Patent Document

FIELD OF THE INVENTION 
     The present invention relates generally to fields of medicine having to do with obtaining, storing, and treating bone marrow, i.e., the fields of oncology, orthopaedic surgery, or radiology. More particularly, the invention concerns devices and methods for bone marrow aspiration, storage, and the combining of harvested marrow with biomaterials or medical devices. In a preferred embodiment, the invention includes aspiration of marrow into a cartridge to minimize bacterial contamination and clotting while facilitating storage or the combining of harvested material with biomaterials or medical devices. 
     BACKGROUND OF THE INVENTION 
     Specimens of bone, marrow, and fluids present in the medullary cavity of bone are biopsied to diagnose various diseases and harvested for medical treatment. These specimens are difficult to obtain since human bone has a hard outer cortex. Traditionally, marrow has been removed with large bore needles. A needle with an inserted stylet is pushed through an incision in the patient&#39;s skin and pressed through the muscle tissue and cortex of bone. The stylet is withdrawn and a syringe is attached to the needle. Bone marrow fluid is drawn using negative pressure. The needle may be gyrated to free the marrow sample for withdrawal. 
     Aspiration and biopsies are most commonly performed on the hip bone in adults and in long bones such as the femur in adolescents. Devices and systems for bone marrow tissue collection and processing for transplantation have been described. U.S. Pat. No. 5,199,942 to Gillis relates to a method for autologous hematopoietic cell transplantation of patients receiving cytoreductive therapy. U.S. Pat. Nos. 4,486,188, and 4,481,946 to Altshuler relate to an apparatus and method using a pair of needles, one to aspirate and a second to infuse intravenous solutions into bone. The apparatus reportedly has chambers, a fluid flow controller, valves, and syringes. The method appears to use simultaneous aspiration and infusion to recover bone marrow. Altshuler (U.S. Pat. No. 4,366,822) relates to the removal and separation of bone marrow cells by interposing a filtration chamber between a bone marrow needle and aspirator. 
     Baldridge (U.S. Pat. No. 5,357,974) relates to a bone marrow biopsy instrument including a hollow aspirate needle, a hollow biopsy needle telescoped within the aspirate needle and a solid stylet removably telescoped within the biopsy needle. U.S. Pat. No. 5,282,477 to Bauer relates to a device for performing a bone marrow biopsy such that it is possible to know during the biopsy whether tissue has been removed from the patient. Lee (U.S. Pat. No. 4,513,754) relates to a biopsy device that reportedly allows for the interchange of single-use needles. 
     Bone marrow biopsy needles and biopsy needles are common in the prior art. U.S. Pat. Nos. 3,477,423; 4,142,517; 4,356,828; 4,630,616; 5,012,818; 5,385,151; 5,394,887; and 5,538,009; and PCT publication WO 91/06246 relate to the general structure and orientation of components of biopsy needles. 
     Problems with prior art bone marrow harvest and manipulation devices include mechanical designs that allow exposure of marrow to air or unsterile surroundings during harvest, storage, and mixing of harvested bone marrow with any other biomaterial; inadequate storage or inefficient devices for mixing freshly harvested, tissue with biomaterials. Because of such problems, known procedures are not completely satisfactory, and the present inventor has searched for improvements. 
     SUMMARY OF THE INVENTION 
     The present invention seeks to overcome these and other drawbacks inherent in the prior art by providing a catheter/needle combination tip and bone marrow collection device that allow a completely enclosed sterile system for harvesting bone marrow, for storage of harvested marrow, and for mixing harvested marrow with a further biomaterial. 
     Accordingly, the present invention provides a bone marrow aspiration device comprising a catheter having a bore and a port; a needle having a bore and a port, the needle being fittable into the catheter bore and, when fitted, is rotatable or translatable relative to the catheter so as to move the catheter port and the needle port between an open port position and a closed port position; a housing having a bore, the housing capable of being rotationally or translationally coupled to the needle; and a suction conduit attachable to the housing. When in use, bone marrow is moved by aspiration from within bone through the open port position into the needle bore and into the housing bore. 
