Electro-mechanical surgical device

Information

  • Patent Grant
  • 6793652
  • Patent Number
    6,793,652
  • Date Filed
    Tuesday, November 28, 2000
    24 years ago
  • Date Issued
    Tuesday, September 21, 2004
    20 years ago
Abstract
An electro-mechanical surgical device includes: a housing; an elongated shaft extending from the housing, a distal end of the elongated shaft being detachably coupleable to a surgical instrument; at least two axially rotatable drive shafts disposed within the elongated shaft, a distal end of each of the drive shafts being configured to couple with the surgical instrument; a steering cable arrangement, the steering cable arrangement being configured to steer the distal end of the elongated shaft; and a motor system disposed within the housing, the motor system being configured to drive the drive shafts and the steering cable arrangement. A control system may be provided for controlling the motor system. A remote control unit may also be provided for controlling the motor system via the control system. Sensors, such as optical or Hall-effect devices, may be provided for determining the position of the elements of the surgical instrument based on the detected rotation of the drive shafts. A memory unit stores a plurality of operating programs or algorithms, each corresponding to a type of surgical instrument attachable to the electro-mechanical surgical device. The control system reads or selects from the plurality of operating programs or algorithms, the operating program or algorithm corresponding to the type of surgical instrument attached to the electro-mechanical surgical device.
Description




FIELD OF THE INVENTION




The present invention relates to an electro-mechanical surgical device.




BACKGROUND INFORMATION




The literature is replete with descriptions of surgical devices. For example, U.S. Pat. No. 4,705,038 to Sjostrom et al. describes a surgical system for powered instruments. The system includes a handpiece containing a motor and including a recess adapted to receive one of a plurality of surgical devices. A pair of reed switches is disposed within the recess, and each of the surgical devices includes one or two magnets adapted to actuate the reed switches in a particular combination when the device is assembled with the handpiece. The combination of reed switches activated by the magnets of the assembled handpiece and surgical device identifies to the system the surgical device so assembled with the handpiece. The number of possible surgical devices identifiable by this system is limited to the four possible combination of up to two magnets.




U.S. Pat. No. 4,995,877 to Ams et al. describes a device with a rotationally-driven surgical instrument. The device includes a hand-held element containing a driving motor for driving a tool insert. The device further includes a control unit having a storage unit for storing operational data manually set by the user of the device. Such data may be transferred to a code carrier, which is insertable into a plug-in facility.




U.S. Pat. No. 5,249,583 to Mallaby describes an electronic biopsy instrument with wiperless position sensors. A slotted disc and a cam are affixed to a drive shaft, which is driven by a motor. A pair of sensors is arranged so that each sensor is activated when the slot of the slotted disc is positioned over the sensor to thereby determine the position of a cannula and a stylet of the instrument. The sensors, slotted disc, cam, motor and rechargeable batteries for powering the instrument are contained within a housing of the instrument.




U.S. Pat. No. 5,383,880 to Hooven describes an endoscopic surgical system with sensing means. The instrument includes a motor disposed within a hand-held housing. A sensor is provided in the head of an instrument of the system for sensing the blood oxygen content of adjacent tissue.




Similarly, U.S. Pat. No. 5,395,033 to Byrne et al. describes an endoscopic surgical instrument having a pair of jaws. A permanent magnet is disposed in a distal end of one of the jaws, and a magneto-resistive sensor is disposed in a distal end of the other one of the jaws. The magnet produces a magnetic field between the jaws, and the sensor measures the variations in the magnetic field so that the distance between the jaws may be determined.




U.S. Pat. No. 5,467,911 to Tsuruta et al. describes a surgical device for stapling and fastening body tissues. The device includes an operation section and an insertion section, which is detachably attachable to the operation section.




U.S. Patent Nos. 5,518,163, 5,518,164 and 5,667,517, all to Hooven, describe an endoscopic surgical system, which includes a motor disposed in a handle portion. A sensing member, which is used to sense the blood oxygen content of adjacent tissue, is disposed in a head of the instrument. A contact is also provided in the head of the instrument. When a firing nut of the system has moved forward in the head to drive and form surgical staples disposed therein, the firing nut engages the contact, thereby reversing the motor to retract the firing nut.




U.S. Pat. No. 5,653,374 to Young et al., U.S. Pat. No. 5,779,130 to Alesi et al. and U.S. Pat. No. 5,954,259 to Viola et al. describe a self-contained powered surgical apparatus, which includes a motor assembly and power source disposed within a hand-held instrument body.




These instruments and systems described above suffer numerous disadvantages. For example, in several of the above-described instruments and systems, a motor is disposed within a handle of the instrument. Due to size considerations, these motors generally provide limited torque. In certain of the instruments and systems described above, a battery is provided within the handle for powering the motor. Such battery systems, however, provide limited electrical power to the motors, further limiting the torque output by the motors.




In addition, it is generally not possible to accurately ascertain the positions of the operative elements of the aforementioned instruments and systems.




A further disadvantage of the above-described instruments and systems is that such instruments and systems typically require manual manipulation and operation. When a motor is provided in the handle of such instruments, manual manipulation and operation is awkward and cumbersome to the operator.




It is therefore an object of the present invention to provide an electro-mechanical surgical device, in which a motor system is provided remote from the surgical instrument.




It is a further object of the present invention to provide an electro-mechanical surgical device, which is operable via a remote control unit.




It is another object of the present invention to provide an electro-mechanical surgical device, in which the relative position of the components thereof may be accurately determined. It is still another object of the present invention to provide an electro-mechanical surgical device, which includes a plurality of operating programs or algorithms. Each operating program or algorithm corresponds to a respective surgical instrument or attachment attachable to the electro-mechanical surgical device.




SUMMARY




The above and other beneficial objects and advantages of the present invention are most effectively attained by providing an electro-mechanical surgical device as described herein. In one example embodiment, an electro-mechanical surgical device includes: a housing; an elongated shaft extending from the housing, a distal end of the elongated shaft being detachably coupleable to a surgical instrument; at least two axially rotatable drive shafts disposed within the elongated shaft, a distal end of each of the drive shafts being configured to couple with the surgical instrument; a steering cable arrangement being configured to steer the distal end of the elongated shaft; and a motor system disposed within the housing and configured to drive the drive shafts and the steering cable arrangement.




In another example embodiment, the electro-mechanical surgical device includes a control system and a remote control unit configured to communicate with the control system to control the motor system via the control system. The remote control unit may include a wired remote control unit and/or a wireless remote control unit.




In yet another example embodiment, the electro-mechanical surgical device includes a sensor configured to detect the rotation of the drive shaft. The control system is configured to determine a position of the elements of the surgical instrument based on the detected rotation of the drive shaft.




In still another example embodiment, the electro-mechanical surgical device includes a first memory unit configured to store a plurality of operating programs or algorithms, each corresponding to a respective type of surgical instrument. The a control system is configured to detect the type of surgical instrument attached to the electro-mechanical surgical device and to select or read the operating program or algorithm corresponding to the attached surgical instrument.











BRIEF DESCRIPTION OF THE DRAWINGS





FIG. 1

is a perspective view of an electro-mechanical surgical device according to the present invention;





FIG. 2

is a side elevational view, partially in section, of a flexible shaft of the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 3

is a cross-sectional view of the flexible shaft taken along the line


3





3


shown in

FIG. 2

;





FIG. 4

is a rear end view of a first coupling of the flexible shaft illustrated in

FIG. 2

;





FIG. 5

is a front end view of a second coupling of the flexible shaft illustrated in

FIG. 2

;





FIG. 6

is a schematic view illustrating a motor arrangement of the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 7

is a schematic view of the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 8

is a schematic view of an encoder of the flexible shaft illustrated in

FIGS. 2 and 3

;





FIG. 9

is a schematic cross-sectional side view of an exemplary circular surgical stapler attachment used in connection with the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 10

is a schematic view of a memory device of the exemplary circular surgical stapler attachment illustrated in

FIG. 9

;





FIG. 11

is a schematic view of a wireless remote control unit of the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 12

is a schematic view of a wired remote control unit of the electro-mechanical surgical device illustrated in

FIG. 1

;





FIG. 13

illustrates a flowchart of a main operating program for operating the electro-mechanical surgical device illustrated in

FIG. 1

;





FIGS. 14



a


-


14




d


illustrate a flowchart of a fire routine for a circular surgical stapler attachment, such as that illustrated in

FIG. 9

;





FIGS. 15



a


and


15




b


illustrate a flowchart of a clamp routine for a circular surgical stapler attachment, such as that illustrated in

FIG. 9

; and





FIG. 16

illustrates a flowchart of an unclamp routine for a circular surgical stapler attachment, such as that illustrated in FIG.


9


.











DETAILED DESCRIPTION




Those skilled in the art will gain an appreciation of the present invention from a reading of the following description when viewed in conjunction with the accompanying drawings of

FIGS. 1-16

, inclusive. The individual reference characters designate the same or similar elements throughout the several views.




