Abstract:
A wound closure device includes an elongated body with proximal and distal ends having a plurality of through-holes along the length and defining a longitudinal axis with a plurality of surface features extending away from the axis. The proximal end is configured and dimensioned to pass through body tissue and thereafter be selectively passed through at least one of the plurality of through-holes such that at least one of the surface features also passes through the through-hole thereby forming a locked closed loop to secure body tissue held therein.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/593,550, filed Feb. 1, 2012, the entire disclosure of which is incorporated by reference herein. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure generally relates to wound closure devices having an uninterrupted or continuous stitch. 
       BACKGROUND OF RELATED ART 
       [0003]    Suturing is a surgical technique involving the connection of tissue by stitching the tissue together with a strand of appropriate material. Suturing often involves piercing a needle with a suture attached thereto through tissue on both sides of a wound, pulling the ends of the suture to bring the sides of the wound together, and tying the suture into a knot. The knot preserves the tension on the suture to maintain the sides of the wound in approximation and allow the tissue to heal. An improperly tied knot can slip and untie at a tension far lower than the tension required to break the suture. When the suture is internal to the body, replacement of a failed suture can require additional surgeries. 
         [0004]    A variety of devices have been developed for the transcutaneous placement, tying, and tightening of suture knots through a tissue tract. Despite the skill and due care involved in placing, tying, and tightening a suture knot using these devices, seepage of blood and fluids at the suture site and into the tissue tract can still occur. 
         [0005]    Thus, improved systems and methods to achieve wound closures, which are substantially free of blood or fluid leakage about the wound closure site remain desirable. 
       SUMMARY 
       [0006]    The present disclosure is directed to a wound closure device having an elongated body having a proximal end and a distal end, the elongated body including a plurality of segments having a plurality of preformed through-holes and a plurality of surface features extending generally outward from a longitudinal axis defined by the elongated flexible body; and at least one fiber disposed therethrough the plurality of segments, wherein the proximal end is configured and dimensioned to pass through body tissue and thereafter be selectively passed through at least one preformed through-hole, such that at least one of the plurality of surface features also passes through at least one preformed through-hole. 
         [0007]    The present disclosure also includes a wound closure device comprising a plurality of segments defining an elongated flexible body having a proximal end and a distal end, wherein each of the plurality of segments comprises: at least one surface feature extending generally away from a longitudinal axis defined by the elongated flexible body; and at least one through-hole formed therethrough; and at least one fiber interconnecting the plurality of segments; wherein the proximal end is configured and dimensioned to pass through body tissue and thereafter be selectively passed through the at least one through-hole, such that the at least one surface feature also passes through the at least one through-hole. 
         [0008]    The wound closure devices may include surface features which are configured to lock with at least one preformed through-hole, forming a locked closed loop. Certain embodiments include a plurality of surface features which enables movement of the device through tissue in a first direction and limits movement of the device in a second, opposite direction. 
         [0009]    At least a portion of the plurality of segments may be spatially separated from each other or may be combined to form a substrate. Alternately, the plurality of segments be configured to couple to one another. Movement of the plurality of segments may be restricted along the fiber. 
         [0010]    In certain embodiments, the wound closure device may include two fibers. 
