Patent Document

FIELD OF THE INVENTION  
       [0001]     The present invention relates generally to medical devices and particularly to applying and adjusting tensioning elements to a body organ.  
       BACKGROUND OF THE INVENTION  
       [0002]     A variety of surgical procedures use tensioning elements to effect repair of a body organ. For example, heart disease can be treated with such tensioning elements, which can be used to replace and/or assist the functioning of native structures.  
         [0003]     One type of heart disease occurs when a ventricle becomes dilatated. Ventricular dilatation can reduce the heart&#39;s ability to pump blood, and can lead to a significant increase in wall tension and/or stress. Such wall tension and/or stress can lead to further dilatation, which can lead to heart failure. One method of treating this condition is to apply tensioning elements to the heart wall which absorb some of the tension produced during heart operation, thereby reducing the tension in the heart wall. Determining the proper tension to apply via the tensioning elements can be difficult.  
         [0004]     Heart valve disease is a widespread condition in which one or more of the valves of the heart fails to function properly. Diseased heart valves may be categorized as either stenotic, wherein the valve does not open sufficiently to allow adequate forward flow of blood through the valve, and/or incompetent, wherein the valve does not close completely, causing excessive backward flow of blood through the valve when the valve is closed. Valve disease can be severely debilitating and even fatal if left untreated. Valve disease often involves damaged chordae tendineae, which are thread-like bands of fibrous connective tissue that attach to the mitral or tricuspid valve at one end and to the papillary muscles or the ventricular wall at the other end.  
         [0005]     Various surgical techniques may be used to repair a diseased or damaged heart and/or heart valve. One method for treating defective valves is through repair or reconstruction. A repair technique that has been shown to be effective in treating incompetence is annuloplasty, in which the effective size and/or shape of the valve annulus is modified by securing a repair segment, such as an annuloplasty ring, around the heart valve annulus. For example, the valve annulus may be contracted by attaching a prosthetic annuloplasty repair segment or ring to an interior wall of the heart around the valve annulus. The annuloplasty ring is designed to support the functional changes that occur during the cardiac cycle: maintaining coaptation and valve integrity to prevent reverse flow while permitting good hemodynamics during forward flow.  
         [0006]     In many diseased valves, the chordae tendineae are either ruptured, otherwise damaged, or of an improper length. When chordae tendineae are too long, too short, or otherwise damaged, the corresponding tricuspid or mitral valve to which they are attached typically may fail to close properly. For example, chordae tendineae which are ruptured or are too long allow a valve to prolapse, wherein one or more valve leaflets swing backward past their proper closed position. This can lead to regurgitation, which is the unwanted backflow of blood from a ventricle to an atrium resulting from imperfections in the valve. When the valve allows such backward flow into an atrium, the corresponding ventricle must pump progressively harder to circulate blood throughout the body, which in turn promotes congestive heart failure.  
         [0007]     Repairing and/or replacing dysfunctional chordae tendineae has been performed for some time. The techniques for such repair are often complicated due to the difficulties in accessing the surgical site, in identifying the dysfunctional chordae tendineae, and in determining the proper length for the repaired and/or replacement chordae tendineae. Determining the proper length for replacement chordae tendineae can be a complex procedure. Additionally, prior methods for replacing and adjusting the length of the chordae tendineae often involved making such adjustments on an arrested heart, whereas the final test of the appropriateness of the adjusted length is typically performed while the heart is beating. According, what has been needed is a method of adjusting replacement chordae lengths on a beating heart.  
         [0008]     Accordingly, there has been a need for an improved apparatus, system, and method to apply and adjust tensioning members on and/or in a body organ, including the repair and replacement of chordae tendineae on heart valves. The present invention satisfies one or more of these needs.  
       SUMMARY OF THE INVENTION  
       [0009]     The present application is generally described with respect to its use in the repair of the mitral valve, which regulates blood flow from the left atrium (LA) to the left ventricle (LV), and more specifically in the replacement of chordae tendineae. However, the invention could also be applied to treatment of other body structures where application of an adjustable tensioning device is desired.  
         [0010]     The invention includes an adjustable support pad system. The adjustable pad includes one or more adjustable securing elements, with each securing element configured to retaining an end of a suture line or other tensioning element. The securing element is adjustable, so that the tension applied to the suture line can be adjusted. In one embodiment the securing element is a rotatable spool-like structure about which the suture line can be wound. The spool can be rotated in one or more directions to increase and/or reduce the tension in the suture line. The securing element may include a locking mechanism, such as a ratchet, segmented coil, clip, and/or cam.  
