PATENT DOCUMENT

Abstract:
A powered surgical apparatus for engaging tissue includes a housing assembly and a movable portion operatively connected to the housing assembly. The movable portion is movable with respect to the housing assembly. In addition, the surgical apparatus includes a power source configured to supply electrical power, and a transmission system configured to transfer at least one of a signal and electrical power between the handle assembly and the movable portion, the transmission system including a first electronic board disposed in the handle assembly and a second electronic board positioned in the movable portion, the second electronic board including a primary control circuit and a secondary control circuit wherein the movable portion is configured and adapted to rotate about a longitudinal axis defined by the powered surgical apparatus.

Full Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 11/651,715, filed, Jan. 10, 2007, entitled “SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS”, now U.S. Patent Publication No. 2008-0167522 A1, the entire disclosure of which is hereby incorporated by reference herein. 
     
    
       [0002]    The present application is related to the following U.S. patent applications, which are incorporated herein by reference: 
         [0003]    (1) U.S. patent application Ser. No. 11/651,807 entitled “SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR,” by J. Giordano et al., now U.S. Patent Publication No. 2008-0167672 A1; 
         [0004]    (2) U.S. patent application Ser. No. 11/651,806 entitled “SURGICAL INSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT AND END EFFECTOR,” by J. Giordano et al., now U.S. Patent Publication No. 2008-0167671 A1; 
         [0005]    (3) U.S. patent application Ser. No. 11/651,768 entitled “PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT,” by F. Shelton et al., now U.S. Pat. No. 7,721,931; 
         [0006]    (4) U.S. patent application Ser. No. 11/651,771 entitled “POST-STERILIZATION PROGRAMMING OF SURGICAL INSTRUMENTS,” by J. Swayze et al., now U.S. Patent Publication No. 2008-0167736 A1; 
         [0007]    (5) U.S. patent application Ser. No. 11/651,788 entitled “INTERLOCK AND SURGICAL INSTRUMENT INCLUDING SAME, by F. Shelton et al., now U.S. Pat. No. 7,721,936; and 
         [0008]    (6) U.S. patent application Ser. No. 11/651,785 entitled “SURGICAL INSTRUMENT WITH ENHANCED BATTERY PERFORMANCE,” by F. Shelton et al., now U.S. Patent Publication No. 2008-0167644 A1. 
       BACKGROUND 
       [0009]    Endoscopic surgical instruments are often preferred over traditional open surgical devices since a smaller incision tends to reduce the post-operative recovery time and complications. Consequently, significant development has gone into a range of endoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.). 
         [0010]    Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision. The end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil. 
         [0011]    An example of a surgical stapler suitable for endoscopic applications is described in U.S. Pat. No. 5,465,895, which discloses an endocutter with distinct closing and firing actions. A clinician using this device is able to close the jaw members upon tissue to position the tissue prior to firing. Once the clinician has determined that the jaw members are properly gripping tissue, the clinician can then fire the surgical stapler with a single firing stroke, thereby severing and stapling the tissue. The simultaneous severing and stapling avoids complications that may arise when performing such actions sequentially with different surgical tools that respectively only sever and staple. 
         [0012]    One specific advantage of being able to close upon tissue before firing is that the clinician is able to verify via an endoscope that the desired location for the cut has been achieved, including that a sufficient amount of tissue has been captured between opposing jaws. Otherwise, opposing jaws may be drawn too close together, especially pinching at their distal ends, and thus not effectively forming closed staples in the severed tissue. At the other extreme, an excessive amount of clamped tissue may cause binding and an incomplete firing. 
         [0013]    Endoscopic staplers/cutters continue to increase in complexity and function with each generation. One of the main reasons for this is the quest to lower force-to-fire (FTF) to a level that all or a great majority of surgeons can handle. One known solution to lower FTF it use CO 2  or electrical motors. These devices have not faired much better than traditional hand-powered devices, but for a different reason. Surgeons typically prefer to experience proportionate force distribution to that being experienced by the end effector in the forming of the staple to assure them that the cutting/stapling cycle is complete, with the upper limit within the capabilities of most surgeons (usually around 15-30 lbs). They also typically want to maintain control of deploying the staples and being able to stop at anytime if the forces felt in the handle of the device feel too great or for some other clinical reason. 
         [0014]    To address this need, so-called “power-assist” endoscopic surgical instruments have been developed in which a supplemental power source aids in the firing of the instrument. For example, in some power-assist devices, a motor provides supplemental electrical power to the power input by the user from squeezing the firing trigger. Such devices are capable of providing loading force feedback and control to the operator to reduce the firing force required to be exerted by the operator in order to complete the cutting operation. One such power-assist device is described in U.S. patent application Ser. No. 11/343,573, filed Jan. 31, 2006 by Shelton et al., entitled “Motor-driven surgical cutting and fastening instrument with loading force feedback,” (“the &#39;573 application”) which is incorporated herein by reference. 
         [0015]    These power-assist devices often include other components that purely mechanical endoscopic surgical instruments do not, such as sensors and control systems. One challenge in using such electronics in a surgical instrument is delivering power and/or data to and from the sensors, particularly when there is a free rotating joint in the surgical instrument. 
