Patent Publication Number: US-2017348047-A1

Title: Sensor systems for use in connection with medical procedures

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to sensor systems and methods of using such systems in connection with surgical procedures. 
     BACKGROUND OF THE INVENTION 
     Currently, there exists some procedures for surgical staff to mitigate the risk of fire, in a surgical environment, due to elevated concentrations of oxygen. However, there is no device to detect oxygen, and/or other gases/chemicals, that could provide an early warning to the staff to remove the ignition source and/or adjust the oxygen source. Oxygen delivery to the patient does not occur in a closed system, and leaking oxygen may propagate to the surgical site, elevating the concentration. At the surgical site there exists an abundance of fuels, and an ignition source in close proximity to those fuels. A warning system could provide medical staff with an early warning so that they could take action to reduce the risk of fire. 
     SUMMARY OF THE INVENTION 
     With parenthetical reference to the corresponding parts, portions or surfaces of the disclosed embodiment, merely for the purposes of illustration and not by way of limitation, the present invention meets the above described need by providing a sensor system ( 10 ) for use during surgical procedures that may be incorporated into trocars and electrosurgical devices. In a first embodiment, an electrosurgical device ( 10 ) having a cutting blade ( 13 ), a user interface ( 16 ) for selecting between on/off and cut/coagulate functions, and a vacuum tube ( 19 ) for evacuation of surgical smoke. The electrosurgical device ( 10 ) may also be provided with visual and audible warning indicators ( 22 ,  25 ). As shown, the electrosurgical device ( 10 ) will be located in a monitoring/surgical site ( 28 ). The electrosurgical device ( 10 ) may also include a sensor ( 31 ). The sensor ( 31 ) may be designed to detect oxygen concentrations at the monitoring/surgical site ( 28 ). The sensor ( 31 ) may also be designed to detect the presence of other gases or chemicals. Some examples of technologies for targeting oxygen, and/or other gases/chemicals, include: luminescence spectroscopy; imaging (e.g., hyperspectral, multispectral, etc.); electrochemical; paramagnetic; Quartz Crystal Microbalancing (QCM); Quantum Dots (QD&#39;s)/indicator strips or dots; ultrasonic; and utilizing refractive properties of light. Some examples of sensor technologies for targeting temperature include: thermocouples; thermistors; Resistive Temperature Devices (RTD); integrated silicone based sensor; infrared (pyrometers); Bragg Grating; Interferometric; Raman (DTS); Brillouin (DTSS); and thermal pile. Sensors for gases include, but are not limited to: CO 2 , CO and alcohol. 
     Data from the sensors ( 31 ) may be transferred along communication lines ( 35 ) to a main control unit ( 38 ). The main unit ( 38 ) includes processors for interacting with the electronics on board the electrosurgical device ( 10 ) and for processing the data received from the sensors. The unit ( 38 ) may include a user interface ( 41 ). The main unit ( 38 ) may include a smoke evacuation system ( 65 ) to remove surgical smoke and debris from the surgical site and/or an electro surgical system ( 68 ) to control an electrosurgical device ( 10 ). Also, the main unit ( 38 ) may include visual and audible warning indicators ( 48 ) and ( 51 ). The main unit ( 38 ) also includes a sensor module ( 54 ) for communicating with the sensor(s) ( 31 ) and processing the data received. The sensor module ( 54 ) may also communicate with the main electronics. The unit ( 38 ) may also include a main electronics board ( 59 ) for handling the whole system (i.e. controlling the electrosurgical device, controlling the smoke evacuation system, utilizing data received from the sensors ( 31 ), and triggering the audible warning and/or warning light). A power unit ( 62 ) provides power for the entire system. 
