Abstract:
The present invention is directed to a method of securing suture within a patient. The method comprises advancing suture material into the patient, passing a portion of the suture material through tissue of the patient, and advancing a fastener catheter and a suture fastener along the suture material. The fastener catheter includes a catheter main body and a handle. The suture fastener has a generally cylindrical body formed of a shape memory material and a suture fastener inner lumen. The suture fastener has at least one engagement tab biased to extend at least partially into the suture fastener inner lumen to engage against and secure one or more lines of suture passing through the suture fastener.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. application Ser. No. 12/552,972, filed Sep. 2, 2009, which is a divisional of U.S. application Ser. No. 12/129,574, filed May 29, 2008, which is a divisional of U.S. application Ser. No. 10/389,721 filed on Mar. 14, 2003, now U.S. Pat. No. 7,381,210, the contents of which are expressly incorporated herein by reference in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    In vertebrate animals, the heart is a hollow muscular organ having four pumping chambers: the left atrium, the left ventricle, the right atrium and the right ventricle. The atria are isolated from their respective ventricles by one-way valves located at the respective atrial-ventricular junctions. These valves are identified as the mitral (or bicuspid) valve on the left side of the heart, and tricuspid valve on the right side of the heart. The exit valves from the left and right ventricles are identified as the aortic and pulmonary valves, respectively. 
         [0003]    The valves of the heart are positioned in valvular annuluses that comprise dense fibrous rings attached either directly or indirectly to the atrial and ventricular muscle fibers. Valve leaflets comprising flexible collagenous structures are attached to, and extend inwardly from, the annuluses to meet at coapting edges. The aortic, tricuspid and pulmonary valves each have three leaflets, while the mitral valve only has two. In normal operation, the leaflets of the mitral valve open as left ventricle dilates thereby permitting blood to flow from the left atrium into the left ventricle. The leaflets then coapt (i.e. close) during the contraction cycle of the left ventricle, thereby preventing the blood from returning to the left atrium and forcing the blood to exit the left ventricle through the aortic valve. Similarly, the tricuspid valve regulates flow from the right atrium into the right ventricle, and the pulmonary valve regulates blood exiting the right ventricle. 
         [0004]    For a number of clinical reasons various problems with heart valves can develop. One common form of heart disease involves the deterioration or degradation of the heart valves which leads to stenosis and/or insufficiency. Heart valve stenosis is a condition in which the valve does not open properly. Insufficiency is a condition in which the valve does not close properly. Insufficiency of the mitral valve, most common because of the relatively high fluid pressures in the left ventricle, results in mitral valve regurgitation (“MR”), a condition in which blood reverses its intended course and flows “backward” from the left ventricle to the left atrium during ventricular contractions. 
         [0005]    A number of surgical techniques have been developed to repair degraded or otherwise incompetent heart valves. A common procedure involves replacement of a native aortic or mitral valve with a prosthetic heart valve. These procedures require the surgeon to gain access to the heart through the patient&#39;s chest (or possibly percutaneously), surgically remove the incompetent native heart valve and associated tissue, remodel the surrounding valve annulus, and secure a replacement valve in the remodeled annulus. While such procedures can be very effective, there are shortcomings associated with such replacement valves. For example, the invasive nature of the implantation procedure typically results in substantial patient discomfort and requires patients to remain hospitalized for extended recovery periods. In addition, the two basic types of commercially available replacement valves, mechanical valves and tissue valves, each have shortcomings of their own. Mechanical replacement valves typically offer extended operational lifetimes, but the patient is usually required to maintain a regimen of anti-coagulant drugs for the remainder of his or her life. Tissue valves typically offer a higher degree of acceptance by the body which reduces or eliminates the need for anti-coagulants. However, the operational lifetimes of tissue valves is typically shorter than mechanical valves and thus may require a subsequent replacement(s) during the patient&#39;s lifetime. 
         [0006]    As an alternative to prosthetic heart valve replacement, it is often preferable to remodel the native heart valve and/or the surrounding tissue. Remodeling of the valve often preserves left ventricular function better than mitral valve replacement because the subvalvular papillary muscles and chordae tendineae are preserved (most prosthetic valves do not utilize these muscles). Valvular remodeling can be accomplished by implanting a prosthetic ring (a.k.a. “annuloplasty ring”) into the valve annulus to reduce and/or stabilize the structure of the annulus in order to correct valvular insufficiency. Annuloplasty rings are typically constructed of a resilient core covered with a fabric sewing material. Annuloplasty procedures can be performed alone, or they can be performed in conjunction with other procedures such as leaflet repair. Although such annuloplasty procedures have become popular and well accepted, reshaping the surrounding annulus and traditional leaflet repairs do not always lead to optimum leaflet coaptation. As a result, some patients may still experience residual mitral valve regurgitation following such annuloplasty procedures. 
         [0007]    A recently developed technique known as a “bow-tie” repair has also been advocated for repairing insufficient heart valves, in particular the mitral valve. The mitral valve bow-tie technique involves suturing the anterior and posterior leaflets together near the middle of their coapting edges, thereby causing blood to flow through two newly formed openings. While this does reduce the volume of blood that can flow from the atrium to the ventricle, this loss is compensated by improved leaflet coaptation which reduces mitral regurgitation. This process as originally developed by Dr. Ottavio Alfieri involved arresting the heart and placing the patient on extracorporeal bypass and required invasive surgery to access and suture the leaflets together. More recently, however, some have advocated a “beating heart” procedure in which the heart is accessed remotely and remains active throughout the bow-tie procedure. 
