Abstract:
The invention provides a wire dispensing device for use with forceps which attaches to a pair of forceps and provides a continuous source of wire or suture material for surgical procedures and means for covering the exposed end of the wire.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to the field of surgical instruments, and more particularly to the field of orthopedic, maxillofacial and reconstructive surgical instruments.  
       BACKGROUND OF THE INVENTION  
       [0002]     Broken or shattered bones are sometimes treated by stabilizing the bone fragments by the method of wiring the bone fragments to a support structure, or to other bones. The wiring method commonly used requires passing pieces of wire, typically 4-10 inches cut from spools from a surgical assistant to the surgeon. This procedure is problematic because the wire ends are exposed and can perforate surgical gloves. The 22-26 gauge wire easily punctures surgical gloves and skin. Puncture wounds occur when the wire is passed, twisted and cut. This problem is particularly dangerous if the patient has an infectious disease such as AIDS. This problem has been described in the medical literature. See, for example, Avery, C. M. Johnson, P. A., “Surgical glove perforation and maxillofacial trauma: To plate or wire?” Br. J. Oral Maxillofac. Surg., vol. 30, no. 1, pp. 31-35 1992, and Avery, C. M. E., Taylor, J. and Johnson, P. A., “Double gloving and a system for identifying glove perforations in maxillofacial trauma surgery,” Br. J. Oral Maxillofac. Surg., vol. 37, no. 4, pp. 316-319 1999. The present invention provides a device and method which largely eliminates the perforation problem due to exposed wire ends.  
         [0003]     A broken jaw or mandibular fracture is commonly treated by stabilizing the bone fragments. Typically, a metal bar called an arch bar is attached to the teeth using wire. The arch bar is placed on the outside surface of the teeth. Solid stainless steel wire is wrapped around each tooth and twisted around the arch bar. The twisted end of the wire is bent back over onto itself. Alternatively, the bone fragments can be wired directly to each other. This arrangement stabilizes the Jaw during the healing process. This treatment is also used to stabilize bone ‘fragments in orthopedic and reconstructive surgery.  
         [0004]     Typically, the wire is handled and twisted using forceps. The prior art reflects several techniques for accomplishing this task.  
         [0005]     For example, the Corwin Automatic Twisting Forceps utilize engagement of a wire with a rod having a spiral thread. By pulling the ring on the end of the rod, the wires are twisted as the rod rotates.  
         [0006]     U.S. Pat. No. 3,759,302 to Attenborough describes a wire twisting device that utilizes wire guides and a screw drive mechanism.  
         [0007]     U.S. Pat. No. 4,656,860 to Orthuber et al describes an electrically driven device to bend and twist wire pieces.  
         [0008]     U.S. Pat. No. 4,903,826 discusses a dispenser for surgical guidewire. This invention is designed for inserting catheters into arteries, and bears minimal relevance to the objects of the present invention. Also, this patent contains no mention whatsoever of fastening the device to forceps.  
         [0009]     U.S. Pat. No. 1,380,433 for a dental wire dispenser and mounting tool is designed for dental pins used for dental implants. The description of this device requires use of small segments of wire and therefore bears no similarities to the instant invention, and in fact, misses the point of the present invention.  
         [0010]     U.S. Pat. No. 6,093,179, is directed to a guide wire dispenser for a feeding tube. This bears no relevance to the instant invention since a significant point of novelty in the instant invention is that it is specifically adapted for use with forceps. The &#39;179 patent contains no suggestion of substituting surgical wire, nor is there any indication that the &#39;179 device can be used with forceps to manipulate the wire, such as is the case with the instant invention.  
         [0011]     U.S. Pat. No. 3,995,628 is directed to a catheter insertion device. This is a hand-held spool for inserting a catheter into a patient. This disclosure contains no mention of wire, or means for manipulation. The &#39;628 patent is clearly directed for use in a different field than the present invention.  
         [0012]     WO 98/42398 is directed to a wire dispenser apparatus. This is a hand-held spool of wire, which functions similarly to U.S. Pat. No. 3,995,628, discussed above.  
         [0013]     WO 97/14469 is directed to Forceps for the Surgical Introduction of Catheters and the Like. This is a pair of forceps having a channel to receive wire. This disclosure contains neither suggestion of a wire dispenser nor any reference at all to the source of the wire.  
         [0014]     These prior art devices are cumbersome and awkward to use. They are especially ill-suited for use in a patient&#39;s mouth. The present invention provides an elegant solution to the problem of glove perforation as well as an improvement to the customary surgical procedures using wire.  
