|00001
`
`as) United States
`a2) Patent Application Publication (10) Pub. No.: US 2005/0131390 Al
`(43) Pub. Date: Jun. 16, 2005
`
`Heinrich et al.
`
`(54)
`
`SURGICAL INSTRUMENTS INCLUDING
`MEMS DEVICES
`
`Related U.S. Application Data
`
`(76)
`
`Inventors: Russell Heinrich, Madison, CT (US);
`Douglas J. Cuny, Bethel, CT (US)
`
`Correspondence Address:
`Paul R Audet
`
`US Surgical
`Tyco Healthcare Group
`150 Glover Avenue
`Norwalk, CT 06856 (US)
`
`(21)
`
`Appl. No.:
`
`-10/510,940
`
`22)
`
`PCT Filed:
`
`Apr. 25, 2003
`
`(60) Provisional application No. 60/375,495, filed on Apr.
`25, 2002. Provisional application No. 60/375,496,
`filed on Apr. 25, 2002.
`
`Publication Classification
`
`(51)
`
`Int. C1? wo... A6LB 17/00; A61B 18/18;
`A61D 1/00; A61B 17/08
`(52) BSC ceoseseensccens 606/1; 606/41; 606/219
`
`(57)
`
`ABSTRACT
`
`Surgical instruments are disclosed that are couplable to or
`have an end effector or a disposable loading unit with an end
`effector, and at least one micro-electromechanical system
`(MEMS)device operatively connectedto the surgical instru-
`ment for at least one of sensing a condition, measuring a
`
`IS 1005
`
`(86)
`
`PCT No.:
`
`PCT/US03/13056
`
`parameter and controlling the condition and/or parameter.
`
`IS 1005
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`US 2005/0131390 Al
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`Jun. 16, 2005
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`SURGICAL INSTRUMENTS INCLUDING MEMS
`DEVICES
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`[0001] The present application claims the benefit of and
`priority to U.S. Provisional Application Ser. No. 60/375,495
`and U.S, Provisional Application Ser. No. 60/375,496, both
`of which were filed on Apr. 25, 2002, and the entire
`disclosures of which are incorporated herein by reference.
`
`BACKGROUND
`
`[0002]
`
`1. Technical Field
`
`[0003] The present disclosure relates to surgical instru-
`ments and, more particularly to mechanical, electro-me-
`chanical and energy based surgical instruments and systems.
`
`[0004] The present disclosure relates generally to surgical
`instruments and systems and, more specifically, to surgical
`stapler instruments and systems and energy based instru-
`ments and systems, having micro-electromechanical system
`(MEMS) devices for sensing, monitoring, controlling, mea-
`suring and/or regulating conditions and/or parameters asso-
`ciated with the performance of various surgical procedures.
`
`[0005]
`
`2. Background of Related Art
`
`[0006] Surgical instruments used in open and minimally
`invasive surgery are limited in their ability to sense and/or
`control conditions and/or parameters and factors critical to
`effective operation. For example, conventional surgical
`instruments cannot measurably detect the amount of tissue
`positioned between tissue contacting surfaces of an end
`effector of the surgical instrument.
`
`are
`(MEMS)
`systems
`[0007] Micro-electromechanical
`integrated micro devices or systems combining electrical
`and mechanical components. They are fabricated using
`integrated circuitry (i.c., I.C.) batch processing techniques
`and can range in size from micrometers to millimeters.
`These micro-electromechanical systems sense, control and/
`or actuate on the micro scale, and function individuallyor in
`arrays to generate effects on the macro scale.
`
`In general, MEMS devices are complex systems
`[0008]
`which individually include one or more electrical systems
`and/or one or more micro-mechanical systems. The micro-
`mechanical systems are fabricated using many of the same
`fabrication techniques that have miniaturized electroniccir-
`cuits and made mass production of silicon integrated circuit
`chips possible.
`In particular, MEMS devices
`include
`mechanical micro-structures, micro-sensors, micro-actua-
`tors and electronics integrated in the same environment(L.e.,
`on a silicon chip) by using micro-fabrication technology.
`Micro-fabrication technology enables fabrication of large
`arrays of devices, which individually perform simple tasks
`but in combination can accomplish complicated functions.
`
`[0009] MEMSdevices are advantageous for many rea-
`sons.