     The bone marrow aspiration device may further comprise a cartridge fittable into the housing, the cartridge having a cartridge bore, wherein, when in use, bone marrow is moved by aspiration from within bone through the open port position into the needle bore and into the cartridge bore. The cartridge may be prepackaged with a biomaterial, may be disposable, and is preferably provided as a sterile, single-use unit. Either embodiment of the bone marrow aspiration device, i.e., with or without the cartridge, may further comprise a cap rotatably or translatably attachable to the housing; may further comprise a mixing apparatus to form a bone marrow aspiration device and biomaterial mixing system; the cap may be a tissue processing apparatus; the cap may comprise a compartment for biomaterial storage; and the device may be sterile. Where the embodiment has both a cap and a cartridge, the cap and cartridge may be rotatable with respect to the housing to enhance mixing within the cartridge. 
     In further embodiments of the bone marrow aspiration device; the device may further comprise a structure that eliminates blocking of the suction conduit during use, the housing or the cartridge may comprise a compartment for biomaterial storage, or the housing or the cartridge may further comprise a biomaterial for mixing with harvested bone marrow. 
     The catheter port may be an end-port having a cut selected from the group consisting of an angle cut and a straight cut, and, in this case, the needle port is a side-port. The needle port may be an end-port, and, in this case, the catheter port is a side-port. Where the needle port is an end-port and a side-port, the catheter port is a side-port. 
     In a particularly preferred embodiment, a bone marrow aspiration device is provided; the device comprises a catheter having a first end and a second end, a catheter bore, and a catheter coupler at the second end; a needle having a first end and a second end, a needle bore, and a needle coupler at the second end for coupling to the catheter coupler and to a housing; wherein the catheter and the needle each have at the first end either an end-port, or a closed trocar cutting tip and a side-port adjacent the cutting tip; a housing having a housing bore, the housing capable of being coupled to the needle coupler; and a cap rotatably attachable to the housing, the cap having a suction conduit. When the catheter has an end-port, the needle has a closed trocar cutting tip and a side-port; and when the catheter has a closed trocar cutting tip and side-port, the needle has an end-port, such that when the needle is fitted into the catheter bore, the needle and the catheter and are rotatable or translatable relative to each other between a closed position where an end-port is not open to a side-port, and an open position where an end-port is open to a side-port and, when in use, bone marrow is moved by aspiration from within bone through an open port position, through a side-port, through the needle bore and into the housing bore. This preferred embodiment may further comprise a cartridge fittable into the housing bore, and, when in use, bone marrow is moved by aspiration from within bone through an open port position, through a side-port, through the needle bore and into the cartridge bore. 
     A bone marrow aspiration device and biomaterial mixing system is an aspect of the invention. The device and mixing system comprises the bone marrow aspiration device as described herein and a mixing apparatus positioned within the housing or the cartridge. When in use, bone marrow is moved by aspiration from within bone through the open port position into the needle bore and into the housing bore or cartridge bore and is available for mixing. The bone marrow aspiration device and biomaterial mixing system may further comprise a biomaterial within the housing or cartridge for mixing with harvested bone marrow. 
     A catheter/needle combination tip for bone marrow aspiration is a further aspect of the present invention. The combination tip comprises a catheter having a first end and a catheter bore; and a needle having a first end and a needle bore, the needle being fittable into the catheter bore. The catheter and the needle each have at the first end either an end-port or a closed trocar cutting tip and a side-port adjacent the cutting tip. When the catheter has an end-port, the needle has a closed trocar cutting tip and a side-port; and when the catheter has a closed trocar cutting tip and side-port, the needle has an end-port; such that when the needle is fitted into the catheter bore, the needle and the catheter and are rotatable or translatable relative to each other between a closed position where an end-port is not open to a side-port, and an open position where an end port is open to a side-port. For this embodiment of the catheter/needle combination tip, when the needle has an end-port, the needle further has a side-port adjacent the end-port. 
