Abstract:
Tissue fixation members interact with a housing to hold tissue relative to the housing and allow the orientation and position of the grasped tissue to be manipulated with improved efficacy. The tissue fixation members can be easily and quickly moved between deployed and retracted positions to reversibly grasp and release tissue.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of: 
     U.S. Provisional Patent Application No. 61/638,979 which was filed Apr. 26, 2012, entitled: TISSUE FIXATION DEVICE. 
     The above-identified document is herein incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     The present disclosure includes examples of tissue fixation devices. Specifically, the tissue fixation devices described herein may be used with a uterine manipulator to grasp, retain and release cervical tissue. It will be appreciated that the disclosed embodiments may have applications outside of uterine manipulation, and may be used on other bodily tissues. 
     In some surgical procedures, it is desirable to control the position and orientation of an organ, such as a uterus, to help the surgeon operate on the uterus or on other parts of the body adjacent to the uterus. Uterine manipulator devices can be used to position and orient a uterus during surgery. U.S. Patent Application Publication No. US2012/0109147 discloses an example uterine manipulator system. Typical uterine manipulator systems consist of a bell-housing or cup shaped member that fits around the cervix and a rod member that is inserted through the cervix and into the uterus. The bell housing can be sized and shaped to compress the cervical tissue against the rod member to help the surgeon grasp the cervix and manipulate the position and orientation of the uterus. The bell housing can also provide a cutting guide to facilitate incision placement, for example colpotomy incisions and incisions requiring a safe distance from the ureters and uterine arteries. However, if the cervical tissue fixation within the bell housing is insufficient, a uniform colpotomy incision is difficult to achieve. Furthermore, the risk of damaging surrounding tissues, such as the ureters and uterine arteries, will increase if the tissue fixation is insufficient. The compressive forces imparted to the cervical tissue between the bell housing and the rod member are usually not sufficient enough to tightly grasp the cervix and ensure safe incision placement. Accordingly, it has been known to include a balloon in combination with the rod member which can be inflated inside of the uterus to provide additional pressure on the cervical tissue between the balloon and the bell housing to force the cervical tissue down into the bell housing and increase the gripping force of the bell housing on the cervix. However, the internal balloon may not create optimal tissue fixation, especially in patients with anatomical abnormalities, rigid tissues, scar tissue, and the like. Additionally, the balloon may leak or become accidentally “nicked” by other surgical instruments during the surgical procedure. This may result in loss of tissue fixation that can delay and complicate surgical incisions and/or removal of the uterus through the vagina in the case of a hysterectomy procedure. Moreover, it may not be desirable to use a balloon inside of a uterus containing cancerous cells, because the cancerous cells can be broken loose by the balloon and spread to other parts of the body. Sufficient tissue fixation is typically not achieved with a balloon, as is evidenced by workarounds currently used by many surgeons. For example, surgeons are known to use adjunctive stitches through the cervix which are then tied to the instrument to increase tissue fixation. This workaround adds additional steps to the surgery and further complicates things by making it difficult to quickly remove the bell housing and/or uterine manipulator from the patient if an emergency situation arises, such as the need to defibrillate the patient&#39;s heart. 
     Accordingly, it is desirable to provide a device that achieves reliable tissue fixation, with or without a balloon, that will last throughout the entire surgical procedure and that will not be compromised by rigid tissue, anatomical abnormalities, scar tissue, cancerous tissue, or the like. In some cases, it may also be desirable to generate tissue fixation close to certain incision sites, such as the colpotomy incision site, to increase the control, placement and precision of the incision. It is also desirable to provide a device that employs a simple actuation mechanism to quickly and easily engage and disengage the tissue fixation mechanism during surgery. 
     An example of the present technology disclosed herein includes a tissue fixation assembly shaped to be attached to a uterine manipulator. The assembly includes a housing, a fixation member carriage with deployable fixation members, and a cap. The fixation member carriage and fixation members are captured between the housing and the cap. In one example, a suture is attached to the fixation member carriage and is actuatable to move the fixation member carriage to deploy or retract the fixation members. The assembly may be inserted into a vagina and receive cervical tissue within the housing. The fixation members may then be deployed inwardly from the housing to grip the cervical tissue. The fixation members may also be locked in the deployed position to maintain the grip on the tissue. The fixation members may also be easily retracted to release the tissue and remove the device as needed. 
