Patent Application
20190388142
The present disclosure relates to in vivo systems and methods of identifying tissue parameters (e.g., tissue type) and assessing the conditions of the tissue during a surgical procedure, More specifically, the present disclosure relates to systems and methods for measuring the relative level of blood circulation in tissue with an energy-based surgical instrument for vessel sealing.
Correctly identifying tissue parameters including tissue type is important for any surgical operation. But it is especially important during laparoscopic operations when a surgeon can only view tissue through a camera. A camera, however, may provide a surgeon with a limited view of the tissue. As a result, several ex vivo and in vivo methods have been proposed to measure different characteristics of tissue in order to identify and assess the tissue.
Publication number US 2008/0200843 describes a method and apparatus for measuring human tissue properties in vivo. The method is based on sensing the mechanical response of tissue. The method includes applying a predetermined force to the surface of a patient with a probe and measuring the displacement of the probe as a function of applied force, Tissue properties are then determined based on the result of measuring the displacement of the probe.
Publication number US 2008/0154145 describes a method and apparatus for determining characteristics of biological tissues. Tissue characteristics are determined by introducing a sound wave into the tissue and recording the response of the tissue to the sound wave.
Publication number US 2009/0124902 describes a method for classifying tissue from the lumbar region using a combination of ultrasonic and optical measurements.
In publication number US 2007/0276286, a miniature electrode array is used to stimulate tissue and to measure a tissue response in order to provide tissue diagnosis and spatial tissue mapping.
Publication number US 2005/0283091 describes a method and apparatus for determining the conditions of biological tissue. The method includes exciting tissue with electrical signals at different frequencies and analyzing the cross-correlation of response signals with delayed excitation signals, Cross-correlation products are then auto-correlated. Cross-correlation products correspond to tissue conditions and auto-correlation products correspond to changes in the tissue conditions.
Publication number US 2003/0060696 discloses an apparatus for recognizing tissue type using multiple measurement techniques. For example, electrical signals are applied to a tissue via electrodes to measure impedance magnitude and phase at a plurality of frequencies. The phase information at the plurality of frequencies is compared with the phase information of known tissue types to identify the tissue type.
Publication number US 2002/0077627 describes a method for detecting and treating tumors using localized impedance measurements. The method includes providing an impedance measurement apparatus having a plurality of resilient members deployable to sample tissue impedance through a plurality of conductive pathways, information from the impedance measurements is then used to determine the condition of the tissue.
Publication number US 2009/0253193 describes a device for characterizing tissue ex vivo. The device includes a set of independent electrodes that scan the tissue by moving a voltage gradient across the tissue surface and acquiring impedance spectrographs that may be mapped to an image.
U.S. Pat. No. 5,769,791 describes a tool for nondestructive interrogation of the tissue including a light source emitter and detector, which may be mounted directly on the surgical tool in a tissue contacting surface or mounted remotely and guided to the surgical field with fiber optic cables.
Publication number US 2009/0054908 describes a system having a surgical instrument with a sensor for generating a signal indicative of a property of a patient's tissue. The signal is converted into a current dataset and stored. A processor compares the current dataset with other previously stored datasets and uses the comparison to assess a physical condition of the tissue and/or to guide a procedure being performed on the tissue.
Although existing methods can provide various measurements of tissue parameters, these methods may be difficult to implement because of their complexity and may provide inaccurate measurements.
The systems and methods according to embodiments of the present disclosure provide accurate information about tissue parameters and conditions. These systems and methods also provide a relatively quick and simple way to identify tissue parameters and conditions during laparoscopic procedures without requiring the introduction of additional instruments or tools into a patient's body.
According to one aspect, the present disclosure features a method of determining a tissue parameter. The method includes applying a probing signal to tissue, monitoring a response signal over an interval longer than an interval between two successive cardiac contractions, determining the amplitude of the response signal, determining the level of blood circulation in the tissue based upon the amplitude of the response signal, and determining a tissue parameter based upon the level of blood circulation. The probing signal is configured to interact with the tissue in a predetermined way.
