Source: https://patents.justia.com/patent/10179247
Timestamp: 2019-08-21 23:32:51
Document Index: 474679021

Matched Legal Cases: ['§ 1040', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'art 20', 'artz\n4665927']

US Patent for Interstitial laser therapy control system Patent (Patent # 10,179,247 issued January 15, 2019) - Justia Patents Search
Justia Patents Laser ApplicationUS Patent for Interstitial laser therapy control system Patent (Patent # 10,179,247)
Feb 4, 2008 - Novian Health, Inc.
An interstitial laser therapy control system is disclosed. The control system includes a thermistor controller apparatus, a microprocessor, a storage device, at least one input device, a display, an electro-mechanical shutter switch, an electro-mechanical emergency shutoff switch, and an electro-mechanical master power switch. The microprocessor is configured to monitor temperatures detected by one or more thermistors connected to the thermistor controller. Based on the temperatures, the microprocessor determines when treatment has been successful and when application of laser energy needs to be halted. The control system also enables an operator to pause and resume treatment using the input device. The electro-mechanical shutter switch sends a signal to a laser source to close a shutter on the laser. The electro-mechanical emergency stop button causes power to be cut off to the laser source. The electro-mechanical master power switch shuts off power to all components in the interstitial laser therapy apparatus.
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The present disclosure relates in general to an interstitial laser therapy control system, an in particular to a control system including a thermistor controller, a computer, and one or more electro-mechanical buttons or switches for controlling and monitoring application of interstitial laser energy to a tumor, and for determining when to stop applying such interstitial laser energy.
Interstitial laser treatments of tissue (such as tumors) including malignant tumors (such as breast, liver, brain, and neck tumors), have been in development for more than a decade. For example, U.S. Pat. No. 5,169,396, U.S. Pat. No. 5,222,953, U.S. Pat. No. 5,569,240, U.S. Pat. No. 5,853,366, U.S. Pat. No. 6,603,988, U.S. Pat. No. 6,701,175, U.S. Pat. No. 6,865,412, U.S. Pat. No. 7,041,109, and U.S. Pat. No. 7,171,253 disclose various apparatus and methods for performing interstitial laser treatments of tumors. Certain of these patents disclose laser probes and thermal probes for conducting interstitial laser energy treatment. Certain of these patents disclose other apparatus for conducting interstitial laser treatments. There is a need for a control system for facilitating control of the interstitial laser apparatus during interstitial laser therapy.
The control system of the present disclosure controls the amount of ablative laser energy applied to a tissue of interest, monitors the progress of an interstitial laser treatment, shuts off a laser source if temperatures above a maximum treatment temperature are detected, and provides an operator various software controlled and electro-mechanical input options for halting or otherwise controlling the application of laser energy to the tissue of interest. It should be appreciated that the control system monitors and controls the amount of laser energy applied based on temperatures detected in the center of a tissue of interest such as a tumor mass, as well as adjacent to the tissue of interest. In one embodiment, the control system includes a computer including a microprocessor, a storage device, and at least one input device, a thermistor controller, and a plurality of electro-mechanical switches. The control system also includes software stored on the storage device and executable by the microprocessor for monitoring the treatment and the patient during treatment. The thermistor controller enables the control system to monitor and act based on the temperatures detected in and around the tissue of interest. It should be appreciated that for purposes of brevity of this application, the tissue of interest to be treated will sometimes be referred to as the “treated tissue” and sometimes be referred to as the “tumor”; however, it should be appreciated that the present disclosure is not limited to the treatment of tumors. It should be appreciated that in different embodiments, the interstitial laser therapy control system is used to monitor interstitial laser energy delivered to tissue other than tumors.
In one embodiment, the control system of the present disclosure includes various electrical and electro-mechanical components that monitor temperature and enable operator control of interstitial laser treatments. In this embodiment, the control system includes a thermistor controller for receiving data representing the resistance detected at one or more thermistors and converting the data to temperature data, a microprocessor, a storage device such as a hard disk, at least one input device such as a mouse, a display device, and at least one electro-mechanical switch or button. In one embodiment, the microprocessor is configured to send and receive signals from a laser source to enable the microprocessor to control the amount of laser energy delivered by the laser source. The laser source in various embodiments is a diode laser source. It should be appreciated that any appropriate laser source is contemplated by the control system disclosed herein. The microprocessor is also configured to receive signals from the thermistor controller representing temperatures detected in the tumor and the tissue adjacent to the tumor. In this embodiment, the storage device stores software which when executed by the microprocessor sends signals to the laser source based on the temperatures detected in the tumor or the tissue adjacent to the tumor. The at least one electro-mechanical switch or button enables an operator to also send a signal directly to the laser source to stop generating laser energy, or to deprive the laser source of electricity, thereby preventing it from generating laser energy (and thus effectively stopping treatment).
In one embodiment, the microprocessor and the storage device are part of a computer. In this embodiment, the at least one input device such as a mouse is connected to the computer, as is the display. The microprocessor is configured to execute software stored on the storage device to control and monitor interstitial laser therapy. In one embodiment, the software is configured to enable an operator to manage a patient database stored on the storage device. In this embodiment, the software is configured to prevent an operator from performing an interstitial laser treatment unless the patient on whom the treatment is to be performed is represented in the database.
The control system is also configured to enable an operator to provide a kit identifier, such as one or more of a series of control numbers, serial numbers, and lot numbers from an interstitial laser therapy kit. In one embodiment, the microprocessor is configured to determine whether the kit including a laser probe, a thermal probe, two probe holders, an optical fiber, and a kit identifier has already been used to perform interstitial laser therapy. In different embodiments, the microprocessor simply checks a database stored on the storage device to determine whether the kit identifier as entered has already been stored. If the kit has not been previously used, the control system enables the operator to perform interstitial laser therapy using the kit combined with an interstitial laser therapy apparatus and monitored and controlled by the control system.
In one embodiment, the microprocessor is configured to control an interstitial laser treatment by monitoring the temperature of the tumor and the tissue adjacent to the tumor and determining whether laser energy may be safely applied. The microprocessor in different embodiments also displays various reminders to the operator, such a reminder to turn on an infusion pump. In these embodiments, the microprocessor is configured to receive as input temperatures from the thermistor controller indicating temperatures detected in the tumor in the tissue adjacent to the tumor. In one embodiment, the temperatures detected by each thermistor are displayed by the display device in real time as a bar in a bar chart. In this embodiment, the control system enables the operator to visually monitor the relative temperatures of each thermistor simultaneously. In one embodiment, the operator ultimately decides based on the displayed temperature data whether to increase or decrease laser energy or saline flow. In this embodiment, the microprocessor sends a signal to the laser source if certain predetermined conditions are met to turn off the laser source.
In another embodiment, the microprocessor is configured to perform calculations about any changes in the amount of ablative laser energy or saline solution flow rate that should be applied to the tumor to result in successful ablation. In this embodiment, the microprocessor is configured to send signals to the laser source causing the laser source to provide more or less ablative laser energy, or to generate and display a message to the operator to manually alter the rate of saline infusion.
In different embodiments, the control system monitors an interstitial laser treatment to determine whether treatment is successful. In these embodiments, the control system includes a variable indicating number of non-functional thermistors that must detected to automatically stop treatment. If the thermistor controller indicates during treatment that the maximum number of non-functional thermistors value has been reached, the control system causes the laser source to stop generating laser energy.
