The invention relates to controlling tissue surgery based on tissue interactions with surgical energy devices such as lasers.
There are a number of surgical devices utilized by surgeons that deliver one or more types of energy to cut, coagulate, ablate, remove or otherwise treat tissue of a patient. Surgical energy devices include ultrasonic devices, electrosurgical devices utilizing monopolar and/or bipolar RF (Radio-Frequency) current, microwave and/or thermal energy devices, and higher-frequency electromagnetic radiation delivery devices such as lasers. Examples of medical laser systems utilizing hollow waveguides are provided by Temelkuran et al. in U.S. Pat. Nos. 7,167,622 and 7,331,954, and by Goell et al. in U.S. Pat. No. 8,280,212, all assigned to OmniGuide, Inc. of Cambridge, Mass.
Various imaging techniques assist surgeons to access and treat targeted tissue. As an example, a fluorescence endoscopy video system is described by Cline et al. in U.S. Pat. No. 6,821,245. Compounds that generate fluorescence when excited are referred to as fluorophores; exogenous fluorophores include certain photoactive drugs and dyes delivered to selected tissue, while endogenous fluorophores are normally present in most tissues. Fluorescence guidance may be particularly useful in minimally invasive procedures, where the surgical site is seen through an endoscope or other visualization system inside a body cavity under artificial illumination, making landmarks or distinguishing features otherwise evident during open-field surgery less visible to the surgeon.
During fluorescence-guided surgery, one or more fluorophores are “pumped”, that is, are energized to an excited state, with specific electromagnetic wavelengths to identify tissues which are to be treated or removed with a surgical tool, such as a scalpel, laser or electro-cautery device. For example, U.S. Patent Publication No. 2004/0142485 by Flower et al. describes the use of indocyanine green “ICG” to identify and then treat choroidal neovascularizations. See also U.S. Patent Publication No. 2013/0078188 by Tsien et al. In some procedures, another fluorophore is used to identify tissues which are not to be removed and are to be protected from inadvertent damage by the treatment device, such as described by Tsien et al. in U.S. Patent Publication No. 2012/0148499.
A difficulty in targeting desired tissue may arise when utilizing a non-visible energy beam such as a CO2 laser beam. Positioning of an ultrasonic beam utilizing one or more light sources is disclosed by McCarty in U.S. Pat. No. 5,107,709. It is known to align non-visible laser beams utilizing phosphor screens available from LUMITEK International, Inc. of Ijamsville, Md., especially for bench testing and research purposes. Visible aiming beams utilized with CO2 lasers are described by Michael Black in U.S. Pat. No. 5,420,882, by Temelkuran et al. in U.S. Pat. No. 7,331,954, by Shapira et al. in WO2006/135701 and by Gannot et al. in U.S. Patent Publication No. 2006/0052661, for example. However, there remains a need to optimize tissue treatment under actual conditions which may vary from patient to patient, and may vary among different tissues and locations within each patient.
It is therefore desirable to have an improved system and method to effectively treat selected tissue within a patient utilizing surgical energy devices.
An object of the present invention is to locate the thermal footprint of a surgical energy device and adjust delivered energy as needed to minimize damage to non-targeted tissue.
Another object of the present invention is to estimate the thermal effects of full treatment on selected tissue by determining the amount of quenching of fluorescence in the tissue utilizing an initial, lower level of treatment.
A still further object of the invention is to utilize quenching of fluorescence to guide the use of surgical energy to enable more tissue sparing by controlling the energy thermal footprint.
This invention results from the realization that quenching of fluorescence in tissue can generate feedback to confirm or adjust one or more of the location, size and thermal profile of the thermal footprint of an energy beam to optimize delivery of energy to tissue during surgery.
This invention features a system having a radiation source of at least a first wavelength of illuminating radiation directable to a target location on tissue of a patient at a surgical site to cause at least one type of fluorophore associated with the tissue to fluoresce. The system further includes an energy source of at least a first surgical energy directable to the target location and having a plurality of power settings, at least one of the power settings being capable of quenching fluorescence of the fluorophore. The system preferably includes a processor capable of adjusting at least one of a plurality of system control settings to alter the amount of quenching of the fluorophore, the system control settings including the plurality of power settings.
