Abstract:
The present invention provides for a removable second stage biocompatible substrate filter that includes biocompatible implant material configured to trap second stage operative particulate matter that may include at least one of bone fragments, plasma, stem cells, cellular matter, and growth factors captured from irrigation fluid. The second stage biocompatible substrate filter may be configured to combine with bone fragments captured from irrigation fluid by a first stage filter and may be configured to be operable with a reaming and collection device.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application (docket no. 709.00003) is a continuation of U.S. patent application Ser. No. 14/305,049 (docket no. 709.00002) titled  Apparatus for Harvesting Improved Bone Graft Material Utilizing an Implantable Biodegradable Filter , filed on Jun. 6, 2014, which, in turn, is a continuation of U.S. patent application Ser. No. 13/091,123 (docket no. 709.00001) titled  Apparatus, System, and Method for Harvesting Improved Bone Graft Material with Reamer - Irrigator - Aspirator  ( RIA )  Device  filed on Apr. 21, 2011, which, in turn, claimed priority to U.S. Provisional Patent Application Ser. No. 61/326,234 (docket no. GEN2010-03), filed on Apr. 21, 2010, titled  Apparatus, System, and Method for Harvesting Improved Bone Graft Material with Reamer - Irrigator - Aspirator  ( RIA )  Device , the entire contents of each of which are hereby incorporated into this application by reference to provide continuity of disclosure. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention is in the technical field of medical devices. More particularly, the present invention is in the technical field of harvesting bone graft materials using a reamer device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Currently, materials in the output stream from a reaming device, such as the Reamer-Irrigator-Aspirator provided by Synthes, are not fully and efficiently collected. While there have been some attempts to collect large scale material, other materials such as plasma, and other cellular elements are not currently collected and are discarded. Further, the approach used even to collect the large scale materials, essentially bone fragments, is not efficient for medical personnel to use in the operating room. 
       SUMMARY OF THE INVENTION 
       [0004]    The present invention provides for a removable second stage biocompatible substrate filter that includes biocompatible implant material configured to trap second stage operative particulate matter that may include at least one of bone fragments, plasma, stem cells, cellular matter, and growth factors captured from irrigation fluid. The second stage biocompatible substrate filter may be configured to combine with bone fragments captured from irrigation fluid by a first stage filter, defining a combined product. Furthermore, the second stage filter may be configured to be operable with a reaming and collection device. 
         [0005]    The removable second stage biocompatible substrate filter may have a substrate that is a porous and hydrophilic membrane that may be configured as an implantable product for implantation within humans. In this embodiment, the first stage operative particulate matter and the bone fragments may conform to a size and geometric shape consistent with an undulated surface of the second stage filter. 
         [0006]    In some embodiments the second stage may be a centrifuge and the combined product may be configured to unroll into sheets. 
         [0007]    In some embodiments the bone fragments from the first stage may be a first size and the second stage operative particulate matter may be a second size. Similarly, the second stage biocompatible substrate filter may comprise a biocompatible implant material configured to retain second stage operative particulate matter. The second stage biocompatible substrate filter may be configured to combine with first stage operative particulate matter captured from irrigation fluid by a first stage filter. The first stage operative particulate matter may include material of a first size and the second stage operative particulate matter may include material of a second size. 
         [0008]    The removable second stage biocompatible substrate filter may be configured to be operable with a reaming and collection device wherein the second stage operative particulate matter retained may be one of bone fragments, plasma, stem cells, cellular matter, and growth factors captured from irrigation fluid and the first stage operative particulate matter may include bone fragments. Furthermore, the first stage operative particulate matter may include at least one of bone fragments, plasma, stem cells, cellular matter, and growth factors captured from irrigation fluid. 
