Patent Abstract:
An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line. The assembly further includes a mechanism for releasably binding the suture guide to the surface of the holder and a detachable handle extendibly attached to the holder by means of a lanyard so that the handle can be detached to afford an unobstructed view of the surgical site, but cannot be removed from the surgical site until the holder has also been removed.

Full Description:
RELATED APPLICATIONS  
       [0001]    This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 387,909, filed on Jul. 31, 1989 and Ser. No. 444,189 filed on Nov. 30, 1989. The present invention relates to a surgical suture guide used to control the dimension and/or shape of a suture line placed during surgical repair of an organ or body part. In particular, the present invention relates to a combination of a flexible suture guide releasably attached to a rigid holder for controlling the spacing and placement of surgical sutures.  
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    During surgical repair of an organ or other body part, the surgeon typically makes an incision to open the organ. Upon closure of the surgical wound, sutures are placed in the various layers of tissue to draw the two edges of the wound together so that the healing process can reform a smooth and competent surface. However, sutures often tear through the tissue if they are subjected to stress, thus damaging the surgical closure of the wound. It would be desirable in many instances to have a means for lending permanent support to strengthen and support the wall of the organ into which the surgical incision has been placed. Alternatively, in many instances it would be preferred to have a biodegradable suture guide.  
           [0003]    In many cases, the incision is not a straight line, but is shaped to conform to an anatomical requirement, making it difficult for the surgeon to balance the tension on the sutures to form the desired shape. In a number of instances the suture line is substantially curvilinear and it is of utmost importance that the suture line maintain a predetermined dimension. For example, when two blood vessels, or other vessels, such as intestines, are sutured together, the need exists for some means of preventing the suture line from constricting the vessel so as to create a potential point of blockage. Similar problems arise during bowel and bronchial resection. As another example, when the surgeon is reducing the size of a stomach by surgical means, the need exists for a means to assure that the reshaped organ will have a particular circumferential dimension and that the pleats used to reduce the size of the organ are evenly distributed so as to avoid formation of areas of reduced flexibility along the suture line. In other situations, such as in cosmetic surgery, the surgeon may desire to assure that the suture line is limited to a predetermined length.  
           [0004]    In all of these situations, it is desirable to use a suture guide to aid the surgeon in achieving the desired dimension of the surgical closure and/or to rigidly support the area where the sutures are placed, thus avoiding the danger that the sutures will tear through the tissue or that the suture line will act like a draw string and undesirably bunch up the tissue.  
           [0005]    These problems are particularly acute in the surgical procedure known as annuloplasty wherein any of a number of types of prostheses have been used in surgical correction of deformed mitral or bicuspid heart valves.  
           [0006]    Diseases and certain natural defects to heart valves can impair the functioning of the cusps of the valves in preventing regurgitation of blood from the ventricle into the atrium when the ventricle contracts. For example, rheumatic fever and bacterial inflammations of the heart tissue can distort or dilate the valvular annulus, thus resulting in displacement of the cusps away from the center of the valve and causing leakage of blood during ventricle contraction.  
           [0007]    Two techniques, generally known as annuloplasty, are- used to reshape the distended and/or deformed valve annulus. In the technique known as “plication,” the circumference of the valve annulus is reduced by implanting a rigid or semi-rigid prosthetic ring of reduced circumference about the base of the annulus while the annulus is pleated to reduce its circumference to that of the ring. In the technique known as “reconstruction”, the circumference of the annulus is not reduced, but the annulus is restructured into an elongate shape. To accomplish this goal, a rigid or semi-rigid ring having the same circumference as the annulus but in an elongate or elliptical shape is surgically implanted about the base of the valve. Both plication and restructuring are intended to eliminate the gap in the closure of the distended valve by bringing back together the tips of the valve cusps.  
           [0008]    Many different types of prostheses have been developed for use in annuloplasty surgery. In general, prostheses are annular or partially annular shaped members that fit about the base of the valve annulus. Initially the prostheses were designed as rigid frame members, or “rings”, of metallic or other rigid materials that flex little, if at all, during the normal opening and closing of the valve. Since a normal heart valve annulus continuously flexes during the cardiac cycle, a rigid ring prosthesis interferes with this movement and thereby restricts movement of the valve itself. Sutures used to implant rigid ring prostheses consequently undergo stresses sufficient to tear the sutures loose. Examples of rigid annuloplasty ring prostheses are disclosed in U.S. Pat. No. 3,656,185, issued to Carpentier on Apr. 18, 1972; and U.S. Pat. No. 4,164,046, issued to Cooley on Aug. 14, 1979.  
