US20100222901A1 - Post-Sterilization Programming of Surgical Instruments - Google Patents

Abstract

A surgical instrument with a programmable control unit and methods for programming the control unit while the surgical instrument is in a sterile container. The method may comprise packaging the surgical instrument in the container and then sterilizing the surgical instrument while the surgical instrument is in the container. The method may further comprise programming the surgical instrument while the surgical instrument is in the container with a programming device positioned outside of the container.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present continuation application claims benefit of U.S. patent application Ser. No. 11/651,771, filed on Jan. 10, 2007, which is incorporated herein by reference. The following applications are also incorporated by reference:
• (1) U.S. patent application Ser. No. ______, entitled “SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS,” by J. Giordano et al. (Attorney Docket No. 060338/END5923USNP);
• (2) U.S. patent application Ser. No. ______, entitled “SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR,” by J. Giordano et al. (Attorney Docket No. 060339/END5924USNP);
• (3) U.S. patent application Ser. No. ______, entitled “SURGICAL INSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT AND END EFFECTOR,” by J. Giordano et al. (Attorney Docket No. 060340/END5925USNP);
• (4) U.S. patent application Ser. No. ______, entitled “PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT,” by F. Shelton et al. (Attorney Docket No. 060341/END5926USNP);
• (5) U.S. patent application Ser. No. ______, entitled “INTERLOCK AND SURGICAL INSTRUMENT INCLUDING SAME, by F. Shelton et al. (Attorney Docket No. 060343/END5928USNP); and
• (6) U.S. patent application Ser. No. ______, entitled “SURGICAL INSTRUMENT WITH ENHANCED BATTERY PERFORMANCE,” by F. Shelton et al. (Attorney Docket No. 060347/END5931USNP).
BACKGROUND
• 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.).
• 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.
• 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.
• 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.
• 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 CO₂or 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.
• 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 '573 application”) which is incorporated herein by reference.
• 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.
SUMMARY
• In one general aspect, the present invention is directed to a surgical instrument, such as an endoscopic or laparoscopic instrument. According to one embodiment, the surgical instrument comprises an end effector comprising at least one sensor transponder that is passively powered. The surgical instrument also comprises a shaft having a distal end connected to the end effector and a handle connected to a proximate end of the shaft. The handle comprises a control unit (e.g., a microcontroller) that is in communication with the sensor transponder via at least one inductive coupling. Further, the surgical instrument may comprise a rotational joint for rotating the shaft. In such a case, the surgical instrument may comprise a first inductive element located in the shaft distally from the rotational joint and inductively coupled to the control unit, and a second inductive element located distally in the shaft and inductively coupled to the at least one sensor transponder. The first and second inductive elements may be connected by a wired, physical connection.
• That way, the control unit may communicate with the transponder in the end effector without a direct wired connection through complex mechanical joints like the rotating joint where it may be difficult to maintain such a wired connection. In addition, because the distances between the inductive elements may be 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.
• In another general aspect of the present invention, the electrically conductive shaft of the surgical instrument may serve as an antenna for the control unit to wirelessly communicate signals to and from the sensor transponder. For example, the sensor transponder could be located on or disposed in a nonconductive component of the end effector, such as a plastic cartridge, thereby insulating the sensor from conductive components of the end effector and the shaft. In addition, the control unit in the handle may be electrically coupled to the shaft. In that way, the shaft and/or the end effector may serve as an antenna for the control unit by radiating signals from the control unit to the sensor and/or by receiving radiated signals from the sensor. Such a design is particularly useful in surgical instruments having complex mechanical joints (such as rotary joints), which make it difficult to use a direct wired connection between the sensor and control unit for communicating data signals.
• In another embodiment, the shaft and/or components of the end effector could serve as the antenna for the sensor by radiating signals to the control unit and receiving radiated signals from the control unit. According to such an embodiment, the control unit is electrically insulated from the shaft and the end effector.
• In another general aspect, the present invention is directed to a surgical instrument comprising a programmable control unit that can be programmed by a programming device after the instrument has been packaged and sterilized. In one such embodiment, the programming device may wirelessly program the control unit. The control unit may be passively powered by the wireless signals from the programming device during the programming operation. In another embodiment, the sterile container may comprise a connection interface so that the programming unit can be connected to the surgical instrument while the surgical instrument is in its sterilized container.
FIGURES
• Various embodiments of the present invention are described herein by way of example in conjunction with the following figures wherein:
• FIGS. 1 and 2 are perspective views of a surgical instrument according to various embodiments of the present invention;
• FIGS. 3-5 are exploded views of an end effector and shaft of the instrument according to various embodiments of the present invention;
• FIG. 6 is a side view of the end effector according to various embodiments of the present invention;
• FIG. 7 is an exploded view of the handle of the instrument according to various embodiments of the present invention;
• FIGS. 8 and 9 are partial perspective views of the handle according to various embodiments of the present invention;
• FIG. 10 is a side view of the handle according to various embodiments of the present invention;
