The Hensler Bone Press (HBP) is a patent-pending device which maximizes the collection and separation of autologous bone during fusion procedures. Our product quickly and efficiently separates bone from fluid during surgery, which yields a semi-dry graft-ready material for fusion procedures. The press head has been highly engineered and tested to maximize the proficient separation of autologous bone from blood. Instructions for use for bone fusion application (Package insert).
The HBP employs a proven 2-step method, as to allow little to no interruption of the case for both apllications of use. This process of bone collection and separation for fusion cases has been simplified to allow the surgeon and/or assist to maintain efforts on the surgery, while producing a favorable and moldable graft for use as the surgeon desires, such as interbody or on-lay fusion. The application for ultrasonic tissue collection and seperation allows for the maximum amount of sterile tissue to be delivered to pathology, while simultaneously not interupting the case during full canister transfers between the 1st assist and the surgical tech.
Step 1 — Collection of the autologous bone or tissue, fluid and blood from surgical site.
Step 2 — Press mechanism combined with surgical grade mesh to separate autologous bone or tissue from fluid.
After the press has been manually deployed down, simply tilt the container to suction away fluid leaving only semi-dry autologous bone or tissue. The same is true for the ultrasonic application. There is a 0.20mm lip around the edge of the press head, not allowing for increased pressures to potentially harm the bone or tissue. The bone has already been tested by a clinical pathologist after use of the press, which revealed no evidence of bone cell damage or death under light microscopy. Lastly, stage the bone or tissue for use as the surgeon deems appropriate.
The HBP is also patent-pending for the STERILE collection of abnormal tissue, such as malignant tumors, when used as an auxillary device attached to the evacuation tubing of an ultrasonic device. Ultrasonic devices have been used successfully for the ultrasonic cutting, irrigation, and evacuation of abnormal tissue for multiple surgical disciplines. Current methodology for the collection of abnormal tissue, after it's been cut away with use of various ultrasonic devices, is accomplished with a non-sterile permeable cloth sock and collection chamber off the sterile field. This renders the tissue contamainated. Pathologist are forced to spend significant time sifting through clotted blood, contaminated tissue and cloth fibers, which makes tissue diagnosis more difficult. By using the HBP, the pathologist will be sent the maximum amount of tissue, free of significant blood and contaminants. This is not only a cost savings, by decreasing the billable time required by the pathologist, but the non-contaminated tissue will be largely free of clotted blood and potential contaminants for improved accuracy during pathology diagnosis. Instructions for use for ultrasonic application (Package insert).
This device allows for simultaneous operations. As collection of bone or tissue takes place, the press device can be utilized in parallel on the surgical table by the tech or nurse. This exchange process can occur as many times as the case necessitates.
The HBP is available for purchase. The HBP is a 510-K EXEMPT, Class II disposable device.
The FDA Establishment number is: 3009657922, Regulation number 880.6740.
The HBP is subject to good manufacturing practices and compliance to 21 CFR Part 820, Quality System Regulation.
Please contact us for pricing and availability for an evaluation and/or for purchase.