POWERED SURGICAL DEVICES HAVING TISSUE SENSING FUNCTION
20210212681 ยท 2021-07-15
Inventors
Cpc classification
A61B2017/0046
HUMAN NECESSITIES
A61B17/0682
HUMAN NECESSITIES
A61B2090/064
HUMAN NECESSITIES
A61B2017/00398
HUMAN NECESSITIES
International classification
Abstract
A surgical device includes an end effector and a handle assembly. The end effector includes a body portion and a tool assembly disposed at a distal end of the body portion. The tool assembly is insertable into tissue and includes an anvil assembly, a cartridge assembly, and a sensor disposed on an outer surface of the anvil assembly or the cartridge assembly for measuring a preselected mechanical property of the tissue. The handle assembly is operably coupled to the end effector. The handle assembly includes a power-pack including a controller circuit board configured to receive sensor data of the sensor corresponding to the preselected mechanical property and to control a function of the end effector in response to the sensor data.
Claims
1-20. (canceled)
21. A surgical device, comprising: an end effector including an anvil assembly and a cartridge assembly, the anvil and cartridge assemblies each having a tissue contacting surface and an outer surface disposed on opposed sides of the anvil and cartridge assemblies, the anvil assembly including sensors disposed on the outer surface thereof, at least one of the sensors being a first sensor configured to detect a mechanical property of the anvil assembly, and at least one of the sensors being a second sensor configured to measure a physiological parameter of tissue.
22. The surgical device according to claim 21, wherein the first sensor is a strain gauge.
23. The surgical device according to claim 21, wherein the first sensor is selected from the group consisting of a piezoelectric sensor, an accelerometer, a pressure sensor, and a laser.
24. The surgical device according to claim 21, wherein the second sensor is selected from the group consisting of a conductivity sensor, an optical sensor, a biochemical sensor, an acoustic sensor, and a light sensor.
25. The surgical device according to claim 21, wherein the anvil assembly includes an anvil plate and an anvil cover having an inner surface secured over the anvil plate, the outer surface of the anvil assembly defined on the anvil cover and the tissue contacting surface of the anvil assembly defined on the anvil plate.
26. The surgical device according to claim 25, wherein a sensor is disposed on the inner surface of the anvil cover.
27. The surgical device according to claim 21, wherein the cartridge assembly includes a staple cartridge and a cartridge carrier having an inner surface defining an elongated support channel dimensioned to selective receive the staple cartridge therein.
28. The surgical device according to claim 27, wherein a sensor is disposed on the inner surface of the cartridge carrier.
29. The surgical device according to claim 21, wherein the end effector further includes a microcontroller and a memory, the microcontroller electrically coupled to the sensors and the memory, the microcontroller configured to receive and measure electrical signals from the sensors and record sensor data in the memory.
30. The surgical device according to claim 29, further comprising: a handle assembly operably coupled to the end effector, the handle assembly including a power-pack having a controller circuit board configured to receive and process the sensor data, and control a function of the end effector in response to the processed sensor data.
31. The surgical device according to claim 30, further comprising: an adapter assembly interconnecting the handle assembly and the end effector.
32. The surgical device according to claim 21, wherein the end effector includes a knife operably associated with and slidably disposed between the anvil and cartridge assemblies, the knife having a sensor disposed thereon for measuring a property of tissue.
33. The surgical device according to claim 32, wherein the sensor on the knife is disposed on an outer surface of a blade of the knife.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the present disclosure are described herein with reference to the accompanying drawings, wherein:
[0017]
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[0020]
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[0022]
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[0027]
DETAILED DESCRIPTION OF EMBODIMENTS
[0028] Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. Throughout this description, the term proximal refers to a portion of a device, or component thereof, that is closer to a user, and the term distal refers to a portion of the device, or component thereof, that is farther from the user.
[0029] Turning now to
[0030] The handle assembly 100, the adapter assembly 200, and the end effector 300 will only further be described to the extent necessary to disclose aspects of the present disclosure. For a detailed description of the structure and function of exemplary handle and adapter assemblies, and end effectors, reference may be made to commonly owned U.S. Patent Publication No. 2016-0310134 (the '134 Publication), the entire contents of which are incorporated herein by reference.