     Those of skill in the art will recognize that the following description is merely illustrative of the principles of the disclosure, which may be applied in various ways to provide many different alternative embodiments and may be applicable outside the fields of surgery or medical devices. While the present disclosure is made in the context of tissue fixation related to the cervix, for the purposes of illustrating the concepts of the design, it is contemplated that the present design and/or variations thereof may be suited to other uses for grasping any bodily tissue. Moreover, the devices and methods set forth herein may be used in open, percutaneous, and/or minimally invasive procedures. 
     All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. 
     Standard medical planes of reference and descriptive terminology are employed in this specification. A sagittal plane divides a body into right and left portions. A mid-sagittal plane divides the body into equal right and left halves. A coronal plane divides a body into anterior and posterior portions. A transverse plane divides a body into superior and inferior portions. Anterior means toward the front of the body. Posterior means toward the back of the body. Superior means toward the head. Inferior means toward the feet. Medial means toward the midline of the body. Lateral means away from the midline of the body. Axial means toward a central axis of the body. Abaxial means away from a central axis of the body. Ipsilateral means on the same side of the body. Contralateral means on the opposite side of the body. These descriptive terms may be applied to an animate or inanimate body. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the present disclosure will now be discussed with reference to the appended drawings. It will be appreciated that these drawings depict only typical examples of the present disclosure and are therefore not to be considered limiting of its scope. 
         FIG. 1  is a perspective view of a tissue fixation device according to one example of the present disclosure having a housing, a cap, and deployable fixation members; 
         FIG. 2  is a side view of the tissue fixation device of  FIG. 1 ; 
         FIG. 3A  is a top view of the tissue fixation device of  FIG. 1  with the fixation members in a retracted position;  FIG. 3B  is a top view of the tissue fixation device of  FIG. 1  with the fixation members in a deployed position; 
         FIG. 4  is an exploded view of the tissue fixation device of  FIG. 1 ; 
         FIG. 5  is a top exploded view of the tissue fixation device of  FIG. 1 ; 
         FIG. 6  is a bottom exploded view of the tissue fixation device of  FIG. 1 ; 
         FIG. 7A  is a top view of the housing and fixation member carriage assembly of the tissue fixation device of  FIG. 1  with the fixation members in a retracted position and dashed lines indicating suture paths under the fixation member carriage assembly;  FIG. 7B  is a top view of the housing and fixation member carriage assembly of the tissue fixation device of  FIG. 1  with the fixation member in a deployed position; 
         FIG. 8  is a side cross-sectional view of the tissue fixation device of  FIG. 1  with the fixation members in a retracted position, taken along section line  8 - 8  in  FIG. 7A ; 
         FIG. 9  is a perspective view of another tissue fixation device in accordance with the present disclosure with the tissue fixation members in the deployed configuration; 
         FIG. 10  is a perspective view of the tissue fixation device of  FIG. 9  with the tissue fixation members in the retracted configuration; 
         FIG. 11  is an exploded view of the tissue fixation device of  FIG. 9 ; 
         FIG. 12  is a perspective view of another tissue fixation device in accordance with the present disclosure with the tissue fixation member in the deployed configuration; 
         FIG. 13  is a perspective view of the tissue fixation device of  FIG. 12  with the tissue fixation member in the retracted configuration; 
         FIG. 14  is a perspective view of another tissue fixation device in accordance with the present disclosure with the tissue fixation members in the deployed configuration; 
         FIG. 15  is a perspective view of the tissue fixation device of  FIG. 14  with the tissue fixation members in the retracted configuration; 
         FIG. 16  is a perspective view of another tissue fixation device in accordance with the present disclosure with the tissue fixation members in the deployed configuration; 
         FIG. 17  is another perspective view of the tissue fixation device of  FIG. 16  with the tissue fixation members in the deployed configuration; 
         FIG. 18  is a perspective view of the tissue fixation device of  FIG. 16  with the tissue fixation members in the retracted configuration; 
         FIG. 19  is a perspective view of another tissue fixation device in accordance with the present disclosure with the tissue fixation members in the deployed configuration; and 
         FIG. 20  is a perspective view of the tissue fixation device of  FIG. 19  with the tissue fixation members in the retracted configuration. 
     
    
    
     DETAILED DESCRIPTION 
     While certain embodiments are shown and described in detail below by way of illustration only, it will be clear to the person skilled in the art upon reading and understanding this disclosure that changes, modifications, and variations may be made and remain within the scope of the technology described herein. Furthermore, while various features are grouped together in the embodiments for the purpose of streamlining the disclosure, it is appreciated that features from different embodiments may be combined to form additional embodiments which are all contemplated within the scope of the disclosed technology. 