         [0008]    One particular method for performing a beating heart bow-tie procedure (i.e. without extracorporeal bypass) has been proposed by Dr. Mehmet Oz, of Columbia University. (See PCT publication WO 99/00059, published Jan. 7, 1999, the contents of which are incorporated herein by reference). In one embodiment of this procedure, the associated device consists of a forceps-like grasper used to grasp and hold the mitral valve leaflets in a coapted position prior to the connecting step. Since the mitral valve leaflets curve toward and slightly into the left ventricular cavity at their mating edges, the grasper device is passed through a sealed aperture in the apex of the left ventricle. The edges of the mating mitral valve leaflets are then grasped and held together, and subsequently a fastening device such as a clip or suture is utilized to fasten them. The Mehmet Oz disclosure also discloses teeth on the grasper device that are linearly slidable with respect to one another so as to permit alignment of the mitral valve leaflets prior to fastening. Since the procedure is done on a beating heart, it will be readily understood that the pressures and motions within the left ventricle and mitral valve leaflets are severe and render Dr. Oz&#39;s procedure very skill-intensive. 
         [0009]    The bow-tie technique has proved to be a viable alternative for treating otherwise incompetent heart valves. Nonetheless, shortcomings associated with the current bow-tie procedures have been identified. Current systems typically include tissue stabilizing devices having mechanical graspers, barbed members, and vacuum devices. Often, use of these devices results in the less than optimal leaflet stabilization and fastener placement. Many of these problems arise from the fact that the surgeon is required to capture, retain and fasten the leaflets in one relatively inflexible procedure. These difficulties are compounded when the leaflets are small or calcified making them difficult to pull together, and in beating heart procedures in which the leaflets are actively functioning. In addition, the size and complexity of most current devices make minimally invasive surgical procedures more difficult, if not impossible. In light of the foregoing, there is presently a need for improved systems for stabilizing multiple tissue heart valve leaflets and placing a fastening device therebetween. More specifically, there is a present need for an improved bow-tie procedure for repairing a patient&#39;s mitral valve. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    The present invention solves the problem of effectively stabilizing at least one tissue portion in vivo. Additionally, the present invention provides a device capable of delivering a fastener to the stabilized tissue portion through a catheter from a remote insertion location. 
         [0011]    In one aspect, the present invention is directed to a system for repairing tissue within the heart of a patient and includes a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter capable of applying at least one suture to the tissue, and a fastener catheter capable of attaching at least one fastener to the suture. The therapy catheter and the fastener catheter are capable of traversing the internal lumen of the guide catheter. 
         [0012]    In another aspect, the present invention pertains to a system for repairing tissue within the heart of a patient and comprises a guide catheter having a proximal end, a distal end, and at least one internal lumen formed therein, a therapy catheter having at least one needle lumen in communication with at least one needle port positioned therein, at least one needle positioned within the needle lumen, and a fastener catheter having at least one fastener detachably coupled thereto. In addition, the fastener catheter includes at least one cutting member. 
         [0013]    In yet another aspect, the present invention discloses a system for repairing tissue within the heart of a patient and includes a guide wire capable of being inserted into the patient and advanced through a circulatory pathway, a therapy catheter attachable to the guide wire and capable of applying at least one suture to the tissue, and a fastener catheter attachable to the guide wire and capable of attaching at least one fastener to the suture. 
         [0014]    In a further aspect, the present invention pertains to a guide catheter for delivering a tissue repair device to tissue located within the heart of a patient and comprises an outer wall defining an outer wall lumen, a directing lumen capable of receiving a steering device therein and a flexible support device positioned within the outer wall lumen. 
         [0015]    In another aspect, the present invention discloses a catheter for delivering a suture to tissue within the heart of a patient and includes an elongated body having a distal end, at least one suction recess formed on the distal end, at least one needle port located proximate to the suction recess, at least one needle lumen having at least one needle positioned therein in communication with the needle port, at least one needle receiving port having at least one needle catch located therein positioned proximate to the suction recess, and at least one actuator member in communication with the needle. 
         [0016]    In yet another aspect, the present invention is directed to a catheter for delivering a suture to tissue within the heart of a patient and comprises an elongated body having a distal end with at least one suction recess formed thereon, at least one needle port located proximate to the suction recess, at least one needle lumen having at least one detachable needle attached to suture material positioned therein and in communication with the needle port, at least one needle receiving port located proximate to the suction recess, at least one needle trap capable of receiving the detachable needle positioned within the needle receiving port, and at least one actuator member in communication with the needle. 
         [0017]    In yet another aspect, the present invention pertains to a device for applying a fastener to suture material attached to tissue within the body of a patient and includes a catheter body having a proximal end and a distal end, an inner body defining a suture recess and an actuation recess, and a movable sleeve defining a deployment lumen. The suture recess on the inner body is in communication with a fastener lumen capable of receiving a fastener therein. The actuation recess is in communication with an actuation lumen formed in the inner body. The deployment lumen formed in the movable sleeve is sized to receive the inner body therein and includes a cutting recess having a cutting member located proximate thereto. 
         [0018]    In another aspect, the present invention is directed to a fastener attachable to suture material and comprises a fastener body having at least one attachment lumen formed therein and at least one engagement member attached to the fastener body wherein the engagement member is capable of engaging and retaining the suture material. The engagement member defines an engagement aperture which is in communication with the attachment lumen. The attachment lumen is capable of receiving at least one suture therein. 