Referring to

FIG. 1

, there is seen a perspective view of an electro-mechanical surgical device


10


according to an example embodiment of the present invention. Electro-mechanical surgical device


10


may include, for example, a remote power console


12


, which includes a housing


14


having a front panel


15


. Mounted on front panel


15


are a display device


16


and indicators


18




a


,


18




b


, which are more fully described hereinbelow. A flexible shaft


20


may extend from housing


14


and may be detachably secured thereto via a first coupling


22


. The distal end


24


of flexible shaft


20


may include a second coupling


26


adapted to detachably secure a surgical instrument or attachment to the distal end


24


of flexible shaft


20


. The surgical instrument or attachment may be, for example, a surgical stapler, a surgical cutter, a surgical stapler-cutter, a linear surgical stapler, a linear surgical stapler-cutter, a circular surgical stapler, a circular surgical stapler-cutter, a surgical clip applier, a surgical clip ligator, a surgical clamping device, a vessel expanding device, a lumen expanding device, a scalpel, a fluid delivery device or any other type of surgical instrument. Such surgical instruments are described, for example, in U.S. patent application Ser. No. 09/324,451, entitled “A Stapling Device for Use with an Electro-mechanical Driver Device for Use with Anastomosing, Stapling, and Resecting Instruments,” U.S. patent application Ser. No. 09/324,452, entitled “Electro-mechanical Driver Device for Use with Anastomosing, Stapling, and Resecting Instruments,” U.S. patent application Ser. No. 09/351,534, entitled “Automated Surgical Stapling System,” U.S. patent application Ser. No. 09/510,926, entitled “A Vessel and Lumen Expander Attachment for Use with an Electro-mechanical Driver Device,” U.S. patent application Ser. No. 09/510,927, entitled “Electro-mechanical Driver and Remote Surgical Instruments Attachment Having Computer Assisted Control Capabilities,” U.S. patent application Ser. No. 09/510,931, entitled “A Tissue Stapling Attachment for Use with an Electro-mechanical Driver Device,” U.S. patent application Ser. No. 09/510,932, entitled “A Fluid Delivery Mechanism for Use with Anastomosing, Stapling, and Resecting Instruments,” and U.S. patent application Ser. No. 09/510,933, entitled “A Fluid Delivery Device for Use with Anastomosing, Stapling, and Resecting Instruments,” each of which is expressly incorporated herein in its entirety by reference thereto.




Referring to

FIG. 2

, there is seen a side view, partially in section, of flexible shaft


20


. According to one embodiment, flexible shaft


20


includes a tubular sheath


28


, which may include a coating or other sealing arrangement to provide a fluid-tight seal between the interior channel


40


thereof and the environment. Sheath


28


may be formed of a tissue-compatible, sterilizable elastomeric material. The sheath


28


may also be formed of a material that is autoclavable. Disposed within the interior channel


40


of flexible shaft


20


, and extending along the entire length thereof, may be a first rotatable drive shaft


30


, a second rotatable drive shaft


32


, a first steering cable


34


, a second steering cable


35


, a third steering cable


36


, a fourth steering cable


37


and a data transfer cable


38


.

FIG. 3

is a cross-sectional view of flexible shaft


20


taken along the line


3





3


shown in FIG.


2


and further illustrates the several cables


30


,


32


,


34


,


35


,


36


,


37


,


38


. Each distal end of the steering cables


34


,


35


,


36


,


37


is affixed to the distal end


24


of the flexible shaft


20


. Each of the several cables


30


,


32


,


34


,


35


,


36


,


37


,


38


may be contained within a respective sheath.




Referring now to

FIG. 4

, there is seen a rear end view of first coupling


22


. First coupling


22


includes a first connector


44


, a second connector


48


, a third connector


52


and a fourth connector


56


, each rotatably secured to first coupling


22


. Each of the connectors


44


,


48


,


52


,


56


includes a respective recess


46


,


50


,


54


,


58


. As shown in

FIG. 4

, each recess


46


,


50


,


54


,


58


may be hexagonally shaped. It should be appreciated, however, that the recesses


46


,


50


,


54


,


58


may have any shape and configuration to non-rotatably couple and rigidly attach the connectors


44


,


48


,


52


,


56


to respective drive shafts of the motor arrangement contained within the housing


12


, as more fully described below. It should be appreciated that complementary projections may be provided on respective drive shafts of the motor arrangement to thereby drive the drive elements of the flexible shaft


20


as described below. It should also be appreciated that the recesses may be provided on the drive shafts and complementary projections may be provided on the connectors


44


,


48


,


52


,


56


. Any other coupling arrangement configured to non-rotatably and releasably couple the connectors


44


,


48


,


52


,


56


and the drive shafts of the motor arrangement may be provided.




One of the connectors


44


,


48


,


52


,


56


is non-rotatably secured to the first drive shaft


30


, and another one of the connectors


44


,


48


,


52


,


56


is non-rotatably secured to the second drive shaft


32


. The remaining two of the connectors


44


,


48


,


52


,


56


engage with transmission elements configured to apply tensile forces on the steering cables


34


,


35


,


36


,


37


to thereby steer the distal end


24


of the flexible shaft


20


. The data transfer cable


38


is electrically and logically connected with data connector


60


. Data connector


60


includes, for example, electrical contacts


62


, corresponding to and equal in number to the number of individual wires contained in the data cable


38


. First coupling


22


includes a key structure


42


to properly orient the first coupling


22


to a mating and complementary coupling arrangement disposed on the housing


12


. Such key structure


42


may be provided on either one, or both, of the first coupling


22


and the mating and complementary coupling arrangement disposed on the housing


12


. First coupling


22


may include a quick-connect type connector, which may use, for example, a simple pushing motion to engage the first coupling


22


to the housing


12


. Seals may be provided in conjunction with any of the several connectors


44


,


48


,


52


,


56


,


60


to provide a fluid-tight seal between the interior of first coupling


22


and the environment.




Referring now to

FIG. 5

, there is seen a front end view of the second coupling


26


of flexible shaft


20


. Second coupling


26


includes a first connector


66


and a second connector


68


, each being rotatably secured to the second coupling


26


and each being non-rotatably secured to a distal end of a respective one of the first and second drive shafts


30


,


32


. A quick-connect type fitting


64


is provided on the second coupling


26


for detachably securing the surgical instrument or attachment thereto. The quick-connect type fitting


64


may be, for example, a rotary quick-connect type fitting, a bayonet type fitting, etc. A key structure


74


is provided on the second coupling


26


for properly aligning the surgical instrument or attachment to the second coupling


26


. The key structure or other arrangement for properly aligning the surgical instrument or attachment to the flexible shaft


20


may be provided on either one, or both, of the second coupling


26


and the surgical instrument or attachment. in addition, the quick-connect type fitting may be provided on the surgical instrument or attachment. A data connector


70


, having electrical contacts


72


, is also provided in the second coupling


26


. Like the data connector


60


of first coupling


22


, the data connector


70


of second coupling


26


includes contacts


72


electrically and logically connected to the respective wires of data transfer cable


38


and contacts


62


of data connector


60


. Seals may be provided in conjunction with the connectors


66


,


68


,


70


to provide a fluid-tight seal between the interior of second coupling


26


and the environment.




Disposed within housing


14


of the remote power console


12


are electro-mechanical driver elements configured to drive the drive shafts


30


,


32


and the steering cables


34


,


35


,


36


,


37


to thereby operate the electro-mechanical surgical device


10


and the surgical instrument or attachment attached to the second coupling


26


. In the example embodiment illustrated schematically in

FIG. 6

, five electric motors


76


,


80


,


84


,


90


,


96


, each operating via a power source, may be disposed in the remote power console


12


. It should be appreciated, however, that any appropriate number of motors may be provided, and the motors may operate via battery power, line current, a DC power supply, an electronically controlled DC power supply, etc. It should also be appreciated that the motors may be connected to a DC power supply, which is in turn connected to line current and which supplies the operating current to the motors.





FIG. 6

illustrates schematically one possible arrangement of motors. An output shaft


78


of a first motor


76


engages with the first connector


44


of the first coupling


22


when the first coupling


22


, and, therefore, flexible shaft


20


, is engaged with the housing


14


to thereby drive the first drive shaft


30


and first connector


66


of second coupling


26


. Similarly, an output shaft


82


of a second motor


80


engages the second connector


48


of first coupling


22


when first coupling


22


, and, therefore, flexible shaft


20


is engaged with the housing


14


to thereby drive the second drive shaft


32


and second connector


68


of second coupling


26


. An output shaft


86


of a third motor


84


engages the third connector


52


of the first coupling


22


when the first coupling


22


, and, therefore, flexible shaft


20


, is engaged with the housing


14


to thereby drive the first and second steering cables


34


,


35


via a first pulley arrangement


88


. An output shaft


92


of a fourth motor


90


engages the fourth connector


56


of the first coupling


22


when the first coupling


22


, and, therefore, flexible shaft


20


, is engaged with the housing


14


to thereby drive the third and fourth steering cables


36


,


37


via a second pulley arrangement


94


. The third and fourth motors


84


,


90


may be secured on a carriage


100


, which is selectively movable via an output shaft


98


of a fifth motor


96


between a first position and a second position to selectively engage and disengage the third and fourth motors


84


,


90


with the respective pulley arrangement


88


,


94


to thereby permit the flexible shaft


20


to become taut and steerable or limp as necessary. It should be appreciated that other mechanical, electrical or electro-mechanical mechanisms may be used to selectively engage and disengage the steering mechanism. The motors may be arranged and configured as described, for example, in U.S. patent application Ser. No. 09/510,923, entitled “A Carriage Assembly for Controlling a Steering Wire Mechanism Within a Flexible Shaft,” which is expressly incorporated herein in its entirety by reference thereto.




