Catheter-based system classifying tissue of a subject to provide therapy

Abstract

A system is provided for classifying tissue of a subject to provide therapy. The system includes a catheter insertable in a lumen of the subject, where the catheter includes a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, and at least one energy delivery device configured to transmit electromagnetic energy through tissue at a distal end of the at least one energy delivery device, where the at least one energy delivery device is positioned on a distal end of the at least one needle; and a spectral signal analyzer configured to measure a response of the tissue to different frequencies of the electromagnetic energy at the distal end of the at least one energy delivery device, wherein the measured response indicates tissue classification at the distal end of the at least one energy delivery device.

Description

A CATHETER-BASED SYSTEM AND METHOD FOR CLASSIFYING TISSUE OF A SUBJECT TO PROVIDE THERAPYCROSS-REFERENCE TO RELATED APPLICATION

[0001] This present application claims priority under 35 U.S.C. § 119(e) from U.S. Provisional Application 63 / 728,257 filed on December 5, 2024. The entire disclosure of U.S. Provisional Application 63 / 728,257 is specifically incorporated herein by reference.FIELD OF THE INVENTION

[0002] The invention relates to the field of medical treatment of tissue surrounding vessels, and more specifically to classifying the tissue surrounding the vessels to enable identification of the type of tissue and / or the state of tissue in response to the medical treatment.BACKGROUND

[0003] There are several conventional intravascular devices with that used needles for providing various types of therapy and / or for navigation of obstruction within a vessel. The types of therapy may include, for example, thermal ablation and infusion of fluids into, or beyond, the vessel walls. For example, a micro-infusion device may be configured to reduce vessel wall inflammation by injecting physician-specified fluids. In another application, needles may be used to inject fluid via the arterial wall for ethanol ablation of the renal nerves to treat hypertension. In another application, needles may be used to puncture the intimal layer of a vessel when readvancing back into the vessel to create a sub-intimal bypass. In clinical practice the advancement of the needles is usually guided via imaging, for example angiography or ultrasound imaging.

[0004] Image based needle placement in conventional devices typically is not accurate enough, especially when a needle is used within a vessel to deliver therapy. Therefore, additional feedback is required to better understand where the needle is with respect to the vessel wall by assessing the type of tissue that is surrounding the tip of the needle. Additionally, when therapy is delivered, it is desirable to monitor the delivery of the therapy and its effectiveness. Althoughneedles with sensors exist for percutaneous placement, there are no catheter-based systems with tissue type sensing at the needle tip for accurate intravascular needle placement and / or therapy guidance.SUMMARY

[0005] According to a representative embodiment, a system is configured to classify tissue of a subject to provide therapy to the tissue. The system includes a catheter insertable in a lumen of the subject, where the catheter includes a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, and at least one energy delivery device configured to transmit electromagnetic energy through tissue at a distal end of the at least one energy delivery device, where the at least one energy delivery device is positioned on a distal end of the at least one needle; and a spectral signal analyzer configured to measure a response of the tissue to different frequencies of the electromagnetic energy at the distal end of the at least one energy delivery device, where the measured response indicates a type of the tissue and / or a state of the tissue at the distal end of the at least one energy delivery device.

[0006] According to another representative embodiment, a system is configured to classify tissue of a subject to provide therapy to the tissue. The system includes a catheter insertable in a lumen of the subject, where the catheter includes a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, and multiple electrodes configured to transmit an electrical signal at different frequencies through tissue between the electrodes to provide an impedance signal for measuring impedance of the tissue between the electrodes, where at least one electrode of the multiple electrodes is positioned on the at least one needle; and an impedance measurement device configured to receive the impedance signal from at least one electrode of the multiple electrodes, and to determine the impedance of the tissue between the electrodes based on the impedance signal. The system may further include a processing unit configured to receive the determined impedance from the impedance measurement device, and to determine a type of the tissue and / or a state of the tissue between the electrodes based on the determined impedance using electrical spectroscopy.

[0007] According to another representative embodiment, a system is configured to classify tissueof a subject to provide therapy to the tissue. The system includes a light source configured to generate light; a catheter insertable in a lumen of the subject, where the catheter includes a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject; and at least one optical fiber configured to transmit the light from the light source through tissue at a distal end of the at least one optical fiber, where the at least one optical fiber is positioned on the at least one needle; and a spectrometer configured to receive the light transmitted through the tissue via the at least one optical fiber, and to perform optical spectroscopy to measure an optical spectrum of the received light that has interacted with the tissue through absorption, scattering, and / or fluorescence to determine a type of tissue of the tissue and / or a state of the tissue at the distal end of the at least one optical fiber, where the optical spectroscopy includes diffuse reflectance spectroscopy (DRS), fluorescence, or Raman spectroscopy.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The example embodiments are best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like tools.

[0009] FIG. 1 is a simplified block diagram and cross-sectional view of a system for classifying tissue of a subject to provide therapy to the tissue, according to a representative embodiment.

[0010] FIG. 2 shows an illustrative set of optical spectra corresponding to different types of tissue, respectively, for identification of tissue by a controller, according to a representative embodiment.

[0011] FIG. 3A is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes in an extended position outside the catheter body, according to a representative embodiment.

[0012] FIG. 3B is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes in a retracted position within the catheter body, according to a representative embodiment.

[0013] FIG. 3C is a top plan view of a cylinder slideably positioned within the catheter body, where the multiple extendable needles are attached to the cylinder, according to a representative embodiment.

[0014] FIG. 4 is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes, and electrodes on the catheter body, according to a representative embodiment.

[0015] FIG. 5 is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes, and ultrasound imaging elements on and the catheter body, according to a representative embodiment.

[0016] FIG. 6A is a cross-sectional view of the distal portion of a catheter body including multiple extendable needles with electrodes, and a retractable sheath in an un-retracted position for covering the catheter body, according to a representative embodiment.

