Composable and multi-modal system for applying interventions on surfaces and volumes of patient tissue

Abstract

Systems, methods, and apparatus for planning and delivering multi-modal interventions with enhanced precision and flexibility utilize a network of catheters that form an array of pre-defined locations on or within a target tissue. Software can digitally represent the network of catheters and intervention variables, enabling the generation of spatial and temporal intervention plans that apply specified modalities. Functional support apparatus actuate inserts through the network of catheters to deliver interventions according to the plan. To optimize spatial and temporal combinations for better therapeutic outcomes, reduced toxicity, and streamlined workflows, planning can be enhanced by representing intervention locations and other variables in the network of catheters with mathematical structures, such as multi-dimensional vectors, matrices, or tensors. In doing so, 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 consistency with therapeutic goals.

Description

Related Applications

[0001] This application is an international (PCT) application of U.S. Provisional Patent Application No. 63 / 601,213, filed on November 20, 2023, entitled “COMPOSABLE, MULTI-MODAL SYSTEMS AND DEVICES FOR APPLYING ONE OR MORE INTERVENTIONS ACROSS SURFACES AND / ORVOLUMES”, which is incorporated herein by reference. Technical Field

[0002] This application generally relates to medical devices, systems, and methods of use. In particular, this application relates to combinatorial multimodal systems and / or devices for applying one or more interventions to the surface and / or volume of a patient's anatomy. Background Technology

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

[0004] A major limitation lies in the reliance on handheld devices for applying these modalities to target tissue. Common examples include topical sprays, intervention needles, and ultrasound probes. The manual nature of these interventions, combined with the irregular shape of anatomical surfaces and tissue volumes, limits the geometrical precision of modal application. Therefore, achieving precise spatial distribution of interventions on target tissue becomes challenging.

[0005] Another limitation concerns the implementation of multimodal interventions, which are often required in complex clinical scenarios. In existing technologies, each modality typically requires a separate device and its own planning and delivery workflow. Therefore, combining multiple modalities is time-consuming, costly, and procedurally inefficient. This fragmented approach inherently compromises the geometrical coordination of the modalities and limits the ability to accurately calculate their combined effects. Summary of the Invention

[0006] This disclosure provides a system and method for delivering multimodal interventions to surface or internal tissues of a patient with improved precision, efficiency, and versatility. Specifically, the system includes a catheter-insertion network designed to facilitate the accurate application of multiple modalities within a customized geometry corresponding to the target tissue.

[0007] In the disclosed system, a network of catheters is placed on or within tissue, creating a grid or lattice of locations whose coordinates define precise locations for modal delivery. This network is mapped to a digital representation in software, enabling users to model, plan, and optimize interventions. The software determines the type, combination, and spatial configuration of modalities, as well as the corresponding catheter locations and duration of application. Functional support devices operatively connected to the software actuate inserts through the catheter network to deliver the planned intervention at pre-specified locations.

[0008] This system can actuate different inserts simultaneously or sequentially based on user-defined goals. For example, a therapeutic insert delivering a treatment modality can be paired with a measurement insert in a nearby catheter to assess real-time treatment efficacy. Alternatively, multiple therapeutic inserts can be applied sequentially to the same tissue volume, thereby enabling temporal combinations of modalities to enhance treatment efficacy.

[0009] Workflow flexibility is a key advantage of this system. In one implementation, the catheter is placed on or within the patient's tissue prior to software planning. This placement can be digitized using sensors, photography, or diagnostic imaging, and the resulting data is transmitted to the software used for intervention planning. In another implementation, the intervention is first planned within the software using input data about the target tissue, such as images or diagnostic scans. The virtual catheter placement is iteratively optimized, and then the physical placement of the catheter is performed to reproduce the virtual configuration.

[0010] Catheter placement can be performed manually or with robot assistance to ensure high fidelity between physical placement and software-generated plans. Optional applicators, which can be rigid or articulated, can further improve the accuracy of catheter placement by conforming to the shape of the underlying tissue and providing a guide path for catheter insertion.

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

[0012] For example, linear programming or genetic algorithms can be used to find the optimal catheter insertion arrangement that balances multiple objectives, such as dose distribution and procedural constraints. Furthermore, 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 be dynamically adjusted by incorporating feedback from real-time monitoring of the intervention, thus iteratively refining the plan based on observed effects.

[0013] Furthermore, artificial intelligence (AI) algorithms extend the system's capabilities by enabling automated decision-making and planning for complex scenarios. AI can simulate the potential outcomes of various intervention strategies, assess trade-offs between competing goals, and generate highly customized plans to suit the individual patient's anatomy and conditions. For example, AI-driven simulations may predict the combined effects of multiple modalities on pathological tissue and surrounding healthy tissue, providing insights into how to adjust interventions to achieve maximum benefit.

[0014] The disclosed system addresses the shortcomings of existing technologies by providing a comprehensive solution for applying single or multimodal interventions precisely, efficiently, and universally to different anatomical and clinical settings.

[0015] The catheter and insert assembly disclosed herein may include one or more (e.g., 2 to 250) catheters having a first end, a second end, and a lumen extending between the first and second ends. The lumen may be configured to receive insertion, positioning, and repositioning of an insert within the lumen, and in some cases, the first end of the catheter may be open, thereby providing access to the lumen. In some embodiments, the second end may be open, allowing the insert therein to extend beyond the second end. Alternatively, the second end may be closed, preventing the insert from extending beyond the second end, which may be advantageous in situations where exposure of the insert to tissue is not preferred. Additionally or alternatively, features of the catheter may be specifically designed for functions performed by the insert.

[0016] The inserter can be configured to be inserted into the first end of the catheter and moved within the lumen to a location adjacent to the patient's target tissue, enabling it to perform one or more tasks and / or provide one or more interventions on the target tissue. In some embodiments, the catheter may include multiple position indicators positioned thereon.

[0017] The catheter can be flexible, allowing it to bend or flex to navigate through and / or adjacent to target tissue. In some cases, the catheter may contain metal, plastic, vinyl, rubber, latex, silicone, and / or combinations thereof. Additionally or alternatively, the catheter may be bioabsorbable, radio-opaque, porous for measuring tissue properties, configured to release therapeutic agents, heat-resistant, configured to conduct electricity, configured to shield electricity, configured to conduct heat, configured to perform measurements, configured to shield (radioactively or otherwise) tissue, configured to deliver therapy, and / or configured to shield heat.

[0018] In some implementations, the catheter and insert assembly may include a removable stylet extending through a portion or the entire length of the lumen. The stylet may be configured to increase catheter stiffness and / or improve catheter maneuverability as it traverses patient tissue to within and / or adjacent to target tissue. Once the catheter is in place, the stylet can be removed from the lumen, allowing the insert to be inserted into the catheter during insertion.

[0019] A catheter and insert assembly comprising multiple catheters can be configured such that one or more inserts can simultaneously or sequentially deliver different treatments and / or collect different measurements at multiple catheter and / or insert locations during a single encounter with a patient.

[0020] Inserts included in and / or used with the catheter and insert assemblies disclosed herein may include metals, wires, fiber optic cables, plastics, vinyl, and / or combinations thereof. In some cases, the insert may have an active tip, such as a drug-impregnated absorbent pad, a temperature probe, a needle tip, a radioactive material, a measuring device, a therapeutic device, and / or combinations thereof. Additionally or alternatively, the insert may be configured as, for example, a therapeutic modality, a measuring device, a radiation shielding device, a heating device, a radiator, a cryotherapy device, a protective device, and / or a device for measuring or detecting the temperature, humidity, radiation level, force, pH level, conductivity, impedance, electromagnetic spectrum characteristics, visual appearance, and / or chemical composition of target tissue.

[0021] The use and / or operation of the catheter and insert assembly disclosed herein can be controlled by, for example, a clinician, a software interface, a processor, and / or a robot. For example, placement of the catheter on a patient's surface, insertion of the catheter into the patient's tissue, and / or movement of the insert within the catheter can be controlled by a clinician, a software interface, a processor, and a robot.

[0022] In some cases, the insert can be activated before insertion into the catheter or when it is in the desired position within the catheter.

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

[0024] In some implementations, one or more catheters of the catheter and insert assembly may be configured to cooperate with an applicator or retainer to deliver an intervention to target tissue. The applicator may be specific to the use of the catheter and insert assembly, and in some cases, the applicator may be adjustable in size and / or shape. Typically, the applicator may include one or more ports into which the catheter can be inserted in any desired pattern. For example, an exemplary applicator may include sixteen ports arranged in a grid pattern, and the catheter may be inserted into any of these ports (e.g., 1 to 16) in any suitable pattern to treat the target tissue. Once the catheter is positioned in the applicator, an insert can be advanced into the lumen of the corresponding catheter, allowing the intervention to be applied to the target tissue. Additionally or alternatively, the catheter may reside in all ports of the exemplary applicator, and the insert may be inserted into some (e.g., 1 to 15) or all (in this case, 16) of the catheters in a manner consistent with the intervention plan.

[0025] Methods of treating a patient’s target tissue using the catheter and insert assembly disclosed herein may include positioning the insert at a desired location within the catheter, which is positioned adjacent to the patient’s target tissue. The desired location may be sufficiently close to the target tissue (e.g., in contact with a surface, inserted into a surface, and / or within a target distance from a surface) to perform an action thereon, and once the location is reached, the action may be initiated and / or maintained at the desired location for a period of time, as may be prescribed by an intervention program (e.g., disclosed herein).

[0026] Exemplary actions include, but are not limited to, delivery of therapeutic modalities, delivery of drugs, delivery of heat, delivery of cryotherapy, use of measuring devices, shielding of 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 therapy, topical application of drugs and / or drug injection.

[0027] In some implementations, the insert can be moved to multiple locations within the catheter, as specified by the intervention plan. Additionally or alternatively, the insert can be used in multiple catheters and / or multiple inserts can be used in the same and / or different catheters, as specified by the intervention plan. For example, in one implementation, a first insert can be removed from a first catheter, and a second insert can be positioned within the first catheter at a desired location within the catheter, positioned adjacent to the patient's target tissue, the desired location being sufficiently adjacent to the target tissue to perform an action thereon. The action of the second insert can then be initiated and / or performed at the desired location in response to, for example, the intervention plan. For example, the first insert can apply a first therapy to the target tissue, and the second insert can apply a different (e.g., the same intervention but a different dose or a different intervention) second therapy to the target tissue. Alternatively, the first insert can apply a treatment or intervention to the target tissue, and the second insert can measure the outcome of the treatment / intervention applied to the target and / or protect adjacent target tissue from the effects of treatment when treatment is applied by the first insert.

[0028] In some implementations, the inserter can be used in multiple catheters and / or at multiple locations within the catheters during intervention. For example, the inserter can be removed from a first catheter and then inserted / positioned within a second catheter positioned adjacent to (e.g., adjacent to the first catheter, which is spatially separated from the second catheter and adjacent to a different region of the target tissue, etc.) the patient's target tissue. The action performed by the inserter can then be activated or retained within the second catheter.

[0029] In some implementations, an intervention plan for treating a patient's target tissue can be generated by receiving information about the target tissue and one or more catheter and insert assemblies (such as those disclosed herein). The intervention plan can be generated, for example, by a processor and / or software running on the processor, and can include instructions for treating the target tissue using one or more catheter and insert assemblies and / or one or more inserts used within one or more catheters. Once generated, the intervention plan can be provided to a clinician. In some cases, the intervention plan may include instructions regarding the type, size, dosage, function, and / or configuration of the catheters and / or inserts used for treating the target tissue. Typically, the intervention plan includes instructions for placing and holding one or more inserts at one or more desired locations within one or more catheters, such that each insert reaches the desired location and remains in the desired location for a duration defined by the intervention plan.

