Patent Document

RELATED APPLICATION(S) 
     The present application claims benefit of U.S. Provisional Application Ser. No. 60/946,012, filed Jun. 25, 2007, the contents of which are incorporated by reference herein in their entirety. 
    
    
     BACKGROUND 
     When soft tissue tears away from bone, reattachment becomes necessary. Various devices, including sutures alone, screws, staples, wedges, and plugs have been used in the past to secure soft tissue to bone. 
     Recently, various types of threaded suture anchors have been developed for this purpose. Some threaded suture anchors are designed to be inserted into a pre-drilled hole. Other suture anchors are self-tapping. 
     In repair of tissue attachments to bone, e.g. in the shoulder, techniques have been developed that vastly increase the repaired tissue to bone area resulting in a repair that more closely replicates the original structure. These repair techniques are commonly referred to as “double row fixation” and includes the typical edge repair location as well as an additional “medial row” of fixation using an additional, medially located (relative to the edge repair) set of suture anchors to secure tissue to bone. 
     Correct placement of the additional tissue anchors medial to the edge repair is often critical to the success of this repair technique. If the medial anchors are placed too medial in relation to the first row (i.e. too far medially inward from the tissue edge) damage can occur to the humeral head. Additionally, the relative placement of anchors is important. If the anchors are placed too close or far apart from each other, the strength of the repair may not add value to the overall reconstruction at the repair site. 
     SUMMARY 
     The inventors have realized that one may facilitate proper placement of suture anchors, e.g. medial row anchors in a “double row” repair. A “paddle style” grasper is structured to allow a desired depth of tissue bite while the width of the paddles are configured in such a way as to allow for fixation points to ideally spaced. With the grasper properly placed on the tissue, “punch through” suture anchors are deployed at the at “anchor targets” on the grasper paddles. A “punch tip” on the anchors pierce the tissue grasped by the grasper and penetrate, e.g., thread into adjacent bone tissue. With the anchors properly placed the grasper is removed, and sutures from the two anchors are attached to one another forming, e.g. a mattress style stitch to secure the tissue to the bone. 
     In one aspect, an instrument is disclosed including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second bottom anchor target slot; and a joint member connected to the proximal ends of the top jaw member and the bottom jaw member. 
     In some embodiments, the top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue. 
     In some embodiments, the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot. 
     In some embodiments, the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot. 
     In some embodiments, the top jaw member and bottom jaw member each include a paddle extending along a longitudinal axis between the proximal end of the jaw member and the distal end of the jaw member, the paddle further extending along a transverse axis, transverse to the longitudinal axis, extending between a first side and a second side of the paddle. 
     In some embodiments, the first top anchor slot includes an aperture formed in the first side of the top jaw member paddle; the second top anchor slot includes an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot includes an aperture formed in the first side of the bottom jaw member paddle; and the second bottom anchor slot includes an aperture formed in the second side of the bottom jaw member paddle. 
     In some embodiments, the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned at points substantially equidistant from the proximal end of the bottom jaw member. 
     In some embodiments, when the jaw members are in the tissue engaging position, the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles, and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles. 
     In some embodiments, the tissue engaging position consists of the open position. Some embodiments include an endoscopic assembly including a grasping instrument the type described above. The assembly further includes a handle; a controller mounted on the handle; and a stem operatively connecting the controller to the instrument to selectively articulate the jaw members. 
     Some embodiments include a surgical cannula surrounding at leas a portion of the stem or the instrument. 
     In another aspect, a surgical kit is disclosed including a first and a second suture anchor. Each anchor includes a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; and a suture portion extending from the second end of the punch tip portion. The kit also includes a grasper including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second bottom anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member. 
     The top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue. 
     When the jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot; and the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot. 
     In some embodiments, the first top anchor slot includes an aperture formed in the first side of the top jaw member paddle; the second top anchor slot includes an aperture formed in the second side of the top jaw member paddle; the first bottom anchor slot includes an aperture formed in the first side of the bottom jaw member paddle; and the second bottom anchor slot includes an aperture formed in the second side of the bottom jaw member paddle. 
