Abstract:
A system for suture passage through a tissue according to embodiments of the present invention includes a suture snare, the suture snare comprising a resilient anchor element and a suture capture element, a substantially rigid passer tube, an actuator rod, a snare enclosure formed by the passer tube and actuator rod, the actuator rod movable to move the snare enclosure between a closed configuration which completely captures a portion of the suture snare and an open configuration which does not completely capture the portion of the suture snare, and a piercing tip configured to form a hole through the tissue, wherein at least one dimension of the resilient anchor element in an undeformed state is larger than a largest dimension of the hole, and the anchor element deforms during insertion of the resilient anchor element through the hole and substantially resumes its prior shape after passing through the hole.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/353,650, filed on Jun. 10, 2010, and claims foreign priority to French Patent Application No. FR1055393, filed Jul. 2, 2010, both of which are incorporated herein by reference in their entireties for all purposes. 
     
    
     TECHNICAL FIELD 
       [0002]    Embodiments of the present invention relate generally to suture passing, and more specifically to systems and methods for releasably grasping and passing through tissue a suture snare having a resilient anchor element. 
       BACKGROUND 
       [0003]    Suture passing in the gleno-humeral space during instability repair is often difficult due to the limited accessibility of the space, the location of implants and sutures around the glenoid rim, and the common requirement of both re-attaching the labrum and plication of the tendon capture. Current techniques use two instruments to pass and retrieve sutures, which requires a second portal to the gleno-humeral space. Similar challenges are experienced in other types of surgeries, particularly arthroscopic surgeries. 
       SUMMARY 
       [0004]    Embodiments of the present invention permit an ability to continually sew or stitch bites of tissue together by passing a suture snare through the tissue, then picking it up on the other side of the tissue with the same device. This allows for single portal, single handed suture passage in a repeatable pattern, completing each suture path in one evolution, according to embodiments of the present invention. Embodiments of the present invention permit reattachment of a suture snare in vivo after deploying the suture snare through tissue and optionally making multiple suture passes before (or after) attaching the suture to the snare, and pulling both snare and suture through tissue. 
         [0005]    Embodiments of the present invention permit snare attachment to a suture passer which can be deployed and removably attached to the tissue, then reattached in vivo, permit an ability to make several tissue passes in the same evolution, and/or permit single-portal suture passing and retrieval, with a one-handed device. 
         [0006]    A system for suture passage through a tissue according to one embodiment of the present invention includes a suture snare, the suture snare including a resilient anchor element and a suture capture element, a passer tube, wherein the passer tube is substantially rigid, an actuator rod, a snare enclosure formed by the passer tube and the actuator rod, wherein the actuator rod is movable to move the snare enclosure between a closed configuration in which the snare enclosure completely captures a portion of the suture snare and an open configuration in which the snare enclosure does not completely capture the portion of the suture snare and permits release of the suture snare from the snare enclosure, and a piercing tip configured to form a hole through the tissue, wherein at least one dimension of the resilient anchor element in an undeformed state of the resilient anchor element is larger than a largest dimension of the hole, and wherein the resilient anchor element is configured to deform during insertion of the resilient anchor element through the hole by the snare enclosure and to substantially resume the undeformed state after passing through the hole. 
         [0007]    A method for suture passage through a tissue according to an embodiment of the present invention includes capturing at least a portion of a suture snare with a snare enclosure, the snare enclosure formed by a passer tube and an actuator rod, wherein the actuator rod is movable to move the snare enclosure between a closed configuration in which the snare enclosure completely captures the portion of the suture snare and an open configuration in which the snare enclosure does not completely capture the portion of the suture snare and permits release of the suture snare from the snare enclosure, piercing the tissue from a first tissue side to a second tissue side to form a hole, wherein the suture snare comprises a resilient anchor element and a suture capture element, and wherein at least one dimension of the resilient anchor element in an undeformed state of the resilient anchor element is larger than a largest dimension of the hole, passing the resilient anchor element through the hole from the first tissue side to the second tissue side by passing the snare enclosure through the hole and by deforming the resilient anchor element, releasing the portion of the suture snare from the snare enclosure by moving the actuator rod to place the snare enclosure into the open configuration, moving the actuator rod to place the snare enclosure into the closed configuration, and passing the snare enclosure back through the hole from the second tissue side to the first tissue side as the undeformed state of the resilient anchor element holds the resilient anchor element on the second tissue side. 
