Abstract:
An insertion handle for medical implants includes a handle with an elongate shaft extending therefrom and connection means for the implant disposed at the end of the shaft opposite the handle. The connection means includes a pivotable attachment for the implant that is controlled remotely from the handle. Both angle of the implant with respect to the handle and shaft as well as the attachment may be separately controlled and adjusted. Remote angular adjustment facilitates insertion of implants in to small surgical sites because the orientation of the implant may be repeatedly, remotely adjusted as the implant is inserted. Connectors may also be provided at the engagement surface between the handle and implant in order to provide communication with the implant or surgical site. The connectors also may serve as torque bearing members to avoid the need for separate torque bearing means such as keyways and the like.

Description:
RELATED APPLICATION DATA 
     This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 61/212,808, filed Apr. 16, 2009, and titled Insertion Handle For Implant, which is incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention generally relates to the field of surgical tools such as tools used in orthopedic surgical procedures. In particular, embodiments of the present invention are directed to an insertion handle for implants such as spinal implants. 
     BACKGROUND 
     A variety of devices for holding, manipulating and inserting medical implants during surgical procedures are known in the art. As techniques for less-invasive surgeries are refined, surgical access openings are made increasingly smaller in an attempt to reduce patient trauma and recovery time. 
     In light of the developments in less-invasive surgeries, there is a continuing need for such devices that provide for greater and more precise control over the manipulation and orientation of implants being inserted. 
     SUMMARY OF THE DISCLOSURE 
     In one implementation, the present disclosure is directed to an apparatus for inserting a medical implant. The apparatus includes: a handle; an outer shaft extending from the handle along a shaft axis; an inner control shaft extending through the outer shaft along the shaft axis; an actuator disposed with the handle and cooperating with the inner control shaft to move the inner control shaft within the outer shaft in response to user manipulation of the actuator; and pivotable connection means disposed on the outer shaft opposite the handle and cooperating with the inner shaft to engage or release an implant, and to angularly position the implant with respect to the shaft axis in response to movement of the inner control shaft, the pivotable connection means including user selectable lock means for selectively locking an implant engaged thereon at a fixed angle relative to the shaft axis. 
     In another implementation, the present disclosure is directed to an apparatus for inserting a medical implant. The apparatus includes: a handle; an outer shaft extending from the handle along a shaft axis; a rotatable inner shaft extending through the outer shaft along the shaft axis; an actuation member disposed with the handle and cooperating with the inner shaft to permit user rotation of the inner shaft; a distal end member mounted on the outer shaft opposite the handle, the distal end member having an annular wall defining an opening in a direction transverse to shaft axis with an inner engagement surface, and defining a window opening through the annular wall substantially in line with the outer shaft; a pivot member disposed within the opening defined by the annular wall of the distal end member, the pivot member having an outer engagement surface facing at least a portion of the inner engagement surface and being rotatable within the opening about an axis transverse to the shaft axis; and an attachment screw rotatably mounted in the pivot member and extending through the window opening along a screw axis, the attachment screw operatively connected to the inner shaft to permit rotational drive of the attachment screw through variable angles between the screw axis and shaft axis; wherein the annular wall is deformable at least in part in response to a medical implant being tightly threaded onto the attachment screw to force engagement between the engagement surfaces to selectively lock the pivot member at a fixed angle with respect to the shaft axis. 
     In still another implementation, the present disclosure is directed to a method for inserting a medical implant using an insertion handle. The method includes: attaching the medical implant to a distal end of the insertion handle wherein a first angle is formed between an axis of the implant and an axis of the insertion handle; locking the implant against rotation at the first angle; inserting the implant at a surgical site to a first position; unlocking the implant to permit rotation; changing the angle between the implant axis and the handle axis to a second angle; locking the implant against rotation at the second angle; inserting the implant to a final position; and detaching the insertion handle from the implant. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For the purpose of illustrating the invention, the drawings show aspects of one or more embodiments of the invention. However, it should be understood that the present invention is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein: 
         FIG. 1  is a perspective view of one embodiment of the present invention. 
         FIG. 2A  is a side view of the embodiment shown in  FIG. 1 . 
