Abstract:
One aspect of the present disclosure includes a system comprising prosthetic chordae, at least one attachment member including a channel, a female securing member, and a papillary penetration member configured to pass through the channel, the chordae, and the securing member when implanted in a patient&#39;s heart. The penetration member includes an axis.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority from U.S. Provisional Patent Application Ser. No. 61/164,937, filed Mar. 31, 2009, the subject matter of which is incorporated hereby incorporated by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to cardiac valve repair, and more particularly to a pre-sized prosthetic chordae assembly (PCA) and apparatus for implanting the pre-sized PCA to repair mitral and tricuspid valves. 
       BACKGROUND OF THE INVENTION 
       [0003]    Heart valve replacement is a well known procedure in which an artificial heart valve prosthesis is implanted in place of a diseased or malfunctioning heart valve. Heart valve prostheses may be mechanical or bioprosthetic. Use of mechanical valves typically requires extensive anticoagulation therapy. The need for anticoagulation therapy can be avoided in general by the use of artificial biological heart valves, such as bovine xenografts. Nevertheless, dystrophic calcification with subsequent degeneration is the major cause of failure of such bioprostheses in the long term. 
         [0004]    When mitral or tricuspid valve replacement is performed, the chordae tendineae are cut, thus leaving the geometry and function of the ventricle impaired and in need of reconstruction. As an alternative to conventional heart valve replacement operations, diseased and malfunctioning chordae can be repaired by surgically replacing diseased heart chordae with artificial chordae. One known way of replacing a malfunctioning chordae uses a simple suture with a needle on each end of the suture. The suture is stitched through the papillary muscle and secured thereto with a knot. The two ends of the suture are then similarly stitched through the free ends of the valve leaflets. 
         [0005]    Operations to repair heart valve chordae are technically demanding. For example, when a second knot is needed to secure the suture to the valve leaflets, the length of the suture spanning the distance between the papillary muscle and the valve leaflet is likely to change since there is nothing holding the suture in place. This complication increases the skill and time required to perform the procedure. Moreover, the valve will not function properly if the length of the artificial chordae between the papillary muscle and valve leaflet is overly long or overly short. 
       SUMMARY OF THE INVENTION 
       [0006]    According to one aspect of the present invention, a pre-sized prosthetic chordae assembly includes a male attachment unit and a female securing member. The male attachment unit includes a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. The female securing member is for receiving the papillary penetration member. 
         [0007]    According to another aspect of the present invention, an apparatus is provided for implanting a pre-sized prosthetic chordae assembly in a subject. The apparatus comprises a proximal handle, a distal applicator end, and an actuating mechanism. The distal applicator end is operably linked to the proximal handle via an intermediate portion that defines a longitudinal axis. The distal applicator end comprises opposable first and second jaw members. Each of the first and second jaw members includes a port for receiving the pre-sized prosthetic chordae assembly. The actuating mechanism extends between the proximal handle and the distal applicator end. The actuating mechanism is for actuating the second jaw member. 
