Abstract:
Devices, systems and methods for compressing, cutting, incising, reconfiguring, remodeling, attaching, repositioning, supporting, dislocating or altering the composition of tissues or anatomical structures to alter their positional or force relationship to other tissues or anatomical structures. In some applications, the invention may be used to improve patency or fluid flow through a body lumen or cavity (e.g., to limit constriction of the urethra by an enlarged prostate gland).

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to and the benefit of pending U.S. Provisional Application No. 61/800,303 filed Mar. 15, 2013 entitled “Devices, Systems And Methods For Treating Benign Prostatic Hyperplasia And Other Conditions,” which application is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    Benign Prostatic Hyperplasia (BPH) is one of the most common medical conditions that affect men, especially elderly men. It has been reported that, in the United States more than half of all men have histopathologic evidence of BPH by age 60 and, by age 85, approximately 9 out of 10 men suffer from the condition. Moreover, the incidence and prevalence of BPH are expected to increase as the average age of the population in developed countries increases. Despite extensive efforts in both the medical device and pharmaco-therapeutic fields, current treatments remain only partially effective and are burdened with significant side effects. Thus, there remains a need for the development of new devices, systems and methods for treating BPH as well as other conditions in which one tissue or anatomical structure impinges upon or compresses another tissue or anatomical structure. 
       SUMMARY 
       [0003]    Embodiments disclosed herein include a system for treatment of a prostate. The system includes a first anchor configured to be placed on an outer surface of a capsule of the prostate. The first anchor is fixed to an end portion of a flexible connector. The system includes a second anchor configured to be placed on an outer surface of a capsule of the prostate. The second anchor slidably engages the flexible connector. The second anchor is configured to allow the connector to slide only in one direction. A portion of the connector is placed across a urethral surface of the prostate. 
         [0004]    In some embodiments, the first anchor is configured to toggle about the connection point with the end portion of a flexible connector. In some embodiments, the second anchor is configured to create a 180 degree bend in the flexible connector. In some embodiments, the second anchor comprises a rounded projection and a stopping latch. In some embodiments, the system includes a wire having an angled distal end, and the angled distal end of the wire cooperates with the stopping latch of the second anchor to eject the second anchor from the system. In some embodiments, the end of the first anchor is angled. In some embodiments, the system includes a wire including an angled distal end, and the angled distal end of the wire cooperates with the angled end of the first anchor to eject the first anchor from the system. In some embodiments, multiple second anchors are loaded within the system. In some embodiments, the first anchor and the second anchor are carried by a penetrating member. In some embodiments, the first anchor is ejected from a portion of the penetrating member proximal to a distal end portion of the penetrating member. In some embodiments, the second anchor is ejected from a portion of the penetrating member proximal to a distal end portion of the penetrating member. 
         [0005]    Embodiments disclosed herein include method of placing anchors proximate prostate tissue. The method includes placing a delivery system proximate a prostate gland. The delivery system includes a penetrating member, a first anchor, a second anchor, and a flexible connector. The first anchor is fixed to the connector and the second anchor is configured to allow the connector to slide only in one direction. The method includes advancing the penetrating member to penetrate the prostatic capsule at a first location and deploying the first anchor to a position proximate an outer surface of the prostatic capsule. The method includes advancing the penetrating member to penetrate the prostatic capsule at a second location and deploying the first anchor to a position proximate an outer surface of the prostatic capsule. The connector connects the first anchor and second anchor and is positioned such that a segment of the connector engages a portion of the prostatic urethra of the prostate gland. 
         [0006]    In some embodiments, the system further includes a deployment wire and the first anchor is deployed by engaging an end of the deployment wire with an end of the first anchor. In some embodiments, the system further includes a deployment wire and the second anchor is deployed by engaging an end of the deployment wire with an end of the second anchor. In some embodiments, the method further includes setting a tension on the connector. In some embodiments, the tension is maintained by features on the second anchor. In some embodiments, the tension is maintained by the cooperation of a rounded projection and a stopping latch on the second anchor. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]      FIG. 1A  illustrates an anchor according to an embodiment displacing and/or compressing tissue. 
           [0008]      FIG. 1B  illustrates an anchor according to an embodiment for providing an anchor point for a connector, such as suture. 
           [0009]      FIG. 1C  illustrates implantation of an anchor according to an embodiment. 
           [0010]      FIG. 1D  illustrates an anchor according to an embodiment for providing an anchor point for a connector, such as suture. 
           [0011]    FIG.  1 E and  1 E′ illustrate an anchor according to an embodiment in which tissue is displaced towards bone. 
           [0012]    FIG.  1 F through  1 F″″ illustrate placement of a one-piece anchor according to an embodiment. 
           [0013]    FIG.  1 G through  1 G″ illustrate placement of a one-piece anchor according to an embodiment. 
           [0014]      FIG. 2A ,  2 B and  2 B′ illustrate embodiments of anchors configured to securely attached to a connector such as a suture. 
           [0015]      FIG. 3A through 3C  illustrate delivery of an anchor system that includes a connector such as a suture according to an embodiment. 
           [0016]      FIG. 4A and 4B  illustrate an alternate anchor system that includes a connector such as a suture according to an embodiment. 
           [0017]      FIG. 5A through 5C  illustrate a tissue-piercing anchor including a depth control feature according to an embodiment. 
