Abstract:
Apparatus for approximating and closing the walls of a hole or puncture in a physiological shell structure which, in one preferred form, comprises a pair of components that manipulate wire suture. The first component, sometimes referred to herein as a suture introducer, locates the edges of the hole and passes wire suture through them. The second component, sometimes referred to herein as a suture tensioner, gathers the free ends of the wire suture and twists them together, which in turn closes the hole. After the wire suture has been twisted sufficiently to effect closure, the excess wire is trimmed away. The apparatus can deploy more than one wire suture at a time if desired. Using self-locating features and tactile feedback, the apparatus is particularly well adapted to access remote surgical sites.

Description:
REFERENCE TO PENDING PRIOR PATENT APPLICATION  
       [0001]    This patent application claims benefit of pending prior U.S. Provisional Patent Application Serial No. 60/163,923, filed Nov. 5, 1999 by Gregory E. Sancoff et al. for DEVICE FOR APPROXIMATING AND CLOSING THE WALLS OF A HOLE OR PUNCTURE IN A PHYSIOLOGICAL SHELL STRUCTURE, which pending prior patent application is hereby incorporated herein by reference. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    This invention relates to surgical apparatus and methods in general, and more particularly to apparatus and methods for approximating and closing the walls of a hole or puncture in a physiological shell structure.  
         BACKGROUND OF THE INVENTION  
         [0003]    Many surgical procedures require the insertion of instruments or catheters into vessels or organs through a small insertion placed in the wall of the structure (e.g., arteries and veins). Once the procedure is completed, these holes often need to be closed with sutures. Unfortunately, when the hole is difficult to see or physically reach, conventional needles and sutures are not easily utilized since this requires finding the edges of the hole, passing sutures through the edges, and then tying secure knots.  
           [0004]    As a result, one object of the present invention is to provide means for locating and suturing remote tissue edges.  
           [0005]    Another object of the present invention is to provide for the delivery of a device to the surgical site that locates itself to the tissue edges so that the device can deliver needleless sutures (e.g., needleless wire sutures) for tissue closure.  
           [0006]    And another object of the present invention is to provide for needleless suturing of tissue so as to eliminate the need to shuttle a needle in and out of the tissue where there is little room to do so.  
           [0007]    Still another object of the present invention is to provide means for producing a knot (e.g., twists or turns) in the wire suture that does not require the cumbersome manual manipulations of the surgeon.  
           [0008]    Yet another object of the present invention is to provide suturing means whereby both the suture placement and the knot formation are somewhat automated, yet the surgeon still has tactile feedback in these operations so that control is not lost.  
           [0009]    And another object of the present invention is to provide a novel method for approximating tissue.  
         SUMMARY OF THE INVENTION  
         [0010]    These and other objects are addressed by the present invention which, in one preferred form, comprises a pair of components that manipulate wire suture so as to close holes in physiological shell structures. The first component, sometimes hereinafter referred to as a suture introducer, locates the edges of the holes and passes wire suture through them. The second component, sometimes hereinafter referred to as a suture tensioner, gathers the free ends of the wire suture and twists them together, which in turn closes the holes. After the wire suture has been twisted sufficiently to effect closure, the excess wire is trimmed away. The apparatus can deploy more than one wire suture at a time if desired. Using self-locating features and tactile feedback, the apparatus is particularly well adapted to access remote surgical sites. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]    These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:  
         [0012]    [0012]FIGS. 1 and 2 are perspective views of a suture introducer formed in accordance with the present invention;  