         [0011]    A method of closing a wound comprising wound closure devices of the present disclosure is described herein. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    Various embodiments of the present disclosure will be described hereinbelow with reference to the Figures wherein: 
           [0013]      FIG. 1  is a perspective view of a wound closure device according to the present disclosure, the device possessing a plurality of through-holes; 
           [0014]      FIG. 2  is an enlarged view of a portion of the wound closure device of  FIG. 1 ; 
           [0015]      FIG. 3  is an enlarged view of a portion of an alternate embodiment of the wound closure device according to the present disclosure; 
           [0016]      FIG. 4  is an enlarged view of a portion of yet an alternate embodiment of the wound closure device according to the present disclosure; 
           [0017]      FIG. 5  is an enlarged view of a portion of another embodiment of the wound closure device according to the present disclosure; 
           [0018]      FIG. 6A  is an enlarged view of a portion of another embodiment of the wound closure device according to the present disclosure; 
           [0019]      FIG. 6B  is an enlarged view of the wound closure device of  FIG. 5A  according to the present disclosure; 
           [0020]      FIG. 7  is an enlarged view of a portion of a separate embodiment of the wound closure device according to the present disclosure; 
           [0021]      FIGS. 8A-E  are top plan views of various embodiments of the plurality of through-holes of the device of  FIG. 1 ; and 
           [0022]      FIGS. 9-12  illustrate a series of steps employing a method of closing a wound in accordance with the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    The present disclosure provides for wound closure devices configured to form either uninterrupted or continuous stitches. The terms “uninterrupted” and “continuous” as used herein denote a single wound closure device being used to make two or more stitches. The wound closure device includes a plurality of segments, each of the segments including one or more surface features disposed on an outer periphery thereof and one or more openings defined within the segment. In embodiments, some of the segments may include only surface features, whereas some of the other segments include only the openings. The surface features are configured to interface with the openings of the segments. In embodiments, the openings may have a shape that is uniquely configured to match the surface features, allowing the surface features to pass through the openings and interlock therewith, thereby acting as a unidirectional locking mechanism. The surface features interlace through the openings and are secured therein via a frictional fit after tension is applied to the wound closure device. 
         [0024]    The wound closure device of the present disclosure may be utilized with various wound closure techniques and tissue connection procedures, including, but not limited to, endoscopic techniques, plastic and reconstructive surgeries, general wound closure, cardiovascular, orthopedics, obstetrics, gynecology and urology, and combinations thereof. Suitable tissue types include, but are not limited to, various layers of muscle, ligaments, tendons, fascia, fat, skin, combinations thereof, and the like. 
         [0025]    Referring now in detail to the drawings in which like reference numerals are applied to like elements in the various views, a wound closure device  10  is shown in  FIG. 1 . The wound closure device  10  includes a flexible elongated body  20  defining a longitudinal axis A-A, the elongated body having a first end  12  attached to a needle  22  and a second end  18 . In embodiments, the second end  18  may also be attached to a needle (not shown). The needle  22  includes a sharpened tip  23  which is configured and dimensioned to pass through body tissue. 
         [0026]    The flexible body  20  includes a plurality of segments  15 . As shown in  FIG. 2 , each of the segments  15  includes a body  13  defining one or more surface features  14  and one or more preformed through-holes  19  therethrough. 
         [0027]    With reference to  FIGS. 1 and 2 , the device  10  may also include one or more fibers  21  interconnecting the segments  15  along the longitudinal axis A-A. As shown in  FIG. 2 , the segments  15  are separated from each other and are interconnected via the fibers  21 . The segments  15  may be loosely disposed or attached thereon the fibers  21  or may be secured thereto. Alternatively, the fibers  21  may be at least partially embedded in the segments  15  using any suitable technique where molten material (e.g., polymer) is formed around the fibers  21 . In general, the fibers  21  extend the entire length of the elongated body  20  from the proximal end  12  to the distal end  18 . 
         [0028]    The fibers  21  reinforce the device  10  by providing additional structural support to the segments  15 . As previously described, the fibers interconnect the segments, and may provide spatial separation between the segments. The fibers may be stitched therethrough the segments, enabling the segments to slidingly engage the fibers. Alternatively, the segments may be fixedly disposed on fibers via methods including overmolding, or the use of adhesives. 
         [0029]    In other embodiments illustrated in  FIG. 3 , each of the segments  115  may be integrally formed with at least one neighboring segment  115  to form a continuous substrate  130 , such as a chain or a ribbon, linking the plurality of segments  115 . Two fibers  121  reinforce the segments  115 . The fibers  121  run therethough the segments  115  and are enclosed within the segments  115 . At least one through-hole  119  is disposed within each segment  115 . Although a triangular through-hole  119  is illustrated, other shapes and geometries of through-holes are envisioned and described herein. 
