U8005383880A
`.
`5,383,880
`[11] Patent Number:
`.
`[19]
`Umted States Patent
`
`Hooven
`[45] Date of Patent:
`Jan. 24, 1995
`
`[54] ENDOSCOPIC SURGICAL SYSTEM WITH
`SENSING MEANS
`Invent“ MiChael 13- Home“, Cincmnati’ 0hi°
`[75]
`-
`,
`.
`.
`-
`.
`.
`7
`[ 3] ASSlgnee
`Emcon’lnc’ S°mervme’ NJ
`[21] Appl. No.: 991,619
`_
`[22] Ffled:
`
`Dec. 169 1992
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`5,197,649
`3/1993 Bessler et a1.
`.................... 227/19 X
`
`5,207,691
`5/1993 Nardella .........
`227/901x
`5,258,007 11/1993 Spetzleretal. .....
`227/901 x
`
`.
`Primary Examiner—Rmaldi I. Rada
`Attorney, Agent. or Firm—Paul A. Coletti
`
`Related US. Application Data
`
`[57]
`
`ABSTRACT
`
`[63]
`
`Continuation-impart of Ser. No. 822,478, Jan. 17, 1992,
`abandoned.
`Int. 0.6 .............................................. A61B 17/12
`[51]
`
`[52] us. Cl. ....................................
`606/142; 606/213.
`227/175; 227/901
`[58] Field of Search ......................... 227/19, 901, 175;
`173/6, 10, 176; 606/213, 142
`
`An endos00pic surgical system which includes an in-
`strument for carrying out a step in the procedure. The
`instrument is P°Wer Operated and the ”Stem incmdes
`sensing means to control the operation of the instru-
`mm-
`
`6 Claims, 15 Drawing Sheets
`
`
`
`1'
`
`IS 1004
`
`1
`
`IS 1004
`
`

`

`US. Patent
`
`Jan. 24 1995
`
`5,383,880
`
`
`
`2
`
`

`

`5,383,880
`
`
`
`3
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 3 of 15
`
`5,383,880
`
`‘I‘IIII.-'“;
`
`
`
`§§§§§§§§§§§S\§§m¥hfi%m
`
`4
`
`
`
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 4 of 15
`
`5,383,880
`
`
`
`5
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 5 of 15
`
`5,383,880
`
`
` g
`El\«i
`
`
`4:4ll'fii=11|==....I
`-"I‘.\II."I‘“|.\“I.I
`
`
`mmMK
`
`mm
`
`mmmk
`
`wk
`
`kk
`
`QAVE
`
`6
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 6 of 15
`
`5,383,880
`
`
`
`.|ll'.IvIll!i‘lli"IiI.‘II‘flala;<\\\\
`
`
`
`\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\
`
`
`
`S\\\\\\\\\\\\\\
`.hn..Rx;
`§§aE?“3353.
`
`=5.“
`
`xh«tr/4
`mxx,
`fi‘fl‘u~'“‘§u\x
`‘fl‘!
`’i‘lil.‘.lIl
`Ja;u_1m,
`
`no
`
`3‘
`
`'
`
`2".”
`
`7
`
`
`
`
`
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 7 of 15
`
`5,383,880
`
`
`
`8
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 8 of 15
`
`5,383,880
`
`
`
`9
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 9 of 15
`
`5,383,880
`
`
`
`10
`
`10
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 10 of 15
`
`5,383,880
`
`[2]
`
`I20
`
`I2]
`
`11
`
`11
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`5,383,880
`
`
`
`12
`
`

