Abstract:
A suture anchor is provided which includes a hollow member having an outer surface defining an enclosure therein, the member having a longitudinal axis and a slot through a portion of the outer surface in a direction transverse to the longitudinal axis, the slot providing an opening into the enclosure. The suture anchor further includes a one-way valve positioned within the enclosure at the slot to allow entry of a suture through the slot into the enclosure and to prevent the exit of the suture from the enclosure. A device is provided for deploying the suture anchor. The deployment device includes an elongate hollow member having a suture anchor release zone positioned at the distal end thereof, a launch bar having at least a portion thereof positioned in the release zone, wherein the launch bar is movable within the release zone between a resting position and a launching position and is operatively connected to an actuation member positioned proximally to the elongate member. The hollow elongate member defines a housing for receiving a plurality of suture anchors in tandem along the longitudinal axis of the hollow member, wherein each of the suture anchors is configured for release from the release zone when such suture anchor is positioned within the release zone upon movement of the launch bar from the resting position to the launching position.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to surgical suture anchors and a tool for deploying them, and more particularly to suture anchors that can be deployed to anchor sutures already in place in tissue. 
       BACKGROUND 
       [0002]    Sutures are used to approximate, or bring together, tissue separated, for example, by some trauma, or wound or during a surgical procedure to close an incision or an organ perforation. Suturing instruments generally include a needle and a trailing length of suture material. In endoscopic procedures, the instruments placed through an instrument channel may include needles and sutures for stitching such a wound, incision or perforation within the patient&#39;s body cavity. An exemplary suturing device is shown in U.S. Pat. No. 7,131,978. 
         [0003]    In some cases, the leading, or distal end, of the suture material is attached during manufacture to a small anchor, sometimes referred to as a T-tag, to stabilize the tissue and the suture as the surgeon pulls the suture material through tissue. Anchors are commonly utilized to retain sutures in a patient&#39;s body. The anchors may be formed of metal, such as stainless steel or titanium, or of a biodegradable material. Several known anchors rely upon mechanical interlocks between the body tissue and the anchor to retain the anchor in place against the influence of forces transmitted through the suture to the anchor. It has previously been suggested to construct anchors in the manner disclosed in U.S. Pat. Nos. 5,405,359; 5,403,348; 5,203,787; 5,046,513; and 5,041,129. 
         [0004]    In many cases, however, the suture does not include an anchor and the ends of the suture are tied using conventional suturing and knotting techniques. Only after the wound or incision is sutured, does the practitioner, such as a surgeon, physician, or clinician, determine that a suture anchor is needed. It is not believed that securing sutures with an anchor, after the suture is already in place, has heretofore been done. It is the current thought that the wound or incision would have to be sutured a second time with an anchor/suture combination. 
         [0005]    Physicians have often used endoscopes to examine, to biopsy, and to ablate the tissue of patients within lumens such as the esophageous and the bowel or other body cavity and internal patient sites. An endoscope generally includes either a rigid or flexible tube containing one or more optical fiber systems and, for operative uses (human or veterinary), one or more channels for passage of medical instruments. The optical system includes a light delivery system to illuminate the organ or site under inspection and a camera system to transmit the image of the site of interest to the viewer. The light source is normally outside the body and the light is typically directed via optical fiber bundles to the area of interest. A physician performing a therapeutic procedure with the use of an endoscope places a long, flexible instrument through the endoscope&#39;s instrument channel and then positions the instrument near the site within the body cavity, lumen or other internal site of interest where a therapeutic procedure is to be performed. 
       SUMMARY OF THE INVENTION 
       [0006]    A suture anchor for securing a section of a suture already in place in a patient&#39;s tissue is provided. The suture anchor includes a hollow member having an outer surface defining an enclosure, the hollow member having a longitudinal axis and a slot through a portion of the outer surface in a direction transverse to the longitudinal axis, the slot providing an opening into the enclosure. The suture anchor further includes a one-way valve positioned within the enclosure at the slot to allow entry of a suture through the opening into the enclosure and to prevent the exit of the suture from the enclosure. In one embodiment, the one-way valve is a leaf spring biased toward contact with a surface of the enclosure and positioned such that it spans at least a portion of the opening in a direction parallel to the longitudinal axis of the hollow member. 