• FIGS. 11,13-14,16, and22 are perspective views of a surgical instrument according to various embodiments of the present invention;
• FIGS. 12 and 19 are block diagrams of a control unit according to various embodiments of the present invention;
• FIG. 15 is a side view of an end effector including a sensor transponder according to various embodiments of the present invention;
• FIGS. 17 and 18 show the instrument in a sterile container according to various embodiments of the present invention;
• FIG. 20 is a block diagram of the remote programming device according to various embodiments of the present invention; and
• FIG. 21 is a diagram of a packaged instrument according to various embodiments of the present invention.
DETAILED DESCRIPTION
• 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.
• FIGS. 1 and 2 depict an endoscopicsurgical instrument10 that comprises ahandle6, ashaft8, and an articulatingend effector12 pivotally connected to theshaft8 at anarticulation pivot14. Correct placement and orientation of theend effector12 may be facilitated by controls on thehand6, including (1) a rotation knob28 for rotating the closure tube (described in more detail below in connection withFIGS. 4-5) at a free rotating joint29 of theshaft8 to thereby rotate theend effector12 and (2) anarticulation control16 to effect rotational articulation of theend effector12 about thearticulation pivot14. In the illustrated embodiment, theend effector12 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.
• Thehandle6 of theinstrument10 may include aclosure trigger18 and a firingtrigger20 for actuating theend effector12. 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 theend effector12. Theend effector12 is shown separated from thehandle6 by the preferably elongateshaft8. In one embodiment, a clinician or operator of theinstrument10 may articulate theend effector12 relative to theshaft8 by utilizing thearticulation control16, 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.
• Theend effector12 includes in this example, among other things, astaple channel22 and a pivotally translatable clamping member, such as ananvil24, which are maintained at a spacing that assures effective stapling and severing of tissue clamped in theend effector12. Thehandle6 includes apistol grip26 towards which aclosure trigger18 is pivotally drawn by the clinician to cause clamping or closing of theanvil24 toward thestaple channel22 of theend effector12 to thereby clamp tissue positioned between theanvil24 andchannel22. The firingtrigger20 is farther outboard of theclosure trigger18. Once theclosure trigger18 is locked in the closure position, the firingtrigger20 may rotate slightly toward thepistol grip26 so that it can be reached by the operator using one hand. Then the operator may pivotally draw the firingtrigger20 toward thepistol grip12 to cause the stapling and severing of clamped tissue in theend effector12. The '573 application describes various configurations for locking and unlocking theclosure trigger18. In other embodiments, different types of clamping members besides theanvil24 could be used, such as, for example, an opposing jaw, etc.
• It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician gripping thehandle6 of aninstrument10. Thus, theend effector12 is distal with respect to the moreproximal handle6. 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.
• Theclosure trigger18 may be actuated first. Once the clinician is satisfied with the positioning of theend effector12, the clinician may draw back theclosure trigger18 to its fully closed, locked position proximate to thepistol grip26. The firingtrigger20 may then be actuated. The firingtrigger20 returns to the open position (shown inFIGS. 1 and 2) when the clinician removes pressure. A release button30 on thehandle6, and in this example, on thepistol grip26 of the handle, when depressed may release the lockedclosure trigger18.
• FIG. 3 is an exploded view of theend effector12 according to various embodiments. As shown in the illustrated embodiment, theend effector12 may include, in addition to the previously-mentionedchannel22 andanvil24, a cuttinginstrument32, a sled33, astaple cartridge34 that is removably seated in thechannel22, and ahelical screw shaft36. The cuttinginstrument32 may be, for example, a knife. Theanvil24 may be pivotably opened and closed at apivot point25 connected to the proximate end of thechannel22. Theanvil24 may also include atab27 at its proximate end that is inserted into a component of the mechanical closure system (described further below) to open and close theanvil24. When theclosure trigger18 is actuated, that is, drawn in by a user of theinstrument10, theanvil24 may pivot about thepivot point25 into the clamped or closed position. If clamping of theend effector12 is satisfactory, the operator may actuate the firingtrigger20, which, as explained in more detail below, causes theknife32 and sled33 to travel longitudinally along thechannel22, thereby cutting tissue clamped within theend effector12. The movement of the sled33 along thechannel22 causes the staples of thestaple cartridge34 to be driven through the severed tissue and against theclosed anvil24, 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 sled33 may be part of thecartridge34, such that when theknife32 retracts following the cutting operation, the sled33 does not retract. Thechannel22 and theanvil24 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. Thecartridge34 could be made of a nonconductive material (such as plastic) and the sensor may be connected to or disposed in thecartridge34, as described further below.
• It should be noted that although the embodiments of theinstrument10 described herein employ anend effector12 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.
• FIGS. 4 and 5 are exploded views andFIG. 6 is a side view of theend effector12 andshaft8 according to various embodiments. As shown in the illustrated embodiment, theshaft8 may include aproximate closure tube40 and adistal closure tube42 pivotably linked by a pivot links44. Thedistal closure tube42 includes anopening45 into which thetab27 on theanvil24 is inserted in order to open and close theanvil24. Disposed inside theclosure tubes40,42 may be aproximate spine tube46. Disposed inside theproximate spine tube46 may be a main rotational (or proximate) driveshaft48 that communicates with a secondary (or distal) driveshaft50 via a bevel gear assembly52. Thesecondary drive shaft50 is connected to adrive gear54 that engages aproximate drive gear56 of thehelical screw shaft36. Thevertical bevel gear52bmay sit and pivot in an opening57 in the distal end of theproximate spine tube46. Adistal spine tube58 may be used to enclose thesecondary drive shaft50 and the drive gears54,56. Collectively, themain drive shaft48, thesecondary drive shaft50, and the articulation assembly (e.g., the bevel gear assembly52a-c), are sometimes referred to herein as the “main drive shaft assembly.” Theclosure tubes40,42 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., thedrive shafts48,50) may be made of a nonconductive material (such as plastic).
