Patent Publication Number: US-2009222081-A1

Title: Methods and apparatus for reducing valve prolapse

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/023,368, filed Jan. 24, 2008, entitled METHODS AND APPARATUS FOR REDUCING VALVE PROLAPSE, the disclosure of which is incorporated by reference herein in its entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to methods and devices for limiting valve regurgitation. More specifically, the present invention relates to medical devices and methods for implanting medical devices percutaneously to reduce or limit valve prolapse and regurgitation. 
     BACKGROUND 
     The human heart generally includes four valves. Of these valves, a most critical one is known as the mitral valve. The mitral valve is located in an opening between the left atrium and left ventricle. The mitral valve acts as a check valve and is intended to prevent regurgitation of blood from the left ventricle into the left atrium when the left ventricle contracts. In preventing blood regurgitation the mitral valve must be able to withstand considerable back pressure as the left ventricle contracts. 
     The valve cusps or leaflets of the mitral valve are anchored to the muscular wall of the heart by delicate but strong fibrous cords so as to support the cusps during left ventricular contraction. In a healthy mitral valve, the geometry of the mitral valve ensures that the cusps overlie each other to preclude regurgitation of the blood during left ventricular contraction. 
     Many known methods for treating mitral regurgitation resort to open heart surgery, typically by implanting artificial valves. Such procedures are expensive, are extremely invasive requiring considerable recovery time and, most significantly, pose mortality risks. Further, such open heart procedures are particularly stressful on patients whom already have a cardiac condition. As such, open heart surgery is typically reserved as a last resort and is usually employed late in the mitral regurgitation progression. Moreover, the effectiveness of such procedures is difficult to assess during the procedure and may not be known until a much later time. Therefore, the ability to make adjustments or modifications to the prostheses in order to obtain optimum effectiveness is extremely limited. Later corrections, if made at all, require still another open heart surgery bringing all of the risks and disadvantages discussed previously. 
     Based on the foregoing, it would be advantageous to employ a less invasive procedure to treat mitral regurgitation or any other valve regurgitation issues. 
     BRIEF SUMMARY OF THE INVENTION 
     Embodiments of the present invention are directed to medical devices, systems and methods for implanting a medical device into the heart to minimize valve prolapse. In one embodiment, the medical device may include a loop portion and an intermediate portion. The loop portion includes an outer periphery and an inner periphery, the outer periphery being configured to be positioned above the valve of the heart and lodged against tissue of the heart. The intermediate portion is configured to extend from the inner periphery of the loop portion and configured to substantially minimize or limit upward movement of leaflets of the valve. 
     In another embodiment, the loop portion is configured to self expand and bias against heart tissue adjacently above a valve annulus. The device may also include tines extending from an outer periphery of the loop portion. Further, the device may include a tissue growth member promote tissue growth therein. In another embodiment, the loop portion and the intermediate portion can exhibit a substantially flat shape. 
     In another embodiment, the loop portion includes a tubular configuration, the outer periphery of the tubular configuration being sized and configured to lodge against tissue at a lower portion of the left atrium with the intermediate portion extending from a lower portion of the tubular configuration. 
     In still another embodiment, the intermediate portion includes multiple intermediate portions extending between different portions of the loop portion. The intermediate portion may also include multiple lines extending in a first direction from the inner periphery and multiple lines extending in a second direction from the inner periphery. With this arrangement, the first direction is substantially transverse to the second direction. 
     In another embodiment, the intermediate portion exhibits a coiled configuration so as to allow blood flow therethrough while still substantially preventing upward movement of the leaflets. Further, in another embodiment, the intermediate portion exhibits a curved or arcuate configuration to provide a back-stop to the leaflets of the valve. 
     In another embodiment of the present invention, the medical device includes a tubular portion and an intermediate portion. The tubular portion includes an outer periphery and a lower portion, the outer periphery being configured to be lodged against tissue of the heart adjacently above an annulus of the valve. The intermediate portion is configured to extend from the lower portion of the tubular portion and is configured to extend over leaflets of the valve to substantially minimize or limit upward movement of the leaflets of the valve. 
