Abstract:
A system and method for repairing a human heart uses a catheter with an extendable tip and multiple tissue fasteners. The catheter is advanced into a human heart with the extendable tip adjacent a first tissue portion. The extendable tip is extended to form a tissue-receiving opening, the first tissue portion is positioned within the tissue-receiving opening, and the extendable tip is withdrawn to mechanically hold the first tissue portion. A first tissue fastener is secured to the first tissue portion, which is then released from the tissue-receiving opening. A second tissue fastener may subsequently be passed through a second tissue portion.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 13/584,476, filed Aug. 13, 2012, entitled “Single Catheter Mitral Valve Repair Device and Method for Use,” now U.S. Pat. No. 8,475,472, which is a continuation of U.S. patent application Ser. No. 13/027,045, filed Feb. 14, 2011, entitled “Single Catheter Mitral Valve Repair Device and Method for Use,” now U.S. Pat. No. 8,241,304, which is a continuation of U.S. patent application Ser. No. 11/450,602, filed Jun. 9, 2006, entitled “Single Catheter Mitral Valve Repair Device and Method for Use,” now U.S. Pat. No. 7,887,552, which is a continuation of U.S. patent application Ser. No. 10/233,879, filed Sep. 3, 2002, entitled “Single Catheter Mitral Valve Repair Device and Method for Use,” now U.S. Pat. No. 7,083,628. This application discloses subject matter related to U.S. patent application Ser. No. 09/562,406, filed May 1, 2000, entitled “Minimally Invasive Mitral Valve Repair Method and Apparatus,” now U.S. Pat. No. 6,626,930. The disclosures of all of the aforementioned United States patent applications are expressly incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     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. 
     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. 
     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 heart contractions. 
     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. Such procedures require the surgeon to access 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 these procedures can be very effective, there are associated shortcomings. For example, the highly 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, 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 thereby reducing or eliminating the need for anti-coagulants, but the operational lifetimes of tissue valves is typically shorter than mechanical valves and thus may require a subsequent replacement(s). 
     As an alternative to prosthetic heart valve replacement, it is often preferable to remodel the native heart valve and/or surrounding tissue. Remodeling procedures often preserve 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). Typically, valvular remodeling is accomplished by implanting a prosthetic ring (“annuloplasty ring”) into the valve annulus to reduce and/or stabilize the structure of the annulus 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 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 annuloplasty procedures. 
     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, in its simplest form, suturing the anterior and posterior leaflets together near the middle of their coapting edges, thereby causing blood to flow through two newly formed side openings. While this does reduce the volume of blood that flows from the atrium to the ventricle, this loss is more than compensated by improved leaflet coaptation, which reduces mitral regurgitation. As originally developed by Dr. Ottavio Alfieri, this process involved arresting the heart, and placing the patient on extra corporeal 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 leaflets are accessed remotely and the heart remains active throughout the procedure. 
     A particular method for performing a beating heart bow-tie procedure (i.e. without extra corporeal bypass) has been proposed by Dr. Mehmet Oz, of Columbia University. The method and devices for performing the method are described in PCT publication WO 99/00059, published Jan. 7, 1999. In one embodiment of the disclosed procedure, the associated device consists of a forceps-like grasper used to grasp and hold the mitral valve leaflets in a coapted position for suturing. Since the mitral valve leaflets meet and 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 a fastening device such as a clip or suture is utilized to fasten them. The fastening device should be applied to the leaflet tissue with sufficient tissue purchase to prevent tear out or other failure, but close enough to the edges to ensure that the newly created side holes are as large as possible. The Mehmet Oz disclosure thus illustrates that teeth of the grasper device can be 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. Thus the procedure taught by Dr. Mehmet Oz is very skill-intensive. 
     The bow-tie technique has proved to be a viable alternative for treating otherwise incompetent heart valves. Nonetheless, several shortcomings associated with current bow-tie procedures have been identified. Current systems include devices having mechanical graspers, barbed members, and vacuum devices that simultaneously capture and retain the valve leaflets prior to applying a fastening device thereto. 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 throughout the surgery. 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 there between. 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 
     The single catheter mitral valve repair device of the present invention may be used to repair tissue throughout a patient&#39;s body. However, it is particularly useful in repairing dysfunctional mitral valve tissue by stabilizing discreet valvular tissue pieces and deploying a fastening device therethrough, thereby coapting the tissue pieces. 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). 
