Kambiz Behzadi Presents BMD at LSI USA ‘23

Transcription

Kambiz Behzadi  0:05  

Hello, my name is Kambiz Behzadi. I'm a practicing Orthopedic surgeon in Northern California. My company develops tools, techniques and implants that makes surgical procedure Safer for Patients. I like to discuss an unsolved problem in total hip replacement surgery. This surgical procedure is a $7 billion industry. It's estimated that 13% of hip replacements failed within the first 10 years, and 75% of these failures occur due to aseptic loosening aseptic loosening occurs when a surgical implant fails to bond to bone. These failures cause pain, suffering and loss of mobility for the patient. When hip replacement fails, a revision surgeries performed to correct the problem. These were efficient surgeries cost up to $2 billion per year, and the results are rarely as good as a primary procedure. Up until now, the implant itself has been blamed for aseptic loosening. I really believe that the surgeon assembly technique is actually responsible for these problems, and developing alternatives to the primitive tools that surgeons are forced to rely on with these new tools. The surgeon will have an alternate assembly technique that will prevent aseptic loosening and the need for revision surgery. orthopedic surgeons use a technique of bonding implants to bone known as press fixation central this technique is a surgical mallet which is used to repeatedly impact the implant into the bone cavity. The goal of this technique is to obtain optimal stability of the implant through interference fit. interference fit is achieved with the implant is fully grasped within the concavity. This occurs when the implant is properly sized and it's neither too tight or too loose. However, finding the proper size of the implant is elusive because it can only be determined qualitatively to the surgeons auditory and tactile senses. Only by listening for the changes in pitch and feeling for the changes in the bones grasp of the implant can the surgeon know whether they've reached optimal implant stability. Most surgeons never develop the qualitative sensors they need because 80% of surgeons who perform total hip replacement perform less than 10 per year. When a surgeon performs a hip replacement, they must first size the bone carry by broaching or removing the bone cavity. He's going cavities have certain physical properties and behaviors when stretch they behave like springs and produce a reactive force that grasps the implant. These physical properties can be modeled with a classical stress strain curve of material size. Each cavity is unique because each patient has a different bone mineral density based on age and sex, and all one cavities have their own distinct elastic limit or sweet spot of optimal stability. This is the point at which the cavity can no longer stretch to fit the implant. This limit is known to be between half a millimeter to a millimeter past this point and the cavity fractures. Conversely, if the bone is not stretched enough, then a tight fit is not obtained at all. In the sizing process the first air is introduced. Error is also possible when force is applied to install the implants. At this stage, the surgeon uses a surgical mallet to repeatedly strike the implant to the bone cavity. And here the surgeon has no idea how much force they're applying with each mallet strike. Mallet strikes vary wildly in the amount of force and this compounds the original sizing error because in a CT fractures damage the bone cells and bone vascularity. Considering all this is clear that surgeons do not have the proper tools to press with implants reliably. I'm developing a set of assistive technologies to help surgeons press with implants properly. These technologies provide a quantitative method of sizing bone and uncontrolled method of applying source for student install intense, these technologies will prove to be safer, more efficient, and in time they will become the standard of care. These technologies are premised on replacing surgical mallet with an alternative force applied by the man that is problematic for two reasons the mallet gives a surgeon no control over either the magnitude or the direction of force that they apply. When the magnitude of force is unregulated. The surgeon surgeon can either over impact or under impact the implant into the bone cavity, both of which can cause aseptic loosening. When the directional force is unregulated, the surgeon can cause undesirable torques with each mallet strike. This can cause mouth position of the implant which can also necessitate hip revision surgery to replace the surgical mallets and developing vibratory insertion tools, these tools will utilize both Sonic and ultrasonic vibrations. This technology for implant insulation has a distinct advantage. It disarms frictional forces at the implant on interface. This allows easy control of alignment and requires much less force for implant installation. When less force is applied, bone cells and bone vascularity are not damaged. And when frictional forces are dramatically reduced, surgeons can continuously adjust the alignment of the implant. This type of adjustment is not possible with the surgical mallet. With each mallet strike. The implant is locked into position with no possibility of Adjusting to implant between metal strikes. The development of vibratory insertion technology is also critical to the development of next generation of implants many future implants will have delicate sensors to detect infection and metal debris and the high magnitude impacts of the ballot may damage the sensors. For administration to also incorporate a new technology and IV display will provide the positional readings of the implants alignment. This will give the surgeon the opportunity to make real time adjustments. Even with all this functionality, this to delight handheld and will not add cognitive load for the surgeon. To accompany the weapon insertion tool, there are two systems that can size go and cavities quantitatively. The first system uses a sensor suite with a bomb preparation tool. This suite measures forces both within the bone and within the tool itself. These measurements are fed into feedback algorithm that signals to the surgeon when they've reached the last pillar of bone. The second system utilizes analog electronics to measure current and power consumption. These variables have a direct relationship with the frictional forces that exist at the infant on infants. This relationship can be utilized to quantitatively identify the elastic limit of bone and therefore the sweet spot of optimal stability for each patient. The immediate market for the verb insertion tool is the global total hip replacement market. The eventual market will expand into knee and shoulder arthroplasty and then into trauma related implants. We're talking about here standardizing the assembly technique in orthopedic surgery. We don't know if any other company that's thought of this endeavor. Once these technologies are developed, anticipate licensing them to the major medical device companies anticipate these tools will easily pass 510 K premarket notification. The commercialization phase will also involve collaboration with these companies to manufacture market and distributed tools. The basic tool itself would likely cost no more than $2,000 to produce it will have a durable lifetime of two to three years or an expanded lifetime with maintenance and service contract. In the United States, they may be up to 10,000 hospitals and surgery centers that may each make a capital purchase. The tool will be open source along for use by all medical device companies. This tool presents an opportunity for additional revenue because it requires a disposable adapter for use with various implants. Disposable adapters can be produced at a low cost and retail that high premium. The orthopaedic disposal market is a $59 billion industry and working with academic researchers and contract engineers to develop these ideas. I'm seeking 4 million in funding to finish development of these tools. With this funding. These tools could be ready for clinical testing within 18 to 24 months. Thank you very much