     In a second embodiment, a monitoring site ( 100 ) such as a surgical area for a laparoscopic procedure is shown. A trocar ( 103 ) may be inserted into a cavity of a patient for a laparoscopic procedure. The trocar ( 103 ) may provide for insufflation of the cavity through an insufflator or the like. The pressurization of the cavity, such as a peritoneal cavity, provides space for manipulating instruments inside the cavity. While the insufflator introduces gas into the cavity, gases are removed from the cavity through an outlet that conveys the gas through a filter ( 106 ). The filter removes smoke and debris from the gas. The gas may be conveyed to the main unit ( 112 ) where it may enter a sensor ( 115 ) to test for oxygen levels, the presence of other gases, temperature or the like. The main unit ( 112 ) may be provided with electrical output, fiber optic, or other data transmission lines ( 118 ) for sending warning signals to visual warnings ( 121 ) and/or auditory warnings ( 124 ), disposed in the surgical theater near the monitoring site ( 100 ). The main unit ( 112 ) may be provided with a user interface ( 127 ), a sensor processing ( 130 ), a power unit ( 133 ), a pump ( 136 ) for drawing gas from the surgical site, an audible warning ( 139 ), and a visual warning ( 142 ). The unit ( 112 ) includes a main processor ( 145 ) that provides for controlling the overall functionality and processing of the system. 
     In a third embodiment, the present invention may also provide for remote sensing features for a sensing system. The remote sensor ( 200 ) may be provided with sensing film or sensing technology (e.g. sensor spot, chemical coating, etc.) ( 203 ), and a processor ( 202 ) to control the functions of the remote sensor ( 200 ) [e.g. user interface ( 201 ), audible warning ( 206 ), warning light ( 209 ), and receiver/transmitter ( 210 )] The remote sensor ( 200 ) may also transmit a wireless signal via receiver/transmitter ( 210 ) to a main processing unit ( 212 ) disposed at a remote location. The main processing unit ( 212 ) may include a receiver/transmitter ( 213 ) for communicating with the remote sensor ( 200 ) via wireless signal. The main processing unit ( 212 ) may also include a user interface ( 215 ), a sensor processing module ( 218 ), a power unit ( 221 ), a main electronics board ( 224 ), audible warnings ( 227 ), and/or visual warnings ( 230 ). 
     In a fourth embodiment, an imaging device is utilized to view the monitoring site ( 300 ). The imaging device may include sensor film or sensing technology (e.g. sensor spot, chemical coating, etc.) ( 303 ). A secondary camera ( 306 ) and a tertiary camera ( 309 ) may also be included, with the potential for the cameras to have a receiver/transmitter ( 307 ,  308 ) for communication. A main unit ( 310 ) may include a user interface ( 313 ), a primary camera ( 316 ), a processor ( 319 ) for processing image data, audible and/or visual alarms ( 322 ,  325 ), a power unit ( 328 ) and a main processor ( 331 ). The main unit ( 310 ) may also include a receiver/transmitter ( 329 ) to communicate with the supplemental cameras, or it may utilize communication lines ( 332 ,  334 ) to communicate with the supplemental cameras. The imaging technology may utilize spectroscopy technologies for sensing oxygen. When the oxygen reaches a certain level, a warning may be triggered. 
     In a fifth embodiment, the presence of oxygen may be detected by utilizing properties of light. A device ( 402 ) having a reflector/receiving pad ( 403 ) and a user interface ( 406 ) may be provided at the monitoring site ( 400 ). The device ( 402 ) may also include a receiver/transmitter ( 407 ) to communicate with the main unit ( 410 ). A main unit ( 410 ) may be provided with a user interface ( 413 ), a main processor ( 416 ), a data/light processor ( 419 ) for processing light properties or data received from the reflector/receiving pad ( 403 ). A wavelength/photon source ( 422 ) generates light for transmission to the reflector/receiving pad. The main unit ( 410 ) operates the overall system. 
     A sixth exemplary of the present disclosure provides an apparatus for sensing during medical procedures. The apparatus includes a surgical device, and a control unit comprising a user interface, a power unit, a motor, a warning element, a processor, and a memory including computer program instructions, the user interface operable to select between an on or off setting for the apparatus, the power unit operable to connect with a power source. The apparatus further includes a sensor located on at least one of the surgical device and the control unit, the sensor operable to sense a presence of gases, and a conduit comprising a vacuum tube fluidly coupled to the surgical device and the control unit, and a communication line operable to transmit electronic signals between the surgical device, the control unit and the sensor, wherein the power unit operable to provide power to the surgical device, the control unit and the sensor, and wherein the motor is operable to urge a fluid to pass from the surgical device through the conduit to the control unit. 