In one embodiment, the control system determines that treatment is successful when the temperatures detected by all of the functional thermistors in tissue adjacent to the tumor have reached a certain, predetermined minimum successful treatment temperature. In different embodiments, the control system determines that treatment is successful when one or more but less than all the thermistors measuring temperatures in the tissue adjacent to the tumor detect a temperature in excess of the predetermined minimum successful treatment temperature.
It should be appreciated that after treatment has been terminated (i.e., the laser source is no longer applying laser energy to the tissue of interest), the control system in one embodiment continues to monitor tissue temperatures of tissue around or adjacent to the tissue of interest. This enables an operator to determine when the tissue has cooled enough to safely remove the probes from the tissue.
In one embodiment, if the temperature detected at the tip of the laser probe exceeds a certain predetermined maximum temperature, the control system causes a signal to be sent to the laser source to cause the laser source to cease generating laser energy. In one embodiment, the laser source only resumes applying laser energy after the operator selects a resume treatment button with the mouse or other input device.
In one embodiment, the control system enables an operator to select a pause treatment button using the mouse or other input device during interstitial laser treatment. Selecting the pause treatment button causes the control system to send a signal to the laser source to cause the laser source to stop generating laser energy. In different embodiments, after the control system pauses treatment, it enables an operator to select a resume treatment button with the mouse or other input device. When selected, the resume treatment button causes the control system to send a signal causing the laser source to continue applying laser energy to the tumor. It should be appreciated that in these embodiments, the control system continues to monitor temperatures of thermistors in the tumor and in tissue adjacent to the tumor.
In different embodiments, the control system also includes electro-mechanical buttons or switches that enable the operator to control application of laser energy by mechanically causing the control system to send signals to the laser source. In these embodiments, the signals are sent to the laser source regardless of whether the microprocessor is responsive to selections made with the mouse or other input device. It should be appreciated that the electro-mechanical buttons or switches redundantly enable the control system to prevent laser energy from being applied to the tumor during treatment. In one embodiment, the control system includes an electro-mechanical shutter switch, an electro-mechanical emergency shutoff button, and an electro-mechanical master power switch.
In one embodiment, the control system includes an electro-mechanical shutter switch mounted on an enclosure housing the electronic components of an interstitial laser therapy apparatus. In this embodiment, actuating the electro-mechanical shutter switch causes a signal to be sent to the laser source that causes the laser source to cease generating laser energy. In one embodiment, the signal causes the laser source to close a shutter over the laser beam that prevents laser energy from being transmitted through an optical fiber. It should be appreciated that in various embodiments, actuating the shutter switch does not turn the power of the laser source off—it merely causes a signal to be sent to the laser source that prevents a laser beam from being generated. In certain embodiments, actuating the electro-mechanical shutter switch also causes a signal to be sent to the microprocessor that causes the microprocessor to generate and display a message indicating that treatment has been paused. In this embodiment, actuating the electro-mechanical shutter switch functions identically to selecting the pause treatment button provided by the control system. In this embodiment, the control system continues monitoring and displaying the temperature detected at each thermistor of the laser and/or thermal probes. The control system also enables an operator to select a resume treatment button to resume treatment after the electro-mechanical shutter switch has been actuated.
The control system in one embodiment also includes an electro-mechanical emergency shutoff button. In one embodiment, the electro-mechanical emergency shutoff button is a red mushroom palm button prominently located and easily accessible on the enclosure of the interstitial laser therapy apparatus. Actuating the electro-mechanical emergency shutoff button causes a signal to be generated and sent to the laser source which turns off the power of the laser source. Actuating the electro-mechanical emergency shutoff button therefore enables the operator to guarantee that interstitial laser energy is no longer applied to the tissue of interest. In one embodiment, actuating the electro-mechanical emergency shutoff button does not cause the control system to send a signal to the microprocessor indicating that laser energy is no longer being applied to the tumor. However, in one embodiment, the microprocessor is configured to detect after a few seconds of the laser source being powered off that the laser source is no longer in communication with the microprocessor. When the microprocessor detects failed communication with the laser source, the control system generates and displays a message indicating that the laser source is unresponsive and that treatment has been paused. In one embodiment, the control system does not enable the operator to resume treatment after actuating the electro-mechanical emergency stop button.
The control system includes an electro-mechanical master power switch in one embodiment. Actuating the master power switch causes power to be turned off to all the components of the interstitial laser therapy apparatus. Since the power to the microprocessor is also turned off, actuating the electro-mechanical master power switch disables further tracking of the treatment by the control system. It should be appreciated that in different embodiments, the interstitial laser therapy apparatus includes an Uninterruptable Power Supply (UPS). In these embodiments, actuating the electro-mechanical master power switch shuts off power to all components of the interstitial laser therapy apparatus immediately regardless of whether a UPS is present. In different embodiments, actuating the electro-mechanical master power switch does not immediately cause all the components of the interstitial laser therapy apparatus to turn off—rather, at least one component (i.e., the computer) continue receiving power from the UPS for a few seconds or a few minutes.
It should thus be appreciated that the control system enables an operator to initiate, perform, monitor, and record the results of an interstitial laser treatment. It should be further appreciated that the control system determines when treatment is successful, determines when treatment needs to be stopped for potential safety concerns, and enables an operator to stop treatment with certainty by actuating any one of one or more electro-mechanical switches or buttons.
It is therefore an advantage of the present disclosure to provide a control system that monitors interstitial laser treatment and determines whether to stop treatment based on temperatures indicated by thermistors in tissue around the tissue of interest. It is a further advantage of the present disclosure to provide a control system that enables an operator to monitor an interstitial laser treatment and stop the treatment if necessary.
FIG. 2A is a diagrammatic view of the thermistor controller.
FIG. 2B is a diagrammatic view of the laser source including the shutter of the laser source.
Interstitial Laser Therapy Apparatus
Referring now to the drawings, and particularly to FIG. 1, one embodiment of a platform for the disclosed interstitial laser therapy apparatus and the interstitial laser therapy kit is shown. As illustrated in FIG. 1, an imaging device or unit such as a conventional rotatable or positionable digital mammography device or unit 12 provides a platform for the interstitial laser therapy apparatus. The mammography unit 12 includes a suitable stereotactic device or unit 14. It should be appreciated that the imaging device or unit may be any suitable device or unit including but not limited to x-ray, ultrasound, or magnetic resource imaging devices. It should also be appreciated that the stereotactic device or unit 14 may be any suitable device or unit. The illustrated stereotactic device 14 includes conventional aligned extendable probe holder attachments 16a and 16b, suitably attached at the bottom of the stereotactic device 14. The illustrated stereotactic device 14 includes a compression plate 18 suitably attached at the bottom of the stereotactic device 14 below the upper and lower probe holder attachments 16a and 16b. For ease of illustration, FIG. 1 shows a saline bag instead of a body part (such as a breast) containing the tumor which would be treated using the interstitial laser therapy apparatus.