         [0019]    The present invention also discloses various methods of repairing heart valve tissue within the body of a patient. In one aspect, a method of repairing tissue within the heart of a patient is disclosed which includes advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with the therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and joining the first and second leaflets by reducing the distance between the first and second sutures. 
         [0020]    An alternate method of repairing tissue within the heart of a patient is disclosed and comprises advancing a guide catheter through a circulatory pathway to a location in the heart proximate to a heart valve, advancing a therapy catheter through the guide catheter to the heart valve, stabilizing a first leaflet with the therapy catheter, deploying a first suture into the stabilized first leaflet, disengaging the first leaflet from the therapy catheter while leaving the first suture attached thereto, stabilizing a second leaflet with said therapy catheter, deploying a second suture into the second leaflet, disengaging the second leaflet from the therapy catheter while leaving the second suture attached thereto, and removing the therapy catheter from the guide catheter. Thereafter, a fastener catheter is positioned over the first and second suture and advanced through the guide catheter to the heart valve. Once positioned, the first and second leaflets are joined by reducing the distance between the first and second sutures and a fastener is deployed from the fastener catheter. 
         [0021]    Other objects, features, and advantages of the present invention will become apparent from a consideration of the following detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein: 
           [0023]      FIG. 1  shows a perspective view of an embodiment of the guide catheter of the present invention; 
           [0024]      FIG. 2  shows a cross-sectional view of an embodiment of the guide catheter of the present invention; 
           [0025]      FIG. 3  shows a cross-sectional view of an alternate embodiment of the guide catheter of the present invention; 
           [0026]      FIG. 4  shows a cross-sectional view of the embodiment of the guide catheter shown in  FIG. 3 ; 
           [0027]      FIG. 5  shows a perspective view of an embodiment of the therapy catheter of the present invention; 
           [0028]      FIG. 6  shows an embodiment of the therapy device handle of the present invention; 
           [0029]      FIG. 7  shows an perspective view of an embodiment of the elongated body of the present invention having a suture attachment tip attached thereto; 
           [0030]      FIG. 8A  shows a cross-sectional view of an embodiment of the elongated body of the present invention; 
           [0031]      FIG. 8B  shows a cross sectional view of an alternate embodiment of the elongated body of the present invention; 
           [0032]      FIG. 8C  shows a side cross-sectional view of the embodiment of the elongated body shown in  FIG. 8B ; 
           [0033]      FIG. 9  shows a top cross-sectional view of an embodiment of the elongated body of the present invention; 
           [0034]      FIG. 10  shows a side cross-sectional view of the embodiment of the elongated body shown in  FIG. 9  prior to actuation; 
           [0035]      FIG. 11  shows a side cross-sectional view of an embodiment of the elongated body shown in  FIG. 10  during actuation; 
           [0036]      FIG. 12  shows a side cross-sectional view of an embodiment of the elongated body shown in  FIG. 10  following actuation; 
           [0037]      FIG. 13  shows another side cross-sectional view of an embodiment of the elongated body shown in  FIG. 10  during actuation; 
           [0038]      FIG. 14  shows another side cross-sectional view of an embodiment of the elongated body shown in  FIG. 10  following actuation; 
           [0039]      FIG. 15  shows a top cross-sectional view of an alternate embodiment of the elongated body of the present invention; 
           [0040]      FIG. 16  shows a side cross-sectional view of the embodiment of the elongated body shown in  FIG. 15  prior to actuation; 
           [0041]      FIG. 17  shows a side cross-sectional view of an embodiment of the elongated body shown in  FIG. 15  during actuation; 
           [0042]      FIG. 18  shows a side cross-sectional view of an embodiment of the elongated body shown in  FIG. 15  following actuation; 
           [0043]      FIG. 19  shows a perspective view of an embodiment of the fastener catheter of the present invention; 
           [0044]      FIG. 20  shows an embodiment of the fastener catheter handle of the present invention; 
           [0045]      FIGS. 21   a  and  21   b  show a perspective view of the components of the fastener tip of the present invention; 
           [0046]      FIG. 22  shows a perspective view of the fastener tip of the present invention having a fastener attached thereto; 
           [0047]      FIG. 23  shows a side view of an embodiment of the fastener of the present invention; 
           [0048]      FIG. 24  shows a side view of the fastener of the present invention attached to suture material; 
           [0049]      FIG. 25  shows a perspective view of a guidewire traversing the mitral valve within a heart; 
           [0050]      FIG. 26  shows a perspective view of a guide catheter positioned proximate to the mitral valve within a heart; 
           [0051]      FIG. 27  shows a perspective view of a therapy catheter advancing through a guide catheter to a position proximate to the mitral valve of a heart; 
           [0052]      FIG. 28  shows a perspective view of a therapy catheter stabilizing a first leaflet of the mitral valve of a heart; 
           [0053]      FIG. 29  shows a perspective view of the first leaflet of the mitral valve having a suture applied thereto; 
           [0054]      FIG. 30  shows a perspective view of a therapy catheter stabilizing a second leaflet of the mitral valve of a heart; 
           [0055]      FIG. 31  shows a perspective view of the first and second leaflets of the mitral valve having sutures applied thereto; 
           [0056]      FIG. 32  shows a perspective view of a fastener catheter advancing through a guide catheter to a position proximate to the mitral valve of a heart; 
           [0057]      FIG. 33  shows a perspective view of the fastener catheter of the present invention applying a fastener to suture material attached to the mitral valve; 
           [0058]      FIG. 34  shows a perspective view of the fastener applied to suture material attached to the first and second leaflet of the mitral valve; 
           [0059]      FIG. 35  shows a perspective view of another embodiment of the present invention wherein a dilator is used to introduce the guide catheter onto the left atrium; 
           [0060]      FIG. 36  shows a perspective view of the dilator of the present embodiment traversing the atrial septum; 
           [0061]      FIG. 37  shows a perspective view of the guide catheter of the present embodiment positioned within the left atrium proximate to the mitral valve; 
           [0062]      FIG. 38  shows a perspective view of an alternate embodiment of the therapy catheter advanced through the guide catheter to the mitral valve; 
           [0063]      FIG. 39  shows a perspective view of the embodiment of the therapy catheter shown in  FIG. 38  having an inflatable positioning balloon positioned thereon inflated; 
           [0064]      FIG. 40  shows a perspective view of the embodiment of the therapy catheter shown in  FIG. 38  engaging a first leaflet; 
           [0065]      FIG. 41  shows a perspective view of the first leaflet of the mitral valve having a suture attached thereto; 
           [0066]      FIG. 42  shows a perspective view of the embodiment of the therapy catheter shown in  FIG. 38  engaging the second leaflet of the mitral valve; 
           [0067]      FIG. 43  shows a perspective view of the first and second leaflets of the mitral valve having sutures attached thereto; and 
           [0068]      FIG. 44  shows another perspective view of the first and second leaflets of the mitral valve having sutures attached thereto. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0069]    Disclosed herein is a detailed description of various embodiments of the present invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The overall organization of the detailed description is for the purpose of convenience only and is not intended to limit the present invention. 
