Patent Grant
11737819
The present invention relates generally to a system and method for applying energy for the treatment of tissue, and more particularly to a system and method for an improved graphical user interface that provides independent control of multiple radiofrequency probes during an ablation procedure.
Lower back injuries and chronic back pain are a major health problem resulting not only in a debilitating condition for the patient, but also in the consumption of a large proportion of funds allocated for health care, social assistance and disability programs. Disc abnormalities and pain may result from trauma, repetitive use in the workplace, metabolic disorders, inherited proclivity, or aging. The existence of adjacent nerve structures and innervation of the disc are very important issues with respect to patient treatment for back pain.
A minimally invasive technique of delivering high-frequency electrical current has been shown to relieve localized pain in many patients. Generally, the high-frequency current used for such procedures is in the radio frequency (RF) range, i.e. between 100 kHz and 1 GHz and more specifically between 300-600 kHz. The RF electrical current is typically delivered from a generator via a plurality of connected electrodes that are placed in a patient's body, in a region of tissue that contains a neural structure suspected of transmitting pain signals to the brain. The electrodes generally include an insulated shaft with an exposed conductive tip to deliver the radio frequency electrical current. Tissue resistance to the current causes heating of tissue adjacent resulting in the coagulation of cells (at a temperature of approximately 45° C. for small unmyelinated nerve structures) and the formation of a lesion that effectively denervates the neural structure in question. Denervation refers to a procedure whereby the ability of a neural structure to transmit signals is affected in some way and usually results in the complete inability of a neural structure to transmit signals, thus removing the pain sensations.
To extend the size of a lesion, radiofrequency treatment may be applied in conjunction with a cooling mechanism, whereby a cooling means is used to reduce the temperature of the tissue near an energy delivery device, allowing a higher voltage to be applied without causing an unwanted increase in local tissue temperature. The application of a higher voltage allows regions of tissue further away from the energy delivery device to reach a temperature at which a lesion can form, thus increasing the size/volume of the lesion.
Such procedures can be done using any suitable number of probes (e.g., from one probe up to four probes), or more, at a time. If one of the probes encounters a condition that causes the probe to stop during its procedure, however, the probe remains inactive until all remaining probes have completed their procedures. Once the other probes have completed their procedures, a user can troubleshoot the problem probe and restart the problem probe's procedure. Unfortunately, such workflow requires the user to waste valuable time waiting for procedures to finish, adding probe procedure times together, which extends the overall time that the patient must endure the treatment procedure.
A graphical user interface can be provided on a display screen to allow the user to control the various procedures. However, the size of the graphical user interface is practically limited by the size of the display screen. For each probe that is communicatively coupled with the controller, multiple pieces of information are often displayed in the graphical user interface. This can lead to visual clutter and inhibit an operator or physician from locating significant data within the interface. Additionally, current interfaces can allow the operator or physician to adjust aspects of the treatment procedures in ways that are unsafe for the patient.
Thus, the present disclosure is directed to systems and methods for an improved graphical user interface that provides independent control of multiple radiofrequency probes during an ablation procedure.
Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.
In one aspect, the present disclosure is directed to a system for delivering energy to a patient's body. The system can includes a plurality of probes each having an elongate member with a distal region having an electrically non-conductive outer circumferential portion and a proximal region. Each of the plurality of probes further includes an electrically conductive energy delivery device extending distally from the electrically non-conductive outer circumferential portion for delivering one of electrical and radiofrequency energy to the patient's body. The energy delivery devices further include an electrically conductive outer circumferential surface. The system also includes a touch-sensitive display screen and a controller communicatively coupled to each of the plurality of probes and the touch-sensitive display screen. The controller includes memory and a processor. The memory stores instructions that, when executed by the processor, cause the processor to perform operations including displaying a virtual control object in the user interface of the touch-sensitive display screen. The virtual control object is associated with an operating parameter of a treatment procedure performed by the probe. The operations include detecting a user touch action directed to the virtual control object. The operations include performing a control action associated with the treatment procedure that includes adjusting the operating parameter associated with the virtual control object when the user touch action directed to the virtual control object is detected. The operations include converting the virtual control object into a non-control label based, at least in part, on a current status of the treatment procedure. The controller is configured to prohibit adjustment of the operating parameter using the non-control label in response to a user touch action that is directed to the non-control label.
In a particular embodiment, the virtual control object is converted into the non-control object when adjusting the operating parameter associated with the virtual control object would be unsafe for the patient.
In a particular embodiment, the virtual control object is converted into the non-control object in response to at least one of the treatment procedure being initiated or the time remaining associated with the treatment procedure being less than a predetermined time threshold.
In a particular embodiment, converting the virtual control object into the non-control label includes changing a visual characteristic of the virtual control object. The visual characteristic can include at least one of a color, size, brightness, font, location, or contrast of the virtual control object.
In a particular embodiment, converting the virtual control object into the non-control label includes changing a location of the virtual control object within the user interface.
In a particular embodiment, the controller may be further configured to display a second non-control label in the user interface that is separate from the virtual control object and non-control label. The second non-control label can have a visual characteristic that is distinct from the virtual control object.