Referring now to

FIG. 7

, there is seen a schematic view of the electro-mechanical surgical device


10


. A controller


122


is provided in the housing


14


of remote power console


12


and is configured to control all functions and operations of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


. A memory unit


130


is provided and may include memory devices, such as, a ROM component


132


and/or a RAM component


134


. ROM component


132


is in electrical and logical communication with controller


122


via line


136


, and RAM component


134


is in electrical and logical communication with controller


122


via line


138


. RAM component


134


may include any type of random-access memory, such as, for example, a magnetic memory device, an optical memory device, a magneto-optical memory device, an electronic memory device, etc. Similarly, ROM component


132


may include any type of read-only memory, such as, for example, a removable memory device, such as a PC-Card or PCMCIA-type device. It should be appreciated that ROM component


132


and RAM component


134


may be embodied as a single unit or may be separate units and that ROM component


132


and/or RAM component


134


may be provided in the form of a PC-Card or PCMCIA-type device. Controller


122


is further connected to front panel


15


of housing


14


and, more particularly, to display device


16


via line


154


and indicators


18




a


,


18




b


via respective lines


156


,


158


. Lines


116


,


118


,


124


,


126


,


128


electrically and logically connect controller


122


to first, second, third, fourth and fifth motors


76


,


80


,


84


,


90


,


96


, respectively. A wired remote control unit (“RCU”)


150


is electrically and logically connected to controller


122


via line


152


. A wireless RCU


148


is also provided and communicates via a wireless link


160


with a receiving/sending unit


146


connected via line


144


to a transceiver


140


. The transceiver


140


is electrically and logically connected to controller


122


via line


142


. Wireless link


160


may be, for example, an optical link, such as an infrared link, a radio link or any other form of wireless communication link.




A switch device


186


, which may be, for example, an array of DIP switches, may be connected to controller


122


via line


188


. Switch device


186


may be used, for example, to select one of a plurality of languages used in displaying messages and prompts on the display device


16


. The messages and prompts may relate to, for example, the operation and/or the status of the electro-mechanical surgical device


10


and/or to any surgical instrument or attachment attached thereto,




According to the example embodiment of the present invention, a first encoder


106


is provided within the second coupling


26


and is configured to output a signal in response to and in accordance with the rotation of the first drive shaft


30


. A second encoder


108


is also provided within the second coupling


26


and is configured to output a signal in response to and in accordance with the rotation of the second drive shaft


32


. The signal output by each of the encoders


106


,


108


may represent the rotational position of the respective drive shaft


30


,


32


as well as the rotational direction thereof. Such encoders


106


,


108


may be, for example, Hall-effect devices, optical devices, etc. Although the encoders


106


,


108


are described as being disposed within the second coupling


26


, it should be appreciated that the encoders


106


,


108


may be provided at any location between the motor system and the surgical instrument or attachment.





FIG. 8

is a schematic view of an encoder


106


,


108


, which includes a Hall-effect device. Mounted non-rotatably on drive shaft


30


,


32


is a magnet


240


having a north pole


242


and a south pole


244


. The encoder


106


,


108


further includes a first sensor


246


and second sensor


248


, which are disposed approximately 90° apart relative to the longitudinal, or rotational, axis of drive shaft


30


,


32


. The output of the sensors


246


,


248


is persistent and changes its state as a function of a change of polarity of the magnetic field in the detection range of the sensor. Thus, based on the output signal from the encoders


106


,


108


, the angular position of the drive shaft


30


,


32


may be determined within one-quarter revolution and the direction of rotation of the drive shaft


30


,


32


may be determined. The output of each encoder


106


,


108


is transmitted via a respective line


110


,


112


of data transfer cable


38


to controller


122


. The controller


122


, by tracking the angular position and rotational direction of the drive shafts


30


,


32


based on the output signal from the encoders


106


,


108


, can thereby determine the position and/or state of the components of the surgical instrument or attachment connected to the electro-mechanical surgical device


10


. That is, by counting the revolutions of the drive shaft


30


,


32


, the controller


122


can determine the position and/or state of the components of the surgical instrument or attachment connected to the electro-mechanical surgical device


10


.




For example, in a circular surgical stapler attachment


250


, such as that shown schematically in cross-section in

FIG. 9

, the circular surgical stapler attachment


250


includes a coupling


260


adapted by size and configuration to cooperate with the second coupling


26


of flexible shaft


20


to detachably attach the circular surgical stapler attachment


250


thereto. Circular surgical stapler attachment


250


includes an anvil portion


254


having an anvil


256


mounted on the distal end of an anvil stem


258


. The anvil stem


258


is extended and retracted by the operation of an anvil drive shaft


262


, which is rotatably secured within the body portion


252


of the circular surgical stapler attachment


250


. A proximal end of the anvil drive shaft


262


includes a first connector


268


adapted by size and configuration to couple with the first connector


66


of second coupling


26


. Circular surgical stapler attachment


250


further includes a staple driver/cutter


264


driven by the rotation of a staple driver/cutter drive shaft


266


. The proximal end of the staple driver/cutter drive shaft


266


includes a second connector


270


, which is adapted by size and configuration to couple with the second connector


68


of second coupling


26


. Thus, in the example circular surgical stapler attachment


250


shown in

FIG. 9

, the extension and retraction of the anvil


256


is effected by the operation of the first motor


76


, and the extension and retraction of the staple driver/cutter


264


is effected by the operation of the second motor


80


. The pitch of the anvil drive shaft


262


and the pitch of the stapler driver/cutter drive shaft


266


are predetermined and known quantities. That is, the advancement distance of the anvil


256


and the staple driver/cutter


264


are functions of, and ascertainable on the basis of, the rotation of the respective drive shaft


30


,


32


. By ascertaining an absolute position of the anvil


256


and the staple driver/cutter


264


at a point in time, the relative displacement of the anvil


256


and staple driver/cutter


264


, based on the output signal from the encoders


106


,


108


and the known pitches of the anvil drive shaft


262


and staple driver/cutter drive shaft


266


, may be used to ascertain the absolute position of the anvil


256


and staple driver/cutter


264


at all times thereafter. The absolute position of the anvil


256


and staple driver/cutter


264


may be fixed and ascertained at the time that the circular surgical stapler attachment


250


is first coupled to the flexible shaft


20


. Alternatively, the position of the anvil


256


and the staple driver/cutter


264


relative to, for example, the body portion


252


may be determined based on the output signal from the encoders


106


,


108


.




Circular surgical stapler attachment


250


further includes a data connector


272


adapted by size and configuration to electrically and logically connect to connector


70


of second coupling


26


. In the example embodiment, data connector


272


includes contacts (not shown) equal in number to the number of leads


72


of connector


70


. Contained within the circular surgical stapler attachment


250


is a memory unit


174


electrically and logically connected with the data connector


272


. Memory unit


174


may be in the form of, for example, an EEPROM, EPROM, etc. and may be contained, for example, within the body portion


252


of circular surgical stapler attachment


250


.





FIG. 10

schematically illustrates the memory unit


174


. As seen in

FIG. 10

, data connector


272


includes contacts


276


, each electrically and logically connected to memory unit


174


via a respective line


278


. Memory unit


174


is configured to store, for example, a serial number data


180


, an attachment type identifier (ID) data


182


and a usage data


184


. Memory unit


174


may additionally store other data. Both the serial number data


180


and the ID data


182


may be configured as read-only data. In the example embodiment, serial number data


180


is data uniquely identifying the particular surgical instrument or attachment, whereas the ID data


182


is data identifying the type of the attachment, such as, for example, a circular surgical stapler attachment, a linear surgical stapler attachment, etc. The usage data


184


represents usage of the particular attachment, such as, for example, the number of times the anvil


256


of the circular surgical stapler attachment


250


has been advanced or the number of times that the staple driver/cutter


264


of the circular surgical stapler attachment


250


has been advanced or fired.




It should be appreciated that each types of surgical instrument or attachment attachable to the distal end


24


of the flexible shaft


20


may be designed and configured to be used a single time or multiple times. The surgical instrument or attachment may also be designed and configured to be used a predetermined number of times. Accordingly, the usage data


184


may be used to determine whether the surgical instrument or attachment has been used and whether the number of uses has exceeded the maximum number of permitted uses. As more fully described below, an attempt to use a surgical instrument or attachment after the maximum number of permitted uses has been reached will generate an ERROR condition.




It should be appreciated that the circular surgical stapler attachment


250


illustrated in

FIG. 9

is intended to be merely an example of a surgical attachment used in conjunction with the electro-mechanical surgical device


10


. It should be further appreciated that any other type of surgical instrument or attachment, such as those enumerated hereinabove, may be used in conjunction with the electro-mechanical surgical device


10


. Regardless of the particular type of surgical instrument or attachment, in the example embodiment of the present invention, the surgical instrument or attachment includes the coupling elements


268


,


270


,


272


, as necessary for proper operation of the surgical instrument or attachment, as well as the memory unit


174


. Although the drive shafts and motors are described herein as effecting particular functions of the circular surgical stapler attachment


250


, it should be appreciated that the drive shafts and motors may effect the same or other functions of other types of surgical instruments or attachments.