• Abearing38, positioned at a distal end of thestaple channel22, receives thehelical drive screw36, allowing thehelical drive screw36 to freely rotate with respect to thechannel22. Thehelical screw shaft36 may interface a threaded opening (not shown) of theknife32 such that rotation of theshaft36 causes theknife32 to translate distally or proximately (depending on the direction of the rotation) through thestaple channel22. Accordingly, when themain drive shaft48 is caused to rotate by actuation of the firing trigger20 (as explained in more detail below), the bevel gear assembly52a-ccauses thesecondary drive shaft50 to rotate, which in turn, because of the engagement of the drive gears54,56, causes thehelical screw shaft36 to rotate, which causes theknife32 to travel longitudinally along thechannel22 to cut any tissue clamped within the end effector. The sled33 may be made of, for example, plastic, and may have a sloped distal surface. As the sled33 traverses thechannel22, the sloped forward surface may push up or drive the staples in thestaple cartridge34 through the clamped tissue and against theanvil24. Theanvil24 turns the staples, thereby stapling the severed tissue. When theknife32 is retracted, theknife32 and sled33 may become disengaged, thereby leaving the sled33 at the distal end of thechannel22.
• According to various embodiments, as shownFIGS. 7-10, the surgical instrument may include abattery64 in thehandle6. The illustrated embodiment provides user-feedback regarding the deployment and loading force of the cutting instrument in theend effector12. In addition, the embodiment may use power provided by the user in retracting the firingtrigger18 to power the instrument10 (a so-called “power assist” mode). As shown in the illustrated embodiment, thehandle6 includes exteriorlower side pieces59,60 and exteriorupper side pieces61,62 that fit together to form, in general, the exterior of thehandle6. The handle pieces59-62 may be made of an electrically nonconductive material, such as plastic. Abattery64 may be provided in thepistol grip portion26 of thehandle6. Thebattery64 powers amotor65 disposed in an upper portion of thepistol grip portion26 of thehandle6. Thebattery64 may be constructed according to any suitable construction or chemistry including, for example, a Li-ion chemistry such as LiCoO₂or LiNiO₂, a Nickel Metal Hydride chemistry, etc. According to various embodiments, themotor65 may be a DC brushed driving motor having a maximum rotation of, approximately, 5000 RPM to 100,000 RPM. Themotor64 may drive a 90°bevel gear assembly66 comprising afirst bevel gear68 and asecond bevel gear70. Thebevel gear assembly66 may drive aplanetary gear assembly72. Theplanetary gear assembly72 may include apinion gear74 connected to a drive shaft76. Thepinion gear74 may drive amating ring gear78 that drives ahelical gear drum80 via adrive shaft82. Aring84 may be threaded on thehelical gear drum80. Thus, when themotor65 rotates, thering84 is caused to travel along thehelical gear drum80 by means of the interposedbevel gear assembly66,planetary gear assembly72 andring gear78.
• Thehandle6 may also include arun motor sensor110 in communication with the firingtrigger20 to detect when the firingtrigger20 has been drawn in (or “closed”) toward thepistol grip portion26 of thehandle6 by the operator to thereby actuate the cutting/stapling operation by theend effector12. Thesensor110 may be a proportional sensor such as, for example, a rheostat or variable resistor. When the firingtrigger20 is drawn in, thesensor110 detects the movement, and sends an electrical signal indicative of the voltage (or power) to be supplied to themotor65. When thesensor110 is a variable resistor or the like, the rotation of themotor65 may be generally proportional to the amount of movement of the firingtrigger20. That is, if the operator only draws or closes the firingtrigger20 in a little bit, the rotation of themotor65 is relatively low. When the firingtrigger20 is fully drawn in (or in the fully closed position), the rotation of themotor65 is at its maximum. In other words, the harder the user pulls on the firingtrigger20, the more voltage is applied to themotor65, causing greater rates of rotation. In another embodiment, for example, the control unit (described further below) may output a PWM control signal to themotor65 based on the input from thesensor110 in order to control themotor65.
• Thehandle6 may include amiddle handle piece104 adjacent to the upper portion of the firingtrigger20. Thehandle6 also may comprise abias spring112 connected between posts on themiddle handle piece104 and the firingtrigger20. Thebias spring112 may bias the firingtrigger20 to its fully open position. In that way, when the operator releases the firingtrigger20, thebias spring112 will pull the firingtrigger20 to its open position, thereby removing actuation of thesensor110, thereby stopping rotation of themotor65. Moreover, by virtue of thebias spring112, any time a user closes the firingtrigger20, the user will experience resistance to the closing operation, thereby providing the user with feedback as to the amount of rotation exerted by themotor65. Further, the operator could stop retracting the firingtrigger20 to thereby remove force from thesensor100, to thereby stop themotor65. As such, the user may stop the deployment of theend effector12, thereby providing a measure of control of the cutting/fastening operation to the operator.
• The distal end of thehelical gear drum80 includes adistal drive shaft120 that drives aring gear122, which mates with apinion gear124. Thepinion gear124 is connected to themain drive shaft48 of the main drive shaft assembly. In that way, rotation of themotor65 causes the main drive shaft assembly to rotate, which causes actuation of theend effector12, as described above.
• Thering84 threaded on thehelical gear drum80 may include apost86 that is disposed within aslot88 of a slottedarm90. The slottedarm90 has anopening92 at itsopposite end94 that receives apivot pin96 that is connected between the handleexterior side pieces59,60. Thepivot pin96 is also disposed through anopening100 in the firingtrigger20 and anopening102 in themiddle handle piece104.
