Abstract:
A tissue grasping instrument and method for use in arthroscopic surgery is disclosed. Typically, the instrument will be used in the manipulation of sutures and a graft in the form of an acellular matrix during the repair of rotator cuffs.

Description:
FIELD OF THE INVENTION  
       [0001]     This invention generally concerns instrumentation and methods useful in the field of arthroscopic surgery. The invention specifically concerns instrumentation and methods useful in handling and stitching tissues and tissue grafts during arthroscopic rotator cuff repair surgery.  
       BACKGROUND OF THE INVENTION  
       [0002]     In the field of arthroscopic surgery, typically proper instrumentation can is important to a successful procedure. Accordingly, a large number of specialized instruments have been developed, some with very fine differences from existing instruments, mainly to meet specific needs or doctor preferences. For example, some instruments, such as U.S. Pat. No. 5,947,982, incorporated entirely herein by reference, only pass sutures and do not grasp tissue. In general, the needs of arthroscopic or “closed” surgery are discussed in U.S. Pat. No. 5,843,100, whose contents are also entirely incorporated herein by reference.  
         [0003]     U.S. Pat. No. 5,575,801, issued Nov. 19, 1996 and incorporated entirely herein by reference, shows a method and apparatus for use in arthroscopic rotator cuff surgery. In this patent, a trigger operated tool is shown for grasping the rotator cuff and holding it over the shoulder bone. The upper jaw of the instrument has an aperture and the lower jaw has a slot. The aperture and slot are aligned when the jaw is closed. As shown in  FIG. 3B  of that patent, the hole in the first jaw is used to remove the suture from the body while the jaw is closed. The method and instrument of this patent combine to form an older more traditional regimen for fixing torn rotator cuffs because grafts are not used.  
         [0004]     However, in more advanced and modern rotator cuff procedures, a graft of some type is used to fill the gap formed by the torn area or the poor tissue quality of the rotator cuff, either of which may be incapable of handling anchoring forces on their own. In such procedures, this graft: (1) needs to be sutured before and after placement in the body, (2) the sutures need to be manipulated in situ as the graft is sutured to the rotator cuff and anchored to the bone, and (3) then the excess suture threads need to be removed after implantation of the graft in the patient. An exemplary graft material is GRAFTJACKET™ acellular matrix, sold by Wright Medical Technology, Inc., of Arlington, Tenn., the assignee of this application. The acellular matrix is manufactured according to U.S. Pat. Nos. 4,865,871; 5,024,830; and 5,336,616.  
         [0005]     Accordingly, a specialized tool and method capable of being used for this purpose and through an arthroscopic (e.g. 7 mm) cannula is needed.  
         [0006]     Therefore, there is room for improvement in the art.  
       SUMMARY OF THE INVENTION  
       [0007]     It is an object of the invention to provide a surgical instrument, comprising: a handle portion; a body portion; a jaw portion, the jaw portion comprising first and second jaws for gripping tissue there between; wherein the second jaw has a closed perimeter hole extending there through.  
         [0008]     It is a further object of the invention to provide an arthroscopy method, comprising the steps of: grasping a tissue between first and second jaws of an instrument, one of the jaws having a center hole and the other of the jaws having a u-shaped opening; passing a suture through the tissue and the center hole of the one jaw and the u-shaped opening of the other jaw; opening the jaws to release the tissue from the grasp of the jaws and release the suture from the jaw with said u-shaped opening; and pulling the thread with the instrument while the jaws are opened.  
         [0009]     It is yet a further object of the invention to provide a method of using a surgical instrument having a first jaw having a slit and a second jaw having a hole, comprising the steps of: grasping a portion of a tissue between the first and second jaws; puncturing the tissue with a hollow surgical needle in the area of the slit of the first jaw and the hole of the second jaw.  
         [0010]     These and other objects of the invention are described herein. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]      FIG. 1  depicts an exemplary embodiment of a tissue grasping instrument according to the invention.  
         [0012]      FIG. 2A  depicts a plan view of an exemplary embodiment of the jaw portion of a tissue grasping instrument according to the invention.  
         [0013]      FIG. 2B  depicts a perspective view of an exemplary embodiment of the jaw portion of a tissue grasping instrument according to the invention.  
         [0014]      FIG. 2C  depicts a plan view of a first alternative embodiment of a first jaw for use with a tissue grasping instrument according to the invention.  
         [0015]      FIG. 2D  depicts an elevation view of a second alternative embodiment of a jaw for use with a tissue grasping instrument according to the invention.  
         [0016]      FIG. 3  depicts a close up of the teeth structure of an exemplary embodiment of the jaw of a tissue grasping instrument according to the invention.  
         [0017]      FIGS. 4A and 4B  depict alternative exemplary embodiments of a tissue grasping instrument according to the invention.  
         [0018]      FIGS. 5A, 5B ,  5 C,  5 D,  5 E depict the instrument according to an exemplary embodiment used according to an exemplary method according to the invention.  
         [0019]      FIG. 6  depicts a tissue graft positioned between bone anchors and a rotator cuff, according to an exemplary embodiment of the method according to the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0020]      FIG. 1  depicts an exemplary embodiment of a tissue grasping instrument  100  according to the invention.  