     In another embodiment, the tubular portion includes a tissue growth member configured to promote tissue in-growth therein and help permanently attach the tubular portion in the heart. Further, in still another embodiment, the medical device may include tines at the outer periphery of the tubular portion, the tines being configured to lodge the tubular portion against the tissue of the heart. In another embodiment, the tubular portion includes an upper loop portion and a lower loop portion with intermediate extensions therebetween to define the tubular portion. 
     In another embodiment, the intermediate portion includes multiple intermediate portions extending between different portions of the lower portion of the tubular portion. Further, the intermediate portion can include a first set of multiple lines extending in a first direction from the lower portion of the tubular portion and a second set of multiple lines extending in a second direction from the lower portion of the tubular portion such that the first direction is substantially transverse to the second direction. 
     In another embodiment, the tubular portion is configured to self expand and bias against the tissue of the heart adjacently above the valve. 
     In still another embodiment of the present invention, the medical device includes an intermediate portion, an anchor portion and a plurality of tabs. The intermediate portion is configured to be positioned above a leaflet free-edge of the valve. The anchor portion is configured to extend from the intermediate portion and configured to lodge against heart tissue above the valve. The plurality of tabs are coupled to the intermediate portion and are configured to abut against leaflets of the valve and substantially minimize or limit upward movement of the leaflets of the valve. In another embodiment, the multiple tabs extend downward and outward from opposite sides of the intermediate portion. 
     In accordance with another embodiment of the present invention, a method is provided for reducing valve prolapse. The method includes disposing a frame within the heart adjacent a valve and limiting movement of at least one leaflet of the valve with a portion of the frame. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The foregoing and other advantages of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which: 
         FIG. 1  is a profile view of a medical device system, according to one embodiment of the present invention; 
         FIG. 1A  is a partial cross-sectional view of a portion of the medical device system of  FIG. 1 , depicting a medical device in a constrained position within a distal portion of a catheter, according to another embodiment of the present invention; 
         FIGS. 2A and 2B  are cross-sectional views of a heart, depicting the medical device of  FIG. 1  being deployed above the mitral valve in the heart; 
         FIGS. 3A through 3C  are respective top views of various embodiments of the medical device depicted in  FIG. 2B ; 
         FIGS. 4A and 4B  are respective top views of additional embodiments of the medical device depicted in  FIG. 2B , according to the present invention; 
         FIGS. 5 and 5A  are perspective and top views, respectively, of a medical device, according to another embodiment of the present invention; 
         FIG. 5B  is a top view of another embodiment of the medical device of  FIG. 5 , according to the present invention; 
         FIGS. 6 and 6A  are perspective and top views, respectively, of a medical device, according to another embodiment of the present invention; 
         FIG. 6B  is a top view of another embodiment of the medical device of  FIG. 6 , according to the present invention; 
         FIG. 7  is a cross-sectional view of a heart with a medical device implanted therein according to an embodiment of the present invention; 
         FIG. 7A  is a top view of the medical device of  FIG. 7 ; 
         FIG. 8  is a profile view of the left side of the heart, depicting a medical device being deployed below the mitral valve to effectively shorten cordae in the heart, according to another embodiment of the present invention; 
         FIGS. 8A and 8B  are enlarged side views of the medical device of  FIG. 8  being deployed and attached to the cordae, according to another embodiment of the present invention; 
         FIG. 9  is an enlarged side view of a medical device, depicting the medical device being used to effectively shorten cordae in the heart, according to another embodiment of the present invention; 
         FIG. 10  is a perspective view of a medical device for implanting within the left ventricle, according to another embodiment of the present invention; and 
         FIGS. 10A and 10B  are side views of the medical device of  FIG. 10  being deployed within the left ventricle of the heart, according to anther embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
     Referring to  FIGS. 1 and 1A , a medical device system  10  is shown that may be used for advancing a medical device  12  that is configured to be employed to substantially prevent valve prolapse in, for example, the mitral valve. In particular, a distal portion  16  of a catheter  14  of the medical device system  10  may be advanced into the left atrium to implant the medical device  12  adjacent to and around the atrioventricular valve annulus in the left atrium. 
