Patent Publication Number: US-2021186481-A1

Title: Pre-shaped tissue anchors and needles for tissue anchor deployment

Description:
RELATED APPLICATIONS 
     This application is a continuation of International Patent Application No. PCT/US2019/049356, filed Sep. 3, 2019, which claims the benefit of U.S. Patent Application No. 62/727,628, filed Sep. 6, 2018, and of U.S. Patent Application No. 62/838,438, filed Apr. 25, 2019, the entire disclosures of which are incorporated by reference for all purposes. 
    
    
     BACKGROUND 
     Technical Field 
     The disclosure herein relates to devices for anchoring to biological tissue. 
     Description of Related Art 
     Biocompatible implant devices, such as heart valves, may be implanted in patients to treat various conditions. Anchoring to cardiac tissue can be associated with certain complications and/or issues. 
     SUMMARY 
     In some implementations, the present disclosure relates to a tissue anchor comprising a memory metal wire configured to transition between an at least partially straightened delivery configuration and an expanded deployed configuration forming an anchor, and a suture-attachment feature configured to have a suture coupled thereto. In the expanded deployed configuration, one or more portions of the memory metal wire extend radially outward from a center of the tissue anchor. 
     In the expanded deployed configuration, the memory metal wire may form a plurality of loop projections. For example, the suture-attachment feature may comprise a connection portion of the memory metal wire between circumferentially-spaced radial inner ends of adjacent loop projections of the plurality of loop projections. In some embodiments, the tissue anchor further comprises a suture coupled to the suture-attachment feature and having one or two suture tails extending therefrom. 
     In the expanded deployed configuration, the memory metal wire may form a clover form. For example, the clover form may have two free ends. In some embodiments, the memory metal wire is flat in the expanded deployed configuration. In some embodiments, the memory metal wire is configured to transition to the expanded deployed configuration in response to a stimulus. In the expanded deployed configuration, the memory metal wire may form a spiral form or a grill form. 
     In some implementations, the present disclosure relates to an anchor delivery system comprising a main shaft having an atraumatic tip and an interior lumen, a needle having a distal end and an interior lumen, the needle being disposed within the interior lumen of the main shaft and configured to be extended from the distal end of the main shaft in a deployed position of the needle, a pusher disposed within the interior lumen of the needle and configured to be extended from the distal end of the needle in a deployed position of the pusher. The anchor delivery system further comprises a memory metal wire disposed in the interior lumen of the needle in an at least partially straightened delivery configuration, the memory metal wire being configured to automatically assume an expanded deployed configuration when ejected from the interior lumen of the needle by the pusher, and a suture coupled to a suture-attachment feature of the memory metal wire within the interior lumen of the needle. 
     In some implementations, the present disclosure relates to a method of deploying a tissue anchor. The method comprises providing an anchor delivery system comprising a main shaft having an atraumatic tip and an interior lumen, a needle having a distal end and an interior lumen, the needle being disposed within the interior lumen of the main shaft and configured to be extended from the distal end of the main shaft in a deployed position of the needle, a pusher disposed within the interior lumen of the needle and configured to be extended from the distal end of the needle in a deployed position of the pusher, a memory metal wire disposed in the interior lumen of the needle in an at least partially straightened delivery configuration, the memory metal wire being configured to automatically assume an expanded deployed configuration when ejected from the interior lumen of the needle by the pusher, and a suture coupled to a suture-attachment feature of the memory metal wire within the interior lumen of the needle. The method further comprises positioning the atraumatic tip of the main shaft against a target tissue, moving the needle to the deployed position, thereby puncturing through the target tissue with the needle, ejecting the memory metal wire from the interior lumen of the needle while the needle is in the deployed position, and forming a memory metal wire into an expanded tissue anchor form on a distal side of the target tissue. 
     In some embodiments, the method further comprises pre-shaping the memory metal wire in the expanded tissue anchor form, compressing the memory metal wire into a compressed delivery configuration, and inserting the memory metal wire into the interior lumen of the needle in the compressed delivery configuration. In some embodiments, the expanded tissue anchor form has a clover shape comprising a plurality of radially-extending loop projections. Moving the needle to the deployed position may comprise puncturing the target tissue with a point of the needle being substantially aligned with a longitudinal axis of the main shaft. For example, the needle may comprise an elongated shaft forming the interior lumen of the needle, the elongated shaft having a bend feature that is configured to align the point of the needle with a longitudinal axis of the elongated shaft. 
     In some implementations, the present disclosure relates to a needle comprising a tip portion comprising a sharp point one or more distal beveled surfaces, and a proximal beveled surface. The needle further comprises an elongated shaft forming an interior lumen. The elongated shaft includes a bend configured to align the sharp point of the needle with a longitudinal axis of the elongated shaft. 
     The proximal beveled surface and at least a portion of the one or more distal beveled surfaces may be radiused surfaces. For example, the radiused surfaces can be formed using electropolishing. In some embodiments, portions of the one or more distal beveled surfaces adjacent to the point of the needle are not radiused. In some embodiments, the bend has an angle between about 3°-5°. 
     In some implementations, the present disclosure relates to a needle delivery assembly comprising a main shaft, having a distal end and an interior lumen, a needle having a distal end and an interior lumen, wherein the needle is configured to be slidably disposed (e.g., slip-fit) within the interior lumen of the main shaft in a stored position of the needle, and to extend from the distal end of the main shaft in a deployed position of the needle, an ejector configured to be slidably disposed within the interior lumen of the needle in a stored position of the ejector, and to extend from the distal end of the needle in a deployed position of the ejector, a repair device configured to be slidably disposed in the needle, and a suture connected to the repair device. The ejector is configured to push the repair device at least partially out of the needle when the ejector is moved from the stored position of the ejector to the deployed position of the ejector. 
     In some embodiments, the ejector comprises an interior lumen, the suture is disposed at least partially within the interior lumen of the ejector, and the interior lumen of the ejector is sized to prevent the repair device from entering into the interior lumen of the ejector. The interior lumen of the main shaft can be sized to accommodate a second needle slidably disposed therein. In some embodiments, the distal end of the needle comprises a tip, the tip is disposed against a wall of the interior lumen of the main shaft in the stored position of the needle, and the tip is positioned near a center of the interior lumen of the main shaft in the deployed position of the needle. The distal end of the main shaft can comprise an atraumatic blunt end, an expandable balloon, and/or a suction device. 
     In some implementations, the present disclosure relates to a needle comprising a distal end and an interior lumen. The distal end comprises a tip, a distal beveled edge, and a proximal beveled edge. The proximal beveled edge and at least part of the distal beveled edge have a radiused surface. In some embodiments, an entirety of the distal beveled edge is radiused. The radiused surface can be electropolished. A radius of the radiused surface may be between about 25 and about 500 μm (about 0.001 and about 0.02 inches), and/or between about 130 and about 400 μm (about 0.005 and about 0.015 inches). The tip can be electropolished. A radius of the tip can be between about 25 and about 250 μm (about 0.001 and about 0.01 inches). In some embodiments, the radius of the tip is between about 25 and about 130 μm (about 0.001 and about 0.005 inches). 
     In some implementations, the present disclosure relates to a needle comprising a distal end and an interior lumen. The distal end comprises a tip and is angled such that the tip is aligned with a central axis of the needle. 
     In some implementations, the present disclosure relates to a needle comprising a distal end and an interior lumen. The distal end comprises a tip, and the tip is coincident with the interior lumen of the needle. 
     In some implementations, the present disclosure relates to a needle comprising a distal end and an interior lumen. The distal end comprises a tip. An ejector is slidably disposed (e.g., slip-fit) within the interior lumen. A position of the tip is adjacent to an outside surface of the ejector. 
     In some implementations, the present disclosure relates to a repair method comprising providing a needle delivery assembly. The needle delivery assembly comprises a main shaft having a distal end and an interior lumen. The needle delivery assembly further comprises a needle having a distal end and an interior lumen, wherein the needle is configured to be slidably disposed (e.g., slip-fit) within the interior lumen of the main shaft in a stored position of the needle, and to extend from the distal end of the main shaft in a deployed position of the needle. The needle delivery assembly further comprises an ejector configured to be slidably disposed within the interior lumen of the needle in a stored position of the ejector, and to extend from the distal end of the needle in a deployed position of the ejector. The needle delivery assembly further comprises a repair device configured to be slidably disposed in the interior lumen of the needle, and a suture connected to the repair device. The method comprises positioning the distal end of the main shaft at a target tissue, puncturing through the target tissue with the needle, advancing and pushing, using the ejector, the repair device out of the interior lumen of the needle while the needle is in a puncture position, and withdrawing the main shaft, the needle, and the ejector from the target tissue. 
