Abstract:
Aspects of the present invention relate to arthroscopic repair surgery and more specifically to rotator cuff tendon tears in the shoulder. One aspect of the invention may comprise a device used to place one or more sutures within the tendon in a grasping type stitch. The suture may then be secured to the humerus bone via a bone anchor or tunnel allowing the tendon to heal.

Description:
PRIORITY 
       [0001]    This application claims priority to U.S. Provisional Application No. 6/641,469, filed May 2, 2012, entitled Suture Device for Rotator Cuff Repair and Other Orthopedic Procedures, which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to medical devices. In particular, but not by way of limitation, the present invention relates to an arthroscopic rotator cuff tendon repair device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Tendon injuries throughout the body are commonly seen in an orthopedic surgery practice. In general, complete disruption of the bone insertion of a tendon or in the mid-substance of a tendon requires surgical treatment. Repair of the tendon again relies on fixation to bone or to tendon using suture and/or bone tunnels/suture anchors. 
         [0004]    Current rotator cuff repair methods and tools rely on an instrument that places a suture through the tendon in a single pass. One technique to place the suture comprises a “shuttle relay” technique which involves using a hollow-bore needle to place a smooth suture through the tendon. This suture is called the ‘passing suture.’ The permanent suture is then tied to the passing suture and is used to pull the permanent suture into place. There are also several known devices that use a harpoon styled device to push the suture through the tendon. In these devices, the permanent suture is loaded on to the device which then grabs the tendon and holds it. The harpoon is then deployed and pierces the permanent suture and pushes it through the tendon. In another method, the tendon may be pierced with a device that has a sharp, tapered end and a grasping jaw. Once the grasping jaw has been passed through the tendon, it can grasp the permanent suture. The suture is then pulled through the tendon. 
         [0005]    These current arthroscopic techniques allow the surgeon to only perform a single pass of suture through the tendon at a time. The fixation of the tendon to the bone needs to be secure and last long enough for the tendon to heal, approximately 6-8 weeks. In these devices and techniques, the fixation strength relies on the interface between the suture anchor and bone, the suture and suture anchor, the strength of the suture, and the interface between the suture and tendon. 
         [0006]    During a traditional rotator cuff repair, a single, medial row of suture anchors is used to establish contact between the suture and bone. The suture is then passed through the tendon using one of the above known techniques. Additionally, a second, lateral row of suture anchors may be used to increase the bone/tendon/suture interface and increase the contact area between the tendon and bone, the so-called “footprint.” The addition of a second lateral row is known as a double row technique. In both cases, the interface between suture and tendon is the same. A simple stitch or horizontal mattress suture is commonly used. 
         [0007]    The healing rate of rotator cuff tendon tears treated in this manner is known to be poor. There is no difference when comparing healing rates between a single or double-row technique. In both cases, the failures tend to be at the suture-tendon interface and come as little surprise. Due to the tight spaces within the shoulder and other joints, it is technically challenging and time consuming to perform a grasping-type suture technique arthroscopically, which is why rotator cuff tendon repairs continue to rely on simple suture techniques. 
       SUMMARY OF THE INVENTION 
       [0008]    Although improvements to the above-described devices and techniques have focused on improving the strength of the suture anchor/bone interface and the strength of the suture, improving the strength of the suture tendon interface has been neglected in prior devices and techniques. Although physicians generally recognize multiple techniques to place this suture, current techniques in arthroscopic and mini-open repair of rotator cuff tendon do not use grasping type suturing techniques. What is needed is a new suture device and technique that allows a grasping type suture technique to be applied arthroscopically or with mini-open techniques. 
         [0009]    As such, one embodiment of the invention comprises medical device comprising a grasping portion, an extension portion, and a spiral-shaped piercing device. The extension portion is one of integrated and coupled to the grasping portion and the spiral-shaped piercing device one of encircles at least a portion of one of the grasping portion and the extension portion, and is encircled by at least one of a portion of the grasping portion and extension portion. 