         FIG. 2B  is a cross-sectional view of the embodiment shown in  FIG. 1  taken through Line A-A. 
         FIGS. 2C-2E  are detailed cross-sectional views of the pivoting head shown in  FIG. 2B  in various angular positions. 
         FIGS. 3A-3E  illustrate an implantation sequence of top views of an embodiment of the present invention with an implant and a surgical treatment site shown. 
         FIG. 4  is perspective view of an alternative embodiment of the present invention shown with an implant attached. 
         FIG. 5A  is a side view of yet another alternative embodiment of the present invention. 
         FIG. 5B  is a cross-sectional view of the embodiment shown in  FIG. 5A  taken through Line A-A. 
         FIG. 5C  is a broken top view of the embodiment shown in  FIG. 5A . 
         FIG. 5D  is a broken cross-sectional view of the embodiment shown in  FIG. 5A  taken through line A-A. 
         FIG. 6A  is a side view of yet another alternative embodiment of the present invention. 
         FIG. 6B  is a front end view of the embodiment shown in  FIG. 6A . 
         FIG. 6C  is a broken cross-sectional view of the embodiment shown in  FIG. 6B  taken through line A-A. 
         FIG. 6D  is a detailed cross-sectional view of the pivoting head shown in  FIG. 6C . 
         FIG. 7A  is a perspective view of yet another embodiment of the present invention. 
         FIG. 7B  is a side view of the embodiment shown in  FIG. 7A . 
         FIG. 7C  is a cross-sectional view of the embodiment shown in  FIG. 7B  taken through Line B-B. 
         FIG. 7D  is a cross-sectional view of the embodiment shown in  FIG. 7B  taken through Line C-C. 
         FIG. 8  is an enlarged side view of the attachment end of an insertion handle according to an embodiment of the present invention. 
         FIG. 9A  is a side view of the proximal end of yet another embodiment of the present invention. 
         FIG. 9B  is a side cross-sectional view of the embodiment shown in  FIG. 9A . 
         FIG. 9C  is an axial cross-sectional view of the embodiment shown in  FIG. 9A  taken through line A-A. 
         FIG. 10  is an axial cross-sectional view of yet another embodiment of the present invention. 
         FIG. 11A  is an end view of yet another embodiment of the present invention. 
         FIGS. 11B and 11C  are side cross-sectional views of the embodiment shown in  FIG. 11A  taken through line A-A with the actuator lock in different positions. 
         FIG. 11D  is a side cross-sectional view of the embodiment shown in  FIG. 11A  taken through line B-B. 
         FIGS. 12A and 12B  are side and top views respectively of yet another embodiment of the present invention. 
         FIG. 13A  is a top view of yet another embodiment of the present invention. 
         FIG. 13B  is a cross-sectional view looking in the superior direction of the embodiment shown in  FIG. 13A . 
         FIG. 13C  is a detailed cross-sectional view of the distal end of the embodiment shown in  FIG. 13B . 
         FIG. 13D  is a detailed cross-sectional view of the proximal end of the embodiment shown in  FIG. 13B . 
         FIG. 14A  is a top view of yet another embodiment of the present invention. 
         FIG. 14B  is an enlarged section view of the embodiment in  FIG. 14A  at circle B. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present invention pertain to a surgical device which is used to surgically place an implant into the desired location of the body. More particularly, embodiments of the present invention are designed to allow placement of an implant into a position that is rotationally different than the position in which it is first inserted into the body. Such rotationally variable placement is achieved in embodiments of the present invention while maintaining constant attachment to the implant to permit forcible manipulation thereof. 
     Turning now to  FIG. 1 , one embodiment of inserter  10  is shown, which is comprised of a handle  12 , a shaft  14  attached thereto, a distal end member, formed for example, as a pivot cage  18  attached to the other end of the shaft  14 , a pivot member or head  16  captured inside a transverse opening defined by the annular wall of the pivot cage  18  and an attachment screw  22  partially contained in the pivot head  16 . The attachment screw  22  protrudes from the distal end of the inserter  10  from the pivot head  16  through the pivot cage  18  via the pivot cage window  20 . At the proximal end of the handle is an attachment actuator  24  which is rotationally coupled to the attachment screw  22  as will be shown herein. 
