Abstract:
A suture delivery system includes a distal portion having a central opening therein and one or more flanges surrounding said central opening; a body portion connected with said distal portion; and at least one suture strand and needle combination removably connected with at least one of said distal portion and said body portion, wherein a first portion of said suture strand engages said flanges of said distal portion and said body portion stores a second portion of said suture strand and said needle.

Description:
CROSS REFERENCES 
     This application claims priority to U.S. Provisional Patent Application No. 61/539,774, filed Sep. 27, 2011. 
    
    
     TECHNICAL FIELD OF THE INVENTION 
     The present invention relates generally to surgical tools and, more particularly, to a device for enhancing the process of reconnecting soft tissue with underlying bone structures. 
     BACKGROUND OF THE INVENTION 
     Staples and orthopedic washers have been used for many years to surgical attach soft tissues to underlying bone structures. Prior art staples are metallic “U”-shaped structures wherein the legs of the staple are driven into the underlying bone structure to sandwich the soft tissue between a web that connects the legs of the staple and the underlying bone. Examples of such staples are described in U.S. Pat. Nos. 4,592,346 and 4,793,335. 
     Prior art orthopedic washers are typically round or oval in shape with an open center and provided with multiple sharp pins as well as blunt posts on the underside of the washer. The washer is secured to the bone by a screw. Similarly to the prior art staples described above, the soft tissue that is to be secured is sandwiched between the washer and the underlying bone. The washer is held in place by the screw and sharp pins, while the blunt posts ensure that sufficient space is maintained between the washer and the bone to avoid damaging the soft tissue being secured. 
     In each case, these prior art devices are intended to ensure proper contact between the bone and soft tissue, with some degree of compression being exerted, to facilitate reconnection of the soft tissue to the bone. In the case of each type of device, the device is also used as an anchor for sutures that are used to further secure a larger area of soft tissue. These devices are used, for example, to reinforce fracture sites, to reduce potential space between the bone and overlying soft tissue, and to promote vascularity to the periosteal surface. 
     However, these prior art devices suffer from several drawbacks. First, the nature of these devices requires that they be constructed of a metallic or hard plastic material. Further, the device remains in the body following the subject procedure. Thus, the use of these prior art devices involves the introduction and continued presence—coupled with the possible need for subsequent removal—of an additional foreign body in the patient. This creates a possible additional avenue for infection at the surgical site. Further, it subjects these devices to significant regulation, which in turn increases the cost of producing the devices. 
     Therefore, it would be advantageous to provide a device that facilitates anchoring of sutures for securing soft tissue to underlying bone structures yet is removable prior to suturing. 
     SUMMARY OF THE INVENTION 
     One aspect of the invention generally pertains to a suture delivery system that provides quick and accurate placement and secure and repeatable anchoring of one or more sutures at a fixation site. 
     Another aspect of the invention generally pertains to a suture delivery system that is removable prior to suturing and capable of using low cost, disposable materials in its construction. 
     In accordance with the above aspects of the invention, there is provided a suture delivery system that includes a distal portion having a central opening; a body portion; and at least one suture strand and needle combination removably connected with at least one of the distal, or body portions. 
     These aspects are merely illustrative of the innumerable aspects associated with the present invention and should not be deemed as limiting in any manner. These and other aspects, features and advantages of the present invention will become apparent from the following detailed description when taken in conjunction with the referenced drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Reference is now made more particularly to the drawings, which illustrate the best presently known mode of carrying out the invention and wherein similar reference characters indicate the same parts throughout the views. 
         FIG. 1  is a top view of a suture delivery system according to an embodiment of the present invention. 
         FIG. 2  is a side view of the suture delivery system of  FIG. 1 . 
         FIG. 3  is a bottom view of the suture delivery system of  FIG. 1 . 
         FIG. 4  is a top view of a suture delivery system according to another embodiment. 
         FIG. 5  is a top view of a suture delivery system according to yet another embodiment. 
         FIG. 6  is a side view of another embodiment of a suture delivery system. 
         FIG. 7  is a perspective view of the embodiment of  FIG. 6  in which the two halves of the device are separated from one another. 
         FIG. 8  is a perspective view of the two halves of the device of  FIGS. 6 and 7  from the opposite direction of  FIG. 7 . 
     
    
    
     DETAILED DESCRIPTION 
     In the following detailed description numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. For example, the invention is not limited in scope to the particular type of industry application depicted in the figures. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention. 