     In some implementations, the present disclosure relates to a repair method comprising providing a needle delivery assembly. The needle delivery assembly comprises a main shaft having a distal end and an interior lumen, and a first needle having a distal end and an interior lumen, wherein the first needle is slidably disposed (e.g., slip-fit) within the interior lumen of the main shaft in a stored position, the distal end of the first needle extends from the distal end of the main shaft in a deployed position. The needle delivery assembly further comprises a first ejector slidably disposed within the interior lumen of the first needle in a stored position, the distal end of the first ejector extends from the distal end of the first needle in a deployed position. The needle delivery assembly further comprises a first repair device slidably disposed in the first needle, and a first suture connected to the first repair device. The needle delivery assembly further comprises a second needle having a distal end and an interior lumen, wherein the second needle is slidably disposed within the interior lumen of the main shaft in a stored position, the distal end of the second needle extends from the distal end of the main shaft in a deployed position. The needle delivery assembly further comprises a second ejector slidably disposed within the interior lumen of the second needle in a stored position, the distal end of the second ejector extends from the distal end of the second needle in a deployed position. The needle delivery assembly further comprises a second repair device slidably disposed in the second needle, and a second suture connected to the second repair device. The first ejector is configured to push the first repair device out of the first needle when the first ejector extends from the distal end of the first needle in the deployed position. The second ejector is configured to push the second repair device out of the second needle when the second ejector extends from the distal end of the second needle in the deployed position. The method further comprises positioning the distal end of the main shaft at a first target tissue area, positioning a tip of the first needle near a center of the main shaft, puncturing, using the first needle, through the first target tissue area, advancing and pushing, using the first ejector, the first repair device out of the first needle while the first needle is adjacent to the first target tissue, and withdrawing the main shaft, the first needle, and the first ejector from the first target tissue. 
     In some embodiments, the method further comprises positioning the distal end of the main shaft at a second target tissue, positioning a tip of the second needle near the center of the main shaft, puncturing, by the second needle, through the second target tissue, advancing and pushing, by the second ejector, the second repair device out of the second needle while the second needle is adjacent to the second target tissue, and withdrawing the main shaft, the second needle, and the second ejector from the tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. 
         FIG. 1  is a cut-away anterior view of the human heart showing the internal chambers, valves, and adjacent structures. 
         FIG. 2  is a perspective view of a healthy mitral valve with the leaflets closed. 
         FIG. 3  is a top view of a dysfunctional mitral valve with a visible gap between the leaflets. 
         FIG. 4  shows a simplified cross-sectional view of a heart with four chambers and an apex region. 
         FIG. 5  illustrates the advancement of a device through an accessed region of the heart. 
         FIG. 6  shows an exemplary embodiment of a needle penetrating through a valve leaflet. 
         FIG. 7  shows an exemplary embodiment of a needle penetrating through a valve annulus. 
         FIG. 8  is a cross-sectional view of an exemplary embodiment of a needle delivery device. 
         FIG. 9  illustrates the needle delivery device shown in  FIG. 8  with the needle penetrating the tissue. 
         FIG. 10  illustrates the needle delivery device shown in  FIG. 8  with the pledget deployed by the pledget ejector. 
         FIG. 11  illustrates the needle delivery device shown in  FIG. 8  with the pledget deployed in place and the needle delivery device retracting. 
         FIG. 12A  is a side view of an exemplary embodiment of a needle. 
         FIG. 12B  is a view taken in the direction of arrows  12 B- 12 B in  FIG. 12A . 
         FIG. 13  is a side view of an exemplary embodiment of a needle. 
         FIG. 14  is a side view of an exemplary embodiment of a needle. 
         FIG. 15  is a side view of an exemplary embodiment of a needle. 
         FIG. 16  shows the needle of  FIG. 15  with a pusher extending from an end of the needle. 
         FIG. 17  is a perspective, partially sectioned view of an exemplary embodiment of a needle delivery device with four needles. 
         FIG. 18  illustrates the needle delivery device shown in  FIG. 17  with one of the needles optionally rotating and extending to penetrate the tissue. 
         FIG. 19  illustrates the needle delivery device shown in  FIG. 17  with a pledget deployed from the extended needle shown in  FIG. 18 . 
         FIG. 20  illustrates the needle delivery device shown in  FIG. 17  with the pledget deployed in place and the needle delivery device retracting from the tissue. 
         FIG. 21  illustrates the needle delivery device shown in  FIG. 17  with the needle and the pledget ejector retracting into the main shaft. 
         FIG. 22  illustrates the needle delivery device shown in  FIG. 17  with the needle and pledget ejector back to the main shaft. 
         FIG. 23A-23C  illustrate an exemplary embodiment of an anchor member. 
         FIGS. 24A-24C  illustrates an exemplary procedure for securing an exemplary embodiment of an attachment member to a tissue member with the exemplary anchor member of  FIGS. 23A-23C . 
         FIGS. 25-26  illustrate another exemplary embodiment of an anchor member. 
         FIG. 27  illustrates a needle having a deflected tip in accordance with one or more embodiments. 
         FIGS. 28A-28C  illustrate views of a pre-shaped tissue anchor in accordance with one or more embodiments. 
         FIGS. 29-31  illustrate stages of a procedure for deploying a pre-shaped tissue anchor using a tissue anchor delivery system in accordance with one or more embodiments. 
         FIGS. 32-34  illustrate additional example tissue anchor forms in accordance with embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     As illustrated in  FIG. 1 , the human heart  10  has four chambers, which include two upper chambers denoted as atria  12 ,  16  and two lower chambers denoted as ventricles  14 ,  18 . A septum  20  divides the heart  10  and separates the left atrium  12  and left ventricle  14  from the right atrium  16  and right ventricle  18 . The heart further contains four valves  22 ,  24 ,  26 , and  28 . The valves function to maintain the pressure and unidirectional flow of blood through the body and to prevent blood from leaking back into a chamber from which it has been pumped. 
     Two valves separate the atria  12 ,  16  from the ventricles  14 ,  18 , denoted as atrioventricular valves. The left atrioventricular valve, the mitral valve  22 , controls the passage of oxygenated blood from the left atrium  12  to the left ventricle  14 . A second left valve, the aortic valve  24 , separates the left ventricle  14  from the aortic artery (aorta)  30 , which delivers oxygenated blood via the circulation to the entire body. The aortic valve  24  and mitral valve  22  are part of the “left” heart, which controls the flow of oxygen-rich blood from the lungs to the body. The right atrioventricular valve, the tricuspid valve  26 , controls passage of deoxygenated blood into the right ventricle  18 . A fourth valve, the pulmonary valve  28 , separates the right ventricle  18  from the pulmonary artery  32 . The right ventricle  18  pumps deoxygenated blood through the pulmonary artery  32  to the lungs wherein the blood is oxygenated and then delivered to the left atrium  12  via the pulmonary vein. Accordingly, the tricuspid valve  26  and pulmonic valve  28  are part of the “right” heart, which control the flow of oxygen-depleted blood from the body to the lungs. 
     Both the left and right ventricles  14 ,  18  constitute “pumping” chambers. The aortic valve  24  and pulmonic valve  28  lie between a pumping chamber (ventricle) and a major artery or vein and control the flow of blood out of the ventricles and into circulation. The aortic valve  24  and pulmonic valve  28  normally have three cusps, or leaflets, that open and close and thereby function to prevent blood from leaking back into the ventricles after being ejected into the lungs or aorta  30  for circulation. 
     Both the left and right atria  12 ,  16  are “receiving” chambers. The mitral valve  22  and tricuspid valve  26 , therefore, lie between a receiving chamber (atrium) and a ventricle so as to control the flow of blood from the atria to the ventricles and prevent blood from leaking back into the atrium during ejection into the ventricle. The mitral valve  22 , includes two cusps, or leaflets (shown in  FIG. 2 ), and the tricuspid valve  26  normally include three cusps, or leaflets. The mitral valve  22  and the tricuspid valve  26  are encircled by a variably dense fibrous ring of tissues known as the annulus. The valves  22 ,  26  are anchored to the walls of the ventricles by chordae tendineae (chordae)  42 . The chordae tendineae  42  are cord-like tendons that connect the papillary muscles  43  to the leaflets of the mitral valve  22  and tricuspid valve  26  of the heart  10 . The papillary muscles  43  are located at the base of the chordae  42  and are within the walls of the ventricles. They serve to limit the movements of the mitral valve  22  and tricuspid valve  26  and prevent them from being reverted. The papillary muscles  43  do not open or close the valves of the heart, which close passively in response to pressure gradients; rather, the papillary muscles  43  brace the valve leaflets against the high pressure needed to circulate the blood throughout the body. Together, the papillary muscles  43  and the chordae tendineae  42  are known as the subvalvular apparatus. The function of the subvalvular apparatus is to keep the valves from prolapsing into the atria when they close. 