           [0009]    Others have suggested the use of completely flexible annuloplasty ring prostheses. Examples of completely flexible ring prostheses are disclosed in U.S. Pat. No. 4,290,151, issued to Massana on Sep. 22, 1981, and are discussed in the articles of Carlos D. Duran and Jose Luis M. Ubago, “Clinical and Hemodymanic Performance of a Totally Flexible Prosthetic Ring for Atrioventricular Valve Reconstruction”, 5  Annals of Thoracic Surgery , (No. 5), 458-463, (November 1976) and M. Puig Massana et al, “Conservative Surgery of the Mitral Valve Annuloplasty on a New Adjustable Ring”,  Cardiovascular Surgery  1980, 30-37, (1981).  
           [0010]    Flexible prostheses generally include an inner support member formed from a flexible material. This support member is wrapped in woven, biocompatible cloth material. Realignment of the valve cusps during opening and closing of the valve is obtained by the proper suturing of the ring about the valve annulus. However, completely flexible ring prostheses provide almost no support to the suture area during the precarious implant procedure. Even though the surgeon attempts to evenly distribute the sutures along the periphery of the valvular annulus, during implant the drawstring effect of the sutures tends to bunch the material covering the flexible ring so that the sutures also bunch together at localized areas around the ring. This phenomenon, known as multiple plications in the heart valve annulus, causes rigid areas around the annulus. Thus, the flexible ring actually ends by imparting areas of rigidity and thereby distorts the valve annulus during the opening and closing of the valve despite the desired reduction in circumference of the valvular annulus.  
           [0011]    To overcome some of the drawbacks of rigid ring prostheses, still further types of annuloplasty prostheses have been designed to allow for adjustment of the ring circumference, either by the surgeon during implant, or automatically as the implanted. ring moves during the opening and closing of the valve. This type of adjustable prosthesis is typically designed in combination with a rigid, or at least partially rigid, frame.  
           [0012]    An example of a self adjusting ring prosthesis is taught in U.S. Pat. No. 4,489,446, issued to Reed on Dec. 25, 1984. To provide for self adjustment of the prosthetic annul-us, two reciprocating rigid metal pieces form the frame. U.S. Pat. No. 4,602,911, issued to Ahmadi et al. and U.S. Pat. No. 4,042,979, issued to Angell on Aug. 23, 1977, provide further adjustable ring protheses having a mechanism for adjusting the circumference of the ring. But due to rigidity of the frame members, the self-adjusting prostheses do not overcome many of the disadvantages of other types of rigid ring prostheses.  
           [0013]    U.S. Pat. No. 4,055,861, issued to Carpentier on Nov. 1, 1977, teaches an annuloplasty ring prosthesis having a flexibility between the completely flexible rings discussed above and the various types of rigid ring. The ring of Carpentier is deformable to an equal degree and simultaneously in all directions and preferably has the elasticity of an annular bundle of 2 to 8 turns of a cylindrical bristle of poly(ethylene terephthalate).  
           [0014]    While rigid and semi-rigid annuloplasty rings eliminate the bunching caused by flexible rings, the restrictive nature of such rings is generally detrimental to the valve&#39;s ability to open and close normally. It thus remains an object of the invention to provide a surgical means for reshaping a deformed or dilated heart valve annulus having none of the above described drawbacks associated with known annuloplasty ring prostheses.  
           [0015]    For use in annuloplasty of heart valves, as in other applications, it is desirable that a suture guide be entirely flexible, light weight, and compliant while having sufficient strength to withstand stress placed upon the sutures sewn through and around it. However, an entirely flexible suture guide cannot prevent bunching of the tissue in the draw-string effect described above and thus cannot assure that the suture line and the tissue into which it is placed will maintain any desired dimension, for example, a desired circumference. Therefore the need exists for a means of temporarily providing rigidity and fixed dimension to the suture guide during the surgery, but rendering the suture-guide freely flexible once the surgery has been accomplished.  
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0016]    The present invention may be better understood and the advantages will become apparent to those skilled in the art by reference to the accompanying drawings, wherein like reference numerals refer to like elements in the several figures, and wherein:  
         [0017]    [0017]FIG. 1 is a perspective exploded view of a flexible suture guide mounted on a rigid holder assembly in accordance with an embodiment of the invention  
         [0018]    [0018]FIG. 1A is a top view in partial cross-section of a length of a flexible suture guide in accordance with the present invention.  
         [0019]    [0019]FIG. 1B is a top view in partial cross-section of the flexible suture guide of the present invention sutured into a ring configuration.  
         [0020]    [0020]FIG. 2 is an exploded view of the guide mount portion and lower part of the handle portion of the holder assembly of FIG. 1 without the suture guide.  
         [0021]    [0021]FIG. 3 is a perspective view of a flexible suture guide of the present invention mounted on the assembled guide mount and lower handle portions seen in FIG. 2.  
         [0022]    [0022]FIG. 4 is a cross-sectional view of the assembled guide mount and lower handle portions of FIG. 3 along line  4 - 4 .  
         [0023]    [0023]FIG. 5 is a top view of the guide mount seen in FIG. 3 with a flexible suture guide tautly secured thereto.  