           [0018]      FIG. 6A and 6B  illustrate a tissue-approximation system with a tensioning element according to an embodiment. 
           [0019]      FIG. 7A and 7B  illustrate a method for displacing prostatic tissue using suture. 
           [0020]      FIG. 8A and 8B  illustrate embodiments of delivery of an anchor that is detachable from a delivery system. 
           [0021]      FIG. 9A and 9B  illustrate embodiments of a one-piece anchor. 
           [0022]      FIG. 9C ,  9 C′ and  9 D illustrate embodiments of an anchor that is formed in-situ. 
           [0023]      FIG. 10A through 10C  illustrate embodiments of staple-like anchors and placement of such anchors in tissue. 
           [0024]      FIG. 11A and 11B  illustrate embodiments of anchors that include barb-like features. 
           [0025]      FIG. 12A through 12C  illustrate embodiments of staple-like anchors and placement of such anchors in tissue. 
           [0026]      FIG. 12D  illustrates a system and method for forming staple-like anchors in situ according to an embodiment. 
           [0027]      FIG. 13A through 13E  illustrate systems for deploying a series of anchors according to various embodiments. 
           [0028]      FIG. 14A and 14B  illustrate multiple anchor loading systems according to various embodiments. 
           [0029]      FIG. 15A and 15B  illustrate multiple anchor delivery systems according to various embodiments. 
           [0030]      FIG. 16 through 18  illustrate various embodiments of methods to retract, displace, or compress prostatic tissue using configurations of anchors and suture. 
           [0031]      FIG. 19 through 21B  illustrate various embodiments of systems and methods to tighten and/or secure suture in configurations of anchors and suture. 
           [0032]      FIG. 22A through 22D  illustrate various embodiments of methods to retract, displace, or compress prostatic tissue using configurations of multiple anchors and suture. 
           [0033]      FIG. 23  illustrates a delivery system for placing an anchor according to an embodiment. 
           [0034]      FIG. 24A through 24C  illustrate cross-sectional views of various embodiments of a delivery system for placing an anchor. 
           [0035]      FIG. 25A and 25B  illustrate a device for holding a delivery device in position at a tissue location according to an embodiment. 
           [0036]      FIG. 26  illustrates various embodiments of methods to secure an anchor to tissue. 
           [0037]      FIG. 27  illustrates a delivery needle for delivering anchors according to an embodiment. 
           [0038]      FIG. 28 through 29B  illustrate suture anchors according to an embodiment. 
           [0039]      FIG. 30A through 34  illustrate a delivery method to retract, displace, or compress prostatic tissue according to an embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0040]    The following description of the preferred embodiments of the invention is not intended to limit the invention to these preferred embodiments, but rather to enable a person of ordinary skill in the art to make and use this invention. Disclosed herein are systems and methods for treating conditions wherein a tissue (e.g., the prostate gland) has a) become enlarged and/or b) undergone a change in form, position, structure, rigidity or force exertion with respect to another anatomical structure and/or c) has begun to impinge upon or compress an adjacent anatomical structure (e.g., the urethra). 
         [0041]    Anchors disclosed herein can be placed using steps of a method for compressing an anatomical region using a delivery device according to the following general description. Anchors of certain embodiments can be placed using variations of this general description. The delivery device is introduced in an anatomical region such that distal end of the delivery device is located adjacent to a target anatomical region to be treated. In one embodiment of a method, the delivery device is introduced transurethrally into the prostatic urethra. Thereafter, a puncturing element is advanced to puncture the anatomical region. In this example, the puncturing element punctures the prostate gland such that the distal end of the puncturing element is located in the pelvic cavity. The delivery device can include an anchor of certain embodiments herein, the anchor being carried by the puncturing element. The puncturing element can include a pusher element that can facilitate delivery and placement of certain anchors. Other elements that reversibly lock certain parts of the delivery device relative to each other can also facilitate delivery of anchors. An imaging modality can be used to verify the accurate placement and working of the delivery device and the anchor. In certain embodiments, the pusher element is pushed in the distal direction to push at least part of an anchor out of the puncturing element. In certain cases, at least part of the anchor is thereby deployed in the anatomy (e.g. in the pelvic cavity surrounding the prostate gland). Thereafter, the puncturing element is withdrawn by pulling it in the proximal direction. In embodiments in which part of the anchor includes a tensioning member, the delivery device can include a tension element that is used to set tension on such a tensioning member. For example, a tensioning element can be pulled in the proximal direction to set the tension. In certain embodiments, the tension element is pulled further in the proximal direction to compress the anatomical region between proximal and distal parts of an anchor. In certain embodiments, the proximal part of the anchor is then securely locked onto the tension member. Then, the proximal part of the anchor may be detached from the delivery device in certain embodiments. The detachment can be performed by a variety of mechanisms including, but not limited to, the anchor detachment mechanisms disclosed elsewhere in this patent application. In some embodiments, any excess length of the tension member is removed. This removal can be done using a variety of methods including, but not limited to, the methods disclosed elsewhere in this patent application such as cutting, delinking, melting, and breaking Thereafter, the delivery device is withdrawn from the anatomy. It should be understood that these deployment steps may be repeated in the same, opposing, or neighboring tissues to essentially tack up the encroaching tissue (e.g. prostatic tissue, tumor, relaxed tissue, expanded tissue or growth). It may be desired that over time the anchors become completely embedded within the tissue and covered to prevent encrustation, clotting, or other tissue or body-fluid interaction—this may be facilitated by the processes, therapeutic agents and coatings described elsewhere in the application. Although these anchors are shown on either side of the tissue, it may be possible to deploy either or both of them within the body of the tissue itself to help bury them and eliminate the possibility that they may interact with other parts of the body. It should further be noted that in the case of application to the prostate, that this technique may be used on any of the lateral or middle lobes to compress or hold the prostate gland away from the lumen of the urethra. 
