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Capacitive Stimulation of Bones to Enhance Fracture Recovery. John Chi, Mike Desalvio , Kevin Ip Mike Nguyen, Khine Win. Bone Fracture. Osteoporosis affects 75 million worldwide (1) 1 in 3 women over 50 1 in 5 men over 50 In Europe, it costs more to treat than cancer (2)
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Capacitive Stimulation of Bones to Enhance Fracture Recovery John Chi, Mike Desalvio, Kevin Ip Mike Nguyen, Khine Win
Bone Fracture • Osteoporosis affects 75 million worldwide (1) • 1 in 3 women over 50 • 1 in 5 men over 50 • In Europe, it costs more to treat than cancer (2) • In US: 2 million fractures costs $17 billion (3) • Inpatient Care (57%), Long-Term (30%), Outpatient (13%) • Reduce Costs by reducing time for recovery
Studies • Evidence suggests that an electrical current can stimulate cell growth and thus bone repair • Lorich: Capacitive stimulation of rat MC3T3-E1 bone cells (4) • Nakajima: Electrical Accupuncture in Rats (5)
Lorich Study • MC3T3-E1 • Mouse Osteoblastic Cells • Capacitive Coupled cells to 20 mV/cm • Increase in cell proliferation
Nakajima Study • Surgically fractured Rat Tibia • Stuck a needle at surgical site • Cathode end • A second needle 15 mm away • Anode end • Stimulation of electrodes daily over 3 weeks
Nakajima Study • Rat Bone mass (radiograph): • Electrical group: 35.66 +/- 4.27 mm2 • Control group: 29.72 +/- 6.39 mm2 • Sham group: 32.60 +/- 5.73 mm2 • Mechanical testing: • Electrical group: 16.54+/-9.92 N • Control group: 6.67+/-3.12 N • Sham group: 7.13+/-3.57 N
Results • Improvement was seen at the cellular and structural level through capacitive coupling • Design a device to stimulate bone growth via capacitive electrical stimulation
Capacitive Coupling Device • Using a cathode and anode to promote bone growth, low level AC current increases flow of calcium ions into osteoblasts
Design Considerations • Infection • Ease of use • Patient psychology (fear of needles) • Level of discomfort • Storage
Device Features • Disposable needle cartridges • Friendly appearance (soft edges, friendly colors) • Computer-controlled needle insertion (feedback on skin for galvanic responses to fear and pain to adjust needle insertion rate) • Gradual increase in current to therapeutic levels
Device Features • Soft adhering strap • Disposable needle • Controlled delivery • User-friendly • Needles not visible • UV Sterilization • Ultrasonic measures
Research vs Device • Research shows electrical stimulation can produce bone growth (osteoblasts) • Device uses technology verified by research to provide bone growth in patients with fractures • Research involves methodology only • Device considers many factors, hygeine, patient psychology, practitioner usage
Research vs Device • Research done in clinical and sterile environment (lab) • Device is robust and functions in varied environments (hospitals, doctor’s office, home) • Research feedback is crude (requires x-ray) • Device provides “friendly” feedback through ultrasound
Reference • EFFO and NOF (1997) Who are candidates for prevention and treatment for osteoporosis? OsteoporosInt 7:1. • Luo L and Xu L (2005) Analysis of direct economic burden of osteoporotic hip fracture and its influence factors. Chinese Journal of Epidemiology (Vol.9). • Burge R, Dawson-Hughes B, Solomon DH, et al. (2007) Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 22:465. • Biochemical pathway mediating the response of bone cells to capacitive coupling.Lorich DG, Brighton CT, Gupta R, Corsetti JR, Levine SE, Gelb ID, Seldes R, Pollack SR. ClinOrthopRelat Res. 1998 May;(350):246-56. • Effect of electroacupuncture on the healing process of tibia fracture in a rat model: a randomised controlled trial. Nakajima M, Inoue M, Hojo T, Inoue N, Tanaka K, Takatori R, Itoi M. Acupunct Med. 2010 Sep;28(3):140-3. Epub 2010 Jun 15.