Patent Publication Number: US-2020281584-A1

Title: Suturing devices and methods for suturing an anatomic valve

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 15/594,412, filed May 12, 2017, which is divisional of U.S. patent application Ser. No. 14/111,534, filed Feb. 4, 2014, titled “SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMIC VALVE,” now U.S. Pat. No. 9,649,106, which is a U.S. National Phase of International Patent Application No. PCT/US2012/033396, filed Apr. 12, 2012, titled “SUTURING DEVICES AND METHODS FOR SUTURING AN ANATOMIC VALVE”, which claims the priority benefit of U.S. Provisional Application No. 61/476,236, filed Apr. 15, 2011, the entirety of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     Embodiments of the present inventions relate to suturing devices and methods. Some embodiments of the present invention relate to suturing devices and methods for suturing an anatomic valve, for example, a heart valve such as a mitral valve, an aortic valve, a tricuspid valve, or a pulmonary valve. 
     BACKGROUND 
     Health practitioners frequently use sutures to close various openings such as cuts, punctures, and incisions in various places in the human body. Generally, sutures are convenient to use and function properly to hold openings in biological tissue closed thereby aiding in blood clotting, healing, and prevention of scaring. 
     There are some circumstances under which it is not feasible to use conventional sutures and suturing methods to close an opening. Additionally, there are some circumstances under which the use of conventional sutures and suturing methods require invasive procedures that subject a patient to risk of infection, delays in recovery, increases in pain, and other complications. 
     Some heart valves may be weakened or stretched, or may have other structural defects, such as congenital defects, that cause them to close improperly, which can lead to blood flow contrary to the normal flow direction. This condition, referred to as regurgitation, incompetence, or insufficiency, can reduce blood flow in the normal direction. Regurgitation causes the heart to work harder to compensate for backflow of blood through these valves, which can lead to enlargement of the heart that reduces cardiac performance. While the tricuspid valve and the pulmonary valve may present these conditions, the mitral valve and aortic valve more frequently demonstrate these conditions. 
     A number of procedures have been developed to repair valves that do not close properly. Among these procedures is the Alfieri technique, sometimes called edge-to-edge repair, which involves suturing edges of the leaflets and pulling the leaflets closer together. In another technique, the chordae tendineae are replaced or shortened. A patch is sometimes applied to leaflets that have openings therein. In some instances, leaflets are reshaped by removing a section of the leaflet that is to be treated and the surrounding portion of the leaflet is sutured closed. Some valves are treated by attaching a ring around the outside of the malfunctioning valve. In a mitral valve annuloplasty, for example, a device such as in the shape of a ring or a partial ring may be implanted surrounding the mitral valve to pull the leaflets together. Sutures may be used to attach the annuloplasty ring to the base of the valve. Other valves may be replaced with biological or mechanical replacements. These procedures are frequently performed by highly invasive procedures, which sometimes require opening a patient&#39;s chest, stopping the patient&#39;s heart and routing blood through a heart-lung machine. Robotically-assisted procedures have been employed to reduce the size of the openings required for such procedures. 
     SUMMARY OF THE DISCLOSURE 
     Embodiments of suturing devices and methods for suturing biological tissue are disclosed herein. The suturing devices and their methods of use can be useful in a variety of procedures, such as treating (e.g., closing) wounds and naturally or surgically created apertures or passageways. For example, the suturing devices can be used to treat an anatomical valve, such as a heart valve, including heart valves that may be weakened or stretched, or have other structural defects, such as congenital defects, that cause them to close improperly. In some embodiments, one or more suturing devices can be used to treat or repair valves, such as the tricuspid, pulmonary, mitral, and aortic valves, for example. In some embodiments, one or more suturing devices can be used to perform procedures such as edge-to-edge repair (like an Alfieri technique), annuloplasty (with or without a ring or other implant), suturing of ventricular spaces, suturing of the chordae, suturing in other locations in the heart, replacement of the chordae tendineae, shortening of the chordae tendineae, patch application, leaflet reshaping, and attachment of prosthetics, such as rings and biological or mechanical replacement valves, for example. 
     In some embodiments, the suturing devices can be used to close or reduce a variety of other tissue openings, lumens, hollow organs or natural or surgically created passageways in the body. In some embodiments, the suturing devices can be used to suture prosthetics, synthetic materials, or implantable devices in the body. For example, the devices can be used to suture pledget within the body. 
     In some embodiments, a suturing device can comprise an elongate body having a distal end, a single arm, a needle, and a protective member. The single arm can be connected with the elongate body near the distal end for movement between a retracted position and an extended position. The arm can comprise a first suture mount located near a free end of the arm and configured to releasably retain a first suture portion. A needle can be configured to move between a retracted position and a deployed position to retrieve the first suture potion retained in the first suture mount when the first needle is moved from the retracted position to the advanced position and returned to the retracted position. The first protective member can be configured to inhibit contact between a distal end of the first needle and surrounding tissue during at least a portion of the movement of the first needle from its retracted position toward its deployed position. 
     In some embodiments, a suturing device can comprise an elongate body having a proximal end and a distal end, and a handle at the proximal end. A first arm and a second arm can connect to the elongate body near the distal end, and the first arm and the second arm can be configured to move between a first position, in which the first arm and second arm are retracted within the elongate body, and a second position, in which the first arm and the second arm have free ends extending away from the elongate body. The first arm and the second arm can form an angle between each other and can each have at least one suture mount at their free ends. The suture mounts can be configured to releasably retain a suture portion. A needle arm can connect to the elongate body proximal to the first and second arm, and can extend from a retracted position, in which the needle arm is retracted in the elongate body, to an extended position, in which the needle arm extends distally and outwardly from the elongate body. The needle arm can rotate around the elongate body at least between a first position where the needle arm is aligned with the free end of the first arm and a second position where the needle arm is aligned with the free end of the second arm. The device can also comprise a first needle and a second needle that can have a retracted position in which a distal point of each needle is within the needle arm. The first needle can move from the retracted position to a deployed position in which the distal point of the first needle extends out of the needle arm into the suture mount of the first arm when the needle arm is in the first position. The second needle can move from the retracted position to a deployed position in which the distal point of the second needle extends out of the needle arm into the suture mount of the second arm when the needle arm is in the second position. 
     Methods of suturing anatomic valves are also described. In some embodiments, an elongate body can be positioned at least partially within the anatomic valve. An arm can be deployed from the elongate body with the first arm releasably holding a first suture portion. A free end of the arm can be positioned at or near a base of the valve. A first needle can be deployed from the elongate body such that the first needle penetrates the valve at a first location and engages the first suture portion. The valve tissue and surrounding anatomy can be protected from a distal end of the first needle as the first needle is deployed to the first location. The first suture portion can be drawing through the leaflet. A second suture portion can be passed through the valve at a second location. The first and second suture portions can be secured together. 
     In some embodiments, an anatomic valve can be sutured by positioning an elongate body at least partially within the anatomic valve, deploying an arm from the elongate body on a first side of a valve with the first arm releasably holding first and second suture portions. A free end of the arm can be positioned at or near a base of the valve. First and second needles can be deployed from the elongate body on a second side of the valve such that the first needle penetrates the valve at a first location and engages the first suture portion and the second needle penetrates the valve at a second location and engage the second suture portion. The first and second suture portions can be drawn through the valve from the first side to the second side. The first and second suture portions can be secured together. 
     In some embodiments, an anatomic valve can be sutured by positioning an elongate body at least partially within the anatomic valve and deploying at least two arms from the elongate body with each arm releasably holding a suture portion. A free end of each of the arms can be positioned at or near a base of the valve. Needles can be deployed from the elongate body such that each needle penetrates the valve and engages a corresponding suture portion. The suture portions can be drawn through the leaflet. The suture portions can be secured together in groups of no less than two. 
     In some embodiments, an anatomic valve can be sutured by positioning a suturing device comprising an elongate body through the valve and extending a plurality of arms from the elongate body of the suturing device, with each of the arms carrying an end of a suture. At least a pair of arms can be positioned at or near a base of the valve. A protection member can be extended from the elongate body toward a first one of the arms positioned at or near a base of the valve. A needle can be advanced through the protection member, through tissue of the valve at a first location, and into contact with a first one of the suture ends carried by the first arm. The needle can be retracted through the tissue of the valve to draw the first suture end through the tissue. The protection member can be rotated along the elongate body such that the protection member extends toward a second one of the arms positioned at or near a base of the valve. A needle can be advanced through the protection member, through tissue of the valve at a second location, and into contact with a second one of the suture ends carried by the second arm. The needle can be retracted through the tissue of the valve to draw the second suture end through the tissue. A distance between the first and second locations can be closed with said suture placed through said locations. 
     In some embodiments, a mitral valve can be sutured by delivering a suturing device transapically through the heart and into the left ventricle. The suturing device can have a proximal end, a distal end, an elongate body extending between the proximal end and the distal end, and a handle at the proximal end. At least the distal end of the device can be delivered through the mitral valve. A first arm and a second arm can be extended from the elongate body from a first position, in which the first arm and the second arm are retracted into the elongate body, to a second position, in which the first arm and the second arm have free ends extending away from the elongate body. The first arm can carry a first suture end and the second arm can carry a second suture end. The first and second arm can be at or near a base of the valve on the atrial side of the valve. 
     A needle arm can be extended from a retracted position in which the needle arm is retracted into the elongate body to an initial extended position in which the needle arm is located proximal to the arms. The needle arm in the initial extended position can extend outwardly away from the elongate body in a distal direction on the ventricular side of the valve between adjacent chordae. The needle arm can be rotated toward the first arm with the needle arm remaining on the ventricular side of the valve such that the needle arm extends toward the first arm positioned at or near a base of the valve. 
     A first needle can be advanced distally out of the needle arm, through tissue of the valve at a first location, and into contact with the first suture end. The first needle can be retracted through the tissue of the valve to draw the first suture end through the tissue, and a first length of suture can run from the first suture end through the tissue. The needle arm can be rotated toward the second arm with the needle arm remaining on the ventricular side of the valve such that the needle arm extends toward the second arm positioned at or near a base of the valve. A second needle can be advanced distally out of the needle arm, through tissue of the valve at a second location, and into contact with the second suture end. The second needle can be retracted through the tissue of the valve to draw the second suture end through the tissue, and a second length of suture can run from the second suture end through the tissue. 
     The needle arm can be rotated back to the initial extended position. The needle arm can be moved proximally back to the retracted position. The first and second arms can be moved from the second position back to the first position. The suturing device can be withdrawn from the mitral valve, and the first and second lengths of suture can remain within the tissue. A first distance between the first and second locations can be closed to a second distance between the first and second locations. 
     In some embodiments, tissue can be sutured by delivering a suturing device to a location adjacent the tissue. The suturing device can have a proximal end, a distal end, an elongate body extending between the proximal end and the distal end, and a handle at the proximal end. At least the distal end of the device can be delivered to the location adjacent the tissue. A first arm and a second arm can be extended from the elongate body from a first position, in which the first arm and the second arm are retracted into the elongate body, to a second position, in which the first arm and the second arm have free ends extending away from the elongate body and the first arm and second arm form an angle between each other. The first arm can carry a first suture end and the second arm can carry a second suture end. The first and second arm can be adjacent a first side of the tissue. 
     A needle arm can be moved from a retracted position in which the needle arm is retracted into the elongate body to an extended position in which the needle arm extends toward the first arm. The needle arm can be located on the opposite side of the tissue from the first arm and the second arm. A first needle can be advanced out of the needle arm, through tissue at a first location, and into contact with the first suture end. The first needle can be retracted through the tissue to draw the first suture end through the tissue, and a first length of suture can run from the first suture end and through the tissue. The needle arm can be rotated toward the second arm such that the needle arm extends toward the second arm. A second needle can be advanced out of the needle arm, through tissue at a second location, and into contact with the second suture end. The second needle can be retracted through the tissue to draw the second suture end through the tissue, and a second length of suture can run from the second suture end and through the tissue. 
     The needle arm can be moved back to the retracted position. The first and second arms can be moved from the second position back to the first position. The suturing device can be withdrawn from the tissue location, and the first and second lengths of suture can remain within the tissue. 
     In some embodiments, an anatomic valve can be sutured by positioning an elongate body at least partially within the anatomic valve. A first arm can be deployed from the elongate body, and the first arm can releasably hold a first suture portion at a free end. The free end of the first arm can be positioned at or near an edge of a first leaflet on a first side of the valve. A first needle arm can be deployed from the elongate body on an opposite side of the valve such that the first leaflet is positioned between the needle arm and the first arm. A first needle can be deployed from the first needle arm such that the first needle penetrates the first leaflet at a first location and engages the first suture portion. The first suture portion can be drawn through the first leaflet. A second suture portion can be passed through the second leaflet at a second location, and the two leaflets can be drawn together using a suture placed through the first and second location. 
     The disclosure describes examples of some embodiments of the inventions. The designs, figures, and description are non-limiting examples of some embodiments of the inventions. Other embodiments of the devices and methods may or may not include the features disclosed herein. Moreover, disclosed advantages and benefits may apply to only some embodiments of the inventions, and should not be used to limit the inventions. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above-mentioned and other features disclosed herein are described below with reference to the drawings of specific embodiments. The illustrated embodiments are intended for illustration, but not limitation. The drawings contain the following figures: 
         FIG. 1  illustrates a method of providing access to an exemplifying use environment, such as an aortic valve of a heart. 
         FIG. 2A  illustrates a method of providing access to an exemplifying use environment, such as a mitral valve of a heart. 
         FIG. 2B  illustrates a method of providing access to an exemplifying use environment, such as a mitral valve of a heart. 
         FIG. 3  is a perspective view of an embodiment of a suturing device with suture clasp arms in a retracted position and a casing shown in cross-section. 
         FIG. 4  is an enlarged perspective view of the embodiment of  FIG. 3  with the casing shown in cross-section, showing suture catch mechanisms in a partially advanced position. 
         FIG. 5  is a perspective view of the embodiment of  FIG. 3 , with the suture clasp arms in an extended position and the suture catch mechanisms in a partially advanced position. 
         FIG. 6  is a perspective view of the embodiment of  FIG. 3 , as in  FIG. 5 , showing a casing attached to the device. 
         FIG. 7A  is a plan view of the embodiment of  FIG. 3 , with the suture clasp arms in an extended position. 
         FIG. 7B  is a plan view as in  FIG. 7A , but with the suture clasp arms retracted. 
         FIG. 8  is a cross-sectional view of the embodiment of  FIG. 3 , along a line VIII-VIII in  FIG. 6 . 
         FIG. 9  is a cross-sectional view of the embodiment of  FIG. 3 , along a line IX-IX in  FIG. 7A . 
         FIG. 10  is a schematic representation an embodiment of a suturing device positioned in a passage through a valve. 
         FIG. 11  is a schematic representation as in  FIG. 10  with suture clasp arms positioned around first and second leaflets of the valve. 
         FIG. 12  is a schematic representation as in  FIG. 11  with suture clasp arms retracted. 
         FIG. 13  is a schematic representation as in  FIG. 12  showing suture catch mechanisms engaging the suture clasp arms. 
         FIG. 14  is a schematic representation as in  FIG. 13  showing the suture catch mechanisms and suture portions retracted through the first and second leaflets. 
         FIG. 15  is a schematic representation as in  FIG. 14  showing the suture portions extending through the first and second leaflets and being joined by a knot. 
         FIG. 16  is a plan view of an embodiment of a suturing device system with two suturing devices and a suture joining device. 
         FIG. 17  is a plan view of an embodiment of a suturing device with a suture clasp arm in an extended position. 
         FIG. 18  is an enlarged perspective view of the distal end of the suturing device of  FIG. 17  with the suture clasp arm in an extended position. 
         FIG. 19  is a schematic representation an embodiment of a first suturing device positioned in a passage through a valve. 