     As illustrated with reference to  FIG. 2 , the mitral valve  22  includes two leaflets, the anterior leaflet  52  and the posterior leaflet  54 , and a diaphanous incomplete ring around the valve, called the annulus  60 . The mitral valve  22  has two primary papillary muscles  43 , the anteromedial and the posterolateral papillary muscles, which attach the leaflets  52 ,  54  to the walls of the left ventricle  14  via the chordae tendineae  42 . The tricuspid valve  26  typically is made up of three leaflets with three papillary muscles. However, the number of leaflets can range between two and four. The three leaflets of the tricuspid valve  26  are referred to as the anterior, posterior, and septal leaflets. Although both the aortic and pulmonary valves each have three leaflets (or cusps), they do not have chordae tendineae. 
     Various disease processes can impair the proper functioning of one or more of the valves of the heart. These disease processes include degenerative processes (e.g., Barlow&#39;s disease, fibroelastic deficiency), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis). Additionally, damage to the ventricle from prior heart attacks (e.g., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy) can distort the valve&#39;s geometry causing it to dysfunction. However, the vast majority of patients undergoing valve surgery, such as mitral valve surgery, suffer from a degenerative disease that causes a malfunction in a leaflet of the valve, which results in prolapse and regurgitation. 
     Generally, a heart valve can malfunction two different ways. One possible malfunction, valve steno sis, occurs when a valve does not open completely and thereby causes an obstruction of blood flow. Typically, stenosis results from buildup of calcified material on the leaflets of the valves causing them to thicken and thereby impairing their ability to fully open and permit adequate forward blood flow. 
     Another possible malfunction, valve regurgitation, occurs when the leaflets of the valve do not close completely thereby causing blood to leak back into the prior chamber. There are three mechanisms by which a valve becomes regurgitant or incompetent; they include Carpentier&#39;s type I, type II and type III malfunctions. A Carpentier type I malfunction involves the dilation of the annulus such that normally functioning leaflets are separated from each other and fail to form a tight seal (e.g., do not coapt properly). Included in a type I mechanism malfunction are perforations of the valve leaflets, as in endocarditis. A Carpentier&#39;s type II malfunction involves prolapse of one or both leaflets above the plane of coaptation. This is the most common cause of mitral regurgitation and is often caused by the stretching or rupturing of chordae tendineae normally connected to the leaflet. A Carpentier&#39;s type III malfunction involves restriction of the motion of one or more leaflets such that the leaflets are abnormally constrained below the level of the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (IIIa) or dilation of the ventricle (IIIb). 
       FIG. 3  illustrates a mitral valve  22  having leaflets that do not properly coapt due to tethering and/or prolapse. Prolapse occurs when a leaflet  52 ,  54  of the mitral valve  22  is displaced into the left atrium  12  (see  FIG. 1 ) during systole. Because one or more of the leaflets  52 ,  54  prolapse, the mitral valve  22  does not close properly, and, therefore, the leaflets fail to coapt. This failure to coapt causes a gap  63  between the leaflets  52 ,  54  that allows blood to flow back into the left atrium  12 , during systole, while it is being ejected into the left ventricle  14 . As set forth above, there are several different ways a leaflet can malfunction, which can thereby lead to regurgitation. 
     Although stenosis or regurgitation can affect any valve, stenosis is predominantly found to affect either the aortic valve  24  or the pulmonic valve  28 , whereas regurgitation predominately affects either the mitral valve  22  or the tricuspid valve  26 . Both valve stenosis and valve regurgitation increase the workload on the heart  10  and can lead to very serious conditions if left un-treated. Since the left heart is primarily responsible for circulating the flow of blood throughout the body, malfunction of the mitral valve  22  is particularly problematic and often life threatening. Accordingly, because of the substantially higher pressures on the left side of the heart, left-sided valve dysfunction is much more problematic. 
     Malfunctioning valves can either be repaired or replaced. Repair typically involves the preservation and correction of the patient&#39;s own valve. Replacement typically involves replacing the patient&#39;s malfunctioning valve with a biological or mechanical substitute. Typically, the aortic valve  24  and pulmonic valve  28  are more prone to stenosis. Because stenotic damage sustained by the leaflets is irreversible, the most conventional treatment for stenotic aortic and pulmonic valves is removal and replacement of the diseased valve. The mitral valve  22  and tricuspid valve  26 , on the other hand, are more prone to deformation. Deformation of the leaflets, as described above, prevents the valves from closing properly and allows for regurgitation or back flow from the ventricle into the atrium, which results in valvular insufficiency. Deformations in the structure or shape of the mitral valve  22  or tricuspid valve  26  are often repairable. 
     An improperly functioning mitral valve  22  or tricuspid valve  26  is often repaired, rather than replaced. Conventional techniques for repairing a cardiac valve are labor-intensive, technically challenging, and require a great deal of hand-to-eye coordination. They can be, therefore, very challenging to perform, and require a great deal of experience and extremely good judgment. For instance, the procedures for repairing regurgitating leaflets can require resection of the prolapsed segment and insertion of an annuloplasty ring so as to reform the annulus of the valve. Additionally, leaflet sparing procedures for correcting regurgitation can be similarly labor-intensive and technically challenging, if not requiring an even greater level of hand-to-eye coordination. These procedures can involve the implantation of sutures (e.g., ePTFE suture, for example, GORE-TEX® sutures, W. L. Gore, Newark, Del.) so as to form artificial chordae in the valve. In these procedures, rather than performing a resection of the leaflets and/or implanting an annuloplasty ring into the patient&#39;s valve, the prolapsed segment of the leaflet is re-suspended using artificial chord sutures. 
     Regardless of whether a replacement or repair procedure is being performed, conventional approaches for replacing or repairing cardiac valves are typically invasive open-heart surgical procedures, such as sternotomy or thoracotomy, that require opening up of the thoracic cavity so as to gain access to the heart. Once the chest has been opened, the heart is bypassed and stopped. Cardiopulmonary bypass is typically established by inserting cannulae into the superior and inferior vena cavae (for venous drainage) and the ascending aorta (for arterial perfusion), and connecting the cannulae to a heart-lung machine, which functions to oxygenate the venous blood and pump it into the arterial circulation, thereby bypassing the heart. Once cardiopulmonary bypass has been achieved, cardiac standstill is established by clamping the aorta and delivering a “cardioplegia” solution into the aortic root and then into the coronary circulation, which stops the heart from beating. Once cardiac standstill has been achieved, the surgical procedure can be performed. 
     Needle delivery devices described by the present disclosure can be used in a wide variety of applications. In accordance with some embodiments disclosed herein, the heart can be accessed through one or more openings made by a relatively small incision(s) in a portion of the body proximal to the thoracic cavity, for instance, in between one or more of the ribs of the rib cage, proximate to the xyphoid appendage, or via the abdomen and diaphragm. Access to the thoracic cavity can be sought so as to allow the insertion and use of one or more thorascopic instruments, while access to the abdomen can be sought so as to allow the insertion and use of one or more laparoscopic instruments. Insertion of one or more visualizing instruments can then be followed by transdiaphragmatic access to the heart. Additionally, access to the heart can be gained by direct puncture (e.g., via an appropriately sized needle, for instance an 18-gauge needle) of the heart from the xyphoid region. Access can also be achieved using percutaneous means. Accordingly, the one or more incisions should be made in such a manner as to provide an appropriate surgical field and access site to the heart. See, e.g., “Full-Spectrum Cardiac Surgery Through a Minimal Incision Mini-Sternotomy (Lower Half) Technique”, Doty et al.,  Annals of Thoracic Surgery  1998; 65(2): 573-577 and “Transxiphoid Approach Without Median Sternotomy for the Repair of Atrial Septal Defects”, Barbero-Marcial et al.,  Annals of Thoracic Surgery  1998; 65(3): 771-774, which are specifically incorporated in their entirety herein by reference. 
     The term “minimally invasive” is used herein according to its broad and ordinary meaning and may refer to any manner by which an interior organ or tissue can be accessed with as little as possible damage being done to the anatomical structure through which entry is sought. Typically, a minimally invasive procedure is one that involves accessing a body cavity by a small incision made in the skin of the body. The term “small incision” is used according to its broad and ordinary meaning and may refer to an incision having a length generally of about 1 cm to about 10 cm, or about 4 cm to about 8 cm, or about 7 cm in length. The incision can be vertical, horizontal, or slightly curved. If the incision is placed along one or more ribs, the incision may follow the outline of the rib. The opening should extend deep enough to allow access to the thoracic cavity between the ribs or under the sternum and is preferably set close to the rib cage and/or diaphragm, dependent on the entry point chosen. 