         [0013]    [0013]FIG. 3 is a cross-sectional view of the suture introducer shown in FIGS. 1 and 2;  
         [0014]    [0014]FIG. 4 is an enlarged sectional view of the distal end of the suture introducer shown in FIG. 3;  
         [0015]    [0015]FIG. 5 is a sectional view taken along line  5 - 5  of FIG. 4;  
         [0016]    FIGS.  6 - 15  are a series of perspective and sectional views showing the suture introducer of FIG. 1 delivering suture to tissue;  
         [0017]    [0017]FIG. 16 is a perspective view of a suture tensioner formed in accordance with the present invention;  
         [0018]    [0018]FIG. 17 is a sectional view of the suture tensioner&#39;s support tube;  
         [0019]    [0019]FIG. 18 is a partial schematic view of the suture tensioner&#39;s twisting shaft;  
         [0020]    FIGS.  19 - 24  are a series of sectional and perspective views showing the suture tensioner of FIG. 16 gathering, supporting, twisting and cutting the two free ends of a length of suture wire;  
         [0021]    [0021]FIG. 25 is a perspective view showing a catheter extending through a vascular structure (e.g., a femoral artery);  
         [0022]    [0022]FIG. 26 is an exploded perspective view of an over-the-catheter suture introducer which is adapted to ride along the catheter so as to position the suture introducer at the hole in a vascular structure;  
         [0023]    [0023]FIGS. 27 and 28 show front and side views of selected portions of the suture introducer shown in FIG. 26; and  
         [0024]    FIGS.  29 - 33  are a series of schematic views showing the over-the-catheter suture introducer of FIG. 26 delivering suture to a vascular structure. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0025]    The present invention uses two components to place wire sutures. The first component, sometimes hereinafter called the suture introducer, locates the tissue edges which are to be approximated and deploys the suture wire through the edges of the tissue at approximately opposite sides of the opening. The suture introducer is then removed and the second component, sometimes hereinafter called the suture tensioner, is introduced in order to gather the two free ends of the suture wire together and allow the user to twist those ends together until the opposing edges of the tissue are brought in close approximation to each other. The suture tensioner then allows the user to cut off and remove the excess wire.  
         [0026]    Looking now at FIGS.  1 - 13 , there is shown a suture introducer  5  formed in accordance with the present invention. Suture introducer  5  generally comprises three concentric elements: a wire advance plunger  10 , a housing  15 , and a sleeve  20 . As seen in FIG. 3, wire advance plunger  10  is the innermost element and is located on the inside of housing  15  at the housing&#39;s proximal end. Sleeve  20  is located on the outside of housing  15  at the housing&#39;s distal end.  
         [0027]    Housing  15  has an inner channel  25  (see FIGS.  3 - 5 ) that contains the suture wire  30 . Wire advance plunger  10  is located inside the proximal end of wire channel  25 . The proximal end of plunger  10  comprises a round knob  35  against which the user can manually apply pressure so as to initiate wire deployment. The distal end of wire advance plunger  10  is located proximally to the proximal end of suture wire  30 . Advancing plunger  10  causes the plunger to push suture wire  30  distally down channel  25 .  
         [0028]    The cross-sectional shape of channel  25  (see FIG. 5) is generally rectangular with rounded corners so that the channel can snugly hold two strands of suture wire  30  that are arranged alongside each other. The cross-sectional shape of plunger  10  conforms to the cross-sectional shape of channel  25  for a distance at least equal to the stroke length of the plunger. The two strands of suture wire  30  are part of the same piece of wire which has been folded at a midpoint  40  (see FIG. 3). The wire midpoint  40  is located near the distal end of the plunger (see FIG. 3) and the two free ends  45 ,  50  (see FIGS. 3, 4 and  9 ) of the wire are located near the distal end of the housing.  
         [0029]    Wire channel  25  extends to the distal end of the housing  15 , where the channel bifurcates into two, separate, diametrically-opposed channels  55 ,  60  (see FIG. 4) that turn outward at a point on the device that is located just underneath the edges of the hole  65  which is to be sutured (see, for example, FIG. 11).  
