Abstract:
A tool for delivering bio-compatible solid, fluid or mixed solid and fluid substances to an operating site within a patient. The tool has a tubular body or barrel with a central longitudinal through hole and a flow control valve for selectively allowing material to flow from a holding chamber within the barrel through an extender tip to a dispensing end of the tool. A plunger having a piston at one end may be inserted through the dispensing end of the barrel and drawn distally to aspirate material into the holding chamber using a syringe attached to the proximal end of the barrel, after which the valve is closed to retain the material in the chamber. The plunger, which fits into the through hole from either end of the barrel, is then removed and re-inserted into the proximal end of the barrel, the barrel valve is opened, and the plunger is pushed to move the material in the holding chamber through the extender tip and out the distal end of the barrel. An optional rod and multi-pronged blade mixing assembly may be inserted into the proximal end of the barrel to mix stored material after it is aspirated into the holding chamber and before it is dispensed.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to a tool for holding and dispensing orthobiologics, osteobiologics, and other biomaterials used in the treatment of bone and joint defects. 
         [0002]    In orthopedic surgery it is often necessary to fill bone defects or cavities within a human or animal body to either support or enhance the biological repair of bone. For this purpose, a myriad of biomaterials are currently employed, including but not limited to calcium phosphate and calcium sulfate ceramics, collagen and collagen based materials, de-mineralized bone matrix, autologous and allologous bone and tissue, resorbable and non-resorbable polymers, composites, blood, bone marrow aspirate, platelet rich plasma, extra-cellular matrix (ECM), proteins, growth factors, organic molecules, tissue engineered medical products, and combinations thereof. 
         [0003]    In structure, these biomaterials can either be porous or non-porous solids, composite solids, fluids, composite fluids, fluid &amp; solid mixtures, hydrogels, pastes, putties, fibers, sponges, or any combination thereof. In origin, they are synthetic, natural, or organic. 
         [0004]    In performing surgery to fill a bone void or joint defect, the technique and procedure used by an orthopedic surgeon to deliver a biomaterial to the void or defect site varies by both patient case and choice of biomaterial. While the patient case invariably influences the surgeon&#39;s choice of biomaterial to be used, it is the delivery system and procedure for delivering the biomaterial that often engenders complication and increases the risk of human error. 
         [0005]    Too often, existing biomaterial delivery tools are either inaccurate, inefficacious, multi-staged and time-consuming, or limited in the type, shape, or form of material that can be delivered. 
         [0006]    In the case of ceramics, such as calcium phosphate and calcium sulfate solids, a common method of delivery is to pour small solid items (available in a variety of sizes and shapes) into the bone cavity and then position those items as desired, using a manually operated instrument. With this prior art technique it is not feasible to quickly and accurately dispense a controlled amount of biomaterial to the desired location, especially since the working area for a surgeon in this type of procedure is typically only a few centimeters. 
         [0007]    Thus, to ensure accuracy of biomaterial placement, the surgeon must exercise caution and sacrifice time. Further, this prior art technique only works when the configuration of the defect allows for pouring, the defect is superficial, or the size of the working area and proximity of other tissues do not obstruct the surgeon&#39;s view of the void or defect. 
         [0008]    Frequently, however, ceramics and many of the other biomaterials are preloaded in syringes or other dispensers from which such preloaded materials are held in the barrel of a tubular delivery device which acts as a holding chamber, with a cap and a plunger at opposite ends of the tube closing the chamber and preventing the material from falling out. However, once the cap is removed, the biomaterial falls out, so that the existing cap and plunger arrangement does little more than allow for pouring out the biomaterial. 
         [0009]    When the bone cavity to be filled is in a hard-to-reach location within the body, such as the femoral head (which can be greater than 8 inches from the lateral incision point, especially with an obese patient), the aforementioned device is useless, since it is not practical to remove the cap at the defect site within the body, when working at such a distance through the usual small incision (typically 2 cm.). 
         [0010]    It is often desirable to mix solid biomaterials with blood, bone marrow aspirate, or platelet rich plasma before dispensing into the defect or void of the operative site. A problem that often arises, however, is that the dispensing tools that are designed for these applications are generally not capable of aspirating fluid directly into the material holding chamber and/or do not have mechanisms for mechanically mixing biomaterials and biological fluids within the same dispensing system. 
         [0011]    For de-mineralized bone matrix (DBM), for instance, the DBM is usually packaged in a sterile vial or jar from which it is removed and placed in a container or tray for mixing. A biological fluid is usually then added to and mechanically mixed in that container, and the mixture is transferred into the dispensing tool and dispensed with the aid of a plunger. This multi-step procedure is unduly time consuming, results in considerable mixture waste, and requires substantial effort and caution on the part of the person handling the biomaterial, resulting in increased risk of human error. 
