Abstract:
A suture lock according to the present invention provides sufficiently secures a suture thread in place in a quick and efficient manner. It eliminates the need for a laproscopic surgeon to tie complex or multi-step knots. The suture lock generally comprises a suture lock body having a suture channel that allows a suture thread to be drawn into the suture lock body. A plurality of teeth extends into an opening of the suture channel in such a manner that an inserted suture thread will be locked in place. In addition, a guide portion eases insertion of a suture thread free end by simplifying relative rotational adjustment of the lock. An embodiment of the present invention may be fabricated from a material or materials that naturally dissolve within the human body.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a continuation of co-pending U.S. patent application Ser. No. 12/231,748, entitled Suture Lock, filed on Sep. 5, 2008, which claimed the benefit of U.S. Provisional Patent Application Ser. No. 60/967,531, entitled Suture Lock, filed on Sep. 5, 2007, and which was a continuation-in-part of U.S. patent application Ser. No. 10/841,255, entitled Suture Lock, filed on May 7, 2004, now U.S. Pat. No. 7,862,584, which claimed the benefit of U.S. Provisional Patent Application Ser. No. 60/468,496, filed on May 7, 2003. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The need for this invention arises from surgical practice and procedures, particularly surgical practice and procedures using laparoscopic instruments. Utilizing laparoscopic instruments involves making small incisions in the area of the surgical site. An endoscope may be inserted into one of the incisions to view the field of the operation inside the patient and laparoscopic surgical instruments are inserted into the same or other incisions and manipulated from outside the patient&#39;s body using video screen visualization, usually enlarged, to guide the work. 
         [0003]    Anything that can reduce the number of steps to be performed during surgery can markedly reduce the stress of the procedure, both on the patient and on the doctor. Reducing the number of steps also reduces the time involved for the procedure, which is a priority in invasive procedures. Surgeons performing such operations are under considerable stress because remote manipulation of the surgical instruments using a video screen for visualization, rather than seeing the site of the operation directly, requires the learning of a great many techniques that are radically different from those performed when the surgical site is open to view. The required techniques include indirect hand-eye coordination and the cooperation between surgeons to place and secure sutures at the surgical site. 
         [0004]    The placing of sutures during a laparoscopic surgical procedure may require two surgeons. The surgeons must cooperate in a multi-step process performed with multiple surgical instruments to manipulate the suture needle and the suture thread. The needle and suture thread are passed back and forth from one to the other, while placing the sutures by tying one or more knots. 
         [0005]    Finally, prior sutures have generally been tightened and secured by tying knots in the suture thread. Such knots permanently fix a suture in place and are not able to be removed once in place without removing the entire suture. While some knots have been designed to be tightened further after placement, none allow the surgeon to loosen them if needed to reduce excessive tension on the tissue, which can prevent blood flow to the wound inhibiting healing, causing sclerosis and producing excessive scare tissue. 
         [0006]    Suture locks and cooperating devices have been developed to simplify the laparoscopic surgical process. For instance, suture locks disclosed in U.S. Pat. Nos. 5,413,585, 5,735,877, 5,741,301, 5,895,393, 6,015,428 and 6,475,229, the specifications of which are incorporated herein by reference, have made the surgical process easier. 
         [0007]    Wilk, U.S. Pat. No. 5,391,173, describes a suture device for locking a suture. The device requires that a suture is forced into a small opening or inserted into a larger opening that does not have a retaining mechanism. Colvin et al., U.S. Pat. No. 6,066,160, describes a suture locking device that requires threading of the suture through a small aperture. Schwartz et al., U.S. Pat. No. 6,432,123, describes a suture locking device that uses a locking ring to hold the suture in place. These patents contain advancements over the prior art, but still leave room for improvement, such as the ease of securing a suture thread, the overall time needed to properly complete a suture, or the ability to adjust a suture to increase or decrease suture tension as needed. 