     Not every feature of each embodiment is labeled in every figure in which that embodiment appears, in order to keep the figures clear. Similar reference numbers (for example, those that are identical except for the first numeral) may be used to indicate similar features in different embodiments. 
     Any of the devices described herein may be fabricated from metals, alloys, polymers, plastics, ceramics, glasses, composite materials, or combinations thereof, including but not limited to: titanium, titanium alloys, commercially pure titanium grade 2, ASTM F67, Nitinol, cobalt chrome, stainless steel, UHMWPE, PEEK, and biodegradable materials, among others. Different materials may be used within a single part. The devices disclosed herein may also encompass a variety of surface treatments or additives, including but not limited to: anti-microbial additives, analgesics, anti-inflammatories, etc. Any device disclosed herein may include a radiographic marker for imaging purposes. Any device disclosed herein may be color-coded or otherwise marked to make it easier for the surgeon to identify the type and size of the device. 
       FIGS. 1-8  illustrate one example of a tissue fixation device  10 . The tissue fixation device  10  can include a housing  12 , a cap  14 , and a fixation member carriage assembly  16  (not visible in  FIGS. 1 and 2 ) which carries at least one fixation member  18 . In some examples, the fixation member  18  may be a needle. The fixation member carriage assembly  16  can be captured between the housing  12  and cap  14 , and may be rotatable within a track  26  formed in the housing  12  and/or the cap  14 . It is appreciated that in other embodiments, the cap  14  may be integral with the housing  12  and not formed as a separate element. 
     The cap  14  and housing  12  may be referred to as a bell cap or a bell housing, as they may form a bell shape in some examples. In some examples, the housing  12  can have at least one enclosed section that completely encloses at least one planar surface. The at least one planar surface can be defined by a cross-sectional plane through the housing that results in a planar surface that is completely enclosed by an open portion of the housing. In other words, the planar surface is an empty plane that is completely bounded by the housing  12 . For example, with reference to  FIG. 2 , if a cross section of the housing  12  is taken perpendicular to the longitudinal central axis  35  and through the top portion of the housing, or the cap  14 , a circular planar surface would be created which lies within the opening of the housing  12  and which is completely bounded by or surrounded by the housing  12  or cap  14 . On the other hand, if the perpendicular cross-sectional plane were moved lower on the housing to where it crosses the struts  22 , housing inner space  33 , and windows  23 , then this would result in a planar surface that is not completely bounded on all sides, or surrounded by the housing  12  because the windows  23  are open. 
     In other examples, the housing  12  may not have at least one enclosed section. In these examples there may be discontinuities or breaks in the housing (not shown) of any size or shape. In these examples, the at least one fixation member can be deployed away from an inner surface  42  of the housing and into the opening to grip tissue. The at least one fixation member can be also be retracted away from the opening toward an inner surface of the housing to release the tissue. 
     Referring to  FIGS. 3A and 3B , the device can be actuable between a fixation member  18  retracted configuration, and a fixation member  18  deployed configuration. From the top or bottom perspective, the device can be radially symmetric. The embodiment shown in  FIGS. 1-8  includes three curved fixation members  18 . It will be appreciated that other embodiments may include more or fewer fixation members  18 . 
     Referring to  FIGS. 4 and 5 , housing  12  can be substantially circular or cylindrical in shape. However, the housing  12  can also be conical, frustoconical, funnel, ovoid, or polygonal in shape, or any combination of shapes thereof. The shape of the housing is not as important as the ability of the housing to enclose tissue to be grabbed by one or more fixation members, as will be apparent from the present disclosure. Continuing with  FIGS. 4 and 5 , housing  12  may include an attachment portion  20  which may be shaped to connect to a uterine manipulator (not shown). A plurality of struts  22  can project superiorly from the attachment portion  20  and terminate at a carriage support  24 . Windows  23  may be interspersed between the struts  22 . However, in other embodiments, the housing may not include struts  22  or windows  23 . The carriage support  24  can be ring-shaped, and include a carriage track  26 , which may be substantially circular. An outer rim  28  can circumscribe the outer diameter of carriage track  26 , and a step  30  may be formed intermediate the track  26  and the outer rim  28 . One or more apertures  32  can open through the carriage support  24 , and may pass through at least a portion of the outer rim  28  and step  30 . A housing inner wall  34  can circumscribe the inner diameter of the carriage track  26 , and may include a plurality of discontinuations, or wall gaps  36 . At least one edge  38  of each wall gap  36  may be beveled. When operatively assembled, the fixation members  18  are deployable through the wall gaps  36 ; the beveled edges  38  may promote smooth deployment of the fixation members  18  and prevent the fixation members  18  from hanging up or being caught in the wall gaps  36 . 