In one embodiment, the thermistor controller (as generally shown in FIG. 2A) and associated hardware receives a signal from the thermistors positioned within the tumor being treated or in tissue adjacent to the treated tissue. In different embodiments, the thermistor controller, the computer 110, the keyboard 208, the mouse 206, and the display 112 comprise a control system for controlling application of interstitial laser energy and monitoring an interstitial laser treatment. The thermistor controller converts data received from one or more thermistors (which typically indicates a resistance in the thermistor that varies as the temperature of the thermistor changes) into one or more numbers indicating the temperature detected by the thermistor. The thermistor controller sends the converted temperature data to the computer 110 for processing, as discussed below. In different embodiments, the thermistor controller is configured to receive readings from multiple thermistors simultaneously. In one embodiment, the thermistor controller is configured to receive resistance data from six thermistors and convert the resistance data to temperature data. In this embodiment, the thermistor controller sends data to the microprocessor as a set of thermistor temperature data. That is, the thermistor controller communicates the temperature data to the microprocessor as sets of data about the thermistors in the probes. In different embodiments, the thermistor temperature data set includes one or more thermistor temperatures and an indication that one or more thermistors is not functioning properly. Thus, the data contained in the thermistor temperature data set enables the microprocessor to determine the temperatures detected by the thermistors as well as whether the thermistors are functioning properly.
In one embodiment, the laser source 108 includes a compact, computer-controlled diode laser source which is coupled to an optical fiber delivery system. The laser source 108 in one embodiment is a diode laser source that delivers 805 nm light radiation. In one embodiment, the laser 108 is classified as a Class IV medical laser as described in 21 C.F.R. § 1040.10(b)(11) by the U.S. Center for Devices and Radiological Health (CDRH). Therefore, the apparatus disclosed includes a laser source 108 with software-limited power of 8 watts continuous wave (CW). Further, the apparatus in one embodiment includes a protective case which prevents unintended human exposure to laser radiation above Class I limits, a safety shutter (as generally shown in FIG. 2B) that prevents laser energy from exiting the instrument except during operation, and appropriate warning labels. In one embodiment, the shutter covers the optical emission point of the laser energy such that when the shutter is closed, laser energy cannot be emitted even if the laser source 108 is powered on. In this embodiment, when the shutter is opened, the laser source 108 emits laser energy. In different embodiments, the laser source 108 is configured to send one or more signals to a microprocessor to communicate the status of the laser source. In one embodiment, the laser source sends messages indicating whether it is emitting laser energy and whether the shutter is open or closed. In different embodiments, the laser source also sends a signal indicating the amount of energy being emitted. The laser source 108 in different embodiments is also configured to respond to one or more signals sent by a microprocessor, such as heartbeat signals, signals requesting the laser source 108 to close the shutter, or signals requesting that the laser source 108 change the amount of laser energy being emitted. It should be appreciated that in different embodiments, laser sources that are not diode laser sources with the above specifications can be used to perform interstitial laser treatment. For example, a YAG laser source may be used to provide interstitial laser energy. For convenience, the any suitable laser source for performing interstitial laser therapy will be referred to throughout this application as a “laser source.”
Laser Type Diode Laser Laser Class Class 4 Max Power Output 8 W Wavelength 805 nm ± 15 nm Mode of Operation Continuous wave Optical Output Multimode Calibration Internal, automatic, ±20%
Power Source 120 V~12 A 60 Hz Nominal Voltage 120-240 V AC Nominal Frequency 50-60 Hz Nominal Current 12 A max Electrical shock protection Metal case-grounded Class I Equipment Protective grounding including hospital grade plug and outlet Patient Connection Type BF patient-connected laser and thermal probe 102s.
Height 51 in Depth 32 in Width 24 in Weight (est.) 250 lbs (with cart 20) Power cord length 12 ft Ordinary Protection Not protected against ingress of moisture. Operating Environment 10°-40° C., 0-80% RH, decreasing linearly to 50% RH at 40° C. Altitude Sea level to 2,000 meters. Probe Type Disposable, single use probes
Referring to FIGS. 3 and 3A, in different embodiments, the laser probe 100 is constructed from hollow 14 gauge 304 stainless steel and includes a cannula 100a and a stylet 100b. In some such embodiments, the cannula 100a is a trocar, which enables an operator to pierce a patient's skin using the tip of the cannula. The laser probe also includes a thermistor TL 100e located on the tip of the laser probe 100, mounted externally to the cannula 100a. It should be appreciated that in different embodiments, the laser probe 100 does not include a thermistor TL, or includes a thermistor TL 100e which is not mounted externally to the cannula 100a. In various embodiments in which the laser probe 100 includes a thermistor TL, the laser probe 100 includes a laser probe wire 100c that connects the thermistor to the laser probe connector 100d. The probe is configured to be insertable through at least one laser probe channel in each probe holder 50 and 52. Moreover, the hollow cannula 100a is configured so that when the stylet 100b is removed from the cannula 100a, the optical fiber 116 and a quantity of saline solution are insertable in the cannula 100a. The laser probe thermistor wire 100c is configured to communicate a signal indicating the resistance detected by the laser probe thermistor to the thermistor controller contained in cart 20. Laser probe connector 100d is configured to be insertable in laser probe connector socket 28 on connector box 24 to connect the laser probe thermistor wire 100c to the thermistor controller. It should be appreciated that in different embodiments, the laser probe includes a cannula without a trocar which is configured to receive the stylet. In these embodiments, the operator makes an incision with a scalpel or other appropriate cutting tool such that the laser probe 100 is insertable in the tumor mass. Alternatively, if the operator performs a biopsy prior to inserting the laser probe 100 as discussed below, a cannula without a stylet (not shown) is insertable in the cavity left by the biopsy. In still other embodiments, the laser probe 100 does not include the stylet 100b. In such embodiments, the operator performs a biopsy prior to inserting the laser probe 100 as discussed below; thus, the stylet is not necessary to pierce the skin and enable the laser probe 100 to be inserted.
In one embodiment, illustrated in FIGS. 3 and 3B, the thermal probe 102 is constructed of solid 14 gauge 304 stainless steel and includes five internal thermistors 102d (referred to in one embodiment as T1, T2, T3, T4, and T5, where T1 is closest to the tip of the probe) that detect resistances at various locations along the length of the thermal probe 102. The thermal probe 102 is configured to include a thermal probe thermistor wire 102a and a thermal probe connector 102b to enable an operator to connect the thermal probe 102 to the thermal probe connector socket 26 on the connector box 24 such that resistances detected by the one or more thermistors 102d of the thermal probe 102 are communicated to the thermistor controller. In different embodiments, the thermal probe wire includes more than one thermistor wire such that a single thermal probe wire is configured to transmit resistances detected by each of a plurality of thermistors. In an embodiment illustrated by FIG. 3B, the thermal probe 102 includes a series of spaced-apart marks 102c that enable the operator to properly position the thermal probe 102 with respect to the laser probe 100, as discussed below.
Referring now to FIGS. 3 and 3C, the probe holders 50 and 52 in one embodiment are configured to be rotatably inserted in the probe holder attachments 16a and 16b. In one embodiment, each probe holder 50 and 52 includes an integrated bushing 50a or 52a which is rotatably insertable in a hole in each of the probe holder attachments 16a and 16b. In a different embodiment, the bushing is not integrated with the probe holder 50 or 52. In either embodiment, the bushing 50a or 52a includes a channel 50b or 52b into which that the laser probe 100 is insertable such that the bushing, the channel in the bushing, the hole in the probe holder attachments, and the laser probe 100 are co-axial when the probe holder 50 and 52 has been rotatably inserted into the probe holder attachment 16a or 16b. Probe holders 50 and 52 each further include thermal probe channels 50c and 52c to enable the operator to insert the thermal probe 102 at a known distance from the laser probe 100. In one embodiment, the spaced-apart marks 102c of the thermal probe 102 enable the operator to position the thermal probe 102 at a desired depth in the probe holders 50 and 52 with respect to the laser probe 100.