Referring again to

FIG. 7

, in accordance with the example embodiment of the present invention, the controller


122


is configured to read the ID data


182


from the memory unit


174


of the surgical instrument or attachment when the surgical instrument or attachment is initially connected to the flexible shaft


20


. The memory unit


174


is electrically and logically connected to the controller


122


via line


120


of data transfer cable


38


. Based on the read ID data


182


, the controller


122


is configured to read or select from the memory unit


130


, an operating program or algorithm corresponding to the type of surgical instrument or attachment connected to the flexible shaft


20


. The memory unit


130


is configured to store the operating programs or algorithms for each available type of surgical instrument or attachment, the controller


122


selecting and/or reading the operating program or algorithm from the memory unit


130


in accordance with the ID data


182


read from the memory unit


174


of an attached surgical instrument or attachment. As indicated above, the memory unit


130


may include a removable ROM component


132


and/or RAM component


134


. Thus, the operating programs or algorithms stored in the memory unit


130


may be updated, added, deleted, improved or otherwise revised as necessary. It should be appreciated that the serial number data


180


and/or usage data


184


may also be used to determine which of a plurality of operating programs or algorithms is read or selected from the memory unit


130


. It should also be appreciated that the operating program or algorithm may alternatively be stored in the memory unit


174


of the surgical instrument or attachment and transferred to the controller


122


via the data transfer cable


38


. Once the appropriate operating program or algorithm is read or selected by, or transmitted to, the controller


122


, the controller


122


causes the operating program or algorithm to be executed in accordance with operations performed by the user via the wired RCU


150


and/or the wireless RCU


148


. As indicated hereinabove, the controller


122


is electrically and logically connected with the first, second, third, fourth and fifth motors


76


,


80


,


84


,


90


,


96


via respective lines


116


,


118


,


124


,


126


,


128


and controls such motors


76


,


80


,


84


,


90


,


96


in accordance with the read, selected or transmitted operating program or algorithm via the respective lines


116


,


118


,


124


,


126


,


128


.




Referring now to

FIG. 11

, there is seen a schematic view of wireless RCU


148


. Wireless


148


includes a steering controller


300


having a plurality of switches


302


,


304


,


306


,


308


arranged under a four-way rocker


310


. The operation of switches


302


,


304


, via rocker


310


, controls the operation of first and second steering cables


34


,


35


via third motor


84


. Similarly, the operation of switches


306


,


308


, via rocker


310


, controls the operation of third and fourth steering cables


36


,


37


via fourth motor


92


. It should be appreciated that rocker


310


and switches


302


,


304


,


306


,


308


are arranged so that the operation of switches


302


,


304


steers the flexible shaft


20


in the north-south direction and that the operation of switches


306


,


308


steers the flexible shaft


20


in the east-west direction. Reference herein to north, south, east and west is made to a relative coordinate system. Alternatively, a digital joystick, analog joystick, etc. may be provided in place of rocker


310


and switches


302


,


304


,


306


,


308


. Potentiometers or any other type of actuator may also be used in place of switches


302


,


304


,


306


,


308


.




Wireless RCU


148


further includes a steering engage/disengage switch


312


, the operation of which controls the operation of fifth motor


96


to selectively engage and disengage the steering mechanism. Wireless RCU


148


also includes a two-way rocker


314


having first and second switches


316


,


318


operable thereby. The operation of these switches


316


,


318


controls certain functions of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


in accordance with the operating program or algorithm corresponding to the attached surgical instrument or attachment, if any. For example, where the surgical instrument is a circular surgical stapler attachment


250


, such as that shown in FIG.


9


and described hereinabove, operation of the two-way rocker


314


may control the advancement and retraction of the anvil


256


. Wireless RCU


148


is provided with yet another switch


320


, the operation of which may further control the operation of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


in accordance with the operating program or algorithm corresponding to the attached surgical instrument or attachment, if any. For example, when the circular surgical stapler attachment


250


is attached to the flexible shaft


20


, operation of the switch


320


initiates the advancement, or firing sequence, of the staple driver/cutter


264


.




Wireless RCU


148


includes a controller


322


, which is electrically and logically connected with the switches


302


,


304


,


306


,


308


via line


324


, with the switches


316


,


318


via line


326


, with switch


312


via line


328


and with switch


320


via line


330


. Wireless RCU


148


may include indicators


18




a


′,


18




b


′, corresponding to the indicators


18




a


,


18




b


of front panel


15


, and a display device


16


′, corresponding to the display device


16


of the front panel


15


. If provided, the indicators


18




a


′,


18




b


′ are electrically and logically connected to controller


322


via respective lines


332


,


334


, and the display device


16


′ is electrically and logically connected to controller


322


via line


336


. Controller


322


is electrically and logically connected to a transceiver


338


via line


340


, and transceiver


338


is electrically and logically connected to a receiver/transmitter


342


via line


344


. A power supply, not shown, for example, a battery, may be provided in wireless RCU


148


to power the same. Thus, the wireless RCU


148


may be used to control the operation of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


via wireless link


160


.




Wireless RCU


148


may include a switch


346


connected to controller


322


via line


348


. Operation of switch


346


transmits a data signal to the transmitter/receiver


146


via wireless link


160


. The data signal includes identification data uniquely identifying the wireless RCU


148


. This identification data is used by the controller


122


to prevent unauthorized operation of the electro-mechanical surgical device


10


and to prevent interference with the operation of the electro-mechanical surgical device


10


by another wireless RCU. Each subsequent communication between the wireless RCU


148


and the electro-mechanical device surgical


10


may include the identification data. Thus, the controller


122


can discriminate between wireless RCUs and thereby allow only a single, identifiable wireless RCU


148


to control the operation of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


.




Based on the positions of the components of the surgical instrument or attachment attached to the flexible shaft


20


, as determined in accordance with the output signals from the encoders


106


,


108


, the controller


122


may selectively enable or disable the functions of the electro-mechanical surgical device


10


as defined by the operating program or algorithm corresponding to the attached surgical instrument or attachment. For example, where the surgical instrument or attachment is the circular surgical stapler attachment


250


illustrated in

FIG. 9

, the firing function controlled by the operation of the switch


320


is disabled unless the space or gap between the anvil


256


and the body portion


252


is determined to be within an acceptable range. The space or gap between the anvil


256


and the body portion


252


is determined based on the output signal from the encoders


106


,


108


, as more fully described hereinabove. It should be appreciated that the switch


320


itself remains operable but that the controller


122


does not effect the corresponding function unless the space or gap is determined to be within the acceptable range.




Referring now to

FIG. 12

, there is seen a schematic view of a wired RCU


150


. In the example embodiment, wired RCU


150


includes substantially the same control elements as the wireless RCU


148


and further description of such elements is omitted. Like elements are noted in

FIG. 12

with an accompanying prime. It should be appreciated that the functions of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


may be controlled by the wired RCU


150


and/or by the wireless RCU


148


. In the event of a battery failure, for example, in the wireless RCU


148


, the wired RCU


150


may be used to control the functions of the electro-mechanical surgical device


10


and any surgical instrument or attachment attached to the flexible shaft


20


.




As described hereinabove, the front panel


15


of housing


14


includes display device


16


and indicators


18




a


,


18




b


. The display device


16


may include an alpha-numeric display device, such as an LCD display device. Display device


16


may also include an audio output device, such as a speaker, a buzzer, etc. The display device


16


is operated and controlled by controller


122


in accordance with the operating program or algorithm corresponding to a surgical instrument or attachment, if any, attached to the flexible shaft


20


. If no surgical instrument or attachment is so attached, a default operating program or algorithm may be read or selected by, or transmitted to, controller


122


to thereby control the operation of the display device


16


as well as the other aspects and functions of the electro-mechanical surgical device


10


. If the circular surgical stapler attachment


250


illustrated in

FIG. 9

is attached to flexible shaft


20


, display device


16


may display, for example, data indicative of the gap between the anvil


256


and the body portion


252


as determined in accordance with the output signal of encoders


106


,


108


, as more fully described hereinabove.




Similarly, the indicators


18




a


,


18




b


are operated and controlled by controller


122


in accordance with the operating program or algorithm corresponding to the surgical instrument or attachment, if any, attached to the flexible shaft


20


. Indicator


18




a


and/or indicator


18




b


may include an audio output device, such as a speaker, a buzzer, etc., and/or a visual indicator device, such as an LED, a lamp, a light, etc. If the circular surgical stapler attachment


250


illustrated in

FIG. 9

is attached to the flexible shaft


20


, indicator


18




a


may indicate, for example, that the electro-mechanical surgical device


10


is in a power ON state, and indicator


18




b


may, for example, indicate whether the gap between the anvil


256


and the body portion


252


is determined to be within the acceptable range as more fully described hereinabove. It should be appreciated that although only two indicators


18




a


,


18




b


are described, any number of additional indicators may be provided as necessary. Additionally, it should be appreciated that although a single display device


16


is described, any number of additional display devices may be provided as necessary.