       SUMMARY OF THE INVENTION 
       [0008]    A suture lock according to the present invention sufficiently secures a suture thread in place in a quick and efficient manner. This novel design allows a single surgeon, perhaps working in a laparoscopic environment, to suture a surgical site with one or more suture locks and without the need of tying complex or multi-step knots. The suture lock generally comprises a body having a suture channel that allows a suture thread to be drawn into the body. A plurality of teeth extends into an opening of the suture channel in such a manner that an inserted suture thread will be locked in place. In addition, an embodiment of the present invention allows a suture thread, which was previously drawn into and secured by the suture lock body, to be released by a surgeon if desired, for example to reduce suture tension, and to be reengaged in its secured, cinched state. Furthermore, an embodiment of the present invention may be fabricated from a material or materials that naturally dissolve within the human body. 
         [0009]    According to any embodiment of a suture lock according to the present invention, such suture lock includes a suture lock body, which may be a unitary member, having a front surface generally opposed from a back surface, and a left surface extending at least partially between and coupled to the front surface and the back surface. A right surface of the body is generally opposed from the left surface, the right surface and the left surface defining a width therebetween. The suture lock body also has a bottom surface extending between and coupled to the front surface and the back surface, the bottom surface also extending between and coupled to the right surface and the left surface. A top surface is generally opposed from the bottom surface, the top surface and the bottom surface defining a height therebetween. The suture lock body also includes a first channel formed in the right surface, the first channel extending longitudinally through the top surface and through the bottom surface. The first channel extends laterally between the front surface and the back surface. The first channel extends between a first open end at the right surface and a first terminal end, the first channel defining generally opposed front and back right guide wings. The first open end may be laterally wider than the first terminal end, thereby providing a funneling effect. Disposed at least partially in the first channel is a suture locking mechanism. A suture attachment site is also provided as a part of the lock body, preferably separate from the suture locking mechanism. 
         [0010]    According to any embodiment of a suture lock according to the present invention, the suture locking mechanism may include a plurality of teeth, at least two of which have converging longitudinal edges. The plurality of teeth may include one or more pairs of symmetrical teeth. The converging longitudinal edges may be at least substantially coplanar. At least two of the teeth may be located closer to the first terminal end than to the first open end. At least two pairs of the teeth may be located closer to the first terminal end than to the first open end. 
         [0011]    According to any embodiment of a suture lock according to the present invention, the suture locking mechanism may include a predetermined grit of abrasive bonded to at least a portion of the first channel. 
         [0012]    According to any embodiment of a suture lock according to the present invention, the suture attachment site may include a through bore. The through bore may extend through the left surface and through the back right guide wing. The through bore may be formed along a longitudinal bore axis, the longitudinal bore axis disposed at a through bore angle relative to the bottom surface. The longitudinal bore axis may be oriented substantially perpendicular skew to the converging longitudinal edges of at least two teeth, if utilized for the locking mechanism. The through bore angle may be an angle of between about zero degrees and about forty-five degrees. For example, the through bore angle may be an angle of about twenty-five degrees. Affixed to the suture lock body, such as by an adhesive, may be a suture thread extending at least partially through the through bore. 
         [0013]    According to any embodiment of a suture lock according to the present invention, the front right guide wing and the back right guide wing may be asymmetric. Such asymmetry may be provided, for example, by the front right guide wing having a sloped top surface. 
         [0014]    According to any embodiment of a suture lock according to the present invention, the suture lock may further include a second channel formed in the top surface, the second channel extending longitudinally through the left surface and through the terminal end of the first channel. The second channel may extend laterally between the front surface and the back surface. The second channel may extend between a second open end at the top surface and a second terminal end, and the second channel may form generally opposed front and back top guide wings. The first open end may be laterally wider than the first terminal end and the second open end may be laterally wider than the second terminal end. The height measured through the front top guide wing may be less than the height measured through the back top guide wing. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is a top-right perspective view of a first embodiment of a suture lock according to the present invention. 
           [0016]      FIG. 2  is a front-right perspective view of the embodiment of  FIG. 1 . 
           [0017]      FIG. 3  is a top-left perspective view of the embodiment of  FIG. 1 . 
           [0018]      FIG. 4  is a top plan view of the embodiment of  FIG. 1 . 
           [0019]      FIG. 5  is a bottom plan view of the embodiment of  FIG. 1 . 