         [0011]     The adjustable pad is configured to be attached to the outside of the organ. In use, the adjustable pad is sutured or otherwise secured to the outside of a body organ, with a tensioning element (such as a suture line) passing from the adjustable pad, into the body organ, and to an opposing attachment point. A first end of the suture line is secured to the tensioning element, and the second or opposing end of the suture line is attached to the opposing attachment point. The opposing attachment point may be inside or outside the body organ.  
         [0012]     In an embodiment, the adjustable pad can be sutured or otherwise attached to the outside of the ventricle of a human heart. The adjustable pad is configured to provide a supporting structure for one end of the suture line or other tensioning element, thereby protect the organ wall from damage that might occur if the suture line were attached directly to the organ wall. The adjustable pad also provides the ability to adjust the length of (and thereby the tension in) the suture line, without having to retie either end of the suture line. With the adjustable pad positioned on the outside of a human heart, a surgeon could thus adjust the tension while the heart is beating, thus permitting the surgeon to see the functioning of the heart (and hence the effectiveness of the current tension setting in repairing heart function) in real time via echocardiography or other imaging techniques while he or she is adjusting the tension in the suture line or other tensioning element.  
         [0013]     The invention can be used for correction of mitral valve prolapse using replacement chordae, such as expanded neochordae suture (such as polytetrafluroethylene (e-P TFE)). One or more replacement chordae sutures can be passed from an adjustable chordal pad, through the heart wall, and then tied in position on the desired leaflet. This part of the procedure could also be reversed, with one or more replacement chordae sutures tied to the leaflet and passed through the heart wall to an adjustable chordal pad. The desired number and length of the replacement chordae depend on the needs of the particular patient, including characteristics of the valve annulus, the valve leaflets, and the existing chordae. This portion of the procedure can be performed on a beating or arrested heart.  
         [0014]     With the replacement chordae in place, the surgeon can adjust the chordae length from the outside of the heart by adjusting the adjustable chordal pad. In one embodiment, the adjustable chordae pad includes an adjustable tensioning element in the form of a spool-like structure that can have an end of one or more replacement chordae wound therearound. By rotating the spool-like structure in one direction or the other, the surgeon or other user can shorten (tighten) or lengthen (loosen) the replacement chordae. Depending on the particular application, one or more adjustable chordal pads may be used on a patient&#39;s heart. Additionally, the adjustable support pad may have one or more separate spools, each of which may be separately adjustable from the other spools. With separate replacement chordae wound upon separately adjustable spools on a single support pad, the support pad serves as a platform for multiple replacement chordae.  
         [0015]     The apparatus can be used in conjunction with other repair procedures on the particular body organ or body structure involved. For example, replacing chordae tendineae can be combined with application of a heart valve annuloplasty ring or other techniques that can reshape the heart valve annulus to a desired shape, and/or prevent the heart valve annulus from further and undesired deformation. Moreover, the invention is not limited to heart treatments. Other organs and body structures could also be treated. For example, the invention could be used to apply tension to treat a pelvic organ prolapse, to reinforce muscles, and/or to reshape a body structure.  
         [0016]     The apparatus may include a flange and/or cannula that passes into the body organ and which may provide a protective surface between the organ wall and the tensioning element.  
         [0017]     Various aspects of the invention can be used individually or in combination to repair a body organ. The invention is applicable to various ways of accessing the organ for repair, including an open surgical approach or a minimally-invasive approach such as percutaneous or intercostal.  