In some embodiments, the first surgical energy is a beam of electromagnetic radiation such as a laser beam generated by the energy source. In certain embodiments, the processor includes at least one detector to detect quenching of fluorescence at the surgical site and at least one image processor capable of generating an image of the surgical site to depict changes in fluorescence. In some embodiments, the processor includes a controller to adjust the system control settings, such as at least one of power level, pulse rate, pulse width, pulse shape and duty cycle for delivery of electromagnetic radiation and/or altering the power and/or wavelength of the illuminating radiation. In certain embodiments, the controller is capable of moving the surgical energy to a different location on tissue at the surgical site.
In a number of embodiments, the radiation source provides at least a second wavelength of illuminating radiation to enable a user to see the surgical site. In certain embodiments, the system further includes at least one fluid source having at least two fluid control settings for at least one of fluid flow rate and temperature, and the adjustable system control settings include at least some of the fluid control settings.
This invention also features a method for optimizing treatment of tissue of a patient at a surgical site by directing at least a first wavelength of illuminating radiation to a target location on the tissue of the patient to cause at least one type of fluorophore associated with the tissue to fluoresce. The method further includes directing at least a first surgical energy from an energy source to the target location at one of a plurality of power settings, at least one of the power settings capable of quenching fluorescence of the fluorophore. At least one of a plurality of system control settings is adjusted to alter the amount of quenching of the fluorophore, the system control settings including the plurality of power settings.
In what follows, preferred embodiments of the invention are explained in more detail with reference to the drawings, in which:
This invention may be accomplished by a system and method for optimizing delivery of energy to tissue of a patient at a surgical site by directing at least a first wavelength of illuminating radiation to a target location on the tissue of the patient to cause at least one type of fluorophore associated with the tissue to fluoresce. At least a first surgical energy is directed to the target location at one of a plurality of power settings, at least one of the power settings being capable of quenching fluorescence of the fluorophore. At least one of a plurality of system control settings is adjusted to alter the amount of quenching of the fluorophore, the system control settings including the plurality of power settings.
In other words, systems and methods according to the present invention utilize fluorescence quenching to locate and/or control the thermal footprint of delivered energy, especially close to the surface area of tissue heated by a surgical energy device such as device that emits a surgical laser beam which itself is not visible to the unaided human eye, such as one or more laser beams generated by a CO2 laser. There are a number of techniques according to the present invention to alter system settings to change the thermal footprint of delivered energy. Modifying the thermal footprint by adjusting one or more parameters of at least one delivered fluid is discussed in more detail below.
The following terms are defined as used herein. “Visible” means perceptible directly by the unaided human eye, whether viewed in line-of-sight or through an endoscope or other visualization system. “Spot size” is the radius at which the electromagnetic field amplitude and intensity drop to 1/e and 1/e2 of their axial values, respectively, where “e” is the base of the natural logarithm, having a value of approximately 2.71828. “Power settings” means at least one of power level, pulse rate, pulse width, pulse shape and duty cycle for delivery of electromagnetic radiation. “Pulse shape” includes the shape of the pulse during the entire of the period of the pulse, including the time there is no energy until a subsequent pulse begins, that is, the overall shape during a single period. “Fluid control settings” means at least one of fluid flow rate or fluid temperature. A fluid control setting is increased by increasing fluid flow and/or by decreasing temperature of the fluid. “System control settings” means at least one of power settings, amount of converging or diverging of a surgical energy beam as delivered to tissue, distance of the distal end of the surgical energy delivery device from tissue, fluid control settings, and/or of fluorescence pump wavelength and/or other illuminating wavelength, distinct from any surgical wavelengths generated by the surgical energy device. “Thermal footprint” of delivered energy means the area or volume of tissue directly affected by the delivered energy both laterally, that is, in surface area, and in depth, that is, in volume, to the degree that tissue becomes thermally altered, especially when it becomes denatured or necrotic. “Thermal profile” of delivered energy means the cross-sectional boundary in three dimensions of thermal alteration within tissue, also referred to as thermal spread.
Surgical techniques employing energy, such as electro-cautery or laser cutting, produce more heat relative to cold steel. It is known that heat quenches fluorescence. Thus, to take full advantage of promising fluorescence-guided surgery, it will be important to assess and control the thermal as well as the optical tissue interactions. Visible or otherwise detectable quenching may be utilized according to the present invention as a real time temperature indicator as the surgeon nears sensitive areas, allowing for real time location, power and cooling adjustments. Analysis of the pattern of quenching may also be used to sharpen or otherwise shape or adjust thermal profiles, thereby increasing the precision of laser surgery procedures. For CO2 laser surgery, and for surgery with wavelengths which are not visible to the naked eye, quenching may also be used to i) help locate otherwise invisible laser beams and/or ii) create a registration for subsequent procedures.