     The medical device system  10  may include a handle  20  having an actuator  22 , a fluid port  24  and a disengagement portion  26 . Further, the medical device system  10  may include a catheter  14  having a proximal portion  28  and a distal portion  16  with a catheter lumen  30  extending therethrough. The proximal portion  28  of the catheter  14  is coupled at a distal end of the handle  20 . The distal portion  16  of the catheter  14  may be sized and configured to hold and maintain the medical device  12  when advancing the medical device to the mitral valve in the heart. Further, the medical device  12  may be coupled to the medical device system  10 , within the lumen  30 , via one or more lines or tethers  32 . The tether(s)  32  can extend through the catheter  14  and can be coupled to the handle  20 . The tether(s)  32  may further be releasable via the disengagement portion at the handle  20 . Such a medical device system  10  can be advanced to the left atrium via a guide wire (not shown) by advancing the distal portion  16  of the catheter  14  over the guide wire through a rapid exchange (Rx) lumen  34  subsequent to the guide wire being properly advanced to the heart. Disclosure of a tethering system as well as the rapid exchange lumen can be found in Applicant&#39;s pending patent application, application Ser. No. 11/836,051, the disclosure of which is incorporated herein in its entirety. It should be noted that the medical device system  10  can also be configured to facilitate over the wire delivery, as known in the art. 
     With respect to  FIG. 1A , an enlarged view of the medical device  12  is shown at the distal portion  16  of the catheter  14  (shown in cross-section) in a constrained configuration. The catheter  14  may also include a coil  36  positioned proximally the medical device  12  with the tether  32  extending through or along side the coil  36 . The coil  36  may extend through the catheter lumen  30  to the handle  20  and is configured to either push the medical device  12  from the catheter  14  while the catheter remains fixed or hold the medical device  12  in a substantially fixed position while the catheter  14  is moved proximally via the actuator  22  to, thereby, deploy the medical device  12  from the catheter  14 . 
     Referring to  FIGS. 2A and 2B , there is depicted a side profile view of a left portion of a heart  3 , including a defect in the mitral valve  11  causing regurgitation between the left atrium  5  and the left ventricle  7 . In particular,  FIG. 2A  depicts leaflets  9  of the mitral valve  11  in a prolapsed state, allowing blood back-flow back into the left atrium  5  (the defect). 
     The catheter  14  may be advanced into the left atrium  5 , for example, via a transseptal puncture through the septum wall. The physician can utilize imaging techniques to determine a desired position to begin deployment of the medical device  12 . Once the catheter  14  is in the desired position, the medical device  12  may be deployed from the catheter  14  and may be positioned at a lower portion of the left atrium  5 , for example above and adjacent to the mitral valve  11  or around the atrioventricular valve annulus  13  in the left atrium  5 , as depicted in  FIG. 2B . When deployed from the catheter  14 , the medical device  12  may be configured to self expand and bias against the tissue wall  15  of the left atrium  5 . Once confirmation that the medical device  12  is in a desired position and properly engaged against the tissue wall  15 , the one or more tethers  32  may be disengaged from the medical device  12  and the catheter  14  may be withdrawn from the left atrium  5 . With this arrangement, the periphery of the medical device  12  is configured to be positioned against the valve annulus  13  such that the medical device  12  provides a back-stop (not shown) over the leaflets  9  to, thereby, substantially prevent valve prolapse and the associated mitral regurgitation. The medical device  12  and “back-stop” are described in further detail hereafter. 
     Referring now to  FIGS. 3A through 3C , various embodiments of the medical device, such as depicted in  FIG. 2B , are illustrated with the medical devices being shown from a top view with the leaflets in a coapted position. Each of these embodiments of the medical device may be substantially flat or planar when in their relaxed fully expanded position. However, when lodged adjacently above the mitral valve, the medical device may flex and be slightly out of plane, but still exhibit a substantially flat shape or geometry. 