[0031] With reference now to
[0032] As shown in
[0033] The main controller circuit board 126a includes a 1-wire communication system including three 1-wire buses which enables communication between the power-pack 120 and the battery 122, the power-pack 120 and the adapter assembly 200 (
[0034] The power-pack 120 further includes motors 128 (e.g., a first motor 128a, a second motor 128b, and a third motor 128c) each electrically connected to the controller circuit board 126 and the battery 122. The motors 128a, 128b, 128c are disposed between the motor controller circuit board 126a and the main controller circuit board 126b. Each of the motors 128a, 128b, 128c includes a respective motor shaft 129a, 129b, 129c extending therefrom for transmitting rotative forces or torque.
[0035] Each of the motors 128a, 128b, 128c is controlled by a respective motor controller (not shown) disposed on the motor controller circuit board 126a, and each motor controller is electrically coupled to a main controller or master chip disposed on the main controller circuit board 126b via the first ribbon cable 126c which connects the motor controller circuit board 126a with the main controller circuit board 126b. The master chip is also coupled to memory, which is also disposed on the main controller circuit board 126b.
[0036] Each of the motor 128a, 128b, 128c is supported on a motor bracket 130 such that the motor shafts 129a, 129b, 129c are rotatably disposed within respective apertures of the motor bracket 130. The motor bracket 130 rotatably supports three rotatable drive connector sleeves 132a, 132b, 132c that are keyed to respective motor shafts 129a, 129b, 129c of the motors 128a, 128b, 128c. The drive connector sleeves 132a, 132b, 132c non-rotatably receive proximal ends of respective coupling shafts 142a, 142b, 142c of a plate assembly 140 of the handle assembly 100, when the power-pack 120 is disposed within the outer shell housing 112.
[0037] The motor bracket 130 also supports an electrical adapter interface receptacle 134. The electrical adapter interface receptacle 134 is in electrical connection with the main controller circuit board 126b by a second ribbon cable 126d. The electrical adapter interface receptacle 134 defines a plurality of electrical slots for receiving respective electrical contacts or blades extending from a pass-through connector 144 of the plate assembly 140 of the handle assembly 100.
[0038] Rotation of the motor shafts 129a, 129b, 129c by respective motors 128a, 128b, 128c function to drive shafts and/or gear components of the adapter assembly 200 in order to perform the various operations of the surgical device 10. In particular, the motors 128a, 128b, 128c of the power-pack 120 are configured to drive shafts and/or gear components of the adapter assembly 200 in order to selectively move a tool assembly 320 (
[0039] Referring now to
[0040] Rotatable connector sleeves 210a, 210b, 210c are disposed within the outer knob housing 202 and are configured and adapted to mate, through a keyed and/or substantially non-rotatable interface, with respective coupling shafts 142a, 142b, 142c (
[0041] Adapter assembly 200 includes a plurality of force/rotation transmitting/converting assemblies (not shown), each disposed within an inner housing assembly (not shown) of the outer knob housing 202 and the outer tube 204. Each force/rotation transmitting/converting assembly is configured and adapted to transmit/convert a speed/force of rotation (e.g., increase or decrease) of the coupling shafts 142a, 142b, 142c (
[0042] Specifically, each force/rotation transmitting/converting assembly is configured and adapted to transmit or convert a rotation of the first, second and third coupling shafts 142a, 142b, 142c of the handle assembly 100 into: axial translation of an articulation bar (not shown) of the adapter assembly 200 to effectuate articulation of the end effector 300 (
[0043] As shown in
[0044] The circuit board 224 includes a memory configured to store data relating to the adapter assembly 200 such as unique ID information (electronic serial number); type information; status information; whether an end effector has been detected, identified, and verified; usage count data; and assumed autoclave count data. The electrical assembly 220 serves to allow for calibration and communication of information (e.g., identifying information, life-cycle information, system information, force information) to the main controller circuit board 126b (
[0045] With reference now to
[0046] The switch actuator 240 is slidingly disposed within the distal portion 204a of the outer tube 204. The switch actuator 240 is longitudinally movable between proximal and distal portions, and toggles the switch 230 during movement between the proximal and distal positions.