     One or more other incisions can be made proximate to the thoracic cavity to accommodate insertion of a surgical scope. Such an incision is typically about 1 cm to about 10 cm, or about 3 cm to about 7 cm, or about 5 cm in length and should be placed near the pericardium so as to allow ready access to, and visualization of, the heart. The surgical scope can be any type of endoscope, a thorascope or laparoscope, depending upon the type of access and scope to be used. The scope may generally have a flexible housing and at least an about 16-times magnification. Insertion of the scope through an incision can allow a practitioner to analyze and “inventory” the thoracic cavity and the heart so as to further determine the clinical status of the subject and plan the procedure. For example, a visual inspection of the thoracic cavity can reveal important functional and physical characteristics of the heart and can indicate the access space (and volume) required at the surgical site and in the surgical field in order to perform the reparative cardiac valve procedure. At this point, the practitioner can confirm that access of one or more cardiac valves through the apex of the heart or another access site is appropriate for the particular procedure to be performed. 
     With reference to  FIGS. 4 and 5 , once a suitable entry point has been established, a suitable access device  500  ( FIG. 5 ) can be advanced into the body in a manner so as to make contact with the heart  10 . In some embodiments, the shaft/needle used for leaflet puncture is small enough and/or designed to penetrate into the thoracic cavity percutaneously, such that the access device  500  is not necessary. The advancement of the device can be performed in conjunction with sonography or direct visualization (e.g., direct transblood visualization). For instance, the device can be advanced in conjunction with TEE guidance or ICE so as to facilitate and direct the movement and proper positioning of the device for contacting the appropriate apical region of the heart. Typical procedures for use of echo guidance are set forth in Suematsu, Y.,  J. Thorac. Cardiovasc. Surg.,  2005; 130:1348-1356, herein incorporated by reference in its entirety. However, the device  500  may be advanced in any manner. 
     Referring to  FIGS. 4 and 5 , one or more chambers  12 ,  14 ,  16 ,  18  in the heart  10  can be accessed by the device  500 . Access into a chamber in the heart can be made at any suitable site of entry. Entry into the left ventricle  14  through the apex or apical region of the heart (e.g., at or adjacent to the apex  72 ) is illustrated by  FIG. 5 . Typically, access into the left ventricle  14 , for instance, to perform a mitral valve repair, is gained through making a small incision into the apical region, close to (or slightly skewed toward the left of) the median axis  74  of the heart  10 . Typically, access into the right ventricle  18 , for instance, to perform a tricuspid valve repair, is gained through making a small incision into the apical region, close to or slightly skewed toward the right of the median axis  74  of the heart  10 . The apex/apical region of the heart is a bottom region of the heart that is within the left or right ventricular region but is distal to the mitral valve  22  and tricuspid valve  26  and toward the tip or apex  72  of the heart  10 . More specifically, an “apex region,” or “apical region,” of the heart is within a few centimeters to the right or to the left of the septum  20  of the heart  10 . Accordingly, the left and right ventricles can be accessed directly via the apex  72 , or via an off-apex location that is in the apical region, but slightly removed from the apex  72 , such as via a lateral ventricular wall, a region between the apex and the base of a papillary muscle, or even directly at the base of a papillary muscle. The device  500  can access the heart in any manner. 
     The access device  500  can be used to provide needles  86  (see  FIGS. 6-22 ) and/or delivery devices  75  to access cardiac valves. Various procedures can be performed in accordance with the needles and delivery devices described herein in order to effectuate a cardiac valve repair, which will depend on the specific abnormality and the tissues involved. For example, needles  86  (see  FIG. 6 ) and/or needle delivery devices  75  (see  FIG. 8 ) can be used for a wide variety of different procedures, including, but not limited to, the implantation of one or more artificial chordae tendineae into one or more leaflets of a malfunctioning mitral valve  22  and/or tricuspid valve  26 , an Alfieri procedure, and an annuloplasty procedure, and a wide variety of other procedures. In an exemplary embodiment, the needles are configured to pass through the native valve tissue, deploy a repair component, and retract back through the valve tissue. Referring to  FIG. 6 , in the case of an implantation of an artificial chorda, the needle  86  is inserted through the valve leaflet  52 . As will be described in more detailed below, a repair device  92  (not shown in  FIG. 6 ) is deployed. Then, the needle is retracted. The repair device  92  can be secured to another portion of heart tissue to complete the repair.  FIG. 7  illustrates the use of a needle to perform an annuloplasty. The needle  86  is inserted through the valve annulus  60  as shown in  FIG. 7 , a repair device (not shown in  FIGS. 7 and 8 ) is deployed, and the needle is retracted. 
     As illustrated in  FIG. 5 , the needle delivery devices  75  can be introduced into the ventricle  14  of the heart and advanced in such a manner so as to contact one or more cardiac tissues (for instance, a leaflet  52 ,  54 , an annulus  60 , a cord  42 , a papillary muscle  43 , or the like) that are in need of repair. Sonic guidance, for instance, TEE guidance or ICE, can optionally be used to assist in the advancement of the device into the ventricle. 
     The needle delivery devices  75  described herein can take a wide variety of different forms. Referring to  FIGS. 8-11 , in one exemplary embodiment, the needle delivery device  75  comprises a main shaft  78  with an interior lumen and a functional distal portion  81  having a tip  84  configured for repairing a cardiac valve tissue, for instance, a mitral valve leaflet  52 ,  54  or annulus  60 . The tip  84  can take a wide variety of different forms. In the illustrated embodiment, the tip can have an atraumatic blunt end, to avoid pushing the entire device through the valve tissue, such as a leaflet  52 ,  54  or annulus  60 . An end protector  88  can be provided at the distal end of the shaft  78  to provide the blunt end. In some embodiments, the end protector  88  can comprise an expandable balloon. In one exemplary embodiment, the distal portion  81  comprises a suction device for holding the tissue, such as leaflet tissue  52 ,  54  still as the tissue is acted upon by the needle  86 . The suction device can take a wide variety of different forms. One exemplary suction device that can be used is disclosed in U.S. Patent Application Publication No. 2017/0304050 A1, which is incorporated herein by reference in its entirety. The needle delivery device  75  can be manipulated in such a manner so that a selected cardiac tissue (for instance, a papillary muscle, one or more leaflet tissues, chordae tendineae, or the like) is contacted with the functional distal portion  81  of the needle delivery device  75  and a repair effectuated, for instance, a mitral or tricuspid valve repair. 
     In the example illustrated by  FIG. 8 , a needle  86  having a distal end  98  and an interior lumen  108  is disposed in the delivery device  75 . A repair device  92  and a repair device ejector  90  are disposed in the needle  86 . The repair device  92  can take a wide variety of different forms. Examples of repair devices  92  include, but are not limited to, knots, pledgets, anchors, and the like. The repair device  92  can be any device or structure for providing a reinforcement or backing to tissue, such as leaflet tissue  52 ,  54  or annulus tissue  60 . The repair device ejector  90  can take a wide variety of different forms. Any device capable of deploying the repair device  92  from the needle can be used. In the example illustrated by  FIG. 8 , the repair device ejector  90  comprises a hollow tube. In the example illustrated by  FIG. 8 , a suture  94  is connected to the repair device  92  and extends through the hollow ejector  90 . The term “suture” is used herein according to its broad and ordinary meaning, and may refer to any elongate strip, strand, wire, tie, line, string, ribbon, strap, or other form or type of material that may be used in medical procedures. Although a single suture is described in some embodiments, it should be understood that such description is applicable to any number, form, or configuration of suture(s). 
     In certain embodiments, the repair device  92  comprises a pledget or other tissue anchor will. In some embodiments, the pledget  92  has suture tails  102 ,  94  running at least partially therethrough in a delivery configuration, as shown in  FIGS. 8 through 11 . Having a pledget or other type of tissue anchor with pre-attached suture tails in accordance with some implementations of the embodiments of  FIGS. 8 through 11  can advantageously provide a relatively efficient deployments and anchoring process. For example, once the pledget or other tissue anchor  92  is deployed from the needle  86 , there may advantageously be no need to further attach sutures or other tethers to the anchor, as sutures are pre-attached to the tissue anchor  92 . 
     Referring to  FIGS. 8 and 9 , the needle  86  may be configured to be slidably disposed (e.g., slip-fit) within the main shaft  78 . In  FIG. 9 , the distal end  98  of the needle  86  extends from the distal end  96  of the main shaft  78 . The distal end  98  of the needle  86  may be configured to penetrate the target tissue  52 , as shown. In some embodiments, the needle  86  can be electropolished to make it smooth. The repair device  92  has a stored position and a deployed position. The repair device  92  in stored in the distal end  98  of the needle  86 . The repair device may be compressed to allow storing. The stored repair device  92  can be parallel with the axis of the needle  86 , compressed or otherwise configured to allow for storage in a small area. The repair device  92  can be configured to expand and/or rotate when deployed out of the needle  86 . In some embodiments, the deployed repair device  92  is substantially orthogonal to the axis of the needle  86 . 
