Flat suture banding system and methods

A surgical tensioning device for holding separated tissues in contact with one another. The device comprises a frame having two opposing first and second sides and a lower surface and an upper surface, and a band for extending through and around said separated tissues to be held together in conjunction with said frame. The band has two ends releasably attached to the sides of the frame. When the ends are secured to the sides of the frame, the band holds separated tissues together and establishes a path of tension along its length that extends linearly between the two ends of the band.

BACKGROUND OF THE INVENTION

The present invention is related to the general surgical repair of separated body tissues, and more particularly to internally fixating and stabilizing such body tissues, specifically bones.

In the present state of the art, there are a number of systems available to repair biological tissues separated in surgery or by injury. These products serve to approximate and stabilize the tissues so that healing may commence and provide compression in the interface to promote healing. Compression and stability are critical for proper anatomical healing of tissue. With the correct amount of compression applied to the interface of the tissue portions to be joined, signals are sent to the tissue, thus allowing the tissue to remodel in proper anatomical position. The amount of compression applied to the tissue interface needs to be appropriate to the type of tissue that is being healed.

Twisted wires are also typically used to keep bone fragments together so they may heal. Twisted wires only hold tension as long as the twisted wire pair remains stable. Often the wires untwist too soon, thus failing to keep the bone fragments together so that they may heal. Wires can also cut into the bone fragments, thereby allowing them to separate so that healing is difficult.

When it is necessary to access the thoracic cavity for a medical procedure, for example, it is required to cut the sternum into two pieces using a sternal saw. Once the procedure is completed within the thoracic cavity, the sternum must be repaired. For such repairs, it is known to use a dynamic compression device, such as the spring device A shown inFIG. 1. Some of the drawbacks of this typical device A, and others which are used include:

1. Bulky spring materials, while occupying substantial space, often do not store much energy. Some use polymer elastic bands, while other use coiled springs;

2. Wires are sometimes used to wrap the bones into position in compression with one another. However, wires can have sharp ends that can damage adjunctive tissues, and the wires can also cut into the bone, as mentioned above. Knot stacks in suture can interfere with the natural movement of surrounding tissues; and

3. Current banding systems that incorporate a biasing mechanism to achieve dynamic compression put the biasing mechanism in line with the band or suture. This practice competes with precious space at the healing site. Suture or bands are used to approximate tissues so that they may heal. It is desirable to obtain the best purchase possible on the tissue, so that the binding mechanics offered by the suture may be utilized. The best purchase is optimized by ensuring that the suture has the greatest contact area with the tissue. If a biasing mechanism is interfering with this concept, the biasing mechanism may diminish the suture's ability to hold the tissues together.

Bands are advantageous over wires for a number of reasons. A band, by definition, is wide. In being wide, a band distributes its forces over a wider surface area. This inhibits the band from digging into the bone, unlike wires. In being wide, a band affords a larger cross-sectional area whereby more material may be realized, thus presenting the opportunity to offer as much strength in the construct as is necessary to hold the bone fragments together. As such, bands address wires' two main weaknesses, namely, digging into the bone fragments being held together and, not having sufficient cross sectional area.

Bands have different attributes than wires, some of which are difficult to manage. With strength comes stiffness, as mentioned elsewhere herein. The larger cross-section of the band significantly increases the stiffness of the band. While stiffness and rigidity are good attributes in that they can stabilize the bone union, these attributes can also prevent the band from following the contours of the bone when inserted. This can lead to capturing tissues underneath the band that ultimately destabilize the union as the tissues continue to compress and disappear over time. Binding the band ends together can also impose some problems. Generally this involves a mechanism on one band end that interfaces with holes or slots or contours on the other band end. This creates a tensioning system that is incremental in nature. As in the twisted wire system, this mechanical interface of the two ends is the weakest link in the system. This mechanical interface becomes stronger as the incremental steps become larger. But larger incremental steps aren't conducive to fine tuning the tension, so this is problematic. Flat sutures have been used to tie tissues together but the residual tension supplied in such a knotted structure is insufficient for optimum healing. There is a lot of fuss/time associated with trying to keep and hold a desirable tension with these flat sutures. What is needed is an attachment means that provides variable tensioning. Another problem associated with all banding systems is that they tension by pulling asymmetrically to one side requiring constant re-centering while tensioning the band. What is needed therefore is a banding system with the ability to tension symmetrically without requiring re-centering of the band.