`In particular, MEMS devices can be so small
`that
`hundreds can be fit
`in the same space, which perform the
`same or many different functions, as compared to a single
`macro-device, which performs a single function. Moreover,
`using I.C. batch processing techniques, hundreds to thou-
`sands of these MEMSdevices can be fabricated on a single
`silicon wafer. This mass production greatly reduces the price
`
`of individual devices. Thus, MEMS devices are relatively
`less expensive than their macro-world counterparts. In addi-
`tion, cumbersome electrical components are typically not
`needed with MEMSdevices, since the electronics can be
`placed directly on the MEMSdevice. This integration also
`has the advantage of picking up less electrical noise, thus
`improving the precision and sensitivity of sensors, As dis-
`cussed above, MEMSdevices provide some of the func-
`tionality of analytical
`instrumentation, but with vastly
`reduced cost, size, and power consumption, and an ability
`for real-time, in situ measurement.
`
`(0010] Examples of micro-electromechanical systems are
`disclosed in U.S. Pat. No. 6,127,811 to Shenoy et al.; U.S.
`Pat. No. 6,288,534 to Starkweather et al.; U.S. Pat. No.
`6,092,422 to Binnig et al.; U.S. patent application Ser. No.
`2001/0020166 PCTfiled Apr. 30, 1997, Microtechnology in
`Modern Health Care by P. Detemple, W. Ehrfeld, H. Fre-
`imuth, R. Pommersheim, and P. Wagler in Medical Device
`Technology, November 1998; and Microelectromechanical
`Systems (MEMS): ‘Technology, Design and Applications,
`coordinator: Lee, Abraham, University of California, Los
`Angeles, Department of Engineering, Information Systems
`and ‘Technical Management, Short Course Program, Engi-
`neering 823.53, May 19-22, 1997, the entire contents of each
`of which are incorporated herein by reference.
`
`[0011] Accordingly, a need exists for surgical instruments
`that can sense a multitude of parameters and factors, such as,
`for example,
`the distance between the tissue contacting
`surfaces of the surgical instrument. Such a surgical instru-
`ment can, according to the conditions sensed and/or mea-
`sured, utilize, display, record and/or automatically control
`the position of the tissue contacting surfaces of the surgical
`instrument or alert a surgeon prior to operation of the
`surgical instrument.
`
`In view of the foregoing, the needexists for the use
`[0012]
`of micro-electromechanical systems in combination with the
`surgical instruments and systems and,
`in particular in sta-
`pling instruments and energy based surgical instruments for
`monitoring, controlling and regulating conditions and/or
`parameters associated with the performance of various
`mechanical, electro-mechanical and electrosurgical proce-
`dures.
`
`SUMMARY
`
`[0013] The present invention is direct to surgical instru-
`ments including an end effector configured and adapted to
`engage tissue, and at
`least one micro-electromechanical
`system (MEMS)device operatively connected to the surgi-
`cal
`instrument
`for at
`least one of sensing a condition,
`measuring a parameter and controlling the condition and/or
`parameter adjacent the end effector. The at least one MEMS
`device is operatively connected to the end effector. The at
`least one MEMSdeviceis at least one of a pressure sensor,
`a strain sensor, a displacement sensor, an optical sensor, a
`biosensor, a temperature sensor, a torque sensor, an accel-
`erometer, a flow sensor, an electrical sensor and a magnetic
`sensor for at least one of sensing, measuring and controlling
`the associated condition and/or parameter.
`
`It is contemplated that the surgical instrument is a
`[0014]
`surgical stapler and the end effector includes a staple car-
`tridge assembly, and an anvil operatively associated with the
`staple cartridge, the staple cartridge and the anvil being
`
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`US 2005/0131390 Al
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`Jun. 16, 2005
`
`movably connected to one another to bring one into juxta-
`position relative to the other. Each of the staple cartridge and
`the anvil define tissue contacting surfaces andthe at
`least
`one MEMS deviceis operatively connectedtoat least one of
`the tissue contacting surface of the staple cartridge and the
`tissue contacting surface ofthe anvil. A plurality of MEMS
`devices are connectedto the surgical instrument, the MEMS
`devices being configured and adapted to measure distance
`between the tissue contacting surface of the staple cartridge
`assembly and the tissue contacting surface of the anvil.