     A seventh exemplary embodiment of the present disclosure provides an apparatus for sensing during medical procedures. The apparatus includes a remote sensing device comprising a user interface, a sensor, a processor, a memory including computer program instructions, a receiver, and a transmitter, the processor with the memory including the computer program instructions being operable to control the user interface, the sensor, the receiver, and the transmitter. The apparatus further includes a control unit comprising a control user interface, a power unit, a warning element, control receiver, a control transmitter, a control processor, and a control memory including control computer program instructions, the user interface operable to select between an on or off setting for the apparatus, the power unit operable to connect with a power source, wherein the remote sensing device with the receiver and the transmitter is operable to communicate with the control unit with the control receiver and the control transmitter, wherein the sensor is operable to sense a presence of gases relative to the remote sensing device, and wherein the control processor with the control memory including the control computer program instructions is operable to active the warning element in response to sensed gas. 
     An eighth exemplary embodiment of the present disclosure provides apparatus for sensing during medical procedures. The apparatus includes a monitoring device including a user interface and a reflector pad. The apparatus further includes a control unit comprising a control user interface, a power unit, a processor, a memory including computer program instructions, a photon emitter, a light processor, and a warning element, wherein the photon generate light for transmission to the reflector pad, wherein the reflector pad is operable to reflect light received from the photon emitter to the light processor, wherein the light processor with the processor and the memory including computer program instructions are operable to determine a presence of oxygen between the monitoring device and the control unit. 
     A ninth exemplary embodiment of the present disclosure provides an apparatus for sensing during medical procedures. The apparatus includes a remote sensing device including a user interface, a sensor, a processor, a memory including computer program instructions, a receiver, and a transmitter, the processor with the memory including the computer program instructions being operable to control the user interface, the sensor, the receiver, and the transmitter. The apparatus further includes a control unit comprising a control user interface, a power unit, a warning element, control receiver, a control transmitter, a control processor, and a control memory including control computer program instructions, the user interface operable to select between an on or off setting for the apparatus, the power unit operable to connect with a power source, wherein the remote sensing device with the receiver and the transmitter is operable to communicate with the control unit with the control receiver and the control transmitter, wherein the sensor is operable to sense a presence of gases relative to the remote sensing device, and wherein the control processor with the control memory including the control computer program instructions is operable to active the warning element in response to sensed gas. 
     The following will describe embodiments of the present disclosure, but it should be appreciated that the present disclosure is not limited to the described embodiments and various modifications of the invention are possible without departing from the basic principle. The scope of the present disclosure is therefore to be determined solely by the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a block diagram of a first embodiment of the invention shown in connection with an electrosurgical device. 
         FIG. 2  is a block diagram of an alternate embodiment of the invention shown in connection with a laparoscopic procedure utilizing a trocar. 
         FIG. 3  is a block diagram of a remote sensing system of the present invention. 
         FIG. 4  is a block diagram of an imaging system of the present invention. 
         FIG. 5  is a block diagram of a detection system utilizing properties of light. 
         FIG. 6  is a block diagram of an alternate embodiment with one or more sensors for detecting the concentration levels at the monitoring site. 
         FIG. 7  is a block diagram of an alternate embodiment where the system pulls air from the surgical site to the main housing where it detects the concentration levels. 
         FIG. 8  is a block diagram of an alternate embodiment operable to sense within a patient airway. 
         FIG. 9  presents an exemplary remote sensing system for performing exemplary embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     At the outset, it should be clearly understood that like reference numerals are intended to identify the same structural elements, portions or surfaces consistently throughout the several drawing figures, as such elements, portions or surfaces may be further described or explained by the entire written specification, of which this detailed description is an integral part. Unless otherwise indicated, the drawings are intended to be read (e.g., cross-hatching, arrangement of parts, proportion, debris, etc.) together with the specification, and are to be considered a portion of the entire written description of this invention. As used in the following description, the terms “horizontal”, “vertical”, “left”, “right”, “up” and “down”, as well as adjectival and adverbial derivatives thereof, (e.g., “horizontally”, “rightwardly”, “upwardly”, etc.), simply refer to the orientation of the illustrated structure as the particular drawing figure faces the reader. Similarly, the terms “inwardly” and “outwardly” generally refer to the orientation of a surface relative to its axis of elongation, or of rotation, as appropriate. 