     In a further embodiment of the catheter/needle combination tip, the needle and the catheter each further have a second end, and the needle second end further comprises a coupler for rotationally or translationally coupling to the catheter second end, and for rotationally or translationally coupling to an aspiration source; and the catheter second end further comprises a coupler for rotationally or translationally coupling to the needle second end. An aspiration source may be a syringe, or a connection to suction such as a vacuum line, for example. 
     A bone marrow aspiration device comprising the catheter/needle combination tip herein described is another embodiment of the present invention. The device further comprises a housing having a housing bore, the housing capable of being coupled to the needle coupler and capable of being attached to a suction conduit; and a suction conduit. When in use, bone marrow is moved by aspiration from within bone through the needle bore and into the housing bore. 
     A method of obtaining bone marrow from a subject using a bone marrow aspiration device of the present invention is a further aspect of the invention. The method comprises the steps of attaching a suction source to the suction conduit of an assembled bone marrow aspiration device of the present invention; inserting the device into bone so that an opened position of the needle and catheter is within bone marrow; rotating or translating the catheter or the needle to form an open port position; and collecting bone marrow into the housing by applying suction to the device. The method may further comprise the step of inserting a cartridge into the housing; or where the cap or housing contains a biomaterial, the method may further comprise the step of rotating the cap with respect to the housing to mix the biomaterial with collected bone marrow. 
     In use, the bone marrow aspiration device includes a needle within a catheter, the needle and catheter interacting so as to open and close the needle lumen. This device further includes a fillable housing or a fillable tissue collection cartridge that fits into the housing, a cap and a suction port. The needle and catheter combination tip serves multiple functions: first, it acts as a trocar to cut through soft-tissue or bone; second, it provides a conduit between bone and the outside of the body; and third, it is a valve to open or close the needle lumen. The suction conduit communicates with the inside of the housing or cartridge to allow applied suction to draw bone marrow up the needle lumen and into the housing or cartridge for storage. This apparatus facilitates soft tissue and bone puncture, aspiration of bone marrow, storage of harvested marrow, and the combining of harvested marrow with a biomaterial or medical device. 
     The cartridge, housing, or cap can further be configured with a mixing apparatus, for example, a paddle, blade, flute, bead, finger, plunger, or the like, to facilitate mixing of an agent with harvested bone marrow. Additionally, the cartridge, housing, or cap can be configured with a compartment having a penetrable barrier such as a valve, seal, cap, or diaphragm, for example. The compartment may contain, separated from the marrow, an active agent or biomaterial. In use, the penetrable barrier separates the marrow from the agent until the mixing apparatus is engaged to breach the barrier and mix the marrow with the agent or biomaterial. 
     Collected bone marrow can be combined with antibiotics, anticoagulants, growth factors, anti-inflammatories, agents that may enhance tissue storage or viability, biomaterials of diverse shape and structure, or the like. Solid, porous, fibrous, gelatinous, or fluid materials can be stored in the cartridge and mixed with bone marrow during the aspiration procedure. U.S. Pat. No. 5,199,942 is incorporated by reference herein for teachings regarding use of growth factors relating to bone marrow. 
     Further, components of the aspiration device such as the tip, housing, or cap, for example, can be rotated or translated to facilitate mixing. The housing, which may be elongated in a preferred embodiment, has the catheter/needle combination tip on a first end and may have a cap with suction port on a second end. The cap may be removable and can engage the cartridge or mixing apparatus so as to stir the marrow into an agent or biomaterial. 
     The suction port may be designed to remain clear by providing a baffle, a filter, or other internal structure that prohibits harvested material from moving into the suction port. Such a structure would eliminate blocking of the suction tube, and loss of semisolid bone tissue and free fluid. The baffle, filter, or other structure can be combined to selectively filter the marrow aspirate so as to enhance its handling properties and mode of action when used as a transplant tissue. 