`
`[0015] The MEMSdevices can be configured and adapted
`to measure the amount ofpressure applied to tissue clamped
`between the tissue contacting surface of the staple cartridge
`and the tissue contacting surface of the anvil. The MEMS
`devices are configured and adapted to measure the thickness
`of the tissue clamped between thetissue contacting surface
`of the staple cartridge and the tissue contacting surface of the
`anvil.
`
`It is envisionedthat the end effector is configured
`[0016]
`and adapted to perform an anastomosis. The surgical instru-
`ment can be a linear stapler that is adapted to perform an
`endoscopic gastrointestinal anastomosis.
`It is further con-
`templated that the surgical instrument is an annular stapler
`that is adapted to perform an end-to-end anastomosis.
`
`the end effector is a jaw
`is envisioned that
`It
`[0017]
`mechanism including a pair of jaw members pivotably
`coupled to the distal end of the elongate shaft. It is further
`envisioned that at least one MEMSdevice is provided on at
`least one ofthe pair ofjaw members.The MEMSdevicesare
`provided at least at one of a proximal end, a distal end and
`along a length of each of the pair of jaw members.
`
`It is envisioned that the jaw mechanism is config-
`[0018]
`ured and adapted to perform an electrosurgical function. The
`jaw mechanism is configured and adaptedto deliver elec-
`trosurgical energy to a target surgical site.
`
`It is further envisioned thatthe surgical instrument
`(0019]
`is operatively couplable to a robotic system, wherein the end
`effector is configured and adapted to be remotely operated
`by the robotic system.
`
`It is contemplated that the surgical instrument can
`[0020]
`include a loading unit having a proximal end and a distal
`end,
`the proximal end being selectively removably con-
`nected to the surgical instrument, the end effector is opera-
`tively connected to and part of the loading unit, and the
`loading unit includes the at least one MEMS device.
`
`[0021] The end effector can be a surgical stapler including
`a staple cartridge assembly, and an anvil operatively asso-
`ciated with the staple cartridge assembly, the staple cartridge
`assembly and the anvil being movable and juxstaposable
`relative to one another. Each of the staple cartridge assembly
`and the anvil define tissue contacting surfaces and wherein
`at least one MEMSdeviceis operatively connected to the at
`least one of the tissue contacting surface of the staple
`cartridge assembly and the tissue contacting surface ofthe
`anvil.
`
`applied to tissue and the thickness of tissue clamped
`between the tissue contacting surface of the staple cartridge
`assembly and the tissue contacting surface of the anvil.
`
`(0023] The loading unit can include an elongate shaft
`having a distal end,
`the end effector being operatively
`connected to a distal end of an elongate shaft and the staple
`cartridge and the anvil are oriented transversely with respect
`to the elongate shaft.
`
`It is envisioned that the end effector is configured
`[0024]
`and adapted to perform an anastomosis.It is further envi-
`sioned that the end effector is a jaw mechanism including a
`pair of jaw members pivotably coupledto the distal end of
`the elongate shaft. The at least one MEMSdevice is pro-
`videdon at least oneof the pair of jaw members. The MEMS
`devices can be providedat least at one of a proximal end, a
`distal end and along a length of each of the pair of jaw
`members.
`
`It is envisioned that the jaw mechanismis config-
`[0025]
`ured and adapted to perform an electrosurgical function. The
`jaw mechanism can be configured and adapted to deliver
`electrosurgical energy to the target surgical site.
`
`It is envisioned that each of the plurality of MEMS
`{0026]
`devicesis electrically connected to a control box via a lead
`wire extending from the housing.
`
`[0027] The surgical instrument can further include a con-
`trol box electrically connected to each of the plurality of
`MEMS devices via at least one wire lead.
`
`(0028] According to another aspect of the present inven-
`tion,
`there is provided a robotic system for performing
`surgical tasks a frame, a robotic arm connectedto the frame
`and movable relative to the frame, an actuation assembly
`operatively associated with the robotic arm for controlling
`operation and movement of the robotic arm, a loading unit
`including an elongate shaft operatively connected to the
`robotic arm, and an end effector operatively coupled to a
`distal end of the elongate shaft and configured to engage
`tissue, and at
`least one micro-electromechanical system
`(MEMS)device operatively connected to the loading unit
`for at least one of sensing a condition, measuring a param-
`eter and controlling the condition and/or parameter adjacent
`the end effector.