         [0008]    According to another aspect of the present invention, a method is provided for implanting a pre-sized prosthetic chordae assembly in a subject. One step of the method includes providing a pre-sized prosthetic chordae assembly. The pre-sized prosthetic chordae assembly includes a male attachment unit comprising a plurality of pre-sized prosthetic chordae fixedly connected to at least one male attachment member and a papillary muscle penetration member that is connected to and extends substantially axial to the at least one male attachment member. An apparatus for implanting the pre-sized prosthetic chordae assembly is also provided. The apparatus comprises a proximal handle, a distal applicator end operably linked to the proximal handle, and an actuating mechanism. The distal applicator end comprises opposable first and second jaw members. The actuating mechanism extends between the proximal handle and the distal applicator end. The female securing member and the male attachment unit are loaded onto the first and second jaw members, respectively. Next, the distal applicator end is positioned about a papillary muscle so that the first and second jaw members are disposed about opposite sides of the papillary muscle. The proximal handle is then operated to actuate the second jaw member such that the papillary penetration member pierces the papillary muscle and is received by the female securing member. The distal applicator end is retracted so that the female securing member and the male attachment unit are slidably removed from the first and second jaw members, respectively, and remain implanted in the subject. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The foregoing and other features of the present invention will become apparent to those skilled in the art to which the present invention relates upon reading the following description with reference to the accompanying drawings, in which: 
           [0010]      FIG. 1A  is a perspective view of a pre-sized prosthetic chordae assembly (PCA) constructed in accordance with one aspect of the present invention; 
           [0011]      FIG. 1B  is a perspective view of an apparatus for implanting the pre-sized PCA of  FIG. 1A  in a subject constructed in accordance with another aspect of the present invention; 
           [0012]      FIG. 2A  is an enlarged perspective view of the pre-sized PCA shown in  FIG. 1A ; 
           [0013]      FIG. 2B  is a perspective view showing a prosthetic chordae of the pre-sized PCA in  FIG. 2A ; 
           [0014]      FIG. 2C  is a cross-sectional view taken along Line  2 C- 2 C in  FIG. 2A ; 
           [0015]      FIG. 2D  is a cross-sectional view showing the pre-sized PCA of  FIG. 2C  in an exploded configuration; 
           [0016]      FIG. 3  is a perspective view showing an alternative configuration of the apparatus in  FIG. 1B ; 
           [0017]      FIG. 4  is a magnified perspective view showing a distal applicator end of the apparatus in  FIG. 1B ; 
           [0018]      FIG. 5  is an exploded perspective view of the apparatus in  FIG. 1B ; 
           [0019]      FIG. 6A  is a side view showing an actuating mechanism of the apparatus in  FIG. 1B ; 
           [0020]      FIG. 6B  is a magnified side view showing a distal end of the actuating mechanism in  FIG. 6A ; 
           [0021]      FIG. 7  is a process flow diagram illustrating a method for implanting a pre-sized PCA in a subject according to another aspect of the present invention; 
           [0022]      FIG. 8  is a perspective view showing the pre-sized PCA of  FIG. 1A  loaded onto the distal applicator end; 
           [0023]      FIG. 9  is a perspective view showing the distal applicator end in  FIG. 8  positioned about a papillary muscle; 
           [0024]      FIG. 10  is a perspective view showing the distal applicator end engaging the papillary muscle in  FIG. 9 ; 
           [0025]      FIG. 11  is a perspective view showing the distal applicator end being retracted from the papillary muscle in  FIG. 10 ; and 
           [0026]      FIG. 12  is a perspective view showing the pre-sized PCA secured to the papillary muscle in  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    The present invention relates to cardiac valve repair, and more particularly to a pre-sized prosthetic chordae assembly (PCA) and apparatus for implanting the pre-sized PCA to repair mitral and tricuspid valves. As representative of the present invention,  FIGS. 1A-B  illustrate a pre-sized PCA  10  ( FIG. 1A ) and an apparatus  12  ( FIG. 1B ) for implanting the pre-sized PCA in a subject. Although the present invention is described herein as being useful for treating a dysfunctional mitral valve (not shown), it should be appreciated that other cardiac valves, such as the tricuspid valve (not shown) are also treatable using the present invention. 
         [0028]    Referring to  FIGS. 2A-D , one aspect of the present invention includes a pre-sized PCA  10 . As shown in  FIG. 2A , the pre-sized PCA  10  comprises a male attachment unit  14  and a female securing member  16  for receiving a papillary muscle penetration member  18  of the male attachment unit. The male attachment unit  14  comprises a plurality of pre-sized prosthetic chordate  20  fixedly connected to at least one male attachment member  13 . The pre-sized prosthetic chordae  20  can be identically or similarly constructed as those described in U.S. patent application Ser. No. 12/238,322, filed Sep. 28, 2007, the entirety of which is hereby incorporated by reference. 
         [0029]    As shown in  FIG. 2A , each of the pre-sized prosthetic chordae  20  includes a first end portion  22 , a second end portion  24 , and a middle portion  26  extending between the first and second end portions. Each of the pre-sized prosthetic chordae  20  is comprised of a plurality of loop members  28  arranged in a daisy chain or ladder-like configuration. Each of the loop members  28  comprises two generally parallel strands  30  and includes first and second ends  32  and  34  respectively defining first and second arcuate junctions  36  and  38 . The distance between the first and second arcuate junctions  36  and  38  is about 1 cm; however, it should be appreciated that the distance between the first and second arcuate junctions will depend upon anatomical variation between subjects. The two generally parallel strands  30  are fluidly connected to the first and second arcuate junctions  36  and  38  of each loop member  28 . Each loop member  28  has a size and length that is substantially equal to the size and length of the other loop members. 