         [0010]    Another embodiment of the invention comprises a method of surgically suturing internal body tissue. One such method comprises creating a surgical endoscopic incision and placing a suture device into the incision, with the suture device comprises a grasping portion. The grasping portion is then extended towards the internal body tissue and moved from a substantially open position to a substantially closed position. In closing the grasping portion, the internal body tissue is grasped by the grasping potion and a spiraled needle is rotated, suturing the body tissue. The spiraled needle is then retracted and the body tissue is released from the grasping portion. 
         [0011]    And yet another embodiment of the invention comprises an arthroscopic rotator cuff tendon grasping-type suturing system comprising a pair of actuation triggers. A first of the actuation triggers is operatively coupled to a pair of jaws and a second of the actuation triggers is operatively coupled to a cannulated needle. The cannulated needle comprises one or more sutures. 
         [0012]    The above-described embodiments and implementations are for illustration purposes only. Numerous other embodiments, implementations, and details of the invention are easily recognized by those of skill in the art from the following descriptions and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    Various objects, advantages and an understanding of the present invention are more readily appreciated by reference to the following Detailed Description and to the appended claims when taken into account with the accompanying Drawings, wherein: 
           [0014]      FIG. 1  illustrates a side view of a portion of a medical device including an grasping portion and a corkscrew shaped suture needle constructed in accordance with aspects of the present invention; 
           [0015]      FIG. 2  illustrates a side view of the corkscrew shaped suture needle of  FIG. 1  constructed in accordance with aspects of the present invention; 
           [0016]      FIG. 3  illustrates a side view of a device where body tissue is located between a pair of grasping portion jaws in a closed position and a suture needle has made multiple passes through the tissue being sutured; 
           [0017]      FIG. 4  illustrates a side view of a device comprising a housing and an actuation device used to deploy and operate the suture system constructed in accordance with aspects of the present invention; 
           [0018]      FIG. 5  illustrates four sequential images of a portion of a device being used to deploy the suture needle, insert the suture through multiple passes of the needle into the tissue, retract the needle, and retract the deployment element, leaving the suture in the body tissue, according to one embodiment of the invention; 
           [0019]      FIG. 6  illustrates a side view of another embodiment of a device constructed in accordance with aspects of the present invention; 
           [0020]      FIG. 7  illustrates a method that may be carried out with the embodiments described herein; 
           [0021]      FIG. 8A  illustrates a top view of a grasping portion and corkscrew shaped suture needle of a medical device constructed in accordance with aspects of the present invention; 
           [0022]      FIG. 8B  illustrates a side view of a grasping portion and corkscrew shaped suture needle of a medical device constructed in accordance with aspects of the present invention; and 
           [0023]      FIG. 8C  illustrates an end view of a grasping portion and corkscrew shaped suture needle of a medical device constructed in accordance with aspects of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    Turning first to  FIG. 1 , seen is one embodiment of a portion of a medical device  100 . The portion of the device  100  seen in  FIG. 1  comprises a grasping portion  110  and a spiral-shaped piercing device  120 . As seen in  FIG. 1 , the grasping device  110  may comprise a pair of jaws and the spiral-shaped piercing device  120  may comprise a corkscrew-shaped needle. The jaws may be substantially parallel and may be longitudinally-aligned. Furthermore, the jaws may be referred to herein as jaw sections. The use of the grasping portion  110  provides the ability to implement a grasping-type suture technique, which may prevent a placed suture from sliding along longitudinal-aligned collagen fibers in the sutured body tissue. 
         [0025]    The grasping portion  110  may be one of integrated to and coupled to an extension portion  130 . The term integrate, integrated, and other similar terms may be used throughout the specification to describe a singular entity or unit while the term couple, coupled, and other similar terms may refer to individual parts that have been joined together to form a larger unit, where appropriate. 