         [0042]    As shown in  FIG. 1  A-G, in some embodiments of the invention, helical or coiled anchors can be employed. Such anchors can be deployed by a variety of delivery mechanisms, including rotating delivery mechanisms, and straight, hollow delivery mechanisms such as a needle or trocar in which a helical structure  100  can be stored in a linear configuration. The helical structure  100  can penetrate a prostate partially ( FIG. 1A ) or ( FIG. 1B ) through a target structure or tissue plane such as the capsule of a prostate, and can also be deployed entirely outside a target structure or tissue plane such as outside of the prostate ( FIG. 1C ), distal from the delivery trajectory.  FIG. 1  A-C depict a lobe of the prostate gland PG as the target tissue. In  FIG. 1B , the helical structure  100  is depicted as anchored to the prostatic capsule. The helical structure provides the ability to engagably secure to a tissue plane which location is not precisely known. By compressing such helical or coiled anchors, tension on a connecting member, such as a suture, can be provided. For example, by pulling the connecting member  150  proximally, the helical structure  100  can be compressed against tissue such as the prostatic capsule PC or the prostatic gland PG. When the connecting member  150  is tethered to proximal anchor, the compression on the helical structure  100  creates tension in the connecting member between the helical structure  100  and the proximal anchor. Proximal anchors are described in more detail in other embodiments disclosed herein.  FIG. 1D  depicts an anchor in which the coiled structure  100  is generally in the same plane and thus most of the coil can be placed in contact with tissue, thereby increasing the footprint of this distal section of the anchor against tissue. In the embodiment shown in FIG.  1 E and  1 E′, the helical structure  100  is depicted as having its distal end anchored to bone and its proximal end as anchored to the prostatic capsule PC. In  FIG. 1E , the helical structure  100  is stretched to extend between the bone and the prostatic capsule PC. In FIG.  1 E′, the spring-like structure  100  has been released and allowed to retract, which pulls the prostatic capsule PC towards the bone and help open the urethra. 
         [0043]    Another embodiment of a coiled anchor in an alternative orientation is shown in FIG.  1 F through  1 F″′. In this embodiment, the distal end  100  of the anchor begins to coil up as it is pushed beyond the end of the delivery mechanism  200  and into the anatomy beyond the prostatic capsule as depicted in  FIG. 1F  and FIG.  1 F′. As more of the anchor is pushed beyond the end of the delivery mechanism  200 , the proximal end  190  of the anchor can emerge from a slot  210  along a portion of the length of the distal section of the delivery mechanism  200  as depicted in FIG.  1 F″. The proximal end  190  of the anchor can include a preformed leg or tail that is capable of being held in a straightened configuration until it emerges from the delivery mechanism  200 , at which point it assumes a comparatively curved configuration as depicted in FIG.  1 F″′. The anchor provides a custom-fit or one-size-fits-all approach in that the amount of curved section versus the straight section can vary based on the tissue thickness between the urethra and capsule of the prostate. The distal end  100  of the anchor can include barbs or other structure that prevent the coil from unwinding and thereby allow the anchor to maintain tension on tissue. Further, pushing on the proximal tail  190  of the anchor can force more of the anchor beyond the prostatic capsule, which would reduce the length of the anchor in tissue. That is, the proximal tail  190  and the distal coil  100  would be closer together and the barbs or other structure that prevent the coil from unwinding would keep the tissue in compression. This and other embodiments disclosed herein provide a means of biasing the distal end of the anchor to compress, displace, or otherwise modify tissue. The displacement of the urethra can be adjusted over time by displacement of the proximal tail toward the distal coil (e.g., inflation of a balloon in the urethra). 
         [0044]      FIG. 1G ,  1 G′ and  1 G″ show an embodiment of an anchor that can be used to put tension on a connecting member  150  by a rotational motion. Similar to other embodiments, there is a proximal tail  190  and a distal coil  100 . In this case, the distal coil  100  has a corkscrew-type configuration that allows the depth of the coil to be set in the tissue by rotating the anchor such that the distal coil “screws” through the prostatic capsule or other tissue plane. A non-circular cross section for at least the proximal tail  190  can facilitate the rotational motion. Any of the implants can be resorbable or biodegrable with a degradation profile that allows the implant to dissolve after the compressed tissue of the prostate gland has atrophied. 
         [0045]    As shown in  FIGS. 2  A-B′, in some embodiments of the invention, multiple anchors can be provided pre-assembled on a connecting member in series within a puncturing element, wherein the distance between the anchors is adjustable, for instance by at least one of the anchors being slideably included on the connecting member for successive deployments. A mass of tissue can be captured between two of the anchors  400  and  410  by delivering one anchor to a position distal of the mass of tissue, and the other anchor to a position proximal to the mass of tissue. As one embodiment, the anchors  400  and  410  can be stainless steel, stamped from sheet. As one embodiment, the connector  150  can be injection molded polyester. A compressive force can be exerted on the mass of tissue by moving at least one of the anchors over the connecting member in the direction of the other anchor. 