     In some embodiments, the first top anchor slot and second top anchor slot are positioned at points substantially equidistant from the proximal end of the top jaw member; and the first bottom anchor slot and second bottom anchor slot are positioned points substantially equidistant from the proximal end of the bottom jaw member. 
     In some embodiments, when the jaw members are in the tissue engaging position, the first top anchor slot is substantially aligned with the first bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles, and the second top anchor slot is substantially aligned with the second bottom anchor slot along an axis substantially orthogonal to the transverse and longitudinal axes of the top and bottom jaw member paddles. 
     In some embodiments the kit includes an anchor driver configured to engage the second end of the punch tip portion of at least one of the first and second anchors and drive the punch tip through tissue grasped by the grasper and into a portion bone located adjacent the bottom jaw member. 
     In some embodiments, the punch tip portion of each of the suture anchors includes a threaded tip, and the anchor driver is adapted to rotate and drive the at least one of the first and second anchors to bore into the portion of bone. 
     In some embodiments, the kit includes a suture welder including: a suture holding element adapted to receive the suture portions of the first and second suture anchors and place the suture portions in proximity to each other, a welding element adapted to apply energy to areas of the suture portions to at least partially fuse the suture portions to each other. 
     In some embodiments, the welding element includes a heater adapted to heat the suture portions. 
     In some embodiments, the welding element includes an ultrasound unit adapted to apply ultrasound energy to the areas of the suture portions to at least partially fuse the suture portions to each other. 
     In some embodiments, the suture welder further includes a tensioner adapted to apply tension to the suture portions. 
     In another aspect a method for securing a portion of tissue to an adjacent portion of bone is disclosed including providing a first and a second suture anchor each including a rigid punch tip portion having a first end adapted to penetrate through tissue and into bone and second end; a suture portion extending from the second end of the punch tip portion. The method includes providing a grasper including: a top jaw member extending between a proximal end and a distal end and including a first top anchor target slot and a second top anchor target slot; a bottom jaw member extending between a proximal end and a distal end and including a first bottom anchor target slot and a second top anchor target slot; a joint member connected to the proximal ends of the top jaw member and the bottom jaw member. The top and bottom jaw members, in an open position, define an area for receiving a portion of tissue, and the joint member articulates the jaw members from the open position to a tissue engaging position where the top and bottom jaw members grasp the portion of tissue. 
     The jaw members are in the tissue engaging position, the first top anchor slot and first bottom anchor slot are adapted to receive a first anchor extending into the first top anchor slot, through the portion of tissue, and out of the first bottom anchor slot. 
     When the jaw members are in the tissue engaging position, the second top anchor slot and second bottom anchor slot are adapted to receive a second anchor extending into the second top anchor slot, through the portion of tissue, and out of the second bottom anchor slot. 
     The method further includes grasping the portion of tissue between the top and bottom jaw elements such that the bottom jaw element is adjacent the bone; positioning first and second anchors proximal the first and second top anchor slots, respectively; driving the punch tip portions of first and second anchors, respectively, through the first and second top anchor slot, through the tissue, through the first and second bottom anchor slots, and into the bone; removing the grasper; and attaching the suture portions of the first and second anchors to each other to secure the tissue to the bone. 
     In some embodiments attaching the suture portions of the first and second anchors to each other includes: placing the suture portions in proximity to each other; applying energy to the suture portions to at least partially fuse the suture portions to each other. 
     In some embodiments, attaching the suture portions of the first and second anchors to each other includes tensioning the suture portions to secure the tissue to the bone. 
     In some embodiments, the energy includes thermal energy. 
     In some embodiments, the energy includes heat energy. 
     In some embodiments, the tissue includes a portion of a rotator cuff. 
     In some embodiments, the bone includes a portion of a humerous bone head. 
     Various embodiments may include any of the features described above, alone or in combination. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing will be apparent from the following more particular description of example embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments of the present invention. 