         [0030]      FIG. 2B  illustrates one example of a pre-sized prosthetic chordae  20  having a ladder-like configuration. In  FIG. 2B , the pre-sized prosthetic chordate  20  can comprise a continuous first strand  180  of a material (e.g., a suture) having an arcuate first end portion  22  and a second end portion  24  that is formed into a knot  182 . At least one rung  184  is axially-spaced between the first and second end portions  22  and  24  of the first strand  180 . As shown in  FIG. 2B , each of the rungs  184  includes first and second ends  186  and  188  that are securely connected to the first strand  180  by first and second knots  180 ′ and  180 ″. The rungs  184  can be made of any biocompatible material, such as suture material. During implantation of the pre-sized PCA  10 , the first strand  180  can be cut at a plurality of points (indicated by “X”) to quickly and easily adjust the length of the prosthetic chordae  20  so that the pre-sized PCA optimally conforms to the cardiac anatomy of the subject. 
         [0031]    Each loop member  28  is made from a relatively elastic and flexible biocompatible material. Examples of such biocompatible materials can include Teflon and expanded polytetrafluoroethylene (ePTFE). ePTFE, for example, may be suture material or fabric material. Besides Teflon and ePTFE, it should be apparent to one skilled in the art that there are other suitable biocompatible materials, such as those frequently used to form sutures. 
         [0032]    Each of the pre-sized prosthetic chordae  20  comprises an elongated, unitary unit of four interconnected loop members  28 . Each of the pre-sized prosthetic chordae  20  is comprised of a single strand or fiber, such as a suture; however, it should be appreciated that the pre-sized prosthetic chordae may be comprised of multiple units, e.g., multiple sutures. Where each of the pre-sized prosthetic chordae  20  is comprised of multiple sutures, for example, each of the sutures can be fixedly joined to form each of the loop members  28 . It should also be appreciated that any number of loop members  28  can be used to form the pre-sized prosthetic chordae  20 . Accordingly, each of the pre-sized prosthetic chordae  20  is adjustable to a pre-determined length by adding or removing any desired number of loop members  28 . 
         [0033]    As noted above, the male attachment unit  14  comprises a plurality of pre-sized prosthetic chordate  20  fixedly connected to at least one male attachment member  13 . In one aspect of present invention, each of the pre-sized prosthetic chordae  20  ( FIG. 2A ) is fixedly sandwiched between a first male attachment member  40  and a second male attachment member  42 . The first male attachment member  40  comprises a pledget having first and second surfaces  44  and  46  ( FIG. 2D ). The first male attachment member  40  can be made of any medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). As shown in  FIG. 2A , the first male attachment member  40  additionally includes a rigid or semi-rigid backing  48  for supporting the papillary muscle penetration member  18 . The backing  48  can be comprised of a hardened polymer, for example, that extends across all or a portion of the second surface  46  of the first male attachment member  40 . 
         [0034]    The second male attachment member  42  comprises a pledget having by first and second surfaces  50  and  52  ( FIG. 2D ). The second male attachment member  42  can be made of any medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). The second male attachment member  42  includes at least one channel  54  ( FIG. 2A ) that extends between the first and second surfaces  50  and  52  and is capable of receiving the papillary muscle penetration member  18 . As shown in  FIG. 2D , each of the pre-sized prosthetic chordae  20  is securely attached to the first surface  50  of the second male attachment member  42  using sutures or clips (not shown), for example. It will be appreciated, however, that each of the pre-sized prosthetic chordae  20  may be securely attached to the second surface  52  of the first male attachment member  40 . 
         [0035]    As noted above, the male attachment unit  14  also includes a papillary muscle penetration member  18  for penetrating a papillary muscle  56  ( FIG. 9 ). The papillary muscle penetration member  18  ( FIG. 2D ) can comprise a needle having a proximal end  58  and a sharpened distal tip  60 . Where the papillary muscle penetration member  18  comprises a needle, the needle can have any desired gauge between 10 and 33. As shown in  FIG. 2D , the proximal end  58  of the papillary muscle penetration member  18  is securely connected to the second surface  46  of the first male attachment member  40 . It will be appreciated, however, that the proximal end  58  of the papillary muscle penetration member  18  can be disposed between the first and second surfaces  44  and  46  of the first male attachment member  40 . 