In another aspect, the present disclosure is directed to a system for delivering energy to a patient's body. The system includes a plurality of probes each including an elongate member having a distal region with an electrically non-conductive outer circumferential portion and a proximal region. Each of the plurality of probes further includes an electrically conductive energy delivery device extending distally from said electrically non-conductive outer circumferential portion for delivering at least one of electrical or radiofrequency energy to the patient's body and having an electrically conductive outer circumferential surface. The system includes a touch-sensitive display screen and a controller communicatively coupled to each of the plurality of probes and the touch-sensitive display screen. The controller includes memory and a processor. The memory stores instructions that, when executed by the processor, cause the processor to perform operations including determining whether an operating parameter of a treatment procedure that is being performed by at least one of the plurality of probes qualifies as contextually important based, at least in part, on a status of the treatment procedure. The operations include displaying an urgent label within a user interface of the touch-sensitive display that includes real-time values of the operating parameter.
In a particular embodiment, the urgent label includes real-time values of the operating parameter.
In a particular embodiment, the operations can include displaying a non-urgent label that describes the operating parameter when it is determined that the operating parameter does not qualify as contextually important.
In a particular embodiment, the operations can further include displaying a non-urgent label that is separate from the urgent label. The urgent label can have a visual characteristic that is distinct from the non-urgent label. As examples, the visual characteristic can include at least one of size, color, brightness, font, location, or contrast.
In a particular embodiment, the operations can further include converting the urgent label to a non-urgent label when it is determined that the operating parameter no longer qualifies as contextually important based, at least in part, on the current phase of the treatment procedure.
In some embodiments, the operating parameter can include at least one of impedance, time remaining, or temperature at a distal region of the at least one of the plurality of probes. In such embodiments, the operating parameter can qualify as contextually important when the status of the treatment procedure includes actively delivering at least one of electrical and radiofrequency energy to the patient's body.
In another aspect, the present disclosure is directed to a method for delivering energy to a patient's body using a probe. The method includes displaying, by one or more control devices, a virtual control object within a user interface of a touch-sensitive display screen. The virtual control object is associated with an operating parameter of a treatment procedure performed by the probe. The operations include detecting, by the one or more control devices, a user touch action directed to the virtual control object; when the user touch action directed to the virtual control object is detected, performing, by the one or more control devices, a control action associated with the treatment procedure that includes adjusting the operating parameter associated with the virtual control object; and converting, by the one or more control devices, the virtual control object into a non-control label based, at least in part, on a current status of the treatment procedure, wherein the controller is configured to prohibit adjustment of the operating parameter using the non-control label in response to a user touch action that is directed to the non-control label.
In a particular embodiment, the urgent label is visually emphasized with at least one of a color, size, contrast, or brightness, as compared with surrounding portions of the user interface.
In a particular embodiment, the virtual control object is converted into the non-control object when adjusting the operating parameter associated with the virtual control object would be unsafe for the patient.
In a particular embodiment, converting the virtual control object into the non-control label includes changing a visual characteristic of the virtual control object. The visual characteristic can include at least one of a color, size, brightness, font, location, or contrast of the virtual control object.
In a particular embodiment, the controller may be further configured to display a second non-control label in the user interface that is separate from the virtual control object and non-control label. The second non-control label can have a visual characteristic that is distinct from the virtual control object.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, explain the principles of the invention.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which refers to the appended figures, in which:
Reference will now be made in detail to one or more embodiments of the invention, examples of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the invention include these and other modifications and variations as coming within the scope and spirit of the invention.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
For the purposes of this invention, a lesion refers to any effect achieved through the application of energy to a tissue in a patient's body, and the invention is not intended to be limited in this regard. Furthermore, for the purposes of this description, proximal generally indicates that portion of a device or system next to or nearer to a user (when the device is in use), while the term distal generally indicates a portion further away from the user (when the device is in use).
According to one aspect of the present disclosure, a controller can be communicatively to a plurality of probes and a touch-sensitive display screen. The controller can be configured to display a user interface on the touch-sensitive display that allows the user to control (e.g., start, stop, adjust) aspects of the treatment procedures performed with the probes. For example, in some embodiments, the controller may display a virtual control object (e.g., a button) that permits control of an operating parameter, such as a target probe temperature. However, it may be disadvantageous to adjust various parameters at different times before or during the treatment procedures. For example, it may be unsafe to adjust a target temperature for the probe tip once the treatment procedure has been started. The controller may be configured to convert virtual control objects into non-control labels based on a current status of the treatment procedure. The controller may be configured to prohibit adjustment of the operating parameter using the non-control label in response to a user touch action that is directed to the non-control label.
For example, when the treatment procedure is initiated, the controller may convert a virtual control object that is configured to adjust the target temperature into a non-control label that displays the target temperature. In another example, the controller may be configured to convert a virtual control object that is configured to stop the treatment procedure into a non-control label when it becomes unsafe for the patient for the treatment procedure to be stopped.
Virtual control objects and non-control labels may have differing visual characteristics such that an operator or physician can easily distinguish the virtual control objects from the non-control labels. Example visual characteristics include color, size, brightness, font, location, or contrast.