         [0009]    In one embodiment the removable second stage biocompatible substrate filter may include biocompatible implant material configured to retain second stage operative particulate matter wherein the second stage biocompatible substrate filter may be configured to combine with operative particulate matter captured from irrigation fluid by a first stage filter. The first stage retained material and the second stage retained material may be obtained from a reaming device utilizing an irrigation fluid supply and a suction source. An output of the reaming device may be connected to an input of a first stage filter container. In this embodiment, a flow of materials suspended in the irrigation fluid may pass through a first connecting tube and the flow of materials suspended in the irrigation fluid may be filtered by the first stage filter. The first stage retained material may be separated from the flow of materials suspended in the irrigation fluid by a filter possessing a first particulate size selectivity. The first stage filter may further provide a first stage output flow of materials suspended in irrigation fluid. The first stage filter may allow for the collection of a first sized particulate matter of at least one or more of irrigation fluid, plasma, stem cells, growth factors, and cellular matter. Furthermore, the first stage output flow of materials may be suspended in the irrigation fluid and passed through a first stage output. In this embodiment the input of a second stage filter container may be connected by a second connecting tube to the output of the first stage filter container. Therefore, the first stage output flow of materials suspended in the irrigation fluid may be filtered by the second stage filter. In this embodiment the second stage filter may retain a second sized particulate matter different than the first stage filter that includes a portion of at least one or more of plasma, stem cells, growth factors, and cellular matter, and may allow for the passing of a portion of the irrigation fluid as output flow. Additionally, the second stage filter container may include an evacuation port to permit the flow of materials suspended in the irrigation fluid to be evacuated from the second stage filter container in a continuous process. The continuous process may include the first stage filter container receiving output from the reaming device and output from the second stage filter simultaneously. Therefore, the biocompatible substrate may be configured to receive at least a portion of the first stage retained material in combination with at least a portion of the second stage retained material to create a combined graft product. 
         [0010]    In this embodiment, the substrate may be a porous and hydrophilic membrane configured as an implantable product for implantation within humans. The first stage retained material and the second stage retained material may conform to a size and geometric shape consistent with an undulated surface of the second stage filter. In some embodiments the second stage may be a centrifuge and the combined product may be configured to unroll into sheets. Furthermore, the first stage may be a grate and the second stage may be a centrifuge or vice versa. As stated above, the substrate may be a porous and hydrophilic membrane of a size and geometric shape consistent with an undulated surface of the second stage filter and configured as an implantable product to envelop a human bone. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]      FIG. 1A  is a diagram of the prior art RIA device. 
           [0012]      FIG. 1B  is a diagram of the prior art RIA device tubing interface. 
           [0013]      FIG. 2  shows the bi-lumen tube conned to a tube port in a RIA or other device. 
           [0014]      FIG. 3  shows the improved stage 1 filter with the water irrigation hose bypassing the filter (not integrated). 
           [0015]      FIG. 4  shows the Stage 1 filter with an integrated pass through irrigation source hose for use with the bi-lumen tubing. 
           [0016]      FIG. 5  shows the stage 1 filter with the lid open, and stage 1 material inside. 
           [0017]      FIG. 6  shows the removed filter plate from the stage 1 filter with the stage 1 material being collected from the filter plate into a canister for later use. 
           [0018]      FIG. 7  shows the stage 1 filter connected to a stage 2 collector centrifuge, with a collagen sponge or filter cylinder inside in one embodiment of the invention. 
           [0019]      FIG. 8  shows the collagen filter removed from the centrifuge after collection, then cut into a flat “pad” of stage 2 material on the collagen filter or sponge in one embodiment. 
           [0020]      FIG. 9  shows the collagen or other filter material removed from the centrifuge, cut and laid flat as a stage 2 pad. 
           [0021]      FIG. 10  shows an alternative stage 2 collector using a filtration system, containing a collagen or other materials filter plate or sponge. 
           [0022]      FIG. 11  shows the collagen filter being removed from the stage 2 filter, for use of the retained stage 2 materials. 
           [0023]      FIG. 12  shows stage 1 material in one embodiment being added to the stage 2 materials on a collagen filter, pad, or sponge and use as part of a bone graft in a patient. In this case the collagen filter, or sponge would be placed inside the patient along with the stage 1 and stage 2 materials, which may be modified in proportions. The filter, in one embodiment, would dissolve at a later time. 
           [0024]      FIG. 13  shows an alternative embodiment of stage 1 materials being added to the stage 2 materials on a collagen filter, pad, or sponge and use as part of a bone graft in a patient. 
