Patent Application
20250166838
Surgical procedures are typically performed in surgical operating theaters or rooms in a healthcare facility such as, for example, a hospital. Various surgical devices and systems are utilized in performance of a surgical procedure. In the digital and information age, medical systems and facilities are often slower to implement systems or procedures utilizing newer and improved technologies due to patient safety and a general desire for maintaining traditional practices.
Systems, methods, and instrumentalities are disclosed herein for a (e.g., pre-, in-, and/or post-operative) patient monitoring system. A surgical system may include a processor. The surgical system may obtain a first data stream and a second data stream associated with a same measurement. The surgical system may determine a first control parameter based at least in part on the first data stream. The surgical system may determine a second control parameter based at least in part on a second data stream. The surgical system may compare the first control parameter and the second parameter. The surgical system may select a data stream between the first data stream and the second data stream based on the comparing. The surgical system may generate a control signal based on the selected data stream.
Comparing the first control parameter and the second parameter further may include calculating a first difference between the first control parameter and a current control parameter. Comparing the first control parameter and the second parameter further may include calculating a second difference between the second control parameter and the current control parameter. Comparing the first control parameter and the second parameter further may include selecting a control parameter that is associated with less difference. The data stream associated with the selected control parameter may be selected.
Comparing the first control parameter and the second parameter may include determining a first risk level associated with the first control parameter. Comparing the first control parameter and the second parameter may include determining a second risk level associated with the second control parameter. Comparing the first control parameter and the second parameter may include selecting a control parameter that is associated with a lower risk level. The data stream associated with the selected control parameter may be selected.
Comparing the first control parameter and the second parameter may include determining a first surgical action of the surgical system associated with the first control parameter. Comparing the first control parameter and the second parameter may include determining a second surgical action of the surgical system associated with the second control parameter. Comparing the first control parameter and the second parameter may include comparing the first surgical action and the second surgical action to a predetermined list of preferred surgical actions. Comparing the first control parameter and the second parameter may include selecting a control parameter that is associated with a preferred surgical action. The data stream associated with the selected control parameter may be selected.
Comparing the first control parameter and the second parameter may include determining a current physiologic situation associated with a patient. Comparing the first control parameter and the second parameter may include selecting, between the first control parameter and the second control parameter, a parameter based on current physiologic situation associated with a patient, wherein the data stream associated with the selected control parameter is selected.
The surgical system may identify a disagreement between the first data stream and the second data stream. The surgical system may determine a cause of the identified disagreement. The data stream may be selected based on the cause of the identified disagreement.
The surgical system may detect a disagreement between the first data stream and the second data stream. The comparing of the first control parameter and the second control parameter and the selecting of the data stream may be performed based on the detection of the disagreement between the first data stream and the second data stream.
The surgical system may detect a measurement difference between the first data stream and the second data stream. The surgical system may compare the measurement difference to a threshold value. The comparing of the first control parameter and the second control parameter and the selecting of the data stream may be performed based on the measurement difference being above the threshold value.
The first data stream and the second data stream may be associated with a control loop of the surgical system.
The surgical system may obtain a third data stream associated with the measurement. The surgical system may compare the first data stream and the second data stream to the third data stream. The surgical system may identify, based on the comparing to the third data stream, a data stream consistent with the third data stream. The data stream may be selected based on the identified data stream consistent with the third data stream.
A more detailed understanding may be had from the following description, given by way of example in conjunction with the accompanying drawings.
The surgical system 20002 may be in communication with a remote server 20009 that may be part of a cloud computing system 20008. In an example, the surgical system 20002 may be in communication with a remote server 20009 via an internet service provider's cable/FIOS networking node. In an example, a patient sensing system may be in direct communication with a remote server 20009. The surgical system 20002 (and/or various sub-systems, smart surgical instruments, robots, sensing systems, and other computerized devices described herein) may collect data in real-time and transfer the data to cloud computers for data processing and manipulation. It will be appreciated that cloud computing may rely on sharing computing resources rather than having local servers or personal devices to handle software applications.
The surgical system 20002 and/or a component therein may communicate with the remote servers 20009 via a cellular transmission/reception point (TRP) or a base station using one or more of the following cellular protocols: GSM/GPRS/EDGE (2G), UMTS/HSPA (3G), long term evolution (LTE) or 4G, LTE-Advanced (LTE-A), new radio (NR) or 5G, and/or other wired or wireless communication protocols. Various examples of cloud-based analytics that are performed by the cloud computing system 20008, and are suitable for use with the present disclosure, are described in U.S. Patent Application Publication No. US 2019-0206569 A1 (U.S. patent application Ser. No. 16/209,403), titled METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB, filed Dec. 4, 2018, the disclosure of which is herein incorporated by reference in its entirety.
The surgical hub 20006 may have cooperative interactions with one of more means of displaying the image from the laparoscopic scope and information from one or more other smart devices and one or more sensing systems 20011. The surgical hub 20006 may interact with one or more sensing systems 20011, one or more smart devices, and multiple displays. The surgical hub 20006 may be configured to gather measurement data from the sensing system(s) and send notifications or control messages to the one or more sensing systems 20011. The surgical hub 20006 may send and/or receive information including notification information to and/or from the human interface system 20012. The human interface system 20012 may include one or more human interface devices (HIDs). The surgical hub 20006 may send and/or receive notification information or control information to audio, display and/or control information to various devices that are in communication with the surgical hub.