         [0046]    To maintain the compressive force, the moving anchor or anchors can be locked onto the sliding member by a variety of mechanisms, as illustrated in  FIG. 2A-B .  FIG. 2A  illustrates an embodiment of a push-nut or zip-tie like locking mechanism. The anchor system includes a proximal anchor  400  and a distal anchor  410 . Distal anchor  410  includes a lock mechanism  415  that in  FIG. 2A  is depicted as a cut-out flap that allows connecting member  150  to travel only one way through the distal anchor  410 , analogous to a push-nut or zip-tie.  FIG. 2A  depicts the connecting member  150  as having a cap  155  against which the proximal anchor  400  can seat, but other mechanisms for fastening the proximal anchor  400  to the connecting member  150  are contemplated as described herein. 
         [0047]      FIG. 2B  illustrates an embodiment of a circumferential pivot-to-clamp mechanism. Clamping anchor  300  resides on the connecting member  150  and clamps onto the connecting member  150  when anchor wings  310  are pivoted from one configuration to another. It can be preferable that the unclamped configuration is such that the anchor wings  310  are substantially parallel to the connecting member  150  and the clamped configuration is such that the anchor wings  310  are substantially perpendicular to the connecting member  150 . Thus, when the clamping anchor  300  is clamped, the perpendicular anchor wings  310  provide a larger footprint to present to the tissue being displaced or compressed. The pivoting action engages the central section of the clamping anchor  300  with the connecting member such that the clamping anchor  300  is secured in place. Otherwise, the clamping anchor  300  can be free to slide along the connecting member  150 . 
         [0048]    These and other embodiments employing slide and lock anchors can advantageously be used to load multiple anchors on a single connecting member, reduce delivery sheath size, simplify delivery mechanism and obtain automatic locking upon deployment of an anchor. 
         [0049]    As shown in  FIG. 3  A-C, in some embodiments, a profile of a shaft of a device can be reduced by employing an anchoring system having a primary anchor  500  and a secondary anchor  590  that can be attached to each other by a length of suture  550  ( FIG. 3A ). The primary anchor  500  can be pre-bonded to the suture  550  and can be slid over a needle or trocar  560 . The primary anchor  590  can be pushed off the needle or trocar  560  at the time of delivery by a pusher  530  ( FIG. 3A and 3C ). The primary anchor  500  can have a tail  505  that can be pre-formed to take a curved position if unconstrained ( FIG. 3B ), but can get straightened out when assembled onto the needle or trocar  560 . This can provide a feature that facilitates flipping and engagement of the anchor inside of tissue or on the other side of a tissue plane once the anchor is pushed off the trocar. 
         [0050]      FIG. 4  A-B depict a variation of the embodiments of  FIG. 3A-3C  in which the primary anchor  500  can be prebonded to the suture  550  and can be located inside a needle or trocar  560 . The secondary anchor  590  can be housed outside the needle or trocar  560  and can be supported by a pusher  530  ( FIG. 4A ). The secondary anchor  590  can completely surround the suture  550  after assembly ( FIG. 4B ), which can reduce the risk of detachment from the suture  550 . 
         [0051]    As shown in  FIG. 5A-5C , in some embodiments a tissue anchor  600  can be employed having a rim  610  or depth stop  620  for the purpose of preventing undue protrusion of the anchor  600  into surrounding tissue, for instance in the case of providing an anchor to the capsule of a prostate, without creating a risk of penetrating adjacent rectal tissue. The anchor  600  can be connected to a proximal anchor via a connecting member  150 . 
         [0052]    As is shown in  FIG. 6  A-B, in some embodiments a spring-loaded member  720  can provide tension to a connecting member  150  between two tissue anchors  700 ,  790 . As shown in the embodiment in  FIG. 6A , a pair of tissue anchors  700 ,  790  can be positioned on the same side of a tissue plane or separate tissue planes as desired to achieve the intended effect, and be connected by a connecting member  150 . The anchor section, indicated by the arrows A and A′ in  FIG. 6  can be looped behind a second tissue plane. A coiled tensioning member  720  can be positioned over the anchor section, and after expansion, increase the length of the anchor section, as shown in  FIG. 6B , thereby pulling the two tissue planes in closer proximity. 
         [0053]    As is shown in  FIG. 7  A-B, in some embodiments of the invention a body lumen, such as a urethra, can be enlarged by the employment of a suture  150  only, in which the suture has been knotted  151 , or by a combination of a suture  150  and an adhesive  160  placed at the point where the suture  150  is intended to secure tissue. 
         [0054]    In the embodiment of  FIG. 7A , a suture  150  can be introduced through the wall of the urethra UT, directed in a loop behind the prostatic capsule and redirected to the lumen of the urethra UT, where the suture ends are tied together under tension, putting a compressive force on the prostate tissue. In the embodiment of  FIG. 7B , the suture  150  can be anchored to the wall of the urethra UT, directed to and through the prostatic capsule and fixated under tension by the application of a surgical glue  160 . 