`

`US. Patent
`
`'
`
`Jan. 24, 1995
`
`Sheet 12 of 15
`
`5,383,880
`
`fi—
`
`200
`
`20/
`
`FIG-/8 -w
`
`202
`
`205
`
`XXXX
`
`13
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 13 of 15
`
`5,383,880
`
`momzmm
`
`_tomzmm_tomzmw
`dvGEQIOME
`tog.34k0%_mOkSfiOq-EOKQDKUQ
`
`3.3.me
`
`\EQQQQ\mtOkc‘QEE
`
`15th00
`
`0504
`
`tmmb
`
`MUVKQMKE
`
`9-GE
`
`14
`
`14
`
`
`
`
`
`
`
`
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 14 of 15
`
`5,383,880
`
`FIG -20A
`
`PHYSICIAN AC TIVATES OR
`
`ENABLES SYSTEM
`
`
`
`SEND SIGNAL (5)
`
`TO ACTUATOR(SI
`
`
`
`
`RECEIVE SIGNAL (3)
`
`FROM SENSOR (SI
`
`
` IS SYSTEM
`IN RANGE T0
`
`IS THERE
`
`NO
`
`YES
`
`ABORT,-
`RELEASE CONTROL TO
`
`ERROR 0N DISPLAY
`
`PHYS/CAN, INDICATE
`
` HAS
`"FIRE " BUTTON
`
`
`NO
`BEEN PRESSED
`
`
`7
`
`
`YES
`
`FIRE
`
`TO
`FIG - 208
`
`15
`
`
`
`
`A PROBLEM WITH
`
`
`THE ACTUATORIS)
`FOR PHYSICIAN
`OR SE7NSOR(S)
`
`
`
`
`FIRE ?
`
`ENABLE
`"FIRE" BUTTON
`
`15
`
`

`

`US. Patent
`
`Jan. 24, 1995
`
`Sheet 15 of 15
`
`5,383,880
`
`FIG - 208
`
`FROM
`
`FIG -20A
`
`REVERSE
`
`ACTUATOR(SI
`
`A PPROPR/ATE
`
`
`
`FIRED COMPLETELY
`
`
`
`AND CORRECTLY
`
`HAS DEVICE
`
`
`
`YES
`
`NO
`
`INDICATE PROBLEM /
`
`DIAGNOSIS
`
`INDICATE
`
`TAKE ACTION
`
`PROPER ACTUAT/ON
`
`AS DETERMINED
`
`OF INSTRUMENT
`
`BY DIAGNOSIS
`
`ACTUATOR (SI
`
`REVERSE
`
`APPROPRIATE
`
`16
`
`16
`
`