         [0021]     Tissue grasping instrument  100  generally comprises a handle portion  20 , a body portion  30 , and a jaw portion  40 .  
         [0022]     Jaw portion  40  comprises first and second jaws  41   a,    41   b.  As shown by arrow B in  FIGS. 2A and 2B , first and second jaws  41   a,    41   b  are designed to move with respect to each other, preferably, but not absolutely, as described as follows. Second jaw  41   b  is at least integral, and preferably unitary (for ease of construction) with second elongated body portion  31   b.  First jaw  41   a  is pivotally mounted to both of the first and second elongated body portions  31   a,    31   b,  by any suitable mechanism, preferably pivot pins  36  as shown. Accordingly, as the elongated body portions  31   a,    31   b  linearly move with respect to each other, e.g., first elongated body member  31   a  moves in the direction of arrow A, the first jaw  41   a  is caused to pivot in the direction of arrow B. This mechanism or mechanisms closely similar thereto are well known in this field of art and shown, for example, in U.S. Pat. Nos. 5,318,579 and 5,961,530, both of whose contents are incorporated by reference herein. Both jaws  41   a,    41   b  have a plurality of teeth  50 , whose details will be discussed below.  
         [0023]     During use of tissue grasping instrument  100 , the instrument will be positioned such that first and second jaws  41   a,    41   b  will typically be the upper and lower jaws, respectively.  
         [0024]     Optionally, as shown in  FIG. 2D , through the use of connecting arms and linkages (not shown), the jaws  41   a,    41   b,  may open and close via pure vertical movement (arrows C) rather than pivoting, whereby jaws  41   a,    41   b  are always parallel with each other. The use of parallel closing jaws  41   a,    41   b  allow for the even distribution of clamping force across a larger surface area for a wide range of tissue thicknesses.  
         [0025]     Handle portion  20  comprises first and second finger grip bodies  1 ,  2 . First finger grip body  1  is typically unitary with second elongated body  31   b,  but can be integral therewith. Second finger grip body  2  is linked to first elongated body  31   a  through pivot arm  12  and pins  5 . Pivot arm  12  may either be unitary with finger grip  2  and first elongated body member  31   a  or a separate member linked by pivot pins (not shown). Thus, as first and second finger grip bodies  1 ,  2  are moved towards and away from each other, this causes relative linear movement between first and second elongated bodies  31   a,    31   b,  as known in the art from the patents listed above and incorporated by reference herein.  
         [0026]     Optional ratchet arm  7  has two purposes. First, ratchet arm  7  can be used to make sure when second finger grip body is moved towards first finger grip body, it does so in the proper plane and there is no twisting of tissue grasping instrument  100  that could cause tissue grasping instrument  100  to fail. Second, ratchet  7  capable of locking the tissue grasping instrument  100  and hence jaw portion  40  at specific incremental positions. Such use is described, for example, in U.S. Pat. No. 5,613,977 whose contents are incorporated by reference herein.  
         [0027]     Spring  9  can be used to provide feedback to the user. Finger grip body  2  has an additional pivot linkage point  4  with pivot arm  12 . Planar spring  3  normally causes finger grip  2  to move with pivot arm  12 . However, if too much force is applied to finger grip body  2  (i.e., would damage tissue in jaw  40 ), spring  3  gives way, causing finger grip body  2  to move with respect to pivot arm  12 . Therefore, spring  3  acts as a safety bias against application of an over pressure to the tissue or graft as second finger grip body  2  is moved towards first finger grip body  1 .  
         [0028]     All major component parts of tissue grasping instrument  100  are typically made of stainless steel; however, it is possible to make tissue grasping instrument  100  out of plastic for one-time use unless the overall structure of tissue grasping instrument  100  becomes too complex, such as with the addition of the optional ratchet arm  7  and spring  3  and  9 .  
         [0029]      FIG. 2B  depicts a perspective view of an exemplary embodiment of the jaw portion of a tissue grasping instrument  100  according to the invention. First jaw  41   a  has a center hole  43   a  bound by a perimeter wall  42   a  that has a narrower slit/slot  44  in communication therewith, typically in the free end of first jaw  41   a  opposite the body portion  30 . Second jaw  41   b  just has a closed center hole  43   a  bound by perimeter wall  42   b.  The center holes  43   a,    43   b  will typically be coaxial and the same size, though neither of these are necessary or critical. Both center holes  43   a,    43   b  go completely through their respective jaw members  41   a,    41   b.    
         [0030]     As shown in  FIG. 2C , it is possible for slit  44  to be so wide that first jaw  41   a  can be considered u-shaped and having an open center portion  43   a.    