For example, the sensing systems may include the wearable sensing system 20011 (which may include one or more HCP sensing systems and/or one or more patient sensing systems) and/or the environmental sensing system 20015 shown in
The biomarkers measured by the sensing systems may include, but are not limited to, sleep, core body temperature, maximal oxygen consumption, physical activity, alcohol consumption, respiration rate, oxygen saturation, blood pressure, blood sugar, heart rate variability, blood potential of hydrogen, hydration state, heart rate, skin conductance, peripheral temperature, tissue perfusion pressure, coughing and sneezing, gastrointestinal motility, gastrointestinal tract imaging, respiratory tract bacteria, edema, mental aspects, sweat, circulating tumor cells, autonomic tone, circadian rhythm, and/or menstrual cycle.
The biomarkers may relate to physiologic systems, which may include, but are not limited to, behavior and psychology, cardiovascular system, renal system, skin system, nervous system, gastrointestinal system, respiratory system, endocrine system, immune system, tumor, musculoskeletal system, and/or reproductive system. Information from the biomarkers may be determined and/or used by the computer-implemented patient and the surgical system 20000, for example. The information from the biomarkers may be determined and/or used by the computer-implemented patient and the surgical system 20000 to improve said systems and/or to improve patient outcomes, for example.
The sensing systems may send data to the surgical hub 20006. The sensing systems may use one or more of the following RF protocols for communicating with the surgical hub 20006: Bluetooth, Bluetooth Low-Energy (BLE), Bluetooth Smart, Zigbee, Z-wave, IPv6 Low-power wireless Personal Area Network (6LoWPAN), Wi-Fi.
The sensing systems, biomarkers, and physiological systems are described in more detail in U.S. application Ser. No. 17/156,287 (attorney docket number END9290USNP1), titled METHOD OF ADJUSTING A SURGICAL PARAMETER BASED ON BIOMARKER MEASUREMENTS, filed Jan. 22, 2021, the disclosure of which is herein incorporated by reference in its entirety.
The sensing systems described herein may be employed to assess physiological conditions of a surgeon operating on a patient or a patient being prepared for a surgical procedure or a patient recovering after a surgical procedure. The cloud-based computing system 20008 may be used to monitor biomarkers associated with a surgeon or a patient in real-time and to generate surgical plans based at least on measurement data gathered prior to a surgical procedure, provide control signals to the surgical instruments during a surgical procedure, and notify a patient of a complication during post-surgical period.
The cloud-based computing system 20008 may be used to analyze surgical data. Surgical data may be obtained via one or more intelligent instrument(s) 20014, wearable sensing system(s) 20011, environmental sensing system(s) 20015, robotic system(s) 20013 and/or the like in the surgical system 20002. Surgical data may include, tissue states to assess leaks or perfusion of sealed tissue after a tissue sealing and cutting procedure pathology data, including images of samples of body tissue, anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices, image data, and/or the like. The surgical data may be analyzed to improve surgical procedure outcomes by determining if further treatment, such as the application of endoscopic intervention, emerging technologies, a targeted radiation, targeted intervention, and precise robotics to tissue-specific sites and conditions. Such data analysis may employ outcome analytics processing and using standardized approaches may provide beneficial feedback to either confirm surgical treatments and the behavior of the surgeon or suggest modifications to surgical treatments and the behavior of the surgeon.
As illustrated in
The surgical hub 20006 may be configured to route a diagnostic input or feedback entered by a non-sterile operator at the visualization tower 20026 to the primary display 20023 within the sterile field, where it can be viewed by a sterile operator at the operating table. In an example, the input can be in the form of a modification to the snapshot displayed on the non-sterile display 20027 or 20029, which can be routed to the primary display 20023 by the surgical hub 20006.
Referring to
As shown in
Other types of robotic systems can be readily adapted for use with the surgical system 20002. Various examples of robotic systems and surgical tools that are suitable for use with the present disclosure are described herein, as well as in U.S. Patent Application Publication No. US 2019-0201137 A1 (U.S. patent application Ser. No. 16/209,407), titled METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL, filed Dec. 4, 2018, the disclosure of which is herein incorporated by reference in its entirety.
In various aspects, the imaging device 20030 may include at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.
The optical components of the imaging device 20030 may include one or more illumination sources and/or one or more lenses. The one or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and/or surgical instruments.
The illumination source(s) may be configured to radiate electromagnetic energy in the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (e.g., can be detected by) the human eye and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in air that range from about 380 nm to about 750 nm.
The invisible spectrum (e.g., the non-luminous spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma ray electromagnetic radiation.
In various aspects, the imaging device 20030 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, an arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope.
The imaging device may employ multi-spectrum monitoring to discriminate topography and underlying structures. A multi-spectral image is one that captures image data within specific wavelength ranges across the electromagnetic spectrum. The wavelengths may be separated by filters or by the use of instruments that are sensitive to particular wavelengths, including light from frequencies beyond the visible light range, e.g., IR and ultraviolet. Spectral imaging can allow extraction of additional information that the human eye fails to capture with its receptors for red, green, and blue. The use of multi-spectral imaging is described in greater detail under the heading “Advanced Imaging Acquisition Module” in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S. patent application Ser. No. 16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed Dec. 4, 2018, the disclosure of which is herein incorporated by reference in its entirety. Multi-spectrum monitoring can be a useful tool in relocating a surgical field after a surgical task is completed to perform one or more of the previously described tests on the treated tissue. It is axiomatic that strict sterilization of the operating room and surgical equipment is required during any surgery. The strict hygiene and sterilization conditions required in a “surgical theater,” e.g., an operating or treatment room, necessitate the highest possible sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize anything that comes in contact with the patient or penetrates the sterile field, including the imaging device 20030 and its attachments and components. It will be appreciated that the sterile field may be considered a specified area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or the sterile field may be considered an area, immediately around a patient, who has been prepared for a surgical procedure. The sterile field may include the scrubbed team members, who are properly attired, and all furniture and fixtures in the area.