         FIG. 20  is a schematic representation as in  FIG. 19  with a suture clasp arm positioned around a first leaflet of the valve. 
         FIG. 21  is a schematic representation as in  FIG. 20  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 22  is a schematic representation as in  FIG. 21  showing the suture catch mechanism and a suture portion retracted through the first leaflet. 
         FIG. 23  is a schematic representation as in  FIG. 22  showing a second suturing device positioned in the passage through the valve. 
         FIG. 24  is a schematic representation as in  FIG. 23  with the suture clasp arm positioned around a second leaflet of the valve. 
         FIG. 25  is a schematic representation as in  FIG. 24  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 26  is a schematic representation as in  FIG. 25  showing the suture catch mechanism and a suture portion retracted through the second leaflet. 
         FIG. 27  is a schematic representation as in  FIG. 26  showing the suture portions extending through the first leaflet and the second leaflet and being joined by a first knot. 
         FIG. 28  is a plan view of an embodiment of a suturing device with a suture clasp arm in an extended position. 
         FIG. 29  is an enlarged perspective view of the distal end of the suturing device of  FIG. 28  with the suture clasp arm in an extended position. 
         FIG. 30  is a schematic representation of an embodiment of a first suturing device positioned in a passage through a valve. 
         FIG. 31  is a schematic representation as in  FIG. 30  with a suture clasp arm positioned around a first leaflet of the valve. 
         FIG. 32  is a schematic representation as in  FIG. 31  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 33  is a schematic representation as in  FIG. 32  showing the suture catch mechanism and a suture portion retracted through the first leaflet. 
         FIG. 34  is a schematic representation as in  FIG. 33  showing a second suturing device positioned in the passage through the valve so as to permit a suture clasp arm to extend from the second suturing device. 
         FIG. 35  is a schematic representation as in  FIG. 34  with the suture clasp arm positioned around a second leaflet of the valve. 
         FIG. 36  is a schematic representation as in  FIG. 35  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 37  is a schematic representation as in  FIG. 36  showing the suture catch mechanism and a suture portion retracted through the second leaflet. 
         FIG. 38A  is a plan view of an embodiment of a suturing device with two suture clasp arms in an extended position. 
         FIG. 38B  is an enlarged perspective view of the distal end of the suturing device of  FIG. 38A  with the suture clasp arms in an extended position. 
         FIG. 39A  is an enlarged perspective view of a distal end of an embodiment of a suturing device with two suture clasp arms in a retracted position. 
         FIG. 39B  is an enlarged perspective view of the distal end of the suture device of  FIG. 39A  with the suture clasp arms in an extended position. 
         FIG. 40  is a schematic representation of an embodiment of a suturing device positioned in a passage through a valve. 
         FIG. 41  is a schematic representation as in  FIG. 40  with a suture clasp arm positioned around a first leaflet of the valve. 
         FIG. 42  is a schematic representation as in  FIG. 41  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 43  is a schematic representation as in  FIG. 42  showing the suture catch mechanism and a suture portion retracted through the first leaflet. 
         FIG. 44  is a schematic representation as in  FIG. 43  showing the suturing device positioned in the passage through the valve so as to permit a second suture clasp arm to extend from the suturing device. 
         FIG. 45  is a schematic representation as in  FIG. 44  with the suture clasp arm positioned around a second leaflet of the valve. 
         FIG. 46  is a schematic representation as in  FIG. 45  showing a suture catch mechanism engaging the suture clasp arm. 
         FIG. 47  is a schematic representation as in  FIG. 46  showing the suture catch mechanism and a suture portion retracted through the second leaflet. 
         FIG. 48  is a schematic representation of an embodiment of a suturing device positioned in a passage through a valve with a first suture clasp arm positioned around a first leaflet of the valve, and a second suture clasp arm positioned around a second leaflet of the valve. 
         FIG. 49  is a schematic representation as in  FIG. 47 or 48  showing the suture portions extending through the first leaflet and the second leaflet. 
         FIG. 50  is a schematic representation as in  FIG. 49  showing the suture portions extending through the first leaflet and the second leaflet and being joined by a first knot. 
         FIG. 51  is a schematic representation as in  FIG. 50  showing the suture portions extending through the first leaflet and the second leaflet and being joined by a first knot that has been pulled between the leaflets. 
         FIG. 52  is a schematic representation as in  FIG. 51  showing the suture portions extending through the first leaflet and the second leaflet and being joined by a first knot that has been pulled through one of the leaflets. 
         FIG. 53  is a schematic representation as in  FIG. 49  showing the suture portions extending through the first leaflet and the second leaflet and being joined by a first knot. 
         FIG. 54  illustrates placement of suture through a bicuspid valve near a central portion of each leaflet. 
         FIG. 55  illustrates placement of three sutures through a bicuspid valve near a central portion of each leaflet. 
         FIG. 56  illustrates placement of suture through a bicuspid valve at locations spaced from the center of each leaflet. 
         FIG. 57  illustrates placement of suture through a bicuspid valve at multiple locations spaced from the center of each leaflet. 
         FIG. 58  illustrates placement of suture through a tricuspid valve. 
         FIG. 59  illustrates placement of suture through a valve. 
         FIG. 60  illustrates placement of suture through a valve. 
         FIG. 61  illustrates placement of suture through chordae tendineae and myocardium. 
         FIG. 62  is a schematic perspective view of an embodiment of a suturing device comprising two needles and a single arm having two suture mounts. 
         FIG. 63  is a schematic side view of the suturing device of  FIG. 62  with the arm extended and a protective member extended. 
         FIG. 64  is a schematic side view of the suturing device of  FIGS. 62 and 63  with a needle extended through the protective member. 
         FIG. 65  is a schematic representation of the suturing device of  FIGS. 62-64  positioned in a passage through a valve, such as the mitral valve via transapical entry. 
         FIG. 66  is a schematic representation as in  FIG. 65  with the arm extended and the protective member extended. 
         FIG. 67  is a schematic representation as in  FIG. 66  with the needle extended to pierce the valve and engage the arm. 
         FIG. 68  is a schematic partial cross-sectional view of the arm, needles and valve of  FIG. 67 , taken along line  68 - 68 . 
         FIG. 69  is a schematic partial cross-sectional view as in  FIG. 68  illustrating suture portions positioned through two locations in the valve. 
         FIG. 70  is a schematic partial cross-sectional view as in  FIG. 69  with the suture portions secured together. 
         FIG. 71  is a schematic partial cross-sectional view of an arm, a needle, and a valve similar to  FIG. 68 , except the arm comprises a single suture mount and a single needle is illustrated. 
         FIG. 72  is a schematic partial cross-sectional view as in  FIG. 71  with a first suture portion positioned through the valve and a second arm and a second needle illustrated in the process of placing a second suture portion through a second location in the valve. 
         FIG. 73  is a schematic representation as in  FIG. 72  with two suture portions positioned through the valve and first ends of the suture portions being secured together. 
         FIG. 74  is a schematic representation as in  FIG. 73  with the second suture ends having been pulled to draw the secured first ends toward a first side of the valve. 
         FIG. 75  is a schematic representation as in  FIG. 74  with the second suture ends secured together. 
         FIG. 76  is a schematic perspective view of an embodiment of a suturing device comprising two needles and a single arm having two suture mounts, the two needles being located distally of the arm and configured for proximal movement to engage the arm. 
         FIG. 77  is a schematic representation of the suturing device of  FIG. 76  positioned within a passage of a valve, such as a mitral valve via access through the inferior vena cava and the atrial septum. 
         FIG. 78  is a schematic representation as in  FIG. 77  with the arm extended and a protective member extended. 
         FIG. 79  is a schematic representation as in  FIG. 78  with a needle advanced through the protective member to engage the arm. 
         FIG. 80  is a schematic perspective view of a suturing device comprising two needles and a single arm having two suture mounts, the two needles being located proximally of the arm and configured for distal movement to engage the arm, and the arm having an extended position in which the arm is oriented at an angle of less than 90° relative to a longitudinal axis of the suturing device. 
         FIG. 81  is a schematic representation of the suturing device of  FIG. 80  being positioned in a passage of a valve, such as a mitral valve such as by access through the inferior vena cava and the atrial septum, with the arm extended. 
         FIG. 82  is a schematic representation as in  FIG. 81  with a protective member extended. 
         FIG. 83  is a schematic representation as in  FIG. 82  with a needle being advanced through the protective member to engage the arm. 
         FIG. 84  is a schematic representation of suture placement locations according to an embodiment. 
         FIG. 85  is a schematic representation of suture placement locations according to an embodiment. 
         FIG. 86  is a schematic illustration of a human heart showing the chordae tendineae. 
         FIG. 87  is a schematic perspective view of an embodiment of a suturing device. 
         FIG. 88  is a schematic illustration of the suturing device of  FIG. 87  with six arms extended, with each arm having two suture mounts, and a protective member extended. 
         FIG. 89  is a schematic representation of the suturing device of  FIGS. 87 and 88  positioned in a passage through a valve, such as the mitral valve via transapical entry. 
         FIG. 90  is a schematic representation as in  FIG. 89  with the arms extended. 
         FIG. 91  is a schematic representation as in  FIG. 90  with the protective member extended. 
         FIG. 92  is a schematic representation as in  FIG. 91  with the protective member positioned for movement of a needle through the protective member to engage a first arm. 
         FIG. 93  is a schematic representation as in  FIG. 92  with the protective member positioned for movement of a needle through the protective member to engage a second arm. 
         FIG. 94  is a schematic representation as in  FIG. 93 , with suture portions passed through  12  locations in the valve. 
         FIG. 95  is a plan view of an embodiment of a suturing device. 
         FIG. 96  is a schematic perspective view of an embodiment of a suturing device. 
         FIG. 97  is a schematic perspective view of an embodiment of a suturing device with a needle arm and two suture arms in an extended position. 
         FIG. 98  is a cross sectional view of an embodiment of a suture arm. 
         FIG. 99  is a cross sectional view of a section of the device of  FIG. 95 , showing the needle arm extended and aligned with an extended suture arm. 
         FIG. 100  is a top view of the device of  FIG. 95 , with the suture arms extended. 
         FIG. 101  is a cross sectional view of a distal section of an embodiment of a needle arm. 
         FIG. 102  is a top view of an embodiment of an extrusion. 
         FIG. 103  is a schematic representation of the suturing device of  FIG. 95  positioned in a passage through a valve, such as the mitral valve via transapical entry. 
         FIG. 104  is a schematic representation as in  FIG. 103  with the arms extended. 
         FIG. 105  is a schematic representation as in  FIG. 104  with the arms positioned against the valve. 
         FIG. 106  is a schematic representation as in  FIG. 105  with the protective member extended. 
         FIG. 107  is a schematic representation as in  FIG. 106  with the protective member positioned for movement of a needle through the protective member to engage a first arm. 
         FIG. 108  is a schematic representation as in  FIG. 107  with the needle engaging a first arm. 
         FIG. 109  is a schematic representation as in  FIG. 108  with the needle arm in a position between the two suture arms. 
         FIG. 110  is a schematic representation as in  FIG. 109  with the protective member positioned for movement of a needle through the protective member to engage a second arm. 
         FIG. 111  is a schematic representation as in  FIG. 110  with the needle engaging a second arm. 
         FIG. 112  is a schematic representation as in  FIG. 111  with the needle arm in a position between the two suture arms. 
         FIG. 113  is a schematic representation as in  FIG. 112 , with suture portions passed through two locations in the valve. 
         FIG. 114  is a schematic representation as in  FIG. 112 , showing the suture portions passing through two locations in the valve and being joined by a first knot. 
         FIG. 115  is a schematic representation of a cross sectional side view of a valve, showing a tube positioned around a suture passing through the valve. 
         FIG. 116  is a schematic representation as in  FIG. 115  showing two suture ends having been tightened and secured together. 
         FIG. 117  is a side view of a knot placement device. 
         FIG. 118  is a cross-sectional view of a knot and knot placement device. 
         FIG. 119  is a cross-sectional view of an embodiment of a knot and knot placement device. 
     
    
    
     DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS 
     Embodiments of suturing devices and methods for suturing biological tissue are disclosed herein. The suturing devices and their methods of use can be useful in a variety of procedures, such as treating (e.g., closing) wounds and naturally or surgically created apertures or passageways. For example, the suturing devices can be used to treat an anatomical valve, such as a heart valve, including heart valves that may be weakened or stretched, or have other structural defects, such as congenital defects, that cause them to close improperly. In some embodiments, one or more suturing devices can be used to treat or repair valves, such as the tricuspid, pulmonary, mitral, and aortic valves, for example. In some embodiments, one or more suturing devices can be used to perform procedures such as edge-to-edge repair (like an Alfieri technique), annuloplasty (with or without a ring or other implant), suturing of ventricular spaces, suturing of the chordae, suturing in other locations in the heart, replacement of the chordae tendineae, shortening of the chordae tendineae, patch application, leaflet reshaping, and attachment of prosthetics, such as rings and biological or mechanical replacement valves, for example. 
     In some embodiments, the suturing devices can be used to close or reduce a variety of other tissue openings, lumens, hollow organs or natural or surgically created passageways in the body. In some embodiments, the suturing devices can be used to suture prosthetics, synthetic materials, or implantable devices in the body. For example, the devices can be used to suture a pledget within the body. 
     Access Methods and Devices 
       FIG. 1  illustrates an exemplifying use environment for suturing an aortic valve  4 . Adaption of the devices and methods disclosed herein for suturing a heart valve may also be made with respect to procedures for suturing other bodily tissue and procedures for suturing prosthetics, synthetic materials, or implantable devices in the body. As depicted by  FIG. 1 , a guide wire  10  can be advanced through the aorta  2  to a position at or near the aortic valve  4 . The guide wire  10  can be advanced into the aorta  2  through a subclavian artery (not shown). It is anticipated that the heart may be accessed through any of a variety of pathways. For example, the heart may be accessed through the inferior vena cava  3 , the superior vena cava  5 , or other vascular access. With the guide wire  10  in place, the physician can insert a sheath  12  to a position at or near the aortic valve  4 . This sheath  12  is typically a single lumen catheter with a valve on its proximal end. The valve can be used, for example, to prevent extraneous bleed back or to introduce medication into the patient&#39;s body. A suturing device, such as those described further below, can then be advanced through the lumen of the sheath  12 . In an alternative embodiment, the suturing device can be advanced over the guide wire  10  and positioned at or near the aortic valve  4  without the need to insert an introducer sheath  12 . 
       FIG. 2A  illustrates another exemplifying use environment for suturing a mitral valve  8 . As depicted by  FIG. 2A , a guide wire  10  is advanced into the left ventricle  6  of the heart through a puncture or incision  9  near an apex  7  of the left ventricle  6 . The heart may be accessed through a limited thoracotomy, small trocar puncture, or small catheter puncture. Other access paths may be used. The guide wire  10  can then be further positioned at or near the mitral valve  8 . With the guide wire  10  in place, the physician can insert a sheath  12  to the left ventricle  6 . The sheath  12  can be placed at or near the mitral valve  8 . The suturing device can then be advanced through the lumen of the sheath  12 . In an alternative embodiment, the suturing device can be advanced over the guide wire  10  and positioned at or near the mitral valve  8  without the need to insert an introducer sheath  12 . 
       FIG. 2B  illustrates another exemplifying access route for suturing a mitral valve  8 . As depicted by  FIG. 2B , a guide wire  10  is advanced through the inferior vena cava  11  into the right atrium  13  of the heart and through a puncture or an incision near the atrial septum  15  and into the left atrium  17 . The guide wire  10  can then be further positioned at or near the mitral valve  8 . With the guide wire  10  in place, the physician can insert a sheath  12  to the left atrium  17 . The sheath  12  can be placed at or near the mitral valve  8 . The suturing device can then be advanced through the lumen of the sheath  12 . In an alternative embodiment, the suturing device can be advanced over the guide wire  10  and positioned at or near the mitral valve  8  without the needs to insert an introducer sheath  12 . In some embodiments, for any of the access routes discussed above, the device can be inserted without a guide wire. 