       FIGS. 1-3  illustrate a suture delivery system according to an embodiment of the present invention. The system includes a base  10 . In the illustrated embodiment, the base  10  is provided with a roughly hourglass shape composed of a distal  12  portion and a body portion that is formed by a proximal  14  portion and an extended handle portion  16 . Distal portion  12 , alternately referenced as a suture loop snare, is advantageously provided with a central opening  18 , which accommodates a surgical screw as described in more detail below. Distal portion  12  is also be provided with a break or slot  20  in one side, preferably the side opposite of the connection between the distal portion  12  and the handle  16 , to facilitate removal of the base  10  from the surgical screw after implantation of the screw in the underlying bone. Thus, the distal portion  12  will have what may be considered to be “C” shape. 
     The underside, or middle, of the distal portion  12  is provided with one or more slots or flanges  22  to capture a portion of several suture strands  24  that are advantageously packaged with the base  10  to form the system. The flanges  22  of the distal portion  12  route the suture strands  24  around the central opening  18  of the distal portion so that they do not interfere with the initial insertion of a surgical screw through the central opening  18 . However, the flanges  22  do position the suture strands immediately adjacent to the edges of the central opening  18  to encourage capture of the suture strands by the surgical screw. This arrangement results in a portion of the suture strands being wrapped around the surgical screw to form an extremely solid base connection for the suture strands  24 . It should be noted that the suture strands  24  are preferably arranged such that the middle section of each suture strand  24  is positioned in the flanges  22  of the distal portion  12 . 
     The underside of the handle  16  portion of the base  10  is also provided with slots or flanges  26  to capture the bulk of the suture strands  24  packaged with the system. Alternately, the handle portion  16  may be composed of a pair of horizontal surfaces with the suture strands sandwiched therebetween. In yet another embodiment, the handle portion  16  is formed into a tube through which the suture strands  24  are threaded in preparation for delivery. In essence, the underside of the handle  16  serves as the primary storage area for the suture strands  24 . The flanges  26  of the handle open toward the bottom to allow the suture strands to be released from the handle after placement of the base  10  and implantation of the surgical screw. 
     In a similar manner, the underside of the proximal portion  14  is provided with slots or flanges  28  to capture needles  30  that are pre-threaded onto the suture strands  24 . Thus, after implantation of the surgical screw, and the resultant fixation of the suture strands  24  at the implantation site, needles are immediately available to the surgeon to begin suturing. 
     As alluded to above, the base  10  serves primarily as an advantageous initial delivery system to ensure quick and accurate placement and, significantly, secure and repeatable anchoring of the suture strands  24  by the surgical screw. Once the surgical screw has been inserted through the central opening  18  of the distal portion  12  and then secured into the underlying bone, which, again, involves capture of the middle portion of the suture strands  24  to anchor those strands, the base  10  is removed by simply passing the surgical screw through the slot  20  of the distal portion  12  and pulling the base  10  away from the suture strands  24  and needles  30 . This leaves the site completely unobstructed with the suture strands  24  and needles  30  perfectly positioned for subsequent suturing. Furthermore, the suture strands  24  are securely anchored by the surgical screw. 
     An additional advantage of the described system is that the base  10  can be constructed of low cost, flexible plastic material or reinforced paper. The base  10  is intended to be a single use, disposable unit. 
     While the illustrated embodiment has been described in connection with the use of a surgical screw, the system may be utilized with essentially any known surgical hardware, including staples or rivets, in the same manner as described above. 
     A further advantage of the described system is that the base  10  may also be used for the application of bone wax to the fixation point. Bone wax may be applied to the underside of the distal portion  12  surrounding the central opening  18  during manufacture of system and prior to packaging. 
       FIGS. 4 and 5  illustrate additional embodiments of a suture delivery system. The primary difference between the versions in these figures and the embodiments described above resides in the use of multiple suture snares in the distal portion  12  of these embodiments. More particularly,  FIG. 4  illustrates a version utilizing two snares  40 . As with the previously described embodiment, each snare  40  is generally C-shaped with a break or slot  20  in one side, preferably the side opposite of the connection between the snare  40  and a connecting portion  42  that connects the snares  40  with the handle portion  16 , to facilitate removal of the base  10  from the surgical screw after implantation of the screw in the underlying bone. The underside, or middle, of each snare  40  is provided with one or more slots or flanges  22  to capture a portion of the suture strands  24 . This embodiment is particularly useful for forming a suture bridge that is anchored to the surgical screw. 
       FIG. 5  illustrates a version utilizing three snares  40 . As with the previously described embodiment, each snare  40  is generally C-shaped with a break or slot  20  in one side, preferably the side opposite of the connection between the snare  40  and a connecting portion  42  that connects the snares  40  with the handle portion  16 , to facilitate removal of the base  10  from the surgical screw after implantation of the screw in the underlying bone. The underside, or middle, of each snare  40  is provided with one or more slots or flanges  22  to capture a portion of the suture strands  24 . The embodiment of  FIG. 5  is particularly useful for forming an enhanced tangential anchor site or for enhanced radial pull of soft tissue to the anchor site(s). 