     
    
     
       FIGURES 
         [0016]    Various embodiments of the present invention are described herein by way of example in conjunction with the following figures wherein: 
           [0017]      FIGS. 1 and 2  are perspective views of a surgical instrument according to various embodiments of the present invention; 
           [0018]      FIGS. 3-5  are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention; 
           [0019]      FIG. 6  is a side view of the end effector according to various embodiments of the present invention; 
           [0020]      FIG. 7  is an exploded view of the handle of the instrument according to various embodiments of the present invention; 
           [0021]      FIGS. 8 and 9  are partial perspective views of the handle according to various embodiments of the present invention; 
           [0022]      FIG. 10  is a side view of the handle according to various embodiments of the present invention; 
           [0023]      FIGS. 11 ,  13 - 14 ,  16 , and  22  are perspective views of a surgical instrument according to various embodiments of the present invention; 
           [0024]      FIGS. 12 and 19  are block diagrams of a control unit according to various embodiments of the present invention; 
           [0025]      FIG. 15  is a side view of an end effector including a sensor transponder according to various embodiments of the present invention; 
           [0026]      FIGS. 17 and 18  show the instrument in a sterile container according to various embodiments of the present invention; 
           [0027]      FIG. 20  is a block diagram of the remote programming device according to various embodiments of the present invention; and 
           [0028]      FIG. 21  is a diagram of a packaged instrument according to various embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0029]    Various embodiments of the present invention are directed generally to a surgical instrument having at least one remote sensor transponder and means for communicating power and/or data signals to the transponder(s) from a control unit. The present invention may be used with any type of surgical instrument comprising at least one sensor transponder, such as endoscopic or laparoscopic surgical instruments, but is particularly useful for surgical instruments where some feature of the instrument, such as a free rotating joint, prevents or otherwise inhibits the use of a wired connection to the sensor(s). Before describing aspects of the system, one type of surgical instrument in which embodiments of the present invention may be used—an endoscopic stapling and cutting instrument (i.e., an endocutter)—is first described by way of illustration. 
         [0030]      FIGS. 1 and 2  depict an endoscopic surgical instrument  10  that comprises a handle  6 , a shaft  8 , and an articulating end effector  12  pivotally connected to the shaft  8  at an articulation pivot  14 . Correct placement and orientation of the end effector  12  may be facilitated by controls on the hand  6 , including (1) a rotation knob  28  for rotating the closure tube (described in more detail below in connection with  FIGS. 4-5 ) at a free rotating joint  29  of the shaft  8  to thereby rotate the end effector  12  and (2) an articulation control  16  to effect rotational articulation of the end effector  12  about the articulation pivot  14 . In the illustrated embodiment, the end effector  12  is configured to act as an endocutter for clamping, severing and stapling tissue, although in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical instruments, such as graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy devices, ultrasound, RF or laser devices, etc. 
         [0031]    The handle  6  of the instrument  10  may include a closure trigger  18  and a firing trigger  20  for actuating the end effector  12 . It will be appreciated that instruments having end effectors directed to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector  12 . The end effector  12  is shown separated from the handle  6  by the preferably elongate shaft  8 . In one embodiment, a clinician or operator of the instrument  10  may articulate the end effector  12  relative to the shaft  8  by utilizing the articulation control  16 , as described in more detail in pending U.S. patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled “Surgical Instrument Having An Articulating End Effector,” by Geoffrey C. Hueil et al., which is incorporated herein by reference. 
         [0032]    The end effector  12  includes in this example, among other things, a staple channel  22  and a pivotally translatable clamping member, such as an anvil  24 , which are maintained at a spacing that assures effective stapling and severing of tissue clamped in the end effector  12 . The handle  6  includes a pistol grip  26  towards which a closure trigger  18  is pivotally drawn by the clinician to cause clamping or closing of the anvil  24  toward the staple channel  22  of the end effector  12  to thereby clamp tissue positioned between the anvil  24  and channel  22 . The firing trigger  20  is farther outboard of the closure trigger  18 . Once the closure trigger  18  is locked in the closure position, the firing trigger  20  may rotate slightly toward the pistol grip  26  so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firing trigger  20  toward the pistol grip  12  to cause the stapling and severing of clamped tissue in the end effector  12 . The &#39;573 application describes various configurations for locking and unlocking the closure trigger  18 . In other embodiments, different types of clamping members besides the anvil  24  could be used, such as, for example, an opposing jaw, etc. 
         [0033]    It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping the handle  6  of an instrument  10 . Thus, the end effector  12  is distal with respect to the more proximal handle  6 . It will be further appreciated that, for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. 
         [0034]    The closure trigger  18  may be actuated first. Once the clinician is satisfied with the positioning of the end effector  12 , the clinician may draw back the closure trigger  18  to its fully closed, locked position proximate to the pistol grip  26 . The firing trigger  20  may then be actuated. The firing trigger  20  returns to the open position (shown in  FIGS. 1 and 2 ) when the clinician removes pressure. A release button  30  on the handle  6 , and in this example, on the pistol grip  26  of the handle, when depressed may release the locked closure trigger  18 . 
         [0035]      FIG. 3  is an exploded view of the end effector  12  according to various embodiments. As shown in the illustrated embodiment, the end effector  12  may include, in addition to the previously-mentioned channel  22  and anvil  24 , a cutting instrument  32 , a sled  33 , a staple cartridge  34  that is removably seated in the channel  22 , and a helical screw shaft  36 . The cutting instrument  32  may be, for example, a knife. The anvil  24  may be pivotably opened and closed at a pivot point  25  connected to the proximate end of the channel  22 . The anvil  24  may also include a tab  27  at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close the anvil  24 . When the closure trigger  18  is actuated, that is, drawn in by a user of the instrument  10 , the anvil  24  may pivot about the pivot point  25  into the clamped or closed position. If clamping of the end effector  12  is satisfactory, the operator may actuate the firing trigger  20 , which, as explained in more detail below, causes the knife  32  and sled  33  to travel longitudinally along the channel  22 , thereby cutting tissue clamped within the end effector  12 . The movement of the sled  33  along the channel  22  causes the staples of the staple cartridge  34  to be driven through the severed tissue and against the closed anvil  24 , which turns the staples to fasten the severed tissue. U.S. Pat. No. 6,978,921, entitled “Surgical stapling instrument incorporating an E-beam firing mechanism,” which is incorporated herein by reference, provides more details about such two-stroke cutting and fastening instruments. The sled  33  may be part of the cartridge  34 , such that when the knife  32  retracts following the cutting operation, the sled  33  does not retract. The channel  22  and the anvil  24  may be made of an electrically conductive material (such as metal) so that they may serve as part of the antenna that communicates with the sensor(s) in the end effector, as described further below. The cartridge  34  could be made of a nonconductive material (such as plastic) and the sensor may be connected to or disposed in the cartridge  34 , as described further below. 