     The purpose of the device is to monitor the concentration of oxygen in medical environments for the purposes of providing a warning for elevated oxygen concentrations and mitigating risks of fires due to elevated oxygen levels. Based on the sensors utilized, the device of the present invention may also be used to identify potential fire hazards due to other gases or chemicals. 
     Referring now to the drawings, and more particularly to  FIG. 1  thereof, this invention provides an electrosurgical device  10  having a cutting blade  13 , a user interface  16  for selecting between on/off and cut/coagulate functions, and a vacuum tube  19  for evacuation of surgical smoke. An example of an electrosurgical device  10  is shown in U.S. Pat. No. 9,289,261 which is incorporated herein by reference. The electrosurgical device  10  may also be provided with visual and audible warning indicators  22 ,  25 . As shown, the electrosurgical device  10  will be located in a monitoring/surgical site  28 . The electrosurgical device  10  may also include a sensor  31 . The sensor  31  may be designed to detect oxygen concentrations at the monitoring/surgical site  28 . The sensor  31  may also be designed to detect the presence of other gases or chemicals or properties. Some examples of technologies for targeting oxygen, and/or other gases/chemicals include: luminescence spectroscopy; imaging (e.g., hyperspectral, multispectral, etc.); electrochemical; paramagnetic; Quartz Crystal Microbalancing (QCM); Quantum Dots (QD&#39;s)/indicator strips or dots; ultrasonic; and utilizing refractive properties of light. Some examples of sensor technologies for targeting temperature include: thermocouples; thermistors; Resistive Temperature Devices (RTD); integrated silicone based sensor; infrared (pyrometers); Bragg Grating; Interferometric; Raman (DTS); Brillouin (DTSS); and thermal pile. Sensors for gases include, but are not limited to: CO 2 , CO and alcohol. 
     Data from the sensor  31  may be transferred along communication lines  35  to a main control unit  38 . The main unit  38  (or control unit) includes processors for interacting with the electronics on board the electrosurgical device and for processing the data received from the sensor. The main unit  38  may include a user interface  41 . The main unit  38  may include a smoke evacuation system ( 65 ) to remove surgical smoke and debris from the surgical site and/or an electro surgical system ( 68 ) to control an electrosurgical device ( 10 ). Also, the main unit  38  may include visual and audible warning indicators  48  and  51 . The main unit  38  also includes a sensor module  54  for communicating with the sensor(s)  31  and processing the data received. The sensor module  54  may also communicate with the main electronics. The unit  38  may also include a main electronics board  59  for handling the whole system (i.e., controlling the electrosurgical device, controlling the smoke evacuation system, utilizing data received from the sensor  31 , and triggering the audible warning and/or warning light). A power unit  62  provides power for the entire system. 
     Turning to  FIG. 2 , a monitoring site  100  such as a surgical area for a laparoscopic procedure is shown. A trocar  103  may be inserted into a cavity of a patient for a laparoscopic procedure. The trocar  103  may provide for insufflation of the cavity through an insufflator or the like via air transmission line  107  and main unit  112 . The pressurization of the cavity such as a peritoneal cavity provides space for manipulating instruments inside the cavity. While the insufflator introduces gas into the cavity, gases are removed from the cavity through an outlet that conveys the gas through a filter  106 . The filter removes smoke and debris from the gas. The gas may be conveyed to the main unit  112  through air transmission line  107  where it may enter a sensor  115  to test for oxygen levels, the presence of other gases, temperature or the like. The main unit  112  may be provided with electrical output, fiber optic, or other data transmission lines  118  (or conduit) for sending warning signals to visual warnings  121  and/or auditory warnings  124 , disposed in the surgical theater near the monitoring site  100 . The main unit  112  may be provided with a user interface  127 , a sensor processing unit  130 , a power unit  133 , a pump  136  for drawing gas from the surgical site, an audible warning  139  and a visual warning  142 . The unit  112  includes a main processor  145  that provides for controlling the overall functionality and processing of the system. 