`

`2
`standpoint, considerable design engineering is required
`to permit function of the active portion of the instru-
`ment given the physical limits of force and stroke of the
`surgeon’s hand.
`Another problem, particular to endoscopic proce-
`dures, is that the surgeon can no longer feel tissue with
`his hands to determine thickness, consistency, texture,
`etc.
`
`1
`
`5,383,880
`
`ENDOSCOPIC SURGICAL SYSTEM WITH
`SENSING MEANS
`
`RELATED PATENT APPLICATIONS
`
`5
`
`This is a continuation-in-part patent application of
`co-pending patent application Ser. No. 822,478 filed
`Jan. 17, 1992, now abandoned.
`FIELD OF THE INVENTION
`
`This invention relates to a system for use endoscopic
`procedures. More specifically, this invention relates to a
`system which will automatically sense physical proper-
`ties of the tissue on which the procedure is being con-
`ducted and/or certain parameters of an endoscopic
`surgical instrument.
`BACKGROUND OF THE INVENTION
`
`15
`
`It should also be pointed out, that for medical reasons
`10 it is often desirable to make endoscopic instruments
`disposable. A major reason for this is that small, intri-
`cate, reusable instruments are difficult to sterilize and, if
`you can make the instrument disposable these steriliza-
`tion problems are eliminated. However, making the
`instrument disposable will often increase the cost of the
`instrument and this cost must be balanced with the
`medical advantage. Another problem with endoscopic
`instruments is their access limitations; that is, the ability
`to manipulate the head of the instrument after it has
`been placed in the cannula is difficult and the scope of
`movement is limited.
`
`20
`
`SUMMARY OF THE INVENTION
`
`Endoscopic surgery has been gaining wide accep-
`tance as an improved and cost effective technique for
`conducting certain surgical procedures. In endoscopic
`surgery, a trocar, which is a pointed piercing device, is
`sent into the body with a cannula placed around the
`trocar. After the trocar accomplishes piercing of the
`abdominal walls, it is removed and the cannula remains
`in the body. Through this cannula, endoscopic proce-
`dures are possible. Often multiple openings are pro-
`duced in the body with a trocar so that an endoscopic
`instrument may be placed in one cannula, appropriate
`viewing mechanisms placed in another cannula and
`fiber optics for illuminating the surgical field placed in
`yet another cannula. Generally, these endoscopic pro-
`cedures take place under insufflation. As more is
`learned about endoscopic procedures and more instru-
`ments developed, the type of procedures that may be
`performed endoscopically will increase. Presently, typi-
`cal procedures are gall bladder removal, tissue repair
`and various sterilization procedures.
`Broadly, the instruments used in surgery can be clas-
`sified into two broad classes. One class is manipulation
`devices; that is, devices which will grasp tissue, position
`tissue, irrigate, apply suction, and the like. The second
`class may be termed active devices. Generally, these
`devices either cut or staple tissue and some devices may
`combine these actions. Examples of such devices are
`electrosurgery instruments, ultrasonic instruments, la-
`sers, circular stapling instruments, linear stapling instru-
`ments, ligating and cutting instruments and the like.
`While endoscopic surgical procedures have substan-
`tial benefits to the patient, they do present certain prob-
`lems to the surgeon conducting the procedure. For
`example, because the active part of the instrument is
`further removed from the manipulative part of the in-
`strument, any slight movement of that manipulative
`part is magnified when it reaches the active part. Hence, 55
`when placing and forming a staple in tissue, the hand of
`the surgeon must be a lot steadier during the endoscopic
`procedure than If that same procedure was done during
`standard open surgery. Another difficulty arises be-
`cause the surgeon, conducting the procedure, cannot
`see the field in which he is operating in a direct manner
`but is watching that field on an appropriate video dis-
`play and manipulating the instrument based on what he
`sees on that video display. Hence, in designing endo-
`scopic surgical instruments, considerable effort is made
`to reduce the force required in order to operate the
`instrument and allow the surgeon to have greater con-
`trol over the instrument. Also, from an engineering
`
`25
`
`30
`
`The endoscopic surgical system of the present inven-
`tion provides a system allowing for a high degree of
`control in the manipulation of the active part or business
`head of an endoscopic instrument. Furthermore, my
`new system may provide greater access for the head of
`an endoscopic instrument during the surgical proce-
`dure. My new endoscopic system allows for greater
`forces to be applied at the head of the instrument while
`maintaining that head under stable control during the
`surgical procedure. My new endoscopic system may be
`35 disposable and even when disposable, in certain designs,
`may provide considerable reduction in cost. My new
`system allows the surgeon to expend less energy during
`the surgical procedure thus providing for improved
`manipulation and control of the instrument during the
`procedure. My new endoscopic system provides sens-
`ing feedback to the surgeon to compensate for the loss
`of tactile feedback. In certain designs of my new endo-
`scopic system, the surgeon is provided with consider-
`able knowledge regarding the instrument. For example,
`the surgeon may be informed as to the position of the
`instrument in the procedure, the operation of the instru-
`ment; i.e., whether it is in a position to be activated and
`activated correctly and the like.
`In its broadest sense, my new endoscopic system
`comprises an instrument which is to be used in conduct-
`ing a step in an endoscopic procedure. Connected to
`that instrument
`is suitable power means which will
`operate the active or business head of the instrument to
`conduct a desired step in the procedure. The instrument
`also includes a sensing means which controls and/or
`monitors the operation of the instrument while conduct-
`ing the desired step in the procedure and provides feed-
`back information to the surgeon. According to the pres-
`- ent invention, there is provided an endoscopic instru-
`ment which has a head portion for carrying out a step in
`an endoscopic procedure. The step may be ligating,
`stapling, cutting, manipulation of the tissue etc. or com-
`binations of these steps. Connected to this head portion
`is a shaft. The instrument includes means for applying
`65 energy to the head portion either by or through the
`shaft. In preferred embodiments of the present inven-
`tion, the shaft is encased in a housing and a motion is
`provided to the shaft; i.e., rotation, longitudinal move-
`
`45
`
`50
`
`17
`
`17
`
`