     The suture  94  can take a wide variety of different forms. For example, the suture  94  can be a suture, a wire, etc. In some embodiments, the suture  94  is a suture made of PTFE or ePTFE material. In some embodiments, the suture  94  comprises UHMwPE (ultra-high molecular weight polyethylene) material (e.g., DYNEEMA®, Koninklijke DSM, Heerlen, The Netherlands), for example, FORCE FIBER® suture (Teleflex Medical, Gurnee, Ill.). The distal end  100  of suture  94  is attached to the repair device  92 . The proximal end  102  of suture  94  extends from the proximal end of the main shaft  78  and the ejector  90 . In one embodiment, the suture  94  is looped through the center of the repair device  92 . The loop  100  is formed at the distal end of the suture  94 , leaving two proximal ends  102 . 
     Referring to  FIGS. 9 and 10 , the ejector  90  is slidably disposed (e.g., slip-fit) within the needle  86 . In  FIG. 10 , a distal portion  104  of the ejector  90  extends from the distal end  98  of the needle  86 , for example on the atrium side of valve leaflet tissue  52 . The ejector  90  is configured to push the repair device  92  out of the distal end  98  of the needle  86 . In the embodiment illustrated, the ejector  90  comprises an interior lumen  106 . The suture  94  passes through the interior lumen  106  of the ejector  90 . The distal end  104  of the ejector  90  prevents the repair device  92  from entering into the interior lumen  106  of the pledget ejector  90 . Alternatively, the suture  94  can pass through the interior lumen  108  of the needle  86  and run parallel with the pledget ejector  90 . 
       FIGS. 9-11  show the operation of the needle delivery device  75 . As illustrated in  FIG. 9 , the needle delivery device  75  has been positioned at a desired repair area. For example, the end projector  88  may be localized to the intended valve leaflet tissue  52 ,  54  or annulus tissue  60 . The needle  86  may be advanced to puncture through the tissue. In some embodiments, both the ejector  90  and the suture  94  move with the needle. The repair device  92  remains inside the needle  86 . 
     As illustrated in  FIG. 10 , the needle  86  can be maintained for a period in a puncture position. The ejector  90  advances and pushes the repair device  92  out of the needle  86 . The repair device  92  may be moved to its deployed position and configuration. For example, the repair device  92  can move to a position that is orthogonal to the axis of the needle  86 . 
     As illustrated in  FIG. 11 , the main shaft  78 , the needle  86 , and the ejector  90  are withdrawn from the tissue  52  while remaining in their extended condition of  FIG. 11 . In some alternative embodiments, the ejector  90  and/or the needle  86  can be retracted into the main shaft  78  before moving the main shaft  78 . The repair device  92  with the loop  100  covers the tissue puncture site and can be used to anchor the suture  94  on to another tissue area to connect the repair device  92  to another repair device. 
     Another aspect of the present disclosure is an improved needle. In some embodiments, the needle is a hypodermic needle. The disclosed needles are designed to provide cardiac tissue penetration, such as valve leaflet tissue  52 ,  54  or valve annulus tissue  60 , with reduced axial tensile force and/or a smaller cutting area. The reduced force and/or smaller cutting area prevents coring of the tissue. Preventing coring allows the puncture wound to seal itself immediately or more quickly when the needle is removed. Coring is the effect of needles forming a “crescent moon” shaped cut, followed by the displacement of the flap created by the cut. The problem with this coring cutting action is that the resulting cut hole can be large and thereby reduce the holding ability of the repair device through tissue, such as a valve leaflet and/or valve annulus tissue. 
     Referring to  FIGS. 12A and 12B , in one exemplary embodiment, the configuration of the needle tip changes the way the needle penetrates through tissue and leaves a smaller cut area once the needle is removed. The needle  86  comprises a tip  110 , a distal beveled edge  112 , and a proximal beveled edge  114 . The tip  110  can be very sharp or pointed to facilitate initial penetration of the needle through the tissue. A portion  1200  of the distal beveled edge  112  can have sharp cutting surfaces. A remainder of the distal beveled edges  112  and proximal beveled edges  114  have smoothed, non-cutting surfaces. The portion  1202  (e.g., the non-sharp surface of the beveled edge  112  and the beveled edge  112 ) can be made smoothed in a wide variety of different ways. For example, the portion  1202  can be polished in any conventional manner. In one exemplary embodiment, the portion  1202  is smooth, with non-cutting electropolished surfaces. The non-cutting surfaces are configured to stretch the tissue rather than cut it. Thus, non-cutting surfaces result in a reduced size puncture hole when the needle  86  is removed, that is the stretched tissue can return to its original size or close to its original size, where cut tissue cannot. 
     The distal beveled portion  112  may be formed from two beveled cuts, each deflecting away from the tip  110 . Furthermore, the portion  1200  of the distal beveled portion  112  may advantageously be relatively sharp compared to the radiused edges/surfaces of the proximal beveled surface  114  and the radiused portion  1202  of the distal beveled surface/portion  112 . The distal  112  and proximal  114  beveled portion may be separated by an inflection point  1207 , which may be aligned with or near the central axis  1209  of the needle  86 . The radiused portion  1202  of the needle may induce stretching of the tissue rather than cutting tissue. For example, the radiused portion  1202  may cause the needle puncture to be dilated during the insertion of the needle and deployment of the pledget, suture knot, memory metal wire anchor, or other type of distal anchor. When the needle is removed, the dilated tissue may relax back to its previous form to result in a relatively smaller puncture dimension. 
     With only the portion  1200  of the distal beveled portion  112  remaining un-radiused and relatively sharp, the tissue cut area may be relatively smaller than for needles having distal penetration portions that are not radiused. Furthermore, tissue stretch area may be maximized or relatively larger. The sharp portion  1200 , however, may promote ease of tissue penetration when cutting through tissue during initial needle penetration. 
     In other exemplary embodiments illustrated in  FIG. 13 , all beveled edges  112 ,  114  are radiused such that once a tissue penetration is achieved, the advancement of the needle  86  stretches the tissue rather than cutting. In some embodiments, all beveled edges  112 ,  114  are electropolished or polished to form a radius in some other manner. Radiused edges of bevels, away from the penetrating tip, can be from about 25 to about 500 μm (from about 0.001 to about 0.02 inch), or any sub range in between. In some exemplary embodiments, the radiused edges of bevels can be from about 130 to about 400 μm (from about 0.005 to about 0.015 inch), or any range in between. In some other exemplary embodiments, the radiused edges of bevels can be from about 180 to about 300 μm (from about 0.007 to about 0.012 inch), or any range in between. In some exemplary embodiments, the radiused edges of bevels can be about 250 μm (about 0.01 inch). In some embodiments, the cutting tip  210  can be also radiused from about 25 to about 130 μm (from about 0.001 to about 0.005 inch) without greatly increasing the force to penetrate tissue. In some exemplary embodiments, the cutting tip  210  can be radiused from about 25 to about 250 μm (from about 0.001 to about 0.01 inch), or any range in between. In some embodiments, the tip  210  is electropolished to radius the tip. Alternatively, the tip can be radiused in some other manner. 
       FIG. 14  illustrates another embodiment of a needle  86 . An angle θ or bend can be provided near the sharp end of the needle. The bend is configured to cause a centralized initial tissue puncture (e.g., aligned with a central axis  1400  of the needle  86 ) followed by stretching of tissue rather than cutting action. Because the tip  110  is aligned with the central axis  1400 , the bent tip  110  will cause the initial loading of the needle tip  110  to be on the central axis  1400  of the needle  86 . This on-axis loading prevents lateral movement and/or torqueing of the needle  86  as it penetrates through tissue. 
       FIG. 15  illustrates another exemplary embodiment of a needle  86 . In the example illustrated by  FIG. 15 , the sharp tip  110  of the needle  86  is coincident with the interior lumen wall  108  of the needle  86 . Referring to  FIG. 16 , this positioning of the sharp tip  110  creates additional protection for the suture  94 , both for initial deployment as well as for subsequent deployments. That is, the positions of the sharp tip  110  adjacent to the outside surface  116  of the ejector  90  prevents direct contact of the suture  94  with the sharp tip  110 . 
       FIG. 17  illustrates another embodiment of the needle delivery device  75 . The illustrated needle delivery device  75  contains more than one needle  86 , which allows for the placement of multiple repair devices  92 , thus reducing the number of penetrations needed through the valve introducer. The needle delivery device can contain 2, 3, or more needles with pre-loaded repair devices and/or lines  94 . The number of needles can be selected to optimize the volume of the main shaft  78  of the delivery device  75  that is filled with needles. For example, three, or five needles can result in a majority of a circular tube being filled with the needles. 
     In certain embodiments, the repair device  92  comprises a pledget or other tissue anchor will. In some embodiments, the pledget  92  has suture tails (e.g., suture tail(s)  94 ) running at least partially therethrough in a delivery configuration, as shown in  FIGS. 17 through 22 . Having a pledget or other type of tissue anchor with pre-attached suture tails in accordance with some implementations of the embodiments of  FIGS. 17 through 22  can advantageously provide for relatively efficient deployment and/or anchoring processes. For example, once the pledget or other tissue anchor  92  is deployed from the needle  86 , there may advantageously be no need to further attach sutures or other tethers to the anchor, as sutures are pre-attached to the tissue anchor  92 . 