     In one aspect, the repair device of the present invention comprises an extendable engagement tip having at least one port formed thereon, at least one deployable fastener in communication with the engagement tip, and one or more actuator members in communication with the port(s). The deployable fastener is capable of controllably engaging and fastening tissue located proximal to the engagement tip. 
     In another aspect of the present invention, the repair device comprises a handle, an elongated body, and an extendable engagement tip. The handle comprises a stationary handle body, an engagement tip actuator in communication with the stationary handle body, a fastener deployment housing in communication with the stationary handle body, and a vacuum connector capable of placing a vacuum source in communication with the stationary handle body. The elongated body comprises a flexible body member, at least one vacuum lumen, one or more actuation lumens and one or more fastener lumens. Optionally, the elongated body can also comprise one or more auxiliary lumens. The one or more actuation lumens are capable of receiving one or more actuation members therein. Similarly, the one or more fastener lumens are capable of receiving at least one deployable fastener therein. The extendable engagement tip comprises a fastener deployment housing capable of attaching to the elongated body, an actuation flange attached to the fastener deployment housing, an extendable tip attached to the actuation flange and in communication with the engagement tip actuator, a vacuum port in communication with the vacuum connector, and at least one deployable fastener in communication with the fastener deployment housing. 
     The present invention also discloses a method of repairing tissue using the repair device of the present invention and comprises grasping a first tissue portion with a vacuum force, stabilizing the first tissue portion with a mechanical force, deploying a tissue fastener into the stabilized first tissue portion, disengaging the first tissue portion, grasping at least a second tissue portion with a vacuum force, stabilizing at least a second tissue portion with a mechanical force, deploying at least a second tissue fastener into at least the second stabilized tissue portion, disengaging at least the second tissue portion, and coapting the first tissue portion and at least the second tissue portion with the first tissue fastener and at least the second tissue fastener. 
     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 
       The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein: 
         FIG. 1  shows a perspective view of the mitral valve repair device of the present invention; 
         FIG. 2  shows a perspective view of the handle portion of the mitral valve repair device of the present invention; 
         FIG. 3  shows a cross-sectional view of the handle portion of the mitral valve repair device of the present invention; 
         FIGS. 4A and 4B  show alternate cross-sectional views of the elongated body of the mitral valve repair device of the present invention; 
         FIGS. 5A and 5B  show alternate perspective views of the engagement tip of the mitral valve repair device of the present invention; 
         FIG. 6  shows a cross-sectional view of the engagement tip of the mitral valve repair device of the present invention; 
         FIGS. 7A and 7B  show alternate perspective views of the engagement tip of the mitral valve repair device of the present invention in an extended position; 
         FIG. 8  shows a cross-sectional view of the engagement tip of the mitral valve repair device of the present invention in a retracted position wherein the deployable needle is deployed; 
         FIG. 9  shows a cross-sectional view of the engagement tip of the mitral valve repair device of the present invention in a retracted position wherein the deployable needle is retracted and is engaging a needle catch; 
         FIG. 10  shows a perspective view of the mitral valve repair device of the present invention having attached fastener material to a first tissue portion; 
         FIG. 11  shows a perspective view of the mitral valve repair device of the present invention having attached fastener material to a second tissue portion; 
         FIG. 12  shows a perspective view of discreet tissue portions having fastener material positioned therethrough; and 
         FIG. 13  shows a perspective view of discreet tissue portions being coapted with fastener material. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     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 description is for the purpose of clarity only and is not intended to limit the present invention. 
     The single catheter mitral valve repair device 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 single catheter mitral repair device disclosed herein is designed to minimize trauma to the patient before, during, and after a minimally invasive surgical procedure while providing improved tissue stabilization and enhanced placement of a fastening device thereon. While the single catheter mitral valve repair device of the present invention may be used to repair tissue throughout a patient&#39;s body, it is particularly useful in repairing dysfunctional mitral valve tissue by stabilizing discreet valvular tissue pieces and deploying a fastening device therethrough, thereby coapting the tissue pieces. 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). 