         [0036]    As shown in  FIG. 2D , the female securing member  16  of the pre-sized PCA  10  comprises a pledget having by first and second surfaces  62  and  64 . The female securing member  16  can be made of any suitable medical grade material, such as a durable fibrous material (e.g., gauze) or polymer (e.g., ePTFE). The female securing member  16  includes at least one channel  66  that extends between the first and second surfaces  62  and  64  and is capable of receiving the papillary muscle penetration member  18 . The second surface  64  of the female securing member  16  also includes a protective member  68  to prevent the distal tip  60  of the papillary muscle penetration member  18  from damaging cardiac structures once the pre-sized PCA  10  is implanted. The protective member  68  can include a piece of cotton or gauze, for example, that is integrally formed with or securely attached to the second surface  64  of the female securing member  16 . Alternatively, the protective member  68  can comprise a deformable backing that bubbles outward when the distal tip  60  of the papillary muscle penetration member  18  extends through the channel  66 . 
         [0037]    As shown in  FIG. 1B  and  FIGS. 3-6B , another aspect of the present invention includes an apparatus  12  for implanting the pre-sized PCA  10  ( FIG. 2A ) in a subject. The apparatus  12  ( FIG. 1B ) comprises a proximal handle  70  operably linked to a distal applicator end  72  via an elongated intermediate portion  74 . The elongated intermediate portion  74  defines a longitudinal axis LA that extends between the proximal handle  70  and the distal applicator end  72 . The distal applicator end  72  of the apparatus  12  includes first and second jaw members  76  and  78  adapted to deliver the female securing member  16  ( FIG. 2A ) and the male attachment unit  14 , respectively. As described in more detail below, an actuating mechanism  80  ( FIG. 5 ) for actuating the second jaw member  78  ( FIG. 1B ) extends between the proximal handle  70  and the distal applicator end  72  of the apparatus  12 . 
         [0038]    Referring to  FIG. 1B , the proximal handle  70  includes a handle member  82  that extends substantially perpendicular to the longitudinal axis LA and a lever  84 . The lever  84  is movable from a first position to a second position (indicated by dashed line). Using tactile force, for example, movement of the lever  84  from the first position to the second position is used to operate the actuating mechanism  80  and thereby actuate the second jaw member  78 . 
         [0039]    It will be appreciated that the proximal handle  70  can have other configurations besides the one shown in  FIG. 1B . As shown in  FIG. 3 , for example, the proximal handle  70  can be constructed so that both the handle member  82  and the lever  84  extend substantially parallel to the longitudinal axis LA of the apparatus  12 . Additionally, the proximal handle  70  can include an adjustment mechanism  86  (e.g., a knob) to control rotation of the distal applicator end  72  about the longitudinal axis LA. For example, the adjustment mechanism  86  can be manipulated to cause the distal applicator end  72  to rotate in a clock-wise or counter-clockwise direction relative to the longitudinal axis LA to facilitate implantation of the pre-sized PCA  10 . 
         [0040]    As noted above, the distal applicator end  72  of the apparatus  12  includes opposable first and second jaw members  76  and  78  ( FIG. 4 ). Each of the first and second jaw members  76  and  78  includes a proximal end  88  and a distal end  90 . The distal end  90  of each of the first and second jaw members  76  and  78  includes first and second ports  92  and  94 , respectively, for receiving the female securing member  16  ( FIG. 2A ) and the male attachment unit  14 . Each of the first and second ports  92  and  94  ( FIG. 4 ) is defined by first and second openings  96  and  98 , each of which are in fluid communication with opposing longitudinal slots  100 . The second opening  98  of the second jaw member  78  is adapted to receive the first male attachment member  40 , and the first opening  96  of the first jaw member  76  is adapted to receive the female securing member  16 . Each of the longitudinal slots  100  is adapted to receive the papillary muscle penetration member  18  and extends along a portion of the distal end  90  of the first and second jaw members  76  and  78 . 