         [0007]    The slot may be configured such that it forms a straight cut through the hollow member at an angle relative to the longitudinal axis of the hollow member. The cut is preferably configured such that it defines an apex and a pair of end sections. When the hollow member is a cylinder, the cut will appear as an ellipse. However, the hollow member may form a number of different shapes and is not limited to a cylinder. 
         [0008]    In another embodiment, the one-way valve may be a resilient wire having a first end attached to a first surface of the enclosure and a second free end biased toward contact with a second surface of the enclosure, wherein the second surface of the enclosure faces and is spaced from the first surface of the enclosure. The second free end in this embodiment is positioned such that it spans the cut of the slot at the apex thereof in a direction parallel to the longitudinal axis of the hollow member. 
         [0009]    A device is provided for deploying the suture anchor. The deployment device includes an elongate hollow member having a longitudinal axis, a distal end and a proximal end, a tip of reduced diameter relative to the elongate member at the distal end of the elongate member, a suture anchor release zone in the elongate member positioned adjacent to and proximal to the tip, a launch bar having at least a portion thereof positioned in the release zone, wherein the launch bar is movable within the release zone between a resting position and a launching position and is operatively connected to an actuation member positioned at the proximal end of the elongate member. The hollow elongate member defines a housing for receiving a plurality of suture anchors in tandem along the longitudinal axis of the hollow member, wherein each of the suture anchors is configured for release from the release zone when positioned within the release zone upon movement of the launch bar from the resting position to the launching position. 
         [0010]    The release zone is shown in one embodiment herein as configured for holding a single suture anchor therein until the launch bar is moved to the launching position. 
         [0011]    In the embodiment shown herein suitable for use with an endoscope, the elongate member is a cylinder dimensioned in cross-section to allow the elongate member to pass through a channel leading to an internal site in a patient. The tip is preferably conical in shape. The release zone is shown in one embodiment to define an opening in the elongate member. 
         [0012]    A method for deploying one or more suture anchors is also provided. Further, a method for sterilizing and packaging the deployment device is also provided. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The novel features of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to organization and methods of operation, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in conjunction with the accompanying drawings in which: 
           [0014]      FIG. 1  is a perspective view of a surgical suture anchor and a section of a suture. 
           [0015]      FIG. 2  is a section view through the line  2 - 2  of  FIG. 1 , showing the suture at the entry of the slot but still outside of the suture anchor. 
           [0016]      FIG. 3  is a section view through the line  2 - 2  of  FIG. 1  showing the suture entering the slot in the suture anchor. 
           [0017]      FIG. 4  is a section view through the line  2 - 2  of  FIG. 1  showing the suture captured in the suture anchor. 
           [0018]      FIG. 5  is a perspective view of a suture anchor being deployed to a section of suture. 
           [0019]      FIG. 6  is a view of a suture anchor in the deployment device showing the suture captured in the anchor, as in  FIG. 4 . 
           [0020]      FIG. 7  is a view of the suture anchor being ejected from the deployment device. 
           [0021]      FIG. 8  is an alternative view of the ejection of the suture anchor of  FIG. 7 . 
           [0022]      FIG. 9  is a view of the deployment device being withdrawn from the suture and deployed anchor. 
           [0023]      FIG. 10  is a view of the deployment device of  FIG. 9  being drawn back into the endoscope. 
           [0024]      FIG. 11  is a view of a suture anchor engaging a section of suture in tissue following the completion of the anchor deployment procedure. 
       
    
    
     DETAILED DESCRIPTION 
       [0025]    Before the present method and embodiments of an instrument are disclosed and described, it is to be understood that this invention is not limited to the particular process steps and materials disclosed herein as such process steps and materials may vary somewhat. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to be limiting since the scope of the present invention will be limited only by the appended claims. 
         [0026]    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs. Although any method, instrument and materials similar or equivalent to those described herein may be used in the practice or testing of the invention, particular embodiments of a method, instrument and materials are now described. 
         [0027]    It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. 
         [0028]    In describing and claiming the present invention, the following terminology will be used in accordance with the definitions set out below. 
