity of titanium skull plates will make patients feel pain and discomfort.
VESTAKEEP® implant grade polyetheretherone cranial-maxillofacial implants have been certified by FDA 510(K).
PEEK materials have been used in dental implant accessories such as temporary base, healing cap, and healing base for more than 10 years. The VESTAKEEP® porcelain enhanced PEEK is a new material designed specifically for the dental prosthetics. Compared with common metals, zirconia, alumina and other materials, it has the following advantages: 1:1 cutting in CAD/CAM process, no sintering, more accurate; Low density, light weight, comfortable to wear; Soft texture, damping effect for each bite; Excellent biocompatibility, will not release metal or monomer and other substances incompatible with the human body, prevent gingival allergy and colored porcelain modified PEEK gives out a natural white luster, beautiful and durable.
Implantable fluid pump
This is an implantable, battery-operated pump that transports excess ascites from a patient with hepatic ascites to the bladder and out of the body. Eliminate the pain caused by regular puncture of traditional puncture.
Hypoglossal nerve stimulation system
VESTAKEEP® hypoglossal nerve stimulation system, made from implanted grade polyetherketone, is CE certified for the treatment of obstructive sleep apnea syndrome (OSA). In clinical trials in the United States and Australia, the vast majority of patients showed significant decreases in obstructive sleep apnea and significant improvements in sleep quality, quality of life, and overall health.
In order to meet various clinical needs, Evinco has successively developed various derivatives of VESTAKEEP® imbedding PEEK, barium sulfate developed PEEK and carbon fiber (CF) enhanced PEEK, and carried out PEEK coating research with some companies that provide coating services for medical devices. Existing test results from independent testing institutions indicate that VESTAKEEP® implantable PEEK has excellent tensile and shear strength and is strongly coated to meet all FDA requirements. With the in-depth research on PEEK performance and the development of PEEK based derivatives, PEEK polymers have an immeasurable application prospect in the medical field.