         [0070]    The mitral valve repair system of the present invention is designed for use in a surgical treatment of bodily tissue. As those skilled in the art will appreciate, the exemplary mitral valve repair system disclosed herein is designed to minimize trauma to the patient before, during, and subsequent to a minimally invasive surgical procedure while providing improved tissue stabilization and enhanced placement of a fastening device thereon. The mitral valve repair system of the present invention includes a guide catheter capable of being introduced into body of a patient and advanced to an area of interest, a therapy catheter capable of traversing or otherwise engaging the guide catheter and applying a suture to a repair site, and a fastener catheter capable of applying a fastening device to the attached suture. While the guide catheter, therapy catheter, and fastener catheter cooperatively enable a surgeon to deliver a suture to a repair site in vivo, the various components of the present invention may be used individually. For example, the therapy catheter, the fastener catheter, or both may be coupled to a guidewire and advanced to a repair site in vivo without the use of the guide catheter. The mitral valve repair system of the present invention is useful in repairing dysfunctional mitral valve tissue by stabilizing discreet valvular tissue pieces and deploying a fastening device therethrough. However, the mitral valve repair system may be used to repair tissue throughout a patient&#39;s body as desired. For example, the present invention may also be used to repair arterial septal defects (ASD), ventricular septal defects (VSD), and defects associated with patent foramen ovale (PFO). 
         [0071]      FIGS. 1-4  show various illustrations of the guide catheter of the present invention. As shown in  FIG. 1 , the guide catheter  10  comprises a guide body  12  having a proximal end  14  and a distal end  16 . Those skilled in the art will appreciate that the guide catheter  10  of the present invention may be manufactured from a variety of materials, including, without limitation, various plastics, thermoplastics, silicones, elastomers, ceramics, composite materials, or various combinations of the aforementioned materials. In addition, the guide catheter  10  may be manufactured in various lengths and widths as desired by the user.  FIGS. 2-4  show various embodiments of the guide catheter  10 . As shown in  FIG. 2 , the guide catheter  10  includes an outer wall  18  defining at least one internal lumen  20 .  FIGS. 3-4  illustrate alternate embodiments wherein the outer wall  18  defines an internal lumen  20  and includes at least one directing lumen  22  formed therein. The directing lumen  22  is sized to receive a guidewire (not shown) or steering device (not shown) therein. In another embodiment, at least one flexible support structure such as a coiled wire support (not shown) may be embedded within the outer wall  18  of the guide catheter  10 . 
         [0072]      FIG. 5  shows a perspective view of an embodiment of the therapy catheter  30  of the present invention. As shown in  FIG. 5 , the therapy catheter  30  includes an elongated body  32  having a therapy device handle  34  located at the proximal end and a suture attachment tip  36  located at the distal end Like the guide body  12  of the guide catheter  10 , the elongated body  32  may be manufactured in a variety of shape, sizes, lengths, widths, and biologically-compatible materials as desired. 
         [0073]      FIG. 6  shows a more detailed illustration of the therapy device handle  34  of the present invention. As shown, the therapy device handle  34  comprises a handle body  38  having at least a suction connector  40  and a elongated body receiver  42  attached thereto. The suction connector  40  is capable of coupling to a vacuum source (not shown). The elongated body receiver  42  is capable of receiving the elongated body  32  ( FIG. 5 ) thereon. A first actuator  44  is located within a first actuator recess  46  formed on the handle body  38 . Similarly, a second actuator  48  is positioned within a second actuator recess  50  formed in the handle body  38 . As shown in  FIG. 6 , a suction actuator  52 , configured to open or close the fluid path between suction connector  40  and elongated body receiver  42 , may be located within a suction actuator recess  54  proximal to the first and second actuators  44 ,  48 . 