Buckles demonstrate many of the needed aspects of joining two strap ends together in surgery. However, what is needed is a buckle/strap system that has the ability to free one strap end from the buckle such that it can be attached to a needle, routed through tissue, simply detached from the needle, and then attached to the buckle.

SUMMARY OF THE INVENTION

The present invention pertains to a surgical tensioning device for holding separated tissues in contact with one another. Improved devices and techniques are disclosed for holding two tissue portions in a state of compression and tension that address and overcome these shortcomings in an innovative way.

The present invention comprises a frame or a buckle frame. The frame may be rigid and has two opposing first and second sides and a lower surface and/or lower side and an upper surface and/or upper side. The lower surface and/or lower side of the frame is the surface and/or side that is in contact with the tissue(s) being held together. In one embodiment, the two opposing first sides of the frame may be parallel to one another. The device further comprises a suture or band for extending through and/or around the separated tissues to be held together in conjunction with said frame. The suture or band has a first end, that is releasably securable to the first side of the frame and a second end that is releasably securable to the second side of the frame. Thus, when the first end of the band is secured to said first side after routing the first end through and/or around the tissues and the second end is secured to the second side of said frame, said suture or band holds the separated tissues in contact with one another and establishes a path of tension along its length that extends linearly between the two ends of the band.

In one embodiment, the band is sufficiently flexible to provide tension along its length. In another embodiment, the band or suture is substantially flat. Also, independently, in one embodiment, a needle may be secured to either the first or second end of the band or suture of the device. Preferably, the frame or buckle has an opening that is sized appropriately to allow the passage of a needle that is secured to an end of the band or suture. In addition, the surfaces of the frame, for example, the surfaces of the interior of the frame, are adapted to guide the band so that the band can be easily threaded into the frame or buckle. As discussed below, the surface of the bar and corresponding mating surface on the frame may be textured or roughened for holding the band more securely once tensioned.

In one aspect of the present invention, the first side of the frame of the present device comprises a member around which said first end of the band may be secured. The member may be in the form of a pin or bar and may be rigid. In addition, in a preferred embodiment, the first end of the suture or band may be directly attached to a needle and may be secured to the first side of said frame at the member on the first side with the aid of a knot after being routed through and around said tissues. The member in the first side of the frame may have a circular cross section or any other cross section. In addition, the member may be textured or roughened to provide improved performance, that is, to secure or knot the first end of the band better relative to when the surfaces are not textured, once the band is fully secured and tensioned.

In another aspect of the invention, the first side of the frame may further comprise a slot. In this embodiment, the device further comprises an attachment mechanism that is used to attach or secure the first end of the suture or band at the slot in the frame or buckle frame. The slot in the frame may be integral and is preferably sized and adapted to mate and lock with the attachment mechanism after the attachment mechanism has been routed through and/or around said tissues. In this embodiment, the attachment mechanism is preferably secured to first end of the band or suture on one end and a needle on the other end. The attachment mechanism may be secured to the first end of the suture or band via a loop. The attachment mechanism preferably comprises a tab that can pass through the slot in the frame. Once the attachment mechanism is inserted into the slot, the tab inserts into the slot and then pops out and engages into the slot, thus locking the attachment mechanism at the slot on the first side of the buckle frame. In addition, the attachment mechanism may comprise a tapered face and may be sufficiently rigid to promote cutting through the tissue, and furthermore, the tapered face of the attachment mechanism may be sharpened to promote cutting through the tissue. The attachment mechanism may further comprise notches designed to enable breaking of the attachment mechanism at such pre-defined location. Preferably such notches are used to easily remove or disengage the needle from the attachment mechanism.

