Abstract:
Methods and devices for the treatment of cardiac valve dysfunction through the placement of lines and anchors. The lines and anchors can form artificial chordae between valve leaflets and the ventricular wall or papillary muscles or connect the two valve leaflets together. The methods and devices offer a mechanism for performing this technique with the heart still beating, and allows for the placement of multiple lines with a single device.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Application Ser. No. 62/326,609, filed on Apr. 22, 2016, entitled “Catheter With a Collapsible Funnel-Shaped Suction Cup for Placing Prosthetic Chords for a Heart Valve,” the disclosure of which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The various embodiments relate to treatment of mitral valve dysfunction through the placement of artificial chordae between the leaflets and the ventricular wall or papillary muscles in general, and more particularly to replacing the chordae with sutures and pledgets threaded thereon, and further to approximating opposing leaflets together. 
       BACKGROUND INFORMATION 
     1. Field of the Disclosure 
       [0003]    The disclosure herein relates to methods and devices for treating mitral valve dysfunction through the placement of artificial chordae between the leaflets and the ventricular wall or papillary muscles, while the heart is still beating. The disclosure herein further relates to the placement of multiple artificial chordae with a single device, and the approximation of leaflets. 
       2. Description of the Background 
       [0004]    As illustrated in  FIG. 1 , the human heart  10  has four chambers, which include two upper chambers denoted as atria  12 ,  16  and two lower chambers denoted as ventricles  14 ,  18 . A septum  20  divides the heart  10  and separates the left atrium  12  and left ventricle  14  from the right atrium  16  and right ventricle  18 . The heart further contains four valves  22 ,  24 ,  26 , and  28 . The valves function to maintain the pressure and unidirectional flow of blood through the body and to prevent blood from leaking back into a chamber from which it has been pumped. 
         [0005]    Two valves separate the atria  12 ,  16  from the ventricles  14 ,  18 , denoted as atrioventricular valves. The left atrioventricular valve, the mitral valve  22 , controls the passage of oxygenated blood from the left atrium  12  to the left ventricle  14 . A second valve, the aortic valve  24 , separates the left ventricle  14  from the aortic artery (aorta)  30 , which delivers oxygenated blood via the circulation to the entire body. The aortic valve  24  and mitral valve  22  are part of the “left” heart, which controls the flow of oxygen-rich blood from the lungs to the body. The right atrioventricular valve, the tricuspid valve  26 , controls passage of deoxygenated blood into the right ventricle  18 . A fourth valve, the pulmonary valve  28 , separates the right ventricle  18  from the pulmonary trunk  32 . The right ventricle  18  pumps deoxygenated blood through the pulmonary trunk  32  and arteries to the lungs wherein the blood is oxygenated and then delivered to the left atrium  12  via the pulmonary veins. Accordingly, the tricuspid valve  26  and pulmonary valve  28  are part of the “right” heart, which control the flow of oxygen-depleted blood from the body to the lungs. 
         [0006]    Both the left and right ventricles  14 ,  18  constitute “pumping” chambers. The aortic valve  24  and pulmonary valve  28  lie between a pumping chamber (ventricle) and a major artery and control the flow of blood out of the ventricles and into the circulation. The aortic valve  24  and pulmonary valve  28  have three cusps, or leaflets, that open and close and thereby function to prevent blood from leaking back into the ventricles after being ejected into the lungs or aorta  30  for circulation. 
         [0007]    Both the left and right atria  12 ,  16  are “receiving” chambers. The mitral valve  22  and tricuspid valve  26 , therefore, lie between a receiving chamber (atrium) and a ventricle so as to control the flow of blood from the atria to the ventricles and prevent blood from leaking back into the atrium during ejection out of the ventricle. Both the mitral valve  22  and tricuspid valve  26  include two or more cusps, or leaflets (shown in  FIG. 3 ), that are encircled by a variably dense fibrous ring of tissues known as the annulus. The valves are anchored to the walls of the ventricles by chordae tendineae (chordae)  42 . The chordae tendineae  42  are cord-like tendons that connect the papillary muscles  44  to the leaflets of the mitral valve  22  and tricuspid valve  26  of the heart  10 . The papillary muscles  44  are located at the base of the chordae  42  and are within the walls of the ventricles. They serve to limit the movements of the mitral valve  22  and tricuspid valve  26  and prevent them from inverting. The papillary muscles  44  do not open or close the valves of the heart, which close passively in response to pressure gradients; rather, the papillary muscles  44  brace the valves against the high pressure needed to circulate the blood throughout the body. Together, the papillary muscles  44  and the chordae tendineae  42  are known as the subvalvular apparatus. The function of the subvalvular apparatus is to keep the valves from prolapsing into the atria when they close. 
         [0008]    The tricuspid valve  26  in  FIG. 1  typically is made up of three leaflets with three papillary muscles. However, the number of leaflets can range between two and four. The three leaflets of the tricuspid valve  26  are referred to as the anterior, posterior, and septal leaflets. Although both the aortic and pulmonary valves each have three leaflets (or cusps), they do not have chordae tendineae. The mitral valve  22  has two papillary muscles  44 , the anteromedial and the posterolateral papillary muscles, which attach the leaflets  52 ,  54  to the walls of the left ventricle  14  via the chordae tendineae  42 . 
         [0009]      FIG. 2  is an illustration of a cutaway anterior view of the “left heart”  200  in systole, as indicated by the contracted ventricular wall  201 . Illustrated in  FIG. 2  is the mitral valve  22  having a posterior leaflet  203  and an anterior leaflet  204 , the mitral valve in a closed position. Also visible is the aortic valve  24  which is an open configuration during systole, and permits bloodflow from the left ventricle  14  to the aorta  30 . During systole, when a healthy mitral valve is closed, blood does not flow from the left atrium  12  to the left ventricle  14 . 