         [0024]    [0024]FIG. 6 is a perspective view of a guide mount in accordance with another embodiment of the invention.  
         [0025]    [0025]FIG. 7 is a cross-sectional view of a suture guide having a lenticular cross-sectional shape in accordance with another embodiment of the invention.  
         [0026]    [0026]FIG. 8 is a side perspective sectional view of a handle assembly in accordance with another embodiment of the invention.  
         [0027]    [0027]FIG. 9 is a bottom view of the handle extension of FIG. 8.  
         [0028]    [0028]FIG. 10 is a top view of the housing of FIG. 8.  
         [0029]    [0029]FIG. 11 is a perspective view of a suture guide holder in accordance with another embodiment of the invention.  
         [0030]    [0030]FIG. 12 is an exploded view of the guide mount portion and lower handle portion of the suture guide holder of FIG. 11.  
         [0031]    [0031]FIG. 13 is a top view of the guide mount portion of the suture guide holder of FIG. 11.  
         [0032]    [0032]FIG. 14 is a perspective view of a linear suture guide holder in accordance with another embodiment of the invention.  
         [0033]    [0033]FIG. 15 is a perspective view of the suture guide holder of FIG. 14 with a suture guide attached.  
         [0034]    [0034]FIG. 16 is a perspective view of a circular suture guide holder in accordance with another embodiment of the invention.  
         [0035]    [0035]FIG. 17 is a perspective view of the suture guide holder of FIG. 16 with a suture guide attached.  
         [0036]    [0036]FIG. 18 is a cross-sectional view of the suture guide and holder of FIG. 17 taken along line  18 - 18 .  
     
    
     SUMMARY OF THE INVENTION  
       [0037]    The present invention overcomes the above discussed disadvantages by providing an assembly for holding a substantially flexible suture guide in a substantially taut position for placing a suture line having a predetermined dimension. When attached to the holder assembly, the flexible suture guide assumes a shape or geometry, such as a circumference, that conforms to the shape or geometry of that portion of the body organ or vessel that is being sutured. The holder assembly can be formed to hold the suture guide in any desired shape, whether straight, curvilinear, or a combination of the two and the suture guide can be either biodegradable or permanently implantable. Thus the surgeon undertaking reconstructive surgery is aided in achieving a suture line of any desired shape, geometry and/or dimension.  
         [0038]    The assembly includes a holder portion having a surface against which the suture guide is positioned and held tautly in a fixed shape, geometry and/or dimension. More particularly, the holder assembly includes a body having an outwardly facing surface, generally flat, against which the suture guide is tautly positioned so that the suture guide assumes the shape, geometry and/or dimension desired for the suture line. Preferably, this surface is formed with at least one depression for receiving a portion of the suture guide. The assembly further includes a detachable handle and a mechanism for releasably binding the suture guide to the surface.  
         [0039]    The flexible suture guide used with the assembly of the invention comprises a generally elongated flexible body element having an internal flexible rib encased within a biocompatible covering, such as a woven cloth material. The suture guide can be formed of either biodegradable or non-biodegradable materials depending upon whether its purpose is to serve as a permanent support to prevent tearing out of the sutures placed through it or whether the suture-supporting function is to be a temporary one. In addition to its function as a post-surgical support for sutures, during surgery when used in combination with the holder disclosed herein, the suture guide serves as a rigid support and template by which the surgeon controls the length of the finished suture line. For instance, if the task is to suture together two ends of a bowel from which a section has been removed, the combination of suture guide and holder assure that the circumference of the surgical jointure is substantially similar to the circumference of the nearby regions of the colon, rather than smaller or larger.  
         [0040]    Therefore, the holder device is designed to lend a temporary rigidity or tautness to the suture guide while lending to it a shape selected to facilitate the suturing task. For instance, when the task is to place a line of sutures around the circumference of a curvilinear surface, the holder is designed to fit around at least a portion of the circumference while holding the suture guide against the said circumference to aid the surgeon in making a surgical jointure that does not distort the said circumference.  
         [0041]    In use, the suture guide is releasably retained against the outwardly facing body surface by a means for releasable attachment, for example one or more threads, pieces of Velcro™, and the like, placed so that the suture guide lies along and temporarily substantially assumes the shape of the body. The means for attachment may also be a biodegradable adhesive having the capacity to firmly attach the suture guide to the holder body for sufficient time to complete the surgery, but having the capacity to dissolve or be dissolved once the suture line has been placed. In one embodiment, the thread attaches the suture guide to the body surface at least at two points, for example at its extreme ends, by passing at least partially through the suture guide and about the body, i.e., by means of an in and out stitch or stitches.  
