Abstract:
An anchoring system for securing tissue to bone includes an implant having a body through which a suture eyelet extends transversely, a suture recess extending along a portion of a length of the body, having a predetermined depth below an outer surface of the body, and a suture pinch ramp disposed at a proximal end of the suture recess. The suture pinch ramp has a depth approximately equal to the predetermined depth at a distal end thereof and sloping outwardly in a proximal direction so that a depth of a proximal end of the suture pinch ramp approaches zero. An insertion member includes an insertion tube and a handle which is engageable with the anchor body to deploy the anchor in a selected bone site.

Description:
[0001]    This application is a divisional of U.S. application Ser. No. 13/573,791, entitled Suture Anchors and Methods of Use and filed on Oct. 3, 2012, issuing as U.S. Pat. No. 9,402,617 on Aug. 2, 2016, which in turn claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/542,688, entitled Suture Anchor, filed on Oct. 3, 2011. All of the foregoing applications are commonly assigned and expressly incorporated herein by reference, in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    There are many suture anchor designs on the market today which are intended to secure suture, wherein the suture is passed through soft tissue to bone. Preferred methods often use anchors that do not require placing knots in the suture to secure the tissue to the anchor. This shift has allowed for a simpler, less time consuming procedure. Also, the knots have been shown to be a common source of anchor failure. 
         [0003]    However, the knotless anchors have many challenges. Many anchors can change the tension in the suture during deployment, which requires the surgeon to estimate how much tension will be added during the final installation step. This can result in under- or over-tensioning of the tissue against the bone. Anchors that allow the suture to be tensioned after the anchor is implanted can be complicated, with many components which lead to expensive and unreliable anchors. These types of anchors can have user-assisted tensioning devices that can lead to over-tensioned suture that have the ability to pull the anchor out of the bone. 
         [0004]    Other anchors that allow the suture to be tensioned prior to implanting the anchor can leave the sutures with uneven tension. Also, many of the anchors are unable to utilize more than two suture ends and have undesirable metal components. 
         [0005]    There have been many different anchors used t secure suture to bone. As described above, the knotless anchor designs are preferred due to knot failures. 
         [0006]    The PUSHLOCK™ anchor, marketed by Arthrex, is a two-part anchor. The tip of the anchor has an eyelet through which the suture legs are loaded. This tip is placed at the bottom of a hole drilled into the bone. At this point, the surgeon may adjust the tension on the suture, thereby pulling the tissue closer to the surface of the bone. Since the suture is tensioned all at once, without any engagement with the hole when the rear portion of the anchor is driven into the hole, the tension may not be correct. Once the rear portion of the anchor is in the hole, the suture tension cannot be adjusted. 
         [0007]    Smith and Nephew market the KINSA™ suture anchor. This anchor is a knotless design made of PEEK (polyether ether ketone) which is tapped into a pre-drilled hole in the bone. The anchor is preloaded with suture tied in a one-way sliding knot within the anchor body, which allows the surgeon to adjust the tension after the anchor has been deployed. This cannot utilize suture that is already passed through tissue and only can provide a simple stitch in the tissue. 
         [0008]    The POPLOK™ by Conmed Linvatec is another knotless anchor. It is a two piece polymer anchor that has the ability of accepting and tensioning the suture individually prior to locking the suture to the anchor. However, the anchor has multiple pieces that can fail. 
         [0009]    The VERSALOK™ by Mitek is also a knotless anchor. It is a two piece polymer and metal design that has the ability of accepting and tensioning the suture individually prior to locking the suture to the anchor. It does have multiple parts forming the anchor and the inner member is metallic. 
         [0010]    The CUFFLINK™ Knotless and CUFFLINK SP™ Knotless suture (self punching with metal tip) anchors, also marketed by Mitek, are fabricated of PEEK, using a one-piece polymer design without the employment of any metal. The design allows the anchor to accept more than two suture ends, and each of these ends can be tensioned or have tension released individually by hand, prior to final anchor deployment, providing the surgeon the ability to achieve the desired tension on each suture. The anchor may also accept tissue (such as a tendon, ligament, zenograft, allograft, or collagen scaffold) with or without suture, enabling a direct tissue to bone repair. The metal tip version allows the anchor to be malleted directly into the bone without the need for a pilot hole. Finally, the design incorporates a metal deployment device to provide strength to the anchor during deployment, thereby reducing breaking of the anchor. 
