Abstract:
A method and apparatus for securing separate loops of suture with a coaxial mechanical fastener. Separate loops of suture extend from opposite ends of the mechanical fastener. A wire snare facilitates pulling the suture through the fastener. A suturing instrument provides for the infusion of pressurized physiologic solutions into the left ventricle so that the proper replacement suture length can be demonstrated real time prior to crimping the fastener. The instrument incorporates a slotted release site so that the fastener and suture can be released from the device tip once the fastener is secured. A method of securing suture coming from cardiac valve leaflets and or other structures like papillary muscles permits a more atraumatic orientation of the fastener coaxial with the suture strands.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not Applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       REFERENCE TO A “SEQUENCE LISTING” 
       [0003]    Not applicable. 
       BACKGROUND OF THE INVENTION 
       [0004]    1. Field of the Invention 
         [0005]    The use of a mechanical fastener or “knot” to secure or connect together a loop of surgical suture can provide an accepted alternative to the hand tying of a manual knot. Unlike a hand-tied manual knot, which is composed only of multiple throws of the suture itself, a mechanical suture fastener leaves behind inside of the patient another structural element in addition to the suture. Therefore, to be useful a mechanical fastener must be safe and ergonomic to deploy on the suture and present minimal risk to the patient&#39;s long-term clinical outcome. Inadvertent damage by the mechanical fastener to the placed suture or injury to the tissue or surrounding tissue structures is unacceptable. 
         [0006]    Alternative knot replacement techniques and technologies to obviate the need for hand tying include sutures provided with pre-tied knots, barbed sutures, unidirectional cable ties or other mechanisms with integrated latching features. 
         [0007]    An example of a simple mechanical fastener to help secure suture is seen in the use of generally V-shaped metal or plastic clips, sometimes called hemoclips. Such V-shaped clips can be placed around suture segments and then compressed together to hold suture strands together or to augment hand-tied knots. This type of clip application to suture often proves unreliable because stress concentrations on the suture in the narrow compression zone can lead to suture breakage and inadequate clip compression readily allows suture slippage. 
         [0008]    An example of a more customized commercially available product uses a hollow titanium sleeve compressed or crimped around suture to hold two sections of suture within the crimped sleeve to preclude the strands of suture from slipping relative to each other. (TK™ Device, TI-KNOT® titanium knots, LSI SOLUTIONS®, Victor, N.Y.; U.S. Pat. Nos. 5,520,702; 5,643,289; 5,669,917; 5,766,183; 6,368,344; 6,641,592; 6,997,931; 7,235,086; 8,398,680). This titanium mechanical fastener is held circumscribed in the distal end of a customized surgical instrument. Both of the cut ends from a single strand of suture are pulled through the distal end of the device, while they are simultaneously pulled from the distal end of the mechanical fastener through its internal channel and out its proximal end. As the suture ends are pulled away from the fastener, the loop of suture at the distal end of the fastener is reduced in diameter. Suture can be placed around a tissue structure or through one or more tissue structures so that the closing loop described at the distal end of the titanium fastener draws the tissue together for compression or apposition. Compressing the mechanical fastener secures the suture within the fastener to hold the tissue in its desired position. 
         [0009]    With this type of unidirectional hollow mechanical fastener holding a closed loop of suture, the fastener itself essentially becomes oriented perpendicular to the axis of the suture upon crimping. In other words, the two segments of suture coming into the distal end of the mechanical fastener are under tension in the opposite direction from each other and are thus splayed out in a linear orientation perpendicularly to the fastener. In most clinical applications, this non-coaxial fastener orientation does not compromise the wound closure or surrounding tissue structures. The technique of bringing together tissue through the use of a closed loop of suture held with a perpendicular fastener has become an accepted means of holding tissue or enabling wound closure in many surgical applications. Suture secured with a mechanical fastener can also be used to hold tissue against a surgical prosthetic material such as a hernia mesh or heart valve sewing ring. (CK™ Device, COR-KNOT® titanium knots, LSI SOLUTIONS®, Victor, N.Y.). 
         [0010]    Over the past decade, this single loop mechanical fastener technology has been successfully used in many surgical applications such as for ligating blood vessels or for wound closures in tissues ranging from stomach to intestine to bladder. Until this current invention, mechanical fasteners were only envisioned for use to secure one strand of suture exiting from one end of the fastener yielding a single (i.e., unidirectional) closing suture loop and a perpendicularly oriented mechanical fastener. 
         [0011]    In some critical surgical applications, if the mechanical suture fastener extends perpendicularly away from the tensioned suture towards adjacent structures, surrounding tissue structures or prosthetic materials may be subjected to an unacceptable risk of damage. In some heart surgery procedures, it may be very desirable to have a minimal profile coaxial fastener to connect more than one loop of suture exiting at either end of this fastener (i.e., bidirectional plurality of loops). For example, there is no known fastener that can be used to safely connect the papillary muscles to the mitral leaflets with suture. 
         [0012]    The human heart has four chambers and four valves. The upper chambers, called the right atrium and left atrium, receive blood coming to the heart from the systemic venous circulation and from the pulmonary veins, respectively. The lower, more muscular, chambers of the heart pump blood back from the heart towards the lungs through the right ventricle and towards the systemic circulation from the left ventricle. The right and left atria receiving chambers are separated from their respective right and left ventricles by two separate atrial valves, called the tricuspid and mitral valves, respectively. Atrial valves have cusps or leaflets that are held like parachutes by cord-like attachment structures, called chordae tendineae. These valve leaflets open during diastole when blood flows through the atria toward the ventricle and close to preclude blood passage back into the atria during systole when heart contraction occurs. The chordae tendineae structures help prevent valve leaflet prolapse (i.e., pathologic excessive movement) by connecting valve leaflets to muscular projections in the ventricles called papillary muscles. (Chordae tendineae structures are not part of the pulmonary valve at the exit of the right ventricle or the aortic valve at the left ventricle; these valves preclude return of blood from the lungs and body, respectively.) Atrial valves occur in a wide variety of shapes and sizes. Common heart valve disease processes often involve elongation or disruption of atrial valve chordae tendineae, which can lead to leaky heart valves. 
         [0013]    The purpose of this disclosure is to address the need for improved chordae tendineae replacement during atrial valve repair. Better technology and methods for real time evaluation of the correct suture length for replacement chordae tendineae under functional surgical conditions could help many patients. Precise replacement of damaged native chordae tendineae can re-establish proper atrial valve closure. 