         [0026]    Turning briefly to  FIG. 4 , seen is a device  400  comprising a housing  440  and a trigger  450  where a top jaw section  412  is hingedly and/or rotatably coupled to the grasping portion  420 . The top jaw section  412  may also be hingedly and/or rotatably coupled to the extension portion  430 . Furthermore, as seen in  FIG. 4 , and in returning to  FIG. 1 , the spiral-shaped piercing device  120 ,  420  which may comprise an elongated spiral-shaped needle, may encircle, or be adapted to encircle, at least a portion of the grasping portion  110 ,  410 . 
         [0027]    As seen in  FIG. 1 , the jaw sections may comprise a middle portion  114  and a distal end  116 . When the grasping portion is in a closed position, as seen in  FIG. 1 , there may be an open space  115  between the jaw sections in at least part of the middle portion  114 . Additionally, when in the closed position, at least a portion of the distal end  116  of a jaw section may be in contact with at least a portion of the distal end  116  of the other jaw section. Furthermore, it is contemplated that a height  118  of each jaw section may comprise about 5 mm A width of each jaw section may also comprise about 5 mm Each of the width and height  118  may fall within the range of about 4 mm to about 6 mm, although alternative sizes are contemplated. A length of each jaw section may comprise about 20 mm, although the length of teach jaw section may comprise about 15-25 mm in one embodiment. The open space distance  117  may comprise a distance of about 0.5 mm, although the range of the distance  117  may be from about 0.1 mm to about 1 mm However, larger or smaller (pediatric) sizes are contemplated. Furthermore, generally circular jaw sections and extension portions  130  are contemplated. 
         [0028]    As seen in  FIG. 1 , at least part of the extension portion  130  and/or the grasping portion  110  may comprise one or more grooves, such as, but not limited to, the spiraled groove  160  seen in  FIG. 1 . This groove  160  may extend along at least a portion of the length of the extension portion  130  and/or grasping portion  110  and may be adapted to receive the spiral-shaped piercing device  120 . Alternatively, or additionally, the groove  160  may be located on an inner surface of the housing  440 . 
         [0029]    Turning now to  FIG. 2 , seen is the spiral-shaped piercing device  220 . One spiral-shaped piercing device  220  may comprise a cannulated needle. For example, a tip  222  of the cannulated needle may be adapted to pierce body tissue such as, but not limited to, a rotator cuff tendon. The needle may comprise a threadable and flexible suture material such as, but not limited to, a polymeric thread, and the suture material may be secured to the needle (i.e. by an anchor, a notch in the needle, or a knot). It is contemplated that the suture material may be removed from the needle—for example, by retracting the needle when the suture material is coupled to the needle through a notch, or through the use of a trigger  450  as seen in  FIG. 4 . 
         [0030]    The trigger  450  may comprise one or more triggers, with each trigger being operatively coupled to one or more of the grasping portion  410 , extension portion  430  and/or the spiral-shaped piercing device  420 . As seen in  FIG. 3 , in one embodiment, the spiral-shaped piercing device  320  may be one of coupled and integrated to a bearing platform  370 . One of the triggers  450  may be coupled and/or integrated to the bearing platform  370  and may move the bearing platform  370  towards the tissue  390 . The spiral-shaped piercing device  320  may then be rotated through the tissue  390  upon reaching the tissue  390 . Movement of the trigger  450  towards or away from the handle  480  may move (i) the grasping portion between the closed position seen in  FIG. 1  and the open position seen in  FIG. 4 , and vice versa, (ii) the spiral-shaped piercing device  420  from the semi-retracted position seen in  FIG. 4  to the extended position seen in  FIG. 1 , and vice versa, and (iii) the grasping portion distal end  116  from a position proximal a housing distal end  426  to the position seen in  FIG. 4 , and vice versa. It is contemplated that other open/closed grasping positions and retracted and extended positions beyond those seen in the figures are contemplated. 