Wearable sensing system 20011 illustrated in
The environmental sensing system(s) 20015 shown in
The surgical hub 20006 may use the surgeon biomarker measurement data associated with an HCP to adaptively control one or more surgical instruments 20031. For example, the surgical hub 20006 may send a control program to a surgical instrument 20031 to control its actuators to limit or compensate for fatigue and use of fine motor skills. The surgical hub 20006 may send the control program based on situational awareness and/or the context on importance or criticality of a task. The control program may instruct the instrument to alter operation to provide more control when control is needed.
The modular control may be coupled to non-contact sensor module. The non-contact sensor module may measure the dimensions of the operating theater and generate a map of the surgical theater using, ultrasonic, laser-type, and/or the like, non-contact measurement devices. Other distance sensors can be employed to determine the bounds of an operating room. An ultrasound-based non-contact sensor module may scan the operating theater by transmitting a burst of ultrasound and receiving the echo when it bounces off the perimeter walls of an operating theater as described under the heading “Surgical Hub Spatial Awareness Within an Operating Room” in U.S. Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, which is herein incorporated by reference in its entirety. The sensor module may be configured to determine the size of the operating theater and to adjust Bluetooth-pairing distance limits. A laser-based non-contact sensor module may scan the operating theater by transmitting laser light pulses, receiving laser light pulses that bounce off the perimeter walls of the operating theater, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating theater and to adjust Bluetooth pairing distance limits, for example.
During a surgical procedure, energy application to tissue, for sealing and/or cutting, may be associated with smoke evacuation, suction of excess fluid, and/or irrigation of the tissue. Fluid, power, and/or data lines from different sources may be entangled during the surgical procedure. Valuable time can be lost addressing this issue during a surgical procedure. Detangling the lines may necessitate disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular enclosure 20060 may offer a unified environment for managing the power, data, and fluid lines, which reduces the frequency of entanglement between such lines.
Energy may be applied to tissue at a surgical site. The surgical hub 20006 may include a hub enclosure 20060 and a combo generator module slidably receivable in a docking station of the hub enclosure 20060. The docking station may include data and power contacts. The combo generator module may include two or more of: an ultrasonic energy generator component, a bipolar RF energy generator component, or a monopolar RF energy generator component that are housed in a single unit. The combo generator module may include a smoke evacuation component, at least one energy delivery cable for connecting the combo generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and/or particulates generated by the application of therapeutic energy to the tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component. The fluid line may be a first fluid line, and a second fluid line may extend from the remote surgical site to a suction and irrigation module 20055 slidably received in the hub enclosure 20060. The hub enclosure 20060 may include a fluid interface.
The combo generator module may generate multiple energy types for application to the tissue. One energy type may be more beneficial for cutting the tissue, while another different energy type may be more beneficial for sealing the tissue. For example, a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution where a hub modular enclosure 20060 is configured to accommodate different generators and facilitate an interactive communication therebetween. The hub modular enclosure 20060 may enable the quick removal and/or replacement of various modules.
The modular surgical enclosure may include a first energy-generator module, configured to generate a first energy for application to the tissue, and a first docking station comprising a first docking port that includes first data and power contacts, wherein the first energy-generator module is slidably movable into an electrical engagement with the power and data contacts and wherein the first energy-generator module is slidably movable out of the electrical engagement with the first power and data contacts. The modular surgical enclosure may include a second energy-generator module configured to generate a second energy, different than the first energy, for application to the tissue, and a second docking station comprising a second docking port that includes second data and power contacts, wherein the second energy generator module is slidably movable into an electrical engagement with the power and data contacts, and wherein the second energy-generator module is slidably movable out of the electrical engagement with the second power and data contacts. In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port, configured to facilitate communication between the first energy-generator module and the second energy-generator module.
Referring to
A surgical data network having a set of communication hubs may connect the sensing system(s), the modular devices located in one or more operating theaters of a healthcare facility, a patient recovery room, or a room in a healthcare facility specially equipped for surgical operations, to the cloud computing system 20008.
The surgical hub 5104 may be connected to various databases 5122 to retrieve therefrom data regarding the surgical procedure that is being performed or is to be performed. In one exemplification of the surgical system 5100, the databases 5122 may include an EMR database of a hospital. The data that may be received by the situational awareness system of the surgical hub 5104 from the databases 5122 may include, for example, start (or setup) time or operational information regarding the procedure (e.g., a segmentectomy in the upper right portion of the thoracic cavity). The surgical hub 5104 may derive contextual information regarding the surgical procedure from this data alone or from the combination of this data and data from other data sources 5126.