     Embodiments of Suturing Devices and Methods, Such as for Suturing Valve Leaflets 
       FIGS. 3-9  illustrate an embodiment of a suturing device  100  that can be used to suture an anatomical valve, such as a heart valve. While the device  100  will be described with reference to suturing an anatomical valve, such as a heart valve, the device  100  could be used to suture other biological tissue and implantable devices and materials. The suturing device  100  can comprise a distal assembly  102 , one or more suture clasp arms  104  (also labeled as  104 A,  104 B), and one or more suture catch mechanisms  106  (referred to in some embodiments as “needles”). Each arm can have one or more suture portions  130  attached to it. The suturing device  100  can further comprise an elongate body (not shown) to facilitate manipulation of the suture clasp arm(s)  104  and the suture catch mechanism(s)  106  from a remote location. For example, the elongate body can comprise one or more lumens to accommodate a length of suture, or one or more actuator rods for manipulating the suture clasp arm(s)  104  and the suture catch mechanism(s)  106 , or both. In some embodiments, the distal assembly  102  can comprise a portion of the elongate body. 
     The distal assembly  102  can comprise a proximal mount  108 , distal mount  110 , a hub  112 , and a casing  114  ( FIG. 6 ). The proximal mount  108  can be fixedly connected to the distal mount  110  by the casing  114 . The hub  112  can be positioned within the casing  114  for sliding movement between the proximal mount  108  and the distal mount  110 . 
     The proximal mount  108  can be connected to the elongate body (not shown). Alternatively, a distal end of the elongate body can form or be integrally formed with the proximal mount  108 . In some embodiments, the elongate body can comprise the casing  114 . The proximal mount  108  can comprise one or more lumens  116 , as shown in  FIGS. 3 and 5 . 
     The hub  112  can be fixedly connected to the suture catch mechanism(s)  106  and an actuator rod  118 . The actuator rod  118  can move through a lumen  116  in the proximal mount  108 . Accordingly, distal advancement of the actuator rod  118  causes distal advancement of the suture catch mechanism(s)  106 . The hub  112  can comprise one or more lumens  120 . 
     The suture clasp arm(s)  104  can be pivotally connected to the distal mount  110  such that the suture clasp arm(s)  104  can move between a retracted position, illustrated in  FIGS. 3-4 , and an extended position, illustrated in  FIGS. 5-7A . Although the arms  104  of the device  100  that is illustrated in  FIGS. 3-9  pivot about a distal end of the arms  104 , the arms  104  can pivot about a proximal end of the arms  104  in other embodiments. 
     The suture clasp arm(s)  104  can be connected to an actuator rod  124 , which can move through a lumen  116  in the proximal mount  108 . The arm(s)  104 , the distal mount  110 , and the rod  124  can be connected such that distal movement of the rod  124  causes the arm(s)  104  extend and proximal movement of the rod  124  causes the arm(s)  104  to retract. In some embodiments, the arm(s)  104  can extend to a position that is substantially perpendicular to their fully-retracted position. In other embodiments, the arm(s)  104  can move less than 90° between the fully-retracted position and the fully-extended position. 
     The distal mount  110  can comprise one or more lumens  122  ( FIG. 5 ) to allow movement of the suture catch mechanism(s)  106  through the distal mount  110 . Additionally or alternatively, the one or more lumens  122  can accommodate a length of suture, the actuator rod  124 , or both. 
     The suture clasp arm(s)  104  can have suture clasps  126  to releasably hold a suture portion  130 . The suture catch mechanism(s)  106  can be advanced to engage the suture portion(s)  130  held by the suture clasp arms(s). Once the suture catch mechanism(s)  106  have engaged the suture end portion(s)  130 , the suture catch mechanism(s)  106  can be retracted to pull the suture ends from the suture claps  126 . 
     In some embodiments, the suture clasps  126  can be positioned on the suture clasp arm  104  such that the suture catch mechanism  106  retrieves the suture end portion  130  retained in the suture clasp  126  while the suture clasp arm  104  is at least partially retracted from its fully-extended position. In some embodiments, the suture clasps  126  can be positioned on the suture clasp arm  104  such that the suture catch mechanism  106  retrieves the suture end portion  130  retained in the suture clasp  126  while the suture clasp arm  104  is fully retracted. In some embodiments, the suture catch mechanism  106  can be advanced in a continuously longitudinal direction to engage the suture clasp  126  of the suture clasp arm  104  while the suture clasp arm is fully retracted. In some embodiments, the suture clasp  126  can be located on a proximally-facing side of a suture clasp arm  104  that pivots about a distal end of the suture clasp arm. In some embodiments, the suture clasp  126  can be located on a distally-facing side of a suture clasp arm  104  pivots about a proximal end of the suture clasp arm. 
     In some embodiments, the suture clasp arm  104  can be configured to receive a tissue-piercing portion of the corresponding suture catch mechanism  106 . For example, in some embodiments, when the suture catch mechanism  106  is fully advanced, the tissue-piercing portion can be fully received with the corresponding suture clasp arm  104 . In some embodiments, the suture clasp arm  104  can receive the tissue-piercing portion of the suture catch mechanism  106  when the arm is at least partially closed. In some embodiments, suture clasp arm  104  can receive the tissue-piercing portion of the suture catch mechanism  106  when the arm is fully retracted. 
     In some embodiments, the device  100  can comprise a recess  140  between the suture clasp arm  104  and the distal mount  110 , or other component of the distal assembly  102 , when the suture clasp arm  104  is fully retracted, as illustrated in  FIG. 7B . In some embodiments, a tissue portion, such as a valve leaflet, can be received with the recess  140  with the suture clasp arm  104  fully retracted and without damaging the tissue portion. In some embodiments, the tissue portion can be held in the recess  140  by the suture clasp arm  104  while the suture clasp arm is fully retracted. In some embodiments, the tissue portion can be held in the recess  140  by the suture clasp arm  104  while the suture clasp arm is at least partially retracted. 
     In some embodiments, the recess  140  can have a size and shape to receive a leaflet of a valve between the elongate body and the arm when the arm is at least partially retracted without damaging the leaflet. In some embodiments, the recess  140  can have a size and shape to receive a leaflet of a valve between the elongate body and the arm when the arm is fully retracted without damaging the leaflet. In some embodiments, the recess  140  can have a size and shape to retain the leaflet between the elongate body and the arm when the arm is at least partially retracted without damaging the leaflet. In some embodiments, the recess  140  can have a size and shape to retain the leaflet between the elongate body and the arm when the arm is fully retracted without damaging the leaflet. 
     In some embodiments, the device  100  can be manipulated with the suture clasp arm(s)  104  in the extended position to place a tissue portion, such as a leaflet of a valve, between the suture clasp arm  104  and the distal mount  110 , as shown, for example, in  FIG. 11 . In some embodiments, the suture clasp arm  104  can be at least partially closed about the tissue portion. In some embodiments, the suture clasp arm  104  can be fully closed about the tissue portion. In some embodiments, the suture clasp arm  104  can be at least partially retracted to securely hold the tissue portion between the suture clasp arm  104  and the distal mount  110 . In some embodiments, the suture clasp arm  104  can be moved to the retracted position to securely hold the tissue portion between the suture clasp arm  104  and the distal mount  110 , as shown, for example, in  FIG. 12 . In some embodiments, the tissue portion is not damaged by closing the suture clasp arm  104  about the issue portion or holding the tissue portion between the suture clasp arm  104  and the distal mount  110 . 
     With the tissue portion held between the arm  104  and the distal mount  110 , the corresponding suture catch mechanism  106  can be advanced to engage the suture portion  130  held by the suture clasp  126  of the arm  104 , as shown, for example, in  FIG. 13 . The suture portion  130  can then be drawn through the tissue portion by the suture catch mechanism  106 , as shown, for example, in  FIG. 14 . In other embodiments, the suture catch mechanism(s)  106  can be advanced toward the suture clasp arm(s)  104  and retrieve the suture ends from the suture clasps  126  when the arm(s)  104  are in the extended position. In some embodiments, the suture catch mechanism can be a needle. 
     In some embodiments, the distal assembly  102  can comprise a tube or conduit  128  to accommodate a suture and prevent damage to the suture by any component of the device  100 . In some embodiments, the conduit  128  extends through a lumen  116  in the proximal mount  108 , a lumen  120  in the distal mount  110 , and a lumen  122  in the hub  112 . 
     Further details regarding devices, structures, and methods that may be incorporated with the above embodiments are provided in U.S. Pat. No. 7,090,686 and U.S Patent Application Publication No. 2008/0269786, published on Oct. 30, 2008, all of which are hereby incorporated by reference herein in their entireties and are to be included as part of this specification. For example, in some embodiments having a plurality of arms  106  and a plurality of suture catch mechanisms  106 , each arm  104  and each suture catch mechanism  106  of the device  100  can be independently actuated to move individually between the retracted position and the extended position. 
       FIGS. 10-15  illustrate a method for suturing an anatomical valve according to one embodiment. For example, the method can be used to perform edge-to-edge repair of a mitral valve. The distal end of a suturing device  100  can be positioned between leaflets  132  of a valve, as shown in  FIG. 10 . The device  100  can be advanced through the vasculature to the desired position using any of the access routes discussed above, and with or without a guide wire. For example, the device  100  can be advanced through the inferior vena cava into right atrium and through the septum and positioned in the passage through the mitral valve  8  ( FIG. 2 ). 
     The suturing device  100  can be advanced to allow suture clasp arms  104  to extend from the distal assembly  102 . The suture clasp arms  104  can then be extended and the device  100  can be retracted until the suture clasp arms  104  extend around a first leaflet  132 A and a second leaflet  132 B of the valve, as shown in  FIG. 11 . 
     Once the suture clasp arms  104  have been properly positioned around the first and second leaflets  132 , the suture clasp arms  104  can be retracted to trap portions of the first and second leaflets  132 , for example between the suture clasp arms  104  and the distal mount  110  in the recess  140 , as illustrated in  FIG. 12 . 
     With the first and second leaflets  132  trapped the suture catch mechanisms  106  can be advanced from the distal assembly  102  to penetrate the first and second leaflets  132  and engage the suture portions  130  held by the suture clasp arms  104 , as illustrated in  FIG. 13 . 
     After the suture portions  130  have been engaged, the suture catch mechanisms  106  and engaged suture portions  130  are then retracted through the tissue of the first and second leaflets  132  into the distal assembly  102 , as shown in  FIG. 14 . The suture clasp arms  104  can be extended to release the first and second leaflets  132 . After the first and second leaflets have been released, the device  100  can be advanced slightly so that the suture clasp arm  104  can be moved to the retracted position without pinching the leaflets  132 . The first suturing device  100  can then be withdrawn from the valve. 
     As shown in  FIG. 15 , after the suturing device  100  has been withdrawn, the suture portions  130  extend from the leaflets  132 . The suture portions  130  can be pulled to draw the first leaflet  132 A and the second leaflet  132 B towards one another. The suture portions  130  can then be secured together to limit movement of the leaflets  132 A,  132 B relative to one another, as illustrated in  FIG. 15  for example. In some embodiments, the sutures  130  can hold a portion of the leaflets  132 A,  132 B in contact with one another. In other embodiments, the sutures  130  merely hold the leaflets  132 A,  132 B in closer proximity to one another than they had previously been. The suture portions  130  can be secured together by tying a knot  134  according to any known method or by applying a knot  134 , such as described in U.S. Patent Publication No. 2007/0010829 A1, published Jan. 11, 2007, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification. The suture portions  130  can be secured together exterior to the body or within the body. Any excess portion of sutures  130  can be trimmed. In some embodiments, one or more pledgets can be attached to the suture portions  130 , either before or after the knot is tied or applied, and located distal and/or proximal to the knot  134 . 
       FIG. 16  illustrates an embodiment of a system of devices that can be used to suture an anatomical valve, such as a heart valve. In some embodiments, the device can be included in a system of devices used to suture an anatomical valve, such as the system illustrated in  FIG. 16 . The system of  FIG. 16  includes two suturing devices  1100 A,B, each of which can comprise a distal assembly  1102 A,B, a single suture clasp arm  1104 A,B, and a single suture catch mechanism  1106 A,B (shown in  FIGS. 21 and 25 ). Further description herein of either suturing device  1100 A or  1100 B may omit the letter A or B following the reference number, as it will be appreciated that the components described can refer to either device. 
     The devices can be substantially similar but with at least the exception that the single suture clasp arm  1104  of each suturing device is oriented generally opposite that of the other suturing device with respect to their handles  1144 . As illustrated, the devices have elongate bodies of differing lengths, but in other embodiments the elongate bodies can be substantially the same length. The system can also include a suture joining device  135 , which can be used to apply a knot to two or more suture ends or otherwise join two or more suture ends. Further details regarding the device for joining sutures are provided in U.S. Patent Application Publication No. 2011/0190793, published on Aug. 4, 2011, which is hereby incorporated by reference herein in its entirety and should be considered as part of this specification. Additionally, description of a device for joining sutures can be found below, and with respect to  FIGS. 117-119 . 
     The suturing devices  1100 A,B can comprise an elongate body  1142  to facilitate manipulation of the suture clasp arm  1104  and the suture catch mechanism (not visible) from a remote location. For example, the elongate body can comprise one or more lumens to accommodate a length of suture, or one or more actuator rods for manipulating the suture clasp arm  1104  and the suture catch mechanism, or both. 
     The suturing devices  1100 A,B can comprise a handle  1144  with one or more actuators and/or pulls  1146  for moving the suture clasp arm  1104  and the suture catch mechanism  1106 . In various embodiments, the handle can be of different shapes and configures, such as the handles of  FIG. 16 , or the handle illustrated in  FIG. 17 . Further details regarding handles and associated components, including actuator rods, are provided in U.S Patent Application Publication No. 2008/0269786, published on Oct. 30, 2008, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification. 
       FIG. 18  illustrates a distal assembly  1102 A of one of the suturing devices  1100 A with the suture clasp arm  1104 A in an extended position. In some embodiments, the suture clasp arm  1104 A can pivot about an axis located at a distal end of the suture clasp arm  1104 A to move the suture clasp arm  1104 A from a retracted position to an extended position, as illustrated in  FIG. 18 . The same description can apply to the other suturing device  1100 B. 
       FIGS. 19-27  illustrate a method according to one embodiment for suturing an anatomical valve, such as edge-to-edge repair of a mitral valve. Although the illustrated method involves two devices  1100 A,B, each having a single suture clasp arm  1104  and a single suture catch mechanism  1106 , the illustrated method can also be practiced using a single suturing device  1100  having more than one arm  1104  and more than one suture catch mechanism  1106 , as described further below. 
     The distal end of a first suturing device  1100 A can be positioned between leaflets  132  of a valve, as shown in  FIG. 19 . The device  1100 A can be advanced through the vasculature to the desired position using any of the access routes discussed above, and with or without a guide wire. For example, the device  1100 A can be advanced through the inferior vena cava into right atrium and through the septum and positioned in the passage through the mitral valve  8  ( FIG. 2 ). 
     The suturing device  1100 A can be advanced to allow a suture clasp arm  1104 A to extend from the distal assembly  1102 A. The suture clasp arm  1104 A can then be extended and the device  1100 A can be retracted until the suture clasp arm  1104 A extends around a first leaflet  132 A of the valve, as shown in  FIG. 20 . 