         [0030]      FIG. 4  illustrates another embodiment of a wound closure device  210 , in which at least two segments  215  are joined together, creating a unit  231 . Fibers  221  are disposed therethrough the units  231  and interconnect the units  231 . The fibers  221  enable spatial separation from one unit  231  to the neighboring unit  231 . As illustrated in  FIG. 4 , the units  231  are slidably disposed on the fibers  221 . Movement of the units  231  across the fibers in not limited, that is, the units  231  may freely move laterally across the fibers  221 . Methods for restricting lateral movement of segments and units will be described below. At least one through-hole  219  is disposed within each segment  115 , and two through-holes  219  are disposed within each unit  231 . Although a triangular through-hole  219  is illustrated, other shapes and geometries of through-holes are envisioned and described herein. Further, although two through-holes are illustrated, it is envisioned that each unit  231  may have one or more through-holes  219 . 
         [0031]    With reference to  FIGS. 5-7 , other embodiments of a wound closure device are shown in which movement of the segments or units along the fibers is restricted or limited. It should be understood the embodiments and methods described herein below may be used or combined with other embodiments described herein. For example, bumpers, knots, and spacers may be utilized with various embodiments described herein to restrict movement of segments and units. 
         [0032]    Embodiments shown in  FIGS. 5-7  illustrate methods for restricting movement of segments along the fibers in at least one direction. For example,  FIG. 5  illustrates a wound closure device  310  having knots  340  disposed on each side  315   a ,  315   b , of the segment  315  to secure and/or restrict lateral movement of the segment  315  along the fiber  321 . The knots  340  may be disposed a predetermined distance or length along the fiber  321 , allowing the segment  315  to travel along a predetermined length of the fibers  321  delineated by the knots  340 . In further embodiments, the knots  440  may be disposed along a single side of the segments  415  preventing movement of the segments  315  along the fibers  321  only in a single direction (e.g., distally). 
         [0033]    The knots  340  may be formed by tying knots at specified locations or lengths of the fiber  321 . For ease of manufacturing, the fiber  321  may be tied in a knot  340 , in between or after each segment  315  is inserted on the fiber  321 . In other embodiments, a separate filament or fiber may used to tie a knot thereon the fiber  321 .  FIGS. 6A and 6B  show another embodiment of a wound closure device  410  utilizing bumpers  442 . Although the bumpers  442  are illustrated on one side of the segment  415 , the bumpers  442  may be disposed on both sides of the segment  415 . Further, the bumpers  442  may be disposed in between each segment  415  or alternatively, the bumpers  442  may be disposed at specified locations along the fiber  421 . Alternately, bumpers  442  may be disposed only along one fiber  421 , enabling flexing or bending of the segment relative to the fiber  421 . That is, by having the bumpers  442  disposed on one side of the segment  415 , the segment  415  is free to bend such that the segment  415  may be oriented horizontal in relation to the fiber  421 , flattening out the wound closure device, facilitating tissue insertion. 
         [0034]    It should be noted that  FIG. 6B  is similar to  FIG. 6A , however  FIG. 6B  illustrates one fiber  421  running therethough the segment  415 . 
         [0035]    Bumpers  442  may be formed from the same or different materials as the fibers  421  or segments  415 . In certain embodiments, the bumpers  442  may be secured to the fibers  421  via an adhesive or other suitable technique. 
         [0036]      FIG. 7  shows yet another embodiment of the wound closure device  510 . The wound closure device  510  includes a plurality of spacers  544 , each of which is disposed about the fibers  521  between the segments  515 . The spacers  544  may be loosely or slidably disposed on the fibers  521  or may be secured thereto via overmolding, stitching, adhesive, and combinations thereof. The spacers  544  may of different or same lengths and evenly space apart the segments  515 . In addition, the spacers  544  also spatially separate segments  515  at a predetermined distance along the length of the fibers  521 . 