         [0042]    The means for releasable attachment of the suture guide to the body must be such that the suture guide can be released from the body once the suture line has been placed by the surgeon without disturbing the sutures sufficiently to cause dislocation or tearing of the sutures through the tissue. For example, if the means for releasable attachment is one or more threads, a portion of the thread(s) affixing the suture guide to the body can be positioned to be cut by scissors, or the like, to freely release the suture guide from the body. When the thread or threads are cut or otherwise ruptured, the suture guide is freely released from the body.  
       DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0043]    The present invention is directed to a holder assembly for holding a substantially flexible, implantable suture guide in a substantially taut position for suturing along a suture line having a desired shape or dimension, such as the desired circumference to which an enlarged heart valve annulus is to be reduced by the formation of pleats about the base of the valve annulus. The suture guide of the invention is formed from a freely flexible rib encased within a woven cloth covering. In use, the flexible suture guide of the invention is held taut by the holder assembly and in a configuration determined by the shape of the holder assembly while the surgeon uses the support provided by the taut suture guide to evenly place the sutures and to draw the tissue by means of the sutures passed through the suture guide into a suture line having a shape substantially similar to that of the suture guide and holder. For example, for use in annuloplasty, the holder assembly can be C-shaped so that the suture guide temporarily affixed thereto assumes a C-shaped configuration. The suture guide can then be sutured to the base of a heart valve annulus so as to restrict the circumference of a dilated and/or deformed valve annulus to a more normal one. When the suture guide is released from the holder, it will assume any shape that that portion of the body organ or vessel assumes in accordance with the dynamic function of the organ or vessel.  
         [0044]    Generally the guide mount assembly includes a guide support formed with a shape similar to that of the desired suture line, as in the above example wherein the holder assembly is in the general shape of the valve annulus about which the suture guide is to be surgically placed to assist in holding pleats in the walls of the annulus. The suture guide is mounted along at least a portion of this guide support, for example along a straight or a curved portion.  
         [0045]    The holder assembly allows the surgeon to properly position the suture guide while the suture guide is used to draw the sutures and associated tissue into the desired configuration during the suturing process. The freely flexible suture guide is given temporary rigidity during surgery by the detachable holder assembly, thus lending precision to the surgeon in controlling the placement and location of the stitches in the suture line. In an annuloplasty, for example, the potential for forming multiple plications as the circumference of the valve annulus is adjusted is thus greatly reduced.  
         [0046]    Referring now to FIG. 1A, the suture guide  10  is an elongate, flexible member of a predetermined dimension. Due to its flexibility, the length of suture guide  10  can be manipulated to assume any desired shape, ie., circular, C-shaped, straight, curvilinear or a combination of curvilinear and straight segments. In FIG. 1B, suture guide  10  is shown as shaped into a ring by suturing the two ends together with sutures  11 . As shown in FIG. 1A, suture guide  10  comprises a substantially flexible inner rib  14  encased within covering  16 .  
         [0047]    Rib  14  comprises a flat, rod-like or tubular piece of biocompatible resilient, flexible material, such as mylar or silicone rubber. Rib  14  can also contain a substance opaque to x-rays, for example, about 10 to 15 weight percent, preferably 13 weight percent, of barium sulfate so that the location of the suture guide can be determined in post-operative x-rays. The outer covering  16  is formed from any biocompatible material having sufficient strength to serve as an anchor to sutures without tearing and sufficient flexibility to be formed into a tight covering for rib  14  without restricting flexibility of suture guide  10 . Preferably, the outer covering  16  is a woven cloth having a nap to encourage tissue ingrowth, for example a dacron velour. This outer covering  16  is tightly wrapped and sewn about frame  14  so as to completely encase it. The thickness of the outer cloth  16  is sufficient to allow the surgeon to pass a suture therethrough.  
         [0048]    [0048]FIG. 1 shows an exploded view of one embodiment of a holder assembly to which a suture guide is mounted, as seen generally at  12  and  10  respectively. The holder assembly  12  includes a guide mount assembly  18  and handle assembly  40  comprising a handle  42  and housing  44 .  
         [0049]    [0049]FIGS. 2 through 5 illustrate in greater detail the guide mount assembly  18  and how the suture guide  10  is mounted thereon. Guide mount assembly  18  includes a guide support  20 . For illustrative purposes, the suture guide assembly  18  here shown is one intended for use in plication of a distended heart valve annulus. Therefore facing edge of guide support  20  is generally C-shaped or annular, having a shape and circumferential dimension similar to that the surgeon desires to achieve in the human heart annulus by means of annuloplasty surgery. More particularly, support  20  is generally lenticular, having a C-shaped portion  28 , with its ends connected by a straight side  30 .  
         [0050]    The suture guide  10  is fitted into a groove or trough  32  located about the curved C-shaped portion  28  of the guide support  20  Trough  32  is dimensioned to receive a portion of the suture guide  10 , as best seen in FIG. 4. The positioning of the suture guide  10  within the trough  32  conforms guide  10  to the shape of the guide support  20  while exposing a substantial portion of the covering  16  outside of the trough  32  to allow the surgeon to pass a suture therethrough.  