`
`Theat least one MEMSdevice is at least one of a
`[0029]
`pressure sensor, a strain sensor, a displacement sensor, an
`optical sensor, a biosensor, a temperature sensor, a torque
`sensor, an accelerometer, a flow sensor, an electrical sensor
`and a magnetic sensor for at least one of sensing, measuring
`and controlling an associated condition and/or parameter.
`
`In one embodimentthe endeffector includes a pair
`[0030]
`of jaw members movably coupled to the distal end of the
`elongate shaft.
`It is envisioned that a plurality of MEMS
`devices are provided on each of the pair of jaw members.
`Preferably, a plurality of MEMS devices are provided at
`least at one of a proximal end, a distal end and along a length
`of each of the pair of jaw members.
`
`[0022] The MEMS devices are configured and adapted to
`measure distance between the tissue contacting surface of
`the staple cartridge assembly and the tissue contacting
`surface of the anvil. The MEMS devices are configured and
`adapted to measure at least one of the amount of pressure
`
`{0031] The loading unit can be connected to the robotic
`arm via a bayonet-type connection.
`
`In another embodiment, the end effector is config-
`[0032]
`ured and adapted to perform an electrosurgical function.
`
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`US 2005/0131390 Al
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`Jun. 16, 2005
`
`the end effector is configured and adapted to
`Preferably,
`deliver electrosurgical energy to the target surgical site.
`
`the robotic system
`In yet another embodiment,
`[0033]
`includes a controller having a processor and a
`further
`receiver for receiving electrical signals transmitted from the
`actuation assembly and for controlling the operation and
`movement of the loading unit.
`
`[0034] The end effector can be a fastener applier, a sur-
`gical stapler, a vessel clip applier or a vascular suturing
`assembly.
`
`[0035] As a surgical stapler, the end effector includes a
`staple cartridge assembly andan anvil operatively associated
`with the staple cartridge assembly and in juxtaposition
`relative to the staple cartridge assembly, and wherein at least
`one MEMSdevice is operatively connected to each of the
`staple cartridge assembly and the anvil. The staple cartridge
`assembly defines a tissue contacting surface and wherein at
`least one MEMS device is operatively connected to the
`tissue contacting surface of the staple cartridge assembly.
`The anvil defines a tissue contacting surface and wherein at
`least one MEMS device is operatively connected to the
`tissue contacting surface of the staple cartridge.
`
`[0036] The MEMSdevices can be configured and adapted
`to measure distance betweenthe tissue contacting surface of
`the staple cartridge assembly and the tissue contacting
`surface ofthe anvil. Alternatively, the MEMSdevices can be
`are configured and adapted to measure the amount of
`pressure applied to tissue clamped between the tissue con-
`tacting surface of the staple cartridge assembly and the
`tissue contacting surface of the anvil.
`
`[0037] The staple cartridge assembly and the anvil are
`desirably transversely oriented with respect to the elongate
`shaft. It is envisioned that the staple cartridge assembly and
`the anvil are pivotably connected to the distal end of the
`elongate shaft.
`
`[0038] As a vessel clip applier, the end effector includes a
`body portion having a distal end and a proximal end,
`wherein the proximal end is operatively connectable to the
`robotic arm, and a jaw assembly operatively connected to
`the distal end of the body portion, wherein the jaw assembly
`includes a first and a second jaw portion. Each ofthefirst
`and the second jaw portions includes at least one MEMS
`device operatively connected thereto.
`
`[0039] As a vascular suturing assembly, the end effector
`includes an elongate body having a distal end and a proximal
`end, wherein the proximal end in operatively connectable to
`the robotic arm, and a pair of needle receiving jaws pivot-
`ably mounted to the distal end of the elongate body portion,
`the pair of needle receiving jaws being configured and
`adapted to pass a surgical needle and associated length of
`suture material therebetween. Preferably, at least one MEMS
`component is operatively connected to each of the pair of
`needle receiving jaws.
`
`[0040] According to yet another aspect of the present
`invention a loading unit for use with a surgical instrumentis
`provided and includes an elongate tubular shaft having a
`proximal end and a distal end, an end effector operably
`connected to the distal end of the tubular shaft, a connector
`for connecting the proximal end of the tubular shaft to a
`surgical instrument, and at least one micro-electromechani-
`
`cal system (MEMS)device operatively connected to the
`loading unit for at least one of sensing a condition, measur-
`ing a parameter and controlling the condition and/or param-
`eter adjacent the end effector.
