Systems and devices for placement and use of medical instruments and methods for using same
Patent Information
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- GEOMETRY THERAPEUTICS INC
- Filing Date
- 2024-12-26
- Publication Date
- 2026-07-30
AI Technical Summary
Traditional manual methods for positioning and using medical instruments lack precision, reproducibility, and efficiency, particularly in complex anatomical regions, leading to suboptimal treatment outcomes and increased patient risk.
An insert positioning device with a directional subunit and a controller/processor system that enables precise alignment and deployment of medical instruments using a plurality of ports, conduits, and templates, guided by spatial coordinates and intervention plans.
Enhances treatment efficacy and efficiency by ensuring precise placement of medical instruments, reducing invasiveness, and improving patient safety through robotic precision and multi-modal therapeutic applications.
Smart Images

Figure 00000000_0000_ABST
Abstract
Description
SYSTEMS AND DEVICES FOR PLACEMENT AND USE OF MEDICAL INSTRUMENTS AND METHODS FOR USING SAMERELATED APPLICATION
[0001] This application is an INTERNATIONAL (PCT) application of, and claims priority to United States Provisional Patent Application Number: 63 / 616,282, filed on 29 December 2023 and entitled “SYSTEMS AND DEVICES FOR PLACEMENT AND USE OF MEDICAL INSTRUMENTS AND METHODS FOR USING SAME,” which is incorporated herein by reference.FIELD OF USE
[0002] This application generally relates to medical devices, systems, and methods for use. In particular, the application pertains to systems and devices for positioning and using medical instruments to treat target tissue of a subject.BACKGROUND
[0003] The advancement of medical technology has significantly improved the ways in which clinicians diagnose, monitor, and treat diseases. Critical to these processes are medical instruments such as probes, sensors, catheters, needles, electrodes, and applicators. These instruments are often deployed to administer interventions directly on or within specific tissues, enabling precise and localized treatment.However, traditional manual methods for positioning and using these instruments present significant limitations in precision, reproducibility, and efficiency.
[0004] One challenge with manual deployment is the lack of precision necessary for reaching specific target tissues, particularly in complex anatomical regions. Misplacement or inadequate alignment of instruments can result in suboptimal treatment outcomes, increased patient risk, and the need for repeated interventions. Furthermore, manual methods are constrained by the physical dexterity and visualization capabilities of the clinician, limiting the scope of multi-instrument procedures that are often required for advanced therapeutic applications.SUMMARY
[0005] System and devices for performing an intervention upon and / or treating target tissue may include an insert positioning device and a controller and / or processor forcontrolling an operation of the insert positioning device and / or a component thereof. The insert positioning device may include an insert interface configured with a plurality of ports; a directional subunit configured to maneuver along at least one axis to align with specific ports of the plurality of ports; an insert mobilizing device configured to move an insert through the directional subunit, into a port of the plurality of ports, and through the port toward the target tissue; and a housing configured to house the insert interface, the directional subunit, and the insert mobilizing device. In some embodiments, the insert interface may include one or more regions, or windows, through which an insert may travel without out a port (e.g., the region or window may be open to ambient air and / or covered with a membrane (e.g., paper, vinyl, or plastic that allows for traverse of the insert). After traversing the insert interface and / or a port in the insert interface, the insert can be further mobilized to the target tissue directly or into a conduit, a template, or a conduit-template system that guides the insert to the target tissue.
[0006] In some embodiments, a processor may be communicatively coupled to the controller, the insert positioning device, and / or the insert mobilizing device and may be configured to receive input parameters and generate an intervention plan, wherein the intervention plan may include one or more selected spatial port identifiers (e.g., spatial coordinates) for insert deployment and functional instructions for the insert. On some occasions, the processor may be configured to manage overlapping or non-overlapping regions of the insert interface to optimize insert deployment.
[0007] In some embodiments, the systems and / or devices may further comprise and / or be configured to cooperate and / or communicate with one or more conduits. The conduits may be tubes with a central lumen sized, shaped, and / or configured to cooperate with (e.g., allow movement of) one or more inserts. Each conduit may be coupled to a port of the plurality of ports and configured to direct an insert toward the target tissue and / or deliver an insert proximate to the target tissue. In some instances, one or more of the conduits may be transparent to allow visual confirmation of insert movement.
[0008] In some embodiments, the systems and / or devices disclosed herein may further comprise and / or be configured to cooperate and / or communicate with one or more subject interface devices and / or templates. The subject interface template may be configured to be placed proximate to the target tissue and may include oneor more extensions configured to be in communication with, and / or direct an insert toward the target tissue via, for example, communication with the insert interface. Additionally, or alternatively, the subject interface template may be in communication with one or more conduits wherein a first end of each conduit may be coupled to a port of the plurality of ports in the insert interface and a second end of each conduit may be coupled to the subject interface template positioned proximate to the target tissue.
[0009] In some embodiments, the insert mobilizing device may include a motorized spool configured to extend and retract the insert through the conduit responsively to, for example, actuation by the controller and / or an instruction from the processor.
[0010] The plurality of ports may be arranged in any appropriate pattern, including a radial, spiral, and / or grid pattern and each port of the plurality of ports may be correlated with one or more identifiers (e.g., identification numbers, spatial coordinates (e.g., X-, Y-, and / or Z-coordinates), row and column number, etc.). In some embodiments, a distance between the ports may be uniform throughout the pattern / insert interface and, in other embodiments, distances between the ports may vary. For example, there may be a greater concentration and / or density of ports near a center or an edge of the insert interface than a remainder of the insert interface.
[0011] The directional subunits may be adjustable in angle, pitch, and yaw to align with a ports of the plurality of ports so that the insert mobilizing device may mobilize an insert into the port according to, for example, an intervention plan as, for example, described herein. In some embodiments, the systems and / or devices disclosed herein may include a plurality of directional subunits and each directional subunit of the plurality of directional subunits being independently adjustable in angle, pitch, and yaw to align with different ports of the plurality of ports simultaneously and / or sequentially. In some instances, each directional subunit of the plurality of directional subunits may be dedicated to an individual port or set of ports (e.g., a region of the insert interface) to enable simultaneous multi-port operation. Additionally, or alternatively, each directional subunit of the plurality of directional subunits may be dedicated to an individual insert of a plurality of inserts.
[0012] In some embodiments, the systems and / or devices disclosed herein may include a plurality of insert interfaces and, in these embodiments, each insert interface of the plurality of insert interfaces may have a dedicated directional subunit.
[0013] The inserts disclosed herein may be configured as a measurement device, a treatment delivery device, a brachytherapy device, a cryotherapy device, a hyperthermia device, a laser therapy device, a ultrasound therapy device, a radiofrequency ablation (RFA) therapy device, a microwave therapy device, a electroporation therapy device, a physical manipulation device, a removal of tissue device, a topical medication delivery device, a shielding device, a thermal insulating device, and / or an injection device. At times, a functionality of an insert may be supported and / or provided by an insert functionality support device in communication with the insert. For example, the insert functionality support device may provide power and / or medication to the insert, receive data from the insert, and / or activate (e.g., turn off and / or on) the insert. In some embodiments, the functionality support device may be included in the housing that houses the insert interface, the directional subunit, and / or the insert mobilizing device.
[0014] Additionally, or alternatively, in some embodiments, the systems and devices disclosed herein may include a locking mechanism configured to secure the directional subunit in a fixed position relative to the insert interface, wherein the locking mechanism may be selectively adjustable to allow movement when required and to prevent undesired motion during operation. At times, the locking mechanism may be a mechanical clamp that engages with the guide rails of the directional subunit and / or electronically actuated and controlled by the processor based on intervention parameters. Additionally, or alternatively, the locking mechanism may provide variable resistance to movement, enabling fine adjustments during manual or automated alignment. Additionally, or alternatively, the locking mechanism may include a feedback sensor configured to confirm that the device may be secured in the desired position before intervention begins.
[0015] The systems and / or devices disclosed herein may be used to, for example, performing an intervention on and / or treatment of target tissue of a subject, generate and / or execute an intervention plan. For example, a method executed by a processor and / or controller may for performing an intervention on target tissue may include receiving an intervention plan defining a type of intervention to be delivered by one or more insert(s) via a port the insert interface communicatively coupled to a first end of a conduit. The insert is configured to pass through both the port and the conduit.
[0016] Then, an indication that a subject interface template and a plurality of extensions extending from the subject interface template are in a desired position relative to the target tissue may be received. At least one extension of the plurality of extensions may be in communication with a second end of the conduit. Next, instructions may be provided to an insert positioning device responsively to receipt of the indication. When the instructions are executed by the insert positioning device, the insert positioning device may move to a position corresponding to the port of the plurality of ports (i.e., a selected port).
[0017] Upon receipt of an indication that the subject interface template may is in the desired position, an instruction may be provided to the insert positioning device to deploy, or extend, the insert through the port of the plurality of ports and into the conduit so that the insert travels through the port, the conduit, and the extension coupled to the second end of the conduit. The insert may then be activated via, for example, the processor providing instructions to the insert, to deliver the type of intervention defined by the intervention plan. Additionally, or alternatively, the processor may instruct an insert functionality device communicatively coupled to the processor and the insert to activate the insert.
[0018] In some embodiments, data may be received from the insert.Exemplary data includes a measurement, a status update, a confirmation that the insert delivered the intervention, and / or an indication that the insert has, or has not, reached a desired position within a conduit, an insert interface, a subject interface, and / or an extension of the subject interface. In some embodiments, an instruction may be provided to the insert positioning device to adjust a position of the insert within the conduit responsively to the data received from the insert.
[0019] In some embodiments, the processor and / or controller may provide instructions to the insert positioning device, which when executed by the insert positioning device cause the insert positioning device to retract the first insert from a port and deploy a second insert through the same and / or a different port. Additionally, or alternatively, in systems with two or more insert positioning devices, the processor and / or controller may providing instructions to a second insert positioning device, which when executed by the second insert positioning device cause the second insert positioning device to move to a position corresponding to a second port. In addition, instructions to the second insert positioning device to deploy, or extend, the second insert through the second port and into the secondconduit so that the second insert travels through the second port, the second conduit, and the second extension coupled to a second end of the second conduit upon receipt of the indication that the subject interface template may be in the desired position may also be provided to the second insert positioning device.
[0020] In some embodiments, the insert interface may be divided into regions served by distinct directional subunits and, at times, each directional subunit of a plurality of directional subunits may execute separate portions of the intervention plan as may occur when for example, the intervention plan specifies simultaneous or sequential activation of multiple inserts in overlapping or non-overlapping regions of the target tissue.
[0021] Methods for generating an intervention plan for treatment of target tissue of a subject may include receiving operational parameters for an insert positioning device, receiving anatomical data for the subject and intervention parameters for the target tissue, the intervention parameters including at least one port through which an insert may be to extend and a type of intervention to be performed by the insert, generating the intervention plan using the operational parameters for an insert positioning device, the anatomical data for the subject, and the intervention parameters for the target tissue, and providing instructions to the insert positioning device so that the insert positioning device may execute at least a portion of the intervention plan. At times, the intervention parameters may include a plurality of ports through which a corresponding plurality of inserts are to extend sequentially and / or simultaneously.