In still another aspect of the invention, the present device further comprises a bar or pin that is moveably attached to the second side of the frame via an attachment. The bar or pin and bar attachment are adapted to hold tension across the suture or band by pinching the second band end between the bar and the second frame side. The bar attachment is adapted to mechanically constrain movement of the bar into the inside of the frame and away from the upper surface about the second side of frame. In addition, when the bar or pin has a circular cross section, the bar attachment is adapted to prevent rotational movement of the bar once it has been engaged to pinch the second band end between itself and the second frame side.

In yet another aspect of the invention, the bar is attached outside the second side of the frame via the bar attachment. In this embodiment, the bar attachment is adapted to mechanically constrain movement of the bar into the inside of the frame and away from the upper surface about the second side of frame. The bar can have any profile. In one embodiment, its profile is round, that is, it has a circular cross section. In the embodiment where the bar has a circular cross section, the bar attachment is adapted to prevent, in addition, rotational movement of the bar. Further, in this embodiment, the space between the first and second sides of the frame and the space between the bar and the outside of the second side may be substantially similar and sized to allow said band to pass through easily. Further, and independently, the surfaces of the bar and the outside of the second side of the frame, that is the mating surface for the bar, may be textured or roughened to provide improved performance, that is, to secure the second end of the band better relative to when the surfaces are not textured, once the band is tensioned.

In accordance with the device described above, when the second band end is routed around and through tissues being held together and from the bottom up through the center of the frame and over the second frame side and down between the second frame side and bar such that when second band end is tensioned and released, the bar holds the tension by pinching the band between the bar and second frame side.

In another embodiment, the bar is attached inside the frame at the second side of the frame via the bar attachment. In this embodiment, preferably, a support or buttress is provided inside the frame at the second frame side that includes an upper cam surface. The bar is attached at the second frame side, via a bar attachment, to the support on the upper cam surface of the support, so that the upper cam surface is contiguous with the upper surface of the frame at the second side of the frame. In this embodiment, the bar attachment is adapted to mechanically constrain movement of the bar into the inside of said frame and away from the upper surface of the frame and away from the support about the second side of frame. The bar can have any profile. In one embodiment, its profile is round, that is, it has a circular cross section. In the embodiment where the bar has a circular cross section, the bar attachment is adapted to prevent, in addition, rotational movement of the bar. The cam surface allows for supplying more leverage to the hinging attachment mechanism such that the bar can be forced harder into and be better locked inside the upper cam surface of the support against the second frame side. Further, in this embodiment, the space between the bar and the inside of the first side of the frame and the space between the bar and the inside of the second side are substantially similar and are sized to allow suture or band to pass through easily. Further and independently, the surfaces of the bar and the inside of the second side of the frame, that is the mating surface for the bar, may be textured or roughened to provide improved performance, that is, to secure the second end of the band better relative to then the surfaces are not textured, once the band is tensioned. In the embodiment of the device where a needle is attached to the second end of the band, the bar is adapted to move away from the second frame side to a sufficient distance so as to allow the needle to pass around the bar.

In accordance with the device described above, when the second band end is routed around and through tissues being held together and from the bottom up through the center of the frame and over the bar and down between the bar and second side of frame such that when second band end is tensioned and released, the bar holds said tension by pinching the band between the bar and second frame side.

In accordance with yet another embodiment of the present device is described a surgical tensioning device for holding separated tissues in contact with one another wherein the device comprises a frame with two opposing first and second sides, which are preferably parallel to each other, and a lower surface and/or lower side and an upper surface and/or upper side. The lower surface and/or lower side is the surface and/or side that is in contact with the tissue(s) being held together. The device further comprises a band or suture for extending around and/or through the separated tissues to be held together in conjunction with the frame. The band in this embodiment has a first end that is releasably securable to the first side of the frame and, a second end that is releasably securable to the second side of said frame. When the first and second ends are secured to both first and second sides of the frame, after either the first end or the second end or both ends are routed through and round the separated tissues to be held together, the band holds the separated tissues together and establishes a path of tension along its length.

