Project Description

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HOW IT WORKS
The Misonix BoneScalpel® is a novel and unique surgical device in that it offers a gentler osteotomy as compared to standard bone cutting tools. It efficiently slices crystalline bone while leaving elastic soft tissues largely unaffected during incidental contact. This can be particularly important during spinal surgery where bone segments are frequently removed in close vicinity to the spinal cord, nerve roots and major arteries. Ultrasonic cutting of bone is made possible by amplifying an electrical signal and converting it into a high back-and-forth motion of a blunt blade at the extremely high frequency of 22,500 times per second.

HOW IT CUTS
The ultrasonically vibrating blade compresses the bone through repetitive impacts at 22,500 times per second cleaving its way into the bone and creating the cut. Tactile feedback allows the surgeon to sense differences in bone density as he or she is cutting through cortical and cancellous layers. Due to its elasticity, soft tissue is minimally affected during incidental contact with the blade. This is beneficial, for example in spinal decompression surgery when bone is being removed to relieve pressure on a spinal nerve to treat spinal stenosis.

CUTTING SELECTIVELY AND WITH FEEL
BoneScalpel is unique in that it offers a gentler osteotomy as compared to standard bone cutting tools. It efficiently slices crystalline bone while leaving elastic soft tissues largely unaffected during incidental contact.* Imagine being able to cut a tiny window into the calcified shell of a raw egg without puncturing the underlying membrane… For a spine surgeon this translates into being able to dissect the vertebral arch all the way down to the ligamentum, which covers the spinal cord. This is a routine yet delicate procedure used for nerve decompressions or spinal fusions that is normally done by subsequently switching to less aggressive cutting tools.
*Contact to soft tissues should be brief and under moderate pressure

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MAKING SPINE SURGERY SAFER
BoneScalpel offers a number of benefits to surgeons, anesthesiologists and patients. Of highest significance is a substantial reduction of blood loss and use of blood products during the most complex spinal procedures involving the fusion of vertebrae over multiple levels. A reduction in blood loss can make it easier for surgeons and anesthesiologists to manage the patient’s shifting fluid balance during long surgeries. Blood transfusions, while generally safe and routine, are still an extra burden to the patient extending the recovery and come at remaining risks for transmitting diseases. In addition, BoneScalpel’s precision and ability to differentiate between rigid bone and elastic nerve structures become very important when relieving spinal nerves from pain causing compressions, as being caused by abnormal bone growth or degeneration of the spinal column after decades of use.

ENTERING-A-NEW-ERAS

ENTERING A NEW ERA

Historically, manual bone cutting tools range from biting bone punches to pounding mallets and chisels.
The invention of powered rotary drills offered an advancement in efficacy and convenience but with limitations
in delicate areas where any tissue in contact could be shredded into pieces, or where soft tissues could on
occasion wrap dangerously around the rotating drill shaft. Bone dissection with the BoneScalpel, in contrast,
promises to take spine surgery into a new era. It allows the surgeon to cut bone with the accuracy and precision
of a kerrison while providing greater speed and ease of use than conventional spinning power tools without the
risk of collateral tissue damage or nerve wrapping
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REDUCING BONE BLEEDING

Estimated blood loss for standard spinal fusion without use of BoneScalpel varies between less than 500 cc
to 3,000 cc and well above for complex cases. 30% of spinal fusions require transfusions with blood products.
The higher the blood loss the higher the shift in the patient’s fluid balance, the more blood products are
needed (and with that the risk for disease transmission or adverse reactions) and the longer the stay in the ICU.
Blood products are also costly.
Bone dissections with BoneScalpel have shown significant reductions in blood loss
as well as transfusions with cell savers in multilevel fusions when compared to two
control groups using standard manual cutting tools. BoneScalpel was favorable with a:



• 31-38% reduction in blood loss (EBL)

• 49-53% reduction in transfusion with cell savers
REDUCING-BLOOD-LOSS1
REDUCING-USE-OF-CELL-SAVERS1
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REDUCING BONE CUTTING TIMES

Multiple surgeons report significant time savings when performing bone dissection en-bloc in multilevel
decompressions and fusions with the Misonix BoneScalpel. Repeatable time savings up to
an hour have been reported from multiple surgeons.
The following factors contribute to time savings in multilevel procedures:

• Efficient bone cutting en-bloc as traditionally only possible with mallet & chisel

• Reduced interference from having to manage bone bleeding or switching tools

• Ability to use BoneScalpel adjacent to delicate structures instead of having to switch to manual tools

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CLINICAL EVIDENCE

BoneScalpel Brochure

BoneScalpel MIS Update SellSheet

BoneScalpel Abstracts on Clinical Use

BoneScalpel Surgical Technique Guide by Dr. Pakzaban

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