         [0012]    The majority of the dispensing tools on the market are designed only to deliver a specific biomaterial, and thus are limited in their usability. DBM dispensers, for instance, are designed only to deliver DBM and DBM doused in a biological fluid. Since DBM is typically in a fibrous putty form, it can be forced into the tapered tubular compartment of the standard DBM dispenser, which is an open end hollow long plastic tube, where it will compress against the compartment walls, permitting the dispenser&#39;s dispensing end to be left open or unsealed. For ceramics, for instance, which comprise a large portion of the bone-biomaterial market, this design does not work, since the ceramic items tend to undergo brittle failure when compressed, causing material debris and bulk material to fall out of the dispensing chamber. 
         [0013]    A syringe is usually used to dispense fluids such as hydrogels and growth factor treatments, and is unsuitable for dispensing solid ceramic-like material. 
         [0014]    An object of the present invention is to provide a biomaterial dispensing tool that is capable of holding and effectively dispensing a variety of biomaterials and fluids, including solid biomaterials of various shapes, into hard-to-reach anatomical sites; and efficiently provide for mixing of aspirate and pre-filled material in a single step within an isolated sterile chamber. 
       SUMMARY OF THE INVENTION 
       [0015]    A tool for dispensing solid, fluid or mixed bio-compatible material has a tubular body or barrel with a longitudinal cavity including a material holding chamber. The cavity extends between a proximal loading end and a distal dispensing end of the barrel. A material flow control valve is disposed between the distal end of the chamber and the dispensing end of the barrel. An aspirating assembly is detachably secured to the proximal end of the tubular body for aspirating material into the holding chamber while preventing flow of any solid material contained in the chamber toward the proximal end of the tubular body. A removable slidable plunger arrangement is provided to seal the longitudinal cavity adjacent either end of the tubular body in order to facilitate aspiration of fluid and fluid mixtures into the holding chamber via the proximal end of the tubular body and dispensing of solid material and solid-fluid material mixtures from the distal end of the ubular body. 
     
    
     
       IN THE DRAWING 
         [0016]      FIG. 1  is an isometric drawing of an orthobiologics delivery tool according to a preferred embodiment of the invention. 
           [0017]      FIG. 2  is an exploded isometric view of the tool shown in  FIG. 1 . 
           [0018]      FIG. 3A  is a top plan view of the tool shown in  FIG. 1 . 
           [0019]      FIG. 3B  is a front cross-sectional elevation view of the tool shown in  FIG. 3A , taken along the cutting plane  3 B- 3 B. 
           [0020]      FIG. 4A  is a top plan view of the tubular body or barrel  2  shown in  FIG. 1 . 
           [0021]      FIG. 4B  is a front cross-sectional view of the barrel  2  shown in  FIG. 4A , taken along the cutting plane  4 B- 4 B. 
           [0022]      FIG. 5  is an isometric view of the flow regulation valve  3  shown in  FIG. 1 . 
           [0023]      FIG. 6A  is a top plan view of the cap  4  shown in  FIG. 1 . 
           [0024]      FIG. 6B  is a front cross-sectional view of the cap  4  shown in  FIG. 6A , taken along the cutting plane  6 B- 6 B. 
           [0025]      FIG. 7  is a front elevation view of the syringe needle  5  shown in  FIG. 1 . 
           [0026]      FIG. 8A  is a top plan view of the plunger  6  shown in  FIG. 1 . 
           [0027]      FIG. 8B  is a top plan view of the plunger  6  shown in  FIG. 8A  with the valve  51  unfastened. 
           [0028]      FIG. 8C  is a front cross-sectional view of the plunger  6  shown in  FIG. 8B , taken along the cutting plane  8 C- 8 C. 
           [0029]      FIG. 9A  is a top plan view of the plunger  33 . 
           [0030]      FIG. 9B  is a front cross-sectional view of the plunger  33  shown in  FIG. 9A , taken along the cutting plane  9 B- 9 B. 
           [0031]      FIG. 10A  is a top plan view of the mixing assembly  36 . 
           [0032]      FIG. 10B  is a front cross-sectional view of the mixing assembly  36  shown in  FIG. 10A , taken along the cutting plane  10 B- 10 B. 
           [0033]      FIG. 11  is a top plan view of the barrel shown in  FIGS. 4A and 4B  with the mixing assembly attached. 
           [0034]      FIG. 12  is a top plan view of the tool shown in  FIG. 1 , in aspirating configuration. 