         [0008]    While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  illustrates a perspective view of a suture passer device, according to embodiments of the present invention. 
           [0010]      FIG. 2  illustrates an exploded perspective view of the suture passer device of  FIG. 1 , according to embodiments of the present invention. 
           [0011]      FIG. 3  illustrates a partial longitudinal cross section view of the suture passer device handle of  FIGS. 1 and 2 , according to embodiments of the present invention. 
           [0012]      FIG. 4  illustrates a perspective view of a piercing tip, according to embodiments of the present invention. 
           [0013]      FIG. 5  illustrates a front view of the piercing tip of  FIG. 4 , according to embodiments of the present invention. 
           [0014]      FIG. 6  illustrates a side view of the piercing tip of  FIGS. 4 and 5 , according to embodiments of the present invention. 
           [0015]      FIG. 7  illustrates a top view of the piercing tip of  FIGS. 4-6 , according to embodiments of the present invention. 
           [0016]      FIG. 8  illustrates a bottom view of the piercing tip of  FIGS. 4-7 , according to embodiments of the present invention. 
           [0017]      FIG. 9  illustrates a cross sectional view of the piercing tip of  FIGS. 4-8 , taken along line C-C of  FIG. 6 , according to embodiments of the present invention. 
           [0018]      FIG. 10  illustrates a suture snare, according to embodiments of the present invention. 
           [0019]      FIG. 11  illustrates a resilient anchor element of a suture snare captured by a snare enclosure formed by a piercing tip and a passer tube, with the snare enclosure in a closed configuration, according to embodiments of the present invention. 
           [0020]      FIG. 12  illustrates a resilient anchor element released from the snare enclosure with the snare enclosure in an open configuration, according to embodiments of the present invention. 
           [0021]      FIG. 13  illustrates a snare enclosure retracted back into the closed position after release of the resilient anchor element, according to embodiments of the present invention. 
           [0022]      FIG. 14  illustrates a resilient anchor element of a suture snare being passed through labrum tissue by a suture passer with the resilient anchor element captured by a snare enclosure of the suture passer, according to embodiments of the present invention. 
           [0023]      FIG. 15  illustrates a suture passer with the snare enclosure in an open configuration for hooking or capturing the resilient anchor element of the suture snare, according to embodiments of the present invention. 
           [0024]      FIG. 16  illustrates an optional passage of the suture passer through capsule tissue and subsequent capture of the resilient anchor element by the snare enclosure of the suture passer, according to embodiments of the present invention. 
           [0025]      FIG. 17  illustrates the suture snare being pulled through the labrum and the capsule, pulling the suture along therewith, according to embodiments of the present invention. 
           [0026]      FIG. 18  illustrates an alternative suture passer and snare enclosure configuration, according to embodiments of the present invention. 
           [0027]      FIG. 19  illustrates a piercing tip and a passer tube forming a snare enclosure in a closed configuration, according to embodiments of the present invention. 
           [0028]      FIG. 20  illustrates the piercing tip and the passer tube of  FIG. 19  forming a snare enclosure in an open configuration, according to embodiments of the present invention. 
           [0029]      FIG. 21  illustrates a piercing tip and passer tube forming an alternative snare enclosure in a closed configuration, according to embodiments of the present invention. 
           [0030]      FIG. 22  illustrates the piercing tip and passer tube of  FIG. 21  forming the alternative snare enclosure in an open configuration, according to embodiments of the present invention. 
       
    
    
       [0031]    While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. 
       DETAILED DESCRIPTION 
       [0032]      FIG. 1  illustrates a perspective view of a suture passer device  100 , according to embodiments of the present invention. Suture passer  100  includes a passer tube  102  and a handle portion  104 , according to embodiments of the present invention. The handle portion  104  includes an actuator button  110 , and the passer tube  102  includes a curved portion  106 . Suture passer  100  also includes a piercing tip  108 , according to embodiments of the present invention. 