[0022] Additionally, or alternatively, in some embodiments, the systems, methods, and / or devices disclosed herein may comprise receiving by, for example, a processor or computing device, an intervention plan defining, selecting, or otherwise setting a parameter for an insert to be positioned proximate to the target tissue in accordance with the intervention plan. An instruction to an insert mobilizing device in communication with the processor to deploy, or extend, the insert toward the target tissue in a manner consistent with the intervention plan may then be provided to the insert mobilizing device. In some embodiments, the insert may be active upon deployment. Additionally, or alternatively, the insert may be activated to deliver a type of intervention defined by the intervention plan when, for example, the insert is proximate to the target tissue. In some embodiments, activation of the insert mayinclude providing an instruction to an insert functionality support device communicatively coupled to the processor and the insert to activate the insert.
[0023] In some embodiments, the insert mobilizing device may deploy the insert through an insert interface that includes a plurality of ports the insert is configured to pass through. Each port of the plurality of ports may be associated with an identifier and in some embodiments, the intervention plan may include the identifier for one or more ports through which the insert is to be deployed.
[0024] In some instances, delivery of an insert to a port may be performed by one or more directional subunits configured to move the insert mobilizing device to a position that may be defined by the intervention plan. In some embodiments, the insert interface may be divided into regions and or sets of ports and each region and / or set of ports may be served by a distinct, or separate, directional subunits and / or insert mobilizing device that may perform an operation in accordance with the intervention plan.
[0025] In some embodiments, an instruction to the insert mobilizing device to deploy, or extend, the insert toward the target tissue may be responsive to receipt of an indication that the target tissue is ready for treatment and / or a device configured to deliver the insert proximate to the target tissue is in a desired position. For example, the indication that the target tissue is ready for treatment may be an indication that a subject interface template configured to be in communication with the insert is in a desired position relative to the target tissue.
[0026] In some embodiments, instructions may be provided to an insert positioning device, which when executed by the insert positioning device cause the insert positioning device to move to the insert to a position in accordance with the intervention plan prior to provision of the instructions to deploy or extend the insert toward the target tissue. Additionally, or alternatively, instructions may be provided to the insert positioning device to adjust a position of the insert before, during, and / or after delivery of an intervention to the target tissue.BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The present invention is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which:
[0028] FIG. 1 A is a schematic diagram of a portion of a first insert with an inactive portion an active tip, in accordance with some embodiments disclosed herein.
[0029] FIG. 1 B is a schematic diagram of a second insert that includes an active portion that extends along the entire length of second insert, in accordance with some embodiments disclosed herein.
[0030] FIG. 1C is a schematic diagram of a third insert that includes an inactive portion and an active portion embodied as a continuous segment , in accordance with some embodiments disclosed herein.
[0031] FIG. 1 D is a schematic diagram of a fourth insert that includes a plurality of active positions and inactive positions arranged in an alternating pattern at regular intervals along the length of fourth insert, in accordance with some embodiments disclosed herein.
[0032] FIG. 1 E is a schematic diagram a fifth insert that includes a plurality of active positions and inactive positions arranged in an alternating pattern at irregular intervals along the length of fifth insert, in accordance with some embodiments disclosed herein.
[0033] FIG. 1 F is a schematic diagram of a portion of a first conduit / insert assembly, in accordance with some embodiments disclosed herein.
[0034] FIG. 1G is a schematic diagram of a portion of a second conduit / insert assembly, in accordance with some embodiments disclosed herein.
[0035] FIG. 2A provides a rendering of a frontal view of a first exemplary insert interface, in accordance with some embodiments disclosed herein.
[0036] FIG. 2B provides a rendering of a frontal view of a second exemplary insert interface, in accordance with some embodiments disclosed herein.
[0037] FIG. 2C provides a rendering of a frontal view of a third exemplary insert interface, in accordance with some embodiments disclosed herein.
[0038] FIG. 2D provides a rendering of a frontal view of a fourth exemplary insert interface, in accordance with some embodiments disclosed herein.
[0039] FIG. 3A is a diagram of components included in an exemplary directional subunit, in accordance with some embodiments disclosed herein.
[0040] FIG. 3B provides a diagram of a side perspective view of an exemplary locking mechanism, in accordance with some embodiments disclosed herein.
[0041] FIG. 4A is a schematic diagram of a side view of an exemplary insert positioning device, in accordance with some embodiments disclosed herein.
[0042] FIG. 4B is a schematic diagram of a top view of the insert positioning device of FIG. 4A, in accordance with some embodiments disclosed herein.
[0043] FIG. 4C is a schematic diagram of a first perspective view of the insert positioning device of FIG. 4A, in accordance with some embodiments disclosed herein.
[0044] FIG. 4D is a schematic diagram of a second perspective view of the insert positioning device of FIG. 4A, in accordance with some embodiments disclosed herein.
[0045] FIG. 4E is a schematic diagram of a side view of another exemplary insert positioning device, in accordance with some embodiments disclosed herein.
[0046] FIG. 4F provides a diagram of a system including the insert positioning device of FIG. 4A and insert interface, in accordance with some embodiments disclosed herein.
[0047] FIG. 4G provides a diagram of a system including the insert positioning device of FIG. 4A and a curved insert interface, in accordance with some embodiments disclosed herein.
[0048] FIG. 5 provides a diagram of an exemplary insert positioning device with two directional subunits, in accordance with some embodiments disclosed herein.
[0049] FIG. 6A provides a block diagram of a first exemplary insert placement system, in accordance with some embodiments disclosed herein.
[0050] FIG. 6B provides a block diagram of a second exemplary insert placement system, in accordance with some embodiments disclosed herein.
[0051] FIG. 6C provides a block diagram of a third exemplary insert placement system, in accordance with some embodiments disclosed herein.
[0052] FIG. 6D provides a block diagram of a fourth exemplary insert placement system, in accordance with some embodiments disclosed herein.
[0053] FIG. 6E provides a block diagram of a fifth exemplary insert placement system, in accordance with some embodiments disclosed herein.
[0054] FIG. 7 is a flowchart showing an exemplary process for generating an intervention plan and / or using one or more of the systems and / or devices disclosedherein to administer an intervention to a subject, in accordance with some embodiments disclosed herein.
[0055] FIG. 8A1 provides a block diagram of an exemplary system, in accordance with some embodiments disclosed herein.
[0056] FIG. 8A2 provides a diagram of an exemplary system, in accordance with some embodiments disclosed herein.
[0057] FIG. 8B provides a rendering of a front-side perspective view of a subject interface template, in accordance with some embodiments of the present invention.
[0058] FIG. 8C provides a rendering of a back-side perspective view of the subject interface template of FIG. 8B, in accordance with some embodiments of the present invention.
[0059] FIG. 8D provides a rendering of a top-perspective view of an exemplary subject with an area, or region, of target tissue positioned on subject’s skin below the subject’s right eye and on the right side of the subject’s nose, in accordance with some embodiments of the present invention.
[0060] FIG. 8E provides a rendering of a top-perspective view of subject interface template positioned above the subject’s face, in accordance with some embodiments of the present invention.
[0061] FIG. 8F provides rendering of a side view of the subject with the subject interface template of FIG. 8B positioned over the subject’s face so that extensions of the subject interface template have moved / articulated within their respective ports so that each a distance each extension extends from the subject interface template corresponds to the topology of the subject’s face, in accordance with some embodiments of the present invention.
[0062] FIG. 8G provides a rendering of a top view of the subject’s face with target tissue and a grid of points superimposed thereon, in accordance with some embodiments of the present invention.
[0063] FIG. 8H provides a rendering of a GUI that may be provided to a user so that the user may input instructions that may be used to generate an intervention plan for target tissue, in accordance with some embodiments of the present invention.
[0064] FIG. 8I provides a rendering of the GUI of FIG. 8H with a treatment area comprising target tissue superimposed thereon, in accordance with some embodiments of the present invention.
[0065] FIG. 8J provides a rendering that shows the subject receiving an intervention via one of the systems and devices disclosed herein, in accordance with some embodiments of the present invention.
[0066] FIG. 8K provides a rendering that shows the subject receiving an intervention via one of the systems and devices disclosed herein and a partial array of conduits, in accordance with some embodiments of the present invention.
[0067] FIG. 8L provides a rendering of that shows inserts partially extended through the conduits of the partial array of conduits of FIG. 8K, in accordance with some embodiments of the present invention.
[0068] FIG. 8M provides a rendering of that shows inserts fully extended through the conduits of the partial array of conduits of FIG. 8K, in accordance with some embodiments of the present invention.
[0069] Throughout the drawings, the same reference numerals, and characters, unless otherwise stated, are used to denote like features, elements, components, or portions of the illustrated embodiments. Moreover, while the subject invention will now be described in detail with reference to the drawings, the description is done in connection with the illustrative embodiments. It is intended that changes and modifications can be made to the described embodiments without departing from the true scope and spirit of the subject invention as defined by the appended claims.WRITTEN DESCRIPTION
[0070] Medical instruments such as probes, sensors, catheters, needles, electrodes, topical applicators, and / or protective devices (collectively referred to herein as “inserts”) may be used to diagnose, monitor, and / or treat disease by, for example, administering an intervention, medical treatment, and / or performing a procedure (at times collectively referred to herein as an “intervention”). Traditionally, these inserts are introduced onto the surface of a subject or into subject tissue manually by a clinician or technician. However, manual methods may lack necessary precision and are limited by the fact that a clinician only has two hands in which to hold and aim an insert so only one or two inserts may be used at the same time.Herein, we describe an insert placement system and / or device that is configured to, for example, guide positioning, deployment, retrieval, and / or use of inserts to target intervention areas of a subject using, for example, robotic arms and / or other devices (e.g., gears, pulleys, motors, etc.). The systems and / or devices disclosed herein may direct movement of an insert out of the insert positioning system and / or device via a two-dimensional and / or three-dimensional, coordinate system or other port identifier or set of port identifiers (e.g., port number, port row and column identifier, etc.) which can be indexed to a subject’s surface or internal tissue (e.g., target tissue such as a tumor, lesion, infection, etc.). Additionally, or alternatively, the port identifiers and / or coordinate system can be indexed to an intermediate delivery system, such as a template, series of conduits, an applicator, and / or combination thereof, that itself interfaces with subject tissue.
[0071] The insert placement systems and devices disclosed herein include an insert positioning device that is configured to receive and direct an insert out of the system and / or device via a precise trajectory through an insert interface, which may be, for example, a port, a portal, an applicator, and / or an interface device by which an insert exits the system and / or device to be delivered to target tissue. A position (e.g., port identifier, X-, Y-, and / or Z- coordinates, etc.) of an insert’s exit in the insert interface can be defined by, for example, port identifiers and / or a coordinate system that specifies the location of physical openings (ports) in the insert interface and / or grid coordinates in a two- and / or three-dimensional representation (e.g., computer model and / or image provided via a graphic user interface (GUI) to a user and / or clinician) of the insert interface.
[0072] In some embodiments, the physical ports and / or the port identifiers and / or grid coordinates of the insert interface are configured to accept insertion of one or more inserts therein and / or enable the positioning (e.g., movement) of one or more inserts therein so that one or more of the inserts may be positioned proximate to and / or inserted into target tissue of a subject. Inserts may be, for example, an intervention modality, measurement device, and / or a protection device. Mechanical movement of the insert to the insert positioning device and onward through the insert interface may be performed by, for example, an insert mobilizing device disclosed herein such as a motorized spool, insert supply, and / or gear. Instructions for movement of an insert to the insert positioning device and onward through the insert interface to a subject’s target tissue may be controlled by an insert placementsystem and / or insert positioning device using, for example, input received by a processor via a user-facing software interface (e.g., GUI and / or input device like a keyboard or trackpad). In some embodiments, the insert placement systems and devices disclosed herein may include one or more inserts that may have the same, or differently functional, modalities.