         [0029]    As used herein, the term “patient,” used herein, refers to any human or animal on which a suturing procedure may be performed. 
         [0030]    As used herein, the term “biocompatible” includes any material that is compatible with the living tissues and system(s) of a patient by not being substantially toxic or injurious and not causing immunological rejection. “Biocompatibility” includes the tendency of a material to be biocompatible. 
         [0031]    As used herein, the term “bioabsorbable” includes the ability of a material to be dissolved and/or degraded, and absorbed, by the body. 
         [0032]    As used herein, the term “proximal” (or any form thereof), with respect to a component of an instrument, means that portion of the component that is generally nearest the practitioner, physician, or surgeon, or nearest to the end of the instrument handled by the practitioner, physician, or surgeon, when in use; and with respect to a direction of travel of a component of an instrument, means toward the end of the instrument generally nearest the practitioner, physician, or surgeon, or handled by the practitioner, physician, or surgeon, when in use. 
         [0033]    As used herein, the term “distal” (or any form thereof), with respect to a component of an instrument, means that portion of the component that is generally farthest from the practitioner, physician, or surgeon, or farthest from the end of the instrument handled by the practitioner, physician, or surgeon, when in use; and with respect to a direction of travel of a component of an instrument, means away from the end of the instrument generally nearest the practitioner, physician, or surgeon, or handled by the practitioner, physician, or surgeon, when in use. 
         [0034]    As used herein, the term “transverse” (or any form thereof), with respect to an axis, means extending in a line, plane or direction that is across such axis, i.e., not collinear or parallel therewith. “Transverse” as used herein is not to be limited to “perpendicular 
         [0035]    As used herein, the term “longitudinal axis”, with respect to an instrument, means the exact or approximate central axis defined by said instrument along its greater dimension, i.e., along its length, from its distal end to its proximal end, and vice versa, and is not intended to be limited to imply a straight line, wherein, for example, an instrument includes a bend angle as described herein, it is intended that “longitudinal axis” as used herein follows such bend angle. 
         [0036]    As used herein, the term “internal site” of a patient means a lumen, body cavity or other location in a patient&#39;s body including, without limitation, sites accessible through natural orifices or through incisions. 
         [0037]    The present invention has application in conventional endoscopic and open surgical instrumentation, as well as application in robotic-assisted surgery. The embodiments shown illustrate the use of the invention in connection with an endoscope within an internal site of a patient. The invention is useful in a variety of minimally invasive medical procedures, including without limitation medical procedures performed through laparoscopic incisions for access to body cavities and internal organs of the body. The invention also encompasses apparatus and methods employing endoscopic devices in general, including various forms and variations of endoscopes, including without limitation: laparoscopes, gastroscopes, peritoneoscopes, sigmoidoscopes, fiberoptic endoscopes, arthroscopes, amnioscopes, and the like. 
         [0038]    Referring to  FIGS. 1-4 , the embodiment of the suture anchor  10  includes a hollow cylinder  26  which may be open or closed at one or both ends  14 ,  16  and defines an internal chamber or lumen  12 . A slot  20  is cut into the cylinder  26 , in a direction transverse to the longitudinal axis  18  of cylinder  26 , beginning at an apex  22  and ending at bottom ends  24 . To facilitate the smooth entry of a section of suture  44 , the slot  20  is preferably cut at an acute or obtuse angle relative to the axis  18 , rather than cut perpendicular to the axis  18 . In one embodiment, the slot is configured such that it forms a cut through the hollow cylinder  26  at an angle relative to the longitudinal axis  18  of the cylinder  26 . The cut of the slot defines an apex  22  and a pair of end sections  24 . 
         [0039]    A valve  30  is housed in the lumen  12  of anchor  10 . In the embodiment shown, the valve may be a leaf spring, formed from a flexible, but resilient wire or band attached at one end  34  to a bottom surface  36  of lumen  12 . A free end  32  of valve  30  is biased toward the top surface  38  of lumen  12 , forming a one way gate at slot  20  into lumen  12 . The leaf spring wire or band bends over itself as shown in  FIGS. 2-3  to create the spring-like tension in valve  30 . 