[0047] As shown in
[0048] Referring now to
[0049] The end effector 300 includes a proximal body portion 310 and a tool assembly 320. The proximal body portion 310 is releasably attachable to the distal cap 206 (
[0050] As shown in
[0051] The proximal body portion 310 of the end effector 300 includes a drive assembly 315 operably associated with and slidably disposable between the anvil and cartridge assemblies 330, 340 for driving the ejection of staples (not shown) from the cartridge assembly 340 of the tool assembly 320, and an articulation link (not shown) for effectuating an articulation of the tool assembly 320. The drive assembly 315 includes an elongated drive beam 316 and an I-beam 317 having a central wall portion 318 including a knife 319. The knife 319 can travel through the longitudinal slots 332a, 342a defined in the tissue contacting surfaces 332, 342 of the anvil and cartridge assemblies 330, 340, between the staple forming pockets 332b and the retention slots 345 also defined in the respective tissue contacting surfaces 332, 342, to longitudinally cut stapled tissue.
[0052] The anvil assembly 330 and the cartridge assembly 340 include respective tissue contacting surfaces 332, 342 between which tissue is grasped, and respective outer surfaces 334, 344. The anvil assembly 330 includes one or more sensors 336 disposed on the outer surface 334 thereof. The sensors 336 may be any sensor configured to detect a mechanical property of anvil assembly 330 such that a behavior of the tissue (e.g., target tissue) may be monitored while under a loading condition (e.g., during clamping and/or firing of the end effector 300). The sensors 336 may be, for example, strain gauges, piezoelectric sensors (e.g., films, cables crystals, etc.), accelerometers, pressure sensors, lasers (e.g., for displacement measurements), and combinations thereof that detect stress, relaxation, strain, creep, mechanical energy, and/or mechanical power, etc., input into the tool assembly 320, and in turn, into the tissue clamped therein.
[0053] Additionally, and in accordance with the present disclosure, one or more of the sensors 336 may be configured to measure a physiological parameter of tissue adjacent to the tool assembly 320. Such sensors include, for example, a conductivity/resistivity sensor; an optical sensor such as a CCD or CMOS image sensor; an electrical, electrochemical, or chemical sensor for measuring characteristics such as impedance, temperature, or pH; a biochemical sensor; an acoustic sensor such as an ultrasound; a light sensor such as a photodiode; and other sensors within the purview of those skilled in the art for measuring and/or identifying a physiological condition or state of the target tissue and/or the adjacent tissue.
[0054] The sensors 336 are shown disposed in spaced relation relative to each other linearly along the outer surface 334 of the anvil assembly 330. It should be understood that the number of sensors 336 and the configuration of the sensors 336 on the outer surface 334 of the anvil assembly 300 may be modified. For example, the sensors 336 may measure the same mechanical property in replicates (e.g., duplicate or triplicate) to improve and/or verify the accuracy of measurement. As another example, the sensors 336 may detect multiple mechanical properties to provide more information about the behavior of the tissue. As yet another example, the sensors 336 may be spaced along the entire length of the outer surface 334 of the anvil assembly 330 to monitor characteristics and mechanical properties of the tool assembly 320, for different tissue clamped in tool assembly 320, and in turn, corresponding behavior of the target tissue along the length of the target tissue.
[0055] Sensors 336 (not explicitly shown) may additionally or alternatively be disposed on the inner surface 331c of the anvil assembly 330 in a similar manner as the sensors 336 disposed on the outer surface 334 of the anvil assembly 330, as discussed above. Positioning the sensors 336 on the inner and/or outer surfaces 331c, 334 of the anvil assembly 330 allows for measurements of the desired metric(s) of the tissue disposed within the tool assembly 320 of the end effector 300 indirectly, without having to touch the tissue directly with the sensors 336. For example, as discussed above, the sensors 336 may be strain gauges configured to measure deformation of the anvil assembly 330 due to the force exerted on the anvil assembly 330 by the tissue compressed within the tool assembly 320. Accordingly, varying the position of the sensors 336 about the tool assembly 320 and/or increasing the number of sensors 336 disposed thereon may improve resolution of the tissue measurements (e.g., tissue compression forces).