[0030] In some embodiments, one or more inserts used with a treatment plan may be communicatively coupled to a functional support device, such as a drug source, energy source, heat source, cold source, radiation source, etc., and in these embodiments, information regarding communication between the functional support device and the inserts (e.g., fluid communication, near-field communication, radio frequency identification, etc.) 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 the insert is positioned at a desired location within the catheter, indicated by (e.g., tactile feedback, visual observation (e.g., naked-eye or imaging device (e.g., ultrasound)) and / or communication between the insert and a processor that administers and / or generates the intervention plan).

[0031] In some embodiments, a system for planning and delivering multimodal interventions to patient tissue may include a network of catheters configured to be placed on or within the tissue, the network comprising a grid or matrix of predefined locations for delivering the intervention. Additionally or alternatively, the catheter network may include an applicator and / or be configured to cooperate with an applicator having multiple ports arranged in the form of a grid or matrix of predefined locations for delivering the intervention. The applicator may also facilitate delivery and / or placement of the working end of each catheter in the catheter network adjacent to the patient's target tissue. In some embodiments, the applicator may have a flexible shape and / or size (e.g., expandable or retractable) such that it can be bent or hinged to conform to the target tissue.

[0032] In some embodiments, a system for planning and delivering multimodal interventions to patient tissue may include a network of catheters configured to be placed on or within the tissue. The catheter network may include multiple catheters, such as those disclosed herein, arranged in a form such as a two-dimensional or three-dimensional grid, array, lattice, shape, contour, and / or irregular arrangement with predefined locations. The system may also include one or more inserts, each configured to pass through the lumen of a catheter among the multiple catheters to deliver one or more intervention modalities to specific locations within the catheter network grid or array. One or more inserts may be communicatively and / or operatively coupled to a functional support device (e.g., a heat source, cold source, radiation source, drug source, observation device (e.g., fiber optic or camera)), the functional support device being configured to realize and / or actuate the function of one or more inserts and / or communicate with one or more inserts. The system may also include memory storing a set of instructions executable by a processor, causing the processor to represent the catheter network and its associated locations digitally as, for example, multidimensional vectors, matrices, and / or tensors; model intervention variables, including insertion modality type, modality delivery parameters, and tissue characteristics, using, for example, machine learning and / or AI models; receive treatment goals; determine an effective configuration of the intervention modality using the modeling results and the received treatment goals; and generate an intervention plan using the effective configuration of the intervention modality. In some cases, generating an intervention plan may include applying computational algorithms (including optimization and artificial intelligence algorithms) to the data and / or catheter network, insertion, intervention modality, and / or its mathematical construction. In some embodiments, generating an intervention plan may include simulating multiple intervention strategies and evaluating trade-offs between competing treatment goals and / or predicting the combined effects of multiple intervention modalities on pathological tissue and surrounding healthy tissue.

[0033] Intervention plans can specify the location, duration, and / or combinations thereof of intervention modalities to be delivered via catheters in a catheter network and inserts placed within the catheters in the catheter network. In some cases, determining an efficient configuration of the intervention modality may include using optimization algorithms (e.g., linear programming or genetic algorithms) to balance intervention objectives (e.g., dose distribution, therapeutic efficacy, normal tissue avoidance, and / or procedural efficiency). In some implementations, modeling of intervention variables employs machine learning models, multidimensional vectors, matrices, and / or tensors. In some cases, machine learning models may employ neural networks and / or decision trees to analyze historical intervention data and / or predict the optimal configuration of treatment modalities for a given patient-specific tissue characteristic. Additionally or alternatively, modeling may include modeling the catheter network, inserts, and / or intervention variables as mathematical constructs selected from a group comprising multidimensional vectors, matrices, and tensors.

[0034] In some embodiments, the system may further include a feedback system configured to receive data from target tissue or a network of catheters and transmit the data to a processor. The instruction set further includes a set of instructions for updating the intervention plan in response to the received data. When executed by the processor, this set of instructions causes the processor to dynamically update the intervention plan in response to the received data and / or iteratively refine the intervention plan during the delivery phase using feedback, for example, from the feedback system. An exemplary feedback system includes an imaging device, tactile feedback provided to a system user, catheters and / or inserts, inputs to the processor, and communication between the catheters and / or inserts and the processor.

[0035] Additionally or alternatively, the method for delivering multimodal interventions to patient tissues may be performed by a processor or system (such as the system described herein) and may include: generating a digital representation of a catheter network comprising multiple catheters having lumens configured to mate with inserts and arranged in a grid or array at predefined locations; associating intervention variables with the digital representation of the catheter network, including insert type, tissue characteristics, intervention modality type, and intervention modality delivery constraints; modeling the catheter network and intervention variables; and generating an intervention plan specifying the location of the intervention within the catheter network, the duration of the intervention within the catheter network, and the combination of intervention modalities applied within the catheter network.

[0036] In some cases, an instruction may be received that the catheter network has been placed on or within the patient's tissue according to the intervention plan, and in response to the received instruction, the catheter network actuation insert may be used to deliver the planned intervention modality to a designated location within the catheter network according to the intervention plan.

[0037] In some implementations, the intervention plan can be updated and / or iterated in response to feedback from the organization during the intervention.

[0038] Any of the methods described herein can be instantiated as an instruction set stored in, for example, memory, a non-transitory machine-readable medium, a processor-readable medium, and / or a computer-readable medium. Attached Figure Description

[0039] The invention is illustrated in the accompanying drawings by way of example rather than limitation, wherein:

[0040] Figure 1A This is a block diagram of an exemplary system according to some embodiments of the present invention;

[0041] Figure 1B This is a block diagram of a first rectangular applicator with a single port according to some embodiments of the present invention;

[0042] Figure 1C This is a block diagram of a second rectangular applicator with two ports according to some embodiments of the present invention;

[0043] Figure 1D This is a block diagram of a third rectangular applicator having four ports arranged in two columns and two rows according to some embodiments of the present invention;

[0044] Figure 1E This is a block diagram of a circular applicator with four ports according to some embodiments of the present invention;

[0045] Figure 1F This is a block diagram of a rectangular applicator with four ports according to some embodiments of the present invention;

[0046] Figure 1G This is a side view of a third rectangular applicator according to some embodiments of the present invention;

[0047] Figure 1H This is a cross-sectional view of a system according to some embodiments of the present invention, the system comprising a component bent into a first configuration. Figure 1F A rectangular applicator with four ports;

[0048] Figure 1I This is a cross-sectional view of a system according to some embodiments of the present invention, the system comprising a component bent into a second configuration. Figure 1F A rectangular applicator with four ports;

[0049] Figure 2A This is a schematic diagram of a portion of a first catheter / insertion assembly according to some embodiments disclosed herein;

[0050] Figure 2B This is a schematic diagram of a portion of a second catheter / insertion assembly according to some embodiments disclosed herein;

[0051] Figure 3A This is a front view schematic diagram of a first dual-catheter system according to some embodiments disclosed herein;

[0052] Figure 3B This is a front view schematic diagram of a second dual-catheter system according to some embodiments disclosed herein;

[0053] Figure 3C This is a diagram of a first dual-catheter system / insertion assembly according to some embodiments disclosed herein;

[0054] Figure 3D This is a diagram of a second dual-catheter system / insertion assembly according to some embodiments disclosed herein;

[0055] Figure 3EThis is a figure of a first instance in a time series of the use of a single insert in a first dual-catheter system according to some embodiments disclosed herein;

[0056] Figure 3F This is based on some of the implementation methods disclosed herein. Figure 3E A graph of the second instance in the time series;

[0057] Figure 4A This is a front view schematic diagram of a third dual-catheter system according to some embodiments disclosed herein;

[0058] Figure 4B This is a front view schematic diagram of a fourth dual-catheter system according to some embodiments disclosed herein;

[0059] Figure 4C This is a diagram of a third dual-catheter system / insertion assembly according to some embodiments disclosed herein;

[0060] Figure 4D This is a diagram of a fourth dual catheter system / including an insert assembly of the fourth dual catheter system according to some embodiments disclosed herein;

[0061] Figure 4E This is a figure of a first instance in a time series of the use of a single insert in a third dual-catheter system according to some embodiments disclosed herein;

[0062] Figure 4F This is based on some of the implementation methods disclosed herein. Figure 4E A graph of the second instance in the time series;

[0063] Figure 5A This is a front view schematic diagram of a first three-catheter system according to some embodiments disclosed herein;

[0064] Figure 5B This is a front view schematic diagram of a second or third catheter system according to some embodiments disclosed herein;

[0065] Figure 5C This is a diagram of a first three-catheter system / insertion assembly according to some embodiments disclosed herein;

[0066] Figure 5D This is a diagram of a second or third catheter system / including an insert assembly of a second or third catheter system according to some embodiments disclosed herein;

[0067] Figure 5E This is a diagram of a first instance in the time series of some embodiments disclosed herein, and Figure 5F This is a graph showing the time series of the repeated use of inserts in the first three-catheter system according to some embodiments disclosed herein;

[0068] Figure 5F This is based on some of the implementation methods disclosed herein. Figure 5E A graph of the second instance in the time series;

[0069] Figure 5G This is a schematic diagram of the opening end of a catheter according to some embodiments disclosed herein;

[0070] Figure 6 This is a flowchart illustrating a process for generating an intervention plan according to some embodiments of the present invention, the intervention plan including the use of one or more catheter / catheter system and insert assemblies disclosed herein and activation of one or more inserts residing within a catheter and / or catheter arrangement to measure or deliver treatment to a patient's target tissue;

[0071] Figure 7 This is a flowchart illustrating a process of applying treatment to target tissue using one or more inserts according to some embodiments of the present invention;

[0072] Figure 8A This is a flowchart illustrating a process of applying treatment to target tissue using multiple individual catheters or one or more multi-catheter systems according to some embodiments of the present invention;

[0073] Figure 8B This illustrates some embodiments of the invention, such as... Figure 8A The flowchart of the first sub-process of the process shown is included.

[0074] Figure 8C This illustrates some embodiments of the invention, such as... Figure 8A The flowchart of the second sub-process of the process shown;

[0075] Figure 9A This is a schematic diagram of a two-dimensional flat surface of a patient according to some embodiments disclosed herein, on which Cartesian grid points (represented as circles or dots) or coordinates are superimposed;

[0076] Figure 9B This is a schematic diagram of an uneven or curved surface of a patient according to some embodiments disclosed herein, on which Cartesian grid points (represented as circles or dots) or coordinates are superimposed; and

[0077] Figure 9C This is a schematic diagram of the approximate spherical surface volume of a patient according to some embodiments disclosed herein, on which Cartesian grid points (represented as circles or points) or coordinates are superimposed;

[0078] Figure 9D It is a schematic diagram of the three-dimensional cube volume of a patient according to some of the embodiments disclosed herein, on which Cartesian grid points (represented as circles or points) or coordinates are superimposed;

[0079] Figure 10 This is a flowchart illustrating a process 1000 for generating an intervention plan for treating a target tissue using multiple individual catheters or one or more multi-catheter systems according to some embodiments of the present invention.