In an alternative embodiment, illustrated in FIGS. 3D, 3E, and 3F, the probe holders 50 and 52 include two channels 50b or 52b that have the same diameter and are co-axial. The channels are separated by a space between the channels 54, into which the probe holder attachments 16a and 16b are inserted. The probe holders 50 and 52 are alignable with the probe holder attachments 16a and 16b such that a hole in the probe holder attachments 16a and 16b with the same diameter as the channels 50b and 52b is coaxial with the channels. The laser probe 100 is insertable through the channels such that the laser probe passes through the channels and through the hole in the probe holder attachment 16a or 16b. In this embodiment, the probe holder 50 or 52 pivots about the axis shared by the channels 50a and 50b, the hole in the probe holder attachments 16a and 16b, and the laser probe 100. In the embodiments illustrated in FIGS. 3D, 3E, and 3F, the probe holders 50 and 52 still include a plurality of thermal probe channels 50c and 52c to enable the operator to position the thermal probe 102 at a known distance from the laser probe 100. In different embodiments, the probe holders 50 and 52 include two or more thermal probe channels 50c and 52c, and the probe holder channels 50c and 52c are evenly or unevenly spaced.
In one embodiment, illustrated in FIG. 3G, the probe holders 50 and 52 include laser probe channels 50b and 52b and a plurality of thermal probe channels 50c and 52c. The probe holders 50 and 52 each also include a space in the laser probe channel 50b and 52b into which the probe holder attachments 16a and 16b are insertable. In this embodiment, the probe holders also include a connecting member 56 for connecting the probe holder 50 to the probe holder 52. It should be appreciated that in different embodiments the connecting member 56 is replaceable, to enable the probes 50 and 52 to be connected at different distances from each other, depending on the distance between the probe holder attachments 16a and 16b.
It should be appreciated that a further alternative embodiment, the interstitial laser therapy kit disclosed herein includes a single probe holder 50, as illustrated by FIG. 3H. In this embodiment, the probe holder 50 includes a laser probe channel 50b and a plurality of thermal probe channels 50c. Further, the laser probe channel 50b includes two spaces 54 into which the probe holder attachments 16a and 16b are insertable. In this embodiment, the probe holder 50 is configured to be connectable with two probe holder attachments 16a and 16b, despite only being a single probe holder 50. In different embodiments, the single probe holder 50 includes a single space 54 and is configured to be connectable only to one of the probe holder attachments 16a or 16b.
Referring to FIG. 3, the optical fiber 116 in one embodiment includes a connector 116a that enables an operator to connect the optical fiber 116 to the optical fiber connector 30 on connector box 24. In one embodiment, the optical fiber 116 also includes a connector cover 116b that prevents the optical fiber 116 from becoming scratched and/or dirty when it is not connected to the connector box 24. It should be appreciated that because of the fragile nature of the optical fiber 116, the operator should inspect the optical fiber 116 prior to each interstitial laser treatment to ensure that the optical fiber 116 is in good condition and that there are no kinks or tears (a kink is defined as any bend that has a defined or obvious inflection point). The operator should also inspect the optical fiber connector 116a at the end of the optical fiber 116 for wear, damage, dirt, or other material or conditions which may obstruct the transmission of laser energy.
In one embodiment, illustrated in FIG. 3, the syringe 118 is a 60 cc syringe capable of dispensing saline solution, as discussed below. The syringe 118 includes a connector 118a that is threadably connectable with one end of the saline tube 114. The syringe 118 also includes a plunger 118b. The saline tube 114 includes two ends, one end of which is threadably connectable with the syringe 118, and the other end of which is threadably connectable with a port 104b of the hemostasis valve.
In an embodiment of the hemostasis valve illustrated in FIG. 3, the hemostasis valve is a y-shaped connector with three ports 104a, 104b, and 104c. Port 104a is configured to be connectable to the laser probe 100 such that when connected, the hemostasis valve 104 and the laser probe 100 share the same axis. Port 104b is configured to be connectable with an end of the saline tube 114. Port 104c is configured to accept the optical fiber 116 to enable the optical fiber 116 to be inserted in the hemostasis valve 104 and into the laser probe 100. In an embodiment, ports 104a and 104b for connection to the laser probe 100 and the saline tube 114, respectively, include connectors for threadably connecting the saline tube 114 to the hemostasis valve 104 and the hemostasis valve 104 to the laser probe 100. In one such embodiment, these connectors are configured to be hand-tightened by an operator prior to an interstitial laser treatment. In different embodiments, the hemostasis valve and the saline tube in different embodiments are constructed of an appropriate polymer suitable for transferring saline solution into a patient's body.
In different embodiments, the items in the kit may include one or more sheaths 60a, 60b, and 60c made of plastic or another suitable material to protect the items during transportation and before use to perform interstitial laser therapy. In the illustrated embodiment, the laser probe 100 is protected by a plastic sheath 60a, the thermal probe is protected by a plastic sheath 60b, and the optical fiber is protected by a plastic sheath 60c. As further illustrated in FIG. 4, the probe holders 50 and 52 are contained in a plastic bag which is positioned on the support structure inside the container. It should be appreciated that in these embodiments, the support structure 400, the sheaths 60a, 60b, and 60c, and the plastic bag 62 prevent the items in the kit 300 from being damaged during transport and prevent the items from moving while in the container. In different embodiments, one or more of the
Referring now to FIG. 5, prior to performing an interstitial laser treatment, the operator obtains an unopened kit 300 as discussed above. In different embodiments, the operator obtains two or more different kits, each containing one or more of the sterilized items disclosed above. The operator also ensures that an interstitial laser therapy apparatus including the cart 20 and the umbilical assembly (including the umbilical cord 22 and the connector box 24) is available, and that a platform 12 including probe holder attachments 16a and 16b for performing the interstitial laser treatment is also available. In one embodiment, the umbilical assembly enables the operator to perform interstitial laser treatments with electrical and optical components of the interstitial laser therapy apparatus located nearby. In one embodiment, the operator places the wheeled cart 20 near the platform 12 such that the connector box 24 can be placed on or attached to the platform 12 while the umbilical cable 22 remains attached to the cart 20. In one embodiment, the operator affixes the connector box 24 to a Velcro patch or other suitable connecting material included on the platform 12.
In one embodiment, the operator removes the laser probe 100, the thermal probe 102, the optical fiber 116, and the probe holders 50 and 52 from the support structure 400 of the kit 300 and the hemostasis valve 104, the syringe 118, the saline tube 114 from the second kit of disposable items. The operator in one embodiment rotatably inserts the integrated bushing 50a and 52a of each of the probe holders 50 and 52 into one a hole in one of the probe holder attachments 16a and 16b. The operator then inserts the laser probe 100 into the holes 50b and 52b in the integrated bushings 50a and 52a or the probe holders 50 and 52 which enable such that the integrated bushing 50a and 52a, the holes in the probe holder attachments 16a and 16b, and the laser probe are co-axially aligned. The operator selects a desired channel 50c and 52c in the probe holders 50 and 52 in which to insert the thermal probe 102 based on the desired distance of the thermal probe 102 from the laser probe 100. The operator inserts the thermal probe 102 into the channels in the probe holders 50, 52. In different embodiments, the operator additionally adjusts the relative positioning of the probes 100 and 102 using the spaced-apart marks 102c that are included on the thermal probe 102 as a guide.