         [0074]      FIGS. 7-10  show various illustrations of the elongated body  32  and the suture attachment tip  36  of the present invention. As shown in  FIG. 7 , the elongated body  32  includes a suction recess  56  having a first needle port  58 A and a second needle port  58 B located proximate thereto. The elongated body  32  or the suture attachment tip  36  may include a guidewire port  60  capable of receiving a guidewire  62 .  FIG. 8A  shows a cross sectional view of the elongated body  32 . As shown, the elongated body  32  comprises an outer wall  64  defining a suction lumen  66 . The suction lumen  66  is in fluid communication with the suction recess  56  ( FIG. 7 ) and the vacuum source (not shown) attached to the suction connector  40  located on the therapy device handle  34  ( FIG. 6 ). A first needle lumen  68  having a first needle  70  located therein may be formed in or otherwise positioned proximate to the outer wall  64  of the elongated body  32 . Similarly, a second needle lumen  72  having a second needle  74  located therein may be formed in or otherwise positioned proximate to the outer wall  64  of the elongated body  32 . The first and second needles  70 ,  74  are coupled to or otherwise in communication with the first and second actuators  44 ,  48  located on the therapy device handle  34  ( FIG. 6 ). The forward and rearward movement of the first and second actuators  44 ,  48  results in the longitudinal movement of the first and second needles  70 ,  74  thereby permitting the first and second needles,  70 ,  74  to extend from and retract into the first and second needle lumens  68 ,  72 . Those skilled in the art will appreciate that the first and second needles  70 ,  74  may be capable of individual or simultaneous movement. A first suture lumen  76  having a first suture  78  located therein and a second suture lumen  80  having a second suture  82  located therein may be formed within or located proximate to the outer wall  64  of the elongated body  32 . Of course one of skill in the art will recognize that references herein to “sutures” include not just traditional suture material, but also any material of sufficient length and flexibility to accomplish the purposes of this tissue repair system. In one embodiment, a guidewire lumen  84  sized to receive guidewire  62  therein may be positioned within or proximate to the outer wall  64  of the elongated body  32  and may be in communication with the guidewire port  60  formed on the suture attachment tip  36 . 
         [0075]      FIGS. 8B-8C  show various illustrations of an alternate embodiment of the present invention, wherein an inflatable positioning balloon  252  is positioned on the outer wall  64  of the elongated body  32 . As shown, the inflatable positioning balloon  252  is in fluid communication with an inflation lumen  84 ′ positioned within the elongated body  32 . The inflation lumen  84 ′ may be in fluid communication with an inflation source in ways known to those skilled in the art and may be attached to or otherwise in communication with the therapy device handle  34  ( FIG. 5 ), thereby permitting the position of the therapy catheter  30  to be manipulated without using a guidewire. Moreover, the positioning balloon  252  can be used to hold the therapy device steady once in position. 
         [0076]      FIGS. 9-10  show various illustrations of the present invention prior to use. As shown, a first needle receiving port  86 A may be positioned within or proximate to the suction lumen  56  co-aligned with and opposing the first needle port  58 A. Similarly, a second needle receiving port  86 B may be positioned within or proximate to the suction lumen  56  co-aligned with and opposing the second needle port  58 B. The first needle receiving port  86 A is in communication with the first suture lumen  76  and contains at least a first needle catch  88 A attached to the first suture  78  therein. Likewise, the second needle receiving port  86 B is positioned proximate to the suction recess  56  opposing the second needle port  58 B. The second needle receiving port  86 B is in communication with the second suture lumen  80  and contains a second needle catch  88 B attached to the second suture  82  therein. 
         [0077]      FIGS. 11-12  show an embodiment of the therapy catheter of the present invention during various stages of use. As shown in  FIG. 11 , forward movement of the first actuator  44  within the first actuator recess  46  ( FIG. 6 ) results in the first needle  70  advancing through the first needle port  58 A and traversing the suction recess  56 . Continued actuation of the first actuator  44  results in the first needle  70  advancing through the first needle receiving port  86 A and engaging the first needle catch  88 A positioned within the first suture lumen  76 . The first needle catch  88 A engages and is retained on the first needle  70 . The user may then retract the first needle  70 , thereby pulling the first suture across the suture recess  56 . To retract the first needle  70 , the user rearwardly moves the first actuator  44 . As shown in  FIG. 12 , the first needle  70  having the first needle catch  88 A attached thereto is retracted through the first needle receiving port  86 A, traverses the suction recess  56 , and enters the first needle lumen  68  through the first needle port  58 A.  FIG. 12  shows the first suture  78  traversing the suction recess  56 . 
         [0078]    Similarly, as shown in  FIG. 13 , forward movement of the second actuator  48  ( FIG. 6 ) results in the second needle  74  advancing through exiting the second needle port  58 B and traversing the suction recess  56 . Like the actuation process described above, the continued actuation of the second actuator  48  results in the second needle  74  advancing through the second needle receiving port  86 B and engaging the second needle catch  88 B positioned within the second suture lumen  80 . The second needle catch  88 B is then engaged and retained on the second needle  74 . Thereafter, the user may retract the second needle  74  thereby pulling the second suture across suture recess second needle port  58 B. To retract the second needle  74 , the user rearwardly moves the second actuator  48 . As shown in  FIG. 14 , the second needle  74  having the second needle catch  88 B attached thereto is retracted through the second needle receiving port  86 B, traverses the suction recess  56 , and enters the second needle lumen  72  through the second needle port  58 B. The second suture  82 , which is attached to the second needle catch  88 B, thus traverses the suction recess  56 . 