     With respect to  FIG. 3A , in one embodiment, the medical device  12  may include a looped frame  42  for implanting over the mitral valve. The looped frame  42  may be a circular shaped, oval shaped or any other suitable geometry for disposal over the mitral valve. The looped frame  42  may include an outer periphery  44  and an inner periphery  46 . The inner periphery  46  of the looped frame  42  may define an interior space with a single intermediate cross-member  48  extending across a central portion of the interior space of the looped frame  42 . With this structure, it is most advantageous to orient the looped frame so that the intermediate cross-member  48  is transverse to a free edge  17  of the leaflets  9 . As previously set forth, the medical device  12  includes a low profile having a substantially flat shape (see  FIG. 2B ) such that the cross-member  48  is configured to extend longitudinally over the free edge  17  of the leaflets  9  of the valve perpendicularly or at a desired angle relative thereto. In this manner, when the valve is in an open position (not shown), blood can pass into the left ventricle. When the valve is intended to be in a closed position, the cross-member  48  overcomes the defect and substantially prevents the valve leaflets  9  from extending upward with the cross-member  48  sitting adjacently against the leaflets  9  and acting as a back-stop for the valve leaflets  9  in the closed position. 
     With respect to  FIG. 3B , another embodiment of a medical device  50  is provided. Such medical device  50  can also include a looped frame  52  including an outer periphery  54  and an inner periphery  56 , similar to the previous embodiment, except in this embodiment, the medical device  50  can include multiple cross-members  58  or struts extending across an interior space defined by the inner periphery  56  of the looped frame  52 . Similar to the previous embodiment, it may be desired to orient this device so that the cross-members  58  are transverse to, or at an acute angle relative to, the leaflet free edge  17 , such as depicted in  FIG. 3B . 
       FIG. 3C  illustrates another embodiment of a medical device  60 , similar to the previous embodiments, including a looped frame  62  having an outer periphery  64  and an inner periphery  66 . In this embodiment, the looped frame  62  may include multiple cross-members or lines  68  extending transverse to each other. In particular, within an interior space defined by the inner periphery  66  of the looped frame  62 , there can be multiple, substantially parallel lines  68  or cross members extending in a first direction and multiple parallel lines  68  or cross members extending in a second direction, the first direction being substantially transverse to the second direction to provide a screen like configuration. In another embodiment, the lines  68  may extend within the interior space, connected to the looped frame  62  at opposing sides, but extend in a non-parallel configuration. In either case, this embodiment allows the medical device  60  to be positioned without a specific orientation with respect to the leaflet free edge  17 . In each of these embodiments, the cross-members or lines provide a permanent back-stop to the valve leaflet of, for example, the mitral valve. 
     Referring now to  FIGS. 4A and 4B , other embodiments of a medical device that can be implanted, similar to the shown in  FIGS. 2A and 2B , are disclosed. With respect to  FIG. 4A , the medical device  70  may include a frame  72  with a circular structure or curved structure having two free ends  74  with an intermediate portion  76  therebetween. The intermediate portion  76  extending between the two free ends  74  may include a coiled or semi-coiled configuration. The two free ends  74  include free end portions  78  that can bias outward against the tissue to assist in lodging the medical device  70  in proper position. Further, the free end portions  78  may include tines  79  to facilitate anchoring the medical device  70  within the heart valve. The intermediate portion  76  least is sized and configured to have at least a portion thereof positioned adjacently above the leaflets of a valve so as to provide a back-stop to substantially prevent regurgitation. Further, as in the previous embodiments, the frame  72  may be sized and configured to be readily collapsed or pulled into and disposed out of a catheter (not shown) for delivery and deployment adjacent the mitral leaflets in the left atrium. It is also contemplated that the medical device  70  of this embodiment can be employed with a single free end, rather than the two free ends. 
       FIG. 4B  discloses another embodiment of a medical device  80  with an intermediate portion  82  similar to the previous embodiment, except in this embodiment there are no free ends. In particular, the medical device  80  of this embodiment includes a looped frame  84  having an outer periphery  86  and an inner periphery  88  with an intermediate portion  82  extending within an interior space defined substantially by the inner periphery  88  of the looped frame  84 . As in previous embodiments, the frame  84  may include tines  89  to anchor within the tissue adjacently above a valve, such as a mitral valve. The intermediate portion  82  may exhibit a coiled configuration sized and configured to be positioned above leaflets of a valve to resist vertical movement of the leaflets and, thereby, provide a back-stop for the leaflets of the valve. 