[0073] In some embodiments, the insert placement systems and devices disclosed herein may use and / or include one or more geometrically arranged conduits, such as catheters or tubes, each configured to accept insertion and / or enable the positioning (e.g., movement) of one or more inserts therein to be positioned proximate to and / or inserted into target tissue of a subject. One or more conduits may be directly attached to the insert interface as, for example, a tube directly connected to a physical port of the insert interface. The conduits may be flexible and / or capable of being maneuvered into position proximate to target tissue of a subject. Additionally, or alternatively, one or more conduits may be indexed to the port identifiers and / or coordinate system of the insert interface such that the conduit can receive an insert after the insert exits from the insert interface despite a separation in space from the insert interface. Inserts may be, for example, an intervention modality, measurement device, and / or a protection device. Mechanical movement of the insert to the insert positioning device and onward through the insert interface and conduit(s) beyond the insert interface may be effected by an insert mobilizing device disclosed herein such as a motorized spool, insert supply, and / or gear. Instructions for movement of an insert from the insert positioning device and onward through the insert interface to a position within or relative to one or more conduits may be controlled by an insert positioning device using, for example, input received by a processor via a user-facing software interface. The one or more inserts may have the same, or differently functional modalities.
[0074] In some embodiments, the insert placement systems and devices disclosed herein may use and / or include of one or more geometrically arranged templates that may be placed near, adjacent to, and / or inside the subject’s anatomy and, on some occasions, may conform to a shape of a subject’s anatomy and / or target tissue for the purpose of, for example, providing further directional guidance for insert placement and / or increasing treatment / intervention efficacy. In one example, a template may be and / or resemble a needle guide, positioning template, 3D printed surface guide and / or applicator such as those used for performance of apercutaneous biopsy and / or delivery of prostate brachytherapy. Each of the templates may be configured to accept insertion and / or enable the positioning (e.g., movement) of one or more inserts therein to be positioned proximate to and / or inserted into target tissue of a subject. On some occasions, one or more templates may be directly attached to the insert interface. For example, a template with needle ports may cooperate with (e.g., be affixed to) the insert interface such that the template’s needle ports are aligned with the ports of the insert interface. Additionally, or alternatively, one or more templates may be indexed to a set of port identifiers and / or a coordinate system of the insert interface such that the template can receive an insert after the insert exits from the insert interface even when there is a separation in space from the insert interface. Inserts may be, for example, an intervention modality, measurement device, and / or protection device (e.g., heat sink and / or radiation shield). Additionally, or alternatively, one or more templates may be coupled to an insert interface (e.g., insert interface 200) via one or more conduits wherein a first end of each conduit may be coupled to a port of the plurality of ports in the insert interface and a second end of each conduit may be coupled to the subject interface template, which, on some occasions, may be positioned proximate to the target tissue.
[0075] In some embodiments, the systems and / or devices disclosed herein may directly couple with target tissue without a template or conduits by positioning the tissue adjacent to the insert interface such that an insert may exert its function immediately beyond the insert interface and / or over a small separation distance between an active end of an insert and the insert interface. For example, a series of skin interventions (i.e., heat, brachytherapy, or superficial injection) can be delivered to specific ports and / or spatial coordinates on a flat skin surface provided that the patient is positioned such that the target skin region is facing the plurality of ports in the insert interface with, for example, a small separation between them.
[0076] Mechanical movement of the insert to the insert positioning device and onward through the insert interface and optional templates(s) beyond the insert interface may be effected by an insert mobilizing device disclosed herein such as a motorized spool, insert supply, and / or gear. Instructions for movement of an insert from the insert positioning device and onward through the insert interface to a position within or relative to one or more templates may be controlled by an insert positioning device using, for example, input received by a processor via a user-facing software interface. The one or more inserts may have the same, or differently functional, modalities.
[0077] In some embodiments, the insert placement systems and devices disclosed herein may be configured to cooperate with and / or incorporate one or more functional support devices that enable the inserts to deliver different therapies, and / or collect different measurements simultaneously or in sequence via one or more insert interface positions during a single, or multiple, encounter(s) with a subject and / or target tissue of a subject. In some embodiments, the insert interface positions may index to conduits, applicators, or templates described herein. On some occasions, the insert positioning devices and systems disclosed herein may provide for, or enable, composability of multiple therapeutics and diagnostic measurements across positions within, or on, a subject and / or the combined application of multiple functional modalities (e.g., treatments, measurements, etc.) toward target tissue of the subject via, for example, a grid- or lattice-like network of positions distributed on, and / or within, subject tissue anatomy that is accessed by a portion of the insert positioning devices and systems disclosed herein that may be in proximity to and / or in contact with the target tissue. Exemplary target tissue includes, but is not limited to, a tumor, lesion, cyst, abscess, infection, area of inflammation, mole, keloid, area of discoloration, and / or scar.
[0078] The inserts of the insert placement systems and devices disclosed herein may be configured to, for example, facilitate treatment of and / or intervention upon target tissue of a subject, administer treatment to and / or intervention upon a subject at a desired location, shield and / or protect tissue proximate to the target tissue, deliver medication to target tissue, and / or collect information and / or measurements regarding the target tissue and / or the subject at, for example, one or more positions within and / or on target tissue accessed and / or treated by the insert placement system. On some occasions, an insert may be activated (e.g., turned on) prior to the insert’s arrival to a desired position on, or within, target tissue.Exemplary treatments that may be delivered to target tissue via the insert placement systems and devices disclosed herein include, but are not limited to, brachytherapy, cryotherapy, hyperthermia, laser therapy, ultrasound therapy, radiofrequency ablation (RFA) therapy, microwave therapy, electroporation therapy, physical manipulation (for example, massage or microneedling), removal of tissue (for therapeutic or diagnostic purposes), and topical or injected medication. When aninsert is a measurement device, it may be configured to measure, for example, temperature, humidity, radiation levels, force, displacement, pH level, electrical conductance, electrical impedance, electromagnetic spectrum properties, visual appearance and / or chemical composition of the target tissue (e.g., a concentration of a pharmaceutical or hormone present in, or proximate to, the target tissue). When an insert is a device configured to protect tissue and / or assist with the provision of treatment to the target tissue the insert may include, for example, material that blocks movement of radioactive particles (e.g., lead), a suction cannula, and / or a heat sink. In some cases, an insert may have an active tip for deploying its function, such as an absorbent pad saturated with medication, a temperature probe, a needle tip, a stylet, an ablation tool, a suction tool, a cutting canula, and / or a piece of radioactive material. In some cases, an insert may deploy its function along the entire insert, a continuous segment of the insert, or at active positions within the insert and / or a conduit for the insert that are positioned at regular or irregular intervals throughout some or all of the length of the insert.
[0079] In many instances (e.g., where conduits are included in the insert placement system and devices disclosed herein), the conduits may be flexible so that their shape and / or configuration may be adapted or otherwise bent or curved to be proximate to the target tissue and the inserts described herein may be rigid enough to be inserted into, and / or be moved within, the conduit and flexible enough to bend with, for example, a curvature of the conduit that is positioned proximate to target tissue. Conduits may comprise, for example, metal, plastic, vinyl, rubber, latex, silicone and / or combinations thereof and, on some occasions may be transparent or semi-transparent so that, for example, movement of an insert therein may be visually observed. In some cases, a conduit may have specific properties such as, for example, resorbability so that it can be left within tissue, porousness for measurement of tissue properties or release of therapeutics, and / or radio opaqueness for visualization on fluoroscopy or during other imaging procedures. In some embodiments, the walls of the conduit may have variable thickness or be hollow so that they can be filled with liquid / metal / gas. Likewise, conduits may have asymmetric combinations of these features. Inserts may be made from, for example, metal, wire, fiber-optic cables, plastic, vinyl, and / or combinations thereof. On some occasions, the conduit systems disclosed herein may be configured to accept a plurality of inserts at the same and / or at different times (e.g., a first insert ispositioned within and then subsequently removed from the conduit and a second insert is inserted into the same conduit). In some embodiments, a conduit may be configured to function without an insert and / or an insert may be configured to function without a conduit.
[0080] In some instances (e.g., where templates are included in the insert placement system and devices disclosed herein), the templates may be either rigid or flexible so that their shape and / or configuration may be adapted or otherwise bent or curved to be proximate to the target tissue and the inserts described herein may be rigid enough to be inserted into, and / or be moved within, the template and flexible enough to bend with, for example, a curvature of the template that is positioned proximate to target tissue. Similarly, templates may have independently moving or articulating rigid and / or soft (e.g., foam or rubber) parts to conform to proximate tissue. Templates may comprise, for example, metal, plastic, vinyl, rubber, latex, silicone and / or combinations thereof and, on some occasions may be transparent or semi-transparent so that, for example, movement of an insert therein may be visually observed. In some cases, a conduit may have specific properties such as, for example, resorbability so that it can be left within tissue, porousness for measurement of tissue properties or release of therapeutics7and / or radio opaqueness for visualization on fluoroscopy or during other imaging procedures. In some embodiments, the walls of the template may have variable thickness or be hollow so that they can be filled with a liquid, metal, solid, and / or gas. Likewise, templates may have asymmetric combinations of these features. Inserts may be made from, for example, metal, wire, fiber-optic cables, plastic, vinyl, and / or combinations thereof. On some occasions, the template systems disclosed herein may be configured to accept a plurality of inserts at the same and / or at different times (e.g., a first insert is positioned within and then subsequently removed from the template and a second insert is inserted into the same template at the same or different position). In some embodiments, a template may be configured to function without an insert and / or an insert may be configured to function without a template.
[0081] The systems, devices, and methods disclosed herein enable a user to generally compose an intervention, comprising of one or more therapeutic, protective, treatment, and / or diagnostic modalities, across an arbitrary tissue (e.g., target tissue) surface or volume. Deployment of various therapeutic and diagnostic modalities may be controlled by software and / or hardware that direct inserts to a gridor lattice meshwork of positions on or within tissue-of-interest, which may be, for example, a surface-of-interest (e.g., skin, organ surface, bone, ligament) or inside a volume-of-interest (e.g., a field of interstitial tissue, a surgical incision, a traumatic opening (e.g., puncture or gun-shot wound), and / or a hollow organ or cavity). In some embodiments, the grid or lattice meshwork of positions may refer to positions defined by their location relative to, or inside of, one or more geometrically arranged conduit(s) and / or template(s).
[0082] Thus, the systems, devices, and methods disclosed herein leverage robotics, automation, and sophisticated port identification and / or coordinate systems to enhance the positioning and deployment of medical instruments (also referred to herein as (“inserts”) to enable clinicians to precisely plan and target tissues using predefined port identifiers and / or spatial coordinates indexed to the anatomy of the patient. These advancements not only improve treatment efficacy and efficiency of performance but also reduce the invasiveness of procedures, enhancing patient safety and recovery times.
