Monitoring device degradation based on component evaluation

• US 9,737,301 B2
• Filed: 09/05/2014
• Issued: 08/22/2017
• Est. Priority Date: 09/05/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Baber, Daniel L., Swayze, Jeffrey S., Beckman, Andrew T., Houser, Kevin L.
• Primary Examiner(s): Weeks, Gloria R
• Application Number:
  US14/478,908
• Publication Number:
  US 20160066910A1
• Time in Patent Office: 1,082 Days
• Field of Search: 2271801
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61B 17/105 Wound clamp magazines for packaging sharps A61B50/3001
• CPC Class Codes: A61B 17/1155 Circular staplers comprising a plurality of staples
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00061 spectrum
• CPC Class Codes: A61B 2017/00066 intensity
• CPC Class Codes: A61B 2017/00075 Motion
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00199 : with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00393 : with means for switching between functions
• CPC Class Codes: A61B 2017/00398 : using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 : with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00725 : Calibration or performance testing
• CPC Class Codes: A61B 2017/00734 : battery operated
• CPC Class Codes: A61B 2017/00876 : magnetic
• CPC Class Codes: A61B 2017/07214 : Stapler heads
• CPC Class Codes: A61B 2017/07257 : characterised by its anvil
• CPC Class Codes: A61B 2017/07271 : characterised by its cartridge
• CPC Class Codes: A61B 2017/07285 : characterised by its cutter
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2018/00648 : using more than one sensed parameter
• CPC Class Codes: A61B 2090/037 : with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/064 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/0803 : Counting the number of times an instrument is used
• CPC Class Codes: A61B 2090/0806 : Instrument detectors with a removable part, e.g. working tip
• CPC Class Codes: A61B 2090/0807 : Indication means
• CPC Class Codes: A61B 2090/0808 : for indicating correct assembly of components, e.g. of the surgical apparatus
• CPC Class Codes: A61B 2090/081 : for contamination or dirt
• CPC Class Codes: A61B 2090/0811 : for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/0814 : Preventing re-use
• CPC Class Codes: A61B 2090/0818 : Redundant systems, e.g. using two independent measuring systems and comparing the signals
• CPC Class Codes: A61B 2090/304 : using chemi-luminescent materials
• CPC Class Codes: A61B 2090/309 : using white LEDs
• CPC Class Codes: A61B 2090/702 : Devices for testing the cleaning process, e.g. test soils
• CPC Class Codes: A61B 2505/05 : Surgical care
• CPC Class Codes: A61B 2562/0223 : Magnetic field sensors
• CPC Class Codes: A61B 2562/0247 : Pressure sensors
• CPC Class Codes: A61B 2562/0257 : Proximity sensors
• CPC Class Codes: A61B 2562/0261 : Strain gauges
• CPC Class Codes: A61B 2562/029 : Humidity sensors
• CPC Class Codes: A61B 2562/043 : in a linear array
• CPC Class Codes: A61B 2562/06 : Arrangements of multiple sensors of different types
• CPC Class Codes: A61B 2562/223 : Optical cables therefor
• CPC Class Codes: A61B 5/067 : using accelerometers or gyroscopes
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6847 : mounted on an invasive device
• CPC Class Codes: A61B 5/6885 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4483 : characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/70 : Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61B 90/90 : Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/92 : coded with colour
• CPC Class Codes: A61B 90/94 : coded with symbols, e.g. text
• CPC Class Codes: A61B 90/96 : using barcodes
• CPC Class Codes: A61B 90/98 : using electromagnetic means, e.g. transponders
• CPC Class Codes: G01R 33/072 : Constructional adaptation of the sensor to specific applications
• CPC Class Codes: G06F 1/266 : Arrangements to supply power to external peripherals either directly from the computer or under computer control, e.g. supply of power through the communication port, computer controlled power-strips
• CPC Class Codes: G06F 1/28 : Supervision thereof, e.g. detecting power-supply failure by out of limits supervision
• CPC Class Codes: G06F 1/30 : Means for acting in the event of power-supply failure or interruption, e.g. power-supply fluctuations for resetting only G06F1/24
• CPC Class Codes: G06F 1/305 : in the event of power-supply fluctuations
• CPC Class Codes: G06F 1/3215 : Monitoring of peripheral devices
• CPC Class Codes: G06F 1/3287 : by switching off individual functional units in the computer system
• CPC Class Codes: H02H 1/06 : Arrangements for supplying operative power power supply arrangements in general G05F, H02M
• CPC Class Codes: H02H 11/002 : in case of inverted polarity or connection; with switching for obtaining correct connection
• CPC Class Codes: H02H 3/02 : Details
• CPC Class Codes: H02H 3/04 : with warning or supervision in addition to disconnection, e.g. for indicating that protective apparatus has functioned watching of pilot wires H02H1/0084; protection of protective arrangements H02H7/008; indication of the state of electronic switches H03K17/18
• CPC Class Codes: H02H 3/06 : with automatic reconnection
• CPC Class Codes: H02H 3/087 : for dc applications
• CPC Class Codes: H02H 3/18 : responsive to reversal of direct current
• CPC Class Codes: H02H 3/202 : for dc systems
• CPC Class Codes: H02H 3/207 : also responsive to under-voltage window comparators for indication G01R19/165
• CPC Class Codes: H02H 3/243 : for DC systems
• CPC Class Codes: H02H 7/20 : for electronic equipment for converters H02H7/10; for electric measuring instruments G01R1/36; for dc voltage or current semiconductor regulators G05F1/569; for amplifiers H03F1/52; for electronic switching circuits H03K17/08
• CPC Class Codes: H02J 1/001 : Hot plugging or unplugging of load or power modules to or from power distribution networks
• CPC Class Codes: H02J 1/10 : Parallel operation of dc sources
• CPC Class Codes: H02J 2310/23 : The load being a medical device, a medical implant, or a life supporting device
• CPC Class Codes: H02J 7/0068 : Battery or charger load switching, e.g. concurrent charging and load supply H02J7/0013 takes precedence
• CPC Class Codes: Y02D 10/00 : Energy efficient computing, e.g. low power processors, power management or thermal management