     The aspiration system allows indirect manipulation of the tissue and mixing apparatus by the surgeon. Indirect manipulation may include actions such as turning or translating the combination tip, housing, or cap, or shaking the aspiration device once removed from the patient. Suction and flow of air and tissue through the device may further facilitate mixing. 
     The device of the invention can be disposable or be designed for multi-patient use. The cartridge can be prepackaged with agents or biomaterials, or filled operatively. The device is fabricated out of a biocompatible material such as a plastic, an elastomer, a metal, or a ceramic, for example. “Plastic”, as used herein, includes but is not limited to polycarbonate, acrylic, methylmethacrylate, polyurethane, nylon, delrin, or TEFLON□, for example. “Elastomer”, as used herein, includes but is not limited to silicone, or rubber, for example. “Metal”, as used herein, includes but is not limited to stainless steel, titanium, chromium cobalt, or derivatives thereof. “Ceramic”, as used herein, includes but is not limited to silica glasses, calcium carbonate, or calcium phosphate, for example. 
     In a preferred embodiment, the method of the present invention includes sharp trocar dissection of the soft-tissue, sharp interosseous entry, bone marrow needle aspiration, marrow collection, and tissue mixing within a clean, sterile and optimized environment. This system allows for collection and optimization of bone marrow without direct manipulation by the surgeon. Direct manipulation means manipulating with human hands, a spatula, in a bowl or other means that generally exposes the tissue to air or surgical instruments. 
     Following long-standing patent law convention, the terms “a” and “an” mean “one or more” when used in this application, including the claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of specific embodiments presented herein. 
         FIG. 1  provides an illustrated cross-sectional view of an aspiration device of the present invention in use. A human hand  600  is shown holding the device in bone  10  and  20  while bone marrow  30  is suctioned into a cartridge  300  and mixed with a solid biomaterial  500 . 
         FIG. 2  provides an assembly view of the components of the aspiration device of  FIG. 1  in a cross-sectional plane view showing suction conduit  410 , cap  400 , housing  200 , cartridge  300 , needle  110 , housing coupler  130 , and catheter  120  with rotational control mechanism including a rotational stop pin  170  and rotational groove  180 . 
         FIG. 3  shows an oblique view of a cartridge with cartridge housing  305 , penetrable, removable, self-sealing end cap  320  and penetrable, movable end cap  310 . Penetrable barrier  340  is shown integral to the end caps. 
         FIG. 4  provides an oblique view of cartridge  306  containing biomaterials in fiber sheet form  510 , cartridge  307  containing biomaterials in particulate form  520 , and cartridge  308  containing biomaterials in a putty consistency form  530 . 
         FIG. 5   a - FIG. 5   d  show a component exploded view of the tip of the aspiration device of  FIG. 1  having an embodiment incorporating a catheter/needle combination tip for bone marrow collection.  FIG. 5   a - FIG. 5   b  show the tip of catheter  120  having an angled cut  190  for use with needle  110  of  FIG. 5   c  and  FIG. 5   d . Needle  110  has needle trocar cutting tip  160  and needle side-port  100 . When assembled, rotational or translational movement of catheter  120  relative to needle  110  aligns catheter tip  190  and needle side-port  100  for aspiration. 
         FIG. 6   a - FIG. 6   d  show a further embodiment of a catheter/needle combination tip for a bone marrow aspiration device.  FIG. 6   a  and  FIG. 6   b  show catheter  121  having catheter trocar tip  111 , catheter side-port  101  for use with needle  112  of  FIG. 6   c  and  FIG. 6   d . Needle  112  has end port  102  and side-port  100 . When assembled, rotational movement of catheter  121  relative to needle  112  aligns catheter side-port  101  and needle side-port  100  for aspiration; further, translational movement of catheter  121  relative to needle  112  allows access to needle end-port  102  allowing aspiration. 
         FIG. 7  provide a further embodiment of a needle for use with catheter  121  of  FIG. 6   a  and  FIG. 6   b . Needle  113  has end-port  102 ; translational movement of needle  113  within catheter  121  opens catheter side-port  101  and allows aspiration. In this configuration, housing coupler  130  rotational control mechanism is replaced with a translational control mechanism or combined rotational and translational control mechanism. 