[0080] Throughout the accompanying drawings, unless otherwise stated, the same reference numerals and characters are used to denote the same features, elements, components, or portions of the illustrated embodiments. Furthermore, although the invention will now be described in detail with reference to the accompanying drawings, this specification has been completed in conjunction with illustrative embodiments. Changes and modifications may be made to the described embodiments without departing from the true scope and spirit of the invention as defined by the appended claims. Detailed Implementation

[0081] This document discloses multifunctional devices, systems, and / or methods capable of delivering multiple intervention and / or treatment modalities to target tissues and / or adjacent tissues with high geometrical precision and flexibility, while enabling robust planning and execution workflows to optimize intervention efficacy and efficiency of intervention delivery. The systems and devices disclosed herein (in some cases, referred to herein as “catheter and insert assembly”) may include one or more geometrically arranged catheters (e.g., catheters or tubes), each configured to receive insertion and / or enable one or more functional inserts therein to be positioned (e.g., moved) to adjacent and / or inserted into the patient’s target tissues. Inserts may be, for example, intervention modalities, treatment modalities, measuring devices, and / or protective devices. Movement of the inserts within the catheter can be controlled manually and / or by a software interface, processor, and / or robot. One or more inserts may have the same or different functional modalities. In some cases, the catheter-insert system and insert assembly disclosed herein can be partially or completely operated robotically.

[0082] In some embodiments, the catheter-insertion systems and insert assemblies disclosed herein can be configured to cooperate with one or more support devices, enabling the insert to deliver different treatments and / or collect different measurements simultaneously or sequentially at multiple catheter and / or insert sites during a single contact with the patient. In some cases, the catheter-insertion systems and insert assemblies disclosed herein can provide or enable the composability and / or combined application of multiple therapeutic and diagnostic measurements at multiple sites within the patient, targeting the patient's target tissue via, for example, a grid or lattice network of locations distributed on the catheter-insertion system that can be adjacent to and / or contact the target tissue. Exemplary target tissues include, but are not limited to, tumors, lesions, cysts, moles, keloids, areas of skin discoloration, and / or scar tissue.

[0083] The inserts and insert components of the catheter-insert systems disclosed herein can be configured, for example, to facilitate treatment of a patient's target tissue, administer treatment to a patient at a desired location, shield and / or protect tissue adjacent to the target tissue, deliver medication to the target tissue, and / or collect information and / or measurements about the target tissue and / or the patient at one or more locations, such as within a catheter. In some cases, the insert can be activated prior to insertion into the catheter and / or activated (e.g., opened) once in the desired location within the catheter. Exemplary treatments that can be delivered to target tissue via one or more of the catheter-insert systems and devices disclosed herein include, but are not limited to, brachytherapy, cryotherapy, thermotherapy, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulations (e.g., massage or microneedling), and local or injectable medications. When the insert is a measuring device, it can be configured to measure, for example, the temperature, humidity, radiation level, force, pH level, conductivity, impedance, electromagnetic spectrum characteristics, visual appearance, and / or chemical composition of the target tissue (e.g., the concentration of a drug or hormone present in or adjacent to the target tissue). When the insert is a device configured to protect tissue and / or assist in delivering treatment to target tissue, the insert may include, for example, materials that block the movement of radioactive particles (e.g., lead), aspiration cannulas, and / or heat sinks.

[0084] In many cases, catheters can be flexible, such that their shape and / or configuration can be adapted or otherwise bent or flexed to be adjacent to target tissue, and the inserts described herein can be sufficiently rigid to be inserted into and / or move within the catheter, and sufficiently flexible to bend with the curvature of the catheter, for example, positioned adjacent to the target tissue. Catheters can comprise, for example, metals, plastics, vinyls, rubber, latex, silicone, and / or combinations thereof. In some cases, catheters can have specific properties, such as reabsorbability that allows them to remain within tissue, porosity for measuring tissue properties or therapeutic agent release, and / or radio opaqueness for visualization during fluoroscopy or other imaging procedures. In some embodiments, the walls of the catheters can have variable thickness or be hollow, allowing them to be filled with liquid / metal / gas. Similarly, catheters can have asymmetrical combinations of these features. Inserts can be made of, for example, metals, wires, fiber optic cables, plastics, vinyls, and / or combinations thereof. In some cases, the insert may have an edged tip, such as a drug-impregnated absorbent pad, temperature probe, needle tip, and / or radioactive material. In some cases, the catheter system disclosed herein may be configured to receive multiple inserts at the same time and / or at different times (e.g., a first insert is positioned within the catheter and subsequently removed from the catheter, and a second insert is inserted into the same catheter). In some embodiments, the catheter may be configured to function without an insert and / or the insert may be configured to function without a catheter.

[0085] The systems, apparatus, and methods disclosed herein enable users to comprehensively combine multiple therapeutic and / or diagnostic modalities on the surface or volume of any tissue (e.g., target tissue). The deployment of the various therapeutic and diagnostic modalities can be controlled by software and / or hardware that guides functional inserts to grid or lattice grid locations within a catheter, the catheter being geometrically positioned adjacent to the target tissue, which can be, for example, a surface of interest (e.g., skin, organ surface, bone, ligament) or within a volume of interest (e.g., a hollow organ or cavity). In some cases, the interventions disclosed herein may involve the application of one or more therapies to the target tissue, and in some instances, "intervention" and "therapy" may be used interchangeably herein.

[0086] Now turn to the attached image. Figure 1AThis is a block diagram of an exemplary system 100 that can be used to treat a patient's target tissue using one or more of the devices, systems, and / or methods disclosed herein. System 100 includes: a computer / processing unit 105, a database 125, a controller 115, multiple (first to nth) insert function support devices 110A, 110B, 110C to 100N, one or more optional port applicators 120, and one or more catheters and / or inserts 130 coupled to one or more port applicators 120. Although shown as separate components, two or more components of system 100 may reside in the same housing and / or device. One or more catheters and / or inserts 130 may include any of the catheters, inserts, and / or catheter-insert systems and insert assemblies disclosed herein.

[0087] Each of the multiple insert function support devices 110A, 110B, 110C to 110N can be configured to couple a corresponding insert to one or more catheters either via direct coupling or via one or more applicators 120 to provide and / or facilitate the provision of one or more functions (e.g., heat, radiation, medication, vacuum, etc.) to one or more inserts. In some embodiments, coupling an insert to one or more function support devices 110A, 110B, 110C to 110N can activate (e.g., open or initiate the delivery of medication to the absorbent pad of the insert) the insert. Additionally or alternatively, the insert can be activated when the function support devices 110A, 110B, 110C to 110N are opened and / or begin supplying functionality to the insert. In some cases, the insert can perform its function without being coupled to the function support devices 110A, 110B, 110C to 110N, for example, when the insert can be heated, cooled, and / or immersed in medication prior to use. Alternatively, when the insert performs a protective and / or absorbing function (e.g., lead for preventing accidental exposure to radiation or thermal insulation for preventing undesirable tissue heating or cooling), the insert may not be coupled to the functional support devices 110A, 110B, 110C to 110N.

[0088] In some embodiments, the insert can be driven through a catheter to a desired location by being attached to a filament, which is moved by a device and / or component (e.g., a robot and / or a mechanism that rotates a filament reel to push the filament forward or pull it backward) residing within one or more of the insert functional support devices 110A, 110B, 110C to 110N. Additionally or alternatively, one or more of the functional support devices 110A, 110B, 110C to 110N can be directly coupled to the catheter. For example, the material of the catheter itself can be used for treatment or measurement without requiring a dedicated insert.

[0089] The computer / processing unit 105 may be configured to, for example, perform one or more of the methods disclosed herein. In some embodiments, the computer / processing unit 105 may be a neural network, an AI engine, an AI architecture, a machine learning architecture, a computational engine, a simulation engine, and / or a computer modeling apparatus. In some cases, the computer / processing unit 105 and / or the database 125, or the apparatus communicating with the computer / processing unit 105 and / or the database 125, may reside in a desktop and / or cloud computing environment. Additionally or alternatively, the computer / processing unit 105 may be configured to generate or otherwise design an intervention plan for a patient's target tissue, which utilizes the systems and / or apparatuses disclosed herein to treat the target tissue using a composable set of interventions on a desired geometry. Intervention plans can be generated using information such as that about the patient (e.g., age, sex, 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 catheter and its location therein, how the catheter system, catheter-insertion system will be positioned near the target tissue (e.g., via a natural or surgical opening), and / or information about the inserts available for treating the target tissue. Intervention plans may include, for example, the type, size, and / or configuration of the catheter and / or inserts used to treat the target tissue. Additionally or alternatively, intervention plans may include, for example, the type, size, duration, intensity, and / or location within the catheter where the insert may be positioned for use in treating or measuring the target tissue. In some implementations, intervention plans may model the treatment effect or its distribution on a patient representation (e.g., photographs, diagnostic images), including the effects of combining different treatment modalities. A dedicated coordinate system can be used to guide the intervention to specific locations accessible by the catheter system and to model the effects of the intervention. Intervention plans may require users to specify predefined locations on the catheter for functional deployment and / or the intervention plan may enable the insert to be positioned at locations defined in the intervention plan (e.g., based on the distance the insert travels from the functional support device via the catheter).

[0090] Optional applicator 120 can be used to configure the catheter position to a desired geometric configuration on the patient surface or within a tissue volume. Additionally or alternatively, applicator 120 can also be used to couple an insert to the correct catheter and / or hold the catheter and / or insert in place relative to the target tissue. Applicator 120 can be of any size and / or shape and can include any number of ports 140, which may or may not be used according to the intervention plan described herein. Applicator 120 can be rigid or have independently articulated or movable components to conform to patient tissue. Specific applicator 120 sizes, shapes, and / or number of ports can be selected for use in response to, for example, catheter type, insert type, target tissue size, in vivo location, and / or type.

[0091] Figures 1B to 1F These are block diagrams of exemplary top views of exemplary dispensers 120B to 120F, wherein Figure 1B A first rectangular applicator 120B with a single port 140 is shown; Figure 1C A second rectangular applicator 120C with two ports 140A and 140B is shown; Figure 1D A third rectangular dispenser 120D is shown, having four ports 140A, 140B, 140C and 140D arranged in two columns and two rows. Figure 1E A circular dispenser 120E with four ports 140A, 140B, 140C, and 140D is shown; and Figure 1F A rectangular applicator 120F with four ports 140A, 140B, 140C and 140D is shown. Figure 1G This is a side block view of a system 180 including a third rectangular applicator 120D, which has a first conduit 150A extending from a first port 140A and a second conduit 150B extending from a third port 140C. A first insert 160A is positioned within the first conduit 150A at a first dwell position, and a second insert 160B is positioned within the second conduit 150B at a second dwell position. Notably, Figures 1B to 1F This is an exemplary rigid applicator, but applicator 120 may also have movable or hinged components, for example, these components can help conform to the shape of the intended patient surface or volume. Figure 1H and Figure 1I Examples of it are provided. Figure 1HA cross-section of system 182 is provided, which includes a rectangular applicator 120F that has been bent into an arched configuration to conform to the shape of a curved target tissue. The bending of the rectangular applicator 120F can be performed before use (e.g., in a factory or laboratory, before contact with a patient) and / or during use. For example, a clinician can place the rectangular applicator 120F on the target tissue in an unbent or straight / flat shape, which can conform to the tissue upon contact with the tissue by, for example, pressing and / or gravity, through articulation of one or more movable and / or articulated components (e.g., joints, sutures, and / or shape memory materials). System 182 also includes four catheters 140A, 140B, 140C, and 140D, respectively positioned within each of four ports 140A, 140B, 140C, and 140D. Each of the catheters 140A, 140B, 140C and 140D has an insert 150A, 150B, 150C and 150D respectively positioned therein as shown in the figure.