In some embodiments, the controller may be configured to display operating parameters to the operator and/or physician in an intelligent manner based on the contextual importance of the respective parameter. The controller can be configured to determine whether a given operating parameter qualifies as contextually important based, at least in part, on a status of the treatment procedure. The controller may display an urgent label that includes real-time values of the operating parameter (e.g., critical values) when it is determined that the operating parameter qualifies as contextually important. For example, the various operating parameters (e.g., current temperature of the probe tip, time remaining) may qualify as contextually important during the treatment procedure, but may not qualify before the treatment procedure is initiated. Thus, the controller may intelligently display real-time values of contextually important operating parameters based on the status of the treatment procedure. The status of the treatment procedure can also include other information, such as the difference between the operating parameter and an associated threshold or critical value. One of ordinary skill in the art would understand that the contextual importance of the operating parameters can depend on a variety of information associated with the status of the treatment procedure.
Urgent labels and non-urgent labels may have differing visual characteristics such that an operator or physician can easily distinguish the urgent labels from the non-urgent labels. Example visual characteristics include color, size, brightness, font, location, or contrast. For instance, urgent labels (e.g., critical values) can be displayed in larger font (e.g., 30 point font or larger) to be legible to a physician who is not directly next to the display screen, for example, standing six feet away or more. The non-urgent labels (e.g., non-critical values) can be displayed in a smaller font (e.g., 10-18 point font or smaller) such that a technician standing close to the display screen (e.g., one to two feet) can read the non-urgent labels. As such, the non-urgent labels can provide information to the technician without adding visual clutter for the physician.
Additionally, in some embodiments, information displayed on the user interface (e.g., urgent labels, non-urgent labels, virtual control objects, non-control objects) may be color coded such that the operator and/or physician can easily classify the information. For example, a plurality of channel control regions can be displayed within the user interface, and each channel control region can correspond with one or more of the plurality of probes. Each channel control region can have an associated color. Information displayed within each channel control region may be displayed in the respective color of each channel control region. However, controls (e.g., virtual control objects) may be displayed in a color that is distinct from the respective colors of the plurality of channel control regions. As an example, four channel control regions may be displayed. Information in a first channel control region may be displayed in orange; information in a second channel control region may be displayed in green; information in a third channel control region may be displayed in blue; and information in a third channel control region may be displayed in purple. However, virtual control objects may be displayed within two or more of the channel control regions in white to visually distinguish the virtual control objects from other portions of the channel control region (e.g., the non-control labels).
In some embodiments, an alarm and/or warning window may be displayed within a channel to indicate an unsatisfactory condition with the associated treatment procedure. For example, the controller may be configured to detect when an operating parameter (e.g., an actual temperature, impedance, power output, etc.) has exceeded a threshold associated with the operating parameter. Depending on the severity of the problem, the controller may automatically stop the treatment procedure and display an alarm or may provide a warning to the user. Such alarms and/or warning may be displayed in a color that is distinct from the colors of the channel control regions. Additionally, the channel control region and/or alarm window may be outlined or emphasized in a color that is distinct from the colors of the channel control regions, such as red or white. The alarm and/or warning may include information displayed in the same color as the outline or another color that is distinct from the colors of the channel control regions, such as yellow. In some embodiments, warnings may include text displayed in one color (e.g., yellow), and alarms may include text displayed in a different color (e.g., white).
In some embodiments, if all channel control regions become inoperative such that energy is not delivered to the plurality of probes, a “global alarm” may be displayed. The global alarm may include a window that is superimposed over two or more of the channel control regions. Two or more of the channel control regions may be darkened (e.g., faded to black) to emphasize the global alarm. The global alarm may include a message displayed in a color that provides a high contrast with a background of the message (e.g., white text over a black background).
Referring now to the drawings,
The controller 103 may correspond to any suitable processor-based device(s), such as a computing device or any combination of computing devices. Thus, in several embodiments, the controller 103 may include one or more processor(s) and associated memory device(s) configured to perform a variety of computer-implemented functions. As used herein, the term “processor” refers not only to integrated circuits referred to in the art as being included in a computer, but also refers to a controller, a microcontroller, a microcomputer, a programmable logic controller (PLC), an application specific integrated circuit, and other programmable circuits. Additionally, the memory device(s) of the controller 103 may generally comprise memory element(s) including, but not limited to, computer readable medium (e.g., random access memory (RAM)), computer readable non-volatile medium (e.g., a flash memory), a compact disc-read only memory (CD-ROM), a magneto-optical disk (MOD), a digital versatile disc (DVD) and/or other suitable memory elements. Such memory device(s) may generally be configured to store suitable computer-readable instructions that, when implemented by the processor(s) configure the controller 103 to perform various computer-implemented functions, such as one or more aspects of the methods 800, 900 described below with reference to
In addition, as shown, a distal region 124 of the cable 104 may include a splitter 130 that divides the cable 104 into two distal ends 136 such that the probes 107 can be connected thereto. A proximal end 128 of the cable 104 is connected to the generator 102. This connection can be permanent, whereby, for example, the proximal end 128 of the cable 104 is embedded within the generator 102, or temporary, whereby, for example, the proximal end 128 of cable 104 is connected to generator 102 via an electrical connector. The two distal ends 136 of the cable 104 terminate in connectors 140 operable to couple to the probes 107 and establish an electrical connection between the probes 107 and the generator 102. In alternate embodiments, the system 100 may include a separate cable for each probe assembly 106 being used to couple the probes 107 to the generator 102. Alternatively, the splitter 130 may include more than two distal ends. Such a connector is useful in embodiments having more than two devices connected to the generator 102, for example, if more than two probe assemblies are being used.