[0083] Additionally, or alternatively, the systems, devices, and methods disclosed herein provide enhanced versatility and integration over existing systems, particularly in environments where complex anatomical features are present (e.g., the face or internal organs of a subject) and / or multi-modal treatments or diagnostic applications are required. Additionally, or alternatively, the systems, devices, and methods disclosed herein provide a comprehensive system that integrates advanced robotic precision, digital interfaces, and multi-functional support for a wide range of medical instruments, inserts, and procedures while also maintaining adaptability across diverse anatomical regions and clinical scenarios.
[0084] Turning now to the figures, FIG. 1 A is a schematic diagram of a portion of a first insert 140A with an inactive portion 142 an active tip 145. FIG. 1 B is a schematic diagram of a second insert 1406 that includes an active portion 150 that extends along the entire length of second insert 1406. FIG. 1C is a schematic diagram of a third insert 140C that includes an inactive portion 142 and an active portion 155 embodied as a continuous segment 155. FIG. 1D is a schematic diagram of a fourth insert 140D that includes a plurality of active positions 160 and inactive positions 142 arranged in an alternating pattern at regular intervals along the length of fourth insert 140D. FIG. 1 E is a schematic diagram a fifth insert 140E that includes a plurality of active positions 160 and inactive positions 142 arranged in analternating pattern at irregular intervals along the length of fifth insert MODE. First, second, third, fourth, and / or fifth inserts 140A, MOB, 140C, MOD, and / or MOE may be flexible (for example, a catheter, wire, or electrode) and / or rigid (for example a needle or trocar). In some embodiments, a single insert 140 can have more than one function, and in these embodiments, the individual functions can have any of these respective topologies shown in FIGs. 1A-1 E in combination (e.g., a first function / treatment modality is delivered by first insert 140A and a second function / treatment modality is delivered by fifth insert MOE). At times, first, second, third, fourth, and / or fifth inserts 140A, MOB, 140C, MOD, and / or MOE may be collectively referred to herein as “insert 140”.
[0085] FIGs. 1 F and 1G provide a time sequence of insert deployment using a conduit / insert assembly 100, wherein FIG. 1F is a schematic diagram of a portion of conduit / insert assembly 100 that includes a conduit 120 with first insert 140A partially positioned therein and FIG. 1G is diagram of conduit / insert assembly 100 with first insert 140A fully inserted through conduit 120 so that active portion 145 extends from an open end of conduit 120 and may be positioned within and / or proximate to target tissue. Conduit 120 may be a hollow tube with at least one open end made from, for example, plastic, vinyl, memory plastic, and the like and may be configured to accept insertion, movement and / or removal of an insert like an insert 140 therein and / or therefrom. Conduit 120 may also be configured to tolerate and / or assist with one or functions and / or actions performed by the insert. For example, conduit 120 may be configured to be heat resistant, conduct electricity, insulate electricity, conduct heat, and / or insulate heat. As shown in FIGs. 1 F and 1G, conduit 120 is transparent so that insert 140, when inserted therein, may be seen but, this need not always be the case. For example, conduit 120 may be opaque or semi-transparent. Exemplary inserts may be sized, shaped, and / or configured to be inserted into, and move within, a lumen of conduit 120 to, for example, deliver treatment to a subject, take a measurement, provide light, protect tissue, and so on via conduit 120. Insert 150 and inserts 140 with forms as described in FIGS. 1C, 1 D, and 1 E can be inserted in a conduit 120 in the same way as described for the form in FIG 1A (insert 140 with active tip 145). As shown in FIGs. 1 F and 1G, conduit 120 is transparent but this need not always be the case.
[0086] On some occasions, insert 140 may be configured to be positioned proximate to (e.g., on top of or inside) target tissue of a subject via, for example,applying insert 140 and / or an end thereof to the target tissue, wrapping insert 140 around all, or a portion, of the target tissue (e.g., wrapping insert around a limb or protrusion from the body (e.g., nose or ear)), and / or inserting insert 140 into a naturally occurring orifice (e.g., mouth, urethra, etc.) and / or a surgical incision (e.g., endoscopic and / or open surgery). Additionally, or alternatively, insert 140 may be configured to be used non-invasively by positioning an end of conduit 120 proximate to, but not touching, target tissue of the subject that is positioned on an exterior surface of the subject (e.g., skin or eye). Additionally, or alternatively, insert 140 may be configured to be invasively inserted into tissue by means of, for example, a sharp tip. In some embodiments, positioning of insert 140 may be aided by a template that is pre-positioned, non-invasively or invasively, proximate to the target tissue of the subject.
[0087] On some occasions, conduit 120 may be configured to be positioned proximate to (e.g., on top of or inside) target tissue of a subject via, for example, applying conduit 120 and / or an end thereof to the target tissue, wrapping conduit 120 around all, or a portion, of the target tissue, and / or inserting conduit 120 into a naturally occurring orifice (e.g., mouth, urethra, etc.) and / or a surgical incision (e.g., endoscopic). Additionally, or alternatively, conduit 120 may be configured to be used non-invasively by positioning an end of conduit 120 proximate to target tissue of the subject that is positioned on an exterior surface of the subject (e.g., skin or eye). Additionally, or alternatively, conduit 120 may be configured to be invasively inserted into tissue by means of, for example, a sharp tip. Once conduit 120 is in position relative to the subject’s target tissue, insert 140 may be inserted into conduit 120 as, for example, disclosed herein, and arranged at a desired position within conduit 120 (e.g., proximate to and / or within target tissue). Additionally, or alternatively, positioning of conduit 120 may be aided by coupling conduit 120 to a template that may be pre-positioned, non-invasively or invasively, proximate to the target tissue of the subject. Additionally, or alternatively, conduit / insert assembly 100 may be assembled prior to use with a subject and then the assembly may be placed in the desired position proximate to the target tissue.
[0088] Once insert 140 is properly positioned directly within target tissue or within conduit 120 relative to the subject’s target tissue, insert 140 may be activated and / or used to deliver the relevant treatment to the target tissue for a first time period (e.g., 0.1 -180s). In some embodiments, insert 140 may be repositioned withinconduit 120 following the first time period and may be activated again for a second time period. If insert 140 is a measurement device, it may be actively measuring while resident within conduit 120 and / or may be activated to take a measurement at a particular time (e.g., continuously, periodically, and / or on demand). In some cases, insert 140 may be removed from conduit 120 at the conclusion of the first and / or second time period.
[0089] In some embodiments, conduit 120 may be used to introduce a plurality of different inserts (e.g., different types of inserts and / or inserts that provide variations of (e.g., dosage) the same treatment modality) to the target tissue after the first and / or second time period (when insert 140 is used).
[0090] FIGs. 2A, 2B, 2C, and 2D provide renderings of a top view of an exemplary first, second, and third insert interface 200A, 200B, 200C and 200D, respectively. First insert interface 200A of FIG. 2A includes an array of circular ports 220 arranged in a Cartesian grid-like pattern on a first interface body 210A as shown. Second insert interface 200B of FIG. 2B includes an array of ovoid, or elongated, ports 225 arranged in a column pattern on a second interface body 210B as shown. Third insert interface 200C of FIG. 2C includes a permeable material or a window 230 such that, instead of distinct ports and / or holes, any Cartesian coordinate along continuous X and Y axes can be designated as an exit point for the insert and / or conduit that is aimed by, for example, the directional subunit disclosed herein. Fourth insert interface 200 of FIG. 2D includes an array of circular ports 220 arranged in a radial pattern on a circular interface body 210D with varying distances between ports. In this embodiment, the spatial coordinates of the ports have varying distances between ports to match, for example, a circular anatomic target wherein more versatile intervention is desired at the center than at the edges of the target tissue.
[0091] Circular ports 220 and / or ovoid ports 225 may be apertures and / or devices configured to couple to one or more conduits for an insert like the conduits and inserts disclosed herein. At times, a conduit may be permanently and / or removably coupled to a circular port and / or ovoid port 220 and / or 225. Circular ports 220 and / or ovoid ports 225 may be embodied as, for example, holes, clamps, leur couplings, seals, permeable membranes and / or extensions from first, second, and / or third interface body 210A, 210B, and / or 210C.
[0092] In the embodiment of FIG. 2A, the array of ports 220 are arranged in eight columns (labeled 1-8) of eight rows (labeled A-H) although this need not always be the case. For example, an insert interfaces may have varying numbers and / or arrangements of ports 220 including, for example, a Cartesian grid-like pattern with, for example, 25, 100, 240, etc. ports, a plurality of ports 220 radially arranged in concentric circles, and / or a plurality of ports 220 arranged in a spiral formation. A distance between two ports 220 of the array of ports 220 of first may be within a range of 0.1 -20cm in the X and / or Y direction. In some embodiments, a distance between two or more ports 220 may be constant across first insert interface body 210A and, in other embodiments, a distance between two or more ports 220 may vary across first insert interface body 210A. For example, a distance between ports 220 positioned in an approximate center of fourth insert interface body 210D may be closer together than a distance between ports 220 positioned toward an outer edge of fourth insert interface body 210D so that there is a greater concentration of ports 220 in an approximate center of fourth insert interface body 210D than at the outer edges of fourth insert interface body 210D. Additionally, or alternatively, insert interface 200 may have ports of arbitrary dimensions and shapes and, in some embodiments, the ports can be a combination of different shapes and sizes. Additionally, or alternatively, exemplary insert interface(s) 200 may have varying and / or arbitrary dimensions and shapes (e.g., oval, rectangle, triangle, irregular, etc.).
[0093] FIG. 3 is a diagram of components included in an exemplary directional subunit 300 that is used to guide an insert like the inserts described herein, a conduit like the conduits disclosed herein, and / or a flexible medical instrument (i.e., catheter, wire, etc.). For the purpose of the following discussion, the example of a directional subunit 300 that is used to guide insert 140 is used. However, directional subunit 300 may be used with a conduit like conduit 120 and / or a flexible instrument in a manner similar to that described below with regard to insert 140. Directional subunit 300 includes a housing 305 that houses an insert supply 310 of insert material, such as insert 140. Insert supply 310 may be configured to allow for the extension and / or retraction of insert 140 by, for example, directional subunit 300 and / or components thereof. Insert supply 310 may be embodied as, for example, a spool with insert 140 wrapped around it; a reservoir of an insert 140 that may be, for example, coiled and / or folded therein; and / or a housing for storing and / or containing a rigid insert 140in, for example, a linear fashion. A gear 315 is posited at an approximate center of insert supply 310 and is configured to translate motion provided by a motor 325 to insert supply 310 so that insert supply 310 may rotate about a central axis, thereby unwinding insert 140 from insert supply 310. As insert 140 unwinds from insert supply 310, it may extend along a guide structure that includes a base 330 and a guide channel 335 through an aperture 320 in housing 305 so that insert 140 extends out of housing 305 as shown and into a conduit as, for example, disclosed herein. Likewise, insert 140 may be retracted into housing 305 and / or insert supply 310 via reverse motion applied by motor 325 to gear 315. Motor 325 may be, for example, a stepper motor. Although insert supply 310 and motor 325 are shown inside housing 305, this need not always be the case. For example, insert supply 310 and / or motor 325 may be positioned outside housing 305 and directional subunit 300 may be configured direct and / or facilitate the movement of an insert from insert supply 310 and / or motor 325 as, for example, disclosed herein.