     Referring to  FIG. 17 , prior to deployment, the sharp tips  110  of the needles  86  are rotated to be against the inside wall of the main shaft  78 . This protects the sharp tip  110  from damage and prevents the sharp tip  110  from damaging a suture  94  or lines which have been previously deployed. 
     During initial deployment as illustrated in  FIG. 18 , the needle  86  can be rotated for example 180 degrees, causing the sharp tip  110  to be located near the center of the main shaft  78 . Positioning the sharp tip  110  near the center of the main shaft promotes easier placement and improved accuracy of the repair device  92  placement. In other exemplary embodiments, the needle tips  110  are not positioned against the wall  78  and/or the needles are not rotated for deployment. 
     Once the needle is fully displaced as illustrated in  FIG. 19 , the ejector  90  deploys the repair device  92  and the suture  94  out of the needle  86 . The repair device  92  is deployed in an orthogonal position with respect to the penetrated tissue prior to pull-back of the needle  86 .  FIGS. 20 and 21  illustrate retraction of the needle  86  and the ejector  90 . The retraction of the needle  86  and the ejector  90  can be done in the same manner as described with respect to  FIGS. 10 and 11 . Once the ejector  90  is deployed, it can optionally remain in the extended position in order to protect the suture  94  and prevent damage to other lines which can have previously been deployed as illustrated in  FIGS. 20 and 21 . 
     Once the needle is pulled back out of the penetrated tissue as illustrated in  FIG. 22 , the needle  86  can optionally rotate 180 degrees, such that the sharp needle tip  110 , once fully retracted, will again be positioned in such a way that the sharp tip  110  will be located against the inside wall  679  of the main shaft  78 . Once the deployment process of the repair device  92  is complete, subsequent deployments can be accomplished with the same delivery device  75 . The rotation of the needles  86 , the configuration of the needles, and/or radiusing of edges of the needles reduces the possibility of damaging a previously deployed line. 
     Referring to  FIGS. 23A-23B and 24A-24C , an exemplary embodiment of an anchor member  5900  includes a compression portion  5902 , an abutment portion  5904 , a placement member  5906 , and an opening  5910  that extends through the abutment portion  5904  and the compression portion  5902 . The opening  5910  is configured to receive a suture portion  5915  of an attachment member, such as at least a portion of the suture  94  described above. The compression portion  5902  is configured to compress the suture portion  5906  of an attachment member to prevent the attachment member from moving. The placement member  5906  is configured to expand the compression portion  5902  so that the opening  5910  has a larger diameter D than the diameter X of the suture portion  5915 . The placement member  5906  allows the anchor member  5900  to be moved along the suture portion  5915  so that the anchor member  5900  can be placed in a desired location on the suture portion  5915 . Once the anchor member  5900  is placed in a desired location, the placement member  5906  can be removed from the anchor member  5900 , which causes at least a portion of the compression member  5902  to compress such that the diameter D of at least a portion of the opening  5910  is less than the diameter X of the suture portion  5915 . That is, the compression portion  5902  is made of an elastic material or a shape memory material, such as, for example, plastic, steel, shape memory alloy material, such as Nitinol, any combination of these materials, and the like. 
     The compression portion  5902  is made so that it has an original shape (e.g., the shape of the compression portion  5902  that is shown in  FIG. 23C ). The original shape of the compression portion  5902  makes at least a portion of the opening  5910  have a smaller diameter D than the diameter X of the suture portion  5915 . The placement member  5906  is configured to expand the compression portion  5902  such that the entire opening  5910  has a diameter D that is larger than the diameter X of the suture portion  5915 , which allows the anchor member  5900  to be moved up and down the suture portion  5915 . For example, the placement member  5906  may be a cylindrical sleeve. Upon removing the placement member  5906 , the compression portion  5902  moves back to its original shape, which causes at least a portion of the compression portion  5902  to compress and secure the suture portion  5915  in a desired location. Referring to  FIG. 23C , in the illustrated embodiment, the anchor member  5900  is configured such that a lower portion  5908  of the compression portion  5902  is configured to compress the suture portion  5915 . In alternative embodiments, any other portion of the compression portion may be used to compress the suture portion  5915 , or the entire compression portion  5902  can compress the suture or suture  5915 . The abutment portion  5904  is configured to abut against an object that the attachment member is attached to, such as, for example, the annulus, an annuloplasty band, or any other object that the attachment member is attached to. The anchor member  5900  can be made of, for example, plastic, metal, steel, shape memory alloys, combinations of these materials, and the like. The placement member  5906  can be removed by holding the anchor in place and pulling the placement member  5906  or holding the placement member in place and advancing the anchor. In an embodiment, the anchor comprises a knot made from suture, for example, ePTFE suture that features a low-profile insertion configuration and a higher profile anchoring configuration. 
       FIGS. 24A-24C  illustrate the exemplary anchor member  5900  attaching an exemplary embodiment of an attachment member  5402  to a tissue member  6001  (e.g., the annulus of the mitral valve, the annulus of the tricuspid valve, etc.). In the illustrated embodiment, the attachment member  5402  is a T-shaped attachment member that includes a securing portion  6010  and a suture portion  6015 . The securing portion  6010  abuts a second side  6003  of the tissue member  6001 , and the suture portion extends through the tissue member  6001  to a first side  6002  of the tissue member  6001 . After the attachment member  5402  is attached to the tissue member  6001 , the attachment member  5402  is secured to the tissue member  6001  by the anchor member  5900 . Referring to  FIG. 24A , the anchor member  5900  is moved along the suture portion  6015  with the placement member  5906  maintaining the opening  5910  in an expanded state. Referring to  FIG. 24B , the anchor member  5900  is placed in a desired location in which the abutment portion  5904  of the anchor member  5900  is abutting the first side  6002  of the tissue member  6001 . Referring to  FIG. 24C , after the anchor member  5900  is placed in a desired location, the placement member  5906  is removed, which causes a lower portion  5908  of the compression portion to compress against the suture portion  6015 . The compression by the compression portion  5902  on the suture portion  6015  secures the attachment member  5402  to the tissue member  6001 . 
     Referring to  FIGS. 25 and 26 , another exemplary embodiment of an anchor member  6200  includes three or more flap members  6202 . The illustrated embodiment shows an anchor member  6220  that has three flap members  6202 . In alternative embodiments, the anchor member  6200  can have four flap members, five flap members, etc. The flap members  6202  are deflectable, such that each of the flap members  6202  can move from an open position ( FIG. 25 ) to a closed position ( FIG. 26 ). For example, a set shape of the flap members can be the closed position and the flap members can be held in the open position by a placement member. When the placement member is removed, the flap members can spring back toward the closed position from the open position. In some embodiments, the anchor  6200  includes a protector component (not shown), which may protect the suture from damage. For example, certain suture types may be prone to damage in certain situations, such as ePTFE (e.g., GORE-TEX® CV5 and CV4 suture), polypropylene (e.g., Ethicon PROLENE® suture), and/or the like. The protector component may be placed inside the anchor in the pre-deployed state, such that the protector is compressed around the suture, thereby reducing exterior damage. 
     An optional opening  6204  is provided at a center location between the flap members  6202 . When one or more of the flap members  6202  are in the open position, the opening  6204  is configured such that the anchor member  6200  can be moved along a suture portion of an attachment member. When all of the flap members  6202  are in the closed position, the opening  6204  is configured to compress the suture portion of an attachment member such that the suture portion is constrained in a radial direction. The anchor member  6200  is deployed in the open position and moved to a desired location on a suture portion of an attachment member. Once the anchor member  6200  is in the desired position, the flap members  6202  are simultaneously moved from the open position to the closed position. The flap members  6202  provide a force in the radial direction to secure the attachment member to a tissue member (e.g., to secure the attachment member to the annulus of the mitral valve). Alternatively, the flap members  6202  can be moved from the open position to the closed position in a sequential order or random order. During this alternative procedure, a tortuous path is crated with multiple holding points on the suture portion of the attachment member, which will increase the holding force on suture portions that have higher surface lubricities. The holding forces applied by the anchor member  6202 , in effect, create a tourniquet around the suture portion. The anchor can be made from a wide variety of different materials. For example, the anchor member  6202  can be made from plastic, metal, such as steel, shape memory alloys, such as Nitinol, and/or any combination of these materials, and the like. 
     In certain embodiments, the anchor member  6200  can be used with a protecting member (not shown) that is used to prevent surface damage to a suture portion of an attachment member as it is being held by the anchor member  6200 . The anchor member can be deployed by any suitable device, such as, for example, any of the valve repair devices disclosed in the present application. 