In accordance with yet another embodiment of the invention is described a needle guide, adapted to be used in conjunction with any of the devices described above. The purpose of the needle guide is to mitigate or prevent any damage to the bars and attachments of the devices when a large needle of the kind used in these surgical repairs is used. The frame or buckle of the present devices has been designed to be small because this is a desirable quality for orthopedic implants. The needle used in these surgical repairs needs to be abnormally large so that it can pierce sternal bone. Sternal needles therefore are some of the largest needles made for threading sutures. The present needle guide removably fits or attaches to the frames of the present devices. The needle guide comprises slots, preferably integral slots so that the needle guide and slots are a single element, and is sized to fit via the slots over the bar in order to restrain the bar which, when placed over the bar, mitigates or prevents damage to the bar and bar attachment from the needle.

Once the frame of the present devices has been threaded with the suture and the bar(s) is set, the needle guide may be removed as it has no further function. This is desirable as this lowers the profile of the implant.

As used herein, the tissue portions to be held in contact with one another in the present invention comprise biological tissue in the body, including, but not limited to, skin, tendon, bone, ligaments, blood vessels, and organs. In one embodiment, the tissue portions comprise sternal bone that has been cut for a procedure to access the thoracic cavity.

The dermal layer on top of the sternum is rather thin. Even when a surgeon employs only twisted wire to repair the sternum, some patients can feel that wire under their skin. Consequently, the profile of a closure device can have cosmetic as well as practical concerns. The dermal layer over the sternum on an average adult female is 5 to 10 mm thick. A device that is ˜5 mm in height is sufficiently thick to be rather clearly seen in some adults. The profiles of the current inventive devices are spread out over a large surface area, resulting in a much more favorable aspect ratio, it will not be easily seen when viewing the patient from the outside.

A particularly advantageous feature of the invention is that the aspect ratio of the inventive device, defined as the height of the device above the tissue surface, divided by the length of the device, is less than or equal to approximately 0.50, and more preferably approximately 0.10. In addition, the maximum height or profile of the current inventive device at the frame preferably is about 4 mm to about 1 mm.

In certain embodiments, the buckle or frame of the device is fabricated from either tempered stainless steel, spring tempered stainless steel or titanium.

In certain embodiments of the present invention, the pins or bars of the device are fabricated from either tempered stainless steel, spring tempered stainless steel or titanium.

In certain embodiments of the present invention, attachments or straps of the device are fabricated from either spring tempered stainless steel or titanium.

In one embodiment, the band or suture of the present devices is sufficiently flexible to provide tension along its length. In yet another embodiment, the band or suture is substantially flat. The suture or band may be defined by that which is normally available. It may be woven fibers or a monofilament and can be any material. Accordingly, the band may comprise woven, braided, or knitted fibers or metals, or a monofilament, and can be made of any known suture material. The suture may be of any shape, including, but not limited to, round, square, oval, flat (like a strap), or tubular. The shape of the suture or band for particular embodiments will be discussed more fully herein below. In one embodiment of the inventive device, the suture preferably comprises flat or tape suture.

On one end of the suture or band may be a needle or other receptacle to facilitate stitching or weaving in tissue or bone. Accordingly, in one embodiment, a needle may be secured to the second end of the band or suture of the device. Alternately, a needle may be secured to both ends of the suture.

In another aspect of the invention, there is described an advantageous method of repairing separated tissues using a tissue tensioning device comprising a frame having opposing first and second sides, a lower surface, and an upper surface, and a band having a first end and a second end. The method comprises steps of routing a needle attached to the second end of the band through the separated tissues and into close proximity to the second side of the frame, separating the needle from the second end of the band, and securing the second end of the band to the second side of the frame. In one embodiment of the invention, the separating step is performed by cutting the needle away from the second end of the band. The securing step is performed by simply wrapping the second end of the band around the second side of the frame and tying a knot in the band.