[0094] Optionally, directional subunit 300 may include one or more locking mechanisms 350 configured to hold insert 140 in place (e.g., a desired orientation and / or degree of extension and / or retraction) during use. Locking mechanism(s) 350 may be positioned anywhere along the path of the insert as it exits directional subunit 300 and enters insert interface 200 and / or a component thereof (e.g., a port 220). Locking mechanism(s) may be, for example, an electromechanical, mechanical, and / or magnetic locking mechanism and may include a component (e.g., a magnet or catch) configured to directly engage and / or hold (via, for example, magnetic force) insert 140 itself and / or a plurality of components (e.g., two sides of a clamp) that engage or hold insert 140 via mechanical or electromagnetic force. In the embodiment shown in FIG. 3A, directional subunit 300 includes a locking mechanism 350 positioned at the end of the guide channel 335. In the embodiment shown in FIGS. 4A and 4B, the locking mechanism 350 is outside the directional subunit and located adjacent to insert interface 200. However, embodiments where more (e.g., 3, 4, 6, or 8) or less (e.g., 1) locking mechanism(s) 350 may be used within the scope and spirit of the invention. FIG. 3B provides a side perspective view of an exemplary locking mechanism 350 that includes a body 360 with a central aperture 355 through which insert 140 may pass and / or move.
[0095] FIGs. 4A is a schematic diagram that provides a side view, FIG. 4B is a schematic diagram that provides a top view, and FIGs. 4C, 4D, and 4E areschematic diagrams that provide side views of an exemplary insert positioning device 400. Insert positioning device 400 includes a housing 440 (not shown in FIG. 4C, 4D, 4E) that includes a base 445 and insert interface 200 (e.g., insert interface 200A, insert interface 200B, and / or insert interface 200C) positioned on and / or within an exterior surface thereof. Optionally, insert positioning device 400 may include one or more locking mechanisms 350 configured to hold insert 140 in place (e.g., a desired orientation and / or degree of extension and / or retraction) during use. Locking mechanism(s) 350 may be positioned anywhere along the path of the insert as it exits directional subunit 300 and enters insert interface 200 and / or a component thereof (e.g., a port 220).
[0096] Housing 440 houses a frame that assists with the translational movement of directional subunit 300 that, in the embodiment of FIGs. 4A, 4B, 4C, and 4D includes a horizontal guide rail 420 and a vertical guide rail 425. In other embodiments, the frame may include two or more horizontal and / or vertical guide rails (not shown). In the embodiment of FIG. 4E, the frame may also include a forward-backward guiderail 430 to assist with the movement of the directional subunit in the Z- direction. In the embodiment of FIGs. 4A, 4B, 4C, 4D and 4E, a directional subunit is mounted on the vertical guide rail. In other embodiments the directional subunit can be mounted on the horizontal or forward-backward guide rail.
[0097] In the embodiment of FIGs. 4A, 4B, 4C, 4D and 4E, a directional subunit 300 is coupled to an adjustment mechanism 435 that may, for example, rotate directional subunit 300 to adjust an angle 0 (pitch) and / or (|) (yaw) thereof. For example, FIG. 4C shows directional subunit 300 oriented at a first set of angles 01 and <t>i so that insert 140 is directed upward (as oriented in the figure) and FIG. 4D, which is a diagram of a side view of insert positioning device 400 wherein directional subunit 300 is oriented at a second set of angles 02 and / or < 2 so that insert 140 is directed downward (as oriented in the figure). Additionally, or alternatively, an embodiment may include an adjustment mechanism configured to roll and / or move the directional subunit 300 (in addition to yaw and pitch), which may provide additional degrees of freedom when, for example, aperture 320 of directional subunit 300 is not centered with, for example, an insert interface 200 (e.g., insert interface 200A, 200B, and / or 200C) (see e.g., FIGs. 4F ad 4G). Additionally, or alternatively, in some embodiments, angular rotation of directional subunit 300 can be effected by an adjustment mechanism that rotates horizontal guide rail 420 and / or vertical guiderail 425. In these embodiments, horizontal guide rail 420 and / or vertical guide rail 425 may have up to three rotational degrees of freedom (roll, yaw, pitch). Embodiments of insert positioning device 300 may include some, or all, of the translational and / or rotational adjustment mechanisms described.
[0098] A motor (e.g., a stepper motor) (not shown), may move directional subunit 300 in the X-direction along horizontal guide rail 420 and / or in the Y-direction along vertical guide rail 425 to align with a particular port 220 of insert interface 200 according to, for example, instructions received via one or more execution of one or more methods and / or method steps disclosed herein. In some embodiments, a motor may also move directional subunit 300 in the Z-direction to adjust the depth of movement through a particular port 220 or through a coordinate in the insert interface. In some embodiments, a position of directional subunit 300 may sequentially change over time so that, for example, an insert 140 may extend from directional subunit 300 into a first conduit port 220 so that it contacts a first position on a subject for a first duration of time and then is retracted back into directional subunit 300 (e.g., rewound around insert supply 310). Then, directional subunit 300 may be moved in the horizontal and / or vertical directions so that it aligns with a second conduit port 220 and the same insert 140 may extend from directional subunit 300 into the second conduit port 220 so that it contacts a second position on a subject for a second duration of time and then is retracted back into directional subunit 300 upon expiration of the second duration of time. This process may be repeated until insert 140 has contacted all desired positions on the subject. For example, FIG. 4F provides a diagram of insert positioning device 400 when directional subunit 300 is positioned so that insert 140 is aligned with, and extends through, a conduit port 220 at position C6 (i.e., third row and sixth column) of insert interface 200 as shown.
[0099] In some embodiments, insert interface 200 may be curved and / or have an irregular shape to, for example, accommodate subject anatomy or engineering specifications. An example of such a curved insert interface 200’ is provided by FIG. 4G, which provides a diagram of insert positioning device 400 when directional subunit 300 is positioned so that insert 140 is aligned with, and extends through, a conduit port 220 at position B4 (i.e., second row and fourth column) of curved insert interface 200’ as shown.[000100] Additionally, or alternatively, in some embodiments, an insert positioning device may include a plurality of directional subunits, each of which may be separately positioned at an angle and / or in the X-, Y- and / or Z-directions via, for example, movement along horizontal guide rail 420 and / or vertical guide rail 425 to align with a particular opening of an insert interface like insert interface 200. FIG. 5 provides a diagram of an exemplary insert positioning device 500 that includes a first directional subunit 300A positioned at a first position along a vertical guide rail 525 configured to hold two directional subunits 300. First directional subunit 300A is oriented via a first adjustment mechanism 435A at a third set of angles 03 and <t>3 so that an insert 140 is directed upward (as oriented in the figure). Insert positioning device 500 also includes a second directional subunit 300B positioned at a second position along a vertical guide rail 525. Second directional subunit 300B is oriented via a second adjustment mechanism 435B at a fourth set of angles 04 and <t>4 so that a second insert 140’ is directed downward (as oriented in the figure). Additionally, or alternatively, a plurality of directional subunits 300 can be positioned or moved along horizontal guide rail 420 and / or vertical guide rail 425. Individual directional subunits 300 of the plurality of directional subunits 300 can be implemented independently, simultaneously, or in a predetermined sequence. In some embodiments, one or more horizontal guide rails 420 in combination with one or more forward-backward guiderails 430 can form a grid of positions along which the vertical guiderail 425 can translate in order to aid in positioning of insert positioning devices 400.[000101] Additionally, or alternatively, in some embodiments, a plurality of individual directional subunits 300, each with their respective frame including horizontal and / or vertical guiderails 420 and 425, can be included inside housing 440, each of which may be separately positioned at an angle and / or in the X-, Y- and / or Z-directions. These individual directional subunits can be implemented independently, simultaneously, or in a predetermined sequence.[000102] In some embodiments, an insert 140 may extend from directional subunit 300, insert interface 200, and / or housing 440 and directly contact a subject (e.g., not pass through a conduit or template to contact the subject). In these embodiments, subject tissue (e.g., skin) may be placed proximate to directional subunit 300 and / or housing 440 so that insert 140 may directly contact the subject tissue. Additionally, or alternatively, in some embodiments, insert 140 may be configured to be rigid enough to extend through aperture 320 and maintain its shapeuntil it extends far enough away from directional subunit 300 and / or housing 440 to contact subject tissue.[000103] FIGs. 6A-6E provide block diagrams of exemplary first, second, third, fourth, and fifth insert positioning systems 601 , 602, 603, 604, and 605, respectively, that may utilize an insert positioning device like insert positioning device 400 and / or 500 to facilitate treatment of a subject using one or more inserts like insert 140 as, for example, described herein. First, second, third, fourth, and fifth insert positioning systems 601 , 602, 603, 604, and 605 include a computer / processing unit 605, a database 625, a controller 615, and a plurality of insert functionality support devices 610, such as first insert functionality support device 610A, second insert functionality support device 610B, third insert functionality support device 610C, through Nth insert functionality support device 61 ON. Although shown as separate components, two or more components of systems 601 , 602, 603, 604, and 605 may be resident in the same housing and / or device.[000104] Each of the plurality of insert functionality support devices 610A, 610B, 610C-610N may be configured to provide and / or facilitate provision of one or more functionalities (e.g., heat, medication, vacuum, etc.) for one or more inserts via communication through of a respective insert through one or more port(s) 220 and / or insert interface 200. In some embodiments, coupling an insert to one or more functionality support devices 610A, 610B, 610C-610N may activate the insert. Additionally, or alternatively, an insert may be activated once the functionality support device 610A, 610B, 610C-610N is turned on and / or begins to supply the functionality to the insert. In some instances, an insert may perform its function without being coupled to a functionality support device 610A, 610B, 610C-610N as may be the case when, for example, an insert may be heated, cooled, and / or dipped into medication prior to use. Alternatively, when an insert performs a protective function (e.g., lead to prevent unintended exposure to radiation or thermal insulation to prevent undesirable heating or cooling of tissue), the insert may not be coupled to a functionality support device 610A, 610B, 610C-610N.[000105] Computer / processing unit 605 may be configured to, for example, execute one or more methods disclosed herein. Additionally, or alternatively, computer / processing unit 605 may be configured to generate or otherwise design an intervention plan for target tissue of a subject that utilizes the systems and / or devices disclosed herein to treat the target tissue with a single or multi-modal set ofinterventions across a desired geometry. The intervention plans may be generated using, for example, information about a subject (e.g., age, gender, medical diagnosis), information about the target tissue (e.g., type, size, location, anatomical features, geometry, images, scans, X-rays, etc.), information about the insert interface and port and / or grid positions therein, how the insert interface will be positioned proximate to the target tissue (e.g., via a natural opening or invasive access), and / or the type, size, duration, intensity, and / or position at which an insert may be arranged for use when treating, measuring, protecting or otherwise intervening upon the target tissue. Additionally, or alternatively, the intervention plan may be generated using information on whether a conduit system or template external to the positioning device is indexed and / or attached to the insert interface, how the conduit system or external template may be positioned proximate to the target tissue, and / or type, size, duration, intensity, and / or position within a conduit or relative to a template at which an insert may be arranged for use when treating, measuring, protecting or otherwise intervening upon the target tissue.[000106] In some embodiments, intervention plans may model, or predict, treatment effects or distributions on representations of the subject (e.g., photographs, diagnostic images) including the effects of combining different modes of treatment to target tissue. A dedicated coordinate system may be used to direct interventions to particular locations that are accessible by the insert positioning system and model the effects of the interventions. The coordinate system may be defined directly by locations within the target tissue and / or, in cases where a conduit system or template is used, positions that are indexed to a conduit system or template. Additionally, or alternatively, the coordinate system at the site of treatment may be indexed to the coordinates and / or port positions of the insert interface. Intervention plans may require user specification of predesignated positions for functional deployment and / or intervention plans may enable inserts to be localized to positions defined at the time of intervention planning. Additionally, or alternatively, these positions may be defined based upon distance(s) traveled by an insert from the positioning system or a subunit therein.