Optical fiber assembly
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-11-29
- Publication Date
- 2026-04-09
AI Technical Summary
Conventional endoscopic laser therapy lacks precision in identifying and continuously monitoring tissue type during procedures, leading to inefficient and time-consuming treatments due to manual recognition methods and the need for biopsy techniques to determine tissue composition.
A multi-fiber assembly for endoscopic procedures that includes optical fibers for transmitting illumination light and spectroscopic signals, coupled with a spectroscopic system and feedback analyzer to continuously monitor tissue composition and adjust laser settings in real-time, enabling precise identification and treatment of different tissue types.
Enables continuous monitoring and adaptive laser therapy based on tissue composition, improving treatment efficiency and reducing surgical time by allowing instantaneous adjustment of laser settings during procedures.
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Abstract
Description
[Technical field]
[0001] Claiming priority This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 882,837, filed August 5, 2019, U.S. Provisional Patent Application No. 62 / 894,043, filed August 30, 2019, and U.S. Provisional Patent Application No. 63 / 027,022, filed May 19, 2020, which are incorporated by reference herein in their entireties.
[0002] The present specification relates generally to endoscopic systems, and more particularly to multi-fiber assemblies used in endoscopic procedures to transmit illumination to a target and response signals reflected from the target. [Background technology]
[0003] Typically, endoscopes are used to provide access to an internal location of a subject, such as to provide visual access to a physician. Endoscopes are usually inserted into a patient's body to deliver light to a target (e.g., a target anatomical tissue or object) being investigated and collect light reflected from the object. The reflected light carries information about the object being investigated. Some endoscopes include a working channel through which an operator can perform suction or pass instruments such as brushes, biopsy needles, or forceps to remove unwanted tissue or foreign objects from the patient's body, or to perform minimally invasive surgery.
[0004] Laser or plasma systems have been used to deliver surgical laser energy to various target treatment areas such as soft or hard tissue. Examples of laser therapy include ablation, coagulation, vaporization, fragmentation, etc. In lithotripsy applications, lasers have been used to break up stone structures in the kidney, gallbladder, ureter, among other stone-forming areas, or to ablate larger stones into smaller fragments. Summary of the Invention [Means for solving the problem]
[0005] Described herein is a multi-fiber assembly for transmitting illumination light to a target and a response signal reflected from the target, and a method of using such an assembly within an endoscopic procedure. An exemplary device includes a proximal end and a distal end, and a transition section between the proximal end and the distal end. The proximal end includes a first connector that is connected to a light source and a second connector that is configured to be connected to a spectrometer. The distal end includes a shaft that includes at least two first optical fibers for transmitting light and at least one second optical fiber for transmitting a spectroscopic signal. The transition section can couple the first connector to the at least two first optical fibers and the second connector to the at least one second optical fiber.
[0006] Example 1 is an optical transmission device comprising a proximal end comprising a first connector configured to be connected to a light source and a second connector configured to be connected to a spectrometer, a distal end comprising a shaft comprising at least two first optical fibers configured to transmit light and at least one second optical fiber configured to transmit a spectroscopic signal, and a transition section coupling the first connector to the at least two first optical fibers and coupling the second connector to the at least one second optical fiber.
[0007] In Example 2, the subject matter of Example 1 optionally includes the shaft being sized and shaped to extend an elongated channel therethrough to accommodate the at least two first optical fibers and at least one second optical fiber.
[0008] In Example 3, the subject matter of Example 2 optionally includes where the elongate channel includes a working channel of an endoscope.
[0009] In Example 4, the subject matter of any one or more of Examples 1-3 optionally includes at least two first optical fibers positioned radially around at least one second optical fiber within the shaft.
[0010] In Example 5, the subject matter of Example 4 optionally includes at least two first optical fibers positioned radially on either side of the at least one second optical fiber within the shaft.
[0011] In Example 6, the subject matter of any one or more of Examples 1-5 optionally includes at least one second optical fiber extending substantially along a central longitudinal axis of the shaft.
[0012] In Example 7, the subject matter of any one or more of Examples 1-6 optionally includes wherein the transition section is configured to provide a transition of the at least two first optical fibers and the at least one second optical fiber from the first and second connectors, respectively, into the shaft.
[0013] In Example 8, the subject matter of any one or more of Examples 1-7 optionally includes that the proximal end further includes a third connector configured to connect a laser source to at least one of the at least two first optical fibers or the at least one second optical fiber, thereby directing laser energy generated by the laser source to a target of interest.
[0014] In Example 9, the subject matter of Example 8 optionally includes a third connector connected to the at least one second optical fiber.
[0015] In Example 10, the subject matter of any one or more of Examples 1-9 optionally includes, wherein the shaft further includes a laser fiber separate from the at least two first optical fibers and the at least one second optical fiber, and the proximal end further includes a third connector configured to connect a laser source to the laser fiber, and the laser fiber configured to direct laser energy generated by the laser source to a target of interest.
[0016] Example 11 is an endoscope comprising a proximal end forming a handle for a user, the proximal end having a first connector configured to be connected to a light source and a second connector configured to be connected to a spectrometer, and a shaft having a working channel extending therethrough and having a distal portion configured to be inserted into a target of interest, the shaft comprising at least two first optical fibers coupled to the first connector and configured to transmit light from the light source to the target, and at least one second optical fiber coupled to the second connector and configured to transmit a spectroscopic signal from the target to the spectrometer.
[0017] In Example 12, the subject matter of Example 11 optionally includes the working channel being sized and shaped to accommodate at least two first optical fibers and at least one second optical fiber.
[0018] In Example 13, the subject matter of any one or more of Examples 11-12 optionally includes at least two first optical fibers positioned radially around at least one second optical fiber within the shaft.
[0019] In Example 14, the subject matter of any one or more of Examples 11-13 optionally includes at least two first optical fibers positioned radially on either side of the at least one second optical fiber within the shaft.
[0020] In Example 15, the subject matter of any one or more of Examples 11-14 optionally includes at least one second optical fiber extending substantially along a central longitudinal axis of the shaft.
[0021] In Example 16, the subject matter of any one or more of Examples 11-15 optionally includes wherein the shaft comprises a transition section configured to couple the first connector to the at least two first optical fibers and the second connector to the at least one second optical fiber.
[0022] In Example 17, the subject matter of Example 16 optionally includes the transition section being configured to provide a transition of the at least two first optical fibers and the at least one second optical fiber from the first and second connectors, respectively, into the shaft.
[0023] In Example 18, the subject matter of any one or more of Examples 11-17 optionally includes a proximal end further including a third connector configured to connect a laser source to a laser fiber disposed within the shaft, the laser fiber being separate from the at least two first optical fibers and the at least one second optical fiber and configured to direct laser energy generated by the laser source to a target of interest.
[0024] In Example 19, the subject matter of Example 18 optionally includes a third connector connected to the at least one second optical fiber.
[0025] In Example 20, the subject matter of any one or more of Examples 11-19 optionally includes, wherein the shaft further includes a laser fiber separate from the at least two first optical fibers and the at least one second optical fiber, and the proximal end further includes a third connector configured to connect a laser source to the laser fiber, and the laser fiber configured to direct laser energy generated by the laser source to a target of interest.
[0026] This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details regarding the present subject matter are found in the detailed description and the appended claims. Other aspects of the present disclosure will be apparent to one skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be construed as limiting. The scope of the present disclosure is defined by the appended claims and their legal equivalents.
[0027] Various embodiments are illustrated by way of example in the accompanying drawing figures. Such embodiments are illustrative and are not intended to be exhaustive or exclusive embodiments of the present subject matter. [Brief description of the drawings]
[0028] [Figure 1] 1 is a schematic diagram of an exemplary laser therapy system including a laser feedback control system. [Figure 2A] FIG. 1 shows examples of absorption spectra of different types of tissue, including hemoglobin (Hb) and oxyhemoglobin (HbO2). [Figure 2B] FIG. 1 shows examples of absorption spectra of different types of tissue, including hemoglobin (Hb) and oxyhemoglobin (HbO2). [Figure 3A] FIG. 1 shows examples of absorption spectra of different types of tissue including normal and charred tissue, Hb, HbO2, and melanin. [Figure 3B] FIG. 1 shows examples of absorption spectra of different types of tissue including normal and charred tissue, Hb, HbO2, and melanin. [Figure 3C] FIG. 1 shows examples of absorption spectra of different types of tissue including normal and charred tissue, Hb, HbO2, and melanin. [Figure 4] FIG. 1 illustrates the penetration depth of the laser output. [Diagram 5] FIG. 2 is a block diagram illustrating a laser feedback control system for providing a laser output. [Figure 6] 1 is a flow diagram illustrating an example of an algorithm for controlling one or more laser systems based on feedback generated by the laser feedback control system. [Figure 7] 1 is a flow diagram illustrating an example of an algorithm for controlling one or more laser systems based on feedback generated by the laser feedback control system. [Figure 8] FIG. 1 is a timing diagram of an exemplary dual laser system that uses two wavelengths of light to provide tissue ablation and coagulation. [Figure 9A] FIG. 1 is a diagram showing an example of an endoscope into which a laser fiber is inserted. [Figure 9B] FIG. 1 is a diagram showing an example of an endoscope into which a laser fiber is inserted. [Figure 10A] FIG. 1 illustrates an example of a feedback controlled laser treatment system. [Figure 10B] FIG. 1 illustrates an example of a feedback controlled laser treatment system. [Figure 11A] FIG. 1 illustrates an example of an endoscopic system for identifying a target using a diagnostic beam, such as a laser beam. [Figure 11B] FIG. 1 illustrates an example of an endoscopic system for identifying a target using a diagnostic beam, such as a laser beam. [Figure 12] FIG. 1 illustrates reflectance spectra for identifying target types, such as for identifying the composition of different types of kidney stones. [Figure 13A] FIG. 1 illustrates reflectance spectra for identifying target types, such as for identifying the composition of different types of kidney stones. [Figure 13B] FIG. 1 illustrates reflectance spectra for identifying target types, such as for identifying the composition of different types of kidney stones. [Figure 14] FIG. 13C shows light peaks corresponding to different segments of UV wavelengths in the reflectance spectra of several types of stones in FIGS. 13A-B. [Figure 15]FIG. 13C shows light peaks corresponding to different segments of UV wavelengths in the reflectance spectra of several types of stones in FIGS. 13A-B. [Figure 16A] FIG. 1 shows examples of reflectance spectra captured with a UV-VIS spectrometer from various soft and hard tissue compositions. [Figure 16B] FIG. 1 shows examples of reflectance spectra captured with a UV-VIS spectrometer from various soft and hard tissue compositions. [Figure 16C] FIG. 1 shows examples of FTIR spectra of typical stone compositions. [Figure 16D] FIG. 1 shows examples of FTIR spectra of several soft and hard tissue compositions. [Figure 17] 1 is a schematic diagram of a laser treatment system. [Figure 18] 1 is a schematic diagram of a laser treatment system. [Figure 19A] FIG. 1 illustrates an example of a combined laser pulse train generated using multiple (e.g., N) laser pulse trains. [Figure 19B] FIG. 1 illustrates an example of a combined laser pulse train generated using multiple (e.g., N) laser pulse trains. [Figure 20] FIG. 1 is a schematic diagram of an exemplary spectroscopy system with spectroscopic feedback. [Figure 21A] FIG. 1 illustrates an example of an endoscopic laser system having a multi-fiber configuration. [Figure 21B] FIG. 1 illustrates an example of an endoscopic laser system having a multi-fiber configuration. [Figure 21C] FIG. 1 illustrates an example of an endoscopic laser system having a multi-fiber configuration. [Figure 21D] FIG. 1 illustrates an example of an endoscopic laser system having a multi-fiber configuration. [Figure 22] FIG. 1 is a block diagram illustrating an example of a multi-fiber system for use in a distribution fiber optic delivery system. [Figure 23A] FIG. 1 illustrates an example of a multi-fiber accessory having a source optical input and a spectroscopic feedback signal. [Figure 23B] FIG. 1 illustrates an example of a multi-fiber accessory having a source optical input and a spectroscopic feedback signal. [Figure 24A] FIG. 1 illustrates an exemplary method for calculating the distance between a distal end of a laser delivery system (e.g., an optical fiber) and a target. [Figure 24B] FIG. 1 illustrates an exemplary method for calculating the distance between a distal end of a laser delivery system (e.g., an optical fiber) and a target. [Figure 24C] FIG. 1 illustrates an exemplary method for calculating the distance between a distal end of a laser delivery system (e.g., an optical fiber) and a target. [Figure 24D] FIG. 1 illustrates an exemplary method for calculating the distance between a distal end of a laser delivery system (e.g., an optical fiber) and a target. [Figure 25A] FIG. 13 illustrates the effect of the distance between the tissue and the distal end of the spectroscopic probe on the spectrum of reflected light from a target. [Figure 25B] FIG. 13 illustrates the effect of the distance between the tissue and the distal end of the spectroscopic probe on the spectrum of reflected light from a target. [Figure 26] FIG. 1 illustrates an example of an endoscopic system for identifying a target using a diagnostic beam, such as a laser beam. [Figure 27] 1 is a graph of a sequence of laser pulses having different pulse energies or power levels for use in laser treatment of a target tissue or stone structure. [Figure 28] FIG. 1 is a block diagram illustrating an example machine capable of performing any one or more of the techniques (e.g., methods) discussed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0029] Among other things, described herein are multi-fiber assemblies for transmitting illumination light to a target and a response signal reflected from the target, and methods of using such assemblies in endoscopic procedures. An exemplary device includes a proximal end and a distal end, and a transition section between the proximal end and the distal end. The proximal end includes a first connector that is connected to a light source and a second connector that is configured to be connected to a spectrometer. The distal end includes a shaft that includes at least two first optical fibers for transmitting light and at least one second optical fiber for transmitting a spectroscopic signal. The transition section can couple the first connector to the at least two first optical fibers and the second connector to the at least one second optical fiber.
[0030] In endoscopic laser therapy, it is desirable to recognize different tissues and apply laser energy only to the target treatment structure (e.g., cancer tissue, or a specific stone type) and avoid or reduce the exposure of non-treated tissue (e.g., normal tissue) to the laser radiation. Traditionally, the recognition of the target treatment structure of interest is performed manually by an operator, such as by visualizing the target surgical site and its surrounding environment through an endoscope. Such manual techniques may lack precision and, at least in some cases, may not be able to determine the composition of the target, such as due to narrow access to the surgical site and limited visibility during surgery. Biopsy techniques have been used to extract target structures (e.g., tissue) from within the body and analyze their composition ex vivo. However, in many clinical applications, it is desirable to determine tissue composition in vivo to reduce surgical time and complexity and improve the efficacy of the therapy. For example, in laser lithotripsy, in which a laser is applied to crush or fragment stones, automatically recognizing a particular type of stone (e.g., the chemical composition of kidney or pancreatic bile duct or gallbladder stones) in vivo and distinguishing it from surrounding tissue should enable a physician to adjust laser settings (e.g., power, exposure time, or firing angle) to more effectively ablate the target stone while at the same time avoiding radiation to non-treated tissue adjacent to the target stone.