         [0040]    In use, the anchor  10  would be advanced toward a section of suture  44  stitched into tissue  100 . The anchor  10  would be advanced distally. The anchor  10  is passed under the suture  44  with the side of cylinder  26  having the apex  22  of slot  20  facing the suture  44 , away from the tissue  100 . The suture  44  slides into the open apex end  22  of slot  20 , as shown in  FIG. 2 . As the anchor  10  is advanced against the suture section  44 , suture  44  presses against the free end  32  of valve  30  as shown in  FIG. 3 , pushing it downward into lumen  12  enough to allow suture  44  to slide down slot  20 , past the free end  32  of valve  30 , to rest at bottom ends  24  of slot  20 . When anchor  10  is advanced to the point where suture  44  is past free end  32 , free end  32  snaps back to its original position against top surface  38  of lumen  12 , closing the “gate” at slot  20  and thereby preventing suture  44  from exiting the slot  20 . Anchor  10  is thus attached to the suture  44  between the suture  44  and the tissue  100  to assist in securing the suture  44  to the tissues  100 , as shown in  FIG. 11 . 
         [0041]    Referring to  FIGS. 5-10 , an embodiment of a suture anchor deployment device  50  is shown. In  FIG. 5 , the deployment device  50  is shown extending from a working channel  62  of an endoscope  60 . The deployment device  50  may be used with any suitable known endoscope having at the distal end thereof, a camera and lights  64  to enable the practitioner to see the internal site of the patient, and one or more working channels  62  through which various instruments are typically inserted to allow the practitioner to perform desired procedures at the internal site. The working channel  62  includes a longitudinal axis (not shown), as defined herein. 
         [0042]    In one embodiment, deployment device  50  includes a hollow cylinder or tube  52  with an open lumen  54  defining a housing in which a plurality of anchors  10  may be positioned in tandem for deployment to anchor in-place sections of suture  44 . Deployment cylinder  52  has a longitudinal axis  58 . The anchors  10  line up such that the longitudinal axes  18  of the anchors  10  are co-linear to, or parallel to, the longitudinal axis  58  of the deployment cylinder  52 . In the orientation shown in  FIGS. 5-10 , end  16  of anchor  10  is positioned distally and end  14  is proximal to the suture  44  to be anchored. Those skilled in the art will recognize that the orientation of the anchors  10  may change such that end  14  is positioned distally and end  16  is proximal to the suture  44  to be anchored. The difference in orientation would require different maneuvering from the practitioner to secure the anchor  10  to suture section  44 . 
         [0043]    At the distal end  70  of cylinder  52  is a cone-shaped tip  56  of reduced diameter relative to the cross-sectional dimension of the elongate member. The tip  56  facilitates passage of the distal end  70  of deployment device  50  under suture section  44 . Just behind tip  56  is an opening  72  in cylinder  52  which functions as a release zone for the suture anchors. The opening  72  is about the same length as the length of an anchor  10 . The length of opening  72  may be less that the length of cylinder  52  so that the proximal end  16  of anchor  10  is in sufficient contact with cylinder  52  to hold the leading anchor  10  in place until the desired section of suture  44  is captured in slot  20 . The overlap between the end  16  of anchor  10  and the cylinder  52  should not, however, interfere with the launch of anchor  10  from the opening  72  at the release zone. 
         [0044]    A launch bar  74 , as shown in a launching configuration in  FIGS. 7-10 , runs along the bottom interior surface  80  of the lumen  54  of cylinder  52 . The launch bar  74  has a resting position as shown in  FIGS. 5 and 6  wherein the launch bar  74  is flat. When the anchor  10  is to be released from deployment device  50 , as may be determined by the practitioner based on the image observed due to the optical system and camera  64  communicated through the endoscope, the practitioner moves launch bar  74  from its resting position to its launching position by causing the launch bar  74  to be pushed forward (by actuation, for example, of a push rod or a control operatively connected to a push rod, not shown, which applies a force in the distal direction against the proximal end of launch bar  74 ), in a distal direction, along cylinder bottom  80 . The force in the distal direction causes launch bar  74  to bend at first and second joints  76 ,  78 . The section of launch bar  74  between joint  76  and the distal end of launch bar  74  pops up, with joint  78  forming the apex of a triangle, and thus assuming the launching position. 