     Referring now to  FIGS. 5 and 5A , another embodiment of a medical device  90  is provided. The medical device  90  of this embodiment may include a tubular structure  92  with multiple lines  94  extending across a lower portion of the tubular structure  92 . The tubular structure  92  may include an upper looped frame  96  and a lower looped frame  98  with an intermediate extension  102  configured to extend between the upper looped frame  96  and lower looped frame  98  in, for example, a sinusoidal or undulating configuration, or any other suitable configuration to form a tubular structure between the upper looped frame  96  and lower looped frame  98 . The lower looped frame  98  may include, or be coupled to, the multiple lines  94  or struts extending across the lower looped frame  98  such that the lines  94  extend between different points of the lower looped frame  98 . In one embodiment, the lines  94  may extend parallel with respect to each other. In another embodiment the lines  94  may extend in a non-parallel configuration. 
     In another embodiment, the medical device  90  can be formed with one or neither of the upper and lower looped frames. As such, the lines  94  may extend between the lower portion of loops  104  of the sinusoidal or undulating configuration. In this manner, the lines  94  extending across the lower portion of the medical device  90  are sized and configured to act as a back-stop for leaflets of a valve. The medical device  90  of this embodiment may be configured to self expand when delivered, similar to the previously described embodiments, or they may be configured to be expanded over an inflatable balloon or other expansion device, such as known in the art of deploying tubular stents, to implant such device adjacently above a valve. 
     The medical device  90  may also include a tissue growth member  106  disposed over or weaved between the upper looped frame  96  and lower looped frame  98  of the medical device  90 . Such a tissue growth member  106  may permanently attach the medical device  90  to the tissue in the heart while leaving the lines  104  exposed to provide the previously described backstop to prevent valve prolapse. The tissue growth member  106  may be a porous member made from a polymeric or metallic material, such as fabric, felt, Dacron, polyurethane, Nitinol weaves or braids, or any other suitable polymeric or metallic materials configured to induce tissue in-growth, as known in the art. 
     With respect to  FIG. 5B , another embodiment of a medical device  110  is disclosed. This embodiment can include structure similar to that described with respect to the previous embodiment, except additional lines  112  extending between the lower portion of the medical device  110  can extend transverse (or at some other desired angle) with respect to each other, similar to that described with respect to  FIG. 3C . In this manner, the medical device  110  can be implanted adjacently above a valve such that the lines  112  provide a back-stop to substantially prevent valve prolapse in the valve leaflets and regurgitation of blood flow. 
     Other structural configurations can also be employed for a back-stop for a medical device. For example,  FIGS. 6A and 6B , depict a tubular structure, generally similar to the medical device of  FIG. 5A . In particular, the medical device  120  of this embodiment may include an upper looped frame  122  and a lower looped frame  124  with an intermediate portion  126  extending between the upper looped frame  122  and lower looped frame  124  to define the tubular structure. The lower looped frame  124  can include a lower extension portion  128  extending across an interior space defined by the lower looped frame. The lower extension portion  128  may include one or more minor extensions configured to interconnect to the lower looped frame  124  or lower portion of the intermediate portion  126  and interconnect to a back-stop. The back-stop can include a looped or circular portion and is positioned centrally such that the leaflets of a valve can contact at least two portions of the back-stop to, thereby, substantially prevent valve prolapse. 
     In another embodiment, as depicted in  FIG. 6C , there is disclosed a medical device  130  having a tubular structure, similar to the previous embodiment, but with a differently configured back-stop. In particular, the back-stop can include multiple, generally u-shaped extensions  132  configured to extend from a lower portion of the medical device  130  toward a central portion of an interior space defined by the lower portion of the medical device. Each of the u-shaped extensions  132  may be interconnected to define a central portion  134  of the back-stop. 