System 10,
In this construction, processor PR includes a detector DET, box 32, an image processor IP, box 34, and a controller C, box 36, which communicates with surgical energy device SED as illustrated by line 37. In certain constructions, the controller C also communicates with a processor in radiation source IL as indicated by dashed line 37a to alter power, wavelength or other parameter of the illuminating radiation 20. In some constructions, processor PR includes, or communicates with, a display DSP, dashed box 38, which is visible to the surgeon or other user of system 10. Line 37 and dashed line 39 represent either cable or wireless communication with device SED and display DSP, which can be a fixed or a portable display device. Types of displayed images are discussed in more detail below in relation to
Radiation reflected (including scattered radiation) or otherwise emitted from the target location TL is directed to detector DET as represented by line 40. Dashed lines 50 and 52 represent optional access devices such as trocars. A trocar typically includes a cannula, with a proximal seal housing, that is temporarily placed through an incision in skin and underlying muscle; one or more instruments are passed through the trocar to conduct minimally invasive surgery within a body cavity. In other procedures, one or more natural body orifices are utilized. Other tools, such as retractors, suction, irrigation, or tissue manipulation or removal devices may be introduced through the same or other incisions or orifices by humans or by robotic surgical systems.
Examples of known robotic surgical systems utilizing lasers and other instruments are provided by Mohr in U.S. Patent Publication No. 2009/0171372, by Williams et al. in U.S. Patent Publication No. 2009/0248041 and by Prisco et al. in U.S. Patent Publication No. 2010/0249507, for example, all assigned to Intuitive Surgical Operations, Inc. and/or Intuitive Surgical, Inc. of Sunnyvale, Calif., which provides the Da Vinci™ robotic platform. Robotically assisted surgery through a single port utilizing an image capturing device and multiple surgical tools is described by Mohr in U.S. Pat. No. 8,517,933.
In some constructions, detector DET, box 32 in
Controller C adjusts at least one of a plurality of system control settings to alter the amount of quenching of at least one type of fluorophore at target location TL. System control setting include power settings such as at least one of power level, pulse rate, pulse width, pulse shape and duty cycle for delivery of electromagnetic radiation by surgical energy device SED. In some constructions, line 22 represents at least one waveguide which passes through a handpiece such as disclosed by Temelkuran et al. in U.S. Pat. No. 7,331,954.
In certain constructions, at least one fluid source FS, box 60 shown in phantom, delivers at least one gas or liquid to target location TL as indicated by dashed line 62, as controlled by controller C through communications line 64. Several algorithms for operating system 100 are described below.
System 100,
These Novadaq endoscopy systems include a multi-wavelength light source 102, used to both pump a fluorophore present at the surgical site SS' and to illuminate the surgical site SS' and produce a reflected image ultimately depicted on display 112. A multi-wavelength camera 108 includes detectors which are sensitive to both fluorescent light and to the reflected light, which is typically visible to the unaided human eye, although such reflected light is not visible to the unaided human eye in other constructions. The fluorescence endoscopy system also includes an optic, such as a dichroic mirror, or other selective wavelength selective filter or beam splitter for splitting out the reflected light and the fluorescence. It typically also includes a processor within system 114 and a display 112 such as a video screen to display both the reflected and fluorescent wavelengths either in overlay mode, or sequentially, first the image of reflected light, and then the fluorescent image.
System 100 includes a source SED, box 120, of surgical energy which is directed, line 122, to target location TL′. In some constructions, source 120 is part of a laser surgery system such as the Intelliguide™ Laser System commercially available from OmniGuide, Inc. of Cambridge, Mass. The laser surgery system 120 includes a human interface 124, including buttons, dials, knobs or a touch screen, which can be used to select the laser power settings in some constructions. System 100 optionally includes at least one fluid source 130, which generates first fluid flow 136 and is part of the laser surgical system in some constructions. At least one fluid flow valve, represented by foot pedal control 134, also referred to as a footswitch, and a chiller/heater 132 are provided for the fluid source FS in this construction. It may also optionally include a second fluid source with its own independent fluid flow valve and chiller/heater, all represented by dashed line 140 and second foot pedal control 142. In other constructions, knobs, buttons or touch screen control replaces one or both of foot controls 134 and 142. Surgical energy source 120, fluid source 130 and associated controls are integrated into a single unit in some constructions. When the energy source 120 includes a laser and is part of a laser surgery system, the laser surgery system may also includes a flexible waveguide for delivering laser radiation 122 to the surgical site such as the BeamPath™ flexible fiber waveguides available from OmniGuide, Inc. The waveguide is hollow in some constructions. An articulated arm may also be used to deliver free space laser beams to the surgical site. One source of fluid may directed to the center of the hollow waveguide and a second source to an annular area surrounding the waveguide, as will be described further herein.