[0092] Figure 1I A cross-section of system 184 is provided, which includes a rectangular applicator 120F, the rectangular applicator 120F being configured in a manner similar to... Figure 1HThe illustrated system is bent into an arched configuration to conform to the shape of a curved target tissue, the difference being that the arched shape of system 184 is more curved than that of system 182. Similar to system 182, system 184 also includes four catheters 140A, 140B, 140C, and 140D, respectively positioned within each of the four ports 140A, 140B, 140C, and 140D. Each of the catheters 140A, 140B, 140C, and 140D has an insert 150A, 150B, 150C, and 150D positioned therein, as shown. In some embodiments, the catheters and / or inserts of systems 180, 182, and / or 184 may all be identical and may be coordinated to deliver an intervention on the target tissue. Additionally or alternatively, one or more catheters and / or inserts of systems 180, 182, and / or 184 may deliver different interventions and / or measurement modalities. For example, insert 160B of system 180 can deliver drugs to a target or radiation to target tissue, and insert 160A can measure the target tissue's response to an intervention delivered by insert 160B (e.g., temperature, swelling, bleeding, etc.). In another embodiment, inserts 160B and 160C of system 182 can be configured to deliver heat to target tissue, and inserts 160A and 160D can be heat sinks or cryotherapy devices to contain the heat delivered to the target tissue and / or limit the effect of heat on specific portions of the target tissue. In another embodiment, inserts 160B and 160C of system 184 can be configured to create an incision in the target tissue, and inserts 160A and 160D can be configured as a suction cannula configured to aspirate blood or other fluids from tissue adjacent to a portion of the target tissue incised by inserts 160B and 160C. In another embodiment, inserts 160B and 160C of system 184 may be configured to deliver radiation to target tissue, and inserts 160A and 160D may be configured as radiation shields to shield tissue not intended (according to the intervention plan) to be exposed to radiation. Continuing with this embodiment, in some cases, shielding inserts (160A and 160D) and / or radiotherapy inserts (160B and 160C) may be removed from catheters 150A, 150B, 150C, and / or 150D, respectively, allowing for the application of a secondary intervention. Exemplary secondary interventions include using inserts configured to deliver heat, drugs, and / or cryotherapy to increase the efficacy of radiotherapy and / or patient comfort. Figure 2AThis is a schematic diagram of a portion of a first catheter / insertion assembly 201, which includes a catheter 220 (also referred to herein as the "first catheter") having a first position indicator 225A, a second position indicator 225B, a third position indicator 225C, a fourth position indicator 225D, a fifth position indicator 225E, and a sixth position indicator 225F. The first position indicator 225A, the second position indicator 225B, the third position indicator 225C, the fourth position indicator 225D, the fifth position indicator 225E, and / or the sixth position indicator 225F may be, for example, visual markers, radio-proof markers, and / or may be configured with short-range communication devices, such as radio frequency identification (RFID) transponders, configured to, for example, transmit information about the catheter (e.g., catheter type and / or configuration) and / or location identifiers to, for example, a receiver, which in some cases may be positioned on an insert located adjacent to and / or within the catheter 220. In some implementations, each of the first position indicator 225A, the second position indicator 225B, the third position indicator 225C, the fourth position indicator 225D, the fifth position indicator 225E, and the sixth position indicator 225F may have a different identifier (e.g., position 1, position 2, etc.) that can be broadcast or otherwise transmitted via a communication device. Figure 2A and Figure 2B As shown, the first position indicator 225A, the second position indicator 225B, the third position indicator 225C, the fourth position indicator 225D, the fifth position indicator 225E, and the sixth position indicator 225F are spaced approximately uniformly by a distance. For example, the distance between the second position indicator 225B and the third position indicator 225C is approximately equal to the distance between the third position indicator 225C and the fourth position indicator 225D, but this is not always the case. In some embodiments, each of the first position indicator 225A, the second position indicator 225B, the third position indicator 225C, the fourth position indicator 225D, the fifth position indicator 225E, and the sixth position indicator 225F may be determined at the time of intervention planning (e.g., based on the distance the insert travels from the functional support device), rather than being predetermined using position indicators.

[0093] The conduit 220 may be a hollow tube made of, for example, plastic, vinyl, shape memory plastic, etc., and may be configured to receive, move, and / or remove an insert (e.g., a first insert 240A) therein and / or from there. The conduit 220 may also be configured to withstand and / or assist one or more functions and / or actions performed by the insert. For example, the conduit 220 may be configured to be heat-resistant, electrically conductive, electrically insulating, thermally conductive, and / or thermally insulating. Figure 2AAs shown, catheter 220 is transparent so that it can be seen when the first insert 240A is inserted therein, but this is not always the case. For example, catheter 220 may be opaque or translucent. The exemplary insert is sized, shaped and / or configured to be inserted into and move within the lumen of catheter 220 to, for example, deliver treatment to a patient via catheter 220, perform measurements, provide light, protect tissue, etc.

[0094] In some cases, catheter 220 can be configured to be positioned adjacent to the patient's target tissue (e.g., at its top or inside), for example by applying catheter 220 and / or its tip to the target tissue, wrapping catheter 220 around all or part of the target tissue, and / or inserting catheter 220 into a natural lumen (e.g., mouth, urethra, etc.) and / or surgical incision (e.g., endoscope). Additionally or alternatively, catheter 220 can be configured for non-invasive use by positioning the tip of catheter 220 adjacent to the patient's target tissue, which is located on the patient's outer surface (e.g., skin or eye). When catheter 220 is in place relative to the patient's target tissue, a first insert 240A can be inserted into catheter 220 and positioned at a desired location within catheter 220, such as a first indicator position 225A, as... Figure 2A As shown. Alternatively, the catheter / insertion assembly 201 can be assembled before use with a patient, and then the assembly can be placed at the desired location adjacent to the target tissue.

[0095] In some embodiments, catheter 220 may be configured for direct insertion and / or application to target tissue. Additionally or alternatively, catheter 220 may be configured for use with an introducer and / or a core, which may, for example, be positioned within the lumen of catheter 220 and extend through the length of catheter 220 to increase the rigidity of catheter 220 and / or improve its operability during insertion. Once in place, the introducer and / or core can be removed, allowing one or more inserts to be inserted into the lumen.

[0096] When the catheter / insertion assembly 201 is positioned relative to the patient's target tissue and / or the insert 240A is correctly positioned within the catheter 220 and / or adjacent to the target tissue, the insert can be activated and / or used to deliver the relevant treatment to the target tissue for a first time period (e.g., 1 second to 10 minutes or 20 to 80 seconds). In some embodiments, the insert 240A can be repositioned within the catheter 220 after the first time period, and a second time period can be reactivated to deliver the intervention, for example, to different locations within the catheter, to intervene in different portions and / or entirely different parts of the target tissue. When the insert 240 is a measuring device, it can perform measurements continuously, periodically, and / or as needed. Active measurement while residing within the catheter 220 and / or activation to perform measurements at specific times. In some cases, the catheter system / insertion assembly 201 can be removed from the patient at the end of the first and / or second time periods.

[0097] In some embodiments, catheter 220 can be used to introduce multiple different inserts (e.g., inserts delivering different types of modalities and / or inserts providing various variations (e.g., doses) of the same modality) into the target tissue after a first and / or second time period (when using the first insert 240A). For example, Figure 2B This is a schematic diagram of a portion of a second catheter / insertion assembly 202, which includes a primary catheter 220, in which a second insert 240B is positioned, one end of which is positioned adjacent to a second position indicator 225B. The second insert 240B may be used similarly to the first insert 240A and / or in a manner similar to that described above with respect to the first insert 240A.

[0098] In some embodiments, (such as those disclosed herein) a catheter-insertion system may include multiple (e.g., 2 to 1600) catheters, which may be physically separated from each other and / or secured directly and / or indirectly to each other via, for example, sheaths, guide devices, chemical adhesives (e.g., glue and / or epoxy resin) and / or mechanical coupling mechanisms (e.g., clamps or straps). Additionally or alternatively, in some embodiments, one or more catheters of the catheter-insertion system may be attached to another object (e.g., a flat sheet covering tissue, a stent, and / or conforming to the surface of a balloon within a body cavity). Additionally or alternatively, two or more catheters may be individually introduced (e.g., through the same and / or different openings) into the patient or otherwise positioned adjacent to target tissue to form the catheter-insertion system in situ. For example, Figures 3A to 4DSchematic diagrams of catheter-insertion systems and insert assemblies comprising two catheters are provided. In these diagrams, the catheters are directly adjacent to each other, but they are not necessarily adjacent to each other. For example, in some embodiments, the catheters may be spatially separated and parallel to each other and / or oriented at an angle. In embodiments comprising two or more catheters, position indicators may be aligned with each other and / or offset from each other (they may be spatially separated). For example, particularly... Figure 3A A front view schematic diagram of a first dual-catheter system 301 is provided, which includes a first catheter 220 and a second catheter 320. The first catheter 220 has a first position indicator 225A, a second position indicator 225B, a third position indicator 225C, a fourth position indicator 225D, a fifth position indicator 225E, and a sixth position indicator 225F. The second catheter 320 includes the first position indicator 325A, the second position indicator 325B, the third position indicator 325C, the fourth position indicator 325D, the fifth position indicator 325E, and the sixth position indicator 325F. The positions of these position indicators are arranged to correspond to and / or align with the first position indicators 225A, the second position indicators 225B, the third position indicators 225C, the fourth position indicators 225D, the fifth position indicators 225E, and the sixth position indicator 225F of the catheter 220 as shown. Figure 3B This is a front view schematic diagram of a second dual-catheter system 302, which includes a first catheter 220 and a third catheter 331. The third catheter 331 includes a seventh position indicator 325G, an eighth position indicator 325H, a ninth position indicator 325I, a tenth position indicator 325J, and an eleventh position indicator 325K. The positions of these position indicators are arranged offset (e.g., located between) the corresponding positions of the first position indicators 225A, 225B, 225C, 225D, 225E, and 225F of the first catheter 220, as shown in the figure.

[0099] The first dual-catheter system 301 and / or the second dual-catheter system 302 can be configured to receive the insertion of two inserts (one for each catheter) simultaneously and / or at different times. The two inserts can each be positioned within their respective catheters in locations corresponding to one or more position indicators. In some embodiments, the two different inserts can provide the same and / or different functions and / or different doses (e.g., therapeutic modalities). For example, Figure 3CThis is a schematic diagram of a first dual-catheter system / insertion assembly 303, which includes a first dual-catheter system 301 (where both the first catheter 220 and the second catheter 320 are transparent), a first insert 240A (located at a first position indicator 225A of the first catheter 220), and a second insert 240B (located at a first position indicator 325A of the second catheter 320). In another embodiment, Figure 3D This is a schematic diagram of the second dual catheter system 304, which includes the second dual catheter system 302 (where the first catheter 220 and the third catheter 331 are both transparent), the first insert 240A (located at the second position indicator 225B of the first catheter) and the second insert 240B (located at the ninth position indicator 325I of the third catheter 331).

[0100] In some implementations, the same insert can be used in multiple catheters, for example by inserting the insert into a first catheter, removing it after a period of time, and then inserting it into a second catheter. Figure 3E and Figure 3F This is a time sequence of an embodiment of this implementation, wherein the first insert 240A is first positioned within the first conduit 220 (e.g., Figure 3E (as shown), and when the use of the first insert 240A within the first conduit 220 is complete, it is removed from the first conduit 220 and inserted into the second conduit 320 (as shown). Figure 3F (As shown).