The surgical hub 5104 may be connected to (e.g., paired with) a variety of patient monitoring devices 5124. In an example of the surgical system 5100, the patient monitoring devices 5124 that can be paired with the surgical hub 5104 may include a pulse oximeter (SpO2 monitor) 5114, a BP monitor 5116, and an EKG monitor 5120. The perioperative data that is received by the situational awareness system of the surgical hub 5104 from the patient monitoring devices 5124 may include, for example, the patient's oxygen saturation, blood pressure, heart rate, and other physiological parameters. The contextual information that may be derived by the surgical hub 5104 from the perioperative data transmitted by the patient monitoring devices 5124 may include, for example, whether the patient is located in the operating theater or under anesthesia. The surgical hub 5104 may derive these inferences from data from the patient monitoring devices 5124 alone or in combination with data from other data sources 5126 (e.g., the ventilator 5118).
The surgical hub 5104 may be connected to (e.g., paired with) a variety of modular devices 5102. In one exemplification of the surgical system 5100, the modular devices 5102 that are paired with the surgical hub 5104 may include a smoke evacuator, a medical imaging device such as the imaging device 20030 shown in
The perioperative data received by the surgical hub 5104 from the medical imaging device may include, for example, whether the medical imaging device is activated and a video or image feed. The contextual information that is derived by the surgical hub 5104 from the perioperative data sent by the medical imaging device may include, for example, whether the procedure is a VATS procedure (based on whether the medical imaging device is activated or paired to the surgical hub 5104 at the beginning or during the course of the procedure). The image or video data from the medical imaging device (or the data stream representing the video for a digital medical imaging device) may be processed by a pattern recognition system or a machine learning system to recognize features (e.g., organs or tissue types) in the field of view (FOY) of the medical imaging device, for example. The contextual information that is derived by the surgical hub 5104 from the recognized features may include, for example, what type of surgical procedure (or step thereof) is being performed, what organ is being operated on, or what body cavity is being operated in.
The situational awareness system of the surgical hub 5104 may derive the contextual information from the data received from the data sources 5126 in a variety of different ways. For example, the situational awareness system can include a pattern recognition system, or machine learning system (e.g., an artificial neural network), that has been trained on training data to correlate various inputs (e.g., data from database(s) 5122, patient monitoring devices 5124, modular devices 5102, HCP monitoring devices 35510, and/or environment monitoring devices 35512) to corresponding contextual information regarding a surgical procedure. For example, a machine learning system may accurately derive contextual information regarding a surgical procedure from the provided inputs. In examples, the situational awareness system can include a lookup table storing pre-characterized contextual information regarding a surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the contextual information. In response to a query with one or more inputs, the lookup table can return the corresponding contextual information for the situational awareness system for controlling the modular devices 5102. In examples, the contextual information received by the situational awareness system of the surgical hub 5104 can be associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In examples, the situational awareness system can include a machine learning system, lookup table, or other such system, which may generate or retrieve one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.
For example, based on the data sources 5126, the situationally aware surgical hub 5104 may determine what type of tissue was being operated on. The situationally aware surgical hub 5104 can infer whether a surgical procedure being performed is a thoracic or an abdominal procedure, allowing the surgical hub 5104 to determine whether the tissue clamped by an end effector of the surgical stapling and cutting instrument is lung (for a thoracic procedure) or stomach (for an abdominal procedure) tissue. The situationally aware surgical hub 5104 may determine whether the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type, for a consistent amount of smoke evacuation for both thoracic and abdominal procedures. Based on the data sources 5126, the situationally aware surgical hub 5104 could determine what step of the surgical procedure is being performed or will subsequently be performed.
The situationally aware surgical hub 5104 could determine what type of surgical procedure is being performed and customize the energy level according to the expected tissue profile for the surgical procedure. The situationally aware surgical hub 5104 may adjust the energy level for the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than just on a procedure-by-procedure basis.
In examples, data can be drawn from additional data sources 5126 to improve the conclusions that the surgical hub 5104 draws from one data source 5126. The situationally aware surgical hub 5104 could augment data that it receives from the modular devices 5102 with contextual information that it has built up regarding the surgical procedure from other data sources 5126.
The situational awareness system of the surgical hub 5104 can consider the physiological measurement data to provide additional context in analyzing the visualization data. The additional context can be useful when the visualization data may be inconclusive or incomplete on its own.
The situationally aware surgical hub 5104 could determine whether the surgeon (or other HCP(s)) was making an error or otherwise deviating from the expected course of action during the course of a surgical procedure. For example, the surgical hub 5104 may determine the type of surgical procedure being performed, retrieve the corresponding list of steps or order of equipment usage (e.g., from a memory), and compare the steps being performed or the equipment being used during the course of the surgical procedure to the expected steps or equipment for the type of surgical procedure that the surgical hub 5104 determined is being performed. The surgical hub 5104 can provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at the particular step in the surgical procedure.
The surgical instruments (and other modular devices 5102) may be adjusted for the particular context of each surgical procedure (such as adjusting to different tissue types) and validating actions during a surgical procedure. Next steps, data, and display adjustments may be provided to surgical instruments (and other modular devices 5102) in the surgical theater according to the specific context of the procedure.
The first and second jaws 20291, 20290 may be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever the clamped tissue. The first jaw 20291 may be configured to fire at least one fastener a plurality of times or may be configured to include a replaceable multi-fire fastener cartridge including a plurality of fasteners (e.g., staples, clips, etc.) that may be fired more than one time prior to being replaced. The second jaw 20290 may include an anvil that deforms or otherwise secures the fasteners, as the fasteners are ejected from the multi-fire fastener cartridge.
The handle 20297 may include a motor that is coupled to the drive shaft to affect rotation of the drive shaft. The handle 20297 may include a control interface to selectively activate the motor. The control interface may include buttons, switches, levers, sliders, touchscreens, and any other suitable input mechanisms or user interfaces, which can be engaged by a clinician to activate the motor.
