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WO2025144966A1 - Systèmes et dispositifs de placement et d'utilisation d'instruments médicaux et procédés d'utilisation de ceux-ci - Google Patents

Systèmes et dispositifs de placement et d'utilisation d'instruments médicaux et procédés d'utilisation de ceux-ci Download PDF

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Publication number
WO2025144966A1
WO2025144966A1 PCT/US2024/062000 US2024062000W WO2025144966A1 WO 2025144966 A1 WO2025144966 A1 WO 2025144966A1 US 2024062000 W US2024062000 W US 2024062000W WO 2025144966 A1 WO2025144966 A1 WO 2025144966A1
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WO
WIPO (PCT)
Prior art keywords
insert
intervention
target tissue
positioning device
ports
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/062000
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English (en)
Inventor
Anna O. LIKHACHEVA
Shervin SHIRVANI
Arjun MANIYEDATH
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Individual
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Individual
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Publication of WO2025144966A1 publication Critical patent/WO2025144966A1/fr
Pending legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3411—Needle locating or guiding means using mechanical guide means with a plurality of holes, e.g. holes in matrix arrangement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
    • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems

Definitions

  • This application generally relates to medical devices, systems, and methods for use.
  • the application pertains to systems and devices for positioning and using medical instruments to treat target tissue of a subject.
  • 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 for controlling 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.
  • 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).
  • a membrane e.g., paper, vinyl, or plastic that allows for traverse of the insert.
  • 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.
  • the processor may be configured to manage overlapping or non-overlapping regions of the insert interface to optimize insert deployment.
  • 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 one or 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the locking mechanism may provide variable resistance to movement, enabling fine adjustments during manual or automated alignment.
  • the locking mechanism may include a feedback sensor configured to confirm that the device may be secured in the desired position before intervention begins.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • FIG. 1G is a schematic diagram of a portion of a second conduit/insert assembly, in accordance with some embodiments disclosed herein.
  • FIG. 2A provides a rendering of a frontal view of a first exemplary insert interface, in accordance with some embodiments disclosed herein.
  • FIG. 2B provides a rendering of a frontal view of a second exemplary insert interface, in accordance with some embodiments disclosed herein.
  • FIG. 2C provides a rendering of a frontal view of a third exemplary insert interface, in accordance with some embodiments disclosed herein.
  • FIG. 2D provides a rendering of a frontal view of a fourth exemplary insert interface, in accordance with some embodiments disclosed herein.
  • FIG. 3A is a diagram of components included in an exemplary directional subunit, in accordance with some embodiments disclosed herein.
  • FIG. 3B provides a diagram of a side perspective view of an exemplary locking mechanism, in accordance with some embodiments disclosed herein.
  • FIG. 4A is a schematic diagram of a side view of an exemplary insert positioning device, in accordance with some embodiments disclosed herein.
  • 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.
  • 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.
  • FIG. 8A1 provides a block diagram of an exemplary system, in accordance with some embodiments disclosed herein.
  • 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.
  • 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.
  • Inserts 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”).
  • intervention an intervention, medical treatment, and/or performing a procedure (at times collectively referred to herein as an “intervention”).
  • these inserts are introduced onto the surface of a subject or into subject tissue manually by a clinician or technician.
  • 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.
  • 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.
  • 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.
  • 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.
  • one or more templates may be directly attached to the insert interface.
  • 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.
  • 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).
  • 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.
  • 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.
  • a series of skin interventions i.e., heat, brachytherapy, or superficial injection
  • 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.
  • an insert mobilizing device 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.
  • 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.
  • the insert interface positions may index to conduits, applicators, or templates described herein.
  • 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.
  • 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.
  • 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.
  • 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.
  • RPA radiofrequency ablation
  • an insert When an insert 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).
  • an insert 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.
  • 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.
  • 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.
  • 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.
  • 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 an alternating 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).
  • 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.
  • 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.
  • 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.
  • 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. [00092] In the embodiment of FIG.
  • 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.).
  • a directional subunit 300 that is used to guide insert 140 is used.
  • 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 140 in, 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.
  • insert 140 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.
  • 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.
  • directional subunit 300 includes a locking mechanism 350 positioned at the end of the guide channel 335.
  • the locking mechanism 350 is outside the directional subunit and located adjacent to insert interface 200.
  • 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.
  • FIGs. 4A is a schematic diagram that provides a side view
  • FIG. 4B is a schematic diagram that provides a top view
  • FIGs. 4C, 4D, and 4E are schematic 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.
  • 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).
  • 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.
  • the frame may include two or more horizontal and/or vertical guide rails (not shown).
  • the frame may also include a forward-backward guiderail 430 to assist with the movement of the directional subunit in the Z- direction.
  • a directional subunit is mounted on the vertical guide rail.
  • the directional subunit can be mounted on the horizontal or forward-backward guide rail.
  • 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 (
  • 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)
  • 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).
  • 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).
  • an insert interface 200 e.g., insert interface 200A, 200B, and/or 200C
  • angular rotation of directional subunit 300 can be effected by an adjustment mechanism that rotates horizontal guide rail 420 and/or vertical guide rail 425.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • insert interface 200 may be curved and/or have an irregular shape to, for example, accommodate subject anatomy or engineering specifications.
  • FIG. 4G 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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).
  • subject tissue e.g., skin
  • insert 140 may be configured to be rigid enough to extend through aperture 320 and maintain its shape until it extends far enough away from directional subunit 300 and/or housing 440 to contact subject tissue.
  • 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.
  • two or more components of systems 601 , 602, 603, 604, and 605 may be resident in the same housing and/or device.
  • 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.
  • one or more functionalities e.g., heat, medication, vacuum, etc.
  • coupling an insert to one or more functionality support devices 610A, 610B, 610C-610N may activate the insert.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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., for a 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • each of the insert functionality devices i.e., 610A
  • 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.
  • FIG. 8A2 shows a portion of a subject 870 lying on a table.
  • system 800 may not include housing 872.
  • 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.
  • 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 the target 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.
  • dimensions e.g., length, width, height, and/or shape
  • a position e.g., anatomical location (e.g., nose,
  • Exemplary subject information includes, but is not limited to, gender, age, skin color, comorbidities, and pain tolerance.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • a display e.g., a graphic user interface (GUI)
  • GUI graphic user interface
  • 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.
  • GUI 8D-8F and the above discussion
  • this information may be used to, for example, generate an intervention plan as, for example, described herein.
  • 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.
  • GUI 808 provides a rendering of subject 870 as well as target 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.
  • step 715 input and/or instructions regarding an intervention plan may be received via, for example, interaction with GUI.
  • 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.
  • 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.
  • 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.
  • 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.).
  • the intervention plan may be provided to a clinician and/or technician for modification, review, and/or approval.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • the systems and/or devices used to execute 700 may be removed and/or retracted away from the subject.
  • 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.