         [0018]     Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]      FIG. 1  depicts a side view, in partial cross-section, of a device having a tensioning element for application to a body organ according to an embodiment of the invention;  
         [0020]      FIG. 2A  depicts a side view, in partial cross-section, of a further embodiment of the invention;  
         [0021]      FIG. 2B  depicts a side view, in partial cross-section, of the device of  FIG. 2A  with the cams in the open position;  
         [0022]      FIG. 3A  depicts a top view of an adjustable support pad according to a further embodiment of the invention;  
         [0023]      FIG. 3B  depicts a side view, in partial cross section, of the apparatus of  FIG. 3A ;  
         [0024]      FIG. 4A  depicts a top view of an adjustable support pad according to a further embodiment of the invention;  
         [0025]      FIG. 4B  depicts a side view of the apparatus of  FIG. 4A ;  
         [0026]      FIG. 4C  depicts a side view, in close up and partial cross-section, of a portion of the apparatus of  FIGS. 4A and 4B ;  
         [0027]      FIG. 5  depicts a side view, in partial cross-section, of a further embodiment of the invention;  
         [0028]      FIG. 6  depicts a side view, in partial cross-section, of a further embodiment of the invention;  
         [0029]      FIG. 7  depicts a side view, in partial cross-section, of a further embodiment of the invention; and  
         [0030]      FIG. 8  depicts a side view, in partial cross-section, of a system and method for applying replacement chordae to a human heart according to an embodiment of the invention;  
         [0031]      FIG. 9  depicts a top view of a further embodiment of the invention;  
         [0032]      FIGS. 10A and 10B  depict side views, in partial cross-section, of a further embodiment of the invention;  
         [0033]      FIGS. 11A through 11C  depict side views, in partial cross-section, of further embodiments of the invention; and  
         [0034]      FIGS. 12A and 12B  depict perspective views of further embodiments of the invention.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0035]      FIG. 1  depicts an adjustable support pad  10  according to an embodiment of the invention with a tensioning element in the form of a suture line  12  under tension within an organ  14 . The adjustable support pad  10  is placed against the outside of the organ wall  16  and secured thereto via ordinary sutures  18  passing through suture holes  19  on the support pad  10 . The suture line  12  is secured to an attachment point  20  via a suture knot  22 . The suture line  12  passes from the attachment point  20  through a hole  24  in the adjustable pad  10  to a locking mechanism  26 . With the suture line  12  secured to the adjustable support pad  10 , the suture line  12  will have a tensioned portion  28  passing from the attachment point  20  to the adjustable support pad  10 , and a slack portion  30  which is past the adjustable support pad  10 .  
         [0036]     In the particular embodiment of  FIG. 1 , the adjustable pad  10  includes a protective flange  32  which surrounds the pad hole  24  and is secured to a generally tubular cannula  33  that passes through the organ wall  16 . The protective flange  32  and cannula  33  may serve to protect the suture line  12  and/or organ wall  16  from contact therebetween. Note that the flange  32  and/or cannula  33  could be left off of the device, as in the embodiment of  FIGS. 2A and 2B , so that the pad could be secured directly to the organ wall without the pad itself puncturing or otherwise passing through the organ wall. The choice of whether to include the flange  32  and/or cannula  33  depends on the particular application.  
         [0037]     The locking mechanism can comprise one or more mechanisms that engage the suture to prevent its movement in one or more directions. For example, in the embodiment of  FIG. 1 , the locking mechanism  26  comprises two movable engagement structures  34  that engage against the suture line  12  to prevent it from moving with respect to the adjustable pad  10 . The movable engagement structures  34  engage against movable control buttons  36  which a user can use to move the movable engagement structures  34  into or out of engagement with the suture line  12 . The device further includes springs  38  which bias the movable engagement structures  34  into engagement with the suture line  12 , thereby biasing the locking mechanism  26  to the locked position whereby movement of the suture line is prevented in one or more directions. In the particular embodiment of  FIG. 1 , movement of the suture line  12  is prevented in both directions (i.e., into the organ and out of the organ) when the movable engagement structures  34  engage the suture line  12 . Although the embodiment depicted includes two movable engagement structures  34  in opposition to each other, other numbers of movable engagement structures are within the scope of the invention. For example, a single such movable engagement structure could be used without a second opposing movable engagement structure. Such a single movable engagement structure could be combined with an opposing but non-movable engaging structure, depending on the particular application.  