The display device


16


′ and indicators


18




a


′,


18




b


′ of wireless RCU


150


and the display device


16


″ and indicators


18




a


″,


18




b


″ of wired RCU


148


are similarly operated and controlled by respective controller


322


,


322


′ in accordance with the operating program or algorithm corresponding to the surgical instrument or attachment, if any, attached to the flexible shaft


20


.




Referring now to

FIG. 13

, there is seen a flowchart of a main operating program according to the present invention. The main operating program begins at step


1000


and proceeds to step


1002


, during which the electro-mechanical surgical device


10


is initialized. Step


1002


may include initialization steps, such as memory population and initialization, diagnostic self-testing, etc. After initialization step


1002


, it is determined in step


1004


whether a surgical instrument or attachment (“DLU”) is present—that is, installed on the distal end


24


of flexible shaft


20


. If it is determined in step


1004


that no DLU is present, control is transferred to loop


1034


. If it is determined that a DLU is present, the operating program proceeds to step


1006


, in which it is determined whether the FIRE key is pressed. FIRE key, in this context, refers to one of the switches of the wireless RCU


148


and/or wired RCU


150


. More particularly, the FIRE key may correspond to switch


320


of wireless RCU


148


and/or switch


320


′ of wired RCU


150


. If it is determined in step


1006


that FIRE key is pressed, control is transferred to routine A in step


1008


. Routine A is specific to the DLU, if any, attached to the flexible shaft


20


. Routine A is more fully described hereinbelow and in

FIGS. 14



a


-


14




d


. After the execution of routine A in step


1008


, control is transferred to loop


1034


.




If it is determined in step


1006


that the FIRE key is not pressed, it is determined in step


1010


whether the CLAMP key is pressed. In this context, the CLAMP key refers to one of the switches of the wireless RCU


148


and/or wired RCU


150


. More particularly, CLAMP switch may correspond to, for example, switch


316


of wireless RCU


148


and/or to switch


316


′ of wired RCU


150


. If it is determined in step


1010


that CLAMP key is pressed, control is transferred to routine B in step


1012


. Routine B is specific to the DLU, if any, attached to the flexible shaft


20


. Routine B is more fully described hereinbelow and in

FIGS. 15



a


and


15




b


. After the execution of routine B in step


1012


, control is transferred to loop


1034


.




If it is determined in step


1010


that the CLAMP key is not pressed, it is determined in step


1014


whether the UNCLAMP key is pressed. In this context, the UNCLAMP key refers to one of the switches of the wireless RCU


148


and/or wired RCU


150


. More particularly, the UNCLAMP switch may correspond to, for example, switch


318


of wireless RCU


148


and/or to switch


318


′ of wired RCU


150


. If it is determined in step


1014


that UNCLAMP key is pressed, control is transferred to routine C in step


1016


. Routine C is specific to the DLU, if any, attached to the flexible shaft


20


. Routine C is more fully described hereinbelow and in FIG.


16


. After the execution of routine C in step


1016


, control is transferred to loop


1034


.




If it is determined in step


1014


that the UNCLAMP key is not pressed, it is determined in step


1018


whether one or more of STEERING keys are pressed. In this context, the STEERING keys refer to respective switches of the wireless RCU


148


and/or wired RCU


150


. More particularly, the STEERING keys may correspond to switches


302


,


304


,


306


,


308


of wireless RCU


148


and/or switches


302


′,


304


′,


306


′,


308


′ of wired RCU


150


. If it is determined in step


1018


that one or more STEERING keys are pressed, operation of respective steering motor(s) is performed in step


1020


. The steering motors may correspond to third motor


84


and fourth motor


92


as more fully set forth above. After the execution of step


1020


, control is transferred to loop


1034


.




If it is determined in step


1018


that none of the STEERING keys is pressed, it is determined in step


1022


whether the DISENGAGE key is pressed. In this context, the DISENGAGE key refers to one of the switches of wireless RCU


148


and/or wired RCU


150


. More particularly, DISENGAGE key may correspond to switch


312


of wireless RCU


148


and/or switch


312


′ of wired RCU


150


. If it is determined in step


1022


that the DISENGAGE key is pressed, a disengage operation is performed in step


1024


. After the execution of step


1024


, control is transferred to loop


1034


.




If it is determined in step


1022


that DISENGAGE key is not pressed, an IDLE routine is performed in step


1026


.




In step


1028


, it is determined whether to end the operation of the main operating program. If it is determined in step


1028


to not end the operation of the main operating program, control is transferred to loop


1034


. If, however, it is determined in step


1028


to end or terminate the operation of the main operating program, a shutdown routine is executed in step


1030


, and the main operating program is thereafter terminated in step


1032


.




It should be appreciated that the main operating program may determine which, if any, key is pressed in the order illustrated in

FIG. 13

or in any other appropriate order. It should also be appreciated that the main operating program illustrated in

FIG. 13

, as well as the routines illustrated in

FIGS. 14



a


-


14




d


,


15




a


,


15




b


and


16


, may be embodied, for example, in a messaging-based, event-driven and/or polling-type software application.




Referring now to

FIGS. 14



a


-


14




d


, there is seen a flowchart of a firing routine specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be appreciated that the firing routine illustrated in

FIGS. 14



a


-


14




d


represents the routine A of step


1008


of the main operating program illustrated in FIG.


13


and that the firing routine illustrated in

FIGS. 14



a


-


14




d


is specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be further appreciated that other surgical instruments or attachments, such as those enumerated above, may have other firing routines associated therewith.




Proceeding from step


1008


, it is determined in step


1100


whether the DLU—the circular surgical stapler attachment


250


—has been fully opened. This determination may be made based on the signals generated by the encoders


106


,


108


, as more fully described above. If it is determined in step


1100


that the DLU has not been fully opened, an ERROR condition is determined in step


1102


in that the DLU is not ready for firing. Control is then transferred to step


1120


, wherein control returns to the main operating program illustrated in FIG.


13


.




If it is determined in step


1100


that the DLU has been fully opened, it is determined in step


1104


whether the DLU has been fully clamped. This determination may be made, based on the signals generated by the encoders


106


,


108


, as more fully described above. If it is determined in step


1104


that the DLU has not been fully clamped, an ERROR condition is determined in step


1106


in that the DLU is not within an acceptable range for firing. Control is then transferred to step


1120


, wherein control returns to the main operating program illustrated in FIG.


13


.




If it is determined in step


1104


that the DLU has been fully clamped, it is determined in step


1108


whether the DLU has been previously fired. This determination may be made based on the signals generated by the encoders


106


,


108


and/or in accordance with usage data


184


. If it is determined in step


1108


that the DLU has been previously fired, an ERROR condition is determined in step


1110


in that the DLU has been used. Control is then transferred to step


1120


, wherein control returns to the main operating program illustrated in FIG.


13


. It should be appreciated that a similar usage determination may be made in the main operating program illustrated in

FIG. 13

, for example, in the initialization step


1002


or in the DLU presence determining step


1004


, as an alternative or in addition to the determining step


1108


.




If it is determined in step


1108


that the DLU has not been previously fired, a usage count is decremented in step


1112


. The usage count may be stored in usage data


184


as more fully described hereinabove. Several attempts at decrementing the usage count may be made in step


1112


. However, a failure to decrement the usage count may nevertheless occur. In step


1114


, it is determined whether the usage count decrementing step


1112


has failed. If it is determined in step


1114


that the decrementing of usage count failed, a ERROR condition is determined in step


1116


. Thereafter, in step


1118


, a wait loop is executed until all keys of the wireless RCU


148


and/or wired RCU


150


have been released. After it is determined in step


1118


that all keys have been released, control is transferred to step


1120


. Thereafter, control returns to the main operating program illustrated in FIG.


13


.




If it is determined in step


1114


that the usage count decrementing did not fail, the firing motor current limit is set in step


1122


. In this context, the firing motor may correspond to the second motor


80


as more fully described hereinabove. The firing motor is then started in step


1124


to begin the advancement of the staple driver/cutter


264


.




Referring now to

FIG. 14



b


, a timer is set in step


1126


. It is thereafter determined in step


1128


whether the time elapsed for the firing operation has lo exceeded a predetermined threshold. If it is determined in step


1128


that the firing time limit has been exceeded, the firing motor is disabled in step


1130


, and an ERROR condition is determined in step


1132


. Control then proceeds to step


1136


. If, however, it is determined in step


1128


that the firing time has not exceeded the predetermined firing time limit, it is determined in step


1134


whether a hardware current limit has been exceeded. The hardware current limit relates to the resistance of the firing motor to continued operation. A condition that the hardware current limit has been exceeded is indicative that the stapling operation has been successfully completed. If it is determined in step


1134


that the hardware current limit has not been exceeded, the operation of firing motor is continued until either the predetermined firing time limit has been exceeded or the hardware current limit has been exceeded. In either instance control proceeds thereafter to step


1136


.




Step


1136


represents a waiting step, during which a predetermined wait time is permitted to elapse. This wait time permits the driving and driven elements of electro-mechanical surgical device


10


and circular surgical stapler attachment


250


to come to rest before proceeding to step


1138


, in which step the firing motor is stopped.