         [0033]      FIG. 2  illustrates an exploded perspective view of the suture passer device  100  of  FIG. 1 , according to embodiments of the present invention.  FIG. 3  illustrates a partial longitudinal cross section view of the suture passer device handle  104  of  FIGS. 1 and 2 , according to embodiments of the present invention. Button  110 , which may also be referred to as a switch, is coupled to slider  206  by screw  208 , according to embodiments of the present invention. As used herein, the term “coupled” is used in its broadest sense to refer to elements which are connected, attached, and/or engaged, either directly or integrally or indirectly via other elements, and either permanently, temporarily, or removably. 
         [0034]    The slider  206  is coupled to an actuator rod  202  which extends within and slides with respect to the passer tube  102 , according to embodiments of the present invention. The actuator rod  202  may be formed of, for example, 0.025 inch diameter wire-rod. The handle  104  may further include a biasing element, such as, for example, a tension spring  210 . Tension spring  210  may be coupled with a slider attachment mechanism  214  on one end and to an end stop  212  on the other end, according to embodiments of the present invention. Spring  210  thus biases the slider  206  in a direction indicated by arrow  209 , according to embodiments of the present invention. According to embodiments of the present invention, the forward and backward motion of slider  206  is limited by the front and back extents of the slot  204 . Although  FIGS. 2 and 3  depict a particular handle and/or actuator rod  202  actuation mechanism, one of ordinary skill in the art, based on the disclosure provided herein, will recognize the numerous other handle configurations and actuator rod  202  actuation mechanisms that may be used to move the actuator rod  202  with respect to the passer tube  102 . 
         [0035]      FIGS. 4 through 9  illustrate a piercing tip  108  according to embodiments of the present invention. Piercing tip  108  includes a tip  402  which may be very sharp to easily penetrate tissue and/or form a hole through tissue, according to embodiments of the present invention. Piercing tip  108  may also include one or more hook elements  403  formed by downwardly-hanging flanges  404 . The piercing tip  108  may also include a bore  406  formed at its lower end; the bore  406  may be configured for coupling with the distal end of the actuator rod  202 , according to embodiments of the present invention. The actuator rod  202  may be rigidly and/or permanently coupled to the piercing tip  108 , such that moving the actuator rod  202  imparts a corresponding movement to the piercing tip  108 , according to embodiments of the present invention. 
         [0036]      FIG. 10  illustrates a suture snare  150 , according to embodiments of the present invention. Suture snare includes a resilient anchor element  152  and a suture capture element  154 , according to embodiments of the present invention. The resilient anchor element  152  and/or the suture capture element  154  may be formed from one or more wires  156 , for example one or more  0 . 010  inch diameter nitinol shape set wires, according to embodiments of the present invention. For example, the suture snare  150  may be comprised of a shape memory wire folded once, which is formed at one end as a resilient anchor element  152 , and which includes one or more sheath or coating elements  158  between the resilient anchor element  152  and the suture capture element  154  and/or between the suture capture element  154  and the opposite end of the suture snare  150 , according to embodiments of the present invention. 
         [0037]    The resilient anchor element  152  may include shape memory or shape set properties, such that it can be deformed (for example bent, twisted, compressed) while returning to its undeformed state after deformation, according to embodiments of the present invention. The resilient anchor element  152  may be configured to have a square, rectangle, or diamond shape, for example the shape illustrated in  FIG. 10 , in its undeformed, or normal, state. The resilient anchor element  152  may include one or more angular bends (as opposed to curves or continuous curvature), for example, one, two, three, four, or more angular bends, to further emphasize the anchor element&#39;s  152  return to its original shape after deformation, and to provide enhanced anchoring capabilities, according to embodiments of the present invention. The resilient anchor element  152  may be configured to have other shapes; for example, the resilient anchor element  152  may be round, and/or may be formed in the shape of a circle or oval or semi-circle, according to embodiments of the present invention. 