[0101] Figure 4A This is a front view schematic diagram of a third dual catheter system 401, which includes a fourth catheter 420 and a fifth catheter 430, wherein position indicators of the fourth catheter 420 and the fifth catheter 430 are spaced apart from each other unequally along the lengths of the respective fourth catheter 420 and fifth catheter 430. Specifically, the fourth catheter 420 includes a first position indicator 425A, a second position indicator 425B, a third position indicator 425C, a fourth position indicator 425D, a fifth position indicator 425E, a sixth position indicator 425F, and a seventh position indicator 425G, and the fifth catheter 430 includes an eighth position indicator 435H, a ninth position indicator 435I, a tenth position indicator 435J, an eleventh position indicator 435K, a twelfth position indicator 435L, a thirteenth position indicator 435M, and a fourteenth position indicator 435N. These position indicators are arranged along the length of the fifth catheter 430 such that their positions correspond to the first position indicator 425A, the second position indicator 425B, the third position indicator 425C, the fourth position indicator 425D, the fifth position indicator 425E, the sixth position indicator 425F, and the seventh position indicator 425G of the fourth catheter 420, as shown in the figure. Figure 4B This is a front view schematic diagram of a fourth dual-catheter system 402, which includes a fourth catheter 420 and a sixth catheter 450. The sixth catheter 450 includes a twelfth position indicator 435O, a thirteenth position indicator 435P, a fourteenth position indicator 435Q, a fifteenth position indicator 435R, a sixteenth position indicator 435S, a seventeenth position indicator 435T, and an eighteenth position indicator 435U. The positions of these position indicators are arranged offset (e.g., located in between) from the corresponding positions of the first position indicator 425A, the second position indicator 425B, the third position indicator 425C, the fourth position indicator 425D, the fifth position indicator 425E, the sixth position indicator 425F, and the seventh position indicator 425G of the fourth catheter 420, as shown in the figure.

[0102] The third dual-catheter system 401 and / or the fourth dual-catheter system 402 can be configured to accept the insertion of two inserts (one for each catheter) simultaneously and / or at different times, for example, in a manner similar to the insertion and / or movement of the first insert 240A and / or the second insert 240B as shown and described herein. For example, Figure 4C This is a schematic diagram of a third dual-catheter system / insertion assembly 403, which includes a third dual-catheter system 401 (where the fourth catheter 420 and the fifth catheter 430 are both transparent), a first insert 240A (located at a first position indicator 425A within the fourth catheter 420), and a second insert 240B (located at a second position indicator 435B within the fourth catheter 430). As an additional embodiment, Figure 4D This is a schematic diagram of a fourth dual catheter system / insertion assembly 404, which includes a fourth dual catheter system 402 (where the fourth catheter 420 and the sixth catheter 450 are both transparent), wherein a first insert 240A is positioned at a second position indicator 425B within the fourth catheter 420, and a second insert 240B is positioned at a seventeenth position indicator 435Q within the sixth catheter 450.

[0103] and Figure 3E and Figure 3F As shown in the time series, a single insert can be used in both catheters of the third dual-catheter system 401 and / or the fourth dual-catheter system 402, and Figure 4E and Figure 4F The time series of embodiments that achieve this, wherein Figure 4E The diagram shows the first insert 240A initially positioned within the fourth catheter 420, and, upon completion of its use within the fourth catheter 420, removed and inserted into the fifth catheter 430, as shown. Figure 4F As shown.

[0104] For example, Figures 5A to 5D Schematic diagrams of catheter-insertion systems comprising three catheters are provided. In these diagrams, the catheters are directly adjacent to each other, but they do not necessarily have to be adjacent to each other (they can be spatially separated). Figure 5A This is a front view schematic diagram of a first three-catheter system 501, which includes a first catheter 220, a second catheter 320, and a seventh catheter 520, wherein position indicators of the first catheter 220, the second catheter 230, and the seventh catheter 520 are spaced apart from each other at equal lengths along the respective lengths of the first catheter 220, the second catheter 230, and the seventh catheter 520. In particular, the seventh catheter 520 includes a first position indicator 545A, a second position indicator 545B, a third position indicator 545C, a fourth position indicator 545D, a fifth position indicator 545E, and a sixth position indicator 545F. The positions of these position indicators are arranged along the length of the seventh catheter 520 to correspond to the first position indicators 225A, 225B, 225C, 225D, 225E, and 225F of the first catheter 220 and the first position indicators 325A, 325B, 325C, 325D, 325E, and 325F of the second catheter 320, as shown in the figure. Figure 5B This is a front view schematic diagram of a second three-catheter system 502, which includes a first catheter 220, a seventh catheter 520, and an eighth catheter 530. The eighth catheter 530 includes a first position indicator 555A, a second position indicator 555B, a third position indicator 555C, a fourth position indicator 555D, and a fifth position indicator 555E. The positions of these position indicators are arranged offset from (e.g., located between) the corresponding positions of the first, second, third, fourth, fifth, and sixth position indicators of the first catheter 220 and the seventh catheter 520, as shown in the figure.

[0105] The first three-catheter system 501 and / or the second three-catheter system 502 can be configured to accept the insertion of two inserts (one for each catheter) simultaneously and / or at different times, for example, in a manner similar to the insertion and / or movement of the first insert 250A and / or the second insert 250B as shown and described herein. For example, Figure 5CThis is a schematic diagram of a first three-catheter system / insertion assembly 503, which includes a first three-catheter system 501, a first insert 250A (located within the first catheter 220 at the first position indicator 525A), a second insert 240B (located within the second catheter 320 at the first position indicator 335A), and a third insert 240C (located within the seventh catheter 520 at the first position indicator 545A). As an additional embodiment, Figure 5D This is a schematic diagram of a second three-catheter system / insertion assembly 5042, which includes a second three-catheter system 502, wherein a first insert 250A is positioned within a first catheter 220 at a first position indicator 225A, a second insert 250B is positioned within an eighth catheter 520 at a second position indicator 555B, and a third insert 240C is positioned within a seventh catheter 520 at a first position indicator 545A.

[0106] Figure 5E and Figure 5F This illustrates a time series of applications of a single insert within multiple catheters in a three-catheter system, where Figure 54E shows a first insert 240A positioned within a first catheter 220 and a second insert 240B positioned within a seventh catheter 520. When use of the second insert 240B within the seventh catheter 520 is complete, it is removed from the seventh catheter 520 and inserted into the second catheter 320, as shown. Figure 5F As shown, the first insert 240A remains in the first conduit 220. Figure 5E and Figure 5F Provided by way of example and not limitation, and any variations of the first insert 240A, second insert 24B and / or third insert 240C within the first catheter 220, second catheter 320 and / or seventh catheter 520 are within the scope of the invention.

[0107] although Figures 3A to 5D The catheters depicted are positioned adjacent to each other, but this is not mandatory. In some embodiments, two or more catheters may be physically separated from each other, and in some cases, may be oriented substantially parallel to each other and / or at an angle relative to each other. Additionally or alternatively, the catheter system may have any number of catheters that may or may not be independently adjustable and / or movable relative to, for example, the patient's target tissue. Additionally or alternatively, the insert may be moved to one or more locations within the catheter to, for example, deliver treatment and / or obtain measurements of different regions adjacent to the patient's body and / or target tissue.

[0108] although Figures 2A to 5FThe catheter shown is straight, but this is not always the case. In some cases, the catheter may be bent or flexed before use to have, for example, a preset angle (e.g., set at the time of manufacture and / or by the clinician when treating the patient) and / or may be bent during use as the catheter passes through body cavities, surgical openings, and / or orifices, for example, as it travels to the target tissue.

[0109] Each of the catheters disclosed herein may include a first end and a second end, and a central lumen extending between the first end and the second end. As shown and described herein, the lumen may be sized and configured to receive insertion of an insert therein and movement of the insert within the lumen. The first end of the catheter and, in some cases, the second end may be open, for example, so that an insert may be inserted into the first open end and pushed through the lumen to abut and / or move away from the second end. Figure 5G It is a schematic diagram of the open ends of catheters 220, 320, 331, 420, 430, 450, 520 and / or 530, showing a lumen 222 extending from a first end of the catheter to a second end along the length of the catheters 220, 320, 331, 420, 430, 450, 520 and / or 530.

[0110] Figures 6 to 8C and Figure 10 These are flowcharts illustrating exemplary processes 600, 700, 800, and 1000, respectively, for using one or more of the catheters, catheter placements, and / or catheter / catheter systems and insert assemblies disclosed herein. Processes 600, 700, 800, and 1000 can be performed by, for example, system 100, components of system 100, combinations of components of system 100, clinicians, and / or robots. In particular, Figure 6 This is a flowchart illustrating a process 600 for generating an intervention plan that includes using one or more catheter / catheter system and insert assemblies disclosed herein and activating one or more inserts residing within a catheter and / or catheter arrangement to measure or deliver treatment to a patient's target tissue.

[0111] Optionally, in step 605, information about the patient and / or the patient's target tissue may be received by, for example, a computer and / or processing unit (e.g., computer and / or processing unit 105) and / or a controller (e.g., controller 115). Exemplary target tissue information includes, but is not limited to, the size of the target tissue, its location on / within the patient's body, the type and composition / characteristics of the target tissue (e.g., tumor, cyst, lesion, mole, scar tissue, etc.), and / or the size and composition / characteristics of the background tissue. Exemplary information about the patient includes, but is not limited to, medical diagnoses, treatments the patient is receiving, medications the patient is taking, comorbidities, skin color, sex, age, pain tolerance, and / or weight. Information about the patient and / or target tissue may be received from, for example, images, diagnostic scans, the patient's electronic medical records, and / or manually entered by the operator into an interface communicatively coupled to the computer and / or processing unit and / or controller.

[0112] In some cases, the catheter-insertion system may be pre-positioned on or within the target tissue and included in the information received by a computer and / or processing unit (e.g., computer and / or processing unit 105) and / or controller (e.g., controller 115). For example, a radiographic image of the skin surface used for an intervention plan may include a separate skin surface and / or a skin surface with a pre-positioned catheter placed on the surface of the region of interest.

[0113] In some implementations, data from sensors on a pre-positioned catheter may be included in information received by a computer and / or processing unit (e.g., computer and / or processing unit 105) and / or controller (e.g., controller 115).

[0114] In step 610, an intervention plan for the target tissue can be generated using, for example, the information received in step 605. The intervention plan may include catheter placement (e.g., their location, size, configuration, and / or orientation), or in some cases, adjustments to the placement of pre-positioned catheters. For example, the intervention plan may include instructions for positioning and / or using one or more inserts to perform one or more functions on and / or with respect to the target tissue (e.g., the type of treatment modality, the type of insert, the duration of the treatment modality delivery, measurements performed by the insert, the tissue area protected by the insert, the location of the insert (e.g., first insert 240A, second insert 240B, and / or third insert 240C), and / or the dose of treatment to be delivered). The intervention plan may include instructions regarding the operation or function of one or more inserts. Exemplary operation of the inserts includes, but is not limited to, instructions regarding how, when, what, and / or where the insert delivers one or more treatment modalities to the target tissue and / or its area, and the dose of treatment delivered to the target tissue and / or its area. Additionally or alternatively, the intervention plan may include instructions on how and / or when one or more measurements can be taken with the insert and / or on protecting adjacent target tissue and / or tissue of another catheter-insertion system. Optionally, the intervention plan may be provided to clinicians and / or technicians (step 615) for modification, review, and / or approval.

[0115] In step 620, one or more inserts may be received correctly (according to, for example, an intervention plan) positioned within their respective one or more catheters and in accordance with instructions regarding adjacent target tissue specified in the intervention plan. Then, in step 625, one or more inserts may be activated or otherwise opened to, for example, deliver their respective treatments to the target tissue, perform measurements, and / or protect tissue adjacent to the target tissue, according to the intervention plan. In some cases, a pre-generated intervention plan may be received prior to performing step 620, and in these cases, steps 605-615 of process 600 may not be performed. In all cases of performing process 600, performing step 625 may not be necessary. For example, when the insert is configured to dispense medication and / or radiation to the target tissue, the insert may be activated upon insertion into the catheter, and in some embodiments, the insert may be configured to dispense treatment when pushed through the open end of the catheter into the target tissue. In another embodiment, when the insert is a temperature probe, it may be configured to continuously, periodically, and / or as needed measure temperature.

[0116] Figure 7This is a flowchart illustrating a process 700 for administering treatment to target tissue using one or more inserts (e.g., first insert 240A, second insert 240B, and / or third insert 240C), one or more catheters (e.g., first catheter 220, second catheter 320, third catheter 331, fourth catheter 420, fifth catheter 430, sixth catheter 450, seventh catheter 520, and / or eighth catheter 530), or one or more corresponding catheter systems (e.g., first dual-catheter system 301, second dual-catheter system 302, third dual-catheter system 401, and / or fourth dual-catheter system 402, and / or triple-catheter systems (e.g., first triple-catheter system 501 and / or second triple-catheter system 502)). Process 700 can be performed by, for example, a clinician and / or a robot.

[0117] In step 705, an intervention plan and / or one or more instructions (which may or may not be included in the intervention plan) for delivering treatment to the patient's target tissue may be received. In some embodiments, the intervention plan may be similar to the intervention plan described in step 610 above. The catheter and / or catheter system may then be placed in the adjacent target tissue of the patient via any acceptable means or procedure (including, but not limited to, insertion through a natural lumen and / or via a surgical incision) (step 710). In some cases, similar to step 605 above, the pre-positioned catheter-insertion system may be pre-positioned prior to the intervention plan.

[0118] In step 715, the first insert may be inserted into a separate catheter of the catheter and / or catheter system (when the catheter system is inserted in step 710) and positioned at a first location within the catheter, including, for example, the instruction received in step 705. For example, the instruction received in step 705 may require the first insert to be inserted into the catheter until the tip of the first insert reaches a first position indicator of the catheter, and execution of step 715 may comply with that instruction. In some embodiments, the first insert may be activated upon insertion into the catheter. Additionally or alternatively, the first insert may be used and / or activated when it is in the appropriate position within the catheter. In some embodiments, “activation” may include opening the insert, providing energy to the insert, extracting energy from the insert, using the insert for measurement, and / or contacting or pressing the insert into target tissue. Activation and / or use of the first insert at the first location may occur for a first time period.

[0119] Optionally, in step 720, the first insert can be moved (e.g., pushed in or pulled out) to a second position within the catheter, and once in place, the first insert can be used and / or reactivated for a second time period, the duration of which may be the same as and / or different from the first time period. In some embodiments, the use and / or activation of the first insert at the first and second positions may be the same (e.g., the dose administered to the target tissue and / or the measurement performed on the target tissue) and / or may last for the same duration (e.g., the durations of the first and second time periods are the same). Additionally or alternatively, the use and / or activation characteristics of the first insert at the first and second positions may differ from each other (e.g., the dose administered to the target tissue) and / or may last for different durations (e.g., the durations of the first and second time periods are not the same). After step 720, process 700 may proceed to steps 725 and / or 740.

[0120] Optionally, in step 725, the first insert may be removed from the catheter, and the second insert may be inserted into a separate catheter of the catheter and / or catheter system (when the catheter system is inserted in step 710) and positioned at a first location within the catheter, for example, according to an instruction received in step 705. For example, the instruction received in step 705 may require the second insert to be inserted into the catheter until the tip of the first insert reaches a first position indicator of the catheter (of the second insert), and the execution of step 725 may comply with that instruction. When the second insert is in place, it may be used and / or activated at the first location for a first time period (of the second insert).

[0121] Optionally, in step 730, the second insert can be moved (e.g., pushed in or pulled out) to a second position within the catheter, and once in place, the second insert can be used and / or reactivated such that it, for example, delivers treatment to the target tissue at the second position, protects and / or measures the target tissue at the second position for a second time period. In some embodiments, the use and / or activation of the second insert at the first and second positions can be the same (e.g., the dose applied to the target tissue and / or the same measurement of the target tissue at two different time periods) and / or can last for the same duration (e.g., the first and second time periods have the same duration). Additionally or alternatively, the use and / or activation of the first insert at the first and second positions can be different from each other (e.g., the dose applied to the target tissue) and / or can last for different durations (e.g., the first and second time periods have different durations).

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

[0123] In some cases, activation of the first and / or second insert may not be performed in, for example, steps 720, 725, and / or 730, in all instances of execution process 700. For example, when the first and / or second insert is configured to dispense medication and / or radiation to target tissue, the first and / or second insert may be activated upon insertion into the catheter, and in some embodiments, the first and / or second insert may be configured to dispense treatment when pushed through the open end of the catheter into the target tissue.

[0124] When process 700 proceeds to step 740, the catheter in steps 705-720 may be the first catheter, and the first insert may be removed from the first catheter and inserted into a second separate catheter of the catheter and / or catheter system (when the catheter system is inserted in step 710). The first insert (e.g., according to the instructions received in step 705) may be positioned at a first location within the second catheter in a manner similar to that described above with respect to step 725.

[0125] Optionally, in step 745, the first insert can be moved (e.g., pushed in or pulled out) to a second position (of the second insert) within the second catheter, and once in place, the second insert can be used and / or reactivated such that the second insert, for example, delivers treatment to the target tissue at the second position, protects and / or measures the target tissue at the second position for a second time period. In some embodiments, the use and / or activation of the first insert at the first and second positions can be the same (e.g., the dose applied to the target tissue and / or the same measurement performed on the target tissue at two different time periods) and / or can last for the same duration (e.g., the durations of the first and second time periods are the same). Additionally or alternatively, the use and / or activation of the first insert at the first and second positions can be different from each other (e.g., the dose applied to the target tissue and / or the same measurement performed at two different time periods) and / or can last for different durations (e.g., the durations of the first and second time periods are not the same).

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

[0127] Figure 8A This is a flowchart illustrating a procedure 800 for administering treatment to target tissue using multiple individual catheters, one or more multi-catheter systems (e.g., a first dual-catheter system 301, a second dual-catheter system 302, a third dual-catheter system 401 and / or a fourth dual-catheter system 402, and / or a triple-catheter system (e.g., a first triple-catheter system 501 and / or a second triple-catheter system 502)), and one or more inserts (e.g., a first insert 240A, a second insert 240B, and / or a third insert 240C). Multiple individual catheters and multi-catheter systems may be collectively referred to herein as “catheter systems.” Procedure 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 may be received, which may or may not be included in an intervention plan for delivering treatment to, protecting, and / or measuring one or more properties of the patient's target tissue. In some embodiments, the intervention plan may be similar to the intervention plan in step 610 above. The catheter system can then be placed adjacent to the patient's target tissue via any acceptable means or procedure (including, but not limited to, insertion through a natural lumen and / or via a surgical incision) (step 810). In some cases, similar to step 605 above, the catheter-insertion system may be prepositioned prior to the intervention plan.

[0129] In step 815, a first insert may be inserted into a first catheter of the catheter system and positioned at a first location within the first catheter; a second insert may be inserted into a second catheter of the catheter system and positioned at a first location within the second catheter; and / or an optional third insert may be inserted into a third catheter of the catheter system and positioned at a first location within the third catheter. When the first, second, and / or third inserts are in place, each insert may be used and / or activated (step 820) such that each insert, for example, delivers treatment to the target tissue, protects the target tissue, and / or measures the properties of the target tissue at the first location of the respective first, second, and / or third catheter for the same duration and / or the corresponding first, second, and / or third time period. The first, second, and / or third inserts may be used and / or activated, for example, simultaneously, continuously, periodically, and / or as needed. For example, if a first insert delivers thermotherapy to ablate, for example, the target tissue, and a second insert delivers cryotherapy to cool the tissue and reduce swelling after ablation, the first insert can be activated for a first period of time sufficient to ablate the target tissue, and then the second insert can be activated to cool the target tissue after ablation. In another embodiment, for example, where the target tissue is a large tumor, the first, second, and third inserts can be configured to simultaneously deliver brachytherapy to inundate the target tissue at three separate locations. In yet another embodiment, where the target tissue is a tumor, the second insert, when positioned in the middle of the tumor, can be configured to deliver a relatively high dose of brachytherapy, and the first and third inserts (positioned on either side of the middle of the tumor) can be configured to deliver a relatively low dose of brachytherapy, thereby adequately treating the tumor with brachytherapy while reducing the likelihood of irradiating healthy tissue on either side of the middle of the tumor.

[0130] After performing step 825, it can be determined whether treatment administration to the patient is complete. If so, the first, second, and / or third inserts can be removed from the catheter system, and the catheter system can be removed from the target tissue (step 830). Alternatively, performing step 830 may include removing the catheter arrangement with the first, second, and / or third inserts from the target tissue.

[0131] If the treatment administration to the patient is not completed (step 825), process 800 can proceed to, as follows: Figure 8B Step 835 of subprocess 800b shown and / or as Figure 8CStep 845 of subprocess 800c is shown. When subprocess 800b is to be performed (as indicated, for example, by the intervention plan), the first, second, and / or third inserts can be moved (e.g., pushed in or pulled out) to a second / other location within the respective first, second, and / or third catheters, and once in place, the first, second, and / or third inserts can be used and / or activated (step 840) such that, for example, the first, second, and / or third inserts deliver treatment to the target tissue, protect, and / or measure the target tissue for a corresponding second time period at the respective second / other location. In some embodiments, the activation and / or use of the first, second, and / or third inserts at their respective first locations (step 820) and second locations (step 840) can be the same (e.g., the dose administered to the target tissue) and / or can last for the same duration (e.g., the durations of the respective first and second time periods are the same). Additionally or alternatively, the activation and / or use of the first, second, and / or inserts at the first and second locations can be different from each other and / or can last for different durations (e.g., the durations of the first and second time periods are not the same). After performing step 840, process 800b can end, and step 825 can be repeated to determine whether the treatment administration to the patient has been completed.

[0132] Additionally or alternatively, if treatment administration to the patient has not been completed (step 825), process 800 may proceed to, as follows: Figure 8C Step 845 of subprocess 800c is shown. In step 845, the first, second, and / or third inserts can be removed from the respective first, second, and / or third catheters. Then, a fourth insert can be inserted into the first catheter, a fifth insert can be inserted into the second catheter, and / or a sixth insert can be inserted into and / or positioned within the third catheter (step 850). The fourth, fifth, and / or sixth inserts can be activated and / or used to deliver treatment to the target tissue, protect and / or measure the target tissue for the same duration and / or the corresponding fourth, fifth, and / or sixth duration. After performing step 855, process 800c can end, and step 825 can be re-performed to determine whether treatment administration to the patient has been completed.

[0133] In some cases, in all instances of performing process 800, activation and / or use of the first and / or second inserts may not be performed, for example, in steps 820, 840, and / or 855. For example, when the first and / or third inserts are configured to dispense medication and / or radiation to target tissue, the first and / or third inserts may be activated upon insertion into the catheter, and in some embodiments, the first and / or third inserts may be configured to dispense treatment when pushed through the open end of the catheter into the target tissue.

[0134] In some implementations, the positioning of the first insert, the second insert, and / or the third insert can be facilitated by a receiver positioned thereon, configured to, for example, detect signals emitted by one or more position indicators of the catheter.

[0135] Figures 9A to 9D Some embodiments of catheter-insertion systems with geometric configurations corresponding to exemplary clinical scenarios are provided. Figure 9A A schematic diagram 901 is a two-dimensional flat surface of the patient (e.g., a flat portion of the skin on the patient's back), on which Cartesian grid points (represented as circles or dots) or coordinates are superimposed. The lines in schematic diagram 901 correspond to the positioning of the catheter on the surface, and each of the grid points in schematic diagram 901 corresponds to a different potential location for positioning the insert within the catheter, as disclosed herein. Schematic diagram 901 also shows three target locations 910, and the insert can be positioned within the catheter, for example, according to one or more methods disclosed herein, to deliver treatment and / or perform measurements at each of these locations.

[0136] Figure 9B Schematic diagram 902 shows an uneven or curved surface of the patient (e.g., a curved area of ​​skin on the patient's face) overlaid with Cartesian grid points (represented as circles or dots) or coordinates. The lines in schematic diagram 901 correspond to the positioning of the catheter on the surface, and each grid point in schematic diagram 902 corresponds to a different potential location for positioning the insert within the catheter according to the methods disclosed herein. Schematic diagram 902 also shows three target locations 910, and the insert can be positioned within the catheter, for example, according to one or more methods disclosed herein, to deliver treatment and / or perform measurements at each of these locations.

[0137] Figure 9C A schematic diagram 903 is an approximate spherical volume of the patient, which may represent, for example, the inner surface of a patient's cavity (e.g., a breast tumor resection cavity) and / or a hollow organ (e.g., a bladder). Schematic diagram 903 includes a plurality of circumferentially arranged catheters (represented as lines) and potential locations (represented as circles or dots) for positioning an insert within the catheters according to, for example, methods disclosed herein. Schematic diagram 903 also shows three target locations 910, and the insert may be positioned within the catheters according to, for example, one or more methods disclosed herein, to deliver treatment and / or perform measurements at each of these locations.

[0138] Figure 9DA schematic diagram 904 is an approximate cubic volume of the patient, which may represent, for example, a target volume within the interstitial tissue. Schematic diagram 904 includes a three-dimensional grid for potential locations (represented as circles or dots) within and / or on the surface of the patient's cubic volume, for example, positioning an insert within a catheter according to the methods disclosed herein. Schematic diagram 904 also includes one of catheters 920 inserted into the interstitial tissue in a manner parallel to a plurality of other catheters (not shown) to achieve the desired three-dimensional grid of potential insertion locations within and on the surface of the patient's cubic volume. Catheter 920 may be similar to one or more of the catheters disclosed herein. Schematic diagram 904 also illustrates three target locations 910, and an insert may be positioned within the catheter, for example, according to one or more methods disclosed herein, to deliver treatment and / or perform measurements at each of these locations.

[0139] In some embodiments, one or more of the systems disclosed herein may be modular in nature, allowing them to be used together as needed. For example, a first system may comprise multiple radiopaque catheters, and a second system may comprise multiple catheters comprising flexible plastic configured to receive brachytherapy inserts. Alternatively, a heat-resistant catheter system configured to cooperate with a thermal device (e.g., a resistance coil) may be combined with a porous catheter system configured to leach an anti-inflammatory drug that can be administered to a patient after ablation is performed using a thermal device.

[0140] Figure 10 This is a flowchart illustrating a process 1000 for modeling a catheter network including one or more catheters, inserts, and / or applicators disclosed herein to generate an intervention plan. In some cases, the execution of process 1000 may utilize mathematical representations to model the catheter network, catheters, inserts, applicators, and intervention variables (e.g., dose, timing, location, etc.), thereby facilitating, for example, precise calculation, planning, execution, and / or iteration of the intervention plan. In some embodiments, process 1000 is executed to generate a plan for intervention on / in target tissue using multiple individual catheters, one or more multi-catheter systems (e.g., first catheter system 301, second catheter system 302, third catheter system 401 and / or fourth dual catheter system 402, and / or triple catheter systems (e.g., first triple catheter system 501 and / or second triple catheter system 502)) and one or more inserts (e.g., first insert 240A, second insert 240B and / or third insert 240C). Process 1000 can be performed by any device, system and / or system component disclosed herein (e.g., computer / processing unit 105 and / or controller 115).

[0141] In step 1005, data that can be used to generate an intervention plan may be received by, for example, the processor and / or controller executing process 1000. The data may relate to, for example, a catheter network including one or more catheters, inserts, and / or delivery devices; catheter system / network characteristics; insert locations within the catheters; target tissue characteristics; tissue characteristics surrounding or adjacent to the target tissue; intervention characteristics; and / or intervention goals. In some cases, 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 an image). Additionally or alternatively, the data received in step 1005 may include information about grids, lattices, arrays, and / or irregular shapes formed by the catheter network or catheter locations within the catheter network, which may define potential locations for intervention modality delivery. In some implementations, the data may be represented and / or analyzed as representing and / or describing mathematical constructs and / or mathematical objects comprising 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 location within the catheter network (e.g., X, Y, and / or Z coordinates of the location or a one-to-one representation of a specific location with components of a structured array) and / or one or more associated parameters, such as tissue characteristics (e.g., density, pathological distribution, etc.), intervention modality type (e.g., heat, radiation, etc.), and / or operational constraints (e.g., application duration, safety threshold, normal tissue avoidance, etc.).

[0142] In one embodiment, performing step 1010 may include generating a 2x2 matrix that represents the spatial arrangement of four intervention sites arranged in a two-dimensional square pattern on a patient surface adjacent to the target tissue and / or within a catheter network within the target tissue. In some cases, performing step 1010 may further include adding additional dimensions and / or parameters to create tensors and / or structured arrays that include, 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 site). This multidimensional approach enables the management and / or optimization of the inherently complex spatial and temporal relationships of multimodal interventions in the target tissue.

[0143] Mathematical representation allows for the application of computational techniques and / or manipulation of mathematical objects (e.g., using mathematical operations and / or algorithms) to plan and optimize interventions to / on target tissues, thereby generating intervention plans. The execution of process 1000, supported by organizing intervention data into tensors and / or structured arrays, utilizes advanced algorithms that can dynamically analyze and refine planned interventions, which are also included in the 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 example, linear programming techniques can be employed during the execution of step 1015 to identify the optimal path for catheter insertion or delivery scheduling that minimizes procedure time and cost. Similarly, genetic algorithms can be used during the 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 both clinical and logistical challenges.

[0145] Additionally or alternatively, the execution of step 1015 may include using machine learning models to enhance the intervention planning approach 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 high efficacy potential. For example, a neural network may predict an ideal combination of modalities for a specific pathology based on previous cases with similar tissue characteristics and treatment responses.

[0146] In some implementations, machine learning and / or artificial intelligence (AI) algorithms can further extend the system's computational power and / or the capabilities provided by the execution of Process 1000 by enabling automated decision-making and complex scenario planning. For example, AI simulations can evaluate multiple potential intervention strategies, comparing their projected outcomes with predefined treatment goals to generate an intervention plan. In some cases, these simulations can consider factors such as the combined effects of multiple modalities, the likelihood of tissue toxicity, and / or procedural efficiency. For instance, AI-driven simulations performed via Process 1000 can predict how combined thermotherapy and radiotherapy will affect both pathological tissue (e.g., target tissue) and the surrounding healthy area at a specific location. Based on these predictions, the system executing Process 1000 can suggest adjustments to the intervention plan, such as changing the order, intensity, or duration of intervention modal delivery. This level of customization ensures that the intervention plan is tailored to each patient's unique anatomy and clinical condition.

[0147] Optionally, in step 1020, feedback on the intervention plan may be received before or during the execution of the intervention plan or a portion thereof in step 1015, and the intervention plan may be updated and / or iterated in response to the feedback. Exemplary feedback includes, but is not limited to, clinician rejection and / or modification of aspects of the intervention plan, communication from the patient and / or a catheter network including one or more catheters, inserts, and / or applicators, tactile feedback from the clinician executing the intervention plan, and visual feedback from, for example, the clinician executing the intervention plan, imaging and / or image processing devices. This iterative approach ensures that the planned intervention remains consistent with the treatment goals, even if the condition in the target tissue changes. By utilizing these computational techniques, the system is improved in providing precise, efficient, and adaptable multimodal interventions.

[0148] Computational tools (e.g., software, instructions executed by a processor, etc.) used to execute process 1000 can be integrated into the overall workflow of the system and / or apparatus disclosed herein and / or may reside within a cloud computing platform. These computational tools can utilize optimization, machine learning, and / or AI algorithms to develop an initial intervention plan, which can then be validated and refined through user input and / or further computational analysis during the execution of process 1000 or a portion thereof. In some implementations, the execution of process 1000 can supplement or replace the work performed by… Figure 6 Steps 605-610, provided and described herein, involve a user generating an intervention plan without advanced computational algorithms. In some implementations, the execution of steps 615, 620, and / or 625 may occur after the execution of steps 1015 and / or 1020.

Claims

1. A catheter and insert assembly, comprising: A catheter having a first end, a second end, and a lumen extending between the first end and the second end, the first end opening into the lumen, and the lumen being configured to receive insertion, positioning, and repositioning of an insert within the lumen; An inserter configured to be inserted into the first end of the catheter and moved within the lumen to a location adjacent to the patient's target tissue.

2. The catheter and insert assembly of claim 1, wherein the catheter is flexible, such that the shape of the catheter can be bent or flexed to pass through target tissue and / or adjacent target tissue.

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

4. The catheter and insert assembly according to any one of the preceding claims, wherein the catheter is at least one of being bioabsorbable, radiopaque, porous for measuring tissue properties, configured to release a therapeutic agent, heat-resistant, configured to conduct electricity, configured to insulate electricity, configured to conduct heat, configured to perform measurements, configured to shield tissue from radiation, configured to deliver a treatment, and / or configured to insulate heat.

5. The catheter and insert assembly according to any one of the preceding claims further comprises: A removable core needle extending through the length of the lumen, the core needle being configured to increase the stiffness of the catheter and / or improve its operability when traversing through patient tissue to within and / or adjacent to the target tissue, wherein, When the catheter / core assembly is in place, the removable core is removed from the lumen, allowing the insert to be inserted into the catheter.

6. The catheter and insert assembly according to any one of the preceding claims, wherein the catheter includes a plurality of position indicators positioned thereon.

7. The catheter and insert assembly according to any one of the preceding claims, wherein the catheter is a first catheter, and the catheter and insert assembly further comprises: The second catheter has a first end, a second end, and a lumen extending between the first open end and the second open end, the first end opening into the lumen, and the lumen being configured to receive insertion, positioning, and repositioning of an insert within the lumen.

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

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

10. The catheter and insert assembly according to any one of claims 7 to 9, wherein the catheter and the insert assembly are configured such that one or more inserts are capable of simultaneously or sequentially delivering different treatments and / or collecting different measurements at multiple catheter and / or insert locations during a single contact with a patient.

11. The catheter and insert assembly according to any one of the preceding claims, wherein the features of the catheter are specific to the function performed by the insert.

12. The catheter and insert assembly according to any one of the preceding claims, wherein the catheter is a first catheter, and the catheter and insert assembly further comprises: The second catheter has a first end, a second end, and a lumen extending between the first open end and the second open end, the first end opening into the lumen, and the lumen being configured to receive insertion, positioning, and repositioning of an insert within the lumen.

13. The catheter and insert assembly of claim 12, wherein the catheter is a first catheter, and the catheter and insert assembly further comprises: A third catheter has a first end, a second end, and a lumen extending between the first open end and the second open end, the first end opening into the lumen, and the lumen being configured to receive insertion, positioning, and repositioning of an insert within the lumen.

14. The catheter and insert assembly according to any one of the preceding claims, wherein the insert comprises metal, wire, fiber optic cable, plastic, vinyl and / or combinations thereof.

15. The catheter and insert assembly according to any one of the preceding claims, wherein the insert comprises a source end, such as a drug-impregnated absorbent pad, a temperature probe, a needle tip, a radioactive material, a measuring device, a therapeutic device, and / or a combination thereof.

16. The catheter and insert assembly according to any one of the preceding claims, wherein the insert is configured as at least one of a treatment modality, a measuring device, an irradiation shielding device, a heating device, a radiator, a cryotherapy device, and / or a protective device.

17. The catheter and insert assembly according to any one of the preceding claims, wherein the placement of the catheter on the patient surface or the insertion of the catheter into the patient tissue is controlled by at least one of a clinician, a software interface, a processor, and a robot.

18. The catheter and insert assembly according to any one of the preceding claims, wherein movement of the insert within the catheter is controlled by at least one of a clinician, a software interface, a processor, and a robot.

19. The catheter and insert assembly according to any one of the preceding claims, wherein the insert is activated before being inserted into the catheter or when it is in a desired position within the catheter.

20. The catheter and insert assembly according to any one of the preceding claims, wherein the insert is configured as a measuring device.

21. The catheter and insert assembly of claim 20, wherein the insert is configured as a means for measuring at least one of the following: temperature, humidity, radiation level, force, pH level, electrical conductivity, electrical impedance, electromagnetic spectrum characteristics, visual appearance, and / or chemical composition of the target tissue.

22. The catheter and insert assembly according to any one of the preceding claims, wherein the intervention delivered to the target tissue via the catheter and the insert assembly comprises one or more of the following: brachytherapy, cryotherapy, thermotherapy, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulation of tissue, massage, microneedling, topical application of medicine and / or injection of medicine.

23. The catheter and insert assembly according to any one of the preceding claims, wherein the catheter is configured to cooperate with the applicator to deliver an intervention to the target tissue.

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

25. The catheter and insert assembly of claim 23 or 24, wherein the dispenser includes a plurality of ports into which the catheter can be inserted.

26. The catheter and insert assembly of claim 23, 24 or 25, wherein the catheter is insertable into one or more of the plurality of ports.

27. A method of treating a patient’s target tissue using a catheter and insert assembly according to any one of the preceding claims.

28. A method for treating a patient's target tissue, the method comprising: The insert is positioned at a desired location within the catheter, which is positioned adjacent to the patient’s target tissue, the desired location being sufficiently close to the target tissue to perform an action thereon; and The insertion device initiates and / or sustains the execution of the action at the desired location.

29. The method of claim 28, further comprising: Receive an intervention plan for treating the target tissue, wherein the positioning of the insert and / or the duration of its stay at the location are in response to the intervention plan.

30. The method of claim 28 or 29, wherein said action is at least one of the following: delivery of a therapeutic modality, delivery of a drug, delivery of heat, delivery of cryotherapy, use of a measuring device, shielding of 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 therapy, topical application of a drug and / or injection of a drug.

31. The method according to any one of claims 28 to 30, wherein the desired location is a first desired location, the method comprising: After performing the action, the insert is moved to a second desired position within the catheter; and The insertion device initiates and / or sustains the execution of the action at the second desired position.

32. The method according to any one of claims 28 to 31, wherein the insert is a first insert, the method further comprising: Remove the first insert from the catheter; The second insert is positioned at a desired location within the catheter, the catheter being positioned adjacent to the patient’s target tissue, the desired location being sufficiently adjacent to the target tissue to perform an action thereon; and The second insert initiates and / or sustains the execution of the action at the desired location.

33. The method according to any one of claims 28 to 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 according to any one of claims 28 to 33, wherein the first insert applies therapy to the target tissue, and the second insert measures the result of applying the therapy to the target.

35. The method according to any one of claims 28 to 33, wherein the insert is a first insert and the catheter is a first catheter, the method further comprising: The second insert is positioned at a desired location within the second catheter, which is positioned adjacent to the patient’s target tissue, the desired location being sufficiently close to the target tissue to perform an action thereon; and The second insert initiates and / or sustains the execution of the action at the desired location.

36. The method according to any one of claims 28 to 34, wherein the first insert applies the therapy to the target tissue, and the second insert protects tissue adjacent to the target tissue from the effects of the therapy when the therapy is applied by the first insert.

37. The method according to any one of claims 28 to 36, wherein the catheter is a first catheter, the method further comprising: Remove the insert from the first conduit; The insert is positioned at a desired location within the second catheter, which is positioned adjacent to the patient’s target tissue, the desired location being sufficiently close to the target tissue to perform an action thereon; and The insertion device initiates and / or sustains the execution of the action at the desired location within the second catheter.

38. The method according to any one of claims 28 to 37, wherein the insert is a first insert and the catheter is a first catheter, the method further comprising: The second insert is positioned at a desired location within the second catheter, which is positioned adjacent to the patient’s target tissue, the desired location being sufficiently close to the target tissue to perform an action thereon; and The second insert initiates and / or sustains the execution of the action at the desired location.

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

40. The method according to any one of claims 28 to 39, wherein the method is performed by at least one of a clinician and a robot.

41. A method for generating an intervention plan for treating a patient's target tissue, the method comprising: Receive information about the target tissue and one or more catheter and insert assemblies, said one or more catheter and insert assemblies including: A second catheter has a first end, a second end, and a lumen extending between the first open end and the second open end, the first end opening into the lumen, and the lumen being configured to receive insertion, positioning, and repositioning of an insert within the lumen; and An inserter configured to be inserted into the first end of the catheter and moved within the lumen to a location adjacent to the patient's target tissue; and Generate an intervention plan for the target tissue, the intervention plan including instructions for treating the target tissue using the one or more catheter and insert assemblies; and Provide the intervention plan to clinicians.

42. The method of claim 41, wherein the intervention plan includes at least one of the type, size, and configuration of the catheter and / or insert for treating the target tissue.

43. The method according to claim 41 or 42, wherein, The insert is communicatively coupled to a functional support device, the method comprising: Receive information regarding communication between the functional support device and the insert, wherein the generation of the intervention plan is in response to the information regarding communication between the functional support device and the insert.

44. The method of any one of claims 41 to 43, wherein the intervention plan includes instructions for placing and holding the insert within the catheter such that the insert reaches a desired position and remains in the desired position for a duration defined by the intervention plan.

45. The method according to any one of claims 41 to 44, further comprising: Receive an indication that the insert is positioned at the desired location within the catheter; and The insert is activated according to the intervention plan.

46. ​​The method of any one of claims 41 to 45, further comprising receiving information about the patient, wherein the intervention plan is in response to the received information about the patient.

47. A system for planning and delivering multimodal interventions to patient tissues, the system comprising: A catheter network configured to be placed on or within the tissue, the catheter network comprising a plurality of catheters having lumens configured to mate with an insert, the catheters being arranged in a grid or array at predefined locations; One or more inserts configured to pass through the lumen of the catheters in the plurality of catheters to deliver one or more intervention modes to specific locations in a network of catheters or an array; A functional support device operatively coupled to the one or more inserts and configured to actuate the one or more inserts and / or communicate with the one or more inserts; A memory having stored an instruction set that is executed by a processor, causing the processor to: (i) Represent the duct network and its associated locations in a numerical manner; (ii) Modeling intervention variables, including insert modality type, modality delivery parameters, and tissue characteristics; (iii) Receiving treatment goals; (iv) Use the modeling results and the received treatment goals to determine the effective configuration of multiple intervention modalities; and (iv) Generate an intervention plan using an effective configuration of intervention modalities, the intervention plan specifying the location, duration, and combination of intervention modalities to be delivered via catheters in the catheter network and inserts placed within the catheters in the catheter network; and The processor communicates with the memory and is configured to execute the instruction set 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 duct network and transmit the data to the processor, wherein the instruction set further includes an instruction set for updating the intervention plan in response to the received data, the instruction set causing the processor, when executed by the processor, to: The intervention plan is dynamically updated in response 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 duct network and transmit the data to the processor, wherein the instruction set further includes an instruction set for updating the intervention plan in response to the received data, the instruction set causing the processor, when executed by the processor, to: The intervention plan is iteratively refined 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 to the processor, and communication between the conduit and / or insert and the processor.

51. The system according to any one of claims 47 to 50, wherein determining the effective configuration of the modality includes using an optimization algorithm.

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

53. The system according to any one of claims 47 to 52, wherein the modeling of the intervention variable employs a machine learning model.

54. The system according to any one of claims 47 to 53, wherein the machine learning model employs neural networks and / or decision trees to analyze historical intervention data and predict the optimal configuration for a given patient-specific tissue characteristics.

55. The system according to any one of claims 47 to 54, wherein the digital representation of the duct network and its associated locations is at least one of a multidimensional vector, a matrix, and a tensor.

56. The system of claim 55, wherein modeling is performed using at least one of multidimensional vectors, matrices, and tensors.

57. A method for delivering a multimodal intervention to patient tissue, comprising: A digital representation of a catheter network is generated by a processor, the catheter network comprising multiple catheters having lumens configured to mate with inserts and arranged in a grid or array at predefined locations; The processor associates intervention variables with the digital representation of the catheter network, the intervention variables including insert type, tissue characteristics, intervention modality type, and intervention modality delivery constraints; The processor models the duct network and intervention variables; and The processor generates an intervention plan that specifies the location of the intervention within the catheter network, the duration of the intervention within the catheter network, and a combination of intervention modes applied within the catheter network.

58. The method of claim 57, further comprising: The processor receives an indication that the catheter network has been placed on or within the patient's tissue according to the intervention plan; and In response to the received instruction, the processor actuates an insert through the catheter network to deliver the planned intervention modality to a designated location within the catheter network in accordance with the intervention plan.

59. The method of claim 58, further comprising: During the intervention, feedback from the organization is received from the processor, and the intervention plan is dynamically adjusted based on the feedback.

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

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

62. The method according to any one of claims 57 to 61, further comprising employing...

63. The method according to any one of claims 57 to 62, wherein generating the intervention plan further includes simulating multiple intervention strategies and evaluating trade-offs between competing treatment goals.

64. The method according to any one of claims 57 to 63 further includes predicting the combined effects of multiple intervention modalities on pathological tissues and surrounding healthy tissues.

65. A computer-readable medium storing instructions that, when executed by a processor, cause the system to: A digital representation of a catheter network is generated, the catheter network comprising multiple catheters having lumens configured to mate with inserts and arranged in a grid or array at predefined positions; The intervention variables are associated with the numerical representation of the catheter network, including insert type, tissue characteristics, intervention modality type, and intervention modality delivery constraints; Modeling of ductal networks and intervention variables; and An intervention plan is generated, which specifies the location of the intervention within the catheter network, the duration of the intervention within the catheter network, and a combination of intervention modes applied within the catheter network.

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

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