The fluorescence guided laser surgery system 100 may also include a processor such as described above for system 10,
Another aspect of the invention is to use fluorescence quenching to determine and sharpen the thermal profile at the laser tissue interface, such as by delivering cooling fluid around the laser spot at the laser-tissue interface, and thereby sharpening the thermal profile at that interface.
More particularly,
The maximum slope mo of the graph of fluorescence intensity 212 in
The laser beam is heating a volume of tissue, having a parabolic shape in cross section, not only a spot on the surface of the tissue. The size of the spot, however, may be taken as an indication of the depth of the heating as well as its lateral extent, with depth indication being useful to surgeons. Using a pulsed laser source is expected to reduce the depth of heating as well as the lateral extent, while an annular cooling fluid approach is expected to modulate temperature primarily at the tissue-laser interface.
There is more than one approach to narrowing a temperature profile. One approach is to set the energy pulse intensity, width and rate such that the total time the tissue is exposed to laser energy is less than the thermal relaxation time of the tissue being ablated. Since heat diffuses from an area in proportion to its perimeter, more heat will diffuse from the edges of the spot than from the center which will help preferentially to heat the middle of the spot relative to its edges.
Another approach is to make the energy spot size smaller by focusing optical energy using lenses or by controlling the distance between tissue and the energy exit point, such as when an optical fiber is used to guide energy to the tissue. Certain techniques for altering the energy spot size utilizing optical components in a handpiece are provided by Shurgalin et al. in U.S. Patent Publication No. 2013/0064515.
Yet another approach is to direct cooling fluid preferentially around the spot relative to its center, as illustrated in
The cross sections of fluorescence intensity and temperature shown schematically by curve 222,
For example, when a Gaussian beam exits from a waveguide coupled to a laser operating in continuous wave (“CW”) mode, and there are no further optics at the distal end of the waveguide, and the invention is practiced using annular fluid flow, then curve 220,
Under different conditions, when a Gaussian beam exiting from a waveguide coupled to a laser operating in CW mode has been collimated and/or focused to reduce the beam spot size before and also at the laser tissue interface, and if the power settings are unchanged relative to those represented by
Under other conditions, curve 220, in another hypothetical revised
Curve 230,
Brian Masters observed in his Master's Thesis an average decrease in endogenous fluorescence intensity of approximately 1% for every increase in temperature of 1° C. Thus, a ten degree increase in temperature would result in a 10% decrease in fluorescence, and a twenty degree increase in a 20% decrease in fluorescence. See “Variation of Fluorescence With Temperature in Human Tissue”, by Daniel Barton Masters, submitted in partial fulfillment of the requirements for the degree of Master of Science in Biomedical Engineering, May, 2010 Vanderbilt University.
Observed quenching occurs at temperatures well below the temperature at which water vaporizes, 100° C., and thus well below the temperature at which ablation occurs. Most tissue is approximately 70 percent to 80 percent water. Thus, it is a realization of the present inventors that such quenching can make the “invisible” energy beams, such as a CO2 laser beam, effectively visible before it delivers energy used for cutting and ablation.
The relationship between tissue temperature and tissue change, for both tissue effect and visual effect, is shown in Table I:
When water in tissue reaches 100° C., water vapor and solid particulates are created, which appears as “smoke”. Whether cutting or ablation occurs depends on several system control settings as described in more detail below.
Denaturing interferes with fluorescence. As surgical procedures strive to mark not only tissue to be removed, but also mark without damaging protected tissue, controlling heat profiles becomes increasingly important.
Returning to surgery utilizing systems and methods according to the present invention, and using a decrease of fluorescence of 1% per degree centigrade, a body temperature of 37° C., an estimate that 50° C. is the temperature below which the tissue generally fully recovers its body temperature fluorescence intensity, and an estimate that 70° C. is the temperature above which tissue generally does not recover its body temperature fluorescence intensity, it can be seen that, first: if a decrease in intensity of about 13% can be detected, either by the unaided eye of the surgeon, or by a sensor, (50° C.−37° C.=13° C., resulting in a reversible fluorescence intensity decrease of approximately 13%), then confirmation of the location of a surgical beam can be accomplished with no irreversible tissue alterations after the beam is turned off Additionally, the thermal footprint of the energy can be visualized during tissue removal (e.g. cutting or ablation) before irreversible tissue changes occur.
Second, if a change of 40% can be detected, either by the unaided eye of the surgeon, or by a sensor, (77° C.−37° C.=40° C., resulting in a fluorescence intensity decrease of approximately 40%), i) confirmation of the location of a surgical beam can be accomplished, and ii) if desired, a registration mark can be made to identify structures for reference during the procedure. According to this analysis, using 100° C. as the temperature at which cutting and ablation starts, up to a 63% reduction in fluorescence intensity can be generated and detected before cutting into tissue.
The quenching may also differ between tissue types, as appears to be suggested by the work of Daniel Barton Masters. It is known that early stages of cancer may suppress certain emission bands of fluorescence in tissue, as stated by Cline et al. in U.S. Pat. No. 6,821,245, for example. Once calibrated and characterized according to the present invention, differences in quenching are expected by the inventors to provide further assistance in differentiating between such tissue types.
Desirable characteristics of such fluorophores are i) biocompatibility, and preferably FDA approval, such as ICG (indocyanine green), ii) a noticeable change in intensity before a temperature increase to 100° C., and thus before cutting and ablation occur. In an embodiment of the present invention, a noticeable and reversible change in intensity would occur before coagulation and protein denaturation occurs, as in the Master's example of endogenous fluorophores. In another embodiment, an irreversible decrease in fluorescence occurs before cutting and ablation occurs.
Fluorescent lifetime versus temperature has been studied for a family of often-used exogenous dyes, the boron dipyromethane dyes, or BODIPY dyes (4,4-Difluoro-5-Phenyl-4-Bora-3a,4a-Diaza-s-Indacene-3-Propionic Acid, Succinimidyl Ester). Shi and Parks studied BODIPY-R6Gi covalently bonded to a variety of peptides as described in “Fluorescence Lifetime Probe of Biomolecular Conformations” by Xiangguo Shi and Joel J. Parks, J Am Soc Mass Spectrometry 21, 707-718 (2010). Their data show that fluorescent lifetimes can be engineered via selection of the molecule covalently bonded to the starting dye. The data also show that for their system, a factor of two change in quenching rate is achievable over the temperature range of interest, from approximately 310° K, which is body temperature, to 373° K, the temperature at which water boils and ablation and cutting occur. The absolute intensity and change in intensity will be a function of the concentration of the fluorophores and quenching centers, per the Stern-Volmer equation:
F
0
/F
m=1+κqτ0[Q] (1)
where Fm is the measured fluorescence with quenching, F0 is the initial, unquenched fluorescence, κq, is the quencher rate coefficient, τ0 is the lifetime of the radiative excited state without the quencher present, and [Q] is the quencher concentration. Their success in readily modulating quenching rates by derivatizing a well-known fluorophore suggests to the present inventors that a similar approach could readily be used to customize an exogenous dye useful for the present invention.
Sharpening the thermal profile may be accomplished by increasing the flow rate of cooling fluid surrounding the center of the spot or decreasing its temperature. Apparatus for delivering fluid to cool a waveguide is disclosed in U.S. Pat. No. 7,331,954 by Temelkuran et al., for example. See also U.S. Pat. No. 6,343,174 by Neuberger for one or more fluid delivery channels for other purposes.
Most common sources of energy used in surgery (e.g. electro-cautery, laser and ultrasonic energy) have a thermal footprint associated with them.
Laser surgery typically utilizes long, thin, flexible solid or hollow waveguides to deliver specific wavelengths of electromagnetic radiation. Solid core silica fibers, for example, are utilized to guide wavelength of KPT (532 nm), Nd:YAG (1.06 μm), Ho:YAG (2.1 μm) and Tm: YAG (2 μm) lasers for various medical applications. For CO2 laser beams (approximately 10.6 μm wavelength), hollow waveguides are useful, as the CO2 wavelength is generally highly absorbed in materials traditionally used for optical fibers, such as silicates and thermoplastic polymers. A high omnidirectional reflector is disclosed in U.S. Pat. No. 6,130,780 to Joannopoulos et al.
Flexible hollow waveguides are manufactured in some techniques by drawing structured thermoplastic preforms. Examples of such a structure are described by Harrington et al. in U.S. Pat. No. 5,440,664 and by Fink et al. in U.S. Pat. Nos. 6,463,200 and 7,311,962, in which a dielectric stack of materials having different refractive indices is arranged in concentric cylinders about the waveguide axis thus providing the mirror structure that guides the radiation. Flexible hollow waveguides drawn from structured thermoplastic preforms are also disclosed in U.S. Pat. No. 7,272,285 to Benoit et al. and U.S. Pat. No. 7,295,734 to Bayindir et al., as well as in the following U.S. patents assigned to OmniGuide, Inc.: U.S. Pat. No. 6,788,864 by Ahmad et al.; U.S. Pat. No. 6,801,698 by King et al.; U.S. Pat. No. 6,898,359 by Soljacic et al.; and U.S. Pat. No. 7,142,756 by Anderson et al.
At times, certain surgical uses of energy delivery devices such as waveguides may result in tissue debris, fluid, or smoke being generated. Such tissue debris may absorb delivered energy, including backscattered laser energy, and heat or otherwise interfere with the waveguide. Such tissue debris may impede or slow normal passive cooling resulting from thermal dissipation, and/or impede more active cooling resulting from delivered fluid, including gas flow through the waveguide core. The combination of increased heating and reduced cooling may overheat and thus damage the waveguide.
One approach to protect the portion of the surgical energy device is to flow fluid through a conduit such as hollow core waveguides. Gas flow may be used for clearing tissue debris and blood during tissue cutting, for cooling the waveguide and for therapeutic reasons such as assisting tissue coagulation. The gas flowing out of the waveguide may also assist in keeping the waveguide core from clogging and from damage due to the splattering, splashing, or deposition of tissue debris, including smoke and fluids. Protection of the waveguide distal end may also be achieved by a tip attached to the waveguide distal end, such as disclosed by Temelkuran et al. in U.S. Pat. Nos. 7,167,622 and 7,331,954, by Goell et al. in U.S. Pat. No. 8,280,212, and by Anastassiou et al. in U.S. Patent Publication No. 2014/0088577, all assigned to OmniGuide, Inc. of Cambridge, Mass.
In one construction, a waveguide tip with a variable cantilevered distal end portion length allows a user to select a spot size. The illustration of the diverging cone 302 of radiation emerging from the waveguide 300 illustrates how selecting the stand-off distance determines the spot size. The spot size may be determined approximately by directing the laser at a wooden tongue depressor and observing charring of the wood, for example. The spot size for a given waveguide beam divergence may be set during manufacturing, after the product has been sold but before surgery, by the surgical staff, or after or during a procedure. It may be possible to set the stand-off distance once, or many times. The stand-off distance may be set using a push or pull mechanism in the conduit.
The spot size of the laser radiation emitted from the distal tip affects the power density of the laser energy and thereby defines laser tissue interaction, such as cutting or ablation mode, as well as the rate of cutting or ablation. In general, a beam exiting a optical waveguide diverges as shown in
Another way to control the distance between waveguide and the tissue may be by using a proximity sensor built into the waveguide, jacket, or conduit. This proximity sensor may measure a distance to the tissue and provide a feedback to the user or computer interface. Distance may be controlled by the user or pre-programmed into a computer that automatically maintains a preset distance by adjusting the position of the manipulator.
As schematically illustrated in side view in
Two further examples of similar ring- or toroidal-shaped cooling regions 395′ and 395″ are shown in
A further example of an alternative, wider cooling annulus is indicated by arrow 395″ in
As mentioned above, others have suggested utilizing one or more visible aiming beams or a physical projection such as a stand-off tip to assist locating invisible surgical energy beams. For both these pre-alignment approaches, any verification of the alignment takes place outside the patient. Therefore, it is useful and advantageous for the surgeon also be able to easily check and verify correct beam placement inside the patient before the laser power is increased to a power where cutting or ablation takes place. It is also useful for the surgeon to be able to see the actual location of the beam before it cuts or irreversibly alters the tissue, and not rely on proxies, such as the position of a second visible beam or the position of a tip. Thus, it is desirable to see the position of a low-energy beam, where the energy is too low to cut or ablate tissue, and thereby verify proper placement. Systems and methods according to the present invention enable a user to make adjustments to ensure such placement before the power is increased to a level where it causes irreversible tissue alterations.
Iteration toward desirable laser power and cooling fluid settings is accomplished manually, using the surgeon's eyes as the sensor, in certain embodiments such as those illustrated for system 100 in
It can be also useful for the surgeon to have a visual feedback about energy thermal spread during surgical procedure while performing tissue cutting or ablation. Having this feedback may be important in helping to avoid damage of critical structures. In one procedure according to the present invention, at least one critical structure such as a nerve or blood vessel is marked with at least one type of exogenous fluorophore. Fluorescence of the critical structure is quenched as the thermal energy footprint approaches the structure. Decrease of fluorescence intensity corresponding to the threshold temperature (e.g. 50° C. if no irreversible tissue damage is desired) can be detected. The laser or other surgical energy device utilized according to the present invention can be turned off, or proper adjustment of controllable parameters such as laser power, duration or spot size can be made to avoid further energy spread into the critical structure.
As surgeons approach sensitive areas, it may be desirable to adjust laser settings so as to remove tissue more slowly, or to avoid inadvertent damage to such areas due to heat spreading. Fluorescence quenching, starting first in less sensitive areas, may be used to adjust the laser power and pulse rate and duty cycle, energy density or surrounding cooling fluid flow, to create the sharpest dark spot. This setting may then be used for the entire surgery and or as the surgery proceeds to areas closer to structures which are to be protected. The setting adjustments may be made manually, relying on the human eye as the fluorescence intensity detector, or via an electronic sensor and computer interface.
Flow chart 500,
Flow chart 520,
In one sequence of flow chart 520, the sharpness of the thermal profile is increased. First the laser is turned and the system adjusted until quenching is detectable. These adjustments may include any of increasing the power, decreasing the time between pulses or increasing the pulse width, or decreasing the annular fluid flow or increasing the temperature of the annular fluid flow. The sharpness of the profile is analyzed either by the human eye, or via software which measures the slope of the fluorescence versus intensity curve and width of the region of variable fluorescence. If a sharper thermal profile is desired, then the laser system settings may be adjusted until the profile is acceptable for the procedure.
Flow chart 540,
If at least one of the current settings are not acceptable, then at least one setting is selected to be modified, step 548. If the selected setting is within preselected or currently desired ranges of maximum and minimum values for the desired surgical procedure, as determined at step 550, then the selected setting is modified, step 552, and the logic returns to step 544. Preferably, the determination at step 550 that the selected setting is “within” a range allows for at least one incremental increase or decrease in that parameter so the logic can proceed through steps 552 and 554 and still be within the desired range. Otherwise, the logic proceeds to step 544 where another system control setting is selected to be altered, step 552. The logic preferably continues until all current settings are acceptable, step 544 and then surgery is performed, step 546.
Flow chart 560,
Other surgical procedures utilizing quenching of fluorescence are within the scope of the present invention. It can be useful to the surgeon to create a registration mark in the surgical field inside the patient, as is done sometimes outside the patient before starting a procedure, or as it done sometimes following a biopsy, where a marker is left in place to facilitate navigating to places of interest. In addition, irreversible quenching is thought to indicate irreversible changes in tissue which may occur prior to ablation. It may be desirable to identify laser settings which cause such changes.
Although specific features of the present invention are shown in some drawings and not in others, this is for convenience only, as each feature may be combined with any or all of the other features in accordance with the invention. While there have been shown, described, and pointed out fundamental novel features of the invention as applied to one or more preferred embodiments thereof, it will be understood that various omissions, substitutions, and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit and scope of the invention. For example, it is expressly intended that all combinations of those elements and/or steps that perform substantially the same function, in substantially the same way, to achieve the same results be within the scope of the invention. Substitutions of elements from one described embodiment to another are also fully intended and contemplated. It is also to be understood that the drawings are not necessarily drawn to scale, but that they are merely conceptual in nature.
It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto. Other embodiments will occur to those skilled in the art and are within the following claims.
This application claims priority to U.S. Provisional Application No. 61/929,343 filed 20 Jan. 2014.
Number | Date | Country | |
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61929343 | Jan 2014 | US |