The control interface of the handle 20297 may be in communication with a controller 20298 of the handle 20297 to selectively activate the motor to affect rotation of the drive shafts. The controller 20298 may be disposed within the handle 20297 and may be configured to receive input from the control interface and adapter data from the adapter 20285 or loading unit data from the loading unit 20287. The controller 20298 may analyze the input from the control interface and the data received from the adapter 20285 and/or loading unit 20287 to selectively activate the motor. The handle 20297 may also include a display that is viewable by a clinician during use of the handle 20297. The display may be configured to display portions of the adapter or loading unit data before, during, or after firing of the instrument 20282.
The adapter 20285 may include an adapter identification device 20284 disposed therein and the loading unit 20287 may include a loading unit identification device 20288 disposed therein. The adapter identification device 20284 may be in communication with the controller 20298, and the loading unit identification device 20288 may be in communication with the controller 20298. It will be appreciated that the loading unit identification device 20288 may be in communication with the adapter identification device 20284, which relays or passes communication from the loading unit identification device 20288 to the controller 20298.
The adapter 20285 may also include a plurality of sensors 20286 (one shown) disposed thereabout to detect various conditions of the adapter 20285 or of the environment (e.g., if the adapter 20285 is connected to a loading unit, if the adapter 20285 is connected to a handle, if the drive shafts are rotating, the torque of the drive shafts, the strain of the drive shafts, the temperature within the adapter 20285, a number of firings of the adapter 20285, a peak force of the adapter 20285 during firing, a total amount of force applied to the adapter 20285, a peak retraction force of the adapter 20285, a number of pauses of the adapter 20285 during firing, etc.). The plurality of sensors 20286 may provide an input to the adapter identification device 20284 in the form of data signals. The data signals of the plurality of sensors 20286 may be stored within or be used to update the adapter data stored within the adapter identification device 20284. The data signals of the plurality of sensors 20286 may be analog or digital. The plurality of sensors 20286 may include a force gauge to measure a force exerted on the loading unit 20287 during firing.
The handle 20297 and the adapter 20285 can be configured to interconnect the adapter identification device 20284 and the loading unit identification device 20288 with the controller 20298 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., include electrical contacts that engage one another to transmit energy and signals therebetween). Additionally, or alternatively, the electrical interface may be a non-contact electrical interface to wirelessly transmit energy and signals therebetween (e.g., inductively transfer). It is also contemplated that the adapter identification device 20284 and the controller 20298 may be in wireless communication with one another via a wireless connection separate from the electrical interface.
The handle 20297 may include a transceiver 20283 that is configured to transmit instrument data from the controller 20298 to other components of the system 20280 (e.g., the LAN 20292, the cloud 20293, the console 20294, or the portable device 20296). The controller 20298 may also transmit instrument data and/or measurement data associated with one or more sensors 20286 to a surgical hub. The transceiver 20283 may receive data (e.g., cartridge data, loading unit data, adapter data, or other notifications) from the surgical hub 20270. The transceiver 20283 may receive data (e.g., cartridge data, loading unit data, or adapter data) from the other components of the system 20280. For example, the controller 20298 may transmit instrument data including a serial number of an attached adapter (e.g., adapter 20285) attached to the handle 20297, a serial number of a loading unit (e.g., loading unit 20287) attached to the adapter 20285, and a serial number of a multi-fire fastener cartridge loaded into the loading unit to the console 20294. Thereafter, the console 20294 may transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 20298. The controller 20298 can display messages on the local instrument display or transmit the message, via transceiver 20283, to the console 20294 or the portable device 20296 to display the message on the display 20295 or portable device screen, respectively.
The surgical system 20006 may select a controlling data stream between the first data stream 56003 and the second data stream 56004 based on their impacts on the control difference. As shown in
A surgical action (e.g., first surgical action) may be determined and may be associated with the first control parameter 56005. For example, the first surgical action may be a robotic arm making an incision and may be associated with the blood pressure of the patient. A device may monitor the patient's blood pressure and look for a drop which may suggest internal bleeding.
A surgical action (e.g., second surgical action) may be determined and may be associated with the second control parameter 56006. The first surgical action and the second surgical action may be compared to a predetermined list of preferred surgical actions. A control parameter may be selected that is associated with a preferred surgical action. The data stream associated with the selected control parameter may also be selected.
In some examples, the first control parameter 56005 and the second control parameter 56006 relate to the same measurement (e.g., same parameter), and the first control parameter may refer to a first control parameter value, and the second control parameter may refer to a second control parameter value.
As shown, at 56007, the first control parameter 56005 may be compared with the second control parameter 56006. A difference between the first control parameter and the second parameter (e.g., a difference between the first control parameter value and the second control parameter value) may be calculated (e.g., determined). The difference between the first control parameter and the second parameter may represent a discrepancy in a metric, for example, of the first data stream and second data stream. A difference between the first data stream and the second data stream may be determined. The difference between the control parameters and/or the measurement (e.g., a measurement difference) of the data streams may be compared to a threshold (e.g., a threshold value) when determining which to select. For example, if a measurement value is determined to be above the threshold value, the associated control parameter and/or data stream may be selected.
At 56008, a data stream may be selected from either the first data stream 56003 or the second data stream 56004, for example, based on the comparison of the first control parameter 56005 and the second control parameter 56006. The selected data stream 56008 may be used to generate control signal(s). For example, the selected data stream may be sent to a computing system (e.g., a surgical hub) 20006. Control signal 56012 may be generated based on the selected data stream, at 56008.
