Abstract:
The bioinjection device has a housing including a pistol grip and an elongated barrel. A trigger is pivotally mounted to the housing. A plunger and needle are slidable between a first position in which the plunger and needle are slidably disposed in the barrel and a second position in which the plunger and needle extend from an opening in the end of the barrel. A retaining member is disposed about the opening at the end of the barrel. A spring-biased actuation mechanism connects the trigger with the plunger and needle. A membranous cartridge containing bone morphogenic protein, antibiotics, and/or other medication is loaded into the retaining member. A surgeon can inject the cartridge into a bone fracture or degenerative bone tissue during surgery to deliver the medicament directly to the affected site.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 12/901,208, filed Oct. 8, 2010, now U.S. Pat. No. 8,328,753, entitled BIOINJECTION DEVICE, which is a continuation of U.S. patent application Ser. No. 12/458,779, filed Jul. 22, 2009, now U.S. Pat. No. 7,824,359, issued Nov. 2, 2010, entitled BIOINJECTION DEVICE, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/129,849, filed Jul. 24, 2008, the contents of which are incorporated herein by reference in their entirety. 
     
    
     COPYRIGHT NOTICE 
       [0002]    A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent files or records, but otherwise reserves all copyright rights whatsoever. 
       FIELD OF THE INVENTION 
       [0003]    The present invention relates to devices for the delivery of pharmaceuticals, and particularly to a bioinjection device for delivering bone morphogenic protein, antibiotics, etc., directly to the site of a bone fracture, degenerative bone tissue or cartilage, etc., during the course of surgery in the form of a bioabsorbable matrix enclosed within a membrane cartridge. 
       DESCRIPTION OF THE RELATED ART 
       [0004]    Bone is a living tissue and plays a structural role in the body. Disease and damage, however, is often difficult to treat in bones, due to their positioning within the soft tissues of the body. Bone consists of repeating Haversian systems (concentric layers of lamellae deposited around a central canal containing blood vessels and nerves). The central canal is also known as the medullary cavity and is filled with bone marrow. Within the shaft of a long bone, many of these Haversian systems are bundled together in parallel, forming a type of bone called compact bone, which is optimized to handle compressive and bending forces. In some bones, such as the metacarpals, for example, the bones themselves are hollow and contain little, if any, marrow. Near the ends of the bones, where the stresses become more complex, the Haversian systems splay out and branch to form a meshwork of cancellous or spongy bone. Compact bone and cancellous bone differ in density, or how tightly the tissue is packed together. 
         [0005]    Genetic or developmental irregularities, trauma, chronic stress, tumors, and disease can result in pathologies of bones. Some bone diseases that weaken the bones include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget&#39;s disease, and scoliosis. Weakened bones are more susceptible to fracture, and treatment to prevent bone fractures becomes important. Severe fractures, such as those that are open, multiple, or to the hip or back, are typically treated in a hospital. Surgery may be necessary when a fracture is open, severe, or has resulted in severe injury to the surrounding tissues. Severe fractures may require internal devices, such as screws, rods, or plates, to hold the bone in place or replace lost bone during the healing process. 
         [0006]    In order to repair severe fractures, bone cement and the like is often applied within the fracture. However, other healing agents, such as antibiotics or bone morphogenic proteins, often need to be applied prior to cementing or performance of other operations on the bone. Due to the awkward positioning of bone fractures within other tissue, it is often quite difficult to properly apply medicaments and the like within the bone, particularly without damaging the tissue surrounding the bone. Thus, a bioinjection solving the aforementioned problems is desired. 
       SUMMARY 
       [0007]    The bioinjection device is directed towards a device for injecting or implanting a membrane-encased cartridge of pharmaceuticals and/or biologics, bone grafts, radioactive seeds and the like, in a bioabsorbable matrix or carrier directly into the site of a bone fracture, degenerative bone tissue or cartilage, or the like in the course of surgery. The cartridge may contain bone morphogenic protein, antibiotics, bone, bone substitute or the like. 