     Housing  12  may be generally stepped in outer profile, wherein the carriage support  24  has the widest outer diameter, struts  22  form a circle of intermediate diameter, and attachment portion  20  has the narrowest outer diameter. The inner wall  34 , struts  22 , and attachment portion  20 , may surround and define a housing inner space  33 . A lengthwise central axis  35  may extend through the housing inner space  33 , also defined by the inner wall  34 , struts  22 , and attachment portion  20 . The number and width of struts  22  and windows  23  may vary, and in some embodiments the housing  12  may be formed as a continuous piece extending between the attachment portion  20  and the carriage support  24 , with no struts  22  or windows  23  present. The embodiment depicted in  FIGS. 1-8  is generally bell shaped; however in other embodiments the housing  12  and/or the device  10  may have a cylindrical shape and may include a tapered portion at either end. In other embodiments the device  10  may be cup or bowl shaped, or polygonal. 
     Cap  14  may have a ring-shape, and may include an outer side  40  opposite an inner side  42 . An outer surface  44  of the outer side  40  may be positioned as an upper surface, and may include a plurality of steps, ridges and/or grooves which may facilitate gripping and manipulating the cap  14 . As seen in  FIG. 6 , the inner side  42  may have circular outer and inner diameters. A cap inner wall  43  forms the inside diameter of the cap  14 , and may include a plurality of tabs  46  which project inferiorly from the inner wall  43 . Each tab  46  may include at least one beveled edge  48 . A cap outer wall  50  may extend inferiorly, intermediate to and adjoining cap inner wall  43  and cap outer wall  50  and form a track cover  52 . A plurality of cap bosses  54  can project inwardly from the cap outer wall  50 . Each cap boss  54  may include a ramp feature  56  which urges the fixation member  18  inward as it is deployed. The cap  14  can also have beveled edges  48  which can also help urge the fixation member  18  inward as it is deployed. Cap outer wall  50  can include a plurality of recessed alcoves  58  which allow space for the curved fixation members  18  to be retained within the cap outer wall  50  when the fixation members  18  are in the retracted position. Housing  12  and cap  14  may be formed of plastic, or other materials listed herein. 
     Fixation carriage assembly  16  can include a generally circular fixation carriage  60 . A plurality of mounting features  62  can project superiorly from the fixation carriage  60 . Each mounting feature  62  may include a recess  64  through which an opening  66  is formed. Openings  66  can be sized to allow passage of a suture  90 . Each mounting feature  62  can further include a fixation member mount  68 . In the embodiment shown, fixation member mount  68  includes two pin holes  70  through which a mounting pin  72  passes. Fixation member carriage  60  can have a first or superior side  74  and a second or inferior side  76 . A circular setback or groove  78  can be formed on the inferior side  76 , and be sized to receive a suture. 
     Each fixation member  18  can be curved, rigid, and may terminate at a beveled point. The rigid fixation members may be formed of stainless steel, or other materials disclosed herein. Other embodiments may include flexible fixation members, which may be straight or curved, and may be made of Nitinol, for example. The fixation member curvature may be non-concentric with the curvature of the carriage track  26 , for example the fixation member curvature may have a smaller diameter than the diameter of the carriage track. Each fixation member  18  may include a base portion  80 , a shaft  82 , and a point  84 , which may also be referred to as a tip. The fixation may have an arch shape that lies substantially in a single plane in some examples, in other examples, the fixation member can be substantially straight. In yet further examples, the fixation member can have a curved shape in multiple planes or in an infinite number of planes. When assembled into the fixation member carriage assembly  16 , base portion  80  is received in fixation member mount  68 , and a mounting pin  72  may pass through the fixation member mount  68  and base portion  80  to form a hinge type connection, about which the fixation member  18  may pivot. 