         [0036]    It should be noted that although the embodiments of the instrument  10  described herein employ an end effector  12  that staples the severed tissue, in other embodiments different techniques for fastening or sealing the severed tissue may be used. For example, end effectors that use RF energy or adhesives to fasten the severed tissue may also be used. U.S. Pat. No. 5,709,680, entitled “Electrosurgical Hemostatic Device” to Yates et al., and U.S. Pat. No. 5,688,270, entitled “Electrosurgical Hemostatic Device With Recessed And/Or Offset Electrodes” to Yates et al., which are incorporated herein by reference, discloses cutting instruments that use RF energy to fasten the severed tissue. U.S. patent application Ser. No. 11/267,811 to Morgan et al. and U.S. patent application Ser. No. 11/267,363 to Shelton et al., which are also incorporated herein by reference, disclose cutting instruments that use adhesives to fasten the severed tissue. Accordingly, although the description herein refers to cutting/stapling operations and the like, it should be recognized that this is an exemplary embodiment and is not meant to be limiting. Other tissue-fastening techniques may also be used. 
         [0037]      FIGS. 4 and 5  are exploded views and  FIG. 6  is a side view of the end effector  12  and shaft  8  according to various embodiments. As shown in the illustrated embodiment, the shaft  8  may include a proximate closure tube  40  and a distal closure tube  42  pivotably linked by a pivot links  44 . The distal closure tube  42  includes an opening  45  into which the tab  27  on the anvil  24  is inserted in order to open and close the anvil  24 . Disposed inside the closure tubes  40 ,  42  may be a proximate spine tube  46 . Disposed inside the proximate spine tube  46  may be a main rotational (or proximate) drive shaft  48  that communicates with a secondary (or distal) drive shaft  50  via a bevel gear assembly  52 . The secondary drive shaft  50  is connected to a drive gear  54  that engages a proximate drive gear  56  of the helical screw shaft  36 . The vertical bevel gear  52   b  may sit and pivot in an opening  57  in the distal end of the proximate spine tube  46 . A distal spine tube  58  may be used to enclose the secondary drive shaft  50  and the drive gears  54 ,  56 . Collectively, the main drive shaft  48 , the secondary drive shaft  50 , and the articulation assembly (e.g., the bevel gear assembly  52   a - c ), are sometimes referred to herein as the “main drive shaft assembly.” The closure tubes  40 ,  42  may be made of electrically conductive material (such as metal) so that they may serve as part of the antenna, as described further below. Components of the main drive shaft assembly (e.g., the drive shafts  48 ,  50 ) may be made of a nonconductive material (such as plastic). 
         [0038]    A bearing  38 , positioned at a distal end of the staple channel  22 , receives the helical drive screw  36 , allowing the helical drive screw  36  to freely rotate with respect to the channel  22 . The helical screw shaft  36  may interface a threaded opening (not shown) of the knife  32  such that rotation of the shaft  36  causes the knife  32  to translate distally or proximately (depending on the direction of the rotation) through the staple channel  22 . Accordingly, when the main drive shaft  48  is caused to rotate by actuation of the firing trigger  20  (as explained in more detail below), the bevel gear assembly  52   a - c  causes the secondary drive shaft  50  to rotate, which in turn, because of the engagement of the drive gears  54 ,  56 , causes the helical screw shaft  36  to rotate, which causes the knife  32  to travel longitudinally along the channel  22  to cut any tissue clamped within the end effector. The sled  33  may be made of, for example, plastic, and may have a sloped distal surface. As the sled  33  traverses the channel  22 , the sloped forward surface may push up or drive the staples in the staple cartridge  34  through the clamped tissue and against the anvil  24 . The anvil  24  turns the staples, thereby stapling the severed tissue. When the knife  32  is retracted, the knife  32  and sled  33  may become disengaged, thereby leaving the sled  33  at the distal end of the channel  22 . 
         [0039]    According to various embodiments, as shown  FIGS. 7-10 , the surgical instrument may include a battery  64  in the handle  6 . The illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in the end effector  12 . In addition, the embodiment may use power provided by the user in retracting the firing trigger  18  to power the instrument  10  (a so-called “power assist” mode). As shown in the illustrated embodiment, the handle  6  includes exterior lower side pieces  59 ,  60  and exterior upper side pieces  61 ,  62  that fit together to form, in general, the exterior of the handle  6 . The handle pieces  59 - 62  may be made of an electrically nonconductive material, such as plastic. A battery  64  may be provided in the pistol grip portion  26  of the handle  6 . The battery  64  powers a motor  65  disposed in an upper portion of the pistol grip portion  26  of the handle  6 . The battery  64  may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO 2  or LiNiO 2 , a Nickel Metal Hydride chemistry, etc. According to various embodiments, the motor  65  may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 RPM to 100,000 RPM. The motor  64  may drive a 90° bevel gear assembly  66  comprising a first bevel gear  68  and a second bevel gear  70 . The bevel gear assembly  66  may drive a planetary gear assembly  72 . The planetary gear assembly  72  may include a pinion gear  74  connected to a drive shaft  76 . The pinion gear  74  may drive a mating ring gear  78  that drives a helical gear drum  80  via a drive shaft  82 . A ring  84  may be threaded on the helical gear drum  80 . Thus, when the motor  65  rotates, the ring  84  is caused to travel along the helical gear drum  80  by means of the interposed bevel gear assembly  66 , planetary gear assembly  72  and ring gear  78 . 