The cooling device(s) 108 may include any means of reducing a temperature of material located at and proximate to one or more of the probes 107. For example, as shown in
Referring to
The controller 103 may be configured for facilitating communication between the cooling devices 108 and the generator 102. In this way, feedback control is established between the cooling device(s) 108 and the generator 102. The feedback control may include the generator 102, the probes 107 and the cooling devices 108, although any feedback between any two devices is within the scope of the present invention. The feedback control may be implemented, for example, in a control module which may be a component of the generator 102. In such embodiments, the generator 102 is operable to communicate bi-directionally with the probes 107 as well as with the cooling devices 108. In the context of this invention, bi-directional communication refers to the capability of a device to both receive a signal from and send a signal to another device.
As an example, the controller 103 may receive temperature measurements from one or more of the plurality of probes 107. Based on the temperature measurements, the generator 102 may perform some action, such as modulating the power that is sent to the probes 107 (e.g., using one or more control loops). More specifically, aspects of the treatment procedures performed by the various probes 107 may be actively controlled, for example using a control loop (e.g., proportional-integral or proportional-integral-derivative control loop) based on information received by one or more sensors. For example, an amount of energy delivered through the energy delivery devices 192 may be controlled. The flow rate of the peristaltic pumps 122 and resulting cooling may also be actively controlled. In further embodiments, the generator 102 may control the energy delivered to the tissue based on the measured temperature measured by the temperature sensing element(s) 402 (see
More specifically, the pumps may communicate a fluid flow rate to the controller 103 and may receive communications from the controller 103 instructing the pumps to modulate this flow rate. In some instances, the peristaltic pumps may respond to the controller 103 by changing the flow rate or turning off for a period of time. With the cooling devices 108 turned off, any temperature sensing elements associated with the probes 107 would not be affected by the cooling fluid allowing a more precise determination of the surrounding tissue temperature to be made. In addition, when using more than one probe assembly 106, the average temperature or a maximum temperature in the temperature sensing elements associated with probes 107 may be used to modulate cooling.
In other embodiments, the cooling devices 108 may reduce the rate of cooling or disengage depending on the distance between the probes 107. For example, when the distance is small enough such that a sufficient current density exists in the region to achieve a desired temperature, little or no cooling may be required. In such an embodiment, energy is preferentially concentrated between the energy delivery devices 192 through a region of tissue to be treated, thereby creating a strip lesion. A strip lesion is characterized by an oblong volume of heated tissue that is formed when an active electrode is near a return electrode of similar dimensions. This occurs because at a given power, the current density is preferentially concentrated between the electrodes and a rise in temperature results from current density.
The cooling devices 108 may also communicate with the controller 103 to alert the controller 103 to one or more possible errors and/or anomalies associated with the cooling devices 108. For example, if cooling flow is impeded or if a lid of one or more of the cooling devices 108 is opened. The controller 103 may then act on the error signal by at least one of alerting a user, aborting the procedure, and modifying an action.
Still referring to
In addition, as shown in
Further, in several embodiments, the distal supply tube connector 166 may be a male luer-lock type connector and the distal return tube connector 168 may be a female luer-lock type connector. Thus, the proximal supply tube connector 116 may be operable to interlock with the distal supply tube connector 166 and the proximal return tube connector 118 may be operable to interlock with the distal return tube connector 168.
The probe cable connector 172 may be located at a proximal end of the probe assembly cable 170 and may be operable to reversibly couple to one of the connectors 140, thus establishing an electrical connection between the controller 103 and the probe assembly 106. The probe assembly cable 170 may include one or more conductors depending on the specific configuration of the probe assembly 106. For example, in one embodiment, the probe assembly cable 170 may include five conductors allowing probe assembly cable 170 to transmit RF current from the controller 103 to the one or more energy delivery devices 192 as well as to connect multiple temperature sensing devices to the controller 103 as discussed below.
The energy delivery devices 192 may include any means of delivering energy to a region of tissue adjacent to the distal tip region 190. For example, the energy delivery devices 192 may include an ultrasonic device, an electrode or any other energy delivery means and the invention is not limited in this regard. Similarly, energy delivered via the energy delivery devices 192 may take several forms including but not limited to thermal energy, ultrasonic energy, radiofrequency energy, microwave energy or any other form of energy. For example, in one embodiment, the energy delivery devices 192 may include an electrode. The active region of the electrode may be 2 to 20 millimeters (mm) in length and energy delivered by the electrode is electrical energy in the form of current in the RF range. The size of the active region of the electrode can be optimized for placement within an intervertebral disc, however, different sizes of active regions, all of which are within the scope of the present invention, may be used depending on the specific procedure being performed. In some embodiments, feedback from the controller 103 may automatically adjust the exposed area of the energy delivery device 192 in response to a given measurement such as impedance or temperature. For example, in one embodiment, the energy delivery devices 192 may maximize energy delivered to the tissue by implementing at least one additional feedback control, such as a rising impedance value.