In another approach, the separating step is performed by applying tension to the band at a point of weakness in order to break the band. A disclosed point of weakness comprises one or more notches formed in the band. Other known techniques, such as perforation, for creating such points of weakness may be used as well. The securing step comprises inserting an attachment mechanism on the second end of the band into a slot in the second side of the frame. The attachment mechanism comprises a tab which moves to an expanded position after the tab passes through the slot, in order to secure the attachment mechanism to the second side of the frame.

The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now more particularly to the drawings, there is shown inFIG. 1an example of how wires and bands might be used in binding sternal halves together for healing after open heart surgery. As noted above, two different devices are shown side by side, for comparative purposes. Device A is a prior art spring device, while Device B is an inventive device described in related application Ser. No. 12/406,909.

A strap locking system similar to that shown inFIG. 1, with a common buckle1is represented inFIGS. 2A and 2B. A common buckle1, of a type sometimes used for straps on bags, is suitable for use in this application because of its variable tensioning abilities. Lock bar2moves surface6away from surface8when strap tail5is tensioned. As strap tail5is tensioned, strap tail4is pulled into the6/8surface interface. When strap tail5is released, strap tail4holds the dominate tension which pulls lock bar2so that the strap is pinched between surfaces6and8. This is the locked position of the buckle1. Locking bar2is held in position by tabs on both of its ends. The tabs ride in a slot10which is cut out of frame12. Slot10is critical in the operation because it holds face6on locking bar2so that it correctly pinches the strap against surface8. The variability of the tension in each of strap tails4and5cause the lock bar to move in slot10. The lock bar naturally wants to even out these tensions by rotating in slot10. Flats are milled in the lock bar2ends to ride in slot10so that such rotation does not happen.

This buckle1generally has the means to provide variable tensioning to the strap loop. However with a suturing system, it is necessary to have one of these strap ends free so that it may be routed through tissue with a common suture-end-needle arrangement.

Of course, a common buckle1, such as that illustrated, comes pre-threaded. What is needed to make a buckle suitable for a suture application is to have the buckle designed so that it might be threaded by the surgeon. In its common configuration, there is not enough room around locking bar2to fit a suture needle.

The distance the locking bar2has to travel to achieve the aforementioned locking and unlocking functionality is rather small. Therefore, the slots10provided for accommodating the locking bar ends are not long. Should the system be scaled down to the size of a 5 mm wide suture band, the slot10only needs to be 0.020 inches long. At this size, however, the slot does not provide bar travel sufficient to allow a common needle, 0.065 inches in diameter, to be threaded through the buckle. Furthermore, it would be difficult to make this common buckle design open up enough to make such threading easy. Surgeons would like to see an obvious opening for the needle to pass through.

A strap locking system similar to common buckle2is represented inFIGS. 3A and 3B. This system14shown inFIGS. 3A and 3Bcomprises two plates16and18that are joined by strap loop20(shown inFIG. 3B) at one end. Plate16is made smaller than plate18so that strap end22is pinched between adjoining surfaces on plates16and18when threaded as shown inFIG. 3Band then tensioned. The locking difference between plate system14and common buckle1lays in the pinching mechanism. Plate system14moves plate16on a hinge to lock and release strap22. Plate16can only lay parallel to plate18and thus the surfaces on the locking mechanism are confined to plate surfaces as managed by the hinging action. These constraints limit the effectiveness of the locking abilities of plate system14. The pinching surfaces are commonly only lines. Common buckle1can have any approach to the pinching system as defined by slot10and pinching surfaces6and8can be of any shape. Strap locking system14is interesting because it can be easily threaded by a suture-needle construct.

FIG. 4shows a similar buckle design as inFIG. 3where wires are used instead of plates. The pinching surfaces are only opposing lines on either wire. As with the plate system14, this wire buckle system may be threaded with the loose strap end. This works fine as long as the buckle is big enough to be manipulated with fingers. But when the buckle gets small on the scale of a 5 mm tape suture, the buckle becomes too small to manipulate for threading.

The present invention is directed to a strap buckle system that is prethreaded, has good strength holding characteristics, and is small so as to be used with suture sized straps. Furthermore, the present invention provides for holding the buckle open so that it may be easily threaded by a needle/suture construct.

