Intelligent Implant System for Bone Lengthening

A novel implant system for bone elongation will be presented. With this technique, the body's own bone material, so-called callus, can be formed by gradual distraction of the tubular bones, thus achieving an extension of femur and tibia bones. The driving principle of this fully implantable bone lengthening system is based on a shape memory element. During the surgical treatment, the intramedullary nail serves to stabilize the severed bone and enables the formation of new, endogenous bone material to lengthen the limbs or to bridge bone defects. The intramedullary nail is implanted into the medullary cavity and fixed at both ends with locking bolts. A receiver coil implanted under the skin receives the necessary energy twice a day through high-frequency energy transport to activate the thermal phase transformation of the shape memory element. This gradually increases the bone gap by 0.5 mm each time and stimulates callus formation. Consequently, osteoblasts or osteocytes are formed in the area of the desired bone extension and load-bearing bone material is formed. Three nail prototypes have already been tested for their functionality in a cadaver study in a German clinic. Currently a redesign of this intelligent implant system is underway, focusing on a novel coil geometry, a monitoring sensor system and control technology and a novel connection technology for the drive components. With this intelligent implant system, it will be possible for the first time to lengthen the bones in a patient-friendly manner and to continuously monitor, document and evaluate the entire lengthening process

Shape memory driven intramedullary nail for bone elongation

These days, medical applications of shape memory alloys (SMAs) can be found in cardiovascular devices, gastroenterology and urology as well as in the area of orthopedic implants, orthodontic devices and clinical instrumentation. Their functional properties combined with excellent biocompatibility increase the possibility and the performance of minimally invasive surgeries. Overviews of existing applications can be found in [1-2]. Within the medical field, most of the applications with shape memory (SM) material take advantage of the superelasticity of NiTi SMAs. In contradiction to the superelastic or mechanical SM effect, the application described in this study uses the thermal SM effect for a new medical implant. Before explaining the SM driven intramedullary bone nail in detail, a short introduction to the bone elongation technique is given. The background of this application on based in the medical fact that normally any tissue reacts to an injury with repair and healing processes through multiplication of cells. If after a transverse osteotomy a strain stimulus is activated, for example by tensile stress, this multiplication of cells and new formation of tissue may be continued for any length of time. Due to this mechanism, even considerable loss of bone caused by fractures or congenital defective positions, may be compensated without bone grafts. The technique of callus distraction by means of external fixation or intramedullary nail stimulates the formation of callus in the bone gap. Callus is the repair tissue of the bone generated in the fracture gap in case of bone fracture or osteotomy. The gap to be bridged should not be wider than 1 mm per day [3]. The process starts with the exudation of callus around the ends of the broken bone. At first, callus is more like a fibrous tissue. Later it hardens due to deposition of calcium and eventually it is converted into true bone. Three weeks after severance, the vascular system is formed. An overview of current bone lengthening techniques, also called callus distraction, can be found in [3]. External systems are normally used for the extension of bones, the bone fragments being fixed on rings by wires. The decisive disadvantages of those external systems are primarily the considerable risk of infection due to protruding wires, noticeable discomfort for the patient because of the external rings, a coarse cosmetic result because of scarring, as well as rather long hospitalization. Therefore, internal bone extension systems are of great interest to orthopedic surgery