       SUMMARY OF THE INVENTION 
       [0011]    The present invention provides a suture or tissue anchor which is intended to secure suture or tissue to bone. There are many soft tissue to bone repair procedures, such as rotator cuff, SLAP (Superior Labral tear from Anterior to Posterior), and Bankart lesion repairs, or reconstruction of labral tissue to the glenoid rim, in which a surgeon needs to secure tissue in close contact with bone. Often the bone surface is roughened, and when tissue is pulled into intimate contact, the body&#39;s healing response will fuse the tissue and bone together. This suture is then passed through the soft tissue at the desired location, and the suture is secured to the anchor by tying a knot. Other methods include passing suture through the tissue first and then fastening the anchor and suture to the bone without knots. 
         [0012]    More particularly, there is provided in one aspect of the present invention an anchoring system for securing tissue to bone, which comprises an implant having a body which includes a suture eyelet extending transversely therethrough, a suture recess extending along a portion of a length of the body, having a predetermined depth below an outer surface of the body; and a suture pinch ramp disposed at a proximal end of the suture recess. The suture pinch ramp has a depth approximately equal to the predetermined depth at a distal end thereof and sloping outwardly in a proximal direction so that a depth of a proximal end of the suture pinch ramp approaches zero. 
         [0013]    Preferably, the implant further comprises external surface features for securing the implant within surrounding bone. These external surface features comprise bone barbs. Suture barbs are disposed on the outer surface of the body at a proximal end thereof, for clamping suture or tissue between the outer surface of the body and adjacent bone. Bone displacement tabs are disposed on a distal portion of the implant body, for displacing bone distal to suture for allowing optimal suture sliding during initial deployment of the anchor. 
         [0014]    An inner cavity is provided in the anchor body, having an opening at a proximal end of the anchor body for receiving an insertion device. The anchoring body further comprises a suture cleat adjacent to the suture pinch ramp. 
         [0015]    The anchoring system further comprises an insertion member which is engageable with the anchor body to deploy the anchor in bone. The insertion member comprises a proximal handle portion and an insertion tube connected to a distal end of the handle portion. A suture pulley rod is extendable from and retractable into a distal end of the insertion tube. A pair of cleat retainers are provided on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is disposed on the handle portion for retracting and extending the pulley rod relative to the insertion tube. A knob release slide disposed on the handle. 
         [0016]    In another aspect of the invention, there is disclosed a method for securing soft tissue to bone, which comprises steps of driving an implantable anchor having a body distally into a desired bone site, using an insertion device, to a predetermined initial deployment depth, and applying pressure to suture or tissue disposed between the anchor body and adjacent bone, using a recess disposed on an outer surface of the body and a pinch ramp also disposed on the outer surface of the body, proximal to the suture recess. Additional steps include tensioning free ends of the suture or tissue disposed between the anchor body and adjacent bone to a desired level, withdrawing a pulley rod proximally into an insertion tube comprising a portion of the insertion device, and driving the implantable anchor a further distance distally into the bone site to finally deploy the anchor. The suture or tissue is pinched between barbs on an outer surface of the implant body and adjacent bone and also between cleats on both sides of the anchor body to lock the suture or tissue in place. Further inventive method steps include withdrawing the pulley rod from the anchor body and releasing the insertion device therefrom; and trimming the free suture ends to complete the procedure. 
         [0017]    In still another aspect of the invention, there is provided an anchoring system for securing tissue to bone, which comprises an insertion member which is engageable with an anchor body to deploy the anchor body in bone. The insertion member comprises a proximal handle portion, an insertion tube connected to a distal end of the handle portion, and a suture pulley rod extendable from and retractable into a distal end of the insertion tube. A pair of cleat retainers are disposed on a distal end of the pulley rod, wherein a gap is disposed between the pair of cleat retainers. A rotatable knob is provided on the handle portion for retracting and extending the pulley rod relative to the insertion tube, and a knob release slide is disposed on the handle. 