       SUMMARY OF THE INVENTION  
       [0015]     The present invention describes a device which comprises a cartridge which attaches to a pair of forceps which provides a continuous source of wire for surgical procedures, a mount for attaching the cartridge to the forceps, and means for covering the exposed end of the wire, thereby eliminating the passage of wire pieces from the assistant to the surgeon.  
         [0016]     It is an object of the present invention to provide an improved system for surgical procedures which require wiring together bone fragments or teeth for orthopedic, maxillofacial or reconstructive surgery.  
         [0017]     It is a further object of the present invention to provide an improved method for preventing or minimizing perforation of surgical gloves during reconstructive, maxillofacial or orthopedic surgery.  
         [0018]     It is a further object of the present invention to ide an improved device for supplying wire during orthopedic, maxillofacial or reconstructive surgical procedures.  
         [0019]     It is a still further object of the present invention to provide a method of reducing assistant participation during orthopedic, maxillofacial or reconstructive surgical procedures.  
         [0020]     It is a still further object of the present invention to provide a method of reducing wastage of surgical wire or suture.  
         [0021]     It is a still further object of the present invention to provide a device which is capable of delivering more precise lengths of wire or suture for surgical procedures than prior art methods.  
         [0022]     It is a still further object of the present invention to provide an easily sterilizable wire dispenser for dispensing surgical wire or suture.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]      FIG. 1A  is a side view of the cartridge of the present invention.  
         [0024]      FIG. 1B  is a cross-sectional view showing the engagement of the sheath to the cartridge along A-A.  
         [0025]      FIG. 2A  is a top view of forceps showing the mount and wire guide of the present invention.  
         [0026]      FIG. 2B  is a side view of forceps showing groove.  
         [0027]      FIG. 3A  is a side view of one half of the cartridge of the present invention without the sheath and showing the channel or travel of the tab of the sheath.  
         [0028]      FIG. 3B  is an end view showing both halves of the cartridge fitted together.  
         [0029]      FIG. 4  shows how the device of the present invention is mounted onto a pair of forceps.  
         [0030]      FIG. 5  shows the device of the present invention mounted on a pair of forceps with the sheath retracted exposing the wire.  
         [0031]      FIG. 6  shows the device of the present invention mounted on a pair of forceps with the wire exposed and extended through the guide.  
         [0032]      FIG. 7  shows a kit containing the cartridge and forceps of the present invention and a wire cutter for one-step sterilization for surgical procedures.  
         [0033]      FIG. 5A  through  FIG. 8C  show a pinch-clip alternative mounting means.  
         [0034]      FIG. 8B  shows an end view of the cartridge of the present invention having a pinch-clip alternative mounting means.  
         [0035]      FIG. 8C  shows a bottom view of the cartridge of the present invention having a pinch-clip alternative mounting means mounted to a pair of forceps. 
     
    
     DETAILED DESCRIPTION  
       [0036]     Turning now to  FIG. 1 , the device of the present invention consists of three components. The first component is cartridge  10  containing surgical wire  12  or suture material coiled around a hub  4  in an enclosure  16 , which enclosure is typically made of high temperature plastic, such as polysulfone or polyetherimide, for example. Plastics suitable for use in the present invention must be able to withstand high temperatures and chemical sterilization agents. Polyetherimide is commonly available from many plastic supply companies, such as G. E. Plastics, Pittsfield, Mass., for example. The surgical wire is typically stainless steel. The enclosure  16  serves to store the wire and protect the user from the ends of the wire. The enclosure is equipped with a retractable sheath  22  to cover the end of wire  12  where wire  12  exits the enclosure. The two halves are typically designed with holes  24  for circulation of sterilization medium such as steam. The wire is typically stainless steel, for example, annealed type 316LVM stainless steel, gauge  22 ,  24 , or  26 .  
         [0037]      FIGS. 3A and 3B  show the enclosure  16 , which is typically made in two halves  18  fitted together in a clamshell-type configuration.  FIG. 3A  is a side view of the cartridge and  FIG. 3B  is a rear view of the cartridge. The two-halves  18  can be fitted together by any means suitable for this purpose such as an interference fit, a taper-lock fit or a snap fit, or a screw  20 , for example. The cartridge is intended for single use. However the cartridge can also be cleaned, sterilized, refilled with wire and re-sterilized for repeated use.  
         [0038]     Turning back to  FIG. 1A , cartridge  10  comprises channel  40  which receives tab  37  on sheath  22  which prevents sheath  22  from slipping off cartridge  10 . Tab  37  travels in channel  40  to retract sheath  22  thus exposing the end of wire  12  for use and extend the sheath to cover the end of wire  12  when not in use. These features ate shown in  FIG. 1A .  