         [0010]    As illustrated with reference to  FIG. 3 , a top view of a healthy mitral valve  22 , the mitral valve  22  includes two leaflets, the anterior leaflet  204  and the posterior leaflet  203 , and a diaphanous incomplete ring around the valve, called the annulus  205 . The vast majority of patients undergoing valve surgery, such as mitral valve surgery, suffer from a degenerative disease that causes a malfunction in a leaflet of the valve, which results in prolapse and regurgitation. 
         [0011]    One possible malfunction of a heart valve, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber. This type of valve malfunction typically occurs with the mitral valve and tricuspid valve. 
         [0012]    There are three mechanisms by which a valve becomes regurgitant or incompetent; they include Carpentier&#39;s type I, type II and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (e.g., do not coapt properly). Included in a type I mechanism malfunction are perforations of the valve leaflets, as in endocarditis. A Carpentier&#39;s type II malfunction involves prolapse of one or both leaflets above the plane of coaptation. This is the most common cause of mitral regurgitation, and is often caused by the stretching or rupturing of chordae tendineae normally connected to the leaflet. A Carpentier&#39;s type III malfunction involves restriction of the motion of one or more leaflets such that the leaflets are abnormally constrained below the level of the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (IIIa) or dilation of the ventricle (IIIb). 
         [0013]      FIG. 4  illustrates a prolapsed mitral valve  22 . Here, even when in systole, when the anterior  204  and posterior  203  leaflets should be in contact with each other, gap  208  remains between the two. Because one or more of the leaflets  203 ,  204  malfunction, the prolapsed mitral valve  22  does not close properly, and, therefore, the leaflets fail to coapt. This failure to coapt causes a gap  208  between the leaflets  203 ,  204  that allows blood to flow back into the left atrium, during systole, while it is being ejected out of the left ventricle. This can create a regurgitation or other mitral valve insufficiency.  FIG. 4  further illustrates the valve annulus  205 . 
         [0014]    Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve  24  or the pulmonary valve  28 , whereas regurgitation predominantly affects either the mitral valve  22  or the tricuspid valve  26 . Both valve stenosis and valve regurgitation increase the workload on the heart  10  and can lead to very serious conditions if left un-treated; such as endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately, death. Since the left heart is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve  22  or aortic valve  24  is particularly problematic and often life threatening. Accordingly, because of the substantially higher pressures on the left side of the heart, left-sided valve dysfunction is much more problematic. 
         [0015]    All of the references cited in this application are incorporated by reference in their entireties. 
       SUMMARY OF THE INVENTION 
       [0016]    The present application describes methods and devices for minimally invasive, beating-heart, valve repair, including but not limited to mitral valve repair. 
         [0017]    Valve dysfunction can be treated through the placement of artificial chordae between the leaflets and the ventricular wall or papillary muscles or the approximation of leaflets. 
         [0018]    An expandable element can be inserted through a valve leaflet, such as a mitral valve leaflet, in order to connect the leaflet to other tissue of the heart, including other leaflets. Artificial chords can be secured to the leaflets without relying on additional manipulations on the atrial side of the valve leaflets. 
         [0019]    The exemplary embodiments disclosed herein refer to an apparatus having at least two pledgets, a first line, and at least a second line. The first line can have a first end connected to a first of the at least two pledgets and a second end connected to a second of the at least two pledgets. The second line can be connected to the first line. The at least two pledgets and the first and second lines can be positioned inside a hollow elongate tube. The hollow elongate tube can be a needle. 
         [0020]    The exemplary embodiments disclosed herein refer to a method having the steps of introducing a needle into a heart ventricle; contacting the ventricular side of a heart valve leaflet with the needle; piercing the heart valve leaflet with the needle so that at least a portion of the needle extends through the heart valve leaflet; deploying a pledget with a line attached to it on the atrial side of the heart valve leaflet; and withdrawing the needle from the heart valve leaflet back into the ventricle. The needle can have an opening such that when the needle pierces the leaflet, the portion of the needle with the opening passes through to the atrial side of the heart valve leaflet. The pledget and line attached to the pledget can be deployed from the needle through the opening. 
         [0021]    The exemplary embodiments disclosed herein further refer to a method having the steps of introducing a catheter with a suction cup at its distal end into a heart ventricle proximate to a heart valve leaflet; contacting a ventricular side of the heart valve leaflet with a distal end of the suction cup; applying a negative pressure to the ventricular side of the heart valve leaflet; extending a needle out of the distal end of the catheter and suction cup; piercing the heart valve leaflet with the needle, deploying a pledget through the opening of the needle on the atrial side of the heart valve leaflet; withdrawing the needle from the heart valve leaflet into the catheter; and releasing the negative pressure to remove the suction cup from the ventricular side of the heart valve leaflet. The needle can be positioned within the catheter. The needle has an opening, and when the leaflet is pierced with the needle, the opening in the needle passes through the leaflet to the other side of the leaflet. A line is secured to the pledget. When the needle is withdrawn from the leaflet, the pledget and at least a portion of the line that is secured to the pledget remain on the other side of the leaflet. 
         [0022]    The exemplary embodiments disclosed herein further refer to a method of coapting valve leaflets having the steps of introducing into a needle into a heart ventricle; contacting a ventricular side of a first heart valve leaflet with the needle; piercing the first heart valve leaflet with the needle; withdrawing the needle from the first heart valve leaflet contacting a ventricular side of a second heart valve leaflet with the needle; piercing the second heart valve leaflet with the needle; deploying a second pledget through the opening of the needle on the atrial side of the second heart valve leaflet; withdrawing the needle from the second heart valve leaflet; and withdrawing the needle from the ventricle. Piercing the leaflets includes pushing at least a portion of the needle all the way through to the space on the other side of the leaflet. The needle can have an opening, and the portion of the needle with the opening can be pushed through to the other side of the leaflet. The other side of the leaflet can be the atrial side of the leaflet, when the needle makes initial contact with the ventricular side of the leaflet prior to piercing. Deploying a pledget includes deploying a pledget from the opening in the needle. A line can be attached to the pledget such that both the pledget and a portion of the line remain on the other (for example, atrial) side of the leaflet. After the needle is withdrawn from one leaflet, it can pierce a second leaflet, and the method can repeat so that a second pledget and a portion of the line remains on the other (for example, atrial) side of the second leaflet. 