[0017] FIG. 6B is a cross-sectional view of the distal portion of the catheter body including multiple extendable needles with electrodes, and retractable sheath in a retracted position, according to a representative embodiment.

[0018] FIG. 6C is cross-sectional view of the distal portion of a catheter body including multiple extendable needles with electrodes, and a retractable sheath in a retracted position and an isolation sheath for covering the catheter body, according to a representative embodiment.

[0019] FIG. 7 is a flow diagram of a method for classifying tissue of a subject to provide therapy to the tissue, according to a representative embodiment.DETAILED DESCRIPTION

[0020] In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is forpurposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.

[0021] It will be understood that, although the terms first, second, third, etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept.

[0022] The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms “a,” “an” and “the” are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms “comprises,” “comprising,” and / or similar terms specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0023] Unless otherwise noted, when an element or component is said to be “connected to,” “coupled to,” or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.

[0024] The present disclosure, through one or more of its various aspects, embodiments and / or specific features or sub-components, is thus intended to bring out one or more of the advantages as specifically noted below. For purposes of explanation and not limitation, example embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. However, otherembodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted so as not to obscure the description of the example embodiments. Such methods and apparatuses are within the scope of the present disclosure.

[0025] Generally, according to the various embodiment herein, a catheter-based device is provided with one or multiple needles that can be deployed with electrodes on the tips of the one or more needles that enable tissue sensing based on spectral impedance measurements. The tissue sensing may be used for identifying the type of tissue encountered by the needles, and / or for determining a state of the tissue in the course of therapy.

[0026] FIG. 1 is a simplified block diagram and cross-sectional view of a system for classifying tissue of a subject to provide therapy to the tissue, according to a representative embodiment.

[0027] Referring to FIG. 1, the system 100 includes a catheter system 110 configured to be inserted in a vessel (body lumen) 101 of the subject (patient) and a control system 150 configured to control all or part of the operation to classify tissue surrounding the vessel 101 at a target location 102 in order to assist in providing therapy to the tissue at the target location 102. The catheter system 110 is shown positioned within the vessel 101 adjacent to the target location 102. In the depicted embodiment, the catheter system 110 includes a catheter body 112, at least one needle extendable from the catheter body 112, indicated by representative first needle 114 and second needle 116, and at least one energy delivery device, indicated by representative first energy delivery device 121 on the first needle 114 and second energy delivery device 122 on the second needle 116. More particularly, in the depicted embodiment, the first and second energy delivery devices 121 and 122 are positioned at the distal ends of the first and second needles 114 and 116, respectively. In alternative embodiments, both of the first and second energy delivery devices 121 and 122 may be positioned on the same needle (either the first needle 114 or the second needle 116), or one of the first or second energy delivery devices 121 or 122 may be positioned on one needle (either the first needle 114 or the second needle 116), and the other one of the first or second energy delivery devices 121 or 122 may be positioned on the catheter body 112, as discussed below.

[0028] The system 100 further includes a signal generator 120 configured to generate electromagnetic energy across a range of frequencies, which is provided to the tissue at the targetlocation via the first and second energy delivery devices 121 and 122, and a spectral signal analyzer 130 configured to measure spectral response of the tissue to the range of frequencies of the electromagnetic energy, as discussed below. The first energy delivery device 121 is connected to the signal generator 120 and the spectral signal analyzer 130 by first transmission line 123, and the second energy delivery device 122 is connected to the signal generator 120 and the spectral signal analyzer 130 by second transmission line 124. The first and second transmission lines 123 and 124 may run inside or along the surface of the catheter body 112. In addition, the system 100 includes a therapy delivery system 140 configured to deliver therapy to the target location 102 of the tissue via the first and second needles 114 and 116, and / or via the first and second energy delivery devices 121 and 122, as discussed below.

[0029] The first and second needles 114 and 116 have a curved configuration, enabling them to penetrate a vessel wall of the vessel 101 when transitioning from a retracted position to an extended position relative to the catheter body 112. In addition, the first and second needles 114 and 116 may be hollow, enabling fluid therapy to be delivered to the tissue at the target location 102 by the therapy delivery system 140 via infusion through corresponding needle lumens. For example, the first and second needles 114 and 116 may be nitinol hypotubes that are heat set in a curved configuration, as would be apparent to one skilled in the art. The first and second needles 114 and 116 may be retractable into the catheter body 112, or covered by a retractable sheath (not shown), as discussed below, to enable navigation of the catheter system 110 through the vessel 101 without the first and second needles 114 and 116 in the extended position. The catheter system 110 is navigated through the vessel 101 toward the target location 102 using known navigation techniques.

[0030] The first and second energy delivery devices 121 and 122 are configured to transmit the electromagnetic energy from the signal generator 120 to the tissue at the distal ends of the first and second energy delivery devices 121 and 122. The spectral response of the tissue to the electromagnetic energy is then analyzed by the spectral signal analyzer 130 in order to classify the tissue, as discussed below. Classifying the tissue may include determining a type of the tissue and / or determining a state of the tissue through which the electromagnetic energy passes. The types of tissue may be used to verify that the first and second needles 114 and 116 and / or the first and second energy delivery devices 121 and 122 are at the correct location (i.e., the targetlocation 102) for administering therapy to the tissue. For example, when the therapy includes renal denervation, the classified type of tissue may verify that the first and second needles 114 and 116 are near nerves (i.e., in a region with a high nerve density). The different types of tissue may include subcutaneous fat, sliding fat, muscle, and fascicular tissue of nerves, for example. The state of the tissue may be used to monitor progress of the therapy, as the state of the tissue may change as the therapy progresses. Different states of tissue may include normal, tumor, necrotic, hyperplastic, fibrotic and scar tissue, for example. Different states of tissue related to vascular pathology, in particular, may include blood, thrombus, atherosclerotic plaque (fibrocalcific, fibroatheroma), and medial layer of vessel wall, for example.