         [0037]    Wound closure devices of the present disclosure include a plurality of through-holes. The through-holes are flexible and may be compressible or expandable such that a needle and subsequent segments or in some embodiments, units, may be inserted therethrough. The cross-sectional geometry of the through-holes may vary to accommodate different needles and tissue types, providing different holding strengths. As shown in  FIGS. 8A-E , the cross-sectional geometry of the plurality of through-holes  19  may include a key-shape as shown in  FIG. 8A , a compound wedge as shown in  FIG. 8 , a wedge as shown in  FIG. 8C , a circle as shown in  FIG. 8D  and a triangle as shown in  FIG. 8E . The surface features  14  may include barbs, hooks, latches, protrusions, leaves, teeth, and combinations thereof. 
         [0038]    As described herein, the surface features  14  may be aligned in a single direction to allow the elongated body  20  of the wound closure device  10  to move through tissue in one direction and resist moving through tissue in the opposite direction. As shown in  FIG. 1 , the surface features  14  on elongated body  20  may be formed into a single directional wound closure device  10 . The surface features  14  permit movement of device  10  through tissue in the direction of movement of the sharpened tip  23  of needle  22  but are generally rigid in an opposite direction to prevent movement of device  10  in an opposite direction. 
         [0039]    In alternate embodiments, wound closure devices may comprise a bi-directional device, having a needle disposed at both ends of the device. That is, the surface features may be aligned such that a first length of the device can move through tissue in a first direction and resist moving through tissue in the opposite direction, while a second length of the device can move through tissue in a second direction and resist moving through tissue in the opposite direction. With the exception of surface features aligned in two directions, it is envisioned that this device wound operate in the same manner. Mainly, a first needle and a first plurality of segments/units are passed through tissue and therethrough a first through-hole and a second needle and a second plurality of segments/units are passed through tissue and therethrough a second through-hole. 
         [0040]    The surface features  14  may be arranged in any suitable pattern. The number, configuration, spacing and dimensions of the surface features  14  may also be varied based on the tissue in which the wound closure device is intended to be used. In repairing a wound in skin or tendon, the surface features  14  may be made relatively short and more rigid to facilitate entry into this rather firm tissue. In repairing fatty and relatively soft tissue, the surface features  14  may be made longer and spaced apart further to allow the wound closure device  10  to grip the tissue. Larger surface features may also be used for joining fatty and relatively soft tissues, whereas smaller surface features  14  may be more suitable for collagen-dense tissues. 
         [0041]    In embodiments, when repairing tissue with multiple layers of different tissue types, a combination of large and small surface features  14  within the same structure may be used. Use of a combination of large and small surface features  14  within the same wound closure device  10  provides for maximum anchoring properties. 
         [0042]    The surface features may be formed, in embodiments, by making acute angular cuts directly into the segments, with cut portions pushed outwardly and separated from the body to form the surface features  14 . Cutting may be performed using a cutting bed, a cutting bed vise, a cutting template, and/or a blade assembly. In operation, the cutting device may be configured to produce a plurality of axially spaced surface features in the same or at a random configuration, and at different angles in relation to each other. In alternate embodiments, the surface features may be formed using any suitable technique including, but not limited to, injection molding, molding, milling, machining using lasers, machining using mechanical cutters, machining using water jets, and combinations thereof. 
         [0043]    The segments, units, and substrates may be constructed from tapes, slit sheets, ribbons, and combinations thereof. The segments, including the surface features and the through-holes, may be formed using any suitable technique including, but not limited to, injection molding, molding, milling, machining using lasers, machining using mechanical cutters, machining using water jets, and combinations thereof. 
         [0044]    Filaments forming the fibers and the segments may be formed using any technique within the purview of those skilled in the art, such as, for example, extrusion, molding and the like. In embodiments, the fibers and the segments can be extruded through an extruder unit of a conventional type, such as those disclosed in U.S. Pat. Nos. 6,063,105; 6,203,564; and 6,235,869, the entire disclosures of each of which are incorporated by reference herein. 
