Abstract:
A system and method for inserting an implant into soft tissue. The system may include an elongate arm having an implant at a first end of the elongate arm and an actuator at a second end of the elongate arm. The implants may be contained in a cartridge assembly. Methods of inserting an implant may be used during nasal septum reconstruction.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 60/972,449, filed Sep. 14, 2007, and U.S. Provisional Patent Application Ser. No. 61/047,289, filed Apr. 23, 2008, the entire contents of each are expressly incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure relates generally to systems and methods for inserting implants into a patient&#39;s soft tissue. The present disclosure relates more specifically to systems and methods for connecting internal tissues to aid in healing and for approximation of soft tissues during head and neck surgical procedures such as nasal septum reconstruction. 
     BACKGROUND INFORMATION 
     In certain medical procedures, it may be desirable to connect internal tissues to aid in healing. One example of such a procedure is nasal septum reconstruction (also known as septoplasty). During a septoplasty, mucoperichondrial flaps are formed on each side of the septum and the deviated cartilage and bone are removed. During the procedure, it is desirable to approximate the flaps to reduce the deadspace and minimize the likelihood of hematoma between the flaps, which may lead to serious complications such as saddle nose deformity. 
     Existing techniques to approximate the flaps and reduce the deadspace include packing the nasal cavity to bring the flaps into proximity, which can cause high levels of discomfort to the patient and may lead to toxic shock syndrome. More often, the flaps are sutured with a running degradable suture. Suturing in such a small space is very difficult, even for the most highly trained surgeon and can also have complications such as trauma to the lateral wall of the nasal cavity and needle breakage. The use of implants to approximate the flaps and reduce the deadspace near the tissue can reduce patient discomfort and provide for approximation of the soft tissue in specific locations. 
     SUMMARY 
     Exemplary embodiments of the present disclosure comprise an implant system comprising: a first elongate arm having a first end and a second end; a cartridge assembly proximal to the first end, wherein the cartridge assembly comprises a plurality of implants; and a handle assembly proximal to the second end, wherein the handle assembly comprises a handle and an actuator. In certain embodiments, the implant system is configured to discharge an implant from the cartridge assembly when the actuator is actuated. The actuator may comprise a trigger, and the actuator may be configured to engage an actuator rod when the actuator is actuated. The actuator rod may be configured to discharge an implant when the actuator is actuated. Certain embodiments may comprise a biasing member configured to bias the actuator rod away from the first end of the first elongate arm. In certain embodiments, the actuator rod may be configured to move generally parallel to the first elongate arm during use, and the actuator rod may comprise a ram configured to engage the actuator during use. 
     In certain embodiments, the actuator rod may comprise a flexible end proximal to the plurality of implants, and the flexible end of the actuator rod may be configured to engage an implant during use. Certain embodiments may comprise a guide that directs the flexible end of the actuator rod at an angle to the first elongate arm during use, and the guide may be proximal to the first end of the first elongate arm. In certain embodiments, the cartridge assembly may be disposable. 
     Certain embodiments may comprise a second elongate arm comprising a distal end and a proximal end, and the second elongate arm may be generally parallel to the first elongate arm when the actuator is not actuated. In certain embodiments, the implant system may be configured to move the distal end of the second elongate arm closer to the first end of the first elongate arm when the actuator is actuated. Certain embodiments may comprise a cam gear having a cam surface engaged with the second elongate arm, wherein the actuator comprises an actuator gear engaged with the cam gear, and actuation of the actuator causes the cam surface to move the second elongate arm. Certain embodiments may comprise an actuator having a cam surface engaged with the second elongate arm, wherein actuation of the actuator causes the cam surface to move the second elongate arm. In certain embodiments, the plurality of implants are comprised of an absorbable copolymer. 