[0031] In an embodiment, the electromagnetic energy is an electrical signal (e.g., AC current) that is transmitted through the tissue at the target location 102 between the first and second energy delivery devices 121 and 122. It is understood that the tissue “between” the first and second energy delivery devices 121 and 122 includes the tissue physically between and immediately surrounding the first and second energy delivery devices 121 and 122, respectively. In this case, the first and second transmission lines 123 and 124 are sets of electrical wires, the first and second energy delivery devices 121 and 122 are electrodes, and the signal generator 120 is an electrical signal generator configured to generate electrical signals at one frequency or over a range of frequencies. The electrical signals are applied to the tissue via the electrodes. The electric signal generator may be an arbitrary waveform generator (AWG) or a radio frequency (RF) signal generator, for example, and the range of frequencies of the electrical signal may be about 0.1 kHz to about 10MHz, for example, although the range of frequencies may vary to provide unique benefits for any particular situation or to meet application specific design requirements of various implementations, as would be apparent to one skilled in the art.

[0032] In addition, when the electromagnetic energy is an electrical signal, the spectral signal analyzer 130 may be an impedance analyzer or an impedance spectrometer, for example, configured to perform electrical spectroscopy. Accordingly, an excitation electrical signal (e.g., AC current) may be transmitted from the signal generator 120 through the first transmission line 123 to the first energy delivery device 121, and a return electrical signal responsive to the excitation electrical signal may be transmitted back through the second transmission line 124 from the second energy delivery device 122 to the signal generator 120. The spectral signalanalyzer 130 is connected to the first and second transmission lines 123 and 124 and is configured to measure the electrical signals (e.g., AC current and / or voltage) through and between the first and second transmission lines 123 and 124, and to determine impedance of the tissue based on the electrical signals. The spectral signal analyzer 130 is also configured to generate an impedance spectrum of the impedance over the range of frequencies for analysis by the control system 150, discussed below.

[0033] Optionally, to improve the accuracy of the impedance measurement, an application specific integrated circuit (ASIC) (not shown) may be integrated into the catheter body 112. The ASIC contains circuitry configured to inject the AC current for measuring the impedance. With the ASIC in the catheter body 112, it is near the first and second energy delivery devices 121 and 122, such that electronic noise is reduced. Furthermore, a four-point measurement technique may be employed, according to which the impedance measurements are performed at separate points from the emitting and receiving electrodes to minimize effects of the impedance of the electrodes themselves, allowing for a more accurate measurement of the tissue impedance.

[0034] In an alternative embodiment, the electromagnetic energy is an optical signal (e.g., broadband or narrowband light) that is transmitted through the tissue at the target location 102 using one or both of the first and second energy delivery devices 121 and 122. The first and second energy delivery devices 121 and 122 may be combined into one bidirectional optical fiber. In this case, the first and second transmission lines 123 and 124 are optical fibers, the first and second energy delivery devices 121 and 122 are the respective transmission ends of the optical fibers, and the signal generator 120 is an optical signal generator configured to generate optical signals over a range of frequencies. The signal generator 120 may be a broadband light source or a narrowband light source, for example, and the range of frequencies may correspond to wavelengths from about 300nm to about 1800nm, for example, or portions thereof, although the range of frequencies / wavelengths may vary to provide unique benefits for any particular situation or to meet application specific design requirements of various implementations, as would be apparent to one skilled in the art. Broadband light sources may include superluminescent diodes, for example, for emitting light over a wide range of wavelengths to provide continuous light across broad spectral regions. Narrowband light sources may include lasers or LEDs, for example. In some embodiments, broadband and narrowband light sourcesmay be combined. Broadband light sources may be used for diffuse reflectance spectroscopy (DRS), and narrowband light sources may be used for fluorescence or Raman spectroscopy, for example.

[0035] The optical signal may be transmitted through the tissue between the first and second energy delivery devices 121 and 122, or the optical signal may be transmitted and received through the tissue by one of the first or second energy delivery devices 121 or 116. In other words, when the electromagnetic energy is an optical signal, only one of the first or second energy delivery devices 121 or 122 is needed, although both may be used, without departing from the scope of the present teachings.

[0036] In addition, when the electromagnetic energy is an optical signal, the spectral signal analyzer 130 may be an optical spectrometer or optical detector(s) with wavelength filter(s), for example, configured to perform optical spectroscopy. Accordingly, an excitation optical signal may be transmitted from the signal generator 120 to the first energy delivery device 121 through the first transmission line 123, and a return optical signal responsive to the excitation optical signal may be transmitted from the second energy delivery device 122 through the second transmission line 124, or from the first energy delivery device 121 back through the first transmission line 123, to the spectral signal analyzer 130, or vice versa. In this case, the spectral signal analyzer 130 is configured to measure an optical spectrum of the return optical signal that has interacted with the tissue through absorption, fluorescence and / or scattering of the optical signal. The optical spectrum is generated over the range of frequencies / wavelengths for analysis by the control system 150, as discussed below. The optical spectroscopy may include DRS, fluorescence spectroscopy, or Raman spectroscopy, for example, mentioned above, and thus the optical spectrum may include DRS, fluorescence, or Raman spectrum, for example.

[0037] In the depicted embodiment, the catheter system 110 optionally includes a guide wire 111 configured for initial insertion in the vessel 101. The guide wire 111 may be advanced manually by a user (e.g., physician, clinical technician) of the catheter system 110, or automatically under control of a controller (e.g., control system 150, discussed below), as would be apparent to one skilled in the art. The catheter system 110 is inserted in the vessel 101 following the guide wire 111. The guide wire 111 passes through a guide wire lumen (not shown) formed longitudinally through the catheter body 112.

[0038] Also in the depicted embodiment, the catheter system 110 optionally includes an imaging marker 118 positioned on the catheter body 112 at the distal portion of the catheter body 112. The imaging marker 118 is configured to enhance visibility of the distal end of the catheter body 112 using external imaging, such as the x-ray imaging, ultrasound imaging, computed tomography (CT) imaging or magnetic resonance (MR) imaging, for example. The type of marker used for the imaging marker 118 varies with the type of external imaging. For example, the imaging marker 118 may be a radiopaque marker for x-ray and CT imaging, and an echogenic marker for ultrasound imaging.