`

`3
`ment, etc. Means are disposed in the head of the instru-
`ment, to translate the motion of the shaft into a suitable
`force and/or motion in the head to carry out a desired
`step in the procedure; i.e., to set and form staples or to
`ligate a vessel or to sever tissue and so forth. Also,
`disposed in the head portion is a sensing means which
`measures the energy, force, or the motion of the head
`portion. In some instances, the sensing means may mea-
`sure one or more physical parameters of the tissue on
`which it is to work or of the surrounding tissue. Inter-
`connected with that sensing means is a means which
`controls the energy, force and/or the motion of that
`head portion.
`The present invention will be more readily under-
`stood and described in the attached description of the
`drawings taken in conjunction with the description of
`the invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a schematic view of an endoscopic surgical
`system of the present invention interconnected with a
`microprocessor/controller and a video display screen;
`FIG. 2 is a perspective view of an endoscopic sta-
`pling and cutting system in accordance with the present
`invention;
`FIG. 3 is a longitudinal cross-sectional view of the
`handle portion of one embodiment of an endoscopic
`stapling and cutting system of the present invention;
`FIG. 4 is a detail of the gear reduction assembly.
`FIG. 4a is a cross-sectional view taken along line
`A—A of FIG. 4;
`FIG. 4b is a cross-sectional view taken along line
`B—B of FIG. 4;
`FIG. 5 is a longitudinal cross-sectional view of the
`shaft of the system depicted in FIG. 2;
`FIG. 6 is an enlarged longitudinal cross-sectional
`view of the active or business head of the system de-
`picted in FIG. 2;
`FIG. 7 is an enlarged longitudinal cross-sectional
`view of the head of the system depicted in FIG. 6 with
`the head in a closed position;
`FIG. 8 is an enlarged longitudinal cross-sectional
`view of the head of the system depicted in FIG. 6 with
`the head in the position of firing staples;
`FIG. 9 is an enlarged longitudinal cross-sectional
`view of the head of the system of FIG. 6 with the head
`in the closed position after thing the staples;
`FIG. 10 is an enlarged longitudinal cross-sectional
`view of the head of the system depicted in FIG. 6 with
`the head in the open position after the staples have been
`fired;
`FIG. 11 is a perspective view of another embodiment
`of an endoscopic system of the present invention useful
`in placing ligating clips;
`FIG. 12 is a longitudinal cross-sectional View of the
`handle of the instrument depicted in FIG. 11;
`FIG. 13 is an assembly view of the shaft portion of
`the system depicted in FIG. 11;
`FIGS. 14, 15 and 16 are sequential plan view of a clip
`placed in the head of the system depicted in FIG. 11
`when the clips are open, closing and fully closed, re-
`spectively;
`FIG. 17 is a longitudinal cross-sectional view of a
`head of a system of the present invention depicting
`sensing means for sensing properties in the surrounding
`environment;
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`6O
`
`65
`
`5,383,880
`
`4
`FIG. 18 is a block diagram showing the interrelation-
`ship of the principal components of one embodiment of
`a system according to the present invention;
`FIG. 19 is a block diagram depicting a possible set of
`hardware architecture for a system of the present inven-
`tion; and
`FIG. 20!: and FIG. 20b are a simplified flow diagram
`of one possible flow for the control logic for a system
`according to the present invention.
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`Referring to the drawings, there is shown in FIG. 1 a
`perspective view of an endoscopic system according to
`the present invention. In this Figure an endoscopic
`stapling and cutting instrument 30 is interconnected
`with a controller 31 and a video display monitor 32. The
`controller includes a microprocessor, power supply,
`hardwired logic, sensor interface and motor drive cir-
`cuits. The instrument is connected to the controller so
`that the controller can accept, store, manipulate, and
`present data. The controller may feed appropriate sig-
`nals back to the instrument in order to operate the in-
`strument. The controller also acts to supply power to
`the instrument at the appropriate level, frequency, tim-
`ing, etc. Within the controller may be several hard-
`wired logic circuits controlling critical instrument func-
`tions. Also, several sensing circuits may be incorporated
`in the controller to measure voltage, current, power etc.
`The controller may also include a display screen to
`present the data it has received from the instrument and
`manipulate it in a desired way.
`In FIG. 2 there is shown a perspective view of the
`endoscopic instrument depicted in FIG. 1. The instru-
`ment has a handle portion 40. Extending from this han-
`dle portion is a shaft portion 41 and at the end of the
`shaft portion is a desired head or business portion 42 of
`the instrument. The head or business portion is that
`portion of the instrument which accomplishes a step in
`a surgical procedure, whether that be ligating, stapling,
`cutting, manipulating tissue, or combinations of such
`steps. The head and shaft portions of the instrument are
`constructed so that they can be applied through the
`cannula of a trocar as is well known in endoscopy.
`In the embodiment depicted in FIGS. 2 through 9,
`the head portion is a linear stapler and cutter; that is, the
`head portion will place down plural parallel rows of
`staples with the staples offset in the rows. The instru-
`ment will also operate a knife to pass between two adja-
`cent parallel rows of staples. Such an instrument staples
`tissue together and cuts that tissue between the stapled
`portions. Such instruments are used in various types of
`surgical procedures such as bowel and lung resections.
`FIG. 3 is an enlarged, longitudinal cross-sectional
`view of the handle portion of the instrument depicted in
`FIG. 2. In this embodiment, the handle portion includes
`a small DC motor 45 attached to a gear box 46. Extend-
`ing from the gear box is a rotatable drive shaft. The
`rotatable drive shaft extends substantially the length of
`the handle. Also included in the handle and intercon-
`nected with the DC motor are a suitable on-off switch
`48 and a switch 49 to control the power supply being
`provided by the motor. A video display switch may also
`be provided in the handle if desired. While in this em-
`bodiment the motor itself is included in the handle, it
`should be appreciated that the motor could be separate
`from the instrument with appropriate connections so
`that a variety of instruments could be used with detach-
`
`18
`
`18
`
`