     Certain embodiments of the present disclosure comprise an implant system comprising: an elongate arm having a first end and a second end; an implant proximal to the first end; and an actuator proximal to the second end, wherein the implant system is configured to discharge an implant at an angle to the elongate arm when the actuator is actuated. In certain embodiments, the angle may be between 0 and 180 degrees; more specifically the angle may be between 0 and 90 degrees or more specifically between 0 and 45 degrees. In specific embodiments, the angle may be approximately 90 degrees; in still other embodiments, the angle may be approximately 45 degrees. Certain embodiments may comprise an actuator rod between the actuator and the implant, wherein the actuator rod comprises a flexible end proximal to the implant. 
     Other embodiments of the present disclosure comprise a method for approximation of soft tissues, the method comprising. The method may comprise: providing an implant system comprising an elongate arm having a first end and a second end; a cartridge assembly proximal to the first end, wherein the cartridge assembly comprises a plurality of implants; and an actuator configured to discharge an implant from the cartridge assembly. The method may also comprise inserting the elongate arm into a patient&#39;s nasal cavity and locating the first end proximal to a target implant location. The method may also comprise actuating the actuator; and discharging an implant into the target implant location. 
     Other embodiments of the present disclosure comprise an implant for use in approximating tissues, the implant comprising: a base portion; a stem; and a head portion configured for capturing tissue during use. In certain embodiments, the implant may comprise a base portion that is T-shaped or L-shaped. The head portion may be asymmetric and/or comprise a barb. In certain embodiments, the head portion comprises a pair of extensions extending past the stem and a slot in each extension. In certain embodiments, the implant is cannulated. The implant may comprise an aperture extending through the implant. 
     Certain embodiments of the present disclosure comprise an implant system comprising: a first elongate arm having a first end and a second end; an implant proximal to the first end; a handle assembly proximal to the second end, wherein the handle assembly comprises a handle and an actuator; a first actuator rod comprising a first flexible portion proximal to the first end, wherein the first flexible portion is configured to engage the implant; and a second actuator rod comprising a second flexible portion proximal to the first end, wherein the second flexible portion comprises a first tip configured to penetrate tissue 
     In certain embodiments, upon partial actuation of the actuator: the actuator is operatively engaged with the first and second actuator rods; the first flexible portion of the first actuator rod is engaged with the implant; and the second actuator rod is configured such that the first tip extends past the implant. 
     In certain embodiments, upon full actuation of the actuator: the actuator is operatively engaged with the first and second actuator rods; the implant is discharged from the implant system; and the second actuator rod is configured such that the first tip extends past the implant. In certain embodiments, the implant comprises a bevel proximal to the a distal end of the implant. In specific embodiments, the bevel directs the implant toward the second flexible portion when the implant is penetrating into tissue during use. 
     In certain embodiments, the implant comprises an aperture and the second flexible portion is configured to extend through the aperture upon full actuation of the actuator. In specific embodiments, the implant comprises a slot and the second flexible portion is configured to extend through the slot upon full actuation of the actuator. In certain embodiments, the second flexible portion comprises a second tip. The second tip may be configured to extend through an aperture or slot in the implant. 
     Certain embodiments comprise a system configured to discharge the implant at an angle to the first elongate arm. In specific embodiments, the implant is part of a cartridge assembly when the actuator is actuated. Certain embodiments may further comprise a second elongate arm comprising a distal end and a proximal end. In specific embodiments, the second elongate arm is generally parallel to the first elongate arm when the actuator is not actuated. 
     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. 
     Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating specific embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will be apparent to those skilled in the art from this detailed description. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a perspective view of an exemplary embodiment of an implant system. 
         FIG. 2  illustrates a perspective view of the exemplary embodiment of  FIG. 1 . 
         FIG. 3  illustrates an exploded view of the exemplary embodiment of  FIG. 1 . 
         FIG. 4  illustrates a partial section side view of the exemplary embodiment of  FIG. 1 . 
         FIG. 5  illustrates a partial section side view of the exemplary embodiment of  FIG. 1 . 
         FIG. 6  illustrates a partial side view of the exemplary embodiment of  FIG. 1 . 
         FIG. 7  illustrates a partial side view of the exemplary embodiment of  FIG. 1 . 
         FIG. 8  illustrates a partial side view of the exemplary embodiment of  FIG. 1 . 