         FIG. 1  is a perspective view of a paddle grasper. 
         FIG. 2  is a top down view of the paddle grasped. 
         FIGS. 3A-3I  illustrate the use of the paddle grasper to provide fixation of tissue to bone. 
         FIG. 4  is a schematic of an endoscopic system featuring the paddle grasper. 
         FIG. 5  shows an exemplary suture anchor. 
         FIGS. 6A and 6B  show an exemplary suture welder. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG. 1 , grasper  100  includes top jaw member  102  and bottom jaw member  104  connected by joint member  106 . Jaw members  102 ,  104  open to receive a portion of tissue  105 , e.g., a portion of rotator cuff tissue in a shoulder. Joint member  106  allows jaw members  102 ,  104  to engage and grasp the tissue located therebetween (e.g. by articulating jaws  102 ,  104  from an open position to a closed position, or simply by providing mechanical resistance as tissue is received between the jaw members). 
     As shown, the jaw members  102 ,  104  are flat, paddle type jaws. Jaw members  102 ,  104  each include a pair of anchor target slots  108 . As described in further detail below, anchor target slots  108  can be used to easily and reliably provide desired positioning of suture anchors used to secure tissue  105  to bone  110 . 
     Paddle  100  may be constructed of any suitable material, e.g. biocompatible material including metal (e.g. stainless steel), plastic, polymers, and or other materials. 
       FIG. 2  shows a top down view of grasper  100  positioned to grasp tissue  105 . Anchor target slots  108  are formed as aligned pair of, e.g., semicircular apertures in the sides (e.g. in the outer/perimeter edge  101 ) of the upper and lower jaw member paddles (Note that as used herein the term aperture indicates any open region through which a suture anchor may pass, and need not completely surround the anchor). The position of target anchor slots are chosen to correspond to a desired position for a pair of suture anchors  112 . For example, as shown, target anchor slots  108  are placed such they are located a desired distance L from the edge of tissue  105  when the grasper has fully engaged the tissue. Accordingly, anchors  112  inserted at the target anchor locations will be placed at the correct distance medial the edge of tissue  105 . Further anchor targets  108  are positioned distance W apart from each other on either side of jaw members  102 ,  104  Accordingly, anchors  122  inserted at the target anchor locations will be placed at the correct distance relative to each other. Of course, it is to be understood that other configurations may be used to provide any desired anchor placement. 
       FIGS. 3A-3I  illustrate the use of grasper  100  to secure rotator cuff tissue  105  to adjacent humerous head bone  110 . Referring to  FIG. 3A , grasper  100  receives tissue  105  between jaw members  102 ,  104  such that bottom jaw member  104  is adjacent to bone  110 . The grasper is advanced as far as possible in the medial direction, filling the area between jaw members  102 ,  104  with tissue to provide the desired tissue “bite.” A portion of tissue  105  is thereby grasped between jaw members  102 ,  104 .  FIG. 3B  shows a top down view of grasper  100  corresponding to the perspective view shown in  FIG. 3A . 
     Referring to  FIG. 3C , suture anchors  112  are positioned over anchor target slots  108 . Suture anchors  112  each include a rigid (e.g. metal or rigid plastic) punch through portion  114  with a threaded tip  116 . A flexible suture portion  118  extends from the end  119  of punch through portion  114  opposite threaded tip  116 . Suture portions  118  may be made from any suitable suture material, including weldable (e.g. heat- or ultrasound-weldable) material. The ends  119  of punch through portions  114  are engaged by anchor drivers  120  (e.g. manual screw anchor driver, motorized anchor driver, etc.).  FIG. 3D  shows a top down view of grasper  100  corresponding to the perspective view shown in  FIG. 3C . 
     Referring to  FIG. 3E , drivers  120  have been used to drive anchors  112  through tissue  105  and into bone  110 , such that the rigid punch through portions  116  have penetrated (e.g. bored, treaded, augured, etc) into bone  110 . Flexible suture portions  112  extend from the ends  119  of punch through portions  119  out through tissue  105 . In the interest of clarity, anchor drivers  120  are not shown, but remain engaged with ends  119 . In some embodiments, the driving of anchors  112  may be preceded by pre-drilling step when a drill is used to provide a guide hole into the tissue and bone. 