         [0040]    The handle  6  may also include a run motor sensor  110  in communication with the firing trigger  20  to detect when the firing trigger  20  has been drawn in (or “closed”) toward the pistol grip portion  26  of the handle  6  by the operator to thereby actuate the cutting/stapling operation by the end effector  12 . The sensor  110  may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firing trigger  20  is drawn in, the sensor  110  detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to the motor  65 . When the sensor  110  is a variable resistor or the like, the rotation of the motor  65  may be generally proportional to the amount of movement of the firing trigger  20 . That is, if the operator only draws or closes the firing trigger  20  in a little bit, the rotation of the motor  65  is relatively low. When the firing trigger  20  is fully drawn in (or in the fully closed position), the rotation of the motor  65  is at its maximum. In other words, the harder the user pulls on the firing trigger  20 , the more voltage is applied to the motor  65 , causing greater rates of rotation. In another embodiment, for example, the control unit (described further below) may output a PWM control signal to the motor  65  based on the input from the sensor  110  in order to control the motor  65 . 
         [0041]    The handle  6  may include a middle handle piece  104  adjacent to the upper portion of the firing trigger  20 . The handle  6  also may comprise a bias spring  112  connected between posts on the middle handle piece  104  and the firing trigger  20 . The bias spring  112  may bias the firing trigger  20  to its fully open position. In that way, when the operator releases the firing trigger  20 , the bias spring  112  will pull the firing trigger  20  to its open position, thereby removing actuation of the sensor  110 , thereby stopping rotation of the motor  65 . Moreover, by virtue of the bias spring  112 , any time a user closes the firing trigger  20 , the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by the motor  65 . Further, the operator could stop retracting the firing trigger  20  to thereby remove force from the sensor  100 , to thereby stop the motor  65 . As such, the user may stop the deployment of the end effector  12 , thereby providing a measure of control of the cutting/fastening operation to the operator. 
         [0042]    The distal end of the helical gear drum  80  includes a distal drive shaft  120  that drives a ring gear  122 , which mates with a pinion gear  124 . The pinion gear  124  is connected to the main drive shaft  48  of the main drive shaft assembly. In that way, rotation of the motor  65  causes the main drive shaft assembly to rotate, which causes actuation of the end effector  12 , as described above. 
         [0043]    The ring  84  threaded on the helical gear drum  80  may include a post  86  that is disposed within a slot  88  of a slotted arm  90 . The slotted arm  90  has an opening  92  at its opposite end  94  that receives a pivot pin  96  that is connected between the handle exterior side pieces  59 ,  60 . The pivot pin  96  is also disposed through an opening  100  in the firing trigger  20  and an opening  102  in the middle handle piece  104 . 
         [0044]    In addition, the handle  6  may include a reverse motor (or end-of-stroke sensor)  130  and a stop motor (or beginning-of-stroke) sensor  142 . In various embodiments, the reverse motor sensor  130  may be a limit switch located at the distal end of the helical gear drum  80  such that the ring  84  threaded on the helical gear drum  80  contacts and trips the reverse motor sensor  130  when the ring  84  reaches the distal end of the helical gear drum  80 . The reverse motor sensor  130 , when activated, sends a signal to the control unit which sends a signal to the motor  65  to reverse its rotation direction, thereby withdrawing the knife  32  of the end effector  12  following the cutting operation. 
         [0045]    The stop motor sensor  142  may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of the helical gear drum  80  so that the ring  84  trips the switch  142  when the ring  84  reaches the proximate end of the helical gear drum  80 . 
         [0046]    In operation, when an operator of the instrument  10  pulls back the firing trigger  20 , the sensor  110  detects the deployment of the firing trigger  20  and sends a signal to the control unit which sends a signal to the motor  65  to cause forward rotation of the motor  65  at, for example, a rate proportional to how hard the operator pulls back the firing trigger  20 . The forward rotation of the motor  65  in turn causes the ring gear  78  at the distal end of the planetary gear assembly  72  to rotate, thereby causing the helical gear drum  80  to rotate, causing the ring  84  threaded on the helical gear drum  80  to travel distally along the helical gear drum  80 . The rotation of the helical gear drum  80  also drives the main drive shaft assembly as described above, which in turn causes deployment of the knife  32  in the end effector  12 . That is, the knife  32  and sled  33  are caused to traverse the channel  22  longitudinally, thereby cutting tissue clamped in the end effector  12 . Also, the stapling operation of the end effector  12  is caused to happen in embodiments where a stapling-type end effector is used. 
         [0047]    By the time the cutting/stapling operation of the end effector  12  is complete, the ring  84  on the helical gear drum  80  will have reached the distal end of the helical gear drum  80 , thereby causing the reverse motor sensor  130  to be tripped, which sends a signal to the control unit which sends a signal to the motor  65  to cause the motor  65  to reverse its rotation. This in turn causes the knife  32  to retract, and also causes the ring  84  on the helical gear drum  80  to move back to the proximate end of the helical gear drum  80 . 
         [0048]    The middle handle piece  104  includes a backside shoulder  106  that engages the slotted arm  90  as best shown in  FIGS. 8 and 9 . The middle handle piece  104  also has a forward motion stop  107  that engages the firing trigger  20 . The movement of the slotted arm  90  is controlled, as explained above, by rotation of the motor  65 . When the slotted arm  90  rotates CCW as the ring  84  travels from the proximate end of the helical gear drum  80  to the distal end, the middle handle piece  104  will be free to rotate CCW. Thus, as the user draws in the firing trigger  20 , the firing trigger  20  will engage the forward motion stop  107  of the middle handle piece  104 , causing the middle handle piece  104  to rotate CCW. Due to the backside shoulder  106  engaging the slotted arm  90 , however, the middle handle piece  104  will only be able to rotate CCW as far as the slotted arm  90  permits. In that way, if the motor  65  should stop rotating for some reason, the slotted arm  90  will stop rotating, and the user will not be able to further draw in the firing trigger  20  because the middle handle piece  104  will not be free to rotate CCW due to the slotted arm  90 . 