         [0014]    Recent advances in minimally invasive cardiac surgery have enabled remote access to diseased tricuspid and mitral heart valves. For simplicity herein, we will focus only on the mitral valve subsequently in this document. Surgeons have recognized the need for alternative techniques and technologies to provide better options for repairing pathologic mitral valve chordae tendineae. The routine repair of damaged or torn mitral valve chordae tendineae requires placement with a suture (typically a Gore-Tex® suture, W. L. Gore &amp; Associates, Flagstaff, Ariz.) through the mitral leaflet and the adjacent papillary muscle. Hand tying of this thin and slippery suture remains an extremely unreliable technical challenge, especially during minimally invasive cardiac surgery. Bulky hand-tied knots are routinely left at the coaptation zone between the leaflets of the mitral valve and could theoretically interfere with valve leaflet closure. While the anatomic distance between the leaflet and papillary muscle can range from 1 to 2.5 cm, depending on the intraoperative heart&#39;s shape and size, each individual valve repair requires a precise suture length to enable proper leaflet alignment and valve function. Since chordae tendineae replacement sutures often are tied too long or too short and once tied cannot be adjusted, they are frequently cut out, resutured and retied. 
         [0015]    2. Description of Related Art 
         [0016]    Several suboptimal alternatives for mitral chordae tendineae replacement have been offered by other investigators. 
         [0017]    A technique incorporating multiple pre-tied suture loops of a predetermined length and arranged in a series usually of four loops tied into a single suture is used by a limited number of surgeons. This pre-tied suture loop configuration approach to chordae tendineae replacement was first described around 2000 by Drs. von Oppell and Mohr in Leipzig, Germany. While this pre-tied loop approach purports to enable more reliable suture lengths between the leaflets and papillary muscle, it requires an elaborate measurement technique to determine the length the loop should be tied. First the pre-tied loop arrangement is anchored to the papillary muscle by placing suture and hand-tying a knot. Then, each individual loop is sutured and hand-tied usually using two additional sutures to each affected pre-tied suture loop. Because this pre-tied loop technique is complicated and challenging, and still requires significant remote suture placement and hand-tied knotting, this approach is generally limited to a few dedicated centers in Europe. Since 2010, mitral chordae tendineae replacement suture provided in various pre-set lengths with pre-tied loops are commercially available through Santech Medical, Grosswallstadt, Germany. 
         [0018]    In 2012, Isoda et al reported a similar “Loop with Anchor” technique used in their patients for mitral valve prolapse. They describe the use of a rudimentary “handmade knot pusher . . . made from a funnel” which they placed over a finger to improve manual knot tying. 
         [0019]    Ruyra-Baliarda published an article presenting a new surgical device for intraoperative use to aid in chordae tendineae replacement in ten patients beginning in 2007. This mechanical implement is temporarily sewn over the mitral valve to help establish replacement suture length and to preclude over tightening of the hand-tied knots. 
         [0020]    Lattouf (U.S. Pat. No. 6,978,176 B2) describes accessing the mitral valve through the apex of the heart and left ventricle to use a grasper and balloon technique to orient mitral leaflets and subsequently place a clip at the coaptation zone of the leaflets. 
         [0021]    Gammie (U.S. Pat. No. 7,635,386 B1) proposed a suturing technology and method for chordae tendineae replacement that again involves accessing the mitral valve through the left ventricle via the apex of the heart. Several alternative suture placement and knot replacement techniques are described. One embodiment of Gammie illustrates a plug to close the apex of the heart. This plug also acts as a suture fastener to secure a single loop of suture coming from the mitral valve leaflet to an attachment site on the cardiac apex. Gammie&#39;s described unidirectional mechanical suture fastener approach is similar to the aforementioned hollow, crimped titanium mechanical fastener in which a single loop of suture enters the distal apical plug and exits its proximal surface. 
       BRIEF SUMMARY OF THE INVENTION 
       [0022]    With the availability of a mechanical fastener coaxial with one or more loops of suture coming from one end and an additional loop or loops of suture coming from the opposite end, the fastener could then ride essentially parallel to the suture strands, minimizing the fastener&#39;s profile and presenting a reduced risk for damaging adjacent structures. Such technology must be small enough to fit into confined remote surgical fields, reasonably atraumatic and provide a secure suture holding means. Both the fastener and connected strands of suture must be readily released from the deployment device. 
         [0023]    This invention provides a means of securing separate loops of suture through a common mechanical fastener. Moreover this invention permits separate loops of suture to extend from opposite ends of the mechanical fastener to enable a coaxial mechanical fastener orientation relative to the bidirectional suture loops. Novel wire snare mechanisms that permit pulling of the suture through both ends of the fastener are also disclosed. This invention further permits the release of the wire snares, bidirectional mechanical fastener and sutures from the tip of the fastener securing device. One embodiment of this invention offers the infusion of pressurized physiologic solutions through the end of the mechanical fastener deployment device into the left ventricle so that the proper replacement suture length can be demonstrated real time under physiologic conditions prior to crimping the fastener. The fastener deployment device incorporates a slotted release site so that the knot and suture can be liberated from the device tip once the fastener is secured. A method of securing suture coming from cardiac valve leaflets and or other structures like papillary muscles is provided. This method permits a more atraumatic orientation of the fastener so it remains coaxial with the suture strands instead of perpendicular to the suture strands as seen in previous products. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]    The foregoing objects, features and advantages of the invention will become more apparent from a reading of the following description in connection with the accompanying drawings, in which: 
           [0025]      FIG. 1  is a distally oriented perspective view of a bidirectional snare device as presented for use; 
           [0026]      FIG. 2  is an enlarged partial section view of the bidirectional snare device presented in  FIG. 1 ; 
           [0027]      FIG. 3  is a proximally oriented perspective view of the bidirectional snare device of  FIG. 1 ; 
           [0028]      FIG. 4  is an enlarged partial section view of the bidirectional snare device presented in  FIG. 3 ; 
           [0029]      FIG. 5  is a distally oriented perspective view of the bidirectional snare device of  FIG. 1  in preparation for use in a corresponding deployment device when applied to its field of use; 