In some embodiments, the tissue parameter is a tissue type, such as connective tissue, muscle tissue, nervous tissue, or epithelial tissue. In other embodiments, the tissue type includes a vessel type, such as a bile vessel, a lymph vessel, a blood vessel, an artery, an arteriole, a capillary, a venule, or a vein. In yet other embodiments, the tissue parameter is the tissue condition, such as whether the tissue is damaged.
In some embodiments, determining the amplitude of the response signal includes determining the amplitude of the response signal at the frequency of the cardiac contractions or at the harmonics of the frequency of the cardiac contractions. In other embodiments, the method of identifying tissue parameters may include applying the probing signal to different portions of the tissue, determining the amplitude of the resulting response signals to determine the level of blood circulation in the different portions of the tissue, and determining the tissue parameter based on the level of blood circulation in the different portions of the tissue.
The probing signal may be an acoustical signal, an optical signal, or an RF signal: In the case where the probing signal is an RF signal, monitoring the response signal includes monitoring the response signal at a frequency within a range from 10 kHz to 10 MHz. In some embodiments, monitoring the response signal includes monitoring the response signal with an energy-based tissue sealing instrument. In other embodiments, determining the amplitude of the response signal includes determining the amplitude and phase of the response signal.
In another aspect, the present disclosure features another method of determining a tissue parameter. The method includes applying a probing signal to tissue, monitoring a response signal that has interacted with the tissue over an interval longer than an interval between two successive cardiac contractions, monitoring a cardiac signal related to cardiac contractions, correlating the response signal and the cardiac signal, determining a level of blood circulation in the tissue based upon the result of correlating the response signal and the cardiac signal, and determining a parameter of the tissue based upon the result of determining the level of blood circulation in the tissue. In some embodiments, the parameter of the tissue is a type of the tissue. The type of the tissue may be connective tissue, muscle tissue, nervous tissue, or epithelial tissue.
In yet another aspect, the present disclosure features a system for determining a tissue parameter. The system includes a probing signal source configured to apply a probing signal to tissue, a response signal monitor configured to monitor a response signal over an interval longer than an interval between two successive cardiac contractions, and a processor configured to analyze the amplitude of the response signal to determine a level of blood circulation in the tissue. The processor is further configured to determine a tissue parameter based on the level of blood circulation. In some embodiments, the system further includes an electrosurgical energy source configured to apply electrosurgical energy to tissue during an electrosurgical procedure. In these embodiments, the probing signal source is the same source as the electrosurgical energy source.
The systems and methods of in vivo assessment of tissues and vessels will now be described with reference to the accompanying drawings, in which:
Different types of human and animal tissues have different densities of blood vessels (i.e., the number of blood vessels per unit area or volume of tissue) and experience different levels of blood circulation (i.e., the amount of blood flow per unit volume of tissue). These parameters can be used to identify different types of tissues during a surgical procedure. For example. When the tissue structure changes as a result of damage to the tissue, the blood circulation usually changes as well. This phenomenon allows one to distinguish between damaged and normal portions of tissue by comparing corresponding levels of blood circulation. As another example, when tumors form and grow in normal tissue, the density of blood vessels in the tissue increases because these tumors depend on the formation of new blood vessels for their growth. Thus, by measuring the density of blood vessels or the level of blood circulation in tissue, one can distinguish between a tumor and normal tissue.
For some surgical procedures, such as electrosurgical procedures, the surgeon may need to distinguish between blood vessels and other types of vessels, e.g., bile ducts. For blood vessels, the surgeon may need to cheek for blood clots or other structural changes in the blood vessels. For vessel sealing procedures, the surgeon may need to confirm that the vessel has been properly sealed before it is cut. In all of these procedures, the tissue or vessel can be examined to assess blood circulation conditions. Information regarding blood circulation conditions may inform a surgeon regarding the type of the tissue or vessel and/or the condition of the tissue or vessel.