     The anchor members  5900 ,  6200 , as well as any other anchor members described in the present application, can be used to secure any of the attachment members described in the present application, and can be used in any of the procedures described in the present application. The anchor members  5900 ,  6200  can also be used in a wide variety of additional procedures. For example, the anchor members  5900 ,  6200  can be used in any procedure that involves approximating a tissue member. 
     A person skilled in the art should readily understand that, the above disclosed embodiments can be implemented with each other. For example, an exemplary needle delivery device can comprise four needles with the improvements disclosed above and in  FIGS. 12A, 12B, 14, and 15 . 
       FIG. 27  illustrates an embodiment of a needle  586 . A bend having an angle θ is implemented in the needle  586  at a position  508  along a length of the needle shaft. The area  508  may advantageously be approximately 1 cm or less from the tissue-piercing point  506  of the needle. The bend in the needle shaft can be configured to cause a centralized initial tissue puncture, followed by stretching of tissue rather than cutting due at least in part to a beveled edge associated with the portion  502  of the needle tip. For example, the angle θ may advantageously be implemented to cause the point  506  of the needle  586  to be aligned with a central axis  509  of the needle shaft  503 . In some embodiments, the angle θ of the bend  508  is between approximately 3°-5°. Because the point  506  is aligned with the central axis  509 , the bent needle tip may cause the initial loading of the needle tip  510  to be generally on the central axis  509  of the needle shaft  503 . This on-axis loading can prevent or impede lateral movement and/or torqueing of the needle  586  as it penetrates through biological tissue or other material. 
     The tip  510  of the needle  586  represents a multiple-bevel needle tip, as described in detail herein. The multiple-bevel tip  510  may be formed using a plurality of bevel cuts. For example, a first bevel cut may be used to form the proximal beveled surface  514  at the base of the needle tip, which extends from the base of the needle tip  510  to the inflection point  507 . In some implementations, a single bevel cut is used to form the proximal beveled surface  514 , which may have the same surface plane on both sides of the point  506  of the needle tip  510 . 
     The needle tip  510  may further be formed using one or more additional bevel cuts associated with the distal portion  512  of the needle tip  510  that is distal to the inflection point  507 . For example, a first angled bevel cut may be made on a first side of the point  506  of the needle tip, whereas a second angled bevel cut may be made on the opposite side of the needle point  506  in the distal portion  512  of the needle tip  510 . Such angled bevel cuts may advantageously form a relatively sharp tip portion  501  at or near the point  506  of the needle tip  510 . 
     A radiused, or relatively blunt, edge may be created at the portion  502  of the needle tip  510 , as described in detail herein. For example, the portion  502  of the needle tip  510  may be converted to a relatively non-sharp, or rounded, surface in order to induce dilation of the tissue at the puncture site. Generally, dulling of needle surfaces may be considered undesirable in some applications as increasing the resistance of puncture for the needle. In certain medical applications, such additional resistance may increase pain or discomfort associated with needle puncture. However, with respect to solutions relating to embodiments of the present disclosure, such additional puncture resistance may be acceptable as a trade-off for the induced dilation benefits described herein. 
     The bend  508  in the needle shaft may be an axial bend in the needle shaft designed to align the sharp point  506  of the needle tip  510  with the central axis  509  of the needle  586 . The bend  508  in the needle shaft may advantageously minimize or reduce lateral movement of the needle during insertion of the tip  510  through biological tissue. In particular, with respect to certain other needles, the needle tip may tend to be deflected due to the angle of the needle tip surface(s). Such surface(s) may undesirably push or direct the needle tip away from the target penetration point, which may result in tissue damage or injury. With the point  506  of the needle tip  510  aligned with the center axis  509 , a more centered position may be achieved, such that migration of the needle as it penetrates the target tissue may be reduced or prevented. Due to the bend  508 , loading of the needle  586  may be generally coincident with the axis  509  of the needle shaft in one or both directions. In some implementations, when manufacturing the needle  586 , the bend  508  may be implemented prior to implementing the bevel cuts associated with the needle tip  510 . 
     The radiused portion  502  of the needle tip surface may be implemented in any suitable or desirable way. For example, needle tip radiused edge may be achieved using electropolishing or other similar technology. For example, when radiusing the portion  502  of the needle tip surface, the portion  501  that is desired to remain relatively sharp may be covered such that it is not exposed to the electrochemical processes for radiusing the portion  502 , such that only a relatively small portion  501  of the needle tip remaining relatively sharp. When puncturing biological tissue, the through-hole produced may be relatively small for the needle  586 , wherein the tissue around the through-hole may be inclined to dilate, rather than tear, thereby advantageously producing a relatively small through-hole. When the needle tip  510  is subsequently withdrawn from the puncture site, the punctured tissue may be inclined to recede, such that only the small puncture hole produced by the relatively sharp portion  501  of the needle tip  510  remains. Although the illustration of  FIG. 27  shows an inflection bend  508 , in some embodiments, the alignment of the point  506  of the needle tip  510  with the central axis  509  is achieved through a curved or continuous bend. 
     In some implementations, the present disclosure relates to pre-shaped tissue anchors configured to provide increased or desirable holding force when deployed on biological tissue, such as on the distal/atrial side of a heart valve leaflet, as described in detail herein.  FIGS. 28A-28C  illustrate views of a pre-shaped wire tissue anchor  300  in accordance with one or more embodiments of the present disclosure. The anchor  300  may be used in accordance with certain embodiments disclosed herein as an alternative to certain knot-type anchors illustrated and described herein. In its deployed configuration, as illustrated in  FIGS. 28A-28C , the anchor  300  may have a generally planar body/form including a plurality of coplanar force-distributing arms or projections  301  that may extend generally radially outward from a center of the anchor  300 . Although the tissue anchor  300  is illustrated as having four projections/arms  301 , tissue anchors in accordance with the present disclosure can have greater or less than four projections/arms. Furthermore, although projections/arms are illustrated and described, it should be understood that the force-distributing features  301  may have any form or shape. 
     In some embodiments, the projections/arms  301  are formed of a single wire or form, as shown. Although the illustrated anchor  300  is formed to have two free ends  302 , the ends of the anchor may be joined or integrated in some manner. The projections/arms  301  may advantageously be shaped and/or configured such that the anchoring force exerted by the projections/arms is relatively evenly distributed over and against the tissue surface (e.g., atrial side of valve leaflet) when the device is deployed. The projections/arms  301  can advantageously be angularly/circumferentially spaced apart from one another to a maximum degree. The anchor  300  may have a relatively thin and flat profile, which may reduce the risk of thrombus in some implementations. 
     The anchor  300  can be self-expandable and can be formed from a shape-memory material, such as Nitinol, such that the anchor  300  self-expands from a delivery configuration to a deployed configuration when released or deployed from a delivery system or apparatus. In some embodiments, the anchor  300  is formed at least in part from a plastically-expandable material, such as stainless steel or cobalt-chromium alloy, and can be configured to be plastically expanded from a delivery configuration to a deployed configuration by an expansion device. In some embodiments, the anchor  300  may be laser cut or otherwise formed from a flat sheet of metal, such as Nitinol. Alternatively, the anchor  300  can be formed by bending one or more metal wires into the form shown. 
     The projections/arms  301  can extend perpendicularly or substantially perpendicularly to a central axis A of the anchor  300 , which generally may align with tethered suture(s)  394  that are coupled to the anchor in some manner. The suture(s)  394  may be tied or attached to the anchor  300  in any suitable or desirable manner. Although the suture  394  is shown as looped/tied around a connection portion between two projections/arms, suture(s) may be coupled to the anchor at other locations, including across an inner diameter of the anchor  300 , such as is shown by the dashed-line suture  310  in  FIG. 38A . 
     Each of the projections/arms  301  can comprise a respective loop-shaped member spaced including an open area  352  therein. Each projection/arm  301  may include two circumferentially-spaced radial inner ends  317  that are connected to adjacent radial inner ends of one or more adjacent projections/arms by respective connecting portions  315 . The projections/arms  301  and the connecting portions  315  of the anchor  301  may collectively form a simple open- or closed-loop structure wherein a single continuous frame member forms each of the projections/arms and the connecting portions. 
     As shown in  FIG. 28A , the anchor  300  in the deployed configuration can include a projection/arm diameter d 1  and an outer diameter d 2 . The outer diameter d 2  can be defined by the diameter formed from the radial outermost ends of the projections/arms. The number of arms, the length of the arms, and the diameter dimensions of the anchor  300  can be varied as needed for particular anchoring applications. Compared to certain other tissue anchors, the anchor  300  may advantageously provide comparable or greater anchoring/retention force using less material/metal, and therefore may be less susceptible to thrombus formation, be relatively easier to deliver and deploy, and/or provide other benefits. Although a single anchor  600  and associated suture(s) are shown in the needle  686  in  FIG. 29 , in certain embodiments, multiple pre-shaped tissue anchors may be delivered and/or contained within the needle  686 . 