           [0030]      FIG. 5A  is an enlarged top-frontal perspective view of the distal end of the deployment device of  FIG. 5  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0031]      FIG. 5B  is an enlarged bottom-rear perspective view of the deployment device of  FIG. 5  along lines  5 B- 5 B of  FIG. 5  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0032]      FIG. 5C  is a distally oriented perspective view of the bidirectional snare device of  FIG. 1  in an alternate installation configuration for use in a corresponding deployment device when applied to its field of use; 
           [0033]      FIG. 6  is an enlarged top-frontal perspective view of the distal end of the deployment device of  FIG. 5C  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0034]      FIG. 7  is an enlarged bottom-rear perspective view of the deployment device of  FIG. 5  along lines  7 - 7  of  FIG. 5C  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0035]      FIG. 8  is a proximal perspective view of the deployment device of  FIG. 5  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0036]      FIG. 9  is a is an enlarged top-rear perspective view of the distal end of the deployment device of  FIG. 5  with the installed bidirectional snare device of  FIG. 1  as presented for use; 
           [0037]      FIG. 10  is a partial orthogonal section view along lines  10 - 10  in  FIG. 8  of the deployment device of  FIG. 5  with accompanying bidirectional snare device of  FIG. 1 ; 
           [0038]      FIG. 11  is a partial orthogonal section view along lines  11 - 11  in  FIG. 9  of the deployment device of  FIG. 5  with accompanying bidirectional snare device of  FIG. 1 ; 
           [0039]      FIG. 12  is a partial distally oriented rear perspective view of the deployment device with installed bidirectional snare device as shown in  FIG. 8  in the preferred method of use accepting a first suture; 
           [0040]      FIG. 13  is again a partial distally oriented rear perspective view of the deployment device of  FIG. 8  illustrating the partial withdrawal of the bidirectional snare device of  FIG. 1  and the subsequent progressed accommodation of the first suture first shown in  FIG. 12 ; 
           [0041]      FIG. 14  is again a partial distally oriented rear perspective view of the deployment device of  FIG. 8  illustrating the further withdrawal of the bidirectional snare device of  FIG. 1  and the subsequent exit of the first suture from the device of  FIG. 8 ; 
           [0042]      FIG. 15  is again a partial distally oriented rear perspective view of the deployment device of  FIG. 8  with installed bidirectional snare device of  FIG. 1  in the preferred method of use accepting a second suture; 
           [0043]      FIG. 16  is again a partial distally oriented rear perspective view of the deployment device of  FIG. 8  illustrating the further withdrawal of the bidirectional snare device of  FIG. 1 , first initiated in  FIG. 12 , and the subsequent progressed accommodation of the second suture first shown in  FIG. 15 ; 
           [0044]      FIG. 17  is again a partial distally oriented rear perspective view of the deployment device of  FIG. 8  illustrating the almost entire withdrawal of the bidirectional snare device of  FIG. 1 , first initiated in  FIG. 12 , and the subsequent progressed accommodation of the second suture; 
           [0045]      FIG. 18  is a partial distally oriented rear perspective view of the deployment device of  FIG. 8  illustrating the fully accommodated and exiting first and second sutures introduced in  FIGS. 12 and 16 , respectively; 
           [0046]      FIG. 19  is a partial distally oriented rear perspective view of the deployment device of  FIG. 5C  advancing while opposing tension is applied to the exited first and second sutures shown in  FIG. 18 ; 
           [0047]      FIG. 20  is a perspective view of the first and second sutures as applied to tissue in the intended field of use and referred to as a coaxial mechanical fastener; 
           [0048]      FIG. 21  is a distally oriented exploded perspective view of the deployment device of  FIG. 5C ; 
           [0049]      FIG. 22  is a distally oriented, partially sectioned perspective view of the deployment device of  FIG. 5C  showing the introduction of fluid in the intended field of use; 
           [0050]      FIG. 23  is a distally oriented, partial section view along lines  23 - 23  in  FIG. 21 ; 
           [0051]      FIG. 24  is an enlarged perspective view of the middle portion of the deployment device from  FIG. 23 ; 
           [0052]      FIG. 25  is an enlarged perspective view of the distal portion of the deployment device from  FIG. 23 ; 
           [0053]      FIG. 26  is an additional view of the device shown in  FIG. 23  actuated as in the field of use; 
           [0054]      FIG. 27  is an enlarged perspective view of the middle portion of the deployment device from  FIG. 26 ; 
           [0055]      FIG. 28  is an enlarged perspective view of the distal portion of the deployment device from  FIG. 26  illustrating the crimping of a sleeve; 
           [0056]      FIG. 28A  is a partial orthogonal section view along lines  11 - 11  in  FIG. 9  of the deployment device of  FIG. 5C  again illustrating the crimping of the sleeve around suture and the trimming of said suture; 
           [0057]      FIG. 28B  is an alternate enlarged perspective view of the distal portion of the deployment device from  FIG. 26  again illustrating the crimping of the sleeve around suture and the trimming of said suture; 
           [0058]      FIG. 29  is a distal view of a crimped sleeve as produced by the action of the device in  FIG. 26 ; 
           [0059]      FIG. 30  is a partial section schematic view illustrating the human heart in diastole with the left front side removed; 
           [0060]      FIG. 31  is a partial section schematic view illustrating the human heart in systole with the left front side removed; 
           [0061]      FIG. 32  is a partial section schematic view illustrating the human heart in systole with the left front side removed highlighting a ruptured chordae tendineae on the anterior leaflet of the mitral valve; 
           [0062]      FIG. 33  is a partial section schematic view illustrating the human heart in systole with the left front side removed highlighting a correct length hand-tied replacement suture from a papillary muscle to the anterior leaflet of the mitral valve; 
           [0063]      FIG. 34  is a partial section schematic view illustrating the human heart in systole with the left front side removed highlighting a replacement suture tied too long on the anterior leaflet of the mitral valve; 
           [0064]      FIG. 35  is a partial section schematic view illustrating the human heart in systole with the left front side removed highlighting a replacement suture tied too short on the anterior leaflet of the mitral valve; 
           [0065]      FIG. 36  is a partial section schematic view illustrating the human heart in systole with the left front side removed with a suture loop from the papillary muscle and another suture loop from the mitral anterior leaflet both passing through the distal end of the deployment device upon its entry into the left atrium; 
           [0066]      FIG. 37  is a partial section schematic view illustrating the human heart in systole with the left front side removed showing a suture loop from the papillary muscle and another suture loop from the mitral anterior leaflet both passing through the distal end of the deployment device which is now seated on a papillary muscle in the left ventricle; 