In different embodiments, the operator inserts the laser probe 100 into the tumor and the thermal probe 102 into the tissue adjacent to the tumor. The operator in one embodiment positions the patient with respect to the stereotactic imaging device 14 and inserts the laser probe 100 into the probe holders 50 and 52, through the probe holder attachments 16a and 16b, and into the center of the tumor in a substantially continuous motion. In this embodiment, the stylet 100b is positioned in the cannula 100a while the laser probe 100 is inserted into the tumor. The operator then inserts the thermal probe 102 in channels in the probe holders 50 and 52 and into the tissue adjacent to the tumor at a desired distance from the center of the tumor, again in a substantially continuous motion.
In another embodiment, the operator first inserts the laser probe 100 into the probe holders 50 and 52 and through the probe holder attachments 16a and 16b, but not immediately into the tumor. The operator similarly inserts the thermal probe 102 into the probe holders 50 and 52, but not into the tissue adjacent to the tumor. In this embodiment, the patient is positioned under the stereotactic imaging device 14 after the laser probe 100 and/or the thermal probe 102 are positioned in the probe holders 50 and 52. Once the patient is positioned with respect to the probes 100 and 102, the probes are inserted into the tumor and the tissue adjacent to the tumor such that the tip of the laser probe 100 is in the center of the tumor and the thermal probe 102 is a known distance away from the center of the tumor. It should be appreciated that in different embodiments, the operator inserts a biopsy needle in the probe holder attachments 16a and 16b prior to rotatably inserting the probe holders 50 and 52. In these embodiments, inserting the biopsy needle first creates a hole in the tissue which enables the laser probe 100 to be inserted into the previously-created hole. In the various embodiments discussed above, when the patient is positioned with respect to the stereotactic imaging device 14, it should be appreciated that the compression plates 18 enable the tissue surrounding the tumor (i.e., the breast) to be placed under compression. Appropriate apparatus such as a compression plate 18 of the stereotactic imaging device 14 ensure the tissue remains substantially stationary during insertion of the probes 100 and 102, and during treatment.
In one embodiment, the operator connects the laser probe connector 100d to the appropriate socket 28 in the connector box 24. The operator also connects the thermal probe connector 102b to the appropriate socket 26 in the connector box 24. Once the appropriate connections between the probes, the umbilical assembly, and the cart have been made, the operator initiates the calibration and testing functionality of the software installed on the computer 110 to ensure that the thermistors included on the laser probe 100 and the thermal probe 102 are functioning properly. The details of the software calibration procedure are disclosed below.
Once the laser probe 100 has been properly positioned in the tumor, the operator removes the stylet 100b from the cannula 100a. So removing the stylet 100b in one embodiment enables the operator to connect the hemostasis valve port 104a directly to the cannula 100a of the laser probe 100. The operator connects the hemostasis valve 104 to the laser probe 100 using the connector 104a on the hemostasis valve 104. In one embodiment, the hemostasis valve 104 is threadably connectable to the laser probe 100, and the operator screws the connector 104a onto the end of the laser probe 100 by hand until the connection is tight.
In one embodiment, the operator removes the cap from the optical connector 30 on the connector box 24 and the cap 116b from the optical fiber 116. The operator threadably connects the optical fiber 116 to the optical connector 30 using the included connectors. In this embodiment, the operator leaves the protective cap (not shown) on the other end of the optical fiber. The operator then causes the microprocessor to initiate the laser calibration process to ensure the laser source and all the connected optical cables are functioning properly. In different embodiments, the calibration is performed before the optical fiber 116 is threadably connected to the optical connector 30.
In one embodiment, the operator removes the cap from the end of the optical fiber without the connector 116a and inserts that end into the optical fiber port 104c on the hemostasis valve 104. This enables the optical fiber to be positioned within the laser probe 100 such that the tip of the optical fiber 116 is at the center of the tumor. It should be appreciated that in some embodiments, the optical fiber 116 is not inserted in the laser probe 100 until after it has been connected to the optical connector 30 of the connector box 24. In different embodiments, the operator does not insert the optical fiber 116 in the laser probe 100 until after the laser source and all connected optical fibers have been calibrated.
Using standard protocol, the operator in one embodiment prepares the syringe 118 by filling it with a 0.9% sodium chloride (i.e., standard saline) solution and attaching the saline tube 114 to the tip of the syringe 118a. The operator lifts and swivels the barrel clamp 404 and squeezes the plunger release lever 406 on the syringe plunger driver 408. The operator then pulls gently to extend the plunger driver 408 as far as possible. The operator then loads the syringe 118 onto the pump 106, making sure the flange of the syringe barrel is pressed or rolled into the flange clip 410. Squeezing the plunger release lever 406 on the end of the syringe plunger driver 408, the operator slips the end of the syringe plunger 118b into place. The operator then releases the lever 406 and makes sure that the syringe plunger 118b is adequately secured to the plunger driver 408. If so, the operator lowers the barrel clamp 404 onto the barrel of the syringe 118. The operator should thread the tubing 114 through the tubing holders 414.
In one embodiment, once the system is primed, the operator connects the saline tube 114 to the appropriate port 104b on the hemostasis valve. In this embodiment the saline tube 114 includes a connector threadably attachable to the hemostasis valve 104, so the operator hand-tightens the connector on the hemostasis valve 104. In one embodiment, after the saline tube 114 is connected to the hemostasis valve 104, the items contained in the kit 300 are appropriately configured with the stereotactic imaging device 14 and the interstitial laser therapy apparatus to enable interstitial laser treatment.
TABLE 2 Field Name Valid Input Length Required
Ref Phys Patient ID All Characters 50 Maximum Yes Operator Patient ID Numbers 6 Maximum Yes First Name All Characters 50 Maximum Yes Last Name All Characters 50 Maximum Yes Address 1 All Characters 50 Maximum Yes Address 2 All Characters 50 Maximum No City All Characters 50 Maximum Yes State All Characters 50 Maximum Yes Zip Code Numbers 5 or 9 Yes Date of Birth Numbers (mmddyyyy) 8 Yes Social Security Numbers 9 Yes Number Hospital All Characters 50 Maximum No Phone Number Numbers 10 No Cell Phone Number Numbers 10 No Email Address Letters, Numbers, 50 Maximum No ‘.’, ’-’, ‘_’, ‘@’ Contact Person All Characters 50 Maximum No
If the status field associated with any of the six thermistors 716 indicates that the thermistor failed validation, the control system in one embodiment indicates the failure by displaying an appropriate message. In one embodiment, the message additionally instructs the operator to verify that the probes are plugged in to the proper sockets 26 and 28 of the connector box 24 and that the connectors 100d, 102b are adequately tightened. In some embodiments, the control system instructs the operator to verify that the umbilical cable 22 is correctly connected to the cart 20. In one embodiment, the control system enables the operator to re-run the various status tests by re-selecting a Test button 712 displayed in the System Test window 700. This restarts internal testing and validation. If the control system is unable to suggest an action that successfully resolves the indicated failures, the control system in one embodiment instructs the operator to select the Faulty Kit button 714 in the System Test window, select a new interstitial laser therapy kit, and enter the new lot number 706, serial number 708, and control number 710. It should be appreciated that the data contained in the lot number field 706, the serial number field 708, and the control number field 710 represent one embodiment of the kit identifier included in the kit 300 as discussed above.