`

`5,383,880
`
`5
`able motor or power source. Also, if the instrument is to
`be interconnected with a controller to accept, store and
`manipulate data, the motor may be connected to such
`controller and information such as current input, power
`output, voltage and other parameters may be monitored
`by the controller for manipulation, display, and use in a
`suitable manner.
`As depicted in the cross-sectional views in FIGS. 4,
`4a and 4b, the motor shaft 50 extends into the center of
`the gear box 46. The gear box comprises two sets of
`gears 51 and 52, which reduce the rotation of the shaft
`47 with respect to the motor at a ratio of 36:1 or other
`reduction as desired.
`
`Referring to FIG. 5, there is shown an enlarged,
`longitudinal cross-sectional view of the shaft portion of
`the instrument shown in FIG. 2. In this embodiment,
`the shaft housing 60 is flexible. Through the center of
`the housing there extends the rotating, axially flexible,
`torsionally stiff shaft 61. The housing connects the han-
`dle of the instrument to the head of the instrument and
`the flexible shaft is connected to the drive shaft 47.
`FIGS. 6 through 10 are enlarged, longitudinal cross-
`sectional views of the head portion of the instrument
`depicted in FIG. 2. The views depict the head of the
`instrument in the open position prior to being placed on
`tissue (FIG. 6), in the closed position ready for firing
`(FIG. 7), during the firing action (FIG. 8), after the
`firing action has been completed (FIG. 9) and in the
`final open position (FIG. 10) when the instrument may
`be removed. In these figures, like parts are identified
`with the same numerals. The housing 70 of the head is
`suitably connected to the shaft housing 60 either by a
`press fit or ultrasonic welding or other similar means.
`Extending substantially the length of the head and con-
`nected to the rotating shaft 61 is a threaded rod 71. The
`threaded rod has a larger diameter portion 72 adjacent
`the shaft 61 and a smaller diameter portion 73 for the
`remainder of the threaded rod. The head includes a
`staple or staple cartridge portion 74 and an anvil portion
`75. The staple portion and the anvil portion are pivot-
`ally connected To each other by the anvil pivot pin 76.
`Mounted on the larger diameter portion of the threaded
`rod is a closure nut and extending from that closure nut
`77 is a closure pin 78 which moves in a slot 79 disposed
`in the pivotally mounted anvil portion of the head.
`When the flexible shaft is rotated, the threaded rod is
`also rotated and on rotating the closure nut will move
`down the threaded rod and move the closure pin in the
`closure slot to close the anvil portion against the staple
`portion of the head of the instrument. Tissue to be
`treated or manipulated is placed between the anvil por-
`tion and the staple portion of the head of the instrument
`when in the open position. Power is applied to the flexi-
`ble shaft to rotate the shaft and the threaded rod and
`close the anvil portion. As can be appreciated, the
`amount of torque required to pivot the anvil portion
`about the pivot pin can be sensed and the thickness of
`tissue between the anvil and the staple portion deter-
`mined. It is a simple matter for a controller to manipu-
`late this information and inform the surgeon as to
`whether or not he has the appropriate amount of tissue
`between the anvil portion and the staple portion of the
`head of the instrument upon closure or whether he has
`too much or too little tissue-and should re-manipulate
`the instrument. For a constant voltage drive, the force
`required to close the instrument may be measured by
`monitoring motor current. The power delivered to the
`instrument may be controlled by varying motor voltage
`
`6