         [0038]    According to embodiments of the present invention, the resilient anchor element  152  is substantially two-dimensional, in other words, is substantially coplanar. For example, the square-shape of the resilient anchor element  152  shown in  FIG. 10  may extend in substantially the same plane. According to other embodiments of the present invention, the resilient anchor element  152  comprises a three-dimensional shape. For example, the square-shaped resilient anchor element  152  shown in  FIG. 10  may include a bend or wave or J-shape or other three-dimensional feature apparent from a different view. The resilient anchor element  152  may take numerous other three-dimensional shapes, such as, for example, a box, a rectangular frame, a sphere, a ball, a double helix, a pyramid, and/or a horseshoe. One of ordinary skill in the art, based on the present disclosure, will recognize numerous other three-dimensional shapes that may be imparted to resilient anchor element  152 . 
         [0039]      FIGS. 11 through 13  illustrate a suture snare  150  attachment and release process, according to embodiments of the present invention.  FIG. 11  illustrates a resilient anchor element  152  of a suture snare captured by a snare enclosure formed by a piercing tip  108  and a curved portion  106  of a passer tube  102 , with the snare enclosure in a closed configuration, according to embodiments of the present invention.  FIG. 12  illustrates the resilient anchor element  152  released from the snare enclosure with the snare enclosure in an open configuration, according to embodiments of the present invention.  FIG. 13  illustrates a snare enclosure retracted back into the closed position after release of the resilient anchor element  152 , according to embodiments of the present invention. 
         [0040]    The snare enclosure illustrated in  FIGS. 11 through 13  is formed by and/or bounded by the inner portion  412  of hook element  403  and also by the distal end  162  of passer tube  102 , according to embodiments of the present invention. In a closed configuration, the bottom end  408  of flange  404  abuts or is in contact with the passer tube  102  as illustrated in  FIG. 19  and/or the outer surface  410  of piercing tip  108  abuts or is in contact with the passer tube  102 , as illustrated in  FIG. 21 , according to embodiments of the present invention. As such, the closed configuration captures the suture snare  150 , for example the resilient anchor element  152  of suture snare  150 , between the hook element  403  and the distal end  162  of passer tube  102 , thereby preventing the release or the pulling away of the suture snare  150  from within such a snare enclosure  1900 ,  2100  when the snare enclosure is in a closed configuration. 
         [0041]    In an open configuration of the snare enclosure, the hook elements  403  are separated from distal end  162  by a distance which permits the suture snare  150  and/or resilient anchor element  152  to be passed into and out of the snare enclosure. Such an open configuration is illustrated in  FIG. 12 , and permits either release of a suture snare  150  that was held within the snare enclosure or capture or hooking of the suture snare  150  with the one or more hook elements  403 , according to embodiments of the present invention. 
         [0042]    Because the piercing tip  108  is coupled to the actuator rod  202 , sliding the actuator rod  202  with respect to the passer tube  102  moves the piercing tip  108  so as to change the snare enclosure between the open and closed configurations, according to embodiments of the present invention. For example, sliding the button  110  of  FIG. 3  in a direction opposite arrow  209  slides the piercing tip  108  from the position of  FIG. 11  in which the piercing tip  108  abuts the passer tube  102  (e.g. abuts the distal end  162  thereof) to the position of  FIG. 12  in which the piercing tip  108  is separated and pushed outwardly from passer tube  102  (e.g. no longer abuts the distal end  162  thereof), according to embodiments of the present invention. As such, such a sliding motion moves the snare enclosure from the closed to the open configuration. Sliding the button  110  of  FIG. 3  in the direction of arrow  209  slides the piercing tip  108  in the opposite direction toward the distal end  162 , thereby moving the snare enclosure from the open to the closed configuration. According to embodiments of the present invention, the button  110  may simply be released when the snare enclosure is in the open configuration and the spring element  210  will pull the actuator rod  202  and thus the piercing tip  108  back to the position in which the snare enclosure is in the closed configuration. The closed configuration of the snare enclosure, without the snare  150  or resilient anchor member  152  captured thereby, is illustrated in  FIG. 13 . 