TABLE 3 Valid Range Suggested Parameter Definition Of Values Default Value
Laser Probe The Celsius temperature of the 0-110° C. Approximately Thermistor thermistor of the laser probe, 100° C. Max Temp which, if reached, automatically 802 terminates the treatment. Reaching this temperature is undesirable and does not imply successful treatment. Laser Probe The optimal treatment Celsius 0-100° C. Must be Approximately Thermistor temperature of the thermistor of less than or equal to 90° C. Setpoint the laser probe. Laser Probe Temp Thermistor Max Temp. 804 Laser Probe The minimum Celsius 0-100° C. Must be Approximately Thermistor temperature of the thermistor of less than or equal to 80° C. Min Temp the laser probe that insures Laser Probe 806 adequate heating of the tumor. Thermistor Setpoint Temp. Thermal The Celsius temperature that all 0-100° C. Must be Approximately Probe five thermistors of the thermal less than or equal to 60° C. Thermistor probe must reach to automatically Laser Probe Max Temp terminate treatment. Thermistor Setpoint 808 Reaching this temperature Temp. implies successful treatment. Starting The initial power setting of the 1-8 W. 4 W Laser laser, in watts. Power 810
In one embodiment, the operator rotatably inserts the probe holders 50 and 52 into the probe holder attachments 16a and 16b and inserts the laser probe 100 into the appropriate channels in the probe holders. Once the cannula 100a and stylet 100b have been appropriately inserted in the tumor, the operator removes the stylet 100b from the cannula 100a and replaces it with a hemostasis valve 104 and an optical fiber 116. The hemostasis valve 104 is connected to the laser probe 100 by finger-tightening the laser probe connector 104a. The operator connects the optical fiber 116 to the optical connector 30 on the connector box 24 after removing the protective cap from the optical fiber 116. The operator then inserts the optical fiber 116 into the optical fiber port 104c on the hemostasis valve 104 such that the tip of the optical fiber is inside the laser probe 100. In different embodiments, the tip of the optical fiber extends in the laser probe 100 until it is even with the end of the laser probe 100 inserted in the tumor mass. It should be appreciated that if the tip of the optical fiber 116 extends beyond the end of the laser probe, the interstitial laser treatment may be less effective because laser energy does not dissipate as efficiently as if the optical fiber 116 is properly aligned. In different embodiments, therefore, the optical fiber is configured to extend beyond the tip of the laser probe 100 and to efficiently radiate heat energy in the tumor mass. The operator also connects the saline tube 114 to the saline tube connector 104b on the hemostasis valve 104. During treatment, the tip of the optical fiber 116 is irrigated with normal saline solution provided through the saline tube 114 at a rate of between 1 and 2 cc per minute provided by the infusion pump 106. In one embodiment, the saline is para-axially infused along the optical fiber 116 and into the tumor.
The thermal probe 102 in one embodiment is inserted through the probe holders 50 and 52 and into the breast astride and parallel to the laser probe 100 such that the distance from the laser probe 100 is known. In one embodiment, the thermal probe 102 is inserted through a thermal probe channel 50c or 52c in each of two probe holders 50 and 52 such that the thermal probe's 102 distance from the laser probe 100 is easily ascertainable. The probe holders enable the operator to determine the distance between the probes based on the discretion of the operator and the analysis of the desired zone of ablation. In one embodiment, the holes in the probe holders 50 and 52 enable the thermal probe 102 to be positioned 5 millimeters, 7.5 millimeters, or 11 millimeters from the center of the laser probe 100.
In one embodiment, the operator generates a second set of stereotactic images to confirm appropriate positioning of probes 100 and 102 with respect to the tumor and with respect to each other. In one embodiment, after the probes 100 and 102 are appropriately positioned, the operator injects additional anesthetic into the area around the tumor 1 to ensure field anesthesia during interstitial laser treatment. In one embodiment, the additional anesthetic is 30-40 cc of 0.5% bupivacaine HCl (MARCAINE®), provided in the interstitial laser therapy kit 300.
TABLE 4 Pause Yellow Stop Emergency Treatment Shutter Treatment Stop Power Button Switch Button Button Switch Problem Event 1150 202 1152 204 200
Infusion pump problem X X X X X Tumor temperature too high X X X X X Unintended laser exposure X X X X X Fiber optic cable break X X X Thermistor fault requiring X X X termination Laser fault X X X Laser/software X X X communication fault Shutter switch failure X X X Computer hardware fault X X Software fault X X Laser fails to turn off via red X emergency stop button Laser fails to turn off via key X lock Electrical shock X
1. An interstitial laser therapy control system comprising:
a laser source configured to operate with a laser probe positioned in a patient and an optical fiber to emit laser energy through the optical fiber to a tissue of interest of a patient during an interstitial laser treatment;
a thermistor controller configured to operate with a thermal probe positioned in a patient, said thermal probe have a plurality of spaced-apart thermistors;
a microprocessor configured to operate with the laser source, the at least one display device, the at least one input device, the thermistor controller, and the at least one memory device to: (a) receive a plurality of thermistor temperature data sets from the thermistor controller, the thermistor temperature data sets representing temperatures determined based on resistance data detectable by the plurality of thermistors of the thermal probe, wherein each thermistor is configured to provide separate resistance data to the thermistor controller; (b) after the laser source starts emitting an amount of laser energy during the interstitial laser treatment, enable an operator to manually cause via the at least one input device and the microprocessor a change to the amount of laser energy emitted by the laser source during the interstitial laser treatment from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (c) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if a first one of the thermistor temperature data sets indicates that a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, automatically send at least one signal to cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy; (d) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the first one of the thermistor temperature data sets indicates that a second quantity of the thermistors of the thermal probe are not properly functioning, the second quantity being at least equal to the predefined maximum bad thermal probe thermistor limit, automatically send at least one signal to cause the laser source to stop emitting laser energy to terminate the interstitial laser treatment; and (e) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if a second one of the thermistor temperature data sets indicates a temperature of a tissue of interest that exceeds a designated maximum tissue temperature;
an emergency shutoff switch configured to enable the operator to directly cause a cut off of power to the laser source without cutting off power to the microprocessor and the thermistor controller;
a master power switch configured to enable the operator to directly cause a cut off of power to the laser source, the microprocessor, and the thermistor controller; and
wherein the laser source is configured to determine if communication with the microprocessor fails, and if so, stop emitting laser energy.
2. The control system of claim 1, wherein the thermistor temperature data sets also represent temperatures determined based on resistance data detectable by a thermistor of the laser probe, wherein the microprocessor is configured to, after the laser source starts emitting laser energy during the interstitial laser treatment, if the first one of the thermistor temperature data sets indicates that the thermistor of the laser probe is not properly functioning, cause the at least one display device to display an indication that the thermistor of the laser probe is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy.