[0031] Conventional endoscopic laser therapy also has the limitation of not being able to continuously monitor tissue type (e.g., composition) during the procedure. There are many moving parts during an endoscopic procedure, and the tissue viewed from the endoscope may change throughout the procedure. Conventional biopsy techniques require the removal of tissue samples to identify the composition, and therefore cannot monitor the composition of the tissue throughout the procedure. Continuous monitoring and recognition of the structure type (e.g., soft or hard tissue type, normal vs. cancerous tissue, or composition of the stone structure) at the tip of the endoscope can give the physician more information to better tailor the treatment during the procedure. For example, if a physician is breaking up a kidney stone that has a hard surface but a soft core, continuous tissue composition information from the endoscope can allow the physician to adjust the laser settings, such as from a first setting that performs better on the hard surface of the stone to a second different setting that performs better on the soft core of the stone, based on the continuously detected stone surface composition.
[0032] Some features described herein can provide methods and devices that can identify various target compositions (e.g., soft or hard tissues) in vivo, for example, in medical applications, by endoscopy. This can allow a user to continuously monitor the target composition as viewed by the endoscope throughout the procedure. This can also be used in combination with a laser system, where the method can provide feedback to the laser system to adjust settings based on the target composition. This feature can allow instant adjustment of the laser settings within the setting range of the original laser settings selected by the user.
[0033] Some features described herein can be used to provide systems and methods that measure differences in target chemical composition, etc. in vivo and suggest or automatically adjust laser settings to better achieve the desired effect. Examples of targets and applications include laser lithotripsy of kidney stones and laser incision or vaporization of soft tissue. In one example, three main components are provided: a laser, a spectroscopy system, and a feedback analyzer. In one example, a controller of the laser system can automatically program the laser therapy with appropriate laser parameter settings based on the target composition. In one example, the laser can be controlled based on a machine learning algorithm trained by the spectroscopic data. Additionally or alternatively, a user (e.g., a physician) can receive continuous indications of the target type during the procedure and prompt the user to adjust the laser settings. By adjusting the laser settings and matching the laser therapy to the compositional parts of a single stone target, the stone ablation or fragmentation procedure can be performed faster and more energy-efficiently.
[0034] Some features described herein can provide a system and method for providing data input to a feedback analyzer, including internet connectivity and connectivity to other surgical devices with measurement capabilities. In addition, the laser system can provide input data to another system, such as an image processor, so that a treatment monitor can display information about the medical treatment to a user. One example of this is to more clearly distinguish different soft tissues, vascular structures, capsular tissues, and different chemical compositions within the same target, such as stones, within the field of view during the treatment.
[0035] Some features described herein can provide systems and methods for identifying different target types, such as different tissue types or different stone types. In some cases, a single stone structure (e.g., kidney, bladder, pancreatic biliary duct, or gallbladder stones) may have two or more different compositions throughout its volume, such as brushite, calcium phosphate (CaP), calcium oxalate dihydrate (COD), calcium oxalate monohydrate (COM), magnesium ammonium phosphate (MAP), or cholesterol-based or uric acid-based stone structures. For example, the target stone structure may include a first portion of COD and a second portion of COM. According to one aspect, the present specification describes systems and methods for continuously identifying different compositions contained in a single target (e.g., a single stone) based on continuously collecting and analyzing spectroscopic data in vivo. Treatment (e.g., laser therapy) can be adapted according to the identified target composition. For example, in response to identifying a first composition (e.g., COD) in the target stone, the laser system can be programmed with a first laser parameter setting (e.g., power, exposure time, or launch angle, etc.), and the laser system can deliver a laser beam to ablate or spall the first portion accordingly. During the laser therapy, spectroscopic data can be continuously collected and analyzed. In response to identifying a second composition (e.g., COM) different from the first composition in the same target stone being treated, the laser therapy can be adjusted, such as by programming the laser system with a second laser parameter setting (e.g., different power, or exposure time, or launch angle, etc.) different from the laser parameter setting, and delivering a laser beam to ablate or spall the second portion of the same target stone accordingly. In some examples, multiple different laser sources can be included in the laser system. Stone portions of different compositions can be treated by different laser sources. The appropriate laser to use can be determined by identifying the stone type.
[0036] Some features described herein can be used in connection with laser systems for various applications where it may be advantageous to incorporate different types of laser sources. For example, the features described herein may be suitable in industrial or medical settings, such as medical diagnostic, therapeutic, and surgical procedures. The features described herein can be used in connection with endoscopy, laser surgery, laser lithotripsy, laser settings, and / or spectroscopy.
[0037] 1 shows a schematic diagram of an exemplary laser therapy system including a laser feedback control system 100 according to an embodiment of the present disclosure. Exemplary applications of the laser feedback control system 100 include integration into laser systems for many applications, such as industrial and / or medical applications for the treatment of soft (e.g., non-calcified) or hard (e.g., calcified) tissue, or stone structures, such as kidney or pancreatic biliary duct or gallbladder stones. For example, the systems and methods disclosed herein may be useful for the delivery of precisely controlled therapeutic treatments, such as ablation, coagulation, vaporization, or ablation, fragmentation, or fragmentation of stone structures.
[0038] With reference to Figure 1, a laser feedback control system 100 can be in operative communication with one or more laser systems. Figure 1 illustrates a laser feedback system connected to a first laser system 102 and optionally a second laser system 104 (shown in dotted lines), although additional laser systems are contemplated within the scope of the present disclosure.
[0039] The first laser system 102 may include a first laser source 106 and associated components such as a power source, a display, a cooling system, etc. The first laser system 102 may also include a first optical fiber 108 operably coupled to the first laser source 106. The first optical fiber 108 may be configured to transmit laser output from the first laser source 106 to the target tissue 122.
[0040] In one example, the first laser source 106 can be configured to provide a first output 110. The first output 110 can extend over a first wavelength range. According to some aspects of the present disclosure, the first wavelength range can correspond to a portion of the absorption spectrum of the target tissue 122. The absorption spectrum represents the absorption coefficient for a range of laser wavelengths. FIG. 2A shows, as an example, the absorption spectrum 210 of water. FIG. 2B shows, as an example, the absorption spectrum 221 of oxyhemoglobin and the absorption spectrum 222 of hemoglobin. In such an example, it is advantageous that the first output 110 can provide effective ablation and / or carbonation of the target tissue 122 because the first output 110 spans a wavelength range corresponding to the absorption spectrum of the tissue.
[0041] For example, the first laser source 106 may be configured such that the first output 110 emitted in a first wavelength range is absorbed by tissue at a high wavelength (e.g., approximately 250 cm -1 In an exemplary embodiment, the first laser source 106 can emit a first output 110 between about 1900 nanometers and about 3000 nanometers (e.g., corresponding to high absorption by water) and / or between about 400 nanometers and about 520 nanometers (e.g., corresponding to high absorption by oxyhemoglobin and / or deoxyhemoglobin). It has been found that there are two main mechanisms of light interaction with tissue: absorption and scattering. Tissue has high absorption (absorption coefficient of 250 cm -1 When the absorption coefficient exceeds 250 cm, the first absorption mechanism becomes dominant and the absorption is low. -1 When the optical fiber is 100 nm or less, for example for lasers in the 800-1100 nm wavelength range, scattering mechanisms become dominant.
[0042] A variety of commercially available medical grade laser systems may be suitable for the first laser source 106. For example, a semiconductor laser such as an InXGa1-XN semiconductor laser providing a first output 110 within a first wavelength range of about 515 nanometers to about 520 nanometers or about 370 nanometers to about 493 nanometers may be used. Alternatively, an infrared (IR) laser may be used, such as the lasers summarized in Table 1 below. [Table 1]
[0043] Referring to FIG. 1, the laser treatment system of the present disclosure may optionally include a second laser system 104. The second laser system 104 includes a second laser source 116 for providing a second output 120 and associated components such as a power source, a display, a cooling system, etc., as described above. The second laser system 104 may be operatively separate from the first laser source 106, or alternatively, may be operatively coupled to the first laser source 106. In some examples, the second laser system 104 may include a second optical fiber 118 (separate from the first optical fiber 108) operatively coupled to the second laser source 116 to transmit the second output 120. Alternatively, the first optical fiber 108 may be configured to transmit both the first output 110 and the second output 120.
[0044] In certain aspects, the second output 120 can extend over a second wavelength range that is separate from the first wavelength range. Accordingly, there may not be any overlap between the first and second wavelength ranges. Alternatively, the first and second wavelength ranges may have at least a partial overlap with each other. According to some aspects of the present disclosure, the second wavelength range may not correspond to a portion of the absorption spectrum of the target tissue 122 where the incident radiation is strongly absorbed by tissue that has not previously been ablated or carbonized (e.g., as shown in FIG. 2). In some such aspects, it is advantageous for the second output 120 not to ablate non-carbonized tissue. Furthermore, in another example, the second output 120 can ablate previously ablated carbonized tissue. In an additional example, the second output 120 can provide an additional therapeutic effect. For example, the second output 120 can be more suitable for coagulating tissue or blood vessels.
[0045] Laser emission can be largely absorbed by soft or hard tissues, stones, etc. As an example, Figures 3A-3C show the absorption spectra of different tissue types. Figure 3A shows the absorption spectrum 311 of normal tissue (before ablation) and the absorption spectrum 312 of carbonized tissue (after ablation), respectively. Figure 3B shows that within a certain wavelength range (e.g., 450-850 nm), the absorption spectrum follows an exponential decay with respect to the laser wavelength (data shown in Figures 3A and 3B is taken from http: / / omlc.org / spectra / hemoglobin / ). Figure 3C shows optical absorption spectra measured within different media, including water spectra 331A-331C (at concentrations of 75%, 100%, and 4%, respectively), hemoglobin (Hb) spectrum 332, oxyhemoglobin (HbO2) spectrum 333, and melanin spectra 334A-334D (at volume fractions of melanosomes of 2%, 13%, 30%, and 100%, respectively) (data shown in Figure 3C is taken from http: / / www.americanlaserstudyclub.org / laser-surgery-education / ). The wavelengths of water absorption are in the range of 1900 nm-3000 nm. The wavelengths of oxyhemoglobin and / or oxyhemoglobin are in the range of 400 nm-520 nm. While many surgical lasers are highly absorbed within certain limits by water or hemoglobin, there are also media with limited absorption of water, which can be the reason why the inside of an endoscope can be damaged by laser energy.
[0046] FIG. 4 illustrates the penetration depth of a laser output, such as the second output 120 (the data shown in FIG. 4 is taken from http: / / www.americanlaserstudyclub.org / laser-surgery-education / ). As seen therein, the second output 120 may be suitable for effective coagulation due to a penetration depth comparable to the characteristic dimensions of small capillaries (e.g., about 5 to about 10 μm). Further, in certain examples, referring to FIGS. 3A and 3B, the second wavelength range may correspond to low absorption of the second output 120 by uncarbonized tissue, but high absorption by carbonized tissue (e.g., due to ablation of the first output 110). The spectral characteristics of the second output 120 may be such that the absorption of the incident second output 120 by carbonized tissue is high (e.g., about 250 cm -1 It is clear that this corresponds to a larger (greater) absorption. An example of a suitable second laser source is a GaAs laser having a second output 120 in a second wavelength range of about 750 nanometers to about 850 nanometers. X Al 1-X A, or a second output 120 in a second wavelength range of about 904 nanometers to about 1065 nanometers. X Ga 1-X Contains A.
[0047] While two laser systems with overlapping spectra suitable for absorption by tissue (normal and / or carbonized) are described above, in an alternative example, the first laser system 102 can provide the second output 120 instead of the second laser system 104. In one example, the first laser system 102 can provide a first output 110 over a first wavelength range that is suitable for high absorption of previously unablated "normal" tissue (e.g., as shown in FIG. 2), and a second output 120 over a second wavelength range that corresponds to low absorption by tissue prior to carbonization and / or is more suitable for coagulation (e.g., as shown in FIGS. 3A and 3B). The first laser system 102 can provide an additional output over an additional wavelength range.
[0048] Referring again to FIG. 1 . According to an example, the laser therapy system includes a laser feedback control system 100. Referring now to FIG. 5 , as previously described, the laser feedback control system 100 can analyze a feedback signal 130 from the target tissue 122 and control the first laser system 102 and / or the second laser system 104 to generate a suitable laser output to provide a desired therapeutic effect. For example, the laser feedback control system 100 can monitor characteristics of the target tissue 122 during a therapeutic treatment (e.g., ablation) to determine whether the tissue has been suitably ablated prior to another therapeutic treatment (e.g., coagulation of blood vessels). Accordingly, the laser feedback control system 100 can include a feedback analyzer 140.
[0049] With continued reference to FIG. 5, the feedback analyzer 140, according to one example, can monitor the spectroscopic properties of tissue. The spectroscopic properties can include properties such as reflectance, absorption index, and the like. Accordingly, the feedback analyzer 140 can include a spectroscopic sensor 142. The spectroscopic sensor 142 can include a Fourier transform infrared spectrometer (FTIR), a Raman spectrometer, a UV-VIS reflectance spectrometer, a fluorescence spectrometer, and the like. FTIR is a method used for routine, simple, and rapid material analysis. This technique has relatively good spatial resolution and gives information about the chemical composition of materials. Raman spectroscopy has good accuracy in identifying components of hard and soft tissues. As a high spatial resolution technique, Raman spectroscopy is also useful for determining the distribution of components within a target. UV-VIS reflectance spectroscopy is a method of gathering information from light reflected from an object, similar to information provided by the eye or color images made by a high resolution camera, but more quantitatively and objectively. Reflectance spectroscopy provides information about materials since the reflection and absorption of light depends on their chemical composition and surface properties. This technique can also be used to obtain unique information about both the surface and internal properties of a sample. Reflectance spectroscopy can be a useful technique to recognize the composition of hard or soft tissues. Fluorescence spectroscopy is a type of electromagnetic spectroscopy that analyzes fluorescence from a sample. Fluorescence spectroscopy involves using a light beam, usually ultraviolet, that excites material compounds, causing them to emit light, typically in the visible or IR range. This method is applicable to the analysis of some organic components, such as hard and soft tissues.
[0050] The feedback analyzer 140 may optionally include, in one example, an imaging sensor 144 (e.g., a CCD or CMOS camera sensitive to ultraviolet (UV), visible (VIS), or infrared (IR) wavelengths). In some examples, the spectroscopic sensor 142 may include two or more of the types of spectrometers or imaging cameras listed herein to enhance sensing and detection of various features (e.g., carbonized and non-carbonized tissue, vascular structures, etc.).
[0051] In some examples, the spectroscopic sensor 142 (also known as a spectrometer) can include any of the spectrometers listed herein and can further rely on the imaging capabilities of the endoscope used during the therapeutic procedure. For example, the endoscope can be used to visualize anatomical features during the therapeutic procedure (e.g., laser ablation of a tumor). In such cases, the spectroscopic sensor 142 can augment the imaging capabilities of the endoscope. For example, a conventional endoscope can provide narrowband imaging suitable for enhanced visualization of anatomical features (e.g., lesions, tumors, vasculature, etc.). By combining the spectroscopic sensor 142 with endoscopic imaging (white light and / or narrowband imaging), the detection of tissue characteristics such as charring levels can be augmented to precisely control the delivery of the therapeutic procedure.
[0052] 5 , the spectroscopic sensor 142 can be operably coupled to a signal detection optical fiber 150. In such an example, the signal detection optical fiber 150 can have optical characteristics suitable for transmitting a spectroscopic signal from the tissue to the spectroscopic sensor 142. Alternatively, the spectroscopic sensor 142 can be operably coupled to the first optical fiber 108 of the first laser system 102 and / or the second optical fiber 118 of the second laser system 104, thereby detecting the spectroscopic signal via the first optical fiber 108 and / or the second optical fiber 118.
[0053] 1 and 5, the laser feedback control system 100 includes a laser controller 160 in operative communication with each of the spectroscopic sensor 142, the first laser system 102, and optionally the second laser system 104. The laser controller 160 can control one or more laser systems (e.g., the first laser system 102, the second laser system 104, and / or any additional laser systems) operatively connected to the laser controller 160 in accordance with one or more control algorithms described herein to control the laser output from the one or more laser systems to provide a desired therapeutic effect at the target tissue 122.
[0054] Laser controller 160 may include a processor, such as a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or any other equivalent integrated or discrete logic circuitry, as well as any combination of such components, to perform one or more of the functions ascribed to laser controller 160. Optionally, laser controller 160 may be coupled to spectroscopic sensor 142 and one or more laser systems (e.g., first laser system 102, second laser system 104, and optional laser systems not shown herein) by wired or wireless connections.
[0055] The laser controller 160 can be in communication with the feedback analyzer 140 (e.g., via a wired or wireless connection) to receive one or more feedback signals from the feedback analyzer 140. The laser controller 160 can determine one or more characteristics of the target tissue 122 based on the feedback signals, as further described herein. For example, the laser controller 160 can compare the amplitudes of the feedback signals to provide minimum and maximum amplitudes to determine a characteristic of the tissue (e.g., charring, coagulation, etc.).
[0056] In some examples, the feedback analyzer 140 can continuously monitor the target tissue 122 and continuously communicate with the laser controller 160 to provide a feedback signal. In response, the laser controller 160 can continue to maintain the laser system in one or more states until a change in the amplitude of the feedback signal is detected. When a change in the amplitude of the spectroscopic signal is detected, the laser controller 160 can communicate with the one or more laser systems and change states to deliver a desired therapeutic effect. Alternatively or additionally, the laser controller 160 can communicate with an operator (e.g., a medical practitioner) and display one or more outputs indicative of the feedback signal via one or more output systems, and can optionally instruct the operator to perform one or more therapeutic procedures with the first laser system and / or the second laser system to deliver a desired therapeutic effect.
[0057] In the examples described herein, the laser controller 160 can control one or more laser systems by changing the state of the laser systems. According to one embodiment, the laser controller 160 can control each laser system independently. For example, the laser controller 160 can send a separate control signal to each laser system and control each laser system independently from the other laser systems. Alternatively, the laser controller 160 can send a common signal to control one or more laser systems.
[0058] In some examples, each of the laser systems can be associated with two distinct states: a first state in which the laser system generates a laser output, and a second state in which the laser system does not generate a laser output. For example, the first laser system 102 can have a first state in which the first output 110 (e.g., a first wavelength range) is generated, and a second state in which the first output 110 is not generated. Similarly, the second laser system 104 can have a first state in which the second output 120 (e.g., a second wavelength range) is generated, and a second state in which the second output 120 is not generated. In such examples, the laser controller 160 can control one or more laser systems by sending control signals that change the state of the laser system from the first state to the second state or from the second state to the first state. Furthermore, optionally, each laser system can have an additional state, for example, a third state in which a laser output of a different wavelength range is generated. Accordingly, additional control signals can be sent by the laser controller 160 to the laser systems to change their state from their current state to one or more additional states (e.g., from the first state to a third state, from the second state to the third state, from the third state to the first state, and from the third state to the second state) to generate a laser output that provides the desired therapeutic effect.
[0059] [Example Laser System Control Algorithm] 6 and 7 are flow charts illustrating an example of an algorithm for controlling one or more laser systems using the laser feedback control system 100 according to some examples described in the present disclosure. According to the control algorithm 600 shown in FIG. 6, in step 602, a first signal (e.g., a spectroscopic signal) can be detected by the feedback analyzer 140 (e.g., the spectroscopic sensor 142 or the imaging sensor 144). In step 604, the laser controller 160 can receive the first signal from the feedback analyzer 140. The first signal can correspond to a first characteristic. In step 606, the laser controller 160 can determine whether the first signal is approximately equal to a first preset value. For example, the laser controller 160 can compare the amplitude of the first signal to a target value or a preset extreme value (e.g., a maximum or minimum amplitude) to determine a first characteristic of the target tissue 122. The first characteristic can be indicative of a characteristic of the tissue after undergoing a therapeutic procedure (e.g., ablated or charred tissue). The laser controller 160 can determine that the desired therapeutic effect has been achieved based on the first characteristic (comparison between the first signal and the first preset value) and can send a first control signal to the first laser system 102 to change the first laser system 102 from a first state to a second state of the first laser system 102 in step 608. According to one example, this can result in the first laser system 102 not generating the first output 110 as a result of delivery of a satisfactory therapeutic effect (e.g., ablation). Alternatively, if in step 606 it is determined that the first signal is not approximately equal to the first preset value (not sufficiently ablated), the laser controller can not send any control signal and the feedback analyzer can continue to monitor the first signal.
[0060] Optionally, at step 612, the feedback analyzer 140 may receive a second signal separate from the first signal. The second signal may be indicative of a first characteristic of the target tissue having a second preset value. For example, the amplitude of the reflected light from the tissue in the second signal may be different from the first signal. At optional step 614, the second signal may be received by the laser controller 160. At optional step 616, the laser controller 160 may determine whether the second signal is approximately equal to the second preset value. For example, the second signal (e.g., a spectroscopic signal or image) may indicate that the target tissue 122 has not been carbonized by absorption of the first output 110 (e.g., the measured signal amplitude is less than a preset maximum amplitude of the spectroscopic signal or image of the ablated tissue). In some examples, such a condition may indicate insufficient ablation or other unsatisfactory therapeutic effect, and it is desirable to continue to deliver laser power so that the tissue can be ablated. In response, at optional step 618, the laser controller 160 can communicate with the first laser system 102 to send a second control signal. The second control system can maintain the first laser system 102 in the first state (e.g., to continue to deliver the first output 110). Alternatively, if the first laser system is in the second state (e.g., off), at optional step 620, the second control signal can change the state of the first laser system to the first state (e.g., on), e.g., to continue to deliver additional ablation to the target tissue.
[0061] In optional step 620, after the laser controller 160 determines satisfactory delivery of the therapeutic condition, the laser controller 160 may perform additional control actions to deliver additional laser power (e.g., a different wavelength) to deliver additional therapeutic effect.
[0062] 7 illustrates a control algorithm for controlling a dual laser system. The algorithm 700 may be suitable when the laser controller 160 is in operative communication with two or more laser systems. In some such examples, as described above, the first laser system 102 may be configured to deliver a first output 110 (e.g., a first wavelength range) and the second laser system 104 may be configured to deliver a second output 120 (e.g., a second wavelength range different from the first wavelength range). The control algorithm 700 may control the first laser system 102, the second laser system 104, and optionally additional laser systems.
[0063] According to the control algorithm 700, at step 702, a first signal (e.g., a spectroscopic signal or an image) may be detected by the feedback analyzer 140. At step 704, the laser controller 160 may receive the first signal from the feedback analyzer 140. At step 706, the laser controller 160 may determine whether the first signal is approximately equal to a first preset value (e.g., within a specified tolerance range of the first preset value). For example, the laser controller 160 may compare an amplitude of the first signal to a target value or a preset extreme value (e.g., a maximum or minimum amplitude) to determine a first characteristic of the target tissue 122. The first characteristic may be indicative of a characteristic of the tissue after undergoing a therapeutic procedure (e.g., ablated or charred tissue). The laser controller 160 can determine that the desired therapeutic effect has been achieved based on the first characteristic meeting a target value or preset criteria and can send a first control signal to the first laser system 102 to change the first laser system 102 from a first state to a second state of the first laser system 102 at step 708. For example, the laser controller 160 can determine that the ablation is satisfactory based on the reflected light from the ablated tissue and send a first control signal to the first laser system to return the first laser system to an OFF state. Alternatively, in an illustrative example, the laser controller 160 can provide an output to an operator (e.g., a medical professional) to indicate that the desired therapeutic effect has been reached and / or to indicate to the operator that the state of the first laser system is to be changed to an “OFF” state.
[0064] At step 708, the laser controller 160 may also send a fourth signal to the second laser system 104 to change from the second state of the second laser system 104 to the first state of the second laser system 104. For example, the second laser system 104 may be more suitable for ablating carbonized tissue. Accordingly, upon detecting that the tissue is sufficiently carbonized (e.g., step 708), the laser controller 160 may, in some examples, send a first control signal to switch the first laser system 102 off and a fourth control signal to switch the second laser system 104 on. An exemplary timing diagram of the states of the first and second laser systems is shown in FIG. 8.
[0065] In some examples, the first control signal and the fourth control signal may be sent simultaneously. Alternatively, the first control signal and the fourth control signal may be sent sequentially.
[0066] Returning to FIG. 7, in optional step 710, the feedback analyzer 140 can detect a second signal (e.g., a spectroscopic signal or an image) separate from the first signal. For example, the second signal can indicate that the target tissue 122 has not been carbonized by absorption of the first output 110 (e.g., the measured signal amplitude is greater than a preset maximum amplitude of the spectroscopic signal of the ablated tissue). In some instances, such a condition can indicate insufficient ablation or other unsatisfactory therapeutic effect, and it is desirable to continue to deliver laser power so that the tissue can be ablated. In optional step 712, the laser controller can receive the second signal and, in optional step 714, compare the second signal to a second preset value. If the second signal is approximately equal to the second preset value (e.g., within a specified tolerance range of the second preset value), in optional step 716, the laser controller 160 can send a second control signal to the first laser system and a third control signal to the second laser system. An exemplary timing diagram of the states of the first and second laser systems is shown in FIG.
[0067] The second control signal, in some examples, can change the first laser system from the second state (e.g., OFF) to the first state (e.g., ON). Alternatively, if the first laser system is in the first state (e.g., ON), the second control signal can maintain the first laser system 102 in the first state (e.g., to continue to deliver the first output 110). Optionally, at step 716, the laser controller 160 can send a third control signal to the second laser system 104 when the second laser system 104 is in its first state, thereby changing the second laser system 104 from the first state (e.g., ON) of the second laser system 104 to the second state (e.g., OFF) of the second laser system 104. Alternatively, the third control signal can maintain the second laser system 104 in the second state (e.g., OFF) when the second laser system is in the second state.
[0068] According to some examples, a first state of each of the first laser system 102 and the second laser system 104 may correspond to the generation of a first output 110 by the first laser source 106 and the generation of a second output 120 by the second laser source 116, respectively. Accordingly, the first state of each of the first laser system 102 and the second laser system 104 may represent an "on" state. In some such examples, the second state of each of the first laser system 102 and the second laser system 104 may correspond to an "off" state.
[0069] 5, the laser feedback control system 100 can include one or more output systems 170. The one or more output systems 170 can communicate with and / or deliver signals to a user and / or other systems, such as an irrigation / suction / pumping system, or a light display controller, or other system used in a therapeutic procedure. In some examples, the output system 170 can include a display 172. The display 172 can be a screen (e.g., a touch screen), or in alternative examples, can simply be a visual indicator (e.g., LED lights of one or more colors). In additional examples, the output system 170 can include an audio output system 174 (e.g., a speaker, an alarm system, etc.) capable of providing an audio signal. The output system 170 can provide one or more outputs (e.g., an LED light of a first color, a first message on a screen, an alarm sound of a first tone) to indicate that a desired therapeutic effect has been achieved. The output can be provided, for example, at step 610, and optionally at step 620. In a further optional example, output system 170 can provide one or more different outputs when the desired therapeutic effect is not achieved. For example, output system 170 can provide one or more outputs (e.g., a second color LED light, a second message on the screen, a second tone alarm) to indicate that the desired therapeutic effect is not being achieved. Such outputs can prompt an operator (healthcare professional) to take one or more steps (e.g., perform additional therapeutic steps using one or more laser systems and provide additional laser outputs).
[0070] 8 illustrates a timing diagram of a dual laser system having a laser feedback control system 100 according to an example that delivers tissue ablation and coagulation by utilizing two optical wavelengths. However, as previously described, the laser feedback control system 100 can be utilized with single or multiple optical wavelength systems to optimize the delivery of laser therapy or other types of therapeutic effects to the target tissue 122. The therapeutic effects can be delivered in any sequence, including simultaneously. Alternatively, the therapeutic effects can be delivered at different times.
[0071] According to an example, the laser energy from the first laser system 102 and the second laser system 104 can be delivered to a target (e.g., a tissue surface), such as sequentially in one example. The first and second laser systems can deliver their respective laser energy through the same optical fiber. Alternatively, the first and second laser systems can each deliver their respective laser energy through a separate optical fiber. Amplitude A max An optical feedback signal 810 having an amplitude of 810A can be reflected from the tissue surface and detected and analyzed by the feedback analyzer 140. The first and second laser systems can alternate between their respective operating states (e.g., ON or OFF). As shown in FIG. 8, the first laser system 102 can be switched to or maintained in its first state (e.g., ON) 820A, and the second laser system 104 can be switched to or maintained in a second state (e.g., OFF). The first laser can be used to ablate and carbonize tissue. During operation of the first laser system 102, a first signal can be received by the laser controller 160 and its amplitude can be adjusted to a threshold level A. minThe wavelength of the output from the first laser system 102 can be in a first wavelength range in the absorption spectrum of the target, such as a wavelength suitable for effective carbonization of the target tissue. Tissue has high absorption of the laser energy. In one example, the first laser output is in the UV-VIS or deep infrared wavelength range.
[0072] The laser controller 160 can then change the state of the laser systems such that the first laser system 102 is in a second state (e.g., OFF) and the second laser system 104 is in a first state (e.g., ON) 830A. The output from the second laser system 104 can be highly absorbed by the carbonized tissue, thus ablating the carbonized tissue and virtually eliminating the carbonization. The wavelength of the output from the second laser system 104 can be in a second wavelength range in the absorption spectrum of the target. The second wavelength range can be different from the first wavelength range of the output from the first laser system 102. The wavelength of the output from the second laser system 104 can also be suitable for effective coagulation. In one example, the second laser output is in the infrared wavelength range (e.g., 100-300 μm). The decarburization process causes the amplitude of the signal (e.g., the second signal) to drop to an initial level A. max 8. The laser controller 160 can accordingly change the state of the lasers such that the first laser system 102 is in a first state (e.g., ON) and the second laser system 104 is in a second state (e.g., OFF). This process can be repeated such that the first laser system 102 and the second laser system 104 are repeatedly switched to the ON states 820B and 830B, respectively, in an alternating manner as shown in FIG. 8 until the desired tissue ablation and / or coagulation is achieved. In some examples, the optical feedback signal 810 discussed herein can be provided to an electrosurgical system that can controllably adjust and optimize an electrosurgical energy distinct from the laser energy.
[0073] [Exemplary Endoscopic System with Target Identification] Figures 9-11 demonstrate how target composition analysis can be performed entirely within an endoscope. Target composition analysis can be performed via spectroscopy with a laser fiber and possibly a camera on the distal tip of a digital endoscope.
[0074] 9A-9B show an example of an endoscope with a laser fiber inserted therein. An elongated body portion of the exemplary endoscope 910 encloses various components including a laser fiber 912, an illumination source 914, and a camera 916. The laser fiber 912 is an example of an optical path 108 of the laser system 102 or laser system 202. The laser fiber 912 can extend along a working channel 913 within the elongated body of the endoscope 910. In some examples, the laser fiber 912 can be separate from the endoscope. For example, the laser fiber 912 can be fed along the working channel of the endoscope prior to use and retrieved from the working channel of the endoscope after use.
[0075] The illumination source 914 may be part of a visualization system that allows the operator to visualize the target structure (e.g., tissue or stone structure). An example of an illumination source may include one or more LEDs configured to emit light distally away from the distal end of the elongated body of the endoscope to illuminate an area of the target structure. In one example, the illumination source 914 may emit white light to illuminate the target structure. The white light may allow the physician to observe stone or tissue discoloration or other color-based effects near the distal end of the body of the endoscope. In one example, the illumination source 914 may emit blue light to illuminate the target structure. Blue light may be indicative of thermal tissue spreading and thereby well suited to detect damage in tissue. Other colors and / or color bands, such as red, amber, yellow, green, etc., may also be used.
[0076] The camera 916 is part of the visualization system. The camera 916 is an example of the imaging sensor 244. The camera 916 can capture a video image or one or more still images of the illuminated target structure and the surrounding environment. The video image can be real-time or near real-time with relatively low latency for processing, so that the physician can observe the target structure while manipulating the endoscope. The camera 916 can include a lens and a multi-pixel sensor located in the focal plane of the lens. The sensor can be a color sensor, such as a sensor that provides red, green, and blue light intensity values for each pixel in the video image. The circuit board can produce a digital video signal representing the captured video image of the illuminated stone. The digital video signal can have a video refresh rate of 10 Hz, 20 Hz, 24 Hz, 25 Hz, 30 Hz, 40 Hz, 50 Hz, 60 Hz, or another suitable video refresh rate.
[0077] 10A-10B show examples of feedback-controlled laser treatment systems. In FIG. 10A, laser treatment system 1000A includes an endoscope 910 integrated with a feedback-controlled laser treatment system 1010 that receives camera feedback. Laser treatment system 1000A is an example of laser treatment system 100 and includes endoscope 910, feedback-controlled laser treatment system 1010, laser source 1020, and light source 1030. In various examples, a portion or the entirety of feedback-controlled laser treatment system 1010 can be embedded in endoscope 910.
[0078] The feedback controlled laser therapy system 1010 is an example of a laser feedback control system 200 and includes a spectrometer 1011 (an example of a spectroscopic sensor 242), a feedback analyzer 1012 (an example of at least a portion of the feedback analyzer 240), and a laser controller 1013 (an example of the laser controller 260). The laser source 1020 is an example of a laser system 202 and can be coupled to the laser fiber 912. Fiber-integrated laser systems can be used in endoscopic procedures due to their ability to pass laser energy through flexible endoscopes and effectively treat hard and soft tissues. These laser systems produce laser output beams within a wide wavelength range from the UV range to the IR range (200 nm to 10,000 nm). Some fiber-integrated lasers produce output within wavelength ranges that are highly absorbed by soft or hard tissues, such as 1900-3000 nm for water absorption, or 400-520 nm for oxyhemoglobin and / or deoxyhemoglobin absorption. Table 1 above is a summary of IR lasers that emit within the high water absorption range of 1900-3000 nm.
[0079] Some fiber-integrated lasers produce output in wavelength ranges that are minimally absorbed by the target soft or hard tissue. These types of lasers provide effective tissue coagulation due to their penetration depths similar to the diameter of small blood capillaries, 5-10 μm. Examples of laser sources 1020 include GaN lasers emitting at 515-520 nm, InP lasers emitting at 370-493 nm, and GaN lasers emitting at 515-520 nm, among others. X Ga 1-X N laser, Ga emitting at 750-850 nm X Al 1-X A laser, or In emitting at 904-1065 nm X Ga 1-X In lasers that emit UV-VIS, such as A lasers X Ga 1-X N semiconductor lasers.
[0080] The light source 1030 can generate an electromagnetic radiation signal, which can be transmitted to the target structure 122 via a first optical path extending along the elongated body of the endoscope. The first optical path can be located within the working channel 913. In one example, the first optical path can be an optical fiber separate from the laser fiber 912. In another example, as shown in FIG. 10A, the electromagnetic radiation signal can be transmitted through the same laser fiber 912 used to transmit the laser beam. The electromagnetic radiation exits the distal end of the first optical path and is projected onto the target structure and the surrounding environment. As shown in FIG. 10A, the target structure is within the field of view of the endoscopic camera 916, and thus, in response to the electromagnetic radiation being projected onto the target structure and the surrounding environment, the endoscopic camera 916, such as a CCD or CMOS camera, can collect a signal reflected from the target structure 122, generate an imaging signal 1050 of the target structure, and deliver the imaging signal to the feedback-controlled laser therapy system 1010. In some examples, imaging systems other than CCD or CMOS cameras, such as laser scanning, can be used to collect the spectral response.
[0081] In addition to or instead of the feedback signal (e.g., imaging signal) generated and transmitted through the camera system 916, in some examples, the signal reflected from the target structure can additionally or alternatively be collected and transmitted to the feedback-controlled laser treatment system 1010 through a separate fiber channel or laser fiber, such as one associated with the endoscope 910. FIG. 10B shows an example of a laser treatment system 1000B including an endoscope 910 integrated with a feedback-controlled laser treatment system 1010 configured to receive spectroscopic sensor feedback. The reflected spectroscopic signal 1070 (which is an example of the feedback signal 130 of FIGS. 1 and 2 ) can return to the feedback-controlled laser treatment system 1010 through the same optical path used to transmit the electromagnetic radiation from the light source 1030 to the target structure, such as the laser fiber 912. In another example, the reflected spectroscopic signal 1070 can proceed to the feedback-controlled laser treatment system 1010 through a second optical path, such as an optical fiber channel separate from the first optical fiber transmitting the electromagnetic radiation from the light source 1030 to the target structure.
[0082] The feedback controlled laser therapy system 1010 can analyze one or more feedback signals (e.g., the imaging signal 1050 of the target structure or the reflected spectroscopic signal 1070) to determine an operating condition for the laser source 1020. The spectrometer 1011 can generate one or more spectroscopic characteristics from the one or more feedback signals, such as by using one or more of an FTIR spectrometer, a Raman spectrometer, a UV-VIS spectrometer, a UV-VIS-IR spectrometer, or a fluorescence spectrometer, as discussed above with reference to the spectroscopic sensor 242. The feedback analyzer 1012 can be configured to identify or classify the target structure as one of a plurality of structure categories or types, such as by using one or more of the target detector 246 or the target classifier 248. The laser controller 1013 can be configured to determine an operating mode of the laser system 1020, as also discussed above with reference to FIG. 2.
[0083] The light source 1030 can produce electromagnetic radiation in the UV to IR light range. Table 2 below provides examples of light sources 1030 for spectroscopy systems applicable to the examples discussed herein. [Table 2]
[0084] In some examples, the feedback analyzer 1012 can determine a distance 1060 (shown in FIG. 10A ) between the distal end of the laser fiber 912 and the target structure 122, or between the distal end of an optical path that receives the reflected signal and transmits it back to the spectrometer 1011, and the target structure 122. The distance 1060 can be calculated using a spectroscopic characteristic, such as a reflection spectrum produced by the spectrometer 1011. The laser controller 1013 can determine a threshold (d th The laser source 1020 can be controlled to deliver laser energy to the target structure 122 if the distance 1060 satisfies a condition, such as less than d ) or within a specified laser firing range. In one example, the target structure 122 is identified as an intended treatment structure type (e.g., a specified soft tissue type or a specified stone type) but the target structure 122 is not within range of the laser (e.g., d > d th ), the laser controller 1013 can generate a control signal to "lock" the laser source 1020 (i.e., prevent the laser source 1020 from firing). With information about the distance 1060 and whether the target structure is out of range of the laser (d>d th ) can be provided to the physician, who can then adjust the endoscope 910, such as by repositioning the distal end of the laser fiber 912 to get closer to the target. The distance 1060, as well as the target structure type, can be continuously monitored, determined, and provided to the physician. If the target is recognized as the intended treatment structure type and is within range of the laser (d≦d th), the laser controller 1013 can issue a control signal to "unlock" the laser source 1020, which can then aim and fire at the target structure 122 according to the laser operating mode (e.g., power setting). Examples of methods for calculating distance 1060 from spectroscopic data are discussed below, such as with reference to Figures 24A-24D.
[0085] In some examples, the spectrometer 1011 can be configured to further use information regarding the geometry and positioning of an optical path configured to transmit electromagnetic radiation from the light source to the target to generate a spectroscopic characteristic (e.g., a reflected spectrum). For example, the outer diameter of the laser fiber 912, or the outer diameter of a separate optical path that transmits the spectroscopic signal reflected from the target to the spectrometer 1011, or the projection angle of said fiber or path from the endoscope 910 can affect the intensity of the reflected signal. The outer diameter and / or projection angle can be measured and provided to the spectrometer 1011 to obtain the reflected spectrum data. As discussed above, the distance 1060 between the target structure and the distal end of the fiber can be calculated using the spectral data, the measured outer diameter of the fiber or optical path and its projection angle, and / or an input signal from the endoscope image processor.
[0086] 11A-11B are diagrams illustrating an example of an endoscopic system that uses a diagnostic beam to identify a target. As shown in FIG. 11A, the endoscopic system 1100A can include an endoscope 1110 and an optical fiber 1120A that can be insertable through a working channel 1112 of the endoscope 1110. The endoscope 1110 can include at least one endoscopic illumination source 1130 or can be otherwise coupled to the at least one endoscopic illumination source 1130 via an endoscope port 1114. The at least one endoscopic illumination source 1130 can controllably provide different illumination doses. The optical fiber 1120A can be coupled to a non-endoscopic illumination source 1140, such as via an endoscope port 1114, when inserted through the working channel 1112. The non-endoscopic illumination source 1140 can be different from the at least one endoscopic illumination source 1130. The non-endoscopic illumination source 1140 can emit a diagnostic beam 1142 through the optical fiber 1120A near a distal end 1116 of the endoscope 1110. The optical fiber 1120A can direct a diagnostic beam 1142 to the target 1001. In one example, the non-endoscopic illumination source 1140 can be a laser source configured to emit a diagnostic beam including a laser beam. In various examples, a white light lamp, an LED light source, or a transillumination light source can be inserted through a working channel of the endoscope or can be inserted through another port, such as a laparoscopic port.
[0087] The endoscope system 1100A may include a controller 1150. The controller 1150 may controllably operate at least one endoscope illumination source 1130 in different operating modes, including, for example, a first mode having a first dose and a second mode having a second dose less than the first amount. In one example, the controller 1150 may generate a control signal to change the illumination mode (e.g., from the first mode to the second mode) in response to a trigger signal. In one example, the endoscope includes an imaging system 1160 capable of acquiring an image of the target 1001, and the controller 1150 may generate a control signal to the endoscope to change the illumination mode (e.g., from the first mode to the second mode) in response to a change in brightness or intensity of the image of the target. Hereinafter, the first mode is referred to as a high illumination mode, and the second mode is referred to as a low illumination mode. In one example, the high illumination mode and the low illumination mode can be provided by different endoscope illumination sources, such as a first endoscope illumination source configured to emit illumination light under the high illumination mode and a different second endoscope illumination source configured to emit illumination light under the low illumination mode. The illumination light can be emitted near the distal end 1116 of the endoscope 1110. In one example, the illumination light can travel through a different optical path within the working channel 1112 than the optical fiber 1120A. The optical path can direct the illumination light 1132 to the same target 1001 as the diagnostic beam is projected.
[0088] The controller 1150 can generate a control signal to the non-endoscopic illumination source 1140 to emit a diagnostic beam 1142 (e.g., a laser beam having a lower therapeutic level of energy) when the at least one endoscopic illumination source 1130 changes from a high illumination mode to a low illumination mode. In one example, the low illumination mode includes switching off the illumination of the endoscope. By darkening the illumination at the target site under the low illumination mode, reflection from the target of the diagnostic beam incident on the target can be enhanced, which can help improve target identification.
[0089] In some examples, the controller 1150 can generate a control signal to the display to display an image of the target while the illumination mode is in the second mode, the image being a modified image of a previous or current image of the target. The controller 1150 can determine the composition of the target based on the diagnostic beam incident on the target and the light from the diagnostic beam reflected from the target. In one example, the controller 1150 can determine a first composition of a first portion of the stone target and a different second composition of a second portion of the stone target. Based on the identified compositions of the different portions of the target, the controller 1150 can program a first laser setting or generate a recommendation to program the first laser setting to target the first portion of the stone target. The controller 1150 can further program a second laser setting, different from the first laser setting, to target the second portion of the stone target.
[0090] In one example, after the non-endoscopic illumination source 1140 stops emitting the diagnostic beam 1142, the controller 1150 can generate a control signal to the endoscope to change the illumination mode from a low illumination mode back to a high illumination mode.
[0091] FIG. 11B shows an example of an endoscope system 1100B, which is a variant of the endoscope system 1100A. In this example, the diagnostic beam 1142 can be transmitted through an optical fiber 1120B. Unlike the optical fiber 1120A, which is inserted into the working channel 1112 of the endoscope 1110, the optical fiber 1120B can be positioned separately from the working channel 1112. In some examples, as shown in FIG. 11B, the diagnostic beam 1142 can be delivered through a secondary port 1115, such as a laparoscope port in one example, which is separate from the endoscope port 1114 used to deliver the endoscope illumination light. The optical fiber 1120B can be positioned such that both the distal end 1116 of the endoscope 1110 and the distal end of the optical fiber 1120B are aimed at the target 1001.
[0092] FIG. 12 and FIG. 13A-B illustrate reflectance spectrum data for identifying different types of targets, such as for identifying the composition of several different types of kidney stones, via UV-VIS spectroscopy or UV-VIS-IR spectroscopy. The reflectance spectrum data was collected by pointing a UV-VIS spectrometer or UV-VIS-IR spectrometer at each of the images of five primary types of kidney stones, including calcium oxalate stones (monohydrate), calcium oxalate stones (dihydrate), calcium phosphate stones, struvite stones, and uric acid stones. In one example, the electromagnetic radiation can include one or more ultraviolet wavelengths between 10 nm and 400 nm. In another example, as shown in FIG. 12, the reflectance spectrum used to identify different types of targets can be recoded from the spectrometer within a wavelength range of 200-1100 nm. In FIG. 12, reflectance spectra of kidney stone compositions including ammonium magnesium phosphate (AM MAG) hydrate, calcium oxalate (CA) monohydrate, calcium oxalate (CA) hydrate, calcium phosphate (CA), and uric acid are shown. The reflectance spectra of these stone compositions are more distinguishable in the lower wavelength range (e.g., below 400 nm) compared to the higher wavelength range (e.g., above 400). FIG. 13A shows a portion of the reflectance spectra shown in FIG. 12 in the wavelength range of 200-400 nm, including ammonium magnesium phosphate hydrate spectrum 1310, calcium oxalate monohydrate spectrum 1320, calcium oxalate hydrate spectrum 1330, calcium phosphate spectrum 1340, and uric acid spectrum 1350. This UV wavelength range is one range where differences can be discerned within the spectrum of the stone image. FIG. 13B shows the reflectance spectra of various kidney stone compositions in the wavelength range of 400-700 nm, including a cystine spectrum 1360, a uric acid spectrum 1370, and a calcium oxalate monohydrate spectrum 1380. It is possible to distinguish between different types of targets, such as different types of kidney stones, by UV-VIS or UV-VIS-IR spectroscopy.
[0093] Therefore, since the UV wavelength range is expected to distinguish different target compositions, such as kidney stones, a light source that allows analysis of this region is required in the system. Figure 14 shows light peaks 1410, 1420, 1430, and 1440 that cover respective segments of the UV wavelength range, approximately 250 nm, 280 nm, 310 nm, and 340 nm, respectively. Figure 15 overlays these light peaks 1410-1440 on the normalized reflectance spectra of several types of stones from Figures 13A-13B. These light peaks 1410-1440 demonstrate potential light sources that would allow the spectrometer to analyze target compositions within the UV wavelengths.
[0094] FIG. 16A shows an example of normalized reflectance spectra captured with a UV-VIS spectrometer from various tissue types, including cartilage spectrum 1610, bone spectrum 1620, muscle spectrum 1630, fat spectrum 1640, and liver tissue spectrum 1650. FIG. 16B shows another example of normalized reflectance spectra captured with a UV-VIS spectrometer from various soft and hard tissues, including cartilage spectrum 1610, bone spectrum 1620, muscle spectrum 1630, fat spectrum 1640, liver tissue spectrum 1650, and blood vessel spectrum 1660. The reflectance spectrum data shown in FIG. 16A-B demonstrates the feasibility of analyzing the composition of targets from methods that can be utilized within the working channel of an endoscope. Similar to spectra captured from stone images, the UV-VIS region can be used to identify different types of targets. FIG. 16C shows an example of an FTIR spectrum of a typical stone composition, and FIG. 16D relates to exemplary FTIR spectra of several soft and hard tissue compositions.
[0095] Exemplary Laser Treatment System The features described herein can be used in connection with laser systems for a variety of applications in which it may be advantageous to incorporate different types of laser sources. For example, the features described herein may be suitable in industrial or medical settings, such as medical diagnostic, therapeutic, and surgical procedures.
[0096] The features described herein can be used with fiber integrated laser systems and spectroscopy systems that can be used in combination with endoscopes.
[0097] 17-18 show schematic diagrams of a laser therapy system according to various examples described in the present disclosure. The laser therapy system can include a laser system configured to deliver laser energy toward a target and a laser feedback control system configured to be coupled to the laser system. The laser system can include one or more laser modules 1710A-1710N (e.g., solid-state laser modules) capable of emitting similar or different wavelengths from UV to IR. The number, output power, emission range, pulse shape, and pulse train of the integrated laser modules are selected to balance the cost of the system and the performance required to deliver a desired effect to the target.
[0098] One or more laser modules 1710A-1710N may be fiber integrated and included in the laser coupling system. Fiber integrated laser systems may be used in endoscopic procedures due to their ability to pass laser energy through flexible endoscopes and effectively treat hard and soft tissues. These laser systems produce laser output beams within a wide wavelength range from the UV range to the IR range (e.g., 200 nm to 10,000 nm). Some fiber integrated lasers produce output within wavelength ranges that are highly absorbed by soft or hard tissues, such as 1900-3000 nm for water absorption, or 400-520 nm for oxyhemoglobin and / or deoxyhemoglobin absorption. Various IR lasers may be used as laser sources in endoscopic procedures, such as those described above with reference to Table 1.
[0099] Each of the laser modules 1710A-1710N may consist of multiple solid-state laser diodes integrated with optical fibers to increase output power and deliver emissions to the target. Some fiber-integrated lasers produce output in wavelength ranges that are minimally absorbed by target soft or hard tissues. These types of lasers provide effective tissue coagulation due to a penetration depth similar to the diameter of small capillaries of 5-10 μm. The fiber-integrated laser modules 1710A-1710N described by various examples of the present disclosure have several advantages. In one example, the light emitted by the laser module has a symmetric beam quality and a circular and smooth (homogenized) intensity profile. A compact cooling arrangement is integrated into the laser module, making the overall system compact. The fiber-integrated laser modules 1710A-1710N can be easily combined with other fiber optic components. Additionally, the fiber-integrated laser modules 1710A-1710N are compatible with standard fiber optic connectors, which allows the modules to work well with most optical modules without alignment. Furthermore, the fiber integrated laser modules 1710A-1710N can be easily replaced without changing the alignment of the laser coupling system.
[0100] In some examples, the laser module can produce laser output in a wavelength range that is highly absorbed by some materials, such as soft or hard tissue, stone, bone, teeth, etc., e.g., 1900-3000 nm for water absorption, or 400-520 nm for oxyhemoglobin and / or deoxyhemoglobin absorption, as shown in FIG. 3C. In some examples, the laser module can produce laser output in a wavelength range that is less absorbed by targets, such as soft or hard tissue, stone, bone, teeth, etc. This type of laser provides more effective tissue coagulation due to a penetration depth similar to the diameter of small blood capillaries (e.g., 5-10 μm), as shown in FIG. 3C. Commercially available solid-state lasers are potential emission sources for the laser module. Examples of laser sources for the laser module are GaN (emitting at 515-520 nm) or In. X Ga 1-X In lasers emitting UV-VIS, such as N (emitting at 370-493 nm), GaXAl1-XA lasers (emitting at 750-850 nm), or InXGa1-XA lasers (emitting at 904-1065 nm). X Ga 1-X Such laser sources may include N semiconductor lasers. Such laser sources may also be applicable for tissue coagulation applications.
[0101] The laser feedback control system can comprise one or more subsystems including, for example, a spectroscopy system 1720, a feedback analyzer 1730, and a laser controller 1740.
[0102] Spectroscopic System 1720 The spectroscopy system 1720 can send a control light signal from a light source to a target, such as, but not limited to, a stone, soft or hard tissue, bone, or tooth, or an industrial target, and collect the reflected spectral response data from the target. The response can be delivered to a spectrometer through a separate fiber, a laser fiber, or an endoscope system. The spectrometer can send the digital spectral data to a system feedback analyzer 1730. Examples of light sources for a spectroscopy system covering the UV to IR light range can include those described above with reference to Table 2. FIG. 20 shows a schematic diagram of the spectroscopy system 1720 with an example feedback analyzer 1730.
[0103] Optical spectroscopy is a powerful method that can be used for easy and rapid analysis of organic and inorganic materials. According to various examples described in this disclosure, the spectroscopic light source can be integrated into a separate fiber channel, laser fiber, or endoscope system. The light source signal reflected from the target can be rapidly collected and delivered to a spectrometer by an imaging system including a detector, such as a CCD or CMOS sensor, which can be included in a digital endoscope. Other imaging systems, such as laser scanning, can also be used to collect the spectroscopic response. Optical spectroscopy has several advantages. Optical spectroscopy can be easily integrated with a fiber laser delivery system 1701. Optical spectroscopy is a non-destructive technique for detecting and analyzing the chemical composition of materials, and the analysis can be performed in real time. Optical spectroscopy can be used to analyze different types of materials, including, for example, hard and soft tissues, stone structures, etc.
[0104] A variety of spectroscopic techniques can be used alone or in combination to analyze the target chemical composition and create spectroscopic feedback. Examples of such spectroscopic techniques can include UV-VIS reflectance spectroscopy, fluorescence spectroscopy, Fourier transform infrared spectroscopy (FTIR), or Raman spectroscopy, among others. Table 2 above presents examples of light sources for spectroscopic systems covering the UV to IR light range applicable to one example. Generally, when performing spectroscopic measurements in the visible and near IR range, tungsten halogen light sources are used. Deuterium light sources are known for their stable output and are used for UV absorption or reflectance measurements. Mixing halogen light with deuterium light results in a broad spectral range light source that provides a smooth spectrum from 200 to 2500 nm. For applications where long life and high output power are required, such as fluorescence measurements, xenon light sources are used. LED and laser diode light sources provide high power at precise wavelengths and have long life, short warm-up times, and high stability. Spectroscopic light sources can be integrated into separate fiber channels, laser fibers, or endoscope systems. The source signal reflected from the target can be rapidly detected and delivered to a spectrometer through a separate fiber channel or laser fiber.
[0105] Feedback Analyzer 1730 The feedback analyzer 1730 can receive input from a variety of sources, including spectroscopic response data from a spectrometer to suggest or directly adjust laser system operating parameters. In one example, the feedback analyzer 1730 can compare the spectroscopic response data with an available database library of target composition data. Based on the spectroscopic system feedback, the signal analyzer detects the target material composition and suggests a laser operating mode, such as operating parameters (also referred to as a laser setup), for at least one laser module to achieve effective tissue treatment for the identified tissue composition. Examples of operating parameters can include at least one laser wavelength, pulsed or continuous wave (CW) emission mode, peak pulse power, pulse energy, pulse rate, pulse shape, and simultaneous or sequential pulse emission from at least one laser module. Although not explicitly stated, sequential pulses include a burst of pulses that cooperate to deliver a selected pulse energy. As described herein, a pulse generally refers to the time between the start and stop of laser emission from a laser module. As long as the selected average laser power is maintained, the intensity of the laser energy during each pulse may vary and have the shape of an increasing or decreasing ramp or sinusoidal profile, or any other shape, alone or in combination with the pulse sequence. For example, if there is only one pulse, a 2W average power setting with a pulse energy of 1 J occurs at a frequency of 2 Hz. However, the energy can also be delivered in rapid succession as two 0.5 J pulses occurring at a rate of 2 Hz. Each of those pulses can have a similar or different pulse shape. The feedback analyzer 1730 utilizes algorithms and input data to directly adjust or suggest laser operating parameters such as those described in the examples above.
[0106] In some examples, the feedback analyzer 1730 can utilize the input data to calculate and control the distance between the distal end of the laser delivery system 1701 (fiber) and the target based on a specially developed algorithm. In the case of a moving target (e.g., a stone), the feedback analyzer 1730 can adjust or suggest laser operating parameters that use steam bubbles in water to create a suction effect to draw targets above a predetermined threshold toward the distal end of the fiber. This feature minimizes the effort that the user must exert to maintain an effective treatment distance with the moving target. The distance between the target and the distal end of the fiber can be calculated using the spectral data, the known outer diameter of each fiber and its projection angle from the endoscope, and / or an input signal from the endoscope image processor. Figures 24A-24D show, by way of example, how to calculate the distance between the distal end of the laser delivery system 1701 (fiber) and the target. The dependence of the spectral reflection signal on the distance between the target and the laser delivery system 1701 is shown in Figures 24A-24B. FIG. 24A shows an example of the reflected signal intensity at 730 nm measured at different distances between the tissue and the distal tip of the spectroscopic probe. FIG. 24B shows an example of the reflected signal intensity at 450 nm measured at different distances between the tissue and the distal tip of the spectroscopic probe. Such a dependency can be determined using the spectral data and information about the geometry of the laser delivery system. Analysis of the spectroscopic signal allows for a rapid estimation of the distance and delivery of this information to the user.
[0107] FIG. 24C is an exemplary algorithm for distance calculation between the fiber and the tissue target. In one example, the spectroscopic system sends a control light signal from a light source to the target, collects spectral response data from the target, delivers the response signal to a spectrometer, and sends the digital spectral data from the spectrometer to a feedback analyzer. The calibration curve 1000 shown in FIG. 24C represents the relationship between the spectral reflected signal intensity (e.g., the spectroscopic signal reflected from the target structure in response to electromagnetic radiation) and the distance 1060 between the distal end of the fiber and the target structure using a feedback signal reflected from the target structure, such as those shown in FIGS. 10-11. The calibration curve 1000 can be generated by measuring the reflected signal intensity at different distances between the tissue and the spectroscopic probe distal end when the target structure is projected by electromagnetic radiation of a characteristic wavelength (e.g., 450 nm or 730 nm). By referring to the calibration curve, analysis of the spectroscopic signal allows for a quick estimation of the distance.
[0108] An exemplary process for generating a calibration curve is as follows: First, a reference value for each distance can be calculated. The calibration curve itself cannot be used to identify the distance because the light reflection intensity depends on the reflection of the test piece, etc. An example of a reference value for canceling the effect of the reflection of the test piece is as follows: Reference value = dI / dx*1 / I (1)
[0109] During the in vivo surgical process, the operator can move the fiber or endoscope while continuously recording spectroscopic feedback until the reflectance spectrum of the target tissue composition can be detected.
[0110] Referring to FIG. 24C, a first spectrum can be measured at a distance x1 where the reflected signal intensity is I1. At this timing, the actual value of x1 and the curve of the reflected signal intensity are unknown. Then, the fiber or the endoscope distal end (the reflected light detector) can be moved continuously, and the next reflected light intensity I2 corresponding to a distance x2 can be measured. x2 can be close to x1, and therefore the curve between x1 and x2 can be approximated linearly. At this timing, x1, x2, and the curve of the reflected signal intensity are unknown. Using I1, I2, and Δ(x2-x1), a comparison value can be calculated as follows: Comparison value = Δ(I2-I1) / Δ(x2-x1)*1 / I1(2)
[0111] The reference values are then searched for values identical to the comparison value. r ) is found to be identical to the comparison value given in equation (2), then x r It can be determined that the distance between the two reference values (x r1 , x r2 ), the fiber or endoscope distal end (reflected light detector) can continue to move and the next reflected light intensity I3 corresponding to distance x3 can be measured. x3 can be close to x2, so the curve between x2 and x3 can be approximated linearly. At this timing, x1, x2, x3, and the curve of the reflected signal intensity are unknown. Using I1, I2, I3, Δ(x2-x1), and Δ(x3-x2), a new comparison value can be calculated as follows: Comparison value = Δ(I3-I2) / Δ(x3-x2)*1 / I2(3)
[0112] Then, x r1 +Δ(x2-x1) and x r2 For a value equal to +Δ(x2-x1), a reference value is searched for. The reference value can be compared to the comparison value given in equation (3). The distance with the reference value that is more similar to the comparison value is presumed to be the actual distance.
[0113] Referring to FIG. 24D, during an in vivo surgical process, an exemplary method can include moving the fiber or endoscope while continuously recording the spectroscopic feedback until a reflected spectrum of the target composition is detected. In most cases when the spectroscopic distal end is moving toward the target, the intensity of the detected reflected light is initially weak and increases as the distance between the target and the fiber end decreases. For example, a first spectrum was measured at a distance d1 where the reflected signal intensity is I1. By continuing to move the fiber or endoscope distal end slightly toward the target and continuously collecting reflected data, the method can measure the next reflected light intensity I2 corresponding to a distance d2. The method can then include calculating a value of the reflected signal intensity change slope=Δ(I2-I1) / Δ(d2-d1). To make the calculated slope value independent of the reflected signal intensity, the calculated slope can be normalized. The final formula for calculating the reflected signal intensity change slope at a measured distance is: Gradient (normalized) = [Δ(I2-I1) / Δ(d2-d1)] / I o (4) In the above formula, I o =AVERAGE(I1,I2).
[0114] The method can then compare the calculated slope to the slope of a calibration curve in a library to allow an estimate of the required distance. All calculations can be done at high speed using software.
[0115] 25A-25B show the effect of the distance between the tissue and the spectroscopic probe distal tip on the spectrum of reflected light from a target. FIG. 25A shows exemplary normalized UV-VIS reflectance spectra of various soft tissue types, including bladder endothelium spectrum 2511, stomach endothelium spectrum 2512, stomach smooth muscle spectrum 2513, subureteral spectrum 2514, ureteral endothelium spectrum 2515, renal calyx spectrum 2516, bladder muscle spectrum 2517, and medulla spectrum 2518. FIG. 25B shows exemplary UV-VIS reflectance spectra of certain tissues recorded at different distances between the tissue and the spectroscopic probe distal tip, such as 0-0.25 inches. FIG. 25A shows several examples of soft tissue spectra of animals. FIG. 25B presents exemplary UV-VIS reflectance spectra of tissues recorded at different distances between the tissue and the spectroscopic probe distal tip. In this example, as discussed above with reference to Figures 24A-B, the reflected signal intensities of two spectral maxima at 450 nm and 730 nm were measured and presented at different distances between the target tissue and the distal end of the spectroscopic probe.
[0116] [Laser Controller 1740] The laser controller 1740 can be integrated with a laser coupling system. The laser coupling system couples one or more laser modules (e.g., solid-state laser modules) to a fiber. The laser controller 1740 can be coupled to a feedback analyzer 1730, which can send an optimized signal with suggested settings directly to the laser controller 1740 (automatic mode) or can request operator approval to adjust the laser settings (semi-automatic mode). FIG. 17 is a schematic diagram of a fully automated laser system. FIG. 18 is a schematic diagram of a semi-automated laser system, where the system requires user approval, such as via a user interface including an input 1850 and a display 1860. In one example, the laser settings can be adjusted within a range of settings, which in one example can be pre-determined by a user at the start of a procedure.
[0117] In some examples, the laser controller 1740 can combine two or more laser pulse trains to create a combined laser pulse train. FIG. 19A shows an example where the laser controller 1740 can generate multiple (e.g., N) laser pulse trains 1910A-1910N, combine the laser pulse trains 1910A-1910N into a combined pulse train 1920, and expose a target to the combined pulse train at 1930. FIG. 19B shows an example of an output laser pulse train 1942 combined from three different laser trains 1941A, 1941B, and 1941C emitted from different laser modules. As shown in FIG. 19B, the laser trains 1941A, 1941B, and 1941C can be turned on at different times and / or turned off at different times according to a feedback analyzer signal. In the example shown in FIG. 19B, the output combined laser pulse train 1942 can include temporally overlapping portions of two or more of laser trains 1941A, 1941B, and 1941C.
[0118] The combination of the laser modules 1910A-1910N, the spectroscopic system 1720, and the feedback analyzer 1730 allows the laser feedback system 1740 described herein to continuously identify the target composition through the endoscope and update the laser settings throughout the procedure.
[0119] The main components of the laser system can be easily customized depending on the targeted medical procedure. For example, the laser controller 1740 accommodates different laser types and their combinations. This allows a wider range of output signal options, including power, wavelength, pulse rate, pulse shape and profile, single laser pulse trains, and combined laser pulse trains. The operating mode of the laser system can be automatically adjusted or suggested for each desired optical effect. The spectroscopy system collects information about the target material that is useful for diagnostic purposes to ensure that the laser parameters are optimal for the target. The feedback analyzer 1730 can automatically optimize the operating mode of the laser system, reducing the risk of human error.
[0120] [Internet of Things (IoT) System 1750] In some examples, the laser system can include an optional IoT system 1750 that supports storing the spectral database library in the cloud 1752, supports rapid access to the spectral and optimal setup database library, and enables communication between the cloud 1752 and the feedback analyzer 1730. Cloud storage of data supports the use of artificial intelligence (AI) techniques to provide input to the feedback analyzer 1730, supports instant access to algorithms and database improvements.
[0121] According to various examples described herein, the IoT system 1750 can include a network where the components of the laser system can communicate and interact with other components via the Internet. The IoT supports rapid access to a spectral database library stored in the cloud 1752 and performs communication between the cloud 1752 and the feedback analyzer 1730. In addition, all of the components of the laser system can be remotely monitored and controlled via the network, if necessary. One example of such successful connectivity is the Internet of Medical Things (also called the Internet of Health Things). This is an example of a possible application of the IoT for medical and health-related purposes, including the collection and analysis of data for research and monitoring.
[0122] In various examples, the IoT system 1750 can accommodate access to various cloud resources, including cloud-based detection, recognition, or classification of target structures (e.g., stone structures or anatomical tissues). In some examples, a machine learning (ML) engine can be implemented in the cloud 1752 to provide cloud-based target detection, identification, or classification services. The ML engine can include trained ML models (e.g., machine-readable instructions executable on one or more microprocessors). The ML engine can receive target spectroscopy data from a laser system or retrieve target spectrometry data stored in the cloud 1752, perform target detection, identification, or classification, and generate outputs such as labels representing tissue types (e.g., normal tissue or cancerous lesions, or tissues at specific anatomical sites), or stone types (e.g., kidney, bladder, pancreatic bile duct, or gallbladder stones with a specific composition). The target spectroscopy data can be automatically uploaded to the cloud 1752 at the end of a procedure or other scheduled times, among other clinical data collected from the patient before or during a procedure. Alternatively, a system user (e.g., a clinician) may be prompted to upload the data to the cloud 1752. In some examples, the output may further include the probability that the target is identified as tissue or stone, or the probability that the target is classified as a particular tissue or stone type. A system user (e.g., a clinician) may use such cloud services to obtain near real-time information about the target tissue or stone in vivo, such as while performing an endoscopic laser procedure.
[0123] In some examples, the ML engine can include a training module configured to train the ML model using training data such as that stored in the cloud 1752. The training data can include spectroscopic data associated with target information such as tags identifying target types (e.g., stone type or tissue type). The training data can include laboratory data based on spectroscopic analysis of various tissue types and / or stone types. Additionally or alternatively, the training data can include clinical data acquired in vitro or in vivo from multiple patients. In some examples, patient identification information can be removed from the patient clinical data (e.g., spectroscopic data) before such data is used and uploaded to the cloud 1752 for training the ML model or for performing target detection, identification, or classification using the trained ML model. The system can associate the de-identified patient clinical data with the tag identification source of the data (e.g., hospital, laser system identification, procedure time). The clinician can analyze and confirm the target type (e.g., stone or tissue type) during or after the procedure and associate the target type with the de-identified patient clinical data to form the training data. Advantageously, the use of anonymized patient clinical data can increase the robustness of cloud-based ML models, since additional data from a large patient population can be included to train the ML models. This can also enhance the performance of ML models to recognize rare stone types, since spectroscopic data from rare stone types is difficult to obtain clinically or from a laboratory.
[0124] Various ML model architectures and algorithms can be used, such as decision trees, neural networks, deep learning networks, support vector machines, etc. In some examples, as additional spectroscopic data becomes available, training of the ML model can be performed continuously or periodically, or in near real-time. Training involves algorithmically adjusting one or more ML model parameters until the ML model being trained meets a specified training convergence criterion. The resulting trained ML model can be used in cloud-based target detection, recognition, or classification. With the ML model trained with the large amount of data stored in the cloud 1752 and additional data added to the cloud 1752 on a continuous or periodic basis, the ML-based target recognition with cloud connectivity described herein can improve the accuracy and robustness of in vivo target detection, recognition, and classification.
[0125] Exemplary Endoscopic Laser Systems 21A-21D show examples of endoscopic laser systems 2100A and 2100B including an endoscope 2110 with an integrated multi-fiber accessory and a surgical laser system including a feedback controlled laser therapy system 1010 and a laser source 1020 as shown in FIG. 10A. Alternatively, the spectroscopic response can be collected and delivered to a spectrometer by an imaging system including a detector such as a CCD or CMOS sensor. A target composition analysis can be performed via spectroscopy through one or more of the cores of the multi-fiber accessory while the target is illuminated by a light source transmitted through one or more of the other cores of the multi-fiber accessory.
[0126] 21A, the endoscopic laser system 2100A includes a multi-fiber accessory that includes an optical path 2116 that is used to transmit the spectroscopic signal back to the spectrometer 1011 as well as deliver the surgical laser energy from the laser source 1020 to the target structure. In one example, the optical path 2116 includes an optical fiber embedded in and extending along the elongated body of the endoscope 2110. In another example, the optical path 2116 includes two or more optical fibers extending along the elongated body of the endoscope 2110. The laser controller 1013 can control the timing of the laser firing so that the transmission of the spectroscopic signal and the delivery of the laser energy occur at different times or simultaneously.
[0127] The multi-fiber accessory may include two or more light source fibers 2114 embedded in and extending along the elongated body of the endoscope 2110. By way of example and not limitation, FIG. 21C illustrates a radial cross-section of the elongated body of the endoscope 2110 with multiple light source fibers 2114 and light paths 2116 positioned longitudinally within the elongated body of the endoscope, with the light source fibers 2114 radially distributed around the periphery of the light path 2116, such as circumferentially relative to the light path 2116 on the radial cross-section of the elongated body of the endoscope. In the example illustrated in FIG. 21C, the light path 2116 may be located substantially at a central longitudinal axis of the elongated body of the endoscope 2110. By way of example and not limitation, six light source fibers may be positioned around the light path 2116 as illustrated in FIG. 21C. Other numbers of light source fibers and / or light source fibers at other positions relative to the light path 2116 may also be used. For example, FIG. 21D shows two light source fibers 2114 positioned radially on either side of the light path 2116. The light source fibers 2114 can be coupled to the light source 1030. Alternatively, the light source fibers 2114 can be coupled to the illumination source 914, as shown in FIGS. 9A-9B. Whether the illumination source 914 (e.g., one or more LEDs) or a remote light source 1030, such as external to the endoscope, the light from the endoscope light source can serve to illuminate the target and produce a spectroscopic signal reflected from the target surface, which can be collected for spectroscopic analysis. The feedback analyzer 1012 can determine the distance 1060 between the distal end of the endoscope 2110 and the target structure 122, as also shown in FIGS. 10-11.
[0128] 21B shows an endoscopic laser system 2100B that includes a multi-fiber accessory. Instead of delivering laser energy through optical path 2116, a separate laser fiber 2120 can be used to deliver the surgical laser energy from the laser source 1020 to the target structure. Optical path 2116 is used as a dedicated spectroscopic signal fiber to transmit the spectroscopic signal back to the spectrometer 1011.
[0129] Figures 22 and 23A-23B show an example of a multi-fiber system that can be used in a fiber optic delivery system such as that discussed above with reference to Figures 21A-21D. In the example shown in Figure 22, the multi-fiber system 2200 includes a first fiber 2210 coupled to a light source and configured to direct illumination light to a target, and a separate second fiber 2220 coupled to a spectrometer and configured to transmit a reflectance signal (e.g., light reflected from the target) to the spectrometer indicative of a spectral characteristic of the target.
[0130] 23A-B are diagrams of an exemplary multi-fiber accessory having a source light input and a spectroscopic feedback signal. As shown in FIG. 23A, the multi-fiber accessory 2300A can include a distal portion 2310, a transition section 2320A, and a proximal portion 2330A. The distal portion 2310 includes a shaft that can be sized and shaped to enclose the first fiber 2210 and the second fiber 2220, and the transition section 2320A located proximal to the distal portion 2310. The first fiber 2210 and the second fiber 2220 can be embedded in and extend along the longitudinal shaft of the distal portion 2310. The shaft can be sized and shaped to extend through a working channel of an endoscope. In some examples, the first fiber 2210 can include two or more optical fibers each coupled to a light source, and / or the second fiber 2220 can include one or more optical fibers. In some examples, the second fibers 2220 can be radially distributed around the first optical fiber 2210, as shown in Figures 21C-21D. In one example, at least one of the second optical fibers 2220 can extend substantially along a central longitudinal axis of the shaft. Two or more first optical fibers 2210 can be positioned radially on either side of a second optical fiber 2220 that extends along a central longitudinal axis of the shaft.
[0131] The proximal portion 2330A comprises a first connector 2332 configured to be connected to a light source and a second connector 2334 configured to be connected to a spectrometer. The transition section 2320A interconnects the distal portion 2310 and the proximal portion 2330A and can be configured to couple the first connector 2332 to the first fiber 2210 and the second connector 2334 to the second fiber 2220. Thus, the transition section 2320A provides a transition of the optical fibers 2210 and 2220 from the first connector 2332 and the second connector 2334, respectively, to a single shaft.
[0132] The shaft can include an insertable distal end 2312 extending distally from the distal portion 2310. The insertable distal end 2312 can be configured to be inserted into a patient. The proximal portion 2300A can be associated with (e.g., included within) a handle through which a user manipulates the multi-fiber accessory 2300A. In one example, at least a portion of the multi-fiber accessory 2300A (e.g., one or more of the distal portion 2310, the transition section 2320A, or the proximal portion 2330A) can be included in or insertable into a working channel of an endoscope.
[0133] FIG. 23B illustrates another example of a multi-fiber accessory 2300B that is a variant of the multi-fiber accessory 2300A. In the example illustrated in FIG. 23B, the proximal portion 2330B can further include a third connector 2336 configured to couple a laser source to one of the optical fibers 2210 or 2220. Similar to FIG. 23A, a transition section 2320B interconnects the distal portion 2310 and the proximal portion 2330B. Laser energy generated from a laser source can be transmitted from the proximal portion 2330B to the distal portion 2310 through one of the optical fibers 2210 or 2220 and delivered to a target treatment site via the insertable distal end 2312. In some examples, the multi-fiber accessory 2300B can further include a laser fiber that is different from the optical fibers 2210 or 2220. The laser fiber can be positioned within a working channel of the endoscope, such as within a shaft. Laser energy generated from the laser source can be transmitted through the laser fiber to the distal portion 2310.
[0134] Example Applications of Laser Systems The laser systems described in accordance with various examples herein can be used in many applications, such as endoscopic hard or soft tissue surgery, to improve the effectiveness of ablation, coagulation, vaporization, or other laser action.
[0135] One application of the laser system for tissue surgery applications involves using a laser system to provide effective tissue ablation and coagulation rather than the use of two different foot pedals as is often done with commercially available devices such as laser and plasma devices. An exemplary system utilizes two or more solid state laser modules emitting at two different wavelengths coupled through fibers into a laser controller and a UV-VIS reflectance spectroscopy system that delivers a spectral signal to a feedback analyzer that suggests alternative settings to the user before being adjusted.
[0136] In one example, two laser modules can be provided, including a first laser module that can emit at a high tissue absorption light wavelength for a more efficient ablation / carbonation process, and a second laser module that can emit at a lower tissue absorption light wavelength for more efficient coagulation, such as due to a penetration depth similar to the diameter of small blood capillaries. Examples of the first laser module can include an InXGa1-XN semiconductor laser emitting in the UV-VIS summarized in Table 1, a GaN emitting at 515-520 nm, an InXGa1-XN emitting at 370-493 nm, or an IR laser emitting in the high water absorption range of 1900-3000 nm. Examples of the second laser module can include a GaXAl1-XA emitting at 750-850 nm, or an InXGa1-XA emitting at 904-1065 nm. Both the first and second laser modules can be coupled to the laser controller by a laser coupling system.
[0137] The spectroscopic light source can be integrated into a separate fiber channel, laser fiber, or endoscope system. The spectroscopic light source signal reflected from the target can be rapidly detected and delivered to the spectrometer through a separate fiber channel or laser fiber. Alternatively, the spectroscopic system can collect the spectroscopic signal from an imaging system including a detector such as a CCD or CMOS sensor. Based on the spectroscopic system feedback, the signal analyzer can detect the target material composition, suggest a first or second laser module setup to achieve effective tissue treatment, and deliver a signal to the output system that is used to provide the suggested setup information to the user.
[0138] This example allows for tissue ablation and coagulation by utilizing two or more laser pulses with optical wavelengths controlled by a feedback analyzer system. However, feedback control can also be utilized with single or multiple optical wavelength systems to optimize simultaneous delivery of unique actions to a target. These actions can only be simultaneous from the user's perspective, and the features described herein are not limited to delivering wavelengths at exactly the same time.
[0139] An exemplary time operation diagram of this laser with spectroscopic feedback is presented in Figure 8. As shown in Figure 8, the amplitude A max The optical feedback signal having an amplitude equal to or greater than a threshold level A is continuously delivered to and reflected from the target surface and detected and analyzed by the signal analyzer. The user can then choose to ablate the soft tissue and then turn the first laser ON while leaving the second laser OFF, or maintain the first laser ON. During operation of the first laser, the optical feedback signal has an amplitude equal to or greater than a threshold level A. min The signal analyzer then changes the state of the lasers, the first laser is turned OFF and the second laser is turned ON. The second laser is now highly absorbed by the carbonized tissue, and thus the carbonized tissue is ablated, virtually eliminating the carbonization. The wavelength of the second laser also provides effective coagulation. The decarburization process causes the amplitude of the optical feedback pulse to drop back to the initial level A. max When this occurs, the signal analyzer again changes the state of the lasers, the first laser is turned ON and the second laser is turned OFF. The above process can be repeated until the required amount of tissue ablation and coagulation is achieved.
[0140] Another application of the laser system relates to an efficient laser lithotripsy process for fragmenting kidney or bladder stones in a patient. This application relates to a process in which a multi-wavelength laser energy having a wavelength that is poorly absorbed by the target is first used to heat the target, and then a wavelength of stronger absorption is used to fragment the target, e.g., a kidney stone. During laser lithotripsy, fragmentation of kidney or bladder stones can be achieved by photothermal action. The stone can absorb high laser energy, thus causing a rapid temperature rise above the threshold for chemical decomposition, resulting in its decomposition and fragmentation. In one example, laser lithotripsy can include a two-stage process. The first stage is a pre-heating stage, in which the stone is heated using laser energy of a first wavelength, resulting in lower laser energy absorption by the stone. The second stage then involves application of laser energy having a second wavelength, resulting in stronger laser energy absorption by the stone than the first wavelength. Such a multi-stage process allows for better control of the vapor bubble criteria and reduces the strength of the shock waves generated (reducing the backward movement effect of the stone) compared to fragmentation processes.
[0141] In one example, the laser system utilizes two or more solid-state laser modules emitting at two different wavelengths coupled through fibers into a laser controller and a spectroscopy system that delivers a spectral signal to a feedback analyzer that suggests alternative settings to the user before being adjusted. The first laser module can emit at a lower stone / water absorption light wavelength for efficient pre-heating, and the second laser module can emit at a higher stone / water absorption light wavelength for more efficient stone fragmentation. The first laser module in this application can produce an output at a lower stone or water absorption wavelength. This laser provides effective and uniform stone pre-heating. Examples of first laser sources for the first laser module can include GaXAl1-XA emitting at 750-850 nm, or InXGa1-XA emitting at 904-1065 nm. Examples of the second laser source can include a GaN laser emitting at 515-520 nm summarized in Table 1, or a UV-VIS laser such as an InXGa1-XN laser emitting at 370-493 nm, or an IR laser emitting within the high water and stone absorption range of 1900-3000 nm.
[0142] Both the first and second laser modules can be coupled to the laser controller by a laser coupling system. The spectroscopic light source can be integrated into a separate fiber channel, laser fiber, or endoscope system. The spectroscopic light source signal reflected from the target can be rapidly detected and delivered to the spectrometer through a separate fiber channel or laser fiber. Alternatively, the spectroscopic system can collect the spectroscopic signal from an imaging system including a detector such as a CCD or CMOS sensor.
[0143] Based on the spectroscopic system feedback, the signal analyzer can detect the target material composition, suggest a first or second laser module setup to achieve an effective multi-step stone treatment process, and deliver a signal to the output system that is used to provide the user with the suggested setup information. The laser system can simultaneously deliver effective stone preheating and fragmentation by utilizing two or more laser pulses from laser modules with optical wavelengths controlled by the feedback analyzer system. However, feedback control can also be utilized by single or multiple optical wavelength systems to optimize the simultaneous delivery of unique effects to the target stone composition.
[0144] Yet another application of the laser system concerns the process for performing ablation of hard tissues, e.g. teeth, bones, etc., where high laser output power is required. While the effectiveness of soft tissue laser surgery is based on low-temperature water evaporation at 100 °C, hard tissue cutting processes require much higher ablation temperatures of the order of 5,000 °C. To deliver enhanced output power, the laser system can combine a larger number of laser modules to increase the integrated output power to a level sufficient to treat the target. The following lasers can be used as emission sources: InXGa1-XN semiconductor lasers emitting in UV-VIS, GaN emitting at 515-520 nm, InXGa1-XN emitting at 370-493 nm, or IR lasers at 1900-3000 nm, as summarized in Table 1. Laser sources for laser modules applicable to this example can include, for example, GaXAl1-XA lasers emitting at 750-850 nm, or InXGa1-XA lasers emitting at 904-1065 nm.
[0145] The laser module can be integrated into the laser controller by a laser coupling system. To achieve the required high power, multiple laser modules can be coupled into the system. The spectroscopic light source can be integrated into a separate fiber channel, laser fiber, or endoscope system. The spectroscopic light source signal reflected from the target can be rapidly detected and delivered to the spectrometer through a separate fiber channel or laser fiber. Alternatively, the spectroscopic system can collect the spectroscopic signal from an imaging system that includes a detector such as a CCD or CMOS sensor.
[0146] Based on the spectroscopic system feedback, the signal analyzer can detect the target material composition, suggest the laser module setup and number of laser modules to achieve an effective multi-step treatment process of the required output power, and deliver a signal to the output system that is used to provide the user with the suggested setup information. The laser system can simultaneously deliver the required high laser output power by increasing the number of laser modules included in the treatment process that utilizes two or more laser pulses with optical wavelengths controlled by the feedback analyzer system. Feedback control can also be utilized by single or multiple optical wavelength systems to optimize the simultaneous delivery of unique actions to the target stone composition. These actions can be simultaneous only from the user's perspective and are not limited to delivering wavelengths at exactly the same time.
[0147] The features described herein can be used to provide a method for identifying the composition of a target. The target can be a medical target, such as soft and hard tissues in vivo, in some examples, through the use of a surgical accessory. The accessory can be used endoscopically or laparoscopically. The accessory can consist of a single device that includes multiple optical fibers, at least one fiber intended to provide source illumination and at least one fiber intended to guide reflected light to a spectrometer. This allows the user to continuously monitor the composition of the tissue or target throughout the procedure, with or without direct endoscopic visualization. This can also be used in combination with a laser system, where the accessory can provide feedback to the laser system to adjust settings based on the composition of the tissue or target. This feature allows instantaneous adjustment of the laser settings within the setting range of the original laser settings selected by the user. The features described herein can be used with a spectroscopic system, which can be used with a laser system that is integrated with optical fibers. The spectroscopic light source can be transmitted through at least one of the fibers in the multi-fiber accessory. The light source signal reflected from the target can be rapidly collected and delivered to the spectrometer via an additional fiber in the multi-fiber.
[0148] An exemplary method can utilize the spectroscopic input data to calculate and control the distance between the distal end of the laser delivery system 1701 (such as a fiber) and the tissue or target based on an algorithm. The method can be applied to both soft and hard tissue types in an in vivo surgical process. The distance between the target and the distal end of the fiber can be calculated based on an analysis of the spectral data. The outer diameter of each fiber and its projection angle from the endoscope affect the intensity of the reflected light that is measured to obtain the spectral data. The features described herein allow the distance to be calculated without sequential illumination by lights with different numerical aperture values.
[0149] In the case of moving stones, the method can control the distance and adjust or suggest laser operating parameters that use steam bubbles in water to create a suction effect to draw targets above a certain threshold towards the distal end of the fiber. This feature minimizes the effort that the user needs to exert to maintain an effective treatment distance with a moving target.
[0150] UV-VIS-IR reflectance spectroscopy according to the various examples discussed herein can be used alone or in combination with other spectroscopic techniques to produce spectroscopic feedback including analysis of material chemical composition and to measure reflected light intensity during in vivo diagnostic or therapeutic procedures. Reflected light can provide the same information as color images made by the eye or a high-resolution camera, but more quantitatively and objectively. Reflectance spectroscopy provides information about materials since the reflection and absorption of light depends on their chemical composition and surface properties. It is also possible to obtain unique information about both the surface and internal properties of a sample using this technique.
[0151] Yet another application of the laser system relates to a process of identifying target types, such as determining the composition of a stone target during laser lithotripsy. According to some examples discussed herein, an endoscope system has a light source, which provides illumination light to a target inside a human body through a light guide of an endoscope. A doctor uses the laser system to break up a stone under illumination light from the endoscope system. This situation can be somewhat problematic when the laser system is used to detect stone composition. The light reflected from the stone is weak, whereas the illumination light from the endoscope system is strong. Therefore, it can be difficult to analyze the composition of the stone under illumination by the endoscope system.
[0152] FIG. 26 illustrates an example of an endoscopic system 2600 configured to identify a target (e.g., identify the composition of a stone target) using a diagnostic beam such as a laser beam. The system 2600 can include a controller 2650 that can control both the endoscopic light source 2630 and the laser generator module 2640. The controller 2650 can detect the input of a command to activate a stone composition detection mode by a physician through the laser system. The controller 2650 can then send a command to the endoscopic light source 2630 to turn off the illumination or to switch from a high illumination mode to a low illumination mode, in which a reduced amount of illumination is projected on the target for a certain period of time. During such low illumination or non-illumination periods, the laser system 2640 can emit a laser beam to the target and receive reflected light from the stone. The detector 2660 can use the reflected light to perform target identification. By darkening the illumination (or turning off the illumination) on the target site under the low illumination mode, the reflection of the laser beam incident on the target from the target can be enhanced, which can help improve target identification.
[0153] After determining that target identification is complete, the detector 2660 can send an end command to the controller 2650. The controller 2650 can then send a command to re-illuminate the target or switch from low illumination to high illumination mode again. In one example, when the endoscope light source 2630 receives a command to stop illumination or switch from high illumination mode to low illumination mode, the image processor 2670 in the endoscope system 2600 can capture a still image of the target and display the still image on the monitor of the endoscope system during that period. Variations of the endoscope system 2600 for identifying targets, such as those discussed above with reference to FIGS. 11A-11B, are also contemplated.
[0154] FIG. 27 shows a graph 2700 of a laser pulse sequence having different pulse energy or power levels, such as may include a first pulse train 2710 and a second pulse train 2720. The pulses in the second pulse train 2720 have a higher energy or power level than the pulses of the first pulse train 2710. The first pulse train 2710 and the second pulse train 2720 may be generated by respective laser sources and each may be emitted in the form of a respective laser beam from a distal end of an endoscope. The first pulse train 2710 may be generated substantially constantly, such as for a specific period of time (e.g., controlled by a user). The second pulse train 2720 may be generated intermittently, such as for a specific period of time during which the first pulse train 2710 is delivered. For example, the second pulse train 2720 may be delivered between two pulses of the first pulse train 2710 or between two trains of the first pulse train 2710. 27, the pulses in a first pulse train 2710 have a constant energy or power level, and a second pulse train 2720 includes only one pulse having a higher energy or power level than the first pulse train 2710. In some examples, the second pulse train 2720 can include two or more pulses, each having a higher energy or power level than the first pulse train 2710.
[0155] The sequence of laser pulses shown in FIG. 27 can be used by a laser lithotripsy system to provide cracking and fragmentation of stone structures, such as kidneys. As shown in FIG. 27, the sequence represents time in the X-direction of the graph, but is annotated by locations "A" and "B" on the stone or other target. Thus, the sequence of laser pulses represents a spatiotemporal pattern of laser pulses having different pulse energy or power levels. In this example, location "A" is at or near the center of the stone or other target, and location "B" is at or near the periphery of the stone or other target. Laser pulses delivered between location "A" and location "B" indicate pulses delivered when the laser fiber 140 is translating from location "A" to location "B" or when the laser fiber 140 is translating from location "B" to location "A", such as can include using an actuator. The first pulse train 2710 can be selected to cause cracking of the target stone without fragmenting the target stone. Thus, in FIG. 27, such a first pulse train 2710 can be delivered, starting at location "A", proceeding towards the center of the stone, then towards the periphery of the stone to location "B", then back to location "A" at the center of the stone, at which point a higher energy pulse 2720 can be delivered in a first attempt to fragment the target stone. If such fragmentation with the higher energy pulse 2720 is not successful, a further first pulse train 2710 can be delivered, proceeding from the location towards the center of the stone towards the periphery of the stone to location "B", then back to location "A" at the center of the stone, at which point another higher energy pulse 2720 can be delivered in a second attempt to fragment the target stone. Further iterations are possible. The same or different locations "B" towards the periphery of the stone can be used for various iterations, with different locations "B" in different iterations causing multiple cracks along such a path from location "A" to such different peripheral locations "B". It may be preferable to use the higher energy pulses 2720 only toward the center of the stone, such as to minimize the effects of the second pulse train 2720 on neighboring tissue.
[0156] In some examples, the sequences of laser pulses having different pulse energies or power levels shown in Figure 27 can be used by an endoscopic system to provide hemostasis or coagulation at a target site. In one example, a first pulse train 2710 and a second pulse train 2720 can be delivered to a target site in a spatiotemporal pattern, e.g., alternating in time, to facilitate an efficient hemostasis or coagulation process.
[0157] Pulses having different energy or power levels, such as the first pulse train 2710 and the second pulse train 2720, can be controllably activated via a user-operable actuator, such as a button or foot pedal. For example, a user can activate the delivery of the first pulse train 2710 using a first activation pattern (e.g., a single press of a button or foot pedal) and the delivery of the second pulse train 2720 using a second activation pattern (e.g., two presses of a button or foot pedal). In one example, the first pulse train 2710 and the second pulse train 2720 can each be controlled via a separate actuator. Additionally or alternatively, the first pulse train 2710 and the second pulse train 2720 can be controllably activated automatically, such as based on a feedback signal from the target. For example, a spectrometer can collect spectroscopic data of the target, and a feedback analyzer can analyze the spectroscopic data to identify the composition of different portions of the stone structure. Based at least on such identification, different energy pulses, such as a first pulse train 2710 or a second pulse train 2720, can be delivered to different portions of the target, each having an identified composition.
[0158] 28 generally illustrates a block diagram of an example machine 2800 capable of performing any one or more of the techniques (e.g., methods) discussed herein. Portions of this description may apply to the computing framework of various parts of the laser treatment system according to the examples discussed herein.
[0159] In alternative embodiments, the machine 2800 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked arrangement, the machine 2800 may operate in the capacity of a server machine, a client machine, or both in a server-client network environment. In one example, the machine 2800 may act as a peer machine in a peer-to-peer (P2P) (or other distributed) network environment. The machine 2800 may be a personal computer (PC), a tablet PC, a set-top box (STB), a personal digital assistant (PDA), a mobile phone, a web appliance, a network router, a switch or bridge, or any machine capable of executing (sequentially or otherwise) instructions that specify actions to be taken by the machine. Furthermore, although only a single machine is shown, the term "machine" shall also be construed to include any group of machines that individually or collectively execute one (or more) sets of instructions to perform any one or more of the methods discussed herein, such as cloud computing, software as a service (SaaS), other computer cluster configurations, etc.
[0160] The examples described herein may include or operate by logic or multiple components or mechanisms. A circuit set is a group of circuits implemented in tangible entities including hardware (e.g., simple circuits, gates, logic, etc.). The membership of a circuit set is flexible over time and underlies the variability of the hardware. A circuit set includes members that, when in operation, can perform specified operations alone or in combination. In one example, the hardware of a circuit set can be invariably designed to perform a specific operation (e.g., hardwired). In one example, the hardware of a circuit set can include variably connected physical components (e.g., execution units, transistors, simple circuits, etc.) including computer-readable media (e.g., magnetically, electrically movable arrangements of invariant dense particles, etc.) physically modified to encode instructions for specific operations. When connecting the physical components, the underlying electrical properties of the hardware components are changed, for example, from insulator to conductor, or vice versa. These instructions, in operation, enable embedded hardware (e.g., an execution unit or a loading mechanism) to hardwire the members of the circuit set via variable connections to perform a specific portion of the operation. Accordingly, the computer-readable medium is communicatively coupled to other components of the circuit set members when the device is operating. In one example, any of the physical components can be used in two or more members from two or more circuit sets. For example, under operation, an execution unit can be used by a first circuit of a first circuit set at one time and can be used again by a second circuit of the first circuit set or by a third circuit in the second circuit set at a different time.
[0161] The machine (e.g., computer system) 2800 may include a hardware processor 2802 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 2804, and a static memory 2806, some or all of which may communicate with each other via an interlink (e.g., a bus) 2808. The machine 2800 may further include a display unit 2810 (e.g., a raster display, a vector display, a holographic display, etc.), an alphanumeric input device 2812 (e.g., a keyboard), and a user interface (UI) navigation device 2814 (e.g., a mouse). In one example, the display unit 2810, the input device 2812, and the UI navigation device 2814 may be touch screen displays. The machine 2800 may further include a storage device (e.g., a drive unit) 2816, a signal generating device 2818 (e.g., a speaker), a network interface device 2820, and one or more sensors 2821, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or other sensor. The machine 2800 may include an output controller 2828, such as a serial (e.g., Universal Serial Bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC), etc.) connection, for communicating with or controlling one or more peripheral devices (e.g., a printer, a card reader, etc.).
[0162] The storage device 2816 can include a machine-readable medium 2822 on which is stored one or more data structures or sets of instructions 2824 (e.g., software) that implement or are utilized by any one or more of the techniques or functions described herein. The instructions 2824 can also reside, completely or at least partially, within the main memory 2804, within the static memory 2806, or within the hardware processor 2802 during its execution by the machine 2800. In one example, one or any combination of the hardware processor 2802, the main memory 2804, the static memory 2806, or the storage device 2816 can constitute a machine-readable medium.
[0163] Although the machine-readable medium 2822 is depicted as a single medium, the term “machine-readable medium” may include a single medium or multiple media (e.g., a centralized or distributed database, and / or associated caches and servers) configured to store one or more instructions 2824.
[0164] The term "machine-readable medium" may include any medium capable of storing, encoding, or carrying instructions for execution by the machine 2800 that cause the machine 2800 to perform any one or more of the techniques of this disclosure, or capable of storing, encoding, or carrying data structures used by or associated with such instructions. Non-limiting examples of machine-readable media may include solid-state memory, and optical and magnetic media. In one example, a dense machine-readable medium includes a machine-readable medium that includes a plurality of particles having an unchanging (e.g., stationary) mass. Accordingly, a dense machine-readable medium is not a transitory propagating signal. Particular examples of dense machine-readable media may include non-volatile memory such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EPSOM)) and flash memory devices, magnetic disks such as internal hard disks and removable disks, magneto-optical disks, and CD-ROM and DVD-ROM disks.
[0165] The instructions 2824 may be further transmitted or received by a communications network 2826 using a transmission medium via a network interface device 2820 utilizing any one of a number of transmission protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Exemplary communications networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile telephone networks (e.g., cellular networks), Plain Old Telephone (POTS) networks, and wireless data networks (e.g., the Institute of Electrical and Electronics Engineers (IEEE) 802.11 family of standards known as WiFi®, the IEEE 802.16 family of standards known as WiMax®), the IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, among others. In one example, the network interface device 2820 can include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connecting to the communications network 2826. In one example, the network interface device 2820 can include multiple antennas for wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-output (MIMO), or multiple-input single-output (MISO) techniques. The term "transmission medium" shall be interpreted to include any intangible medium capable of storing, encoding, or carrying instructions for execution by the machine 2800, including digital or analog communications signals or other intangible media for facilitating communication of such software.
[0166] [Additional notes] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, for illustrative purposes, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as "examples." Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only the elements shown or described are provided. Furthermore, the inventors also contemplate examples (or one or more aspects thereof) that use any combination or permutation of the elements shown or described for the particular example (or one or more aspects thereof) or for other examples (or one or more aspects thereof) shown or described herein.
[0167] The terms "a" or "an" are used herein to include one or more, without depending on any other instance or use of "at least one" or "one or more," as is common in patent documents. The term "or" is used herein to refer to a non-exclusive "or," such that "A or B" includes "A but not B," "B but not A," and "A and B," unless otherwise indicated. The terms "comprise" and "in which" are used herein as the plain English equivalents of the respective terms "comprise" and "wherein." Also, in the following claims, the terms "comprise" and "comprise" are open-ended, i.e., a system, device, article, composition, configuration, or process that includes elements other than those recited after such term in a claim is also deemed to be within the scope of that claim. Moreover, in the following claims, terms such as "first," "second," and "third" are used only as labels and are not intended to impose numerical requirements on their objects.
[0168] The above description is intended to be illustrative, not limiting. For example, the above-described examples (or one or more aspects thereof) can be used in combination with each other. Other embodiments can be used by those skilled in the art, etc., upon reviewing the above description. The Abstract is provided to enable the reader to quickly ascertain the nature of the technical disclosure in accordance with 37 CFR §1.72(b). The Abstract is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to simplify the disclosure. This should not be construed as intending that any unclaimed disclosed feature is essential to any claim. Conversely, the subject matter of the invention may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as an example or embodiment, with each claim standing alone as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. A medical optical system, A feedback analyzer and An optical transmission device, A connector assembly including a first connector operably connected to a light source, a second connector operably connected to the feedback analyzer, and a third connector operably connected to a laser system, A shaft configured to extend through a working channel of the medical optical system, comprising: (i) at least one first optical fiber directing irradiation light emitted by the light source to an anatomical target of the patient; (ii) at least one second optical fiber transmitting a response signal from the anatomical target in response to irradiation of the anatomical target to the feedback analyzer; and (iii) at least one third optical fiber directing a laser signal emitted by the laser system to the anatomical target; An optical transmission device comprising a transition section mechanically coupled between the shaft and the connector assembly, Equipped with, A medical optical system characterized in that the feedback analyzer is configured to determine the characteristics of the anatomical target using the response signal from the anatomical target.
2. A medical optical system according to Claim 1, characterized in that the at least one second optical fiber extends along the substantially central longitudinal axis of the shaft.
3. A medical optical system according to Claim 1, characterized in that the at least one first optical fiber includes two or more first optical fibers radially positioned around the at least one second optical fiber within the shaft.
4. A medical optical system according to claim 3, characterized in that the two or more first optical fibers are positioned radially on both sides of the at least one second optical fiber.
5. A medical optical system according to Claim 1, characterized in that the transition section is configured to provide the transition of the at least one first optical fiber and the at least one second optical fiber from the first connector and the second connector to the shaft, respectively.
6. A medical optical system according to Claim 1, wherein the feedback analyzer comprises a spectrometer configured to determine the characteristics of the anatomical target based on spectral analysis of the response signal from the anatomical target.
7. A medical optical system according to Claim 1, characterized in that the characteristics of the anatomical target include the type or composition of the anatomical target.
8. A medical optical system according to claim 1, comprising the laser system, wherein the laser system is One or more laser sources, each configured to generate its own laser pulse, A laser controller operably coupled to the third connector controls the generation and delivery of each laser pulse to the anatomical target, A medical optical system characterized by comprising the following:
9. An optical transmission device for transmitting multiple optical signals during a medical laser treatment of a patient, A connector assembly including a first connector operably connected to a light source, a second connector operably connected to a feedback analyzer, and a third connector operably connected to a laser system, A shaft comprising: (i) at least one first optical fiber directing irradiation light emitted by the light source to the anatomical target of the patient; (ii) at least one second optical fiber transmitting a response signal from the anatomical target in response to the irradiation of the anatomical target to the feedback analyzer; and (iii) at least one third optical fiber directing a laser signal emitted by the laser system to the anatomical target; An optical transmission device comprising a transition section mechanically coupled between the shaft and the connector assembly.
10. An optical transmission device according to claim 9, characterized in that the at least one second optical fiber extends along the substantially central longitudinal axis of the shaft.
11. An optical transmission device according to claim 9, characterized in that the at least one first optical fiber includes two or more first optical fibers radially positioned around the at least one second optical fiber within the shaft.
12. An optical transmission device according to claim 11, characterized in that the two or more first optical fibers are positioned radially on both sides of the at least one second optical fiber.
13. An endoscope system, Endoscope including working channel, A light source that emits irradiation light to irradiate the anatomical target of the patient, An optical transmission device, A connector assembly including a first connector operably connected to the light source, a second connector operably connected to a feedback analyzer, and a third connector operably connected to a laser system, A shaft configured to extend through the working channel of the endoscope, comprising: (i) at least one first optical fiber for transmitting the irradiation light to the anatomical target; (ii) at least one second optical fiber for transmitting a response signal in response to the irradiation of the anatomical target to a feedback analyzer; and (iii) at least one third optical fiber for directing the laser signal emitted by the laser system to the anatomical target. An optical transmission device comprising a transition section mechanically coupled between the shaft and the connector assembly, An endoscope system characterized by comprising the following features.
14. The endoscope system according to claim 13, further comprising the feedback analyzer configured to determine the characteristics of the anatomical target using the response signal from the anatomical target.
15. An endoscope system according to claim 14, wherein the feedback analyzer comprises a spectrometer configured to determine the characteristics of the anatomical target based on spectral analysis of the response signal.
16. An endoscope system according to claim 14, characterized in that the characteristics of the anatomical target include the type or composition of the anatomical target.
17. An endoscope system according to claim 13, comprising the laser system, wherein the laser system One or more laser sources, each configured to generate its own laser pulse, A laser controller operably coupled to the third connector controls the generation and delivery of each laser pulse to the anatomical target, An endoscope system characterized by being equipped with the following features.
18. An endoscope system according to claim 17, characterized in that the at least one second optical fiber extends along the substantially central longitudinal axis of the shaft.
19. An endoscope system according to claim 17, characterized in that the at least one first optical fiber includes two or more first optical fibers radially positioned around the at least one second optical fiber within the shaft.
20. An endoscope system according to claim 19, characterized in that the two or more first optical fibers are positioned radially on both sides of the at least one second optical fiber.