Bone Biopsy System Devices

We are pleased to introduce our new extensive line of manual bone biopsy systems with device features exclusive to Merit. To support initial bone purchase, several systems include a unique introducer—engineered with a patented perforating cannula—to provide a controlled and effective alternative to powered access needles. Understanding that physicians have personal preferences, Merit systems also give the advantage of access choice: direct or guided via the Seldinger-inspired approach.

Patented Perforating Cannula

Designed to access hard-to-reach lesions, the Merit patented perforating cannula can assist with accuracy of introducer placement through dense bone. After the cannula is anchored in the periosteum, if a stylet needs to be exchanged for a drill, this can be done without losing the introducer’s place in the bone. Furthermore, when using with a drill insert, the edges of the perforating cannula simultaneously cut around the drill as the drill tip enters into the bone. This combined technology works together to support the introducer in penetrating the cortex as well as facilitating tactile control.

The introducer with perforating cannula is available in three Merit Bone Biopsy Systems: the Madison™, the Madison Mini™, and the Huntington™.

The Madison Perforating Bone Biopsy System is a direct access system. Through its perforatingcannula, a trocar-tip stylet aids with initial bone entry, and a drill insert supports traversing hard bone and reaching deep-set or small cortical abnormalities in both axial and appendicular cases. The drill is locked inside the perforating cannula at a set-distance while drilling to maximize accuracy in cannula placement and precise sampling.

Also referred to as the Madison’s “little sister,” the Madison Mini Small Bone Biopsy System is a direct access system with a removable handle—a useful feature when working with small rounded bones that have little soft-tissue surroundings. Like the Madison System, the Madison Mini introducer includes a trocar-tip stylet with perforating cannula.

Made popular by the aforementioned Madison System, the perforating cannula and drilling technology are now improved upon by way of the Huntington Guided, Perforating Bone Biopsy System. Instead of a trocar-tip stylet, the Huntington System has a tri-angled tip with longitudinal groove that facilitates a collection channel for bone evacuation upon first contact with bone. Designed for hard bone procedures and reaching sclerotic lesions, the Huntington facilitates initial purchase on the cortex, even in oblique approaches. As a guided access system, it accommodates guide wire access when the Seldinger-inspired technique is desired.

Sclerotic Lesions: Manual Versus Power Biopsy Devices

Whether using a guided or a direct access technique, we believe that the best access technology is simple, straightforward, and resides within the palm of your hand. Our patented perforating cannula is a significant feature of our bone biopsy systems, and it is why our devices are engineered for manual use instead of with a power access needle. In comparison to power access needles, manual biopsy devices can prove useful—particularly when working with sclerotic or blastic lesions.

Samples taken with power access needles may run the risk of getting caught within the biopsy needle, as Chang et al. observed1. Blastic lesions, they note, are more tightly packed with dense connective tissues, such as osteoid, and therefore more difficult to expel from the biopsy needle tip. The stiffness of this tissue, they mention, could have also contributed to the progressive bending and curling of the biopsy needle’s serrated edge over the lesion, trapping subsequent samples.

From a pathologist’s perspective, Klein further addresses using power access needles on sclerotic lesions.2 He writes, “The combined effects of friction and compression play havoc with densely sclerotic lesions biopsied with any hard, cylindrical object, and…these effects are even worse when a power instrument is added…I have come to believe that densely sclerotic lesions should never be biopsied in this way.” Furthermore, Klein notes that friction generates heat, which can cook the bone tissue.

Data from multiple studies show that Merit manual bone biopsy systems take adequate samples in 100% of cases, even in osteoid osteomas, and have a pathological diagnostic success rate of approximately 81-90%.3,4,5 We advise on taking several, incremental, samples via the one coaxial tract to optimize diagnostic yield and for preservation of architecture.