       
    
    
       [0025]    Note that the specific examples provided are not intended to be limiting but are specific embodiments of the invention. Various alternative materials and processes may be used as known in the art. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    Referring to  FIG. 1A , the depiction of the RIA which stands for Reamer Irrigator Aspirator. Depicted is a power source  101 , a drill of any variety used within the operating room. The RIA device  102  which is designed as a medullary bone graft harvesting device. The bone graft material would be harvested from the medullary canal of a native human femur  103  using the RIA device  102 . A guide wire  104  is inserted into the medullary canal providing a guide for the RIA device  102  to remain within the medullary canal. The reamer head  105  is designed to cut the bone that is currently being harvested by the device. Through Port  106 , the entry portal, saline is pumped into the device exiting out of Port  107 . Suction is applied to the device through Port  109 , providing an avenue for fluid as well as bone graft material to exit the medullary canal via Port  108 . It is then tunneled through Port  109  to a collection device or to the waste suction canister within the operating room.  FIG. 1B  is a depiction of the current device in larger scale at the region where the suction as well as irrigation ports meet with the RIA device  102 . The RIA device  102  with Port  106 , is the port allowing for saline to float within the device and Port  109  being the port providing suction and an avenue for the evacuation of material from the medullary canal. 
         [0027]      FIG. 2  is a depiction of the improved tubing system in one embodiment of this current invention. Depicted is the RIA device  102  with modified coupling Zones  201  as well as  202 .  201  would be the coupling point for saline inflow into the RIA device  102 ; whereas, Port  202  would provide for efflux and evacuation of fluid as well as bone graft material that is applied via suction. The suction source would be obtained through a source available within the operating room. The tubing is coupled  203  to provide for less entanglement and more streamlined use within the operating room. These tubes would branch allowing for filtration I separation canisters, to be described later. Tube  204  would provide an inflow source for saline whereas Tube  205  would provide suction as well as an egress pathway for bone graft as well as saline or other fluids. 
         [0028]      FIG. 3  depicts an embodiment of a modified Stage 1 filter for the collection of materials from the harvesting site. Saline and bone graft material would flow into the device via Tube  205 . The device container,  301 , would contain a hinged lid  302 . Within the container  301 , would be a Removable Porous Filter,  303 , that is porous in nature to capture large bone graft material but provide for the flow through of saline, blood products, plasma, cells, and growth factors, and other particulate matter of a specific geometrically limited size. The material would be drawn through the filter via suction applied through Tube  304 . Also depicted in  FIG. 3  would be Tubing  204  that would allow for saline to flow to the RIA device  102  and provide irrigation to facilitate the evacuation of bone graft material. 
         [0029]      FIG. 4  is an alternative embodiment of the Stage 1 filter. Tube  401  would be contained within the Filter Device container,  301 , once again avoiding significant entanglement and providing for more efficient use within the operating room. The remaining portion of the device would function very similar as the device in  FIG. 3 . A hinged lid,  302 , providing access to Porous Filter  303 , would catch material entering via Tube  205  once again allowing for saline, blood products, plasma, cells, growth factors and other particulate matter of a specific geometrically limited size to pass through and be drawn out via Port  304 . 
         [0030]      FIG. 5  shows one depiction of the initial stage filter with additional details noted. Through Tube  205  saline as well as graft material evacuated from the medullary canal would enter Stage 1 container  301 . The lid now hinged open, depicted at  302 , allows for access to Porous Filter  303  containing Bone Graft Material  501 . The remaining portion of the fluid, containing blood products, plasma, cells, growth factors and other particulate matter of a specific geometrically limited size would be evacuated via suction, through Tube  304 . 
         [0031]      FIG. 6  depicts the removal of the material off of Porous Filter  303 . Bone Graft Material  501  would then be removed via Spatula Device  601  into Container  602 . These Devices,  601  as well as  602 , would be sterile and used within the operative field. The Collection Container  602  provides for a sterile container to contain the Bone Graft Material  501  for later re-implantation at the desired clinical site. 
         [0032]      FIG. 7  represents one embodiment of the second stage filtration system which would be designed to remove excess water yet retain additional graft material including but not limited to blood products, plasma, cellular bone marrow/stem cell elements, as well as growth factors and other particulate matter of a specific geometrically limited size. Depicted in  FIG. 7  is the Porous Filter  303  contained within the Filtration container  301  covered by Lid  302 . Initial material harvested from the RIA device  102  would enter the container via Tube  205 . Large bone graft material would be trapped by Porous Filter  303  allowing for the pass through/flow through of the remaining material through Tube  304 . This material once again would represent blood products, plasma, and cellular elements including stem cells as well as growth factors and other particulate matter of a specific geometrically limited size. This material would then enter Centrifugal Filtration Device  701 . This device would contain a porous filtration capturing membrane  801 . It will be covered and contained within the centrifugal filtration device via Lid  703 . The porous filtration capturing membrane  801  would be porous in its design to allow for capturing of blood products, plasma, cellular elements/stem cells, as well as growth factors and other particulate matter of a specific geometrically limited size, yet provide for the separation of fluid. This separation would then allow for a concentration of the graft elements and further to extract fluid from the system via centrifugation. The fluid may exit via Tubing  702  connected to an evacuation port in the various embodiments of the second stage filter as illustrated, for example, in  FIG. 7 . 