After the firing motor is stopped in step


1138


, the motor current limit is set to full scale in step


1140


, and then the firing motor is started in step


1142


in a reverse direction to retract the staple driver/cutter


264


and return the same to its initial position. Then, once the gap between the anvil


256


and the body portion


252


has exceeded the acceptable range, the indicator


18




a


,


18




b


corresponding to an IN-RANGE indicator is turned off in step


1144


. Alternatively, the IN-RANGE indicator may be turned off in step


1144


upon the start of the reversal of the motor in step


1142


. After the IN-RANGE indicator is turned off in step


1144


, the timer is reset in step


1146


. Referring now to

FIG. 14



c


, it is determined in step


1148


whether a predetermined time limit for completing the retraction of the staple driver/cutter


264


, based on the timer reset in step


1146


, has been exceeded. If it is determined in step


1148


that the predetermined time limit has been exceeded, an ERROR condition is determined in step


1150


in that the retraction operation failed to be completed within the permissible predetermined time limit. If, however, it is determined in step


1148


that the predetermined time limit has not been exceeded, it is determined in step


1152


whether retraction of the staple driver/cutter


264


has been completed. If it is determined in step


1152


that the retraction of the staple driver/cutter


264


has not been completed, control returns to step


1148


. Retraction of staple driver/cutter


264


continues until either the predetermined time limit has been exceeded as determined in step


1148


or the retraction has been completed as determined in step


1152


. It should be appreciated that the determination made in step


1152


may be based on the signals generated by the encoders


106


,


108


. After it is determined that the retraction of staple driver/cutter


264


has been completed (step


1152


) or that the predetermined time limit has been exceeded (step


1148


), the unclamp motor current limit is set of full scale in step


1154


. In this context, the unclamp motor may correspond to first motor


76


as more fully described hereinabove.




In step


1156


, the halfway point between the current position of the anvil


256


and the final, unclamped position of the anvil


256


is calculated. A “phantom” destination position is set in step


1158


to a predetermined setpoint plus a predetermined bias value to ensure that the unclamp motor achieves its maximum, or full, current to thereby ensure the maximum torque output from the unclamp motor. In step


1160


, the movement of the unclamp motor is initiated. In step


1162


, the timer is set, and in step


1164


a destination flag is cleared.




Referring now to

FIG. 14



d


, it is determined in step


1166


whether the anvil


256


has passed the halfway point determined in step


1156


. If it is determined in step


1166


that the anvil


256


has passed the halfway point determined in step


1156


, the “true” final destination position for the anvil


256


is set in step


1170


, thereby superceding the “phantom” final destination set in step


1158


. Control is then transferred to step


1174


. If, however, it is determined in step


1166


that the position of the anvil


256


is not past the halfway point determined in step


1156


, control is directly transferred to step


1174


, bypassing the destination resetting step


1170


.




In step


1174


, it is determined whether the anvil


256


has reached the “true” final destination set in step


1170


. It should be appreciated that the position of the anvil


256


may be determined in accordance with the signals output by encoders


106


,


108


as more fully described hereinabove. If it is determined in step


1174


that anvil


256


has reached its “true” final destination set in step


1170


, control is transferred to step


1180


, described below. If, however, it is determined in step


1174


that the “true” final destination of the anvil


256


has not been reached, it is determined in step


1176


, with reference to the timer reset in step


1162


, whether a predetermined time limit has been exceeded. If it is determined in step


1176


that the predetermined time limit has not been exceeded, control is returned to step


1166


, and the unclamp motor continues its operation to further unclamp the anvil


256


. If, however, it is determined in step


1176


that the predetermined time limit has been exceeded, and ERROR condition is determined in step


1178


in that the anvil


256


could be moved into its “true” final destination within the predetermined time limit. Control is thereafter transferred to step


1180


, in which the steering mechanism is disengaged. In the example embodiment of electro-mechanical surgical device


10


described above, the steering mechanism may include the fifth motor


96


and/or carriage


100


as more fully described hereinabove. After the steering mechanism has been disengaged in step


1180


, a wait loop is executed in step


1182


until all keys of wireless RCU


148


and/or wired RCU


150


have been released. Once all of the keys have been released, control returns in step


1184


to the main operating program illustrated in FIG.


13


.




Referring now to

FIGS. 15



a


and


15




b


, there is seen a flowchart of a clamp routine specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be appreciated that the clamp routine illustrated in

FIGS. 15



a


and


15




b


represents the routine B of step


1012


of the main operating program illustrated in FIG.


13


and that the clamp routine illustrated in

FIGS. 15



a


and


15




b


is specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be further appreciated that other surgical instruments or attachments, such as those enumerated above, may have other clamping routines associated therewith.




Proceeding from step


1012


, it is determined in step


1200


whether a DLU open flag is set. If it is determined in step


1200


that the DLU open flag is not set, an ERROR condition is determined in step


1202


in that the DLU is not ready to clamp. A wait loop is executed thereafter in step


1204


, and once all keys of wireless RCU


148


and/or wired RCU


150


have been released, control returns in step


1206


to the main operating program illustrated in FIG.


13


.




If, however, it is determined in step


1200


that the DLU open flag is set, it is determined in step


1208


whether the gap between the anvil


256


and the body portion


252


is greater than a predetermined threshold G


1


, such as, for example, 5.0 mm. This determination may be made based on the signals generated by the encoders


106


,


108


, as more fully described above. If it determined that the gap between the anvil


256


and the body portion


252


is less than the predetermined threshold G


1


, control proceeds to step


1220


. If, however, it is determined in step


1208


that the gap between the anvil


256


and the body portion


252


is greater than the predetermined threshold G


1


, control proceeds to step


1210


in which a CLAMP motor speed and torque limit are set to the respective maximum values. In this context, the CLAMP motor may correspond to first motor


76


as more fully described hereinabove. A timer is reset in step


1212


, and the control loop of steps


1214


and


1218


is executed until either a predetermined time period for reaching a gap of less than the predetermined threshold G


1


is exceeded or the gap is determined to be less than the predetermined threshold G


1


. If it is determined in step


1214


that the predetermined time period has been exceeded, an ERROR condition is determined in step


1216


in that the clamp operation is considered to have failed. After step


1216


is performed, step


1204


is performed, in which a wait loop is executed until all keys of wireless RCU


148


and/or wired RCU


150


have been released. Thereafter, control returns in step


1206


to the main operating program illustrated in FIG.


13


.




If it is determined in step


1214


that the predetermined time period has not been exceeded, it is determined in step


1218


whether the movement of the anvil


256


to a location in which the gap between the anvil


256


and the body portion


252


is less than the predetermined threshold G


1


has been completed. If it is determined in step


1218


that this move has not been completed, the operation of CLAMP motor is continued, and control returns to step


1214


. If however, it is determined in step


1218


that the move is complete, control proceeds to step


1220


.




In step


1220


, a speed lower than the maximum speed set in step


1210


is set for the CLAMP motor and a torque limit lower than the torque limit set in step


1210


is set for the CLAMP motor. Thereafter, in step


1222


, a position bias is set to ensure that the CLAMP motor outputs full torque when the gap between the anvil


256


and the body portion


252


approaches the bias value. The bias value may be, for example, approximately 1.0 mm to ensure full torque output from the CLAMP motor when the gap is approximately equal to 1.0 mm.




Referring now to

FIG. 15



b


, control proceeds to step


1224


, in which a timer is reset. In step


1226


, the value of the current gap between the anvil


256


and the body portion


252


is displayed on the display device


16


. In step


1228


, it is determined whether the gap between the anvil


256


and the body portion


252


is less than a predetermined threshold G


2


. This determination may be made based on the signals generated by the encoders


106


,


108


, as more fully described above. The predetermined threshold G


2


may be, for example, 2.0 mm. If the gap between the anvil


256


and the body portion


252


is determined in step


1228


to be less than the predetermined threshold G


2


, control proceeds to step


1230


, in which an IN-RANGE indicator is activated and a DLU ready flag is set. The IN-RANGE indicator may correspond to one of the indicators


18




a


,


18




b


, either one or both of which may be, for example, LED elements or other audio or visual indicators. If it is determined in step


1228


that the gap between the anvil


256


and the body portion


252


is not less than the predetermined threshold G


2


, control proceeds to step


1232


, in which it is determined whether the gap between the anvil


256


and the body portion is less than or equal to another predetermined threshold G


3


. This determination may be made based on the signals generated by the encoders


106


,


108


, as more fully described above. The predetermined threshold G


3


may be, for example, 1.0 mm. If it is determined in step


1232


that the gap between the anvil


256


and the body portion


252


is less than or equal to the predetermined threshold G


3


, control proceeds to step


1238


, described below. However, if it is determined in step


1232


that the gap between the anvil


256


and the body portion


252


is greater than the predetermined threshold G


3


, it is determined in step


1234


whether the current limit to the CLAMP motor has been reached for a predetermined time limit. That the current limit to the CLAMP motor has been reached for the predetermined time limit is indicative that tissue is fully clamped between the anvil


256


and the body portion


252


. The predetermined time limit may be, for example, 1.0 second. If it is determined in step


1234


that the current limit to the CLAMP motor has been reached for the predetermined time limit, control proceeds to step


1238


. If, however, it is determined in step


1234


that the current limit to the CLAMP motor has not been exceeded for the predetermined time limit, it is determined in step


1236


whether the CLAMP key has been released. If it is determined in step


1236


that the CLAMP key has not been released, control returns to step


1226


. If it is determined in step


1236


that the CLAMP key has been released, control proceeds to step


1238


.