         [0038]     In some applications, fluid leakage out of the organ  14  through the pad hole  24  may be of concern. In many cases the tightness of the pad hole  24  about the suture line  12  can prevent such leakage. Natural bodily sealing processes, such as blood clotting and/or tissue ingrowth in front of or into the pad hole  24 , can further prevent such leakage. The pad hole  24  may include a sealant (not shown) against such leakage, such as a biocompatible sealant positioned within the pad hole  24 . Sizing the pad hole  24  so that the suture line  12  just fits therethrough, without substantial spacing between the suture line  12  and the walls of the pad hole  24 , will also help to prevent leakage. The walls of the pad hole  24  could also be formed from flexible and/or padded material that places some inward pressure against the suture line  12 , thereby preventing fluid leakage. For example, a compressible material such as silicon or another compressible polymer could form all or part of the walls of the pad hole  24 , and would press inwardly against the suture line  12  if the pad hole  24  was sized correctly, e.g., sized with a diameter that will compress against the suture line  12  to prevent leakage around the suture line  12 . The walls of the pad hole  24  might also be formed of, or lined with, a biocompatible material that encourages tissue ingrowth, so that the tissue ingrowth acts to block leakage. Additionally, the locking mechanism itself may help to prevent such leakage, in that the locking mechanism, depending on the particular embodiment, may block all or a substantial portion of the pad hole  24  that is not already taken up by the suture line  12 . In another embodiment, the flange or other material in the support pad through which the suture is intended to pass could be solid (i.e., without a pre-formed pad hole therethrough) material, in which case the user could create a pad hole using a suturing needle through which the suture was threaded. The user would drive the suture-threaded needle through the material, thus creating the pad hole and passing the needle and suture assembly through the newly-created pad hole in the adjustable support pad. The suture would thus penetrate the flange or other material, creating a hole only large enough for the suture material. If compressible material were involved, the compressible material could engage against the small suture hole to further prevent leakage.  
         [0039]      FIGS. 2A and 2B  depict a further embodiment of the invention, wherein an adjustable support pad  10  includes a locking mechanism formed by two movable engagement structures in the form of opposing cams  40 . In  FIG. 2A  the cams  40  are in the locked or engaging position wherein longitudinal movement of the tensioning line  12  is prevented, but in  FIG. 2B  the cams  40  are rotated to their open or unlocked position. The cams  40  may be biased by springs or other biasing devices [not shown] toward the closed position, but such bias may not be needed where the tension in the tensioned side  28  of the tensioning line  12 , combined with contact with the cams  40  against the tensioning line  12  as is passes through the cams  40 , pulls the cams  40  to their closed position.  
         [0040]     Note that the particular embodiment of  FIGS. 2A and 2B  does not include the flange and cannula (elements  32  and  33  in  FIG. 1 ). Accordingly, while the tensioning line  12  passes through the organ wall, the adjustable support pad  10  is secured directly to the outside of the organ wall and does not puncture or otherwise pass through the organ wall.  
         [0041]      FIGS. 3A and 4B  depict a further embodiment of the invention, with an adjustable support pad  10  having a lower “fixed” portion  42  and an upper rotatable portion  44 . The support pad  10  includes several sets of suture holes  46  through which suture can be passed to suture the support pad  10  to the surface of an organ wall. The tensioning line  12  passes up through the pad hole  24 , across the upper portion  44  and down through the suture slot  48 , and is then secured to a suture tie point  50 . With the tensioning element  12  thus secured to the support pad  10 , the user can rotate the upper portion  44 , which will cause the tensioning element  12  to be tightened as it is wrapped about a center spindle  52 , which in the embodiment of  FIG. 3A  is positioned on the upper portion  44  and will rotate therewith. Note, however, that the spindle could be fixed to the lower portion  42  of the adjustable support pad  10 , in which case the spindle would not rotate as the tensioning line  12  was wound thereon. In use, the surgeon or other user secures the support pad  10  to the organ wall (which can be accomplished via suture or other suitable attachment means), leads the tensioning line  12  through the pad hole  24  into the suture slot  48 , ties off the tensioning line  12  to the tie point  50 , adjusts the tension in the tensioning line  12  by rotating the upper rotatable portion  44  until the desired tension is achieved (which can be confirmed by monitoring the organ characteristics during tensioning via an imaging system such as echocardiography), and then secures the upper rotatable portion  44  in a fixed position so that it will not take in or let out any additional tensioning line  12 . The order of these steps could be varied, depending on the particular application.  
         [0042]     In the embodiment of  FIGS. 3A and 3B , the spindle  50  includes an outer circumference  54  having notches  56 . These notches  56  can be used to secure the upper rotatable portion  44  in a fixed position. For example, once the desired tension in the tensioning line  12  was achieved, the user could secure a suture line to a part of the fixed lower portion (such as one of the suture holes  46 ), then run that suture line across the upper portion  44  and though one or more of the notches  56 , and then return the line to the fixed lower portion to be tied off. A suture line thus installed would prevent unwanted rotation of the upper portion  44 .  