Determining when a data stream (e.g., a control data stream or first data stream) lacks agreement (e.g., a disagreement) with another data stream (e.g., a second data stream) and/or how to handle the inaccurate (e.g., not chosen) data stream may be provided.
In some examples, a disagreement between the first data stream and the second data stream may be identified, and a cause of the identified disagreement may be identified. The data stream is selected based on the cause of the identified disagreement. For example, a cause of disagreement between the first data stream 56003 and the second data stream 56004 may be identified and/or determined. The cause of disagreement between the first data stream 56003 and the second data stream 56004 may include but not be limited to: an equipment (e.g., device, software, etc.) malfunction; equipment interference; physiologic responses; and perceived data errors. For example, a physiologic situation (e.g., a current physiologic situation) associated with the patient may be determined to be a drop in body temperature. This drop in body temperature may be important for the surgeon to notice as the drop in body temperature may affect other behaviors during the procedure. The selected control parameter, selected between the first and second control parameters, may be based off a physiologic situation of the patient.
In examples, the first data stream and the second data stream may be integrated within a control loop (e.g., closed loop) of the surgical system to continuously adjust and/or refine surgical actions for precise and/or responsive operation.
Equipment (e.g., device, software, etc.) malfunction may include but not be limited to the equipment having a faulty (e.g., bad) connection to a patient, or equipment damage, for example. Equipment malfunction may include situations where the equipment is not functioning as intended, is unresponsive, or is providing inaccurate or inconsistent readings, for example. A faulty connection may be a faulty connection within the equipment itself. A faulty connection within the equipment may include but not be limited to a loose, corroded, worn, or damaged connection, for example. The faulty connection of the equipment may include a faulty connection with a surgical device to the patient. A faulty connection of a surgical device to the patient may include but not be limited to a loose sensor, improper placement, and/or improper materials. Frequent false alarms may cause unnecessary anxiety for both the patient and healthcare providers. Frequent false alarms may lead to alarm fatigue which may cause real emergencies to be overlooked.
In examples, if a connection within a surgical device and/or equipment is incomplete or inadequate, a signal may not appear and/or be inaccurate (e.g., signal drift may occur). For example, signal drift may lead to inaccurate readings, which may result in incorrect data collection and analysis. Signal drift may also undermine the reliability of the device, reducing the trustworthiness of the readings over time and/or may result in lower confidence of the device. Signal drift may require recalibration of the device to maintain accuracy, which is time-consuming and may result in loss of time that is critical to a successful outcome for the patient. However, if signal drift is not noticed by the operator of the device, poor decision-making may occur due to inaccurate data and/or an automated system that relies on this data may lose precision and/or accuracy.
An improper placement of a surgical device on a patient may include the surgical device not being placed on the intended (e.g., correct, required, etc.) anatomy of the patient. If the surgical device is improperly placed on the patient, a signal may appear (e.g., a signal may appear stable). If the surgical device is improperly placed on the patient, a signal that appears may not be accurate. In examples, if a blood pressure cuff is placed on a patient, the blood pressure cuff should be placed (e.g., attached) on the inside of the arm of the patient. If the blood pressure cuff is not placed on the inside of the arm of the patient, the signal may not be accurate.
In examples, a monopolar ground pad may not be properly adhered to a patient. The monopolar ground pad may include an adhesive lead. If the adhesive lead forms a faulty connection with the patient (e.g., is partially connected, or falling off, etc.), a signal may not appear and/or be inaccurate.
In examples, a fingertip pulse oximeter (pulse-ox) may not be properly adhered to a patient. If the fingertip pulse-ox forms a faulty connection with the patient (e.g., is slipping off the patient), a signal may not appear and/or be inaccurate. The pulse-ox may measure the pulse (e.g., pulse rate, or rate of pulse) of the patient. An improperly placed sensor of the pulse-ox might detect incorrect and/or erratic signals, leading to an inaccurate pulse reading.
In examples, a ventilator outlet may form a faulty connection with a patient. If the ventilator outlet forms a faulty connection with the patient (e.g., the outlet is into another closed system), a signal may not appear and/or be inaccurate. If the ventilator outlet forms a faulty connection with the patient (e.g., the outlet is leaking out of the system), no measurement (e.g., measurement of O2, sedation, and/or another gaseous substance) may occur. Faulty connection of the ventilator outlet with the patient may result in errors (e.g., critical errors) in the treatment of the patient, for example, improper oxygenation or inadequate sedation, potentially compromising patient safety and the effectiveness of the ventilation.
If a system includes multiple leads and/or inputs including but not limited to some of the inputs missing and/or not being connected, a signal may not appear and or be inaccurate (e.g., the signal may appear stable but be an incomplete signal). In examples, EKG lead(s) may not be attached properly to a patient. For example, if EKG leads are placed improperly on a patient, it may result in inaccurate readings or misinterpretation of the heart's electrical activity, potentially leading to incorrect diagnoses or missed detection of critical cardiac conditions.