     Once the suture clasp arm  1104 A has been properly positioned around the first leaflet  132 A, the suture catch mechanism  1106 A can be advanced from the distal assembly  1102 A to penetrate the first leaflet  132 A and engage the suture portion  130 A held by the suture clasp arm  1104 A, as illustrated in  FIG. 21 . In some embodiments, the suture clasp arm  1104 A can be moved to the retracted position to securely hold a portion of the first leaflet  132 A between the arm  1104 A and the elongate body, for example, before the suture catch mechanism  1106 A is advanced through the first leaflet  132 A to engage the suture end, as described above. 
     After the suture portion  130 A has been engaged, the suture catch mechanism  1106 A and engaged suture portion  130 A are then retracted through the tissue of the first leaflet  132 A into the distal assembly  1102 A, as shown in  FIG. 22 . The device  1100 A can be advanced slightly so that the suture clasp arm  1104 A can be moved to the retracted position without pinching the first leaflet  132 A. The first suturing device  1100 A can then be withdrawn from the valve. 
     A second suturing device  1100 B can then be advanced into the heart and positioned between the leaflets  132 A,  132 B of the valve, as shown in  FIG. 23 . The suture clasp arm  1104 B can then be extended and the device  1100 B can be advanced such that the suture clasp arm  1104 B extends around the tip of the second leaflet  132 B, as shown in  FIG. 24 . 
     Once the suture clasp arm  1104 B has been properly positioned around the second leaflet  132 B, the suture catch mechanism  1106 B can be advanced from the distal assembly  1102 B to penetrate the second leaflet  132 B and engage the suture portion  130 B held by the suture clasp arm  1104 B, as illustrated in  FIG. 25 . As noted above with respect to the first leaflet  132 A, in some embodiments, the suture clasp arm  1104 B can be moved to the retracted position to securely hold a portion of the second leaflet  132 B between the arm  1104 B and the distal assembly  1102 B before the suture catch mechanism  1106 B is advanced through the second leaflet  132 B to engage the suture portion  130 B. 
     After the suture portion  130 B has been engaged, the suture catch mechanism  1106 B and engaged suture portion  130 B are then retracted through the tissue of the second leaflet  132 B into the distal assembly  1102 B, as illustrated in  FIG. 26 . The suture clasp arm  1104 B can then be closed after slightly advancing the device  1100 B to avoid pinching the second leaflet  132 B as the arm  1104 B is closed. Once the suture clasp arm  1104 B is closed, the suturing device  1100 B can be withdrawn from the patient&#39;s heart. 
     As shown in  FIG. 27 , after the suturing device  1100 B has been withdrawn, the suture portions  130 A,B will extend proximally from the leaflets  132 A,  132 B. The suture portions  130 A,B can then be secured together, as illustrated in  FIG. 27 , by tying a knot  134  according to any known method or by applying a knot  134 . In some embodiments, one or more pledgets can be attached to the suture portions  130 A,B, either before or after the knot is tied or applied, and located distal and/or proximal to the knot  134 . The suture portions  130 A,B can be secured together exterior to the body or within the body. Any excess portion of sutures  130  can be trimmed. The suture portions  130 A,B can then be pulled to draw the first leaflet  132 A and the second leaflet  132 B towards one another. A second knot can then be tied or applied to the sutures  130  to limit movement of the leaflets  132 A,  132 B relative to one another, as described above. In some embodiments, the sutures  130  can hold a portion of the leaflets  132 A,  132 B in contact with one another. In other embodiments, the sutures  130  merely hold the leaflets  132 A,  132 B in closer proximity to one another than they had previously been. 
     When a device having a plurality of arms and a plurality of suture catch mechanisms is used, the device can be configured to place a single suture  130  through both the first leaflet  132 A and the second leaflet  132 B. The single suture  130  can be placed through the first and second leaflets  132  either simultaneously or sequentially. In some embodiments, the suture portions  130  can be pulled to draw the first leaflet  132 A and the second leaflet  132 B towards one another without applying a knot to the suture  130  beforehand. Accordingly, a single knot  134  can be applied to the suture  130  to hold the leaflets  132 A,  132 B in proximity to one another. 
       FIGS. 28 and 29  illustrate an embodiment of a suturing device  2100 A that can be used to suture an anatomical valve, such as a heart valve. The suture device  2100 A illustrated in  FIGS. 28 and 29  is similar is some respects to the suturing devices illustrated and described above. For example, the suturing device  2100 A of  FIGS. 28 and 29 , like the suturing device  1100  of  FIGS. 17 and 18 , can comprise a distal assembly  2102 A, a single suture clasp arm  2104 A, and a single suture catch mechanism  2106 A. 
     As illustrated in  FIGS. 28 and 29 , the suturing device  2100 A can comprise an elongate body  2142 A to facilitate manipulation of the suture clasp arm  2104 A and the suture catch mechanism  2106 A from a remote location. For example, the elongate body can comprise one or more lumens to accommodate a length of suture, or one or more actuator rods for manipulating the suture clasp arm  2104 A and the suture catch mechanism  2106 A, or both. The suturing device  2100 A can comprise a handle with one or more actuators and/or pulls  2146 A for moving the suture clasp arm  2104 A and the suture catch mechanism  2106 A. Further details regarding handles and associated components, including actuator rods, are provided in U.S Patent Application Publication No. 2008/0269786, published on Oct. 30, 2008, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification. 
     In some embodiments, the suture clasp arm  2104 A can pivot about an axis located at a proximal end of the suture clasp arm  2104 A when the suture clasp arm  2104 A is in a retracted position, as illustrated in  FIGS. 28 and 29 . 
     A method of suturing anatomical valves, such as edge-to-edge repair of a mitral valve, is illustrated in  FIGS. 30-37 . Although the illustrated method involves two devices  2100 A,B, each having a single suture clasp arm  2104 A,B and a single suture catch mechanism  2106 A,B, the illustrated method can also be practiced using a device  2100  having more than one arm  2104  and more than one suture catch mechanism  2106 , as discussed above, for example. 
     The distal end of a first suturing device  2100 A can be positioned between leaflets  132  of a valve, as shown in  FIG. 30 . The device  2100 A can be advanced through the vasculature to the desired position using any of the access routes discussed above, and with or without a guide wire. For example, the device  2100 A can be advanced through a subclavian artery into the aorta to position the device  2100 A in the passage through the aortic valve  4  ( FIG. 1 ). Alternatively, the device  2100 A can be inserted through a puncture or small incision  9  in the heart to position the device  2100 A in the passage through the mitral valve  8 , as shown in  FIG. 2 . Such a puncture can be located at or near the apex of the heart  7 . 
     As illustrated in  FIG. 30 , the suturing device  2100 A can be positioned to allow a suture clasp arm  2104 A to extend from the distal assembly  2102 A. The suture clasp arm  2104 A can then be extended and the device  2100 A can be advanced until the suture clasp arm  2104 A extends around a first leaflet  132 A of the valve, as shown in  FIG. 31 . 
     Once the suture clasp arm  2104 A has been properly positioned around the first leaflet  132 A, the suture catch mechanism  2106 A can be advanced from the distal assembly  2102 A to penetrate the first leaflet  132 A and engage the suture portion  130 A held by the suture clasp arm  2104 A, as illustrated in  FIG. 32 . In some embodiments, the suture clasp arm  2104 A can be moved to the retracted position to securely hold a portion of the first leaflet  132 A between the arm  2104 A and the distal assembly  2102 A before the suture catch mechanism  2106 A is advanced through the first leaflet  132 A to engage the suture end, as described above, for example. 
     As shown in  FIG. 33 , once the suture portion  130 A has been engaged, the suture catch mechanism  2106 A and engaged suture portion  130 A are then retracted through the tissue of the first leaflet  132 A into the distal assembly  2102 A. The device  2100 A can be retracted slightly so that the suture clasp arm  2104 A can be moved to the retracted position without pinching the first leaflet  132 A. The first suturing device  2100 A can then be withdrawn from the valve. 
     A second suturing device  2100 B can then be advanced into the heart and positioned between the leaflets  132 A,  132 B of the valve, as shown in  FIG. 34 . The suture clasp arm  2104 B can then be extended and the device  2100 B can be advanced such that the suture clasp arm  2104 B extends around the tip of the second leaflet  132 B, as shown in  FIG. 35 . 
     In the illustrated embodiment, once the suture clasp arm  2104 B has been properly positioned around the second leaflet  132 B, the suture catch mechanism  2106 B can be advanced from the distal assembly  2102 B to penetrate the second leaflet  132 B and engage the suture portion  130 B held by the suture clasp arm  2104 B, as illustrated in  FIG. 36 . As noted above with respect to the first leaflet  132 A, in some embodiments, the suture clasp arm  2104 B can be moved to the retracted position to securely hold a portion of the second leaflet  132 B between the arm  2104 B and the distal assembly  2102 B before the suture catch mechanism  2106 B is advanced through the second leaflet  132 B to engage the suture portion  130 B. 
     After the suture portion  130 B has been engaged, the suture catch mechanism  2106 B and engaged suture portion  130 B are then retracted distally through the tissue of the second leaflet  132 B into the distal assembly  2102 B, as illustrated in  FIG. 37 . The suture clasp arm  2104 B can then be closed after slightly retracting the device  2100 B to avoid pinching the second leaflet  132 B. Once the suture clasp arm  2104 B is closed, the suturing device  2100 B can be withdrawn from the patient&#39;s heart. 
     In some embodiments, a suturing device  3100  can have a plurality of arms  3104 . In some embodiments, the arms can be spaced at varying intervals around the circumference of the elongate body. In some embodiments, a plurality of arms can extend from one side of the elongate body and a corresponding plurality of arms can extend from an opposite side of the elongate body.  FIGS. 38A and 38B  illustrate a view of a suturing device  3100  having two arms  3104 A,B. As illustrated, the arms are spaced approximately 180 degrees from each other about the elongate body  3142 . In some embodiments, the suturing device can have two suture catch mechanisms  3106 A,B, one associated with each arm. The device can be designed so that the plurality of arms is deployed simultaneously, and that the plurality of suture catch mechanisms is deployed simultaneously. Alternatively, the device can be designed so that each arm and each suture catch mechanism can be deployed separately. In some embodiments, the suturing device can be used as a system with a suture joining device  135 , as discussed above with respect to  FIG. 16 . Many aspects of the suturing device can function substantially the same as aspects of the device described with respect to  FIGS. 28-37 . Unless discussed otherwise, components can be considered to have substantially the same function and operate in substantially the same manner as similarly labeled components described with respect to  FIGS. 28-37 . As a non-limiting example, the device can comprise a distal assembly  3102  and a handle with one or more actuators and/or pulls  3146  for moving the suture clasp arms  3104  and deploying the suture catch mechanisms  3106 . 
     In some embodiments, a suturing device can have a distal assembly  3102 ′ as seen in  FIGS. 39A and 39B .  FIG. 39A  illustrates a device with two suture arms  3104 A′,B′ that are in a retracted position. In  FIG. 39B , both suture arms  3104 A′,B′ are in an extended position, and suture catch mechanisms  3106 A′,B′ have extended through the corresponding arms at suture clasps  3126 A′,B′. In some embodiments, the arms can extend and retract simultaneously or in sequence, and in some embodiments the suture catch mechanisms can extend and retract simultaneously or in sequence. Also as illustrated, in some embodiments a suturing device can comprise a tapered portion  3113 ′ at a distal end and/or a guide wire lumen  3111 ′ that can be used if the device advances over a guide wire. 
     A method of suturing anatomical valves, such as edge-to-edge repair of a mitral valve, with a dual arm suturing device is illustrated in  FIGS. 40-47 . The method is described with reference to the suturing device  3100  of  FIGS. 38A and 38B , but any dual arm suturing device can be used, such as one with a distal assembly as described with reference to  FIGS. 39A and 39B . The suturing device  3100  can be advanced to a desired position between leaflets  132  of a valve, as shown in  FIG. 40 , by any of the methods discussed above with reference to the method of  FIGS. 30-37 , and with or without a guide wire. In the embodiment illustrated, the suturing device  3100  may be delivered transapically into the left ventricle, and delivered so that the distal end of the device extends through the mitral valve into the left atrium. However, the device can also be designed for an approach to pass through the septum between the right and left atrium, through the mitral valve and into the left ventricle. The locations and configurations of the suture clasp arms  3104  and the suture catch mechanisms  3106  may be appropriately designed based on the desired method of approach and based on the desired location to be sutured. For example, while the arms  3104  in the embodiment of  FIG. 40  are shown proximal to the suture catch mechanisms  3106 , in a different device the arms  3104  may be located distal to the suture catch mechanisms. 
     For suturing a mitral valve as shown in  FIG. 40 , the device can be positioned such that at least one of the suture clasp arms, a first arm  3104 A, can be extended from the device, and the device can be advanced until the first arm  3104 A extends around or adjacent to a first leaflet of the valve  132 A, as shown in  FIG. 41 . Accordingly, when suturing the mitral valve, the arm  3104 A can be positioned on a proximal side, or the ventricular side, of the leaflet  132 A. The arm  3104 A carries an end of a suture portion  130 A.  FIG. 40  shows arm  3104 A being deployed independently of arm  3104 B, but in other embodiments, both arms can be deployed together. 
     As described with respect to  FIG. 32 , once the first suture clasp arm  3104 A is properly positioned, the suture catch mechanism  3106 A can be advanced from the distal assembly  3102  from a location distal to the leaflet  132 A (or on the atrial side of the leaflet, for a mitral valve procedure) to penetrate the first leaflet  132 A and engage the suture portion  130 A held by the first suture clasp arm  3104 A, as illustrated in  FIG. 42 . In some embodiments, the first suture clasp arm  3104 A can be moved to the retracted position to securely hold a portion of the first leaflet  132 A between the first arm  3104 A and the distal assembly  3102  before the suture catch mechanism  3106 A is advanced through the first leaflet  132 A to engage the suture end. 
     As shown in  FIG. 43 , once the suture portion  130 A has been engaged, the suture catch mechanism  3106 A and engaged suture portion  130 A are then retracted through the tissue of the first leaflet  132 A into the distal assembly  3102 . The device  3100  can be retracted slightly so that the first suture clasp arm  3104 A can be moved to the retracted position without pinching the first leaflet  132 A, as illustrated in  FIG. 44 . The suturing device  3100  can then be retracted at least far enough to allow the second suture clasp arm  3104 B to extend from the device. 
     As illustrated in  FIG. 45 , the second suture clasp arm  3104 B can extend from the device and the device can be advanced, and moved laterally if necessary, such that the second suture clasp arm  3104 B extends around the tip of the second leaflet  132 B. In some embodiments, the second suture clasp arm  3104 B can extend before or while the first arm  3104 A is retracted. 
     As with the first arm  3104 A, once the second suture clasp arm  3104 B has been properly positioned around the second leaflet  132 B, a suture catch mechanism  3106 B can be advanced from the distal assembly  3102  to penetrate the second leaflet  132 B and engage the suture portion  130 B held by the suture clasp arm  3104 B, as illustrated in  FIG. 46 . As noted above with respect to the first leaflet  132 A, in some embodiments, the suture clasp arm  3104 B can be moved to the retracted position to securely hold a portion of the second leaflet  132 B between the arm  3104 B and the distal assembly  3102  before the suture catch mechanism  3106 B is advanced through the second leaflet  132 B to engage the suture portion  130 B. In some embodiments, the suture catch mechanism can be the same catch mechanism as the one used with the first arm  104 A. In the illustrated embodiment, the suture portions  130 A,B are portions of separate sutures, but in some embodiments the suture portions  130 A,B can be portions of the same suture. 
     After the suture portion  130 B has been engaged, the suture catch mechanism  3106 B and engaged suture portion  130 B are then retracted distally through the tissue of the second leaflet  132 B into the distal assembly  3102 , as illustrated in  FIG. 47 . The suture clasp arm  3104 B can then be closed after slightly retracting the device  3100  to avoid pinching the second leaflet  132 B. Once the suture clasp arm  3104 B is closed, the suturing device  3100  can be withdrawn from the patient&#39;s heart. 