         [0030]    A tapered rounded protrusion  70  is formed at the distal end of housing  15  for insertion into the hole  65  which is to be sutured. The edges of hole  65  are located along the housing, in part, by a groove  75  that extends around the perimeter of the housing proximal to protrusion  70 . The elasticity of typical physiological shell structures (e.g., arteries, veins, etc.), and the tight fit of the protrusion  70  into the hole  65 , causes the walls of hole  65  to locate into groove  75  and thereby help position suture introducer  5  relative to the tissue (e.g., tissue  80 ) which is to be sutured. In this respect it should be appreciated that the tissue to be sutured (e.g., tissue  80 ) may be an interior structure such as an artery or vein which may in turn lie below the outside surface of another anatomical structure (e.g., skin  85 ) such as is shown in FIGS. 8 and 9.  
         [0031]    Sleeve  20  slides along the outside of housing  15 . The cross-sectional shapes of the sleeve&#39;s interior and the housing&#39;s exterior are preferably slightly elliptical so as to prevent relative rotation of the sleeve and housing with respect to one another; however, if desired, the cross-sectional shapes of the sleeve&#39;s interior and the housing&#39;s exterior can also be formed round if desired, such as is shown in FIG. 5. The distal end of the device has an internal step  90  (see FIGS. 3 and 4) that limits the forward motion of the sleeve relative to housing  15 . At this limit position, the rounded protrusion  70  of the housing  15  extends beyond the end of sleeve  20 . When protrusion  70  is inserted into the hole  65  which is to be sutured, the walls of tissue  80  not only locate into groove  75 , but also sit against the end of sleeve  20  (see FIG. 8), thereby positioning the edges of the tissue adjacent to the diametrically opposite wire exit points of the bifurcated channels  55  and  60 .  
         [0032]    When wire suture  30  is deployed, the two distal ends  45 ,  50  of the wire move out of these exit points, through tissue  80 , and finally into wire-receiving channels  95 ,  100  located in the distal end of sleeve  20  (see FIGS. 4 and 9). These channels  95 ,  100  are in line with the trajectory of the suture wire  30  as the wire penetrates the tissue  80 . The channels  95 ,  100  not only receive the wire ends  45 ,  50  exiting the tissue but also hold onto those wire ends once the wire ends have entered the receiving channels  95 ,  100 , whereby the wire ends can be pulled away from tissue  80 , as will hereinafter be discussed in further detail.  
         [0033]    Various means may be provided to hold onto the wire ends  45 ,  50  after they have entered the wire-receiving channels  95 ,  100 . By way of example but not limitation, sleeve  20  may have an inner frictional member  105  (see FIG. 4), part of which forms the proximal walls of channels  95 ,  100 . The inner frictional member  105  slides against housing  15  with some amount of resistance. The remainder of sleeve  20  is composed of two arms  110 ,  115  (see FIG. 4) that form the distal walls of channels  95 ,  100  and are connected to the distal end of sleeve  20 . As a result of this construction, when sleeve  20  is retracted proximally with the wire ends  45 ,  50  in wire-receiving channels  95 ,  100 , the friction of the inner frictional member  105  with housing  15  causes the channel walls to collapse on the wire ends and hold the wire ends to the sleeve as sleeve  20  is pulled proximally. FIGS. 9 and 11 show cross-sectional views of the wire-receiving channels  95 ,  100  in the open and closed configurations, respectively. Handle  120  (see FIG. 1) at the proximal end of sleeve  20  allows the user to manually pull the sleeve back, which in turn causes the captured suture wire to move with the sleeve. Sleeve  20  is pulled back from the surgical site, bringing the two wire ends  45 ,  50  with it.  
         [0034]    Thus, by positioning the distal end of suture introducer  5  in the hole  65  in tissue  80 , and by pushing down on plunger  10  and then pulling back on sleeve  20 , the middle  40  of suture wire  30  will have been pushed down wire channel  25  and will lie in the wire channel at the base of the protrusion  70  located at the distal end of housing  15 , and the two free ends  45 ,  50  of the suture wire will have been withdrawn proximally by sleeve  20 . Thus, the two free ends  45 ,  50  of suture wire  30  will have been passed through tissue  80  and been moved away from the surgical site, but the middle portion  40  of suture wire  30  will still reside inside the distal end of housing  15 .  