         [0079]      FIG. 15  illustrates an alternate embodiment of the present invention. As shown, the elongated body  32  includes a suction recess  90  formed thereon which is in fluid communication with a suction lumen  92  formed therein which in turn is in communication with a vacuum source (not shown) attached to the suction connector  40  ( FIG. 6 ). First and second needle ports  94 A,  94 B, respectively, are positioned within or proximate to the suction recess  90 . Similarly, first and second needle receiving ports  96 A,  96 B, respectively, are positioned within or proximate to the suction recess  90  and are co-aligned with and opposed to the first and second needle ports  94 A,  94 B. The first needle port  94 A communicates with a first needle lumen  98 . A first deployment rod  100  having a first detachable needle  102  attached thereto is located within the first needle lumen  98 . The first detachable needle  102  is coupled to a first suture  104  located within the first needle lumen  98 . Similarly, the second needle port  94 B communicates with a second needle lumen  106 . A second deployment rod  108  having a second detachable needle  110  attached thereto is located within the second needle lumen  106 . The second detachable needle  110  is coupled to a second suture  112  located within the second needle lumen  106 . The first needle receiving port  96 A leads to a first needle trap lumen  114 A formed in or positioned proximate to suction recess  90 . A first needle trap  116 A capable of receiving and retaining the first detachable needle  102  therein is positioned within the first needle trap lumen  114 A. Similarly, the second needle receiving port  96 B leads to a second needle trap lumen  114 B formed in or positioned proximate to the suction recess  90  Like the first needle trap  116 A, a second needle trap  116 B capable of receiving and retaining the second detachable needle  110  therein is positioned within the second needle trap lumen  114 B. 
         [0080]      FIGS. 16-18  show the embodiment of  FIG. 15  during use. Forward movement of the first actuator  44  results in first needle rod  100  extending from first needle lumen  98 .  FIG. 17  shows the first needle rod  100  with a first detachable needle  102  attached thereto extended through the first needle port  94 A traversing the suction recess  90 , and entering into the first needle trap lumen  114 A through the first needle receiving port  96 A. The first detachable needle then engages the first needle trap  116 A. Thereafter, the first needle rod  100  is retracted into the first needle lumen  98 , thereby leaving first detachable needle  102  in first needle trap  116 A. To retract the first needle rod  100 , the user moves the first actuator  44  a rearward direction which causes the first needle rod  100  to retract into the first needle lumen  98 .  FIG. 18  shows the first needle rod  100  retracted into the first needle lumen  98 . As a result, the first suture  104  which is attached to the first detachable needle  102  traverses the suction recess  90 . Those skilled in the art will appreciate that a second needle (not shown) may be deployed in a similar manner. 
         [0081]      FIGS. 19-21  show various illustrations of the fastener catheter of the present invention. As shown in  FIG. 19 , the fastener catheter  130  comprises a fastener catheter body  132  having a fastener catheter handle  134  attached at the proximal end and a fastening tip  136  at the distal end. The fastener catheter  130  may be manufactured in a variety of shapes, sizes, lengths, widths, and biologically-compatible materials as desired. 
         [0082]      FIG. 20  shows a more detailed illustration of a preferred fastener catheter handle  134  of the present invention. As shown, the fastener catheter handle  134  comprises a fastener handle body  138  having an auxiliary connector  140  and a fastener body receiver  142  attached thereto. The auxiliary connector  140  may be capable of coupling to a variety of devices including, for example, a vacuum source or a visualization device. The fastener body connector  142  is capable of receiving and coupling to the fastener catheter body  132  ( FIG. 19 ). A fastener actuator  144  may be positioned within a fastener actuator recess  146  formed on the fastener handle body  138 . The fastener actuator  144  positioned within the fastener actuator recess  146  may be capable of being positioned in three distinct locations. For example, in a non-actuated condition, the fastener actuator  144  may be located in a first position  148 . Thereafter, the user may partially actuate the fastener catheter  130  by positioning the fastener actuator  144  in a second position  150 , thereby deploying a fastening device (not shown) from the fastener catheter  130  ( FIG. 19 ). The user may then fully actuate the fastener catheter  130  by moving the fastener actuator  144  to a third position  152  within the fastener actuator recess  146 , thereby actuating a cutting member (discussed below) located on or proximate to the fastening tip  136 . 
         [0083]      FIGS. 21   a  and  21   b  illustrate, in exploded fashion, pieces of fastening tip  136 . An inner body  154  includes a suture recess  160  formed in the side thereof, which in turn is in communication with an internal fastener lumen  158 . Inner body  154  also includes a pin  162  extending radially outward therefrom. Sleeve  156  comprises an axial deployment lumen  166  of sufficient diameter to receive inner body  154  therein. Sleeve  156  also comprises a cutting recess  168  formed in an axial side thereof and a cutting member  170  on a proximal edge of cutting recess  168 . Slot  172  extends parallel to the axis of the deployment lumen  166  and may extend radially through to fastener lumen. Pin recess  172  receives pin  162  in sliding relation. 