         FIG. 9  illustrates a partial exploded view of the exemplary embodiment of  FIG. 1 . 
         FIG. 10  illustrates a partial section view of the exemplary embodiment of  FIG. 1 . 
         FIG. 11  illustrates a partial section view of the exemplary embodiment of  FIG. 1 . 
         FIG. 12  illustrates a perspective view of a component of the exemplary embodiment of  FIG. 1 . 
         FIG. 13  illustrates a perspective view of a component of the exemplary embodiment of  FIG. 1 . 
         FIGS. 14-25  illustrate perspective and orthogonal views of a component of the exemplary embodiment of  FIG. 1 . 
         FIGS. 26-27  illustrate the exemplary embodiment of  FIG. 1  during use. 
         FIGS. 28-29  illustrate orthogonal views of a first exemplary embodiment of an implant and installation component. 
         FIGS. 30-32  illustrate orthogonal views of a second exemplary embodiment of an implant and installation component. 
         FIGS. 33-34  illustrate orthogonal and perspective views of a third exemplary embodiment of an implant and installation component. 
         FIGS. 35-36  illustrate perspective views of a fourth exemplary embodiment of an implant. 
         FIGS. 37-39  illustrate orthogonal and perspective views of a fifth exemplary embodiment of an implant and installation component. 
         FIGS. 40-41  illustrate perspective and orthogonal views of a sixth exemplary embodiment of an implant. 
         FIGS. 42A-46  illustrate orthogonal and perspective views of a fifth exemplary embodiment of an implant and installation component. 
         FIGS. 47-51  illustrate sectional views of a portion of an implant system. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Referring now to the exemplary embodiment shown in  FIGS. 1 through 12 , an implant system  100  comprises a handle assembly  130  and a cartridge assembly  160  that can be coupled to or separated from handle assembly  130 . Handle assembly  130  comprises a right casing  132  and a left casing  134 , a counter tension arm  136 , a cam gear  138 , a handle  131 , and an actuator  140 . In the embodiment shown, actuator  140  comprises a trigger  141  and an actuator arm  146 . In other embodiments, actuator  140  may comprise different configurations, such as including a cam surface, a lever, switch, or other actuating mechanism. In the exemplary embodiment shown, actuator  140  also comprises a pivot point  145  and a gear  148 , Handle assembly  130  further comprises a plurality of screws  142  and pins  144  to couple right casing  132  to left casing  134 . Right casing  132  and left casing  134  can be coupled with glue, ultrasonic welding or other commonly practiced methods. Cartridge assembly  160  comprises a housing  162  and a cartridge arm  164 . A cartridge lock  147  can be positioned to retain cartridge assembly  160  to handle assembly  130  or to release cartridge assembly  160  from handle assembly  130 . 
     As shown in the views of  FIGS. 4-8 , cartridge assembly  160  comprises an actuator rod  165  with a ram  163 . As actuator  140  is actuated (i.e. pulled toward handle  131 ), actuator  140  pivots around pivot point  145 , and gear  148  engages cam gear  138 . In addition, actuator arm  146  moves toward ram  163 . As shown in  FIG. 7 , when actuator  140  is pulled a sufficient amount, actuator arm  146  engages ram  163  and moves actuator rod  165  within cartridge arm  164  of cartridge assembly  160 . 
     In the exemplary embodiment shown in  FIGS. 4-8 , cam gear  138  has an eccentric cam surface  139  that engages counter tension arm  136 . Eccentric cam surface  139  has an effective diameter that is variable for a portion of cam surface  139  and constant for a portion of cam surface  139 . In this exemplary embodiment, the effective diameter is the distance from the center of cam gear  138  to the portion of cam surface  139  engaging counter tension arm  136 . As cam gear  138  rotates (while actuator  140  is being pulled), cam surface  139  initially causes counter tension arm  136  to move towards cartridge arm  164 . At a certain point in the actuation of actuator  140  (just past the location shown in  FIG. 7 ), the effective diameter of cam surface  139  reaches a maximum value. As the actuation of actuator  140  is continued, counter tension arm  136  is moved to the position shown in  FIG. 8 . In this manner, counter tension arm  136  moves toward cartridge arm  164 , and can provide backing support for tissue located between counter tension arm and cartridge arm  164 . 