         [0043]     The upper portion  44  can be configured to be easily snapped off of or otherwise removed from the lower portion  42 , thus allowing the user to remove and/or replace the upper portion when necessary and/or convenient during a particular procedure. For example, a user could initially disassemble the device prior to installation, and then pass the tensioning element out of the organ, thread the tensioning element through the lower portion, secure the lower portion to the organ wall, thread the tensioning element through the upper portion, secure the upper portion to the lower portion, and then adjust the tension in the tensioning element. The user could also remove the upper portion after the lower portion was already secured to the organ wall.  
         [0044]      FIGS. 4A and 4B  depict a further embodiment of the invention where an adjustable support pad  10  includes a base portion  60  having a rotatable upper portion  62 . In the particular embodiment depicted, the tensioning line would be passed through the pad hole  24 , passes over the top of the rotatable upper portion  62  through a tensioning line groove  63  and down through a slot  64 , and is secured to the rotatable upper portion  62  at one or more suture tie-off holes  66 . Note that these same tie-off holes  66  can also be used to secure the adjustable pad  10  to the surface of a body organ via suture.  
         [0045]     The rotatable upper portion  62  is rotated, causing the tensioning line  12  to wrap around the spool  68  and thereby adjusting the tension in the tensioning line  12 . In the embodiment of  FIGS. 4A and 4B , there is a ratchet-like structure  70  on the rotatable upper portion  62  that allows the rotatable upper portion  62  to be rotated in a first rotatable direction  72 , but prevents rotatable movement of the rotatable upper portion  62  in a second rotatable direction  74 . The ratchet-like structure  70 , depicted in greater detail in  FIG. 4C , includes an arm  76  having an angled downward projection  78  at its end. The angled downward projection  78  has flat face  80  on one side and an angled face  82  on an opposing side. When the upper portion  62  is secured to the base portion  60 , the angled downward projection  78  lodges within gear-like recesses  84  formed in the base portion  60  in a circular pattern of which at least a portion lies underneath the angled downward projection  78  when the upper portion  62  is secured to the base portion  60 . When the rotatable upper portion  62  is rotated in the first rotatable direction  72 , the angled face  82  is presented to the gear-like recesses  84 , which allows the rotatable upper portion  62  to rotate as the angled face  82  rises and falls over the gear-like recesses  84 . When the rotatable upper portion  62  is rotated in the second rotatable direction  74 , the flat face  80  is presented to the gear-like recesses  84 , which prevents rotation of the rotatable upper portion  62  due to the engagement of the flat face  80  against corresponding surfaces of the gear-like recesses  84 . Note that the user can manually release the ratchet mechanism by lifting the arm  76  until the angled downward projection  78  is clear of the gear-like recesses  84 , at which point the upper rotatable portion  62  may be rotated in either direction  72 ,  74 .  
         [0046]     The embodiment depicted in  FIG. 4A  also includes locking suture holes  86   a ,  86   b  on the rotatable upper portion  62 , with a suture-receiving groove  87  passing therebetween. A user can lock the rotatable upper portion  62  in place to prevent rotation in either rotatable direction  72 ,  74  by passing a line of suture from one of the suture tie-off holes  66   a , up through a first locking suture hole  86   a , across a suture groove  87  in the top of the rotatable upper portion  62 , back through a second locking suture holes  86   b , and then to another of the suture tie-off holes  66   b . In the embodiment depicted, the suture groove  87  passes over the tensioning line groove  63 , so that a suture tightened across the suture groove  87  will engage the portion of the tensioning line passing through the tensioning line groove  63 . With the suture tightened and tied off at either end to the suture tie-off holes  66   a ,  66   b , the suture will thus prevent rotation of the rotatable upper portion in either direction  72 ,  74 , while also providing some resistance against sliding of the tensioning line through the tensioning line groove  63 .  
         [0047]     Depending on the particular application, one or more tensioning lines can be secured to a single adjustable support pad. For example, in the device depicted in  FIG. 5 , multiple tensioning lines  12   a ,  12   b ,  12   c  are slidably secured to a single adjustable support pad  10 . The multiple tensioning lines  12   a ,  12   b ,  12   c  can be secured in place to prevent sliding in one or more directions using locking mechanisms such as those discussed above.  