         [0041]      FIG. 5  is an exploded view of the apparatus  12  in  FIG. 1B  showing the components of the actuating mechanism  80 , as well as multiple housing components  102  used to house the actuating mechanism. As shown in  FIG. 5 , the actuating mechanism  80  extends between the proximal handle  70  and the distal applicator end  72  of the apparatus  12 . The actuating mechanism  80  comprises first and second L-shaped arm members  104  and  106 , each of which has a proximal end  108  and a distal end  110 . The proximal end  108  of each of the first and second L-shaped arm members  104  and  106  includes first and second lever arms  112  and  114 , respectively, that form the movable lever  84  of the proximal handle  70 . Additionally, the proximal end  108  of each of the first and second L-shaped arm members  104  and  106  includes a lateral slot  116  for operably connecting the first and second lever arms  112  and  114  with a control shaft  118 . 
         [0042]    The distal end  110  of the actuating mechanism  80  has a jack stand-like configuration. As shown in  FIGS. 6A-B , the distal end  110  of each of the first and second L-shaped arm members  104  and  106  is adapted to securely mate with the first and second jaw members  76  and  78 , respectively. Additionally, the distal end  110  of each of the first and second L-shaped arm members  104  and  106  includes a slot  120  ( FIG. 6B ) adapted to receive a first cross arm  122 , a central cross arm  123 , and a second cross arm  124 . 
         [0043]    The actuating mechanism  80  additionally comprises a control shaft  118  that is located between the first and second L-shaped arm members  104  and  106  and includes a proximal end  126  and a distal end  128 . The proximal end  126  of the control shaft  118  includes a guide pin  130  capable of mating with the slot  120  of the first and second L-shaped arm members  104  and  106  and the lateral slot  116  ( FIG. 6A ) of the first and second lever arms  112  and  114 . The distal end  128  of the control shaft  118  includes a plurality of pins  132  capable of mating with the first, central, and second cross arms  122 ,  123  and  124 . 
         [0044]    As shown in  FIG. 5 , the actuating mechanism  80  additionally includes wedge-shaped first and second plate members  134  and  136 , each of which includes a first end  138  and a second end  140 . The first end  138  of each of the first and second plate members  134  and  136  is capable of mating with the first and second L-shaped arm members  104  and  106 , respectively. Each of the first and second plate members  134  and  136  includes an axial slot  142  extending between the first and second ends  138  and  140 . The axial slot  142  of each of the first and second plate members  134  and  136  is capable of receiving a proximal end  144  of first and second distal elements  146  and  148 . The proximal end  144  of each of the first and second distal elements  146  and  148  includes a laterally-extending slot  150  for mating with the central cross arm  123  ( FIG. 6B ). 
         [0045]    Operation of the actuating mechanism  80  begins by depressing the movable lever  84 . As the movable lever  84  is depressed, the first and second lever arms  112  and  114  progressively urge the guide pin  130  in a proximal direction so that the control shaft  118  moves laterally towards the proximal handle  70 . As the control shaft  118  is moved laterally, the first and second cross arms  122  and  124  are pulled in a proximal direction along the slot  120  of each of the first and second L-shaped arm members  104  and  106 . Movement of the first and second cross arms  122  and  124  causes the proximal end  144  of each of the first and second distal elements  146  and  148  to move axially towards the control shaft  118  along the axial slot  142  of each of the first and second plate members  134  and  136 . Consequently, the first and second distal elements  146  and  148  cause the second jaw member  78  to move in an axial direction towards the first jaw member  76 . 
         [0046]      FIG. 7  illustrates another aspect of the present invention. In  FIG. 7 , a method  160  is provided for implanting a pre-sized PCA  10  ( FIG. 8 ) in a subject. The method  160  ( FIG. 7 ) can be used to replace diseased or damaged native chordae (not shown). Disease or damage to native chordae can be caused by a variety of factors, such as infection, trauma, and old age. Disease or damage to the native chordae can rupture of the chordae and lead to valvular regurgitation (e.g., mitral valve regurgitation). Advantageously, the method  160  provides a simple and effective means for replacing damaged or diseased chordae to mitigate or prevent cardiac valve dysfunction. 