The tissue portions to be held in contact with one another in the present invention comprise biological tissue in the body, including, but not limited to, skin, tendon, bone, ligaments, blood vessels, and organs. In one embodiment, the tissue portions comprise sternal bone that has been cut for a procedure to access the thoracic cavity. The suture may comprise woven, braided, or knitted fibers or metals, or a monofilament, and can be made of any known suture material. The suture may be of any shape, including, but not limited to, round, square, oval, flat (like a strap), or tubular. The shape of the suture for particular embodiments will be discussed more fully hereinbelow. In one embodiment of the inventive device, the suture preferably comprises flat or tape suture.

In certain preferred embodiments, the buckle or frame of the device is fabricated from either tempered stainless steel, spring tempered stainless steel or titanium.

FIG. 5represents one embodiment of the invention. As shown inFIGS. 5A,5B and5C, a rigid frame25contains a member26on one end or side and buckle23on the other end or opposing side end with a member32linked via attachments34to frame25at this opposing end or side. The member26is preferably in the form of a substantially rigid pin or bar in this embodiment. The member32is preferably in the form of a substantially rigid pin or bar in this embodiment. Attachments34are preferably in the form of straps in this embodiment. These attachment members that link the rigid pin or bar32to the frame25, are preferably constructed to yield to slight pressure and form around frame25. Pin or bar32ultimately pinches the suture, band, or strap up against the inside surface of frame25at33. Suture or band or strap24has a first end or tail31that is attached to needle28at a junction29, and is attached to the frame25around bar or pin26as described herein. Suture or band24is pre-threaded through the buckle23so that the other tail or second end27of the suture or band is easily threaded into buckle23through a window (not shown) held open by attachment straps34. As tension is applied to suture tail27, the pin or bar32rotates to move from the outside of frame25to the inside of frame25. Attachment straps34yield and form around frame25in this process. The straps serve to hold the pin in proper position to pinch the suture against the inside surface of frame25when tension is released on suture tail27. Straps34also keep the bar or pin32from rotating.

During surgery, the above embodiment is used as follows. Needle28is routed through or around tissue and then into frame25and around pin26. A knot30is then tied in the suture end around pin26. Needle28can be removed before or after this step by simply cutting the suture/strap24at suture end31with scissors. Buckle23is then activated to approximate tissues by pulling on suture end27. Locking pin32works in concert with straps34to loosen the buckle, thereby allowing the suture to pass through the buckle. When suture end27is released, suture gets pinched at33in the buckle23.

In the above embodiment, the second end27of the suture/strap24comes pre-threaded in the buckle. The other or first end31comes attached to needle28for passing suture end through tissue. First suture end31is then tied in a knot that attaches it to the buckle. The needle is easily removable from the suture end. The buckle/suture construct or flat suture band system is now complete in a few easy steps, realizing the goals of the present invention.

Although round bars or pins are shown as engaging against flat surfaces in this embodiment, contoured pins with contoured mating surfaces on the pin and frame respectively, may be used to increase the buckle's holding performance. The mating surfaces, contoured or otherwise, may be further roughened or textured if more performance or better grip or holding is required.

In certain preferred embodiments of the present invention, the pins or bars of the device are fabricated from either tempered stainless steel, spring tempered stainless steel or titanium.

In certain preferred embodiments of the present invention, attachments or straps of the device are fabricated from either spring tempered stainless steel or titanium.

Buckle23has attachment straps34that perform the same function as slot10does in the buckle1, yet the buckle23is simple enough to allow the free second end of suture27to be threaded through the buckle. Attachment straps34provide the same two functions slot10does in buckle1; first to guide the pin into its mating locking inside frame25, and second to keep the pin or bar32from rotating in the lock. Attachment straps34also hold a window open to allow the threading of free suture end27. Although the buckles represented inFIGS. 3 and 4are capable of being threaded, it would be difficult to manage with gloved fingers on such a small scale. This is all done in a low profile device as is required for such surgical implants. A downsized version of buckle1would have a larger profile due to the material needed around the slots.