         [0031]      FIG. 3  depicts a close up of the teeth  50  structure of an exemplary embodiment of the jaw portion  40  of a tissue grasping instrument  100  according to the invention. As previously mentioned, each of first and second jaws  41   a,    41   b  have a plurality of teeth  50 . Each tooth  50  is spaced from the adjacent tooth  50  by a trough  52 , whose shape and/or form is immaterial. While teeth  50  are shown herein as having pointed tips  52 , other tip configurations are possible if they allow for grasping tissue. Tips  51  may be coated with materials  55  for protecting the grasped material. Such coating materials are typically soft materials (relative to the material of the teeth  50 ) and may include silicon-based coatings. The teeth  50  of first jaw  41   a  are preferably out of phase with the teeth  50  of second jaw  41   b  and line up with troughs  52  of second jaw  41   b  as shown by phantom lines C. Similarly, the teeth  50  of second jaw  41   b  are preferably out of phase with the teeth  50  of first jaw  41   a  and line up with troughs  52  of first jaw  41   a  as also shown by phantom lines C. Furthermore, when jaw portion  40  is closed, the tips  51  of teeth  50  do not come into contact with each or fill each others&#39; troughs  52 ; they are spaced apart by a predetermined distance D. This is because tissue grasping instrument  100  is intended for use with a particular acellular matrix that should not be subjected to undue squeezing, etc., and is not intended merely for grasping suture thread or tissue resistant to squeezing as in the prior art such as U.S. Pat. Nos. 5,797,927 and 6,554,844 and U.S. Published Application No. 2003/0083695.  
         [0032]      FIGS. 4A and 4B  depict alternative exemplary embodiments of a tissue grasping instrument  100  according to the invention. In particular,  FIG. 4A  shows left and right handed versions of tissue grasping instrument  100 , as generally described in U.S. Pat. No. 4,957,498, contents are incorporated by reference herein. It is even possible that jaw portion  40  can be swivelable so one instrument can be used in any orientation.  FIG. 4B  shows a straight (in-line) jaw portion  40  rather than an angled jaw portion  40 .  
         [0033]     The above-described instrument is especially suitable for use with the following method.  
         [0034]     As shown in  FIG. 5A , tissue  200  is grasped between first and second jaws  41   a,    41   b.  Feedback from optional spring  9  can tell the doctor if he is squeezing too hard and potentially damaging tissue  200 . While tissue  200  may comprise traditional soft tissue such as a patient&#39;s existing rotator cuff, the instrument  100  according to the invention is especially suitable for use with tissue  200  comprising a form of acellular tissue matrix, for example, GRAFTJACKET™, as previously mentioned. GRAFTJACKET™ acellular tissue matrix is quite strong and hard to puncture for purposes of suturing; especially in the closed confines inside of a shoulder during arthroscopy. For purposes of the claims, “tissue” can even mean anything used to symbolize or represent tissue during a demonstration of the instrument according to the invention, e.g., cardboard.  
         [0035]     Hollow needle  300  is moved in the direction of arrow E and used to puncture a hole in tissue  200 . This hole will be coincident or align with the center holes  43   a,    43   b  of first and second jaws  41   a,    41   b,  respectively. Shuttle  350 , having a conventional suture grasping area  351 , is contained/threaded within needle  300 . Shuttle  350  gives suture the necessary stiffness to drive it through the various needles and cannulae. While shuttle  350  is conventional, it is possible to have applications in which shuttle  350  is not used. Ultimately, shuttle  350  protrudes through the bottom side of tissue  200  ( FIG. 5C ). Hollow needle  300  is then removed from the surgical area ( FIG. 5B ; arrow F). As shown in  FIG. 6 , this process can be applied occur adjacent already-positioned sutures  710  threaded through suture anchors  715  positioned in the shoulder bone (humerus)  700  or already-positioned sutures  610  located adjacent tear T in the torn rotator cuff  600  of the patient over which the graft  200  is placed for support.  
         [0036]     While the preferred method is described with respect to the use of the suture shuttle, a suture with a pre-attached solid needle may also be passed through the openings in the jaws and through the tissue or the graft in a similar manner as the hollow needle with the shuttle/suture combination.  
         [0037]     As shown in  FIG. 5D , jaws  41   a,    41   b  are then opened (separated). Due to slit  44  of first jaw  41   a,  the portions of shuttle  350  and suture  360  contained therein are released from the center hole  43   a  of first jaw  41   a  and any mechanical influence therefrom. However, on the opposite side of tissue  200 , shuttle  350  remains contained (constrained) within the closed perimeter center hole of second jaw  41   b  ( FIG. 5C ).  
         [0038]     As instrument  100  is moved in direction G ( FIG. 5D ), away from tissue  200 , typically as instrument  100  is being removed from the patient&#39;s body, shuttle  350  is pulled by the closed perimeter wall  42   b  of the center hole  43   b  of second jaw  41   b.  Furthermore, as soon as first and second jaws  41   a,    41   b  clear the edge of tissue  200 , jaws  41   a,    41   b  can be closed again to grip shuttle  350  to provide additional pulling friction to shuttle  350  and suture  360  ( FIG. 5E ).  
         [0039]     After the leading end of shuttle  350  has been removed from the body/surgical area, suture (not shown) is then threaded in the suture grasping area  351  in a conventional manner and then pulled into the surgical area, also in a conventional manner.  
         [0040]     While the invention has been described in the form of a preferred embodiment and method, deviations from the described structure and method are possible while staying within the scope of the invention and the claims.