     Referring to  FIGS. 7A ,  7 B, and  8 , fixation member carriage assembly  16  may be mounted in the upper portion of housing  12 , such that fixation member  60  is received in carriage track  26 . A line gap or suture gap  86  may be formed between the groove  78  and outer rim  28 . A first line, or suture  90  may be threaded through one opening  66 , along suture gap  86  in a first direction  100  and through one aperture  32 . A knot  92  may be formed in the suture end remaining at opening  66 , the knot residing in recess  64  immediately adjacent opening  66 , and the knot preventing withdrawal of the first suture through the opening  66 . A second suture  94  may be threaded through a second opening  66 , along suture gap  86  in a second direction  102  opposite the first direction, and through another aperture  32 . The second suture  94  may also be knotted, forming knot  96  to prevent withdrawal. When the first and second sutures are thus placed, pulling on the first suture  90  will pull the fixation member carriage assembly  16  in the first direction  100 , and pulling on the second suture will pull the fixation member carriage assembly  16  in the second, or opposite, direction  102 . The sutures  90 ,  94  may be replaced by another type of line, flexible member, rigid member, filament, braid, yarn, cable, wire, chain, strap, lacing, or the like. 
     In an alternative threading embodiment, a single suture can be used. A first end of the suture is passed down through one opening  66 , along suture gap  86  and out one aperture  32 . The first end is then passed partially around the housing  12 , up into a second aperture  32 , along suture gap  86  and up through a second opening  66 . The suture is knotted at both of the openings  66 , and a length of suture is left along the housing  12 , between the two openings  32 . With this threading, pulling on one end of the length of suture will pull the fixation member carriage assembly  16  in one direction, and pulling on the second end of the length of suture will pull the fixation member carriage assembly  16  in the opposite direction. 
     The sutures or portions of the sutures may be color-coded. For example, the first suture may be colored green and the second suture may be colored red; of course any color scheme may be used so long as the sutures are visually distinct. Similarly, if one suture is used, different portions of the one suture may be color coded differently. In one example, the green color may be used to indicate that pulling on the green suture (or green portion) will deploy the fixation members and the red color may be used to indicate that pulling on the red suture (or red portion) will retract the fixation members. Also, portions of the suture(s) may be colored to a specific length in order to be used as visual indicators to show when the fixation members are fully deployed or retracted. For example, if all the red color is hidden because it has been drawn into the suture gap  86  that may provide indication that the fixation members are fully deployed. In some examples, only one suture, or one portion thereof, may be colored, a second portion or a second suture retaining its natural color. 
     In other embodiments, one or more sliding tabs, levers or other actuation features may be used instead of the sutures to move the fixation member carriage and/or deploy the one or more fixation members. The actuation features may push, pull or otherwise urge movement of the fixation member carriage and/or fixation members. 
     When the cap  14  is fitted to the housing  12 , tabs  46  may fit into wall gaps  36 , although inferior to each tab  46  an open portion of each gap can remain, the open portion sized to permit passage of the fixation member tip  84  and shaft  82 . Fixation member carriage assembly  16  can thus be captured in an enclosure formed between the carriage track  26  and track cover  52 . When the tissue fixation device  10  is in the retracted configuration, each fixation member  18  is substantially contained in a fixation member retention space  88  bounded by fixation member carriage  60 , track cover  52 , housing inner wall  34  and cap outer wall  50 . In this configuration, each fixation member tip  84  is adjacent to, but not extending beyond, a wall gap  36 . To move the device  10  into the deployed configuration, the appropriate suture is pulled, for example suture  90 , and fixation member carriage assembly  16  will be pulled along carriage track  26  in direction  100 . As the carriage assembly  16  travels, carrying fixation members  18 , fixation member tips  84  will encounter ramp features  56  of bosses  54  and be forced, or deflected, through the open portions of wall gaps  36 , thus being inwardly deployed. The deployment paths of fixation members  18  may be coplanar in some embodiments, and the fixation members  18  may be deployed along a plane perpendicular to a lengthwise central axis  35  of the housing  12 . In other embodiments, the fixation members  18  may move up and/or down out of a plane perpendicular to a lengthwise central axis  35  of the housing  12 . In these embodiments, the deployment paths of the fixation members  18  may be parallel to the central housing axis, or at an acute angle to the axis; the paths themselves may be nonlinear, curved, helical, or the like. The fixation members  18  may pierce tissue, such as cervical tissue, positioned in the housing inner space  33 . Deployment can stop when the fixation member bases  80  become wedged between housing inner wall  34  and cap ramp feature  56 . Another stop to the carriage motion may be formed when mounting feature  62  of the carriage assembly  16  encounters cap boss  54 . Because of the wedging engagement of the fixation member bases between the housing  12  and cap  14 , the deployed fixation members can be locked in the deployed configuration and remain deployed until they are intentionally retracted. 