In step


1238


, the operation of the CLAMP motor is stopped. Thereafter, in step


1240


, a wait loop is executed until all keys of wireless RCU


148


and/or wired RCU


150


have been released. After all keys have been released, control returns in step


1242


to the main operating program illustrated in FIG.


13


.




Referring now to

FIG. 16

, there is seen a flowchart of an unclamp routine specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be appreciated that the unclamp routine illustrated in

FIG. 16

represents the routine C of step


1016


of the main operating program illustrated in FIG.


13


and that the unclamp routine illustrated in

FIG. 16

is specific to a circular surgical stapler attachment


250


, such as that illustrated in FIG.


9


. It should be further appreciated that other surgical instruments or attachments, such as those enumerated above, may have other unclamp routines associated therewith.




Proceeding from step


1016


, a torque limit for an UNCLAMP motor is set in step


1300


to its maximum value. The UNCLAMP motor may correspond to the CLAMP motor as more fully described hereinabove. The UNCLAMP motor may also correspond to the first motor


76


as more fully described hereinabove.




In step


1302


, the destination position for the anvil


256


is set to a value representative of its fully unclamped position. The operation of the UNCLAMP motor is initiated in step


1304


. In step


1306


, it is determined whether the UNCLAMP key has been released. If it is determined in step


1306


that the UNCLAMP key has been released, control proceeds to step


1314


. If it is determined in step


1306


that the UNCLAMP key has not been released, it is determined in step


1308


whether the gap between the anvil


256


and the body portion


252


is greater than or equal to a predetermined threshold G


4


, which is defined in accordance with the destination position set in step


1302


. This determination may be made based on the signals generated by the encoders


106


,


108


, as more fully described above. If it is determined in step


1308


that the gap between the anvil


256


and the body portion


252


is greater than or equal to the predetermined threshold G


4


, a DLU opened flag is set in step


1310


. Control then proceeds to step


1312


. If it is determined in step


1308


that the gap between the anvil


256


and the body portion


252


is less than the predetermined threshold G


4


, it is determined in step


1312


whether the unclamp operation is complete. That is, whether the destination position for the anvil


256


set in step


1302


has been reached. If it is determined in step


1312


that the movement of the anvil


256


is not complete, control returns to step


1306


. If it is determined in step


1312


that the movement of the anvil


256


is complete, the operation of the UNCLAMP motor is stopped in step


1314


. Control then returns in step


1316


to the main operating program illustrated in FIG.


13


.




It should be understood that the operation of the several motors and switch elements as described above with respect to the circular surgical stapler attachment


250


are specific to the circular surgical stapler attachment


250


. The motor(s) and/or switch(es) may perform other functions when other surgical instruments or attachments are attached to flexible shaft


20


.




Thus, the several aforementioned objects and advantages of the present invention are most effectively attained. Those skilled in the art will appreciate that numerous modifications of the exemplary embodiment described hereinabove may be made without departing from the spirit and scope of the invention. Although a single exemplary embodiment of the present invention has been described and disclosed in detail herein, it should be understood that this invention is in no sense limited thereby and that its scope is to be determined by that of the appended claims.