The system 100 includes a power supply 122, an energy output stage 124, and an instrument 126. The power supply 122 supplies power to the energy output stage 124, which generates energy and provides the energy to the instrument 126. The instrument 126, in turn, applies the generated energy to the tissue 101, which includes at least one vessel 102. For an RF-based tissue-sealing system, the energy output stage 124 generates RF energy and the instrument 126 applies the RF energy to the tissue 101 through at least one contact to seal the tissue 101.
The system 100 also includes a sensor 112, a microprocessor 114, a user interface 116, and a display 118. The sensor 112 senses various parameters and/or properties of tissue 101 at the operating site and transmits sensor signals representing the sensed parameters or properties of the tissue 101 to the microprocessor 114. The microprocessor 114 processes the sensor signals and generates control signals based on the processed sensor signals to control the power supply 122 and/or the energy output stage 124. For example, the microprocessor 114 may regulate the voltage or current output from the power supply 122 or the energy output stage 124 based on the processed sensor signals.
The sensor 112 is configured to measure various electrical or electromechanical conditions at the operating site such as tissue impedance, changes in tissue impedance, tissue temperature, changes in tissue temperature, leakage current, applied voltage, and applied current. The sensor 112 continuously measures one or more of these conditions so that the microprocessor 114 can continually adjust the energy output from the power supply 122 and/or the energy output stage 124 during a sealing procedure. For example, in an RF-based vessel sealing instrument, the sensor 112 may measure tissue impedance and the microprocessor 114 may adjust the voltage generated by the energy output stage 124.
The user interface 116 is coupled to the microprocessor 114 allowing a user to control various parameters of the energy applied to the tissue 101 during a surgical procedure. For example, the user interface 116 may allow a user to manually set, regulate and/or control one or more parameters of the energy delivered to the tissue, such as voltage, current, power, frequency, and/or pulse parameters, e.g., pulse width, duty cycle, crest factor, and/or repetition rate.
The microprocessor 114 can execute software instructions for processing data received from the user interface 116 and for outputting control signals to the power supply 122 and/or the energy output stage 124. The software instructions are stored in an internal memory of the microprocessor 114, an internal or external memory bank accessible by the microprocessor 114 and/or an external memory, e.g., an external hard drive, floppy diskette, or CD-ROM. Control signals generated by the microprocessor 114 may be converted to analog signals by a digital-to-analog converter (DAC) (not shown) before being applied to the power supply 122 and/or energy output stage 124.
For some embodiments of an RF-based tissue-sealing system, the power supply 122 is a high-voltage DC power supply that produces RF current. In these embodiments, the microprocessor 114 transmits control signals to the power supply to control the magnitudes of the RF voltage and current output from the power supply 122. The energy output stage 124 receives the RF current and generates one or more pulses of RF energy. The microprocessor 114 generates control signals to regulate the pulse parameters of the RF energy, such as pulse width, duty cycle, crest factor, and repetition rate. In other embodiments, the power supply 122 is art AC power supply, and the energy output stage 124 may vary the waveform of the AC signal generated by the power supply 122 to achieve a desired waveform.
As described above, the energy-based tissue-sealing system 100 includes a user interface 116, The user interface 116 includes an input device, such as a keyboard or touch screen, through which a user enters data and commands. The data may include the type of instrument, the type of procedure, and/or the type of tissue. The commands may include target effective voltage, current, or power level, or other commands for controlling parameters of the energy that is delivered from the energy output stage 124 to the instrument 126.
The system 100 also includes a probing signal source 108 and a response signal monitor 105. The probing signal source 108 applies a probing signal 109 to the tissue 101 and the response signal monitor 105 senses a response signal 104. The response signal 104 is the probing signal 109 that has been transmitted and/or scattered by the tissue 101 and vessel 102. The probing signal 109 and the response signal 104 may be acoustical signals, optical signals, RF signals, or any combination of these signals. In some embodiments, the probing signal source 108 is the energy output stage 124, The energy output stage 124 may generate a probing signal 109 that is the same as the electrosurgical energy applied to the tissue 101 to perform an electrosurgical procedure (e.g., vessel sealing). Alternatively, the energy output stage 124 may generate a probing signal 109 that has parameters that are different from the parameters of the electrosurgical energy applied to the tissue 101.