         [0008]    The device includes a housing having an upper portion and a lower gripping portion. The lower gripping portion may be rotatable with respect to the upper portion and includes a handle member and a trigger member. The trigger member is pivotally secured to the handle member. Further, the upper portion of the housing has an open interior region formed therein. 
         [0009]    A shaft is slidably mounted within the open interior region of the upper portion of the housing. The shaft has opposed forward and rear ends and is elongated along a longitudinal axis. Further, the shaft has a channel formed therethrough, also extending along the longitudinal axis from the forward end to the rear end. 
         [0010]    At least one lever arm is pivotally mounted within the housing, with the at least one lever arm having opposed first and second ends. The first end of the lever arm is attached to the rear end of the shaft, and the second end is attached to the trigger member so that rotation of the trigger member with respect to the handle member drives sliding translation of the shaft with respect to the upper portion of the housing. 
         [0011]    A needle is slidable within the channel formed through the shaft, the needle having opposed front and rear ends. The front end of the needle terminates in a relatively sharp point. The rear end thereof is attached to the at least one lever arm so that rotation of the trigger member with respect to the handle member drives forward sliding translation of the needle with respect to the upper portion of the housing and the shaft. Preferably, the at least one lever arm includes a pair of lever arms, including a first lever arm driving movement of the shaft and a second lever arm driving movement of the needle. 
         [0012]    A retaining member has opposed front and rear ends. The front end is open and the rear end is attached to a forward portion of the upper portion of the housing. An opening is formed through the rear end of the retaining member and the forward portion of the upper portion so that the forward end of the shaft and the front end of the needle selectively and slidably project therethrough into an open interior region of the retaining member. The retaining member is preferably releasably attached to the forward portion of the upper portion of the housing. 
         [0013]    A cartridge is releasably received within the open interior region of the retaining member. The cartridge includes an outer shell membrane and a medicament contained within the outer shell. The forward end of the shaft contacts the membrane so that actuation of the trigger member causes the shaft and the needle to slide forward, with the shaft pushing the cartridge out of the retaining member for deployment thereof into the bone fracture. As the shaft pushes the implant out of the retaining member, the needle pierces the outer shell membrane to release the medicament into the fracture or degenerative tissue. 
         [0014]    These and other features of the present invention will become readily apparent upon further review of the following specification and drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is an environmental, perspective view of a bioinjection device according to the present invention; 
           [0016]      FIG. 2  is a side view of the bioinjection device according to the present invention, broken away and partially in section to show details thereof; 
           [0017]      FIG. 3  is a perspective view of a membranous cartridge for use with a bioinjection device according to the present invention; 
           [0018]      FIG. 4  is a partial side view in section of the bioinjection device, showing a cartridge extended from the device for injection or implantation; 
           [0019]      FIG. 5  is a side view of a plurality of removable and fillable heads of a bioinjection device according to the present invention; 
           [0020]      FIG. 6A  is a perspective view of an alternative embodiment of the bioinjection device according to the present invention; 
           [0021]      FIG. 6B  is a perspective view of another alternative embodiment of the bioinjection device according to the present invention; 
           [0022]      FIG. 7  is an exploded view of a plurality of alternative bone implants for use with the bioinjection device according to the present invention; 
           [0023]      FIG. 8  is a front view of a human leg broken away to show the bone implants of  FIG. 7  inserted within a channel formed within a bone; 
           [0024]      FIG. 9  is a side view of an alternative embodiment of the head of the bioinjection device according to the present invention; and 
           [0025]      FIG. 10  is a side view of another alternative embodiment of the bioinjection device according to the present invention. 
       
    
    
       [0026]    Similar reference characters denote corresponding features consistently throughout the attached drawings. 