           [0020]      FIG. 6  is a right elevation view of the embodiment of  FIG. 1 . 
           [0021]      FIG. 7  is a left elevation view of the embodiment of  FIG. 1 . 
           [0022]      FIG. 8  is a cross-sectional view taken along line  8 - 8  of  FIG. 5 . 
           [0023]      FIG. 9  is a cross-sectional view taken along line  9 - 9  of  FIG. 4 . 
           [0024]      FIG. 10  is a third perspective view of the embodiment of  FIG. 1 , further including a suture thread inserted through a suture thread aperture. 
           [0025]      FIG. 11  is a front elevation view of the embodiment of  FIG. 10  with the suture thread advanced through two opposing portions of tissue. 
           [0026]      FIG. 12  is a first rear elevation view of the embodiment of  FIG. 11  rotated about the free end of the suture thread. 
           [0027]      FIG. 13  is a second rear elevation view of the embodiment of  FIG. 11  rotated about the free end of the suture thread, the suture thread free end advanced through the tissue such that it starts to engage the suture lock. 
           [0028]      FIG. 14  is a third rear elevation view of the embodiment of  FIG. 11  rotated about the free end of the suture thread, the suture thread free end further further advanced and further engaging the suture lock. 
           [0029]      FIG. 15  is a fourth rear elevation view of the embodiment of  FIG. 11  rotated about the free end of the suture thread, the suture thread free end fully engaging the suture lock having the free end trimmed. 
           [0030]      FIG. 16A  is a first right bottom perspective view of the embodiment of  FIG. 12  showing the suture thread free end moving in a first direction. 
           [0031]      FIG. 16B  is a second right bottom perspective view of the embodiment of  FIG. 16A  showing the suture thread free end engaging the suture guide thread. 
           [0032]      FIG. 16C  is a third right bottom perspective view of the embodiment of  FIG. 16A  showing the suture thread free end engaged with the suture lock. 
           [0033]      FIG. 17A  is a first right bottom perspective view of the embodiment of  FIG. 12  showing a suture thread engaging a guide thread and a suture lock from a second direction. 
           [0034]      FIG. 17B  is a right front perspective view of the embodiment of  FIG. 17A  showing the suture thread engaging the front right guide wing and the guide thread. 
           [0035]      FIG. 17C  is a second right bottom perspective view of the embodiment of  FIG. 17A  showing the suture thread engaged with the suture lock. 
           [0036]      FIG. 18  is a right bottom perspective view of the embodiment of  FIG. 12  showing a suture thread engaging a guide thread and a suture lock from a third direction. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0037]    Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention that may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. While terms such as top, bottom, front, rear, left and right are used in describing the invention, such terms are not intended to be limiting, but are used merely to aid in an understanding of the invention. 
         [0038]      FIG. 1  depicts a first perspective view of an embodiment  100  of a suture lock according to the present invention. Referring also to  FIGS. 2-9 , the suture lock  100  is preferably a unitary molded suture lock body  102  having a locking mechanism  120  and a guiding portion  160 . The suture lock body  102  preferably has a front surface  105  generally opposed from a back surface  107 . The body  102  further includes a left surface  110  extending at least partially between and coupled to the front surface  105  and the back surface  107 . A right surface  104  generally opposes the left surface  110 . The right surface  104  and the left surface  110  generally define a width  112  therebetween. A bottom surface  108  of the body  102  extends between and is coupled to the front surface  105  and the back surface  107 . The bottom surface  108  also extends between and is coupled to the right surface  104  and the left surface  110 . The body  102  further includes a top surface  106  generally opposed from the bottom surface  108 , where the top surface  106  and the bottom surface  108  define a height  114  therebetween. The locking mechanism  120  preferably includes a plurality of teeth  122  disposed at least partially in a first channel  124  formed in the right surface  104  of the suture lock body  102 . Alternately, the locking mechanism  120  may be any number of variations of high friction surfaces or geometries. For example surfaces composed of multiple barbs or hooks disposed at