• In addition, thehandle6 may include a reverse motor (or end-of-stroke sensor)130 and a stop motor (or beginning-of-stroke)sensor142. In various embodiments, thereverse motor sensor130 may be a limit switch located at the distal end of thehelical gear drum80 such that thering84 threaded on thehelical gear drum80 contacts and trips thereverse motor sensor130 when thering84 reaches the distal end of thehelical gear drum80. Thereverse motor sensor130, when activated, sends a signal to the control unit which sends a signal to themotor65 to reverse its rotation direction, thereby withdrawing theknife32 of theend effector12 following the cutting operation.
• Thestop motor sensor142 may be, for example, a normally-closed limit switch. In various embodiments, it may be located at the proximate end of thehelical gear drum80 so that thering84 trips theswitch142 when thering84 reaches the proximate end of thehelical gear drum80.
• In operation, when an operator of theinstrument10 pulls back the firingtrigger20, thesensor110 detects the deployment of the firingtrigger20 and sends a signal to the control unit which sends a signal to themotor65 to cause forward rotation of themotor65 at, for example, a rate proportional to how hard the operator pulls back the firingtrigger20. The forward rotation of themotor65 in turn causes thering gear78 at the distal end of theplanetary gear assembly72 to rotate, thereby causing thehelical gear drum80 to rotate, causing thering84 threaded on thehelical gear drum80 to travel distally along thehelical gear drum80. The rotation of thehelical gear drum80 also drives the main drive shaft assembly as described above, which in turn causes deployment of theknife32 in theend effector12. That is, theknife32 and sled33 are caused to traverse thechannel22 longitudinally, thereby cutting tissue clamped in theend effector12. Also, the stapling operation of theend effector12 is caused to happen in embodiments where a stapling-type end effector is used.
• By the time the cutting/stapling operation of theend effector12 is complete, thering84 on thehelical gear drum80 will have reached the distal end of thehelical gear drum80, thereby causing thereverse motor sensor130 to be tripped, which sends a signal to the control unit which sends a signal to themotor65 to cause themotor65 to reverse its rotation. This in turn causes theknife32 to retract, and also causes thering84 on thehelical gear drum80 to move back to the proximate end of thehelical gear drum80.
• Themiddle handle piece104 includes abackside shoulder106 that engages the slottedarm90 as best shown inFIGS. 8 and 9. Themiddle handle piece104 also has a forward motion stop107 that engages the firingtrigger20. The movement of the slottedarm90 is controlled, as explained above, by rotation of themotor65. When the slottedarm90 rotates CCW as thering84 travels from the proximate end of thehelical gear drum80 to the distal end, themiddle handle piece104 will be free to rotate CCW. Thus, as the user draws in the firingtrigger20, the firingtrigger20 will engage the forward motion stop107 of themiddle handle piece104, causing themiddle handle piece104 to rotate CCW. Due to thebackside shoulder106 engaging the slottedarm90, however, themiddle handle piece104 will only be able to rotate CCW as far as the slottedarm90 permits. In that way, if themotor65 should stop rotating for some reason, the slottedarm90 will stop rotating, and the user will not be able to further draw in the firingtrigger20 because themiddle handle piece104 will not be free to rotate CCW due to the slottedarm90.
• Components of an exemplary closure system for closing (or clamping) theanvil24 of theend effector12 by retracting theclosure trigger18 are also shown inFIGS. 7-10. In the illustrated embodiment, the closure system includes ayoke250 connected to theclosure trigger18 by a pin251 that is inserted through aligned openings in both theclosure trigger18 and theyoke250. Apivot pin252, about which theclosure trigger18 pivots, is inserted through another opening in theclosure trigger18 which is offset from where the pin251 is inserted through theclosure trigger18. Thus, retraction of theclosure trigger18 causes the upper part of theclosure trigger18, to which theyoke250 is attached via the pin251, to rotate CCW. The distal end of theyoke250 is connected, via apin254, to afirst closure bracket256. Thefirst closure bracket256 connects to asecond closure bracket258. Collectively, theclosure brackets256,258 define an opening in which the proximate end of the proximate closure tube40 (seeFIG. 4) is seated and held such that longitudinal movement of theclosure brackets256,258 causes longitudinal motion by theproximate closure tube40. Theinstrument10 also includes aclosure rod260 disposed inside theproximate closure tube40. Theclosure rod260 may include a window261 into which apost263 on one of the handle exterior pieces, such as exteriorlower side piece59 in the illustrated embodiment, is disposed to fixedly connect theclosure rod260 to thehandle6. In that way, theproximate closure tube40 is capable of moving longitudinally relative to theclosure rod260. Theclosure rod260 may also include adistal collar267 that fits into acavity269 inproximate spine tube46 and is retained therein by a cap271 (seeFIG. 4).
• In operation, when theyoke250 rotates due to retraction of theclosure trigger18, theclosure brackets256,258 cause theproximate closure tube40 to move distally (i.e., away from the handle end of the instrument10), which causes thedistal closure tube42 to move distally, which causes theanvil24 to rotate about thepivot point25 into the clamped or closed position. When theclosure trigger18 is unlocked from the locked position, theproximate closure tube40 is caused to slide proximately, which causes thedistal closure tube42 to slide proximately, which, by virtue of thetab27 being inserted in thewindow45 of thedistal closure tube42, causes theanvil24 to pivot about thepivot point25 into the open or unclamped position. In that way, by retracting and locking theclosure trigger18, an operator may clamp tissue between theanvil24 andchannel22, and may unclamp the tissue following the cutting/stapling operation by unlocking theclosure trigger18 from the locked position.
• The control unit (described further below) may receive the outputs from end-of-stroke and beginning-of-stroke sensors130,142 and the run-motor sensor110, and may control themotor65 based on the inputs. For example, when an operator initially pulls the firingtrigger20 after locking theclosure trigger18, the run-motor sensor110 is actuated. If thestaple cartridge34 is present in theend effector12, a cartridge lockout sensor (not shown) may be closed, in which case the control unit may output a control signal to themotor65 to cause themotor65 to rotate in the forward direction. When theend effector12 reaches the end of its stroke, thereverse motor sensor130 will be activated. The control unit may receive this output from thereverse motor sensor130 and cause themotor65 to reverse its rotational direction. When theknife32 is fully retracted, the stopmotor sensor switch142 is activated, causing the control unit to stop themotor65.
