Patent Publication Number: US-11660191-B2

Title: Method to reduce mitral regurgitation

Description:
This application is a Continuation of U.S. patent application Ser. No. 15/431,166, filed Feb. 13, 2017; which is a Continuation of U.S. patent application Ser. No. 15/158,217, filed May 18, 2016 (now U.S. Pat. No. 9,603,709); which is a Division of U.S. patent application Ser. No. 13/770,652, filed Feb. 19, 2013 (now U.S. Pat. No. 9,370,424); which is a Continuation of U.S. patent application Ser. No. 12/400,350, filed Mar. 9, 2009 (now U.S. Pat. No. 8,382,829); which claims the priority of U.S. Provisional Patent Application Ser. No. 61/035,201, filed on Mar. 10, 2008, the disclosure of each of these is incorporated by reference herein. 
    
    
     TECHNICAL FIELD 
     The present invention generally relates to surgical methods of securing tissue anchors for reducing the size of an orifice through a tissue and, more particularly, methods of securing tissue anchors for reducing the circumferential orifice of the mitral valve during an annuloplasty surgical procedure. 
     BACKGROUND 
     The mitral valve is composed of valve leaflets, or flaps of tissue, that open and close tightly to ensure that the flow of blood through the heart is in one direction only. The leaflets are held in position by a ring of tissue, the annulus, surrounding and attaching the leaflets to the walls of the heart between the left atrium and left ventricle. Chordae tendineae are tendons that tether the leaflets to papillary muscles within the left ventricle, which prevent the leaflets from prolapsing into the left atrium. A dysfunction of any one of these portions of the mitral valve anatomy can cause mitral regurgitation, or the partial backflow of blood from the left ventricle into the left atrium. Depending on the severity of the condition, the individual may experience a range of symptoms, including shortness of breath, pulmonary edema, or decreased exercise tolerance. 
     Surgical procedures may be used for reducing mitral regurgitation. Some of these procedures have included plicating the mitral valve tissue in order to reduce the size of the orifice created between the leaflets. One such surgical procedure, annuloplasty, is particularly useful in treating mitral valve regurgitation. Annuloplasty modifies the annulus, through one or more plications, and this can return the valve to a functional geometry. 
     However, many annuloplasty procedures are highly invasive and may incorporate open heart surgery, which poses significant risk to the patient. Therefore, there is a need for a less invasive approach for plicating tissue by eliminating the need for open heart surgery while returning the mitral valve to a functional geometry. 
     SUMMARY 
     In one illustrative embodiment of the present invention, a method of repairing the mitral heart valve is described. The method includes securing a first tissue anchor to a position on a posterior portion of the annulus of the mitral valve and a second tissue anchor to a position on an anterior portion of the annulus of the mitral valve. At least one tensile member is spanned between the first and second tissue anchors and across the orifice of the mitral valve. When tension is applied to the at least one tensile member, the posterior portion of the annulus is pulled toward the anterior portion of the annulus. 
     In another illustrative embodiment of the present invention, a second method of repairing the mitral heart valve is described. This second method includes directing a guide-wire into the left ventricle, across a position on a posterior portion of the annulus, through the left atrium, across a position on the anterior portion of the annulus, and then returning into the left ventricle. A first tissue anchor is directed along the guide-wire to the position on the anterior portion of the annulus and secured. A second tissue anchor is then directed along the guide-wire to the position on the posterior portion of the annulus and secured. At least one tensile member is spanned between the first and second tissue anchors and across the orifice of the mitral valve. When tension is applied to the at least one tensile member, the posterior portion of the annulus is pulled toward the anterior portion of the annulus. 
     In another illustrative embodiment of the present invention, a third method of repairing the mitral heart valve is described. This third method includes directing a guide-wire into the right atrium, across the intra-atrial septum, into the left atrium to a position on the posterior portion of the annulus. A first tissue anchor is directed along the guide-wire to the position on the posterior portion of the annulus and secured. A second guide-wire is then directed into the right atrium, across the intra-atrial septum, into the left atrium to a position on the anterior portion of the annulus. A second tissue anchor is directed along the second guide-wire to the position on the anterior portion of the annulus and secured. At least one tensile member is spanned between the first and second tissue anchors and across the orifice of the mitral valve. When tension is applied to the at least one tensile member, the posterior portion of the annulus is pulled toward the anterior portion of the annulus. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIGS.  1 - 6    are respective fragmentary cross-sectional views of the heart illustrating successive steps of one exemplary procedure for advancing and securing first and second tissue anchors to the posterior and anterior annulus, respectively, of the mitral valve. 