     As can be seen in  FIGS. 2A-2E , the attachment actuator  24  is connected to an attachment shaft  26  which passes through the inside of the handle  12  and the shaft  14 . The attachment shaft distal end  28  has a hexagonal sided ball end shaped to engage the attachment screw interface  30 . Interface  30  may be a socket configured to receive ball shaped distal end  28 , thus forming a universal joint. This engagement of the attachment shaft distal end  28  and the attachment screw interface  30  enables rotational force applied by the user to the attachment actuator  24  to be transferred through the attachment shaft  26  to the attachment screw  22 . This rotational force turns the screw to engage a medical implant. In this embodiment, the engagement and tightening of the medical implant (as will be explained in more detail herein) both attaches the implant to the inserter  10  and also rotationally locks the pivot head  16  to the pivot cage  18  fixing the angle between the insertion handle  12  and the implant. This rotation is accomplished by providing clearance for the attachment shaft  26  both by an attachment shaft taper  34  and with a pivot head pocket  32 . The geometry of the pivot head pocket  32 , the attachment shaft taper  34  and the pivot cage window  20  allows the pivot head  16  and attachment screw  22  to rotate through a predetermined angle as shown in  FIGS. 2C-2E . This angle can be designed as needed to allow for the appropriate amount of rotation of the implant relative to the inserter  10  as will be described in more detail below. 
       FIGS. 3A-3E  depict the inserter  10  being used to place an implant  36  into an intervertebral space  50  in a patient&#39;s spine, and the use of one embodiment of a user selectable lock means to position the implant angularly with respect to the inserter longitudinal axis to facilitate placement. In  FIG. 3A , implant  36  is attached to the inserter  10  via an implant interface  38  which conforms to the pivot cage  18 . Implant  36  has an elongated shape along implant axis  8 . Implant axis  8  is oriented at a predetermined angle to screw axis  7  along attachment screw  22 . Due to the pivotability of pivot head  16 , the angle between the implant axis  8  and the longitudinal axis  5  of shaft  14  may be selected by the user as described herein. 
     Rotation of the attachment actuator  24  threads the attachment screw  22  through the implant interface  38  into the implant  36 . The implant  36  is also fixed at a predetermined angle relative to the inserter  10  by rotation of the attachment screw  22  into the implant until the implant  36  is pressed against the implant interface  38  which in turn is pressed against the pivot cage  18  which in turn is compressed against the pivot head  16 . Thus, in this embodiment the user selectable lock means comprises the annular walls of the pivot cage  18  being deformable at least in part so that the inner surface of the annular wall can engage at least part of the outer surface of pivot head  16 . In this manner, the compressed assembly clamps the pivot head  16  and pivot cage  18  together and prevents rotation of the pivot head  16 . It will be apparent to those schooled in the art that the implant interface  38  is not required to accomplish the attachment of the inserter  10  to the implant  36 , neither is it required to accomplish the prevention of rotation of the pivot head  16 . Alternate embodiments of the current invention are possible which integrate the implant interface  38  as part of the pivot cage  18  or as part of the implant  36 . The implant interface  38  is useful in that different implant interface  38  designs will enable the same inserter  10  to be used on many different implants  36 . 
     Returning to  FIGS. 3A and 3B , the inserter  10  is used to guide the implant  36  accurately and safely through a narrow surgical opening  44  with a lateral side  45  and a medial side  47  created between an inferior vertebra  40  by removing the superior facet and a superior vertebra  42  by removing the inferior facet. The intervertebral space  50  is created by removing a portion of the disc annulus  46  and disc nucleus  48 . As illustrated in  FIG. 3A , the implant  36  is initially inserted along a straight insertion path (arrow) parallel to the medial side  47  and on the longitudinal axis  5  of the handle into the disc and then further up against the inner wall of the annulus  46  as shown in  FIG. 3B . At this stage the implant axis  8  and the shaft axis  5  are at a first angle with respect to each other. This is not an optimal position for the implant  36 . Rather there is a need to rotate the implant  36  to move it towards the center of the intervertebral space  50 . This rotation may be accomplished in steps in this embodiment by first pivoting the inserter  10  towards the lateral side  45  of the surgical opening  44  and next by rotating the attachment actuator  24  (curved arrow) to rotate the attachment screw  22  and loosen the compression between the implant  36  and the pivot head  16 . This release of compression allows the implant  36 , attachment screw  22 , and pivot head  16  to rotate when additional forward movement (hollow arrow) presses the implant  36  against the annulus  46  as shown in  FIG. 3C . At the same time the insertion handle shaft  14  pivots back towards the medial side  47  of the surgical opening  44  to form a second angle between the implant axis  8  and the shaft axis  5 . The attachment actuator  24  can then be rotated (curved arrow) back to compress the implant  36  against the implant interface  38  and lock the pivot head  16  in the pivot cage  18  to allow the inserter  10  to axially and pivotally advance the rotational locked implant  36 . 
