Patent Description:
The labrum is a soft-tissue structure that lines and reinforces the ball-and-socket joint of the shoulder and the hip. When the labrum is torn, frayed, or otherwise damaged as a result of injury, femoroacetabular impingement, or oftentimes as part of the aging process, a substitute fascia or soft-tissue graft may be used to surgically repair, replace, or augment the damaged labrum.

Traditionally, a surgeon must accurately determine the required length of allograft fascia needed to replace the damaged portion of the patient's labrum (segmental or circumferential) prior to inserting the prepared graft into the joint space. In addition, the preparation of the fascia graft is a labor-intensive undertaking for surgeons, meticulously suturing the graft to ensure a proper length, cross-sectional diameter, and maintaining the graft's rigidity for each patient and/or circumstance, during the surgical procedure. These techniques are complex and time consuming and difficult to achieve both repeatedly and consistently. <CIT> discloses a a pre-sutured allograft construct comprising a tissue roll extending from a first end to a second end and a stitched pattern securing the tissue roll. The stitched pattern extends through a certain region which comprises a series of whip stitches. Furthermore, a method of making the construct is disclosed.

This Summary is not intended to identify key aspects or essential aspects of the claimed subject matter. Moreover, this Summary is not intended for use as an aid in determining the scope of the claimed subject matter.

The present invention is set forth in the claims.

Additional objects, advantages and novel features of the technology will be set forth in part in the description which follows, and in part will become more apparent to those skilled in the art upon examination of the following, or may be learned from practice of the technology.

Non-limiting and non-exhaustive embodiments of the present invention, including the preferred embodiment, are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified. Illustrative embodiments of the invention are illustrated in the drawings, in which:.

Embodiments are described more fully below in sufficient detail to enable those skilled in the art to practice the system and method. However, embodiments may be implemented in many different forms and should not be construed as being limited to the embodiments set forth herein. The following detailed description is, therefore, not to be taken in a limiting sense.

Various embodiments of the systems and methods described herein relate to a pre-sutured, soft-tissue matrix allograft construct, or a pre-sutured construct, for the surgical replacement, reconstruction, repair, and/or augmentation of the labrum due to defects and tears resulting from injury, degeneration, trauma, or disease. The pre-sutured constructed is designed for placement into a labrum area that has been resected, filling the area where tissue has been removed or augmenting/repairing damaged labrum by reinforcement. Embodiments of the pre-sutured construct provide the surgeon practitioner with a mechanism to restore function and support after surgical intervention, improving the life of the patient while reducing operating time and complexity. In addition to reducing operating time with the patient on the operating table, a surgeon may work alone, without a second set of hands, to help with customization of the pre-sutured construct.

Embodiments of the pre-sutured construct may be formed from soft tissues such as, for example, fascia, tendon, or iliotibial band and may be pre-sutured into a cylindrical shape for ease of use. Embodiments of the pre-sutured construct may include three adjustable lengths (e.g., small, medium, large), each provided in two diameters to cover all potential requirements for replacement, repair, reconstruction, or augmentation of the labrum. The standard lengths cover segmental and circumferential procedures.

Embodiments of pre-sutured construct feature a pre-sutured pattern of whip and circumferential stitches that form five regions along a length of the allograft construct: two opposing end regions disposed at the outermost ends of the allograft construct, two opposing adjustable regions disposed adjacent to and inward from the end regions, and one non-adjustable central region disposed between the two adjustable regions. The suture pattern and associated suturing method result in a pre-sutured allograft construct that holds its shape such that it may be pre-sutured and manufactured as a sterile allograft construct product the surgeon orders, rather than sutures or prepares during the surgical procedure, and that features an adjustable length that may be adjusted prior or during the surgical procedure while it is being placed in the surgical site.

Turning to exemplary embodiments, <FIG> illustrate top and detail views of one embodiment of a pre-sutured construct <NUM>. In this embodiment and as shown in <FIG>, the pre-sutured construct <NUM> has five regions moving from right to left, namely a first end region <NUM>, a first adjustable region <NUM>, a central region <NUM>, a second adjustable region <NUM>, and a second end region <NUM>.