[0039] Also in the depicted embodiment, the catheter system 110 optionally includes an expansion device 119 attached to the catheter body 112, and configured to expand to the inner diameter of the vessel 101 near the target location 102. In the expanded state, the expansion device 119 secures the catheter body 112 in place against the vessel walls, thereby immobilizing the catheter body 112 to enable accurate deployment the first and second needles 114 and 116 into the vessel walls, e.g., during treatment by the therapy delivery system 140. The expansion device 119 may be implemented as an inflatable balloon (inflatable by gas or liquid) or an expandable basket (e.g., formed of nitinol), for example, although any compatible expansion device insertable in the vessel 101 may be incorporated without departing from the scope of the present teachings. The expandable nitinol basket, in particular, secures the catheter body 112 in place without interrupting blood flow through the vessel during therapy.

[0040] The therapy delivery system 140 is configured to deliver therapy to the target location 102 of the tissue after the target location 102 has been verified, e.g., based on the classification of the tissue and / or using the imaging marker 118. The therapy delivery system 140 may be a fluid and / or drug therapy system that includes a syringe containing the fluid and / or the drug to be delivered to the target location through the first and second needles 114 and 116. The syringe may be operated manually by the user or automatically by a robotic device under control of the control system 150, as would be apparent to one skilled in the art.

[0041] Alternatively, the therapy delivery system 140 may be a radio frequency (RF) thermal therapy system or a pulsed field ablation system, for example, that includes a RF signal generator configured to generate RF energy or pulsed RF energy, respectively, which is applied to the target location 102 through one or more ablation electrodes at the distal portion of the catheterbody 112 to provide thermal or pulsed field ablation of the tissue. In an embodiment, all or some of the ablation electrodes may be the first and second energy delivery devices 121 and 122, implemented as electrodes, as discussed above. The RF frequencies of the RF energy may range from about 50kHz to about 5MHz, for example, or portions thereof, for the thermal or pulsed field ablation.

[0042] Alternatively, the therapy delivery system 140 may be a laser therapy system or a photochemical therapy system (e.g., photo-dynamic therapy (PDT)) that includes an optical energy source, such as a laser diode or a light emitting diode (LED), configured to generate optical energy (e.g., laser energy). The optical energy is applied to the target location 102 through one or more ablation optical fibers emitting light at the distal portion of the catheter body 112 to provide thermal ablation or photochemical ablation of the tissue. In an embodiment, all or some of the ablation optical fibers may be the first and second energy delivery devices 121 and 122, implemented as optical fibers, as discussed above. The optical frequencies of the optical energy may range from about lOOnm to about 400nm for an ultraviolet (UV) optical source (e.g., excimer laser), about 400nm to about 700nm for a visible optical source (e.g., He-Ne laser, diode laser), and about 700nm to about 1mm for an infrared (IR) optical source (e.g., CO2 laser, Nd:YAG laser).

[0043] The control system 150 is configured to implement and / or manage all or part of the processes described herein with regard to classifying tissue and performing therapy based on the classification using the catheter system 110. In the depicted embodiment, the control system 150 includes a controller 151 configured to interface with the user, control navigation and deployment of the catheter system 110 through the vessel 101, and perform classification of the tissue, control the therapy based at least in part on the classification of the tissue. In the depicted embodiment, the controller 151 includes one or more processors indicated by processor 152 and one or more memories indicated by memory 153. The controller 151 may also control external and intravascular imaging of the vessel 101 and the catheter system 110 by an imaging system 156, such as an x-ray imaging device for angiography and / or venography imaging, or an ultrasound imaging device, for example, working in conjunction with the catheter system 110. Alternatively or in addition, pre-recorded roadmaps from CT images or MR images, for example, may be used to assist navigation. The control system 150 may further include a user interface154 and a display 155. Images provided by the imaging system 156 may be displayed on the display 155.

[0044] With regard to classifying the tissue, in particular, the processor 152 of the controller 151 is configured to receive the signal spectrum from the spectral signal analyzer 130, and to classify the tissue based on the signal spectrum. For example, when the spectral signal analyzer 130 is an impedance analyzer or an impedance spectrometer, the processor 152 classifies the tissue using the impedance spectrum of the tissue obtained in response to electrical signals. When the spectral signal analyzer 130 is a spectrum analyzer or an oscilloscope, the processor 152 classifies the tissue using the optical spectrum of the tissue obtained in response to optical signals. The processor 152 matches the received signal spectrum with known signal spectra corresponding to the different types of tissue, or corresponding to different states of the same type of tissue, in order to classify the tissue.

[0045] In this context, FIG. 2 shows an illustrative set of optical spectra (diffuse reflection spectra) corresponding to different types of tissue, respectively, for identification of tissue by the controller 151, according to a representative embodiment. Referring to FIG. 2, the optical spectra are shown as magnitude of absorption as a function of wavelength of light provided by the signal generator 120 (e.g., broadband or narrowband light source). In the depicted example, spectrum 201 corresponds to muscle, spectrum 202 corresponds to fascicular tissue of nerves, spectrum 203 corresponds to subcutaneous fat, and spectrum 204 corresponds to sliding fat. Accordingly, the controller 151 is able to identify the tissue by matching the optical spectrum received from the spectral signal analyzer 130 with the most similar one of the spectra 201 to 204. This may be done using a look-up table and / or a previously trained machine learning model, for example, as would be apparent to one skilled in the art.

[0046] Referring again to FIG. 1, the processor 152 of the controller 151 is representative of one or more processing devices, and may be implemented by a general purpose computer, a central processing unit (CPU), a digital signal processor (DSP), a graphical processing unit, a computer processor, a microprocessor, a state machine, programmable logic device, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), or combinations thereof, using any combination of hardware, software, firmware, hard-wired logic circuits, or combinations thereof. Any processor or processing unit herein may include multiple processors,parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices. The processor 152 may also refer to a collection of processors within a single computer system or distributed among multiple computer systems, such as in a cloudbased or other multi-site application. Programs have software instructions performed by one or multiple processors that may be within the same computing device or which may be distributed across multiple computing devices.