           [0035]      FIG. 13  is a top plan view of the tool as shown in  FIG. 12 , illustrating the action of the plunger while aspirating. 
           [0036]      FIG. 14  is a top plan view of the tool as shown in  FIG. 11 , in mixing configuration. 
           [0037]      FIG. 15  is a top plan view of the tool as shown in  FIG. 11 , in dispensing configuration. 
           [0038]      FIG. 16  is a top plan view of the tool as shown in  FIG. 15 , illustrating the action of the plunger while dispensing. 
       
    
    
     DETAILED DESCRIPTION 
       [0039]    Referring to  FIGS. 1 through 4B , the orthobiologics delivery tool  1  has a tubular body or barrel  2 , flow valve  3 , removable cap  4 , syringe needle  5 , two-shaft plunger  6 , O-ring seals  7 ,  8  and  9 , and an engagement member  10 . 
         [0040]    The central longitudinal cavity  11  ( FIG. 4B ) is preferably (but not necessarily) cylindrical and runs through the entire barrel  2 , and the orthobiologic or other biomaterial to be dispensed is stored in the portion of that cavity extending between the cap  4  and valve  3 , which portion constitutes the material holding chamber  60 . 
         [0041]    Referring generally to  FIGS. 4A and 4B , the barrel  2  is a hollow body whose external shape can be of any desired configuration but which is preferably generally cylindrical. The external transverse cross-sectional dimensions of the barrel  2  can vary or be constant along its length. 
         [0042]    The cross-sectional shape of the central longitudinal cavity  11  can be round, radial, polygonal, closed polycentric curved, or closed amorphous. That cavity should preferably have transverse cross-sectional dimensions and shape that are uniform along its length, except in the area of the valve gland  12  of the valve  3 . 
         [0043]    The valve gland  12  ( FIG. 4A ) is a chamber that intersects the central cavity  11  and whose shape conforms to the external shape of the valve  3  ( FIG. 5 ). 
         [0044]    An elongated extender tip  13  adjacent the dispensing end  14  of the barrel  2  allows for effective dispensing. The tip  13  can be of any length but is preferably at least as long as the holding chamber  60  so as to facilitate complete aspiration to the holding chamber as hereafter described, and its external shape can be round, radial, polygonal, closed polycentric curved, closed amorphous, or variable, where the shape and transverse cross-sectional dimensions along the full length of the extender tip  13 , which may be integral with or attached to the tubular body or barrel  2 . 
         [0045]    A profile feature  27  on the barrel  2  comprises a material stop  15  which restricts rotational movement of the valve&#39;s stopping rod  16  and thus prevents the valve  3  ( FIG. 5 ) from further movement when the stopping structure  16  and the material stop  15  are in contact. The form, shape, and orientation of the profile feature  27  will vary with the type of valve and stopping structure that are used, where different valve types have different shapes and actuating mechanisms and can be oriented in different directions with respect to the flow of material. 
         [0046]    An air vent hole  17  near the end  18  of the material holding chamber  60  within the barrel  2  allows the two-shaft plunger  6  to be inserted into the central longitudinal cavity  11  at the chamber end  18  of the barrel  2  without excessive back pressure while the valve  3  is closed (see  FIG. 15 ). 
         [0047]    An engagement feature  19  at the chamber end  18  of the barrel  2 , preferably internal threading, allows the externally threaded portion of the cap  4  ( FIGS. 2 and 6A ) to be fastened to the barrel  2  as shown in  FIG. 1 . The engagement feature is optional, since the seal(s)  8  on the cap  4  frictionally fasten it to the central longitudinal cavity  11  on the end  18  of the barrel  2 . The cap  4  may also be self-sealing, making the seal(s)  8  unnecessary. If an engagement feature  19  is used, its shape or form should engage with the engagement feature  20  on the cap  4 . The form of the engagement feature  19  is that of a non-permanent fastener(s), including but not limited to: a thread, pinhole, snap ring groove, snap hook, and/or mounting boss. 
         [0048]    Another engagement feature  21  on the barrel  2  allows the engagement member  10  ( FIGS. 2 and 4B ) to hold the valve  3  in the valve gland  12 , while allowing the valve  3  to rotate between open and closed positions. The engagement feature  21  is optional as engagement may selectively be permanent or non-permanent, since the O-ring seal  7  on the valve  3  effectively fastens the valve  3  to the valve gland  12 . The valve  3  may also be self-sealing, making the seal  7  unnecessary. 