         FIGS.  7 - 8    are respective fragmentary cross-sectional views of the heart illustrating successive steps of one exemplary procedure for reducing the size of the mitral valve orifice by tensioning the tensile members extending between the first and second tissue anchors. 
         FIG.  9    is an enlarged cross-sectional view of the repaired mitral valve resulting from the procedures illustrated in  FIGS.  1 - 8   . 
         FIGS.  10 - 13    are respective fragmentary cross-sectional views of the heart illustrating successive steps of another exemplary procedure for advancing and securing first and second tissue anchors to the posterior and anterior portions of the annulus, respectively, of the mitral valve. 
         FIG.  14    is an enlarged cross-sectional view of the heart illustrating the first and second tissue anchors secured to the posterior and anterior annulus, resulting from the procedure illustrated in  FIGS.  10 - 13   . 
         FIG.  15    is an enlarged cross-sectional view illustrating an exemplary method of reducing the size of the mitral valve orifice by tensioning a tensile member extending between the first and second tissue anchors. 
         FIG.  16    is an enlarged cross-sectional view of the repaired mitral valve resulting from the procedure shown in  FIGS.  10 - 15   . 
         FIG.  17 A  is a top view illustrating the mitral valve from the left atrium before tissue plication and with the first and second tissue anchors positioned at the P3 and A3 regions, respectively. 
         FIG.  17 B  is a top view illustrating the mitral valve from the left atrium after tissue plication and with the first and second tissue anchors positioned at the P3 and A3 regions, respectively. 
         FIG.  170    is a top view illustrating the mitral valve from the left atrium after tissue plication and with the first and second tissue anchors positioned at the P1 and A1 regions, respectively. 
         FIG.  170    is a top view illustrating the mitral valve from the left atrium after tissue plication with the first and second tissue anchors positioned at the P3 and A3 regions, respectively, and third and fourth tissue anchors positioned at the P1 and A1 regions, respectively. 
         FIG.  17 E  is a top view lustrating the mitral valve from the left atrium after tissue plication and with a first staple positioned between the P3 and A3 regions and a second staple positioned between the P1 and A1 regions. 
     
    
    
     DETAILED DESCRIPTION 
     The method begins in  FIG.  1    by percutaneously accessing the right atrium  10  of the heart  14  from a suitable venous access site. The venous access site can be located near the jugular vein, superiorly, from the femoral vein, inferiorly, or from other suitable superficial veins. A first guide-wire  18  is directed into the venous access site, through the inferior or superior vena cava  22 ,  26 , as appropriate, and into the right atrium  10 . Suitable guide-wires  18  can include commercially-available guide-wires commonly used in catheter-based procedures, including steerable guide-wires. The first guide-wire  18  can then be directed across the intra-atrial septum  30 , for example near the fossa ovalis  34 , and into the left atrium  38  in accordance with known transseptal procedures. 
     Though not specifically shown, the first guide-wire  18  can alternatively be directed into the left atrium  38  through other known venous access sites, such as the coronary sinus  42 . 
     After the first guide-wire  18  is in position, a guide catheter  46  can be advanced over the first guide-wire  18  and into the left atrium  38 . The guide catheter  46  can be any suitable catheter that can be directed through the vascular system to aid in the delivery of subsequent surgical devices, such as tissue anchors  50 ,  52  ( FIG.  3    and  FIG.  5   ) for use with the procedures described herein. Though not specifically shown, a physician can also use additional surgical instruments, such as an obturator, to sufficiently dilate the puncture through the intra-atrial septum  30  to accommodate the larger diameter guide catheter  46 . 