         [0018]    The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIGS. 1-4  are isometric views of an implantable anchor constructed in accordance with the principles of the present invention, illustrating the anchor from four different perspectives; 
           [0020]      FIG. 5  is an elevational view of the anchor of  FIGS. 1-4 ; 
           [0021]      FIG. 6  is an elevational view similar to  FIG. 5 , from an opposed orientation; 
           [0022]      FIG. 7  is an isometric view of the insertion system of the present invention; 
           [0023]      FIG. 8  is an isometric view similar to  FIG. 7  illustrating the assembled insertion system and anchor of the present invention in position to be deployed; 
           [0024]      FIG. 9  is an isometric view similar to  FIG. 8 , wherein the assembly is being inserted into a desired bone location; 
           [0025]      FIGS. 10-13  are isometric views illustrating the insertion system of the present invention, including the handle portion; 
           [0026]      FIG. 14  is an elevational view illustrating a first step of a method of using the present invention; 
           [0027]      FIG. 15  is an isometric view showing the same step as that shown in  FIG. 14 ; 
           [0028]      FIG. 16  is an elevational view similar to  FIG. 14  with the suture removed for clarity; 
           [0029]      FIG. 17  is an isometric view similar to  FIG. 15  with the suture removed for clarity; 
           [0030]      FIG. 18  is an elevational view showing a second step of the described inventive method; 
           [0031]      FIG. 19  is an isometric view of the step illustrated in  FIG. 18 ; 
           [0032]      FIG. 20  is an elevational view similar to  FIG. 18 , with the suture removed for clarity; 
           [0033]      FIG. 21  is an isometric view similar to  FIG. 19 , with the suture removed for clarity; 
           [0034]      FIG. 22  is an elevational view showing a third step of the described inventive method; 
           [0035]      FIG. 23  is an isometric view of the step illustrated in  FIG. 22 ; 
           [0036]      FIG. 24  is an elevational view similar to  FIG. 22 , with the suture removed for clarity; 
           [0037]      FIG. 25  is an isometric view similar to  FIG. 23 , with the suture removed for clarity; 
           [0038]      FIG. 26  is an elevational view of the anchor of the present invention showing a step which is performed prior to final deployment of the anchor; 
           [0039]      FIG. 27  is an elevational view similar to  FIG. 26 , showing the illustrated step from a different orientation; 
           [0040]      FIG. 28  is an elevational view illustrating the first step of the inventive method which is also shown in  FIGS. 14-17 , with the suture removed for clarity; 
           [0041]      FIG. 29  is an elevational view similar to  FIG. 28 , illustrating the second step of the inventive method which is also shown in  FIGS. 18-21 , with the suture removed for clarity; 
           [0042]      FIG. 30  is an elevational view similar to  FIGS. 28 and 29 , illustrating the third step of the inventive method which is also shown in  FIGS. 22-25 , with the suture removed for clarity; 
           [0043]      FIG. 31  is an elevational view similar to  FIG. 30 , showing the proximal withdrawal of the suture pulley rod in accordance with the method of the present invention; and 
           [0044]      FIG. 32  is an elevational view similar to  FIGS. 28-31 , showing the final completed deployment of the inventive anchor. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0045]    The inventive system and methods disclosed herein comprise a simple-to-insert suture anchor which allows adjustment of suture or tissue tension prior to deployment, does not change the tension on the suture or tissue (and as a result, the captured tissue) when it is deployed, does not require a knot to secure the suture or tissue, and accepts multiple suture ends. 