         [0023]    These and aspects of the exemplary embodiments will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, illustrating by way of example the principles of the various exemplary embodiments. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0024]    In order to facilitate a fuller understanding of the exemplary embodiments, reference is now made to the appended drawings. These drawings should not be construed as limiting, but are intended to be exemplary only. 
           [0025]      FIG. 1  depicts a cut-away anterior view of the human heart in diastole. 
           [0026]      FIG. 2  depicts a cut-away anterior view of the left portion of a human heart in systole. 
           [0027]      FIG. 3  depicts a top view of a healthy mitral valve with the leaflets closed. 
           [0028]      FIG. 4  depicts a top view of a dysfunctional mitral valve with a visible gap between the leaflets. 
           [0029]      FIG. 5  depicts a perspective view of a needle with pledgets in accordance with an exemplary embodiment. 
           [0030]      FIG. 6  depicts a perspective view of a needle with a pledget and a line in accordance with an exemplary embodiment. 
           [0031]      FIG. 7  depicts a side view of a needle in accordance with an exemplary embodiment. 
           [0032]      FIGS. 8A and 8B  depict views of a needle with a puncturing tip retracted and exposed, respectively, in accordance with an exemplary embodiment. 
           [0033]      FIGS. 9A-9F  depict a needle approaching and puncturing cardiac tissue, deploying a pledget, and removal of a needle in accordance with an exemplary embodiment. 
           [0034]      FIG. 10A  depicts a cutaway anterior view of a human heart with a pledget and line implanted in accordance with an exemplary embodiment. 
           [0035]      FIG. 10B  depicts a top view of the pledget of  FIG. 10A , on top of a mitral valve leaflet. 
           [0036]      FIG. 11  depicts an exemplary embodiment of a method of implantation in accordance with the exemplary embodiment of  FIGS. 10A and 10B . 
           [0037]      FIG. 12A  depicts a cutaway anterior view of a human heart with a plurality of pledgets in accordance with an exemplary embodiment. 
           [0038]      FIG. 12B  depicts a top view of the pledgets of  FIG. 12A  and leaflets of a mitral valve leaflet. 
           [0039]      FIG. 12C  depicts a close-up of a portion of the view of  FIG. 12A . 
           [0040]      FIG. 13  depicts an exemplary embodiment of a method of implantation in accordance with the exemplary embodiment of  FIGS. 12A and 12B . 
           [0041]      FIG. 14A  depicts a cutaway anterior view of a human heart with a plurality of pledgets and sutures in accordance with an exemplary embodiment. 
           [0042]      FIG. 14B  depicts a top view of the pledgets of  FIG. 14A  and leaflets of a mitral valve. 
           [0043]      FIG. 15  depicts an exemplary embodiment of a method of implantation in accordance with the exemplary embodiment of  FIGS. 14A and 14B . 
           [0044]      FIG. 16A  depicts a cutaway anterior view of a human heart with a plurality of pledgets and sutures in accordance with an exemplary embodiment. 
           [0045]      FIG. 16B  depicts a top view of the pledgets of  FIG. 16A  and leaflets of a mitral valve. 
           [0046]      FIG. 16C  depicts a close-up of a portion of the view of  FIG. 16A . 
           [0047]      FIG. 17A  depicts a cutaway anterior view of a human heart with pledgets coapting mitral valve leaflets together in accordance with an exemplary embodiment. 
           [0048]      FIG. 17B  depicts a top view of the pledgets of  FIG. 17A  and leaflets of a mitral valve. 
           [0049]      FIG. 18  depicts a close-up of a portion of the view of  FIG. 17A . 
           [0050]      FIG. 19  is a side cross section of an embodiment of an artificial chord delivery device. 
           [0051]      FIG. 20  illustrates an embodiment of a transventricular wall approach for the artificial chord delivery device shown in  FIG. 19 . 
           [0052]      FIG. 21  illustrates an embodiment of a transseptal approach for the artificial chord delivery device shown in  FIG. 19 . 
           [0053]      FIG. 22  illustrates an alternative transventricular wall approach for the artificial chord delivery device shown in  FIG. 19 . 
           [0054]      FIG. 23  illustrates an example of an artificial chord placed using the artificial chord delivery device. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0055]    The following description is intended to convey a thorough understanding of the embodiments by providing various embodiments and details involving a device and method for delivering a suture line and pledgets to repair a mitral valve by replacing one or more chordae with suture line. In various embodiments, the device can also be used in a method for approximating the valve leaflets together. It is understood, however, that the invention is not limited to these specific embodiments and details, which are exemplary only. It is further understood that one possessing ordinary skill in the art, in light of known devices, systems and methods, will appreciate the use of the invention for its intended purposes and benefits in any number of alternative embodiments. 
         [0056]    There is a significant need to perform mitral valve repairs using less invasive procedures while the heart is still beating. Accordingly, there is a continuing need for new procedures and devices for performing cardiac valve repairs, such as mitral and tricuspid valve repairs, which are less invasive, do not require cardiac arrest, and are less labor-intensive and technically challenging. Chordal replacement procedures and artificial chordae that ensure the appropriate chordal length and spacing so as to produce a competent valve are of particular interest. The methods and repair devices presented herein meet these needs. 
         [0057]    Repair of the chordae of a cardiac valve, such as that provided by the methods described herein, assist the valve leaflets such that they can meet in the correct position, and the valve can once again function properly. This will repair the leaking of the valve, and then in turn alleviate the symptoms associated with such leaking, regurgitation, or other insufficiency. 