     Turning to  FIG. 3 , the present invention may also provide for remote sensing features for a sensing system. The remote sensor  200  may be provided with sensing film or sensing technology (e.g., sensor spot, chemical coating, etc.), and a processor  202  to control the functions of the remote sensor  200  (e.g., user interface  201 , audible warning  206 , warning light  209 , and receiver/transmitter  210 ). The remote sensor  200  may also transmit a wireless signal via receiver/transmitter  210  to a main processing unit  212  disposed at a remote location. The main processing unit  212  may include a receiver/transmitter  213  for communicating with the remote sensor  200  via wireless signal. The main processing unit  212  may also include a user interface  215 , a sensor processing module  218 , a power unit  221 , a main electronics board  224 , audible warnings  227 , and/or visual warnings  230 . 
     Turning to  FIG. 4 , the present invention may also provide an imaging device is utilized to view the monitoring site  300 . The imaging device may include sensor film or sensing technology (e.g., sensor spot, chemical coating, etc.)  303 . A secondary camera  306  and a tertiary camera  309  may also be included, with the potential for the cameras to have a receiver/transmitter  307 ,  308  for communication. A main unit  310  may include a user interface  313 , a primary camera  316 , a processor  319  for processing image data, audible and/or visual warning  322 ,  325 , a power unit  328  and a main processor  331 . The main unit  310  may also include a receiver/transmitter  329  to communicate with the supplemental cameras, or it may utilize communication lines  332 ,  334  to communicate with the supplemental cameras  306 ,  309 . The imaging technology may utilize spectroscopy technologies for sensing oxygen. When the oxygen reaches a certain level, a warning may be triggered. 
     In  FIG. 5 , the presence of oxygen may be detected by utilizing properties of light. A device having a reflector/receiving pad  403  and a user interface  406  may be provided at the monitoring site  400 . The device may also include a receiver/transmitter  407  to communicate with the main unit  410 . A main unit  410  may be provided with a user interface  413 , a main processor  416 , a data/light processor  419  for processing light properties or data received from the reflector/receiving pad  403 . A wavelength/photon source  422  generates light for transmission to the reflector/receiving pad. The main unit  410  operates the overall system. 
     In  FIG. 6 , illustrated is a block diagram of an alternate embodiment wherein the system is operable to pull air from the surgical site to the main housing where it detects the concentration levels of oxygen and/or other gases. The embodiment illustrated in  FIG. 6  can be used in laparoscopic surgery as well as any other type of surgery. Shown in  FIG. 6  is filter  606  located at monitoring site  600  operable to remove smoke and debris from a gas. Also optionally shown at monitoring site  600  is warning light  604  and audible warning  602 . Filter  606  is fluidly coupled to air transmission line  608 , which is also fluidly coupled to main unit  612 . Warning light  604  and audible warning  602  are coupled to light transmission line  610  which is coupled to main unit  612 . Main unit  612  includes a main electronics board  620 , which includes a processor and a memory including computer program instructions. Main unit  612  also includes warning light  614 , audible warning  616 , pump  618 , power unit  620 , sensor module  626 , user interface  624  and sensor  622 . 
     Power unit  620  provides power to main unit  612 . Main electronics board  620  with its processor and memory including computer program instructions is operable to control each of the elements of main unit  612 . Pump  618  may include a motor operable to urge air or gas to pass through filter  606  through air transmission line  608 . User interface  624  any combination of displays and on/off switches for operating the entire device shown in  FIG. 6 . Sensors  622  are operable to sense oxygen or gas concentration levels. Sensor module  626  is operable to interpret the sensed data. It should be appreciated that sensor module  626  may be included with main electronics board  620  as part of the processor. 
     Referring to  FIG. 7 , illustrated is a block diagram of an alternate embodiment with one or more sensors for detecting the concentration levels of oxygen and/or other gases at the monitoring site or surgical site. Shown in  FIG. 7  is monitoring site  700  such as a surgical area or area of a patient that is of medical interest. Sensors  704  are operable to be located at the monitoring site  700 . Sensors  704  may be operable to detect oxygen concentrations or whether oxygen concentrations or other gases at the monitoring site  700  are above a predetermined threshold. An exemplary threshold would be a concentration of oxygen which is indicative of an environment with enough oxygen to become flammable. Sensors  704  may also be operable to detect the presence of other gases, or chemicals at or relative to monitoring site  700 . Included with sensors  704  at the monitoring site  700  are audible warning element  706  and warning light  702 . It should be appreciated that embodiments include presence or absence of audible warning element  706  and warning light  702 . Data from sensor  704  may be transferred along data/light transmission line  708  to main unit  710 . The main unit  710  shown in  FIG. 7  is operable to process the information from the one or multiple sensors. The main unit  710  include a main electronics board  718 , which may include a processor and a memory including computer program instructions for controlling the system depicted in  FIG. 7 , utilizing data received from sensors  704 , determining whether the data received from sensors  704  is above a predetermined threshold, and triggering the audible warning and/or warning lights. Main unit  710  also includes a power unit  716  operable to provide power for the entire system illustrated in  FIG. 7 . Also shown within main unit  710  are warning light  712 , audible warning  714 , sensor module  720 , and user interface  722 . 