         FIG. 8   a  shows a further embodiment of a catheter  133  allowing translation and  FIGS. 8   b  and  8   c  show catheter  135  that allows both rotational and translational movement when used with needle  134 . 
         FIG. 9  shows cartridge  309  having biomaterial compartment  350 , internal penetrable barrier  360 , plunger  370 , and mixing apparatus  380  for combining biomaterial  540  with bone marrow. 
         FIG. 10  shows an embodiment of an aspiration device of the present invention lacking a housing for the direct attachment of a syringe or suction line to the quick connect coupler  700  further showing the catheter  710 , needle with closed sharp cutting tip  720 , and the open position of the catheter end-port and needle side-port  740  and a plurality of open catheter and needle side ports  730 . 
     
    
    
     LIST OF REFERENCE NUMERALS 
     
         
         
           
               10  cancellous bone and bone marrow tissue 
               20  cortical bone 
               30  bone marrow aspirate (tissue) 
               100  needle side-port 
               101  catheter side-port 
               102  needle end-port 
               110  needle with trocar cutting tip 
               111  catheter trocar tip 
               112  needle with end-port and side-port 
               113  needle with end-port 
               120  catheter with angle cut tip 
               121  catheter with trocar tip 
               130  catheter, needle and housing rotational coupler 
               133  catheter, needle and housing translational coupler 
               135  catheter, needle and housing rotational and translational coupler 
               140  catheter bore 
               150  needle bore 
               160  needle trocar cutting tip 
               170  rotational stop pin 
               180  rotational groove 
               190  catheter tip angle cut 
               200  housing 
               210  housing bore 
               300  cartridge 
               305  cartridge housing 
               306  cartridge with fiber sheet 
               307  cartridge with particulate 
               308  cartridge with putty 
               309  cartridge with mixing apparatus 
               310  penetrable and movable end cap 
               320  penetrable, removable and self-sealing end cap 
               330  cartridge bore 
               340  penetrable barrier 
               350  biomaterial compartment 
               360  internal penetrable barrier 
               370  tissue processing accessory 
               380  mixing apparatus 
               400  cap 
               410  suction conduit 
               420  suction port bore 
               500  solid biomaterial 
               510  fiber sheet biomaterial 
               520  particulate biomaterial 
               530  putty consistency biomaterial 
               540  biomaterial 
               600  human hand illustration 
               610  suction line 
               700  quick couple connector for syringe or suction line attachment 
               710  catheter with end-port and a plurality of side-ports 
               720  needle with a closed cutting tip and a plurality of side-ports 
               730  needle and catheter side ports in open position 
               740  needle side-port and catheter end-port in open position 
           
         
       
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention includes devices for penetrating soft-tissue and bone, for forming a conduit to bone marrow, for facilitating withdrawal of marrow, for containing harvested marrow, and for combining harvested marrow with further materials or devices. 
     An embodiment of an aspiration device of the present invention includes a tip, housing, and suction conduit. The device may further include a cartridge or cap. The tip may include needle  110 , catheter  120 , and housing coupler  130 . In one embodiment, housing  200  may contain cartridge  300 , may have a cap  400 , and is ergonomically formed for human hand use. Housing  200  may be clear for viewing tissue. Suction conduit  410  is preferably formed to have a sharp tube for penetrating cartridge  300  at a first end and a connector for suction line  610  at a second end. Cap  400  may be removable from housing  200  and may contain suction conduit  410 . 