     In addition to the movement of counter tension arm  136 , the actuation of actuator  140  also causes actuator arm  146  to move towards ram  163 . As explained above, when actuator arm  146  reaches the position shown in  FIG. 7 , it engages ram  163  and causes actuator rod  165  to slide within cartridge assembly  160 . As shown in  FIGS. 9 and 10 , cartridge assembly  160  comprises housing  162 , cartridge arm  164 , ram  163 , actuator rod  165 , a cartridge  166  holding a plurality of implants  167 , a guide  168 , a support member  161  and a biasing member  169 . Actuator rod  165  comprises a distal end  173  that engages guide  168  during operation. Biasing member  169  exerts a force against ram  163  and biases ram  163  and actuator rod  165  towards the proximal end of cartridge assembly  160  (i.e. the end distal from guide  168 ). As previously described, actuator  140  can be actuated so that actuator arm  146  contacts ram  163 . Continued actuation of actuator  140  can cause actuator arm  146  to overcome the force exerted by biasing member  169 , so that ram  163  and actuator rod  165  are moved towards guide  168 . 
     In the exemplary embodiment shown, guide  168  comprises a curved surface  178  that receives distal end  173  as actuator rod  165  is actuated during operation. As actuator rod  165  moves toward guide  168 , distal end  173  engages curved surface  178  and is directed towards an implant  167 . Distal end  173  can thereby displace an implant  167  from cartridge  166  (as shown in  FIG. 11 ). During use, cartridge  166  can be located proximal to a tissue (not shown) into which implant  167  will be implanted. Distal end  173  can exert a sufficient force on implant  167  to cause implant  167  to penetrate the tissue. Though the guide  168  is shown to translate the distal end  173  ninety degrees, it should be noted that this translation can be any direction between 0° and 180°. In the exemplary embodiment shown, implant  167  is therefore ejected or discharged at an angle of approximately ninety degrees to cartridge arm  164 . In other embodiments, implant  167  may be discharged at an angle to cartridge arm  164  that is greater than or less than ninety degrees. In one exemplary embodiment, implant  167  may be discharged at an angle to cartridge arm  164  that is approximately 45 degrees. 
     Referring now to the exemplary embodiment of  FIG. 12 , a perspective view of the underneath side of cartridge assembly  160  shows one orientation of housing  162 , cartridge arm  164 , actuator rod  165 , cartridge  166 , implants  167  and guide  168 . In the exemplary embodiment shown, distal end  173  is narrower than the remaining portions of actuator rod  165  and enters cartridge  166 . In other exemplary embodiments, distal end  173  may have a different configuration than that shown in  FIG. 12 . For example distal end  173  may not be narrower than the remaining portions of actuator rod  165 . Implants  167  extend from cartridge  166  in a manner so that distal end  173  can discharge the implant  167  that is proximal to guide  168 . In certain embodiments, a biasing member  186  biases implants  167  towards guide  168 . When one implant  167  is discharged, distal end  173  is retracted back into the cartridge assembly  160 , and the remaining implants  167  move towards guide  168 . A subsequent actuation of actuator  140  will then discharge an additional implant  167 . 
     As shown in  FIG. 13 , distal end  173  may comprise any of several different configurations. For example, distal end  173  may be a ribbon or strip of constant width as shown in end  173 A, or distal end  173  may comprise a varying width as shown in end  173 B. Distal end  173  may also comprise a varying thickness as shown in an end  173 C. Distal end  173  may also have a cut-out (or cut-outs) as shown in  173 D or tabs as shown in  173 E. Distal end  173  may be made of any suitable material. Examples of such materials comprise plastic and/or metal, including superelastic materials such as nickel titanium, commonly referred to as Nitinol®. It is understood by one skilled in the art that other embodiments of distal end  173  may comprise combinations of the features disclosed, or additional features. 