         [0049]    Referring generally to  FIG. 5 , the valve  3  as shown is a cylinder valve, and it regulates the flow of materials and material mixtures through the material holding chamber  60  ( FIG. 4B ) and out of the dispensing end  14  of tool  1  ( FIGS. 2 and 15 ). The valve may alternatively be of any other common type, such as a ball valve, gate valve, or iris valve, etc. Its general form for this application is that of a hollow body whose central cavity  22  can have any of various orientations with respect to the central longitudinal cavity  11  of the barrel  2 . The shape of the valve&#39;s central cavity  22  is adapted to selectively effect and interrupt communication between the adjacent ends of the cavity  11 , and can be round, radial, polygonal, closed polycentric curved, or closed amorphous. 
         [0050]    When the valve  3  is in an open position, meaning that material is allowed to flow, the valve&#39;s central cavity  22  aligns with the central longitudinal cavity  11  of the barrel  2 , so that the valve does not obstruct material flow through the central longitudinal cavity  11 . When the valve is in a closed position, material flow is blocked. 
         [0051]    Referring generally to  FIGS. 6A and 6B , the cannulated cap  4  has a hollow body whose purpose is both to fasten the syringe needle  5  ( FIG. 7 ) to the barrel  2  as shown in  FIG. 1 . Due to its small cross-section, the cannula hole  23  in the cap  4  prevents the orthobiologic material from falling out of the chamber end  18  of the central longitudinal cavity  11  of the barrel  2 . The external shape of the cap  4  can be round, radial, polygonal, closed polycentric curved, or closed amorphous; its external transverse cross-sectional dimensions, along its length, can be variable or constant. 
         [0052]    The central longitudinal cavity  23  of the cap  4  can have a cross-section which is round, radial, polygonal, closed polycentric curved, or closed amorphous, and should be sufficiently small to prevent flow of the smallest unit of any solid biomaterial contained in the substance or mixture to be dispensed. 
         [0053]    The cap  4  contains two engagement features: a permanent or non-permanent engagement feature  24  (preferably internal threading), which fastens to and is complementary in shape or form to the engagement feature  25  (preferably external threading) of the syringe needle  5 , and an optional non-permanent engagement feature  20  (preferably external threading) which fastens to the engagement feature  19  (preferably internal threading) of the barrel  2  on the chamber side  18 . The form of an engagement feature can be that of a fastener(s), such as but not limited to: a thread, pinhole, snap ring groove, snap hook, and/or mounting boss. 
         [0054]    Referring to  FIG. 7 , the syringe needle  5  has an engagement feature  25  (preferably external threading) which fastens to the engagement feature  24  (preferably internal threading) of the cap  4  ( FIG. 6B ). The engagement feature can be that of a permanent or non-permanent fastener(s), including but not limited to a non-locking thread, pinhole, snap ring groove, snap hook, and/or mounting boss. 
         [0055]    Referring generally to  FIGS. 8A through 8C , the plunger  6  comprises a shaft  50 , a second shaft  50   a  cooperating with the shaft  50  to provide a needle valve  51 , and O-ring seals  9 . The shaft  50 , which may typically be 4 to 8 inches long, has a transverse cross-sectional shape at the piston  26  which conforms to that of the central longitudinal cavity  11  of the barrel  2  ( FIG. 4B ). The seals  9  can be of any type, i.e., O-rings, grommets, molds, etc, as long as the seals are capable of maintaining a seal and/or a significant pressure difference between the internal compartments of the tool  1  ( FIG. 1 ,  FIGS. 4A and 4B ) and the atmosphere. The piston  26  may also be self-sealing, making the seals  9  unnecessary. 
         [0056]    An axial air shaft  30  and vent hole  29  within the shaft  50  allows for air to bypass the seal created by the seals  9  at the piston  26 , which is desirable when the plunger  6  is used to aspirate a large amount of fluid into the material holding chamber  60  ( FIGS. 1 ,  4 B and  13 ). The air shaft  30  may extend the entire length of the shaft  50  or less than the full length thereof, and may be oriented in a direction that is either parallel or non-parallel to the longitudinal axis of the shaft. 
         [0057]    The orientation of the air shaft  30  and vent hole  29  are dependent upon the type of valve that is used, and the vent hole  29  is unnecessary for certain valve types. The valve  51  as shown is a type of needle valve, but can be of any common type, i.e., a ball valve, gate valve, iris valve, cylinder valve, etc. Its general form, orientation with respect to the air holes and/or air shafts, and open-close mechanism are dependent on the type of valve used. As shown in  FIG. 8B , when the valve  51  is closed, the seals  28  and  42  seal the shaft  51  and prevent air from moving out of the vent hole  29  and bypassing the seal created by the seals  9  at the piston  26  of the shaft  50 . 