         [0048]     In a further embodiment such as that depicted in  FIG. 6 , a single adjustable support pad  10  includes multiple locking mechanisms  26   a ,  26   b ,  26   c , each of which can secure one or more tensioning lines  12   a ,  12   b ,  12   c . Such an embodiment can be particularly useful for applications where there is a need for multiple tensioning lines that must be individually secured and adjusted at a position where there is limited room for adjustable support pads. By separating the locking mechanisms on a single pad, the tension of one or more individual tensioning lines can be easily adjusted without interfering with the tension in one or more of the other tensioning lines secured to other locking mechanisms.  
         [0049]     The adjustable support pad can be formed from various biocompatible materials, including metals, polymers, ceramics, and/or composites. The adjustable support pad can also be configured to conform to the body organ. For example, an adjustable support pad for use in replacing chordae tendineae can be configured to conform to the outer surface of the human heart, such as an outer surface at or adjacent the apex of the heart. Such an adjustable support pad could, for example, be initially formed having an organ-facing surface that generally matches the corresponding outer surface of the heart to which the adjustable support pad will be secured. The adjustable support pad can be formed as a rigid structure, or can be formed as a generally flexible structure that can flex to modify its shape to better conform to the body organ of the particular application.  
         [0050]     The tensioning element can take various forms. It may be a common suture. For applications where the tension was desired to be temporary, or where body tissue was expected to grow and take over the role of applying the tension, the tensioning line and/or adjustable support pad could be formed from material that is absorbed over time. For other applications, however, the tensioning line and/or adjustable support pad can be formed from non-absorbable material. The tensioning element can also contain bumps, ridges, or gears to facilitate one-directional tensioning against a locking mechanism, and could allow for the release of such tensioning.  
         [0051]     The tensioning line can include a shock absorbing component positioned between the adjustable support pad  10  and the tensioning line attachment point  20  on the organ  14 , such as the nitinol spring  88  depicted in the tensioning line  12  of  FIG. 7 , which may be particularly useful for an organ that may flex and/or otherwise deform in shape to the point where tension on a regular tensioning line might become excessive during organ deformation. In the case of a tensioning line being used as a replacement for chordae tendineae, the shock absorbing mechanism could be used to mimic the effect of the papillary muscle or muscles.  
         [0052]      FIG. 8  depicts an adjustable support pad used to implant a tensioning line in the form of a replacement chordae  90  in a heart  92 . A first end  94  of the replacement chordae  90  has been attached to a heart valve leaflet  96 . An adjustable support pad  10  has been secured to the heart outer surface  98 , with the flange  32  and pad hole  24  penetrating the heart wall  100 . In the embodiment depicted, the adjustable support pad  10  is positioned adjacent the lower portion of the heart ventricle  102  and adjacent the apex  104 , which will approximate the attachment position of the native chordae being replace in this embodiment, which would have been attached to the papillary muscle which in turn is attached to the heart in the lower ventricular portion. The replacement chordae  90  has been passed through the heart wall  100  and into the pad hole  24  of the adjustable support pad  10 .  
         [0053]     Note that the order of the steps discussed above could be varied. For example, the replacement chordae could be initially secured to the adjustable support pad  10 , then passed through the heart wall  100  and secured to the valve leaflet  96 . Also, the steps could be performed on a beating heart, and/or on an arrested heart with the patient on bypass.  
         [0054]     With the replacement chordae  90  and adjustable support pad  10  in place, the tension in the replacement chordae  90  can be adjusted to the desired level. Adjusting the tension may preferably be performed on a beating heart, but in some applications the heart may need to be arrested depending on patient condition, etc. Adjusting the tension may be performed concurrently with monitoring of the heart and valve performance, which can be monitored by an imaging technique such as echocardiography. In the embodiment of  FIG. 8 , an imaging system  106  provides real-time imaging of the heart and valve, with an imaging device  108  such as an ultrasound transducer providing a signal that is processed into images displayed on a display  110 . The user can adjust the tension while concurrently monitoring the performance of the heart valve. Note that concurrently can include, but does not require, simultaneous monitoring and tensioning adjustment. For example, a user may concurrently adjust the tension and monitor heart/valve performance by making an initial adjustment to the tension, pausing to monitor the heart/valve performance on the imaging system, then make an additional adjustment to the tension based on the monitored heart valve performance, then pause again to monitor the performance, etc. After the desired tension is achieved and the replacement chordae  90  is secured in the adjustable support pad  10 , any excess replacement chordae  90  (i.e., the slack portion  30 ) can be cut off.  