Abstract

A surgical instrument is disclosed. The surgical instrument includes a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw between an open configuration and an approximated configuration. In addition the surgical instrument includes a cutting member movable during a firing stroke to cut tissue captured between the first jaw and the second jaw, the cutting member comprising a cutting surface at a distal portion thereof. In addition, the surgical instrument further includes a sensing module operable to measure a characteristic of the cutting surface.

Claims

1. A surgical instrument, comprising:

a first jaw;

a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other one of the first jaw and the second jaw between an open configuration and an approximated configuration to capture tissue therebetween;

a cutting member movable during a firing stroke to cut the tissue captured between the first jaw and the second jaw in the approximated configuration, the cutting member comprising a cutting surface at a distal portion thereof;

a sensing module operable to measure a characteristic of the cutting surface, wherein the sensing module comprises;

an optical sensor that defines an optical sensing region; and

a light source operable to emit a light; and

a cleaning mechanism;

wherein the cutting surface reflects the light emitted by the light source, and wherein the optical sensor is operable to measure at least one intensity of the reflected light while the cutting surface is advanced through the optical sensing region, and wherein the cleaning mechanism is configured to clean the cutting surface before the cutting surface enters the optical sensing region.

2. The surgical instrument of claim 1, wherein the second jaw comprises a staple cartridge, the staple cartridge comprising:

a cartridge body; and

a plurality of staples deployable from the cartridge body during the firing stroke, wherein the plurality of staples are deployable into the tissue captured between the first jaw and the second jaw.

3. The surgical instrument of claim 2, wherein the sensing module comprises an optical sensor housed within the cartridge body.

4. The surgical instrument of claim 1, further comprising:

a processor; and

a memory coupled to the processor to store program instructions, wherein the program instructions cause the processor to evaluate sharpness of the cutting surface.

