Orthopaedics

Controllable Compression™ Technology

BME’s Nitinol implant are the only controllable heat-activated
implants on the market. Unlike superelastic and body
temperature-activated Nitinol staples, the OSStaple™ lines (smooth,
barbed, step and arc) are heated using the patented OSSforce™ Implant
Controller. The OSSforce™ is a bipolar electrical resistance unit that
safely warms each implant to non-necrotic temperatures using
implant-specific time and power settings. With the OSSforce™, the
surgeon can adjust the amount of compressive force our implants exert,
making this Nitinol fixation system the only one suitable for cases
involving questionable bone quality. Other methods of heating
heat-activated staples, such as the application of electrocautery, are
unsafe for the patient and may damage hospital equipment. Through
design innovations and sophisticated manufacturing techniques, BME has
become the world leader in shape memory implant development and
production.

HyProCure has been created to provide the best solution to an extremely common condition, instability of the subtalar joint complex. This subtalar stabilization device transposes the negative space of the sinus tarsi into a positive space. Due to the unique design of HyProCure, utilizing both the canalis and sinus portion of the sinus tarsi, it restores the normal triplane motion while eliminating the excessive motion of the talus on the calcaneus.

Unlike any other sinus tarsi stabilization device, HyProCure is medially anchored into the canalis portion of the sinus tarsi. The lateral end of HyProCure prevents the abnormal closure of the space. The forces from the talus simply glide over HyProCure. It reorients the posterior facet of the talus to its corresponding calcaneal surface and the proper dimensions of the sinus tarsi are restored. True functional mobility of the talus on the calcaneus is repaired to give its helicoidal glide and the entire talocalcaneonavicular joint is made congruent.

HyProCure offers a life-long solution and due to its revolutionary design offers patients from pediatric to geriatric with a flexible condition the option of this minimally invasive, life changing solution.

The OSSpineâ„¢ implant offers controlled compression of vertebral segments at the time of surgery to enhance fixation and graft retention. It also actively compresses the fusion construct compensating for any graft subsidence that may occur during healing.

Our Nitinol Technology
Nitinol is an alloy comprised of approximately 50% nickel and 50% titanium. It can exist in two phases, or states: martensite and austenite. These phases are similar to the phases in which other substances can exist (in the case of water, for instance, liquid and solid ice). Nitinol’s martensitic phase is associated with lower temperatures and a molecular arrangement that allows the metal to be softer and more malleable. Its austenitic phase is associated with higher temperatures and a cubic, more stable and rigid molecular arrangement.

Though a manufacturing process, Nitinol can be programmed to transform from martensite to austenite through a designated temperature range. Heating Nitinol though this transformation temperature range causes it to change from a softer metal to a stronger metal.

In addition to change in the molecular arrangement, Nitinol also possesses two characteristics that are displayed as the material is heated through its transformation temperature range: shape recovery (or shape memory) and superelasticity. Shape recovery occurs when a Nitinol device, when heated though its transformation temperatures, returns to a predetermined shape. Superelasticity refers to the characteristic of the metal to store heat energy and use that energy to exhibit a spring-like behavior. Both of these characteristics can work hand-in-hand. For instance, a Nitinol device in martensite that is heated through its transformation temperature will exhibit a shape recovery effect as it transforms to austenite. If that device is physically prevented from fully returning to its predetermined shape, it is said to be in a constrained martensite state. As long as a heat source is available, the device will continually attempt to return to its austenitic phase and its predetermined shape and thus it will exhibit a spring-like behavior.

Biocompatibility
Nitinol possesses additional characteristics that make it a beneficial material for orthopaedic use. It is highly biocompatible when properly surface treated and has been used in orthodontic wires and cardiac stents for decades. BME employs a sophisticated manufacturing process that creates a protective corrosion resistant surface and minimizes nickel on the surface.

Strength
With comparable treatments, Nitinol has a higher breaking strength than 316L stainless steel when in austenite. This allows for the development of low-profile fixation devices that provide excellent strength and construct stability.

