Abstract:
A passive retrieving interosseous suture passing instrument ( 10 ) having a guide handle ( 13 ) with a proximal end for grasping and a distal end for engagement with a bone ( 11 ) to which suture ( 22 ) is to be attached. The bone ( 11 ) is provided with a first tunnel ( 15 ), and a suture retrieving arm ( 12 ) carried at the distal end of the guide handle ( 13 ) is provided with a distal tip dimensioned to be received in the first tunnel ( 15 ).

Description:
CROSS REFERENCE 
       [0001]    This application claims the benefit of International Patent Application No. PCT/US2013/057485, filed on 30 Aug. 2013, for Transosseous Attachment Method and Instruments and U.S. Provisional Patent Application No. 62/025,044, filed on 16 Jul. 2014, for Passive Retrieving Interosseous Suture Passing Device, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The invention relates to techniques and instruments for surgical transosseous attachments, for example, the attachment of ligaments, tendons, fascia, and muscle to an adjacent bone to effect a repair of a joint. Typical joints subjected to repair are the hands, feet, ankle, knee and shoulder. 
         [0003]    Transosseous attachment instruments of the type presently described, are generally referred to as a tunneler as they are not only utilized for the transosseous passing of suture, but in addition, are generally utilized to also guide bone tunneling procedures. Tunneler instruments of the prior art are at a disadvantage in that they require excessive procedural step to form the intersecting tunnels and transosseously pass suture through the intersecting tunnels. In addition, the prior art tunneler instruments cannot assure quick and effective transosseous placement and passing of the suture on each and every attempt, and in addition, the prior tunneler instruments are generally single use instruments which cannot be readily disassembled, disinfected and reused. 
         [0004]    Tunneler instruments of the prior art such as illustrated in U.S. Pat. No. 8,449,552, issued on May 28, 2013, for Surgical Drill Guide with Awl and Method of Use, do not provide a passive means for capturing the suture and therefore quick and effective transosseous placement, and passing of the suture cannot be assured on each and every attempt. With this and other prior art tunnelers, in order to capture the suture passed through a suture retrieving element, additional active manipulation of the suture retrieving element must be taken in order to effect capture of the suture to be retrieved, and assured capture of the suture upon active manipulation of the suture retrieving element cannot be guaranteed. 
         [0005]    It is therefore an object of the present invention to provide an intersosseous suture passing tunneling device which possesses passive retrieving capabilities in the suture retrieving element of the tunneler and which absolutely assures quick and effective transosseous placement and passing of the suture on each and every attempt. 
       SUMMARY OF THE INVENTION 
       [0006]    The passive retrieving intersosseous suture passing instrument of the present invention includes a guide handle having a proximal end for manual grasping and a distal end for engagement with a bone to which suture is to be attached, the bone being provided with a first tunnel. A suture retrieving arm is carried at the distal end of the guide handle and it is provided with a distal tip which is dimensioned to be received in this first bone tunnel. The retrieving arm is also provided with a window therethrough which is aligned with a central guide bore passing through the handle for receiving a bone tunneling implement, such as a drill or awl, to form a second intersecting tunnel in the bone which passes through the window. 
         [0007]    A suture passing awl is provided which is dimensioned and configured to be received in the central guide bore of the guide handle and to carry and pass suture through the window for capture and retention in the window of the suture retrieving arm. The instrument of the present invention is characterized by a passive suture capture device in the window which is adapted to passively engage suture carried on the awl under a pinching spring biased engagement sufficient to prevent withdrawal of the suture from the window when the awl is withdrawn, thus always insuring effective transosseous placement and passing of the suture on each and every attempt. 
         [0008]    The passive suture capture device may take on various forms. In one of the more preferred embodiments, the passive suture capture device is comprised of a spaced pair of nitinol wires having their free distal ends depending into the window and positioned for passage of the suture passing awl therebetween under spring biased engagement of the nitinol wires against the suture being carried on the awl. Preferably the nitinol wires are replaceable and the suture retrieving arm carrying the nitinol wires includes spring clips for retaining the proximal ends of the replaceable nitinol wires. 