[0047] The memory 153 stores instructions executable by the processor 152 that, when executed, cause the processor 152 to implement all or part of various more processes, as discussed herein. The memory 153 may include main memory and / or static memory, where such memories may communicate with each other and the processor 152 via one or more buses. The memory 153 may be implemented by any number, type and combination of random access memory (RAM) and read-only memory (ROM), for example, and may store various types of information, such as software algorithms, artificial intelligence (Al) machine learning models, and computer programs, all of which are executable by the processor 152. The various types of ROM and RAM may include any number, type and combination of computer readable storage media, such as a disk drive, flash memory, an electrically programmable read-only memory (EPROM), an electrically erasable and programmable read only memory (EEPROM), registers, a hard disk, a removable disk, tape, compact disk read only memory (CD-ROM), digital versatile disk (DVD), floppy disk, Blu-ray disk, a universal serial bus (USB) drive, or any other form of storage medium.

[0048] The memory 153 is a tangible storage medium for storing data and executable software instructions, and is non-transitory during the time software instructions are stored therein. As used herein, the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period. The term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time. The memory 153 may store software instructions and / or computer readable code that enable performance of various functions. The memory 153 may be secure and / or encrypted, or unsecure and / or unencrypted.

[0049] The user interface 154 is configured to provide information and data output by the processor 152 and the memory 153 to the user and / or for receiving information and data input bythe user. That is, the user interface 154 enables the user to enter data and to control or manipulate aspects of the processes described herein, and also enables the processor 152 to indicate the effects of the user’s input, which may include control or manipulation of the catheter system 110, the signal generator 120, the spectral signal analyzer 130, and the therapy delivery system 140. All or a portion of the user interface 154 may be implemented by a graphical user interface (GUI) displayed on the display 155. The user interface 154 may include one or more interface devices, such as a mouse, a keyboard, a trackball, a joystick, a microphone, a video camera, a touchpad, a touchscreen, voice or gesture recognition captured by a microphone or video camera, for example.

[0050] The display 155 may be a monitor such as a computer monitor, a television, a liquid crystal display (LCD), an organic light emitting diode (OLED), a flat panel display, a solid-state display, or a cathode ray tube (CRT) display, or an electronic whiteboard, for example. The display 155 includes a screen, which may be used for viewing images of the catheter system 110 and the tissue within the vessel 101 of the subject during the procedure.

[0051] The process of classifying the tissue and providing therapy based on the tissue classification may be repeated as needed. For example, medical imaging may be incorporated to determine the level of completion of the therapy, as would be apparent to one skilled in the art. The medical imaging may include intravascular imaging, such as intravascular ultrasound (IVUS) or optical imaging, and / or external imagining, as discussed above.

[0052] FIGs. 3A and 3B are top plan views of the distal portion of a catheter body including multiple extendable needles with electrodes, according to a representative embodiment. FIG. 3A shows the catheter body with the extendable needles in an extended position, and FIG. 3B shows the catheter body with the extendable needles in a retracted position within the catheter body. FIG. 3C is a top plan view of a cylinder slideably positioned within the catheter body, where the multiple extendable needles are attached to the cylinder, according to a representative embodiment. Although depicted with electrodes on distal ends of the extendable needles, it is understood that the configurations shown in FIGs. 3 A, 3B and 3C are also applicable to optical fibers on the distal ends of the extendable needles.

[0053] Referring to FIGs. 3 A, catheter body 312 is similar to the catheter body 112, discussed above. The catheter body 312 includes an optional imaging marker 318 (e.g., radiopaque marker)set back from its distal end for tracking the catheter body 312, and a guide wire lumen 311 for accommodating a guide wire (not shown) for navigation. The catheter body 312 further includes curved needles extending therefrom and corresponding slots into which the curved needles are retracted, e.g., to enable the navigation of the catheter body 312 through a vessel. In particular, the catheter body 312 houses first needle 321, second needle 322, third needle 323, fourth needle 324, and fifth needle 325. Additional sixth needle 326 and seventh needle 327, shown in FIG.3C, are not visible from the perspective shown in FIG. 3A.

[0054] Each of the first to seventh needles 321 to 327 has a corresponding slot into which it is retractable. For example, as shown in FIGs. 3A and 3B, the second needle 322 is retractable into corresponding slot 332, the third needle 323 is retractable into corresponding slot 333, and the fourth needle 324 is retractable into corresponding slot 334. The slots corresponding to the other needles are not visible the perspective shown in FIGs. 3A and 3B. Notably, although a single set of retractable needles (first to seventh needles 321 to 327) is shown, it is understood that additional set(s) of multiple retractable needles may be arranged along the length of the catheter body 312 without departing from the scope of the present teachings.

[0055] For purposes of illustration, the first needle 321 includes a pair of electrodes, indicated by first electrode 341 and second electrode 342 positioned on the distal end of the first needle 321. As discussed above, an electrical signal at different frequencies is transmitted between the first and second electrodes 341 and 342 to provide an impedance signal for measuring impedance of the tissue between the first and second electrodes 341 and 341. By having pairs of electrodes (e.g., first and second electrodes 341 and 342) on multiple needles, the local tissue impedance can be measured at each needle having a pair of electrodes, and impedance between electrodes on different needles can also be measured by electronically switching between the different electrodes on the different needles, under control of the controller 151, for example.

[0056] Further, for purposes of illustration, the second needle 322 includes a single electrode, indicated by third electrode 343, and the fifth needle 325 includes another single electrode, indicated by fourth electrode 344, at the respective distal ends. In this configuration, as discussed above, an electrical signal at different frequencies is transmitted between the third and fourth electrodes 343 and 344 to provide an impedance signal for measuring impedance of the tissue between the third and fourth electrodes 343 and 344. A tomographic image may be generated bycombining measurements between different electrodes on the different needles by electronically switching between the different electrodes.