       DETAILED DESCRIPTION 
       [0027]    The present invention relates to a bioinjection device  10 . As shown in  FIG. 1 , device  10  is used to place a cartridge  12  into a fracture, degenerative tissue, or the like of a spinal segment S. The cartridge  12  contains a medicament (bone morphologic protein, antibiotics, or the like disposed in a bioabsorbable matrix or carrier) for the healing of the spinal segment S. It should be understood that spinal segment S, having vertebral bodies V, disc D and facet joint F, of  FIG. 1  is shown for exemplary purposes only and is not intended to limit the type of bone or fracture that the cartridge  12  and device  10  may be used to treat. 
         [0028]    As best shown in  FIGS. 1 and 2 , the device  10  includes a housing  32  having a barrel-shaped upper portion  33  and a lower gripping portion  35 . The lower gripping portion  35  may be rotatable with respect to the upper portion  33  and includes a pistol grip handle member  34  and a trigger member  36 . The trigger member  36  is pivotally secured to the handle member  34  by a pivot pin  39  or the like. Trigger member  36  preferably has a plurality of finger receiving grooves or recesses  38  formed therein, as shown in  FIG. 2 , allowing for optimal gripping and actuation by the surgeon. Further, an upper gripping handle  11  may be mounted on an upper surface of housing  32 , allowing the surgeon to better grip and secure tool  10  during the surgical operation. 
         [0029]    As noted above, the lower portion  35 , including both handle member  34  and trigger member  36 , may be rotatable about pivot  37 , allowing the lower gripping portion  35  to be rotated if necessary, depending upon the nature of the particular operation. The lower portion  35  may further be selectively locked in place with respect to the upper portion  33 . Further, as shown in  FIG. 2 , the barrel-shaped upper portion  33  of housing  32  has an open interior region formed therein. 
         [0030]    As shown in  FIG. 2 , a shaft  16  is slidably mounted within the open interior region of the upper portion  33  of the housing  32 . The shaft has opposed forward and rear ends  21 ,  22 , respectively, and is elongated along a longitudinal axis, as shown. Further, the shaft  16  has a longitudinally extending channel  25  formed therethrough, extending from the forward end  21  to the rear end  22 . Shaft  16  is preferably resiliently or spring-biased with respect to housing  32 . In the preferred embodiment, a stop  13 , such as a disc, is mounted to a central portion of shaft  16 , as shown in  FIG. 2 , with a spring  20  or other resilient element being biased between the stop  13  and the inner wall of forward portion  50  of housing  32 . 
         [0031]    At least one lever arm is pivotally mounted within housing  32  for the actuation of shaft  16 . Preferably, the at least one lever arm includes a pair of lever arms with a first lever arm  28  driving movement of the shaft  16 , and a second lever arm  26  driving movement of needle  18 , as will be described in greater detail below. First lever arm  28  has opposed first and second ends, with the first end of first lever arm  28  being secured to the rear end  22  of shaft  16 , and the second end being secured to the trigger member  36  so that rotation of the trigger member  36  with respect to the handle member  34  drives sliding translation of the shaft  16  with respect to the upper portion  33  of the housing  32 . 
         [0032]    Needle  18  is slidably received within the channel  25  formed through the shaft  16 , with the needle  18  having opposed front and rear ends  27 ,  29 , respectively (the front end or tip  27  of needle  18  is best shown in  FIG. 4 ). The front end  27  of needle  18  is preferably formed as a relatively sharp point. The rear end  29  of needle  18  is secured at  24  to the second lever arm  26  so that rotation of trigger member  36  with respect to the handle member  34  drives forward sliding translation of the needle  18  with respect to the upper portion  33  of the housing  32  and also with respect to the shaft  16 ; i.e., actuation of trigger member  36  causes forward sliding of shaft  16  within the housing  32  and also forward sliding of needle  18  within the shaft  16 . 
         [0033]    A retaining member  14  is further provided, with the retaining member having opposed front and rear ends. As shown, retaining member  14  preferably forms a pair of gripping jaws for releasably holding implant  12 . The front end thereof is open and the rear end thereof is secured to mounting member  52 , which is fixed to a forward portion  50  of the upper portion  33  of the housing  32 . The rear portion of retaining member  14  is preferably releasably attached to the mounting member  52  through use of any suitable releasable fastener. The rear portion may have threads  58  formed thereon, as best shown in  FIG. 4 , for reception by a threaded recess  53  formed in mounting member  52 . 