       FIGS. 7 and 7A  illustrate another embodiment of a medical device  140 , deployed within the left atrium  5  of the heart  3  above the leaflets  9  of the mitral valve  11  ( FIG. 7  being a rotated top view of the device). In this embodiment, the medical device  140  may include an intermediate portion  142  with multiple flexible tabs  144 . The intermediate portion  142  may be an elongated member with opposing anchor ends  146  extending from the intermediate portion  142 . The medical device  140  may be self expanding and provide a force, through the self expansion, to anchor itself within heart tissue. The opposing anchor ends  146  are configured to abut against the tissue wall  15  at a lower portion of the left atrium  5  and act as anchors to lodge the medical device  140  within the heart. The intermediate portion  142  is configured to be positioned and suspended adjacently above the mitral valve  11  and configured to be oriented and coincide with the opposed leaflet  9  free-edge  17  of the mitral valve  11 . The multiple flexible tabs  144  extend laterally from the intermediate portion  142 . Further, the multiple flexible tabs  144  extend from opposite sides of the intermediate portion  142  downwardly and laterally outward. Thus, the flexible tabs  144  may extend to a level below the intermediate portion  142  to contact the valve leaflets  9  and substantially prevent the valve leaflets to prolapse. In one embodiment, the tabs  144  may each be of a substantially common length and width. In another embodiment, the tabs  144  may exhibit different lengths, widths or both to provide different structural and flexible characteristics while biasing the leaflets of the valve. The tabs  144  are flexible and resilient and can be formed from a polymeric material or a metallic material, such as Nitinol. With this arrangement, the medical device can be lodged in a lower portion of the left atrium with multiple tabs  144  extending from an intermediate portion  142  of the medical device  140  to bias the leaflets  9  and act as a back-stop to the leaflets  9  of the mitral valve  11 . 
     Referring now to  FIG. 8 , a medical device  150  is shown deployed via a catheter  14  over individual cordae  19  below the mitral valve  11 , the mitral valve having the defect or prolapsed position  159  (leaflets shown in outline form in the defective position). As depicted in  FIGS. 8A and 8B , the medical device  150  may include an intermediate portion  152  with a first end  154  and an opposite second end  156 . The intermediate portion  152 , when in a constrained position, is elongated and is configured to be disposed along side an individual cordae  19 . The first end  154  and the second end  156  each include a grasping portion  158  configured to grasp a section of the cordae  19 . Once the medical device  150  is placed over the cordae  19  with the grasping portions  158  fully engaged and grasping the cordae  19 , and with the elongated intermediate portion  152  substantially fully extended in an elongate constrained position, the catheter  14  may disengage the medical device  150  from the constrained position and allow the intermediate portion  152  to move to an unconstrained position, as depicted in  FIG. 8B . In the unconstrained position, the intermediate portion  152  moves to a non-elongate position and can curl or move outward. In other words, the first end  154  and second end  156  move closer to one another when the intermediate portion  152  transitions to an unconstrained or free state. With this arrangement, the cordae  19  is also moved together to pull slack from the cordae  19  so as to shorten an effective length of the cordae  19 . Such a medical device  150  can be positioned on other cordae  19  until it is determined that the leaflets  9  are no longer in the prolapsed position  159 . 
       FIG. 9  discloses another embodiment of a medical device  160  to effectively shorten a length of the cordae  19  to substantially prevent valve prolapse. In particular, the medical device  160  may include a u-shaped portion  162  and a middle portion  164  forming an E-shaped configuration. When in the constrained position, the middle portion  164  is open (not shown) with respect to the u-shaped portion  162 . In such open position, the medical device  160  is open to receive a cordae  19 . The middle portion may them be displaced to an unconstrained position or a closed position, trapping the cordae  19  between the middle portion  164  and the u-shaped portion  162 , as depicted. Each leg of the E-shaped configuration may include a nub  166  so as to substantially prevent the medical device  160  from becoming loose or migrating from the cordae  19 . It is noted that while in the unconstrained position, the medical device  160  pulls the cordae  19  taut by removing slack in the cordae  19  to, thereby, effectively shorten the length or of the cordae  19  and substantially prevent valve prolapse. 