       FIG. 3F  shows a top down view of grasper  100  corresponding to the perspective view shown in  FIG. 3E . Arrows indicate the rotation of anchor  112  by driver  120  to auger through tissue  105  and thread into bone  110 . 
     Referring to  FIG. 3G , grasper  100  has been removed, and anchor drivers  120  withdrawn from the treatment area. Punch through portions  114  of anchors  112  are securely anchored at the desired position (both relative to tissue  105  and each to each other) in bone  110 . Flexible suture portions  118  extend from ends  119  of punch through portions  114 , passing out through tissue  105 . 
     Referring to  FIG. 3H , suture welder  122  engages flexible suture portions  118  extending from tissue  105 . Welder  122  captures suture portions  118  in between welder jaws  124 . Suture portions  118  are tensioned to secure tissue  105  to bone  110  (e.g. with a mattress style stitch or other suitable stitch known in the art). Welder  122  brings areas of flexible suture portions  118  into proximity with each other and applies energy (e.g. heat energy from a heating element, ultrasound energy from a ultrasound transducer, etc.) to fuse the areas together, thereby forming a knotless suture stitch connecting anchors  112  to each other to secure tissue  105  to bone  110 . For example, tensioner  123  may apply tension in opposing directions to suture portions  118  (as indicated by dark arrows). It is to be understood that any other suitable technique for attaching anchors  112  may be used, including, for example, performing a conventional knotted stitch with flexible suture portions  118 . 
     In various embodiments, welder  122  may be any suitable welder, e.g. of the types available from Axya Medical, Inc. of Beverly, Mass., including those described in, U.S. Pat. No. 7,090,111, issued Aug. 16, 2006, U.S. Pat. No. 6,923,824, issued Aug. 2, 2005, U.S. Pat. No. 6,669,705, issued Dec. 30, 2003, U.S. Pat. No. 6,666,877, issued Dec. 23, 2003, U.S. Pat. No. 6,409,743, issued Jun. 25, 2002, U.S. Pat. No. 6,358,271, issued Mar. 19, 2002, U.S. Pat. No. 6,286,746, issued Sep. 11, 2001, U.S. Pat. No. 6,217,591, issued Apr. 17, 2001, U.S. Pat. No. 6,174,324, issued Jan. 16, 2001, U.S. Pat. No. 6,106,545, issued Aug. 22, 2000, U.S. Pat. No. 6,056,751, issued May 2, 2000, U.S. Pat. No. 5,964,765, issued Oct. 12, 1999, and U.S. Pat. No. 5,893,880, issued Apr. 13, 1999 the contents of each of which are incorporated by reference herein in their entirety. 
       FIG. 3I  shows welder  122  retracted from the area after the formation of knotless stitch  126 . Note that by employing grasper  120 , proper placement of anchors  112  was easily accomplished. The above steps may be repeated to deliver additional anchors. 
     Note that while the above examples show a grasper  100  featuring paddle type jaw members  102 ,  014  each having a pair of anchor target slots  108 , any suitable jaw shape featuring and number of anchor target slots may be used. For a given embodiment, placement of the anchor target slots is determined by the desired positioning of the anchors to be implanted. 
     Referring to  FIG. 4 , in some embodiments grasper  100  is incorporated in endoscopic system  400 . Endoscopic system  400  includes handle  402  with a controller  404 . Stem  406  connects controller  404  to grasper  100 , allowing an operator to articulate grasper  100  (e.g. to advance, retract, rotate, etc. grasper  100 , or to articulate jaws  102 ,  104  to engage tissue  105 ). Grasper  100  and stem  406  are contained in a surgical cannula  408  or other tube which can be inserted into the patient through a small incision. In various embodiments, endoscopic system  400  may include any of the various features or devices familiar in the art of endoscopic surgery. 