         [0009]    The awl is keyed to the guide handle for guided orientation relative to the handle when fully seated therein to ensure proper orientation of the suture carried on the awl for engagement with the passive suture capture device. The awl is also preferably pointed at its distal end for creating a bone tunnel while simultaneously carrying the suture, which is exposed on the sides of the awl. 
         [0010]    In a different embodiment, the suture capture device may consist of a flexable and penetrable capture wall confined within the window of the suture retrieving arm, such as a wall or sleeve of silicone or a wall of one or more layers of a fine mesh, such as a metal or plastic mesh. Alternatively the suture capture choice may consist of a metal trap door configuration. 
         [0011]    The suture retrieving arm of the instrument may be constructed of one piece or may be constructed of two pieces which are interconnected and include a detachable oriented bone tunneling spike at the forward distal end of the suture retrieving arm, and wherein the spike carries the suture passing window at its distal end. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    Other objects and advantages appear hereinafter in the following description and claims. The accompanying drawings show, for the purpose of exemplification, without limiting the scope of the present invention or the appended claims, certain practical embodiments of the present invention wherein: 
           [0013]      FIG. 1  is a side view of one embodiment of the tunneler instrument of the present invention showing the suture pushing awl partially inserted into the instrument; 
           [0014]      FIG. 2  is a side view of the tunneler shown in  FIG. 1  illustrating the suture pushing awl fully inserted and engaged within the tunneler instrument; 
           [0015]      FIG. 3  is a perspective view of the tunneler instrument shown in  FIG. 1  as seen from the front; 
           [0016]      FIG. 4  is an enlarged view in side elevation of the passive suture retrieving arm which is positioned on the forward end of the tunneler instruments shown in  FIGS. 1, 2 and 3 ; 
           [0017]      FIG. 5  is a front view of the passive suture retrieving arm shown in  FIG. 4 ; 
           [0018]      FIG. 6  is a perspective rear view of the passive suture retrieving arm shown in  FIG. 4 ; 
           [0019]      FIG. 7  is an enlarged perspective view of the forward end of the tunneler instrument of the present invention shown as detached from the handle portion of the tunneler instrument of the present invention thereby illustrating in part how the instrument may be disassembled for cleaning and sterilization; 
           [0020]      FIG. 8  is a perspective view of the tunneler instrument of the present invention showing and illustrating the internal parts to further illustrate the inner workings of the instrument and its capability to be fully disassembled for cleaning and sterilization; 
           [0021]      FIG. 9  is an enlarged perspective view of the forward end of the suture pushing awl loaded with a suture; 
           [0022]      FIG. 10  is an enlarged perspective view of the forward end of the suture pushing awl shown in an inverted position with the suture removed; 
           [0023]      FIG. 11  is a side view in partial section illustrating the application of the tunneler instrument of the present invention to a humeral head; 
           [0024]      FIG. 12  is an enlarged view in side elevation of the passive suture retrieving arm illustrated in  FIG. 4  with the addition of steel spring clips retaining the proximal ends of the replaceable nitinol wires utilized for the passive suture capturing device; 
           [0025]      FIG. 13  is an enlarged front view of the passive suture retrieving arm incorporating another embodiment of the passive suture capture device in the retrieving arm window in the form of a metal trap door; 
           [0026]      FIG. 14  is an enlarged front view of the passive suture retrieving arm illustrating another embodiment of the passive suture capture device in the suture passing window of the arm in the form of one or more layers of a fine metal or plastic mesh; and 
           [0027]      FIG. 15  is an enlarged perspective view of the forward end of the tunneler instrument of the present invention illustrating the suture retrieving arm including a bone tunneling spike attached to its forward end and illustrating yet another embodiment of the passive suture capture device in the form of a wall or sleeve of silicone. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0028]    The following illustrated examples depict instruments and techniques to pass a suture through a portion of the head of the humeral bone at the shoulder of a human patient to repair damaged soft tissue associated with the shoulder joint. However, instruments and techniques according to the present invention may be used to pass a suture through any joint bone. 