         [0043]      FIGS. 14-17  illustrates a suture passer  100  used to pass a suture snare through tissue, according to embodiments of the present invention.  FIGS. 14-17  illustrate a procedure in which suture is passed through a labrum tissue  252  which is attached to a glenoid  250  in order to attach it to a capsule tissue  256  element, according to embodiments of the present invention. A cannula  254  may be used to provide a pathway for the suture passer  100  to access the capsule  256 , according to embodiments of the present invention. Although a particular procedure is shown and described, one of ordinary skill in the art, based on the disclosure provided herein, will appreciate a number of other similar and/or non-similar procedures in which device  100  may be used. 
         [0044]      FIG. 14  illustrates a resilient anchor element  152  of a suture snare being passed through labrum tissue  252  by a suture passer with the resilient anchor element  152  captured by a snare enclosure of the suture passer, according to embodiments of the present invention. At least a portion of the suture snare  150  is captured by the snare enclosure; for example, a portion of the resilient anchor element  152  is captured by the snare enclosure. The tissue may be pierced with piercing tip  108  from a first tissue side  258  to a second tissue side  260  to form a hole, according to embodiments of the present invention. The resilient anchor element  152  may then be passed through the hole from the first side  258  to the second side  260  by passing the snare enclosure through the hole and by deforming the resilient anchor element  152 , according to embodiments of the present invention. 
         [0045]    Once the resilient anchor element  152  has been passed through the hole from the first side  258  to the second side  260 , the resilient anchor element  152  resumes its undeformed or normal shape or state, according to embodiments of the present invention. The snare enclosure may be placed into an open configuration to release the suture snare  150  and/or the resilient anchor element  152 , according to embodiments of the present invention. According to embodiments of the present invention, the resilient anchor element  152  is released from the snare enclosure upon opening of the snare enclosure; according to other embodiments of the present invention, the snare enclosure and/or piercing tip  108  is moved away from the resilient anchor element, or turned, in order to cause release of the resilient anchor element  152  from the snare enclosure. 
         [0046]    Once the snare enclosure has been moved to the open configuration and the suture snare  150  released, the snare enclosure may be moved back into the closed configuration, and the piercing tip  108  and snare enclosure withdrawn back through the hole in the tissue  252  from the second side  260  to the first side  258 , according to embodiments of the present invention. Without the resilient anchor element  152 , the piercing tip  108  and/or passer tube  102  might tend to pull the suture snare  150  back through the hole along with the rest of the device  100 . However, the resilient anchor element  152  may have at least one dimension in an undeformed state that is larger than a largest dimension of the hole, according to embodiments of the present invention. Thus, the undeformed state of the resilient anchor element  152  holds the resilient anchor element  152  on side  260  as the rest of the piercing tip  108  and passer tube  102  are withdrawn, according to embodiments of the present invention. 
         [0047]    As illustrated in  FIG. 15 , once the resilient anchor element  152  has been passed through tissue  252 , and before the suture passer  100  is removed through the cannula  254 , the snare enclosure formed by the piercing tip  108  and the passer tube  102  may be used to pick up or capture the resilient anchor element  152  to pull it back up through cannula  254 , according to embodiments of the present invention. According to embodiments of the present invention, the hook elements  403  are used to hook the resilient anchor element  152  when the snare enclosure is in the open configuration. 
         [0048]    In addition, in a similar manner, multiple passes of the resilient anchor element  152  may be achieved through tissue  252  at different hole locations using the suture passer device  100 , from surface  258  to  260  and/or from surface  260  to  258 , without withdrawing the device  100  or the piercing tip  108  from within the capsule  256 , according to embodiments of the present invention. After the final suture pass, the resilient anchor element  152  may be picked up by the device  100  as illustrated in  FIG. 15 , and withdrawn through the cannula  254 , for example to tie a knot or connect the suture to other tissue, according to embodiments of the present invention. 