Referring in detail to
Further, as shown, the temperature sensing element 402 of each probe 107 protrudes beyond the energy delivery device 192. Placing the temperature sensing elements 402 at this location, rather than within a lumen 450 defined by the energy delivery device 192, is beneficial because it allows the temperature sensing element 402 to provide a more accurate indication of the temperature of tissue proximate to the energy delivery device 192. This is due to the fact that, when extended beyond the energy delivery device 192, the temperature sensing element 402 will not be as affected by the cooling fluid flowing within the lumen 450 as it would be were it located within lumen 450. Thus, in such embodiments, the probe assembly 106 includes a protrusion protruding from the distal region of the probe assembly, whereby the protrusion is a component of the temperature sensing element 402. Referring still to
In addition, the probe assembly 106 may further include a thermal insulator 430 located proximate to any of the temperature sensing elements 402, 404. As such, the thermal insulator 430 may be made from any thermally insulating material, for example silicone, and may be used to insulate any temperature sensing element from other components of the probe assembly 106, so that the temperature sensing element will be able to more accurately measure the temperature of the surrounding tissue. More specifically, as shown, the thermal insulator 430 is used to insulate the temperature sensing element 404 from cooling fluid passing through the shaft supply tube 302 and the shaft return tube 304.
In further embodiments, the probe assembly 106 may also include a radiopaque marker 440 incorporated somewhere along the elongate shaft 184. For example, as shown in
Further, as shown, the elongate shaft 184 and the electrode 192 overlap to secure the electrode in place. In this embodiment, the lumen defined by the elongate shaft 184 and the electrode 192 at this portion of the distal tip region 190 contains a radiopaque marker 440 made of silver solder, which fills the lumen such that any cooling fluid supplied to the probe assembly 106, that is not located within one of the cooling tubes described earlier, is confined to the distal tip region 190 of probe assembly 106. Thus, in such an embodiment, the silver solder may be referred to as a flow impeding structure since it functions to restrict the circulation of fluid to a specific portion (in this case, at least a portion of distal region 190) of the probe assembly 106.
In other words, cooling fluid may flow from the cooling devices 108, through the cooling supply tubes to the distal tip region 190 of the probe assembly 106. The cooling fluid may then circulate within the lumen 450 defined by the electrode 192 to provide cooling thereto. As such, the internally-cooled probe as described herein is defined as a probe having such a configuration, whereby a cooling medium does not exit probe assembly 106 from a distal region of probe assembly 106. The cooling fluid may not circulate further down the elongate shaft 184 due to the presence of the silver solder, and flows through the cooling return tubes back to the cooling devices 108. In alternate embodiments, other materials may be used instead of silver solder, and the invention is not limited in this regard. As described above, providing cooling to the probes 107 allows heat delivered through the energy delivery devices 192 to be translated further into the tissue without raising the temperature of the tissue immediately adjacent the energy delivery device 192.
As mentioned above, the system 100 of the present invention may further include one or more introducer tubes. Generally, introducer tubes may include a proximal end, a distal end, and a longitudinal bore extending therebetween. Thus, the introducer tubes (when used) are operable to easily and securely couple with the probe assembly 106. For example, the proximal end of the introducer tubes may be fitted with a connector able to mate reversibly with handle 180 of probe assembly 106. An introducer tube may be used to gain access to a treatment site within a patient's body and a hollow elongate shaft 184 of a probe assembly 106 may be introduced to said treatment site through the longitudinal bore of said introducer tube. Introducer tubes may further include one or more depth markers to enable a user to determine the depth of the distal end of the introducer tube within a patient's body. Additionally, introducer tubes may include one or more radiopaque markers to ensure the correct placement of the introducers when using fluoroscopic guidance.
The system may also include one or more stylets. A stylet may have a beveled tip to facilitate insertion of the one or more introducer tubes into a patient's body. Various forms of stylets are well known in the art and the present invention is not limited to include only one specific form. Further, as described above with respect to the introducer tubes, the stylets may be operable to connect to a power source and may therefore form part of an electrical current impedance monitor. In other embodiments, one or more of the probe assemblies 106 may form part of an electrical current impedance monitor. Thus, the controller 103 may receive impedance measurements from one or more of the stylets, the introducer tubes, and/or the probes 107 and may perform an action, such as alerting a user to an incorrect placement of an energy delivery device 192, based on the impedance measurements.
If not imminent, as shown at 614, the cooling rate can be increased, e.g. by increasing the pump speed (e.g. via the RPM controllers 125) of the peristaltic pumps 122 as shown at 616. After the cooling rate is increased, the ablation 600 continues. If a rising impedance event is imminent, as shown at 618, the cooling rate can be reduced, e.g. by decreasing the pump speed (e.g. via the RPM controllers 125) of the peristaltic pumps 122 as shown at 620. In other words, in several embodiments, the peristaltic pumps 122 may be independently controlled via their respective RPM controllers 125 to alter the rate of cooling to each electrode 192 of the probes 107. In such embodiments, the power supply 126 of the pump assembly 120 may be decoupled, at least in part, from the generator 102. Further, as shown, the system 550 operates using closed-loop feedback control 634, 636.
Once the energy dosage threshold is satisfied, as shown at 622, the treatment procedure is configured to check if the thermal dosage threshold has been satisfied as shown at 624. If the thermal dosage has not been satisfied, as shown at 626, the treatment procedure proceeds through the independent temperature-power feedback control loop as shown at 628. More specifically, in certain embodiments, the amount of energy delivered through the energy delivery device 192 may be controlled by defining a predetermined threshold temperature for treating the tissue, ramping up the temperature of the tissue via the generator 102 through the energy delivery device 192 to the predetermined threshold temperature, and maintaining the temperature of the tissue at the predetermined threshold temperature to create a lesion in the tissue. In such embodiments, the temperature of the tissue may be maintained at the predetermined threshold temperature as a function of at least one of a power ramp rate, an impedance level, an impedance ramp rate, and/or a ratio of impedance to power.