         [0051]    In the embodiment shown in FIGS.  2 - 5 , the guide mount assembly  18  also includes a central support hub  22  to which the guide support  20  is attached by a multiplicity of integrally formed spokes, preferably three, one of which is seen at  24 . The arrangement of mount assembly  18  including, in this instance, a curved guide support  20  with hub  22  and spokes  24 , allows the surgeon to visually observe the heart valve during the suturing process. Central support hub  22  is formed with an annular groove  36 . This groove  36  is formed proximate that end  34  of hub  22  opposite guide support  20 , and defines a post member  38 . That portion of hub  22  remaining on the side of the groove  36  opposite the guide support  20 , and hub end  34 , includes an inwardly tapering peripheral surface, as seen generally at  35 . The hub  22  also includes an open bore  37  through which is fitted a cylindrical plug  39 . The plug  39  is dimensioned to extend out from both sides of the bore  37 . The purpose of tapered surface  35 , and the plug  39  will be described hereinafter.  
         [0052]    As is further seen in FIG. 1, the handle assembly  40  includes an elongated handle  42  having end  54  mounted to housing  44 . While housing  44  may be integrally formed at the end  54  of the post  42 , preferably end  54  is formed with outwardly facing threads that threadably mate with threads formed along a surface of an opening  59  formed in the top of the housing  44 . The opposite end of post  42  is formed with an external etched surface  52  to assist the surgeon in gripping post  42 . In another embodiment, end  54  of post  42  and opening  59  of housing  44  can be formed so that end  54  can be press fit into opening  59 .  
         [0053]    Housing  44  is a thimble-shaped structure having a circular wall  60  defining a cavity  46 . As seen better in FIG. 4, cavity  46  is open at one side, seen generally as opening  45 . The inner surface of the circular wall  60  inwardly converges a short distance from the opening  45 . The cavity  46  is generally wide enough at the open side  45  to snugly receive hub  22 , but the plug  39  extends sufficiently outward from hub  22  to prevent passage through open side  45  into cavity  46 . Wall  60  is formed with two J-shaped notches, seen at  48  and  49  in FIGS. 2 and 3. These J-shaped notches  48  and  49  are formed and positioned to respectively receive the ends of the plug  39  extending outward from the hub  22 . The shape of the notches  48  and  49  defines a landing  50  between the long and short legs of each notch.  
         [0054]    Handle assembly  40  is coupled to the guide mount assembly  18  by inserting end  34  of the hub  22  into the cavity  46 , with one of the outwardly extending ends of the plug  39  passing through a respective one of the J-shaped notches  48  and  49 . The tapered surface  35  of the hub  22  engages the inwardly tapering surface of the wall  60 . This causes a slight compression of the hub end  34 , resulting in a spring force. The spring force acts to restrain the movement of the outwardly extending ends of the plug  39  through the larger legs of the J-shaped notches  48  and  49 . Additional exertion moves the ends of plug  39  through the larger legs of J-shaped notches  48  and  49 , with rotation of handle  40  passing the outward ends of plug  39  across the landings  50  and into the smaller leg of the J-shaped notches  48  and  49 .  
         [0055]    The spring force established by the slight compression of the hub end  34  maintains the coupling between housing  44  and guide mount assembly  18 . The handle  40  is decoupled from the guide mount assembly  18  by reversing the described procedure.  
         [0056]    One embodiment of the means for releasably attaching suture guide  10  to guide support  20  of guide mount assembly  18  is seen in FIG. 5. Guide support  20  is formed with two apertures  66  and  68  extending through guide support  20  and communicating with groove  32 . The exact positioning of apertures  66  and  68  is not critical. As illustrated, apertures  66  and  68  are formed along the straight portion of guide support  20 , at a location proximate two of the spokes  24 .  
         [0057]    One end  71  of a cord or suture thread  70  is passed through one of the apertures, as illustrated hole  66 , and tied off on guide support  20 . The other end  73  of suture  70  is passed through the body of suture guide  10  from one end to the other. This end  73  is then passed first through hole  68  and then through and tied off at hole  66 . After suture guide  10  is sutured into position during surgery, ire., about the valve annulus, that portion of the suture  70  between apertures  66  and  68  is snipped or cut in two. Suture  70  passes-out of suture guide  10  by withdrawing the handle assembly  12 .  
         [0058]    In accordance with another embodiment (not shown), the first end  71  is tied off at hole  66 , with the second end  73  passed first through one end of the suture guide  10 , and then brought back across and passed through the other end of suture guide  10 , through hole  68  and again tied off at hole  66 . Removal of suture  70  is accomplished by snipping the suture in two at any point between the two holes and withdrawing it.  