`
`It is envisioned that at least one MEMSdevice is
`(0041]
`operatively connected tothe end effector.The MEMSdevice
`can be at least one of a pressure sensor, a strain sensor, a
`displacement sensor, an optical sensor, a biosensor, a tem-
`perature sensor, a torque sensor, an accelerometer, a flow
`sensor, an electrical sensor and a magnetic sensorforat least
`one of sensing, measuring and controlling an associated
`condition and/or parameter.
`
`It is contemplated that the surgical instrument is a
`(0042]
`surgical stapler and the end effector includes a staple car-
`tridge assembly and an anvil operatively associated with the
`staple cartridge,
`the staple cartridge and the anvil being
`movably connected to one another to bring one into juxta-
`position relative to the other. Each of the staple cartridge and
`the anvil define tissue contacting surfaces and the at least
`one MEMS device is operatively connectedto at least one of
`ihe tissue contacting surface of the staple cartridge and the
`tissue contacting surface of the anvil.
`
`It is envisioned that a plurality of MEMS devices
`[0043]
`connected to the surgical instrument, the MEMS devices
`being configured and adapted to measure distance between
`ithe tissue contacting surface of the staple cartridge assembly
`and the tissue contacting surface of the anvil. It is further
`envisioned that
`the MEMS devices are configured and
`adapted to measure the amount of pressure applied to tissue
`clamped between the tissue contacting surface of the staple
`cartridge and the tissue contacting surface of the anvil. It is
`still further envisioned that the MEMSdevices are config-
`ured and adapted to measure the thickness of the tissue
`clamped between the tissue contacting surface of the staple
`cartridge and the tissue contacting surface of the anvil.
`
`[0044] The end effector can be configured and adapted to
`perform an anastomosis. The surgical instrument can be a
`linear stapler that
`is adapted to perform an endoscopic
`gastrointestinal anastomosis. The surgical instrument can be
`an annular stapler that is adapted to perform an end-to-end
`anastomosis.
`
`is a jaw
`the end effector
`is envisioned that
`It
`(0045]
`mechanism including a pair of jaw members pivotably
`coupled to the distal end of the elongate shaft. At least one
`MEMSdevice can be provided on atleast one of the pair of
`jaw members. The MEMSdevices can be provided at least
`at one of a proximal end, a distal end and along a length of
`each of the pair of jaw members.
`
`It is contemplated that at least one MEMS device
`[0046]
`is a temperature sensing MEMSdevice. The temperature
`sensing MEMS deviceis positioned on and/or encapsulated
`in thermally conductive tips or elements, wherein the con-
`ductive tips are semi-rigid wires made of shape memory
`metal for a particular application, wherein the conductive
`tips are extendable out from the loading unit and into the
`tissue adjoining the loading unit in order to monitor tem-
`perature of the tissue adjoining the loading unit.
`
`[0047] According to another aspect of the present inven-
`tion, a surgical instrument for use with a loading unit that is
`operatively couplable to the surgical instrument and has an
`end effector with a pair of juxtaposable jaws for performing
`
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`US 2005/0131390 Al
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`Jun. 16, 2005
`
`the end effector having at least one
`a surgical function,
`micro-electromechanical system (MEMS) device opera-
`tively connected thereto for at least one of sensing a con-
`dition, measuring a parameter and controlling the condition
`and/or parameter adjacent
`the end effector. The surgical
`instrument includes a housing, an elongate shaft that extends
`from the housing and has a distal end operatively couplable
`to a
`loading unit of the above type, an approximation
`mechanism for approximating the pair of jaws, an actuation
`mechanism for activating the jaws to perform the surgical
`function, and at least one micro-electromechanical system
`(MEMS)device operatively connected to the surgical instru-
`ment for at
`least one of sensing a condition, measuring a
`parameter and controlling the condition and/or parameter
`adjacent the end effector and for cooperative operation with
`the at least one MEMSof the end effector.
`
`[0058] FIG. 5 is a perspective view of a surgical instru-
`ment for placing clips in laparoscopic or endoscopic proce-
`dures
`incorporating micro-electromechanical
`system
`devices in accordance with the present disclosure;
`
`[0059] FIG. 5A is an enlarged perspective view of the
`indicated region of the surgical instrument depicted in FIG.