         [0055]    As shown in  FIG. 8A , in some embodiments a capsular tab  800  to be placed at the capsule side of the prostate can be attached to an elongated member  830 , such as rod or wire using a sacrificial bond or weld  840 . These embodiments can advantageously be employed to avoid the use of a needle to place the capsular tab, thereby avoiding the cost involved in the manufacture of such needles. The elongated member  830  can be formed to have a pre-set curvature and be housed in a lumen when not in use. The elongated member  830  can be made of any suitable, preferably biocompatible material, including polymeric and metallic substances and compositions. In some embodiments, the elongated member  830  can be advantageously made of metallic alloys, such as Nitinol. The elongated member  830  can have a sharpened tip  835  to more effectively penetrate tissue. On deployment the elongated member  830  and capsular tab  800  can be driven out into the prostate and past the capsule. To deliver the capsular tab, the sacrificial bond or weld  810  can be broken such as by electrolysis. In an alternative embodiment, the elongated member can have a ring holding a section of the capsular tab. The ring can drive the capsular tab and the elongated member out onto the capsule of the prostate together. Upon retraction of the elongated member, the ring can allow the tail-end of the capsular tab to release, leaving the capsular tab on the capsule side. 
         [0056]    As shown in  FIG. 8B , in alternative embodiments, a capsular anchor  800  can serve as a leading point having a tip  805  that penetrates tissue, replacing the beveled portion of a delivery needle. The capsular anchor  800  can be connected to a hypotube  860 . In some embodiments, the hypotube can be advantageously made of metals, such as stainless steel, or of metallic alloys, such as Nitinol. In some embodiments the tip  805  can be made of polymeric materials, such as polyethylene terephtalate, and can be shaped or overmolded onto the capsular anchor. Upon deployment, the hypotube  860  can drive the capsular anchor  800  out into tissue and past the capsule. Upon retraction of the hypotube  860 , the capsular anchor  800  secures tissue. In yet another embodiment the tip can be bioabsorbable. 
         [0057]    In an embodiment of a method to reduce prostatic obstruction, tissue can be pulled away from the urethra via an extra-prostatic approach. A needle or trocar can be inserted transdermally through the obturator foramen or cranial to the superior pubic ramus and into the prostate. A tethered tissue anchor can be deployed from the tip of the needle or trocar into the prostate. The needle can be partially withdrawn, and the tether drawn taught to seat the prostatic anchor against the interior surface of the capsule. A second tissue anchor can then be delivered into the peri-prostatic fascia or the pelvic fascia. 
         [0058]    In another embodiment of method to reduce prostatic obstruction, a capsular anchor can be delivered through the prostatic capsule using a pressurized propulsion mechanism. The pressurized propulsion system can employ a piston assembly to propel the capsular anchor without discharging the propulsion medium, like a compressed gas, into the body. After firing, the trajectory of the capsular anchor can be limited by a tether, such as a length of suture. In another embodiment a pressurized propulsion mechanism can be used to propel a needle or trocar housing the capsular anchor. 
         [0059]    In some embodiments, as illustrated in  FIG. 9  A-D, a capsular anchor on a device to reduce prostatic obstruction can be constructed of a single, deformable member  900 . The member can be used to penetrate the prostatic capsule PC, and subsequently deformed on the outside of the capsule to form an anchor.  FIG. 9A  depicts an anchor in which the proximal part has a series of narrower segments  905 , which provide a position at which the proximal part will more easily bend. Thus, the length of the member within tissue can be customized by bending the proximal part of the member  900  at the appropriate narrower segment  905 . The distal section  910  of member  900  includes a wing  912  that allows the member  900  to penetrate the prostatic capsule PC but not be able to retract back through the prostatic capsule PC. 
         [0060]      FIG. 9B  depicts an expansion mechanism  930  on the distal section of the anchor  900  that is configured to deform and expand, increasing the effective footprint of the anchor on the prostatic capsule PC. In this embodiment, the proximal section of the anchor  900  includes a tail  920  configured to assume a curved configuration when released from a delivery device. 
         [0061]    FIG.  9 C and  9 C′ depict an anchor in which the distal coil  915  is formed by physically deforming distal segments of the anchor against a forming feature (e.g., an anvil) located at the distal end of the delivery member  990 . In this embodiment, the anchor  900  does not have a preformed coil at its distal tip, but instead the distal coil  915  is custom-formed by the features at the end of the delivery member  990 . FIG.  9 C′ depicts the anchor  900  in place in tissue, and include a proximal tail  920  that is also formed by the delivery member  990 .  FIG. 9D  shows more detail of an embodiment of a helical or coiled anchor distal end  915  that can be formed in-situ by advancing a plastically deformable material against an anvil feature in a delivery member  990 . The amount of coiled material can be adjusted to facilitate treatment of different thickness prostates. 
         [0062]    In some embodiments an elastic deformation of a material can be used to exert a force that reduces prostatic obstruction. 
         [0063]      FIG. 10A-C  show embodiments of elastically deformed devices that can introduced into tissue under tension, and that after release from a delivery device can revert to an unconstrained configuration, thereby enlarging a constricted urethral channel. For example,  FIG. 10A  depicts a wire-like or ribbon-like device  1000  implanted in each of two lobes of the prostate gland PG near the urethra UT. As the device  1000  is allowed to assume its unconstrained configuration, it expands the urethral lumen as depicted in FIG.  10 A′.  FIG. 10B  depicts a similar wire-like or ribbon-like device  1000  implanted at the urethral bend near the bladder. Straightening this bend can have the effect of relieving BPH symptoms.  FIG. 10C  depicts another placement of wire-like or ribbon-like devices  1000 . 