     In some embodiments, the first suture clasp arm  3104 A and the second suture clasp arm  3104 B can both be extended from the device at substantially the same time and extend around opposite tips of the leaflets  132 A,  132 B, as illustrated in  FIG. 48 . In other embodiments, the clasp arms can be extended at the same time, but with one having extended before the other. Also as illustrated, suture catch mechanisms can be advanced through the suture clasp arms  3104 A,  3104 B at substantially the same time. In other embodiments, both clasp arms can extend around the leaflets but the suture catch mechanisms can advance one before the other. 
     Methods for Drawing Sutured Leaflets Closer Together 
     As shown in  FIG. 49 , after one or more of the suturing devices has been withdrawn, the suture portions  130 A,  130 B will extend proximally from the leaflets  132 A,  132 B. The methods for drawing sutured leaflets closer together described herein with respect to  FIGS. 49-59  can apply equally to orientations, such as that of  FIG. 15 , reflected in embodiments where suturing devices take different access routes to a valve. Additionally, for all methods described herein, one or more pledgets can be attached to the suture portion(s), either before or after a knot is tied or applied, and located distal and/or proximal to the knot.  FIG. 49  illustrates four strands of suture portion extending from the leaflets, which can comprise either a single suture if the arms described above were carrying the same suture, or two separate sutures, one sutured to each leaflet, if the arms described above were carrying their own suture. If the four strands illustrated in  FIG. 49  are part of the same suture, the ends of the suture may be pulled from outside of the body to apply tension to the suture and draw the leaflets together. The suture portions can be secured together by tying a knot, applying a knot or otherwise joining the suture portions together according to known methods. 
     In some embodiments, for example where two separate sutures are sutured to the leaflets  132 A and  132 B, two ends of the separate sutures can then be secured together, as illustrated in  FIG. 50 , by tying a knot  134  according to any known method or by applying a knot  134 . The suture portions  130 A,B can be secured together exterior to the body or within the body. Any excess portion of sutures can be trimmed. In some embodiments, the free ends of the suture portions  130 A,B can then be pulled to draw the first leaflet  132 A and the second leaflet  132 B towards one another, with the knot or joined portion between the leaflets as illustrated in  FIG. 51 . A second knot can then be tied or applied to the sutures  130 A,B to limit movement of the leaflets  132 A,B relative to each other. 
     In some embodiments, after the knot has  134  has been applied and positioned as shown in  FIG. 51 , just one of the free ends can be pulled initially, drawing the knot through one of the leaflets and out of the body, as illustrated in  FIG. 52 . This leaves a single suture passing through the leaflets. The two portions of the single suture can then be pulled to draw the first leaflet and second leaflet towards each other and a second knot can be tied or applied to the two portions. 
     In some embodiments, where two separate sutures and four suture portions extend from the leaflets, rather than initially securing two ends of the suture portions together, all four portions can be secured together according to any of the methods discussed herein, as illustrated in  FIG. 53 . 
     In some embodiments, where a single suture is positioned through the leaflets or a pair of sutures is positioned through the leaflets such as shown in  FIGS. 51 and 52 , one end of the suture can be secured to a second suture, the second suture can be drawn through the leaflets by pulling on the first suture, and a knot can be tied or applied to the second suture. In this embodiment, a first suture placed by the suturing device can be utilized to guide a second suture or another piece of material across the leaflets. The second suture or other piece of material is, in some embodiments, thicker or stronger than the first suture. In some embodiments, the second piece of material has a greater surface area to engage tissue, which can advantageously minimize dissection of tissue. 
     To accomplish placement of the second suture or additional piece of material in the place of the first suture, the second suture or other piece of material can be attached to one end or a first portion of the already placed suture. The first suture can be attached to the second suture or other piece of material by forming a knot by any known manner, or by otherwise joining them, for example, by welding the material together. 
     Thereafter, the other end or a second portion of the first suture can be pulled away from the leaflets. This causes the thicker suture to be drawn through the tissue and across the leaflets into the same position where the first suture(s) was placed. After the thicker suture has been pulled across the leaflets, the ends of the second suture or piece of material will in one embodiment be outside of the body. 
     The second suture or other piece of material can be detached from the original suture, and if the original suture has not already been removed from the patient, it can then be removed. With the ends of the second suture or other piece of material extending from the opening and out of the patient, that suture or material can be secured together by tying a knot according to any known method or by applying a knot, such as described in U.S. Patent Publication No. 2007/0010829 A1, published Jan. 11, 2007, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification. 
     In some embodiments, once the suture or other material is used to draw the leaflets closer together and the knot is made or applied, the suture or other material can hold a portion of the leaflets  132 A,  132 B in contact with one another. In other embodiments, the suture or other material merely hold the leaflets  132 A,  132 B in closer proximity to one another than they had previously been. 
     When a suturing device having two arms  3104  and two suture catch mechanisms  3106  is used, as discussed with reference to  FIGS. 38A-48 , the device  3100  can be configured to place a single suture  130  through both the first leaflet  132 A and the second leaflet  132 B, either simultaneously or sequentially. In some such embodiments, the suture portions  130  can be pulled to draw the first leaflet  132 A and the second leaflet  132 B towards one another without applying a knot to the suture  130  beforehand. Accordingly, a single knot  134  can be applied to the suture  130  to hold the leaflets  132 A,  132 B in proximity to one another. 
     The suture or sutures  130  can be placed through the leaflets  132  at locations selected by the physician to treat a problem of a particular valve. For example, in some embodiments, a suture or sutures  130  can be passed through the leaflets  132  at locations in or near a central region of the leaflets  132 , as illustrated in  FIG. 54 .  FIG. 55  illustrates an embodiment in which three sutures  130  have been passed through the leaflets  132  in a central region of the leaflets. In some embodiments, a suture or sutures  130  can be passed through a portion of the leaflets  132  that is in proximity to a periphery of the valve, as illustrated in  FIG. 56 . In some embodiments, sutures  130  can be applied to multiple locations between two leaflets  132 , as illustrated in  FIG. 57 . In some embodiments, sutures  130  can be applied to multiple locations between more than two leaflets  132 , as illustrated in  FIG. 58  with respect to a tricuspid valve. 
       FIGS. 59 and 60  illustrate other manners of placing suture through leaflets of a valve. In some embodiments, suture can be placed as shown in  FIG. 59 or 60  using the devices illustrated in  FIGS. 17-18 and 28-29 . The devices can be introduced through the same or different access routes. For example, one device can be introduced to the heart through the vasculature while another device is introduced transapically. In some embodiments, a first suture can be placed through a first leaflet by a first device  1100  as illustrated in  FIGS. 19-22  and a second suture can be placed through a second leaflet by a second device  2100  as illustrated in  FIGS. 30-33 . The second suture can be placed before the first suture in some embodiments. In embodiments involving the placement of multiple sutures, the multiple sutures can be joined with a single knot or with multiple knots. Further information regarding devices and methods for placing suture as shown in  FIGS. 59 and 60  is provided in U.S Patent Application Publication No. 2008/0269786, published on Oct. 30, 2008, and, in particular, the embodiments described in association with  FIGS. 10I-L ,  27 - 28 B,  36 - 39 A-K. 
     Devices and Methods for Techniques Other than Valve Repair 
     The devices and methods described and referenced herein can be used to perform other techniques for valve repair. For example, the devices and methods described above can be used to apply a suture to one or more of the chordae tendineae  136  and myocardium  138 , as illustrated in  FIG. 61 , to restore tension to chordae tendineae that have been come elongated. In some embodiments, the applied suture can be used as a guide suture to deliver a second suture or other material (e.g. artificial chordae) through the chordae, as described above. The devices and methods described above can be used to suture a patch to natural or surgically-created openings in leaflets. The devices and methods described above can be used to attach a ring around the outside of the malfunctioning valve. The devices and methods described above can be used to suture prosthetics to the heart. 
     Further Embodiments of Additional Suturing Devices, Such as for Suturing a Base of a Valve 
       FIG. 62  is a schematic perspective view of an exemplifying embodiment of a distal end  4102  of a suturing device  4100  that can be used to suture an anatomical valve, such as a heart valve. The suturing device  4100  can comprise two suture catch mechanisms  4106  and a single arm  4104  located in proximity to a distal end  4102  of an elongate body  4142 . The arm is configured for movement between a retracted position and an extended position. In some embodiments, the arm can be moved between the retracted and extended position by rotation around an end of the arm that is pivotally coupled to the elongate body  4142 . In other embodiments, the arms can be advanced along their length out of an opening in the elongate body  4142 , as shown and described in U.S. Pat. No. 6,911,034, issued on Jun. 28, 2005, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification. 
     In the embodiment of  FIG. 62 , the single arm  4104  comprises two suture clasps or mounts  4126  in proximity to a free end of the arm  4104 . In some embodiments, the arm  4104  can comprise more than two suture clasps  4126 . The suture clasps  4126  can be located at or near the free end of the arm  4104 . The arm  4104  of this embodiment is sufficiently long to be able to position the suture clasps  4126  at or near a base of a heart valve, such as the mitral valve for example. The arm  4104  illustrated in  FIG. 62  extends generally orthogonally to a longitudinal axis of the elongate body  4142 . 
     The suture clasps  4126  of the arm  4104  are spaced from one another by a distance. The distance between the suture clasps can vary among different embodiments. The magnitude of separation corresponds generally to the magnitude of separation between locations of suture placement in the tissue. The magnitude of separation between the suture clasps can be varied depending on the desired use. 
     In the exemplifying embodiment of  FIG. 62 , the two suture catch mechanisms  4106  are illustrated as needles. The needles can be operated simultaneously in some embodiments and sequentially in other embodiments. As described in connection with the preceding embodiments, the suture catch mechanisms can be deployed and retracted to retrieve suture portions  130  that are releasably held by the arm  4104  (see  FIGS. 65-68 ). Although the embodiment illustrated in  FIG. 62  comprises two needles, the suturing device can comprise more than two needles in some embodiments. The arm(s)  4104  will typically be configured to have the same number of suture mounts as the number of suture catch mechanisms, with each suture mount releasably carrying a suture portion. 
     The exemplifying embodiment of  FIG. 62  also includes protective members  4107  (also described herein as “needle arms”). The protective members  4107  are configured to inhibit contact between a distal end of the suture catch mechanisms and surrounding tissue during at least a portion of the deployment of the needles. In general, the protective members protect the tissue surrounding the suturing device  4100  from damage by the suture catch mechanisms  4106  as the suture catch mechanisms are moved from their retracted positions to the locations of the valve where the suture portions are to be passed through the valve. 
     As illustrated in  FIG. 62 , in embodiments comprising a plurality of suture catch mechanisms, the suturing device can have a separate protective member corresponding to each suture catch mechanism. In other embodiments, the suturing device can have a single protective member configured to protect surrounding tissue from two or more suture catch mechanisms at the same time. 
     In some embodiments, such as that of  FIG. 62 , the protective members can have a generally sleeve-like configuration to generally surround the suture catch mechanisms  4106 . The protective members can entirely surround a circumference of the suture catch mechanisms in some embodiments. In other embodiments, the protective members can merely partially surround a circumference of the suture catch mechanisms. For example, whether surrounding one or more suture catch mechanisms, the protective member can in some embodiments have a generally U-shaped cross-section with the opening in the protective member being oriented to face the elongate body when the protective member is extended. In some embodiments, a protective member can completely surround more than one needle in a single lumen. 
     The protective members preferably extend over the distal ends of the suture catch mechanisms, extend beyond the distal ends of the suture catch mechanisms, or both. 
     The protective members  4107  of the exemplifying embodiment of  FIG. 62  can be moved between a retracted position and an extended position. As illustrated in  FIG. 63 , the protective member  4107  can be extended from the elongate body  4142  in advance of the corresponding suture catch mechanism  4106  such that the distal end of the suture catch mechanism is not exposed to the surrounding tissue as the suture catch mechanism is moved toward the location of the valve to be sutured. 
     In some embodiments, the suture catch mechanism  4106  can be advanced toward the location for suture placement and the arm  4104  once the protective member  4107  has been advanced to the location for suture placement, as illustrated in  FIG. 64  for example. After the suture catch mechanism has retrieved the suture portion from the arm as discussed in connection with the foregoing embodiments, the suture catch mechanism  4106  and the protective member  4107  can be retracted into the elongate body  4142  with the suture portion  130 . The protective members can be placed generally at the location to be sutured before the needles are moved from their retracted positions in some embodiments. In other embodiments, the needles can be moved toward their deployed positions while the protective members are extended. For example, the distal end of the protective member can be located beyond a distal end of the corresponding needle as both are advanced. In this example, once the distal end of the protective member has been placed generally at the location to be sutured, the distal end of the needle can then be advanced beyond the distal end of the protective member to penetrate the tissue of the valve. 
     When a plurality of suture catch mechanisms  4106  are advanced toward the arm  4104  simultaneously, the protective members  4107  may also be advanced simultaneously. Alternatively, the protective members  4107  may be sequentially advanced even though the suture catch mechanisms are advanced simultaneously. The protective members  4107  can, in some embodiments, be advanced simultaneously, although the suture catch mechanisms are advanced sequentially. The use of multiple suture catch mechanisms per arm, as well as the use of the protective member, can be incorporated into any of the devices described herein, including the edge-to-edge repair devices previously described. 
       FIGS. 65-70  schematically illustrate use of the suturing device  4100  of  FIGS. 62-64  according to an embodiment. The valve shown in  FIGS. 65-70  can be a mitral valve  8  and the suturing device can be inserted into the valve via a transapical opening, or using any of the access routes discussed above, with or without a guide wire. Although reference is made to the mitral valve in connection with  FIGS. 65-70 , the description can apply to valves other than the mitral valve. 
     As illustrated in  FIG. 65 , the distal assembly  4102  of the suturing device  4100  is advanced into the passage through the mitral valve  8 . The distal assembly  4102  is advanced sufficiently far through the passage to permit the arm  4104  to be opened without damaging surrounding tissue. Once the arm  4104  is extended, the suturing device is retracted through the passage such that the free end of the arm  4104  is adjacent a base of the valve as illustrated in  FIG. 66 . A protective member  4107  is then advanced to position the distal end of the protective member  4107  at or near a base of the valve. A leaflet  132  of the valve can be posited between the arm  4104  and the protective member in some embodiments, such as that illustrated in  FIG. 66 . Once the protective member has been advanced, the suture catch mechanism  4106  is advanced through the tissue of the valve to engage the arm  4104  as illustrated in  FIG. 67 . 
       FIG. 68  is a schematic a partial cross-sectional view of the arm  4104 , the suture catch mechanisms  4106 , and the valve of  FIG. 67  taken along line  68 - 68 . Although  FIG. 68  illustrates both needles positioned through the tissue at the same time, such an arrangement may not occur in some embodiments, for example when a first needle is deployed and retracted before a second need is deployed. 
     The suture catch mechanisms  4106  are retracted through the tissue with the suture portions  130  into the elongate body  4142 . The protective members  4107  can be retracted into the elongate body  4142  before, after, or with the suture catch mechanisms  4106 .  FIG. 69  illustrates the suture portions  130  positioned through the valve with the suturing device  100  being withdrawn from the valve. 
     With the suture portions  130  positioned through the valve, the suture portions are tightened to draw together the locations of suture penetration. As illustrated in  FIG. 70 , the sutures are then secured together by tying or other methods as described above or in the patents incorporated by reference, which form a part of this specification. 