The faulty (e.g., bad) equipment connection may include but not be limited to the equipment having a faulty connection to another piece of equipment. A faulty connection between pieces of equipment may include but not be limited to: incomplete connection(s) and/or attachment(s) between equipment and data source(s) (e.g., the data source(s) of the equipment); or incomplete connection(s) and/or attachment(s) between equipment and shared data sources from (e.g., of) other equipment. For example, faulty connection may lead to inaccurate readings, which may result in incorrect data collection and analysis. Faulty connection may also undermine the reliability of the device, reducing the trustworthiness of the readings over time and/or may result in lower confidence of the device. However, if faulty connections are not noticed by the operator of the device, poor decision-making may occur due to inaccurate data and/or an automated system that relies on this data may lose precision and/or accuracy.
Incomplete connection(s) and/or attachment(s) between equipment and data source(s) (e.g., the data source(s) of the equipment) may include but not be limited to ends (e.g., proximal ends) of wire leads connected to patient may not be fully plugged in to a home unit. An impact to data may occur and/or an intermittent signal or no signal may be produced.
Incomplete connection(s) and/or attachment(s) between equipment and shared data sources from (e.g., of) other equipment may include an impact to data. The data may not be properly shared. The surgical hub 20006 should be able to resolve between original (e.g., correct) acquired data of a first system and partial or missing data that a second system may receive from a bad connection. If there is a disagreement ween the received data of the first system and the second system, resolution options may include but not be limited to: surgical hub 20006 may ignore (e.g., choose to ignore) analog data from the first system to the second system in favor of digital data transfer; surgical hub 20006 may compensate (e.g., choose to compensate) for analog data to help the surgical hub 20006 match an original data source; surgical hub 20006 may prompt a user of the disagreement, and/or indicate system data connection(s) as the source of error (e.g., likely source of error); or the second system may choose to omit data (e.g., the bad, missing, and/or partial data) entirely from the information received from the first system.
Equipment (e.g., device, software, etc.) malfunction may include but not be limited to damage to equipment used for data transport. Damage to equipment used for data transport may include but not be limited to sterilization (e.g., repeated sterilization) of equipment which may affect the data transfer (e.g., data transfer capabilities) of the equipment. The impact of damage to equipment used for data transport may include but not be limited to an impact to data (e.g., noisy signal, no signal, inaccurate signal, etc.).
Damage to equipment used for data transport may include but not be limited to broken and/or damaged electrical equipment being used before the damage is discovered. The impact of damage to equipment used for data transport may include but not be limited to an impact to data (e.g., noisy signal, no signal, intermittent signal, etc.). Damage to equipment may be visible or not visible to an observer. Damage to equipment may lead to delayed diagnostics, incorrect data interpretation, or failure in communication systems and/or device, potentially compromising the overall functionality and reliability of the system and/or device.
Equipment (e.g., device, software, etc.) malfunction may include but not be limited to damage to equipment used for data acquisition. Patient contacting components may be damaged and output an inaccurate signal. The impact of damage to equipment used for data acquisition may include but not be limited to erroneous readings, a data-offset, or an impact to data (e.g., noisy signal, no signal, intermittent signal, etc.).
The cause of disagreement between the first data stream 56003 and the second data stream 56004 may include but not be limited to equipment and/or capital interference. In examples, another device in the operating room may cause interference (e.g., interfere) with the equipment used to gather data having no impact on a signal and/or patient but calibration may be affected. The surgical hub 20006 may be disrupted by large metal objects, for example. If a metal object is passed through a field (e.g., a surgical field) during a procedure, calibration may be affected. Calibration may be compensated while metal is present to avoid calibration interference.
In examples, another device in the operating room may cause interference (e.g., interfere) with the equipment used to gather data. The addition of another data input to a transfer function may result in imbalance to the output data of a transfer function.
The cause of disagreement between the first data stream 56003 and the second data stream 56004 may include but not be limited to physiologic response(s). Physiologic responses may include but not be limited to physiologic responses that reflect a direct change to patient conditions being measured. In examples, a decrease in patient temperature after suction and/or irrigation may be activated for an extended period, which may result in an influx of cold air into a body cavity. Data may respond by showing a change in measured data that directly matches patient conditions and may be attributable to measured inputs.
Physiologic responses may include but not be limited to physiologic responses that cause an indirect change in perceived data by the measurement system. Physiologic responses that cause an indirect change in perceived data by the measurement system may be a result of changes in patient conditions different from those being measured. In examples, effects on data of vasoconstriction on a fingertip pulse-oxygen readings may be shown regarding O2 consumption, etc. A change in measured data may occur that is indirectly a result of patient conditions caused by inputs that may not be directly measured.
The cause of disagreement between the first data stream 56003 and the second data stream 56004 may include but not be limited to perceived data errors. Perceived data errors may include but not be limited to electrical drift. The causes of electrical drift may include but not be limited to resistance, probe age, or a number of sterilizations.
Perceived data errors may include but not be limited to a perception that the data is erroneous but not erratic. In examples, a stable data source may be wrong (e.g., producing incorrect data), but may be position dependent. Perceived data errors may include but not be limited to a flaw in an interface including the purpose and/or actions of equipment (e.g., not an electrical flaw).
Determining when a first data stream lacks agreement with a second data stream and/or how to handle the inaccurate data stream may include but not be limited to logic pathways and/or responses to the identified disagreement. Logic pathways and/or responses to the identified disagreement may include but not be limited to conflicts in interference; choosing which data stream to use; a third data stream being used to confirm an existing closed loop system; prioritization and/or importance; or determining potential causes of errors in the data stream.
Conflicts of interference may include being an assistant and is not expected to be right (e.g., be right all the time) but may avoid being incorrect. Choosing which data stream to use may include using a temperature, for example. Both sources of data may be related at time 0. Both sources may lose relation as the procedure proceeds.
