Apparatus and method for reconstituting bone with biological fluids prior to surgical implantation

#In certain orthopedic and neurosurgical procedures, cadaveric bone is used to repair or replace damaged bone structures, such as the spine, for example. Tissue banks currently provide cut and processed cadaveric bone for use as struts and fillers in various orthopedic procedures. In many patients, unfortunately, the implanted bone fails to fuse with the patient's own bone. One solution to this problem is to add a stimulant or human growth factor to enhance the probability of fusion. Current procedures for reconstituting cadaveric bone with concentrated growth factor fluids, for example, include simply soaking the bone in the solution for a certain period of time. Notwithstanding its simplicity, this method can be time-consuming and fail to completely permeate the interstices of the bone sample with the fluid.

#The present invention is directed to a novel apparatus and device for reconstituting a bone sample with a biological fluid, such as concentrated plasma or saline solutions, for example, prior to surgical implantation into a patient. In particular, the invention comprises, in certain aspects, a container in which a bone sample may be reconstituted with the desired fluid by applying a vacuum within the container, thereby driving the fluid into the bone for complete, or near complete, permeation of the fluid into the interstices of the bone prior to surgical implantation.

#FIG. 1 is a perspective view of one embodiment of the apparatus of the present invention.

#FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1 showing the air permeable membrane inserted within or between the vacuum tube and the bone chamber of the preferred embodiment of the present invention.

#Referring now to FIG. 1, the present invention, in certain aspects, is directed to a method and apparatus for reconstituting a bone sample with a biological fluid prior to surgical implantation into a patient. As used herein, “bone sample” includes cadaveric bone grafts from animals, including humans, as well as synthetic bone graft material now known or later developed. The term “bone sample” also includes any other implantation or grafting material amenable to reconstitution with a fluid. The prepared bone sample may be used in surgical procedures on human patients as well as in veterinary surgical procedures.

#As shown in FIG. 1, the invention comprises a container 10 having an inner reservoir 11 for holding a fluid F for subsequent reconstitution into a bone sample B. As used herein, “fluid” includes any liquid-based biological fluid (natural or synthetic), such as blood plasma. The blood plasma may contain a high concentration of platelets, growth factors, fibrinogen, and/or other components useful in aiding in bone fusion, for example. An exemplary blood plasma product is that described in the Applicants' co-pending application U.S. Ser. No. 09/994,908, which is incorporated herein by reference in its entirety. The term “fluid” also includes any other solution or suspension, including, but not limited to, saline solutions, dextrose solutions, Ringer's Lactate solutions, and the like. The reservoir 11 includes a closeable port 12 through which ambient air may be drawn through, as discussed further below. Preferably, a stopcock 21 or similar valve device is inserted into the port to regulate the flow of air therein. A Luer lock (not shown) may also be provided within the port to further secure the stopcock within the port. Alternatively, a slidable lid or a simple, non-adjustable stop (not shown) may be placed within the port 12.

#The container also includes an inner bone chamber 13 for maintaining the bone sample B. The container may further include an opening 14 through which the bone sample B is inserted. An open passageway communicating between the bone chamber 13 and the reservoir 11 is provided within the container. Preferably, this passageway is an elongated tube 15, as shown in FIG. 1; however, it will be appreciated by the those of ordinary skill in the art that the tube may be of various lengths depending upon the size of the container and the placement of the bone chamber and reservoir with respect to one another. It will be further appreciated by the skilled artisan that the container may be modified such that the bone chamber and reservoir walls are flush with one another or comprise a common, integral structure (not shown), such that the open passageway communicating between the two areas 11, 13 may simply comprise a hole within the wall(s).