     In another embodiment, a suturing device  5100  of a configuration similar to that of  FIGS. 62-64  may be used, except that the arm  5104  comprises a single suture clasp  5126  rather than a plurality of suture clasps  5126 . As illustrated in  FIG. 71 , when a device having an arm  5104 A with a single suture clasp is used, the suturing device is positioned at least partially in the mitral valve  8  as illustrated and described in connection with  FIGS. 65-67 .  FIG. 71  is a schematic partial cross-sectional view of an arm, a needle, and a valve taken along line  68 - 68  in  FIG. 67  according to an embodiment employing a suturing device having an arm comprising a single suture mount. As illustrated in  FIG. 71 , the arm  5104 A has been positioned on a first side of the valve and a suture catch mechanism  5106 A has passed through the tissue of the valve from a second side of the valve. The suture catch mechanism  5106 A is then retracted to position the suture portion  130  through the valve as illustrated in  FIG. 72 . 
     A second arm  5104 B is then positioned to place a second suture portion at a location spaced from the first location as illustrated in  FIG. 72 . The second arm can be attached to the same elongate body  5142  as the first arm  5104 A in some embodiments. In other embodiments, the second arm can be attached to a second device of similar or identical configuration to the prior device. If a second device is employed, it may be introduced into the mitral valve according to the steps described above in connection with  FIGS. 65-67 and 71  and a second suture portion is placed through the valve as the suture catch mechanism  106  is retracted through the valve. 
       FIG. 73  illustrates two separate suture portions positioned through the tissue of the valve  8 . Also as illustrated in  FIG. 73 , first ends of the suture portions  130  are then secured together by knotting or other means, such as described above or in the patents incorporated by reference, which form a part of this specification. The second ends of the suture portions  130  are then pulled to draw the suture portions through the tissue and position the secured first ends of the suture portions adjacent one side of the tissue, as illustrated in  FIG. 74 . The suture portions  130  are tightened to draw together the locations of suture penetration through the tissue and secured together, as illustrated in  FIG. 75   
       FIG. 76  is a schematic perspective view of an exemplifying embodiment of a suturing device comprising a two suture catch mechanisms  6106  and a single arm  6104  located in proximity to a distal end of an elongate body  6142 . The suturing device illustrated in  FIG. 76  is similar to the suturing device of  FIG. 62 , except (1) the suture catch mechanisms  6106  of suturing device of  FIG. 76  are located distally of the arm  6104  and configured to be moved proximally from the retracted position to the deployed position, (2) the arm  6104  of the embodiment of  FIG. 76  extends distally and outwardly from the elongate body  6142  such that an angle between the arm  6104  and a longitudinal axis of the elongate body  6142  is less than 90°, and (3) other changes to the device of  FIG. 76  compared to the device of  FIG. 62  resulting from the first two differences as will be understood from the foregoing embodiments. 
       FIGS. 77-79  schematically illustrate use of the suturing device  6100  of  FIG. 76  according to an embodiment. The valve shown in  FIGS. 77-79  can be a mitral valve  8  and the suturing device can be inserted into the valve via access through the inferior vena cava and the atrial septum, with or without a guide wire. Although reference is made to the mitral valve in connection with  FIGS. 77-79 , the accompanying description can apply to valves other than the mitral valve. 
     As illustrated in  FIG. 77 , the distal assembly  6102  of the suturing device  6100  is advanced into the passage through the mitral valve  8 . The arm  6104  is extended from the elongate body  6142  and the suturing device is advanced through the passage such that the free end of the arm  6104  is adjacent a base of the valve as illustrated in  FIG. 77 . A protective member  6107  is then advanced to position the distal end of the protective member  6107  at or near a base of the valve. A leaflet  132  of the valve can be posited between the arm  6104  and the protective member in some embodiments, such as that illustrated in  FIG. 78 . Once the protective member has been advanced, the suture catch mechanism  6106  is advanced through the tissue of the valve to engage the arm  6104  as illustrated in  FIG. 79 . 
     Two suture portions are then passed through the valve tissue essentially in the same manner illustrated and described in connection with  FIGS. 68-70 . In embodiments wherein an arm of the suturing device comprises only a single suture mount, the suture portions can be placed through the valve tissue in essentially the same manner illustrated and described in connection with  FIGS. 71-75 . 
       FIG. 80  is a schematic perspective view of an exemplifying embodiment of a suturing device comprising two suture catch mechanisms  7106  and a single arm  7104  located in proximity to a distal end of an elongate body  7142 . The suturing device illustrated in  FIG. 80  is similar to the suturing device of  FIG. 76 , except the suture catch mechanisms  7106  of suturing device of  FIG. 80  are located proximally of the arm  7104  and configured to be moved distally from the retracted position to the deployed position and the suturing device of  FIG. 80  includes other changes compared to the device of  FIG. 76  resulting from the arrangement of the arm and suture catch mechanisms as will be understood from the foregoing embodiments. 
       FIGS. 81-83  schematically illustrate use of the suturing device  7100  of  FIG. 80  according to an embodiment. The valve shown in  FIGS. 81-83  can be a mitral valve  8  and the suturing device can be inserted into the valve via access through the inferior vena cava and the atrial septum, with or without a guide wire. Although reference is made to the mitral valve in connection with  FIGS. 81-83 , the accompanying description can apply to valves other than the mitral valve. 
     As illustrated in  FIG. 81 , the distal assembly  7102  of the suturing device  7100  is advanced into the passage through the mitral valve  8 . The distal assembly  7102  is advanced sufficiently far through the passage to permit the arm  7104  to be opened without damaging surrounding tissue. Once the arm  7104  is extended, the suturing device is retracted through the passage such that the free end of the arm  7104  is adjacent a base of the valve as illustrated in  FIG. 82 . A protective member  7107  is then advanced to position the distal end of the protective member  7107  at or near a base of the valve. A leaflet  132  of the valve can be posited between the arm  7104  and the protective member in some embodiments, such as that illustrated in  FIG. 82 . Once the protective member has been advanced, the suture catch mechanism  7106  is advanced through the tissue of the valve to engage the arm  7104  as illustrated in  FIG. 83 . 
     Two suture portions are then passed through the valve tissue essentially in the same manner illustrated and described in connection with  FIGS. 68-70 , except that the positions of the arm and the suture catch mechanisms have been exchanged relative to the valve. In embodiments wherein an arm of the suturing device comprises only a single suture mount, the suture portions can be placed through the valve tissue in essentially the same manner illustrated and described in connection with  FIGS. 71-75 , except that the positions of the arm and the suture catch mechanisms have been exchanged relative to the valve. 
     Using the methods illustrated and described in connection with  FIGS. 65-75, 77-79, and 81-83  sutures can be passed through a variety of locations near a base of a valve. For example,  FIGS. 84 and 85  schematically illustrate locations  148  where suture can be placed in a valve. As illustrated in  FIG. 84 , the suture can be placed through valve tissue at locations  148  generally between adjacent leaflets  132 . Alternatively or additionally, sutures may be placed through locations  148  at or near a base of a leaflet  132  approximately at the middle of the leaflet  132  as illustrated in  FIG. 85 . The devices and methods illustrated and described in connection with  FIGS. 65-75, 77-79, and 81-83  can be used to perform other procedures, such as attachment of a ring around the outside of the malfunctioning valve and attachment of prosthetic devices to tissue. The protective member or needle arm described above can also be utilized in the embodiments of the suturing device described above for suturing valves, such as edge-to-edge suturing of mitral valves. In such embodiments, the needle arms may be deployed to a position that pinches the leaflet between the suture clasp arm and the needle arm. The suture catch mechanism or needle may then be advanced from out of the needle arm, through tissue of the leaflet, and into engagement with the suture end held by the suture clasp arm. 
     Although methods have been described for suturing valve tissue using a suturing device having an arm with a single suture mount and using a suturing device with multiple suture mounts in a single arm, other embodiments can employ a suturing device comprising an arm having more than two suture clasps and a corresponding number of needles configured to retrieve suture portions from each of the suture clasps. 
       FIG. 86  schematically illustrates the chordae tendineae in the left ventricle of a human heart. Positioning the arms of a suturing device on a side of a valve (e.g., the atrial side) opposite the chordae tendineae can facilitate protection of the chordae tendineae from damage and facilitate the procedure by avoiding tangling of the arms with the chordae tendineae. Protection members (also described herein as “needle arms”), such as those described herein above and below, can help avoid damage to the chordae tendineae by suture catch mechanisms, such as needles for example, located on the same side of the valve as the chordae tendineae (e.g., the ventricular side). 
     Suturing Devices and Methods Having a Plurality of Arms, Such as for Suturing a Base of a Valve 
       FIGS. 87 and 88  illustrate an exemplifying embodiment of a suturing device  8100  having an elongate body and comprising more than one suture arm  8104  at the distal end of the elongate body, with each arm having two suture clasps  8126 . Such embodiments can facilitate performance of annuloplasty. The illustrated embodiment comprises six arms  8104 , with each arm having two suture mounts  8126 , the arms extending perpendicular to a longitudinal axis of the elongate body. Each of the illustrated suture mounts releasably carries a suture portion for retrieval by a suture catch mechanism. Other embodiments can comprise fewer arms or more arms than 6. In some embodiments, the device can comprise a single arm. In some embodiments, the arm(s) can rotate about the elongate body. 
     The arms illustrated in  FIG. 88  are sized to allow the suture mount to be placed at or near a base of the valve when the body of the device is placed in an opening of the valve. In some embodiments, the arms are sized and configured such that each of the suture mounts on all of the arms are at or in proximity of the base of the valve when the device is in a valve and the arms have been deployed. For example, the arms can each have a length of about 1.5 cm and the suture mounts can be located at or near an outermost point of the arms. In other embodiments, the arms may be longer or shorter than 1.5 cm. Various embodiments can have arms of different lengths to accommodate the size of the particular valve to be sutured and the anatomy of the intended patient. 
     The embodiment of  FIGS. 87 and 88  comprises 12 suture catch mechanisms (not illustrated), one for each suture mount of the device. The suture catch mechanisms can be of the type described above and in the patents incorporated by reference (which form a part of this specification), such as needles for example. These needles may be located in carriers in a portion of the elongate body proximal to the arms, arranged circumferentially around the elongate body to correspond in location to the suture mounts on the ends of the arms. The suture catch mechanisms may be actuated by a user to move in a proximal-to-distal direction, extending outwardly away from the elongate body to penetrate through tissue and into engagement with the suture mounts. Proximal retraction of the suture catch mechanism carries suture away from the arms through the tissue and back into the arms. The suture catch mechanisms can be operated independently of each other, or can be operated in groups in some embodiments. For example, two or more needles can be operated simultaneously in some embodiments. Other embodiments are contemplated where there are fewer needles than suture mounts provided on the device, but additional needles can be loaded and reloaded as desired to penetrate through tissue and retrieve suture. In certain embodiments, needles can be housed in a carrier that is rotatable around the circumference of the elongate body to position the needles in the desired location relative to the suture mounts. 
     The suturing device illustrated in  FIGS. 87 and 88  comprises a protection member  8107  that is configured to protect surrounding tissue, e.g. chordae tendineae, from movement of the suture catch mechanisms. The protection member illustrated in  FIGS. 87 and 88  is an elongate body comprising two lumens  8150  extending through a length of the protection member, although the protection member can comprise other numbers of lumens in some embodiments, as discussed above. 
     The protection member  8107  of this embodiment is configured to move between a retracted position parallel to a longitudinal axis of the elongate body and an outwardly extending, deployed position. The protection member is also configured to rotate about the longitudinal axis of the suturing device while the protection member is in the retracted position, the deployed position, and locations between the retracted position and the deployed position in order to point the protection member toward a desired arm. In some embodiments, the protection member is configured to rotate about the suturing device only when the protection member is in a selected one or more positions, e.g. fully-retracted position, fully-deployed position, or selected position between full retraction and full deployment. 
     In some embodiments, the protection member and a cooperating portion of the suturing device can be configured with detents to assist a user in determining when the protection member is aligned with a suture catch mechanism and arm as the protection member rotates. In alternative embodiments, rather than having a single rotating protection member, multiple protection members may be provided, for example, one per arm, having a number of lumens corresponding to the number of suture mounts in each arm. 
     The suturing device illustrated in  FIGS. 87 and 88  can be used to suture a valve without stopping the beating of the heart. In some embodiments, suturing of the heart while beating can allow the effect of suture placement on valve operation to be observed during the procedure, thereby allowing the procedure to be tailored to the needs of the particular valve by placing only those sutures required to repair the valve. For example, if the desired repair of the valve has not been achieved by the placement of initial sutures, continued use of the same device or additional devices may be employed through the same access path (e.g., through a transapical opening) until the procedure is observed to be successful on the beating heart. Once the practitioner observes this success, any access path which has been created to perform the procedure (e.g., the transapical opening) can be closed. 
       FIGS. 89-94  schematically illustrate a method of suturing using the device of  FIGS. 87 and 88 , and more specifically illustrates a method of performing a valve annuloplasty on a beating heart. As illustrated in  FIG. 89 , a distal end  8102  of the suturing device  8100  is positioned in the passage through the valve, such as the mitral valve  8 , using any of the access routes discussed above, and with or without a guide wire. The device is advanced through the valve a sufficient distance to allow the arms  8104  to be deployed without damage to the valve or walls of the heart. 
       FIGS. 89-94  are illustrated to schematically represent transapical access of the device to the mitral valve  8 . However, as discussed herein, other access routes can be used and other valve can be sutured. In  FIG. 89 , the valve is shown in cross section along a plane passing through a longitudinal axis of the suturing device  8100 . In  FIGS. 90-92 , the valve is shown in cross section on two planes, which both intersect the longitudinal axis of the suturing device  8100 . A first plane extends along the arm  8104  which is illustrated at approximately a 9 o&#39;clock position from the elongate body of the suturing device. The second plane extends along the arm  8104  which is illustrated at approximately a 5 o&#39;clock position relative to the elongate body of the suturing device. Thus, five of the arms  8104  are illustrated in  FIGS. 90-92  as generally overlying leaflets  132  of the valve, with a portion of one of the leaflets which underlies the sixth arm being hidden from view. In  FIG. 91 , the planes of cross section of the valve pass generally through the longitudinal axis of the suturing device and extend generally along the arms  8104  which are illustrated at the 5 o&#39;clock and 7 o&#39;clock positions such that all six of the illustrated arms are shown generally overlying the leaflets  132  of the valve  8 . The chordae tendineae are omitted from view in  FIGS. 89-94 . 
     Once the arms have been extended, the device  8100  can be retracted through the valve  8  to place the ends of the arms at or near the base of the valve  8 , as illustrated in  FIG. 90 . In certain embodiments, the length of the arms will not correspond exactly with the size of the valve. In such embodiments, two of the arms may be placed in a desired location with respect to the base of the valve where sutures are desired to be placed. The protective member  8107  is then moved from the retracted position toward the deployed position as illustrated in  FIG. 91 . 
     As shown in  FIG. 91 , the protective member  8107  when deployed can be moved to positions located angularly between the suture arms  8104 . In other embodiments, the protective member  8107  when deployed can be positioned at a rotational orientation relative to the body of the suturing device  8100  that is aligned with at least one of the suture mounts of a suture arm. The ability to move the protective member between the arms can be advantageous in some embodiments. For example, movement of the protective member between the arms can allow the protective member to be rotated about the device between a positioned aligned with a first arm  8104 A, as illustrated in  FIG. 92 , and a position aligned with a second arm  8104 B, as illustrated in  FIG. 93 , without damage to the chordae tendineae. This feature can also help avoid tangling of the protection member  8107  with the chordae tendineae as a reduced number of instances of deployment and retraction occur. 
     In one embodiment, the protective member  8107  is first deployed and positioned in alignment with a suture mount  8126  of the first arm  8104 A, as shown in  FIG. 92 . The end of the protective member  8107  may be located near the end of the arm  8104 A, but on the opposite side of tissue of valve  132 . In some embodiments, the end of the protective member  8107  is positioned a few millimeters away from the arm  8104 A. In other embodiments, this distance may be adjustable. A first suture catch mechanism, such as a needle, can be deployed through one of the lumens of the protective member  8107 , through tissue of valve  132 , and into the suture mount  8126 A of the first arm  8104 A. Retraction of the suture catch mechanism carries a first suture end portion through the tissue of valve  132  and into the elongate body. 