• In other embodiments, rather than a proportional-type sensor110, an on-off type sensor could be used. In such embodiments, the rate of rotation of themotor65 would not be proportional to the force applied by the operator. Rather, themotor65 would generally rotate at a constant rate. But the operator would still experience force feedback because the firingtrigger20 is geared into the gear drive train.
• Theinstrument10 may include a number of sensor transponders in theend effector12 for sensing various conditions related to theend effector12, such as sensor transponders for determining the status of the staple cartridge34 (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 theend effector12, 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 acontrol unit300, which may be housed in thehandle6 of theinstrument10, for example, as shown inFIG. 11.
• As shown inFIG. 12, according to various embodiments thecontrol unit300 may comprise aprocessor306 and one ormore memory units308. By executing instruction code stored in thememory308, theprocessor306 may control various components of theinstrument10, such as themotor65 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 sensor110, the end-of-stroke sensor130, and the beginning-of-stroke sensor142, for example). Thecontrol unit300 may be powered by thebattery64 during surgical use ofinstrument10. Thecontrol unit300 may comprise an inductive element302 (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 theinductive element302 acting as a receiving antenna may be demodulated by ademodulator310 and decoded by adecoder312. The input signals may comprise data from the sensor transponders in theend effector12, which theprocessor306 may use to control various aspects of theinstrument10.
• To transmit signals to the sensor transponders, thecontrol unit300 may comprise anencoder316 for encoding the signals and amodulator318 for modulating the signals according to the modulation scheme. Theinductive element302 may act as the transmitting antenna. Thecontrol unit300 may communicate with the sensor transponders using any suitable wireless communication protocol and any suitable frequency (e.g., an ISM band). Also, thecontrol unit300 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 element302) is shown inFIG. 12, in other embodiments thecontrol unit300 may have separate receiving and transmitting antennas.
• According to various embodiments, thecontrol unit300 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.
• As shown inFIG. 11, thecontrol unit300 may be housed in thehandle6 of theinstrument10 and one or more of thesensor transponders368 for theinstrument10 may be located in theend effector12. To deliver power and/or transmit data to or from thesensor transponders368 in theend effector12, theinductive element302 of thecontrol unit300 may be inductively coupled to a secondary inductive element (e.g., a coil)320 positioned in theshaft8 distally from the rotation joint29. The secondaryinductive element320 is preferably electrically insulated from theconductive shaft8.
• The secondaryinductive element320 may be connected by an electrically conductive,insulated wire322 to a distal inductive element (e.g., a coil)324 located near theend effector12, and preferably distally relative to thearticulation pivot14. Thewire322 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 thearticulation pivot14 and not be damaged by articulation. The distalinductive element324 may be inductively coupled to thesensor transponder368 in, for example, thecartridge34 of theend effector12. Thetransponder368, as described in more detail below, may include an antenna (or coil) for inductive coupling to thedistal coil324, a sensor and integrated control electronics for receiving and transmitting wireless communication signals.
• Thetransponder368 may use a portion of the power of the inductive signal received from the distalinductive element326 to passively power thetransponder368. Once sufficiently powered by the inductive signals, thetransponder368 may receive and transmit data to thecontrol unit300 in thehandle6 via (i) the inductive coupling between thetransponder368 and the distalinductive element324, (ii) thewire322, and (iii) the inductive coupling between the secondaryinductive element320 and thecontrol unit300. That way, thecontrol unit300 may communicate with thetransponder368 in theend effector12 without a direct wired connection through complex mechanical joints like the rotating joint29 and/or without a direct wired connection from theshaft8 to theend effector12, 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) thetransponder368 and the distalinductive element324, and (ii) the secondaryinductive element320 and the control unit300) 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 theinstrument10.
• In the embodiment ofFIG. 12, theinductive element302 of thecontrol unit300 is located relatively near to thecontrol unit300. According to other embodiments, as shown inFIG. 13, theinductive element302 of thecontrol unit300 may be positioned closer to the rotating joint29 to that it is closer to the secondaryinductive element320, thereby reducing the distance of the inductive coupling in such an embodiment. Alternatively, the control unit300 (and hence the inductive element302) could be positioned closer to the secondaryinductive element320 to reduce the spacing.
• In other embodiments, more or fewer than two inductive couplings may be used. For example, in some embodiments, thesurgical instrument10 may use a single inductive coupling between thecontrol unit300 in thehandle6 and thetransponder368 in theend effector12, thereby eliminating theinductive elements320,324 and thewire322. Of course, in such an embodiment, a stronger signal may be required due to the greater distance between thecontrol unit300 in thehandle6 and thetransponder368 in theend effector12. Also, more than two inductive couplings could be used. For example, if thesurgical instrument10 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 joint29 and both sides of thearticulation pivot14, with theinductive element321 on the distal side of the rotary joint29 connected by awire322 to theinductive element324 of the proximate side of the articulation pivot, and awire323 connecting theinductive elements325,326 on the distal side of thearticulation pivot14 as shown inFIG. 14. In this embodiment, theinductive element326 may communicate with thesensor transponder368.
