Michael Hausman, MD, an orthopedic surgeon at Mount Sinai Medical Center in New York City, discusses five points about the Checkpoint Stimulator/Locator, a device designed for use during orthopedic and other types of surgery to prevent nerve damage.
1. How the project began. Dr. Hausman, who was among the surgeons who helped develop Checkpoint Stimulator/Locator, says initial impetus for developing the device was to prevent accidental nerve injuries during surgery. There are several thousand malpractice cases filed every year as a result of accidental nerve damage, and the total costs associated with those cases is often more than $1 billion per year. "When patients suffer nerve injury, it's often a lifelong problem," says Dr. Hausman. "If you disrupt anything else, such as a bone or blood vessel, it can be fixed, but if you accidentally cut a nerve, it's often disabling and there is a permanent deficit. We wanted to create something to help surgeons identify a nerve and protect them."
Checkpoint was designed to show surgeons where a nerve is located so the surgeon can decide to either avoid the nerve or carefully push it aside to expose the surgical site. "Recently, there have been some remarks in the literature that suggest surgeons really should make an effort to identify and protect the nerve as a standard of care," he says. "In ENT, the literature suggests that it is incumbent on the surgeon to do something to protect the nerves. It won't be long until other specialties follow."
2. Ease of use in the OR. When designing the device, the surgeons wanted to create something simple, portable and readily available for use. They wanted to ensure the device was small, battery-powered and disposable so it could be accessed instantaneously by the surgeon and wouldn't place a great burden on the OR staff. "If you have a case and are suddenly worried about the nerve, the Checkpoint provides you with a device immediately ready for use, sterile and easy to operate," says Dr. Hausman. "It's use is intuitive and surgeons need very little to no training to operate the Checkpoint Stimulator."
3. How it works. The Checkpoint Stimulator's probe delivers physiologic stimulus to the nerve in a wave form to mimic the body's natural electrical impulses. The device has a broad range of stimulus intensity — it can create a full strength sustained contraction of a big muscle or stimulate nerve fascicles. The surgeon is able to adjust the size and shape of the electrical impulse as the situation dictates. "The initial goal was to design something that would detect the nerve, but as we've used it, we've actually begun to discover that it can do substantially more than help us find and protect the nerve," says Dr. Hausman. "It's a little bit like having a miniature neurologist with his fancy electrodiagnostic equipment along with him because it can help us determine the variability and contractility of the muscles."
Knowing the viability and contractility of the muscles is useful when surgeons are presented with a situation where they need to decide whether the nerves and muscles are working appropriately or are in need of repair, such as neurolysis, to free the nerve from scar. For instance, if a patient presents a rotator cuff rupture, surgeons can use the Checkpoint to decide whether the muscles are in a good enough condition to proceed with the repair. "We can stimulate the nerve going into the muscle and watch it contract through our arthroscope," he says. "The device works under water in the arthroscopic environment, which is something no other device does. We can assess the function of the nerve to see whether it works and how well it works."
4. Making better outcome predictions. There are some procedures that are dependent on normal nerve conduction and strong muscle function, and if that isn't present, the procedure is more likely to have a bad outcome. If the stimulation shows the nerves and muscles aren't working properly, there are things a surgeon can do to improve function. In one case, a patient was referred to Dr. Hausman after the patient underwent a shoulder operation during which the nerve innervating the biceps was injured Dr. Hausman used the Checkpoint Stimulator to explore the area around the nerve, dissect the nerve under the operating microscope and determined the patient would have a high probability of recovery if he removed the scar tissue.
Dr. Hausman decided to proceed with the scar tissue removal and the patient was able to make a complete recovery. "The chances of nerve injury can be minimized by knowing the proximity of the nerves," he says. "For the second surgery, the device helped me find the damaged nerve, but it also helped me make a decision about the surgery: Did I simply need to remove the scar tissue or did I need to cut out the damaged section and sew the two ends together? It takes a year for the nerve to recover when it is cut and the outcome wouldn't be as good. It isn't clear to the surgeon which procedure would be best and whether the nerve has a chance to recover. The Checkpoint Stimulator helped me make the right guess in this case."
5. Where the Checkpoint Stimulator is now and where it's headed. The Checkpoint was originally distributed in Chicago, New York City, Cleveland and Southern California. The early response has been encouraging and the company, Checkpoint Surgical, has added more representatives to increase the coverage area. Additionally, there has been some demand for the device overseas, and Dr. Hausman said the company is hoping to receive the CE mark clearance by the end of the year.
"Virtually every surgeon who has tried it has reordered it, and for an orthopedic device, that's really unusual," he says. "Our big challenge is really reaching the surgeons — getting the word out and allowing them to try our device. The second challenge is having it approved by hospitals. They are cost sensitive and suspicious of new devices, but they come to realize the value the device provides. The savings from even one prevented nerve injury that results in a lawsuit would pay for a lifetime of Checkpoints for the institution."