         [0031]    Turning now to  FIG. 7 , seen is one method  709  of surgically suturing internal body tissue. One method starts at  701  and at  711  the method  709  comprises creating a surgical endoscopic incision. One incision may be made in the shoulder. At  721  the method comprises placing a suture device such as the device seen in  FIGS. 1-6 , into the incision. One such device comprises the grasping portion  110  seen in  FIG. 1 . At step  731 , the method  709  comprises extending the grasping portion  110  toward the internal body tissue such as, but not limited to, a rotator cuff tendon, and at  741  the method  709  comprises moving the grasping portion from a substantially open position to a substantially closed position. The method  709  at  751  comprises grasping the internal body tissue. Turning now to  FIG. 5 , seen is a grasping portion  510  in a substantially closed position with a body tissue  590  between the distal ends  516 . The embodiment seen in  FIG. 5  may comprise a substantially hollow extension portion  530  and grasping portion  510 , allowing the spiral-shaped piercing device  520  to be placed inside the extension portion  530  and grasping portion  510 . As the body tissue  590  is grasped and held in place by the grasping portion  510 , the spiral-shaped piercing device  520  may be moved towards the tissue  590  with the bearing platform  570 , and the needle may be deployed internally within the device  500 . Although  FIG. 5  shows the spiral-shaped piercing device  520  and bearing platform  570  as internal to and encompassed by the device  500 , it is contemplated that the spiral-shaped piercing device  520  and bearing platform  570  may also encompass the extension portion  530  and grasping portion  510  in a working embodiment, as seen in  FIG. 1 . In the  FIG. 5  embodiment, the extension portion  530  and grasping portion  510  may comprise the grooves  160  seen in  FIG. 1 , located on an internal extension portion  530  and/or grasping portion  510  surface. In the  FIG. 5  embodiment, as with the  FIG. 1  embodiment, the suture may be contained within the cannulated needle. 
         [0032]    Upon grasping the internal body tissue  590 , and as seen at steps  761  and  771  of the method  709 , the spiral-shaped piercing device  520  comprising a spiraled needle may be rotated and the suture may be placed in the tissue. Then, and as seen at steps  781  and  791 , the spiraled needle may be retracted and the body tissue  590  may be released from the grasping portion  510  and the device  500  may be removed, leaving only the suture  505  in the tissue. This increases the strength of the suture-tendon interface and significantly reduces the risk of failure. Healing rates for tendon repairs using a grasping type suture technique are consistently high. 
         [0033]    Although the embodiment shown in  FIG. 5  is described with reference to the method of  FIG. 7 , the embodiment seen in  FIG. 1  and elsewhere may also be used. For example, the spiraled needle may be rotated around the grasping portion  110 , as seen in  FIG. 1 . Rotating a spiraled needle around the grasping portion may comprise advancing the spiraled needle from a retracted starting position, as seen in, for example,  FIG. 4  and the first image of  FIG. 5 , to an extended ending position after the grasping portion is in the substantially closed position, as seen in, for example,  FIGS. 1 ,  3 , and the second image in  FIG. 5 . 
         [0034]    Moving the grasping portion  110  from a substantially open position to a substantially closed position and grasping the internal body tissue  590  may comprise engaging a first trigger  450  on the device  400 , which may be referred to as a suture device. Furthermore, rotating a spiraled needle around the grasping portion, suturing the body tissue, and retracting the spiraled needle comprises engaging a second trigger  450  on the suture device  400 . Additionally, grasping the internal body tissue comprises stabilizing the internal body tissue in a substantially fixed position. It is further contemplated that the steps of rotating a spiraled needle of  761 , suturing the body tissue of  771 , and retracting the spiraled needle  781  may be repeated. One method  709  may further comprise creating a grasping stitch. 