         [0055]     Various methods and devices can be used to adjust and/or maintain the tension. For example, the support pad may include a connecting and/or receiving assembly/device for receiving an adjustment tool that can adjust the tension. As an example, a support pad having a rotatable tensioning adjustment mechanism, such as device discussed and depicted with respect to  FIGS. 4A , and  4 B, could utilize a flat-head or Philips screwdriver-type connection, so that the user could use a simple screwdriver to rotate the rotatable tensioning adjustment mechanism. Such a support pad  10  is depicted in  FIG. 9 , with a base portion  60  and rotatable portion  62 , wherein the rotatable portion  62  includes a generally cross-shaped indentation  112  configured to receive a Philips-head screwdriver tip. Other adjustment tools and connections are also within the scope of the invention, such as an adjustment tool that can be easily connected to and disconnected from the support pad.  
         [0056]     Another tool for adjusting tension may be an elongated adjustment element  114 , such as a flexible adjustment wire or rod, that can remain permanently or removably attached to the support pad  10  at a distal end  113  end with the proximal end  115  extending outside of the patient&#39;s body  116  through the patient&#39;s skin  118 , as depicted in  FIG. 10A . The surgeon or other user can complete the installation of the support pad  10  (which may include making initial tensioning adjustments to the tensioning element), and then close up the surgical openings in the patient except for a small opening  120  (e.g., a port) out of which the elongated adjustment element  114  would extend. The user could thus adjust the tension during and after the procedure wherein the adjustable pad  10  was installed. For example, the patient may recover for a period, and then the surgeon or other user could re-examine the patient (possibly including imaging or other assessment of the patient&#39;s heart function) and perform tensioning adjustments externally in accordance with the re-examination. The device could also include an apparatus and method for remotely disconnecting the elongated adjustment element  114  from the support pad  10 , so that once the surgeon or user is satisfied with the tensioning, the elongated adjustment element  114  could be remotely disconnected from the support pad  10  and removed from the patient  116  without performing major surgery, as depicted in  FIG. 10B .  
         [0057]     Another device and method for adjusting the tension can include the use one or more small motors, such as an electric motor  122 , that can be included in the support pad  10  itself, as in  FIG. 1A . As depicted in  FIG. 11A , the support pad  10  may also include one or more sensors  124  to monitor tension, one or more controllers  126  (such as microprocessors) to process tension signals and control the motor  122  to adjust the tension, and or more batteries  128  to power the motor  122 , controller  126 , and/or sensor  124 .  
         [0058]     In another embodiment, depicted in  FIG. 11B , the electric motor  122  and battery  128  are located some distance from the support pad  10 , such as at a location on or near the surface of the patient&#39;s skin  118 . In the embodiment depicted in  FIG. 11B , an electric motor  122  is located under but adjacent the patient&#39;s skin  118  and other external tissue, in a fashion similar to the locating of modern pacemakers. The electric motor  122  is connected to the support pad  10  via a elongated shaft  130 , which can be flexible or rigid and, in the embodiment depicted in  FIG. 11B , serves to translate motor rotation into rotation of the rotatable portion  62  of the particular support pad  10  depicted. In such an embodiment, the controller and/or sensor (not depicted), if present, can be located with the support pad  10 , with the battery  128  and/or motor  122 , or elsewhere.  
         [0059]     Another embodiment is depicted in  FIG. 11C , wherein the motor  122  itself is located in the adjustable support pad  10 , but the battery  128  to power the motor  122  is positioned remotely under the patient&#39;s skin  118  and external tissue. The battery  128  provides electricity to the motor  122  via one or more small wires  132 . In such an embodiment, the motor controls and/or tension sensors (if present) could be located with the battery  128 , with the motor  122  and/or adjustable support pad  10 , or at another location, depending on the particular application.  