         [0058]    Referring to  FIGS. 5, 10A, and 10B , the exemplary embodiments disclosed herein use a needle  501  such as a hypotube needle, loaded with a line  507  of chordae replacement material, such as a strand of suture line. The line  507  can be any of a suture, suture line, strand, and/or artificial chordae. The line can be made from a wide variety of different materials. For example, the line  507  can be made of ePTFE or other chordae replacement material with one or more pledgets threaded onto the line. For a ventricular approach, the needle is passed into the heart and through the valve leaflet at the desired location. 
         [0059]    Referring to  FIG. 5 , an exemplary embodiment of a hypotube needle  501  is illustrated. The hypotube needle  501  of  FIG. 5  has a sharpened tip  502  and is generally hollow and cylindrical in an exemplary embodiment, with an angled distal end. Inside the needle are a plurality of pledgets  503 ,  504 ,  505  which are rolled, folded, or in any other storage or compressed configuration to allow for storage inside the needle and easy deployment. There can be any number of pledgets. The pledgets  501  are connected to one or more lines  507 . The configuration of the pledgets and/or the line(s) can be adjusted based on the application. For example, the pledget can be rectangular (see  FIG. 6 ) and can be compressed or rolled (see  FIG. 5 ) to fit within the needle. Groups of two or more pledgets can be provided on a strand  507 , allowing for the groups of pledgets to be pulled taught at specific locations. The pledgets  503 ,  504 ,  505  can be attached to each other by a line  507 , or at least one pledget can be attached to at least one separate line. The line  507  can be secured to the distal most pledget at  503  and slidably run through a center or other location  522  of each of the more proximally located pledgets in the needle as illustrated. The line can be secured (e.g., not slideable) to both the distal-most pledget and the proximal-most pledget. A separate strand  507  can be connected to each pledget  503 ,  504 ,  505 , or one strand can be connected to two or more pledgets. The pledgets can be crimped and compressed to occupy less volume in a central shaft of the needle, allowing for a reduced outer diameter of the needle  501 . 
         [0060]    Referring to  FIG. 6 , a perspective view of a hypotube needle  601 , a line  607 , and a deployed and expanded pledget  602  in accordance with an exemplary embodiment is illustrated. The pledget  602  can be square or rectangular in shape, or can be circular or any other shape. For example, the pledget can have a generally flat top surface area and bottom surface area, so as to allow the pledget to act as an anchor on one side of heart tissue  905  (see  FIG. 9F ). The pledget  602  can be any material suitable for implantation and that is biocompatible, such as PTFE, ePTFE, felts made of PTFE and/or ePTFE, polyester, polyethylene terephthalate (PET, DACRON®), or other polymer. The strand can extend through the pledget, and can be secured by a knot or other means as indicated at  620 . In the exemplary embodiment of  FIG. 6 , the pledget  603  and line can be deployed by pushing the pledget out a distal opening  606  in the needle  601  in exemplary embodiments. The line can be made of any suitable material, for example, PET, ePTFE, or PTFE. 
         [0061]    Referring to  FIGS. 6 and 7 , the pledget  603  and line  607  can also be deployed by pushing the pledget out a side opening  704  of a needle  701 . In the example illustrated by  FIG. 7 , hypotube needle  701  can have a tapered or conical tip  702  at the distal end, for penetrating and dilating tissue. Hypotube needle  701  also has a hollow central lumen  705  and a generally cylindrical body  703 . Pledgets can be stored in the central lumen  705  in the manner illustrated in  FIG. 5  or in any other manner. The opening  704  is in the side of the cylindrical body just proximal to the conical tip  702 . The opening  704  is in fluid connection with the central shaft, in which the pledget(s) and line(s) can be dispensed through. The needle can be made of stainless steel or any other suitable material for needles for surgical use. 
         [0062]      FIGS. 8A and 8B  are perspective views of an embodiment of a needle  801 . In the example illustrated by  FIGS. 8A and 8B  the hypotube needle  801  has a conical distal portion  802 , and side opening  803  for the deployment of lines and pledgets, and an opening at the distal end  804  of the conical distal portion  802 .  FIG. 8B  illustrates the same needle as  FIG. 8A , where the opening  804  at the distal end  804  of the conical tip has a piercing element  805  extending therefrom. The piercing element  805  can be an auto incisor in an exemplary embodiment. The auto incisor can be a spring-loaded retracting point or blade, which allows the placement of the blunt tip of distal portion  802  against the cardiac tissue to be punctured, the location to be verified, and the puncture of the tissue to occur only when the piercing element  805  is extended by an actuator.  FIG. 8A  illustrates the needle with the auto incisor retracted, and  FIG. 8B  illustrates the auto incisor in a deployed position. The needle in  FIGS. 8A and 8B  can be used in any of the procedures described herein, including but not limited to inserting artificial chordae and securing opposing edges of two or more leaflets together. 
         [0063]      FIGS. 9A-9F  illustrate the steps involved in the deployment of a line  909  and single pledget  906  in a cardiac tissue  905 . For example, a valve leaflet, such as a mitral valve leaflet or a tricuspid valve leaflet. The line  909  can be used as an artificial mitral valve or tricuspid valve cord or to secure two or more leaflets together (e.g., Alfieri procedure). In this embodiment, a shafted instrument  901 , which can be a hyponeedle, is inserted into the cardiac tissue  905  to deploy a pledget  906 . In the example, the needle  901  has a conical distal end  902  with an opening  904  towards the distal-most end  912 , which is flat or otherwise non-tissue-piercing, and a side opening  910  along a hollow shaft  911 . However, any of the needles disclosed herein can be used to perform the method illustrated by  FIGS. 9A-9F . In  FIG. 9A , the flat distal tip  912  is brought close to the cardiac tissue  905 , which can be mitral valve leaflet tissue.  FIG. 9B  illustrates the same needle  901  after it has been moved closer to the tissue, and flat distal tip  912  now makes contact with tissue  905 .  FIG. 9C  illustrates a needle  901  with a piercing element  913  extended from the distal end of the conical portion, puncturing the tissue  905  as illustrated herein.  FIG. 9D  illustrates the needle  901  with the conical tip  902  and the side opening  910  fully inserted through the cardiac leaflet tissue  905 .  FIG. 9E  illustrates a pledget  906  attached to a line  909  deployed such that the pledget is in an expanded configuration.  FIG. 9F  illustrates the withdrawal of the needle  901  from the cardiac leaflet tissue  905  and pulling the line  909 . For example, the line can pull the pledget  906  against leaflet tissue  905 . 