     The remaining portions of the embodiments of  FIGS. 4 and 5  are essentially the same as the previously described embodiments. 
       FIGS. 6-8  illustrate another embodiment utilizing a slightly different shape. In this embodiment, the base  110  also has a distal portion  112  and a body portion  114 . Advantageously, the base  110 , which may be molded from a plastic or other suitable material, is composed of two, separable halves, creating a “clam-shell” type package.  FIGS. 7 and 8  show the two halves of the base  110  separated from one another so that the interior of the base  110  can be seen. As discussed in more detail below, the two halves of the base  110  are separated from one another after the surgical screw has been inserted through the distal portion  112  and implanted in order to access the suture material and remove the base  110  from the surgical site. 
     The distal portion  112  is generally cylindrically shaped with an open vertical interior space with openings at its top and bottom. This arrangement allows a surgical screw to be inserted through the central opening  118  of the distal portion  112  for implantation. The top end of the distal portion  112  is provided with a series of slots  122 . These slots  122  perform the same function as the slots/flanges  22  in the above described embodiments. In particular, they serve to capture a portion of several suture strands that are packaged with the base  110 . The slots  122  route the suture strands around the central opening  118  of the distal portion  112  so that they do not interfere with the initial insertion of the surgical screw but are positioned immediately adjacent to the central opening  118  to encourage the screw to capture the suture strands. Again, this results in a portion of the suture strands being wrapped around the surgical screw to form an extremely solid base connection for the suture strands. 
     The interior of the body portion  114  of the base  110  provides a suitable interior space  119  to house the bulk of the suture strands for the system. The interior  119  of the body portion  114  is provided with a pair of posts  126  in one half of the body portion  114  and a corresponding pair of mating bosses  127  in the other half of the body portion. When the two halves of the base  110  are pressed together, the posts  126  fit into the bosses  127  in a press fit or snap fit manner to secure the two halves together. Advantageously, the posts  126  and bosses  127  provide a structure around which the suture strands may be wrapped to minimize tangling of the suture strand within the body portion  114 . 
     The body portion  114  is also provided with a port  150  that allows the interior of the body portion to be filled with a fluid material. This is advantageous as surgeons frequently soak sutures in various materials, for example, antibiotics or bone growth stimulants, prior to use. The open interior space of the body portion  114  with the port provides a means to pre-soak the suture. In a preferred embodiment, the port is provided with a resealable closure. The resealable closure may simply be a rubber seal through which a syringe needle may be inserted. In an alternate embodiment, a proprietary needle lock is incorporated into the port to allow for a measure of control over what substances may be injected into the body portion  114   
     The body portion  114  is also provided with a leader tube  125  that communicates with the interior of the body portion  114  and extends horizontally from the body portion  114  toward the top end of the distal portion  112 . The leader tube  125  is provided with a distal orifice  129  at its distal end. During assembly of the system, the suture strands are routed from the interior of the body portion  114 , through the leader tube  125 , and to the slots  122  of the distal portion  112 . 
     The interior  119  of the body portion  114  is also provided with one or more flanges  128  that capture needles that are pre-threaded onto the suture strands. Again, this provides immediately available needles to the surgeon and results in a complete suture package. 
     This embodiment operates in the same basic manner as the embodiments described above. The base  110  serves primarily as an advantageous initial delivery system to ensure quick and accurate placement and, significantly, secure and repeatable anchoring of the suture strands by the surgical screw. Once the surgical screw has been inserted through the central opening  118  of the distal portion  112  and then secured into the underlying bone, which, again, involves capture of the middle portion of the suture strands to anchor those strands, the base  110  is removed by separating the two halves of the base  110  and pulling the base  110  away from the suture strands and needles. This leaves the site completely unobstructed with the suture strands and needles perfectly positioned for subsequent suturing. Furthermore, the suture strands are securely anchored by the surgical screw. 
     An additional advantage of the described system is that the base  10  can be constructed of low cost, flexible plastic material or reinforced paper. The base  10  is intended to be a single use, disposable unit. 
     The preferred embodiments of the invention have been described above to explain the principles of the invention and its practical application to thereby enable others skilled in the art to utilize the invention in the best mode known to the inventors. However, as various modifications could be made in the constructions and methods herein described and illustrated without departing from the scope of the invention, it is intended that all matter contained in the foregoing description or shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present invention should not be limited by the above-described exemplary embodiment, but should be defined only in accordance with the following claims appended hereto and their equivalents.