     Referring now to  FIGS. 14-25 , various exemplary embodiments of implants are illustrated. As shown in  FIGS. 14-16 , implant  167 A comprises a post  121 , a transverse section  122 , a barb  123 , and a pointed tip  124 . Pointed tip  124  reduces the amount of force needed to insert implant  167 A into tissue (not shown), and barb  123  assists in holding implant  167 A in the desired location. Transverse section  122  holds the tissue in place and also reduces the likelihood that implant  167 A will be accidentally pushed through the tissue into which it is inserted. Implant  167 B shown in  FIG. 17  is similar to implant  167 A, but comprises a tip  125  with a straight edge rather than a point. Implant  167 C is also similar, but comprises a tip  126  with a single beveled point rather than the multiple bevel point shown in  FIG. 14 . Implant  167 D shown in  FIG. 19  comprises a barb  127  that is perpendicular to the primary axis (not shown) of the implant. Implant  167 E of  FIG. 20  comprises multiple transverse sections  128 , while implant  167 F shown in  FIG. 21  also comprises multiple barbs  129 .  FIG. 22  shows implant  167 G with a round cross-section instead of the rectangular or square cross-section shown in previous embodiments.  FIG. 23  shows an implant with an elliptical barb  111 .  FIG. 24  illustrates an implant  167 I with a disc-shaped transverse member  112 , while  FIG. 25  illustrates an implant  167 J with a rib  113  rather than a transverse member. 
     In certain embodiments implant  167  may be approximately four to six millimeters long, two to three millimeters wide, and approximately 0.4 to 0.7 millimeters thick. More specifically, implant  167  may be 4.5 to 5.5 millimeters long, 2.3 to 2.7 millimeters wide, and 0.5 to 0.6 millimeters thick. In a specific exemplary embodiment, implant  167  is approximately 5 millimeters long, 2.5 millimeters wide, and 0.55 millimeters thick. In certain exemplary embodiments, implant  167  comprises an absorbable copolymer comprising approximately 60 to 80 percent polyactide and approximately 20 to 40 percent polyglycolide. More specifically, implant  167  may comprise an absorbable copolymer comprising approximately 65 to 75 percent polyactide and approximately 25 to 35 percent polyglycolide. In a specific exemplary embodiment, implant  67  comprises an absorbable copolymer comprising approximately 70 percent polyactide and approximately 30 percent polyglycolide. In still other specific embodiments, implant  67  comprises an absorbable copolymer comprising approximately 90 percent polyactide and approximately 10 percent polyglycolide. In other embodiments, implants  167  may be non-absorbable. 
     Referring now to  FIGS. 26 and 27 , implant system  100  is shown in an exemplary method of use during a nasal septum reconstruction. As shown in  FIG. 26 , implant system  100  is positioned proximal to a patient&#39;s nose  200 . In this embodiment, implant system  100  is positioned so that cartridge arm  164  is proximal to a nasal cavity  210  and counter tension arm  136  is proximal to a nasal cavity  220 . 
     Referring now to  FIG. 27 , implant system  100  is then positioned so that cartridge arm  164  is inserted into nasal cavity  210  and counter tension arm  136  is inserted into nasal cavity  220 . Implant system  100  is inserted the desired amount so that the distal ends of cartridge arm  164  and counter tension arm  136  are located proximal to a target location where it is desired to place an implant  167  into a mucoperichondrial flap formed in the patient&#39;s septum (not visible in  FIGS. 26 and 27 ). When implant system  100  is positioned at the desired location, an operator stabilizes implant system  100  and actuates (i.e. pulls back on) actuator  140 . As described in the discussion of the preceding figures, the actuation of actuator  140  causes counter tension arm  136  to move towards cartridge arm  164 . Counter tension arm  136  can therefore provide backing support to the tissue into which the implant  167  will be inserted. The actuation of actuator  140  also causes distal end  173  of actuator rod  165  to force an implant  167  from cartridge  166 . 