     The process of locking the rotation, advancing and pivoting the inserter  10  and implant  36  as a unit, unlocking the attachment actuator  24  and pivoting the pivot cage  18  and implant  36 , and relocking the rotation is repeated as necessary until the implant  36  is placed at the desired location as shown in  FIG. 3D . Through this process the implant axis  8  is positioned at least at a third angle with respect to the shaft axis  5 . Embodiments of the present invention thus allow placement of an implant  36 , with a rotational orientation that is different from the original insertion orientation, into a surgical site through a much smaller surgical opening  44  with much smaller pivoting angle of the inserter  10  than otherwise possible. 
     After placement of implant  36  at a desired location, the attachment actuator  24  is rotated (curved arrow) until the attachment screw  22  is completely removed from the implant. Then the inserter  10  and implant interface  38  can be removed (hollow arrow) from the surgical site leaving the implant  36  in place as shown in  FIG. 3E . This illustrates just one of the many possible surgical sites were the inserter  10  can be used to advance and rotate a medical implant to a desired location in the body. 
     Turning now to  FIG. 4 , an alternative embodiment of the present invention is shown. In this embodiment, inserter  110  includes access tubing  112 , which are shown parallel to the shaft  14 . Access tubing  112  connects the implant interface  38  to the handle  12 . The access tubing  112  can be used for a number of functions such as delivering fluids or other materials through the handle  12  and implant interface  38  to the implant  36 , removing materials from the implant  36 , containing and/or guiding an actuator such as a tension line or rotator drive, or guiding light or electrical signals. Materials that can be delivered through the access tubing  112  include but are not limited to sterile saline, bone graft, bone morphogenic proteins, cement, medication, etc. It will be apparent to those skilled in the arts that the access tubing  112  can be directed inside the shaft  14  rather than external to it as shown in this figure. 
       FIGS. 5A-5D  depict another embodiment of the present invention. In this embodiment, inserter  210  separates the implant  36  attachment function from the rotation function. There is both an attachment actuator  24  and a separate user selectable pivot lock actuator  212  in the handle  12 . The attachment actuator  24  is connected to the attachment shaft  26 , which when rotated rotates the attachment screw  22  to connect and disconnect to an implant (not shown). The pivot lock actuator  212  is attached to a pivot lock transfer plate  220 , which in turn is attached to a pivot lock shaft  214 . The pivot lock shaft  214  rides between the shaft  14  and the attachment shaft  26 . When the pivot lock actuator  212  is rotated in one direction it advances forward on the threads of the pivot lock adjuster  218 , which advances the pivot lock shaft  214  into the pivot lock  216 , which is contained in the pivot cage  18 . The pivot lock  216  has pivot lock engagement faces  217 , which are configured to engage pivot head engagement faces  219  on the pivot head  16 . When these faces engage, the pivot head  16  is locked rotationally with the pivot cage  18 . When the pivot lock actuator  212  is rotated in the other direction it retracts backwards on the threads of the pivot lock adjuster  218 . A pivot lock release actuator  226 , which may be formed as a biasing element such as a coil spring, then retracts the pivot lock transfer plate  220  and the attached pivot lock shaft  214 . This removes pressure on the pivot lock  216  and allows the pivot head  16  to rotate relative to the pivot cage  18 . In this manner the inserter  210  allows the user to independently actuate the pivot locking and implant attachment functions. It will be apparent to those skilled in the art that this separation of functions can be useful to the surgeon who is using the inserter  210  to place an implant precisely in a patient&#39;s body. 