     As illustrated in  FIG. 5 , in one embodiment, one suture anchor  112  includes an elongated rigid punch through portion  114  which extends along a longitudinal axis between end  119  and threaded tip end  116 . End  119  includes a drive head (e.g. as shown a hexagonal drive head) for engagement with driver  120 . End  116  includes a threaded portion  140  for auguring, boring, etc. through bone and tissue. 
     Anchor  112  includes flexible suture portion  118  extending from end  119 , and secured to punch through portion  114 . Suture portion  118  may be made of a material amenable to bonding through the application of heat or energy thereto such as, for example, nylon (polyamide), polypropylene, Dacron® (polyester), polyglycolic acid (PGA), polyglyconate, and polydioxanone. In some embodiments, rigid punch through portion  114  may also be made of such material. In such cases portion  114  may be bonded to portion  118  by the application by the application of heat or other energy (e.g. ultrasound energy). Other suitable methods of bonding can be used if for example, portion  114  is made of another material, such as stainless steel, titanium, or some other durable, non-degradable, biocompatible material. 
     The suture anchor  112  or parts thereof can be made of a bioresorbable material which will be resorbed after residing in a patient. 
       FIGS. 6A and 6B  show an embodiment of suture welder  122  for creating fused stitch. The suture welder  122  includes a jaw assembly  618  having a first jaw  620  for receiving a first suture segment  622  in recess  640 , and a second jaw  624  for receiving a second suture segment  626  in recess  640  so that the second suture segment is adjacent the first suture segment. The suture welder  122  also includes a heater element  612  positioned between the suture segments  622 ,  626 . The heater element  612  is adapted to melt at least adjacent surfaces of the overlapping first and second suture segments  622 ,  626 . Once melted, the suture segments  622 ,  626  can be pressed together by the jaws  620 ,  624  and allowed to cool to form a fused layer  28  to secure the suture segments  622 ,  626  together. 
     The suture welder  122  beneficially provides a fused stitch  14  an elongated material, such as a surgical suture  616 , wherein the stitch has at least comparable strength to knotted stitches or loops closed by other means. The fused stitch gains its comparable strength from the properties of the fused layer of the stitch, as detailed more fully in U.S. Pat. No. 5,893,880, which is assigned to the assignee of the present disclosure and incorporated herein by reference. 
     In particular, the fused stitch is formed through a welding process in which portions of the suture segments are locally heated through the application of heat thereto until opposing portions melt. The melted portions are then pressed together in an overlapped joint and become fused. The joint includes a fused layer between and joining the first and second suture segments. The fused layer is fused material from the first and second suture segments and preferably is relatively thin and has a relatively large shear area compared to the suture segments. In some embodiments, the suture welder  122  facilitates the creation of such a fused portion by maximizing contact between the suture segments during welding. 
     The fused stitch produced by the suture welder  122  comprises one or more pieces of an elongated material, such as a surgical suture, or other material which is amenable to bonding through the application of heat thereto. Suitable materials for the elongated material include polymers, especially thermoplastic materials such as, for example, nylon (polyamide), polypropylene, DACRON®. (polyester), polyglycolic acid (PGA), polyglyconate, and polydioxanone. The elongated material can be made of a single strand of a substantially monofilamentous material, or it can comprise multiple strands forming a single suture. The multi-strands can be twisted, braided or otherwise interlinked to increase the density, and thus the strength, of the composite strand. 
     As noted above, in some embodiments, welder  122  may produce fused stitch  126  from suture portions  118  by applying other types of energy including ultrasound energy, radio frequency energy, chemical energy, optical energy, etc. 
     The techniques and devices disclosed herein may be used to fixate any suitable tissue to bone, including, but not limited to, muscle tissue, tendons, and ligaments. 
     The techniques and devices disclosed above may be used in treating human patients, veterinary patients, etc. 
     In the event that any technical definitions presented in this application conflict with any documents incorporated by reference, the definition found in the present application should be understood to hold. 
     While particular examples have been provided above, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the claims.

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