Only when the thermal dosage threshold has been satisfied, as shown at 630, the procedure terminates as shown at 632. Thus, the system and method of the present disclosure provides the unique features of probe(s) with inherently high-power demand (i.e. short thermocouple protrusion), a pump-modulated power algorithm, a preset energy dosage or total average power threshold, and/or a rising impedance detection engine 610.
Following treatment, energy delivery and cooling may be stopped and the probes 107 are removed from the introducers, where used. A fluid such as an antibiotic or contrast agent may be injected through the introducers, followed by removal of the introducers. Alternatively, the distal tips of the probes 107 may be sharp and sufficiently strong to pierce tissue so that introducers may not be required. As mentioned above, positioning the probes 107, and more specifically the energy delivery devices 192, within the patient's body, may be assisted by various means, including but not limited to fluoroscopic imaging, impedance monitoring and tactile feedback. Additionally, some embodiments of this method may include one or more steps of inserting or removing material into a patient's body.
A system of the present invention may be used in various medical procedures where usage of an energy delivery device may prove beneficial. Specifically, the system of the present invention is particularly useful for procedures involving treatment of back pain, including but not limited to treatments of tumors, intervertebral discs, facet joint denervation, sacroiliac joint lesioning or intraosseous (within the bone) treatment procedures. Moreover, the system is particularly useful to strengthen the annulus fibrosus, shrink annular fissures and impede them from progressing, cauterize granulation tissue in annular fissures, and denature pain-causing enzymes in nucleus pulposus tissue that has migrated to annular fissures. Additionally, the system may be operated to treat a herniated or internally disrupted disc with a minimally invasive technique that delivers sufficient energy to the annulus fibrosus to breakdown or cause a change in function of selective nerve structures in the intervertebral disc, modify collagen fibrils with predictable accuracy, treat endplates of a disc, and accurately reduce the volume of intervertebral disc tissue. The system is also useful to coagulate blood vessels and increase the production of heat shock proteins.
Using liquid-cooled probes 107 with an appropriate feedback control system as described herein also contributes to the uniformity of the treatment. The cooling distal tip regions 190 of the probes 107 helps to prevent excessively high temperatures in these regions which may lead to tissue adhering to the probes 107 as well as an increase in the impedance of tissue surrounding the distal tip regions 190 of the probes 107. Thus, by cooling the distal tip regions 190 of the probes 107, higher power can be delivered to tissue with a minimal risk of tissue charring at or immediately surrounding the distal tip regions 190. Delivering higher power to energy delivery devices 192 allows tissue further away from the energy delivery devices 192 to reach a temperature high enough to create a lesion and thus the lesion will not be limited to a region of tissue immediately surrounding the energy delivery devices 192 but will rather extend preferentially from a distal tip region 190 of one probe assembly 106 to the other.
Referring to
In several embodiments, each of the channel control regions 143 may also include one or more individual parameter control objects 200 for allowing the user to control aspects of the treatment procedures. Each individual parameter control object 200 can be used to adjusting the respective associated operating parameter. Example operating parameters include a target temperature, a duration time, target impedance, target power delivery, etc.
More specifically, the controller 103 can be configured to detect a user touch action directed to a virtual control object (e.g., an individual parameter control object 200) that has an associated operating parameter (e.g., target temperature, duration time, etc.). The controller 103 can be configured to perform a control action associated with the treatment procedure (e.g., by adjusting the operating parameter). For example, as illustrated in
Referring to
As an example, the controller 103 may be configured to convert the virtual control object 200 into the non-control label 202 when adjusting the operating parameter associated with the virtual control object 200 would be unsafe for the patient. For example, in some circumstances it may be unsafe to adjust one or more specific operating parameters once the treatment procedure has been initiated or at various stages during the treatment procedure. For instance, the virtual control object 200 can be converted into the non-control label 202 when the treatment procedure associated with the respective control channel 143 is initiated.
As shown in
Referring again to
As another example, the controller 103 may be configured to convert the virtual control object into the non-control object in response to a time remaining of the treatment procedure being less than a predetermined time threshold. Referring to
In some embodiments, one or more virtual control object(s) 200 and one or more non-control label(s) 202 can be displayed within the same control region 143. The non-control label(s) 202 can have visual characteristics that are distinctive from the one or more virtual control object(s) 200 such that the user can quickly and easily discern which portions of the user interface 124 are responsive to user touch actions and/or which operating parameters can currently be adjusted.