     The inserter  210  may also include pivot lock adjustment anchors  222  which lock the pivot lock adjuster  218  to the handle  12 , and handle cap anchors  234 , which attach a handle cap  232  to the handle  12 . The handle cap  232  is useful in providing a surface for the surgeon to hammer against to force the implant  36  into a confined intervertebral space  50 . The pivot lock adjuster  218  with its threads can be used to adjust the relative location of the advancement and retraction of the pivot lock actuator  212  and in turn the pivot lock transfer plate  220 , pivot lock shaft  214 , and pivot lock  216 . This allows for adjustment of the locking movement and therefore the locking force between the pivot lock  216  and the pivot head  16 . After this adjustment is made, the pivot lock adjuster anchors  222  fix the pivot lock adjuster  218  to the handle  12  and maintain this locking movement. It will be apparent to those skilled in the art that there are many other mechanisms possible to provide for the adjustment of the locking movement of the inserter  210  without departing from the present invention and this mechanism is provided as but one example. 
     There are also many ways to separate the attachment and rotation functions in embodiments of the present invention to provide separate user selectable lock means. Another such alternative embodiment is shown in the inserter  310  depicted in  FIGS. 6A-6D . In this embodiment the pivot lock shaft  214  is connected to a pivot lock shaft pin  314 , which is connected to the pivot cage  18 . The pivot cage  18  has a pivot cage slot  312  proximal of the pivot lock shaft pin  314 . In this embodiment the pivot lock shaft  214  is retracted via the pivot lock actuator  212  to pull on the pivot lock shaft pin  314 , which reduces the pivot cage slot  312  and compresses the pivot cage  18  around the pivot head  16  locking it rotationally. This method of tensioning a portion of the pivot cage  18  to increase the force between the pivot cage  18  and the pivot head  16  and lock the pivot head  16  rotational is but one alternative. For example, in another alternative, the pivot cage  18  could also be tensioned radially to compress it around the pivot head  16  and lock the pivot head  16  rotationally to the pivot cage  18 . 
     In addition to the alternative embodiments described above,  FIGS. 7A-7D  show yet another alternative embodiment of the present invention including inserter  410 , which can be attached to and rotate an implant  36 . The shaft  14  of inserter  410  is connected from the handle  12  to an attachment grip cage  418 . At least two attachment grips  422  exit the distal end of the attachment grip base  418  and are configured to rotate towards each other and grab an implant (not shown). The attachment grips  422  are connected by an attachment grip pivot  424 , which is contained in the attachment grip base  418 . The attachment pivot  424  is also confined by a tensioning slot  425  in the attachment grip pivot tensioner  426 . Rotation of the attachment actuator  24  in one direction tensions the attachment shaft  26  which retracts the attachment grip pivot tensioner  426 . This action pulls the attachment grip pivot  424  further into the attachment grip cage  418  and up against the anchor pocket  428  preventing the attachment grip pivot  424  from translating in the tensioning slot  425 . A slight rotation of the attachment actuator  24  in the other direction allows the attachment grip pivot  424  to move away from the anchor pocket  428 , which in turn allows the attachment grip pivot  424  to translate in the tensioning slot  425 . The translation of the attachment grip pivot  424  in the tensioning slot  425  results in the pivoting of the attachment grips  422  relative to the attachment grip cage. This enables implant  36  rotation. Further rotation of the attachment actuator  24  in the other direction moves attachment grip pivot  424  and the attachment grips  422  out of the front of the attachment grip cage  418  allowing the attachment grips  422  to separate and release the implant  36 . In this manner the attachment actuator  24  can be used to control both implant attachment/release and implant rotation relative to the inserter  410 . 