       FIG. 1  shows the single catheter mitral valve repair device of the present invention. As shown, the repair device  10  comprises a handle portion  12  attached to an elongated body  14 . An engagement tip  16  is positioned on the distal portion of the elongated body  14 . A vacuum connector  18  is attached to the handle  12 . As those skilled in the art will appreciate, the present invention may be manufactured from a variety of materials including, without limitation, various metals, plastics, thermoplastics, silicones, elastomers, ceramics, composite materials, or various combinations of the aforementioned materials. For example, the handle  12  may be manufactured from polyethylene, while the elongated body  14  is manufactured by an elastomer. In an alternate embodiment the elongated body  14 , the engagement tip  16 , or both may incorporate radio-opaque or echogenic materials, thereby enabling the surgeon to precisely position the repair device  10  within the patient&#39;s body. 
       FIG. 2  shows a perspective view of the handle  12  of the present invention. As shown in  FIG. 2 , the handle  12  comprises a stationary handle body  20  having a tip actuator  22  and a fastener deployment actuator  24  in communication therewith. The tip actuator  22  and fastener deployment actuator  24  are movable relative to the stationary handle body  20 . Exemplary tip actuator members or fastener deployment housings may include, for example, buttons, levers, slidable fixtures, or toggles. The distal portion of the stationary handle body  20  includes a coupling orifice  26  capable of receiving the elongated body  14  therein. In addition, the stationary handle body  20  may include a handle flange  28  located thereon. The stationary handle body  20 , fastener deployment actuator  24 , or tip actuator  22 , may include at least one grip member  30  positioned thereon. As shown in  FIG. 2 , a vacuum connector  18  is in communication with the handle  12 . 
       FIG. 3  shows a cross sectional view of the handle  12  of the present invention. As shown in  FIG. 3 , the stationary handle body  20  defines an actuation channel  32 , which is in communication with the coupling orifice  26  formed on the distal portion of the stationary handle body  20 . The actuation channel  32  formed inside the stationary handle body  20  is capable of receiving the tip actuator  22  and the fastener deployment actuator  24  independently and in telescoping relation therein. Those skilled in the art will appreciate that the present invention permits a user to actuate the tip actuator  22  or the fastener deployment actuator  24  independently. As shown, a bias member  34  may be positioned within the actuation channel  32  and may communicate in biasing relation with the fastener deployment actuator  24 . The tip actuator  22  is in communication with at least one actuator extension member (see  FIG. 7 ) positioned within one or more actuation lumens (see  FIG. 4 ) formed in the elongated body  14 . Similarly, the fastener deployment actuator  24  is in communication with at least one fastener extension member (see  FIG. 6 ) positioned within one or more fastener lumens (see  FIG. 4 ) formed in the elongated body  14 . The vacuum connector  18  is to be connected to an external vacuum source and is in fluid communication with the vacuum lumen  36  formed in the elongated body  14 . 
     The elongated body  14  of the present invention may be manufactured in a variety of lengths or diameters as desired by the user.  FIGS. 4A and 4B  show cross-sectional views of two embodiments of the elongated body  14  of the present invention. As shown in  FIG. 4 , the elongated body  14  of the present invention may comprise at least one vacuum lumen  36 . In the illustrated embodiment, the vacuum lumen  36  is disposed in the center of the device; although those skilled in the art will appreciate that the present invention may be easily manufactured with the vacuum lumen  36  positioned at various locations within or alongside the elongated body  14 . The body member  38  may further include one or more tip actuation lumens  40   a ,  40   b , one or more auxiliary lumens  42 , and one or more fastener lumens  44  formed therein. For example,  FIG. 4B  shows an alternate embodiment of the present invention wherein the body member  38  forms a vacuum lumen  36 , tip actuation lumens  40   a ,  40   b , auxiliary lumens  42 , and two fastener lumens  44   a ,  44   b  therein. Those skilled in the art will appreciate that the one or more auxiliary lumens  42  of the present invention are capable of receiving a guidewire, thereby enabling the present invention to be directed to an area of interest in vivo with a guidewire. The elongated body  14  of the present invention may be attached to the handle  12  in a variety of manners, including, for example, adhesively attached or in snap-fit relation. 