[0056] It is also contemplated to additionally or alternatively include sensor(s) 336 on the inner and/or outer surfaces 341c, 344 of the cartridge assembly 340 (not explicitly shown), and/or on the knife 319 (
[0057] It is envisioned that sensor(s) 336 may also be disposed on the tissue contacting surface 332, 342 of the anvil and/or cartridge assemblies 330, 340. The sensors 336 (not explicitly shown) may be positioned on the tissue contacting surface 332, 342 such that they do not interfere with deployment of the knife and/or staples (e.g., without covering the longitudinal slot 332a and the staple forming pockets 332b of the anvil assembly 330). For example, the sensors 336 may be positioned at proximal and distal end portions of the tissue contacting surface 332 of the anvil assembly 330, outside the area of the tissue contacting surface 332 including the staple forming pockets 332b. Other configurations are envisioned for the positioning or placement of sensor(s) 336, such as adjacent the longitudinal slot 332a and/or between the staple forming pockets 332b in a linear or staggered spaced arrangement along the length of the tissue contacting surface 332.
[0058] Sensors 336 disposed on the tissue contacting surface 332, 342 of the anvil and/or cartridge assemblies 330, 340, as well as on the outer surface 334, 344 of the anvil and/or cartridge assemblies 330, 340 may cooperate together (e.g., direct and indirect tissue contact measurements) to aid in detecting properties, conditions, and/or behaviors of the end effector 300, the tissue, and/or the tissue environment. For example, sensors (not explicitly shown) disposed on the tissue contacting surface 332, 342 of the anvil and/or cartridge assemblies 330, 340 may be configured to measure properties of the tissue clamped between the anvil and/or cartridge assemblies 330, 340 (e.g., tissue thickness or clamping force), and the sensors 336 disposed on the outer surface 334, 344 of the anvil and/or cartridge assembly 330, 340 may be configured to measure properties of the surrounding tissue (e.g., mechanical response to clamping) to determine deployment timing and completion of staple formation.
[0059] With continued reference to
[0060] As shown in
[0061] The memory chip 354 is also configured to store one or more parameters related to the end effector 300. The parameters include, for example, a serial number of a loading unit, a type of loading unit, a size of loading unit, a staple size, information identifying whether the loading unit has been fired, a length of a loading unit, maximum number of uses of a loading unit, and combinations thereof. The memory chip 354 is configured to communicate to the handle assembly 100 the sensor data and/or parameters of the end effector 300, as described above, via the electrical contacts 356, upon engagement of the end effector 300 with the adapter assembly 200, as described below. The sensors 336 may send analog signals (e.g., along a wire), or use wireless communication, to send the sensor data to the microcontroller 350. The sensor data and/or parameters may be processed in the controller circuit board 126 of the handle assembly 100, or in some other remote processor or the like.
[0062] The electrical contacts 356 are disposed on an outer surface of the inner housing 314 and are configured to engage the electrical contacts 258 (
[0063] In operation, upon initial insertion of the end effector 300 into the adapter assembly 200, the switch actuator 240 remains disengaged from the switch 230. With the switch 230 in the unactuated state, there is no electrical connection established between the memory 352 of the end effector 300 and the controller circuit board 126 of the handle assembly 100. Upon a rotation of the end effector 300, the end effector 300 engages the adapter assembly 200 and moves the switch actuator 240 distally, which toggles the switch 230 to actuate the switch 230. With the switch 230 in the actuated state, an electrical connection is established between the memory chip 354 of the end effector 300 and the controller circuit board 126 of the handle assembly 100, through which information about the end effector 300 is communicated to the controller circuit board 126 of the handle assembly 100. Upon both the actuation of the switch 230 and the establishment of a wiping contact between the electrical contacts 356 of the inner housing 314 of the end effector 300 and the electrical contacts 258 of the annular member 250 of the adapter assembly 200, the handle assembly 100 is able to detect that the end effector 300 is engaged with the adapter assembly 200 and to identify one or more parameters of the end effector 300 and/or to process the sensor data from the sensors 336 of the end effector 300. Accordingly, the power-pack 120 is capable of reading the information stored in the memory 352 of the end effector 300 via the adapter assembly 200.