     If desired, the physician can confirm the in vivo location of the guide catheter  46  during any portion of the surgical procedure by visualizing a suitable fluoroscopic marker on the distal end of the guide catheter  46  in a known manner. 
     Turning now to  FIG.  2    with the guide catheter  46  positioned within the left atrium  38 , a second guide-wire  54  can then be directed through the lumen of the guide catheter  46  and into the left atrium  38 . 
       FIGS.  2 - 8    illustrate a first embodiment of a method to repair the mitral valve  56 . The first guide-wire  18  can be directed to a position on a posterior portion of the annulus (i.e. the posterior annulus  66 ) between the posterior and anterior commissures  59 ,  60 . One skilled in the art may generally refer to the illustrated position as the P1 region, which is located laterally at the base of the posterior leaflet  62  along the posterior annulus  66 . Another suitable position could be the P3 region, which is located medially at the base of the posterior leaflet  62  and proximal to the intra-atrial septum  30 . However, the procedure should not be considered limited to these regions of the posterior annulus  66  as one or more regions may be chosen depending on the location of the enlarged orifice through the orifice of the mitral valve  56 . For example, if the posterior and anterior leaflets  62 ,  70  do not coapt at a lateral region of the mitral valve  56 , then the repair can be directed to the A1 to P1 regions; and if the posterior and anterior leaflets  62 ,  70  do not coapt medially, then the repair can be directed more appropriately to the A3 to P3 regions. 
     In the illustrated example of  FIGS.  2 - 8   , once the first guide-wire  18  is directed to the desired position on the posterior annulus  66 , the first guide-wire  18  is then advanced across the posterior annulus  66  and into the left ventricle  48 . 
     In a similar manner, the second guide-wire  54  can be directed to a position on an anterior portion of the annulus (i.e. the anterior annulus  74 ) between the posterior and anterior commissures  59 ,  60 . The position of the second guide-wire  54  on the anterior annulus  74  can be spaced between the posterior and anterior commissures  59 ,  60  at a distance that is similar to the position and spacing of the first guide-wire  18  on the posterior annulus  66 . For example, if the guide-wire  18  is positioned near the P1 region, then the second guide-wire  54  is positioned near the A1 region, which is located laterally at the base of the anterior leaflet  70  along the anterior annulus  74 . Alternatively, if the first guide-wire  18  is positioned near the P3 region, then the second guide-wire  54  is positioned near the A3 region, which is located medially at the base of the anterior leaflet  70  and proximal to the intra-atrial septum  30 . 
     Once the second guide-wire  54  is directed to the desired position on the anterior annulus  74 , the second guide-wire  54  is then advanced across the anterior annulus  74  and into the left ventricle  48 . 
     Though not shown, the physician can, if desired, use known in viva localization techniques in directing the guide-wires  18 ,  54  to the desired locations along the posterior and anterior portions of the annulus  66 ,  74 . Additionally, the guide-wires  18 ,  54  can include a radio-frequency (RF) energy delivery tip to assist with penetration through mitral tissue. For this purpose, a suitable RF energy device may be coupled to one or both of the guide-wires  18 ,  54 . In yet other embodiments, the distal tip of the guide-wires  18 ,  54  can be preformed to curl back on itself to help prevent tissue damage after crossing the mitral valve tissue and entering the left ventricle  48 . 
     Turning now to  FIG.  3   , where the advancement and deployment of the first tissue anchor  50  is shown and described. While any tissue anchor device known in the art can be used, including but not limited to clips, wires, or staples, the particular tissue anchor device shown is collapsible and comprises a plurality of discrete, flat, flexible anchor elements  78  coupled by a flexible tensile member  82 . The anchor elements  78  can be formed from a surgical grade fabric material (e.g., a polyester material such as DACRON) designed to promote tissue in-growth so that the anchor  50  becomes essentially encased in tissue over time. The anchor elements  78  are coupled to the tensile member  82 , in this example a suture, by threading the suture upwardly through the anchor elements  78  and then back downwardly through the anchor elements  78 . A slip knot is then formed, or another type of lock member is used, so that when a proximal end portion of the tensile member  82  is pulled, all of the anchor elements  78  will be drawn together against opposite sides of the annular tissue. This leaves a long “tail” of the suture leading to the venous access site for subsequent tensioning and plication, as will be described below. 
