Adjunct with integrated sensors to quantify tissue compression

• US 9,724,094 B2
• Filed: 09/05/2014
• Issued: 08/08/2017
• Est. Priority Date: 09/05/2014
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon, LLC (Johnson & Johnson)
• Inventors: Shelton, IV, Frederick E., Beckman, Andrew T., Baber, Daniel L., Swayze, Jeffrey S.
• Primary Examiner(s): CHUKWURAH, NATHANIEL C
• Application Number:
  US14/479,119
• Publication Number:
  US 20160066914A1
• Time in Patent Office: 1,068 Days
• Field of Search: 2271791, 2271801, 606220
• 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 with imaging means A61B90/37, A61B34/20
• 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 for prosthetic joint-implanting tools A61F2/4603
• 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 stapling system including a shaft assembly transmits actuation motions from an actuator and an end effector compresses and staples tissue. The end effector comprises an elongated channel; an anvil having a staple forming surface is moveable relative to the elongated channel between an open position and a closed position; and a staple cartridge removably positioned within the elongated channel. The staple cartridge comprises a body having a tissue contacting surface in a confronting relationship with the staple forming surface; a plurality of staple drivers within the cartridge body each supporting a staple; and a tissue thickness compensator positionable between the anvil and the cartridge, the tissue thickness compensator is captured by the staples and assumes different compressed heights within the different staples. The tissue compensator comprises first conductive elements. The system determines properties of tissue compressed between the anvil and the cartridge.

Claims

1. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the first conductive elements comprise a wire mesh;

wherein the system is operable to determine a property of tissue compressed between the anvil and the staple cartridge.

2. The system of claim 1, the first conductive elements comprising one or more wire coils.

3. The system of claim 2, the anvil further comprising one or more eddy current sensors operable to capacitively couple with the one or more wire coils to indicate an amount of compressed tissue in any area of the end effector.

4. The system of claim 2, the staple cartridge further comprising one or more eddy current sensors operable to capacitively couple with the one or more wire coils to indicate an amount of compressed tissue in any area of the end effector.

5. The system of claim 1, the anvil comprising one or more first eddy current sensors, the staple cartridge further comprising one or more second eddy current sensors, the first conductive elements comprising one or more first coils of wire and one or more second coils of wire, wherein the first eddy current sensors capacitively couple with the first coils of wire and the second eddy current sensors capacitively couple with the second coils of wire.

6. The system of claim 1, the anvil comprising second conductive elements operable to capacitively couple with the wire mesh to indicate an amount of compressed tissue in any area of the end effector.

7. The system of claim 1 the staple cartridge further comprising second conductive elements operable to capacitively couple with the wire mesh to indicate an amount of compressed tissue in any area of the end effector.

8. The system of claim 1 wherein staple penetration into the wire mesh indicates a location of the staple or quality of the staple form.

9. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements;

wherein the system is operable to determine a property of tissue compressed between the anvil and the staple cartridge, wherein the first conductive elements comprise a first array of conductors and a second opposing array of conductors, and wherein the first array of conductors are separated from the second array of conductors by an insulator.

10. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements;

wherein the system is operable to determine a property of tissue compressed between the anvil and the staple cartridge, wherein the first conductive elements comprise a first set of conductors and a second set of conductors, and wherein the first set of conductors are configured to apply small pulses of current at predetermined frequencies to the tissue and the second set of conductors are configured to detect the response of the tissue to the pulses of current.

11. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements wherein the system is operable to determine a property of tissue compressed between the anvil and the staple cartridge, and wherein the first conductive elements comprise conductive material embedded in the tissue compensator, and the anvil further comprises second conductive elements operable to electrically couple with the first conductive elements and indicate an amount of compressed tissue in any area of the end effector.

12. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the system is operable to determine a property of tissue compressed between the anvil and the staple cartridge, wherein the first conductive elements comprise conductive material embedded in the tissue compensator, and wherein the staple cartridge further comprises second conductive elements operable to electrically couple with the first conductive elements to indicate an amount of compressed tissue in any area of the end effector.

13. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the first conductive elements comprise a wire mesh, wherein the anvil comprises second conductive elements operable to couple with the first conductive elements to detect inadequate coupling between the first and second conductive elements, and wherein the system is operable to detect the location of the tissue compensator with respect to the end effector.

14. The system of claim 13, the anvil further comprising second conductive elements operable to couple with the first conductive elements to detect inadequate coupling between the first and second conductive elements.

15. The system of claim 14, wherein the first conductive elements are located at edge locations of the tissue compensator.

16. The system of claim 13, the staple cartridge further comprising second conductive elements operable to couple with the first conductive elements to detect inadequate coupling between the first and second conductive elements.

17. The system of claim 16, wherein the first conductive elements are located at edge locations of the tissue compensator.

18. The system of claim 13, wherein the first conductive elements comprise an electrical pattern to store data, the system operable to detect the electrical pattern.

19. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil; and

a plurality of staple drivers within the cartridge body each supporting a staple; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the system is operable to detect the location of the tissue compensator with respect to the end effector, wherein the staple cartridge further comprises second conductive elements operable to couple with the first conductive elements to detect inadequate coupling between the first and second conductive elements, and wherein the first conductive elements are a wire mesh.

20. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil;

a slot defined within the cartridge body; and

a plurality of staple drivers within the cartridge body each supporting a staple;

a cutting member operable to be engaged with the actuation motions such that the cutting member can be moved from a proximal end of the slot to a distal end of the slot; and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the first conductive elements comprise an array of segments arranged perpendicular to the slot, wherein the segments have a first end on a first side of the slot and a second end on a second side of the slot, wherein the segments are connected in parallel at their first ends, wherein the cutting member is configured to cut the segments as the cutting member moves, wherein a change in an electrical property of the first conductive elements indicates the position of the cutting member; and

wherein the system is operable to determine the location in the slot of the cutting member.

21. The system of claim 20, the first conductive elements comprising an array of segments arranged perpendicular to the slot, the segments having a first end on a first side of the slot and a second end on a second side of the slot, the segments connected in parallel at their first ends, wherein the cutting member is configured to cut the segments as the cutting member moves, and wherein a change in the electrical property of the first conductive elements indicates the position of the cutting member.

22. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil;

a slot defined within the cartridge body; and

a plurality of staple drivers within the cartridge body each supporting a staple;

a cutting member operable to be engaged with the actuation motions such that the cutting member can be moved from a proximal end of the slot to a distal end of the slot and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the first conductive elements comprise an array of segments perpendicular to the slot, wherein the segments have a first end on a first side of the slot and a second end on a second side of the slot, wherein the segments have a first parallel connect at their first ends and a second parallel connect at their second ends, wherein the cutting member is configured to cut the segments as the cutting member moves, wherein a change in an electrical property of the first conductive elements indicates the position of the cutting member; and

wherein the system is operable to determine the location in the slot of the cutting member.

23. A surgical stapling system comprising:

an elongated shaft assembly configured to transmit actuation motions from an actuator;

an end effector for compressing and stapling tissue, the end effector operably coupled to the elongated shaft, the end effector comprising;

an elongated channel;

an anvil having a staple forming surface thereon, the anvil moveable relative to the elongated channel between an open position and a closed position; and

a staple cartridge removably positioned within the elongated channel, the staple cartridge comprising;

a cartridge body having a tissue contacting surface in a confronting relationship with the staple forming surface of the anvil;

a slot defined within the cartridge body; and

a plurality of staple drivers within the cartridge body each supporting a staple;

a cutting member operable to be engaged with the actuation motions such that the cutting member can be moved from a proximal end of the slot to a distal end of the slot and

a tissue thickness compensator operable to be positioned between the anvil and the staple cartridge, the tissue thickness compensator configured to be captured by the staples and assume different compressed heights within the staples, the tissue compensator comprising first conductive elements, wherein the first conductive elements comprise a wire mesh, wherein the cutting member is configured to cut the wire mesh as it advances along the slot, wherein a change in an electrical property of the mesh as it is cut indicates the position of the cutting member; and

wherein the system is operable to determine the location in the slot of the cutting member.