[0064] With the end effector 300 engaged to the adapter assembly 200, the sensors 336 of the end effector 300 detect and/or measure mechanical behaviors and/or properties of the tool assembly 320 (specifically anvil assembly 330) in real time during a surgical procedure. The sensor data is transmitted to the microcontroller 350 for processing, stored in the memory 352, and ultimately transferred to the power-pack 120 of the handle assembly 100 via the adapter assembly 200 along the 1-wire bus, or other communication protocol. The power-pack 120 collects and processes the sensor data in real time, and transmits electrical control signals to the motors 128a, 128b, 128c of the handle assembly 100 to control a function of the surgical device 10 (e.g., to change an operating parameter, such as pre-compression time, speed of firing, etc.). The mechanical behaviors and/or properties of the tool assembly 320 detected/measured by sensors 336 are then converted and/or correlated to real time, or near real time, behaviors and/or properties of the target tissue (clamped in the tool assembly 320).
[0065] For example, in a method of using the surgical device 10 of the present disclosure, the end effector 300 is placed at a desired surgical site and the anvil assembly 330 and the cartridge assembly 340 are approximated and clamped to grasp target tissue between the respective tissue contacting surfaces 332, 342 of the anvil and cartridge assemblies 330, 340. One or more of the sensors 336 are strain gauges for measuring stress in the anvil and cartridge assemblies 330, 340, and in turn, for measuring stress in the target tissue, by monitoring a change in resistance through the strain gauges. The sensor 336 measure a deformation of the anvil assembly 330 and/or the cartridge assembly 340, or any portion(s) thereof, due to forces exerted thereon by compressed tissue in the end effector 300.
[0066] In use, the resistance of the sensors 336 (e.g., strain gauges) is sent to the microcontroller 350 of the end effector 300 which, in turn, processes the resistance to calculate a force or pressure on the strain gauges which, ultimately, is transmitted to the power-pack 120 of the handle assembly 100 via the adapter assembly 200. The power-pack 120 processes the sensor data and controls the wait time between clamping of the target tissue and firing of staples from the cartridge assembly 340 until a stress on the target tissue is at a value within an acceptable range of values. Accordingly, the microcontroller 350 may continuously or intermittently monitor the sensors 336 for collection of the sensor data. The handle assembly 100 may provide a visual or audible indication to a user that the surgical device 10 is ready for firing. The wait time is beneficial to minimize or avoid negative acute events related to excess stress in the target tissue, such as bruising, tearing, and bleeding. The sensors 336 control the firing of the surgical device 10 to keep the target tissue stress within an ideal stress region which is beneficial for sealing the target tissue, allowing perfusion for healing, providing hemostasis and pneumostasis, and/or preventing leakage.
[0067] According to the present disclosure, the use of sensors 336 enables the compression on the tissue, by the anvil assembly 330 and the cartridge assembly 340, to be measured indirectly (e.g., without the sensor(s) 336 touching the tissue). The compression on the tissue is calculated by the microcontroller 350, or the like, from variables including, but not limited to, the type of tissue being clamped, the dimensions and material properties of the anvil assembly 330 and the cartridge assembly 340, the amount of time for the clamping, a change in resistance through sensor(s) 336, etc.
[0068] While not wishing to be bound by the present theory, it is believed that staple formation may be dependent on the stress in the target tissue. Having excessing stress may make a staple difficult to form due to it having to pierce the target tissue and fold back into the target tissue. Accordingly, the sensors 336 of the end effector 300 of the present disclosure provides a method of monitoring the target tissue stress and delaying and/or slowing the speed of firing until the target tissue stress is below a value that negatively affects staple formation.
[0069] By monitoring behavior of the tool assembly 320, and specifically the anvil assembly 330, behavior of target tissue is monitored in real-time, and control of the function(s) of the surgical device, in view of the target tissue behavior, may lead to improved performance of the surgical device 10.
[0070] It should be understood that various modifications may be made to the embodiments of the presently disclosed surgical device. For example, it should be understood that the handle assembly 100, the adapter assembly 200, and the end effector 300 may be modified depending on the desired use of the surgical device 10 of the present disclosure. For example, handle assemblies, end effectors and/or adapter assemblies of the present disclosure may be configured to perform, for example, endoscopic gastro-intestinal anastomosis (EGIA) procedures or end-to-end anastomosis (EEA) procedures. For a detailed description of the structure and function of exemplary handle assemblies, adapter assemblies, and end effectors, reference may be made to commonly owned U.S. Patent Publication No. 2016-0296234 (the '234 Publication), the entire contents of which are incorporated herein by reference, and the '134 Publication, the entire contents of which were previously incorporated herein by reference. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.