         [0034]    Further, an opening  19  is formed through the rear end of the retaining member  14 , and a passage  17  is formed through the forward portion  50  of housing  32  so that the forward end  21  of shaft  16  and the front end  27  of the needle  18  selectively and slidably project therethrough into an open interior region of the retaining member  14 . 
         [0035]    Cartridge  12  is releasably received within the open interior region of the retaining member  14 . As best shown in  FIG. 3 , the cartridge  12  includes an outer shell membrane  40  and a medicament  42  contained within the outer shell  40 . The medicament  42  may be a bone morphogenic protein, an antibiotic, or any other desired medicament for the healing of the bone, and may be disposed in a bioabsorbable matrix or carrier. The outer shell may be formed from hydroxyapatite calcium phosphate, or any other biodegradable material that will dissolve and/or fuse within the bone. Preferably, the rear end  46  of shell  40  is formed as a relatively thin membrane that can be pierced by tip  27  of needle  18 . A further thin membrane  44  may be formed between the outer shell  40  and the medicament  42 . 
         [0036]    In use, the cartridge  12  is positioned within retaining member  14 , as shown in  FIG. 2 , with the forward end  21  of shaft  16  contacting the rear surface  46  of the bone implant  12 . Actuation of trigger member  36  causes the shaft  16  and the needle  18  to slide forward. Retaining member  14  is preferably formed from a flexible material, such as rubber, plastic or the like, so that forward movement of shaft  16  pushes the cartridge  12  out of the open front end of the retaining member  14  for deployment thereof into the bone fracture or other damaged or diseased area. As the shaft  16  pushes the cartridge  12  out of the retaining member  14 , the tip  27  of needle  18  pierces the thin membrane  46  to release the medicament  42  into the fracture. The surgeon lodges the pierced cartridge  12  within fracture F or the degenerative bone tissue. 
         [0037]    In  FIG. 9 , retaining member or head  14  of  FIG. 4  has been replaced by an alternative head  214 , having a rear portion  216  with threads  258 , similar to threaded connection  58  of  FIG. 4 . A pair of spring-biased jaws  218  are mounted to the rear portion  216 , with one or both of the jaws  218  being adapted for releasably gripping a bone dowel  220  or the like for insertion into a facet joint FJ. In the embodiments of  FIGS. 2 and 9 , the heads  14 ,  214  and the shaft have relatively small sizes, allowing for placement within the facet joint, as noted above. However, it should be understood that the head and/or shaft may have any suitable size, dependent upon the site for placement of the cartridge. As will be described in detail below, a longer shaft and head may be necessary for injection of cartridges within a larger or longer bone, such as a tibia, and the shaft and head may be appropriately sized dependent upon the intended injection site. 
         [0038]      FIG. 6A  illustrates an alternative embodiment of the bioinjection device. Bioinjection device  100  includes a housing  132  having upper and lower portions  133 ,  135 , similar to that of the embodiment of  FIGS. 1-4 . Similarly, the lower portion  135  includes a handle member  134  and a trigger member  136 , and the upper portion  133  has a handle  111  mounted thereon. Side handles  115  may also be mounted to upper portion  133 , as shown, offering the surgeon a variety of gripping surfaces for differing angles of insertion during an operation. In the embodiment of  FIG. 6A , an elongated tube  114  is mounted to the front end of barrel-shaped upper portion  133 , allowing for the implanting of bone implants where immediate proximity of the surgeon&#39;s hands is not possible, such as in the implantation of implants  112  within channel C formed in tibia T of  FIG. 8 . 