         [0064]    Referring to  FIG. 10A , in an exemplary embodiment, the pledget  1001  abuts the atrial side of a mitral valve leaflet  1005 . The pledget can be brought into contact with the atrial side of the leaflet  1005 , for example, once the delivery device or needle  901  has been removed from the heart ventricle or after the needle has been removed from the leaflet  1005 . The line  1002  is then pulled taught, and the line is anchored to the outside of the ventricular wall at or near the point of entry into the ventricle, for example, the apex, with an anchor  1004 . 
         [0065]      FIGS. 10A-10B  illustrate an exemplary embodiment of a single pledget inserted into the mitral valve leaflet tissue. In  FIG. 10A , a single pledget  1001  attached to a single line  1002  has been implanted. The line  1002  is visible in the left ventricle of this cutaway anterior view of the human heart. The line is anchored into the ventricular wall  1003  of the left ventricle. The anchor  1004  can also be placed into or through the papillary muscle at the discretion of the user. The anchor can be another pledget in an exemplary embodiment. The anchor can be any one or plurality of a pledget, knot, clip, disc, hook, barb, and/or adhesive. Any device capable of securing the line  1002  to the heart tissue can be used. The line can replace or work in conjunction with existing chordae. 
         [0066]      FIG. 10B  illustrates the top view of the mitral valve, with the pledget  1001  abutting the atrial surface of the anterior leaflet  1005  of the mitral valve. In  FIGS. 10A-10B , a single pledget is deployed from a needle, and the line is anchored via anchoring element  1004  near the outside of the apex of the heart such that the line is of an appropriate length to be a replacement or supplemental chordae in the ventricle of the heart. In an exemplary embodiment, the leaflet  1005  is imaged and the length of the line  1002  is adjusted to reduce or eliminate prolapse of the leaflet  1005  and/or the gap  208  illustrated by  FIG. 10B . For example, a leaflet may be imaged by echocardiography (echo), which can also be used to detect regurgitation. 
         [0067]    An exemplary method for inserting the pledgets and line by deploying the line and at least one pledget from a hypotube needle as illustrated in  FIGS. 10A-10B  is shown in  FIG. 11 . In step  1101 , the needle, which can be contained within a delivery device, can be inserted through the ventricle of the heart, near the apex of the heart or any other location as deemed appropriate by the user. The needle is passed into the heart and through the valve leaflet to the desired location. Assistance in positioning the needle can be provided by exemplary embodiments of a deployment device with an outer catheter and a suction cup as disclosed herebelow and illustrated in  FIGS. 19-23 . In step  1102 , the needle is brought to the ventricular surface of a valve leaflet. In step  1103 , the needle punctures the leaflet tissue until an opening in the needle is on the atrial side of the leaflet. The puncturing of the leaflet can be accomplished using an optional piercing element at the distal end of the needle. In step  1104 , a most distal pledget and at least a portion of the line in the needle is deployed on the atrial side of the leaflet. In step  1105 , the needle is retracted from the leaflet, and then from the ventricular wall. Here the line is set to its desired length, and the line, now acting as an artificial chord, can be anchored in step  1107  to the ventricular access location with an anchor. In one exemplary embodiment, in optional step  1106 , the valve is viewed to confirm that the leaflets are coapting while the heart is beating and the length of the line is adjusted if necessary. 
         [0068]      FIGS. 12A-12C  illustrate another exemplary embodiment of pledgets  1201 ,  1202 ,  1203  and lines inserted to replace or work in conjunction with a chordae attached to the left ventricle and mitral valve leaflets.  FIG. 12A  depicts a cutaway anterior view of the human heart, with a single longer line, and a plurality of shorter lines that are each connected to a pledget.  FIG. 12C  illustrates a close-up of a portion of  FIG. 12A . In this configuration, each pledget  1201 ,  1202 ,  1203 , is fixedly attached to a shorter line. The shorter lines  1208 ,  1209 , and  1210 , attached to each pledget,  1201 ,  1202 , and  1203 , respectively, are all connected to a longer line  1204 . The first pledget  1201  is dispensed through, for example, an opening  704  in a needle  701  of  FIG. 7 . The needle is then removed from the leaflet tissue and reinserted into the leaflet tissue. Once the opening of the needle is again on the atrial side of the leaflet, a second pledget  1202  is dispensed. The needle is again withdrawn from the leaflet. The needle can be inserted into the leaflet a third time and a third pledget  1203  is dispensed into the mitral valve leaflet. Any number of pledgets can be deployed in this manner. Once the pledgets have been deployed, the needle is again removed from the leaflet. The three lengths of suture line  1208 ,  1209 , and  1210 , can be secured to each other and to the longer line  1204 , by a connector  1211 . The connector can also be stored in the needle for deployment into the heart. The device used to deploy the pledgets and line is withdrawn from the ventricular wall of the heart, and the line  1204  is pulled so that the pledgets are all pulled into contact with the atrial side of the leaflet. The proximal end  1205  of the line  1204  can be secured against the outside of the heart wall  1206  with an anchor  1207  that can be used to adjust the line to its optimal length to have a desired therapeutic effect on the heart valve leaflets and serve as a replacement or complimentary to the chordae to the mitral valve.  FIG. 12B  illustrates a top view (e.g., from the atrial side) of the mitral valve leaflets, with the first, second, and third pledgets  1201 ,  1202 ,  1203  in position in the anterior leaflet  1208 . 