least partially in the first channel  124 , surfaces of varying grits of bonded abrasive provided in the first channel  124 , rasp-like surfaces composed of patterned ridges disposed at least partially in the first channel  124 , or any variety of high friction surfaces well know by those skilled in the art can be used as the locking mechanism  120 . The first channel  124  preferably extends longitudinally through the top surface  106  and through the bottom surface  108  and laterally between the front surface  105  and the back surface  107 . A pair or plurality of pairs of opposing teeth  122  may be disposed along opposite sides of the first channel  124 , having converging longitudinal edges  123  tapering generally towards each other from a first open end  126  of the first channel  124  towards a first terminal end  128  of the first channel  124 . The teeth  122  included in a pair of opposing teeth are preferably symmetrical. The converging longitudinal edges  123  of opposing paired teeth  122  are preferably at least substantially coplanar and the converging longitudinal edges  123  of adjacent teeth  122 , if more than one tooth  122  is provided along a side of the first channel  124 , are preferably at least substantially coplanar and at least substantially parallel. The first open end  126  is preferably wider than a desired suture thread, thereby easing the process of feeding the thread into the suture lock  100 . On the contrary, the generally V-shaped taper towards the first terminal end  128  is preferably smaller than the desired suture thread, thereby providing a wedging effect to secure the thread to the lock  100 . Therefore, the first open end  126  is preferably laterally wider than the first terminal end  128 . The first channel  124  preferably defines a back right guide wing  162  generally opposed from a front right guide wing  164 , as further discussed below. 
         [0039]    The body  102  also preferably includes a second channel  130  formed in the top surface  106 . The second channel  130  preferably extends longitudinally through the left surface  110  and through the terminal end  128  of the first channel  124 , and laterally between the front surface  105  and the back surface  107 . The second channel  130  is provided with an open end  132  at the top surface  106  and a terminal end  134  generally opposed from the open end  132 . The second channel  130  preferably defines a back top guide wing  168  generally opposed from a front top guide wing  172 , as further discussed below. 
         [0040]    Still referring to  FIGS. 1-9 , a guiding portion  160  is provided to assist in directing a suture thread towards the locking mechanism  120 , or conversely, orienting the lock  100  so that proper engagement of a thread is possible. The guiding portion  160  includes the back right guide wing  162  and front right guide wing  164  both defined by the first channel  124 , and the back top guide wing  168  and back front guide wing  172 , which are defined by the second channel  130 . The back right guide wing  162  extends preferably angularly away from the locking mechanism  120  along a first sloped side  166  of the first channel  124 . A suture attachment site  169  preferably extends through the lock  100  from the left surface  110  at least partially through the back right guide wing  162 . The suture attachment site  169  may be a through bore or lumen  171 , as shown, formed during the molding of a lock  100 . Alternatively, the suture attachment site  169  may include the over molding of a suture thread by the material from which the suture lock  100  is made. The through bore  171  is preferably formed along a longitudinal bore axis  173  disposed at a through bore angle α relative to the bottom surface  108  of the lock  100 , as shown in  FIG. 2 . While the through bore angle α may vary, such as between zero and 90 degrees, depending upon the particular use of the device, a preferred through bore angle α is about 25 degrees. Alternatively, or additionally, the longitudinal bore axis  173  is provided skewed to the converging longitudinal edges  123  of at least two of the teeth  122 , at a preferred angle  175 , such as substantially orthogonally skew as shown. Furthermore, although preferably separated from the teeth  122 , the suture attachment site  169  is not restricted to the position shown. In other words, the site  169  may be altered depending upon physician preference or treatment requirements, such as placing the suture attachment site  169  through the front right guide wing  164 , the back top guide wing  168 , the front top guide wing  172 , or even in a medial location through the device. 