         [0046]    Referring now more particularly to the drawings, there is shown in  FIGS. 1-6  a suture anchor  10  constructed in accordance with the principles of the present invention. The anchor  10  comprises a body  12  having a plurality of proximal suture barbs  14 , as well as bone barbs  16 . A portion of the outer surface of the body  12  comprises a suture recess  18 . An inner cavity  20  ( FIG. 3 ) is provided for accommodating a suture pulley rod, to be described below. The distal end of the anchor body  12  includes bone displacement tabs  22 . 
         [0047]    Within the suture recess  18  are disposed a suture pinch ramp  24 , a suture cleat  26 , and a suture eyelet  28 , which extends transversely through a width of the body  12  so that it is open to opposing sides of the body. 
         [0048]    Now with reference to  FIGS. 7-13 , the insertion system  30  for the anchor  10  will be described. The insertion system or inserter  30  comprises a suture pulley rod  32  ( FIG. 7 ), suture cleat retainers  34  on the distal end of the pulley rod  32  (also  FIG. 7 ), and an insertion tube  36 . In some embodiments, an optional metal distal tip  38  ( FIG. 9 ) may be employed. 
         [0049]    A handle portion  40  of the insertion system  30  is illustrated in  FIGS. 10-13 . The handle portion  40  comprises a knob release slide  42  and a proximal knob  44 . 
         [0050]    The anchor  10  has a number of features that are important to its innovative function. For example, the suture barbs  14  pinch the suture against the surrounding bone when the implant is deployed. The remaining barbs are the bone barbs  16 , distal to the suture barbs  14 , function to engage the bone during the initial and final deployment. The suture recess  18 , because of its recessed profile relative to remaining portions of the outer surface of the body  12 , allows the suture to slide between the anchor body and adjacent bone during the initial deployment. The inner cavity  20  for the suture pulley rod  32 , allows for the metal suture pulley rod  32  to support the anchor during initial deployment. The bone displacement tabs  22  displace the bone distal to the suture to allow for optimal suture sliding during initial deployment. 
         [0051]    The suture pinch ramp  24  helps to maintain tension during individual tensioning of the suture. It is configured to slope outwardly in a proximal direction, so that its distal end is at a depth approximating the depth of the suture recess  18  and its proximal end is at the outer surface of the implant body  12 , i.e. a depth of approximately zero. The suture cleat  26  pinches the suture to increase the suture pullout strength of the construct. The suture eyelet  28  allows for one or more suture ends to be placed in the implant. Each suture end is individually tensionable, as well be described below. Though the tip  46  of the anchor  10  is illustrated as being closed, as shown in  FIG. 9 , the optional metal tip  38  may be added to the anchor  10  to allow for the anchor to be inserted directly into bone without the requirement of a pilot hole. 
         [0052]    The insertion system  30 , as well, has several important features which contribute to the innovative function of Applicant&#39;s inventive system. In particular, the suture pulley rod  32 , in the initial deployment stage, allows the suture to move freely in the suture eyelet  28 , by preventing the suture from entering the suture cleat  26 . The pulley rod  32  also increases the strength of the anchor  10  by extending to the distal tip  46  of the anchor body  12  during initial deployment. The insertion tube  36 , as well as the pulley rod  32 , transmits the insertion force from a mallet to the anchor during initial deployment. Rotation of the proximal knob  44  actuates a mechanism that retracts the pulley rod  32  between initial and final deployment stages. The knob release slide  42  releases the knob  44  to allow for removal of the inserter  30  after final deployment. The suture cleat retainers  34  maintain a set gap in the suture cleat  26  during final deployment. 
         [0053]    The remaining  FIGS. 14-32  will now be referenced in connection with a description of methods of using the inventive system to deploy an anchor  10  in bone  48 . 