           [0067]      FIG. 38  is a partial section schematic view illustrating the human heart in systole with the left front side removed with the deployment device seated on a papillary muscle and infusing saline into the left ventricle with the suture chordae tendineae replacement now set to the correct length; 
           [0068]      FIG. 39  is a partial section schematic view illustrating the human heart in systole with the left front side removed showing the fully emplaced coaxial mechanical fastener of  FIG. 20  holding sutures and the proper leaflet coaptation as set in  FIG. 38 ; 
           [0069]      FIG. 40  is a distally oriented perspective view of an additional embodiment of a bidirectional snare device as presented for use; 
           [0070]      FIG. 41  is an enlarged partial section view of the bidirectional snare device presented in  FIG. 40 ; 
           [0071]      FIG. 42  is a proximally oriented view of the bidirectional snare device presented in  FIG. 40 ; 
           [0072]      FIG. 43  is an enlarged partial section view of the bidirectional snare device presented in  FIG. 42 ; 
           [0073]      FIG. 44  is a perspective view illustrating the application of a single emplaced suture with the apparatus first shown in  FIG. 1 ; 
           [0074]      FIG. 45  is a perspective view illustrating the application of two separate emplaced sutures with the apparatus first shown in  FIG. 1 ; 
           [0075]      FIG. 46  is a perspective view illustrating the application of three separate emplaced sutures with the apparatus first shown in  FIG. 1 ; 
           [0076]      FIG. 47A  is a perspective view of a single suture and crimped sleeve as applied in the intended field of use as a coaxial mechanical fastener; 
           [0077]      FIG. 47B  is a perspective view of the coaxial fastener first shown in  FIG. 47A  with the crimped sleeve removed for clarity; 
           [0078]      FIG. 48A  is a perspective view of two separate sutures and crimped sleeve as applied in the intended field of use as a coaxial mechanical fastener; 
           [0079]      FIG. 48B  is a perspective view of the coaxial fastener first shown in  FIG. 48A  with the crimped sleeve removed for clarity; 
           [0080]      FIG. 49A  is a perspective view of three separate sutures and crimped sleeve as applied in the intended field of use as a coaxial mechanical fastener; 
           [0081]      FIG. 49B  is a perspective view of the coaxial fastener first shown in  FIG. 49A  with the crimped sleeve removed for clarity; 
           [0082]      FIG. 50  is a frontal perspective view of the deployment device of  FIG. 5  with an attachment slotted suture securing reel in the Intended field of use; 
           [0083]      FIG. 51  is an exploded perspective view of the slotted suture securing reel of  FIG. 50 ; 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0084]    Referring to  FIGS. 1 through 4 , a bidirectional snare device  10  is shown.  FIG. 1  is a distally oriented perspective view of the bidirectional snare device  10 . The bidirectional snare device  10  consists of a curved handle  50  which fixedly holds a short wire snare  60  and a long wire snare  70  within a receiving bore  51 . The curved handle  50  is typically comprised of a medical-grade stainless steel and formed in such a manner to allow for manipulation by the user. The short wire snare  60  and long wire snare  70  are also made from medical-grade stainless steel, but in small diameter wire form. The short wire snare  60  and long wire snare  70  pass through a wire bore  81  of a malleable sleeve  80 . The sleeve is typically manufactured form a nonreactive, biocompatible material such as titanium and is fashioned that the distal end has an enlarged flange  82  connected to a body  83  of a slightly smaller diameter. The long wire snare  70  is formed by bending a length of wire  72  into a loop  71  with a twisted end  73 . The short wire snare  60  is formed by bending a substantially shorter length of wire  62  into a loop  61  with a twisted end  63 . The twisted end  73  of the long wire snare  70  is passed directly through the wire bore  81  of the sleeve  80  positioning the loop  71  distally from the flange  82 . The twisted end  63  of the short wire loop  60  is passed through the wire bore  81  of the sleeve  80  from the opposite direction than the long wire snare  70 . The twisted end  63  enters the sleeve  80  from the body  83  side, passes through the wire bore  81 , exits the flange  82  and is looped around the sleeve  80  such that part of the loop  61  is flattened and forms an untwisted pair  64  that wrap around the flange  82  and body  83  of the sleeve  80  and the twisted end  63  is positioned next to the twisted end  73  of the long wire snare  70 . Twisted end  63  and twisted end  73  are inserted into the receiving bore  51  and fixedly attached via mechanical means such as welding or crimping. 
         [0085]      FIG. 2  is an enlarged partial cross-sectional perspective view of the bidirectional snare device  10  of  FIG. 1  showing the twisted end  73  of the long wire snare  70 , clearly shown in  FIG. 1 , adjacent to the untwisted pair  64  of the short wire snare  60  passing through the wire bore  81  of sleeve  80 . 
         [0086]      FIG. 3  is a proximally oriented perspective view of the bidirectional snare device  10  shown in  FIG. 1 . Again, the twisted end  73  of the long wire snare  70  passes through the wire bore  81  of the sleeve  80  with the loop  71  positioned distal to the flange  82 . The short wire snare  60  is passed through the sleeve  80  such that the loop  61  is proximal to the flange  82  and the untwisted pair  64  pass through the wire bore  81  of the sleeve  80  and wraps around the body  83  and the twisted end  63  is positioned parallel to and coincident with the twisted end  73  of the long wire snare  70 . Twisted end  73  and twisted end  63  are fixedly attached to curved handle  50 . 
         [0087]      FIG. 4  is an enlarged partial cross-sectional perspective view of the bidirectional snare device  10  of  FIG. 3  showing the twisted end  73  of the long wire snare  70 , clearly shown in  FIG. 3 , adjacent to the untwisted pair  64  of the short wire snare  60  passing through the wire bore  81  of sleeve  80 . 
         [0088]      FIG. 5  is a distally oriented perspective view of the bidirectional snare device  10  and a deployment device  20 . The curved handle  50  of the bidirectional snare device  10  is inserted through a distal opening  91  and exits an exit port  92  (best illustrated in  FIG. 5B ) in a distal tip  90  until the flange  82  of the sleeve  80  rests firmly against a frontal face  111  of a hammer anvil  110  within the distal tip  90 . 
         [0089]      FIG. 5A  is an enlarged perspective view of the distal end of the deployment device  20  of  FIG. 5  with the installed bidirectional snare device  10  of  FIG. 1 . The twisted end  73  and twisted end  63  of the long wire snare  70  and the short wire snare  60 , respectively exit the distal tip  90  through the exit port  92  (best shown in  FIG. 5B ). The remaining twisted end  73  exits the distal opening  91 , positioning loop  71  distal to the distal tip  90 . The loop  61  of the short wire snare  60  and the untwisted pair  64  exit the distal tip  90  through a loop channel  94 . The sleeve  80  is shown with the flange  82  seated against the frontal face  111  of the hammer anvil  110  within the distal tip  90 . 