         [0045]    The anchors  10  may be made of stainless steel, titanium, nitonal (a nickel-titanium shape memory alloy) or any biocompatible material or bioabsorbable material. As used herein, “shape memory” refers to the tendency of a material to return to a preformed shape following deformation. 
         [0046]    Deployment device  50  may be made of any suitable biocompatible material. Deployment device  50 , and in particular, cylinder  52  thereof is preferably made of a flexible material to allow deployment device  50  to travel through the length of the working channel  62  of an endoscope  60 , which in many embodiments, will require flexibility to enter a patient&#39;s internal sites, particularly if inserted through a natural orifice. In recent literature, a procedure is advanced in which an endoscope is passed through a natural orifice (mouth, anus, etc.), then through an internal incision in the stomach or colon, for example, to avoid any external incisions or scars. 
         [0047]    Referring to the sequence shown in  FIGS. 5-11 , deployment device  50  is advanced distally through a working channel  62  of endoscope  60 . In the orientation shown, an anchor  10  is positioned in the release zone, at opening  72  of the cylinder  52  of deployment device  50  with slot  20  exposed to the suture  44 . Tip  56  of deployment device  50  is eased under a section of suture  44 . The suture  44  slides up the cone shaped tip  56 , onto the exposed surface of anchor  10 . Deployment device  50  is advanced to position the apex  22  of slot  20  of anchor  10  under suture  44 . 
         [0048]    Referring to  FIG. 6 , the deployment device  50  is pulled back in a proximal direction to slide suture section  44  down slot  20  of anchor  10 , past valve  30  as shown in  FIGS. 3 and 4 . Valve  30  snaps back into the closed position, thereby securely attaching anchor  10  to suture section  44 . 
         [0049]    To release anchor  10 , launch bar  74  is moved from the flat resting position shown in  FIG. 6  to the launching position shown in  FIGS. 7 and 8 . The apex formed by joint  78  of launch bar  74  pushes the distal end  16  of anchor  10  upwardly, out of release zone opening  72 . Deployment device  50  is pulled back in the proximal direction into the endoscope  60 , moving the rim  66  of tip  56  along the bottom of anchor  10  while the apex  78  of launch bar  74  lifts the proximal end  14  of anchor  10  upwardly and out of the opening  72  at the release zone of cylinder  52 . 
         [0050]    When the deployment device  50  is completely withdrawn from beneath suture section  44 , anchor  10  remains to anchor the suture  44  in position, as shown in  FIG. 11 , inhibiting the suture  44  from migrating through tissue  100 . 
         [0051]    As the leading anchor  10  is released or launched from the deployment device  50 , the next anchor  10  in line within cylinder  52  advances distally into the opening  72  at the release zone of cylinder  52 . Manual or automatic means, such as a spring-like member, or a push bar, may be provided to advance the next anchor to the release zone. The practitioner positions deployment device  50  adjacent the next section of suture  44  that the practitioner wants to secure with an anchor  10  and repeats the procedure until suture  44  is adequately anchored. 
         [0052]    The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within tie scope of the present invention. 
         [0053]    Preferably, the various embodiments of the invention described herein will be processed before patient use. First, a new or used instrument, in this case, deployment device  50  and new anchors  10  are obtained and if necessary cleaned. The deployment device  50  and anchors  10  can then be sterilized by any suitable known sterilization technique. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam. In one sterilization technique, the deployment device  50  and anchors  10  are placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and instruments are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instruments and in the container. The sterilized instruments can then be stored in the sterile container. The sealed container keeps the deployment device and anchors sterile until it is opened in the medical facility. 
         [0054]    The deployment device  50  and a plurality of anchors  10  can thus be provided as a sterile kit for use, for example, in a hospital or out patient facility. The kit may also include sutures. Alternatively, a plurality of anchors  10  may be provided in a kit for use with an existing deployment device. 
         [0055]    In summary, numerous benefits are apparent which result from employing the concepts of the invention. The foregoing description of one or more embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described in order to best illustrate the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be limited only by the claims appended hereto.