     In previous embodiments the pivot lock  216  included engagement faces  217  configured to engage engagement faces  219  on the pivot head  16  and lock it rotationally. In an alternative embodiment, shown in  FIG. 8 , the engagement faces  217  on the pivot lock  216  are configured to create friction against the pivot head  16  to lock it rotationally. The engagement faces  217  are also configured to allow fluid to flow between the pivot lock  216  and the pivot head  16 . One way to accomplish this is to provide squared off teeth on one of the opposed faces as shown. This is advantageous in that the engagement faces  217  provide for ease of cleaning of the inserter  10  between uses. Furthermore, engagement faces  215  can be provided on the pivot head to engage the pivot cage  218  and to create both friction and ease of cleaning between the pivot head  16  and the pivot cage  18 . 
     Use of the inserter  10  to place an implant  36  into an intervertebral space  50  can include placing many loads and moments on the distal end of the inserter  10 . Those loads and moments placed on the attachment actuator  24  can cause undesired rotation of the attachment actuator. Axial impact forces on the order of 55 lbs or more may be placed on the distal end of the inserter  10 . Torques may be placed about any axis of rotation relative to the inserter shaft  14  ranging from 20 to over 100 inch pounds. Turning now to  FIG. 9A-9C , another alternative embodiment of the current invention is depicted, which includes an actuator lock  240 . The actuator lock  240  is mounted on the handle  12  by means of a pivot pin  254  (see  FIG. 9C ). The proximal end of the actuator lock  240  extends away from the handle  12  and the distal end  251  extends into the handle  12 . The distal end  251  has a stop face  252 , which is configured to engage a ratcheted surface  250  of the attachment actuator  24 . An engagement spring  256  biases the stop face  252  against the ratcheted surface  250  and prevents the attachment actuator  24  from rotating in a direction that loosens the attachment shaft  26 . Depressing the proximal end of the actuator lock  240  towards the handle  12  pivots the actuator lock  240  about the pivot pin  254  and disengages the stop face  252  from the ratcheted surface  250  allowing the attachment actuator to freely rotate. In the embodiment shown, the ratcheted surface  250  is biased relative to the stop face  252  to allow rotation of the attachment actuator  24  in the tightening direction even without depressing the proximal end of the actuator lock  240  towards the handle  12 . Depressing of the actuator lock  240  is only needed to allow the attachment actuator  24  to loosen. It is apparent to those skilled in the art that the ratcheted surface  250  can also be configured to lock the attachment actuator  24  in both the loosening and the tightening directions unless the actuator lock  240  is depressed. Also shown in these figures is a cannulated connecting bolt  242 , which connects the attachment actuator  24  to the handle  12 . The inclusion of bearing  244  facilitates rotation in this connection. Axial force on the handle cap  232 , which is often needed to direct the implant  36  into the intervertebral space  50  is accommodated by the beveled washer  248  located between the cannulated connecting bolt  242  and the bearing  244 . Rotational force is transferred between the attachment actuator  24  and the attachment shaft  26  by the actuator connecting screw  246 . 
     In addition to the actuator lock  240  described above, embodiments of the present invention can also include a pivot lock  340  as shown in  FIG. 10 . The pivot lock  340  also has a proximal end  341  and a distal end  351  and pivots about a pivot lock pin  354 . The distal end  351  has a pivot stop face  352  configured to engage a pivot ratcheted surface  350  located on a pivot lock actuator  212 . A pivot lock spring  356  is positioned between the handle  12  and the proximal end  341  of the pivot lock  340  and biases the pivot stop face  352  into the pivot ratcheted surface  350  thereby preventing rotation of the pivot lock actuator  212 . Depressing the proximal end  341  of the pivot lock  340  rotates the pivot lock  340  about the pivot lock pin  354  and disengages the pivot stop face  352  from the pivot ratcheting surface  350  allowing rotation of the pivot lock actuator  212 . It will be apparent to those skilled in the art that insertion handles in accordance with embodiments of the present invention may include either or both of the pivot lock  340  and the actuator lock  240 . 