Choice of Access

As seen with these systems, Merit gives physicians their choice of access—direct or guided (Seldinger-inspired). While direct access is an excellent, standardized, biopsy approach, guided access may help to simplify a wide range of neuroradiology, interventional radiology, and musculoskeletal radiology procedures. Because the introducer is placed directly over a guide wire and through the line of anesthesia, guided access can assist in creating less traumatic pathways through soft tissues and minimize the need for repeat scanning.

The Kensington™ Guide Wire Bone Biopsy System—also known as the original coaxial system— was created for deep bone, upper spine, and narrow access procedures. Like the Huntington System, the Kensington employs guided access. Its introducer comprises a smooth, tapered cannula and a hollow, blunt stylet.

Other Systems

The Westbrook™ Basic Bone Biopsy System is designed to reach superficial lesions in soft- or normal-density bone. Used with direct access when it is not necessary to cross bony tissue before sampling, the Westbrook still allows for multiple, high-grade sampling in mixed-density masses. Its introducer comprises a smooth, tapered cannula and a trocar-tip stylet.

Preston™ Bone Biopsy Needle: Benefits of Clockwise-Cutting Trephine Teeth

All of the bone biopsy systems contain the Preston™ Bone Biopsy Needle, designed for either incremental sampling of blastic lesions or optional syringe aspiration. With clockwise-cutting trephine teeth—a design advantage many competing bone biopsy devices lack—the Preston supports true cylindrical tissue retrieval. Other competing bone lesion biopsy devices may lose tissue integrity due to damage and crush incurred by a tapered tip. The Preston’s clockwise-cutting trephine teeth retrieves samples that are—by nature of its design—cylindrical and preserved, thereby facilitating efficient penetration without compromising cellular architecture.

Moreover, using systems containing the Preston Bone Biopsy Needle allows for multiple biopsy passes. This may assist during image-guided core-needle biopsy procedures, as studies suggest that obtaining a minimum of three specimens in bone lesions, when possible, optimizes diagnostic yield for accurate histopathological evaluation.6

Each device also has the following additional features, all designed to meet diverse clinical needs in one convenient system:

  • Comfortable-grip handles that lock together (removable options available) and allow for more manual pressure if necessary.
  • Clear depth stoppers give a visual guide for biopsy needle protrusion beyond the introducer and allow for multiple, incremental sampling.

Explore our line of bone biopsy systems and talk to a Merit representative today to discover how our full range of systems can meet your clinical needs.

REFERENCES

  1. Chang, C. Y., Simeone, F. J., & Huang, A. J. (2015). Battery-powered bone drill: Caution needed in densely blastic lesions. Skeletal Radiol, Dec;44(12):1845-1848.
  1. Klein, M. J. (2016). From a pathologist. Skeletal Radiol, Nov;45(11):1553-1554.
  2. Cornelis, F., Silk, M., Schoder, H., et al. (2014). Performance of intra-procedural 18- fluorodeoxyglucose PET/CT-guided biopsies for lesions suspected of malignancy but poorly visualized with other modalities. Eur J Nucl Med Mol Imaging, Dec;41(12):2265- 2272.
  1. Tselikas, L., Joskin, J., Roquet, F., et al. (2015). Percutaneous bone biopsies: Comparison between flat-panel cone-beam CT and CT-scan guidance. Cardiovasc Intervent Radiol, Feb;38(1):167-176.
  1. Laredo, J. D., Hamze, B., & Jeribi, R. (2009). Percutaneous biopsy of osteoid osteomas prior to percutaneous treatment using two different biopsy needles. Cardiovasc Intervent Radiol, Sep;32(5):998-1003.
  1. Wu, J. S., Goldsmith, J. D. Horwich, P. J., et al. (2008). Bone and soft-tissue lesions: What factors affect diagnostic yield of image-guided core-needle biopsy? Radiology, Spe;248(3):962-970.

Please consult the product labels and inserts for any indications, contraindications, potential complications, warnings, precautions and directions for use.