       FIG. 5A  shows a perspective view of the engagement tip  16  attached to the elongated body  14  of the present invention. The engagement tip  16  comprises a fastener deployment housing  46 , an extendable tip  48 , and an actuation flange  50  in communication with the fastener deployment housing  46  and the extendable tip  48 . The fastener deployment housing  46  further includes at least one vacuum port  52  having a tissue support  54  located therein, and a fastener deployment port  56  located thereon. The tissue support  54  may comprise a series of vanes or other supports positioned across or proximate to the vacuum port  52 . The vacuum port  52 , positioned on the fastener deployment housing  46 , is in fluid communication with the vacuum connector  18  positioned on the handle  12  through the vacuum lumen  36  formed in the elongated body  14 . Similarly, the fastener deployment port  56  is in communication with the fastener deployment actuator  24  located on the handle  12  through fastener lumen  44  formed in the elongated body  14 . In an alternate embodiment illustrated in  FIG. 5B , a plurality of fastener deployment ports  56  may be formed on the fastener deployment housing  46  and may be in communication with a plurality of fastener lumens  44  formed in the elongated body  14  (see  FIG. 4B ). The extendable tip  48  of the present invention is in communication with the tip actuator  22  located on the handle  12  through the actuation lumens  40   a ,  40   b  formed in the elongated body  14 . The extendable tip  48  may include a fastener receiver port  58  capable of receiving the deployable tight  64  therein (see  FIG. 6 ). The fastener receiver port  58  is coaligned with or positioned proximate to the fastener deployment port  56  formed on the fastener deployment housing  46 . The fastener receiving port  58  is capable of receiving the deployable needle  64  therein and includes a needle catch  68  attached to fastener material  62  (see  FIG. 6 ). The needle catch  68  may comprise a variety of devices capable of engaging and retaining the deployable needle  64  therein, including, for example, a ferruled or sized ring. In addition, the extendable tip  48  may include a fastener channel  60  capable of receiving fastener material  62  therein. Preferably the fastener channel  60  is open on the distal end of extendable tip  48 , as illustrated. Exemplary fastener materials include, for example, thread, wire, monofilament, braided filament, suture material, needles, sutures, staples, buttons, tissue-graspers, tissue clasps, barbs, and other tissue-coaption devices. 
       FIG. 6  shows a cross sectional view of the engagement tip  16 . The vacuum port  52  is in fluid communication with the vacuum lumen  36 . A deployable needle  64  is in communication with the deployment housing  66  positioned within the fastener lumen  44 . The receiver port  58  is in communication with the auxiliary lumen  42  located in the elongated body  14 . A needle catch  68 , which is capable of engaging and retaining the deployable needle  64 , is attached to fastener material  62  which is positioned within the receiver port  58  and which extends through the auxiliary lumen  42  around the distal end of the engagement tip  16  and back towards the handle  12 . 
       FIGS. 7A and 7B  show the engagement tip  16  of the present invention in an extended configuration, thereby enabling the present invention to grasp and stabilize tissue located proximate thereto with a vacuum force. As shown in  FIG. 7A , actuation members  70   a ,  70   b  are slidably received in the fastener deployment housing  46  and the extendable tip  48 , thereby permitting the extendable tip  48  to be moved, in telescoping relation, relative to the fastener deployment housing  46 . Exemplary actuation members  70   a ,  70   b  may include, for example, rods, shafts, or conduits. The actuation members  70   a ,  70   b  communicate with the tip actuator  22  positioned on the handle  12  through the actuation lumens  40   a ,  40   b  positioned in the elongated body  14 . To actuate the extendable tip  48 , the user advances the tip actuator  22  towards the stationary handle body  20 , thereby advancing the actuation members  70   a ,  70   b  and resulting in the extendible tip  48  extending from the fastener deployment housing  46 . To retract the extendible tip  48 , the user retracts the tip actuator  22  away from the stationary handle body  20 , thereby retracting the actuation members  70   a ,  70   b  and resulting in the extendible tip  48  retracting towards the fastener deployment housing  46 . Those skilled in the art will appreciated that actuation of the tip actuator  22  results in the longitudinal movement of the actuation member  70   a ,  70   b  positioned in the tip actuator lumens  40   a ,  40   b  of the elongated body  14 , thereby resulting in the longitudinal extension and retraction of the extendable tip  48 .  FIG. 7B  shows and alternate embodiment in which there are a plurality (two in the illustrated case) of deployment ports  56 , fastener receiver ports  58  and corresponding fastener channels  60 .  FIG. 7B  illustrates another alternate embodiment in which the faster material is stored within the vacuum lumen  36  (as opposed to the auxiliary lumen  42 , see  FIG. 6 ). 