       FIGS. 11A-D  depict another alternative embodiment of the actuator lock  240 , wherein the attachment shaft  26  is removed as shown in  FIGS. 11B , C and D for clarity. In this embodiment the actuator lock  240  is mounted in through hole  243  that passes through the handle  12 . The actuator lock  240  contains a cam slot  260 , which is configured to engage a transfer pin  262  mounted on the locking carriage  264 . The locking carriage  264  is contained in the handle  12  between the handle cap  232  and the attachment actuator  24 . The locking carriage  264  contains the stop face  252 , which is configured to be received by one of several stop holes  258  located on the attachment actuator  24 . Depressing the actuator lock  240  (arrow in  FIG. 11C ) causes the cam slot  260  to force the transfer pin  262  distally. This action in turn translates the locking carriage  264  and the stop face  252  distally such that the stop face  252  engages one of the stop holes  258  and prevents rotation of the attachment actuator  24 . Pressing the actuator lock  240  in the other direction will disengage the stop face  252  from the stop hole  258  and allow rotation of the attachment actuator  24 . This alternative locking embodiment can be used for preventing movement of either the attachment actuator  24  or the pivot lock actuator  212 . It will be apparent to those skilled in the art that any manner of actuator locks can be used to prevent movement of either or both of the attachment actuator  24  or the pivot locking actuator  212  without departing from the present invention. 
       FIGS. 12A and 12B  depict another embodiment of the present invention that includes additional features. As was described above for the embodiment described in connection with  FIG. 4 , the inserter  10  can include access tubing  112 . The access tubing  112  can interface with an implant  36  by means of implant connectors  282  located at the distal end of the inserter  10 . Connectors  282  may extend through and from implant interface  38 . The connectors can facilitate any manner of interaction with the implant including but not limited to electrical current, optical information, rotational power, fluid pressure, material transport. This interaction can flow one way or the other or both. The inserter  10  can also include an external connector  280  to further allow interaction through the inserter  10  with the implant  36  by means of the implant connectors  282 . The external connector  280  can be configured for any manner of interaction between the inserter  10  and other equipment required for surgery including suction, aspiration, irrigation, injection, illumination, coagulation or other such equipment that is commonly used in surgery. 
     In one exemplary embodiment, the external connector  280  is configured to connect with a saline filled syringe which is used to supply pressurized saline to the implant  36  through the implant connectors  282  in order to expand the implant to a larger size after being implanted through a minimally invasive surgical opening. One example of such an expandable implant is shown and described in co-pending U.S. patent application Ser. No. 11/535,432 filed Sep. 26, 2006, entitled “Selectively Expanding Spine Cage, Hydraulically Controllable in Three Dimensions for Enhanced Spinal Infusion,” which is incorporated by reference herein in its entirety. In another exemplary embodiment, the external connector  280  is configured to supply bone graft and or bone morphogentic protein to the implant to facilitate bony fusion. Although the embodiment shown in  FIGS. 12A  and B includes a single external connector  280  leading to two implant connectors  282 , any number of either of these connectors are possible without departing from the scope of the current invention. 
     In addition to providing an interaction or exchange function between the implant  36  and the inserter  10  as described above, the implant connectors  282  also provide a torque transfer function. As the implant connectors  282  are spaced from the attachment screw  22 , the implant connectors  282  provide resistance to any relative rotation between the implant  36  and the implant interface  38 . This is particularly important as the attachment screw  22  engages the implant  36  through rotational movement. The one or more implant connectors  282  help to prevent any undesired rotation and subsequent loosening of the implant  36  relative to the inserter  10 . For this purpose, implant connectors  282  should have sufficient strength to resist torque in a given application. Persons of ordinary skill in the art may design the size and shape of the implant connectors based on the teachings contained herein in order to withstand anticipated torque for any appropriate medical implant and its intended application. For example, implant connectors  282  can be fabricated from 304 stainless steel and extend 0.5 inches from the implant interface  38  at a location 0.25 inches from the central axis of the implant interface  38  such that they are rigid enough to resist the 100 inch pounds of rotation force placed on the implant  36 . Utilization of the implant connectors for this purpose obviates the need for separate torque bearing structures such as keyways and the like, thus simplifying the engagement surfaces between the implant and inserter. 