         [0035]    Turning now to  FIG. 6 , seen is an arthroscopic grasping-type suturing system  666 . One such system  666  may be similar to the device  100  seen in reference to  FIG. 1  and elsewhere. The system  666  in  FIG. 6  comprises a pair of actuation triggers  650 . A first of the actuation triggers may operatively coupled to a pair of jaws comprising the grasping portion  610 . A second of the actuation triggers may be operatively coupled to a spiral-shaped piercing device  620  comprising a cannulated needle. The cannulated needle may include one or more suture threads. The cannulated needle  620  is in a retracted position in  FIG. 6 , ready to be extended and suture the tissue. 
         [0036]    Operation of a first trigger  650 ′ may deploy the jaws from the retracted position of GI.  6  to a forward position. The first trigger  650 ′ may also change the jaws between an open and a closed position and may hold a rotator cuff tendon in a substantially stable position when the jaws are in the closed position. Operation of a second trigger  650 ″ may deploy the cannulated needle along a longitudinal axis of the jaws when the jaws are in an extended and closed position. The operation of the second trigger  650 ″ may further deploy the cannulated needle in a corkscrew motion along the grooves which may be located in a system housing  640 . The operation of the second trigger may further suture the rotator cuff tendon, remove the suture from the cannulated needle, and retract the cannulated needle from the suture, leaving the placed suture in the tissue. The cannulated needle may be located along a longitudinal axis to the jaws when the jaws are in the closed position. Additionally, it is contemplated that one or more sutures may be coupled to a humerus or other bone via at least one of one or more bone anchors and tunnels. 
         [0037]    The  FIG. 6  system may comprise a pistol grip type handle  668  with a narrow, elongated end  664 . The elongated end  664  may be adapted for introduction through small incisions into the body, such as, but not limited to, a shoulder location. At its end  662  are grasping jaws that can grab and hold the tendon. The corkscrew cannulated needle may be wound within the elongated distal end of the system  666 , mounted to the bearing platform  670 . 
         [0038]    In one embodiment, with the tendon held in place by the first trigger  650 ′, the second trigger  650 ″ may deploy the cannulated needle down the length of the instrument over, or through, the grasping jaws. Grooves may guide the needle into a corkscrew motion, rotating around the instrument as it advances forward. 
         [0039]    The cannulated needle, which is shaped like a corkscrew and can be advanced in a corkscrew-type motion, is an improvement over the older methods because it allows the surgeon to place multiple suture passes through the tendon at one time, using a simple motion, which creates the preferred grasping-type stitch. This provides the user with a stronger suture/tendon interface. Because most rotator cuff tendon repairs fail at the suture/tendon interface, the invention will improve the healing rates of these repairs. 
         [0040]    Turning now to  FIGS. 8A ,  8 B, and  8 C, seen is a grasping portion  810  of another embodiment of a medical device  800 . As seen in  FIGS. 8A and 8B , at least part  813  of at least the top jaw section  812  of grasping portion  810  may be removed. Removal of the part  813  of the top jaw section  812  may enable or otherwise facilitate passage of the spiral-shaped piercing device  820  through the grasping portion  810  by providing a passageway for the spiral-shaped piercing device  820  to travel as it moves towards the distal end  816  of the device  800  to suture the tissue in the device jaws when the jaws are in a closed position. Such an embodiment, and other embodiments, may be used to suture tissue when the jaws are in the open or closed position. As also seen in  FIG. 8C , it is contemplated that the part  813  of the top jaw section  812  and/or the lower jaw section  811  that has been removed may not comprise the entire height  841 ,  843  of the top jaw section  812  or lower jaw section  811  and may only comprises a portion of the height. 
         [0041]    Those skilled in the art can readily recognize that numerous variations and substitutions may be made in the invention, its use and its configuration to achieve substantially the same results as achieved by the embodiments described herein. Accordingly, there is no intention to limit the invention to the disclosed exemplary forms. Many variations, modifications and alternative constructions fall within the scope and spirit of the disclosed invention as expressed in the claims.