The pre-sutured construct <NUM> may be formed from an appropriate soft tissue <NUM> such as, for example, fascia, tendon, or iliotibial band, and may be manufactured in two diameters, a first diameter range of <NUM>-<NUM> and a second diameter range of <NUM>-<NUM>. In this embodiment, the pre-sutured construct <NUM> is shown having a short length, or a length of approximately <NUM> end-to-end, with an approximate <NUM> central region and <NUM> extending between the start of the first adjustable region <NUM> and the end of the second adjustable region <NUM>, rendering the short pre-sutured construct <NUM> adjustable between approximately <NUM> and <NUM>. As shown in <FIG>, and as discussed in detail below, the first and the second adjustable regions <NUM>, <NUM> may each comprise a series of whip and triple circumferential stitches <NUM>, <NUM>', while the central region <NUM> may comprise an alternating series of whip and central circumferential stitches <NUM>, <NUM>' bounded on each end by a partial circumferential stitch <NUM>.

Embodiments of the pre-sutured construct may be manufactured in any reasonable and/or appropriate lengths so as to be applicable to all the potential requirements for replacement, repair, reconstruction, or augmentation of a labrum. For example, <FIG> illustrate a pre-sutured construct <NUM> in a medium length of approximately <NUM> end-to-end, with an approximate <NUM> length of central region <NUM> and <NUM> extending between the start of the first adjustable region <NUM> and the end of the second adjustable region <NUM>, rendering the medium pre-sutured construct <NUM> adjustable between approximately <NUM> and <NUM>. <FIG> illustrate a pre-sutured construct <NUM> in a large length of approximately <NUM> from end-to-end, with an approximate <NUM> length of central region <NUM> and <NUM> extending between the start of the first adjustable region <NUM> and the end of the second adjustable region <NUM>, rendering the large pre-sutured construct <NUM> with an adjustable length between approximately <NUM> and <NUM>. In preparing the various lengths of the pre-sutured construct, the triple circumferential stitches <NUM>' of the first and the second adjustable regions <NUM>, <NUM> and the alternating series of whip and central circumferential stitches <NUM>, <NUM>' of the central region <NUM> may be repeated in any appropriate numbers, as appropriate and/or necessary, to achieve the desired length of each region. The medium pre-sutured construct <NUM> and large pre-sutured construct <NUM> may also be provided in two diameters of <NUM>-<NUM> and <NUM>-<NUM>, respectively.

<FIG> and <FIG> illustrate the steps of an exemplary method of preparing an embodiment of the pre-sutured construct. Initially, the method may begin with obtaining a tissue portion <NUM> (<FIG>) (e.g., fascia) from a donor and evaluating the tissue portion for labrum replacement, repair, reconstruction, and augmentation standards. All excess soft tissue (e.g., connective tissue) not removed during cleansing may be removed prior to suturing.

Next, the technician may measure and cut the tissue portion into a pre-formed shape such as a rectangle, which may include placing the tissue onto a cutting board such that the tissue portion lies flat and the tissue fibers are oriented lengthwise (if applicable) relative to an allograft sizing board/block. Using the sizing board/block, the technician may measure and record a length of the tissue portion. This length measurement may be used to determine a size of the pre-sutured construct to be prepared, with minimum lengths, for example, of small at <NUM>, medium at <NUM>, and large at <NUM>. Using a combination of the sizing block and a ruler, the tissue portion may be adjusted/measured to achieve a rolled diameter between <NUM> to less than <NUM>, as shown in <FIG>, before a sterile marker <NUM> can be used to indicate a trim line, as shown in <FIG>, and the excess tissue is trimmed to create a tissue rectangle, shown in <FIG>, having front internal surface <NUM>, a back external surface <NUM>, a top edge <NUM>, a bottom edge <NUM>, a first edge <NUM>, a second edge <NUM>, and a uniform thickness or diameter of <NUM>-<NUM> when rolled.

Once cut into the pre-formed shape, the shape may be folded in preparation for suturing. Using the tissue rectangle, the technician may prepare a gate fold in the tissue by placing the tissue rectangle onto the cutting board with the external side of the tissue (e.g., fascia) facing down before first folding the top and bottom edges into the middle to form a gate fold <NUM>, as shown in <FIG>, and then folding a now doubled bottom edge upward, leaving an approximate <NUM>/<NUM> of the doubled tissue at the top uncovered or exposed to form an exposed fold portion <NUM> of a pre-folded graft <NUM>, as shown in <FIG>.