[0057] It is understood that the depicted arrangements of electrodes on needles in FIG. 3A are not limiting, and that, in various configurations, all of the first to fifth needles 321 to 325 may include pairs of electrodes, all of the first to fifth needles 321 to 325 may include single electrodes, or the first to fifth needles 321 to 325 may have various combinations of pairs of electrodes, single electrodes and / or no electrodes, or without departing from the scope of the present teachings.

[0058] Referring to FIG. 3C, cylinder 313 is configured to be slideably positioned within the catheter body 312. The first to seventh needles 321 to 327 are attached to and extend from the distal end 314 of the cylinder 313. Accordingly, when the cylinder 313 inside the catheter body 312 is advanced longitudinally in a distal direction within the catheter body 312, the first to seventh needles 321 to 327 extend through corresponding slots in the catheter body 312 (e.g., second to fourth slots 332 to 334), which are aligned with the first to seventh needles 321 to 327, respectively. When the cylinder 313 is retracted longitudinally in a proximal direction within the catheter body 312, the first to seventh needles 321 to 327 are retracted through the corresponding slots in the catheter body. The catheter body therefore has a smooth outer surface enabling unobstructed movement of the catheter body 212 in the vessel.

[0059] In the depicted embodiment, the catheter may further include a catheter handle 350 attached to the catheter body 312. The catheter handle 350 may include a knob 351 on the proximal end of the catheter handle 350, where the knob 351 is operable, e.g., by the user, configured to slide the cylinder 313 longitudinally in the distal and proximal directions within the catheter body 312, causing the first to seventh needles 321 to 327 to extend from and retract into the corresponding slots in the catheter body 312, respectively, as discussed above.

[0060] FIG. 4 is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes, and electrodes on the catheter body, according to a representative embodiment.

[0061] Referring to FIG. 4, catheter body 412 is similar to the catheter body 312, discussed above, except that the catheter body 412 includes multiple body electrodes on the distal portion, indicated by first body electrode 431, second body electrode 432 and third body electrode 433,set back from the distal end of the catheter body 412. In the depicted embodiment, the catheter body 412 includes no imaging marker 318, although in alternative embodiments an imaging marker 318 may be added proximal to the first to seventh needles 321 to 327. The catheter body 412 further includes the curved needles, indicated by the first to seventh needles 321 to 327 retractably extending from corresponding slots, as discussed above. The first to third body electrodes 431 to 433 enable impedance measurements of tissue to be made between an electrode on one of the first to seventh needles 321 to 327 and one of the first to third body electrodes 431 to 433. For example, an impedance measurement may be made between the electrode 344 on the fifth needle 325 and the first body electrode 431 on the catheter body 412. In addition, the configuration in FIG. 4 enables tomographic impedance measurements by electronically switching between electrodes both on the needles (e.g., first to seventh electrodes 321 to 327) and the catheter body (e.g., first to third body electrodes 431 to 433). In an alternative configuration, the catheter body 412 may include just a single electrode, which may act as the return electrode for multiple electrodes on the first to seventh needles 321 to 327.

[0062] FIG. 5 is a top plan view of the distal portion of a catheter body including multiple extendable needles with electrodes, and ultrasound imaging elements on the catheter body, according to a representative embodiment.

[0063] Referring to FIG. 5, catheter body 512 is similar to the catheter body 312, discussed above, except that the catheter body 512 includes an array of intravascular ultrasound imaging (IVUS) elements of an ultrasound imaging system (as the imaging system 156) on its distal portion. The catheter body 512 includes no imaging marker 318. The IVUS elements are indicated by first US imaging element 551, second US imaging element 552 and third US imaging element 553 set back from the distal end of the catheter body 512. The catheter body 512 further includes the curved needles, indicated by the first to seventh needles 321 to 327 retractably extending from corresponding slots, as discussed above.

[0064] The first to third US imaging elements 551 to 553 may be formed of piezoelectric materials (e.g., lead zirconate titanate, piezoelectric micromachined ultrasonic transducers (PMUT), single crystal), or capacitive micromachine ultrasound transducers (CMUTs), for example, as would be apparent to one skilled in the art. The IVUS elements may be configured to generate an internal, cross-sectional image of the blood vessel and its surroundings, and helpwith navigation of the catheter body 512, placement of one or more of the first to seventh needles 321 to 327, and monitoring of the therapy. Alternatively, the imaging elements may be optical coherence tomography (OCT) imaging elements, without departing from the scope of the present teachings.

[0065] FIG. 6A is a cross-sectional view of a distal portion of a catheter body including multiple extendable needles with electrodes, and a retractable sheath in an un-retracted position for covering the catheter body, and FIG. 6B is a cross-sectional view of the distal portion of the catheter body including multiple extendable needles with electrodes, and retractable sheath in a retracted position for covering the catheter body, according to a representative embodiment. FIG. 6C is cross-sectional view of the distal portion of a catheter body including multiple extendable needles with electrodes, and a retractable sheath in a retracted position and an isolation sheath for covering the catheter body, according to a representative embodiment.

[0066] Referring to FIGs. 6A and 6B, a catheter 610 includes a catheter body 612 and a retractable outer sheath 614 covering at least the distal portion of the catheter body 612. The catheter body 612 includes curved needles extending therefrom, indicated by first needle 621 and second needle 622. Energy delivery devices may be positioned on the first and second needles621 and 622, respectively, indicated by first energy delivery device 641 on the first needle 621 and second energy delivery device 642 on the second needle 622. Additional needles and / or energy delivery devices may be present, but not visible from the perspective shown in FIGs. 6A and 6B. For purposes of illustration, the catheter 610 also includes optional guide wire 111 and imaging marker 118 on the catheter body 612, as discussed above, as well as an atraumatic tip 619 configured to minimize tissue damage and trauma during insertion and use of the catheter 610.