FIGS. 6A and 6Bshow another advantageous embodiment of the invention. In this embodiment, the knots30of the prior embodiment, shown inFIG. 5B, are replaced with a different attachment mechanism. The buckle23is otherwise as shown in the prior embodiment. In this embodiment, the suture or strap24is attached to a member or bar on the attachment mechanism37by means of a loop35. The frame25, in the place of the member26on the first side of the frame in the embodiment ofFIGS. 5A-5C, has a slot38that is sized and adapted to mate and lock with a member36in attachment mechanism37. Attachment mechanism37is adapted to follow needle28that is attached to attachment mechanism37at junction29through the tissue and then become attached to buckle frame25. Attachment mechanism37comprises a tapered face39that ends in junction29at which needle28is attached. Attachment mechanism37may be made of any material that is rigid enough to enable cutting tissues. Such material may comprise tempered stainless steel or titanium, for example, in currently preferred embodiments. In addition, the tapered face39might be further sharpened to promote tissue cutting. The attachment mechanism preferably has notches40, or other suitable weakening mechanisms, such as perforations, designed to enable breaking of the suture or strap24at a predefined location. This enables easy removal of the needle28, without the need for a cutting implement, such as scissors, and exposes tab36so that it may engage with slot38.

This embodiment of the invention may be used as follows. Needle28is routed through separated tissues and in doing so, needle28brings attachment mechanism37and the attached suture or strap24though these tissues. Needle28is brought into close proximity to buckle frame25. Attachment mechanism37is then broken along notches40. Attachment mechanism37is then inserted into slot38in buckle frame25. Attachment mechanism is then inserted until tab36pops through slot38and expands, as shown, thus locking the attachment mechanism37to buckle frame25. Suture or strap tail27is then pulled to bring the tissues together.

In the above embodiment, the second end27of the suture/strap24comes pre-threaded in the buckle. The other or first end31comes attached to needle28via an attachment mechanism37for passing the suture end through tissue. First suture end31is then attached to the buckle frame via the attachment mechanism37after the easy removal of needle28using the notches40in the attachment mechanism37. The buckle/suture construct or flat suture band system is now complete in a few easy steps, realizing the goals of the present invention.

FIGS. 7A-7Cillustrate still another embodiment of the present invention, with a buckle42which is similar to the embodiment inFIGS. 6A and 6Bin that it has a similar frame25with a slot38, and a bar or pin32, as well as attachment straps34. Alternatively, in another embodiment (not shown), the frame could be similar to the frame25with a member26on the first side, as shown inFIGS. 5A-5C. Accordingly, the suture band may be secured at the first end31using an attachment mechanism37as shown inFIGS. 6A-6B, wherein the tab36locks into slot38, or, a knot may be tied at the suture end31as shown inFIGS. 5A-5Cwhen the frame has a member26.

In the embodiment depicted inFIGS. 7A-7C, straps34start in the interior of the frame instead of outside the frame. This is managed by placing a buttress42on the interior of the frame and supplying a cam surface44to aid the straps in guiding the bar or pin32. Consequently space36is supplied inside the frame for threading loose suture end27. All the same advantages are realized with buckle42as with buckle23. Buckle42has the additional advantage of having a simple threading route whereas the threading route through buckle23is a bit more complicated.

The cam surface44and strap34combination provide the same two functions as does slot10inFIG. 2; first to guide the pin into its mating locking inside surface of frame25, and second to keep pin32from rotating in the lock. Cam surface44has the additional advantage of supplying more leverage to the hinging strap mechanism such that pin32is forced harder into and better locked inside surface. Although round bars or pins are shown in this embodiment, contoured pins with contoured mating surfaces on the pin and frame respectively, may be used to increase the buckle's holding performance. The mating surfaces, contoured or otherwise, may be further roughened or textured if more performance or better grip or holding is required.

While the inventive concept is disclosed as being particularly adapted for use in repairing the sternum after a thoracic cavity procedure, it is, of course, applicable to a great many other procedures requiring repair of bodily tissue, particularly bone.