         [0029]    Referring to the drawings, the tunneler instrument  10  is utilized for the creation of converging tunnels in bone (transosseous tunneling) both arthroscopically or with open techniques. For illustration purposes only, the tunneler  10  of the present invention is illustrated in the creation of tunnels in the humeral head  11  shown in  FIG. 11  to allow for the repair of a torn rotator cuff 
         [0030]    The tunneler instrument  10  consists of a guide handle  13  having at its forward end a passive suture retrieving arm  12 , and a suture pusher awl  14 . These elements work together to assist in creating two converging tunnels of different length and angles within bone and transosseously pass suture through the tunnels utilizing a passive suture capture or retrieving device on the distal end of suture retrieving arm  12  which interacts with the forward distal end of suture passer awl  14 . The tunneler instrument  10  transosseously passes and passively captures and retrieves suture  22  through the lateral tunnel  21  and medial tunnel  15  respectively, with fewer steps and greater reliability and repeatability than is possible through the use of current techniques. 
         [0031]    An awl or drill (not shown) is first used to create the first or medial tunnel  15  ( FIG. 11 ) in the humeral head  11 . The passive suture retriever arm  12  is constructed of surgical stainless steel or other suitable material and is provided with a sharp distal tip  17  for piercing tissue, such as the percutaneous penetration of the deltoid and to also penetrate the rotator cuff, if desired, thereby eliminating a step. Window  20  is provided in the distal end of arm  12  to allow passage of the complimentary pusher awl  14 , which is used to create the second converging lateral tunnel  21 , as well as for passing suture  22  through the lateral tunnel. With specific reference to  FIGS. 9 and 10 , suture pusher awl  14  has a special “shark mouth” geometry such that a slot  48  is created in the distal tip allowing it to retain a loop of the suture  22  in slot  48  and in side grooves  47  while creating the tunnel  21 , but releases the suture  22  as it is withdrawn from the tunnel  21 . 
         [0032]    The head  18  of passive suture retrieving arm  12  is provided with two side by side passages  23  to receive and tightly retain the upper ends of nitinol wires  35  which have their free distal ends depending downwardly into open window  20  for passively capturing and retrieving suture  22  from the distal end of awl  14 . 
         [0033]    Nitinol wires  35  are spaced side by side as best illustrated in  FIG. 5  and their bottom free ends are disposed within window  20 . Thus when awl pusher  14  is keyed to handle  13  for proper orientation as shown, and is loaded with suture  22  and then penetrated into the bone head  11  to form the lateral tunnel  21  and pushed forward sufficiently to the final position as illustrated in  FIG. 2 . The distal tip  17  of awl  14  passes between nitinol wires  35  and spreads them and flexes them slightly forward as illustrated in  FIG. 10  whereby the nitinol wires  35  tightly engage and capture the suture  22  on both sides of awl  14  to passively capture and retrieve suture  22  from awl  14  when awl  14  is thereafter retracted and withdrawn. The nitinol wires  35  have a bristled surface which captures the suture  22  therebetween under the spring bias of the wires  35 . 
         [0034]    Nitinol has been selected for the wires  35  as it is a metal alloy of nickel and titanium which exhibits the unique properties of shape, memory and super elasticity. It also may be provided with many different surface finishes. For example, it may be provided with a bristled surface for secure engagement of the suture as by chemical etching or sandblasting, or alternatively may be provided with coated polymers. 
         [0035]    Other passive suture capturing and retrieval mechanisms may be substituted for nitinol wires  35 , such as a metal trap door, wire mesh, silicone mesh, suture mesh or any other substance that is capable of passively capturing and retrieving the suture  22  from awl  14  such as described hereinafter. 
         [0036]    After awl  14  is withdrawn, the captured suture  22  remains clamped between nitinol wires  35  and the distal end of arm  12  may then be withdrawn from medial tunnel  15  pulling the captured suture  22  with it. 
         [0037]    Before awl  14  is forced through head  11  to form lateral tunnel  21 , inner guide  41  is advanced forward under the bias of spring  31  ( FIG. 8 ) as controlled with knob  42  so that the forward pointed tip  43  of guide  41  ( FIGS. 3 and 11 ) engages the bone of head  11  at the desired position to maintain the instrument  10  in position for advancement of the awl  14 . 