[0067] Unlike previous embodiments, the catheter body 612 does not include any slots corresponding to the curved needles. Instead, each the of the first and second needles 621 and622 is hinged to the outer surface of the catheter body 612 or otherwise deformable in such a manner that they flatten against the outer surface of the catheter body 612 when the outer sheath 614 is moved laterally in the distal direction over the distal portion of the catheter body 612, and released (unflattened) when the outer sheath 614 is moved laterally in the proximal direction away from the distal portion of the catheter body 612. For example, in FIG. 6A, the outer sheath614 is in the un-retracted position (having been moved in the distal direction), such that the first and second needles 621 and 622 are effectively retracted or flattened against the outer surface of the catheter body 612, and in FIG. 6B, the outer sheath 614 is in the retracted position (having been moved in the proximal direction), such that the first and second needles 621 and 622 are extended away from the outer surface of the catheter body 612.

[0068] Accordingly, when the outer sheath 614 is positioned over the first and second needles 621 and 622, as in FIG. 6A, the catheter body 612 can be navigated through the vessel. Once the catheter body 612 reaches the desired location, the outer sheath 614 is moved laterally in the proximal direction, releasing the first and second needles 621 and 622, as in FIG. 6B, such that they extend from the distal portion of the catheter body 612 in the same manner as discussed above with reference to FIGs. 3A and 3B, for example.

[0069] FIG. 6C shows catheter 610’, which is the same as the catheter 610 in FIG. 6B (with the outer sheath 614 in the retracted position), but with the addition of an isolation sheath 618 on the outer layer of the catheter body 612. The isolation sheath 618 is the outer- most sheath and covers both the outer sheath 614 and the catheter body 612, further aiding navigation of the catheter. In addition, the isolation sheath 618 prevents friction with the vessel wall while the outer sheath 614 is being retracted. Also, the isolation sheath 618 enables optimization of the catheter 610’ mechanically and helps to shield electrical transmission lines (not shown) in the catheter body 612 from external disturbances.

[0070] FIG. 7 is a flow diagram of a method for classifying tissue of a subject to provide therapy to the tissue using a catheter, according to a representative embodiment. The catheter includes a catheter body, at least one needle extendable from the catheter body toward walls of the lumen, and multiple electrodes configured to transmit an electrical signal at different frequencies through tissue between the electrodes. Although FIG. 7 is described with respect to multiple electrodes and electrical signals, it is understood that the discussion applies equally to optical fiber(s) and optical signals, as discussed above.

[0071] Referring to FIG. 7, in block S711, the catheter body is navigated through a lumen of a subject to a target location. The catheter may be navigated along a guide wire previously deployed through the lumen. During the navigation, the at least one needle is in a retracted position along or within the catheter body.

[0072] In block S712, upon reaching the estimated target location, the at least one needle is transitioned from the retracted position to an extended position, such that the at least one needle extends from the catheter body and penetrates the walls of the lumen.

[0073] In block S713, an electrical signal at different frequencies is applied by the electrodes through tissue located between the electrodes of an electrode pair to provide an impedance signal for measuring impedance of the tissue between the electrodes. At least one of the electrodes in the electrode pair is positioned on the at least one needle, and the other electrode of the electrode pair may be positioned on the same needle, on another needle or on the catheter body, as discussed above.

[0074] In block S714, the impedance spectrum of the tissue between the electrodes is determined based on the measured impedance signal between the electrodes. The impedance spectrum of the tissue may be determined using an impedance analyzer or an impedance spectrometer, for example, based on the impedance signal.

[0075] In block S715, the tissue is classified based on the determined impedance spectrum of the tissue. Classifying the tissue includes identifying a type of the tissue or a state of the tissue. The type of the issue indicates whether the at least one needle, the electrodes and / or the distal end of the catheter body are at the correct location in order to apply therapy to the tissue. The state of the tissue indicates the progress of the therapy based on the tissue response. The determined impedance spectrum may be compared to known impedance spectra of different types of tissue and / or different states of tissue to identify the most similar type and / or state of tissue.

[0076] In block S716, therapy is applied to the tissue based at least in part on the type of the tissue and / or the state of the tissue as determined from the impedance spectrum. This may include adjusting the position of the at least one needle and / or the electrodes for applying the therapy. The therapy itself may be fluid or drug therapy delivered to the tissue through the at least one needle, or may be RF ablation therapy delivered to the tissue through the electrodes.

[0077] In accordance with various embodiments of the present disclosure, the methods described herein may be implemented in whole or in part using a hardware computer system that executes software programs stored on non-transitory storage mediums. Further, in an exemplary, nonlimited embodiment, implementations can include distributed processing, component / object distributed processing, and parallel processing. Virtual computer system processing mayimplement one or more of the methods or functionalities as described herein, and a processor described herein may be used to support a virtual processing environment.

[0078] Although catheter systems for classifying tissue and providing therapy based on the tissue classification have been described with reference to exemplary embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the embodiments. Although catheter systems for classifying tissue and providing therapy based on the tissue classification have been described with reference to particular means, materials and embodiments, it is not intended to be limited to the particulars disclosed; rather catheter systems for classifying tissue and providing therapy based on the tissue classification extend to all functionally equivalent structures, methods, and uses such as are within the scope of the appended claims.

[0079] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.

[0080] One or more embodiments of the disclosure may be referred to herein, individually and / or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept. Moreover, although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to thoseof skill in the art upon reviewing the description.

[0081] The Abstract of the Disclosure is provided to comply with 37 C.F.R. § 1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.

[0082] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.