     In an embodiment of a catheter/needle combination tip, needle  110  and catheter  120  operate together to open and close needle side-port  100 . Needle side-port  100  may also be described as a hole, or a slot into needle bore  150 . Catheter  120  and needle  110  are of similar length and form two concentric tubes when assembled. When rotated or translated in relation to each other, ports become aligned allowing aspiration to occur. Catheter  120  may have an angled cut  190  at the tip, and needle  110  has a trocar cutting closed end tip  160  with side-port  100  near closed end  160 . The outer surface of the closed end of the needle is formed with a trocar cutting tip  160 . When assembled, needle  110  runs within catheter  120 . When rotated, needle side-port  100  moves between an open position and a closed position as the side-port rotates from the open to closed side of catheter angled cut tip  190 . When closed, needle  110  and catheter  120  form a sharp cutting tip. When needle  110  and catheter  120  are rotated or translated with respect to each other, an opening forms a notch which increases in area with rotation and translation until the maximum bore area is exposed. When rotated or translated, catheter  120  tends to clear tissue from the inner-running needle side-port  100 . Together catheter  120  and needle  110  act with the housing coupler  130  to form a closeable conduit into housing  200  and a sharp surgical instrument at the tip of the aspiration device. A further embodiment of a catheter/needle combination tip is demonstrated in  FIGS. 6   a - 6   d  where catheter  121  has catheter trocar tip  111  and catheter side-port  101 ; needle  112  has needle side-port  100  and needle end-port  102 . Needle  113  having end-port  102  is also used with catheter  121 ; needle  113  may have end-port  102  cut at an angle or straight cut. 
     Housing coupler  130  joins catheter  120  and needle  110  to housing  200 , provides for rotational movement of needle  110  relative to catheter  120 , and forms a conduit from needle bore  150  into housing  200  or cartridge  300 . When housing  200  is fitted with cartridge  300 , housing coupler  130  sharply protrudes into housing  200  so as to penetrate cartridge  300  and form a direct path for fluid flow from needle  110  tip to the inside of cartridge  300 . Housing coupler  130  may be integral to housing  200  or, when a separate component, may be coupled to housing  200  using quick couple fittings, threads, glue, or a press-fitted structure, for example. Needle bore  150  and housing coupler  130  may be constructed so as to form an arrowhead-like structure at the housing end of needle  110 ; the arrowhead-like structure may include a structure to assist in penetrating penetrable barrier  340 . 
     Housing  200  is preferably elongated, has housing bore  210 , is able to be coupled to a needle/catheter combination tip on a first end, and is open on a second end. The housing exterior may be formed for being handheld. Housing  200  may be clear for tissue  30  viewing, or may have graduations so as to measure the volume of collected tissue  30 . Housing  200  is designed to be used with or without a cartridge  300 . A cap  400  or tissue processing accessory  370  and mixing apparatus  380  can be secured to the open end of the housing or one end of cartridge  300 . Housing  200  may be designed to receive cartridge  300  into bore  210 . When used with cartridge  300 ; housing  200 , cartridge  300 , and cap  400  interact so as to rotate the biomaterial to facilitate mixing with the aspirated marrow. 
     Cap  400  is removable from housing  200 , and provides a suction conduit  410  for applying suction to housing  200  or to cartridge  300 . Suction conduit  410  penetrates cartridge  300  at a first end and connects to a suction line  610  with a second end. Cap  400  has tabs, slots, or similar structures to engage cartridge  300 . Such structures allow cap  400  and cartridge  300  to be movably fastened so as to allow cartridge  300  rotation and translation within housing  200 . 
     Cartridge  300  can be used with cap  400  containing a filter or baffle system in suction conduit  410  to remove any semisolid tissue  30  from the suction port bore  420 . 
     Cartridge  300  fits into housing  200  and is engaged by cap  400 . Counter-rotation of cap  400  and housing  200  turns cartridge  300  within housing  200 . This rotational feature enhances mixing and is the preferred configuration for driving the cartridge  300  for mixing a biomaterial with the aspirated marrow. A further embodiment is a mixing apparatus  380  that can be inserted or incorporated into cartridge  300 . Cartridge  300  is preferably elongated so as to fit into housing bore  210 , has removable, movable, and penetrable end caps  310  or  320 . Said end caps are removable for filling and removal of harvested tissue. End cap  310  can be movable so as to facilitate mixing or pushing out of harvested tissue  30 . End caps may have penetrable barriers  340  so as to allow the sharp needle bore  150  of the combination tip or the sharp suction conduit  410  to enter the cartridge  300 . Cartridge  300  may be clear to observe and measure harvested tissue  30 , and may have graduations. Preferably, cartridge  300  is sterile. End caps  310  and  320  may be penetrable and self-sealing. 