         [0049]    Components of an exemplary closure system for closing (or clamping) the anvil  24  of the end effector  12  by retracting the closure trigger  18  are also shown in  FIGS. 7-10 . In the illustrated embodiment, the closure system includes a yoke  250  connected to the closure trigger  18  by a pin  251  that is inserted through aligned openings in both the closure trigger  18  and the yoke  250 . A pivot pin  252 , about which the closure trigger  18  pivots, is inserted through another opening in the closure trigger  18  which is offset from where the pin  251  is inserted through the closure trigger  18 . Thus, retraction of the closure trigger  18  causes the upper part of the closure trigger  18 , to which the yoke  250  is attached via the pin  251 , to rotate CCW. The distal end of the yoke  250  is connected, via a pin  254 , to a first closure bracket  256 . The first closure bracket  256  connects to a second closure bracket  258 . Collectively, the closure brackets  256 ,  258  define an opening in which the proximate end of the proximate closure tube  40  (see  FIG. 4 ) is seated and held such that longitudinal movement of the closure brackets  256 ,  258  causes longitudinal motion by the proximate closure tube  40 . The instrument  10  also includes a closure rod  260  disposed inside the proximate closure tube  40 . The closure rod  260  may include a window  261  into which a post  263  on one of the handle exterior pieces, such as exterior lower side piece  59  in the illustrated embodiment, is disposed to fixedly connect the closure rod  260  to the handle  6 . In that way, the proximate closure tube  40  is capable of moving longitudinally relative to the closure rod  260 . The closure rod  260  may also include a distal collar  267  that fits into a cavity  269  in proximate spine tube  46  and is retained therein by a cap  271  (see  FIG. 4 ). 
         [0050]    In operation, when the yoke  250  rotates due to retraction of the closure trigger  18 , the closure brackets  256 ,  258  cause the proximate closure tube  40  to move distally (i.e., away from the handle end of the instrument  10 ), which causes the distal closure tube  42  to move distally, which causes the anvil  24  to rotate about the pivot point  25  into the clamped or closed position. When the closure trigger  18  is unlocked from the locked position, the proximate closure tube  40  is caused to slide proximately, which causes the distal closure tube  42  to slide proximately, which, by virtue of the tab  27  being inserted in the window  45  of the distal closure tube  42 , causes the anvil  24  to pivot about the pivot point  25  into the open or unclamped position. In that way, by retracting and locking the closure trigger  18 , an operator may clamp tissue between the anvil  24  and channel  22 , and may unclamp the tissue following the cutting/stapling operation by unlocking the closure trigger  18  from the locked position. 
         [0051]    The control unit (described further below) may receive the outputs from end-of-stroke and beginning-of-stroke sensors  130 ,  142  and the run-motor sensor  110 , and may control the motor  65  based on the inputs. For example, when an operator initially pulls the firing trigger  20  after locking the closure trigger  18 , the run-motor sensor  110  is actuated. If the staple cartridge  34  is present in the end effector  12 , a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to the motor  65  to cause the motor  65  to rotate in the forward direction. When the end effector  12  reaches the end of its stroke, the reverse motor sensor  130  will be activated. The control unit may receive this output from the reverse motor sensor  130  and cause the motor  65  to reverse its rotational direction. When the knife  32  is fully retracted, the stop motor sensor switch  142  is activated, causing the control unit to stop the motor  65 . 
         [0052]    In other embodiments, rather than a proportional-type sensor  110 , an on-off type sensor could be used. In such embodiments, the rate of rotation of the motor  65  would not be proportional to the force applied by the operator. Rather, the motor  65  would generally rotate at a constant rate. But the operator would still experience force feedback because the firing trigger  20  is geared into the gear drive train. 
         [0053]    The instrument  10  may include a number of sensor transponders in the end effector  12  for sensing various conditions related to the end effector  12 , such as sensor transponders for determining the status of the staple cartridge  34  (or other type of cartridge depending on the type of surgical instrument), the progress of the stapler during closure and firing, etc. The sensor transponders may be passively powered by inductive signals, as described further below, although in other embodiments the transponders could be powered by a remote power source, such as a battery in the end effector  12 , for example. The sensor transponder(s) could include magnetoresistive, optical, electromechanical, RFID, MEMS, motion or pressure sensors, for example. These sensor transponders may be in communication with a control unit  300 , which may be housed in the handle  6  of the instrument  10 , for example, as shown in  FIG. 11 . 
         [0054]    As shown in  FIG. 12 , according to various embodiments the control unit  300  may comprise a processor  306  and one or more memory units  308 . By executing instruction code stored in the memory  308 , the processor  306  may control various components of the instrument  10 , such as the motor  65  or a user display (not shown), based on inputs received from the various end effector sensor transponders and other sensor(s) (such as the run-motor sensor  110 , the end-of-stroke sensor  130 , and the beginning-of-stroke sensor  142 , for example). The control unit  300  may be powered by the battery  64  during surgical use of instrument  10 . The control unit  300  may comprise an inductive element  302  (e.g., a coil or antenna) to pick up wireless signals from the sensor transponders, as described in more detail below. Input signals received by the inductive element  302  acting as a receiving antenna may be demodulated by a demodulator  310  and decoded by a decoder  312 . The input signals may comprise data from the sensor transponders in the end effector  12 , which the processor  306  may use to control various aspects of the instrument  10 . 
         [0055]    To transmit signals to the sensor transponders, the control unit  300  may comprise an encoder  316  for encoding the signals and a modulator  318  for modulating the signals according to the modulation scheme. The inductive element  302  may act as the transmitting antenna. The control unit  300  may communicate with the sensor transponders using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band). Also, the control unit  300  may transmit signals at a different frequency range than the frequency range of the received signals from the sensor transponders. Also, although only one antenna (inductive element  302 ) is shown in  FIG. 12 , in other embodiments the control unit  300  may have separate receiving and transmitting antennas. 