Claims

CLAIMS:

1. A system for classifying tissue of a subject to provide therapy to the tissue, the system comprising: a catheter insertable in a lumen of the subject, wherein the catheter comprises: a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, and at least one energy delivery device configured to transmit electromagnetic energy through tissue at a distal end of the at least one energy delivery device, wherein the at least one energy delivery device is positioned on a distal end of the at least one needle; and a spectral signal analyzer configured to measure a response of the tissue to different frequencies of the electromagnetic energy at the distal end of the at least one energy delivery device, wherein the measured response indicates tissue classification at the distal end of the at least one energy delivery device.

2. The system of claim 1, wherein the energy delivery device comprises a plurality of electrodes, wherein at least one electrode of the plurality of electrodes is positioned on the distal end of the at least one needle, and wherein the electromagnetic energy transmitted through the tissue comprises AC current transmitted between the plurality of electrodes, and the spectral signal analyzer measures an impedance spectrum of the tissue.

3. The system of claim 2, further comprising: a therapy delivery system including a radio frequency (RF) signal generator configured to generate RF energy, wherein the therapy comprises thermal or pulsed field ablation of the tissue at a target location within the subject using the plurality of electrodes to apply the RF energy.

4. The system of claim 1 , wherein the energy delivery device comprises at least one optical fiber, wherein the at least one optical fiber includes a transmission end positioned on the distal end of the at least one needle, and wherein the electromagnetic energy transmitted through24the tissue comprises light emitted from the transmission end of the at least one optical fiber, and the spectral signal analyzer measures an optical spectrum of the emitted light that has interacted with the tissue through absorption, scattering, and / or fluorescence.

5. The system of claim 4, further comprising: a therapy delivery system including a laser source configured to generate laser energy, wherein the therapy is initiated through the laser energy via thermal ablation or photochemical ablation of the tissue at a target location within the subject using the at least one optical fiber to apply the laser energy.

6. The system of claim 1, further comprising: a therapy delivery system comprising a syringe, wherein the therapy comprises delivery of a fluid and / or a drug from the syringe to the tissue at a target location via the at least one needle.

7. A system for classifying tissue of a subject to provide therapy to the tissue, the system comprising: a catheter insertable in a lumen of the subject, wherein the catheter comprises: a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, and a plurality of electrodes configured to transmit an electrical signal at different frequencies through tissue between the plurality of electrodes to provide an impedance signal for measuring impedance of the tissue between the plurality of electrodes, wherein at least one electrode of the plurality of electrodes is positioned on the at least one needle; and an impedance measurement device configured to receive the impedance signal from at least one electrode of the plurality of electrodes, and to determine the impedance of the tissue between the plurality of electrodes based on the impedance signal.

8. The system of claim 7, further comprising: a processing unit configured to receive the determined impedance from the impedance measurement device, and to determine a type of the tissue and / or a state of the tissue between the plurality of electrodes based on the determined impedance using electrical spectroscopy.

9. The system of claim 8, wherein, based on the determined type of tissue, the processing unit is further configured to verify a location of a distal end of the at least one needle.

10. The system of claim 7, wherein the plurality of electrodes are located at a distal end of a same needle of the at least one needle.

11. The system of claim 7, wherein the at least one needle comprises a first needle and a second needle, and wherein a first electrode of the plurality of electrodes is located at a distal end of the first needle and a second electrode of the plurality of electrodes is located at a distal end of the second needle.

12. The system of claim 7, wherein a first electrode of the plurality of electrodes is located at a distal end of a needle of the at least one needle, and a second electrode of the plurality of electrodes is located on the catheter body.

13. The system of claim 7, wherein the at least one needle comprises a nitinol hypotube that is heat set in a curved configuration, enabling the at least one needle to penetrate a wall of the lumen.

14. The system of claim 7, wherein the catheter further comprises: a cylinder slideably positioned within the catheter body, wherein the at least one needle is attached to a distal end of the cylinder; and a catheter handle comprising knob configured to slide the cylinder longitudinally within the catheter body, such that the at least one needle extends from a corresponding at least one slotin the catheter body in response to the cylinder being advanced distally in the catheter body using the catheter handle, and the at least one needle retracts through the corresponding at least one slot in the catheter body in response to the cylinder being withdrawn proximally in the catheter body using the catheter handle.

15. The system of claim 7, wherein the catheter further comprises: an imaging marker positioned on the catheter body, and configured to enhance visibility of a distal portion of the catheter body using external imaging.

16. The system of claim 7, wherein the catheter further comprises: a balloon or an expandable nitinol basket configured to position the catheter relative to a wall of the lumen to enable accurate deployment of the at least one needle.

17. The system of claim 7, further comprising: a therapy delivery system configured to deliver the therapy to the subject at a target location within the subject.

18. The system of claim 17, wherein the therapy delivery system comprises a radio frequency (RF) signal generator configured to generate RF energy, and wherein the therapy comprises thermal or pulse field ablation of the tissue at the target location using the plurality of electrodes to apply the RF energy.

19. A system for classifying tissue of a subject to provide therapy to the tissue, the system comprising: a light source configured to generate light; a catheter insertable in a lumen of the subject, wherein the catheter comprises: a catheter body, at least one needle extendable from the catheter body, and configured to enable delivery of the therapy to the subject, andat least one optical fiber configured to transmit the light from the light source through tissue at a distal end of the at least one optical fiber, wherein the at least one optical fiber is positioned on the at least one needle; and a spectrometer configured to receive the light transmitted through the tissue via the at least one optical fiber, and to perform optical spectroscopy to measure an optical spectrum of the received light that has interacted with the tissue through absorption, scattering, and / or fluorescence to determine a type of tissue of the tissue and / or a state of the tissue at the distal end of the at least one optical fiber, wherein the optical spectroscopy comprises diffuse reflectance spectroscopy (DRS), fluorescence, or Raman spectroscopy.

20. The system of claim 19, further comprising: a therapy delivery system configured to deliver the therapy to the subject at a target location within the subject, wherein the therapy delivery system comprises a laser source configured to generate laser energy, and wherein the therapy is initiated through the laser energy via thermal ablation or photochemical ablation of the tissue at the target location within the subject using the at least one optical fiber to apply the laser energy.28

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