     A detailed description has been given of the pivoting function in embodiments of the present invention and possible variations thereof. In many surgical procedures, due to the minimally invasive nature and/or due to the proximal anatomy, the physician may not be able to clearly see in which rotational position of the pivot head  16  is set. It therefore may be desirable in some embodiments to provide a position indicator  370  to indicate rotational position information as shown in  FIGS. 13A-13D  (attachment shaft  26  and pivot lock shaft  214  are removed for further clarity in  FIGS. 13B and 13D ). The position indicator  370  includes a position pivot  376 , a position actuator  372 , a position lever  374 , a position cover  383 , and a position marker  379 . The distal end of the position actuator  372  has a bend  373  which is configured to be received by a distal pocket  375  in the pivot cage  16 . The position actuator  372  extends from the pivot cage  16  back through the shaft  14  between the shaft  14  and the pivot lock shaft  214 . Inside the handle  12 , the position actuator  372  has a proximal bend  381 , which is configured to be received by a proximal pocket  380  in the position lever  374 . Rotation of the pivot cage  16  creates translation of the position actuator  372 , which results in rotation of the position lever  374  about the position pivot  376 . The rotating position lever  374  rotates the position marker  379 , which can be viewed through different position openings  371  in the position cover  383 . The position cover  383  can also have position icons  385 , which may correspond to different rotational positions of the distal end of the inserter  10  to provide additional visual information that relates the position marker&#39;s  379  location in the position opening  371  to a distal end configuration. In addition the position pivot  376  can have a position pointer  377  on its exposed end which also rotates with the pivot  376  to provide additional visual rotation information. Alternatively, the position indicator may be used to position the angle of the pivot head  16  by user manipulation of a member extending outward from position lever  374 . 
     Although embodiments of the present invention described above include certain functions such as the exchange and interface functions with the implant, alternative embodiments of the present invention may provide those functions with a separate device. For example, turning to  FIGS. 14A and 14B , an embodiment of an inserter  10  is shown that interfaces with a tubing set  290  both of which are configured to interface with an implant  36 . The distal end of the tubing set  290  includes an implant interface  38  with implant connectors  282  to interface with the implant  36 . The tubing set  290  also includes access tubing  112  and shaft clips  395 , which are configured to constrain the access tubing  112  to the inserter shaft  14 . The tubing set  290  further may include at least one external connector  280  at the proximal end, which is configured as described above to interface with other surgical equipment. In addition, the tubing set  290  may include a diverter valve  284 . The diverter valve  284  is configured to open or close the connection between the external connector  280  and one or more access tubing  112 . In the embodiment shown in  FIG. 14A , the diverter valve  284  is configured to either provide openings to both access tubing  112  simultaneously, to close the opening to one or the other access tubing  112 , or to close the openings to both access tubing  112  simultaneously. Providing a kit that contains the combination of the inserter  10  and various configurations of access tubing  290  enables more flexibility to the physician to use the current invention to insert and manipulate a wide variety of implants. 
     As better seen in  FIG. 14B , connectors  282  are formed as separate members inserted and secured in implant interface  38 . Each connector  282  includes a passage  281  that communicates with tubing  112 . Tubing  112  enters the back of interface  36  through openings  287  in which the connectors  282  are mounted. O-ring type seals  283  are provided to form a tight seal with corresponding passages  285  in implant  36 . Central passageway  288  is provided for engagement screw  22  to freely pass through interface  38  for engagement with the implant. The mating face of implant  36  is also provided with a threaded hole  286  to receive attachment screw  22 . 
     The present invention can be fabricated from numerous materials know to those skilled in the art. For example the handle  12 , shaft  14 , pivot cage  18  and pivot head  26  can all be made from any one of the number of biocompatible metals such as titanium, titanium alloy, or stainless steels including 303 and 304. The attachment actuator  24 , external connector  280  implant interface  38  can all be made of a polymer such as polyacetal (e.g. Delrin®) or polyether ether keton (PEEK). The entire inserter  10  can be made of inexpensive materials so that it is single use and disposable or of more durable materials so that it can be cleaned and reused several or even hundreds of times. 
     Terms such as “element,” “member,” “device,” “section,” “portion,” “step,” “means” and words of similar import when used in the following claims shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the term “means” followed by a particular function without specific structure or expressly use the term “step” followed by a particular function without specific action. All patents and patent applications referred to above are hereby incorporated by reference in their entirety. 
     Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present invention.