       FIG. 10  discloses another embodiment of a medical device  170  configured to shorten or otherwise remove the slack from the cordae and, thereby, enable the leaflets of the mitral valve to properly coapt. In the presently considered embodiment, the medical device  170  may include a frame  172  with an elongated configuration that can be heat-set into a circular or curved shape or loop with two opposite free ends  174 . The medical device is sized and configured to be pulled into an elongated configuration when positioned within a catheter. In one embodiment, the medical device  170  may include a stent-like structure. Further, the medical device of the presently described embodiment may be self expanding and can move to a looped configuration (or some other suitable configuration) when unconstrained. The medical device  170  may include an upper portion  176  and a lower portion  178  with an intermediate extension  182  extending between the upper portion  176  and the lower portion  178 . The upper portion  176  and the lower portion  178  may be formed from wire, such as Nitinol wire, each having free ends with the intermediate extension  182  being another wire weaved between and around the upper portion  176  and the lower portion  178 . In another embodiment, the medical device  170  may be laser cut from a flat sheet of metal, such as Nitinol, and then heat set into the looped configuration. 
     Referring to  FIGS. 10A and 10B , the medical device  170  depicted in  FIG. 10  may be constrained within a catheter  14  and delivered into the heart  3  and specifically, into the left ventricle  7 . The medical device  170  can then be deployed so as to abut partially against the papillary muscle  21  and the tissue wall  15  in the left ventricle  7  so as to displace the papillary muscle  21  and thereby remove the slack from the cordae  19  extending between the papillary muscle  21  and the leaflets  9  of the mitral valve  11 . The medical device  170  may include tines (not shown) to assist the device in being lodged into, for example, the papillary muscle. Such a medical device  170  may also be positioned to abut against the cordae  19  and/or the papillary muscle  21  and/or the tissue wall  15 . When deploying the medical device  170 , imaging techniques may be employed, as known in the art, to determine if the medical device is properly positioned so that the leaflets  9  are not prolapsed or in a coapted position. If not positioned properly, the medical device  170  can be recaptured and then deployed again until the physician is satisfied with the position of the medical device  170 . The medical device  170  may then completely disengaged from associated tethers and the catheter  14  can be withdrawn such as with previously described embodiments. 
     As known to one of ordinary skill in the art, the materials that may be employed for the various embodiments disclosed herein, as well as be compatible within the human anatomy, may include metals and/or polymers, such as, but not limited to, Nitinol, stainless steel, titanium, tantalum, chrome-moly steel, Teflon, silicon, polyester, polyethylene, polyurethane, acetal, nylon, polyamide, or any combinations thereof, or any other bio-compatible and/or bio-resorbable according to one or more of the variously described embodiments may be laser cut from flat sheets of Nitinol and manipulated into preferred configurations by heat-setting the medical device. The medical devices may also go through various polishing procedures, as known in the art. Further, radio opaque markers may be formed with or secured to the medical device, as known in the art for assistance in positioning the device within the heart. Additionally, it is contemplated that some materials or portions of the various embodiments disclosed herein can be formed from bioresorbable polymers, including polylactide, polyglycolide, poly-L-lactide, poly-DL-lactide, and various combinations thereof, and may be employed within, but not limited to, some of the anchors or tines disclosed herein. 
     While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention includes all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims. For example, the tissue growth member disclosed with respect to the medical device of  FIGS. 5 and 6  can be employed in the medical devices disclosed in  FIGS. 3A through 3C  or any other of the medical devices disclosed herein. Similarly, the tines disclosed in  FIGS. 4A and 4B  can be employed on any of the other medical device embodiments to facilitate lodging the medical device in the heart tissue. Furthermore, while the detailed description has been disclosed as treating the problems of mitral regurgitation, the invention, as disclosed in the embodiments herein or any combinations/modifications thereof, can be employed to treat other valves within the human anatomy, such as the tricuspid valve, the aortic valve, the pulmonic valve, and any other valves within the human anatomy.