     After harvest of bone marrow aspirate, cartridge  300  may be used with a dispenser that receives cartridge  300  and acts on movable end cap  310  so as to push tissue  30  from cartridge bore  330 . 
     Further embodiments include an aspiration device without cartridge  300 ; a further catheter/needle combination tip having a similar mode of operation where catheter  121  has catheter side-port  101  and catheter trocar tip  111 , while needle  112  has needle side-port  100  and needle end-port  102 ; a tissue processing accessory  370  and mixing apparatus  380  for housing  200  or cartridge  300 ; or housing compartment, cartridge biomaterial compartment  350  or cap compartments with an internal penetrable barrier  360  for agent or solid biomaterial  500  storage until mixing. 
     Rotational catheter coupler  130 , translational catheter coupler  133  or combined rotational and translational catheter coupler  135  facilitate movement of the needle within the catheter to open a side-port or end-port and couple the catheter needle assembly to the housing or other accessory such as syringe, suction line  610  or other source of vacuum to facilitate the harvest of bone marrow. 
     The catheter/needle combination tip and bone marrow aspiration device is used during surgery to obtain bone marrow. The tip of the device is pushed through soft-tissue and cortical bone of the ilium  20 , for example; the device is operated so as to open bore  150  of needle  110  and used with suction to draw bone marrow up needle  110  and into housing  200  or cartridge  300 . 
     In conventional practice, an empty cartridge is inserted into the housing to collect bone marrow for storage or in vitro processing. A cartridge containing a biomaterial or a biologically active agent is used for the combining of harvested marrow with such biomaterial or active agent. The biomaterial or active agent may be a conductive matrix from the list including but not limited to formulations of calcium sulfate, calcium carbonate, calcium phosphate, collagen, human cadaver tissue and their mixtures or therapeutic agent from the list including but not limited to bone morphogenic proteins, transforming growth factor, platelet derived growth factor, fibroblast growth factor, heparin, or living cell seeded system. 
     To operate the aspiration device, cap  400  is removed, a cartridge  300  is inserted into housing  200 , cap  400  is then placed on housing  200  so as to engage cartridge  300  and penetrate cartridge barrier  340  with tip needle bore  150  and cap suction conduit  410 . Once cap  400  is secure on housing  200 , suction hose  610  is attached to suction conduit  410 . Needle  110  and catheter  120  are then oriented so as to close needle side-port  100  and form a cutting end with needle trocar tip  160  and catheter angle cut tip  190 . The aspiration device can then be introduced into a body. 
     The catheter/needle combination cutting tip of the aspiration device is pushed through skin and cortical bone until the tip and needle side-port  100  are within cancellous bone and bone marrow tissue  10 . In a particular embodiment, catheter  120  is turned so as to open needle side port  100  to allow suctioning of fluid into needle  110  and into housing  200  or cartridge  300 . During movement of fluid into cartridge  300 , cap  400  can be rotated with respect to housing  200  so as to turn and mix a solid biomaterial  500  or active agent with harvested marrow tissue  30 . 
     Once marrow tissue  30  has been collected in housing  200  or cartridge  300 , needle  110  and catheter  120  are reoriented so as to close needle side-port  100 . Once needle side-port  100  is closed, the aspiration device is repositioned within cancellous bone and marrow tissue  10  or withdrawn from the body. Suction line  610  is then removed, and cap  400  is removed. 