`5;
`
`[0060] FIG. 6 is a perspective view of an energy-based
`surgical instrument incorporating micro-electromechanical
`system devices in accordance with the present disclosure;
`
`(0061] FIG. 6A is an enlarged perspective view of the
`indicated region of the surgical instrument depicted in FIG.
`6;
`
`[0062] FIG. 7 is a perspective view of a robotic system
`that employs micro-electromechanical system devices in
`accordance with the present disclosure;
`
`[0063] FIG. 8 is a block diagram illustrating the compo-
`nents of a disposable loading unit in accordance with the
`present disclosure;
`
`It is an object of the present disclosure to provide
`[0048]
`mechanical, electro-mechanical and energy based surgical
`instruments and systems having micro-electromechanical
`devices associated therewith to monitor, control, measure
`and/or regulate conditions and parameters associated with
`the performance and operation of the surgical instrument.
`[0064] FIG.9is a perspective view, with portions broken
`away, of a robotic system coupled to a loading unit, includ-
`[0049]
`It is a further object of the present disclosure to
`ing an end effector for applying surgical staples;
`provide
`improved mechanical, electro-mechanical
`and
`energy based surgical instruments and systems which are
`more effective, safer and/or easier to use than similar con-
`ventional surgical instruments and systems.
`
`[0065] FIG. 10 isa perspective view, with portions broken
`away, of a robotic system coupled to a loading unit, includ-
`ing an end effector for applying electrosurgical energy;
`
`is another object of the present disclosure to
`It
`[0050]
`improved mechanical, electro-mechanical
`and
`provide
`energy based surgical instruments and systems which better
`control the effects they have on target tissue and on the
`patient.
`
`[0051] These andother objects will be more clearly illus-
`trated below by the description of the drawings and the
`detailed description of the preferred embodiments.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0052] The accompanying drawings, which are incorpo-
`rated in and constitute a part of this specification, illustrate
`embodiments of the present disclosure and, together with the
`detailed description of the embodiments given below, serve
`to explain the principles of the disclosure.
`
`[0053] FIG. 1 is a perspective view ofa surgical stapling
`instrument
`incorporating micro-electromechanical system
`devices, in accordance with the present disclosure;
`
`FIG.2 is a partially exploded perspective view of
`[0054]
`an alternative surgical stapling instrument
`incorporating
`micro-electromechanical system devices in accordance with
`the present disclosure;
`
`[0055] FIG. 3 is a perspective view ofyet another surgical
`stapling instrument incorporating micro-electromechanical
`system devices in accordance with the present disclosure;
`
`[0056] FIG. 3A is an enlarged perspective view of a distal
`end ofthe surgical stapling instrument of FIG. 3;
`
`[0066] FIG. 11 is a perspective view, with portions broken
`away, of a robotic system coupled to a loading unit, includ-
`ing an end effector for applying vessel clips; and
`
`[0067] FIG. 12 isa perspective view, with portions broken
`away, of a robotic system coupled to a loading unit, includ-
`ing an end effector for applying a vascular suture.
`
`DETAILED DESCRIPTION OF PREFERRED
`EMBODIMENTS
`
`[0068] Preferred embodiments of the presently disclosed
`surgical instruments and systems will now be described in
`detail with reference to the drawing figures wherein like
`reference numerals identify similar or identical elements. As
`used herein and asis traditional, the term “distal” will refer
`to that portion which is further from the user while the term
`“proximal” will refer to that portion which is closer to the
`user,
`
`In accordance with the present disclosure, a micro-
`(0069]
`electromechanical system (MEMS) is used to provide highly
`miniaturized MEMS devices and/or systems capable of
`performing various functions, e.g., sensing, monitoring,
`controlling, influencing, regulating and/or measuring vari-
`ous conditions and/or parameters of surgical instruments and
`systems, such as, for example, the distance between and/or
`the pressure applied by the jaws of an end effector. In the
`present disclosure, “controlling” is meant to include influ-
`encing and/or regulating. The MEMS devices and/or sys-
`tems can also provide feedback for automatic (remote or
`manual) control of the operation of the surgical instrument.