         [0069]    An exemplary method for deploying pledgets in the configuration disclosed in  FIGS. 12A-12C , is shown in  FIG. 13 . In step  1301  of this exemplary embodiment, the device is inserted through the ventricular wall. In step  1302 , the needle is brought to the leaflet tissue on the ventricular side of the leaflet. Assistance in positioning the needle can be provided by exemplary embodiments of a deployment device with an outer catheter and a suction cup as disclosed herebelow and illustrated in  FIGS. 19-23 . In step  1303 , the needle punctures the leaflet and extends through it. In step  1304 , a first pledget, securedly attached to the line, is deployed. In step  1305 , the needle is removed from the leaflet but is not fully withdrawn from the ventricle. Steps  1303  through  1305  are repeated until a desired number of pledgets and lines have been deployed in the leaflet tissue. A connector piece holds the lines secured to the pledgets together. The connector piece can be dispensed from the needle in the heart ventricle after any withdrawal of the needle from the leaflet. The connector can also be deployed from the needle prior to any contact of or insertion of the needle into the leaflet. The needle and delivery device can be removed from the heart in step  1306 . In step  1308 , the length of the suture line (or lines) are adjusted so that it is (they are) taught when the valve leaflet is in the closed position. In one exemplary embodiment, the valve is viewed to confirm that the leaflets are coapting while the heart is beating, and the length of the line is adjusted if necessary, shown in step  1307 .  FIG. 12A  illustrates a plurality of pledgets deployed by this method. 
         [0070]      FIGS. 14A-14B  illustrate another exemplary embodiment of using pledgets  1401  and  1402 , and lines  1403 ,  1404  to repair a mitral valve insufficiency or regurgitation. FIG.  14 A illustrates another exemplary embodiment of the implantation of the pledgets. In this embodiment, a single line can be used to deploy pledgets  1401 ,  1402 . The device has been inserted through the ventricular wall, the needle inserted through the anterior mitral valve leaflet, and a pledget  1401  deployed. The device is then removed through the ventricular wall, and the line  1403  secured with an anchor  1411 . The device is then reinserted through the ventricular wall at approximately the same or the exact same location as the first time, then the needle is brought up to the posterior leaflet, puncturing it and deploying another pledget  1402 . The needle and device are then retracted from the heart, and the line  1404  is secured with anchor  1411 . In this way, a plurality of lines  1403 ,  1404 , can be implanted in the heart&#39;s ventricle, all from a single piece of suture line, and tethered at the same anchoring location  1410 . Any number of pledgets and lines can be deployed.  FIG. 14B  illustrates a top view of the mitral valve, having a pledget  1401  abutting the atrial side of the anterior leaflet  1408 , and a pledget  1402  abutting the atrial side of the posterior leaflet  1409 . 
         [0071]      FIG. 15  illustrates an exemplary embodiment of a method for inserting a plurality of pledgets off of a single line. Multiple lines can be positioned in the heart, from a single anchoring location. Assistance in positioning the needle can be provided by exemplary embodiments of a deployment device with an outer catheter and a suction cup as disclosed herebelow and illustrated in  FIGS. 19-23 . Once a first pledget and line have been positioned, as in steps  1101  through  1106  of  FIG. 11 , the device can be pulled back through the ventricle, in step  1501 , and the line can be held external to the heart while the device is passed back into the ventricle. In step  1502  the needle is brought into contact with the leaflet tissue in a desired location. In step  1503 , the needle punctures the valve leaflet again; and in step  1504  another pledget is deployed on the atrial side of the leaflet. In step  1505 , the needle is removed from the leaflet, and in step  1506 , the needle and device are withdrawn back through the ventricular wall. In this way, a plurality of pledgets, and a plurality of lines, can be positioned in the heart, all from a single piece of line. In step  1508 , the lines are anchored to the outside of the heart wall. This process of steps  1501  through  1508  can be repeated as many times as needed to deploy a plurality of pledgets into a leaflet. In one exemplary embodiment, the valve is viewed to confirm that the leaflets are coapting while the heart is beating and the length of the lines is adjusted if necessary, in step  1507 . The valve can be viewed after each instance in which the needle is removed from the heart wall, or at any time during the procedure.  FIG. 14A  illustrates a plurality of pledgets deployed by this method. 
         [0072]      FIGS. 16A-16C  illustrate an insertion of pledgets  1601 ,  1602 ,  1603 ,  1604 , and  1605 , and lines  1610 ,  1611 ,  1612 ,  1613 ,  1614 ,  1615 , and  1616 , involving a combination of the methods described above. Here, a first insertion of the device is made in the ventricular wall, and a plurality of pledgets are deployed by the needle into the anterior leaflet of the mitral valve while the needle remains in the ventricle, consistent with a method disclosed in  FIGS. 12A, 12B, and 13 . Assistance in positioning the needle can be provided by exemplary embodiments of a deployment device with an outer catheter and a suction cup as disclosed herebelow and illustrated in  FIGS. 19-23 . Then the device can be withdrawn from the ventricle, so that the line can be tethered or anchored to the ventricular wall of the heart. The device can then be inserted again through the ventricle, this time with the needle puncturing the posterior leaflet of the mitral valve, and deploying a plurality of pledgets. In  FIGS. 16A-16C , three pledgets  1601 ,  1602 ,  1603  have been deployed into the anterior leaflet and two pledgets  1604 ,  1605  have been deployed into the posterior leaflet, but any number and combination of pledgets can be used.  FIG. 16C  is a close-up view of a portion of  FIG. 16A . The pledgets can be deployed in any order. For example, all pledgets deployed in the anterior valve can be deployed followed by deployment of all pledgets into the posterior valve; the posterior valve pledgets can be deployed before the anterior valve pledgets; or the pledgets be deployed in an alternating manner between the leaflets. The lines secured to pledgets can be connected by connectors  1606 ,  1607 . All of the pledgets can be deployed from the same line, or a new line can be used each time the device is deployed into the ventricle. In an exemplary embodiment, lines  1610 - 1616  are all of the same line of suture material. As with  FIGS. 12A-12B and 13 , connectors  1606 ,  1607  can be dispensed from the needle after any withdrawal of the needle from, or prior to the first insertion of the needle to, the anterior leaflet. A connector can be dispensed from the needle after any withdrawal of the needle from, or prior to the first insertion of the needle into, the posterior leaflet. 