[000107] As shown in FIG. 6A, insert placement system 601 also includes insert mobilizing device(s) 620, insert positioning device(s) 400 and / or 500 and insert interface 200. Insert mobilizing device 620 may include one or more devices configured to dispense (e.g., extend and / or retract) an insert like insert 140 (e.g., fora flexible insert (e.g., insert 140), the insert mobilizing device may be and / or include, for example, insert supply 310, a spooling mechanism, and / or robot that rotates a spool or drum to push the insert forward or pull it backward). An insert may be driven to an intended insert positioning device 400 or 500 and onward to the insert interface 200 by the insert mobilizing device 620. Insert mobilizing device 620 may be and / or include a spool like insert supply 310, a gear like gear 315, and / or a motor like motor 325. In embodiments where there is redundancy of components 310, 315, and / or 325 in insert mobilizing device 620 and directional subunit 300, the components may work in tandem (e.g., course and / or fine adjustment) or independently (e.g., for backup and / or interlock purposes). Insert mobilizing device 620 may be resident within or adjacent to one or more of insert functionality support device(s) 610A, 610B, 610C-610N. Additionally, or alternatively, insert mobilizing device(s) 620 may be resident within insert positioning device(s) 400 or a subunit thereof (e.g., directional subunit 300). Additionally, or alternatively, the component devices that together constitute an insert mobilizing device 620 can be distributed across these other elements of the positioning system.[000108] In the embodiment of FIG. 6A, insert mobilizing device 620 may be configured to accept inserts from a plurality of insert functionality support devices 610A-610N. Additionally, or alternatively, insert mobilizing device 620 may push and / or pull one or more inserts into and / or out of respective ports or coordinates of insert interface 200 according to, for example, one or more sets of position and / or insert functionality instructions provided by, for example, insert positioning device 400 or 500, computer / processing unit 605, database 625, and / or controller 615. In an alternative embodiment, system 601 may be configured so that insert mobilizing device 610 is positioned between controller 615 and the plurality of insert functionality support devices 610A-610N instead of between the plurality of insert functionality support devices 610A-610N and insert positioning device(s) 400 and / or 500.[000109] Insert placement system 602 of FIG. 6B depicts an embodiment wherein each of the plurality of insert functionality support devices 610A-610N has a dedicated insert mobilizing device 620A-620N. All insert mobilizing devices 620A- 620N are coupled to a single insert positioning device 400 or 500 configured to direct one or more inserts extending from one of the plurality of insert mobilizing devices 620A-620N to any position, or port, of insert interface 200 as directed by, forexample, insert positioning device 400 or 500, computer / processing unit 605, database 625, and / or controller 615. In an alternative embodiment, system 602 may be configured so that one or more of the plurality of insert mobilizing device(s) 620A- 620N are positioned between controller 615 and the plurality of insert functionality support devices 610A-610N instead of between the plurality of insert functionality support devices 610A-610N and insert positioning device 400 or 500.[000110] Insert placement system 603 of FIG. 6C depicts an embodiment wherein each of the plurality of insert functionality support devices 610A-610N has a dedicated insert mobilizing device 620A-620N that is coupled to a dedicated insert positioning device 400A / 500A-400N / 500N, each of which are configured to direct one or more inserts extending from one of the plurality of insert positioning device 400A / 500A-400N / 500N to any position, or port, of insert interface 200 as directed by, for example, insert positioning device 400A / 500A-400N / 500N, computer / processing unit 605, database 625, controller 615. In an alternative embodiment, system 603 may be configured so that one or more of the plurality of insert mobilizing device(s) 620A-620N are positioned between controller 615 and a respective one of the plurality of insert functionality support devices 610A-610N instead of as shown in FIG. 6C.[000111] FIG. 6D depicts an embodiment of the insert placement system wherein each of the plurality of insert functionality support devices 610A-610N are coupled to a single insert mobilizing device 620 that is coupled to a plurality of insert positioning devices 400a / 500a-400k / 500k, each of which are configured to direct one or more inserts extending from the respective insert positioning device to the corresponding insert interface 200 region as directed by, for example, insert positioning device 400a / 500a-400k / 500k, computer / processing unit 605, database 625, and / or controller 615. For example, this embodiment may be used in an insert placement system wherein each insert positioning device 400 / 500 serves one quadrant of a square-shaped insert interface 200. A region served by one of the insert positioning devices can include all, or a portion, of the insert interface. The regions served by the plurality of the insert positioning devices 400a / 500a-400k / 500k in this embodiment can be overlapping or non-overlapping. For an embodiment of a placement system that uses discreet ports in the insert interface, the extreme case of nonoverlapping regions would be for each port to be served by its own dedicated insert positioning device. In an alternative embodiment, system 604 may beconfigured so that insert mobilizing device 620 is positioned between controller 615 and the plurality of insert functionality support devices 61 OA-61 ON instead of as shown in FIG. 6D.[000112] Insert placement system 605 of FIG. 6E depicts an embodiment wherein each of the plurality of insert functionality support devices 61 OA-61 ON can have its insert directed to one or more insert mobilizing devices 620i-620m that are in turn coupled to one or more insert positioning devices 400a / 500a-400k / 500k, each of which are configured to direct one or more inserts extending from one of the plurality of insert positioning device 400a / 500a-400k / 500k to a respective region of insert interface 200 as directed by, for example, insert positioning device 400a / 500a- 400k / 500k, computer / processing unit 605, database 625, and / or controller 615. A region served by one of the insert positioning devices 400a / 500a-400k / 500k can include all, or a portion, of the insert interface. The regions served by the plurality of the insert positioning devices 400a / 500a-400k / 500k in this embodiment can be overlapping or non-overlapping. System 605 allows different combinations of an insert functionality support device, insert mobilizing device, and insert positioning device to be activated in sequence or simultaneously, which may enable interventions to be, for example, multimodal and composable in time and space proximate to and / or in the target tissue. In an alternative embodiment, system 605 may be configured so that one or more of the plurality of insert mobilizing device(s) 620i-620m are positioned between controller 615 and a respective one of the plurality of insert functionality support devices 61 OA-61 ON instead of as shown in FIG. 6D. Additionally, or alternatively, in this embodiment each of the insert functionality devices (i.e., 610A) may be configured to deploy multiple inserts simultaneously to multiple insert mobilizing devices 620i-620m.[000113] FIG. 7 is a flowchart showing an exemplary process 700 for generating a intervention plan and / or using one or more of the devices, inserts, insert placement systems, insert assemblies, insert interfaces, and / or intermediary devices (conduits, conduit arrangements, conduit-conduit systems, conduit-template systems, templates) and / or systems including one or more combinations thereof as, for example, disclosed herein. Process 700 may be executed by, for example, any of the devices and / or systems disclosed herein. FIGs. 8A-8M provide diagrams of an exemplary way one or more of the processes disclosed herein may be performed and will be discussed concurrently with discussion of process 700 below.[000114] In an exemplary embodiment, process 700 may be performed by an insert placement system 800 of FIG. 8A1 as shown in rendering 801 of FIG. 8A2. System 800 includes a housing 872 and / or 875, a subject interface template 820, and an array of conduits 825 (with conduits shown in dashed lines) that physically and communicatively couple housing 872 or 872 to subject interface template 820 via insert interface 200 as shown. One or more conduits (e.g., conduit 120) of conduit array 825 may extend through subject interface template 820, thereby forming a corresponding array of extensions 830 as shown in FIG. 8A2 so that, for example, an open and / or active end may be used within and / or proximate to subject tissue as, for example, described herein. In addition, FIG. 8A2 shows a portion of a subject 870 lying on a table.[000115] Housing 872 houses components of a system 800 comprising one or more insert positioning device(s) 400 and / or 500, one or more insert mobilizing device(s) 620A-620N, controller 615, and one or more insert functionality support device(s) 610A-610N. System 800 also includes computer / processing unit 605 and database 625 which may be resident within housing 872 and / or remote from (e.g., connected via a wired and / or wireless network and / or near field communication protocol) the components of housing 875 (e.g., communicatively coupled via wired and / or wireless network). When computer / processing unit 605 and database 625 are remote from one or more insert positioning device(s) 400 and / or 500, one or more insert mobilizing device(s) 620A-620N, controller 615, and one or more insert functionality support device(s) 610A-610N, system 800 may not include housing 872. In some embodiments, an arrangement and / or functionality of components within housing(s) 872 and / or 875 may be similar to that shown in FIGs. 6A, 6B, 6C, 6D, and / or 6E and / or as described herein. In some embodiments, a plurality of housing(s) 872 and / or 875 may be utilized to accommodate a plurality of system(s) 800, each of which may provide one or more specific intervention(s) that is desired for a specific clinical scenario and / or to execute one or more intervention plans.[000116] In step 705, information about the subject and / or target tissue of the subject may be received by, for example, a computer and / or processing unit like computer and / or processing unit 605 and / or a controller like controller 615. Exemplary target tissue information includes, but is not limited to, dimensions (e.g., length, width, height, and / or shape) of target tissue, a position (e.g., anatomical location (e.g., nose, ear, liver, breast, etc., and / or X-, Y-, and / or Z-coordinates) of thetarget tissue on / within the subject’s body, target tissue type and composition (e.g., tumor, cyst, lesion, mole, scar tissue, etc.), and / or dimensions and composition / characteristics of background tissue, underlying tissue, and / or tissue proximate to the target tissue. Exemplary subject information includes, but is not limited to, gender, age, skin color, comorbidities, and pain tolerance. In some embodiments, execution of step 705 may include receiving information about a position and / or orientation (e.g., seated, lying supine, etc.) of a subject prior to, during, and / or after administration of the intervention. Such information may include imaging data of the subject with or without the system and / or devices in position, including but not limited to computed tomography, magnetic resonance, ultrasound, and / or positron emission tomography data. Optionally, execution of step 705 may include receiving information about the systems and / or devices (e.g., inserts, insert placement systems, insert assemblies, insert interfaces, and / or intermediary devices (conduits, conduit arrangements, conduit-conduit systems, conduit-template systems, templates)) and / or systems that may be used to perform an intervention. [000117] FIG. 8B provides a rendering of a front-side perspective view of subject interface template 820 and FIG. 8C provides a rendering of a back-side perspective view of subject interface template 820. Subject interface template 820 includes a body 815 that includes an array of ports, or openings, through which a corresponding array 835 of extensions 830 extend. One or more extensions 830 may include an end 832 configured to be proximate and / or open to target tissue of a subject. At times, an insert may abut end 832 when, for example, end 832 is open or closed. Additionally, or alternatively, an insert may travel through end 832 to contact and / or be positioned proximate to target tissue of the patient. Each extension 830 may be, for example, a terminating end of a conduit (e.g., a conduit passing through a port of body 815 and extending away from it) or a separate device such as a tube, catheter, or insert end that is coupled to a conduit via a conduit coupling as shown in, for example, FIG. 8C. In some embodiments, one or more extensions 830 may be configured to articulate into and / or out of body 815 to, for example, conform to target tissue and / or patient anatomy. At times, one or more extensions may be configured to move into and / or out body 815 in a manner consistent with force applied thereof from, for example, gravity when in contact with subject tissue. Stated differently, one or more extension(s) 830 included within an array 835 of extensions 830 may be configured to move, to capture, for example, a curvature and / or contour of anirregular surface, such as a face, tumor, or organ as, for example, shown in FIG. 8F and / or disclosed herein.