     With the suture catch mechanism retracted and the protective member  8107  deployed, the protective member can be rotated into alignment with a suture mount of the second arm  8104 B, as shown in  FIG. 93 , for example. A second suture catch mechanism, such as a needle, can be deployed through the other of the lumens of the protective member  8107 , through tissue of valve  132 , and into the suture mount  8126 B of the second arm. This suture mount of the second arm preferably holds the second end of the suture mounted in the first arm. Retraction of the suture catch mechanism carries the second suture end portion through the tissue of valve  132  and into the elongate body. The suturing device at this point has desirably placed a suture along the circumference of the valve at an angular distance corresponding to the angular distance between the ends of the two adjacent suture arms. 
     At this point in the procedure only one of the suture mounts from the first arm and the second arm has been used, preferably the suture mounts closest to the corresponding adjacent arm. The protection member  8107  may then be retracted and rotated to a location between another pair of arms, such as the second arm and the third arm. The device  8100  may also be desirably repositioned such that the second and third arms may be positioned as needed at the base of the valve  132 . The steps discussed in connection with  FIGS. 90-93  are then repeated to place a second suture through two additional locations in the valve. In embodiments wherein these steps are repeated for each of the pairs of adjacent suture arms, six sutures  130  may be positioned through the valve as illustrated schematically in  FIG. 94 . Opposing ends of each suture can then be tightened and secured together by any known method, such as those described herein. 
     In some embodiments, methods similar to those described in connection with  FIGS. 89-94  can be used to attached a prosthetic device to cardiac tissue. 
     Suturing Devices and Methods Having Two Arms, Such as for Suturing a Base of a Valve 
       FIGS. 95-97  illustrate an embodiment of a suturing device  9100  that can be used to suture an anatomical valve, such as a heart valve. For example, the suturing device  9100  (as well as similar devices described above) can be used to perform an annuloplasty by plication, where suture(s) are applied to a section of a valve and the suture(s) is tightened to reduce the size of the valve to remodel the valve. The suturing device  9100  illustrated in  FIGS. 95-97  is similar in some respects to suturing devices illustrated and described above. For example, the suturing device can comprise an elongate body  9142  and a distal assembly  9102  that can have one or more suture arms  9104 , as in the suturing device of  FIGS. 87 and 88  described above. As illustrated, the suturing device has only a single suture mount  9126  on each suture arm  9104 , although in some embodiments it can have multiple suture mounts  9126  on each arm  9104 . As described above, the suture mounts  9126  can be configured to releasably hold a suture portion. 
     In some embodiments, the suturing device can have multiple suture arms  9104  and multiple protective members or needle arms  9107 . In the illustrated embodiments, the device has two suture arms  9104 A,B and a single needle arm  9107 . The configuration and deployment of the arms, as well as other features and ways of operating the suturing device, may be as shown and described in the U.S. Pat. No. 6,911,034, the entirety of which is hereby incorporated by reference. The suture arms can be positioned near a distal end of the device, and the needle arm can be positioned proximally to the suture arms, as illustrated in  FIGS. 95-97 . The suture arms and the needle arm can each have a retracted position in which they are retracted within the elongate body, as illustrated in  FIG. 96 . Each suture arm can also have an extended position in which the suture arm rotates about one end and extends away from the elongate body. In some embodiments, the arms  9104 A,B can extend perpendicular to a longitudinal axis of the elongate body when in the extended position. The needle arm can also be deployed to an extended position, in which the needle arm extends away from the elongate body and toward a distal end of the elongate body.  FIG. 97  illustrates an embodiment where both suture arms and the needle arm are in the extended position. 
     As described above, various embodiments can have arms  9104 A,B of different lengths to accommodate the size of the particular valve to be sutured and the anatomy of the intended patient. In some embodiments, the arms are sized and configured such that each of the suture mounts on the arms are at or in proximity of the base of a valve when the device is in the valve and the arms have been deployed. In some embodiments, when the arms have been deployed and the suture mounts are at or in proximity of the base of a valve, the needle arm can be on an opposite side of the valve. In some embodiments, the needle arm in its extended position can extend into alignment with a suture mount of a suture arm, but with the valve between them. Additionally, in some embodiments a suture arm can comprise a sharp edge  10105 , or any hook, point, needle tip, knurling, or other roughening at a distal end on a surface that faces toward a proximal end of the elongate body when the suture arm is extended, as illustrated in  FIG. 98 . The sharp edge or other roughening can help retain the suture arm in a position against tissue of an anatomic valve. 
     Also as described above, the needle arm  9107  can be configured to protect surrounding tissue from movement of a suture catch mechanism, which in some embodiments can be a needle  9106 . The needle arm can comprise one or more lumens  9150  through which one or more needles  9106  can pass. In the illustrated embodiment of  FIG. 97 , the needle arm has two lumens, each of which can be associated with a needle  9106  and a suture mount  9126 . 
     In some embodiments, the needle arm can rotate around the elongate body. As illustrated in  FIG. 97 , the needle arm can extend between the two suture arms  9104 A,B. In  FIG. 99 , the needle arm has rotated into alignment with one of the suture arms  9104 A and a suture mount  9126 A.  FIG. 99  illustrates a cross sectional view of a section of the elongate body with the suture arm  9104 A and the protection member  9107  in their extended positions, and the needle arm aligned with the suture arm  9104 A. As illustrated, a needle  9106  is positioned within the needle arm  9107 . In some embodiments, the needle  9106  can be positioned within the needle arm before the needle arm is deployed to its extended position. 
     In some embodiments, the elongate body can comprise a rotating sleeve  9160 , which can surround an inner cylinder, and which can house the needle  9106  and the needle arm  9107  when the needle arm is in the retracted position. As illustrated, when the needle arm is in its extended position the needle runs through the rotating sleeve, exits the rotating sleeve into a gap, and then enters the needle arm. In some embodiments, the needle can run directly into the needle arm without passing first to a gap between the rotating sleeve and the needle arm. In some embodiments, discussed in more detail below, at least part of the needle can be within an extrusion. In some embodiments, the extrusion can be located only within the needle arm. In some embodiments, the extrusion can extend from the needle arm when the needle arm is in its extended position into the rotating sleeve. 
     When the needle arm begins to move into the extended position from a retracted position within the rotating sleeve it first moves distally until it engages extension surface  9164 . The extension surface angles the needle arm away from the elongate body, such that as the needle arm continues to move forward it moves both away from the elongate body and toward a distal end of the elongate body. In some embodiments, the extension surface  9164  can be at approximately a 45 degree angle. In some embodiments, the needle arm can extend at approximately a 45 degree angle. In other embodiments, the extension surface can be at an angle less than or greater than 45 degrees, and the needle arm can be at an angle less than or greater than 45 degrees. As the needle arm is retracted, it can engage against retraction surface  9166  which can guide the needle arm back into its retracted position within the rotating sleeve  9160 . In some embodiments, the retraction surface can comprise a gap that can allow a needle and/or extrusion to pass through it. 
     In some embodiments, the rotating sleeve  9160  can be configured to rotate about a longitudinal axis of the elongate body. In some embodiments, in addition to being able to rotate, the rotating sleeve can move proximally or distally along the inner cylinder. As the rotating sleeve rotates, the needle arm can rotate with it. As described with respect to  FIGS. 87 and 88 , the sleeve and needle arm, in various embodiments, can be configured to rotate while the needle arm is in the retracted positioned, the extended position, and/or in locations between the retracted position and the extended position in order to point the needle arm toward a desired arm. In some embodiments, when the needle arm is pointed toward a desired arm a gap of greater than or equal to 3 millimeters (or about 3 millimeters) and/or less than or equal to 5 millimeters (or about 5 millimeters) can exist between the needle arm and the suture arm. In some embodiments, the needle arm can point between two arms and a gap of greater than or equal to 3 millimeters (or about 3 millimeters) and/or less than or equal to 5 millimeters (or about 5 millimeters) can exist between the needle arm and a plane on which the two arms lie. 
     In some embodiments, the elongate body can have one or more detents  9162 , which can be positioned such that as the rotating sleeve rotates it can engage a detent when the needle arm is in alignment with a suture arm  9104 . In some embodiments, the detent or detents can be configured such that as the rotating sleeve engages with the detent the sleeve moves distally. In some embodiments, this can be achieved by creating a bayonet connection between the sleeve and the detent(s). The distal motion of the rotating sleeve can drive the needle arm distally, and can be configured such that the needle arm engages tissue of the valve, pinching the valve between the tissue and the suture arm. If the needle arm rotates back, the rotating sleeve can disengage the detent, moving proximally and releasing the valve. In some embodiments, the needle arm can move distally as it comes into alignment with a suture arm, but does not pinch the valve. In some embodiments, the needle arm can move distally as it comes into alignment with a suture arm, but can rotate back without moving proximally. 
     Pinching the valve can help facilitate suturing a valve without stopping the beating of the heart, because it can help ensure desired placement of sutures. As discussed above, suturing of the heart while beating can allow the effect of suture placement on valve operation to be observed during the procedure, thereby allowing the procedure to be tailored to the needs of the particular valve by placing only those sutures required to repair the valve. For example, if the desired repair of the valve has not been achieved by the placement of initial sutures, continued use of the same device or additional devices may be employed through the same access path (e.g., through a transapical opening) until the procedure is observed to be successful on the beating heart. Once the practitioner observes this success, any access path which has been created to perform the procedure (e.g., the transapical opening) can be closed. 
       FIG. 100  illustrates a view of the suturing device from a distal end. As illustrated, the first and second suture arms  9104 A,B have been extended and extend away from the elongate body at approximately 90 degrees from each other. In some embodiments, the suture arms can be positioned at less than 90 degrees from each other, and in other embodiments the suture arms can be positioned at more than 90 degrees from each other. The distance  9127  between the suture mounts  9126 A,B can define the initial width of a suture or other element that can be tightened when performing an annuloplasty. In some embodiments, the distance  9127  can be greater than or equal to 10 millimeters (or about 10 millimeters) and/or less than or equal to 15 millimeters (or about 15 millimeters). Also illustrated in  FIG. 100  is a guide wire  10  and a guide wire lumen  9111  through which the guide wire can pass. As discussed above, in some embodiments the device can advance over a guide wire to reach a location within the heart. 
       FIG. 101  illustrates a cross sectional view of a distal end of a needle arm  9107 . In some embodiments, the needle arm can have one or more channels through which needles can pass. In some embodiments, as illustrated, a needle arm can have one or more extrusions  9170  positioned within one or more channels of the needle arm. The extrusion can be configured to receive a needle  9106 , as illustrated. In some embodiments, the needle arm can have one or more of a draft  9174 , a tunnel  9172 , and/or a suture retaining area  9176 , with the extrusion extending only as far as the draft  9174 . The draft  9174  can guide a needle into the tunnel  9172 , which can help ensure that the needle is aligned to pass through a suture clasp or mount  9126  and receive a section of a suture. The suture retaining area  9176  can be of a size sufficient to house both a needle and a portion of suture caught by the needle. In some embodiments, the needle  9106  can be pre-loaded to the illustrated position, extending through the extrusion and through the tunnel  9172 , before a needle arm is deployed to an extended position. In some embodiments, the needle can be pre-loaded into other positions within the needle arm and/or extrusion, such as within the extrusion but short of the tunnel. The needle  9106  as illustrated in  FIG. 101  (or in any of the embodiments described elsewhere herein) may have a hook at its distal end to engage a portion of suture held by arm  9104 A or  9104 B. Sutures as described herein (or elsewhere in the specification) may have ends that are flattened with a hole formed therein for engaging the needle, as described in the U.S. Pat. No. 7,090,686, the entirety of which is hereby incorporated by reference. 
     In some embodiments, the needle arm can have a single extrusion  9170  with one or more lumens  9150 .  FIG. 102  illustrates a top view of an extrusion  9170  with two lumens  9150  configured to hold two needles  9106 . In some embodiments, the needle arm can have multiple extrusions, each extrusion associated with one or more needles. In some embodiments, the needle arm can have a draft, tunnel, and/or a suture retaining area as described above for each lumen and/or needle. In  FIG. 102 , the extrusion has parallel sides and rounded corners. In other embodiments, the extrusion or extrusions can be square, rounded, ovular, or of any shape that can fit within a needle arm. The various embodiments and configurations of an extrusion or extrusions can be used with any protective member (“needle arm”) discussed in the present application. 
       FIGS. 103-112  illustrate schematically one method of using a suturing device to perform an annuloplasty. The illustrated procedure represents transapical access of the device to the mitral valve  8 , although as discussed herein other access routes can be used, including routes by which the device enters the valve from the atrial side, and other valves can be sutured. The device can also access the valve with or without a guide wire. The valve is shown without surrounding tissue, and in  FIG. 103  a distal end of the device has been inserted through the valve, with the suture arms  9104 A,B and needle arm  9107  in the retracted position. The needle arm is positioned approximately equidistant between the two arms, although in some embodiments the needle arm can be positioned closer to one arm or the other. Also illustrated schematically are chordae tendineae  133  extending from the ventricle side of the valve. 
     The suture arms can be placed in their extended positions, as illustrated in  FIG. 104 . In some embodiments they can reach their extended position simultaneously, and in some embodiments one arm can begin to extend or reach the extended position before the other arm begins to extend. With the suture arms extended, the device can be retracted until the arms engage tissue of the valve, as illustrated in  FIG. 105 . As illustrated, the suture mounts  9126 A,B are along a base of the valve on the same leaflet. In some embodiments, the arms do not extend all the way to the base of the valve, and in some embodiments each arm can be over a different leaflet. 
     Either before, after, or while the suture arms are extending or the device is retracted such that the suture arms can engage tissue of the valve, the needle arm can be deployed to an initial extended position, such as past the chordae, for example.  FIG. 106  illustrates the needle arm in the extended position and the suture arms in place on the valve. The needle arm  9107  can then rotate toward a first arm  9104 A until it is aligned with the arm, as illustrated in  FIG. 107 . As discussed above, in some embodiments, when the needle arm is aligned with the arm it can extend distally and pinch the valve between the suture arm and the needle arm. In other embodiments, there can be a gap between the needle arm and the valve. 
     As the needle arm rotates, it can displace chordae tendineae  133  positioned between the needle arm and the first arm. One advantage of having the needle arm positioned initially equidistant between the two arms  9104 A,B is that it minimizes the distance that the needle arm may need to travel to reach each arm, which can minimize stress on any displaced chordae. The needle arm when extended is preferably positioned between adjacent chordae tendineae, such that movement of the needle arm between the first and second arms does not cause the needle arm to tangle with the chordae tendineae. 
     Once the needle arm is aligned with the suture arm, a needle  9106 A can be extended out of the needle arm and through the suture mount  9126 A, as illustrated in  FIG. 108 . As discussed above, retraction of the needle can carry a first suture end portion from the suture mount, through tissue of the valve, and into the elongate body. The needle arm can then rotate back to its initial extended position, bringing a length of suture  130 A with it, as illustrated in  FIG. 109 . 
     From the initial extended position, the needle arm  9107  can rotate toward second arm  9104 B until it is aligned with the arm, as illustrated in  FIG. 110 . In some embodiments, the needle arm can pinch the valve tissue against the arm, as discussed above. Also as discussed above, and as illustrated, the needle arm can displace chordae tendineae  133  positioned between the needle arm and the second arm  9104 B. 