In some embodiments, converting the virtual control object 200 into the non-control label 202 can include changing a location of the virtual control object within the user interface 142. For example, non-control labels may generally be grouped in a first region of the user interface 142 and virtual control objects can be grouped in a second region of the user interface 142 to visually distinguish the non-control labels from the virtual control objects. Referring to
Still referring to
In some embodiments, the controller 103 can display non-urgent label(s) that are associated with operating parameters that are determined to be not contextually important. As an example, before starting the treatment procedure, a current probe temperature may not be contextually important. As such, a non-urgent label 210 may be displayed that includes the current probe temperature. However, the current impedance measured at the probe 107 may qualify as contextually important at times before and during the treatment procedure. As such, urgent labels 212 that include the current impedance (e.g., real-time values of the current impedance) may be displayed in channel control regions 143 that correspond with both inactive treatment procedures and with active treatment procedures. As yet another example, during performance of the treatment procedure, the current power level may not qualify as contextually important during an active treatment procedure. As such, a non-urgent label 214 may be displayed that includes the current power level.
It should be understood the whether a given operating parameter qualifies as contextually important can change based on the status of the treatment procedure. For example, before the treatment procedure has been initiated, the controller 103 certain operating parameters may automatically qualify as contextually important (e.g., target temperature, duration time). Once the treatment procedure has been initiated at least one of the current impedance, time remaining, or temperature at a distal tip region 190 of the at least one of the plurality of probes 107 may automatically qualify as contextually important. Once a ramp up period has been successfully completed, a different set of operating parameters than during the ramp up period can automatically qualify as contextually important.
As another example, the target temperature and/or duration time of the procedure may qualify as contextually important before the treatment procedure is initiated, and respective urgent labels 216 may be displayed (for example as shown in channel “A” in
In some embodiments, whether a given operational parameter qualifies as contextually important can depend on various other characteristics of the treatment procedure, such as type, mode (e.g., monopolar, bipolar), duration, location of the probes within the patient's body, etc. One or ordinary skill in the art should understand that yet further variations are possible within the scope of this disclosure.
It should also be understood that whether a given operating parameter qualifies as contextually important can change during the treatment procedure. For example, in some embodiments, whether an operating parameter qualifies as contextually important may depend on a comparison between real-time values of the operating parameter and a target value or threshold value associated with the operating parameter. For example, when a monitored operating parameter, such as impedance, deviates from a target impedance value by more than a predetermined amount (or whether rising impedance is likely to occur as described with reference to
In some embodiments, determining whether an operating parameter qualifies as contextually important may be based, at least in part, on whether the information would be important to the physician performing the treatment procedure. As such, in some embodiments, criteria for contextual importance can be set or modified by the physician. The physician generally stands further away from the display screen 123 than a technician or operator. As an example, the physician generally views the display screen 123 from a distance of six or more feet, while the operator generally views the display screen 123 from a distance of one to two feet such that the operator can easily touch the display screen 123 or otherwise engage with controls, for example, to adjust aspects of the treatment procedures. As such, information that is likely to be important to the physician may qualify as contextually important, and, as a result may be displayed using an urgent label such that the urgent label is more visible to the physician than a non-urgent label. For example the urgent label may be bold, larger in size (e.g., 30 point size font or larger) or be displayed in a color with high contrast with have a background color of the user interface 142. In comparison, the non-urgent label may be less bold, smaller (e.g., 10-18 point size font or smaller), and/or displayed with less contrast than the urgent label.
In some embodiments, an alarm and/or warning window 220 may be displayed within a channel control region 143 to indicate an unsatisfactory condition with the associated treatment procedure. For example, the controller 103 may be configured to detect when an operating parameter (e.g., an actual temperature, impedance, power output, etc.) has exceeded a threshold associated with the operating parameter. Depending on the severity of the problem, the controller may automatically stop the treatment procedure and display an alarm or may provide a warning to the user without stopping the treatment procedure. Such alarms and/or warning may be displayed in a color that is distinct from the colors of the channel control regions. Additionally, the channel control region and/or alarm window may be outlined or emphasized in a color that is distinct from the colors of the channel control regions, such as red or white. The alarm and/or warning may include information displayed in the same color as the outline or another color that is distinct from the colors of the channel control regions, such as yellow. In some embodiments, warnings may include text displayed in one color (e.g., yellow), and alarms may include text displayed in a different color (e.g., white).
The alarm window 220 may include a restart button 165 and/or sliding start bar 163 for re-starting the treatment procedure associated with the channel control region 143. The alarm window 220 may also include a stop button 169 for stopping the treatment procedure, if it has not been automatically stopped.
In some embodiments, if all channel control regions become inoperative such that energy is not delivered to the plurality of probes, a “global alarm” may be displayed. The global alarm may include a window that is superimposed over two or more of the channel control regions. Two or more of the channel control regions may be darkened (e.g., faded to black) to emphasize the global alarm. The global alarm may include a message displayed in a color that provides a high contrast with a background of the message (e.g., white text over a black background).