3. An interstitial laser therapy control system comprising:
at least one display device; at least one input device;
at least one memory device; a thermistor controller;
a microprocessor configured to operate with the laser source, the at least one display device, the at least one input device, the at least one memory device, and the thermistor controller to: (a) receive a plurality of thermistor temperature data sets, each data set indicating temperatures determined based on separate resistance data detected by each of a thermistor of the laser probe and a plurality of spaced-apart thermistors of a thermal probe positioned in a patient; (b) determine from a first one of the thermistor temperature data sets whether each thermistor is properly functioning; (c) after the laser source starts emitting an amount of laser energy during the interstitial laser treatment, enable an operator to manually cause via the at least one input device and the microprocessor a change to the amount of laser energy emitted by the laser source during the interstitial laser treatment from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (d) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause a laser source to stop emitting laser energy during the interstitial laser treatment if a second one of the thermistor temperature data sets indicates a temperature for the thermistor of the laser probe above a designated maximum laser probe thermistor temperature; (e) display an indication of a third one of the thermistor temperature data sets, said indication representing temperatures of the thermistor of the laser probe and each thermistor of the thermal probe; (f) store data indicating the tissue of interest reached a designated treatment-complete temperature if a fourth one of the thermistor temperature data sets indicates a temperature for each thermistor of the thermal probe exceeding the designated treatment-complete temperature; (g) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if a fifth one of the thermistor temperature data sets indicates that the thermistor of the laser probe is not properly functioning, cause the at least one display device to display an indication that the thermistor of the laser probe is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy; and (h) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if one of the thermistor temperature data sets indicates that a first quantity of thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
4. The control system of claim 3, wherein the microprocessor is configured to receive thermistor temperature data from the thermistor controller.
5. The control system of claim 3, wherein the designated maximum laser probe thermistor temperature is approximately 100° C.-105° C.
6. The control system of claim 3, wherein the designated treatment-complete temperature is approximately 60° C.
7. An interstitial laser therapy control system comprising:
a thermistor controller;
a laser source configured to operate with a laser probe positioned in a patient and an optical fiber to emit laser energy through the optical fiber to a tissue of interest of a patient during an interstitial laser treatment, said laser source including a shutter;
a microprocessor configured to operate with the thermistor controller, the at least one display device, the at least one input device, and the at least one memory device to: (a) after the laser source starts emitting an amount of laser energy during the interstitial laser treatment, receive a thermistor temperature data set indicating the temperature determined by the thermistor controller from separate resistance data detected by a thermistor of the laser probe and a plurality of spaced-apart thermistors of a thermal probe positioned in a patient; (b) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, enable an operator to manually cause via the at least one input device and the microprocessor a change in the amount of laser energy emitted by the laser source during the interstitial laser treatment from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (c) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the thermistor temperature data set indicates temperature for the thermistor of the laser probe that exceeds a designated maximum laser probe thermistor temperature, automatically send at least one signal to cause the laser source to stop emitting laser energy; (d) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the thermistor temperature data set indicates that a first quantity of thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy; and (e) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the thermistor temperature data set indicates that the thermistor of the laser probe is not properly functioning, cause the at least one display device to display an indication that the thermistor of the laser probe is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
a shutter switch configured to enable the operator to cause at least one signal to be sent to the laser source to cause the shutter of the laser source to close;
an electro-mechanical emergency shutoff switch configured to enable the operator to directly cause a cut off of power to the laser source without cutting off power to the microprocessor and the thermistor controller;
an electro-mechanical master power switch configured to enable the operator to directly cause a cut off of power to the laser source, the microprocessor, and the thermistor controller; and
8. The control system of claim 7, wherein the microprocessor is further configured to after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the thermistor temperature data set indicates that all of the thermistors of the thermal probe are not properly functioning, automatically send at least one signal to cause the laser source, to: (i) stop emitting laser energy, and (ii) terminate said interstitial laser treatment.
9. The control system of claim 7 wherein the designated maximum laser probe thermistor temperature is approximately 100° C.−105° C.
10. An interstitial laser therapy control system comprising:
a microprocessor configured to operate with the laser source, the at least one display device, the at least one input device, the at least one memory device, and the thermistor controller to: (a) obtain a first thermistor temperature data set, a second thermistor temperature data set, a third thermistor temperature data set, and a fourth thermistor temperature data set, wherein each thermistor temperature data set indicates a set of temperatures determined based on separate resistance data detected by each of a plurality of spaced-apart thermistors of a thermal probe positioned in a patient and a thermistor of the laser probe; (b) after the laser source starts emitting an amount of laser energy during the interstitial laser treatment and after obtaining the first thermistor temperature data set, enable an operator to manually cause via the at least one input device and the microprocessor a change in an amount of laser energy emitted by the laser source from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (c) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if the second thermistor temperature data set indicates temperature for the thermistor of the laser probe above a designated maximum temperature; (d) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if the operator activates the at least one input device to pause the interstitial laser treatment; (e) after the laser source is stopped from emitting laser energy to pause the interstitial laser treatment, send at least one signal to cause the laser source to again start emitting laser energy if the operator activates the at least one input device to resume the paused interstitial laser treatment; (f) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the third thermistor temperature data set indicates that a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy; and (g) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the fourth thermistor temperature data set indicates that the thermistor of the laser probe is not properly functioning, cause the at least one display device to display an indication that the thermistor of the laser probe is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
11. The control system of claim 10, wherein if one of the thermistors detects a temperature below a designated temperature, the microprocessor is configured to prevent the laser source from emitting laser energy.
12. The control system of claim 10, wherein the designated maximum temperature is approximately 100° C. to 105° C.
13. An interstitial laser therapy control system comprising:
a thermistor controller configured to receive resistance data from each of a first thermistor of a laser probe positioned in a tissue of interest and a second set of spaced-apart thermistors of a thermal probe positioned in tissue adjacent to the tissue of interest, said thermistor controller configured to convert said resistance data into temperature data;
a laser source configured to operate with the laser probe and an optical fiber to emit laser energy through the optical fiber to the tissue of interest of a patient during an interstitial laser treatment;
a microprocessor configured to operate with the at least one display device, the at least one input device, the at least one memory device, the thermistor controller, and the laser source to: (a) receive a temperature data set; (b) store the temperature data set; (c) determine if the temperature data set indicates that each thermistor is properly functioning; (d) after receiving the temperature data set that indicates that the first thermistor and the second set of thermistors are properly functioning and that indicates that the first thermistor and the second set of thermistors are detecting at least a designated minimum temperature, enable an operator to manually cause via the at least one input device and the microprocessor the laser source to emit a desired amount of laser energy for the interstitial laser treatment; (e) after the laser source starts emitting the desired amount of laser energy during the interstitial laser treatment, enable the operator to manually cause via the at least one input device and the microprocessor a change in the amount of laser energy emitted by the laser source from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (f) after the laser source starts emitting the desired amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if a designated number of the second set of thermistors each provide resistance data that indicate a temperature of the tissue of interest that exceeds a designated maximum tissue temperature; and (g) after the laser source starts emitting the desired amount of laser energy during the interstitial laser treatment, if the thermistor temperature data sets indicates that a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
14. An interstitial laser therapy control system comprising:
a laser source configured to operate with a laser probe and an optical fiber to emit laser energy through the optical fiber to a tissue of interest of a patient during an interstitial laser treatment;
a microprocessor configured to operate with the laser source, the at least one display device, the at least one input device, the at least one memory device, and the thermistor controller to: (a) receive a kit identifier inputted using the at least one input device, the kit identifier associated with each of the laser probe, a thermal probe, the optical fiber insertable into the laser probe, and at least one probe holder, said kit identifier being physically separate from the laser probe, the thermal probe, the optical fiber, and the at least one probe holder; (b) determine whether the inputted kit identifier is valid; and (c) if the kit identifier is valid, (i) enable an operator to manually cause via the at least one input device an amount of laser energy to be emitted by a laser source during the interstitial laser treatment, (ii) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, manually cause via the at least one input device and the microprocessor a change in the amount of laser energy emitted by the laser source from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero, (iii) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if the microprocessor determines that a temperature of a tissue of interest exceeds a designated maximum tissue temperature, and (iv) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if a first quantity of spaced-apart thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
15. The control system of claim 14, wherein the kit identifier is valid if it matches a kit identifier stored in the at least one memory device.