Once folded into the pre-folded graft <NUM>, the technician may initiate the suturing process using a needle threaded with an appropriate flexible strand such as, for example, suture material of rope or wire that is formed of natural or manmade materials that do not react negatively with human tissue. To begin, and as shown in <FIG>, the technician may suture a first construct end by inserting the needle through a back side of the exposed fold portion <NUM> of the pre-folded graft <NUM> at a point that is <NUM>-<NUM> from a first end (e.g., the right-side edge) of the pre-folded graft <NUM>, through a front side of the of the exposed fold portion <NUM>, and then creating a running stitch <NUM> from a top end <NUM> to a bottom end <NUM> of the pre-folded graft by repeatedly passing the needle through all layers of tissue.

Another running stich may then be created from the bottom end <NUM> to the top end <NUM>, without crossing the sutures on the back side of the pre-folded graft <NUM>. Next, the sutures may be pulled tight to remove all slack from the stitches and to gather the tissue into a rolled position, thereby forming a graft roll <NUM> having a bottom fold <NUM>, a middle fold <NUM>, and a top fold <NUM>, where the exposed fold portion of the pre-folded graft forms the top fold <NUM>, as shown in <FIG>. The suture ends <NUM> may be tied at the front side of the graft roll <NUM> into a square knot, with an additional knot to prevent sliding, to complete a first end stitch <NUM>.

The steps described above to form the first construct end may be repeated on the opposing end to form a second construct end with a second end stitch <NUM>, shown in <FIG>. In one embodiment and to assist with the suture pattern discussed below, the technician may create a double knot with the suture ends on both sides to form suture loops <NUM>, as shown in <FIG>, <FIG>, and <FIG>, such that the graft roll <NUM> may be positioned onto a graft preparation board <NUM> by attaching the suture loops to applicable and respective posts, with the top fold <NUM>, and thus the exposed fold portion <NUM>, positioned at the top, as shown in <FIG>. Suture loops <NUM> should be removed prior to implantation.

After completing the first and the second end stitches <NUM>, <NUM>, the technician may suture a whip stitch pattern along a length of the graft roll <NUM>, beginning with the first adjustable region <NUM> and a first whip stitch <NUM> placed <NUM>-<NUM> inward from the end of tissue. To form the first whip stitch <NUM>, the needle <NUM> may be passed into the graft roll <NUM> from an outside of the bottom fold <NUM> to an inside of the bottom fold <NUM>, ensuring the needle passes between the bottom and the middle folds <NUM>, <NUM> without piercing the middle fold, as shown in <FIG>. The suture <NUM> is pulled through, leaving <NUM>-<NUM> of a tail suture <NUM> (<FIG>) remaining, before being passed under the top fold <NUM> and exiting through the outside of the top fold <NUM> in direct alignment above the previous stitch, as shown in <FIG>.

Next, the needle <NUM> may be wrapped over the front of the graft roll <NUM>, inserted through the outside of the bottom fold <NUM> adjacent to the tail suture <NUM>, and passed through the bottom fold <NUM> to the inside between the bottom and the middle folds <NUM>, <NUM>, as shown in <FIG>, before the suture <NUM> is tightened to create a perpendicular stitch <NUM>, or the first whip stitch <NUM> shown in <FIG>.

To continue the whip stitch pattern in the first adjustable region <NUM>, the technician may insert the needle <NUM> a distance of <NUM> (± <NUM>) inward from the previous stitch before passing the needle <NUM> from the front of the graft roll <NUM> under the top fold <NUM> between the middle and the top folds <NUM>, <NUM>, exiting through the outside of the top roll <NUM>, as shown in <FIG>. The needle may then be wrapped over the front of the graft roll <NUM>, passed into the tissue through the outside of the bottom fold <NUM> in alignment with the previous stitch <NUM>, and passed through the bottom fold <NUM> to the inside of the graft roll <NUM> between the bottom and the middle folds <NUM>, <NUM>, as shown in <FIG>, before the suture <NUM> has slack removed to create a perpendicular stitch <NUM>. The steps of inserting the needle through the top fold at the <NUM> offset and passing the needle through the bottom fold in alignment with the previous stitch may be repeated as necessary until the whip stitches of the first adjustable region are complete, as required for the size of allograft construct being manufactured:.