• In addition, thetransponder368 may include a number of different sensors. For example, it may include an array of sensors. Further, theend effector12 could include a number ofsensor transponders368 in communication with the distal inductive element324 (and hence the control unit300). Also, theinductive elements320,324 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 instrument10 (e.g., theclosure tubes40,42), and thewire322 is also preferably insulated from theouter shaft8.
• FIG. 15 is a diagram of anend effector12 including atransponder368 held or embedded in thecartridge34 at the distal end of thechannel22. Thetransponder368 may be connected to thecartridge34 by a suitable bonding material, such as epoxy. In this embodiment, thetransponder368 includes a magnetoresistive sensor. Theanvil24 also includes apermanent magnet369 at its distal end and generally facing thetransponder368. Theend effector12 also includes apermanent magnet370 connected to the sled33 in this example embodiment. This allows thetransponder368 to detect both opening/closing of the end effector12 (due to thepermanent magnet369 moving further or closer to the transponder as theanvil24 opens and closes) and completion of the stapling/cutting operation (due to thepermanent magnet370 moving toward thetransponder368 as the sled33 traverses thechannel22 as part of the cutting operation).
• FIG. 15 also shows thestaples380 and the staple drivers382 of thestaple cartridge34. As explained previously, according to various embodiments, when the sled33 traverses thechannel22, the sled33 drives the staple drivers382 which drive thestaples380 into the severed tissue held in theend effector12, thestaples380 being formed against theanvil24. 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.
• In the embodiments described above, thebattery64 powers (at least partially) the firing operation of theinstrument10. 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 '573 application, which is incorporated herein. It should be recognized, however, that theinstrument10 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, theinstrument10 may include a user display (such as a LCD or LED display) that is powered by thebattery64 and controlled by thecontrol unit300. Data from thesensor transponders368 in theend effector12 may be displayed on such a display.
• In another embodiment, theshaft8 of theinstrument10, including for example, theproximate closure tube40 and thedistal closure tube42, may collectively serve as part of an antenna for thecontrol unit300 by radiating signals to thesensor transponder368 and receiving radiated signals from thesensor transponder368. That way, signals to and from the remote sensor in theend effector12 may be transmitted via theshaft8 of theinstrument10.
• Theproximate closure tube40 may be grounded at its proximate end by the exterior lower and upper side pieces59-62, which may be made of a nonelectrically conductive material, such as plastic. The drive shaft assembly components (including themain drive shaft48 and secondary drive shaft50) inside the proximate anddistal closure tubes40,42 may also be made of a nonelectrically conductive material, such as plastic. Further, components of end effector12 (such as theanvil24 and the channel22) may be electrically coupled to (or in direct or indirect electrical contact with) thedistal closure tube42 such that they may also serve as part of the antenna. Further, thesensor transponder368 could be positioned such that it is electrically insulated from the components of theshaft8 and endeffector12 serving as the antenna. For example, thesensor transponder368 may be positioned in thecartridge34, which may be made of a nonelectrically conductive material, such as plastic. Because the distal end of the shaft8 (such as the distal end of the distal closure tube42) and the portions of theend effector12 serving as the antenna may be relatively close in distance to thesensor368, 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 theinstrument10.
• In such an embodiment, as shown inFIG. 16, thecontrol unit300 may be electrically coupled to theshaft8 of theinstrument10, such as to theproximate closure tube40, by a conductive link400 (e.g., a wire). Portions of theouter shaft8, such as theclosure tubes40,42, may therefore act as part of an antenna for thecontrol unit300 by radiating signals to thesensor368 and receiving radiated signals from thesensor368. Input signals received by thecontrol unit300 may be demodulated by thedemodulator310 and decoded by the decoder312 (seeFIG. 12). The input signals may comprise data from thesensors368 in theend effector12, which theprocessor306 may use to control various aspects of theinstrument10, such as themotor65 or a user display.
• To transmit data signals to or from thesensors368 in theend effector12, thelink400 may connect thecontrol unit300 to components of theshaft8 of theinstrument10, such as theproximate closure tube40, which may be electrically connected to thedistal closure tube42. Thedistal closure tube42 is preferably electrically insulated from theremote sensor368, which may be positioned in the plastic cartridge34 (seeFIG. 3). As mentioned before, components of theend effector12, such as thechannel22 and the anvil24 (seeFIG. 3), may be conductive and in electrical contact with thedistal closure tube42 such that they, too, may serve as part of the antenna.
• With theshaft8 acting as the antenna for thecontrol unit300, thecontrol unit300 can communicate with thesensor368 in theend effector12 without a direct wired connection. In addition, because the distances betweenshaft8 and theremote sensor368 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 theinstrument10. Thesensor368 may include communication circuitry for radiating signals to thecontrol unit300 and for receiving signals from thecontrol unit300, as described above. The communication circuitry may be integrated with thesensor368.
• In another embodiment, the components of theshaft8 and/or theend effector12 may serve as an antenna for theremote sensor368. In such an embodiment, theremote sensor368 is electrically connected to the shaft (such as todistal closure tube42, which may be electrically connected to the proximate closure tube40) and thecontrol unit300 is insulated from theshaft8. For example, thesensor368 could be connected to a conductive component of the end effector12 (such as the channel22), which in turn may be connected to conductive components of the shaft (e.g., theclosure tubes40,42). Alternatively, theend effector12 may include a wire (not shown) that connects theremote sensor368 thedistal closure tube42.