         [0059]    An alternative embodiment of the guide mount assembly so as seen in FIG. 6 includes a guide support  82  having an open C-shaped side  84  but no straight side joining the ends of the C. Except for the stated difference in shape of the guide support  82 , guide mount assembly  80  in FIG. 6 includes elements similar to those described for the suture guide of FIG. 5 (as is indicated by the prime of the previously provided element number), and will be described in no further detail herein. In this embodiment of guide mount assembly  80 , the means for releasably attaching the suture guide to the guide support is a suture (not shown) positioned by tying off as described above across an open space between holes  68 ′ and  66 ′ (not shown).  
         [0060]    In a preferred embodiment of the invention, the handle assembly  40  is tethered to the guide mount assembly  18 . As seen in FIG. 1, this tethering is performed by connecting one end of a lanyard, seen generally at  100 , to the handle assembly  40  and the other end of the lanyard  100  to the guide support  20 , for instance to one of spokes  24 . Lanyard  100  allows a surgeon to detach the handle assembly  40  from the guide support  20  during the suturing procedure to get a clearer view of the surgical site. By tethering handle  40  to the guide mount assembly  18 , the risk of the surgeon leaving the guide support  20  in the patient after completion of the surgical procedure is greatly reduced. Lanyard  100  also allows the surgeon to easily remove the guide support  20  after the handle has been detached.  
         [0061]    In a still further preferred embodiment, a handle assembly  40  is modified to house a spool of suture or string that acts like a tether for the guide mount assembly. The tether is attached at opposite ends to the handle assembly and the guide mount assembly respectively and automatically spools out of the handle assembly when the handle is disconnected from the guide mount assembly.  
         [0062]    This preferred embodiment is better seen in the several FIGS. 8 through 10. The lower portion of a handle assembly in accordance with this embodiment is seen in FIG. 8 at  90 . Handle assembly  90  includes a housing  92 , a handle extension  94 , and a handle post  96 .  
         [0063]    Housing  92  includes a pair of opposing J-shaped notches  98  and  99  that function similarly to the J-shaped notches  48  and  49  described above. The handle extension  94  is fastened to the lower end of the handle post  96  in any suitable manner. As shown, the handle extension  94  includes at one end a bore  102  for receiving the lower end  104  of the handle post  96 . End  104  of the handle post may be held in bore  102  by welding, stamping, or by providing the respective members with interlocking threaded surfaces. Accordingly, neither of these structures of the handle assembly  90  will be discussed in any greater detail.  
         [0064]    The main distinction to the previously described embodiment is that the handle assembly  90  is formed to carry a spool of suture, seen generally at  106 . This suture spool  106  is housed in a bore  112  formed in the handle extension  94 . Handle extension  94  and housing  92  are formed to releasably fit together. Handle extension  94  and housing  92  include mating collars  108  and  110 , respectively. Collar  108  is formed with a groove  114  that receives a tongue  116  extending upward from collar  110 . Tongue  116  is formed with a central aperture  122 , and two opposing cut-aways  118  and  120  that extend out in opposite directions from this aperture  122 .  
         [0065]    Each of the collars  108  and  110  possesses four apertures. Apertures  126 - 129  of collar  108  align with apertures  130 - 133  of collar  110  when the handle extension  94  and housing  92  are fitted together.  
         [0066]    Suture spool  106  comprises a length of suture wound into a cylindrical configuration along lower end  104  of handle post  96 , which fits into bore  112 . The opposite ends of this suture length are tied to the tongue  116  and the handle extension  94 . One end of the suture is drawn through the central aperture of  122  and tied to tongue  116 , as seen at  115 . The opposite end of the suture is drawn through an opening  124  extending from the bore  112  through the handle extension  94  and is tied around the handle extension  94 , as seen at  117 . It should be noted that for the purpose of this invention, the meaning of the term “suture” shall include any cord, string or filamentous material useful for tethering the housing  92  to the handle extension  94 .  
         [0067]    Handle extension  94  and housing  92  are fitted together by placing the tongue  116  into the groove  114 . Sutures are run through aligned apertures to hold the handle extension  94  and housing  92  together. For example, one suture  134  is passed through apertures  126  and  127  of handle extension  94  and apertures  130  and  131  of housing  92 , while a second suture  136  is passed through apertures  128  and  129  of handle extension  94  and apertures  132  and  133  of housing  92 .  
         [0068]    The handle assembly  90  of this embodiment is coupled to the guide mount assembly  18  as stated above. The handle post  96  is removed from the housing  92  by cutting the sutures  134  and  136  and pulling the handle extension  94  away from the housing  92 . Pulling away the handle post  96  unravels the suture spool  106 . After the suture guide is-sutured into position along the suture line, i.e., about a heart valve annulus, the suture(s) holding the guide mount assembly to the suture guide is cut. The guide mount assembly is then removed by pulling on the handle post  96 .  