         [0064]    In some embodiments, anchoring of a tissue constraining member that relieves prostatic obstruction can be accomplished by barbs on the constraining member.  FIG. 11A and 11B  illustrate embodiments of barbed tissue constraining members. In  FIG. 11A , retraction of a delivery member  1150  with respect to an anchor  1100  can deploy barbs  1155 . In some embodiments natural movement of the prostatic tissue can promote advancement of the barbed sections of the constraining member into the tissue. In  FIG. 11B , barbs  1155  on either end of an anchor  1120  allow the anchor to compress tissue. The depth of penetration of the barbed ends through tissue sets the amount of compression on the tissue. 
         [0065]    In some embodiments, plastically deformable tissue constraining members can be formed to function as tissue staples.  FIG. 12  A-C illustrate embodiments of such tissue constraining members  1200 . The figures illustrate various placements of staple-like members  1200  that provide for expansion of the urethral lumen UT. 
         [0066]      FIG. 12D  illustrates an embodiment of an adjustable die  1250 , suitable to form variable curvature staples  1200 . Such customized staples can help reduce or minimize damage to tissue by matching the restraining force of the staple to the specific tissue geometry being restrained. 
         [0067]    As shown in  FIGS. 13A-E , in some embodiments, multiple capsular anchors can be provided in a device, for instance like a needle or trocar, loaded in series within the device for successive deployments. 
         [0068]    FIG.  13 A and  13 A′ illustrate an embodiment of a device  405  capable of deploying the multiple anchors  400 ,  410  depicted in  FIG. 2A . A wire  407  routes through each anchors hole  412  such that the wire can be used with each deployment. The wire can be a threaded member  490  which engages the distal anchor tab  410  via hole  412  and allows for the anchor to be positioned at the desired place in tissue via the stiffness imparted by the threaded member that allows the anchor to be pushed through tissue and/or held in place while a needle containing the anchor is retracted. The wire  407  is then pulled in tension while an anchor  400  is pushed in place to cinch the two anchors together. The proximal anchor  400  emerges from the device and can be pushed against tissue to compress or displace the tissue. The pushing also forced connector  150  through the one-way lock  415  of distal tab  410 . When the two anchors are in the appropriate position the elongate member  490  is unscrewed, retracted back to the next anchor within the device and the next pair of anchors in the device can be deployed by the same mechanism. 
         [0069]    FIG.  13 B and  13 B′ show an embodiment of a device in which multiple capsular anchors  1300  can be loaded in the delivery needle or trocar  1350  and released manually. 
         [0070]      FIG. 13C  shows an embodiment of a device having a slotted delivery needle or trocar  1459  into which multiple anchors  1400  can be loaded. 
         [0071]      FIG. 13D  shows an embodiment of a device having a delivery needle or trocar  1550  which can be preloaded with multiple implants  1500  advanced by an elongated member  1530  like a wire. Implants  1500  include a distal tab  1510  and a coil  1590 , both of which features are disclosed in detail elsewhere herein. 
         [0072]      FIG. 13E  shows an embodiment of a device that can have a series of metallic implants  1600 , like nitinol implants, in a needle  1630  having a slot  1610 . The implants  1600  function to grip a suture  1650 . The series of implants can be advanced out of the end of needle  1630  and deployed to compress tissue. Each implant  1600  can act as a suture lock such that tissue is compressed between suture segments locked by each implant. 
         [0073]    As shown in  FIGS. 14A-B , in some embodiments a handle on a device or a body of a device can contain multiple anchors. 
         [0074]      FIG. 14A  shows an embodiment of a device having a holder  1700  with multiple anchors  1710  that can be advanced by a spring-driven mechanism  1730 . 
         [0075]      FIG. 14B  shows an embodiment of a device with a rotating holder  1800  that can contain multiple anchors  1810 . 
         [0076]    As shown in  FIG. 15A-B , some embodiments can avoid the need for a hollow needle. 
         [0077]      FIG. 15A  shows an embodiment of an implants having sharp tips. The implants can register on a guidewire, which can drive the implants through tissue. A fixed length of a connecting member, such as a suture, can connect the implants. Looking from anterior to posterior, capsular anchors with a fixed connecting member therebetween can be pushed simultaneously with penetrating members from the urethra through the right and left lateral lobes of the prostate to hold back the encroaching tissue. 
         [0078]      FIG. 15B  shows an embodiment of an implant  2000  located on the exterior of a delivery device, such as a sharpened rod or a trocar  2050 . Implant  2000  is connected to a suture  2010 , which in turn can be connected to other implants. Suture  2010 , like the implant, is outside the trocar  2050 . 
         [0079]    As shown in  FIG. 16-18 , in some embodiments a suture loop or double suture configuration can be directed through the prostatic tissue, from the extra-capsular space to the urethral lumen or vice versa. A compressive force can be exerted on the tissue by placing tension on the sutures. Alternatively, these elements can be combined with the adjustable coiled anchors described elsewhere in the application to provide a one-size-fits-all configuration. 