• Typically, surgical instruments, such as theinstrument10, are cleaned and sterilized prior to use. In one sterilization technique, theinstrument10 is placed in a closed and sealedcontainer280, such as a plastic or TYVEK container or bag, as shown inFIGS. 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 theinstrument10 and in thecontainer280. The sterilizedinstrument10 can then be stored in thesterile container280. The sealed,sterile container280 keeps theinstrument10 sterile until it is opened in a medical facility or some other use environment. Instead of radiation, other means of sterilizing theinstrument10 may be used, such as ethylene oxide or steam.
• When radiation, such as gamma radiation, is used to sterilize theinstrument10, components of thecontrol unit300, particularly thememory308 and theprocessor306, may be damaged and become unstable. Thus, according to various embodiments of the present invention, thecontrol unit300 may be programmed after packaging and sterilization of theinstrument10.
• As shown inFIG. 17, aremote programming device320, which may be a handheld device, may be brought into wireless communication with thecontrol unit300. Theremote programming device320 may emit wireless signals that are received by thecontrol unit300 to program thecontrol unit300 and to power thecontrol unit300 during the programming operation. That way, thebattery64 does not need to power thecontrol unit300 during the programming operation. According to various embodiments, the programming code downloaded to thecontrol unit300 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, theremote programming unit320 could be brought into close physical proximity with thesurgical instrument10 so that a low power signal could be used.
• Referring back toFIG. 19, thecontrol unit300 may comprise an inductive coil402 to pick up wireless signals from aremote programming device320. A portion of the received signal may be used by a power circuit404 to power thecontrol unit300 when it is not being powered by thebattery64.
• Input signals received by the coil402 acting as a receiving antenna may be demodulated by a demodulator410 and decoded by a decoder412. The input signals may comprise programming instructions (e.g., code), which may be stored in a non-volatile memory portion of thememory308. Theprocessor306 may execute the code when theinstrument10 is in operation. For example, the code may cause theprocessor306 to output control signals to various sub-systems of theinstrument10, such as themotor65, based on data received from thesensors368.
• Thecontrol unit300 may also comprise a non-volatile memory unit414 that comprises boot sequence code for execution by theprocessor306. When thecontrol unit300 receives enough power from the signals from theremote control unit320 during the post-sterilization programming operation, theprocessor306 may first execute the boot sequence code (“boot loader”)414, which may load theprocessor306 with an operating system.
• Thecontrol unit300 may also send signals back to theremote programming unit320, such as acknowledgement and handshake signals, for example. Thecontrol unit300 may comprise an encoder416 for encoding the signals to then be sent to theprogramming device320 and a modulator418 for modulating the signals according to the modulation scheme. The coil402 may act as the transmitting antenna. Thecontrol unit300 and theremote programming device320 may communicate using any suitable wireless communication protocol (e.g., Bluetooth) and any suitable frequency (e.g., an ISM band). Also, thecontrol unit300 may transmit signals at a different frequency range than the frequency range of the received signals from theremote programming unit320.
• FIG. 20 is a simplified diagram of theremote programming device320 according to various embodiments of the present invention. As shown inFIG. 20, theremote programming unit320 may comprise amain control board230 and a boostedantenna board232. Themain control board230 may comprise acontroller234, apower module236, and amemory238. Thememory238 may stored the operating instructions for thecontroller234 as well as the programming instructions to be transmitted to thecontrol unit300 of thesurgical instrument10. Thepower module236 may provide a stable DC voltage for the components of theremote programming device320 from an internal battery (not shown) or an external AC or DC power source (not shown).
• The boostedantenna board232 may comprise acoupler circuit240 that is in communication with thecontroller234 via an I²C bus, for example. Thecoupler circuit240 may communicate with thecontrol unit300 of the surgical instrument via anantenna244. Thecoupler circuit240 may handle the modulating/demodulating and encoding/decoding operations for transmissions with the control unit. According to other embodiments, theremote programming device320 could have a discrete modulator, demodulator, encoder and decoder. As shown inFIG. 20, theboost antenna board232 may also comprise a transmittingpower amp246, amatching circuit248 for theantenna244, and a filter/amplifier249 for receiving signals.
• According to other embodiments, as shown inFIG. 20, the remote programming device could be in communication with acomputer device460, such as a PC or a laptop, via a USB and/or RS232 interface, for example. In such a configuration, a memory of thecomputing device460 may store the programming instructions to be transmitted to thecontrol unit300. In another embodiment, thecomputing device460 could be configured with a wireless transmission system to transmit the programming instructions to thecontrol unit300.
• In addition, according to other embodiments, rather than using inductive coupling between thecontrol unit300 and theremote programming device320, capacitively coupling could be used. In such an embodiment, thecontrol unit300 could have a plate instead of a coil, as could theremote programming unit320.
• In another embodiment, rather than using a wireless communication link between thecontrol unit300 and theremote programming device320, theprogramming device320 may be physically connected to thecontrol unit300 while theinstrument10 is in itssterile container280 in such a way that theinstrument10 remains sterilized.FIG. 21 is a diagram of a packagedinstrument10 according to such an embodiment. As shown inFIG. 22, thehandle6 of theinstrument10 may include anexternal connection interface470. Thecontainer280 may further comprise aconnection interface472 that mates with theexternal connection interface470 of theinstrument10 when theinstrument10 is packaged in thecontainer280. Theprogramming device320 may include an external connection interface (not shown) that may connect to theconnection interface472 at the exterior of thecontainer280 to thereby provide a wired connection between theprogramming device320 and theexternal connection interface470 of theinstrument10.
• 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.
• 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.
• 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.
• 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.