         [0056]    According to various embodiments, the control unit  300  may comprise a microcontroller, a microprocessor, a field programmable gate array (FPGA), one or more other types of integrated circuits (e.g., RF receivers and PWM controllers), and/or discrete passive components. The control units may also be embodied as system-on-chip (SoC) or a system-in-package (SIP), for example. 
         [0057]    As shown in  FIG. 11 , the control unit  300  may be housed in the handle  6  of the instrument  10  and one or more of the sensor transponders  368  for the instrument  10  may be located in the end effector  12 . To deliver power and/or transmit data to or from the sensor transponders  368  in the end effector  12 , the inductive element  302  of the control unit  300  may be inductively coupled to a secondary inductive element (e.g., a coil)  320  positioned in the shaft  8  distally from the rotation joint  29 . The secondary inductive element  320  is preferably electrically insulated from the conductive shaft  8 . 
         [0058]    The secondary inductive element  320  may be connected by an electrically conductive, insulated wire  322  to a distal inductive element (e.g., a coil)  324  located near the end effector  12 , and preferably distally relative to the articulation pivot  14 . The wire  322  may be made of an electrically conductive polymer and/or metal (e.g., copper) and may be sufficiently flexible so that it could pass though the articulation pivot  14  and not be damaged by articulation. The distal inductive element  324  may be inductively coupled to the sensor transponder  368  in, for example, the cartridge  34  of the end effector  12 . The transponder  368 , as described in more detail below, may include an antenna (or coil) for inductive coupling to the distal coil  324 , a sensor and integrated control electronics for receiving and transmitting wireless communication signals. 
         [0059]    The transponder  368  may use a portion of the power of the inductive signal received from the distal inductive element  326  to passively power the transponder  368 . Once sufficiently powered by the inductive signals, the transponder  368  may receive and transmit data to the control unit  300  in the handle  6  via (i) the inductive coupling between the transponder  368  and the distal inductive element  324 , (ii) the wire  322 , and (iii) the inductive coupling between the secondary inductive element  320  and the control unit  300 . That way, the control unit  300  may communicate with the transponder  368  in the end effector  12  without a direct wired connection through complex mechanical joints like the rotating joint  29  and/or without a direct wired connection from the shaft  8  to the end effector  12 , places where it may be difficult to maintain such a wired connection. In addition, because the distances between the inductive elements (e.g., the spacing between (i) the transponder  368  and the distal inductive element  324 , and (ii) the secondary inductive element  320  and the control unit  300 ) and fixed and known, the couplings could be optimized for inductive transfer of energy. Also, the distances could be relatively short so that relatively low power signals could be used to thereby minimize interference with other systems in the use environment of the instrument  10 . 
         [0060]    In the embodiment of  FIG. 12 , the inductive element  302  of the control unit  300  is located relatively near to the control unit  300 . According to other embodiments, as shown in  FIG. 13 , the inductive element  302  of the control unit  300  may be positioned closer to the rotating joint  29  to that it is closer to the secondary inductive element  320 , thereby reducing the distance of the inductive coupling in such an embodiment. Alternatively, the control unit  300  (and hence the inductive element  302 ) could be positioned closer to the secondary inductive element  320  to reduce the spacing. 
         [0061]    In other embodiments, more or fewer than two inductive couplings may be used. For example, in some embodiments, the surgical instrument  10  may use a single inductive coupling between the control unit  300  in the handle  6  and the transponder  368  in the end effector  12 , thereby eliminating the inductive elements  320 ,  324  and the wire  322 . Of course, in such an embodiment, a stronger signal may be required due to the greater distance between the control unit  300  in the handle  6  and the transponder  368  in the end effector  12 . Also, more than two inductive couplings could be used. For example, if the surgical instrument  10  had numerous complex mechanical joints where it would be difficult to maintain a direct wired connection, inductive couplings could be used to span each such joint. For example, inductive couplers could be used on both sides of the rotary joint  29  and both sides of the articulation pivot  14 , with the inductive element  321  on the distal side of the rotary joint  29  connected by a wire  322  to the inductive element  324  of the proximate side of the articulation pivot, and a wire  323  connecting the inductive elements  325 ,  326  on the distal side of the articulation pivot  14  as shown in  FIG. 14 . In this embodiment, the inductive element  326  may communicate with the sensor transponder  368 . 
         [0062]    In addition, the transponder  368  may include a number of different sensors. For example, it may include an array of sensors. Further, the end effector  12  could include a number of sensor transponders  368  in communication with the distal inductive element  324  (and hence the control unit  300 ). Also, the inductive elements  320 ,  324  may or may not include ferrite cores. As mentioned before, they are also preferably insulated from the electrically conductive outer shaft (or frame) of the instrument  10  (e.g., the closure tubes  40 ,  42 ), and the wire  322  is also preferably insulated from the outer shaft  8 . 
         [0063]      FIG. 15  is a diagram of an end effector  12  including a transponder  368  held or embedded in the cartridge  34  at the distal end of the channel  22 . The transponder  368  may be connected to the cartridge  34  by a suitable bonding material, such as epoxy. In this embodiment, the transponder  368  includes a magnetoresistive sensor. The anvil  24  also includes a permanent magnet  369  at its distal end and generally facing the transponder  368 . The end effector  12  also includes a permanent magnet  370  connected to the sled  33  in this example embodiment. This allows the transponder  368  to detect both opening/closing of the end effector  12  (due to the permanent magnet  369  moving further or closer to the transponder as the anvil  24  opens and closes) and completion of the stapling/cutting operation (due to the permanent magnet  370  moving toward the transponder  368  as the sled  33  traverses the channel  22  as part of the cutting operation). 