       FIGS. 29-31  illustrate a tissue anchor  600  and associated delivery system  670  at various stages of a tissue anchor deployment process in accordance with one or more embodiments. Embodiments of pre-shaped tissue anchors in accordance with the present disclosure may be implemented at least in part by shape-setting an anchor profile in a metal (e.g., memory metal alloy, such as Nitinol) that is relatively elastic (e.g., highly-elastic or super-elastic). In some embodiments, such tissue anchors may comprise material(s) and/or form(s) that allow for the shape of the tissue anchor to be at least partially straightened or manipulated into a pre-deployed state or configuration that allows for relatively easy delivery and placement of the shape-set anchor form as an anchor for attached suture(s). 
     Referring to  FIGS. 29-31 , a needle  686  may be configured to be slidably disposed (e.g., slip-fit) within a shaft or lumen  678  of the delivery system  670 . The anchor  600  can be compressed, straightened, or otherwise constricted to a delivery configuration for delivery to the target anatomy in the delivery system  670 . In the delivery configuration, the anchor  600  can be placed and retained in a generally straightened/compressed configuration in which projections/arms thereof are elongated to form one or more lengths of relatively straightened wire/material. Although the wire  600  is shown in a folded delivery configuration, in some embodiments, the anchor  600  is not folded or overlapped in the delivery configuration. In the delivery configuration, the suture(s)  694  may advantageously be pre-attached/coupled to the anchor  600 , as shown. For example, as in the illustrated embodiment, the suture(s)  694  may be attached to the anchor  600  at or near a fold  605  in the anchor. In some embodiments, the suture(s)  694  may be attached to the anchor  600  at a crimped wire end portion thereof. 
     In  FIG. 30 , the distal end  698  of the needle  686  has been extended from the distal end of the main shaft  678 . The distal end  698  of the needle  686  may be configured to penetrate the target tissue  652 , as shown. In some embodiments, at least a portion of the tip portion of the needle  686  can be electropolished to make it smooth to promote tissue dilation rather than cutting. The anchor  600  may be configured to assume a delivery configuration, as shown in  FIG. 29 , as well as a deployed configuration, as shown in  FIG. 31 , wherein  FIG. 30  shows a partially-deployed configuration. 
     In some embodiments, the tissue anchor  600  in stored in a distal end portion of the needle  686 . With reference to  FIG. 29 , the tissue anchor  600  may be compressed/straightened to allow for storing in the delivery system  670 , as shown. The stored tissue anchor  600  can generally be placed in a configuration in which one or more portions of the wire anchor are at least partially parallel with the longitudinal axis of the needle  686 , such as in a compressed/straightened state or otherwise configured to allow for storage in a relatively small area. With reference to  FIG. 30 , the tissue anchor  600  can be configured to expand and/or rotate when deployed out of the needle  686 . The projections/arms thereof can be heat-set or otherwise shaped to extend axially away from each other when deployed. 
     The tissue anchor  600  may advantageously be coupled to one or more sutures  694  at portion  605 . That is, the portion  605  of the anchor wire  600  may comprise a suture-attachment feature, such as a fold or bend in the wire, an eyelet, a hook, a clamp or crimp in the wire, or the like. In some embodiments, the suture(s)  694  may be tied to the anchor  600  or otherwise engaged with the suture-attachment feature  605 . The suture(s)  694  can take a wide variety of different forms. For example, the suture  694  can be a suture, a wire, a tape, a band, a string, or the like. In some embodiments, the suture  694  comprises PTFE or ePTFE material. In some embodiments, the suture  694  comprises UHMwPE (ultra-high molecular weight polyethylene) material (e.g., DYNEEMA®, Koninklijke DSM, Heerlen, The Netherlands), for example, FORCE FIBER® suture (Teleflex Medical, Gurnee, Ill.). The proximal ends of the suture tails  694  may extend from the proximal end of the delivery system shaft  678  and/or a pusher/ejector  690  component of the delivery system  670 . 
     The pusher/ejector  690  can be slidably disposed (e.g., slip-fit) within the needle lumen. When deploying the tissue anchor  600 , a distal portion  604  of the ejector  690  may extend from the distal end  698  of the needle  686 , for example on the atrium side of valve leaflet tissue. The pusher/ejector  90  may be configured to push the tissue anchor  600  out of the distal end  698  of the needle  686 . In the embodiment illustrated, the pusher/ejector  90  comprises an interior lumen through which the suture tails  694  may be passed. In some embodiments, the distal end  604  of the pusher/ejector  690  prevents the tissue anchor  600  from entering into the interior lumen of the pusher/ejector  90 . Alternatively, the suture  694  may pass through the interior lumen of the needle  686  and run parallel with the pusher/ejector  690 . 
     With reference to  FIGS. 30 and 31 , the delivery system  670  may be positioned against a surface  651  of target biological tissue  652 . For example, an atraumatic tip  688  of the delivery system  670  may be localized to the ventricle side of a target valve leaflet in some implementations. The atraumatic tip  688  may comprise silicone or other at least partially flexible material in a flange configuration at a distal end of the main shaft  678 . The needle  686  may be advanced to puncture through the tissue  652 . In some embodiments, both the pusher/ejector  690  and the suture  694  move with the needle. The tissue anchor  600  may remain inside the needle  686  until it is ejected therefrom using the pusher/ejector  690 . The pusher/ejector  90  may be advanced to push the tissue anchor  600  out of the needle  686 . 
     As shown in  FIG. 31 , the tissue anchor  600  may be moved to its deployed position and configuration as it is ejected from the needle  686 . For example, the tissue anchor  600  can move or be drawn to a position that is substantially orthogonal to the axis of the needle  686  for placement against the distal surface  653  of the target tissue  652 . In some embodiments, the tissue anchor wire is configured to assume the deployment configuration in response to a stimulation of some type, such as an electrical or thermal stimulation. Once the tissue anchor  600  is deployed, the delivery system  670 , the needle  686 , and the pusher/ejector  690  may be withdrawn from the tissue  652 . As deployed, the tissue anchor  600  and suture(s)  694  may cover the tissue puncture site and can be used to anchor the suture  694  onto another tissue area to connect the tissue anchor  600  to another tissue anchor. In some embodiments, the anchor  600  is deployed in combination with a pledget form, which may provide desirable force-distribution and/or tissue protection. 
     The anchor  600  may be used to anchor artificial chordae tendineae to heart valve leaflets, as described in detail herein, and/or may be used for other types of tissue-approximation therapies. Pre-shaped wire tissue anchors in accordance with embodiments of the present disclosure can provide for relatively easy placement of the tissue anchors on the distal side of tissues along with attached sutures. In some embodiments, the anchor  600  may be delivered and/or deployed having a mesh/cloth covering or sleeve around at least a portion thereof, which may serve to protect the adjacent biological tissue and/or provide other benefits. In some embodiments, the anchor is coated or wrapped in material designed and/or configured to promote in-growth of tissue therewith, which may help prevent against tissue abrasion over time. Once deployed, the shape-set wire anchor  600  can assumes its pre-shaped form, thereby providing increased resistance against pulling through the puncture hole in the tissue. The anchor  600  may comprise a wire form that is advantageously rigid enough to be maintained on a distal side of the target tissue without the propensity to be drawn back through a puncture hole implemented to deploy the anchor  600 . Furthermore, the anchor  600  may advantageously be sufficiently rigid to prevent or reduce irritation or my corporation against the adjacent tissue. 
     Although the tissue anchors in  FIGS. 28-31  are illustrated as having a clover-type shape with loop-shaped projections/arms, it should be understood that anchors and/or projections/arms thereof can have a variety of shapes. For example, shapes for projections/arms may generally have one or more narrow portions and one or more wide portions, which may be configured to desirably distribute anchoring forces. Some embodiments of projections/arms or features for tissue anchors in accordance with the present disclosure have any desirable shape including, but not limited to, a mushroom shape, a diamond shape, a circular in shape, or any other shape. In some embodiments, the configuration of one or more of the projections/arms can be different from one or more other projections/arms of the anchor. In some embodiments, the projections/arms of a tissue anchor need not comprise loop-shaped members with central openings and instead can comprise elongated wires or strut members that are secured to a common central portion at only one end of the wire or strut member.  FIGS. 32-34  illustrate additional example tissue anchor forms in accordance with embodiments of the present disclosure, including a flower-type anchor  710  comprising petal-type projections, a spiral-type anchor  720 , and a grill-type anchor, respectively. 
     It is contemplated that the devices and methods disclosed herein can be used in procedures outside the heart. That is, while the embodiments have been described with reference to a heart valve, the needles, devices and methods described above can be used in any procedure that requires penetrating a tissue and providing a reinforcement on the far side thereof. In view of the many possible embodiments to which the principles of the disclosed invention can be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. All combinations or sub-combinations of features of the foregoing exemplary embodiments are contemplated by this application. The scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.