         [0038]    The tunneler instrument  10  is modular in construction and may be easily disassembled for cleaning and sterilization for reuse. As seen in  FIG. 8 , the forward collar  39  may be unscrewed in order to detach the forward end of the tunneler  10  as shown in  FIG. 7 . This also permits removal of the remaining internal parts. Knob  42  may be unscrewed thereby releasing the internal guide  41  and spring  31  for cleaning and sterilization. 
         [0039]    Different passive suture retrieval guide arms  12  may be substituted in order to provide guide tips with different morphologies, which guide tips may be interchangeable intraop to allow lower or different positions on the bone, or to adapt to certain intraop situations. 
         [0040]    Referring to  FIG. 12 , the nitinol wires  35  are replaceable for reuse of the instrument. In this embodiment the distal ends  50  are engaged by stainless steel ribbon spring  51  to temporarily but firmly engage and retain nitinol wires  35  in position. Ribbon spring  51  is retained in position by machine screw  52 . 
         [0041]    Referring next to  FIG. 13 , a metal trap doors passive suture capture device  35 ′ is illustrated in substitution of the nitinol wires previously described. In this embodiment the trap door  35 ′ consists of two side by side vertical sheets of stainless steel which are respectively retained at the side edges of window  20 . The two sheets are separate from each other and meet or adjoin at the middle joint  53 . 
         [0042]    Accordingly, when the forward tip  17  of awl  14  engages the trap door  35 ′, tip  17  penetrates through and between the two side by side metal plates or sheets, thereby separating them and flexing them forward whereby the inner side edges of the metal sheets at  53  engage awl  14  under a pinching spring biased engagement sufficient to prevent withdrawal of suture  22  from the window  20  when awl  14  is withdrawn from window  20 . 
         [0043]    Yet another embodiment of the passive suture capture device is illustrated in  FIG. 14  is a flexible and percutaneously penetrable wall of one or more layers of a fine mesh  35 ″. In this embodiment, the fine mesh  35 ″ permits penetration of the tip  17  of awl  14  through the mesh causing the fibers of the mesh to spread and engage the awl tip with a tight pinching engagement for assured passive capture of the suture  22  carried on awl  14 . 
         [0044]    Referring to  FIG. 15 , the suture retrieving arm  12  in this embodiment consists of two interconnected elements, namely the forward arm  27  which is interconnected with the distal tunneling spike  16  which contains the window  20 . In this arrangement, the spike  16  is first driven into the humeral bone to form a first or medial tunnel and then the forward end of arm  27  is secured to the head  18  of spike  16 . Thereafter in the afore described fashion, the lateral tunnel is then made with awl  14 , which passes through window  20 . 
         [0045]    In this embodiment the passive suture capture device is provided in the form of a capture wall of silicone  35 ″′ which is flexible and percutaneously penetrable, will engage awl  14  under spring bias thereby pinching the suture  22  against awl  14  sufficiently to prevent withdrawal of the suture  22  from window  20  when awl  14  is withdrawn or retracted. 
         [0046]    The head  18  of suture retriever spike  16  is cannulated axially as indicated at  23  and slotted radially at  24  to allow for mounting of the spike  16  into the distal connecting end  25  to temporarily to a driver (not shown) for driving spike  16  into the bone  11 . 
         [0047]    A long loop  30  of suture or wire is secured via passages  43  to head  18  of spike  16  and permits the surgeon or assistant to pull the spike  16  out of the bone  11  when desired to retrieve suture  22 . The end of this loop  30  stays well outside of the body at all times, allowing the surgeon or assistant to readily grab it with their hand and pull. 
         [0048]    In the embodiment of  FIG. 15 , the suture retrieving arm  12  is pivotal as indicated by arrow  28  which allows for vertical pivotal rotation of pitch of the guide handle  13  relative to the spike  16 . To the contrary, in the previous embodiments, the suture retrieving arm  12  is fixed relative to the guide handle  13 .