Continuous Compression™ Technology
BME’s OSStaple™ lines (smooth, barbed, step and arc) are heat-activated Nitinol devices. They remain in martensite (soft and malleable) at room temperature and transform into austenite as they approach 56°C. As they are heated through their transformation temperature range, their shape recovery properties compress the bone fragments to which they are fixated. The surrounding bone tissue constrains the implants, preventing them from fully reaching their predetermined shape and austenite phase. As long as these implants are exposed to heat energy, they will remain in a constrained martensite state, behaving like springs and maintaining a compressive force on the bone fragments (although heated to 56°C, they are programmed to
maintain a significant amount of force as they cool down to normal body temperature). Our implant lines thus produce immediate compression at the time of surgery and continuous compression throughout the healing process.

Controllable Compression™ Technology
BME’s Nitinol implant are the only controllable heat-activated implants on the market. Unlike superelastic and body temperature-activated Nitinol staples, the OSStaple™ lines (smooth, barbed, step and arc) are heated using the patented OSSforce™ Implant Controller. The OSSforce™ is a bipolar electrical resistance unit that safely warms each implant to non-necrotic temperatures using implant-specific time and power settings. With the OSSforce™, the surgeon can adjust the amount of compressive force our implants exert, making this Nitinol fixation system the only one suitable for cases involving questionable bone quality. Other methods of heating heat-activated staples, such as the application of electrocautery, are unsafe for the patient and may damage hospital equipment. Through design innovations and sophisticated manufacturing techniques, BME has become the world leader in shape memory implant development and production.

The Grip is the first addition to BME’s new OSSAnchorâ„¢ line of soft tissue implants. The Grip is able to “hold on” to bone through its unique shape memory and superelastic properties.

The BOSS is a ground-breaking enhancement of our gold standard OSStapleâ„¢ and Step OSStapleâ„¢ implants. Aggressive barbs and a special surface treatment create a powerful, stable construct with more than five times the migration resistance of traditional shape memory bone implants.

The Grip is the first addition to BME’s new OSSAnchor line of soft tissue implants. The Grip is able to “hold on” to bone through its unique shape memory and superelastic properties.

The 9-inch width provides extra firmness and support. The belt can also be used as a back support.

Elastic wrist support with tension strap. 7″ long wrist support features duo-tension elastic for compression, a 4″ tension strap with plastic insert and hook and loop closure. Plastic insert on tension strap provides added stability, without impairing flexibility or dexterity. Support does not exceed beyond palmar crease and allows finger and thumb mobility. Tension strap edge is tapered to prevent snagging. Useful for Tendonitis and Carpal Tunnel Syndrome management.

A support nylon ankle brace for men and women. Recommended for minimum strain and sprains to reduce swelling and add stability. Discreet neutral (Beige) color. Compression 30 mmHg.

Durable, lightweight, design with shorter one-piece wrap-around posterior shell. Provides immobilization for acute ankle injuries and stable fractures of the foot.

The low profile design provides comfortable stability for acute ankle sprains, soft tissue and stress fractures to the lower leg and ankle, and stable fractures of the ankle. Other features include fixed, malleable uprights, a breathable fiber leg wrap, comfortable heel pads and non-skid rocker sole.

NeuroMetrix’s patented, single use biosensor eliminates one of the most time-consuming and error-prone steps in nerve conduction studies – proper placement of electrodes on the patient. Using simple to find anatomical landmarks, the biosensor is accurately applied. Each biosensor is uniquely engineered for the specific nerve tested and connects easily to the NC-stat monitor. Currently, biosensors are available for the median, ulnar, peroneal, tibial, and sural nerves.

A biosensor is a preconfigured array of electrodes, eliminating the need for multiple placement sites and precise measurements. The NC-stat biosensor integrates flexible circuitry and a proprietary electrochemical gel with sensing electrodes. An embedded chip monitors skin surface temperature, an important covariate for nerve conduction studies. A unique serial number is also embedded in the chip to conveniently link patients to their test results.