5. A surgical instrument, comprising:

an anvil;

a staple cartridge, wherein at least one of the anvil and the staple cartridge is movable relative to the other one of the anvil and the staple cartridge between an open configuration and an approximated configuration to capture tissue therebetween; and

a cutting member including a cutting surface at a distal portion of the cutting member, wherein the cutting member is movable relative to the staple cartridge to cut the tissue captured between the anvil and the staple cartridge in the approximated configuration; and

a cutting surface sharpness testing module, comprising;

a cutting surface sharpness testing member, wherein the cutting surface is movable along a path, wherein the cutting surface sharpness testing member is configured to interrupt the path of the cutting surface;

a processor; and

a memory coupled to the processor to store program instructions, wherein the program instructions cause the processor to evaluate sharpness of the cutting surface based upon at least one measurement received by the processor, wherein the at least one measurement is detectable while the cutting surface is in contact with the cutting surface sharpness testing member.

6. The surgical instrument of claim 5, wherein the at least one measurement comprises a time measurement.

7. The surgical instrument of claim 5, wherein the at least one measurement comprises a force measurement.

8. The surgical instrument of claim 7, wherein the cutting surface sharpness testing module comprises a load cell, and wherein the load cell is operable to measure the force measurement.

9. The surgical instrument of claim 7, wherein the program instructions, when executed from the memory, cause the processor to alert a user when the force measurement exceeds a threshold.

10. The surgical instrument of claim 5, wherein the staple cartridge comprises:

a cartridge body;

a plurality of staples deployable from the cartridge body during a firing stroke; and

an elongate slot extending longitudinally along a length of the cartridge body, wherein the path of the cutting surface extends at least partially through the elongate slot, and wherein the cutting surface sharpness testing member is disposed over a proximal portion of the elongate slot.

11. The surgical instrument of claim 10, wherein the cartridge body comprises a cartridge deck, and wherein the cutting surface sharpness testing member is at least partially attached to the cartridge deck.

12. A surgical instrument, comprising:

an anvil;

a staple cartridge, wherein at least one of the anvil and the staple cartridge is movable relative to the other one of the anvil and the staple cartridge between an open configuration and an approximated configuration;

a cutting member including a cutting surface at a distal portion of the cutting member, wherein the cutting member is movable relative to the staple cartridge to cut tissue captured between the anvil and the staple cartridge; and

a cutting surface sharpness testing module, comprising;

tissue thickness sensing means for sensing thickness of the tissue captured between the anvil and the staple cartridge;

tissue load sensing means for sensing resistance of the tissue captured between the anvil and the staple cartridge to the cutting surface;

a processor; and

a memory that stores program instructions, wherein the program instructions cause the processor to;

receive at least one tissue thickness measurement of the tissue captured between the anvil and the staple cartridge from the tissue thickness sensing means;

receive at least one resistance measurement from the tissue load sensing means, the at least one resistance measurement detectable while the cutting surface is in contact with the tissue captured between the anvil and the staple cartridge; and

determine whether the at least one resistance measurement exceeds a threshold resistance value associated with the at least one tissue thickness measurement.

13. The surgical instrument of claim 12, wherein the program instructions cause the processor to alert a user when that at least one resistance measurement exceeds the threshold associated with the at least one tissue thickness measurement.

14. The surgical instrument of claim 12, further comprising a firing lockout mechanism, wherein the program instructions cause the processor to activate the firing lockout mechanism when the at least one resistance measurement exceeds the threshold associated with the at least one tissue thickness measurement.

15. The surgical instrument of claim 12, wherein the memory stores a database, the database comprising:

a plurality of threshold resistance values comprising the threshold resistance value; and

a plurality of ranges of tissue thicknesses each corresponding to one of the plurality of threshold resistance values, wherein the program instructions cause the processor to;

determine a range from the plurality of ranges of tissue thicknesses, the range comprising the at least one tissue thickness measurement, and

compare the at least one resistance measurement to the threshold resistance value associated with the range of tissue thicknesses comprising the at least one tissue thickness measurement.