         [0090]      FIG. 5B  is an enlarged perspective view of the deployment device  20  along lines  5 B- 5 B of  FIG. 5  with the installed bidirectional snare device  10  of  FIG. 1 . The twisted end  73  and twisted end  63  of the long wire snare  70  and the short wire snare  60 , respectively exit the distal tip  90  through the exit port  92 . The loop  71  of the long wire snare  70  is positioned distal to the tip  90 . The loop  61  of the short wire snare  60  and the untwisted pair  64  (not shown) exit the distal tip  90  through a loop channel  94 . 
         [0091]      FIG. 5C  is a distally oriented perspective view of the bidirectional snare device  10  and a deployment device  20  in an alternate assembly configuration. The small loop  61  of the short wire snare  60  is first routed in direction  65  through the exit port  92  over a projecting suture elevator  120 , out of the entry port  96 , through the trough  95  (all part of the distal tip  90  and best shown in  FIG. 7 ). The small loop  61  of the short wire snare is then inserted into the flange  82  and through the wire bore  81  of the sleeve  80  and finally out through the loop channel  94  of the distal tip  90 . The curved handle  50  of the bidirectional snare device  10  is inserted through a distal opening  91  and exits the exit port  92  (best illustrated in  FIG. 7 ) in the distal tip  90  until the flange  82  of the sleeve  80  rests firmly against a frontal face  111  of a hammer anvil  110  within the distal tip  90 . 
         [0092]      FIG. 6  is an enlarged perspective view of the distal end of the deployment device  20  of  FIG. 5C  with the installed bidirectional snare device  10  of  FIG. 1 . The twisted end  73  and twisted end  63  of the long wire snare  70  and the short wire snare  60 , respectively exit the distal tip  90  through the exit port  92  (also best shown in  FIG. 7 ). The remaining twisted end  73  exits the distal opening  91 , positioning loop  71  distal to the tip  90 . The loop  61  of the short wire snare  60  exits the distal tip  90  through a loop channel  94  and the untwisted pair  64  lay within a trough  95  (also better shown in  FIG. 7 ) in the distal tip  90 . The sleeve  80  is shown with the flange  82  seated against the frontal face  111  of the hammer anvil  110  within the distal tip  90 . 
         [0093]      FIG. 7  is an enlarged perspective view of the deployment device  20  along lines  7 - 7  of  FIG. 5C  with the installed bidirectional snare device  10  of  FIG. 1 . The twisted end  73  and twisted end  63  of the long wire snare  70  and the short wire snare  60 , respectively, exit the distal tip  90  through the exit port  92 . The loop  71  of the long wire snare  70  is positioned distal to the tip  90 . The loop  61  of the short wire snare  60  exits the distal tip  90  through a loop channel  94  and the untwisted pair  64  lay within a trough  95  in the distal tip  90 . 
         [0094]      FIG. 8  is a proximally oriented perspective view of the bidirectional snare device  10  and a deployment device  20 . The curved handle  50  of the bidirectional snare device  10  exits the distal tip  90  and remains in line with a shaft tube  230  of deployment device  20 . 
         [0095]      FIG. 9  is an enlarged perspective view of the distal end of the deployment device  20  of  FIG. 8  showing the curved handle  50  and twisted end  73  and twisted end  63  of long wire snare  70  and short wire snare  60 , respectively, running parallel to the axis of the shaft tube  230  of the deployment device  20 . The loop  71  of the long wire snare  70  is shown positioned distal to the distal tip  90  while the loop  61  of the short wire snare  60  is shown exiting the loop channel  94  of the distal tip  90 . 
         [0096]      FIG. 10  is a partial orthogonal section view of the deployment device  20  and bidirectional snare device  10  along lines  10 - 10  of  FIG. 8 . The loop  61  of the short wire snare  60  exits the loop channel  94  of the distal tip  90  while the twisted end  73  of the long wire snare  70  and twisted end  63  of the short wire snare  60 , respectively, exit the exit port  92  of the distal tip  90 . The flange  82  of the sleeve  80  rests flush with the frontal face  111  of the hammer anvil  110 . 
         [0097]      FIG. 11  is a partial orthogonal section view of the deployment device  20  and bidirectional snare device  10  along lines  11 - 11  of  FIG. 9  wherein the flange  82  of the sleeve  80  rests against the frontal face  111  of the hammer anvil  110 , The untwisted pair  64  of the short wire snare  60  rests within the trough  95  of the distal tip  90  and reenters the distal tip  90  through an entry port  96 , routed over a suture elevator  120  and through the exit port  92  parallel to and coincident with the twisted end  73  of the long snare wire  70 . 
         [0098]    Referring to  FIGS. 12 through 19 , the method of loading suture tails  130  of suture  133  from a leaflet  150  (shown in  FIG. 36 ) and suture tails  140  of suture  146  from a papillary muscle  160  (also shown in  FIG. 36 ) into the bidirectional snare device  10  and the deployment device  20 . 
         [0099]      FIG. 12  is a partial distally oriented rear perspective view of the deployment device  20  with installed bidirectional snare device of  FIG. 8  showing suture tails  130  of suture  133  placed into the loop  61  of the short wire snare  60  of the bidirectional snare device  10 . 
         [0100]      FIG. 13  is a progression of  FIG. 12  where the curved handle  50  of the bidirectional snare device  10  is pulled in the direction  52  relative to the deployment device  20 . The loop  61  from  FIG. 12  has retracted into the distal tip  90  pulling the suture tails  130  of suture  133  in direction  131  and further into the distal tip  90  while the loop  71  of the long wire snare  70  of the bidirectional snare device  10  progresses in direction  74  towards the distal tip  90 . 
         [0101]      FIG. 14  is a progression of  FIG. 13  where the curved handle  50  of the bidirectional snare device  10  is pulled further in the direction  52  relative to the deployment device  20 . The loop  61  has collapsed and fully withdrawn from the distal tip  90 , pulling the suture tails  130  of suture  133  in direction  132  fully through and exiting the distal tip  90 . The loop  71  of the long wire snare  70  of the bidirectional snare device  10  progresses further in the direction  74  towards the distal tip  90 . 
         [0102]      FIG. 15  is a partial distally oriented rear perspective view of the deployment device with installed bidirectional snare device of  FIG. 8  showing suture tails  140  of suture  146  placed into the loop  71  of the long wire snare  70  of the bidirectional snare device  10 . 