     The fixation member tips  84  can be shaped similar to a hypodermic needle such that, minimum penetration force is needed to deploy the fixation members  18  into the tissue. Furthermore, in this example, when the three fixation members  18  are fully deployed, the fixation members  18  can engage with over 280 degrees of tissue, creating strong tissue fixation. Moreover, this embodiment allows the fixation members  18  to be close to the outer surface  44  of cap  14  which may serve as a cutting guide during colpotomy incisions. This allows the tissue fixation members to be less than about 0.25 inches from the cutting guide and the interiorly located fixation members  18  will not impinge on the cutting path. It will be appreciated that other size cutting guide tip designs can be made to adjust the distance and orientation of the cutting guide to achieve different incision placements as desired. 
     To move the device  10  into the retracted configuration, the second suture  92  is pulled. The fixation member bases  80  will be disengaged from the inner wall  34  and ramp feature  56 , and fixation member carriage assembly  16  will be pulled in the opposite direction, or direction  102 . As the carriage moves, the inner curved side of the shaft  82  of each fixation member will be forced outward as it encounters inner wall  34 , and fixation members  18  will be retracted in through wall gaps  36 . 
       FIGS. 9-20  show alternative embodiments of tissue fixation devices.  FIGS. 9-11  show a tissue fixation device  110  having a housing  112 , a cap  115 , fixation member carriage  116  and at least two fixation members  114  which rotate into the deployed position in opposite directions. In this example, tissue fixation device  110  has four fixation members  114 . Two of the fixation members rotate into the deployed position in the same direction and the other two fixation members rotate into the deployed position in the opposite direction. However, it will be understood that more or less fixation members  114  can be used in other embodiments without departing from the spirit or scope of the present disclosure. Similar to the example of  FIGS. 1-8 , the fixation members  114  can have beveled tips  118  which interact with ramp features (not shown) to force the fixation members inward toward the tissue as the fixation members  114  rotate into the deployed position, similar to other embodiments disclosed herein. The cap  115  can also have beveled edges  156  which may also help urge the fixation member  18  inward as it is deployed. 
     Operation of this tissue fixation device can be similar to that described above with reference to  FIGS. 1-8 , except that multiple fixation member carriages  116 ,  117  can be stacked on top of each other, with each of the fixation member carriages  116 ,  117  being free to rotate in opposite directions. In this example, two fixation member carriages  116 ,  117  are used. However, in other embodiments, more than two fixation member carriages can be used. Actuation of the fixation members  114  into the deployed position can be accomplished by any mechanical means disclosed herein. In one embodiment, a first suture (not shown) with one end split into two suture portions can be used with one of the split ends connected to the first fixation member carriage  116  in a first direction and the other split end connected to the second fixation member carriage  117  in a second direction. When the first suture is pulled, the two fixation member carriages  116 ,  117  will rotate in opposite directions relative to each other. A second suture (suture) with one end split into two suture portions can be used to reverse the rotation of the two fixation member carriages with the split ends of the second suture connected to the fixation member carriages  116 ,  117  in opposite directions relative to the split ends of the first suture. Thus, when the second suture is pulled, this causes the two fixation member carriages to rotate in opposite directions relative to pulling the first suture. 
       FIGS. 12-13  show a tissue fixation device  210  having a housing  212 , and a helical fixation member  214  which may be formed of a material such as Nitinol.  FIG. 12  shows the helical fixation member  214  in the deployed position, and  FIG. 13  shows the helical fixation member  214  in the retracted position. The helical fixation member  214  can be engaged with a rotatable carriage member  216 . The helical fixation member can have a sharp beveled tip  218  that is angled upward toward the inserted tissue to help draw the fixation member  214  into the tissue as the fixation member is rotated into the deployed position. 
     In use, tissue may be received within housing  212 , and the helical fixation member  214  can be rotatably advanced into the tissue by rotating carriage member  216  to engage and hold the tissue relative to the housing  212 . It will be appreciated that helical fixation member  214  advances along a deployment path which includes a rotational component and an axial component relative to the center housing axis. 