`and/or current to achieve a constant motor speed with
`varying load.
`Mounted in the staple holding portion of the instru-
`ment is a removable staple cartridge 80. The cartridge
`holds four rows of staples 81. The rows are parallel and
`in adjacent rows the staples are off-set as is well known
`in the art. The cartridge is placed so that it is opposite
`the anvil portion of the instrument and snaps into the
`staple holding portion of the instrument as shown. As
`depicted in the figures, extending the length of the sta-
`ple portion of the instrument is the smaller diameter
`portion of the threaded rod. Mounted on this rod, to
`move along the rod as the rod rotates, is a knife member
`82 and a driving wedge member 83 which are inner-
`connected. The wedge member precedes the knife
`member as they move along the threaded rod. As the
`wedge member moves down the threaded rod, it drives
`the staples out of the cartridge, via the individual staple
`drivers 84. The staples pass through the tissue and
`against the anvil to form the staples in the tissue. The
`knife 82 following the driving wedge cuts the tissue
`between adjacent rows of staples. The driving wedge is
`actually two pieces; that is, it has one wedge piece on
`one side of the knife to drive the staples on that side of
`the knife and a like wedge piece on the opposite side of
`the knife to drive the staples on that side of the knife.
`When the anvil portion 75 is closed as shown in FIG.
`7, the closure nut 77 moves a stop member 85 forward
`so that the firing nut 86 on which the knife 82 and
`wedges 83 are disposed is moved forward and engages
`the threads of the smaller diameter portion 73 of the
`threaded rod to move forward along the rod and drive
`the staples 81 and cut tissue. The firing nut 86 is biased,
`using a suitable means, so as not to engage the threaded
`rod until a stop member 85 is activated. Once the firing
`nut has moved to its most forward position to drive and
`form all of the staples and cut the tissue, it engages a
`suitable contact 87 which immediately reverses the
`motor to retract the firing nut. In its fully retracted
`position, the firing nut 86 moves the stop member 85
`rearwardly causing the closure nut 77 to then retract
`and open the anvil portion 75 of the head of the instru-
`ment. Another configuration would be to locate
`contacts in the handle portion of the instrument and use
`a follower nut on the rotating shaft to monitor position.
`It should be pointed out that it is desirable to locate as
`many as possible of the contacts and sensors in the han-
`dle portion of the instrument so that the head or busi-
`ness end can be maintained as small as possible and still
`accomplish the desired step in a procedure. By main-
`taining the head and shaft of the instrument as small as
`possible, the opening in the patient required for insert-
`ing the instrument may be kept small, thus increasing
`some of the benefits of an endoscopic procedure. As can
`be appreciated, various information may be transmitted
`during the operation of the instrument; for example, the
`movement of the stop member pushing the firing nut to
`the threaded rod for movement can be sensed. The most
`forward position of the wedges and. knife may be
`sensed. The reversal of the motor may also be sensed as
`well as the movement of the stop member to open the
`anvil portion etc. Furthermore, if desired the presence
`of a cartridge and the presence of staples in that car-
`tridge may also be sensed. All of this information may
`be fed back to a controller and stored and manipulated
`in the control unit so that the surgeon using the instru-
`ment will instantaneously receive information as to the
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`19
`
`19
`
`