         [0039]     Sheath  22  is typically a metal tubular element having two, longitudinal slits  41  cut into its outer wall at the rim where the cartridge meets the sheath. During assembly, the material between the two slits is bent toward the center of the sheath to form tab  37 . Tab  37  travels in channel  40  to prevent the sheath from sliding completely off of the cartridge  10 .  
         [0040]     Turning now to  FIGS. 2 and 4 , the second component of the present invention is a mount  26  which fits onto one side arm of a pair of forceps  28 . The mount  26  receives the cartridge  10  and comprises a slot  30  for receiving a tab  32  (shown in  FIG. 1 ) on the cartridge  10  to lock the cartridge  10  in place on the forceps  28 . Cartridge  10  may include a  38  to facilitate alignment of the cartridge onto the mount  26 . Rib  38  slidably engages into groove  39  on mount  26 , shown in  FIG. 2B . The mount  26  is positioned on the arm of the forceps so as not to interfere with the handling of the forceps or visualization of the surgical field. The mount  26  may be permanently attached to forceps  28  by welding or other means or mount  26  may be removable from the forceps and attached to the forceps by use of a clip or other attachment mechanism.  
         [0041]     An alternative mount is shown in  FIGS. 8A, 8B  and  8 C. The mount of  FIG. 8  comprises a pinch-style clip which has two opposable flexible arms  36  which deflect to receive one arm of the forceps  28  and contract to form a pressure fit around the arm of the forceps.  FIG. 8B  shows an end view of the cartridge of the present invention having a pinch-clip alternative mounting means.  FIG. 8C  shows a bottom view of the cartridge of the present invention having a pinch-clip alternative mounting means mounted to a pair of forceps. The pinch-clip mount shown in  FIG. 8C  has the added feature of permitting the use of commercially available, non-modified forceps with the cartridge of the present invention.  
         [0042]     Other mounting means obvious to the skilled artisan may also be adapted for used in securing the cartridge to the forceps.  
         [0043]     The third component of the present invention is a pair of forceps  28  which can be specially adapted for use with the present invention, as shown in  FIG. 2 . Forceps so adapted will include a wire guide  34  near the jaws of the forceps  28  for receiving the wire  12 . The guide  34  can be a tubular member mounted on the forceps near the jaw of the forceps or a grooved channel cut into the length of the arm of the forceps. Both entry and exit rims of the guide should also be rounded or smoothed so as to prevent damage to the surface of the wire. Although specially adapted forceps can be used in conjunction with the present invention, such specially adapted forceps are not required. Any suitable forceps can be used with the cartridge of the present invention.  
         [0044]     In use, the components are sterilized. Sterilization can be accomplished by exposing the components to steam autoclave up to 320° F. or 160° C., ethylene oxide, gamma radiation, or cold liquid sterilants. A separate sterile wire cutter  35  is also provided. The components can be sterilized together in a case provided for this purpose. Such a kit is depicted in  FIG. 7 .  
         [0045]     In use, the mount  26  is affixed to the forceps and the device is assembled by inserting the cartridge  10  into the mount  26  until tab  32  snaps into the slot  30  thereby securing the cartridge  10  onto forceps  28 . This is depicted in  FIG. 4 .  
         [0046]     The sheath  22  is then manually retracted thereby exposing the end of the wire  12 . The rim the sheath  22  from which the wire exits is rounded or smoothed to prevent damage to the wire. The wire  12  is manually drawn from the cartridge  10  and passed through the guide  34  to expose the desired length of wire  12 . See  FIG. 6 . The wire  12  is then used in the usual manner, such as wrapping around a tooth or bone fragment, and cut with the wire cutter. When the procedure is complete, the exposed end of wire  12  is pushed back into the cartridge  10  and the sheath  22  is manually slid over the end of the wire  12 , as shown in  FIG. 5 .  
         [0047]     The cartridge  10  is then removed from the mount  26  by pressing the tab  32  into the slot  30  and pulling the cartridge  10  off of the mount  26 . The used cartridge  10  is then disposed of according to appropriate guidelines. If the cartridge is to be re-used, it is cleaned, sterilized, refilled with wire and re-sterilized for use.  
         [0048]     Although this invention has been described with respect to specific materials and embodiments, it is not intended to be limited thereto and certain modifications and substitutions will become apparent to the person of ordinary skill in the art, such modifications and substitutions are intended to fall within the spirit and scope of the invention as described is claimed.