The response signal monitor 105 generates a sensor signal or sensor data based on the response signal 104 and transmits the sensor signal or sensor data to the microprocessor 114. The microprocessor 114 processes the sensor signal or sensor data to determine the level of blood circulation in the tissue 101 or vessel 102. For example, the microprocessor 114 may determine the level of blood circulation based on the magnitude of the sensor signal or the response signal 104.
The response signal 104 may provide information about the tissue type. For example, the response signal 104 may identify the tissue as connective tissue, muscle tissue, nervous tissue, epithelial tissue, or any combination of these tissue types. The response signal 104 may also identify the vessel type within the tissue 101. The vessel types include bile vessels, lymph vessels, and blood vessels. The response signal 104 may distinguish the type of blood vessel that resides in a given portion of tissue. The types of blood vessels include arteries, arterioles, venules, and veins. The response signal 104 may also be used to identify the condition of the tissue, such as whether the tissue is damaged.
The system 100 may determine the level of blood circulation by sensing tissue parameters or properties that depend on the level of blood circulation during a period exceeding one cardiac cycle. In some embodiments, the system 100 may sample tissue parameters or properties for multiple cardiac cycles to more accurately determine the level of blood circulation. In other embodiments, a cardiac signal, which is related to heart contractions (e.g., an electrocardiographic signal), can be used to evaluate the correlation between the parameters of the sensor signal and the cardiac signal to more accurately assess the level of blood circulation.
As described above, the energy-based instrument 126 is also configured to evaluate blood circulation in a given volume of tissue 101. To evaluate blood circulation, the given volume of tissue 101 is first grasped between the jaw members 203, 204 of the energy-based instrument 126. The pressure that is applied to the tissue 101 by the jaw members 203, 204 is selected to provide electrical contact between the electrodes 205, 206 and the tissue 101. However, the amount of pressure applied to the tissue 101 may be lower than the amount of pressure used to compress the tissue 101 during tissue sealing. Then, a probing signal 109 (e.g., an RF signal) is applied to the tissue 101 by the electrodes 205, 206 and a response signal 104 (e.g., tissue impedance) is measured during one or more cardiac cycles.
During the cardiac cycles, the pressure of the blood flowing in the blood vessels 102 varies and, as a result, the relative amount of blood in a given volume of tissue 101 also varies. For example, as shown in
During a cardiac cycle, as the volume of blood in a given volume of tissue increases, a force is applied to the jaw members 203, 204 to increase the distance between the jaw members 203, 204, In some embodiment, the system 100 includes a motion sensor configured to sense the change in distance between the jaw members 203, 204, This distance information may be used together with the response signal 104 to evaluate the level of blood circulation within a given volume of tissue 101.
As described above, a probing signal 109 is applied to a vessel and a response signal 104 is measured over time to identify tissue 101 and/or vessels 102 or to determine parameters of the tissue 101 and/or the vessels 102. The response signal 104 may include the frequency and amplitude of an electrical impedance of the tissue 101. If the frequency of the electrical impedance correlates to the frequency of cardiac contractions, then the vessel 102 is identified as a blood vessel. If the vessel is identified as a blood vessel, the amplitude of the electrical impedance would indicate the level of blood circulation.
Next, in step 506, the amplitude of the response signal 104 is determined. The amplitude of the response signal 104 may be determined at a frequency of the cardiac contractions or at the harmonics of the frequency of the cardiac contractions. Then, in step 508, the level of blood circulation in the tissue is determined based on the amplitude of the response signal 104. In other embodiments, the amplitude and phase of the response signal 104 are analyzed to determine the level of blood circulation in the tissue. Finally, before the process ends in step 511, a tissue parameter is determined in step 510 based on the level of blood circulation.
In some embodiments, the probing signal source 108 of
Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the disclosure.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13040347 | Mar 2011 | US |
| Child | 16562977 | US |