         [0084]      FIGS. 23-24  illustrate fastener  180  of the present invention. Fastener  180  may be manufactured from a variety of materials including, for example, Nickel-Titanium alloys, shape-memory alloys, stainless steel, titanium, various plastics, and other biologically-compatible materials. Fastener  180  has an internal lumen  188  extending axially therethrough and one or more engagement member(s)  184  formed on an end thereof. Between the engagement members is defined engagement aperture  186  which is in communication with attachment lumen  188 . Attachment lumen  188  and engagement aperture  186  are sized to receive a first suture lead  176 A and a second suture lead  176 B therein. Prior to deployment, engagement member(s)  184  are deflected radially away from the axis of the fastener  180  such that engagement aperture  186  has a relative large first diameter sufficient to permit suture leads  176 A and  176 B to slide therethrough. Upon deployment, i.e. after the suture leads  176 A and  176 B have been retracted, engagement members  184  are deflected or permitted to spring back toward the axis of the device such that the engagement aperture  186  assumes a second smaller diameter compressing and securing suture leads  176 A and  176 B in place. Preferably the engagement member(s)  184  tend to spring toward a natural position at the axis of fastener  180 .  FIG. 24  shows the fastener  180  in the deployed configuration in which a suture loop  178  has passed through two discreet tissue portions  200 A,  200 B and suture leads  176 A,  176 B are secured in fastener  180 . Each engagement member(s)  184  may further include a pointed tip  190  which, when the engagement member(s) are in the deployed position, engages and further restricts movement of the suture leads  176 A,  176 B. 
         [0085]    An operational fastening tip  136  with fastener  180  attached thereto and ready for deployment can be seen in  FIG. 22 . Inner body  154  has been placed inside sleeve  156  such that suture recess  160  is in alignment with cutting recess  168 . Pin  172  is in slidable communication with slot  162  thereby permitting relative linear motion, but preventing relative rotational motion, between inner body  154  and sleeve  156 . Fastener  180  has been placed on the end of the fastening tip  136  by deflecting the engagement members  184  radially outward until they can be placed around the outer circumference of the inner body  154 . Accordingly, the fastener is secured to the end of inner body  154  by means of the frictional engagement between the engagement members  184  and the outer surface of inner body  154 . Suture loop  178  extends from the fastener  180 . Suture leads  176 A and  176 B extend through the lumen  188 , through engagement aperture  186 , exit the side of inner body  154  through suture recess  160 , and exit the side of sleeve  156  through cutting recess  168 . 
         [0086]    Deployment of the fastener is a two step process. Once suture  178  has been secured through one or more tissue segments, the fastener tip  136  is coaxed toward the tissue and the suture leads  176 A and  176 B are pulled away from the tissue until the suture loop is sufficiently cinched around the target tissue. Sleeve  156  is then held in place adjacent the tissue while the inner body  154  is pulled axially away. This causes sleeve  156  to push (i.e. slide) fastener  180  off the outer surface of the inner body  154 . When fastener  180  has been completely removed from inner body  154  engagement members  184  spring axially inward thereby reducing the diameter of engagement aperture  186  and securing suture leads  176 A and  176 B. The second deployment step, cutting suture leads  176 A and  176 B, is accomplished when the inner body  154  is pulled sufficiently through sleeve  156  that the suture leads are pinched between the trailing edge of suture recess  160  and cutting member  170  and ultimately cut by cutting member  170 . 
         [0087]    Remote deployment of fastener  180  is accomplished by attaching inner body  154  to fastener actuator  144 , and attaching sleeve  156  to the fastener catheter handle  134 . Thus, axial movement of the fastener actuator  144  relative to the handle  134  causes similar relative movement between inner body  154  and sleeve  156 . For example, in the non-actuated position  148  (see  FIG. 20 ) the distal end of inner body  154  will extend from sleeve  156  a sufficient distance to hold fastener  180  thereon. In the second position  150  the inner body  154  will have been withdrawn into sleeve  156  a sufficient distance to deploy the fastener  180 , and in the third position  152  the inner body  154  will have been withdrawn a sufficient distance to cut the suture leads  176 A and  176 B. 
         [0088]    The present invention also discloses various methods of using the disclose mitral valve repair system to repair discreet tissue portions in vivo. The following paragraphs describe methods of repairing a dysfunctional mitral valve, though those skilled in the art will appreciate that the present invention and procedure may be adapted for use on other valves or in other procedures requiring the attachment of two or more pieces of tissue. 
         [0089]    To repair a dysfunctional or otherwise incompetent heart valve, a guidewire capable of traversing the circulatory system and entering the heart of the patient is introduced into the patient through an endoluminal entry point. For example, the endoluminal entry point may be formed in a femoral vein or right jugular vein. Thereafter, the guidewire is advanced through the circulatory system, eventually arriving at the heart. The guidewire is directed into the right atrium, traverses the right atrium and is made to puncture with the aid of a tran-septal needle or pre-existing hole, the atrial septum, thereby entering the left atrium. As shown in  FIG. 25 , the guidewire  220  may then be advanced through the mitral valve  222  and into the left ventricle  226 . The guidewire  220  traverses the aortic valve  228  into the aorta  230  and is made to emerge at the left femoral artery through an endoluminal exit point. Once the guidewire  220  is positioned, the endoluminal entry or exit port is dilated to permit entry of a catheter therethrough. A protective sheath may be advanced in the venous area to protect the vascular structure. 