         [0073]      FIGS. 17A-17B and 18  depict pledgets  1701 ,  1702  and line  1710  deployed in another manner in accordance with an exemplary embodiment. The illustrated pledgets and line approximate the function of an Alfieri stitch procedure. In  FIGS. 17A and 18 , a cutaway anterior view of the human heart, two pledgets  1701 ,  1702  have been inserted, connected by a line  1710 .  FIG. 18  is a close-up view of a portion of  FIG. 17A . Here a single pledget  1701  is positioned such that it abuts the atrial side of the anterior leaflet  1708  of the mitral valve, and a single pledget  1702  is positioned such that it abuts the atrial side of the posterior leaflet  1709  of the mitral valve. The line  1710  extends around the ventricular side of the valve leaflets  1708 ,  1709 . The line  1710  is pulled tight to pull the centers of the leaflets  1708  and  1709  together. A connector  1720  is placed on the ventricular side of the leaflet  1709  to keep the line  1710  tight. The pledgets  1708 ,  1709  and line or suture  1710  coapt the leaflets together to resolve a mitral valve regurgitation or insufficiency. 
         [0074]    The pledgets and line can be initially implanted in the same way as the previous configurations. That is, the device can be inserted through the ventricular wall, and the needle punctures a first leaflet of the mitral valve, followed by a deployment of a first pledget, which is secured to the end of a line. The needle is then withdrawn from the leaflet, and the line can be pulled so that the pledget abuts the atrial side of the leaflet. Then the needle is inserted into the second leaflet of the mitral valve, and a second pledget is deployed. The needle is removed from the second leaflet, and the line is pulled taught such that the second pledget abuts the atrial side of the second leaflet. The line can be secured to the second pledget by the connector  1720  so that once both pledgets are deployed, the line that connects them is on the ventricular side of the mitral valve, and the device can be withdrawn from the heart through the ventricular wall without any further manipulation of line or pledget. The line can also be slidably engaged with the second pledget, and tied, anchored, or otherwise secured against the ventricular side of the mitral valve. Once the needle has been removed from the second leaflet, the line can be sized to the appropriate length. Again, a connector  1720  attached to the suture can be stored in the needle and dispensed in the ventricle of the heart either prior to any insertion of the needle into a leaflet, or after any withdrawal of the needle from a leaflet. 
         [0075]      FIG. 17B  depicts a top view of a mitral valve where a pledget  1701  on the anterior leaflet  1708  and a pledget  1702  on the posterior leaflet  1709  are abutting the atrial side of the leaflets and are connected on the ventricular side by a suture. The anchoring knots  1711 ,  1712  of the suture line are visible on top of each of the pledgets. The pledgets can also be secured to the suture in any other suitable way. In  FIG. 17B , the valve leaflets are coapted together to hold the centers of the valve leaflets together. The portions of the valve leaflets  1708 ,  1709 , on either side of the pledgets  1701 ,  1702  will open and close to allow the mitral valve to function. Any number of pairs of pledgets attached by a suture line can be deployed. 
         [0076]    Referring to  FIG. 19 , in one exemplary embodiment, the leaflet  1901  is in a temporarily fixed position, so that the needle  1906  can be brought into stable contact with the leaflet  1901  at the desired location on the leaflet. A wide variety of different devices can be used to hold the leaflet  1901 . In an exemplary embodiment, a catheter  1902  with a collapsible suction cup  1904  at the distal end thereof is used to temporarily engage or hold at least a portion of the valve leaflet in a fixed position. The suction catheter  1904  can be used in any of the procedures and devices described herein. Once engaged or held, the leaflet can be punctured with a needle  1906 , and a pledget  1920  with a line attached thereto can be deployed, using the methods disclosed herein. 
         [0077]      FIG. 19  illustrates an exemplary embodiment of a side cross section of a distal end of a delivery device  1900  while engaged with an atrioventricular heart valve leaflet  1901 , for example, a mitral valve leaflet. The delivery device includes an elongate outer catheter  1902  that is deployable using a minimally invasive procedure to the heart valve leaflet. For example, the catheter can be deployed transapically or transseptally. A suction or vacuum catheter  1905  extends through the outer catheter  1902 . A proximal end of a lumen of the suction catheter  1905  is fluidly coupled to a source of suction or vacuum (not illustrated). In one exemplary embodiment, the suction catheter  1905  is filled with a liquid, such as water, blood, or a saline solution. In one example, the suction catheter  1905  contains substantially no air when introduced. A suction cup  1904 , such as a frustoconical suction cup, extends from a distal end of the suction catheter  1905 . In the illustrated embodiment, the suction cup  1904  is collapsible and is extendable out of and retractable into the outer catheter  1902 . Some embodiments of the deployed suction cup  1904  are at least partially axially collapsible when engaging tissue under suction (suction indicated by arrows  1930 ). The device also includes a needle catheter  1907  through which a slidable needle  1906  advances through or retracts from the leaflet  1901 . In the illustrated embodiment, the needle catheter  1907  is generally coaxial with the outer catheter  1902 , but is offset in other embodiments. A line extends through and out of a lumen in the slidable needle  1906 . Other embodiments include at least one additional slidable needle, which permits placing multiple lines in a single operation, or selecting the needle at the more desired position for placing the artificial chord. Some embodiments of the delivery device include an imaging element, for example, an ultrasound transducer, the use of which will be apparent from the following discussion. The needle catheter  1907  can also fit a hypotube needle such as the exemplary embodiments disclosed herein in  FIGS. 5-7, 8A-8B , which can contain one or more pledgets to be dispensed therefrom. 