         [0069]    In another embodiment of the invention, shown in FIGS.  11 - 13 , handle assembly  140  is also modified to house a spool of suture or string that acts like a tether for the guide mount assembly  142 . Referring to FIG. 11, handle assembly  140 , includes housing  144 , handle post  146 , and an enlarged handle portion  148 . Handle post  146  is preferably made of a malleable metal or other material that allows the surgeon to bend the handle to the desired angle while using the suture guide holder assembly. The enlarged handle portion  148  allows the surgeon to grip the handle more easily and also makes it easier for the surgeon to maneuver the suture guide holder into the surgery site. Housing  144  is releasably attached to guide mount  150  as will be described in more detail with reference to FIG. 12. Suture guide  152  is releasably attached to guide mount  150  by threads or sutures (not shown) in a manner which will be described with reference to FIG. 13.  
         [0070]    Referring to FIG. 12, housing  144  includes bore  154  for receiving handle post  146 . The end of handle post  146  may be held in bore  154  by a press fit or friction fit, by welding, or by providing the respective members with interlocking threaded surfaces. Housing  144  also includes a pair of opposing slots  156  for receiving dog ears  158  of the suture spool  160 . Suture spool  160  includes a length of suture or thread  162  wound into a cylindrical configuration along spindle post  164 . One end of the suture  162  is tied to an aperture (not shown) in upper end  166  of suture spool  160 . The other end of suture  162  is affixed to hub  168  of guide mount  150 . Specifically, suture  162  passes down through aperture  170 , up through aperture  172 , and is tied off at aperture  112 . The lower end of spindle post  164  has a pair of opposing notches  174  formed therein which are sized to be received by bore  176  of hub  168 . Spindle post  164 , therefore, is press fit or friction fit into bore  176 .  
         [0071]    Suture spool  160  is housed within the interior cavity (not shown) of housing  144  and is held in place when dog ears  158  snap fit into opposing slots  156 . Housing  144  with suture spool  160  in place is then releasably attached to guide mount  150  by sutures or threads  178  and  180  shown in FIG. 11. Suture  180  passes through a pair of apertures  182  in housing  144  and a pair of apertures  184  in guide mount  150  as illustrated by dotted lines  186  in FIG. 12. Suture  178  passes through a pair of apertures  188  in housing  144  and a pair of apertures  190  in guide mount  150  as shown by dotted lines  192  in FIG. 12.  
         [0072]    Once the suture guide and guide mount assembly has been placed at the surgery site, the surgeon can remove the handle if desired by cutting sutures or threads  178  and  180  at the location of the cutting guides  194  and  196  shown in FIGS. 11 and 12. Cutting guides  194  and  196  consist of a raised platform with a shallow groove  195  formed therein through which the suture passes and a deeper groove  197  formed in the platform perpendicular to the shallow groove through which scissors or other cutting tools can be inserted to clip or cut the suture at that location. When the sutures are cut and the handle is removed, spool  160  remains within housing  144  and suture  162  remains attached to hub  168 . As the handle is pulled away from the guide mount, the suture or thread spools off spindle post  164  thereby providing a tether for removal of the guide mount after the suture guide has been detached from the guide mount and the surgery has been completed.  
         [0073]    Referring to FIG. 13, suture guide  152  is releasably attached to guide mount  150  by sutures or threads  198 ,  200  and  202 . Suture  198  is tied off at aperture  204  and then passes through one end of the suture guide and up through aperture  206  over cutting guide  208  down through aperture  206  again, through suture guide  152 , through aperture  209 , then up through aperture  210  where the other end of suture  198  is tied off. Suture  200  is at one end tied off through aperture  210  and then passes under the guide mount  150  through aperture  211 , through suture guide  152  and up through aperture  212 , across cutting guide  214  and back down through aperture  212 . Suture  200  then passes through suture guide  152  again, through aperture  215  and up through aperture  216  where it is tied off. Finally, suture  202  is tied off at one end at aperture  216  and passes under suture guide  150  through aperture  217 , through suture guide  152 , up through aperture  218 , across cutting guide  220 , down through aperture  218  again where it passes through suture guide  152  and up through aperture  222  where it is tied off.  
         [0074]    Apertures  224  and  226  disposed in guide mount  150  at opposite ends of the suture guide  152  are used to temporarily attach each end of suture guide  152  to each end of the guide mount  150  to hold the suture guide in place during the process of threading sutures  198 ,  200  and  202  through the apertures of the guide mount and the suture guide. Once the threading of sutures  198 ,  200  and  202  is complete, the sutures at  224  and  226  are then removed. The sutures at  224  and  226  are shown for illustration purposes in FIG. 11 at  223  and  225 .  