         [0047]    Step  162  and Step  164  of the method  160  include providing a pre-sized PCA  10  and apparatus  12  for implanting the pre-sized PCA, respectively. The pre-sized PCA  10  can be substantially identical to the pre-sized PCA in  FIGS. 2A-C , and the apparatus  12  can be substantially identical to the apparatus in  FIG. 1B . Prior to replacing a diseased native chordae, the distance between a papillary muscle  56  ( FIG. 9 ) and a location on a mitral valve leaflet (not shown) is first measured. Access to the native chordae may be obtained by open-heart surgery, for example. During surgery, the diseased native chordae are inspected to determine the size of the pre-sized prosthetic chordae  20  needed to replace the diseased native chordae. Generally, the size of the pre-sized prosthetic chordae  20  needed will depend on the size of the heart (not shown), as well as the implantation site. 
         [0048]    A measuring device (not shown) is used to measure the distance between the papillary muscle  56  and the location on the mitral valve leaflet. For example, the measuring device can comprise a measuring device similar or identical to the measuring device disclosed in U.S. patent application Ser. No. 12/238,322. It will be appreciated that other types of measuring devices for measuring the distance between a papillary muscle  56  and a location on a cardiac valve leaflet are known in the art. After determining the distance between the papillary muscle  56  and the location on the mitral valve leaflet, the diseased native chordae are resected and an appropriately-sized PCA  10  selected for implantation. 
         [0049]    At Step  166 , the pre-sized PCA  10  is loaded onto the distal applicator end  72  of the apparatus  12 . As shown in  FIG. 8 , the male attachment unit  14  is mated with the second jaw member  78  by sliding the first male attachment member  40  and the papillary muscle penetration member  18  into the second opening  98  and the longitudinal slot  100 , respectively. Additionally, the female securing member  16  is mated with the first jaw member  76  by sliding the female securing member into the first opening  96  of the first jaw member. 
         [0050]    Once the pre-sized PCA  10  is loaded onto the distal applicator end  72 , the distal applicator end is positioned about the papillary muscle  56  at Step  168 . As shown in  FIG. 9 , the first and second jaw members  76  and  78  are disposed about opposite surfaces of the papillary muscle  56 . Although the first and second jaw members  76  and  78  are shown in  FIG. 9  as being positioned about the apical end of the papillary muscle  56 , it will be appreciated that the first and second jaw members can be positioned about any other desired portion of the papillary muscle (e.g., the basal end). 
         [0051]    With the first and second jaw members  76  and  78  correctly positioned about the papillary muscle  56 , the pre-sized PCA  10  is then secured to the papillary muscle at Step  170 . To secure the pre-sized PCA  10  to the papillary muscle  56 , the movable lever  84  is depressed to actuate the second jaw member  78 . As shown in  FIG. 10 , actuation of the second jaw member  78  causes the papillary muscle penetration member  18  to pierce the papillary muscle  56  and be driven into the female securing member  16 . The lever  84  is depressed until the second jaw member  78  naturally stops and the distal tip  60  of the papillary muscle penetration member  18  is received by the female securing member  16 . 
         [0052]    Once the lever  84  is completely depressed, the distal applicator end  72  is retracted at Step  172 . As shown in  FIG. 11 , the first and second openings  96  and  98  of the first and second jaw members  76  and  78  allows the female securing member  16  and the male attachment unit  14  to be slidably released from the distal applicator end  72 , respectively, and remain affixed to the papillary muscle  56  ( FIG. 12 ). After retracting the apparatus  12  from the subject&#39;s heart, each of the pre-sized prosthetic chordae  20  are securely attached to the mitral valve leaflet as described in U.S. patent application Ser. No. 12/238,322, for example. With the pre-sized PCA  10  implanted in the left ventricle (not shown), the mitral valve leaflet is pulled back into proper alignment so that the mitral valve can function properly and regurgitation through the valve is substantially reduced or prevented. Upon successful placement of the pre-sized PCA  10 , effective valve function is verified (i.e., proper leaflet coaptation) and the open-heart surgery is completed. 
         [0053]    From the above description of the invention, those skilled in the art will perceive improvements, changes and modifications. Such improvements, changes, and modifications are within the skill of the art and are intended to be covered by the appended claims.