[000118] In some embodiments, information received in step 705 may include information regarding one or more systems and / or devices used to execute one or more steps of process 700. For example, execution of step 705 may include receiving information about inserts, conduits, subject interface templates, insert placement systems, insert assemblies, insert interfaces, and / or intermediary devices (conduits, conduit arrangements, conduit-conduit systems, conduit-template systems, templates) and / or systems including one or more combinations thereof. FIGs. 8D-8G provide one example of information that may be received in step 705, wherein FIG. 8D provides a rendering 804 of a top-perspective view of an exemplary subject 870 with an area of target tissue 822 positioned on subject’s skin below the subject’s right eye and on the right side of the subject’s nose. FIG. 8E provides a rendering 805 of a top-perspective view of subject interface template 820 positioned above subject’s 870 face so that array 835 of extensions 830 may come into contact with subject’s 870 face proximate to target tissue 822 as, for example FIG. 8F, which is rendering 805 of a side view of subject 870 on which some, or all, extensions of array 835 of extensions 830 and have moved / articulated within their respective ports of body 815 so that each extension of the plurality of extensions is in contact with subject’s 870 face as shown.[000119] Optionally, in step 710, a display (e.g., a graphic user interface (GUI)) or other input device may be provided to a user so that they may input instructions for the generation of an intervention plan may be provided to the user. FIG. 8G is a rendering 807 of a top view of subject’s 870 face with target tissue 822 and a grid of points 850 superimposed thereon. Rendering 807 may be provided to a user when step 710 is executed. Each point 852 of grid of points 850 corresponds to a position where an extension 830 of array of extensions 835 contacted, or may contact, subject’s 870 face (see e.g., FIGs. 8D-8F and the above discussion) and this information may be used to, for example, generate an intervention plan as, for example, described herein. Additionally, or alternatively, a GUI like GUI 808, which is shown in FIG. 8H may be provided to a user so that he or she may input instructions (via, for example, selection of one or more of the graphic elements and / or icons therein) that may be used to generate an intervention plan for target tissue 822. In particular, GUI 808 provides a rendering of subject 870 as well astarget tissue 822 with an intervention grid 855 superimposed thereon. Each point of intervention grid 855 corresponds to a position where an extension of the array of extensions 830 has contacted subject’s 870 face and / or a position that may be contacted by an insert traveling through a conduit coupled to an extension of array of extensions 830. GUI 808 also includes a menu bar 860 that includes user-selectable icons for different intervention and / or treatment options that may be applied to target tissue 822 such as, for example, radiation, heat, laser, topical, cold, or cryogenic therapies.[000120] In step 715, input and / or instructions regarding an intervention plan may be received via, for example, interaction with GUI. For example, when using GUI 808, a user may select one or more therapy / intervention modalities to be applied to target tissue 822 and / or tissue proximate to target tissue and define one or more characteristics (e.g., duration, dosage amount, sequence, position, etc.) of their application. Additionally, or alternatively, the user may define an area upon which to apply therapy / intervention via, for example, indicating one or more points on intervention grid 855 via which to apply a selected treatment / intervention to the target tissue. An example of how the user may define a treatment area is provided by a GUI 809 as shown in a rendering 809 of FIG. 8I, wherein the user has defined a treatment area 865 by selecting four points on intervention grid 855 proximate to target tissue 822.[000121] In step 720, an intervention plan for the target tissue may be generated using, for example, the information received in step(s) 705 and / or 710 and / or input and / or instructions received in step 715. The intervention plan may include, for example, position, type, dosage, scheduling, and / or other instructions regarding the use of one or more systems and / or devices disclosed herein to deliver treatment and / or an intervention to the target tissue. Additionally, or alternatively, the intervention plan may include instructions for use of one or more inserts to be deployed through one or more positions in the insert interface and onward into positions proximate to target tissue and / or intermediary devices (conduits, templates, subject interface template 820, etc.). Optionally, the intervention plan may be provided to a clinician and / or technician for modification, review, and / or approval.[000122] In step 725, the intervention plan may be performed and / or executed by, for example, placement of subject interface template 820 coupled to array of conduits 825 in contact with the subject’s target tissue and performance of a task(e.g., activation of an insert, pushing an insert through a conduit until it reaches an extension 830, etc.) by one or more components of system 800. At times, initiation and / or execution of step 725 may be responsive to receipt of an indication that the subject and the intervention plan delivery devices (e.g., subject interface template 820, extensions 830, inserts 140, conduits 120, etc.) are in the proper position. In some embodiments, execution of step 725 may include extending one or more inserts 140 into one or more respective insert interface 200 positions and through one or more respective conduits coupled thereto until the one or more inserts reach subject interface template 820 and extend through one or more respective extensions to be proximate to target tissue (step 730). The one or more inserts 140 may then be activated, retained in position, and / or retracted according to the intervention plan (step 735).[000123] In some embodiments, steps 730 and 735 may be repeated to extend, activate, and retract inserts and / or groups of inserts in sequence according to the intervention plan. For example, optionally, in step 740, it may be determined whether the intervention plan is complete (step 740) and, if so, process 700 may end. If not, steps 730 and / or 735 may be repeated. On some occasions, repeating step 730 in line with the intervention plan may include retracting and / or repositioning one or more inserts within a corresponding conduit, insert interface position, and / or interface port; removing a first insert from a first conduit, port, and / or position and inserting a second insert into the first conduit, port, and / or position; and / or removing an insert from the first conduit, port and / or position and inserting into a second conduit, port, and / or position. When process 700 ends, the systems and / or devices used to execute 700 may be removed and / or retracted away from the subject.[000124] In some embodiments, an assembly of subject interface template 820 coupled to array of conduits 825 and housing 872 or 875 may be pre-assembled prior to placement in contact with the target tissue. Additionally, or alternatively, subject interface template 820 (with array 835 of extensions 830 extending therefrom) may be placed in contact with the target tissue and then coupled to array of conduits 825 and housing 872 or 875. FIG. 8J provides a rendering 810 that shows subject 870 with an assembly of subject interface template 820 coupled to array of conduits 825 housing 872 or 875 configured and arranged so that subject interface template 820 is positioned so that extensions of array of extensions 830 may contact subject’s 870 face while each conduit coupling of array 845 of conduitcouplings 840 is coupled to a first end of a conduit and a second end of each conduit is coupled to and / or extends from insert interface 200 as shown.[000125] In some embodiments, a number and / or position of conduits coupled to subject interface template 820 may be responsive to, for example, a characteristic (e.g. size, type, etc.) of the treatment area and / or surrounding tissue (e.g., type of tissue and / or sensitivity of the surrounding tissue to adverse effects caused by application of the treatment). For example, if tissue surrounding the target tissue is particularly sensitive (e.g., a subject’s eye or mouth) then, regions (e.g., conduit couplings) of subject interface template 820 that correspond to the sensitive target tissue may not be coupled to one or more conduits to, for example, avoid contact with the sensitive tissue and / or unintentional spreading of an applied treatment (e.g., heat or radiation) to the sensitive tissue. An example of this embodiment is shown in FIG. 8K, which provides a rendering 811 that shows subject 870 with an assembly of subject interface template 820 coupled to a partial array of conduits 821 and insert interface 200 as shown. The conduits of partial array of conduits 821 are configured and arranged to correspond to positions of target tissue on subject’s 870 face (as opposed to the coupled to every extension 830 as shown in FIG. 8J). Then, a plurality of inserts 140 (shown in solid black lines) may be fed through a respective plurality of conduits of partial array of conduits 821 as shown in a rendering 812 of FIG. 8L until the plurality of inserts 140 reach subject interface template 820 and are positioned proximate to target tissue 822 as shown in a rendering 813 FIG. 8M (step 730) and, in some cases, are activated (step 735) as may be required depending on a type of therapy and / or intervention to be provided by each respective insert 140. In other embodiments, an insert and / or groups of inserts may traverse their respective conduits in sequence rather than all together. For example, if there is only one insert positioning device 400 with one directional subunit 300 in housing 872 or 875, then at most one insert could be mobilized through a conduit at a time. In this scenario, the four positions in treatment area 865 on intervention grid 855, as shown in FIG. 8I, would be intervened upon sequentially through successive extension and retraction of a single insert through the four conduits 821 as opposed to concurrent deployment of four inserts through four separate conduits. Additionally, or alternatively, the clinician may wish to sequence insert mobilization for clinical reasons. For example, according to one intervention plan, target tissue may be treated using a first intervention (e.g., radiation) via a first set of one or more inserts. Then, the first setof inserts may be removed from proximity to the patient and a second set of one or more inserts (e.g., heat) may be used to treat the target tissue, which may increase the efficacy of the first intervention. Then, the second set of insert(s) may be removed from the target tissue and a third set of one or more insert(s) may be introduced to, for example, administer a topical analgesic and / or cryotherapy to reduce swelling.
Claims
CLAIMS\Ne claim:1 . A system for performing an intervention upon target tissue comprising: an insert positioning device, the insert positioning device comprising: an insert interface configured with a plurality of ports a directional subunit configured to maneuver along at least one axis to align with specific ports of the plurality of ports; an insert mobilizing device configured to move an insert through the directional subunit, into a port of the plurality of ports; and a housing configured to house the insert interface, the directional subunit, and the insert mobilizing device; and a controller communicatively coupled to the directional subunit and insert mobilizing device and configured to provide an instruction thereto.
2. The system of claim 1 , further comprising: a plurality of conduits, each conduit of the plurality of conduits being coupled to a port of the plurality of ports and configured to direct an insert toward the target tissue.
3. The system of claim 2, wherein at least one of the conduits is transparent to allow visual confirmation of insert movement.
4. The system of claim 1 , 2, or 3, further comprising: a processor communicatively coupled to at least one of the controller, the insert positioning device, and the insert mobilizing device, the processor being configured to receive input parameters and generate an intervention plan, wherein the intervention plan includes an identifier of a port of the plurality of ports for insert deployment and functional instructions for the insert.
5. The system of any of claims 1-4, wherein the processor is configured to manage overlapping or non-overlapping regions of the insert interface to optimize insert deployment.
6. The system of any of claims 1-5, wherein the insert mobilizing device includes a motorized spool configured to extend and retract the insert through the insert interface.
7. The system of any of claims 1 -6, wherein at least some of the plurality of the ports have varying distances between them to match anatomical structures of a subject.
8. The system of any of claims 1-7, wherein the directional subunitis adjustable in at least one of angle, pitch, and yaw to align insert mobilizing device with a port of the plurality of ports.
9. The system of any of claims 1-8, further comprising a plurality of directional subunits, each directional subunit of the plurality of directional subunits being independently adjustable in adjustable in at least one of an X-direction, a Y- direction a Z-direction, an angle, a pitch, and a yaw to align with different ports of the plurality of ports.
10. The system of claim 9, wherein each directional subunit of the plurality of directional subunits is dedicated to an individual port or set of ports to enable simultaneous multi-port operation.11 . The system of claim 9 or 10, wherein each directional subunit of the plurality of directional subunits is dedicated to an individual insert of a plurality of inserts.