         [0064]      FIG. 15  also shows the staples  380  and the staple drivers  382  of the staple cartridge  34 . As explained previously, according to various embodiments, when the sled  33  traverses the channel  22 , the sled  33  drives the staple drivers  382  which drive the staples  380  into the severed tissue held in the end effector  12 , the staples  380  being formed against the anvil  24 . As noted above, such a surgical cutting and fastening instrument is but one type of surgical instrument in which the present invention may be advantageously employed. Various embodiments of the present invention may be used in any type of surgical instrument having one or more sensor transponders. 
         [0065]    In the embodiments described above, the battery  64  powers (at least partially) the firing operation of the instrument  10 . As such, the instrument may be a so-called “power-assist” device. More details and additional embodiments of power-assist devices are described in the &#39;573 application, which is incorporated herein. It should be recognized, however, that the instrument  10  need not be a power-assist device and that this is merely an example of a type of device that may utilize aspects of the present invention. For example, the instrument  10  may include a user display (such as a LCD or LED display) that is powered by the battery  64  and controlled by the control unit  300 . Data from the sensor transponders  368  in the end effector  12  may be displayed on such a display. 
         [0066]    In another embodiment, the shaft  8  of the instrument  10 , including for example, the proximate closure tube  40  and the distal closure tube  42 , may collectively serve as part of an antenna for the control unit  300  by radiating signals to the sensor transponder  368  and receiving radiated signals from the sensor transponder  368 . That way, signals to and from the remote sensor in the end effector  12  may be transmitted via the shaft  8  of the instrument  10 . 
         [0067]    The proximate closure tube  40  may be grounded at its proximate end by the exterior lower and upper side pieces  59 - 62 , which may be made of a nonelectrically conductive material, such as plastic. The drive shaft assembly components (including the main drive shaft  48  and secondary drive shaft  50 ) inside the proximate and distal closure tubes  40 ,  42  may also be made of a nonelectrically conductive material, such as plastic. Further, components of end effector  12  (such as the anvil  24  and the channel  22 ) may be electrically coupled to (or in direct or indirect electrical contact with) the distal closure tube  42  such that they may also serve as part of the antenna. Further, the sensor transponder  368  could be positioned such that it is electrically insulated from the components of the shaft  8  and end effector  12  serving as the antenna. For example, the sensor transponder  368  may be positioned in the cartridge  34 , which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft  8  (such as the distal end of the distal closure tube  42 ) and the portions of the end effector  12  serving as the antenna may be relatively close in distance to the sensor  368 , the power for the transmitted signals may be held at low levels, thereby minimizing or reducing interference with other systems in the use environment of the instrument  10 . 
         [0068]    In such an embodiment, as shown in  FIG. 16 , the control unit  300  may be electrically coupled to the shaft  8  of the instrument  10 , such as to the proximate closure tube  40 , by a conductive link  400  (e.g., a wire). Portions of the outer shaft  8 , such as the closure tubes  40 ,  42 , may therefore act as part of an antenna for the control unit  300  by radiating signals to the sensor  368  and receiving radiated signals from the sensor  368 . Input signals received by the control unit  300  may be demodulated by the demodulator  310  and decoded by the decoder  312  (see  FIG. 12 ). The input signals may comprise data from the sensors  368  in the end effector  12 , which the processor  306  may use to control various aspects of the instrument  10 , such as the motor  65  or a user display. 
         [0069]    To transmit data signals to or from the sensors  368  in the end effector  12 , the link  400  may connect the control unit  300  to components of the shaft  8  of the instrument  10 , such as the proximate closure tube  40 , which may be electrically connected to the distal closure tube  42 . The distal closure tube  42  is preferably electrically insulated from the remote sensor  368 , which may be positioned in the plastic cartridge  34  (see  FIG. 3 ). As mentioned before, components of the end effector  12 , such as the channel  22  and the anvil  24  (see  FIG. 3 ), may be conductive and in electrical contact with the distal closure tube  42  such that they, too, may serve as part of the antenna. 
         [0070]    With the shaft  8  acting as the antenna for the control unit  300 , the control unit  300  can communicate with the sensor  368  in the end effector  12  without a direct wired connection. In addition, because the distances between shaft  8  and the remote sensor  368  is fixed and known, the power levels could be optimized for low levels to thereby minimize interference with other systems in the use environment of the instrument  10 . The sensor  368  may include communication circuitry for radiating signals to the control unit  300  and for receiving signals from the control unit  300 , as described above. The communication circuitry may be integrated with the sensor  368 . 
         [0071]    In another embodiment, the components of the shaft  8  and/or the end effector  12  may serve as an antenna for the remote sensor  368 . In such an embodiment, the remote sensor  368  is electrically connected to the shaft (such as to distal closure tube  42 , which may be electrically connected to the proximate closure tube  40 ) and the control unit  300  is insulated from the shaft  8 . For example, the sensor  368  could be connected to a conductive component of the end effector  12  (such as the channel  22 ), which in turn may be connected to conductive components of the shaft (e.g., the closure tubes  40 ,  42 ). Alternatively, the end effector  12  may include a wire (not shown) that connects the remote sensor  368  the distal closure tube  42 . 
         [0072]    Typically, surgical instruments, such as the instrument  10 , are cleaned and sterilized prior to use. In one sterilization technique, the instrument  10  is placed in a closed and sealed container  280 , such as a plastic or TYVEK container or bag, as shown in  FIGS. 17 and 18 . The container and the instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument  10  and in the container  280 . The sterilized instrument  10  can then be stored in the sterile container  280 . The sealed, sterile container  280  keeps the instrument  10  sterile until it is opened in a medical facility or some other use environment. Instead of radiation, other means of sterilizing the instrument  10  may be used, such as ethylene oxide or steam. 
         [0073]    When radiation, such as gamma radiation, is used to sterilize the instrument  10 , components of the control unit  300 , particularly the memory  308  and the processor  306 , may be damaged and become unstable. Thus, according to various embodiments of the present invention, the control unit  300  may be programmed after packaging and sterilization of the instrument  10 . 