         [0041]    The front right guide wing  164  also extends preferably angularly away from the locking mechanism  120 , and is preferably asymmetric to the back right guide wing  162 . The top surface  106  along at least a portion of the front right guide wing  164  is preferably provided as an insertion chamfer  174  such that a height  114   c  measured through the front right guide wing  164  is less than a height  114   a  measured through the front top guide wing  172 . Such a design allows free passage of a suture thread past the front right guide wing  164  to make physical contact with the back right guide wing  162 . The combination of the right guide wings  162 , 164  and the top guide wings  168 , 172  provide assisted directionality or tapering towards the locking mechanism  120 , preferably from three directions. While the front surface  105 , the back surface  107 , the bottom surface  108  and the left surface  110  of the lock  100  are shown as being substantially planar with some rounded corners, the outer shape could also be curved, cylindrical or spherical. Additionally, while the front surface  105 , the bottom surface  108  and left surface  110  are shown as being pairwise at least substantially orthogonal, and the back surface  107 , the bottom surface  108  and left surface  110  are shown as being pairwise at least substantially orthogonal, other configurations are contemplated. 
         [0042]      FIG. 3  provides a perspective view of the left surface  110  of the lock  100  from  FIG. 1 , in which the suture thread attachment site  169  may be seen clearly as extending through the suture lock body  102 .  FIGS. 4-7  provide elevation and plan views of the embodiment of  FIG. 1 . As shown in  FIG. 5 , the width  112  of the body  102  may vary. For instance, a width  112   a  measured through the front right guide wing  164  may be less than a width  112   b  measured through the back right guide wing  162 . Additionally, as shown in  FIG. 7 , the height  114  of the body  102  may vary. For instance, a height  114   a  measured through the front top guide wing  172  may be less than a height  114   b  measured through the back top guide wing  168 .  FIG. 8  and  FIG. 9  provide opposing cross-sectional views from proximate the middle of the first channel  124 . 
         [0043]      FIGS. 10-15 , inclusive, generally demonstrate a use of a device  100  according to the present invention. In  FIG. 10 , a suture thread  200  has been fastened to a suture lock  100  according to the present invention. If the lock  100  was provided with a suture attachment lumen, such as that illustrated in  FIGS. 1-9 , the suture thread  200  may be fastened in the lumen by any desirable method. For example, the thread may be held in place by an adhesive or knots may be formed in the thread  200  on either side of the lock  100 . Instead of being provided with a suture attachment lumen, the thread  200  may have been overmolded during the formation of the lock  100 . In other words, the lock  100  may have been formed around the thread  200 , thereby binding the thread  200  in the material of the lock  100 . Regardless of the method of attachment of the thread  200  to the suture lock  100 , it may be preferable to leave a working end  202  extending from the lock  100 . Towards or at the end of the suture thread  200  opposite the suture lock  100 , a suture needle  204  is provided. The suture needle  204  may be crimped or adhered to the end of the suture thread  200 , or the suture thread  200  may be threaded through an eye provided in the needle (not shown). 
         [0044]      FIG. 11  depicts the embodiment of  FIG. 10  having been partially inserted into two portions of tissue to close a suture  300 . The needle  204  was inserted down through a desired amount of a first tissue portion  302  on one side of the suture  300  and up through a desired amount of a second tissue portion  304  on the opposite side of the suture  300 . The thread  200  may have been advanced in this manner by the use of either a physician&#39;s hand directly or a needle driver (not shown) by way of a physician&#39;s hand guiding the needle  204 . This guiding can be through both portions  302 , 304  of the tissue with one motion or with two separate motions; one first through the first portion  302  followed by a second motion through the second portion  304 . The portion of the thread between the suture lock  100  and the first tissue portion  302  forms a guide thread  206 . 
         [0045]    Next, the lock  100  is brought forward and turned in front of the free end of the suture thread  200  as seen in  FIG. 12 . This maneuver may be accomplished by a physician&#39;s hand, directly, or a needle driver or grasper grasping the working end  202  of the thread  200 . Turning to  FIG. 13 , as the suture needle  204  and thread  200  are pulled in a first direction  306 , the lock  100  will have a tendency towards a second direction  308 . The free end of the suture thread  200  is preferably maintained in close proximity, or even touching or crossing, the guide thread  206 , thereby guiding the suture thread  200  into the suture lock  100 , thus securing the thread  200  to the lock  100  by the locking portion  120 . Therefore, the suture thread  200  is preferably manipulated to the correct position by a combination of the guiding portion  160  of the lock  100 , including the right guide wings  162 , 164 , the top guide wings  168 ,  172 , and the guide thread  206  acting as a guide rail. In this manner, the right guide wings  162 , 164  can compensate for variations in angular rotation between the first open end  126  of the first channel  124  and the plane of the free end of the suture thread  200 . In effect, the tapered nature of the guide wings will rotate the first open end  126  to line up with the free end of the suture thread  200 . 