         [0103]      FIG. 16  is a progression of  FIG. 15  where the curved handle  50  of the bidirectional snare device  10  is pulled in the direction  52  relative to the deployment device  20 . The loop  71  of the long wire snare  70  of the bidirectional snare device  10  further retracts in the direction  74  into the distal tip  90  pulling the suture tails  140  of suture  146  toward the distal tip  90 . 
         [0104]      FIG. 17  is a progression of  FIG. 16  where the curved handle  50  of the bidirectional snare device  10  is pulled further in the direction  52  relative to the deployment device  20 . The loop  71  of the long wire snare  70  of the bidirectional snare device  10  has progressed further in the direction  74  and has collapsed and withdrawn from the distal tip  90 , pulling the suture tails  140  of suture  146  in direction  141  fully through and exiting the distal tip  90 . 
         [0105]      FIG. 18  is a final progression of  FIG. 17  where the suture tails  140  of suture  146  have been pulled in direction  142  and completely through the distal tip  90 . The bidirectional snare device  10  (last shown in  FIG. 17 ) is disposed. 
         [0106]      FIG. 19  is a partial distally oriented rear perspective view of the deployment device  20  in  FIG. 8  showing suture tails  130  of suture  133  and suture tails  140  of suture  146  being tensioned in direction  143  as the deployment device  20  is extended in direction  145  to place the distal tip  90  on the desired deployment site. 
         [0107]      FIG. 20  is a perspective view of a coaxial mechanical fastener  30  with suture  133  attached to a leaflet  150  and the suture  146  attached to a papillary muscle  160  a now crimped sleeve  80  retains both suture  133  and suture  146  such that the suture tails  130  exit from the flange  82  of the sleeve  80  and the suture tails  140  exit from the body  83  of the sleeve  80 . 
         [0108]      FIG. 21  is an exploded perspective view of the deployment device  20 . The deployment device  20  comprises a left handle  170 , right handle  180 , and a lever  190  all of which are suitably manufactured from a medical grade plastic via an injection molding process. The lever  190  is constrained by and pivots about posts  191  that are circumferentially disposed within pivot bore  171  of the left handle  170  and a similarly defined pivot bore  181  (not shown) within the right handle  180 . An extension spring  200 , typically made from a biocompatible material such as stainless steel, provides preload to the lever  190  by attaching to a spring tab  192  on the lever  190  via a hook  201  and attaching to a post  172  in the left handle  170  via a loop  202 . A wedge tip  210  is retained in a pocket  193  of the lever  190  by rotational posts  211 . The wedge tip is made, preferably, from a medical grade plastic via the injection molding process. A cutter blade  220 , made from a medical grade metal such as stainless steel is attached to the wedge tip  210  and retained and constrained by the geometry of the wedge tip  210  and an internal bore  231  of a shaft tube  230 . The shaft tube  230 , preferably made from stainless steel, is constrained by mating slots  232  in the shaft tube  230  and fingers  173  and fingers  182  (not shown) within the left handle  170  and right handle  180 , respectively. A fluid-tight seal is maintained at the proximal end of the shaft tube  230  and wedge tip  210  by the installation of an o-ring  240  over a groove  212  of the wedge tip  210 . A fluid housing  250 , made from plastic, is slid over the shaft tube  230  through a shaft bore  251  such that a communication bore  252  aligns with fluid channels  233  in the shaft tube  230 . The hammer anvil  110 , also manufactured from a medical grade metal such as stainless steel or the like, is secured within the distal end of the shaft tube  230  by press fitting a pin  260  through pin hole  97  in the distal tip  90  and pin hole  234  in the shaft tube  230  and through a pin channel  112  in the hammer anvil  110 . The suture elevator  120 , comprised of a medical grade stainless steel, is installed within the shaft tube  230  by press fitting into an elevator slot  235 . 
         [0109]      FIG. 22  is a distally oriented, partially sectioned perspective view of the deployment device  20  of  FIG. 5  showing the introduction of fluid  270  through the communication bore  252  of the fluid housing  250  and subsequently through the fluid channels  233  in the shaft tube  230 . Fluid  270  flows through the shaft tube  230  and out of the distal tip  90  to provide infusion. 
         [0110]      FIG. 23  is a distally oriented, partial section view of the deployment device  20  along lines  23 - 23  in  FIG. 21  wherein the lever  190  is fully extended in its natural position, the wedge tip  210  and attached cutter blade  220  are retracted with the o-ring  240  providing a seal during fluid communication through the fluid housing  250 . The bidirectional snare device  10  is not shown for clarity. 
         [0111]      FIG. 24  is an enlarged partial view of  FIG. 23  illustrating the position of the o-ring  240  on the groove  212  of the wedge tip  210  within the shaft tube  230 . The fluid housing  250  provides a fluid tight seal via the compression fit of shaft bore  251  on the shaft tube  230 . Fluid passes through the fluid housing  250  into the shaft tube  230  by way of fluid channels  233  and through the shaft tube  230  over the wedge tip  210  by way of fluid troughs  213 . 
         [0112]      FIG. 25  is an enlarged partial view of  FIG. 23  illustrating the position of the wedge tip  210  in relation to the hammer anvil  110 . The fluid troughs  213  of the wedge tip  210  communicate fluid to the distal tip  90 . An arm  214  of wedge tip  210  is proximal to and not engaging a ramp  113  of the hammer anvil  110 . The sleeve  80  is shown with the flange  82  resting against the frontal face  111  of the hammer anvil  110 . 
         [0113]      FIG. 26  is a distally oriented, partial section view of the deployment device  20  along lines  23 - 23  in  FIG. 21  wherein the lever  190  is fully retracted in direction  194 , extending the extension spring  200  and driving the wedge tip  210  and cutter blade  220  in direction  215 . The bidirectional snare device  10  is not shown for clarity. 
         [0114]      FIG. 27  is an enlarged partial view of  FIG. 26  illustrating the position of the o-ring  240  on the now advanced groove  212  of the wedge tip  210  within the shaft tube  230 . Fluid is allowed to communicate through the shaft tube  230  by way of the fluid housing  250  and coinciding fluid channels  233  of the shaft tube  230  and over the fluid troughs  213  of wedge tip  210 . 
         [0115]      FIG. 28  is an enlarged partial view of  FIG. 26  illustrating the position of the wedge tip  210  in relation to the hammer anvil  110 . The fluid troughs  213  of the wedge tip  210  communicate fluid to the distal tip  90 . The arm  214  of wedge tip  210  is now engaging the ramp  113  of the hammer anvil  110  and causing the hammer anvil  110  to compress the sleeve  80 . 