     Tissue  30  may be withdrawn from cartridge  300  by penetrating end cap barrier  340  with needle, for example, while the marrow is being contained and kept sterile in the cartridge. Penetrable barriers  340  can seal so as to protect the marrow from environmental contamination or spillage. Further, cartridge  300  may be emptied by removal of end cap  320  and expulsion of tissue  30  from cartridge  300  by dumping harvested tissue into a recipient site, by pushing end cap  310  with a plunger, by installing cartridge  300  into a dispenser that uses a plunger, or by spooning harvested material from cartridge bore  330 . 
     The aspiration device may be single-use and discarded following collection of bone marrow tissue  30  to eliminate risk of interpatient disease transmission. 
     Even though the invention has been described with a certain degree of particularity, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art in light of the foregoing disclosure. Accordingly, it is intended that all such alternatives, modifications, and variations which fall within the spirit and the scope of the invention be embraced by the defined claims. 
     EXAMPLE I 
     Marrow Aspiration from Rabbits with a Syringe, Needle and Stylus System and Unprotected Mixing and Handling 
     The first study of the developing device was used to harvest bone marrow from the iliac crest of rabbits for the mixture of the marrow with a biomaterial to enhance its biological properties. The initial design used a syringe, needle, needle bone stylus and biomaterial compartment. This design successfully harvested marrow but had the following deficiencies: the needle did not close its end port and thus it became blocked with bone, the syringe did not allow continuous aspiration and required the user to remove the device from the subject, empty a small harvest volume from the syringe start the harvest again, and only an end-port was used and blocked easily. This study resulted in a low volume harvest, inconvenience for the surgeon, no protection of the biomaterial and marrow from the environment and required mixing in a bowl outside of the subject invention. It was shown that the combination of marrow with this biomaterial did not significantly enhance bone healing in the rabbit spine. 
     EXAMPLE II 
     Marrow Enhancement of a Synthetic Bone Matrix with and without Heparin 
     In a second study of marrow harvest in rabbits the device of example I was modified to overcome several of the deficiencies of the previous system. It again used a syringe with biomaterial chamber, needle bone stylus attached to the plunger so that they worked together and end-port on the needle. This still required the surgeon to remove the device from the patient for each few cc of marrow harvested and did not sufficiently mix the marrow with the biomaterial and needle end-port obstruction still occurred. It was shown that marrow and marrow with heparin did not significantly enhance the ability of the biomaterial to enhance new bone formation in the spine of rabbits. 
     EXAMPLE III 
     Marrow Harvesting for Stem Cell Expansion for Orthopaedic Implant Seeding 
     Though marrow and marrow combined with heparin did not significantly enhance bone healing in the spinal treatment evaluated developing technology has provided data that indicates that concentrated marrow may have the desired bone healing effect. In a study in baboons marrow was harvested from juvenile animals using a needle with stylus and a quick couple connector for the attachment of a syringe. This system again required repeated aspiration and removal from the harvest site, exposure of the harvested marrow to room air, and suffered from blockage. 
     Though the system still suffered from many of the same deficiencies the concentrated marrow was seeded onto a biomaterial, implanted to heal a defect in the fibula of a baboon and show good efficacy at enhancing the biologic response and healing of the bone defect where implant materials without concentrated marrow did not become will incorporated into bone. 
     EXAMPLE IV 
     Prototype Marrow Aspiration and Biomaterial Mixing System 
     The prototype device of the subject invention was developed with the needle within a catheter, multiple ports into the bore of the needle, a housing and cartridge to collect the marrow, features for mixing within the device and the use of a suction line instead of using a syringe for suction. This system was used in models with simulated marrow and was shown to minimize port blockage, did not require a needle bore stylus to clear the needle, allowed the surgeon to enter the bony site and aspirate marrow from multiple sites within bone without removing the needle/catheter tip from the patient, allowed mixing of the biomaterial and marrow without opening the device and eased the surgeons task by using hospital supply suction versus creating suction by pulling a plunger within the bore of a syringe. 
     References cited herein, to the extent that they provide exemplary procedural or other details supplementary to those set forth herein, are specifically incorporated herein by reference.

Technology Category: a