         [0058]    Whatever valve type is used, it should be capable of (i) preventing the passage of air through the air shaft  30  and/or vent hole  29  and (ii) maintaining the air/fluid seal created by the seals  9  at the piston  26  of the plunger  6  while the plunger  6  is lodged in the central longitudinal cavity  11  of the barrel  2  ( FIG. 4B ). The form, shape, size, and orientation of the seals are dependant on the type of valve utilized. The seals  28  and  42  can be of any type, i.e., O-rings, grommets, molds, etc., as long as they are capable of sealing the air shaft  30  and vent hole  29 . The orientation of the seals will also depend on the type of valve and seals that are used. For certain valve types, the seals may be unnecessary as the valves may be self-sealing or may have built in seals for creating or sustaining pressure differentials, or for regulating the flow of fluids or gases. 
         [0059]    The engagement feature  31  on the shaft  50  and the engagement feature  32  on the valve  51  are optional as these are also dependent on the type of valve utilized. As shown in  FIGS. 8B and 8C , the engagement feature  32  (internal threading) on the valve  51  engages the engagement feature  31  (external threading) on the shaft  50 . These engagement features conform to each other in size and shape, and their general form is that of a non-permanent fastener(s), including but not limited to a thread, pinhole, snap ring groove, snap hook, and/or mounting boss. 
         [0060]      FIGS. 9A and 9B  show a unitary plunger  33  that can be used in cases where only a small amount of aspirate is needed. The plunger  33  is a shaft typically 4 to 8 inches long with a piston  35  on its distal end and O-ring seals  34 . The plunger&#39;s transverse cross-sectional shape at the piston  35  conforms to that of the central longitudinal cavity  11  of the barrel  2  ( FIG. 4B ). The seals  34  can be of any type, i.e., O-rings, grommets, molds, etc., as long as the seals are capable of creating a seal and/or a pressure difference between the internal compartments of the tool  1  ( FIGS. 1 ,  4 B, and  13 ) and the atmosphere. 
         [0061]      FIGS. 10A ,  10 B and  11  show the mixing assembly  36  which comprises a mixing shaft  37  and a barrel engagement member  38 . The mixing shaft  37  is typically 4 to 8 inches long and has an optional grip  42  at the proximal end and a mixing tip  41  at the distal end. 
         [0062]    The mixing tip  41  has transverse a cross-sectional shape and dimensions that allow it to move freely within the central longitudinal cavity  11  of the barrel  2  ( FIG. 4B ). The shaft  37  can move longitudinally through the engagement member  38  in a direction that is coaxial with the longitudinal axis of the barrel  2  ( FIGS. 4B and 15 ), and has an engagement feature  39  (preferably external threading) that allows the mixing assembly  36  to fasten to the engagement feature  19  (preferably internal threading) of the barrel  2 . The engagement feature provides a non-permanent fastener(s), including but not limited to a non-locking thread, pinhole, snap ring groove, snap hook, and/or mounting boss. The seal  40  is optional and includes, but is not limited to O-rings, grommets, and/or molds, etc. 
         [0063]    Referring to  FIGS. 12 through 16 , the plunger  6 , valve  3 , and mixing assembly  36  are the actuating components of the tool. When the plunger  6  is inserted into the dispensing end  14  of the tool  1  ( FIGS. 3A ,  3 B,  12  and  13 ), the plunger  6  is positioned to aspirate ( FIG. 12 ). When the valve  3  is opened, the syringe needle  5  is submerged in a biological fluid, and the plunger  6  is pulled in a direction causing it to move away from the valve  3  ( FIG. 13 ). This action causes fluid to aspirate through the syringe needle  5  and into the material holding chamber  60  of the barrel  2 , which is where the orthobiologic material to be dispensed is stored. 
         [0064]    The valve  3  is then closed, and the cap  4  and syringe needle  5  are then dissembled and removed from the tool  1 . The mixing assembly  36  can then be substituted for the cap  4 , and the mixing shaft  37  can be used to mix the biomaterial and biological fluid, if desired ( FIG. 14 ), after which the mixing assembly  36  is removed from the tool. 
         [0065]    The plunger  6  (or a different plunger) is then inserted into the chamber end  18  of the barrel  2  ( FIG. 15 ), where its piston  26  directly contacts the orthobiologic material and fluid. The dispenser end  14  of the barrel  2  is placed in the desired location for delivery of the orthobiologic material. The valve  3  is opened, and the plunger  6  is then pushed with a motion that causes it to move toward the dispensing end  14  of the barrel  2  until all material is expelled from the dispensing end  14  ( FIG. 16 ).