     In some embodiments, one or more of the anchor elements  78  can include a radiopaque marker for in vivo visualization under a suitable viewing device during the procedure. For example, one such marker can be located on a proximal portion of the tissue anchor  50  and another marker can be located on a distal portion of the tissue anchor  50 . 
     In use, the first tissue anchor  50  with a delivery sheath  86  is directed along the first guide-wire  18 , across the posterior annulus  66 , and into the left ventricle  48 . The first tissue anchor  50  is then at least partially deployed from the delivery sheath  86  on the left ventricular side of the posterior annulus  66 . As necessary, the first guide-wire  18  can be removed before or after the tissue anchor deployment process. Once a sufficient portion of the first tissue anchor  50  has been deployed within the left ventricle  48 , the physician can stop deploying the anchor elements  78 , slightly retract the delivery sheath  86  back across the posterior annulus  66  into the left atrium  38 , and then deploy the remainder of the anchor elements  78  of the tissue anchor  50  within the left atrium  38 , as shown in  FIG.  4   . 
     In  FIG.  5   , the physician pulls on the proximal end portion of the tensile member  82  such that the anchor elements  78  of the first tissue anchor  50  are drawn together against opposite sides of the annular tissue, thereby securing the first tissue anchor  50  to the P1 region of the posterior annulus  66 . 
     Also shown in  FIG.  5   , once the first tissue anchor  50  is secured, the physician can then begin directing the second tissue anchor  52 , with a delivery sheath  90 , along the second guide-wire  54 , across the anterior annulus  74 , and into the left ventricle  48 . As described above, the second tissue anchor  52  is then at least partially deployed from the delivery sheath  90  within the left ventricle  48 , the delivery sheath  90  is then retracted back across the anterior annulus  74 , and the remainder of the second tissue anchor  52  is deployed within the left atrium  38 . 
     While the second tissue anchor  52  has been shown to be similar to the first tissue anchor  50 , it would be understood that a different tissue anchor device structure, or manner of deployment, could be used. 
     In  FIG.  6   , after the second tissue anchor  52  has been deployed and secured to the anterior annulus  74  by a tensile member  94 , the physician can then retract the delivery sheath  90  from the surgical site. 
     With both the first and second tissue anchors  50 ,  52  secured to their respective positions on the posterior and anterior portions of the annulus  66 ,  74 , respectively, the physician can then plicate the tissue, as shown in  FIG.  7   . To plicate the tissue, the physician can pull on the respective proximal end portions of the tensile members  82 ,  94  such that the posterior annulus  66  is pulled toward the anterior annulus  74 . The plication and position of the tissue can be maintained by directing a suture locker  98  along the tensile members  82 ,  94  to the surgical site. The advancing of the suture locker  98  can be accomplished with a delivery catheter  102  in accordance with known methods. Suitable suture lockers  98  can include those shown in U.S. application Ser. No. 11/425,731, which allows the physician to lock the tension and simultaneously cut the tensile members  82 ,  94  to an appropriate length, or the suture locker  98  described in U.S. application Ser. No. 11/753,921, which includes a locker body having a passageway through which the tensile members  82 ,  94  extend and a slidable member that moves from a latent condition to an activated condition to lock the position of the tensile members  82 ,  94  relative to the locker  98 . 
       FIG.  8    illustrates the surgical site after the suture locker  98  is in position, the tensile members  82 ,  94  are locked relative to the suture locker  98 , the tensile members  82 ,  94  have been cut, and the delivery catheter  102  retracted. This is also illustrated, with an enlarged view, in  FIG.  9   . As shown, the first and second tissue anchors  50 ,  52  are secured and tensioned with the locker  98  such that the posterior and anterior leaflets  62 ,  70  come into contact and mitral regurgitation is reduced. 
     Though not specifically shown, the physician can then direct an atrial septal defect closure device to the intra-atrial septum  30  to seal the orifice created by the guide catheter  46  after it has been retracted from the surgical site. Atrial septal defect closure devices are known generally, and can include commercially-available examples such as the BIOSTAR by NMT Medical, Inc. or the AMPLATZER Septal Occluder by AGA Medical Corp. 