Claims
  • 1. An electro-mechanical surgical device, comprising:a coupling configured to detachably attach to a plurality of types of surgical instruments; a common motor system configured to drive each of the plurality of types of surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; and a control system configured to detect the type of surgical instrument attached to the coupling and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling, the control system configured to read a data representing the type of the surgical instrument from a second, digital memory unit disposed in the surgical instrument.
  • 2. The electro-mechanical surgical device according to claim 1, wherein the motor system is powered by line current.
  • 3. The electro-mechanical surgical device according to claim 1, further comprising a DC power supply configured to power the motor system.
  • 4. The electro-mechanical surgical device according to claim 1, further comprising a battery system configured to power the motor system.
  • 5. The electro-mechanical surgical device according to claim 1, further comprising a remote control unit configured to communicate with the control system to control the motor system via the control system.
  • 6. The electro-mechanical surgical device according to claim 5, wherein the remote control unit includes at least one of a wired remote control unit and a wireless remote control unit.
  • 7. The electro-mechanical surgical device according to claim 6, wherein the wireless remote control unit is configured to communicate with the control system via one of a wireless electromagnetic communications link and a wireless optical communications link.
  • 8. The electro-mechanical surgical device according to claim 1, wherein the control system is configured to select the operating program corresponding to the detected type of surgical instrument from the plurality of operating programs stored in the first memory unit.
  • 9. The electro-mechanical surgical device according to claim 1, wherein the first memory unit is configured to permit adding at least one new operating program.
  • 10. The electro-mechanical surgical device according to claim 1, wherein the first memory unit is configured to permit deleting at least one operating program.
  • 11. The electro-mechanical surgical device according to claim 1, wherein the first memory unit is configured to permit revising at least one operating program.
  • 12. The electro-mechanical surgical device according to claim 1, wherein the first memory unit includes a removable memory unit.
  • 13. The electro-mechanical surgical device according to claim 1, wherein the first memory unit includes at least one of a random-access memory and a read-only memory.
  • 14. The electro-mechanical surgical device according to claim 1, further comprising a display device configured to display at least one message in accordance with at least one of an operation and a status of the electro-mechanical surgical device.
  • 15. The electro-mechanical surgical device according to claim 14, wherein the display device is configured to display at least one message in accordance with the execution of the operating program.
  • 16. The electro-mechanical surgical device according to claim 1, further comprising at least one indicator device configured to provide an indication of at least one of an operation and a status of the electro-mechanical surgical device.
  • 17. The electro-mechanical surgical device according to claim 16, wherein at least one of the at least one indicator devices is a visual indicator device.
  • 18. The electro-mechanical surgical device according to claim 1, wherein the motor system is configured to mechanically drive each type of surgical instrument.
  • 19. The electro-mechanical surgical device according to claim 1, wherein the coupling is configured to mechanically detachably attach to the plurality of types of surgical instruments.
  • 20. The electro-mechanical surgical device according to claim 1, wherein the control system is configured to automatically detect the type of surgical instrument attached to the coupling.
  • 21. The electro-mechanical surgical device according to claim 1, wherein the control system is configured to automatically execute the operating program corresponding to the detected type of surgical instrument attached to the coupling.
  • 22. The electro-mechanical surgical device according to claim 1, further comprising at least one rotatable drive shaft arranged between the motor system and the coupling, the motor system configured to drive each type of surgical instrument via the drive shaft.
  • 23. The electro-mechanical surgical device according to claim 1, wherein the motor system includes at least one motor configured to drive each type of surgical instrument.
  • 24. The electro-mechanical surgical device according to claim 1, further comprising a steering arrangement configured to steer the coupling.
  • 25. An electro-mechanical surgical device, comprising:a coupling configured to detachably attach to a plurality of types of surgical instruments; a common motor system configured to drive each of the plurality of types of surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; a control system configured to detect the type of surgical instrument attached to the coupling and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling; and a display device configured to display at least one message in accordance with at least one of an operation and a status of the electro-mechanical surgical device; wherein the at least one message is displayable in a selected one of a plurality of languages.
  • 26. The electro-mechanical surgical device according to claim 25, further comprising a switch device configured to select the one of the plurality of languages.
  • 27. The electro-mechanical surgical device according to claim 26, wherein the switch device includes a DIP switch.
  • 28. An electro-mechanical surgical device, comprising:a coupling configured to detachably attach to a plurality of types of surgical instruments; a common motor system configured to drive each of the plurality of types of surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; a control system configured to detect the type of surgical instrument attached to the coupling and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling; and at least one indicator device configured to provide an indication of at least one of an operation and a status of the electro-mechanical surgical device; wherein at least one of the at least one indicator devices is an audio indicator device.
  • 29. An electro-mechanical surgical device, comprising:at least one of a plurality of types of surgical instruments, each surgical instrument including a second memory configured to store a data representing the respective type of surgical instrument; a coupling configured to detachably attach to each surgical instrument; a common motor system configured to drive each surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; and a control system configured to detect the type of surgical instrument attached to the coupling in accordance with the data representing the type of surgical instrument stored in the second memory and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling.
  • 30. The electro-mechanical surgical device according to claim 29, wherein the control system is configured to select the operating program corresponding to the detected type of surgical instrument from the plurality of operating programs stored in the first memory unit.
  • 31. The electro-mechanical surgical device according to claim 29, further comprising a display device configured to display at least one message in accordance with at least one of an operation and a status of the electro-mechanical surgical device.
  • 32. The electro-mechanical surgical device according to claim 31, wherein the display device is configured to display the at least one message in accordance with the execution of the operating program.
  • 33. The electro-mechanical surgical device according to claim 29, further comprising at least one indicator device configured to provide an indication of at least one of an operation and a status of the electro-mechanical surgical device.
  • 34. The electro-mechanical surgical device according to claim 33, wherein at least one of the at least one indicator devices is a visual indicator device.
  • 35. The electro-mechanical surgical device according to claim 29, wherein the motor system is configured to mechanically drive each surgical instrument.
  • 36. The electro-mechanical surgical device according to claim 29, wherein the coupling is configured to mechanically detachably attach to each surgical instrument.
  • 37. The electro-mechanical surgical device according to claim 29, wherein the control system is configured to automatically detect the type of surgical instrument attached to the coupling in accordance with the data representing the type of surgical instrument stored in the second memory.
  • 38. The electro-mechanical surgical device according to claim 29, wherein the control system is configured to automatically execute the operating program corresponding to the detected type of surgical instrument attached to the coupling.
  • 39. The electro-mechanical surgical device according to claim 29, further comprising at least one rotatable drive shaft arranged between the motor system and the coupling, the motor system configured to drive the surgical instrument attached to the coupling via the drive shaft.
  • 40. The electro-mechanical surgical device according to claim 29, wherein the motor system includes at least one motor configured to drive each type of surgical instrument.
  • 41. The electro-mechanical surgical device according to claim 29, further comprising a steering arrangement configured to steer the coupling.
  • 42. The electro-mechanical surgical device according to claim 29, wherein the motor system is powered by line current.
  • 43. The electro-mechanical surgical device according to claim 29, further comprising a DC power supply configured to power the motor system.
  • 44. The electro-mechanical surgical device according to claim 29, further comprising a battery system configured to power the motor system.
  • 45. The electro-mechanical surgical device according to claim 29, further comprising a remote control unit configured to communicate with the control system to control the motor system via the control system.
  • 46. The electro-mechanical surgical device according to claim 45, wherein the remote control unit includes at least one of a wired remote control unit and a wireless remote control unit.
  • 47. The electro-mechanical surgical device according to claim 46, wherein the wireless remote control unit is configured to communicate with the control system via one of a wireless electro-magnetic communications link and a wireless optical communications link.
  • 48. An electro-mechanical surgical device, comprising:at least one of a plurality of types of surgical instruments, each surgical instrument including a second memory configured to store a data representing the respective type of surgical instrument; a coupling configured to detachably attach to each surgical instrument; a common motor system configured to drive each surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; a control system configured to detect the type of surgical instrument attached to the coupling in accordance with the data representing the type of surgical instrument stored in the second memory and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling; and a display device configured to display at least one message in accordance with at least one of an operation and a status of the electro-mechanical surgical device; wherein the at least one message is displayable in a selected one of a plurality of languages.
  • 49. The electro-mechanical surgical device according to claim 48, further comprising a switch device configured to select the one of the plurality of languages.
  • 50. The electro-mechanical surgical device according to claim 49, wherein the switch device includes a DIP switch.
  • 51. An electro-mechanical surgical device, comprising:at least one of a plurality of types of surgical instruments, each surgical instrument including a second memory configured to store a data representing the respective type of surgical instrument; a coupling configured to detachably attach to each surgical instrument; a common motor system configured to drive each surgical instrument; a first memory unit configured to store a plurality of operating programs, each operating program corresponding to a respective type of surgical instrument; a control system configured to detect the type of surgical instrument attached to the coupling in accordance with the data representing the type of surgical instrument stored in the second memory and to execute the operating program corresponding to the detected type of surgical instrument attached to the coupling; and at least one indicator device configured to provide an indication of at least one of an operation and a status of the electro-mechanical surgical device; wherein at least one of the at least one indicator devices is an audio indicator device.
  • 52. A method of operating an electro-mechanical surgical device, comprising the steps of:(a) storing a plurality of operating programs in a first memory unit of the electro-mechanical surgical device, each of the operating programs corresponding to a respective type of surgical instrument attachable to the electro-mechanical surgical device via a coupling; (b) attaching a surgical instrument to the coupling of the electro-mechanical surgical device, the attaching step (b) including attaching the surgical instrument to a motor system of the electro-mechanical surgical device; (c) detecting a type of the surgical instrument attached in the attaching step (b), the detecting step (c) including reading data representing the type of the surgical instrument from a second, digital memory unit disposed in the surgical instrument; and (d) selecting one of the plurality of operating programs in accordance with the type of surgical instrument detected in the detecting step (c).
  • 53. The method according to claim 52, further comprising the step of executing the operating program selected in the selecting step (d).
  • 54. The method according to claim 52, further comprising the step of storing at least one new operating program in the first memory unit after the storing step (a).
  • 55. The method according to claim 52, further comprising the step of storing at least one revised operating program in the first memory unit after the storing step (a).
  • 56. The method according to claim 52, further comprising the step of displaying at least one message on a display device in accordance with at least one of an operation and a status of the electro-mechanical surgical device.
  • 57. The method according to claim 52, further comprising the step of indicating on an indicator device at least one of an operation and a status of the electro-mechanical surgical device.
  • 58. The method according to claim 52, wherein the detecting step (c) includes automatically detecting the type of surgical instrument attached in the attaching step (b).
  • 59. The method according to claim 52, wherein the selecting step (d) includes automatically selecting the one of the plurality of operating programs in accordance with the type of surgical instrument detected in the detecting step (c).
  • 60. The method according to claim 52, further comprising the step of mechanically driving the surgical instrument attached in the attaching step (b).
  • 61. The method according to claim 52, further comprising the step of mechanically driving the surgical instrument attached in the attaching step (b) in accordance with the one of the plurality of operating programs selected in the selecting step (d).
  • 62. The method according to claim 52, further comprising the step of steering the surgical instrument attached in the attaching step (b).
  • 63. A method of operating an electro-mechanical surgical device, comprising the steps of:(a) storing a plurality of operating programs in a first memory unit of the electro-mechanical surgical device, each of the operating programs corresponding to a respective type of surgical instrument attachable to the electro-mechanical surgical device via a coupling; (b) attaching a surgical instrument to the coupling of the electro-mechanical surgical device, the attaching step (b) including attaching the surgical instrument to a motor system of the electro-mechanical surgical device; (c) detecting a type of the surgical instrument attached in the attaching step (b); (d) selecting one of the plurality of operating programs in accordance with the type of surgical instrument detected in the detecting step (c); and (e) displaying at least one message on a display device in accordance with at least one of an operation and a status of the electro-mechanical surgical device; wherein the at least one message is displayed in the displaying step in one of a plurality of languages.
  • 64. The method according to claim 63, further comprising the step of selecting the one of the plurality of languages.
  • 65. A method of operating an electro-mechanical surgical device, comprising the steps of:(a) storing a plurality of operating programs in a first memory unit of the electro-mechanical surgical device, each of the operating programs corresponding to a respective type of surgical instrument attachable to the electro-mechanical surgical device via a coupling; (b) attaching a surgical instrument to the coupling of the electro-mechanical surgical device, the attaching step (b) including attaching the surgical instrument to a motor system of the electro-mechanical surgical device; (c) detecting a type of the surgical instrument attached in the attaching step (b); (d) selecting one of the plurality of operating programs in accordance with the type of surgical instrument detected in the detecting step (c); and (e) displaying at least one message on a display device in accordance with the operating program selected in the selecting step (d).
  • 66. The method according to claim 65, wherein the at least one message is displayed in the displaying step in one of a plurality of languages.
  • 67. The method according to claim 66, further comprising the step of selecting the one of the plurality of languages.
  • 68. A method of operating an electro-mechanical surgical device, comprising the steps of:(a) storing a plurality of operating programs in a first memory unit of the electro-mechanical surgical device, each of the operating programs corresponding to a respective type of surgical instrument attachable to the electro-mechanical surgical device via a coupling; (b) attaching a surgical instrument to the coupling of the electro-mechanical surgical device, the attaching step (b) including attaching the surgical instrument to a motor system of the electro-mechanical surgical device; (c) detecting a type of the surgical instrument attached in the attaching step (b); (d) selecting one of the plurality of operating programs in accordance with the type of surgical instrument detected in the detecting step (c); and (e) indicating on an indicator device at least one of an operation and a status of the electro-mechanical surgical device; wherein the indicator device includes at least one of an audio indicator device and a visual indicator device.
CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part of U.S. application Ser. No. 09/324,451, filed on Jun. 2, 1999, now U.S. Pat. No. 6,315,184 a continuation-in-part of U.S. application Ser. No. 09/324,452, filed on Jun. 2, 1999, now U.S. Pat. No. 6,443,973 a continuation-in-part of U.S. application Ser. No. 09/351,534, filed on Jul. 12, 1999, now U.S. Pat. No. 6,264,087 a continuation-in-part of U.S. application Ser. No. 09/510,923, filed on Feb. 22, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/324,452, a continuation-in-part of U.S. application Ser. No. 09/510,927, filed on Feb. 22, 2000, which is a continuation-in-part of U.S. application Ser. No. 09/324,452, and a continuation-in-part of U.S. application Ser. No. 09/510,932, filed on Feb. 22, 2000.

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Continuation in Parts (6)
Number Date Country
Parent 09/510932 Feb 2000 US
Child 09/723715 US
Parent 09/510927 Feb 2000 US
Child 09/510932 US
Parent 09/510923 Feb 2000 US
Child 09/510927 US
Parent 09/351534 Jul 1999 US
Child 09/510923 US
Parent 09/324452 Jun 1999 US
Child 09/351534 US
Parent 09/324451 Jun 1999 US
Child 09/324452 US