         [0033]      FIG. 8  is a detailed depiction of the porous filtration capturing membrane within the Filtration Device  701 . The cylindrical porous filtration capturing membrane  801  would be removed from Centrifugal Filtration Device  701  and cut to provide for a rectangular surface and function as a graft impregnated membrane for re-implantation within the patient. 
         [0034]      FIG. 9 , once again, provides for a drawing of this process starting with the Centrifugal Filtration Device  701  that is sealed via Lid  703 . Material filtered through the first stage filtration system enters via Tube  304 . After a centrifugal filtration process takes place, within  701 , the material is trapped within the porous filtration capturing membrane  801  which is porous in nature to provide for the capture of blood products, plasma, cellular elements including stem cells, as well as growth factors and other particulate matter of a specific geometrically limited size, but allow for the pass through of fluid that would exit via Tubing  702  connected to an evacuation port in the various embodiments of the second stage filter as illustrated, for example, in  FIG. 9 . The porous filtration capturing membrane  801  could then be cut to size and later implanted within the patient. 
         [0035]      FIG. 10  represents an alternative embodiment of the second stage filter. This filter would be designed for a more passive filtration process facilitated by vacuum negative pressure. Filtration Canister  1002  would contain a Hinged Lid  1003 . Material exiting the first stage filter would enter the device via Tube  304 . The undulating surface depicted as  1005  would be a filtration surface undulated for increasing surface area. It would reside on top of a porous yet Hydrophilic Membrane  1004  that would facilitate the extraction of fluid. The retention of blood products, plasma, cellular elements including stem cells, growth factors and other particulate matter of a specific geometrically limited size, would take place on the second stage (or any subsequent stage) filtration surface  1005 . Excess fluid would then be evacuated via Tube  1001  connected to an evacuation port in the various embodiments of the second stage filter as illustrated, for example, in  FIG. 10 . 
         [0036]    In  FIG. 11  a more detailed depiction of the second stage filter and hydrophilic membrane is depicted. The undulating Second Stage Filter  1005  would initially lie on top of porous Hydrophilic Membrane  1004 . The Filtration Surface  1005  would then be peeled away from hydrophilic/porous Surface  1004  after it has been exposed to the second stage graft/fluid material. This surface would then be available for implantation within the desired clinical setting. 
         [0037]      FIG. 12  represents the final combination of material from the first as well as second stage of filtration, or any combination of a plurality of filtration stages. Material from the first stage of filtration, depicted as  501 , and being contained within Sterile Container  602 , would then be placed on top of Undulating Porous Sponge  1005 . This would become a combination graft of large fragments of bone graft material from stage 1 combined with desired blood products, plasma, cellular elements/stem cells, growth factors and other particulate matter of a specific geometrically limited size. This combined graft can then be used in the desired clinical location. The location being depicted in  FIG. 12  as  1201 , a tibial bone graft site, although other site may be desired. 
         [0038]    An alternative embodiment of the combined graft would be depicted in  FIG. 13  that would provide for a combination of material from the first stage filtration as well as material captured via centrifugal filtration device and contained within the porous filtration capturing membrane  801 . Material  501  from the first stage of Filtration would be removed from Container  602 . It would then be placed on the cut porous filtration capturing membrane  801 , which would contain blood products, plasma, cellular elements including stem cells as well as growth factors and other particulate matter of a specific geometrically limited size. This would then be made available for implantation within a desired clinical bone graft site depicted as a tibial site  1301  in  FIG. 13 , although other site may be desired. 
         [0039]    It is therefore submitted that the instant invention has been shown and described in what is considered to be the most practical and preferred embodiments. It is recognized, however, that departures may be made within the scope of the invention and that obvious modifications will occur to a person skilled in the art. With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. 
         [0040]    Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.