     With the first method of repairing the mitral valve  56  described with some detail, a second exemplary surgical procedure for repairing the mitral valve  56  can now be described with reference to  FIGS.  10 - 13   . In this method of repairing the mitral valve  56 , the physician approaches the mitral valve  56  from within the left ventricle  48 . 
       FIG.  10    illustrates the directing of a guide-wire  106  into the left ventricle  48 , across the mitral valve  56 , and into the left atrium  38 . This can be accomplished in a known way, such as directing the guide-wire  106  from a suitable arterial access site located near the femoral or iliac arteries. The guide-wire  106  is directed from the arterial access site to the aorta  110 , around the aortic arch  114 , through the aortic valve  118 , and between the pair of chordae tendineae  122  in the left ventricle  48 . As described previously, the guide-wire  106  is then followed by a guide catheter  126 . 
     Though not specifically shown, the percutaneous access can alternately be made from a superior arterial access site so that the guide-wire  106  is directed into the aortic arch  114  from the brachiocephalic trunk  130 , the left common carotid  134 , or the left subclavian arteries  138 . 
     Once the guide-wire  106  is within the left ventricle  48 , it can be steered through the volume of the left ventricle  48  to the mitral valve  56 . More specifically, the guide-wire  106  is steered to cross the mitral valve  56  at the posterior annulus  66 . While the mitral valve  56  can be crossed at several locations, it is preferred that the guide-wire  106  crosses the posterior annulus  66  between the anterior and posterior commissures  74 ,  66  at approximately the P1 region, as shown in  FIG.  10   . While this embodiment of the present invention has been illustrated with the guide-wire  106  crossing the P1 region, it would be understood that other regions of the posterior annulus  66 , i.e. the P2 or P3 regions, could also be used if appropriate. The P1 region can be localized in vivo through fluoroscopy while the physician advances the guide-wire  106  across the P1 region and into the left atrium  38 . As noted above, if desired, the guide-wire  106  can have a radio-frequency (RF) energy delivery tip for assisting with penetration through mitral tissue. 
     After the guide-wire  106  enters the left atrium  38 , it is steered through the volume of the left atrium  38  to the A1 region of the anterior annulus  74 . The guide-wire  106  then crosses the anterior annulus  74  at the A1 region and reenters the left ventricle  48 . 
     As shown in  FIG.  11   , with the guide-wire  106  properly positioned, the surgeon can direct a first tissue anchor  156  with the delivery catheter  158  through the guide catheter  126 , along the guide-wire  106 , across the A1 region, and into the left ventricle  48 . While any suitable tissue anchor device can be used, the tissue anchor  156  illustrated is the same as those described above. Accordingly, the first tissue anchor  156  is at least partially deployed from the delivery catheter  158  on the left ventricular side of the anterior annulus  74 . As necessary, the guide-wire  106  can be removed before or after the tissue anchor deployment process. Once a sufficient portion of the first tissue anchor  156  has been deployed within the left ventricle  48 , the physician can stop deploying, retract the delivery catheter  158  back across the anterior annulus  74  into the left atrium  38 , and then deploy the remainder of the first tissue anchor  156  within the left atrium  38 , as shown in  FIG.  12   . 
       FIG.  12    also illustrates that the physician can then pull on the proximal end portion of the tensile member  162  of the first tissue anchor  156  such that the first tissue anchor  156  is secured to the A1 region of the anterior annulus  74 . 
       FIG.  13    illustrates the directing and deploying of a second tissue anchor  166  along the tensile member  162  at the P1 region of the posterior annulus  66 . As shown, the second tissue anchor  166  has a structure that is similar to the first tissue anchor  156 ; however, this is not required. Thus, deployment of the second tissue anchor  166  can occur in a manner similar to the procedures described above. 
       FIG.  14    is an enlarged view of the mitral valve  56  with the first and second tissue anchors  156 ,  166  positioned and secured to the anterior and posterior portions of the annulus  74 ,  66 , respectively. The tensile members  162 ,  170  of the first and second tissue anchors  156 ,  166 , respectively, extend proximally from the surgical site, through the guide catheter  126  to the incision site. 