Dr. Hausman is a paid consultant of and has financial interest in Checkpoint Surgical.
Learn more about Dr. Michael Hausman.
Related Articles on Orthopedic Surgery:
Steadman Philippon Research Institute Receives $1M Grant To shoulder Research
3 Best Practices for Technologies and Facilities at Hospital-Based Spine Programs
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Checkpoint was designed to show surgeons where a nerve is located so the surgeon can decide to either avoid the nerve or carefully push it aside to expose the surgical site. "Recently, there have been some remarks in the literature that suggest surgeons really should make an effort to identify and protect the nerve as a standard of care," he says. "In ENT, the literature suggests that it is incumbent on the surgeon to do something to protect the nerves. It won't be long until other specialties follow."
2. Ease of use in the OR. When designing the device, the surgeons wanted to create something simple, portable and readily available for use. They wanted to ensure the device was small, battery-powered and disposable so it could be accessed instantaneously by the surgeon and wouldn't place a great burden on the OR staff. "If you have a case and are suddenly worried about the nerve, the Checkpoint provides you with a device immediately ready for use, sterile and easy to operate," says Dr. Hausman. "It's use is intuitive and surgeons need very little to no training to operate the Checkpoint Stimulator."
3. How it works. The Checkpoint Stimulator's probe delivers physiologic stimulus to the nerve in a wave form to mimic the body's natural electrical impulses. The device has a broad range of stimulus intensity — it can create a full strength sustained contraction of a big muscle or stimulate nerve fascicles. The surgeon is able to adjust the size and shape of the electrical impulse as the situation dictates. "The initial goal was to design something that would detect the nerve, but as we've used it, we've actually begun to discover that it can do substantially more than help us find and protect the nerve," says Dr. Hausman. "It's a little bit like having a miniature neurologist with his fancy electrodiagnostic equipment along with him because it can help us determine the variability and contractility of the muscles."
Knowing the viability and contractility of the muscles is useful when surgeons are presented with a situation where they need to decide whether the nerves and muscles are working appropriately or are in need of repair, such as neurolysis, to free the nerve from scar. For instance, if a patient presents a rotator cuff rupture, surgeons can use the Checkpoint to decide whether the muscles are in a good enough condition to proceed with the repair. "We can stimulate the nerve going into the muscle and watch it contract through our arthroscope," he says. "The device works under water in the arthroscopic environment, which is something no other device does. We can assess the function of the nerve to see whether it works and how well it works."
4. Making better outcome predictions. There are some procedures that are dependent on normal nerve conduction and strong muscle function, and if that isn't present, the procedure is more likely to have a bad outcome. If the stimulation shows the nerves and muscles aren't working properly, there are things a surgeon can do to improve function. In one case, a patient was referred to Dr. Hausman after the patient underwent a shoulder operation during which the nerve innervating the biceps was injured Dr. Hausman used the Checkpoint Stimulator to explore the area around the nerve, dissect the nerve under the operating microscope and determined the patient would have a high probability of recovery if he removed the scar tissue.
Dr. Hausman decided to proceed with the scar tissue removal and the patient was able to make a complete recovery. "The chances of nerve injury can be minimized by knowing the proximity of the nerves," he says. "For the second surgery, the device helped me find the damaged nerve, but it also helped me make a decision about the surgery: Did I simply need to remove the scar tissue or did I need to cut out the damaged section and sew the two ends together? It takes a year for the nerve to recover when it is cut and the outcome wouldn't be as good. It isn't clear to the surgeon which procedure would be best and whether the nerve has a chance to recover. The Checkpoint Stimulator helped me make the right guess in this case."
5. Where the Checkpoint Stimulator is now and where it's headed. The Checkpoint was originally distributed in Chicago, New York City, Cleveland and Southern California. The early response has been encouraging and the company, Checkpoint Surgical, has added more representatives to increase the coverage area. Additionally, there has been some demand for the device overseas, and Dr. Hausman said the company is hoping to receive the CE mark clearance by the end of the year.
"Virtually every surgeon who has tried it has reordered it, and for an orthopedic device, that's really unusual," he says. "Our big challenge is really reaching the surgeons — getting the word out and allowing them to try our device. The second challenge is having it approved by hospitals. They are cost sensitive and suspicious of new devices, but they come to realize the value the device provides. The savings from even one prevented nerve injury that results in a lawsuit would pay for a lifetime of Checkpoints for the institution."
Dr. Hausman is a paid consultant of and has financial interest in Checkpoint Surgical.
Learn more about Dr. Michael Hausman.
Related Articles on Orthopedic Surgery:
Steadman Philippon Research Institute Receives $1M Grant To shoulder Research
3 Best Practices for Technologies and Facilities at Hospital-Based Spine Programs
7 Studies on Reducing Spine Surgery Complications
5 Points on a New Device to Prevent Nerve Damage During Orthopedic Surgery