         [0078]    In an embodiment of a method for placing an artificial chord  1908  using the delivery device of  FIG. 19  as an example, a distal end portion of the outer catheter  1902  is positioned in proximity of a location on a leaflet  1901  needing an artificial chord, for example, under echo or fluoroscopic guidance. The suction cup  1904  is extended from the distal end of the outer catheter  1902 , either in close proximity to or at least partially contacting the leaflet  1901 . Suction or vacuum is then applied through the lumen of the suction catheter  1905 , which pulls the leaflet  1901  against an opening or distal end of the suction cup  1904 , thereby capturing and holding the leaflet  1901 . Capture can be confirmed by imaging, for example, echo or fluoroscopy. If the leaflet is not captured at the desired location, the suction is released or reduced sufficiently to permit repositioning the suction cup  1904 . Once properly positioned, the slidable needle  1906  is then advanced from the needle catheter  1907  and through the leaflet  1901 . The slidable needle can be a hypotube needle in accordance with an exemplary embodiment, as disclosed herein. An end of the line  1908  extending from the needle  1906  is secured to the leaflet  1901 , for example, using a knot or clip (see, for example, U.S. Patent Application Publication No. 2014/0114404 A1, which is incorporated herein by reference in its entirety), or using a pledget fixedly or slidably attached to the line. The length of the line is adjusted to correct leaflet motion, for example, by observing reduced regurgitation by Doppler ultrasound imaging. Another end of the line  1908  is then secured to another structure, for example, a ventricular wall, ventricular septum, and/or papillary muscle, to complete the artificial chord. The device and any excess line is removed. 
         [0079]    In some embodiments, the line  1908  is similar to, and is deployed analogously to the artificial chord described in U.S. Pat. No. 7,635,386, the entire content of which is incorporated by reference in its entirety. 
         [0080]    Embodiments of the disclosed system, device, and method include the ability to reposition the suction cup  1904  until the desired positioning is achieved. Another advantage is that the leaflet is captured and immobilized relative to the line  1908  and needle  1906 , which permits a more precise placement of the artificial chord  1908  compared with methods in which the leaflet is moving relative to the line  1908  at some time during deployment. 
         [0081]    The suction catheter  1905  and suction cup  1904  can be used to secure lines to valve tissue in any of the ways described herein.  FIG. 20  illustrates an embodiment of a method for placing an artificial chord on a posterior leaflet of a mitral valve using the delivery device of  FIG. 19 . In the illustrated embodiment, the suction cup  1904  of the device accesses a mitral posterior valve leaflet  2002  through an opening in a ventricular wall  2001 . In other embodiments, the leaflet is an anterior leaflet of the mitral valve, or one of the leaflets of the tricuspid valve. In  FIG. 20 , the delivery device penetrates the ventricular wall above the papillary muscles  2003 . In other embodiments, the delivery device penetrates the ventricular wall proximate a papillary muscle, through a papillary muscle, through the intraventricular septum, or at or near the apex of the heart. In other embodiments, the device can be used to approximate the leaflets together, as accomplished by the Alfieri stitch. 
         [0082]      FIG. 21  illustrates another embodiment of a method for accessing a mitral valve leaflet by a transseptal approach from the right atrium to the left atrium. This approach can be used to tie the mitral valve leaflets together in generally the same manner as described with respect to  FIGS. 17A-17B and 18 . However, the pledgets or other type of anchor are disposed on the ventricular side of the leaflets. Those skilled in the art will understand that a similar approach is useful in accessing the tricuspid valve leaflet where the delivery device accesses the right atrium through, for example, one of the superior or inferior vena cava. A variety of different procedures can be performed by accessing the leaflets of the mitral valve or the tricuspid valve from the atrial side as illustrated by  FIG. 21 . The suction cup  2202  can be used in any procedure to hold heart tissue, such as a valve leaflet  2205 . A needle  2203  or other device can penetrate the heart tissue from the atrial side while the tissue is held by the suction cup  2202 . 
         [0083]    In the example illustrated by  FIG. 22 , the distal end of the outer catheter  2201  and the suction cup  2202  captures or engages tissue other than a leaflet, for example, to stabilize the delivery device. For example, in  FIG. 22 , the suction cup  2202  at the distal end of the outer catheter  2201  engages the left ventricular wall  2204  while the needle (not shown) is deploying a line to the posterior leaflet  2209  of the mitral valve. In other embodiments, the suction cup  2202  engages other tissue, for example, a ventricular wall at or near the apex, an atrial wall, the intraventricular septum, or the interatrial septum, which permits accessing any of the mitral or tricuspid valve leaflets for placing one or more artificial chords. 
         [0084]      FIG. 23  illustrates an embodiment of an artificial chord  2301  delivered according to any of the approaches illustrated in  FIGS. 20-22 . In the illustrated embodiment, a first end of the artificial chord  2301  is secured to the anterior mitral valve leaflet  2302  and a second end is anchored at an outside surface of the ventricular wall  2303 . Other embodiments are anchored at another location, for example, within the myocardium, to a papillary muscle, to the intraventricular septum, or to a natural chord or artificial chord, such as a line. Suitable anchors  2304 ,  2305  include pledgets, knots, clips, discs, hooks, barbs, and/or adhesives. 
         [0085]    The methods and devices described herein are not limited to use within the mitral valve of the heart. They can be used in any heart valve or other valve tissue in the body, such as the tricuspid valve, in which leaflets are to be repaired, coapted, or otherwise repositioned. 
         [0086]    Further, although some of the embodiments have been described herein in the context of a particular implementation in a particular environment for a particular purpose, those of ordinary skill in the art should recognize that its usefulness is not limited thereto and that the various embodiments can be beneficially implemented in any number of environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the embodiments as disclosed herein. While the foregoing description includes many details and specificities, it is to be understood that these have been included for purposes of explanation only, and are not to be interpreted as limitations of the various embodiments. Modifications to the embodiments described above can be made without departing from the spirit and scope of this description.