     In  FIG.  15   , the physician pulls proximally on the tensile members  162 ,  170 , such that the A1 and P1 regions are pulled together, the anterior and posterior leaflets  70 ,  62  coapt, and mitral regurgitation is reduced.  FIG.  15    further illustrates the advancing of a suitable locker  174  with a delivery catheter  178  to the surgical site such that the reduction in the size of the mitral valve  56  is maintained. The locker  174  can be any suitable suture locker device, including those described previously. The tensile members  162 ,  170  are then cut to an appropriate length and the surgical device retracted from the surgical site. The result of the surgical procedure, illustrated in  FIG.  16   , is the first and second tissue anchors  156 ,  166  are secured to the annular tissue, and the tensile member  162 ,  170  extending from the first and second tissue anchors  156 ,  166  are sufficiently tensioned such that the anterior and posterior leaflets  70 ,  62  coapt and mitral regurgitation is reduced or eliminated. 
     While the methods of mitral valve repair have been described and illustrated primarily with the tissue anchor devices being located at the A1 and P1 regions of the annular tissue, it would be understood that other regions of annular tissue could also be used. For example,  FIG.  17 A  illustrates the mitral valve  56  from within the left atrium  38  having tissue anchors  182 ,  186  positioned substantially near the P3 region of the posterior annulus  66  and A3 region of the anterior annulus  74 , respectively, and prior to repair of the mitral valve  56 . Accordingly, tensile members  188 ,  190  extend from the tissue anchors  182 ,  186 , but are not yet tensioned.  FIG.  17 B  illustrates the tensioning and locking of the tensile members  188 ,  190  with a suitable locker  194 , such as those described previously. Accordingly, the posterior annulus  66  is pulled toward the anterior annulus  74  and mitral regurgitation is reduced. 
       FIG.  170    illustrates tissue anchors  198 ,  202  positioned substantially near the P1 region of the posterior annulus  66  and A1 region of the anterior annulus  74 , respectively, as described in the methods above. Tensile members  206 ,  208  are tensioned and locked with a suitable locker  212  such that the posterior annulus  66  is pulled toward the anterior annulus  74  and mitral regurgitation is reduced. 
     As discussed above, the positions of the tissue anchor devices would be primarily determined by the location of the largest orifice through the mitral valve  56 . That is, if the posterior and anterior leaflets  62 ,  70  do not coapt near the posterior commissure  59 , then tissue anchors  182 ,  186  positioned at the A3 and P3 regions can provide the most beneficial repair; if the posterior and anterior leaflets  62 ,  70  do not coapt near the anterior commissure  60 , then tissue anchors  198 ,  202  positioned at the A1 and P1 regions can provide the most beneficial repair. However, if the posterior and anterior leaflets  62 ,  70  do not coapt at a position that is between the posterior and anterior commissures  59 ,  60 , or if there is more than one region at which the leaflets  62 ,  70  do not coapt, then one or more regions can be chosen to include additional tissue anchors to effectuate a mitral valve repair. 
     One example, shown in  FIG.  17 D , illustrates the use of four tissue anchors  182 ,  186 ,  198 ,  202 , and can be the combination of the embodiments shown in  FIGS.  17 B-C . The use of four tissue anchors  182 ,  186 ,  198 ,  202 , spanning the mitral valve  56  at two regions, as shown, can provide improved reduction in the mitral valve size and further reduce mitral regurgitation. Also, as shown in  FIG.  17 D , the position of the lockers  194 ,  212  can be adjusted to the particular needs or preferences of the physician. 
     Alternatively,  FIG.  17 E  illustrates the use of first and second legs  214 ,  216  and the base  218  of two staples as the tissue anchor and tensile members, respectively. The first and second staples can be positioned in a manner that is similar to the tissue anchors  182 ,  186 ,  198 ,  202  of  FIG.  17 D  to pull the posterior annulus  66  toward the anterior or annulus  74  and effectuate mitral valve repair. 
     While the present invention has been illustrated by a description of various preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims.