Composable and multi-modal systems for applying interventions across surfaces and volumes of patient tissue

Abstract

System, methods, and devices for planning and delivering multi-modality interventions with enhanced precision and flexibility utilize a conduit network forming an array of predefined positions on or within target tissue. Software may digitally represent the conduit network and intervention variables, enabling generation of an intervention plan that specifies the spatial and temporal application of modalities. Functional support devices actuate inserts that traverse the conduit network to deliver interventions according to the plan. To optimize spatial and temporal compositions for better therapeutic efficacy, reduced toxicity, and streamlined workflows, planning can be enhanced by representing intervention positions in the conduit network and other variables with mathematical constructs like multidimensional vectors, matrices, or tensors. In so doing, computational techniques, including optimization algorithms, machine learning, and artificial intelligence, can be employed to create and refine intervention plans. In some embodiments, feedback from the tissue dynamically adjusts the plan to ensure alignment with therapeutic goals.

Description

COMPOSABLE AND MULTI-MODAL SYSTEMS FOR APPLYING INTERVENTIONS ACROSS SURFACES AND VOLUMES OF PATIENT TISSUERELATED APPLICATION

[0001] This application is an INTERNATIONAL (PCT) application of, and claims priority to United States Provisional Patent Application Number: 63 / 601 ,213, filed on 20 November 2023 and entitled “COMPOSABLE, MULTI-MODAL SYSTEMS AND DEVICES FOR APPLYING ONE OR MORE INTERVENTIONS ACROSS SURFACES AND / OR VOLUMES,” which is incorporated herein by reference.FIELD OF USE

[0002] This application generally relates to medical devices, systems, and method for use. In particular, the application pertains to composable, multi-modal systems and / or devices for applying one or more interventions to a surface and / or volume of a patient’s anatomy.BACKGROUND

[0003] Local interventions targeting pathological conditions on patient surfaces or within internal tissues frequently involve various modalities, including therapeutic interventions (e.g., heat, cold, radiation, etc.), diagnostic measurements (e.g., temperature, pH, etc.), and protective devices (e.g., radiation shields, heat sinks, etc.). Despite their clinical utility, existing systems for delivering these interventions face significant limitations that hinder their efficacy, versatility, and precision.

[0004] A primary limitation lies in the reliance on hand-held devices for applying these modalities to the target tissue. Common examples include topical sprays, interventional needles, and ultrasound probes. The manual nature of these interventions, coupled with the irregular shapes of anatomical surfaces and tissue volumes, restricts the geometric accuracy with which the modalities are applied. Consequently, achieving precise spatial distribution of the intervention across the target tissue becomes challenging.

[0005] Another limitation pertains to the delivery of multi-modality interventions, which are often desired in complex clinical scenarios. In the current state of the art, each modality typically requires a separate device with its own planning and deliveryworkflow. As a result, combining multiple modalities is time-intensive, costly, and procedurally inefficient. This fragmented approach inherently compromises the geometric coordination of modalities and limits the ability to calculate their combined effects accurately.SUMMARY

[0006] The present disclosure provides a system and method for delivering multimodality interventions to patient surfaces or internal tissues with enhanced precision, efficiency, and versatility. Specifically, the system comprises a conduit-insert network designed to facilitate the accurate application of multiple modalities in a tailored geometric configuration corresponding to the target tissue.

[0007] In the disclosed system, a network of conduits is placed on or within the tissue, creating a grid or lattice of locations whose coordinates define precise positions for modality delivery. This network is mapped to a digital representation within software that enables users to model, plan, and optimize interventions. The software determines the type, combination, and spatial configuration of modalities, along with the corresponding conduit positions and durations of application. Functional support devices, operatively connected to the software, actuate inserts that traverse the conduit network to deliver the planned interventions at pre-specified locations.

[0008] The system enables concurrent or sequential actuation of different inserts based on user-defined objectives. For example, a treatment insert delivering a therapeutic modality may be paired with a measurement insert in a nearby conduit to assess real-time treatment effects. Alternatively, multiple treatment inserts may be applied sequentially to the same tissue volume, enabling temporal composition of modalities for enhanced therapeutic efficacy.

[0009] Workflow flexibility is a key advantage of the system. In one embodiment, conduits are placed on or within patient tissue prior to software planning. This placement may be digitized through sensors, photography, or diagnostic imaging, and the resulting data is transmitted to the software for intervention planning. In another embodiment, the intervention is planned first within the software using input data about the target tissue, such as images or diagnostic scans. Virtual conduit placement is optimized iteratively, and the physical placement of conduits is performed subsequently to replicate the virtual configuration.

[0010] Conduit placement may be achieved manually or via robotic assistance to ensure high fidelity between physical placement and the software-generated plan. Optional applicators, which may be rigid or articulated, can further enhance the precision of conduit placement by conforming to the shape of the underlying tissue and providing guided pathways for conduit insertion.

[0011] The system can leverage mathematical representations to model the conduit network and associated intervention variables, providing a robust framework for computational planning and execution. Specifically, the grid or lattice of conduit positions, along with relevant parameters such as target tissue characteristics, modality types, and delivery constraints, can be represented as multidimensional vectors, matrices, or tensors. These mathematical constructs enable precise and scalable manipulation of spatial and temporal data for intervention planning. By organizing the intervention data into these representations, the system facilitates the application of advanced computational techniques. Optimization algorithms can be employed to determine the most efficient configuration of modalities, minimizing factors such as time, cost, or unintended tissue exposure, while maximizing therapeutic efficacy.

[0012] For example, linear programming or genetic algorithms may be used to find an optimal arrangement of conduit insertions that balances multiple objectives, such as dose distribution and procedural constraints. Additionally, machine learning models, such as neural networks or decision trees, can analyze historical intervention data and patient-specific parameters to predict optimal configurations or identify patterns that enhance treatment outcomes. These models can also adapt dynamically by incorporating feedback from real-time monitoring of the intervention, refining the plan iteratively based on observed effects.

[0013] Additionally, artificial intelligence (Al) algorithms further expand the system’s capabilities by enabling automated decision-making and complex scenario planning. Al can simulate potential outcomes of various intervention strategies, evaluate tradeoffs among competing objectives, and generate highly customized plans tailored to individual patient anatomies and conditions. For instance, Al-driven simulations might predict the combined effects of multiple modalities on both pathological and surrounding healthy tissues, providing insights into how to adjust the intervention for maximum benefit.

[0014] The disclosed system addresses the shortcomings of existing technologies by providing a comprehensive solution for the precise, efficient, and versatile application of single or multi-modality interventions to diverse anatomical and clinical contexts.

[0015] The conduit and insert assemblies disclosed herein may include one or more (e.g., 2-250) conduit(s) with a first end, a second end, and a lumen extending between the first and second end. The lumen may be configured to accept insertion, positioning, and repositioning of an insert within the lumen and, at times, a first end of the conduit may be open thereby providing access to the lumen. In some embodiments, the second end may be open so that an insert therein may extend beyond the second end. Alternatively, the second end may be closed so that the insert cannot extend beyond the second end, which may be advantageous for situations where exposure of the insert to the tissue is not preferred. Additionally, or alternatively, a feature of the conduit may be specific to a function performed by the insert.

[0016] The insert may be configured to be inserted into the first end of the conduit and moved within the lumen to a position proximate to target tissue of a patient so that it may perform one or more tasks and / or provide one or more interventions on the target tissue. In some embodiments, the conduit may include a plurality of position indicators positioned thereon.

[0017] The conduit may be flexible is so that its shape may be bent or curved to navigate through and / or be proximate to the target tissue. At times, the conduit may comprise metal, plastic, vinyl, rubber, latex, silicone and / or combinations thereof. Additionally, or alternatively, the conduit may be bioabsorbable, radio-opaque, porous for measurement of tissue properties, configured to release therapeutics, heat resistant, configured to conduct electricity, configured to insulate electricity, configured to conduct heat, configured to take a measurement, configured to shield (radioactively or otherwise) tissue, configured to deliver a treatment, and / or configured to insulate heat.

[0018] In some embodiments, the conduit and insert assembly may include a removable stylet extending through a portion of, or the entire, length of the lumen. The stylet may be configured to add stiffness and / or increase maneuverability of the conduit while navigating through patient tissue to be within and / or proximate to the target tissue. Once the conduit is placed, the stylet may be removed from the lumen so that the insert may be inserted into the conduit during an insertion process.

[0019] Conduit and insert assemblies that include multiple conduits may be configured to enable one or more inserts to deliver different therapies and / or collect different measurements simultaneously or in sequence at multiple conduit and / or insert positions during a single encounter with a patient.

[0020] Inserts included in and / or used with the conduit and insert assemblies disclosed herein may comprise metal, wire, fiber-optic cables, plastic, vinyl, and / or combinations thereof. In some cases, an insert may have an active tip such as an absorbent pad saturated with medication, a temperature probe, a needle tip, a radioactive material, a measurement device, a treatment device, and / or a combination thereof. Additionally, or alternatively, the insert may be configured as, for example, a treatment modality, a measurement device, a radiation shielding device, a heating device, a heat sink, a cryotherapy device, a protection device, and / or as a device that measures or detects temperature, humidity, radiation levels, force, pH level, electrical conductance, electrical impedance, electromagnetic spectrum properties, visual appearance and / or chemical composition of the target tissue.

[0021] Use and / or operation of the conduit and insert assemblies disclosed herein may be controlled by, for example, a clinician, a software interface, a processor, and / or a robot. For example, placement of a conduit on a patient surface, insertion of a conduit within patient tissue, and / or movement of an insert within the conduit may be controlled by a clinician, a software interface, a processor, and a robot.

[0022] At times, the insert may be activated prior to insertion into the conduit or when in a desired position within the conduit.

[0023] Exemplary interventions and / or treatments delivered to target tissue via the conduit and insert assembly may include one or more of brachytherapy, cryotherapy, hyperthermia, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulation of tissue, massage, microneedling, topical application of medication, and / or injection of medication.

[0024] In some embodiments, one or more conduits of the conduit and insert assembly may be configured to cooperate with an applicator, or holder, to deliver an intervention to target tissue. The applicator may be specific to the use case for the conduit and insert assembly and, on some occasions, may be adjustable in size and / or shape. Often times, the application may include one or more ports into whicha conduit may be inserted in any desired pattern. For example, an exemplary applicator may include sixteen holes arranged in a grid pattern and conduits may be inserted into any number (e.g., 1-16) of these ports in any appropriate pattern to treat target tissue. Once the conduits are arranged in the applicator, inserts may be fed through the lumens of the respective conduits so that the intervention may be applied to the target tissue. Additionally, or alternatively, conduits may reside within all ports of the exemplary applicator and inserts may be inserted into some (e.g., 1- 15), or all (in this case, 16), of the conduits in a manner consistent with an intervention plan.

[0025] Methods for treating target tissue of a patient using the conduit and insert assemblies disclosed herein may include positioning the insert at a desired position within a conduit positioned proximate to target tissue of a patient. The desired position may be proximate enough to the target tissue (e.g., in contact with, inserted into, and / or within a target distance from the surface) to perform an action thereon and, once there, the action may be initiated and / or maintained at the desired position for a length of time, which may be prescribed by an intervention plan as, for example, disclosed herein.

[0026] Exemplary actions include, but are not limited to, delivery of a treatment modality, delivery of medication, delivery of heat, delivery of cryotherapy, taking a measurement device, shielding target tissue, delivery of brachytherapy, delivery of laser therapy, delivery of ultrasound therapy, delivery of radiofrequency ablation (RFA) therapy, delivery of microwave therapy, delivery of electroporation therapy, physical manipulation of tissue, massage, microneedling, topical application of medication, and / or injection of medication.

[0027] In some embodiments, the insert may be moved to multiple positions within a conduit as, for example, prescribed by the intervention plan. Additionally, or alternatively, an insert may be used in multiple conduits and / or multiple inserts may be used in the same conduit and / or different conduits as, for example, prescribed by the intervention plan. For example, in one embodiment a first insert may be removed from a first conduit and a second insert may be positioned within the first conduit at a desired position within the conduit positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon. Then, an action by the second insert may be initiated and / or performed at the desired position responsively to, for example, an interventionplan. For example, the first insert may apply a first therapy to the target tissue and the second insert may apply a second, different (e.g., same intervention but different dose or a different intervention) therapy to the target tissue. Alternatively, the first insert may apply a therapy or intervention to the target tissue and the second insert may measure a result of the application of the therapy / intervention to the target and / or protect tissue proximate to the target tissue from the therapy while it is being applied by the first insert.

[0028] In some embodiments, an insert may be used in multiple conduits and / or at multiple positions within a conduit during an intervention. For example, an insert may be removed from a first conduit and then inserted / positioned within the second conduit that is positioned proximate to (e.g., adjacent to the first conduit, separated in space from the second conduit and proximate to a different region of the target tissue, etc.) the target tissue of a patient. Then, an action performed by the insert may be activated or maintained within the second conduit.

[0029] In some embodiments, an intervention plan for treating target tissue of a patient may be generated by receiving information about the target tissue and one or more conduit and insert assemblies, such as the conduit and insert assemblies disclosed herein, to be used to treat the target tissue. The intervention plan may be generated by, for example, a processor and / or software run on a process and may include instructions for treating the target tissue with the one or more conduit and insert assemblies and / or one or more inserts used within a conduit or plurality of conduits. Once generated, the intervention plan may be provided to a clinician. At times, the intervention plan may include instructions regarding the use of, for example, a type, size, dosage, function, and / or configuration of conduits and / or inserts used to treat the target tissue. Often times, the intervention plan includes instructions for placing and holding one or more insert(s) within one or more conduit(s) at one or more desired positions so that each insert reaches a desired position and remains in the desired position for a length of time defined by the intervention plan.

[0030] In some embodiments, one or more inserts for use with a treatment plan may be coupled to communicatively coupled to a functionality support device such as a source of medication, energy, heat, cold, radiation, etc. and in these embodiments, information about the communication (e.g., fluid communication, near-field communication, radio-frequency identification, etc.) between the functionality supportdevice and the insert(s) may be received and the treatment plan may be generated and / or updated accordingly. In some embodiments, one or more inserts may be activated according to the intervention plan when an indication (e.g., tactile feedback, visual observation (e.g., naked eye or imaging device (e.g., ultrasound), and / or communication between the insert and processor administering and / or generating the intervention plan) that the insert is positioned at the desired position within the conduit.

[0031] In some embodiments, a system for planning and delivering multi-modality interventions to patient tissue may include a conduit network configured to be placed on or within the tissue, the conduit network comprising a grid or lattice of predefined positions for delivering interventions. Additionally, or alternatively, the conduit network may comprise and / or be configured to cooperate with an applicator that has a plurality of ports arranged in a grid or lattice of predefined positions for delivering interventions. The applicator may also facilitate delivery and / or placement of a working end of each of the conduits of the conduit network proximate to target tissue of the patient. In some embodiments, the applicator may be of a flexible shape and / or size (e.g., expandable or contractable) so that it may bend or articulate to conform to target tissue.

[0032] In some embodiments, systems for planning and delivering multi-modality interventions to patient tissue may include a conduit network configured to be placed on or within the tissue. The conduit network may include a plurality of conduits such as the conduits disclosed herein arranged in, for example, a two-dimensional or three-dimensional grid, array, lattice, shape, contour, and / or irregular arrangement with predefined positions. The system may also include one or more inserts, each insert being configured to traverse a lumen of a conduit of the plurality of conduits to deliver one or more intervention modalities to specific locations of the conduit network grid or array. The one or more inserts may be communicatively and / or operatively coupled to a functional support device (e.g., source of heat, cold, radiation, medication, observation device (e.g., an optical fiber or camera), etc.) that is configured to enable and / or actuate a function of, and / or communicate with, the one or more inserts. The system may further comprise a memory with a stored set of instructions thereon, which executed by a processor, cause the processor to digitally represent the conduit network and its associated positions as, for example, a multidimensional vector, a matrix, and / or a tensor; model intervention variables,including insert modality type, modality delivery parameters, and tissue characteristics using, for example, machine learning and / or Al models; receive therapeutic objectives; determine an efficient configuration of intervention modalities using a result of the modeling and the received therapeutic objectives; and generate an intervention plan using the efficient configuration of intervention modalities. At times, generating the intervention plan may include applying computational algorithms, including optimization and artificial intelligence algorithms, to the data and / or conduit network, inserts, intervention modalities, and / or mathematical constructs thereof. In some embodiments, generating the intervention plan may include simulating multiple intervention strategies and evaluating trade-offs among competing therapeutic objectives and / or predicting the combined effects of multiple intervention modalities on pathological and surrounding healthy tissues.

[0033] The intervention plan may specify the locations, durations, and / or combinations of intervention modalities to be delivered via conduits of the conduit network and inserts placed within the conduits of conduit network. In some instances, determining an efficient configuration of intervention modalities may include use of an optimization algorithm, such as a linear programming or genetic algorithm, to balance intervention objectives such as dose distribution, treatment efficacy, normal tissue avoidance, and / or procedural efficiency. In some embodiments, the modelling of intervention variables employs machine learning models, a multidimensional vector, a matrix, and / or a tensor. At times, the machine learning models may employ neural networks and / or decision trees to analyze historical intervention data and / or predict optimal configurations of treatment modalities for a given patient-specific tissue characteristic. Additionally, or alternatively, the modeling may comprise modeling the conduit network, inserts, and / or intervention variables as mathematical constructs selected from the group comprising multidimensional vectors, matrices, and tensors.

[0034] In some embodiments, the system may further include a feedback system configured to receive data from the target tissue or the conduit network and communicate the data to the processor, wherein the set of instructions further include a set of instructions for updating an intervention plan responsively to received data, which when executed by a processor, cause the processor to dynamically update the intervention plan responsively to the received data and / or iteratively refine the intervention plan during the delivery phase using, for example,feedback from the feedback system. Exemplary feedback systems include imaging devices, tactile feedback provided to a user of the system, conduits, and / or inserts and input into the processor, and communication between a conduit and / or an insert and the processor.

[0035] Additionally, or alternatively, methods for delivering multi-modality interventions to patient tissue may be executed by a processor or system such as the systems described herein and may include generating a digital representation of a conduit network, the conduit network comprising a plurality of conduits with lumens configured to cooperate with an insert and arranged in a grid or array of predefined positions; associating intervention variables with the digital representation of the conduit network, the intervention variables including insert types, tissue characteristics, intervention modality types, and intervention modality delivery constraints; modeling the conduit network and intervention variables; and generating an intervention plan specifying locations within the conduit network to apply interventions, durations of application of an intervention within the conduit network, and combinations of intervention modalities to be applied within the conduit network.

[0036] At times, an indication that the conduit network has been placed on or within the patient tissue in accordance with the intervention plan may be received and the inserts may be actuated through the conduit network to deliver the planned intervention modalities to the specified locations within the conduit network in accordance with the intervention plan responsively to the received indication.

[0037] In some embodiments, the intervention plan may be updated and / or iterated upon responsively to feedback from the tissue during the intervention.

[0038] Any of the methods described herein may be instantized as a set of instructions stored in, for example, a memory, a non-transitory machine-, processor- and / or computer-readable media.BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:

[0040] FIG. 1A is a block diagram of an exemplary system, in accordance with some embodiments of the present invention;

[0041] FIG. 1 B is a block diagram of a first rectangularly-shaped applicator with a single port, in accordance with some embodiments of the present invention;

[0042] FIG. 1C is a block diagram of a second rectangularly-shaped applicator with two ports, in accordance with some embodiments of the present invention;

[0043] FIG. 1 D is a block diagram of a third rectangularly-shaped applicator with four ports arranged in two rows of two columns, in accordance with some embodiments of the present invention;

[0044] FIG. 1 E is a block diagram of a circularly-shaped applicator with four ports, in accordance with some embodiments of the present invention;

[0045] FIG. 1 F is a block diagram of a rectangularly-shaped applicator with four ports, in accordance with some embodiments of the present invention;

[0046] FIG. 1G is a block diagram of a side view of third rectangularly-shaped applicator, in accordance with some embodiments of the present invention;

[0047] FIG. 1 H is a cross-section view of a system including the rectangularly- shaped applicator with four ports of FIG. 1 F bent into a first configuration, in accordance with some embodiments of the present invention;

[0048] FIG. 11 is a cross-section view of a system including the rectangularly-shaped applicator with four ports of FIG. 1 F bent into a second configuration, in accordance with some embodiments of the present invention;

[0049] FIG. 2A is a schematic diagram of a portion of a first conduit / insert assembly, in accordance with some embodiments disclosed herein;

[0050] FIG. 2B is a schematic diagram of a portion of a second conduit / insert assembly, in accordance with some embodiments disclosed herein;

[0051] FIG. 3A is a schematic diagram of a front view of a first bi-conduit system, in accordance with some embodiments disclosed herein;

[0052] FIG. 3B is a schematic diagram of a front view of a second bi-conduit system, in accordance with some embodiments disclosed herein;

[0053] FIG. 3C is a diagram of a first bi-conduit system / insert assembly, in accordance with some embodiments disclosed herein;

[0054] FIG. 3D is a diagram of a second bi-conduit system / insert assembly, in accordance with some embodiments disclosed herein;

[0055] FIG. 3E is a diagram of a first instance in a time series of use of a single insert within the first bi-conduit system, in accordance with some embodiments disclosed herein;

[0056] FIG. 3F is a diagram of a second instance in the time series of FIG. 3E in accordance with some embodiments disclosed herein;

[0057] FIG. 4A is a schematic diagram of a front view of a third bi-conduit system, in accordance with some embodiments disclosed herein;

[0058] FIG. 4B is a schematic diagram of a front view of a fourth bi-conduit system, in accordance with some embodiments disclosed herein;

[0059] FIG. 4C is a diagram of a third bi-conduit system / insert assembly, in accordance with some embodiments disclosed herein;

[0060] FIG. 4D is a diagram of a fourth bi-conduit system / insert assembly that includes fourth bi-conduit system, in accordance with some embodiments disclosed herein;

[0061] FIG. 4E is a diagram of a first instance in a time series of use of a single insert within the third bi-conduit system, in accordance with some embodiments disclosed herein;

[0062] FIG. 4F is a diagram of a second instance in the time series of FIG. 4E, in accordance with some embodiments disclosed herein;

[0063] FIG. 5A is a schematic diagram of a front view of a first tri-conduit system, in accordance with some embodiments disclosed herein;

[0064] FIG. 5B is a schematic diagram of a front view of a second tri-conduit system, in accordance with some embodiments disclosed herein;

[0065] FIG. 5C is a diagram of a first tri-conduit system / insert assembly, in accordance with some embodiments disclosed herein;

[0066] FIG. 5D is a diagram of a second tri-conduit system / insert assembly that includes second tri-conduit system, in accordance with some embodiments disclosed herein;

[0067] FIG. 5E is a diagram of a first instance in a time series and 5F are diagrams of a time series of re-using an insert within the first tri-conduit system, in accordance with some embodiments disclosed herein;

[0068] FIG. 5F is a diagram of a second instance in the time series of FIG. 5E in accordance with some embodiments disclosed herein;

[0069] FIG. 5G is a schematic diagram of an open end of a conduit, in accordance with some embodiments disclosed herein;

[0070] FIG. 6 is a flowchart showing of a process for generating an intervention plan that includes use of one or more conduit / conduit system and insert assemblies disclosed herein and activation of one or more inserts resident within a conduitand / or conduit arrangement to make a measurement or deliver treatment to target tissue of a patient, in accordance with some embodiments of the present invention;

[0071] FIG. 7 is a flowchart illustrating a process for the administration of treatment to target tissue using one or more inserts, in accordance with some embodiments of the present invention;

[0072] FIG. 8A is a flowchart that illustrates a process for the administration of treatment to target tissue using a plurality of separate conduits, one or more multiconduit systems, in accordance with some embodiments of the present invention;

[0073] FIG. 8B is a flowchart that illustrates a first subprocess of the process shown in FIG. 8A, in accordance with some embodiments of the present invention;

[0074] FIG. 8C is a flowchart that illustrates a second subprocess of the process shown in FIG. 8A, in accordance with some embodiments of the present invention;

[0075] FIG. 9A is a schematic diagram of a two dimensional flat surface of a patient with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon, in accordance with some embodiments disclosed herein;

[0076] FIG. 9B is a schematic diagram of an uneven, or curved, surface of a patient with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon, in accordance with some embodiments disclosed herein; and

[0077] FIG. 9C is a schematic diagram of an approximately spherical surface volume of a patient with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon, in accordance with some embodiments disclosed herein.

[0078] FIG. 9D is a schematic diagram of a three dimensional cubic volume of a patient with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon, in accordance with some embodiments disclosed herein.

[0079] FIG. 10 is a flowchart that illustrates a process 1000 for the generation of an intervention plan for treating target tissue using a plurality of separate conduits, one or more multi-conduit systems, in accordance with some embodiments of the present invention;

[0080] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes andmodifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.WRITTEN DESCRIPTION

[0081] Disclosed herein are versatile devices, systems, and / or processes capable of delivering multiple intervention and / or treatment modalities to target tissue and / or tissue proximate to target tissue with high geometric precision and flexibility while enabling robust planning and execution workflows to optimize intervention efficacy and efficiency of intervention delivery. The systems (sometimes referred to herein as “conduit and insert assemblies”) and devices disclosed herein may include of one or more geometrically arranged conduits, such as a catheters or tubes, each configured to accept insertion and / or enable the positioning (e.g., movement) of one or more functional inserts therein to be positioned proximate to and / or inserted into target tissue of a patient. Inserts may be, for example, an intervention modality, a treatment modality, measurement device, and / or a protection device. Movement of an insert within a conduit may be manually controlled and / or controlled by a software interface, processor, and / or a robot. The one or more inserts may have the same, or differently functional modalities. On some occasions, the conduit-insert system and insert assemblies disclosed herein may be partially, or wholly operated robotically.

[0082] In some embodiments, the conduit-insert system and insert assemblies disclosed herein may be configured to cooperate with one or more support devices that enable the inserts to deliver different therapies and / or collect different measurements simultaneously or in sequence at multiple conduit and / or insert positions during a single encounter with a patient. On some occasions, the conduitinsert system and insert assemblies disclosed herein may provide for, or enable, composability of multiple therapeutics and diagnostic measurements across positions within a patient and / or the combined application of multiple functional modalities (e.g., treatments, measurements, etc.) to be directed toward target tissue of a patient via, for example, a grid- or lattice-like network of positions distributed across the conduit-insert system that may be in proximity to and / or in contact with the target tissue. Exemplary target tissue includes, but is not limited to, a tumor, lesion, cyst, mole, keloid, area of skin discoloration, and / or scarred tissue.

[0083] The inserts of the conduit-insert system and insert assemblies disclosed herein may be configured to, for example, facilitate treatment of target tissue of apatient, administer treatment to a patient at a desired location, shield and / or protect tissue proximate to the target tissue, deliver medication to target tissue, and / or collect information and / or measurements regarding the target tissue and / or the patient at, for example, one or more positions within a conduit. On some occasions, an insert may be activated (e.g., turned on) prior to insertion into a conduit and / or once in a desired position within the conduit. Exemplary treatments that may be delivered to target tissue via the conduit-insert system(s) and devices disclosed herein include, but are not limited to, brachytherapy, cryotherapy, hyperthermia, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulation (for example, massage or microneedling), and topical or injected medication. When an insert is a measurement device, it may be configured to measure, for example, temperature, humidity, radiation levels, force, pH level, electrical conductance, electrical impedance, electromagnetic spectrum properties, visual appearance and / or chemical composition of the target tissue (e.g., a concentration of a pharmaceutical or hormone present in, or proximate to, the target tissue). When an insert is a device configured to protect tissue and / or assist with the provision of treatment to the target tissue the insert may include, for example, material that blocks movement of radioactive particles (e.g., lead), a suction cannula, and / or a heat sink.

[0084] In many instances, the conduits may be flexible so that their shape and / or configuration may be adapted or otherwise bent or curved to be proximate to the target tissue and the inserts described herein may be rigid enough to be inserted into, conduit and / or be moved within, the conduit and flexible enough to bend with, for example, a curvature of the conduit that is positioned proximate to target tissue. Conduits may comprise, for example, metal, plastic, vinyl, rubber, latex, silicone and / or combinations thereof. In some cases, a conduit may have specific properties such as, for example, resorbability so that it can be left within tissue, porousness for measurement of tissue properties or release of therapeutics, and / or radio opaqueness for visualization on fluoroscopy or during other imaging procedures. In some embodiments, the walls of the conduit may have variable thickness or be hollow so that they can be filled with liquid / metal / gas. Likewise, conduits may have asymmetric combinations of these features. Inserts may be made from, for example, metal, wire, fiber-optic cables, plastic, vinyl, and / or combinations thereof. In some cases, an insert may have an active tip such as an absorbent pad saturated withmedication, a temperature probe, a needle tip, and / or a radioactive material. On some occasions, the conduit systems disclosed herein may be configured to accept a plurality of inserts at the same, and / or at different times (e.g., a first insert is positioned within and then subsequently removed from the conduit and a second insert is inserted into the same conduit). In some embodiments, a conduit may be configured to function without an insert and / or an insert may be configured to function without a conduit.

[0085] The systems, devices, and methods disclosed herein enable a user to generally compose a mixed intervention, comprising of multiple therapeutic and / or diagnostic modalities, across an arbitrary tissue (e.g., target tissue) surface or volume. Deployment of various therapeutic and diagnostic modalities may be controlled by software and / or hardware that direct functional inserts to a grid or lattice meshwork of positions within conduits that are placed in geometric arrangement in proximity to a target tissue, which may be, for example, a surface-of- interest (e.g., skin, organ surface, bone, ligament) or inside a volume-of-interest (e.g., hollow organ or cavity). At times, the interventions disclosed herein may comprise application of one or more therapies to target tissue and, in some instances, “intervention” and “therapy” may be used interchangeably herein.

[0086] Turning now to the figures, FIG. 1A is a block diagram of an exemplary system 100 that may be used to treat target tissue of a patient using one or more devices, systems, and / or methods disclosed herein. System 100 includes a computer / processing unit 105, a database 125, a controller 115, a plurality (first-nth) of insert functionality support devices 110A, 110B, 110C-100N, one or more optional ports applicator(s) 120, and one or more conduits and / or inserts 130 coupled to one or more of ports applicator(s) 120. Although shown as separate components, two or more components of system 100 may be resident in the same housing and / or device. One or more conduits and / or inserts 130 may include any of the conduits, inserts, and / or conduit-insert system and insert assemblies disclosed herein.

[0087] Each of the plurality of insert functionality support devices 110A, 110B, 11OC- WON may be configured to provide and / or facilitate provision of one or more functionalities (e.g., heat, radiation, medication, vacuum, etc.) for one or more inserts via coupling a respective insert to one or more conduits, either via direct coupling or via an applicator(s) 120. In some embodiments, coupling an insert to one or more functionality support devices 110A, 110B, 110C-110N may activate (e.g., turn on orinitiate providing medication to an absorbent pad of the insert) the insert. Additionally, or alternatively, an insert may be activated once the functionality support device 110A, 11 OB, 110C-1100N is turned on and / or begins to supply the functionality to the insert. In some instances, an insert may perform its function without being coupled to a functionality support device 110A, 11 OB, 110C-110N as may be the case when, for example, an insert may be heated, cooled, and / or dipped into medication prior to use. Alternatively, when an insert performs a protective and / or absorbent function (e.g., lead to prevent unintended exposure to radiation or thermal insulation to prevent undesirable heating or cooling of tissue), the insert may not be coupled to a functionality support device 110A, 110B, 110C-110N.

[0088] In some embodiments, an insert may be driven through a conduit to an intended position by attachment to a wire that is mobilized by a device and / or assembly (e.g., a robot and / or a mechanism that rotates a wire drum to push the wire forward or pull it backward) resident within one or more of insert functionality support device(s) 110A, 11 OB, 110C-110N. Additionally, or alternatively, one or more of functionality support device(s) 110A, 11 OB, 110C-110N may be coupled to the conduits directly. For instance, the material of the conduit itself may impart a treatment or take a measurement without need for a dedicated insert.

[0089] Computer / processing unit 105 may be configured to, for example, execute one or more methods disclosed herein. In some embodiments, computer / processing unit 105 may be a neural network, Al engine, Al architecture, machine learning architecture, computation engine, simulation engine, and / or computer modelingdevice. At times, computer / processing unit 105 and / or database 125, or devices in communication with computer / processing unit 105 and / or database 125 may be resident within a desktop and / or cloud-computing environment. Additionally, or alternatively, computer / processing unit 105 may be configured to generate or otherwise design an intervention plan for target tissue of a patient that utilizes the systems and / or devices disclosed herein to treat the target tissue with a composable set of interventions across a desired geometry. The intervention plans may be generated using, for example, information about a patient (e.g., age, gender, medical diagnosis), information about the target tissue (e.g., type, size, location, anatomical features, geometry, images, scans, X-rays, etc.), and / or information about the conduits and positions therein, conduit system how the conduit-insert system will be positioned proximate to the target tissue (e.g., via a natural or surgical opening),and / or inserts available to treat the target tissue. The intervention plans may include, for example, a type, size, and / or configuration of conduits and / or inserts used to treat the target tissue. Additionally, or alternatively, the intervention plans may include, for example, a type, size, duration, intensity, and / or position within a conduit at which an insert may be arranged for use when treating or measuring the target tissue. In some embodiments, intervention plans may model, or predict, treatment effects or distributions on representations of the patient (e.g., photographs, diagnostic images) including the effects of combining different modes of treatment. A dedicated coordinate system may be used to direct interventions to particular locations that are accessible by the conduit system and model the effects of the interventions. Intervention plans may require user specification of predesignated positions on the conduits for functional deployment and / or intervention plans may enable inserts to be localized to positions defined at the time of intervention planning (e.g., based upon distance traveled by an insert through a conduit from the functionality support device).

[0090] Optional applicators 120 may be utilized to configure the positions of a conduit(s) in a desired geometric configuration on the surface of a patient or within a volume of tissue. Additionally, or alternatively, applicators 120 may also be utilized to couple an insert to the correct conduit and / or hold the conduit and / or insert in place relative to the target tissue. Applicators 120 may be of any size and / or shape and may include any number of ports 140 that may, or may not, be used be used according to an intervention plan as described herein. Applicators 120 may be rigid or have parts that are independently articulating or movable to conform to patient tissue. A particular applicator 120 size, shape, and / or number of ports may be selected for use responsively to, for example, conduit type, insert type, the target tissue size, location within the body, and / or type.

[0091] FIGs. 1 B-1 F are block diagrams of exemplary top views of exemplary applicators 120B-120F, respectively, wherein FIG. 1 B illustrates a first rectangularly- shaped applicator 120B with a single port 140; FIG. 1C illustrates a second rectangularly-shaped applicator 120C with two ports 140A and 140B; FIG. 1 D illustrates a third rectangularly-shaped applicator 120D with four ports 140A, 1406, 140C, and 140D arranged in two rows of two columns; FIG. 1 E illustrates a circularly-shaped applicator 120E with four ports 140A, 1406, 140C, and 1400; and FIG. 1 F illustrates a rectangularly-shaped applicator 120F with four ports 140A,1406, 140C, and 140D. FIG. 1G is a block diagram of a side view of a system 180 including third rectangularly-shaped applicator 120D with a first conduit 150A extending from first port 140A and a second conduit 150B extending from third port 140C. A first insert 160A is positioned within first conduit 150A at a first dwell position within first conduit 150A and a second insert 160B is positioned within second conduit 150B at a second dwell position within second conduit 150B. Notably, FIGs. 1B-1 F are exemplary applicators that are rigid, but applicators 120 can also have movable or articulating parts that may, for instance, aid in conforming to the shape of the intended patient surface or volume, examples of which are provided by FIGs. 1 H and 11. FIG. 1 H provides a cross-section of a system 182 that includes rectangularly-shaped applicator 120F that has been bent into an arch-like configuration to conform to curved target tissue of a corresponding shape. The bending of rectangularly-shaped applicator 120F may be done prior to use (e.g., at the factory or in a lab prior to interfacing with the patient) and / or during use. For example, a clinician may place rectangularly-shaped applicator 120F over target tissue in an unbent, or straight / flat shape that may be conformed, via, for example, pressing and / or gravity, on contact with the tissue via, for example, articulation of one or more movable and / or articulating parts (e.g., joints, wires, and / or shape memory materials) therein. System 182 also includes four conduits 140A, 1406, 140C, and 140D positioned within each of four ports 140A, 1406, 140C, and 140D, respectively. Each conduit 140A, 140B, 140C, and 140D have an insert 150A, 150B, 150C, and 150D, respectively, positioned therein as shown.

[0092] FIG. 11 provides a cross-section of a system 184 that includes rectangularly- shaped applicator 120F that has been bent into an arch-like configuration to conform to curved target tissue of a corresponding shape in a manner similar to that shown in FIG. 1 H with the exception that the arch shape of system 184 is more sharply curved than that of system 182. Like system 182, system 184 also includes four conduits 140A, 140B, 140C, and 140D positioned within each of four ports 140A, 140B, 140C, and 140D, respectively. Each conduit 140A, 1406, 140C, and 140D have an insert 150A, 150B, 150C, and 150D, respectively, positioned therein as shown. In some embodiments, all of the conduits and / or inserts of system(s) 180, 182, and / or 184 may be the same and may cooperate to deliver an intervention across target tissue. Additionally, or alternatively, one or more the conduits and / or inserts of system(s) 180, 182, and / or 184 may deliver different modalities of intervention and / ormeasurement. For example, insert 160B of system 180 may deliver medication to target or radiation to target tissue and insert 160A may measure a response (e.g., temperature, swelling, bleeding, etc.) of the target tissue to the intervention delivered by insert 160B. In another example, inserts 160B and 160C of system 182 may be configured to deliver heat to target tissue and inserts 160A and 160D may be heat sinks or cryotherapy devices to contain the heat delivered to the target tissue and / or limit an impact of the heat to a specific portion of the target tissue. In another example, inserts 160B and 160C of system 184 may be configured to make incisions into target tissue and inserts 160A and 160D may be configured as suction canula configured to suck blood or other fluids from the tissue proximate to the portion of the target tissue being incised by inserts 160B and 160C. In another example, inserts 160B and 160C of system 184 may be configured to deliver radiation into target tissue and inserts 160A and 160D may be configured to act as radiation shields, thereby shielding tissue not intended (according to the intervention plan) to be exposed to the radiation. Continuing with this example, at times, the shielding inserts (160A and 160D) and / or radiation therapy inserts (160B and 160C) may be removed from conduits 150A, 150B, 150C, and / or 150D, respectively so that a secondary intervention may be applied thereto. Exemplary secondary interventions include the use of inserts configured to deliver heat, medication, and / or cryotherapy to increase the efficacy of the radiation treatment and / or comfort of the patient. FIG. 2A is a schematic diagram of a portion of a first conduit / insert assembly 201 that includes a conduit 220 (also referred to herein as “first conduit”) with a first, second, third, fourth, fifth, and sixth position indicator 225A, 225B, 225C, 225D, 225E, and 225F. First, second, third, fourth, fifth, and / or sixth position indicator 225A, 225B, 225C, 225D, 225E, and 225F may be, for example, visual markings, radio-opaque markings, and / or may be configured with a short-range communication device, such as a radio frequency identification (RFID) transponder configured to, for example, communicate information about the conduit (e.g., conduit type and / or configuration) and / or a position identifier to, for example, a receiver that, in some cases, may be positioned on an insert positioned proximate to and / or within conduit 220. In some embodiments, each of first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F may have a different identifier (e.g., position 1 , position 2, etc.) that may be broadcast, or otherwise, communicated via the communication device. As shown in FIGs. 2A and 2B, first, second, third, fourth,fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F are approximately evenly spaced apart with a distance between, for example, second position indicator 224B and third position indicator 225C being approximately equal to a distance between third position indicator 225C and fourth position indicator 225D but, this need not always be the case. In some embodiments, each of first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F may be defined at the time of intervention planning (e.g., based upon distance traveled by insert from the functionality support device) rather than predetermined using position indicators.

[0093] Conduit 220 may be a hollow tube made from, for example, plastic, vinyl, memory plastic, and the like and may be configured to accept insertion, movement and / or removal of an insert like a first insert 240A therein and / or therefrom. Conduit 220 may also be configured to tolerate and / or assist with one or functions and / or actions performed by the insert. For example, conduit 220 may be configured to be heat resistant, conduct electricity, insulate electricity, conduct heat, and / or insulate heat. As shown in FIG. 2A, conduit 220 is transparent so that first insert 240A, when inserted therein, may be seen but, this need not always be the case. For example, conduit 220 may be opaque or semi-transparent. Exemplary inserts may be sized, shaped, and / or configured to be inserted into, and move within, a lumen of conduit 220 to, for example, deliver treatment to a patient, take a measurement, provide light, protect tissue, and so on via conduit 220.

[0094] On some occasions, conduit 220 may be configured to be positioned proximate to (e.g., on top of or inside) target tissue of a patient via, for example, applying conduit 220 and / or an end thereof to the target tissue, wrapping conduit 220 around all, or a portion, of the target tissue, and / or inserting conduit 220 into a naturally occurring orifice (e.g., mouth, urethra, etc.) and / or a surgical incision (e.g., endoscopic). Additionally, or alternatively, conduit 220 may be configured to be used non-invasively by positioning an end of conduit 220 proximate to target tissue of the patient that is positioned on an exterior surface of the patient (e.g., skin or eye). Once conduit 220 is in position relative to the patient’s target tissue, first insert 240A may be inserted into conduit 220 and arranged at a desired position within conduit 220, such as first indicator position 225A, as shown in FIG. 2A. Alternatively, conduit / insert assembly 201 may be assembled prior to use with a patient and then the assembly may be placed in the desired position proximate to the target tissue.

[0095] In some embodiments, conduit 220 may be configured to be directly inserted into and / or applied to target tissue. Additionally, or alternatively, conduit 220 may be configured for use with an introducer and / or stylet that may, for example, be positioned within a lumen of conduit 220 and extend through a length of conduit 220 to add stiffness and / or increase maneuverability of conduit 220 during an insertion process. Once in position, the introducer and / or stylet may be removed so that one or more inserts may be inserted into the lumen.

[0096] Once conduit / insert assembly 201 is in position relative to the patient’s target tissue and / or insert 240A is correctly arranged within conduit 220 and / or proximate to the target tissue, the insert may be activated and / or used to deliver the relevant treatment to the target tissue for a first time period (e.g., 1s-10 minutes or 20-80 seconds). In some embodiments, insert 240A may be repositioned within conduit 220 following the first time period and may be activated again for a second time period to, for example, deliver the intervention to a different position within the conduit in order to intervene on a different portion of the target . tissue and / or to different target tissue altogether. When insert 240 is a measurement device, it may be taking measurements continuously, periodically, and / or on an as-needed, actively measuring while resident within conduit 220 and / or may be activated to take a measurement at a particular time. In some cases, conduit system / insert assembly 201 may be removed from the patient at the conclusion of the first and / or second time period.

[0097] In some embodiments, conduit 220 may be used to introduce a plurality of different inserts (e.g., inserts that deliver different types of modality and / or inserts that provide variations of (e.g., dosage) the same modality) to the target tissue after the first and / or second time period (when first insert 240A is used). For example, FIG. 2B is a schematic diagram of a portion of a second conduit / insert assembly 202 that includes the original conduit 220 with a second insert 240B positioned therein with an end of second insert 240B being positioned proximate to second position indicator 225B. Second insert 240B may be similar to and / or used in a manner similar to that described above with regard to first insert 240A.

[0098] In some embodiments, aa conduit-insert system such as those disclosed herein may include a plurality (e.g., 2-1 ,600) of conduits that may be, for example, physically separate from and / or affixed directly and / or indirectly to one another via, for example, a sheath, an introducing device, a chemical bonding agent (e.g., glueand / or epoxy), and / or mechanical bonding mechanism (e.g., a clamp or strap). Additionally, or alternatively, in some embodiments, one or more conduits of a conduit-insert system may be attached to an additional object, (for example, a planar sheet that is draped over tissue, a scaffold, and / or a balloon surface that conforms to the inside of a body cavity). Additionally, or alternatively, two or more conduits may be separately introduced (e.g., through the same and / or a different opening) into a patient’s body or otherwise positioned proximate to target tissue to form a conduitinsert system in situ. For example, FIGs. 3A-4D provide schematic diagrams of conduit-insert system and insert assemblies that include two conduits. In the diagrams, the conduits are directly adjacent to each other, but they need not be. For example, in some embodiments, the conduits may be separated in space and parallel and / or oriented at an angle to one another. For embodiments that include two or more conduits, the position indicators may align and / or be offset from one another, (they can be separated in space). For example, In particular, FIG. 3A is provides a schematic diagram of a front view of a first bi-conduit system 301 that includes first conduit 220 with first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F and a second conduit 320 that includes a first, second, third, fourth, fifth, and sixth position indicator 325A, 325B, 325C, 325D, 325E, and 325F that are arranged to have positions that correspond to and / or align with first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F of conduit 220 as shown. FIG. 3B is a schematic diagram of a front view of a second bi-conduit system 302 that includes first conduit 220 and a third conduit 331 . Third conduit 331 includes seventh, eighth, ninth, tenth, and eleventh position indicators 325G, 325H, 325I, 325J, and 325K, which are arranged to have positions that are offset from (e.g., positioned between) respective positions of first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F of first conduit 220 as shown.

[0099] First and / or second bi-conduit systems 301 and / or 302 may be configured to accept insertion of two inserts (one for each conduit) simultaneously and / or at different times. The two inserts may each be arranged in a position within their respective conduit that may correspond to one or more position indicators. In some embodiments, the two different inserts may provide the same and / or different functionality and / or differing dosages of the same and / or different functionalities (e.g., treatment modalities). For example, FIG. 3C is a diagram of a first bi-conduitsystem / insert assembly 303 that includes first bi-conduit system 301 (wherein both first and second conduits 220 and 320 are transparent), first insert 240A (positioned at first position indicator 225A of first conduit 220), and second insert 240B (positioned at first position indicator 325A of second conduit 320). In another example, FIG. 3D is a diagram of a second bi-conduit system 304 that includes second bi-conduit system 302 (wherein both first and third conduits 220 and 331 are transparent), first insert 240A (positioned at second position indicator 225B of first conduit), and second insert 240B (positioned at ninth position indicator 325I of third conduit 331).

[0100] In some embodiments, the same insert may be used in multiple conduits via, for example, inserting the insert into a first conduit, removing it following a duration of time and then inserting it into a second conduit. FIGs. 3E and 3F are a time series of an example of this embodiment wherein first insert 240A is first positioned within first conduit 220 as shown in FIG. 3E and, once use of first insert 240A within first conduit 220 is complete, it is removed from first conduit 220 and inserted into second conduit 320 as shown in FIG. 3F.

[0101] FIG. 4A is a schematic diagram of a front view of a third bi-conduit system 401 that includes a fourth conduit 420 and a fifth conduit 430, wherein the position indicators for the fourth and fifth conduits 420 and 430 are not equally spaced apart, relative to one another, along a length of the respective fourth and fifth conduits 420 and 430. In particular, fourth conduit 420 includes a first, second, third, fourth, fifth, sixth, and seventh position indicator 425A, 425B, 425C, 425D, 425E, 425F, and 425G and fifth conduit 430 includes an eighth, ninth, tenth, eleventh, twelfth, thirteenth, and fourteenth position indicator 435H, 435I, 435J, 435K, 435L, 435M, and 435N that are arranged along the length of fifth conduit 430 to have positions that correspond to first, second, third, fourth, fifth, sixth, and seventh position indicators 425A, 425B, 425C, 425D, 425E, 425F, and 425G of fourth conduit 420 as shown. FIG. 4B is a schematic diagram of a front view of a fourth bi-conduit system 402 that includes fourth conduit 420 and a sixth conduit 450 that includes a twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, and eighteenth position indicator 4350, 435P, 435Q, 435R, 435S, 435T, and 435U that are arranged to have positions that are offset from (e.g., positioned between) respective positions of first, second, third, fourth, fifth, sixth, and seventh position indicator 425A, 425B, 425C, 425D, 425E, 425F, and 425G of fourth conduit 420 as shown.

[0102] Third and / or fourth bi-conduit systems 401 and / or 402 may be configured to accept insertion of two inserts (one for each conduit) simultaneously and / or at different times in manner similar to, for example, insertion and / or movement of first and / or second insert 240A and / or 240B as shown and described herein. For example, FIG. 4C is a diagram of a third bi-conduit system / insert assembly 403 that includes third bi-conduit system 401 (wherein both fourth and fifth conduits 420 and 430 are transparent), first insert 240A (positioned within fourth conduit 420 at first position indicator 425A), and second insert 240B (positioned within fourth conduit 430 at second position indicator 435B). As an additional example, FIG. 4D is a diagram of a fourth bi-conduit system / insert assembly 404 that includes fourth bi- conduit system 402 (wherein both fourth and sixth conduits 420 and 450 are transparent), wherein first insert 240A is positioned within fourth conduit 420 at second position indicator 425B and second insert 240B is positioned sixth conduit 450 at seventeenth position indicator 435Q.

[0103] As with the time series shown in FIGs. 3E and 3F, a single insert may be used in both conduits of third bi-conduit system 401 and / or fourth bi-conduit system 402 and FIGs. 4E and 4F are a time series of an example of how this may be done, wherein FIG. 4E shows first insert 240A being first positioned within fourth conduit 420 and, once use of first insert 240A within fourth conduit 420 is complete, it is removed from fourth conduit 420 and inserted into fifth conduit 430 as shown in FIG. 4F.

[0104] FIGs. 5A-5D provide schematic diagrams of conduit-insert assemblies that include three conduits. In the diagrams, the conduits are directly adjacent to each other, but they need not be (they can be separated in space). FIG. 5A is a schematic diagram of a front view of a first tri-conduit system 501 that includes first conduit 220, second conduit 320, and a seventh conduit 520, wherein the position indicators for the first, second, and seventh conduits 220, 230, and 520 are equally spaced apart, relative to one another, along a length of the respective first, second, and seventh conduits 220, 230, and 520. In particular, seventh conduit 520 includes a first, second, third, fourth, fifth, and sixth position indicator 545A, 545B, 545C, 545D, 545E, and 545F that are arranged along the length of seventh conduit 520 to have positions that correspond to first, second, third, fourth, fifth, and sixth position indicators 225A, 225B, 225C, 225D, 225E, and 225F of first conduit 220 and first, second, third, fourth, fifth, and sixth position indicators 325A, 325B, 325C, 325D,325E, and 325F of second conduit 320 as shown. FIG. 5B is a schematic diagram of a front view of a second tri-conduit system 502 that includes first conduit 220, seventh conduit 520, and eighth conduit 530, wherein eighth conduit 530 that includes first, second, third, fourth, and fifth position indicators 555A, 555B, 555C, 555D, and 555E that are arranged to have positions that are offset from (e.g., positioned between) respective positions of first, second, third, fourth, fifth, and sixth position indicators of first conduit 220 and seventh conduit 520 as shown.

[0105] First and / or second tri-conduit systems 501 and / or 502 may be configured to accept insertion of three inserts (one for each conduit) simultaneously and / or at different times in manner similar to, for example, insertion and / or movement of first and / or second insert 250A and / or 250B as shown and described herein. For example, FIG. 5C is a diagram of a first tri-conduit system / insert assembly 503 that includes first tri-conduit system 501 , first insert 250A (positioned within first conduit 220 at first position indicator 525A), second insert 250B (positioned within second conduit 320 at first position indicator 335A), and a third insert 240C (positioned within seventh conduit 520 at first position indicator 545A). As an additional example, FIG. 5D is a diagram of a second tri-conduit system / insert assembly 5042 that includes second tri-conduit system 502, wherein first insert 250A is positioned within first conduit 220 at first position indicator 225A, second insert 250B is positioned in eighth conduit 530 at second position indicator 555B, and third insert 240C is positioned in seventh conduit 520 at first position indicator 545A.

[0106] FIGs. 5E and 5F are a time series of showing use of a single insert within multiple conduits of a tri-conduit system, wherein FIG. 54E shows first insert 240A being positioned within first conduit 220 and second insert 240B being positioned within seventh conduit 520. Once use of second insert 240B within seventh conduit 520 is complete, it is removed from seventh conduit 520 and inserted into second conduit 320 as shown in FIG. 5F while first insert 240A remains in first conduit 220. FIGs. 5E and 5F are provided by way of example and not limitation and any variation of first, second, and / or third inserts 240A, 24B, and / or 240C within first, second, and / or seventh conduits 220, 320, and / or 520 is within the scope of the present invention.

[0107] Although the conduits depicted in FIGs. 3A-5D are positioned adjacent to one another, this is not necessarily the case. In some embodiments, two or more conduits may be physically separate from one another and, in some cases may beoriented substantially parallel to one another and / or oriented at an angle relative to one another. Additionally, or alternatively, the conduit systems may have any number of conduits that may, or may not, be independently adjusted and / or movable relative to, for example, target tissue of a patient. Additionally, or alternatively, an insert may be moved to one or more positions within a conduit to, for example, deliver therapy and / or obtain a measurement proximate to different regions of the patient’s body and / or target tissue.

[0108] Although the conduits shown in FIGs. 2A-5F are straight, this not always be the case. On some occasions, a conduit may be curved or bent to have, for example, a pre-set angle (set when, for example, manufactured and / or set by a clinician when treating a patient) prior to use and / or may be curved during use as it, for example, navigates a body cavity, surgical opening, and / or orifice while traveling to target tissue.

[0109] Each of the conduits disclosed herein may include a first end and a second end with a central lumen extending between the first and second ends. The lumen may be sized and configured to accept insertion of an insert therein and movement of the insert while in the lumen as shown and described herein. A first and, in some cases, a second end of the conduit may be open so that, for example, an insert may be inserted into a first open end and be pushed through the lumen to abut and / or exit the second end. FIG. 5G is a schematic diagram of an open end of conduit 220, 320, 331 , 420, 430, 450, 520, and / or 530 showing a lumen 222 that extends along the length of the conduit 220, 320, 331, 420, 430, 450, 520, and / or 530 from the first end to the second end of the conduit.

[0110] FIGs. 6-8C and 10 are flowcharts showing exemplary processes 600, 700, 800, and 1000, respectively, for using one or more of the conduits, conduit arrangements, and / or conduit / conduit system and insert assemblies disclosed herein. Processes 600, 700, 800, and 1000 may be executed by, for example, system 100, a component of system 100, a combination of components of system 100, a clinician, and / or a robot. In particular, FIG. 6 is a flowchart showing of a process 600 for generating an intervention plan that includes use of one or more conduit / conduit system and insert assemblies disclosed herein and activation of one or more inserts resident within a conduit and / or conduit arrangement to make a measurement or deliver treatment to target tissue of a patient.

[0111] Optionally, in step 605, information about the patient and / or target tissue of the patient may be received by, for example, a computer and / or processing unit like computer and / or processing unit 105 and / or a controller like controller 115. Exemplary target tissue information includes, but is not limited to, dimensions of target tissue, position on / within the patient’s body, type and composition / characteristics of target tissue (e.g., tumor, cyst, lesion, mole, scar tissue, etc.), and / or dimensions and composition / characteristics of background tissue. Exemplary information about the patient includes, but is not limited to, a medical diagnosis, treatments the patient is receiving, medications the patient is taking, comorbidities, skin tone, gender, age, pain tolerance, and / or weight. The information about the patient and / or the target tissue may be received from, for example, an image, a diagnostic scan, the patient’s electronic medical record, and / or a manual entry, by an operator, into an interface communicatively coupled to the computer and / or processing unit and / or controller.

[0112] In some cases, a conduit-insert system may be pre-positioned on the surface or within the target tissue and included in the information received by a computer and / or processing unit like computer and / or processing unit 105 and / or a controller like controller 115. For example, a radiographic image of a skin surface used for intervention planning may include the skin surface alone and / or the skin surface with pre-positioned conduits placed over the surface of the region of interest.

[0113] In some embodiments, data from sensors on pre-positioned conduits can be included in the information received by a computer and / or processing unit like computer and / or processing unit 105 and / or a controller like controller 115.

[0114] In step 610, an intervention plan for the target tissue may de generated using, for example, the information received in step 605. The intervention plan may include the placement of conduits (e.g., their location, size, configuration and / or orientation) or, in some cases, adjustments in the placement of pre-positioned conduits. The intervention plan may include, for example, instructions (e.g., type of treatment modality, type of insert, duration of time for the delivery of the treatment modality, measurements to be taken by an insert, regions of tissue to be protected by an insert, a position of an insert such as first, second, and / or third inserts 240A, 240B, and / or 240C within a conduit like conduit 220, and / or a dosage of the treatment to be delivered) for position and / or use of one or more inserts to perform one or more functions to and / or regarding the target tissue. The intervention plan may includeinstructions regarding an operation, or functionality, of one or more inserts. Exemplary operations of insert include, but not limited to, instructions regarding how, when, what, and / or where an insert is to deliver one or more treatment modalities to target tissue and / or a region thereof, a dosage of treatment to deliver to target tissue and / or a region thereof. Additionally, or alternatively, an intervention plan may include instructions regarding how and / or when an insert may take one or more measurements and / or protect tissue proximate to target tissue and / or another conduit-insert system. Optionally, the intervention plan may be provided to a clinician and / or technician (step 615) for modification, review, and / or approval.

[0115] In step 620, an indication that the one or more inserts are correctly (as indicated by, for example, the intervention plan) positioned within their respective conduit(s) and are proximate to the target tissue as specified by the intervention plan may be received. Then, in step 625, the insert (s) may be activated or otherwise turned on to, for example, deliver their respective treatment to the target tissue, take a measurement, and / or protect tissue proximate to the target tissue in accordance with the intervention plan. On some occasions, a pre-generated intervention plan may be received prior to execution of step 620 and, on these occasions, steps 605- 615 of process 600 may not be performed. Execution of step 625 may not be necessary in all instances of execution of process 600. For example, when the insert is configured to dispense medication and / or radiation to the target tissue, the insert may be active when inserted into the conduit and, in some embodiments, may be configured to dispense the treatment when pushed through an open end of the conduit into the target tissue. In another example, when the insert is a temperature probe, it may be configured to measure temperature continuously, periodically, and / or as-needed.

[0116] FIG. 7 is a flowchart illustrating a process 700 for the administration of treatment to target tissue using one or more inserts such as first, second, and / or third inserts 240A, 240B, and / or 240C, one or more conduits such as first, second, third, fourth, fifth, sixth, seventh, and / or eighth conduits 220, 320, 331 , 420, 430, 450, 520, and / or 530, of one or more respective conduit systems such as first, second, third, and / or fourth bi-conduit system 301 , 302, 401 , and / or 402 and / or a triconduit system like first and / or second tri-conduit system 501 and / or 502. Process 700 may be performed by, for example, a clinician and / or a robot.

[0117] In step 705, an intervention plan and / or one or more instructions (that may or may not be included in an intervention plan) for delivering treatment to target tissue of a patient may be received. In some embodiments, the intervention plan may be similar to the intervention plan of step 610 described above. A conduit and / or conduit system may then be placed proximate to the target tissue of a patient (step 710) via any acceptable means or procedure including, but not limited to, insertion through a naturally occurring orifice and / or via a surgical incision. In some cases, the conduit-insert system may have been pre-positioned before intervention planning similar to step 605 described above.

[0118] In step 715, a first insert may be inserted into the conduit and / or an individual conduit of the conduit system (when a conduit system is inserted in step 710) and arranged at a first position within the conduit comprising with, for example, an instruction received in step 705. For example, an instruction received in step 705 may require that a first insert be inserted into the conduit until a tip of the first insert reaches a first position indicator of the conduit and execution of step 715 may be compliant with this instruction. In some embodiments, the first insert may be active upon insertion into the conduit. Additionally, or alternatively, the first insert may be used and / or activated once the first insert is in the proper position within the conduit. In some embodiments, “activation” may include turning the insert on, providing energy to the insert, withdrawing energy from the insert, taking a measurement with the insert, and / or causing the insert to touch, or press into, the target tissue. Activation and / or use of the first insert in the first position may occur for a first time period.

[0119] Optionally, in step 720, the first insert may be moved (e.g., pushed into or pulled out of) to a second position within the conduit and, once in position, the first insert may be used and / or re-activated for a second time period, which may be of the same and / or a different duration than the first time period. In some embodiments, use and / or activation of the first insert at the first and second positions may be the same (e.g., a dosage administered to and / or a measurement taken of the target tissue) and / or may continue for the same length of time (e.g., a duration of the first and second time periods are the same). Additionally, or alternatively, use and / or activation characteristics of the first insert at the first and second positions may be different from one another (e.g., a dosage administered to the target tissue) and / or may continue for the differing lengths of time (e.g., a duration of the first and secondtime periods are the not the same). Following step 720, process 700 may proceed to step 725 and / or 740.

[0120] Optionally, in step 725, the first insert may be removed from the conduit and a second insert may be inserted into the conduit and / or an individual conduit of the conduit system (when a conduit system is inserted in step 710) and arranged at a first position within the conduit according to, for example, an instruction received in step 705. For example, an instruction received in step 705 may require that a second insert be inserted into the conduit until a tip of the second insert reaches a first position indicator (for the second insert) of the conduit and execution of step 725 may be compliant with this instruction. Once the second insert is in the proper position, it may be used and / or activated at the first position for a first time period (for the second insert).

[0121] Optionally, in step 730, the second insert may be moved (e.g., pushed into or pulled out of) to a second position (for the second insert) within the conduit and, once in position, the second insert may be used and / or activated so that it, for example, delivers the treatment to, protects, and / or measures the target tissue at the second position for a second time period. In some embodiments, use and / or activation of the second insert at the first and second positions may be the same (e.g., a dosage administered to the target tissue and / or same measurement taken at two different time periods) and / or may continue for the same length of time (e.g., a duration of the first and second time periods are the same). Additionally, or alternatively, use and / or activation the first insert at the first and second positions may be different from one another (e.g., a dosage administered to the target tissue) and / or may continue for the differing lengths of time (e.g., a duration of the first and second time periods are the not the same).

[0122] When steps 725 or 730 are performed, the second insert may be removed from the conduit and the conduit may be removed from the target tissue (step 735) and execution of process 700 may end. Alternatively, execution of step 735 may include removing an assembly of the conduit and the second insert from the target tissue. When steps 720, 725, 730, or 735 are not performed, process 700 may end following steps 715, 720, 725, or 730, respectively.

[0123] On some occasions, activation of the first and / or second insert may not be executed in, for example, step(s) 720, 725, and / or 730 in all instances of execution of process 700. For example, when the first and / or second insert(s) are configuredto dispense medication and / or radiation to the target tissue, the first and / or second insert(s) may be active when inserted into the conduit and, in some embodiments, may be configured to dispense the treatment when pushed through an open end of the conduit into the target tissue.

[0124] When process 700 proceeds to step 740, the conduit of steps 705-720 may be a first conduit and the first insert may be removed from the first conduit and inserted into a conduit and / or a second individual conduit of the conduit system (when a conduit system is inserted in step 710). The first insert may be arranged at a first position within the second conduit according to, for example, an instruction received in step 705 in a manner similar to that described above with regard to step 725.

[0125] Optionally, in step 745, the first insert may be moved (e.g., pushed into or pulled out of) to a second position (for the second insert) within the second conduit and, once in position, the first insert may be used and / or activated so that it, for example, delivers the treatment to, protects, and / or measures the target tissue at the second position for a second time period. In some embodiments, use and / or activation of the first insert at the first and second positions may be the same (e.g., a dosage administered to the target tissue and / or same measurement taken at two different time periods) and / or may continue for the same length of time (e.g., a duration of the first and second time periods are the same). Additionally, or alternatively, use and / or activation the first insert at the first and second positions may be different from one another (e.g., a dosage administered to the target tissue and / or the same measurement taken at two different time periods) and / or may continue for the differing lengths of time (e.g., a duration of the first and second time periods are the not the same).

[0126] When steps 740 or 745 are performed, the first insert may be removed from the second conduit and the second conduit may be removed from the target tissue (step 750) and execution of process 700 may end.

[0127] FIG. 8A is a flowchart that illustrates a process 800 for the administration of treatment to target tissue using a plurality of separate conduits, one or more multiconduit systems such as first, second, third, and / or fourth bi-conduit system 301 , 302, 401 , and / or 402 and / or a tri-conduit system like first and / or second tri-conduit system 501 and / or 502 and one or more inserts such as first, second, and / or third inserts 240A, 240B, and / or 240C and. The plurality of separate conduits and multi-conduit systems may be collectively referred to herein as a “conduit system.” Process 800 may be performed by, for example, a clinician and / or a robot.

[0128] In step 805, an intervention plan and / or one or more instructions that may, or may not, be included in an intervention plan for delivering treatment to, protecting, and / or measuring one or more characteristics of target tissue of a patient may be received. In some embodiments, the intervention plan may be similar to the intervention plan of step 610 described above. A conduit system may then be placed proximate to the target tissue of a patient (step 810) via any acceptable means or procedure including, but not limited to, insertion through a naturally occurring orifice and / or via a surgical incision. In some cases, the conduit-insert system may have been pre-positioned before intervention planning similar to step 605 described above.

[0129] In step 815, a first insert may be inserted into a first conduit of the conduit system and arranged at a first position within the first conduit, a second insert may be inserted into a second conduit of the conduit system and arranged at a first position within the second conduit, and / or an optional third insert may be inserted into a third conduit of the conduit system and arranged at a first position within the third conduit. Once the first, second, and / or third insert(s) is / are in the proper position, each insert may be and / or used activated (step 820) so that it, for example, delivers the treatment to, protects, and / or measures a characteristic of the target tissue at the first position of the respective first, second, and / or third conduits for a common duration of time and / or for a respective first, second, and / or third time period. The first, second, and / or third inserts may be used and / or activated, for example, simultaneously, serially, periodically, and / or as needed. For example, if the first insert delivers heat therapy to, for example, ablate target tissue, and the second insert delivers cryotherapy to cool tissue following ablation and reduce swelling then, first insert may be activated for a first time period sufficient to ablate the target tissue and then the second insert may be activated to cool the target tissue following ablation. In another example where, for example, the target tissue is a large tumor, the first, second, and third inserts may be configured to emit brachytherapy simultaneously to inundate the target tissue with radiation at three separate locations. In yet another example, where the target tissue is a tumor, a second insert, when positioned in the middle of the tumor, may be configured to emit a relatively high dose of brachytherapy and the first and third inserts (positioned oneither side of the middle of the tumor) may be configured to emit a relatively lower dosage of brachytherapy so that the tumor is adequately treated with brachytherapy while reducing a possibility of irradiating healthy tissue on either side of the middle of the tumor.

[0130] Following execution of step 825, it may be determined if administration of the treatment to the patient is complete and, if so, the first, second, and / or third inserts may be removed from the conduit system and the conduit system may be removed from the target tissue (step 830). Alternatively, execution of step 830 may include removing an assembly of the conduit arrangement and the first, second, and / or third inserts from the target tissue.

[0131] If administration of the treatment to the patient is not complete (step 825), process 800 may proceed to step 835 of sub-process 800b as shown in FIG. 8B and / or step 845 of sub-process 800c of FIG. 8C. When sub-process 800b is to be executed (as directed by, for example, the intervention plan), the first, second, and / or third insert may be moved (e.g., pushed into or pulled out of) to a second / another position within the respective first, second, and / or third conduit(s) and, once in position, the first, second, and / or third insert (s) may be used and / or activated (step 840) so that, for example, the first, second, and / or third insert(s) deliver the treatment to, protect, and / or measure the target tissue at the respective second / another position for a respective second time period. In some embodiments, activation and / or use of the first, second, and / or third insert(s) at their respective first (step 820) and second (step 840) positions may be the same (e.g., a dosage administered to the target tissue) and / or may continue for the same length of time (e.g., a duration of the respective first and second time periods are the same). Additionally, or alternatively, activation and / or use of the first, second, and / or third insert(s) at the first and second positions may be different from one another and / or may continue for the differing lengths of time (e.g., a duration of the respective first and second time periods are the not the same). Following execution of step 840, process 800b may end and step 825 may be re-executed to determine if administration of treatment to the patient is complete.

[0132] Additionally, or alternatively, when administration of the treatment to the patient is not complete (step 825), process 800 may proceed to step 845 of subprocess 800c as shown in FIG. 8C. In step 845, the first, second, and / or third insert (s) may be removed from the respective first, second, and / or third conduit. Then, afourth insert may be inserted into the first conduit, a fifth insert may be inserted into the second conduit, and / or a sixth insert may be inserted into and / or positioned within the third conduit (step 850) and the fourth, fifth, and / or sixth inserts may be activated and / or used to deliver treatment to, protect, and / or measure the target tissue for a common duration of time and / or a respective fourth, fifth, and / or sixth duration of time. Following execution of step 855, process 800c may end and step 825 may be re-executed to determine if administration of treatment to the patient is complete.

[0133] On some occasions, activation and / or use of the first, second, and / or third insert may not be executed in, for example, step(s) 820, 840, and / or 855 in all instances of execution of process 800. For example, when the first second, and / or third insert(s) are configured to dispense medication and / or radiation to the target tissue, the first second, and / or third insert(s) may be active when inserted into the conduit and, in some embodiments, may be configured to dispense the treatment when pushed through an open end of the conduit into the target tissue.

[0134] In some embodiments, positioning of first, second, and / or third inserts may be facilitated by a receiver positioned thereon configured to, for example, detect a signal emitted by one or more position indicators of a conduit.

[0135] FIGs. 9A-9D provide some examples of conduit-insert systems in geometric configurations corresponding to exemplary clinical scenarios. FIG.9A is a schematic diagram 901 of a two- dimensional flat surface of a patient (e.g., a flat portion of skin on a patient’s back) with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon. The lines in diagram 901 correspond to the positioning of conduits on the surface, and each of the grid points of diagram 901 corresponds to a different potential position for an insert to be positioned within a conduit as disclosed herein. Diagram 901 also shows three target positions 910 and an insert may be arranged within a conduit to, for example, deliver therapy and / or take a measurement at each of these positions according to, for example, one or more methods disclosed herein.

[0136] FIG. 9B is a schematic diagram 902 of an uneven, or curved, surface of a patient(e.g., a curved area of skin on a patient’s face) with cartesian grid points (represented as circles, or dots), or coordinates, superimposed thereon. The lines in diagram 901 correspond to the positioning of conduits on the surface, and each of the grid points of diagram 902 corresponds to a different potential position for aninsert to be positioned within a conduit as disclosed herein. Diagram 902 also shows three target positions 910 and an insert may be arranged within a conduit to, for example, deliver therapy and / or take a measurement at each of these positions according to, for example, one or more methods disclosed herein.

[0137] FIG. 9C is a schematic diagram 903 of an approximately spherical volume of a patient that may represent, for example, the inner surface of a cavity (e.g., breast lumpectomy cavity) and / or hollow organ (e.g., bladder) of the patient. Diagram 903 includes a plurality of circumferentially arranged conduits (represented as lines) and potential positions (represented as circles, or dots) for positioning of an insert within a conduit as, for example, disclosed herein. Diagram 903 also shows three target positions 910 and an insert may be arranged within a conduit to, for example, deliver therapy and / or take a measurement at each of these positions according to, for example, one or more methods disclosed herein.

[0138] FIG 9D is a schematic diagram 904 of an approximately cubic volume of a patient that may represent, for example, a target volume within interstitial tissue. Diagram 904 includes a three dimensional lattice of potential positions (represented as circles, or dots) within and / or on the surface of the cubic volume of the patient for positioning of an insert within a conduit as, for example, disclosed herein. Diagram 904 also includes one of the conduits 920 that is inserted into the interstitial tissue in parallel fashion with a plurality of other conduits (not shown) to achieve the desired three dimensional lattice of potential insert positions within and on the surface of the cubic volume of the patient. Conduit 920 may be similar to one or more of the conduits disclosed herein. Diagram 904 also shows three target positions 910 and an insert may be arranged within a conduit to, for example, deliver therapy and / or take a measurement at each of these positions according to, for example, one or more methods disclosed herein.

[0139] In some embodiments, one or more of the system disclosed herein may be modular in nature so that they may be used together as needed. For example, a first system may comprise a plurality of conduits that are radio-opaque and a second system may comprise a plurality of conduits that comprise flexible plastic configured for acceptance of a brachytherapy insert. Alternatively, a system of heat-resistant conduits configured for cooperation with a thermal device (e.g., a resistance coil) may be combined with a porous conduit system configured to leach anti-inflammatory medication that may be dispensed to a patient following ablation performed using the thermal device.

[0140] FIG. 10 is a flowchart that illustrates a process 1000, for modeling a conduit network including one or more conduits, inserts, and / or applicators as disclosed herein to generate an intervention plan using same. At times, execution of process 1000 may utilize mathematical representations to model the conduit network, conduits, inserts, applicators, and intervention variables (e.g., dosage, timing, positions, etc.), thereby facilitating, for example, precise computational planning, execution, and / or iteration of the intervention plan. In some embodiments, process 1000 executed to generate a plan for intervening on / in target tissue using a plurality of separate conduits, one or more multi-conduit systems such as first, second, third, and / or fourth bi-conduit system 301 , 302, 401 , and / or 402 and / or a tri-conduit system like first and / or second tri-conduit system 501 and / or 502 and one or more inserts such as first, second, and / or third inserts 240A, 240B, and / or 240C. Process 1000 may be executed by any of the device, systems, and / or system components disclosed herein such as computer / processing unit 105 and / or controller 115.

[0141] In step 1005, data that may be used to generate an intervention plan may be received by, for example, a processor and / or controller executing process 1000. The data may pertain to, for example, a conduit network including one or more conduits, inserts, and / or applicators, a conduit system / network characteristics, insert positions within conduits, target tissue features, features for tissue surrounding, or proximate to, the target tissue, intervention characteristics, and / or intervention goals may be. At times, the data may be received via, for example, manual input, and / or may include test results, diagnostic imaging, computer- and / or human-generated imaging analysis results, sensor outputs, or manual annotations (e.g., arrows or circles placed on images). Additionally, or alternatively, the data received in step 1005 may include information regarding a grid, lattice, array, and / or irregular shape formed by the conduit network and / or conduit positions within the conduit network, which may define potential positions for intervention modality delivery. In some embodiments, this data may be represented as and / or analyzed to represent and / or be described as a mathematical construct and / or mathematical object including one or more variables and may include a set of multidimensional vectors, matrices, and / or tensors, wherein each element and / or variable of these mathematical constructs / objects may correspond to a specific intervention position (e.g., X-, Y-,and / or Z-coordinates of a position or a one-to-one representation of a specific position with a component of a structured array) within the conduit network and / or one or more relevant parameters, such as tissue characteristics (e.g., density, pathology distribution, etc.), intervention modality types (e.g., heat, radiation, etc.), and / or operational constraints (e.g., duration of application, safety thresholds, normal tissue avoidance, etc.).

[0142] In one example, execution of step 1010 may include generating a two-by-two matrix that may represent a spatial arrangement of four intervention positions arranged in a two-dimensional square pattern within a conduit network on a patient surface proximate to and / or within target tissue. At times, execution of step 1010 may further include adding additional dimensions and / or parameters to create a tensor and / or structured array that includes, for example, temporal data, such as the timing and sequence of intervention modality delivery and / or patient-specific variables, such as tissue sensitivity at each location. This multidimensional approach enables the management and / or optimization of complex spatial and temporal relationships inherent to multi-modality interventions for target tissue.

[0143] The mathematical representations allow for the application of computational techniques and / or manipulation of mathematical objects using, for example, mathematical operations and / or algorithms to plan and optimize interventions to / on target tissue, thereby generating an intervention plan. By organizing intervention data into tensors and / or structured arrays, execution of process 1000 supports use of advanced algorithms that can analyze and refine the planned intervention dynamically, which is also included in execution of step 1015. Optimization algorithms are particularly useful in determining the most efficient configuration of intervention modalities to achieve therapeutic goals while minimizing undesirable effects.

[0144] For instance, linear programming techniques may be employed during execution of step 1015 to identify optimal pathways for conduit insertion or delivery schedules that minimize procedural time and cost. Similarly, genetic algorithms can be used during execution of step 1015 to explore and refine complex configurations to, for example, balance competing objectives such as maximizing dose delivery to pathological tissue while minimizing exposure to healthy tissue. These techniques ensure that the intervention is both efficient and effective, addressing clinical and logistical challenges.

[0145] Additionally, or alternatively, execution of step 1015 may include use of machine learning models to enhance the intervention planning process by incorporating historical data and patient-specific variables to predict optimal configurations. These machine learning models may use, for example, neural networks and decision trees to analyze patterns in past interventions (e.g., learning from successful and unsuccessful outcomes) to iterate on previously generated intervention plans and / or generate new intervention plans with a high likelihood of efficacy. For example, a neural network using may predict the ideal combination of modalities for a specific pathology based on prior cases with similar tissue characteristics and treatment responses.

[0146] In some embodiments, machine-learning and / or artificial intelligence (Al) algorithms can further expand the system’s computational capabilities and / or the capabilities provided via execution of process 1000 by enabling automated decisionmaking and complex scenario planning. For example, Al simulations can evaluate multiple potential intervention strategies, comparing their projected outcomes against predefined therapeutic goals to generate intervention plans. At times, these simulations may consider factors such as the combined effects of multiple modalities, the potential for tissue toxicity, and / or procedural efficiency. For example, an Al-driven simulation performed via execution of process 1000 may predict how combining thermal therapy and radiation therapy at a specific location will affect both the pathological tissue (e.g., target tissue) and surrounding healthy areas. Based on these predictions, a system executing process 1000 may recommend adjustments to the intervention plan, such as altering the sequence, intensity, or duration of intervention modality delivery. This level of customization ensures that the intervention plan is tailored to the unique anatomy and clinical condition of each patient.

[0147] Optionally, in step 1020, feedback regarding the intervention plan prior to, or during, performance of the intervention plan of step 1015, or a portion thereof, may be received and the intervention plan may be updated and / or iterated upon responsively to the feedback. Exemplary feedback includes, but is not limited to, rejection and / or modification of an aspect of the intervention plan by a clinician, communication from the patient and / or the conduit network including one or more conduits, inserts, and / or applicators, tactile feedback from a clinician performing the intervention plan, and visual feedback from, for example, a clinician, image, and / oran image processing device performing the intervention plan. This iterative approach ensures that the planned intervention remains aligned with therapeutic objectives, even as conditions in the target tissue evolve. By leveraging these computational techniques, the system improves upon delivering precise, efficient, and adaptable multi-modality interventions.

[0148] The computational tools (e.g., software, instructions executed by a processor, etc.) used to execute process 1000 may be integrated into the overall workflow of the systems and / or devices disclosed herein and / or may be resident within a cloud computing platform. These computational tools may utilize optimization, machine learning, and / or Al algorithms to develop an initial intervention plan, which is then validated and refined through user input and / or further computational analysis while executing process 1000, or a portion thereof. In some embodiments, execution of process 1000 may complement or replace steps 605-610 provided by FIG. 6 and described herein wherein the user generates an intervention plan without advanced computational algorithms. In some embodiments, execution of steps 615, 620, and / or 625 may be performed following execution of step(s) 1015 and / or 1020.

Claims

CLAIMS\Ne claim:1 . A conduit and insert assembly comprising: a conduit with a first end, a second end, and a lumen extending between the first and second ends, the first end being open to the lumen and the lumen being configured to accept insertion, positioning, and repositioning of an insert within the lumen; the insert, the insert being configured to be inserted into the first end of the conduit and moved within the lumen to a position proximate to target tissue of a patient.

2. The conduit and insert assembly of claim 1 , wherein the conduit flexible is so that the conduit’s shape may be bent or curved to navigate through and / or be proximate to the target tissue.

3. The conduit and insert assembly of claim 1 or 2, wherein the conduit comprises at least one of metal, plastic, vinyl, rubber, latex, silicone and / or combinations thereof.

4. The conduit and insert assembly of any of the above claims, wherein the conduit is at least one of bioabsorbable, radio-opaque, porous for measurement of tissue properties, configured to release therapeutics, heat resistant, configured to conduct electricity, configured to insulate electricity, configured to conduct heat, configured to take a measurement, configured to deliver a treatment, configured to shield tissue from radiation, and / or configured to insulate heat.

5. The conduit and insert assembly of any of the above claims, further comprising: a removable stylet extending through a length of the lumen, the stylet being configured to add stiffness and / or increase maneuverability of the conduit while navigating through patient tissue to be within and / or proximate to the target tissue, wherein the removable stylet is removed from the lumen once the conduit / stylet assembly is in position so that the insert may be inserted into the conduit.

6. The conduit and insert assembly of any of the above claims, wherein the conduit includes a plurality of position indicators positioned thereon.

7. The conduit and insert assembly of any of the above claims, wherein the conduit is a first conduit, the conduit and insert assembly further comprising:a second conduit with a first end, a second end, and a lumen extending between the first and second open ends, the first end being open to the lumen and the lumen being configured to accept insertion, positioning, and repositioning of an insert within the lumen.

8. The conduit and insert assembly of claim 7, wherein the first and second conduits include a plurality of position indicators positioned thereon.

9. The conduit and insert assembly of claim 8, wherein the plurality of position indicators on the first conduit are offset from the plurality of position indicators of the second conduit.

10. The conduit and insert assembly of any of claims 7-9, wherein the conduit and insert assembly is configured to enable the inserts to deliver different therapies and / or collect different measurements simultaneously or in sequence at multiple conduit and / or insert positions during a single encounter with a patient.

11. The conduit and insert assembly of any of the above claims, wherein a feature of the conduit is specific to a function performed by the insert.

12. The conduit and insert assembly of any of the above claims, wherein the conduit is a first conduit, the conduit and insert assembly further comprising: a second conduit with a first end, a second end, and a lumen extending between the first and second open ends, the first end being open to the lumen and the lumen being configured to accept insertion, positioning, and repositioning of an insert within the lumen.

13. The conduit and insert assembly of claim12, wherein the conduit is a first conduit, the conduit and insert assembly further comprising: a third conduit with a first end, a second end, and a lumen extending between the first and second open ends, the first end being open to the lumen and the lumen being configured to accept insertion, positioning, and / or repositioning of an insert within the lumen.

14. The conduit and insert assembly of any of the above claims, wherein the insert comprises metal, wire, fiber-optic cables, plastic, vinyl, and / or combinations thereof.

15. The conduit and insert assembly of any of the above claims, wherein the insert comprises an active tip such as an absorbent pad saturated with medication, a temperature probe, a needle tip, a radioactive material, a measurement device, a treatment device, and / or a combination thereof.

16. The conduit and insert assembly of any of the above claims, wherein the insert is configured as at least one of a treatment modality, a measurement device, a radiation shielding device, a heating device, a heat sink, a cryotherapy device, and / or a protection device.

17. The conduit and insert assembly of any of the above claims, wherein placement of a conduit on a patient surface or insertion of a conduit within patient tissue is controlled by at least one of a clinician, a software interface, a processor, and a robot.

18. The conduit and insert assembly of any of the above claims, wherein movement of an insert within the conduit is controlled by at least one of a clinician, a software interface, a processor, and a robot.

19. The conduit and insert assembly of any of the above claims, wherein the insert is activated prior to insertion into the conduit or when in a desired position within the conduit.

20. The conduit and insert assembly of any of the above claims, wherein the insert is configured as a measurement device.21 .The conduit and insert assembly of claim 20, wherein the insert is configured as a device that measures at least one of temperature, humidity, radiation levels, force, pH level, electrical conductance, electrical impedance, electromagnetic spectrum properties, visual appearance and / or chemical composition of the target tissue.

22. The conduit and insert assembly of any of the above claims, wherein an intervention delivered to target tissue via the conduit and insert assembly include at least one of brachytherapy, cryotherapy, hyperthermia, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulation of tissue, massage, microneedling, topical application of medication, and / or injection of medication.

23. The conduit and insert assembly of any of the above claims, wherein the conduit is configured to cooperate with an applicator to deliver an intervention to target tissue.

24. The conduit and insert assembly of claim 23, wherein a shape of the applicator is adjustable.

25. The conduit and insert assembly of claim 23 or 24, wherein the applicator comprises a plurality of ports into which the conduit may be inserted.

26. The conduit and insert assembly of claim 23, 24, or 25, wherein the conduit may be inserted into one or more of the plurality of ports.

27. A method for treating target tissue of a patient using the conduit and insert assembly of any of the above claims.

28. A method for treating target tissue of a patient comprising: positioning an insert at a desired position within a conduit positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon; and initialing and / or maintaining performance of the action by the insert at the desired position.

29. The method of claim 28, further comprising: receiving an intervention plan for treating the target tissue, wherein the positioning of the insert and / or duration of time spent at the position is responsive to the intervention plan.

30. The method of claim 28 or 29, wherein the action is at least one of delivery of a treatment modality, delivery of medication, delivery of heat, delivery of cryotherapy, taking a measurement device, shielding target tissue, delivery of brachytherapy, delivery of laser therapy, delivery of ultrasound therapy, delivery of radiofrequency ablation (RFA) therapy, delivery of microwave therapy, delivery of electroporation therapy, physical manipulation of tissue, massage, microneedling, topical application of medication, and / or injection of medication.31 .The method of any of claims 28-30, wherein the desired position is a first desired position, the method comprising: following performance of the action, moving the insert to a second desired position within the conduit; and initialing and / or maintaining performance of the action by the insert at the second desired position.

32. The method of any of claims 28-31 , wherein the insert is a first insert, the method further comprising: removing the first insert from the conduit; positioning a second insert at a desired position within the conduit positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon; andinitialing and / or maintaining performance of the action by the second insert at the desired position.

33. The method any of claims 28-32, wherein the first insert applies a first therapy to the target tissue and the second insert applies a second therapy to the target tissue.

34. The method of any of claims 28-33, wherein the first insert applies a therapy to the target tissue and the second insert measures a result of the application of the therapy to the target.

35. The method of any of claims 28-33, wherein the insert is a first insert and the conduit is a first conduit, the method further comprising: positioning a second insert at a desired position within a second conduit positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon; and initialing and / or maintaining performance of the action by the second insert at the desired position.

36. The method of any of claims 28-34, wherein the first insert applies a therapy to the target tissue and the second insert protects tissue proximate to the target tissue from the therapy while it is being applied by the first insert.

37. The method of any of claims 28-36, wherein the conduit is a first conduit, the method further comprising: removing the insert from the first conduit; positioning the insert at a desired position within the second conduit, the second conduit being positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon; and initialing and / or maintaining performance of the action by the insert at the desired position within the second conduit.

38. The method of any of claims 28-37, wherein the insert is a first insert and the conduit is a first conduit, the method further comprising: positioning a second insert at a desired position within a second conduit positioned proximate to target tissue of a patient, the desired position being proximate enough to the target tissue to perform an action thereon; and initialing and / or maintaining performance of the action by the second insert at the desired position.

39. The method of claim 38, wherein the second insert protects tissue proximate to the target tissue from the action performed by the first insert.

40. The method of any of claims 28-39, wherein the method is performed by at least one of a clinician and a robot.41 .A method of generating an intervention plan for treating target tissue of a patient comprising: receiving information about the target tissue and one or more conduit and insert assemblies, the one or more conduit and insert assemblies comprising: a conduit with a first end, a second end, and a lumen extending between the first and second open ends, the first end being open to the lumen and the lumen being configured to accept insertion, positioning, and repositioning of an insert within the lumen; and the insert, the insert being configured to be inserted into the first end of the conduit and moved within the lumen to a position proximate to target tissue of a patient; and generating an intervention plan for the target tissue, the intervention plan including instructions for treating the target tissue with the one or more conduit and insert assemblies; and providing the intervention plan to a clinician.

42. The method of claim 41, wherein the intervention plan includes at least one of a type, size, and configuration of conduits and / or inserts used to treat the target tissue.

43. The method of claim 41 or 42, wherein the insert is communicatively coupled to a functionality support device, the method comprising: receiving information about the communication between the functionality support device and the insert, wherein the generating of the intervention plan is responsive to the information about the communication between the functionality support device and the insert.

44. The method of any of claims 41-43, wherein the intervention plan includes instructions for placing and holding the insert within the conduit so that it reaches a desired position and remains in the desired position for a length of time defined by the intervention plan.

45. The method of any of claims 41-44, further comprising:receiving an indication that the insert is positioned at the desired position within the conduit; and activating the insert according to the intervention plan.

46. The method of any of claims 41-45, further comprising receiving information about the patient, wherein the intervention plan is responsive to the received information about the patient.

47. A system for planning and delivering multi-modality interventions to patient tissue, comprising: a conduit network configured to be placed on or within the tissue, the conduit network comprising a plurality of conduits with lumens configured to cooperate with an insert, the conduits of the plurality of conduits being arranged in a grid or array of predefined positions; one or more inserts configured to traverse a lumen of a conduit of the plurality of conduits to deliver one or more intervention modalities to specific locations of the grid or array; a functional support device operatively coupled to the one or more inserts and configured to actuate and / or communicate with the one or more inserts; a memory with a stored set of instructions thereon, which executed by a processor, cause the processor to:(i) digitally represent the conduit network and its associated positions;(ii) model intervention variables, including insert modality type, modality delivery parameters, and tissue characteristics;(iii) receive therapeutic objectives;(iv) determine an efficient configuration of a plurality of intervention modalities using a result of the modeling and the received therapeutic objectives; and(iv) generate an intervention plan using the efficient configuration of intervention modalities, the intervention plan specifying the locations, durations, and combinations of intervention modalities to be delivered via conduits of the conduit network and inserts placed within the conduits of the conduit network; and the processor in communication with the memory, the processor being configured to execute the set of instructions stored in the memory.

48. The system of claim 47, further comprising:a feedback system configured to receive data from the target tissue or the conduit network and communicate the data to the processor, wherein the set of instructions further include a set of instructions for updating an intervention plan responsively to received data, which when executed by a processor, cause the processor to: dynamically update the intervention plan responsively to the received data.

49. The system of claim 47, further comprising: a feedback system configured to receive data from the target tissue or the conduit network and communicate the data to the processor, wherein the set of instructions further include a set of instructions for updating an intervention plan responsively to received data, which when executed by a processor, cause the processor to: iteratively refine the intervention plan during the delivery phase.

50. The system of claim 48 or 49, wherein the feedback system is an imaging device, tactile feedback provided to a user of the system and input into the processor, and communication between a conduit and / or an insert and the processor.51 .The system of any of claims 47-50, wherein determining an efficient configuration of modalities comprises use of an optimization algorithm.

52. The system of claim 51 , wherein use of the optimization algorithm includes use of linear programming or genetic algorithms to balance intervention objectives such as dose distribution, treatment efficacy, normal tissue avoidance, and / or procedural efficiency.

53. The system of any of claims 47-52, wherein the modelling of intervention variables employs machine learning models.

54. The system of any of claims 47-53, wherein the machine learning models employ neural networks and decision trees to analyze historical intervention data and predict optimal configurations for a given patient-specific tissue characteristic.

55. The system of any of claims 47-54, wherein the digital representation of the conduit network and its associated positions is at least one of a multidimensional vector, a matrix, and a tensor.

56. The system of claim 55, wherein the modeling is performed using the at least one of a multidimensional vector, a matrix, and a tensor.

57. A method for delivering multi-modality interventions to patient tissue, comprising:generating, by a processor, a digital representation of a conduit network, the conduit network comprising a plurality of conduits with lumens configured to cooperate with an insert and arranged in a grid or array of predefined positions; associating, by the processor, intervention variables with the digital representation of the conduit network, the intervention variables including insert types, tissue characteristics, intervention modality types, and intervention modality delivery constraints; modeling, by the processor, the conduit network and intervention variables; and generating, by the processor, an intervention plan specifying locations within the conduit network to apply interventions, durations of application of an intervention within the conduit network, and combinations of intervention modalities to be applied within the conduit network.

58. The method of claim 57, further comprising: receiving, by the processor, an indication that the conduit network has been placed on or within the patient tissue in accordance with the intervention plan; and actuating, by the processor, inserts through the conduit network to deliver the planned intervention modalities to the specified locations within the conduit network in accordance with the intervention plan responsively to the received indication.

59. The method of claim 58, further comprising: receiving, from the processor, feedback from the tissue during the intervention and dynamically adjusting the intervention plan based on the feedback.

60. The method of claim 57, 58, or 59, wherein the modeling comprises modeling the conduit network and intervention variables as mathematical constructs selected from the group comprising multidimensional vectors, matrices, and tensors.

61. The method of claim 60, wherein generating the intervention plan further comprises applying computational algorithms, including optimization and artificial intelligence algorithms, to the mathematical constructs to generate the intervention plan.

62. The method of any of claim 57-61 , wherein further comprising employing63. The method of any of claims 57-62, wherein generating the intervention plan further comprises simulating multiple intervention strategies and evaluating tradeoffs among competing therapeutic objectives.

64. The method of any of claims 57-63, further comprising predicting the combined effects of multiple intervention modalities on pathological and surrounding healthy tissues.

65. A computer-readable medium storing instructions that, when executed by a processor, cause a system to: generate a digital representation of a conduit network, the conduit network comprising a plurality of conduits with lumens configured to cooperate with an insert and arranged in a grid or array of predefined positions; associate intervention variables with the digital representation of the conduit network, the intervention variables including insert types, tissue characteristics, intervention modality types, and intervention modality delivery constraints; model the conduit network and intervention variables; and generate an intervention plan specifying locations within the conduit network to apply interventions, durations of application of an intervention within the conduit network, and combinations of intervention modalities to be applied within the conduit network.

66. The computer-readable medium of claim 65, wherein the instructions further cause the system to integrate feedback from sensors or imaging devices to iteratively update the intervention plan during execution.

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