`

`7
`placement of the staples, the cutting of the tissue, the
`presence of staples in the cartridge, etc.
`Referring to FIGS. 11 through 16, there is depicted
`an endoscopic ligating system of the present invention.
`The ligator comprises a handle portion 80’ having ap-
`propriate on-off 81’ and power control 82” switches. A
`hollow circular casing 83' extends from the handle por-
`tion and a clip applying head portion 84’ is disposed at
`the opposite end of the circular casing. As more clearly
`shown in FIG. 12, in the handle portion is a rotatable
`drive shaft 85'. One end of the drive shaft at the rear of
`the handle includes a connection 86’ so that it can be
`connected to a DC motor or other suitable power
`means. The opposite end of the drive shaft is threaded
`87'. The threaded portion of the drive shaft engages a
`threaded end 88 of a longitudinally moveable rod 89.
`The rod is connected to longitudinally extending shaft
`90. The shaft extends substantially the full length of the
`instrument from the handle to the head or business end
`of the instrument. When the drive shaft 87 is rotated, the
`rod 89 and longitudinally extending shaft 90 move for-
`ward and when the rotation of the drive shaft is re-
`versed, the rod and longitudinal extending shaft is re-
`tracted.
`
`As shown in FIG. 13, the longitudinally extending
`shaft is mounted in a suitable support tube 115. The
`shaft comprises a longitudinally moveable cam channel
`112, an enclosing member 113, a floor 110 opposite the
`enclosing member, a feed bar 99, an end cap 114, and a
`track 98 for holding ligating clips. Attached within the
`cam channel are the jaws 111 of the instrument. In
`operation, when the cam channel is moved forwardly, it
`encloses the jaws and brings them together to close a
`clip which has been placed in the jaws. When the drive
`shaft 87 is reversed, the channel retracts and the jaws
`opens. Also included in the shaft are a magazine or a
`stack of clips 97 held in track 98. The track also holds a
`feeder spring 94, lock lever 95 and feed shoe 96. The
`clips are positioned in the path of the feed bar 99 by
`spring 94. A lifter spring 93 is held in place over clip
`track 98 by shroud 92 and acts to place the first clip of
`the magazine into the plane of the feed bar for position
`in the jaws. The operation of this portion of the instru-
`ment can best be seen in FIGS. 14, 15, and 16. As the
`cam channel 112 is urged forwardly,
`it engages the
`outer surface of the jaws 111 and pushes them towards
`each other to close the clip 120 about tissue 121. When
`the cam channel retracts, the jaws open. The clip maga-
`zine 97 is advanced forwardly and another clip is placed
`within the jaws. This happens when the spring 94 is
`released and the feed shoe advances the next clip from
`the stack of clips, which has been positioned in the path
`of the feed shoe by the spring so that another clip may
`be placed. Suitable sensing members 123 and 124 in the
`jaws can determine whether or not there is an appropri-
`ate clip in the jaws, whether or not the clip is appropri-
`ately closed and when the stack of clips is empty. For
`instance, the appropriate sensing circuits which mea-
`sure voltage, current, power, etc., as described above,
`may be used to determine clip position or clip closure.
`All of this information may be fed back to a controller
`for storage and manipulation and appropriate informa-
`tion reported to the operator of the instrument.
`While I have described my new system with specific
`reference to a linear stapler-cutter instrument and a
`ligating clip applier, it of course, can be used with other
`endoscopic instruments. For example, my new system
`could be used to control an electro-cauterizing instru-
`
`20
`
`5,383,880
`
`8
`ment. My new system could be used to control the
`activation of such an instrument as well as the irrigation
`and suction used with cauterizing instruments.
`In all of the previous embodiments, the sensing mech-
`anism has been used to sense the operation of the instru—
`ment and to sense whether or not appropriate tissue is in
`the appropriate position, etc. It should be appreciated
`that the instruments may also be designed to sense phys-
`ical parameters of the surrounding environment. For
`example, they may sense the blood oxygen content or
`tissue density of adjacent tissue or various hemostasis