For example, <FIG> shows four whip stitches <NUM> spanning approximately <NUM> for a medium construct.

To continue the whip stitch pattern through the central region <NUM>, the technician may insert the needle <NUM> (± <NUM>) beyond the previous stitch, or beyond the final whip stitch in the first adjustable region, before repeating the whip stitch pattern by passing the needle from the front of the graft roll <NUM> under the top fold between the middle and the top folds through to the outside of the top fold, wrapping over the front of the graft roll, passing the needle through the outside of the bottom fold in alignment with the previous stitch, through the bottom fold to the inside of the graft roll between the bottom and the middle folds, and tightening the suture to create a perpendicular stitch. This pattern may be repeated until the whip stitches of the central region are complete depending on the allograft construct size:.

For example, <FIG> shows six (<NUM>) whip stitches <NUM> in the central region <NUM> (adjacent the first adjustable region <NUM>) spanning approximately <NUM> for a medium construct of the graft roll <NUM>.

To complete the whip stitch pattern through the second adjustable region <NUM>, the technician may insert the needle <NUM> a distance <NUM> (± <NUM>) beyond the previous stitch <NUM>, or beyond the final whip stitch in the central region, before repeating the whip stitch pattern by passing the needle from the front of the graft roll <NUM> under the top fold <NUM> between the middle and the top folds <NUM>, <NUM> through to the outside of the top fold <NUM>, wrapping over the front <NUM> of the graft roll <NUM>, passing the needle <NUM> through the outside of the bottom fold <NUM> in alignment with the previous stitch, through the bottom fold to the inside of the graft roll between the bottom and the middle folds, and tightening the suture to create a perpendicular stitch. This pattern may be repeated until the whip stitches <NUM> of the second adjustable region <NUM> are complete depending on the allograft construct size:.

On the final whip stitch, the needle <NUM> shall be passed from the front <NUM> of the graft roll <NUM> under the top fold <NUM>, exiting through the outside of the top fold of the graft roll, as shown in <FIG>, before the tail suture <NUM> is secured and all of the whip stitches are tightened. Completion of the whip stitch pattern results in an intermediate allograft construct with a top <NUM>, a bottom <NUM>, the front <NUM>, and a back <NUM>.

Once the whip stitch pattern is complete, the technician may stitch a pattern of circumferential stitches <NUM>', working from the second end region <NUM> adjacent to the final whip stitch, back through second adjustable region <NUM>, through the central region <NUM>, and through the first adjustable region <NUM> to the first end region <NUM>. The suture pattern may begin with a set of triple circumferential stitches <NUM>' in the second adjustable region <NUM>. To start, the technician may wrap the suture <NUM> around the graft roll <NUM> over the final whip stitch, starting at the top of the intermediate allograft construct, and wrapping the suture <NUM> toward the back of the intermediate construct three times, before passing the needle from the top of the intermediate construct towards a bottom of the intermediate construct at the adjacent whip stitch, as shown in <FIG>, at which point the steps of triple wrapping the suture <NUM> and passing the needle <NUM> through the intermediate construct diagonally from the top of the intermediate construct towards the bottom of the construct at the next whip stitch may be repeated until a requisite number of triple circumferential stitches <NUM>' have been completed in the second adjustable region. In an embodiment, the first circumferential stitch <NUM>' is <NUM> wraps around the graft <NUM>. The second, third, and fourth (if applicable) are <NUM> wraps being on the rough or sutured side:.

For the final triple circumferential stitch in the second adjustable region, the needle may be passed from the top of the intermediate construct and directed towards the bottom of the intermediate construct in a space between the last triple circumferential stitch and the adjacent whip stitch in the central region (not shown).