       FIGS. 14-15  show a tissue fixation device  310  having a housing  312 , and multiple helical fixation members  314 ,  315  which may be formed of a material such as Nitinol.  FIG. 14  shows the helical fixation members  314 ,  315  in the deployed position, and  FIG. 15  shows the helical fixation members  314 ,  315  in the retracted position. The helical fixation members  314 ,  315  can be engaged with a rotatable carriage member  316 . The helical fixation members  314 ,  315  can have sharp beveled tips  318  that are angled upward toward the inserted tissue to help draw the fixation members  314 ,  315  into the tissue as the fixation members  314 ,  315  are rotated into the deployed position. The sharp beveled tips  318  of each of the helical fixation members  314 ,  315  can be positioned out of phase with each other by 180 degrees. 
     In use, tissue may be received within housing  312 , and the helical fixation members  314 ,  315  can be rotatably advanced into the tissue by rotating carriage member  316  to engage and hold the tissue relative to the housing  312 . It will be appreciated that helical fixation members  314 ,  315  advance along a deployment path which includes a rotational component and an axial component relative to the center housing axis. It will be appreciated that other embodiments may include more than two helical fixation members without departing from the spirit or scope of the present disclosure. 
       FIGS. 16-18  show a tissue fixation device  420  having a housing  422  and at least one curved fixation member  424 . In this embodiment there are three curved fixation members  424 , however, other embodiments may include more or fewer curved fixation members  424 . FIGS.  16  and  17  show the curved fixation members  424  in the deployed position and  FIG. 18  shows the curved fixation members  424  in the retracted position. The curved fixation members  424  may be flexible, semi-flexible, or rigid. The curved fixation members  424  may be advanced upward from the housing  422 , through tissue, and the tips  418  of the curved fixation members  424  may then be received in capture features  426  formed in the housing  422  to hold the tissue relative to the housing  422 . Other embodiments may reverse the deployment direction of the curved fixation members  424 . For example, the curved fixation members  424  may be advanced downward from the housing  422 , through tissue, such that the tips  418  of the curved fixation members  424  are received in capture features  426  formed in the lower portion of the housing  422 . In this embodiment, the position of the apertures where the curved fixation members  424  exit the housing and the capture features  426  are reversed. In other embodiments, the curved fixation members  424  may be advanced sideways from the housing  422  and into capture features  426  formed on the sides of the housing  422  such that the apertures where the curved fixation members  424  exit the housing and the capture features  426  lie in a plane substantially perpendicular to the lengthwise central axis of the housing  422 . 
       FIGS. 19-20  show a tissue fixation device  510  having a housing  522  and one or more fixation members  524 . In this example there are three fixation members, however in other examples there may be more or fewer fixation members  524 .  FIG. 19  shows the tissue fixation device  510  with the fixation members  524  in the deployed position.  FIG. 20  shows the tissue fixation device  510  with the fixation members  524  in the retracted configuration. The housing can have angled ramps  528  formed near the beveled tips  518  of the fixation members  524  which force the fixation members toward the center of the tissue fixation device  510  and into the tissue as the fixation members  524  are moved into the deployed position. The fixation members  524  can be moved between the deployed and retracted positions by means discussed herein including sutures, levers, sliding tabs, translating members or any other suitable mechanical means. 
     It should be understood that the present apparatuses and methods are not intended to be limited to the particular forms disclosed. Rather, they are intended to include all modifications, equivalents, and alternatives falling within the scope of the claims. They are further intended to include embodiments which may be formed by combining features from the disclosed embodiments, and variants thereof. 
     The claims are not to be interpreted as including means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) “means for” or “step for,” respectively. 
     The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically. 
     The use of the word “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more” or “at least one.” The term “about” means, in general, the stated value plus or minus 5%. The use of the term “or” in the claims is used to mean “and/or” unless explicitly indicated to refer to alternatives only or the alternative are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and/or.” 
     The terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as has and “having”), “include” (and any form of include, such as “includes” and “including”) and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes” or “contains” one or more steps or elements, possesses those one or more steps or elements, but is not limited to possessing only those one or more elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes” or “contains” one or more features, possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. It is appreciated that various features of the above-described examples can be mixed and matched to form a variety of other alternatives. For example, fixation members, needles, hooks or barbs may be interchangeable in any of the embodiments set forth herein, as may the actuation means for deployment. As such, the described embodiments are to be considered in all respects only as illustrative and not restrictive. Similarly, manufacturing, assembly methods, and materials described for one device may be used in the manufacture or assembly of another device. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.