         [0116]      FIG. 28A  is an orthogonal section view along view lines  28 - 28  of  FIG. 28  illustrating the advanced wedge tip  210  compressing the hammer anvil  110  and sleeve  80  and the also advanced cutter blade  220  impacting the suture elevator  120  and trimming suture tails  130  and suture tails  140 . 
         [0117]      FIG. 28B  is an alternate enlarged partial section view of  FIG. 28  again illustrating the advanced wedge tip  210  compressing the hammer anvil  110  and sleeve  80  and the also advanced cutter blade  220  impacting the suture elevator  120  and trimming suture tails  130  and suture tails  140 . 
         [0118]      FIG. 29  is an enlarged perspective view of the sleeve  80  compressed by the actions detailed in  FIG. 28 . The body  83  of sleeve  80  is compressed, but the flange  82  is intact. 
         [0119]      FIG. 30  shows a schematic illustration of the human heart  40  sectioned to remove the front from the left side of the heart. This heart  40  is shown during diastole which is the filling phase during the cardiac cycle. The right side is not highlighted in this illustration. The left atrium  300  receives blood returning from the lungs through the pulmonary veins  301  and  302 . Two pulmonary veins generally enter to the left atrium  300  on the patient&#39;s right side  300 A and two more on the patient&#39;s left atrial side  3008 . Note the four open arrows  303  coming from the pulmonary veins  301  and  302  illustrating the return of blood flow to the left atrium  300 . During this phase of the cardiac cycle, the anterior leaflet  304  of the mitral valve  305  and the posterior leaflet  306  of the mitral valve  305  are open to permit the blood returning into the atrium  300  to pass into the left ventricle  307 . Note that the chordae tendineae  308  is shown passing from the anterior leaflet  304  of the mitral valve  305  to a papillary muscle  309  in the left ventricle  307 . Note that a second chordae tendineae  310  is shown here passing from the posterior leaflet  306  to another papillary muscle  311 . The thin black arrows  312  indicate the opening of the anterior and posterior mitral valve leaflets,  304  and  306 . The aortic valve  314  is shown in the closed position as it is during diastole due to back pressure from blood in the ascending aorta  315 . For purposes of clarity, this illustration does not show the right atrium or the right ventricle. 
         [0120]      FIG. 31  illustrates the heart  40  now in the contraction phase, systole, of the cardiac cycle. The cardiac walls  316  and septum  317  thicken as the ventricular chamber  318  contracts. The thin black arrows  312  and  313  illustrate that the pressure built up in the left ventricle  307  causes both the anterior mitral leaflet  304  and posterior mitral leaflet  306  to come together and seal at what is called the coaptation zone  319 . The four open arrows illustrate blood leaving the left ventricle and passing through the now open aortic valve  314 . 
         [0121]      FIG. 32  is similar to  FIG. 31  with the schematic heart  40  in systole. However, here the chordae tendineae  308  in  FIG. 30  which should be in continuity between the papillary muscle  309  and anterior leaflet  304  of the mitral valve  305  has been disrupted. This disrupted chordae tendineae  320  is shown partially attached to the papillary muscle  309  and partially attached  320  to the anterior leaflet  304 . The coaptation zone  319  between the anterior leaflet  304  and the posterior leaflet  306  is disrupted allowing blood to pass back into the left atrium  300  instead of being blocked by the coapted mitral valve  305 . This passing of blood back into the right atrium is called regurgitation, and the movement of the anterior leaflet into the left atrium is called prolapse. 
         [0122]      FIG. 33  shows a proper length suture hand-tied replacement  321  for a disrupted chordae tendineae, which is not shown here due to its surgical removal. The open arrows  303  indicating blood show that the blood again passes only towards the now open aortic valve  314 . 
         [0123]      FIG. 34  is similar to the illustration of  FIG. 33  however in  FIG. 34  the hand-tied suture replacement  321  of suture  321 A (for the anterior leaflet  304  disrupted chordae tendineae  308  as shown in  FIG. 32 ) is tied too long so that the anterior leaflet  304  can prolapse into the left atrium  300  thereby rendering the coaptation zone  319  dysfunctional. One open arrow illustrates the passage of blood regurgitating back into the left atrium  300  due to inaccurate knotting of the chordae tendineae replacement suture  321 . 
         [0124]      FIG. 35  is like  FIGS. 33 and 34  however now the chordae tendineae replacement suture  321  is too short. By tying the replacement suture  321  of suture  321 A too short, the coaptation zone  319  of the mitral valve  305  is rendered open. The inappropriate coaptation of the anterior leaflet  304  leaves a space between the anterior leaflet  304  and the posterior leaflet  306  through which blood can pass as illustrated with the open arrow  323 . 
         [0125]      FIG. 36  shows the tip of the deployment device  20  of the present invention passing into the schematic left atrium  300  of the human heart  40 . Note there are two different loops of suture,  324  and  325 , one coming from the papillary muscle  309  and another coming from the anterior leaflet  304  whose chordae tendineae has been removed. 
         [0126]      FIG. 37  shows similar illustration as  FIG. 36  except now the deployment device  20  has passed completely down onto the papillary muscle  309  in the left ventricle  307 . The suture  324  going from the papillary muscle  309  and through the coaxial mechanical fastener  30  is drawn tight. However the suture  325  going to the anterior leaflet  304  has yet to be drawn down into the proper coaptation alignment. 
         [0127]      FIG. 38  shows the schematic heart  40  with the deployment device  20  in place on the papillary muscle  309  and now also infusing pressurized saline  326  into the left ventricle  307  to push upon the inside surfaces of both of the mitral leaflets  304  and  306 , as indicated by the thin black arrows  313 . By drawing the suture  325  from the anterior leaflet  304  in, the anterior leaflet  304  is pulled down into position in the appropriate zone for coaptation. When the suture length is properly set, the lever  190  (not shown) of the deployment device  20  is squeezed, crimping the coaxial fastener  30  and simultaneously cutting away all redundant suture  324  and  325  through the suture hole (not shown). 
         [0128]      FIG. 39  shows the coaxial fastener  30  in place anchoring the suture  325  coming from the anterior leaflet  304  to the papillary muscle  309 . The double headed arrow  327  indicates the direction of the tension from the papillary muscle  309  up to the anterior leaflet  304 . Note that the coaptation zones  319  are completely in contact and the inner surfaces of both the anterior and posterior mitral leaflets  304  and  306  are parallel and aligned. 