         [0046]    The thread  200  is also tensioned to achieve desired approximation of the tissue portions  302 , 304  as seen in  FIG. 14 . This may be done by pulling the thread  200  in the first direction  306 , and thereafter or simultaneously, if desired, in a third direction  310 . If desired, the free end of the suture thread  200  can be pulled generally opposite the third direction  310  while the working end  202  or suture lock itself  100  is pulled generally in the third direction  310 . This will release the tension on the suture  300  and the process can be repeated until the desired suture  300  tension is achieved. Finally, as shown in  FIG. 15 , the suture thread  200  may be trimmed, thereby leaving an adjustment thread  208 , in the event that future adjustment of the suture  300  is required or desired. 
         [0047]      FIGS. 16A-16C  depict a first method of engaging a suture thread with a locking portion of a suture lock using a device according to the present invention where a device has been provided, such as that shown in  FIG. 10 , including a suture thread  200  having a suture needle  204  coupled thereto, the suture thread  200  having been coupled to a suture lock  100 . As described in connection with  FIGS. 11-12 , the needle  204  has been inserted through tissue portions and it is now desirable to engage the suture thread  200  with the lock  100 . The portion of the thread  200  between the suture lock  100  and the first tissue portion  302  forms a guide thread  206 . The thread  200  is maneuvered in a direction  312 , generally laterally towards the front surface  105  and the bottom surface  108 , and is brought into contact with the guide thread  206 , as shown in  FIG. 16B , and then, or contemporaneously, pulled taught in another direction  314 . The thread  200  may, as shown in  FIG. 16C , then be slid along the guide thread  206 , into the first channel  124  to engage teeth  122  disposed in the channel  124 . 
         [0048]      FIGS. 17A-17C  depict a second method of engaging a suture thread with a locking portion of a suture lock using a device according to the present invention where a device has been provided, such as that shown in  FIG. 10 , including a suture thread  200  having a suture needle  204  coupled thereto, the suture thread  200  having been coupled to a suture lock  100 . As described in connection with  FIGS. 11-12 , the needle  204  has been inserted through tissue portions and it is now desirable to engage the suture thread  200  with the lock  100 . The portion of the thread  200  between the suture lock  100  and the first tissue portion  302  forms a guide thread  206 . The thread  200  is maneuvered in a direction  314 , generally laterally towards the bottom surface  108 , and is brought into contact with the guide thread  206 , and the insertion chamfer  174  of the front right guide wing  164 . The contact of the thread  200  with the guide thread  206  and the insertion chamfer  174  causes the lock  100  to rotate  316 , as shown in  FIG. 17B . As the suture thread  200  is tightened, as shown in  FIG. 17C , the thread  200  is situated in the first channel  124 , thereby engaging the teeth  122  disposed therein. 
         [0049]      FIG. 18  depicts a third method of engaging a suture thread with a locking portion of a suture lock using a device according to the present invention where a device has been provided, such as that shown in  FIG. 10 , including a suture thread  200  having a suture needle  204  coupled thereto, the suture thread  200  having been coupled to a suture lock  100 . As described in connection with  FIGS. 11-12 , the needle  204  has been inserted through tissue portions and it is now desirable to engage the suture thread  200  with the lock  100 . The portion of the thread  200  between the suture lock  100  and the first tissue portion  302  forms a guide thread  206 . The thread  200  is maneuvered in a direction  318 , generally laterally towards the right surface  104 , slightly below the bottom surface  108 , and is brought into contact with the guide thread  206  and the back right guide wing  162 . The contact of the thread  200  with the rounded right surface of the back right guide wing  162  causes the lock  100  to rotate  320 . As the suture thread  200  is tightened, the thread  200  is situated in the first channel  124 , thereby engaging the teeth  122  disposed therein. 
         [0050]    The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.