         [0080]      FIG. 16  shows an embodiment of a suture loop  2150  that can be tightened by two spring-loaded mechanisms  2100  like those disclosed elsewhere herein, such as Nitinol coils, outside the prostatic capsule PC. 
         [0081]      FIG. 17  shows an embodiment of a suture loop that can be fitted with T-bars  2200 , pierced outside the prostatic capsule PC and tightened from the center. 
         [0082]      FIG. 18  shows an alternative embodiment of a suture loop that can be anchored with extra-capsular anchors  2300 . 
         [0083]    As shown in  FIG. 19-21 , in some embodiments an anchor or locking device can be positioned on a suture, a suture loop or alternative suture configuration directed through a prostatic urethra. 
         [0084]      FIG. 19  shows an embodiment of a suture configuration that can be anchored by two extra-capsular anchors  2400  where a suture configuration can be tightened by a sliding tightener  2420 . 
         [0085]      FIG. 20  shows an embodiment of configuration wherein two sutures A, B can each be anchored to a different extra-capsular anchor  2500 ,  2500 ′, and where tension on the sutures can be provided by a sliding suture through the tightener  2550  or sliding the tightener along the suture. The sliding tightener  2550  is crimpable or otherwise securable to suture B when the suture has been sufficiently tightened. 
         [0086]      FIG. 21A and 21B  show an embodiment of a tightener  2420  in which a tortuous path can provide a sliding/locking mechanism to tighten a suture configuration that can be anchored to two extra-capsular anchors  2400 .  FIG. 21A  shows the tightener  2420  in a pre-crimped position prior to the path becoming tortuous. After the diameter of the tighteneer  2420  is decreased, the suture path through the tightener will become more tortuous.  FIG. 21B  shows a tightener  2420  that becomes more tortuous as it is “crushed.” 
         [0087]      FIG. 22A ,  22 A′ and  22 A″ show embodiments of a suture loop that can be anchored by two extra-capsular anchors  2500 ,  2500 ′, wherein at least one of the anchors can be located on the suture  2550  in a sliding manner, and where the suture loop can be tightened by advancing the suture through at least one of the anchors. This embodiment can optionally include a suture lock  2555 . In  FIG. 22C , at least one of the sliding anchors can be configured analogous to a clothespin.  FIG. 22D  depicts placement of two anchors  2500 ,  2500 ′ using a device including two delivery needles  2530  and  2540 . Each of the needles  2530  and  2540  can include a slot, which allows suture  2550  to exit the needle after deployment. 
         [0088]      FIG. 23  shows an embodiment in which the delivery device  2690  includes hypodermic tubing  2630 , which houses a capsular anchor assembly  2600  and a guidewire component  2610 .  FIG. 24  A-C show different cross-sectional views to illustrate how the guidewire  2610  can be housed internally in the delivery device along with the capsular anchor assembly  2600 . Preferably, the guide wire  2610  has a round cross-section and is formed from a stainless steel material or a comparatively hard plastic material. 
         [0089]    The delivery sequence for the embodiments illustrated in  FIG. 23  and  FIG. 24A-C  can be as follows: (1) the delivery device  2690  is positioned at the target location on a prostatic lobe; (2) the guidewire  2610  is delivered through prostatic tissue and past the capsular surface; (3) the hypodermic tubing  2630  is delivered over the guide wire  2610  until it has penetrated past the capsular surface of the prostate; and (4) the hypodermic tubing  2630  is pulled back into the delivery device  2690  to deliver and seat the capsular tab  2600  against the capsular surface or within the prostate. 
         [0090]    Regarding the individual delivery steps, the first step has certain challenges that can be addressed as described herein. One of the challenges of delivering the guidewire component is to maintain the position of the delivery device relative to the prostatic lobe while the guidewire is being advanced. This can be done by maintaining compression on the lobe and manually feeding the guidewire through the prostate. A guidewire with a sharp end and small diameter can penetrate through the prostate with comparatively less force than is required to compress the lobe. This force differential will maintain the position of the delivery device relative to the prostatic lobe. Alternatively, a sharp penetrator on the shaft or at the leading edge of the hypodermic tubing could make pilot hole in a position, perpendicular to the delivery device, for the guidewire to enter the prostate. This can ensure that the trajectory of the guidewire is correct. Further, features incorporated on the delivery device can help anchor the device to the prostatic lobe. Such features could be a clamp mechanism which when pushed against the prostatic lobe clamps onto the tissue, as depicted in  FIG. 25A and 25B . Such a clamp mechanism could be part of the tip of the device or a separate clamping feature attached to the tip of the device. Still further, a vacuum system could be used to maintain the position of the delivery device with respect to the prostatic lobe. 
         [0091]    Regarding the second step, the guidewire component can be delivered through the prostate by manually feeding the wire through the prostate (through the device out the back of the handheld portion of the delivery device) or using a spring-loaded mechanism to deliver the guidewire. Once delivered, secure attachment to the capsular surface may be required to assist with the next step. Mechanical features preventing the guidewire from pulling back the prostate can help with such a secure attachment. Alternately, a guidewire to having shape memory features creating a geometry for secure attachment surface can be used.  FIG. 26  illustrates these embodiments. 