         [0129]      FIG. 40  is a distally oriented perspective view of an additional embodiment of a bidirectional snare device  280 . The bidirectional snare device  280  is formed by first forming a small loop  284  and routing the wire pair  288  through the body  83  of the sleeve  80 . Looping the wire pair  288  around the flange  82  of the sleeve  80 . While maintaining a small loop  284 , arrange the wire pair  288  so that one end is substantially longer than the other and create a twisted portion  285  of about ½ inch in length approximately 2 inches from the small loop  284 . Route the remaining long end of wire  283  through the body  83  of the sleeve  80  and form a large loop  282  again feeding the end of the wire  283  back through the flange  82  of the sleeve  80 . Twist a portion  286  of about 3-4 inches in length until it meets the twisted portion  285 . Finally taking the remaining free ends of wire  283 , create a twisted pair end  287  and secure within the receiving bore  51  of the curved handle  50 . 
         [0130]      FIG. 41  is an enlarged partial cross-sectional perspective view of the bidirectional snare device  280  of  FIG. 40  showing the twisted portion  286  and the wire pair  288  adjacent to each other inside of the wire bore  81  of sleeve  80 . 
         [0131]      FIG. 42  is a proximally oriented perspective view of the bidirectional snare device  280  shown in  FIG. 40 . The large loop  282  is distal from the flange  82  of the sleeve  80  and the small loop  284  is proximal to the body  83  of the sleeve  80 . 
         [0132]      FIG. 43  is an enlarged partial cross-sectional perspective view of the bidirectional snare device  280  of  FIG. 42  again showing the twisted portion  286  and the wire pair  288  adjacent to each other inside of the wire bore  81  of sleeve  80 . 
         [0133]    Referring to  FIGS. 44 through 46 , a variety of therapeutic configurations is detailed in conjunction with the bidirectional snare device  10 .  FIG. 44  is a perspective view of a bidirectional snare device  10  being loaded with a single suture  290  with a suture tail  290 A placed though a papillary muscle  160  and fed through the loop  71  of the long wire snare  70  of the bidirectional snare device  10  and the other suture tail  2908  placed through a leaflet  150  and fed through the loop  61  of the short wire snare  60  of the bidirectional snare device  10 . 
         [0134]      FIG. 45  is a perspective view of a bidirectional snare device  10  being loaded with a suture  291  placed though a papillary muscle  160  and the suture tails  291 A fed through the loop  71  of the long wire snare  70  of the bidirectional snare device  10  and a suture  292  placed through a leaflet  150  and the suture tails  292 A fed through the loop  61  of the short wire snare  60  of the bidirectional snare device  10 . 
         [0135]      FIG. 46  is a perspective view of a bidirectional snare device  10  being loaded with a suture  291  placed though a papillary muscle  160  and the suture tails  291 A fed through the loop  71  of the long wire snare  70  of the bidirectional snare device  10  and sutures  292  and suture  293  placed through a leaflet  150  and the suture tails  292 A and suture tails  293 A, respectively, fed through the loop  61  of the short wire snare  60  of the bidirectional snare device  10 . 
         [0136]      FIGS. 47A through 49B  are perspective views illustrating a variety of configurations of coaxial mechanical fasteners  30 .  FIG. 47A  illustrates the use of the single suture  290  forming a loop  290 C proximal to the body  83  of the sleeve  80  and a loop  290 D distal to the flange  82  of the sleeve  80 . Suture tail  290 A and suture tail  290 B exit the sleeve  80  opposite each other. 
         [0137]      FIG. 47B  illustrates the routing of the suture  290  with the sleeve  80  removed for clarity. 
         [0138]      FIG. 48A  illustrates the use of the suture  292  forming a loop  2928  proximal to the body  83  of the sleeve  80  and the single suture  291  forming a loop  2918  distal to the flange  82  of the sleeve  80 . Suture tails  291 A and suture tails  292 A exit the sleeve  80  opposite each other. 
         [0139]      FIG. 488  illustrates the routing of the suture  291  and suture  292  with the sleeve  80  removed for clarity. 
         [0140]      FIG. 49A  illustrates the use of the suture  292  and suture  293  both forming separate loops  292 B and  293 B, respectively, proximal to the body  83  of the sleeve  80  along with suture  291  forming a loop  291 B distal to the flange  82  of the sleeve  80 . Suture tails  292 A and suture tails  293 A exit the sleeve  80  together at the flange  82  opposite from suture tails  291 A exiting from the body  83 . 
         [0141]      FIG. 498B  illustrates the routing of the suture  291 , suture  292 , and suture  293  with the sleeve  80  removed for clarity. 
         [0142]      FIG. 50  is a perspective view of the deployment device  20  with an attached slotted suture securing reel  330  which is used to maintain coaxial alignment of the papillary suture  324  and leaflet suture  325  with the shaft tube  230  of the deployment device  20  while also aiding in suture management. A yard arm  340  of the slotted suture securing reel  330  is positioned on the shaft tube  230  and secured with a screw  380  through a second bore  343 . The yard arm  340  is typically of a machined stainless steel or the like and has the ability to flex slightly about a flexure groove  342 . The leaflet suture  325  is placed within a slot  341  and is free to slide coaxial to the shaft tube  230 . The papillary suture  324  is placed between compression rings  360 , which are customarily made of a rubber material, and secured via a knurled knob  370  that is comprised of a machined metal or molded plastic and whose threaded bore  371  (best shown in  FIG. 51 ) is threaded onto a threaded shaft  381  (also best shown in  FIG. 51 ) of the screw  380 , which is also typically stainless steel, and applies compressional force onto reel plates  350 , which can be manufactured as machined metal or molded plastic, and subsequently the compression rings  360 . 
         [0143]      FIG. 51  is an exploded perspective view of the slotted suture securing reel  330  of  FIG. 50 . The yard arm  340  is attached to the shaft tube  230  of the deployment device  20  by the compressional force applied by the knurled knob  370  whose threaded bore  371  is threaded onto the threaded shaft  381  of the screw  380  and subsequently compresses the reel plates  350  whose bores  351  fit over the threaded shaft  381  of screw  380  and compression rings  360  whose internal diameters  361  also fit over the threaded shaft  381  of screw  380 . 
         [0144]    While the invention has been described in connection with a number of presently preferred embodiments thereof, those skilled in the art will recognize that a number of modifications and changes may be made therein without departing from the true spirit and scope of the invention which accordingly is intended to be defined solely by the appended claims.