         [0075]    Referring to FIG. 13, cutting guides  208 ,  214  and  220  consist of a raised platform with a shallow groove  228  formed therein through which the suture passes and a deeper groove  230  formed in the platform perpendicular to the shallow groove through which a cutting tool may pass in order to cut the suture at the location lying over the deeper groove. The deeper groove is closed at one end by a stop  232  so that the tip of the cutting tool or scissors cannot pass beyond that point. This stop prevents the cutting tool from dipping down into the open space  234  between the spokes of guide mount  150  and accidentally cutting the tissue of the patient.  
         [0076]    When the surgeon is ready to release the suture guide from the suture guide mount  150  he merely snips the sutures  198 ,  200  and  202  by passing the cutting tool into the cutting groove of the cutting guides. When the sutures have been snipped at all three locations, the guide mount can be retrieved by pulling on the tether or otherwise removing it and sutures  198 ,  200  and  202  are removed with the guide mount  150  since they are tied off on the guide mount.  
         [0077]    Referring to FIGS. 14 through 18, there are shown two additional embodiments of suture guide holders for holding a suture guide. FIGS. 14 and 15 illustrate a linear suture guide holder for placing a linear suture guide. FIGS. 16, 17 and  18  illustrate a circular or ring-shaped suture guide holder for placing a circular suture guide.  
         [0078]    Referring to FIG. 14, the linear suture guide holder has a detachable handle  240  of the type shown in FIG. 2 and linear-shaped guide mount  242 . However, the handle embodiment with the tether illustrated in FIGS. 8 and 12 could also be used. Guide mount  242  has a linear groove or trough  244  into which suture guide  246  is fitted as shown in FIG. 15. Apertures  248  formed in guide mount  242  are used to suture the suture guide to the guide mount as shown in FIG. 15. Guide mount  242  also includes cutting guides  252  and  254  at each end of the guide mount.  
         [0079]    Suture guide  246  is tautly secured to the linear guide mount  242  by suture  250 . One end of suture  250  is tied off at aperture  248   a , passes through suture guide  246  up through aperture  248   b  cross cutting guide  252  down through aperture  248   c  through suture guide  246  up through aperture  248   d  where it is tied to a second length of suture  256 . Suture  256  is threaded down through aperture  248   e  through suture guide  246  up through aperture  248   f  across cutting guide  254  down through aperture  248   g  through suture guide  246  and up through aperture  248   h  where it is tied off. Thus, as in previous embodiments, when the surgeon is ready to release the suture guide from the suture guide holder, he merely inserts the cutting tool in the cutting grooves  252  and  254  and cuts sutures  250  and  256  at that location. Suture  250  and  256  are then removed with the suture guide mount  242 . The linear suture guide shown in FIGS. 14 and 15 would be used for any surgical procedure in which the incision is a substantially straight line. The suture guide mount  242  can be any desired length and the suture guide  246  can extend the full length of the suture guide mount  242  as shown in FIG. 15 or could be of a shorter length and sutured to just a portion of suture guide mount  242 . If the surgeon desires a suture guide with a hook or curved end, the suture guide could extend around the edge of suture guide mount  242  to provide one or two curved or hooked ends.  
         [0080]    Referring to FIG. 16, there is shown a circular suture guide holder which would be useful for suturing two blood vessels or other vessels, such as intestines, together. It would also be useful for bowel and bronchial resection. The suture guide holder has a handle  260  which in this embodiment is not shown to be detachable. However, any of the various handle embodiments illustrated previously could be utilized, including the tethering concepts. The suture guide mount  258  is ring shaped with a groove or trough  260  formed on the interior cylindrical surface of the ring. The groove or trough  260  is shaped to receive a circular suture guide  261  as shown in FIG. 17. Suture guide mount  258  has a plurality of apertures  262  evenly spaced about its circumference for use in suturing the suture guide  261  to the suture guide holder as shown in FIG. 17. Suture  264  is threaded through the apertures and through the suture ring in a manner similar to that described with reference to FIGS. 14 and 15 and will not be further be described in connection with this embodiment. Suture  264  can be clipped at two locations such as at  266  and  268  in order release the suture guide from the suture guide holder. Alternatively, cutting guides can be provided as shown in the embodiments previously described and illustrated.  
         [0081]    [0081]FIG. 18 shows a cross section of the suture guide holder with the suture guide attached thereto taken along line  18 - 18  of FIG. 17. FIG. 18 illustrates how groove  260  engages suture guide  261  and depicts rib  263  and the outer covering  265  of the suture guide.  
         [0082]    Various shaped suture guide holders, C-shaped, linear and circular, have been described and illustrated in the figures, however, in accordance with the present invention, the suture guide holder can be constructed in any desired shape depending on the surgical procedure involved. For example, the suture guide holder could be curvilinear for stomach reduction surgery or for certain cosmetic surgeries when it is necessary to place a suture line along an eyelid or an ear.  
         [0083]    While the preferred embodiments have been described, various modifications and substitutions may be made thereto without departing from the scope of the invention. Accordingly, it is to be understood that the invention has been described by way of illustration and not limitation.

Technology Classification (CPC): 0