         [0039]    The elongated tube  114  includes an adjustable portion  126 , allowing for angular adjustment of the tube  114  adjacent the front end of the upper portion  133  of housing  132 . Adjustable portion may be a rotating and selectively locking disc member, as shown, or may be any other suitable angular adjustment device. A central region  128 , preferably being solid and relatively non-flexible, is joined to the flexible portions  126  at one end thereof, and a head  120  is disposed at the other end of tube  114 . Head  120  has an open outer end with external threads  124  formed therearound. 
         [0040]    The retaining jaws  14  of the embodiment of  FIGS. 1-5  are replaced in  FIG. 6A  by a cylindrical retaining member  130  having opposed open ends. Retaining member  130  is formed from a resilient, flexible material, similar to that described above with regard to jaws  14 . Internal threads  140  are formed in one end of the retaining member  130  for releasable attachment to the head  120  via engagement with threads  124 . It should be understood that retaining member  130  may be releasably secured to head  120  through any suitable releasable fastener. 
         [0041]    An implant  112  is received within retaining member  130  for selective dispensing thereof. Similar to that described above with regard to the embodiment of  FIGS. 1-5 , an inner shaft  116 , similar to shaft  16 , extends through tube  114  and is shown in  FIG. 6A  slightly projecting from head  120 . Shaft  116  preferably has a plunger-type shape, as shown, with a relatively wide outer face for pushing the wider implant  112 . A needle  118 , similar to needle  18 , is housed within shaft  116 . The alternative embodiment of  FIG. 6B  is substantially similar to that shown in  FIG. 6A , but shaft  116  terminates in a covering head  117 , which covers and surrounds the needle  118  and prevents the needle  118  from becoming caught in the implant  112 . In operation, the user actuates trigger  136  to slide the shaft  116  and needle  118  forward so that the shaft  116  pushes the implant  112  out of retaining member  130  and needle  118  pierces the implant  112 , as described above. When retaining member  130  is fixed to head  120 , the head of plunger  116  will project out from retaining member  130  (when the trigger is compressed) by approximately one or two mm. 
         [0042]    Implant  112  is preferably formed from materials similar to those described above with reference to implant  12 . However, as best shown in  FIG. 7 , implant  112  preferably includes an upper projecting member  113  and a lower recess  114 . As shown in  FIG. 7 , multiple implants  112  may be stacked through insertion of an upper projecting member  113  into a lower recess  119  of an adjacent implant. 
         [0043]    As shown in  FIG. 5 , the removable retaining members  130  may be stored and filled within a tray  54 . In order to allow for quick insertion and replacement of cartridges  112 , cartridges  112  may be positioned within retaining members  130 , as shown. Tray  54  preferably includes a plurality of channels  56  for filling of cartridges  112  within the stored retaining members  130 . A syringe  62  or other supply of medicament may be applied to ports  60 , which cover and seal channels  56 , allowing the medicament to be transferred to the cartridges  112 . Communication with, and filling of, cartridges  112  may be accomplished through any suitable fluid transfer mechanism. 
         [0044]      FIG. 8  illustrates this stacked implantation within a channel C formed within an exemplary tibia T. Such channels Care often formed from the talus to the knee during the implantation of rods and the like in tibial reconstruction. The device  100  of  FIG. 6  allows for easy insertion of multiple implants  112  within channel C after removal of such a rod. 
         [0045]    In the alternative embodiment of  FIG. 10 , device  200  allows for manual insertion and operation of the implant  112 . A gripping handle portion  204  is secured to a lower surface of mount  202 . Hollow insertion tube  206  is mounted on a front portion of the upper surface of mount  202 , as shown. The rear portion of the upper surface of mount  202  may have a groove, ridge or other means for slidably holding implant  112 . A plunger  208  is provided, with plunger  208  having a gripping, rear portion and a front portion terminating in a plunger head  210 , with needle  212  being positioned centrally therein. In operation, the user loads an implant  112  onto the rear, upper surface of mount  202 , as shown, and pushes implant  112  through tube  206 , for insertion, with plunger head  210  pushing implant through tube  206  and needle  212  piercing the rear end of implant  112 , as described above.