         [0074]    As shown in  FIG. 17 , a remote programming device  320 , which may be a handheld device, may be brought into wireless communication with the control unit  300 . The remote programming device  320  may emit wireless signals that are received by the control unit  300  to program the control unit  300  and to power the control unit  300  during the programming operation. That way, the battery  64  does not need to power the control unit  300  during the programming operation. According to various embodiments, the programming code downloaded to the control unit  300  could be of relatively small size, such as 1 MB or less, so that a communications protocol with a relatively low data transmission rate could be used if desired. Also, the remote programming unit  320  could be brought into close physical proximity with the surgical instrument  10  so that a low power signal could be used. 
         [0075]    Referring back to  FIG. 19 , the control unit  300  may comprise an inductive coil  402  to pick up wireless signals from a remote programming device  320 . A portion of the received signal may be used by a power circuit  404  to power the control unit  300  when it is not being powered by the battery  64 . 
         [0076]    Input signals received by the coil  402  acting as a receiving antenna may be demodulated by a demodulator  410  and decoded by a decoder  412 . The input signals may comprise programming instructions (e.g., code), which may be stored in a non-volatile memory portion of the memory  308 . The processor  306  may execute the code when the instrument  10  is in operation. For example, the code may cause the processor  306  to output control signals to various sub-systems of the instrument  10 , such as the motor  65 , based on data received from the sensors  368 . 
         [0077]    The control unit  300  may also comprise a non-volatile memory unit  414  that comprises boot sequence code for execution by the processor  306 . When the control unit  300  receives enough power from the signals from the remote control unit  320  during the post-sterilization programming operation, the processor  306  may first execute the boot sequence code (“boot loader”)  414 , which may load the processor  306  with an operating system. 
         [0078]    The control unit  300  may also send signals back to the remote programming unit  320 , such as acknowledgement and handshake signals, for example. The control unit  300  may comprise an encoder  416  for encoding the signals to then be sent to the programming device  320  and a modulator  418  for modulating the signals according to the modulation scheme. The coil  402  may act as the transmitting antenna. The control unit  300  and the remote programming device  320  may communicate using any suitable wireless communication protocol (e.g., Bluetooth) and any suitable frequency (e.g., an ISM band). Also, the control unit  300  may transmit signals at a different frequency range than the frequency range of the received signals from the remote programming unit  320 . 
         [0079]      FIG. 20  is a simplified diagram of the remote programming device  320  according to various embodiments of the present invention. As shown in  FIG. 20 , the remote programming unit  320  may comprise a main control board  230  and a boosted antenna board  232 . The main control board  230  may comprise a controller  234 , a power module  236 , and a memory  238 . The memory  238  may stored the operating instructions for the controller  234  as well as the programming instructions to be transmitted to the control unit  300  of the surgical instrument  10 . The power module  236  may provide a stable DC voltage for the components of the remote programming device  320  from an internal battery (not shown) or an external AC or DC power source (not shown). 
         [0080]    The boosted antenna board  232  may comprise a coupler circuit  240  that is in communication with the controller  234  via an I 2 C bus, for example. The coupler circuit  240  may communicate with the control unit  300  of the surgical instrument via an antenna  244 . The coupler circuit  240  may handle the modulating/demodulating and encoding/decoding operations for transmissions with the control unit. According to other embodiments, the remote programming device  320  could have a discrete modulator, demodulator, encoder and decoder. As shown in  FIG. 20 , the boost antenna board  232  may also comprise a transmitting power amp  246 , a matching circuit  248  for the antenna  244 , and a filter/amplifier  249  for receiving signals. 
         [0081]    According to other embodiments, as shown in  FIG. 20 , the remote programming device could be in communication with a computer device  460 , such as a PC or a laptop, via a USB and/or RS232 interface, for example. In such a configuration, a memory of the computing device  460  may store the programming instructions to be transmitted to the control unit  300 . In another embodiment, the computing device  460  could be configured with a wireless transmission system to transmit the programming instructions to the control unit  300 . 
         [0082]    In addition, according to other embodiments, rather than using inductive coupling between the control unit  300  and the remote programming device  320 , capacitively coupling could be used. In such an embodiment, the control unit  300  could have a plate instead of a coil, as could the remote programming unit  320 . 
         [0083]    In another embodiment, rather than using a wireless communication link between the control unit  300  and the remote programming device  320 , the programming device  320  may be physically connected to the control unit  300  while the instrument  10  is in its sterile container  280  in such a way that the instrument  10  remains sterilized.  FIG. 21  is a diagram of a packaged instrument  10  according to such an embodiment. As shown in  FIG. 22 , the handle  6  of the instrument  10  may include an external connection interface  470 . The container  280  may further comprise a connection interface  472  that mates with the external connection interface  470  of the instrument  10  when the instrument  10  is packaged in the container  280 . The programming device  320  may include an external connection interface (not shown) that may connect to the connection interface  472  at the exterior of the container  280  to thereby provide a wired connection between the programming device  320  and the external connection interface  470  of the instrument  10 . 
         [0084]    The various embodiments of the present invention have been described above in connection with cutting-type surgical instruments. It should be noted, however, that in other embodiments, the inventive surgical instrument disclosed herein need not be a cutting-type surgical instrument, but rather could be used in any type of surgical instrument including remote sensor transponders. For example, it could be a non-cutting endoscopic instrument, a grasper, a stapler, a clip applier, an access device, a drug/gene therapy delivery device, an energy device using ultrasound, RF, laser, etc. In addition, the present invention may be in laparoscopic instruments, for example. The present invention also has application in conventional endoscopic and open surgical instrumentation as well as robotic-assisted surgery. 
         [0085]    The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application. 
         [0086]    Although the present invention has been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors may be employed. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations. 
         [0087]    Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.