`characteristics of adjacent tissue and the like may be
`used.
`In FIG. 17, there is depicted the head of an instru-
`ment which includes a sensing member used to sense the
`blood oxygen content of adjacent tissue. In this embodi-
`ment,
`the instrument is a linear stapling instrument
`though other instruments are also meant to be encom-
`passed in this embodiment. FIG. 17 depicts the head or
`business end 160 of such an instrument. The head com-
`prises a staple or staple cartridge holding member 161
`and a pivotally mounted anvil member 162 similar to
`that depicted and described in conjunction with FIG. 6.
`A light emitting diode (LED) 163 and phototransistor
`receiver 164 are disposed in the staple holding member.
`The transistor receiver comprises one or more photo-
`transistors and appropriate resistors. When tissue to be
`manipulated is placed between the staple member and
`the anvil member an electrical pulse is applied to the
`LED to cause light to be emitted by the LED. The
`emitted light contacts the tissue and, depending on the
`properties of the tissue, a portion of the light is reflected
`from the tissue to the photo-transistor thereby creating
`an electrical signal in direct proportion to the received
`optical signal. The amount of light striking the photo-
`transistor may be measured and correlated to a desired
`property of the tissue such as oxygen content. The indi-
`rect measurement of tissue penetration via an opto-elec—
`tronic signal conversion is used to control desired oper-
`ations of the instrument. The operations that might be
`controlled would be the opening and closing of the
`anvil member and/or the firing of the staples. This is
`accomplished by feeding the light measurement to a
`controller which would in turn control
`the power
`source used to operate the instrument. Also, this infor-
`mation could be supplied to the surgeon via a video
`display. The surgeon could use this information to de-
`termine proper positioning of the instrument or other
`procedure related manipulations.
`FIG. 18 portrays in a simple block diagram one form
`of a system according to the present invention. In this
`embodiment the endoscopic instrument is a stapler and
`cutter 200. The status of the instrument and various
`messages are communicated to the user by an interface
`with an endoscopic video camera 201 and monitor sys-
`tem 202. The system also includes an instrument micro-
`processor/controller 203. The endoscopic instrument is
`powered by a DC motor 204 and is connected to the
`controller by a cable 205. The controller is micro-
`processor based and includes circuits for sensing, motor
`control, sensor interface, video interface and power
`supply. The instrument includes miniature sensors to
`detect the power and/or force being used and limit
`switches and contacts to turn the motor on and off at
`predetermined positions. Limit switches are also used to
`detect various interlocks used in the instrument. The
`instrument may also include sensors to determine the
`position of the anvil to the cartridge and whether or not
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`4O
`
`45
`
`50
`
`55
`
`65
`
`20
`
`

`

`5,383,880
`
`9
`in the cartridge. All sensors,
`staples are present
`switches, and motors are connected to the controller via
`the interface cable 205. This information, fed into the
`appropriate controller, is stored and manipulated and
`fed to a central processing communication system.
`Some information will be processed directly through
`the hard wired circuits. It is important to note that it is
`desirable to incorporate critical instrument functions in
`to the hardwired logic of the controller whenever possi~ 10
`ble. The controller then may be used for non-critical
`functions and information processing. The processed
`and manipulated information is fed to a video display
`screen and/or a suitable written or audio display mech-
`anism. The information may also be fed back to the 15
`instrument controller to control some or all of the in-
`strument functions.
`-
`
`10
`ulation, stapling, ligation, cutting or the combina-
`tion of such steps;
`a shaft connected to and extending proximally from
`said head portion,
`means for applying a motion to said shaft,
`means disposed in said head portion for translating
`the motion applied to the shaft into a force and/