         [0090]    As shown in  FIG. 26 , the guide catheter  10  of the present invention may be attached to the guidewire  220  and advanced through the dilated guidewire entry port to a point proximate to the mitral valve  222 . Those skilled in the art will appreciate that the mitral valve repair system of the present invention may approach the mitral valve from an antegrade position or from a retrograde position as desired by the user. Once the guide catheter is suitably positioned in the heart, the therapy catheter  30  may be advanced through the guide catheter  10  to a position proximate to the mitral valve  222 .  FIG. 27  shows the therapy catheter  30  emerging from the guide catheter  10  proximate to the mitral valve  222 . Thereafter, the user may actuate the suction actuator  52  located on the handle body  38  of the therapy device handle  34  ( FIG. 6 ). As a result, a suction force is applied from the suction recess  56  formed on the suture attachment tip  36  of the therapy catheter  30  ( FIG. 7 ) to the tissue located proximate thereto. As shown in  FIG. 28 , a first valve leaflet  240 A is engaged and retained by the suction force applied through the suction recess  56 . With the first valve leaflet  240 A stabilized, the user may apply a suture  242 A thereto as described above. To apply the first suture to the first valve leaflet  240 A, the user actuates the first actuator  44  located on the therapy device handle  34 , which results in the first needle  70  advancing through the first valve leaflet  240 A and engaging and retaining the first needle catch  88 A, thereby applying a first suture  242 A to the tissue ( FIGS. 6-7 ). Thereafter, the user may terminate application of suction force to the first valve leaflet  240 A thereby releasing the sutured tissue.  FIG. 29  shows the first valve leaflet  240 A having a first suture  242 A applied thereto. As shown in  FIG. 30 , the therapy catheter  30  may then be rotated and positioned to engage a second valve leaflet  240 B. Once again, the user may actuate the suction actuator  52  to apply suction force to the second valve leaflet  240 B through the suction recess  56 . With the second valve leaflet  240 B stabilized as shown in  FIG. 30 , the user may apply a suture  242 B thereto by actuating the second actuator  48  located on the therapy device handle  34 , which results in the second needle  74  advancing through the second valve leaflet  240 B and engaging and retaining the second needle catch  88 B, thereby applying a second suture  242 B to the tissue. As shown in  FIG. 31 , the user may terminate the application of suction to the stabilized tissue and remove the therapy catheter from the patient, thereby leaving the first and second sutures  242 A,  242 B attached to the first and second valve leaflets  240 A,  240 B. Note that first and second sutures  242 A and  242 B are actually portions of the same suture such that when the therapy catheter is removed there is a single suture loop through the valve leaflets  240 A and  240 B. 
         [0091]    As shown in  FIGS. 32-33 , the fastener catheter  130  may be attached to the guidewire  220  and will be attached to first and second sutures  242 A,  242 B. Thereafter, the fastener catheter  130  may be inserted into the guide catheter  10  and advanced to a position proximate to the mitral valve  222 . The user then draws the first and second sutures  242 A,  242 B taut while advancing the fastener catheter  130  to the mitral valve  22 , thereby decreasing the distance between the first and second valve leaflets  240 A,  240 B. The user then actuates the fastener actuator  144  which causes the sleeve  156  to engage and apply the fastener  180  to the first and second sutures  242 A,  242 B adjacent the leaflets, as described above. Continued actuation of the fastener actuator  144  causes the cutting member  170  to engage and cut the first and second sutures  242 A,  242 B. As shown in  FIG. 34 , after the fastener catheter  130 , the guide catheter  10 , and the guidewire  220  are removed from the patient, the fastener  180  remains applied to the mitral valve  222 . 
         [0092]      FIGS. 35-44  describe an alternate method of repairing tissue, specifically valve leaflets in this embodiment, in vivo. As shown in  FIG. 35-37 , a guide catheter  10  is advanced through the circulatory system to the right atrium of the heart. Once positioned, a dilator  250  is advanced through the guide catheter  10  and is made to puncture the atrial septum, thereby entering the left atrium. Thereafter, the guide catheter  10  is advanced into the left atrium through the punctured atrial septum and positioned proximate to the mitral valve  222 . As shown in  FIG. 38 , the therapy catheter  30  may be inserted into the guide catheter  10  and advanced to a position proximate to the mitral valve  222 . As shown in  FIG. 39 , an inflatable positioning balloon  252  (discussed above) located on the therapy catheter  30  is inflated to orient and steady the catheter. The suction actuator  52  on the therapy device handle  34  is then actuated to apply a suction force to the suction recess  56  (see.  FIG. 6 ). The inflated balloon  252  engages the second valve leaflet  240 B which forces the suction recess  56  towards the first valve leaflet  240 A, thereby resulting in the stabilization of the first valve leaflet  240 A as shown in  FIG. 40 . As shown in  FIG. 41 , the user may then apply the first suture  242 A to the first valve leaflet  240 A as described above. Once the suture is applied, the user may deflate the inflatable positioning balloon  252  and rotates the therapy catheter  30  approximately  180 ° . Thereafter, the user inflates the positioning balloon  252  and actuates suction actuator  52  to apply a suction force to the suction recess  56 . As shown in  FIG. 42 , the inflatable positioning balloon  252  is again inflated and made to engage the first valve leaflet  240  thereby forcing the suction recess  56  to engage the second valve leaflet  240 B and permitting the stabilization of the second valve leaflet  240 B as shown in  FIG. 42 . Thereafter, the user applies the second suture  242 B to the second valve leaflet  240 B as described above.  FIGS. 43-44  show the first and second valve leaflets  240 A,  240 B having a first and second suture  242 A,  242 B applied thereto. Thereafter, the therapy catheter  30  is removed from the patient&#39;s body and the fastener catheter  130  is used to apply a fastener to the first and second sutures  242 A,  242 B as described above. 
         [0093]    In closing, it is understood that the embodiments of the invention disclosed herein are illustrative of the principals of the invention. Other modifications may be employed which remain within the scope of the present invention. Accordingly, the present invention is not limited to the embodiments shown and described in this disclosure.