Prioritization of importance may include determining when conflict management does not include the data. Prioritization of importance may include determining whether or not the surgeon should be interfered with. In examples, a surgeon dissecting a first system may use O2 management while a second system may monitor temperature. In the system resolving which of the O2 or temperature to display, the more detrimental (e.g., critical) may be suggested to the surgeon. In examples, a single cause of interference may be provided, which create multiple failures. The (e.g., Only the) more problematic and/or prevalent error may be shown and/or displayed. In examples, a body temperature management may be set to manage the body temperature of a patient based off the patient's heart rate, O2 sensor, patient heating (e.g., body temperature), hypothermia, etc.
Prioritization of importance may include but is not limited to risk management. Other forms of monitoring for conflict management may be provided including monitoring for grandiose errors.
Potential causes of errors in the data stream may be determined. Categories of potential causes of errors in the data stream may be provided and distinguished. If an error in the data stream is one that may be corrected, a method of correcting may be determined. If an error in the data stream is one that may not be corrected, a notice may be provided. A determination of how likely a data stream may be incorrect may be provided. A determination of how often a data stream may be incorrect may be provided.
In a number of examples, the surgical system may obtain a first data stream and a second data stream associated with a same measurement.
Example 1. A surgical system comprising:
Example 2. The surgical system of example 1, wherein comparing the first control parameter and the second parameter further comprises:
Example 3. The surgical system of any of examples 1-2, wherein comparing the first control parameter and the second parameter further comprises:
Example 4. The surgical system of any of examples 1-3, wherein comparing the first control parameter and the second parameter further comprises:
Example 5. The surgical system of any of examples 1-4, wherein comparing the first control parameter and the second parameter further comprises:
Example 6. The surgical system of any of examples 1-5, wherein the processor is further configured to:
Example 7. The surgical system of any of examples 1-6, wherein the processor is further configured to:
detect a disagreement between the first data stream and the second data stream; wherein the comparing of the first control parameter and the second control parameter and the selecting of the data stream is performed based on the detection of the disagreement between the first data stream and the second data stream.
Example 8. The surgical system of any of examples 1-7, wherein the processor is further configured to:
Example 9. The surgical system of any of examples 1-8, wherein the first data stream and the second data stream are associated with a control loop of the surgical system.
Example 10. The surgical system of any of examples 1-9, wherein the processor is further configured to:
Example 11. A surgical operating method comprising:
Example 12. The surgical operating method of example 11, wherein comparing the first control parameter and the second parameter further comprises:
Example 13. The surgical operating method of any of examples 11-12, wherein comparing the first control parameter and the second parameter further comprises:
Example 14. The surgical operating method of any of examples 11-13, wherein comparing the first control parameter and the second parameter further comprises:
Example 15. The surgical operating method of any of examples 11-14, wherein comparing the first control parameter and the second parameter further comprises:
Example 16. The surgical operating method of any of examples 11-15, further comprising:
Example 17. The surgical operating method of any of examples 11-16, further comprising:
Example 18. The surgical operating method of any of examples 11-17, further comprising:
Example 19. The surgical operating method of any of examples 11-18, wherein the first data stream and the second data stream are associated with a control loop of the surgical system.
Example 20. The surgical operating method of any of examples 11-19, further comprising:
Although features and elements are described above in particular combinations, one of ordinary skill in the art will appreciate that each feature or element can be used alone or in any combination with the other features and elements. In addition, the methods described herein may be implemented in a computer program, software, or firmware incorporated in a computer-readable medium for execution by a computer or processor. Examples of computer-readable media include electronic signals (transmitted over wired or wireless connections) and computer-readable storage media. Examples of computer-readable storage media include, but are not limited to, a read only memory (ROM), a random access memory (RAM), a register, cache memory, semiconductor memory devices, magnetic media such as internal hard disks and removable disks, magneto-optical media, and optical media such as CD-ROM disks, and digital versatile disks (DVDs). A processor in association with software may be used to implement a radio frequency transceiver for use in a WTRU, UE, terminal, base station, RNC, or any host computer.
This application claims the benefit of the following, the disclosures of which are incorporated herein by reference in its entirety: Provisional U.S. Patent Application No. 63/602,040, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,028, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/601,998, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,003, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,006, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,011, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,013, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,037, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/602,007, filed Nov. 22, 2023,Provisional U.S. Patent Application No. 63/603,031, filed Nov. 27, 2023, andProvisional U.S. Patent Application No. 63/603,033, filed Nov. 27, 2023. This application is related to the following, filed contemporaneously, the contents of each of which are incorporated by reference herein: Attorney Docket No. END9637USNP1, entitled METHOD FOR MULTI-SYSTEM INTERACTION, andAttorney Docket No. END9637USNP13, entitled INVALID DATA STREAM IN A MULTI-SYSTEM INTERACTION.
| Number | Date | Country | |
|---|---|---|---|
| 63602040 | Nov 2023 | US | |
| 63602028 | Nov 2023 | US | |
| 63601998 | Nov 2023 | US | |
| 63602003 | Nov 2023 | US | |
| 63602006 | Nov 2023 | US | |
| 63602011 | Nov 2023 | US | |
| 63602013 | Nov 2023 | US | |
| 63602037 | Nov 2023 | US | |
| 63602007 | Nov 2023 | US | |
| 63603031 | Nov 2023 | US | |
| 63603033 | Nov 2023 | US |