16. The control system of claim 14, wherein the kit identifier is valid if it satisfies a kit identifier validation algorithm performed by the microprocessor.
17. The control system of claim 16, wherein the kit identifier validation algorithm includes performing a calculation on a first part of the kit identifier and comparing the result to a second part of the kit identifier.
18. The control system of claim 14, wherein the microprocessor is additionally configured to operate with another microprocessor over a network to determine whether the kit identifier is valid.
19. An interstitial laser therapy control system comprising:
a thermistor controller configured to: (i) receive a plurality of separate resistance data signals from a plurality of spaced-apart thermistors of a thermal probe positioned in a patient during an interstitial laser treatment, (ii) determine a plurality of temperatures based on said received resistance data signals, and (iii) generate a first thermistor temperature data set and a second thermistor temperature data set after the first thermistor temperature data set;
a laser source configured to operate with a laser probe positioned in a patient and an optical fiber to emit an amount of laser energy through the optical fiber to a tissue of interest of a patient during the interstitial laser treatment;
a microprocessor configured to operate with the thermistor controller, the laser source, and the at least one input device to: (a) after the first thermistor temperature data set indicates that the plurality of thermistors are properly functioning and that the thermistors are each detecting a resistance corresponding to a temperature that exceeds a designated starting temperature, enable an operator to manually cause via the at least one input device and the microprocessor a change in the amount of laser energy emitted by the laser source during the interstitial laser treatment from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; (b) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, determine if the second thermistor temperature data set indicates a temperature for a thermistor of the laser probe exceeds a designated maximum treatment temperature; (c) if the second thermistor temperature data set indicates the temperature for the thermistor of the laser probe exceeds the designated maximum treatment temperature, automatically send at least one signal to cause the laser source to stop emitting laser energy during the interstitial laser treatment; (d) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the second thermistor data set indicates the thermistor of the laser probe is not properly functioning, cause the at least one display device to display an indication that the thermistor of the laser probe is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy; and (e) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if the second thermistor data set indicates that a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
20. The control system of claim 19, wherein the designated maximum treatment temperature is approximately 105° C.
21. The control system of claim 19, wherein the microprocessor is additionally configured to determine whether an interstitial laser therapy kit is valid based on a kit identifier associated with the interstitial laser therapy kit.
22. The control system of claim 19, wherein the microprocessor is configured to, after the laser source starts emitting laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy during the interstitial laser therapy if the second thermistor temperature data set indicates that the temperature detected by one of the thermistors of the thermal probe exceeds a designated success temperature.
23. The control system of claim 22, wherein the designated success temperature is approximately 60° C.
24. The control system of claim 19, wherein the microprocessor is configured to after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, automatically send at least one signal to cause the laser source to stop emitting laser energy if the second thermistor temperature data set indicates that the temperature detected by each of the thermistors of the thermal probe exceeds a designated success temperature.
25. The control system of claim 24, wherein the designated success temperature is approximately 60° C.
26. The control system of claim 19, wherein the microprocessor is configured to determine a change in a saline infusion rate based on the first thermistor temperature data set.
27. An interstitial laser therapy control system, the control system comprising:
a thermistor controller configured to determine a plurality of temperatures based on resistance data from each of a thermistor of a laser probe positioned in a patient and a plurality of spaced-apart thermistors of a thermal probe positioned in a patient;
a laser source configured to operate with the laser probe and an optical fiber to emit an amount of laser energy through the optical fiber to a tissue of interest of a patient during an interstitial laser treatment, the laser source including a shutter, and the shutter configured to prevent emission of laser energy by closing to block a laser beam;
a microprocessor configured to operate with at least one input device to: (i) operate with the thermistor controller and the laser source after receiving a kit identifier for a kit which is usable with the laser source; (ii) enable an operator to manually cause via the at least one input device and the microprocessor a first amount of laser energy above zero to be emitted by the laser source during the interstitial laser treatment; (iii) enable the operator to manually cause via the at least one input device and the microprocessor a change in the amount of laser energy emitted by the laser source during the interstitial laser treatment from the first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero; and (iv) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
a shutter switch configured to operate with the laser source to, after the laser source starts emitting laser energy during the interstitial laser treatment, enable an operator to cause at least one signal to be sent to the laser source to cause the laser source to close the shutter, and wherein the laser source is configured to automatically send at least one signal to the microprocessor indicating that the shutter is closed;
28. An interstitial laser therapy control system, the control system comprising:
a thermistor controller configured to determine thermistor temperatures from resistance data signals received from a plurality of spaced-apart thermistors of a thermal probe positioned in a patient during an interstitial laser treatment;
a laser source configured to operate with a laser probe positioned in a patient and an optical fiber to emit an amount of laser energy through the optical fiber to a tissue of interest of a patient during the interstitial laser treatment, the laser source including a shutter;
a microprocessor configured to: (i) operate with the at least one input device to enable an operator to manually cause via the at least one input device and the microprocessor at least one signal to be sent to the laser source to cause the laser source to start to emit an amount of laser energy for the interstitial laser treatment, (ii) operate with the at least one input device to enable the operator to manually cause via the at least one input device and the microprocessor at least one signal to be sent to the laser source to change an amount of laser energy emitted by the laser source for the interstitial laser treatment from a first amount of laser energy above zero to a second different operator selectable amount of laser energy above zero, (iii) operate to automatically communicate a plurality of heartbeat signals with the laser source at regular intervals, wherein if heartbeat response signals are not successfully communicated, the microprocessor is configured to cause the at least one display device to display a message indicating a communication failure between the microprocessor and the laser source, (iv) operate with the laser source to automatically send a close shutter signal to the laser source to cause the laser source to close the shutter of the laser source to prevent the laser source from emitting laser energy, and (v) after the laser source starts emitting the amount of laser energy during the interstitial laser treatment, if a first quantity of the thermistors of the thermal probe are not properly functioning, the first quantity being at least one and less than a predefined maximum bad thermal probe thermistor limit, the predefined maximum bad thermal probe thermistor limit being greater than one and less than or equal to all of the thermistors of the thermal probe, cause the at least one display device to display, for each thermistor of the thermal probe that is not properly functioning, an indication of that thermistor and an indication that thermistor is not properly functioning, cause the laser source to continue to emit the laser energy, and enable the operator to cause the laser source to stop emitting laser energy;
an electro-mechanical emergency shutoff switch configured to enable the operator to directly cause a cut off of power to the laser source without cutting off power to the thermistor controller and the microprocessor;
29. The control system of claim 28, which includes a shutter switch configured to enable the operator to cause at least one signal to be sent to the laser source to cause the shutter of the laser source to close.
30. The control system of claim 28, wherein the microprocessor is configured to after the power to the laser source is cut off by the electro-mechanical emergency shut-off switch, detect that the laser source is no longer in communication with the microprocessor.
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Patent Publication Number: 20080188841
Assignee: Novian Health, Inc. (Chicago, IL)
Inventors: Anthony J. Tomasello (Libertyville, IL), William Graveman (Tonganoxie, KS), Kambiz Dowlatshahi (Chicago, IL), Henry R. Appelbaum (Chicago, IL)
Application Number: 12/025,162
International Classification: A61B 18/20 (20060101); A61N 5/06 (20060101); A61B 18/24 (20060101); A61B 17/00 (20060101); A61B 90/11 (20160101);