     In the embodiment shown in  FIGS. 26 and 27 , counter tension arm  136  supports tissue on one side of the patient&#39;s septum, while an implant  167  is inserted into a mucoperichondrial flap on the opposite side of the patient&#39;s septum. In certain exemplary embodiments, initial implants  167  are placed anteriorly and superiorly within nasal cavity  210  as compared to subsequent implants  167 . In certain embodiments, implants  167  are placed within approximately two centimeters of each other. In other embodiments, implants  167  are placed within approximately 1.5 centimeters of each other, and in still other embodiments, implants  167  are placed within approximately one centimeter of each other. 
     In certain embodiments, implants  167  may be placed in both nasal cavities  210  and  220 , while in other embodiments implants  167  may be placed in either nasal cavity  210  or nasal cavity  220 . After the operator has placed implants in the bilayered mucosal flaps, the operator may visualize both nasal cavity  210  and  220  to assure adequate approximation and sufficient penetration of all staples through the flaps. After the tissue is appropriately approximated and all flaps are secured, the operator may dispose of cartridge  166  and any remaining implants  167 . However, the remaining components of implant system  100  may be sterilized reused for future procedures. 
     Referring now to  FIGS. 28 and 29 , front and side views are shown of one embodiment of an implant  1 . Implant  1  can be configured for use in conjunction with previously-described embodiments. As shown, a base portion of implant  1  is engaged with a ribbon  2 . In certain embodiments, ribbon  2  is equivalent to distal end  173  of actuator rod  165  of the embodiment described in  FIGS. 1-12 . In this embodiment, implant  1  comprises a T-shaped portion  3  which can act as a support against a tissue surface (not shown) when implant  1  is installed. In the embodiment shown, stem  6  couples T-shaped portion  3  to a barb  55  which has a point  4  created by the intersection of two faces  5  and  7 . In exemplary embodiments, faces  5  and  7  do not need to be symmetrical or of the same length. As shown, the included angle  56  between faces  5  and  7  is slightly modified (as compared, for example, to embodiments shown in  FIGS. 16 and 19 ) by configuring face  7  so that it is angled toward a center axis (not shown) of stem  6 . By angling face  7  towards face  5 , the intersection of faces  5  and  7  at point  4  is closer to the center axis of stem  6 , which can provide for more stable tissue piercing during use. Certain embodiments may also comprise a face  12  as shown in  FIG. 29  to further assist in piercing tissue during use. As shown in  FIG. 28 , a capture surface  8  provides an area that can assist in keeping the back side of pierced tissue in approximation with T-shaped portion  3 . In the embodiment shown, capture surface  8  is extends from only on one side of the stem  6 , but in other embodiments, it could also extend beyond both sides of stem  6 . 
     During use, the embodiment shown in  FIGS. 28 and 29  can be installed similar to other previously-described embodiments. For example, ribbon  2  can be pushed in the direction shown arrow  11 . Ribbon  2  comprises a top portion  9  that can be pushed against the a bottom portion  10  of implant  1 . The action of ribbon  2  against bottom portion  10  of implant  1  can assist pushing point  4  and barb  55  of implant  1  through the desired tissue(s). The tissue can then be captured between the T-shaped portion  3  and the capture surface  8 . Implant  1  and ribbon  2 , as with other embodiments presented in this document, can be made of metal or plastic, and in particular embodiments, biodegradable plastic. The ribbon  2 , as with other embodiments presented in this document, can be made of metal or plastic and superelastic materials such as nickel titanium, commonly referred to as Nitinol®. 
       FIGS. 30-32  present an embodiment which comprises a second (or guide) ribbon  15  configured to create an initial hole in the tissue (not shown) and to give implant  1  stability during deployment. This system consists of the implant  1  being pushed from its bottom by a first ribbon  13 . Second ribbon  15  has been placed against the first ribbon  13  and implant  1 . 
     The two ribbons  13  and  15  can be seen more clearly in  FIG. 31 . The first ribbon  13  has a top surface  19  for pushing against the implant. The second ribbon  15  has a narrowed section or extension  21  with a point at the tip  20 . 