To form the circumferential stitches <NUM>' in the central region <NUM>, the technician may begin with a partial circumferential stitch <NUM> by wrapping the suture <NUM> from the bottom to the top of the intermediate construct and passing the needle <NUM> from the top of the intermediate construct and through to the bottom of the intermediate construct in a space between the next adjacent whip stitches (not shown). The technician may then wrap the suture <NUM> around the intermediate construct, beginning at the bottom and wrapping towards the front one and a half times, before passing the needle <NUM> from the top of the intermediate construct through to the bottom of the intermediate construct in a space between the next adjacent whip stitches, as shown in <FIG>. This process of wrapping the suture <NUM> around the intermediate construct one and a half times before passing the needle <NUM> from the top of the intermediate construct through to the space between the next adjacent whip stitches may be repeated until stopping with the circumferential stitch <NUM>' prior to the final whip stitch <NUM> in the central region. Then, a final partial circumferential stitch <NUM> may be formed by wrapping the suture to the top of the intermediate construct (i.e., ½ wrap) and passing the needle <NUM> from the top of the intermediate construct through to the bottom of the adjacent whip stitch <NUM> in the first adjustable region <NUM>.

To complete the suture pattern, a set of triple circumferential stitches <NUM>' may be formed in the first adjustable region. To start, the technician may wrap the suture <NUM> around the intermediate construct, starting at the top of the intermediate allograft construct, and wrapping the suture toward the back of the intermediate construct three times, before passing the needle <NUM> from the top of the intermediate construct towards a bottom of the intermediate construct at the adjacent whip stitch <NUM> in the first adjustable region, similar to the formation of the triple circumferential stitches <NUM>' in the second adjustable region <NUM>, discussed above in relation to <FIG>. In an embodiment, the first circumferential stitch <NUM>' is <NUM> wraps around the graft <NUM>. The second, third, and fourth (if applicable) are <NUM> wraps being on the rough or sutured side: The steps of triple wrapping the suture and passing the needle <NUM> through the intermediate construct diagonally from the top of the intermediate construct towards the bottom of the construct at the next whip stitch <NUM> may be repeated until the triple circumferential stitches <NUM>', and indeed the entire suture pattern, are complete, and in the last triple stitch <NUM>', the needle comes out adjacent to the tail suture <NUM>:.

For the final triple circumferential stitch <NUM>' in the first adjustable region, the needle <NUM> may be passed from the top of the intermediate construct, straight through to the bottom of the intermediate construct, next to the tail suture <NUM>.

To complete the suture process, the technician may tie the remaining leading suture to the tail suture <NUM> using a square or surgeon's knot, repeating for a total of two knots. The tail suture <NUM> may then be trimmed before the needle is placed next to the surgeon's knots and the main, leading suture is passed through the tissue to complete the pre-sutured allograft construct <NUM> shown in <FIG>. Any remaining suture may be trimmed. The completed pre-sutured allograft construct <NUM> may then be measured with a ruler for overall graft length between the outermost first and second end stitches, for a central length of the non-adjustable central region between the first and second adjustable regions, and for a diameter using a sizing block <NUM>, as shown in <FIG>:.

While small, medium, and large sized constructs are described above, embodiments of the pre-sutured allograft <NUM> construct may have any appropriate overall length between <NUM> and <NUM>, may have adjustability between <NUM> and <NUM>, and may have diameters ranging between <NUM> and <NUM>.

With reference to <FIG>, there is shown pre-suture allograft <NUM> with an overall length <NUM> extending from adjustable region <NUM>, through the length of center region <NUM>, and through adjustable region <NUM>.

Once the suturing process and the pre-sutured allograft construct is complete, the pre-sutured construct <NUM> may be packaged and then sterilized using electron beam (E-beam) irradiation to sterility assurance level (SAL) <NUM>-<NUM>.

Claim 1:
A pre-sutured allograft construct (<NUM>) for repairing, replacing, reconstructing, or augmenting a patient's labrum, comprising:
a tissue roll extending from a first end (<NUM>) to a second end (<NUM>); and
a stitched pattern securing the tissue roll, the stitched pattern extending through an adjustable region (<NUM>, <NUM>) and an adjacent region, wherein:
the adjustable region (<NUM>, <NUM>) comprises a series of triple circumferential stitches (<NUM>') directly overlaying a corresponding series of whip stitches (<NUM>); and
the adjacent region comprises a series of circumferential stitches (<NUM>') alternating with the series of the whip stitches (<NUM>).