         [0045]    The fibers may be formed from one or more filaments (e.g., monofilament or multifilament) and include, but are not limited to, braids, yarns, and combinations thereof. The fibers may be formed using any known technique including, but not limited to, braiding, weaving and/or knitting. The filaments may also be combined to produce non-woven fibers. The filaments may be drawn, oriented, crinkled, twisted, and/or commingled as part of the forming process. 
         [0046]    As used herein, the term “yarn” denotes a plurality of filaments and the term “braid” denotes a plurality of yarns. The yarns may be either heterogeneous or homogeneous. As used herein, the term “heterogeneous yarn” denotes a configuration containing at least two dissimilar filaments mechanically bundled together to form a yarn. The filaments are continuous and discrete so, therefore, each filament extends substantially along the entire length of the yarn and maintains its individual integrity during yarn preparation, processing and use. As used herein, the term “homogeneous yarn” denotes a configuration containing substantially similar filaments. The filaments are also continuous and discrete. Therefore each filament extends substantially along the entire length of the yarn and maintains its individual integrity during yarn preparation, processing and use. The yarns may be further used to form heterogeneous or homogenous braids. 
         [0047]    Referring now to  FIGS. 8-12 , a series of steps for closing a wound using the wound closure device  10  described above is shown. It should be understood that alternate embodiments of the wound closure devices described herein are used in a similar manner. In use, surface features  14  are inserted therethrough through one or more through-holes  19  penetrating through the longitudinal axis of the elongated body  20  of the device  10  and securing the segments  15  through a friction fit. Thus, as tension is applied to the device, a wedging action occurs thereby providing a more secure locking mechanism. The wound closure device  10  and method of closing the wound is intended for general wound closure and can be utilized as either an “uninterrupted” or “continuous” stitch. 
         [0048]    In  FIG. 9 , the tip  23  of the needle  22  of wound closure device  10  is shown having penetrated both wound edges  24   a ,  24   b , and approaching at least one of the plurality of through-holes  19  of wound closure device  10 . 
         [0049]    In  FIG. 10-11 , the tip  23  is shown penetrating through the through-hole  19 . As proximal end  12  penetrates fully through the through-hole  19  and the suture is pulled through the through-hole  19 . The surface features  14  may be compressed as they pass through the through-hole  19  of wound closure device  10  and expand upon exiting the other side of through-hole  19 , thereby preventing reversal of the suture back through the through-hole  19 . Additionally, the cross sectional dimension of flexible body  20  and the diameter of through-hole  19  may be formed so as to create a friction fit between the two, thereby securing device  10  through a friction fit as shown in  FIG. 12 . 
         [0050]    The wound closure device may be formed from any suitable material including both biodegradable and non-biodegradable materials. The term “biodegradable” as used herein is defined to include both bioabsorbable and bioresorbable materials. By biodegradable, it is meant that the material decomposes, or loses structural integrity under body conditions (e.g., enzymatic degradation or hydrolysis) or is broken down (physically or chemically) under physiologic conditions in the body such that the degradation products are excretable or absorbable by the body. It should be understood that such materials include natural, synthetic, bioabsorbable, and/or non-absorbable materials, as well as combinations thereof. 
         [0051]    Suitable materials generally include polymers, metals and metal alloys, each of which may be biodegradable and non-biodegradable. 
         [0052]    Wound closure devices in accordance with the present disclosure may be coated or impregnated with one or more medically useful substances, e.g., bioactive agents, which accelerate or beneficially modify the healing process when the device is applied to a wound or surgical site. Suitable bioactive agents include, for example, biocidal agents, antibiotics, antimicrobial agents, medicants, growth factors, anti-clotting agents, analgesics, anesthetics, anti-inflammatory agents, wound repair agents and combinations thereof. Bioactive agents may be applied onto the wound closure device of the present disclosure utilizing any method within the purview of one skilled in the art including, for example, dipping, spraying, vapor deposition, brushing, compounding and combinations thereof. 
         [0053]    While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of embodiments thereof. Those skilled in the art will envision many other possibilities within the scope and spirit of the disclosure as defined by the claims appended hereto.