     User interface  722  include on/off buttons for operating the main unit  710 . Sensor module  720  is operable for communicating with the sensors  704  and processing the data received. The sensor module  720  may also communicate with the main electronics of main unit  710 . 
     In practice, sensors  704  are operable to be located at a monitoring site  700  (e.g., a surgical site) to sense a centration of oxygen or other gases. Sensors  704  are operable to transmit through data/light transmission line  708  the sensed centration levels to main unit  710 . Main unit  710  with its main electronics board  718  having a process  711 , memory  713  including computer program instructions are operable to determine whether the to activate the warning light  712  and/or the audible warning  714  if the sensed oxygen or other gases are above a predetermined threshold. The main unit  710  is also operable to activate audible warning  706  and warning light  702  should they be present in the system. 
     Reference is now made to  FIG. 8 , which depicts an alternate embodiment of a device operable to sense or detect the concentration levels of oxygen and/or other gases within or around an endotracheal intubation tube. Shown in in  FIG. 8  is airway  800 , which is representative of a person&#39;s airway (e.g., throat airway passage). Temperature sensing element  802  and fiber optic sensing element  804  are operable to be placed through airway  800 . For example temperature sensing element  802  may include a tube shaped thermometer device and fiber optic sensing element  804  may also tube shaped such that they are able to be located down a person&#39;s throat passages; or may be attached/embedded in an endotracheal tube. Temperature sensing element  802  and fiber optic sensing element  804  are coupled and in communication with main unit  806 . Main unit  806  includes a main electronics board  814 , power unit  812 , warning light  808 , audible warning  810 , user interface  816 , sensor processing  818  and signal transmitter/receiver  820  for communicating with temperature sensing element  802  and fiber optic sensing element  804 . Main electronics board  814  may include a processor and a memory including computer program instructions. Embodiments of the temperature sensing element  802  and fiber optic sensing element  804  are operable to be attached or integrated in an endotracheal intubation tube. In other embodiments, the device shown in  FIG. 8  can be attached to other medical instrumentation or equipment. In yet another embodiment, the device shown in  FIG. 8  is standalone. In some embodiments, the device includes a shield or protective covering for the endotracheal intubation tube. 
     Embodiment of the device in  FIG. 8  is operable to sense a temperature with temperature sensing element  802  or with fiber optic sensing element  804 . It is then operable to transmit the sensed data to main unit  814  at which point the processor with the memory and computer program instructions are operable to determine whether to activate the warning light  808  and/or the audible warning  810 . In one embodiment, the warning light  808  and/or audible warning  810  are activated in response to the sensed data being above a predetermined threshold. 
     Referring to  FIG. 9 , shown is an exemplary sensing device  900  operable for sensing at a monitoring site. Shown in  FIG. 9  is communication line  904  coupled to sensors  906 . Communication line  904  is operable to be connected to main unit  902  (or control unit). Main unit  902  includes an on/off switch, a processor, a memory including computer program instructions, and warning lights. The processor is operable to receive sensor data from sensors  906  and to determine whether concentrations of gas or oxygen are above a predetermined threshold. If the concentrations are above a predetermined threshold, the processor is operable to activate the warning lights. 
     The sensors disclosed in the present invention, in addition to mounting on the trocar or electrosurgical device, may be incorporated into surgical drapes defining the perimeter of the surgical site for the surgical procedure. 
     The present invention contemplates that many changes and modifications may be made. Therefore, while the presently-preferred form of the sensor system has been shown and described, and several modifications and alternatives presented, persons skilled in this art will readily appreciate that various additional changes and modifications may be made without departing from the spirit of the invention, as defined and differentiated by the following claims.