         [0060]     As discussed above, the operation of the tensioning adjustment motor could be controlled by circuitry or other controls located on or in the support pad itself or co-located with the battery and/or motor, and/or could be controlled remotely by a surgeon or other user, or by a remote computer, or by combinations thereof, etc. In the case of the control system being remotely located, the remote control signals could be wirelessly transmitted, such as via radio signals, or could be transmitted through small transmittal lines, such as wires and/or fiber-optic lines, that extend from the adjustment motor to a location outside of, or just inside of, the patient&#39;s body. For example, in the embodiment depicted in  FIG. 11B , the motor  122  could be controlled, and/or the controller (if present) could be reprogrammed, and/or the battery  128  could be recharged (where run by batteries), remotely using technology similar to that used to control and/or recharge pacemaker/defibrillator controls and batteries. For example, in the embodiment of  FIGS. 11B and 11C , the batteries could be recharged using magnetic induction by placing a charging element next to the patient&#39;s skin  118  in the area adjacent the battery  128 .  
         [0061]      FIGS. 12A and 12B  depict further embodiments of the invention, with an adjustable support pad  10  having a base portion  134  and a snap-on portion  136 . In the embodiment of  FIG. 12A , the snap-on portion  136  is initially free and unattached from the base portion  134 . In the embodiment of  FIG. 12B , the snap-on portion  136  is movably secured to the base portion  134  via a hinge  138 . The snap-on portion  136  includes one or more snap engaging structures  137  which align with and engage into corresponding recesses  135  in the base portion  134  when the snap-on portion  136  is snapped onto the base portion  134 . In the particular embodiment depicted on  FIGS. 12A and 12B , there are multiple holes  140  passing through the base portion  134 . Depending on the particular application, one or more of the holes  140  can serve as suture holes through which ordinary suture can be used to fasten the support pad  10  to the organ wall, and/or one or more of the holes  140  can serve as pad holes through which a tensioning line (such as the suture line  12  of  FIG. 1 ) is passed. With the base portion  134  secured to the organ and the tensioning line passed through the pad hole  24 , the user adjusts the tension in the tensioning line to the desired level and then secures the tensioning line to prevent further movement to preserve the desired tension.  
         [0062]     The tensioning line can be secured in various ways, depending on the particular application and support pad. For example, the tensioning line could be tied off at the desired tension, and/or one or more portions of the tensioning line could be passed between the base portion  134  and the snap-on portion  136  such that the tensioning line is held firmly in place between the base portion  134  and snap-on portion  136  once the snap-on portion  136  is snapped onto the base portion  134 . One or more portions of the tensioning line could be wrapped around part of the base portion  134  and/or snap-on portion  136  to increase the strength of the locking action on the tensioning line created by snapping the snap-on portion  136  onto the base portion  134 . Where the locking of the tensioning line is accomplished by snapping the snap-on portion  136  onto the base portion  134 , the surgeon or other user can adjust the tension in the tensioning line to a desired level, and then snap the snap-on portion  136  onto the base portion  134 , thereby creating a lock that prevents the tensioning line from further movement and preserves the desired tension. The surgeon or other user can re-adjust the tension by re-opening the support pad  10  (by snapping the snap-on portion  136  off of the base portion  134 ), readjusting the tension in the tensioning line, and then snapping the snap-on portion back onto the base portion  134  to re-establish the locking action that prevents further movement of the tensioning line.  
         [0063]     The support pads  10  of  FIGS. 12A and 12B  include locking lower suture holes  142  and locking upper suture holes  144  in the base portion  134  and snap-on portion  136 , respectively. The upper and lower locking suture holes  142 ,  144  align when the snap-on portion  136  is properly secured to the base portion  134 , and a user can pass ordinary suture through the aligned upper and lower suture holes  142 ,  144  and tie off the suture to lock the snap-on portion  136  onto the base portion  134  in its closed configuration.  
         [0064]     Note that a lid-like structure such as the snap-on portion  136  of  FIGS. 12   a  and  12   b  could be used in combination with the locking mechanisms set forth in other embodiments of the invention, with the lid-like structure acting to protect and/or support the locking mechanism and/or other elements of the support pad. For example, a lid-like mechanism could be combined with the support pad  10  depicted in  FIG. 4A , with the lid-like mechanism acting to hold the rotatable upper portion  62  in place and prevent further rotation when the lid-like structure is snapped-on and/or otherwise secured onto the base portion  60  of the support pad  10  of  FIG. 4A .  
         [0065]     While the invention has been described with reference to particular embodiments, it will be understood that various changes and additional variations may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention or the inventive concept thereof. For example, while the invention is specifically discussed in application with repair and/or replacement of chordae tendineae, it has applicability in other areas where it is desired to repair similar structures. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed herein, but that the invention will include all embodiments falling within the scope of the appended claims.

Technology Category: 1