         [0054]    To deploy the anchor  10  in a suitable bone site, suture  50  is first passed through soft tissue (not shown) requiring repair. Viewing, for example,  FIG. 19 , the suture loops  51  in the suture  50  would normally be occupied by the soft tissue to be approximated against the bone  48 , but that tissue is not shown, for clarity. Alternatively, soft tissue itself may be anchored directly in place within the desired bone site  48 , rather than using suture  50 , in which case the tissue is manipulated in the same way as the suture to be described in this explanation. For this reason, though the term “suture” is used throughout this specification, for convenience, the term should be considered sufficiently broad to include other media having similar functional characteristics, including soft tissue itself. A pilot hole  52  ( FIGS. 9 and 28 ) is drilled or punched into the attachment site (bone  48 ), through the cortical bone layer  54  and into the cancellous bone layer  56 . In some circumstances, the optional metal distal tip  38  may be employed ( FIG. 9 ), in which case the step of drilling a pilot hole is unnecessary. The suture is then fed through the suture eyelet  28 , as shown in  FIGS. 14 and 15 , directly or with a snare. One or more suture ends  58 ,  60  ( FIG. 15 ) may be placed through the eyelet  28 . 
         [0055]    With the anchor  10  and attached inserter  30  positioned at the desired bone site, as shown in  FIGS. 14 and 15 , initial deployment of the anchor  10  can occur. It should be noted that  FIGS. 16 and 17 , and  FIG. 28 , illustrate the same step as  FIGS. 14 and 15 , with the suture  50  removed for clarity. To initiate this initial deployment, a mallet is driven against the proximal end of the handle portion  40  to drive the anchor  10  distally to its initial deployment position, as shown in  FIGS. 18 and 19 , and also in  FIGS. 20 and 21, and 29 , with the suture again removed for clarity. At this juncture, the suture recess  18  is acting to apply pressure to the sutures or tissue  50  disposed between the outer surface of the anchor body  12  and the adjacent bone surface, as well as against the suture pinch ramp  24 . This pressure maintains the tension on the suture  50 . 
         [0056]    The free suture ends  58 ,  60  may be individually tensioned around the suture pulley rod  32  to approximate the tissue within the suture loops  51  up against the anchor and repair site and its surrounding bone  48 . If the suture is over-tensioned, a probe may be used to loosen the tissue side of the suture. 
         [0057]    Once the desired tension is achieved, the suture pulley rod  32  is pulled proximally into the insertion tube  36 , by rotating the threaded proximal knob  44  on the handle portion  40  until further rotation is prevented. When the tube  36  is retracted by the rotation of knob  44 , the gap of the suture cleat  26  is exposed. At this point, the suture cleat retainers  34  are in position on either side of the suture cleat  26 . This retracted pulley rod position is illustrated in  FIGS. 26 and 27 , which is the position required prior to the final insertion step. As noted above, the suture cleat  26  is exposed and held open by the suture cleat retainers  34 , which thus allow the suture to pull into proper position during final insertion. 
         [0058]    At this juncture, the final deployment steps are initiated, as shown in  FIGS. 22 and 23 , and also in  FIGS. 24 and 25, and 30 , wherein the suture  50  has been removed for clarity. With the gap of the suture cleat  26  maintained by the suture cleat retainers  34 , the inserter handle  40  is again malleted, directing insertion force into the insertion tube  36  until the anchor  10  rests below the surface of the bone, as shown in  FIG. 30 . Because the suture  50  has maintained an equal distance from the surface of the bone, post-tensioning and post-final deployment, the tension in the suture  50  is maintained. If additional tension is required, the anchor can be malleted deeper into the bone, pulling the suture ends with it, thereby increasing tension. 
         [0059]    The suture  50  is now pinched between the suture barbs  14  and the bone on the tissue side of the anchor, as shown in  FIG. 23 . It is also pinched between the suture cleats  26  on both sides of the anchor body  12 . Finally, the free suture ends  58 ,  60  are pinched between the suture barbs  14  and the bone opposite to the tissued side of the anchor. 
         [0060]    The suture pulley rod  32  may now be pulled out of the anchor body  12 , as shown in  FIG. 31 , releasing the inserter  30  by actuating the knob release slide  42  to allow the threaded knob  44  to be free to rotate. The knob  44  is then rotated until the inserter is released from the implant. At this juncture, the free suture ends can be cut, as shown in  FIG. 32 , which completes the repair. 
         [0061]    Accordingly, although an exemplary embodiment of the invention has been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.