         [0092]    In the third step the hypodermic tubing is manually fed along the guidewire until it has penetrated past the capsular surface. As the hypodermic tubing is advanced, the guidewire feeds back into it. The pullback features in the guidewire would be pulled into the hypodermic tubing as it is advanced forward. In the fourth step, the hypodermic tubing is manually pulled back to unsheath the capsular tab. Alternately, the hypodermic tubing could use a spring-loaded mechanism (either pre-loaded or loaded as part of the delivery of the hypodermic tubing in step  3 ) to deploy the capsular tab. 
         [0093]      FIG. 27 through 34  depict another embodiment of the invention in which anchor parts are delivered through two different penetrating members.  FIG. 27A and 27B  illustrate two views of a stamped penetrating member assembly  2800 . A channel  2810  is formed by stamping sheet metal such as stainless steel. A wire  2830  is captured by stamped features  2840 . The majority of the penetrating member length has a ribbon-like cross-section. The profile, or cross-section, of the end of the penetrating member can have a concave or double concave configuration. The tri-facet tip  2805  is oriented to drive through tissue. 
         [0094]      FIG. 28  illustrates a distal anchor portion  2900 . The distal anchor portion  2900  can be formed from tubing such as stainless steel tubing. The tubing can be crimped onto a segment of suture  150  and includes a hole  2930  for the suture  150  to exit. The tubing can include a feature  2920  to facilitate crimping, such as a projection into the tubing or a hole for suture to engage when the suture is crimped. The anchor further includes an angled end  2990  that facilitates ejection of the anchor from the penetrating member.  FIG. 29A and 29B  illustrate a proximal anchor section  3000 , which includes a raised pulley feature  3010 , holes for the suture  3020 , a lock feature for one-way cinching  3030 , and optionally an arm  3035  to stiffen the lock feature. The tip  3038  of the lock feature can be bent down to increase engagement with suture, as depicted in  FIG. 29A . The features on the proximal anchor enable one-way cinching of suture. Further, the tip can have features at its end that improve the engagement with suture. The suture can be pulled in one and when tension pulls the suture in the opposite direction, the leading edge of the spring, and any feature thereon, stops the suture from progressing backwards. The edge is formed such that it presses down on the suture. 
         [0095]      FIG. 30A and 30B  illustrate, respectively, a side view and an angled view of the distal end of the first penetrating member  2800 . The penetrating member  2800  holds the first anchor portion  2900  housed in the channel  2839  of the penetrating member. The penetrating member  2800  deploys through the prostate. 
         [0096]      FIG. 31A and 31B  illustrate, respectively, a side view and an angled view of the distal end of the first penetrating member  2800  from which a distal anchor portion  2900  and a suture  150  have been ejected. The distal anchor portion  2900  is ejected by advancing the wire  2830 . The angle on the tip of the wire  2830  hits the angled end of the anchor and ejects the anchor. 
         [0097]      FIG. 32A and 32B  illustrate, respectively, a side view and an angled view of the distal end of the second penetrating member  2800 ′. The penetrating member  2800 ′ holds the proximal anchor  3000  housed in the channel  2810 ′. The penetrating member  2800 ′ deploys through the prostate. 
         [0098]      FIG. 33A and 33B  illustrate, respectively, a side view and an angled view of the distal end of the second penetrating member  2800 ′. The proximal anchor  3000  is ejected by advancing the wire  2830 ′. The angle on the tip of the wire hits the angled end of the anchor, and ejects the anchor. 
         [0099]      FIG. 34  depicts distal anchor  2900  and proximal anchor  3000  in use, compressing tissue. The delivery tool can have an adjustable length between the penetrating members and deploy two anchors at once. In some instances, it may be desirable to measure the prostate thickness and urethra length prior to setting the distance between the penetrating members. 
         [0100]    Certain embodiments relate to a system for treatment of a prostate. The system includes a first anchor, a second anchor, and a tensioner. The first anchor, second anchor, and tensioner are connected to a suture. The system also includes a delivery device having a needle configured to place the first anchor and second anchor outside the prostatic capsule from a position within the prostatic urethra. The tensioner is configured to increase the tension on a length of the suture positioned between the first and second anchor after each anchor has been placed outside the prostatic capsule. 
         [0101]    Certain embodiments relate to a system for treatment of a prostate. The system includes a first anchor connected via a length of a first suture to a tensioner and a second anchor connected to a second suture. The second suture is slidably engaged to the tensioner in a first tensioner configuration and fixedly engaged to the tensioner in a second tensioner configuration. The first anchor and second anchor are each placed outside the prostatic capsule and the tensioner is placed near a urethral surface of the prostate. 
         [0102]    Certain embodiments relate to a method of placing the anchors described herein by penetrating the prostatic capsule with a penetrating member. The penetrating member is a needle, a wire, a trocar, or any of the anchors. 
         [0103]    Certain embodiments relate to a system for treatment of a prostate. The system includes a first anchor configured to be placed on an outer surface of a capsule of the prostate. The first anchor is fixed to an end portion of a flexible connector. A second anchor is configured to be placed on an outer surface of a capsule of the prostate, the second anchor slidably engaging the flexible connector. The second anchor is configured to allow the connector to slide only in one direction and wherein a portion of the connector is placed across a urethral surface of the prostate 
         [0104]    The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is in fact disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art.