Claims (27)

1. A combination comprising:

a surgical instrument comprising a control unit; and

a remote programming device for wirelessly programming the control unit.

2. The combination ofclaim 1, further comprising a container containing the surgical instrument, and wherein the remote programming device is outside of the container.

3. The combination ofclaim 2, wherein the control unit comprises:

a power circuit for passively powering the control unit from wireless signals received from the remote programming device;

a memory for storing code received from the remote programming unit; and

a processor for executing the code stored in the memory.

4. The combination ofclaim 3, wherein the memory further stores a boot loading sequence for execution by the processor.

5. The combination ofclaim 1, wherein the control unit and the remote programming device are inductively coupled.

6. The combination ofclaim 1, wherein the control unit and the remote programming device are capacitively coupled.

7. The combination ofclaim 2, wherein the surgical instrument comprises:

a handle housing the control unit;

a shaft connected to the handle; and

an end effector connected to the shaft.

8. The combination ofclaim 7, wherein the end effector comprises a cutting instrument.

9. The combination ofclaim 8, wherein the housing further comprises:

a motor in communication with the control unit; and

a battery for powering the motor.

10. A method comprising:

packaging a surgical instrument in a container;

sterilizing the surgical instrument while the surgical instrument is in the container; and

programming the surgical instrument while the surgical instrument is in the container with a programming device positioned outside of the container.

11. The method ofclaim 10, wherein programming the surgical instrument comprises wirelessly programming the surgical instrument with the programming device.

12. The method ofclaim 10, wherein the step of programming the surgical instrument is performed after the step of sterilizing the surgical instrument.

13. The method ofclaim 12, wherein the step of sterilizing the surgical instrument comprises subjecting the surgical instrument to radiation.

14. The method ofclaim 13, wherein the radiation comprises gamma radiation.

15. The method ofclaim 12, wherein the step of sterilizing the surgical instrument comprises subjecting the surgical instrument to ethylene oxide.

16. The method ofclaim 10, wherein the surgical instrument comprises a programmable control unit.

17. The method ofclaim 10, wherein:

the surgical instrument comprises an external connection interface;

the container comprises a connection interface that mates with the external connection interface when the surgical instrument is contained in the container; and

programming the instrument comprises connecting the programming device to the connection interface of the container.

18. A combination comprising:

a surgical instrument comprising a handle, wherein the handle comprises:

a control unit in the handle; and

an external connection interface for the control unit; and

a container containing the surgical instrument, wherein the container comprises a connection interface that comprises an interior end that mates with the external connection interface of the surgical instrument and an exterior end at the exterior of the container.

19. The combination ofclaim 18, further comprising a programming device adapted for connection to the exterior end of the connection interface of the container.

20. A surgical instrument comprising a wirelessly programmable control unit.

21. The surgical instrument ofclaim 20, wherein the wirelessly programmable control unit includes an antenna for receiving programming code from a remote, wireless programming device.

22. The surgical instrument ofclaim 20, further comprising:

a motor in communication with the control unit; and

a battery for powering the motor.

23. The surgical instrument ofclaim 22, further comprising an end effector, wherein the end effector comprises a sensor, and wherein the sensor is in communication with the wirelessly programmable control unit.

24. The surgical instrument ofclaim 20, wherein the control unit comprises:

a power circuit for passively powering the control unit from wireless signals received from a remote programming device;

a memory for storing code received from the remote programming unit; and

a processor for executing the code stored in the memory.

25. The combination ofclaim 24, wherein the memory further stores a boot loading sequence for execution by the processor.

26. The combination ofclaim 20, wherein the surgical instrument comprises an endoscopic surgical instrument.

27. The combination ofclaim 23, wherein the end effector further comprises a cutting instrument.

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