       FIGS. 8 and 9  show cross sectional views of the engagement tip  16  of the present invention during use wherein a mechanical stabilization force may be applied to captured tissue.  FIG. 8  shows a cross sectional view of the engagement tip  16  wherein the deployable needle  64  has been deployed from the fastener deployment port  56  located on the fastener deployment housing  46  through the fastener receiver port  58  and into the extendable tip  48 . The deployable needle  64  is attached to the deployment housing  66  positioned within the one or more fastener lumens  44  of the elongated body  14 . The deployment housing  66  is coupled to the fastener deployment actuator  24  positioned on the handle  12 . To deploy the deployable needle  64 , the user advances the fastener deployment actuator  24  on the handle  12  towards the stationary handle body  20 , which results in the longitudinal movement of the deployment housing  66  within the fastener lumen  44  of the elongated body  14 . Longitudinal movement of the deployment housing  66  results in the deployable needle  64  advancing through the fastener deployment port  56  into the fastener receiving port  58  and engaging the needle catch  68  located therein. As shown in  FIG. 8 , the deployable needle  64  has engaged the needle catch  68 . The needle catch  68  is attached to the fastener material  62  located within the auxiliary lumen  42 . 
       FIG. 9  shows a cross sectional view of the engagement tip  16  of the present invention wherein the deployable needle  64 , having engaged and been retained by the needle catch  68  attached to the fastener material  62 , is positioned within the fastener lumen  44  of the elongated body  14 . To retract the deployable needle, the user moves the fastener deployment actuator  24  rearwardly away from the stationary handle body  20 . As a result, the deployment housing  66  moves in a reward longitudinal motion which results in the deployable needle  64 , which is attached to the deployment housing  66 , moving rearwardly. The deployable needle  64 , having the needle catch  68  and the fastener material  62  attached thereto, retracts through the fastener receiving port  58  and enters the fastener deployment port  56 . As shown in  FIG. 9 , the fastener material  62  is in communication with the auxiliary lumen  42  and the fastener lumen  44 , thereby traversing the actuation flange  50 . In an alternate embodiment of the present invention the extendable tip  48 , the fastener deployment housing  46 , or the elongated body  14  may include at least one guidewire retaining device or lumen therein or attach thereto. In yet another alternate embodiment, the positions of the needles and needle catch are reversed (i.e. the needle moves from the extendable tip  48  to engage the needle catch in the port  56 ). 
     The present invention also discloses a method of using the single catheter mitral valve repair device of the present invention to repair discreet tissue portions in vivo. The description below describes a method of repairing dysfunctional heart valves, however, those skilled in the art will appreciate that the present invention may be adapted for use in other tissue repair procedures. 
     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, an endoluminal entry point may be formed in a femoral vein or right jugular vein of a patient. Thereafter, the guidewire may be introduced into the patient through the endoluminal entry point and advanced through the circulatory system, eventually arriving at the heart. Upon arriving at the heart, the guidewire is directed into the right atrium of the heart, traverses the right atrium and is made to puncture the atrial septum, thereby entering the left atrium. The guidewire may then be advanced through the mitral valve while the heart is in diastole and traverses the left ventricle. The guidewire traverses the aortic valve into the aorta and is made to emerge from the left femoral artery through an endoluminal exit point. This methodology of positioning a guidewire is known to physicians skilled in the art of interventional cardiology. Once the guidewire 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. 