         [0035]    In order to release middle portion  40  of suture wire  30  from housing  15 , protrusion  70  is split into two portions, a first portion  125  (FIG. 13) and a second portion  130 . First portion  125  and second portion  130  are connected together by a living hinge. The interface of the split moves along wire channel  25  so that when the protrusion tip is separated into its two portions, the middle section  40  of suture wire  30  can be pulled from wire channel  25 . The living hinge biases the two portions  125 ,  130  away from one another. Sleeve  20  normally fits over this area of protrusion  70  and holds the two portions  125 ,  130  of the protrusion together. The living hinge is located even with or, preferably, proximal to, the point where the wire ends  45 ,  50  exit protrusion  70  of housing  15 .  
         [0036]    After sleeve  20  has been withdrawn to pull the suture ends  45 ,  50  proximally (see FIGS. 12 and 13), the two protrusion portions  125 ,  130  spring apart, thereby exposing wire channel  25  and freeing the middle section  40  of suture wire  30  from housing  15 , so that suture introducer  5  can be withdrawn from the surgical site (see FIG. 14).  
         [0037]    At this point suture wire  30  will extend through opposing sides of hole  65  (see FIGS. 14 and 15). The two wire ends  45 ,  50  are now ready to be twisted together using the aforementioned suture tensioner so as to close and secure the hole  65  in tissue  80 .  
         [0038]    Looking next at FIGS.  16 - 24 , there is shown a suture tensioner  135  formed in accordance with the present invention. Suture tensioner  135  generally comprises two concentric shafts, an outer support tube  140  and an inner twisting shaft  145 .  
         [0039]    As shown in FIGS. 16 and 17, support tube  140  has a sawtooth pattern  150  along the distal end of the shaft and a handle  155  at the proximal end. The user feeds the two free ends  45 ,  50  of suture wire  30  into the distal end of support tube  140  (i.e., through the troughs of the crown) and then up through the shaft and out the proximal end. Then the distal end of the support tube is passed down to the closure site while the two suture ends  45 ,  50  are pulled firmly proximally by the user (see FIGS. 19 and 20). In the embodiment shown in FIGS. 19 and 20, because the outside diameter of support tube  140  is smaller than the separating distance between the exit points of the suture from tissue  80 , the suture wire will be forced between individual teeth  160 . Teeth  160  will support suture wire  30  and prevent the suture wire from tugging on tissue  80  during wire twisting. Light tactile feedback is all that is required to position support tube  140  onto the two free ends  45 ,  50  of suture wire  30 , enabling this to be easily accomplished down a blind hole.  
         [0040]    Twisting shaft  145  is partially constructed of two halves  165 ,  170  that pivot near a handle  175  located at the proximal end of the shaft (see FIG. 16). When the two halves  165 ,  170  are brought together, they form two channels  180  (one of which is shown in FIG. 21) that run the length of the twisting shaft. The channels  180  are open along approximately diametrically opposite sides of the shaft. The two free ends  45 ,  50  of wire suture  30  are each inserted into a channel  180  and the twisting shaft  145  is fed down along the wires and into the interior of support tube  140 . At the end of support tube  140  there is a narrowing of the internal diameter at  185  (see FIGS. 17 and 21) that arrests any further unforced forward advance of twisting shaft  145  relative to the support tube  140  (see FIG. 21). At this relative position, the distal end of twisting shaft  145  is only a short distance from where the ends of the suture wire  30  emerge from tissue  80  and, as such, require only a limited number of twists in order to bring the opposing edges of the tissue together. Because the channels  180  of twisting shaft  145  maintain the wires a distance from the center of rotation of the shaft, twisting shaft  145  will cause the wires to twist about each other along the length between tissue  80  and the distal end of the twisting shaft. Again, tactile feedback will indicate when the wires have been twisted enough to close the distal loop of wire and hence join the edges of the tissue.  