12. The system of any of claims 1-11 , wherein the insert positioning device includes a plurality of insert interfaces.
13. The system of claim 12, wherein each insert interface of the plurality of insert interfaces has a dedicated directional subunit.
14. The system of any of claims 1-13, wherein the insert is configured as at least one of a measurement device, a treatment delivery device, a brachytherapy device, a cryotherapy device, a hyperthermia device, a laser therapy device, aultrasound therapy device, a radiofrequency ablation (RFA) therapy device, a microwave therapy device, a electroporation therapy device, a physical manipulation device, a removal of tissue device, a topical medication delivery device, a shielding device, a thermal insulating device, and an injection device.
15. The system of any of claims 1-14, further comprising: an insert functionality support device in communication with the insert.
16. The system of any of claims 1-15, further comprising: a subject interface template in communication with the conduit.
17. The system of claim 16, wherein the subject interface template includes an extension configured to be positioned proximate to the target tissue and be in communication with the insert interface.
18. The system of any of claims 1 -17, further comprising: a locking mechanism configured to secure the directional subunit in a fixed position relative to the insert interface, wherein the locking mechanism is selectively adjustable to allow movement when required and to prevent undesired motion during operation.
19. The system of claim 18, wherein the locking mechanism is a mechanical clamp that engages with the guide rails of the directional subunit.
20. The system of claim 18 or 19, wherein the locking mechanism is electronically actuated and controlled by the processor based on intervention parameters.21 . The system of claim 18, 19, or 20, wherein the locking mechanism provides variable resistance to movement, enabling fine adjustments during manual or automated alignment.
22. The system of any of claims 18-21, wherein the locking mechanism includes a feedback sensor configured to confirm that the device is secured in the desired position before intervention begins.
23. A method for performing an intervention on target tissue using the system of any of claims 1-22.
24. A method of executing an intervention plan using the system of any of claims 1-22.
25. A method for generating an intervention plan, the intervention plan incorporating use of the system of any of claim 1-22 to perform an intervention on target tissue.
26. A method for performing an intervention upon a target tissue of a subject, comprising: receiving, by a processor, an intervention plan, the intervention plan defining a type of intervention to be delivered by an insert via a port of plurality of ports of an insert interface the insert is configured to pass through, wherein the port is in communication with a first end of a conduit; receiving, by the processor, an indication that a subject interface template and a plurality of extensions extending from the subject interface template are in a desired position relative to the target tissue, at least one extension of the plurality of extensions being in communication with a second end of the conduit; providing, by the processor, instructions to an insert positioning device, which when executed by the insert positioning device cause the insert positioning device to move to a position corresponding to the port of the plurality of ports responsively to receipt of the indication; upon receipt of an indication that the subject interface template is in the desired position, providing, by the processor, an instruction to an insert mobilizing device to deploy, or extend, the insert through the port of the plurality of ports and into the conduit so that the insert travels through the port, the conduit, and the extension coupled to the second end of the conduit.
27. The method of claim 26, further comprising: activating, by the processor, the insert to deliver the type of intervention defined by the intervention plan.
28. The method of claim 27, wherein activating the insert comprises: instructing, by the processor, an insert functionality device communicatively coupled to the processor and the insert to activate the insert.
29. The method of any of claims 26-28, further comprising: receiving, by the processor, data from the insert.
30. The method of claim 26-29 further comprising: providing, by the processor, an instruction to the insert positioning device to adjust a position of the insert within the conduit responsively to the data received from the insert.31 . The method of any of claims 26-30, further comprising: providing, by the processor, an instruction to the insert positioning device to adjust a position of the insert within the conduit.
32. The method of any of claims 26-31 , wherein the insert is configured as at least one of a measurement device, a treatment delivery device, a brachytherapy device, a cryotherapy device, a hyperthermia device, a laser therapy device, a ultrasound therapy device, a radiofrequency ablation (RFA) therapy device, a microwave therapy device, a electroporation therapy device, a physical manipulation device, a removal of tissue device, a topical medication delivery device, a shielding device, a thermal insulating device, and an injection device.
33. The method of any of claims 26-32, wherein the insert is a first insert, the method further comprising: providing, by the processor, instructions to the insert mobilizing device, which when executed by the insert positioning device cause the insert mobilizing device to retract the first insert and deploy a second insert through the port.
34. The method of any of claims 26-33, wherein the insert is a first insert and the port is a first port, the method further comprising:providing, by the processor, instructions to the insert mobilizing device, which when executed by the insert positioning device cause the insert mobilizing device to deploy the insert through a second port of the plurality of ports.
35. The method of any of claims 26-34 wherein the insert is a first insert, the port is a first port, the conduit is a first conduit, the insert positioning device is a first insert positioning device, the extension is a first extension, and the intervention plan further defines a type of intervention to be delivered by a second insert via a second port of plurality of ports of the insert interface the second insert being configured to pass through, the second port, wherein the second port is communicatively coupled to a first end of a second conduit, the method further comprising: providing, by the processor, instructions to a second insert positioning device, which when executed by the second insert positioning device cause the second insert positioning device to move to a position corresponding to the second port; and providing, by the processor, an instruction to the second insert positioning device to deploy, or extend, the second insert through the second port and into the second conduit so that the second insert travels through the second port, the second conduit, and the second extension coupled to a second end of the second conduit upon receipt of the indication that the subject interface template is in the desired position.
36. The method of any of claims 26-35, wherein the insert interface is divided into regions served by distinct directional subunits, each executing separate portions of the intervention plan.
37. The method of any of claims 26-36, wherein the intervention plan specifies simultaneous or sequential activation of multiple inserts in overlapping or nonoverlapping regions of the target tissue.
38. A method for generating an intervention plan for performing an intervention upon of target tissue of a subject, the method comprising:receiving, by a processor, operational parameters for an insert positioning device, the insert positioning device comprising: an insert interface configured with a plurality of ports a directional subunit configured to maneuver along at least one axis to align with specific ports of the plurality of ports; and an insert mobilizing device configured to move an insert through the directional subunit, into a conduit coupled to a port of the plurality of ports, and through the conduit toward the target tissue; receiving, by the processor, anatomical data for the subject and intervention parameters for the target tissue, the intervention parameters including at least one port through which an insert is to extend and a type of intervention to be performed by the insert; generating, by the processor, the intervention plan using the operational parameters for an insert positioning device, the anatomical data for the subject, and the intervention parameters for the target tissue; and providing, by the processor, instructions to the insert positioning device so that the insert positioning device may execute at least a portion of the intervention plan.
39. The method of claim 38, wherein the intervention parameters further include a plurality of ports through which a corresponding plurality of inserts are to extend sequentially and / or simultaneously.
40. An insert positioning device for medical applications, comprising: an insert interface configured with a plurality of ports, wherein each port of the plurality of ports; a directional subunit configured to maneuver along at least one axis to align with specific ports of the plurality of ports; an insert mobilizing device configured to move an insert through the directional subunit and into a port of the plurality of ports; a controller communicatively coupled to the directional subunit and insert mobilizing device and configured to provide an instruction thereto; and a housing configured to housing the insert interface, the directional subunit, the insert mobilizing device, and the controller.41 . The insert positioning device of claim 40, wherein the port of the plurality of ports is coupled to a conduit and the insert mobilizing device is further configured to move the insert through the conduit toward the target tissue.
42. The insert positioning device of claim 40 or 41 , wherein the insert interface is curved to conform to an anatomical structure of the subject.
43. The insert positioning device of any of claims 40-42, further comprising a plurality of insert interfaces, each coupled to a unique directional subunit to enable simultaneous multi-site intervention.
44. The insert positioning device of any of claims 40-43, wherein the adjustment mechanism includes motors providing translational and rotational movements for precise alignment with ports.
45. The insert positioning device of any of claims 40-44, wherein the directional subunit includes a feedback system to adjust its position based on data received from at least one of the target tissue and the insert.
46. The insert positioning device of any of claims 40-45, wherein the insert interface includes overlapping regions of operation shared by a plurality of directional subunits for increased intervention flexibility.
47. The insert positioning device of any of claims 40-46, further comprising: a locking mechanism configured to secure the directional subunit in a fixed position relative to the insert interface, wherein the locking mechanism is selectively adjustable to allow movement when required and to prevent undesired motion during operation.
48. The insert positioning device of claim 47, wherein the locking mechanism is a mechanical clamp that engages with the guide rails of the directional subunit.
49. The insert positioning device of claim 47 or 48, wherein the locking mechanism is electronically actuated and controlled by the processor based on intervention parameters.
50. The insert positioning device of claim 47, 48, or 49, wherein the locking mechanism provides variable resistance to movement, enabling fine adjustments during manual or automated alignment.51 . The insert positioning device of any of claims 47-50, wherein the locking mechanism includes a feedback sensor configured to confirm that the device is secured in the desired position before intervention begins.
52. A method for performing an intervention on target tissue using the insert positioning device of any of claims 40-51.
53. A method of executing an intervention plan using the insert positioning device of any of claims 40-51 .
54. A method for generating an intervention plan, the intervention plan incorporating use of the insert positioning device of any of claim 40-51 to perform an intervention on target tissue.
55. A method for performing an intervention upon a target tissue of a subject, comprising: receiving, by a processor, an intervention plan, the intervention plan defining a parameter for an insert to be positioned proximate to the target tissue in accordance with the intervention plan; and providing, by the processor, an instruction to an insert mobilizing device in communication with the processor to deploy, or extend, the insert toward the target tissue in a manner consistent with the intervention plan.
56. The method of claim 55, wherein the insert mobilizing device deploys the insert through an insert interface that includes a plurality of ports the insert is configured to pass through.
57. The method of claim 55 or 56, wherein the instruction to the insert mobilizing device to deploy, or extend, the insert toward the target tissue is responsive to receipt of an indication that the target tissue is ready for treatment.
58. The method of claim 57, wherein the indication that the target tissue is ready for treatment is an indication that a subject interface template configured to be in communication with the insert is in a desired position relative to the target tissue.
59. The method of any of claims 55-58, further comprising: activating, by the processor, the insert to deliver a type of intervention defined by the intervention plan.
60. The method of any of claims 55-59, wherein activating the insert comprises: instructing, by the processor, an insert functionality device communicatively coupled to the processor and the insert to activate the insert.61 . The method of any of claims 55-60, further comprising: receiving, by the processor, data from the insert.
62. The method of any of claims 55-61 , wherein the insert is configured as at least one of a measurement device, a treatment delivery device, a brachytherapy device, a cryotherapy device, a hyperthermia device, a laser therapy device, a ultrasound therapy device, a radiofrequency ablation (RFA) therapy device, a microwave therapy device, a electroporation therapy device, a physical manipulation device, a removal of tissue device, a topical medication delivery device, a shielding device, a thermal insulating device, and an injection device.
63. The method of any of claims 55-62, further comprising: providing, by the processor, instructions to an insert positioning device, which when executed by the insert positioning device cause the insert positioning device to move to the insert to a position in accordance with the intervention plan prior to provision of the instructions to deploy or extend the insert toward the target tissue.
64. The method of claim 63, further comprising: providing, by the processor, an instruction to the insert positioning device to adjust a position of the insert.
65. The method of any of claims 55-64, wherein the intervention plan specifies simultaneous or sequential activation of multiple inserts in overlapping or nonoverlapping regions of the target tissue.