     With the guidewire suitably anchored, the distal portion of the mitral valve repair device of the present invention may be attached to the guidewire. Thereafter, the elongated body  14  having the engagement tip  16  attached thereto is advanced through the dilated guidewire entry port to a point proximate the cusp portion of the mitral valve. Those skilled in the art will appreciate that the mitral valve repair device  10  of the present invention may approach the cusp of the mitral valve from an antegrade position or from a retrograde position as desired by the user. For a retrograde approach, the user attaches the repair device  10  to the guidewire emerging from the left femoral artery. The device is then advanced along the guidewire to a position proximate the retrograde aspect of the mitral valve. The engagement tip  16  of the mitral valve repair device  10  may be positioned proximate the tissue portion  72  of the mitral valve. Once suitably positioned, the tip actuator  22  positioned on the handle  12  may be actuated, thereby resulting in the extendable tip  48  of the engagement tip  16  extending distally from the fastener deployment housing  46 . Thereafter, an external vacuum source (not shown) may be activated to apply a vacuum force to the mitral valve repair device  10  through the vacuum connector  18 . The external vacuum source (not shown) communicates with the vacuum port  52  located on the engagement tip  16  through the at least one vacuum lumen  36  in the elongated body  14 . With the extendable tip  48  distally extended from the fastener deployment housing  46 , the tissue portion  72  located proximate to the vacuum port  52  is grasped and retained by the vacuum force applied by the external vacuum source (not shown). Once the tissue portion  72  is captured by the vacuum force supplied through the vacuum port  52 , the tip actuator  22  located on the handle  12  is actuated to retract the extendable tip  48  toward the fastener deployment housing  46  thereby mechanically retaining and stabilizing the tissue portion  72  therebetween. Once the tissue is sufficiently stabilized, the fastener deployment actuator  24  located on the handle  12  may be actuated to deploy a fastening device through the tissue portion  72 . To deploy the fastener device the user advances the fastener deployment actuator  24  toward the handle flange  28  positioned on the stationary handle body  20  of the handle  12 , thereby causing the deployable needle  64  to exit the deployment port  56  and traverse the tissue positioned within the actuation flange  50 . Thereafter, the deployable needle  64  enters the receiver port  58  formed on the extendable tip  48  and engages the needle catch  68  which is attached to the fastener material  62  positioned within the fastener channel  60 . The fastener deployment housing  46  is returned to a non-deployed position by the user, thereby resulting in the deployable needle  64 , which has retained the needle catch  68  attached to the fastener material  60 , returning to a non-deployed position within the fastener lumen  44  of the elongated body  14 , and resulting in the tissue portion  72  having fastener material  62  positioned therethrough. As shown in  FIG. 10 , with the fastener material  62  positioned through the tissue portion  72 , the external vacuum source may be deactivated which results in the release of the captured tissue portion  72 . Thereafter, the mitral valve repair device  10  of the present invention is removed from the patient&#39;s body leaving a fastener material  62  attached to the tissue portion  72 . 
     Once removed from the body of the patient, the mitral valve repair device  10  may be reloaded with deployable need and fastener material, rotated, and reintroduced into the patient thereby permitting the device to apply additional tissue fasteners to bodily tissue adjacent that already fastened. At least the distal portion of the mitral valve repair device of the present invention is re-attached to the guidewire. Thereafter, the elongated body  14  having the engagement tip  16  attached thereto is again advanced through the dilated guidewire entry port to a point proximate the cusp portion of the mitral valve. The engagement tip  16  of the mitral valve repair device  10  may be positioned proximate to another tissue portion  74  of the mitral valve. The preceding process is then repeated to secure suture material  62 ′ to tissue portion  74 .  FIG. 11  shows the mitral valve repair device  10  positioned proximate to a second tissue portion  74  located near the first tissue portion  72 . As shown, the fastener material  62 ′ is positioned through the tissue portion  74  and the external vacuum source may be deactivated which results in the release of the captured tissue portion  74 . Thereafter, the mitral valve repair device  10  of the present invention is removed from the patient&#39;s body and may be removed from the patient&#39;s body leaving a fastener material  62 ′ attached to the tissue portion  74 . Thereafter, the fastener material portions  62 ,  62 ′ may be joined to coapt the individual tissue portions  72 ,  74 . As shown in  FIG. 12-13 , a knot  76  is formed in the fastener material  62 ,  62 ′ and advanced to the tissue portions  72 ,  74 . In one embodiment, the knot  76  is formed external the patient&#39;s body and advanced to the repair site with a knot-pushing device. 
     In the alternative embodiments of  FIGS. 4B, 5B and 7B , the repair device need not be removed from the patient between the steps of securing the first and second tissue pieces. The dual fastening system of these alternate embodiments permits the faster material to be placed sequentially in both pieces of tissue simply by rotating the device after securing the first piece of tissue. Lastly, one of skill in the art will understand that if the vacuum source is strong enough, and the needle  64  sharp enough, extendable tip  64  need not translate relative to the deployment housing  46  to mechanically hold the tissue in place. The pieces of tissue can be held together in place with vacuum and punctured without use of mechanical retention. 
     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 are within the scope of the present invention. Accordingly, the present invention is not limited to that precisely as shown and described in the present disclosure.