         [0041]    A spring (not shown) normally limits the closure of the two twisting shaft halves  165 ,  170  so that when the shaft is inserted into support tube  140  and encounters the distal narrowing  185  of the internal diameter of support tube  140 , twisting shaft  145  will slightly resist any further advance of the twisting shaft  145  until the user is ready to cut the wires. The two halves  165 ,  170  of the twisting shaft create a step offset  190  (see FIG. 21) in the channels  180  at the distal end of twisting shaft  145 , causing a slight deviation in the wire path when the halves are closed to the wire twisting position (see FIG. 21). When twisting shaft  145  is thereafter further advanced into the narrowing internal diameter of support tube  140 , the two halves  165 ,  170  of the shaft will be urged together, causing the step offset  190  of the channels to slide past each other and shear the wires just above the twisted section  195  of the wire (see FIG. 22). Then both support tube  140  and twisting shaft  145  are removed, leaving the hole  65  closed and secured by the twisted wire knot  195  (see FIGS. 23 and 24).  
         [0042]    A common situation that requires the closure of a remote anatomical shell structure occurs when a catheter  200  is inserted into the femoral artery  80  through the opening  65  (see FIG. 25). This artery is located relatively far below the surface of the leg so that it can be difficult to suture closed the hole  65  left by the catheter  200  without making a much larger incision into the skin. Furthermore, it is preferable to put the sutures in place before catheter  200  is removed from the artery and then tie the sutures down quickly after the catheter is removed. This has the advantage of reducing blood loss and, by leaving the catheter  200  in place until the sutures are positioned, offers the opportunity of using the catheter to bring the closure device to the edges of the hole  65  in the arterial wall  80 .  
         [0043]    FIGS.  26 - 32  show a modified suture introducer  5 A that comprises a modified housing  15 A that contains suture wire  30  in channels  25 A,  55 A and  60 A that direct it to the tissue as before, but the shape of housing  15 A allows it to slip over catheter  200  and be pushed along its length. The distal tip of housing  15 A has a sharp tapered point  70 A that hugs the surface of the catheter such that when the tip  70 A reaches the hole  65  in the artery  80 , the housing  15 A wedges itself between the catheter and the walls of the hole. When this resistance is felt, the housing  15 A is pushed slightly further before the taper at the front of the housing prevents any further advance. The exit points of the wire channels  55 A,  60 A are now under diametrically opposite edges of the hole  65  in the artery  80 . Wire advance plunger  10 A is pushed forward, deploying wire ends  45 ,  50  through the tissue and into wire receiving channels  95 A,  100 A of the sleeve as before. As the sleeve  20 A is pulled back, it allows the housing components  125 A and  130 A to split (FIG. 32) along a surface that exposes the wire channels, thus allowing the wire to be freed from the device. As both housing  15 A and sleeve  20 A are pulled back, the loop of the wire locates itself in the arterial lumen and as the wire ends  45 ,  50  are pulled, the edges of the hole  65  are drawn closer to each other. At this point suture introducer  5 A is removed from the surgical site and the aforementioned suture tensioner  135  is used as before to twist and cut the wires.  
         [0044]    Wire suture offers the advantage of acting as its own needle and provides the ability to form a knot that can be easily tied and tensioned. These attributes, combined into devices that can locate remote tissue edges, provide an efficient means to close inaccessible surgical openings.  
         [0045]    As used herein, the term “suture wire” is intended to mean any filament-like element consistent with the present invention. By way of example but not limitation, suture wire may comprise a metal (e.g., stainless steel, titanium, Nitinol or other shape memory alloy, etc.), a plastic (e.g., polypropylene, polyimide, etc.), or other materials or combinations of materials.