     The action of this design can be best seen in  FIG. 32 . The first ribbon  13  pushes against the implant  1  at the base of T-shaped portion  18 . In this exemplary embodiment, the tapered end or point  20  of the second ribbon  15  is shown above the implant tip  4  in order to create a leading hole in the tissue for easier deployment. In other embodiments, point  20  can be even with the implant tip  4  or slightly below. With extension  21  in place, the implant  1  is restricted from moving in that direction during installation. During installation, a tissue that implant  1  is being inserted through will exert reactionary forces on chamfer  12  as implant  1  passes through the tissue. These forces will to help direct implant  1  in a direction indicated by arrow  17  as implant  1  is pushed through the tissue. Such a configuration can create a more stable deployment of implant  1  by effectively holding implant  1  in place against extension  21 . 
     Another exemplary embodiment is shown in  FIGS. 33 and 34 . In this embodiment, however, implant  24  is hollow or cannulated and a ribbon  28  is placed in an aperture  27  extending through implant  24 . In the embodiment shown, ribbon  28  has a leading point  23  and implant  24  has a T-shaped portion  26  and a tissue-capturing head  25 . Extra bevels  29  can be added if desired to improve staple insertion through tissue. In alternate embodiments, a second ribbon can be used to push on a base portion of implant  24  during installation. 
     Yet another exemplary embodiment of a cannulated implant  30  is shown in  FIGS. 35 and 36 . In this embodiment, implant  30  comprises a stem, a head portion  31  with a chamfer  37 , and a base with a T-shaped portion  32 . The configuration of this embodiment can provide for a more simplified manufacturing process. For example, if implant  30  is made via an injection molding process, core pins of a mold (not shown) may be used create the cavities  34 ,  35 , and  38  which can be coupled to create one passage  33 . Passage  33  can be configured to accept a narrowed portion or extension of a ribbon, similar to aperture  27  in previously-described embodiments. A chamfer  36  may also be included to assist a ribbon extension in properly loading into the channel  33  in case the alignment is off slightly. 
     Another exemplary embodiment is shown in  FIGS. 37, 38 and 39 . In this embodiment, implant  40  comprises a stem, a head portion  44  and a base with a T-shaped portion  43 . Instead of a single extension being placed in the middle of implant  40 , two extensions  41  are used on either side of the center axis of implant  40 . Extensions  41  may have leading points  42  and extend from a top portion  45  of a single ribbon  39 . The embodiment shown may also provide simplify manufacturing processes (if, for example, implant  40  is manufactured by injection molding or machining) since the slots  46  and  47  are open to the sides. 
     Still another exemplary embodiment is shown in  FIGS. 40 and 41 . In this embodiment, implant  48  comprises a stem  49 , a head portion  51  and a base with a T-shaped portion  50 . In the embodiment shown, head portion  51  comprises a pair of barbs  54  and an asymmetric point  53  that is closer to one barb  54  (i.e. the left barb  54  as shown in  FIG. 41 ) than the other barb  54 . The barb  54  that is closer to asymmetric point  53  also comprises a slot  52  that can accommodate a ribbon with a point (not shown) during deployment. In certain embodiments, asymmetric point  53  which can allow head portion  51  to blend with the ribbon more easily during deployment. 
       FIGS. 42A-46  present an embodiment which comprises a first (or push) ribbon  311  and a second (or guide) ribbon  310 . Second ribbon  310  is configured to create an initial hole in the tissue (not shown) and to give an implant  301  stability during deployment. In  FIG. 42  implant  301  comprises a stem or shaft  303  with a barb  302  on one side and a T-shaped section or crossbar  304  on the other side. This embodiment comprises a tapered end or point  305  proximal to barb  302 . Point  305  can be used to help guide the implant  301  through tissue. Barb  302  comprises a capture surface or overhang  306  and a barb recess or trough  309 . In this embodiment, crossbar  304  comprises two capture surfaces or faces  307  and a crossbar recess or trough  308 . During installation and use, point  305  goes through the tissue until it emerges from the other side. The tissue is then held between the overhang  306  and the faces  307  with the aid of the shaft  303 . 