     A separate needle  9106 B can extend through the needle arm and through the suture mount, as illustrated in  FIG. 111 , and then retract into the elongate body with a second suture end portion. The needle arm can then return to its initial extended position, as illustrated in  FIG. 112 , with a length of suture extending from each arm through the valve and into the needle arm. In some embodiments, the elongate body can have an initial detent that informs a user when the needle arm has returned to its initial extended position. 
     The suture arms and the needle arm can retract into the elongate body. In some embodiments, the needle arm and/or the suture arms can retract into the elongate body before the needle arm returns to the initial extended position, or without the needle arm returning to the initial extended position. Once the needle arm and suture arms are retracted, the device can be removed from the valve and the heart, leaving the suture lengths running through the valve. 
     In some embodiments, the two suture end portions can be parts of separate sutures, as illustrated in  FIG. 113 . The two suture ends that pass through the gap in the valve can be secured together by tying a knot  134  according to any known method or by applying a knot  134 , such as described in U.S. Patent Publication No. 2007/0010829 A1, published Jan. 11, 2007, which is hereby incorporated by reference herein in its entirety and is considered a part of this specification.  FIG. 114  illustrates the sutures after they have been joined together. In some embodiments, the two suture end portions can be ends of the same suture, and it is not necessary to secure the two suture ends together as seen in  FIG. 113 . 
     One or more of the loose suture ends can then be pulled, as described with reference to  FIGS. 50 and 51 , bringing the suture against the valve. The remaining ends can be tightened and tied according to any of the methods described above, such as  FIGS. 69 and 70  and accompanying description, to thereby draw together the locations of suture penetration. In some embodiments, as described above, the initial distance between the set of suture penetrations can be greater than or equal to 10 millimeters (or about 10 millimeters) and/or less than or equal to 15 millimeters (or about 15 millimeters). In some embodiments, the distance between the set of suture penetrations can be tightened to a second distance greater than or equal to 6 millimeters (or about 6 millimeters) and/or less than or equal to 8 millimeters (or about 8 millimeters). The connection between the set of suture penetrations can be referred to as a plication, and in some embodiments multiple plications can be inserted into the valve with the suturing device. The plications can be positioned and sized to reshape the valve according to a desired treatment goal. 
     In some embodiments, a tube  9137  can be inserted over the suture, as illustrated in  FIG. 115 , which is a cross sectional view of a valve with a plication. The tube can be made of metal or a plastic, such as polypropylene, and can be straight or curved. In embodiments where the two suture end portions are part of separate sutures, the tube can be inserted over one of the suture ends that pass through the gap in the valve before the suture ends are secured together. In some embodiments, the tube  9137  can be secured to the two free ends of separate sutures that pass through the gap in the valve, rather than sliding loosely over the joined sutures. The loose ends can then be pulled until the tube sits against or is near the valve. In embodiments where the two suture end portions are part of the same suture, the tube can be inserted over and/or attached to the suture before the suture is attached to the device, or in some embodiments the tube can be attached to the suture after the suture is attached to the device. The tube can be set to a desired length and can help control the distance that the locations of suture penetration are drawn together, as illustrated in  FIG. 116 . In some embodiments, a pledget can be used instead of a tube. With the tube or pledget in place, a knot can be applied on the opposite side of the valve, as illustrated in  FIG. 116 . 
     In some embodiments, in order to maintain consistent tightening among multiple plications, or to monitor the tightening of a single plication, a strain gauge can be connected to the suture. In some embodiments, a strain gauge can be built into the handle of the device. The plication can be tightened until the strain gauge indicates a desired value. In some embodiments, a first plication can be tightened to a desired distance, and the value measured by a strain gauge recorded. Subsequent plications can then be tightened to approximately the same reading of the strain gauge. 
     Because the chordae were pushed aside as the needle arm rotated between the two suture arms, the suture on the ventricle side can run in a generally direct route between the suture penetrations. This can help prevent unnecessary strain on chordae that could result if the suture took a circuitous path around chordae as it ran from one suture penetration to the next. Tightening the suture could pull the suture tight against the base of one or more chordae, potentially damaging the chordae. 
     Example Device for Applying Knots 
     Varying embodiments described herein rely on joining one or more sutures together. The following description relates to devices and methods of joining sutures.  FIG. 117  illustrates one embodiment of a knot placement device  900  that can be used to apply a knot to the suture portion  130 . The knot placement device  900  can include a handle  902  and a shaft  904  extending distally from the handle. The handle  902  can include an elongate tubular body extending from a proximal end to a distal end, and can include an actuator  906  and a distal end portion  910 . The handle  902  can further comprise a cam  908  and a spring  912 , shown in its rest position, disposed between the cam  908  and end portion  910 . The actuator  906  can be a thumb or finger button in contact with the cam  908 . End portion  910  can be fixedly attached to an outer tube  914  by glue, press fit, injection molding, or other suitable means known to one of ordinary skill in the art. An intermediate tube  916  can be concentrically and slidably disposed within the outer tube  914 . A push rod  918  can be concentrically and slidably disposed within the intermediate tube  916  and fixedly attached to the cam  908 . It should be appreciated that it is contemplated that the knot placement device  900  does not necessarily comprise an intermediate tube  916 ; however its inclusion provides certain benefits. 
     Depression of the actuator  906  causes the cam  908  to move distally, compressing the spring  912 , thereby moving the push rod  918 . After traveling for a certain desired distance, the cam  908  engages a proximal end of the intermediate tube  916 , causing the intermediate tube  916  to also move distally. Upon release of the actuator  906 , the spring  912  expands to move the cam  908  and the push rod  918  proximally. In the illustrated embodiment, the intermediate tube  916  can be freely slidable over the push rod  918 . 
     In one embodiment, not shown, the cam  908  can include a detent in the surface which contacts the actuator  906 . The detent can signal to the user a specific degree of advancement of the push rod  918 , the intermediate tube  916 , or both. For example, the detent can signal that the push rod has been advanced sufficiently far to insert the plug into the knot body, as described below. The detent can also indicate travel up until, but not including, the point at which the cam  908  engages the intermediate tube  916 . The detent can be shaped so as to prevent the actuator  906  from returning to its original position. The cam can comprise multiple detents to indicate multiple increments of travel. To return the actuator to its initial position, the actuator and cam can include a mechanism such that after the actuator can be fully depressed, the actuator can automatically return to its initial position. Alternatively, the actuator can have a locked configuration, either at one of the detents or in a fully depressed configuration, and the handle can include a mechanism by which a second actuator can be used to release the cam and actuator to return to their initial positions. 
     In one embodiment, not shown, the intermediate tube  916  can comprise a keyway and the outer tube  914 , the end portion  910 , or both can comprise a key. Alternatively, the intermediate tube  916  can comprise a key and the outer tube  914 , the end portion  910 , or both can comprise a keyway. Providing such a key and keyway can be used to keep the intermediate tube  916  aligned with the outer tube. Other embodiments are contemplated to maintain rotational alignment of the intermediate tube, such as rotationally fixing the intermediate tube relative to the push rod. Providing such a key and keyway can also be used to constrain the range of sliding movement of the intermediate tube  916 . 
     As shown in  FIG. 118 , a knot, comprising a knot body  924  and a plug  926 , can be disposed within the outer tube  914  at its distal end. In another embodiment, the knot body can include an atraumatic tip  932 . The tip  932  can be rounded and have an outer diameter about the same as that of the outer tube  914 . The tip can also include a flat transition  934  as well. The tip  932  can be integrally formed with the knot body  924  or can be separately attached. As illustrated, the tip  932  can have an aperture  936  extending axially through the tip, opening to the cavity inside the knot body. When the knot is delivered into a patient as described above, the atraumatic tip prevents damage to the patient. 
     Alternatively, the fit between the knot body  924  and the outer tube  914  cannot retain the knot body  924  in the outer tube  914 . The knot body  924  can be at the distal end of the outer tube  914 , and can protrude slightly distal to the distal end of outer tube  914 . The plug  926  can be positioned proximal to the knot body  924 , and can be slidably disposed within the intermediate tube  916 , having a distal end located proximally from the knot body and distally from the push rod  918 . The plug  926  has an outer dimension configured to be inserted into an inner cavity of the knot body  924 . The intermediate tube  916  can be sized and positioned such that its distal end can abut knot body  924 . 
     As shown in  FIG. 118 , the outer tube  914  can include a side hole  920  near its distal end. The intermediate tube  916  can include a slot (not shown) extending proximally from its distal end, forming a C-shaped cross section. At a proximal end of the slot, a sharpened cutting surface can be provided to cut suture  130 , as described below. The slot can also be spaced from the distal end of the intermediate tube, such that the distal end of the tube still forms a complete circle in cross-section. The outer tube  914 , intermediate tube  916  and push rod  918  can be made of any suitable material, including but not limited to metals, plastics, and a combination of metals and plastics. 
     As shown in  FIG. 118 , in a preloaded configuration, the knot placement device  900  can include a threader  928  comprising a tab  931  and a looped wire  930  passing through the side hole  920  in the outer tube  914 . The wire  930  extends through the slot  122  located in the intermediate tube  916 , and through knot body  924 , exiting through opening  936  at the distal end of the knot body  924 . The threader  928  can be used to load the suture into the knot placement device as described below. The threader  928  also prevents the knot body  924  from escaping from the placement device  900  when the knot body can be provided with an outer dimension of the same or smaller size than the inner wall of the outer tube  914 . 
     With reference to  FIG. 118 , the knot body  924  can be generally tubular and comprise a proximal end, a distal end, and a longitudinal axis. The knot body  924  further defines an inner cavity and can include an opening  936  at its distal end. The knot body can be of a generally constant inner diameter and outer diameter. Alternatively, the inner diameter, the outer diameter, or both can generally taper along the longitudinal axis of the knot body. Alternatively, the inner diameter, the outer diameter, or both can generally taper along a portion of the longitudinal axis and can be of a generally constant inner diameter, outer diameter or both over a portion of the longitudinal axis. 
     The opening  936  at the distal end of the knot body can, in some embodiments, be of a reduced diameter relative to an inner cavity of the knot body  924 . The knot body also can include an opening at the proximal end. The opening at the proximal end can, in some embodiments, be of a reduced diameter relative to an inner cavity of the knot body  924 . The knot body can further comprise protrusions  938  extending from the inner surface of the knot body  924  toward the longitudinal axis. Protrusions  938  can be formed as rings as illustrated, or as spirals, spikes, bumps, or other suitable structures or combinations of structures. 
     Referring to  FIG. 118 , in one embodiment, the knot body  924  can be located distally from the plug  926  within the outer tube  914 . The plug can be sized to be inserted into the inner cavity of the knot body  924 , and can have a tapered configuration. Alternatively, the plug  926  can have a constant cross-section over a majority of its length, with a tapered, chamfered or rounded distal end for facilitating insertion into the knot body  924 . The outer dimension of the plug  926  can be slightly larger than the inner dimension of the cavity of the knot body  924 , such that when the plug is inserted into the cavity, a relatively secure fit can be provided between the two. The protrusions  938  within the knot body further facilitate the relative securement. The plug  926  can also comprise indentations, not shown, for receiving the protrusions  938  to secure the plug  926  more surely in the knot body  924 . Other embodiments are contemplated wherein protrusions can be formed on the plug  926  with or without indentations formed in the inner cavity of the knot body  924 . It is also contemplated that in some embodiments both the plug  926  and the knot body  924  can comprise protrusions and indentations, respectively. In certain embodiments, insertion of the plug  926  into the knot body  924  can cause the knot body  924  to slightly expand. Both the knot and the knot body can be formed of any suitable resilient materials, and in one embodiment, can be made from the same material as the suture, more preferably polypropylene. 
       FIGS. 118-119  illustrate one embodiment for placing a knot utilizing the knot placement device  900  described above. A pair of sutures ends  130  can be passed through the loop  930  of threader  928 . The threader can be preloaded into the knot placement device  900  as described above. The tab  931  of threader  928  can be pulled proximally to dispose suture  130  in the device. Suture  130  can be held in tension, by hand or otherwise, while the device  900  can be advanced until the knot body  924  or shaft  904  contacts at least one tissue portion. The actuator  906  can be depressed to advance the push rod  918 , thereby forcing the plug  926  distally into the knot body  924  and trapping suture  130  there between the plug  926  and the knot body  924 . The actuator can be further depressed until the cam  908  contacts the proximal end of intermediate tube  916 , causing the intermediate tube  916  to contact knot body  924  and eject the knot from the shaft  904 . Advancement of intermediate tube  916  can also cause cutting surface to sever suture  130  where it extends out of opening. The knot placement device can then be removed, leaving the knot in place against the tissue portions. 
     In one embodiment, the knot can be ejected from the shaft  904  while leaving the sutures  130  un-severed. For example, the knot can be ejected before the cutting surface reaches the suture  130 . In another embodiment, no intermediate tube can be provided, and the suture can be cut manually. 
     In an embodiment including the intermediate tube, the device  900  can be configured such that the distal ends of the outer tube  914 , intermediate tube  916 , and the push rod  918  lie generally flush relative to one another and can be held relatively in position. This position can be held, for example, by depressing the actuator until it rests in a detent in cam  908 . The detent can signal to the user that the plug  926  has been inserted into knot body  924 , but also that the sutures  130  have not been cut. At such time, the placement device can be used to further advance the knot against tissue portions using the distal end surface of the shaft. The actuator can be further depressed to advance the push rod  918  and intermediate tube  916  to sever sutures  130 . 
     The actuator  906  and cam  908  can also be provided with locking mechanisms that prevent the actuator  906  from returning to its original position. Further details are provided in U.S. Patent Application Publication No. 2006/0069397, published on Mar. 30, 2006, the entirety of which is hereby incorporated by reference herein. Such an embodiment can be advantageous to hold the push rod flush with the distal end of the outer tube to provide a surface that can be utilized to further advance and position the knot against tissue portions. 
     It will be appreciated that other embodiments can be contemplated without use of the intermediate tube, but can still be capable of severing the suture. For example, the push rod can be provided with portions of differing diameter. A distal, smaller diameter can be sized to engage the plug  926  to push the plug into the knot body  924 . A proximal, larger diameter can be provided on the push rod, which can include a sharpened surface at the transition between the larger and smaller diameter sections. Once the smaller portion of the push rod pushes the plug  926  into the knot body  924 , the larger portion of the push rod can engage the knot body  924  to push the knot out of the placement device, while the sharpened surface on the push rod can sever the suture. 
     In the embodiment described above, when the knot body  924  and the plug  926  as described above are secured together, suture portions extending through the inner cavity of the knot body will be fixedly secured therein, forming a knot. It will be appreciated that many other embodiments can be possible for forming a knot, including various other shapes and configurations for the knot body and plug, as well as embodiments wherein only one component can be used to provide securement relative to a suture. It will also be appreciated that in those embodiments in which the knot can include a knot body and plug, the plug can be located within the shaft proximally from the knot body or the knot body can be located within the shaft proximally from the plug. 
     After the procedure within the heart is complete, any path that has been opened to provide access for entry of the suturing device to the body (e.g., the transapical opening) can be closed. Additional details regarding closure of transapical openings are provided in U.S. Patent Publication No. 2011/0190793 A1, entitled METHODS AND APPARATUSES FOR SUTURING OF CARDIAC OPENINGS, which is hereby incorporated by reference herein in its entirety and forms a part of this specification. 
     Although the foregoing description of the preferred embodiments has shown, described and pointed out the fundamental novel features of the invention, it will be understood that various omissions, substitutions, and changes in the form of the detail of the apparatus as illustrated as well as the uses thereof, may be made by those skilled in the art, without departing from the spirit of the invention. For example, while the suturing device is described with respect to suturing a valve of a patient&#39;s heart, it is further envisioned that the suturing device could be used to close or reduce a variety of other tissue openings, lumens, hollow organs or natural or surgically created passageways in the body. The suturing device can have any suitable number of arms, such as two or four or more, and any given arm can have one or more suture clasps or openings.