         [0049]    In addition to one or more passes through the same tissue, the suture passer device  100  may also be used to pass the suture snare  150  one or more passes through a different tissue or a different tissue location.  FIG. 16  illustrates an optional passage of the suture passer through capsule tissue  180  and subsequent capture of the resilient anchor element  152  by the snare enclosure of the suture passer  100 , according to embodiments of the present invention. The snare enclosure may be placed into the closed configuration, and the piercing tip  108  may be inserted through tissue element  180  from a first side  182  to a second side  184 , according to embodiments of the present invention. The snare enclosure may then be placed into the open configuration and used to snag or pick up or hook the resilient anchor element  152 , for example the resilient anchor element  152  that has already been passed through labrum tissue  252 , as illustrated in  FIG. 16 , according to embodiments of the present invention. 
         [0050]    Once the resilient anchor element  152  has been hooked or snagged or otherwise placed within the snare enclosure, the actuator rod  202  may be moved to place the snare enclosure into the closed position, and the snare enclosure (and resilient anchor member  152 ) may then be pulled through tissue  180  from second side  184  to first side  182 , as illustrated in  FIG. 17 , according to embodiments of the present invention. The suture  270  may be inserted through the suture capture element  154 , either before or after the suture snare  150  is passed through the tissue  252  and/or  182 , according to embodiments of the present invention. The suture snare  150  may then be pulled by the snare enclosure of the piercing tip  108  and passer tube  102  out through the cannula  254 , thereby causing the suture capture element  154  to pull the suture  270  through the same path, as illustrated in  FIG. 17 , according to embodiments of the present invention. 
         [0051]    Any, or any subset, of these steps may be performed with the same device  100  in the same evolution (for example without withdrawing the device  100  from the gleno-humeral space), according to embodiments of the present invention. The device  100  may permit full operation entirely with a single hand, according to embodiments of the present invention. 
         [0052]      FIG. 18  illustrates an alternative suture passer  190  and snare enclosure configuration, according to embodiments of the present invention. Suture passer  190  includes a side opening in a sharpened cannulated tube, in which a sliding gate traps the snare in the side opening, according to embodiments of the present invention. The suture passer  190  includes a passer tube  102  having a curved portion  106 ; the piercing tip  192  is formed on a distal end  198  of the passer tube  102 , according to embodiments of the present invention. The passer tube  102  includes a sidewall opening  194  located on the passer tube  102  proximally of the distal end  198 . The sidewall opening  194  may be located on the curved portion  106 . The actuator rod comprises a sliding gate  196 , and the snare enclosure is formed by the sidewall opening  194  and the sliding gate  196 , according to embodiments of the present invention. 
         [0053]      FIG. 19  illustrates a piercing tip  108  and a passer tube  102  forming a snare enclosure  1900  in a closed configuration, according to embodiments of the present invention.  FIG. 20  illustrates the piercing tip  108  and the passer tube  102  of  FIG. 19  forming a snare enclosure  1900  in an open configuration, according to embodiments of the present invention.  FIG. 21  illustrates a piercing tip  108  and passer tube  102  forming an alternative snare enclosure  2100  in a closed configuration, according to embodiments of the present invention.  FIG. 22  illustrates the piercing tip  108  and passer tube  102  of  FIG. 21  forming the alternative snare enclosure  2100  in an open configuration, according to embodiments of the present invention. 
         [0054]    According to embodiments of the present invention, the curved portion  106  of the passer tube  102  is curved left, curved right, or extends straight head with respect to the elongated and substantially straight passer tube  102  (for example for use with a hip labrum), according to embodiments of the present invention. According to some embodiments of the present invention, a suture snare  150  is not used, and instead the suture  270  tips are configured to attach directly to the piercing tip  108 . 
         [0055]    Although square, rectangular, and diamond shaped resilient anchor element  152  shapes are described, other shapes may be used; for example, the resilient anchor element  152  may be formed in a different geometric two-dimensional shape, and/or formed into a three-dimensional feature such as, for example, a ferrule, or ball crimped on the end of the suture snare  150 , according to embodiments of the present invention. 
         [0056]    Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.