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Abstract

L'invention concerne des systèmes, des dispositifs et des procédés de placement précis et d'utilisation d'instruments médicaux (également appelés ici « inserts ») pour traiter, mesurer et/ou intervenir sur un tissu dans diverses régions anatomiques, qui peuvent comprendre un dispositif de mobilisation d'inserts pour le déploiement d'instruments médicaux, un dispositif de positionnement d'inserts pourvu d'une sous-unité directionnelle pouvant manœuvrer sur de multiples axes et une interface avec des inserts qui peut comprendre une pluralité d'orifices. Le système supporte des conduits flexibles et des gabarits qui guident des inserts du dispositif à un tissu cible, ce qui permet une localisation précise indexée à des coordonnées spatiales définies par l'interface avec les inserts. Un dispositif de commande et/ou un processeur peuvent générer et exécuter des plans d'intervention qui définissent le positionnement, l'activation et la fonctionnalité des inserts. Le système facilite des thérapies multimodales, des diagnostics et des interventions de protection, ce qui offre une précision, une reproductibilité et une intégration améliorées pour des procédures médicales complexes. Les instruments/inserts médicaux peuvent comprendre des sondes, des aiguilles et des capteurs conçus pour une curiethérapie, une cryothérapie, une thérapie laser, une ablation, une administration de médicament et des diagnostics, entre autres applications.
PCT/US2024/062000 2023-12-29 2024-12-26 Systèmes et dispositifs de placement et d'utilisation d'instruments médicaux et procédés d'utilisation de ceux-ci Pending WO2025144966A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120215052A1 (en) * 2005-07-18 2012-08-23 Nucletron B.V. Apparatus and method for effecting radiation treatment on a pre-selected anatomical portion of an animal body
WO2020191007A1 (fr) * 2019-03-19 2020-09-24 University Of Iowa Research Foundation Appareil de curiethérapie à écran rotatif et procédé
US20210146106A1 (en) * 2019-11-18 2021-05-20 Anna O. LIKHACHEVA Systems and methods for conforming treatment applicators to non-uniform surfaces
US20230172630A1 (en) * 2020-04-10 2023-06-08 Koninklijke Philips N.V. Grid template positioning interventional medicine

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120215052A1 (en) * 2005-07-18 2012-08-23 Nucletron B.V. Apparatus and method for effecting radiation treatment on a pre-selected anatomical portion of an animal body
WO2020191007A1 (fr) * 2019-03-19 2020-09-24 University Of Iowa Research Foundation Appareil de curiethérapie à écran rotatif et procédé
US20210146106A1 (en) * 2019-11-18 2021-05-20 Anna O. LIKHACHEVA Systems and methods for conforming treatment applicators to non-uniform surfaces
US20230172630A1 (en) * 2020-04-10 2023-06-08 Koninklijke Philips N.V. Grid template positioning interventional medicine

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