In one embodiment, the plurality of probes 107 may be operated in a bipolar mode. For example,
Referring to
The method 800 may include, at (802), displaying a virtual control object that is associated with an operating parameter of a treatment procedure in the user interface of the touch-sensitive display screen, for example as described above with reference to
The method may include, at (804), detecting a user touch action directed to the virtual control object, for example as described above with reference to
The method may include, at (806), performing a control action associated with the treatment procedure that include adjusting the operating parameter associated with the virtual control object when the user touch action directed to the virtual control object is detected, for example as described above with reference to
The method may include, at (808), converting the virtual control object into a non-control label based, at least in part, on a current status of the treatment procedure, and the controller may be configured to prohibit adjustment of the operating parameter using the non-control label in response to a user touch action that is directed to the non-control label, for example as described above with reference to
Referring to
The method 900 may include, at (902), determining whether an operating parameter of a treatment procedure that is being performed with at least one of the plurality of probes qualifies as contextually important based, at least in part, on a status of the treatment procedure, for example as described above with reference to
The method 900 may include, at (904), displaying an urgent label within a user interface of the touch-sensitive display that includes real-time values of the operating parameter when it is determined that the operating parameter qualifies as contextually important, for example as described above with reference to
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5334181 | Rubinsky et al. | Aug 1994 | A |
| 5819741 | Karlsson et al. | Oct 1998 | A |
| 5871481 | Kammemberg et al. | Feb 1999 | A |
| 5954719 | Chen et al. | Sep 1999 | A |
| 6356790 | Maguire et al. | Mar 2002 | B1 |
| 6625482 | Panescu et al. | Sep 2003 | B1 |
| 6679269 | Swanson | Jan 2004 | B2 |
| 7122031 | Edwards et al. | Oct 2006 | B2 |
| 8603087 | Rubinsky et al. | Dec 2013 | B2 |
| 8657814 | Werneth et al. | Feb 2014 | B2 |
| 8845630 | Mehta et al. | Sep 2014 | B2 |
| 9005128 | Imamura et al. | Apr 2015 | B2 |
| 9008793 | Cosman, Sr. et al. | Apr 2015 | B1 |
| 9308372 | Sparks et al. | Apr 2016 | B2 |
| 9333031 | Salahieh et al. | May 2016 | B2 |
| 9393071 | Boveja et al. | Jul 2016 | B1 |
| 9427284 | Moss et al. | Aug 2016 | B2 |
| 9495059 | Shikhman et al. | Nov 2016 | B2 |
| 9510887 | Burnett et al. | Dec 2016 | B2 |
| 9510909 | Grant et al. | Dec 2016 | B2 |
| 9522048 | Schmit et al. | Dec 2016 | B1 |
| 9532831 | Reinders et al. | Jan 2017 | B2 |
| 9547752 | Sandhu et al. | Jan 2017 | B2 |
| 9592387 | Skelton et al. | Mar 2017 | B2 |
| 9597145 | Nelson et al. | Mar 2017 | B2 |
| 10216985 | White et al. | Feb 2019 | B2 |
| 20030112390 | Chen et al. | Nov 2003 | A1 |
| 20050177209 | Leung et al. | Aug 2005 | A1 |
| 20050177211 | Leung | Aug 2005 | A1 |
| 20070129633 | Lee et al. | Jun 2007 | A1 |
| 20090138011 | Epstein | May 2009 | A1 |
| 20100016926 | Rittman, III | Jan 2010 | A1 |
| 20110172659 | Brannan | Jul 2011 | A1 |
| 20120209314 | Weir | Aug 2012 | A1 |
| 20120260293 | Young et al. | Oct 2012 | A1 |
| 20130018368 | Chan et al. | Jan 2013 | A1 |
| 20130030426 | Gallardo et al. | Jan 2013 | A1 |
| 20130138097 | Mathur et al. | May 2013 | A1 |
| 20130165919 | Epstein | Jun 2013 | A1 |
| 20130335441 | Zalev et al. | Dec 2013 | A1 |
| 20140330266 | Thompson et al. | Nov 2014 | A1 |
| 20150057945 | White et al. | Feb 2015 | A1 |
| 20150182740 | Mickelsen | Jul 2015 | A1 |
| 20150297282 | Cadouri | Oct 2015 | A1 |
| 20150320478 | Cosman, Jr. | Nov 2015 | A1 |
| 20150320481 | Cosman, Jr. et al. | Nov 2015 | A1 |
| 20160048635 | Warner et al. | Feb 2016 | A1 |
| 20160354142 | Pearson et al. | Dec 2016 | A1 |
| 20170049513 | Cosman, Jr. et al. | Feb 2017 | A1 |
| 20170065352 | Razzaque et al. | Mar 2017 | A1 |
| 20180085188 | Boutoussov et al. | Mar 2018 | A1 |
| 20180110554 | Zarins et al. | Apr 2018 | A1 |
| 20180206922 | Wenderow | Jul 2018 | A1 |
| 20190083169 | Single et al. | Mar 2019 | A1 |
| 20190262071 | Thom | Aug 2019 | A1 |
| 20190269367 | Reinders | Sep 2019 | A1 |
| 20200015879 | McGregor et al. | Jan 2020 | A1 |
| 20200085531 | Harrison | Mar 2020 | A1 |
| Number | Date | Country |
|---|---|---|
| 1 749 492 | Feb 2007 | EP |
| 2 942 023 | Nov 2015 | EP |
| 2012129542 | Sep 2012 | WO |
| WO 2013134133 | Sep 2013 | WO |
| WO 2014144359 | Sep 2014 | WO |
| WO 2016090175 | Jun 2016 | WO |
| WO 2018116273 | Jun 2018 | WO |
| WO 2018200254 | Nov 2018 | WO |
| Entry |
|---|
| International Search Report and Written Opinion dated Nov. 4, 2020, from International Application No. PCT/US2020/032647, 19 pages. |
| Number | Date | Country | |
|---|---|---|---|
| 20200367963 A1 | Nov 2020 | US |