     In the top view of the staple in  FIG. 43 , barb trough  309  and the crossbar trough  308  are more evident. The same is true for  FIG. 44 , which is the bottom view of implant  301 . 
     In  FIGS. 45 and 46  implant  301  is shown in approximation to first ribbon  311  and second ribbon  310  as is the case when deploying implant  301 . Second ribbon  310  has a narrowed section or extension  312  on the distal end with a tapered end or point  313  that initial pierces the tissue creating a leading hole for implant  301  to more easily pass through the tissue. First ribbon  311  has a flat edge  314  on the distal end that pushes against a lower surface  317  of the crossbar  304  in order to push the staple through the tissue. 
     Implant  301  is stabilized during the deployment phase in part by the first ribbon  311  and second ribbon  310 . Extension  312  of first ribbon  310  engages crossbar trough  308  to keep the implant  301  from moving side to side (e.g. towards or away from the plane of the paper in  FIG. 46 ). Extension  312  also fits into or engages barb trough  309  to restrict movement in one direction. Implant  301  is also constrained from rotating in one direction  315  by the rigidity of the implant  312 , whereas implant  312  is constrained in the opposite direction  316  by a channel in the implant system (not shown in  FIGS. 45-46 , but shown as channel  57  in  FIG. 47 ). First ribbon  311  comprises an engagement surface  314  that engages lower surface  317  during installation. In this embodiment, engagement surface  314  is a flat edge at one end of first ribbon  311 . The engagement of these engagement surface  314  and lower surface  317  also tends to keep implant  301  in a stable, straight position during installation. 
     A more detailed set of drawings describing the deployment method of exemplary embodiments is shown in  FIGS. 47 to 51 . In  FIG. 47  the system at rest consists of a channel  57  enclosing a curved first ribbon  59  (shown in solid black heavier line weight) and a curved second ribbon  58 . In certain embodiments, first ribbon  59  is similar to distal end  173  of actuator rod  165  in the embodiment described in  FIGS. 1-12 . In addition to the components described in  FIGS. 1-12 , the system shown in  FIGS. 47-51  comprises second ribbon  58 , which can further assist in placing an implant into a desired tissue location, as described in more detail below. 
     Also shown in the Figures are several implants  60  lined up ready for deployment. In the embodiments shown, channel  57  is resting against a layer of tissue  61 . In  FIG. 48 , an actuator (not shown) has been partially actuated and ribbons  58  and  59  are beginning to deploy such that the distal end  62  of first ribbon  59  is in contact with a first implant  60 . As shown in  FIG. 49 , when actuation of the actuator continues, the ribbons  58  and  59  are further deployed, with second ribbon  58  creating a hole in the tissue  61  and the first ribbon  59  beginning to push implant  60  through that hole. In  FIG. 50 , the actuator has been fully actuated and first and second ribbons  58  and  59  are fully deployed. Implant  60  is now in its installed position with the base portion and head portion on opposite sides of tissue  61 . Although not visible in the cross-section views of  FIGS. 47-51 , implant  60  may comprise a T-shaped base portion on one side of tissue  61  and a barb or tissue-capturing head section on the opposite side of tissue  61  (when implant  60  is in its final installed location). As shown in  FIG. 51 , first and second ribbons  59  and  58  have been retracted to their original position in  FIG. 51  leaving the implant  60  within the tissue  61 . Implant  60  may comprise any of the disclosed embodiments (as well as variations thereof). 
     While exemplary embodiments are described herein, it will be understood that various modifications to the method and apparatus can be made without departing from the scope of the present invention. For example, different configurations of implants may be used. In specific embodiments, an implant may have an L-shaped portion rather than a T-shaped portion near its base. Furthermore, certain embodiments may not comprise implants in a cartridge arrangement. In addition, the implants may be used in procedures other than septoplasty. For example, any area where tissue approximation is necessary in an enclosed space such as peritoneal, urethral, bladder, GI tract, esophageal repair, or joint repair. Furthermore, the sequential recitation of steps in any claim is not a requirement that the steps be performed in any particular order, unless otherwise so stated.