`
`[0057] FIG. 4 is a perspective view ofstill another sur-
`gical stapling instrument
`incorporating micro-electrome-
`chanical system devices in accordance with the present
`disclosure;
`
`[0070] MEMSdevices have the required very small size,
`low power requirements, and ability to be readily integrated
`with standard electrical systems. These characteristics make
`MEMS devices ideal for incorporation into and/or on sur-
`
`17
`
`17
`
`

`

`US 2005/0131390 Al
`
`Jun. 16, 2005
`
`instruments and systems. As will be described in
`gical
`greater detail below, MEMS devices can be utilized in
`conjunction with, and incorporated into and/or on various
`portions and structural elements of surgical instruments and
`systems.
`[0071] MEMSdevices and/or systems considered to be
`within the scope of the present disclosure,
`include,
`for
`example, MEMS sensors and/or sensor devices, actuator
`MEMS devices (motors, hydraulics, pumps, ultrasonic
`devices,etc.), fluid moving and mixing components, heaters,
`and diagnostic MEMS devices for measuring physiologic
`parameters and tissue properties, such as the integrity of a
`staple line or of a repaired or joined tissue by measuring
`fluid, e.g., blood flow and/or presence, and electrical signals
`or pressure within the stapled tissue.
`[0072] Also considered within the scope of this disclosure
`are: types of MEMSdevices and/or systems used to deter-
`mine and/or measure distance including capacitive, mag-
`netic (Hall Effect sensors, for measuring the strength of the
`magnetic field between one or more magnets), light or radio
`frequency (RF) emitting/receiving, and optical fiber inter-
`ferometric sensors; types of MEMSdevices and/or systems
`used to determine and/or measure the amount ofpressure
`applied to tissue including capacitive, piezoelectric, piezore-
`sistive, resonant, light or RF emitting/receiving, and optical
`fiber interferometric sensors; and types of MEMSdevices
`and/or systems used to determine and/or measure tissue
`thickness, and to determine or measure pressure and/or to
`provide pressure data to a processor which correlates the
`pressure data with tissue thickness using a look-up table or
`other data structure. By knowing the tissue thickness, the
`surgeon can then determine the proper size of the staples
`and/or tissue gap between the tissue contacting surfaces of
`the anvil andstaple cartridge before performing the stapling
`procedure.
`[0073] While MEMS devices and/or systems are pre-
`ferred, it is within the scope of the present disclosure and
`envisioned that other types of devices and/or systems can be
`used with or without MEMS devices and/or systems to
`determine and/or measure various conditions and/or param-
`eters.
`
`the surgical instru-
`In a preferred configuration,
`[0074]
`ment can include one or more transducer MEMSdelivery
`devices and/or systems capable of being powered by a
`battery for generating RF or other types of signals. These
`transducer MEMSdelivery devices are aligned with trans-
`ducer MEMSreceiving devices capable of receiving the
`generated signals. Accordingly,
`the distance between the
`transducer MEMSdelivery and receiving devices can be
`measured by a processorcorrelating the transmission time of
`the generated RF signals with distance using a data structure.
`By knowing the distance, the processor can then compute
`the thickness ofthe tissue clamped by the surgical instru-
`ment.
`
`[0075] Further, when the transducer MEMS delivery and/
`or receiving devices press upon the tissue clamped by the
`surgical instrument, pressure from the tissue is applied to the
`transducer MEMSdelivery and/or receiving devices and/or
`systems. The transducer MEMSdelivery and/or receiving
`devices and/or systems in turn determine the applied pres-
`sure and output signals.
`[0076] Alternatively, one or more transducer MEMS
`delivery and/or receiving components, capable of generating
`
`and receiving signalsreflected off a target, can be provided
`on the anvil and/or the staple cartridge in order to determine
`the distance between the tissue contacting surfaces of the
`anvil and the staple cartridge for determining if the staple
`cartridge should be fired.
`[0077] Preferably, circuitry of the MEMSdevices and/or
`systems amplifies the signals, before being transmitted to
`standard electrical components or to the processor,
`for
`analysis using conventional algorithms implemented as a set
`of programmable instructions. The processor analyzes the
`reading to determine if the reading is within the desired
`limits for the surgical instrument and/or the current appli-
`cation. The processor can use at least one or more compara-
`tors to compare the value of the determined reading with
`stored, predetermined values.
`[0078]
`If the determined reading is within the desired
`limits for the surgical instrument, then the surgical instru-
`ment