Bone marrow harvesting and storage

Abstract

Methods of extracting bone and/or cellular material from a patient for possible use in a later surgical procedure, which involves that patient or even a different patient, are provided. An embodiment of the method generally comprises extracting bone and/or cellular material from a patient undergoing a routine surgical procedure, saving the material, and then sending it to a storage, separation, and processing facility (e.g., a “biobank”) for use in a later surgical procedure involving that patient, or a different patient. The material may be cancellous bone, cortical bone chips, or bone marrow. The extracted bone and/or cellular material can be processed at the biobank and used in a multitude of different medical procedures (e.g., as an allograft infused with stem cells for use in a fusion procedure).

1 . A method of harvesting and processing bone and/or cellular material comprising:
 reaming bone with a tool to extract cancellous bone, cortical bone chips, and/or bone marrow material during an orthopedic procedure;   transferring the extracted material to a container fluidly connected with the tool;   sending the extracted material to a facility; and   processing, separating, and/or storing the extracted material at the facility so that the material is usable as at least one of: (1) an allograft infused with stem cells; (2) an autograft with or without stem cells infused; and (3) stem cells,   wherein the surgical procedure is a procedure undertaken by the patient in the ordinary course of events and is not a surgery dedicated predominantly to extracting the cancellous bone, cortical bone chips, and/or bone marrow material.   
     
     
         2 . A method according to  claim 1 , further comprising the step of extracting the cancellous bone, cortical bone chips, and/or bone marrow material using a reamer-irrigator-aspirator. 
     
     
         3 . A method according to  claim 2 , wherein the surgical procedure is a fracture-reduction procedure in which an intramedullary nail is inserted into the bone. 
     
     
         4 . A method according to  claim 2 , wherein the reamer-irrigator-aspirator includes a fluted reaming portion, an aspiration cannula adapted to extract the cancellous bone, cortical bone chips, and/or bone marrow material, and an irrigation channel for providing irrigation at the reaming portion, the aspiration cannula being fluidly connected to the container. 
     
     
         5 . A method according to  claim 1 , further comprising the step of saving and not discarding the extracted cancellous bone, cortical bone chips, and/or bone marrow material, wherein typical practice for the orthopedic procedure is to discard such material. 
     
     
         6 . A method of processing, separating, and/or storing bone or cellular material comprising:
 identifying a set of patients undergoing an existing surgical operation in which a bone of the patient is to be reamed or resected and cancellous bone, cortical bone chips, and/or bone marrow material removed;   screening the patients using a set of criteria to ascertain a subset of patients who qualify to donate cancellous bone, cortical bone chips, and/or bone marrow, wherein a first aspect of the criteria requires the patient to be undergoing an existing operation in the ordinary course of events, which is not a surgery dedicated predominantly to extracting the cancellous bone, cortical bone chips, and/or bone marrow material;   instructing a controlling entity for the surgical operation to send the extracted cancellous bone, cortical bone chips, and/or bone marrow material to a processing, separation, and storage facility; and   processing, separating, and/or storing the cancellous bone, cortical bone chips, and/or bone marrow material so that the material is usable as at least one of: (1) an allograft infused with stem cells; (2) an autograft with or without stem cells infused; and (3) stem cells.   
     
     
         7 . A method according to  claim 6 , wherein the criteria used for screening also involves considering the patient's age, health, and/or quality of the extracted cancellous bone, cortical bone chips, and/or bone marrow material being donated. 
     
     
         8 . A method according to  claim 6 , further comprising the step of maintaining a stem cell biobank using at least one of the extracted cancellous bone, cortical bone chips, and bone marrow material. 
     
     
         9 . A method according to  claim 7 , further comprising the step of supplying stem cells to qualifying patients in need after the processing, separating, or storing step. 
     
     
         10 . A method according to  claim 6 , further comprising the step of instructing the controlling entity to save and not discard the extracted cancellous bone, cortical bone chips, and/or bone marrow material, wherein typical practice for the controlling entity is to discard such material. 
     
     
         11 . A method according to  claim 6 , further comprising the step of accepting payment from the screened patient or patients to store and/or process their extracted cancellous bone, cortical bone chips, and/or bone marrow material for future use. 
     
     
         12 . A method according to  claim 6 , wherein the cancellous bone, cortical bone chips, and/or bone marrow material, after processing and/or separation, is stored as stem cells in a biobank. 
     
     
         13 . A method of processing, separating, and/or storing bone or cellular material comprising:
 identifying a set of patients undergoing an existing surgical operation in which cancellous bone, cortical bone chips, and/or bone marrow material is to be removed from the patient;   screening the patients using a set of criteria to ascertain a subset of patients who qualify to donate the cancellous bone, cortical bone chips, and/or bone marrow material, wherein a first aspect of the criteria requires the patient to be undergoing an existing operation in the ordinary course of events, which is not a surgery dedicated predominantly to extracting the cancellous bone, cortical bone chips, and/or bone marrow material;   obtaining and saving the extracted cancellous bone, cortical bone chips, and/or bone marrow material resulting from the surgical operation, wherein the cancellous bone, cortical bone chips, and/or bone marrow material would have otherwise been discarded after the surgical operation; and   sending the cancellous bone, cortical bone chips, and/or bone marrow material to a processing, separation, and storage facility for processing, separating, and/or storing the cancellous bone, cortical bone chips, and/or bone marrow material so that the material is usable as at least one of: (1) an allograft infused with stem cells; (2) an autograft with or without stem cells infused; and (3) stem cells.   
     
     
         14 . A method according to  claim 13 , wherein the cancellous bone, cortical bone chips, and/or bone marrow material, after processing and/or separation, is stored as stem cells in a biobank. 
     
     
         15 . A method according to  claim 14 , further comprising establishing a registry categorizing the stem cells for future use by the patient or another patient. 
     
     
         16 . A method according to  claim 15 , further comprising identifying a second patient as a candidate for benefiting from use of the patient's stem cells using the registry, and supplying the second patient with such cells for use in a surgical operation. 
     
     
         17 . A method according to  claim 13 , wherein the criteria used for screening also involves considering the patient's age, health, and/or quality of the extracted cancellous bone, cortical bone chips, and/or bone marrow material being donated. 
     
     
         18 . A method according to  claim 13 , wherein the surgical operation is an orthopedic operation involving reaming of a bone of the patient, in particular a medullary canal of the bone.