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WO2020264383A1 - Systèmes, procédés et dispositifs pour guidage d'instrument - Google Patents

Systèmes, procédés et dispositifs pour guidage d'instrument Download PDF

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Publication number
WO2020264383A1
WO2020264383A1 PCT/US2020/039938 US2020039938W WO2020264383A1 WO 2020264383 A1 WO2020264383 A1 WO 2020264383A1 US 2020039938 W US2020039938 W US 2020039938W WO 2020264383 A1 WO2020264383 A1 WO 2020264383A1
Authority
WO
WIPO (PCT)
Prior art keywords
instrument
instrument guide
guide
insert
bracket
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.)
Ceased
Application number
PCT/US2020/039938
Other languages
English (en)
Inventor
Lucas Muller
Cassidy Wang
Dev Mandavia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethos Medical Inc
Original Assignee
Ethos Medical Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US16/810,569 external-priority patent/US20200281561A1/en
Application filed by Ethos Medical Inc filed Critical Ethos Medical Inc
Priority to AU2020304669A priority Critical patent/AU2020304669A1/en
Priority to CA3139694A priority patent/CA3139694A1/fr
Priority to JP2021576834A priority patent/JP2022538126A/ja
Priority to EP20832232.1A priority patent/EP3989850A4/fr
Publication of WO2020264383A1 publication Critical patent/WO2020264383A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • 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
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • 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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • 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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2059—Mechanical position encoders

Definitions

  • the present disclosure relates generally to systems, methods, and devices for instrument guidance and, more particularly, to systems, methods, and devices for guiding the placement of instruments within the body using ultrasound imaging.
  • Ultrasound imaging can provide real-time two-dimensional imaging of a patient’s body, which can be used to assist a healthcare professional to locate a region to insert an invasive medical device (e.g., a needle or a cylindrical instrument such a trocar, etc.). Once the healthcare professional locates the correct insertion point, the healthcare professional may then begin the medical procedure, such as insertion of a catheter, administration of a local anesthetic, or removal of tissue as in a biopsy. Determining at what orientation to insert the invasive medical device to ensure an unobstructed path to the target is challenging, as the ultrasound monitor can only display structures within the patient’s body. It can also be difficult to tell what path the medical device will follow before the device enters the patient’s body.
  • an invasive medical device e.g., a needle or a cylindrical instrument such a trocar, etc.
  • the medical device after the medical device enters the patient's body, it can be difficult to accurately track the path and position of the medical device on the ultrasound monitor.
  • the needle unless the needle is positioned exactly in-plane with the image, the needle may not be visible or may only be partially visible, which means that the needle location or, more importantly, the location of the needle tip is not precisely known.
  • the healthcare professional may make numerous attempts to insert the device before properly entering a tissue mass or penetrating a blood vessel.
  • the healthcare professional can often only estimate the location of the needle end if it is not visible on the ultrasound image. As a result, patients may be injured or made to suffer unnecessary pain. From the healthcare professional’s perspective, these procedures can be time consuming, and can expose the healthcare professional to liability.
  • an exemplary device can include an instrument guide device and a transducer system.
  • the instrument guide device can comprise an instrument guide, an instrument guide insert, and an instrument guide bracket.
  • the instrument guide can include a first aperture, a magnet, and one or more protrusions.
  • the instrument guide can be configured to secure at least one instrument.
  • the instrument guide can be adaptable to secure instruments of different sizes.
  • the instrument guide bracket can be removably attachable to the instrument guide when at least a first protrusion of the instrument guide engages with at least a first opening of the instrument guide bracket.
  • the transducer system can comprise an ultrasound probe bracket and an ultrasound probe.
  • the ultrasound probe bracket can include a first sensor, a transceiver, and a processor.
  • the first sensor can be configured to determine a position of the instrument guide device by wirelessly tracking the magnet located in the instrument guide. That is, as the instrument guide is moved around a body, the first sensor tracks the magnet to determine the position of the instrument guide device.
  • the ultrasound probe bracket further includes a transceiver that is configured to receive the position of the instrument guide device from the first sensor, and then output the position to an external device (e.g., a computing device).
  • the ultrasound probe bracket can further include a cutout sized to allow the instrument guide device to fit within and a member (e.g., snap features, protrusions, cutouts, and/or spring-loaded inserts) that allows the instrument guide device to removably attach to the ultrasound probe bracket.
  • the ultrasound probe bracket can include a single or pair of protruding features that provide attachment to the instrument guide bracket.
  • the ultrasound probe bracket can be sized to fit around the ultrasound probe and can be removably attachable to the ultrasound probe.
  • the ultrasound probe can generate and send image information to the processor. Then, the processor can generate position data using the position of the instrument guide device and/or the image information.
  • the instrument guide can include a plurality of instrument guide inserts having different instrument sizes and/or gauges.
  • the instrument guide can include a single insert that can be rotated to different positions to create different apertures sized to accommodate different instrument sizes and/or gauges.
  • the instrument guide insert can be sized to fit within the first aperture, wherein the at least one instrument is secured to the instrument guide insert.
  • a first insert can be positioned into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket. Also, the first insert can be further positioned into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis and that the first insert induces friction that causes the instrument guide to maintain its orientation.
  • the ultrasound probe bracket is adaptable to fit a plurality of geometries.
  • the instrument guide in response to movement of the instrument guidance system, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
  • a first instrument is removably attachable to the instrument guide when the first instrument is inserted within a second aperture perpendicular to the instrument guide’s axis of rotation.
  • the instrument guide includes a rotation lock configured to allow and prevent rotation of the instrument guide.
  • the processor of the ultrasound probe bracket can determine whether the instrument guide is attached to the instrument guidance system. Also, the ultrasound probe bracket can include a second sensor configured to provide power and disengage power to the instrument guidance device when the instrument guide is attached or detached, respectively. It should be noted that the first sensor can perform all or some of the functions of the second sensor and vice versa.
  • An exemplary method includes a computing device receiving imaging data from an ultrasound device, which the computing device can display.
  • the computing device can also communicate with an instrument guide device to receive position data that indicates an angle of an instrument attached to the instrument guide device.
  • the computing device is preprogrammed with: 1) the physical location of the instrument guide device’s axis of rotation relative to the imaging surface of the ultrasound transducer; and 2) an algorithm to compute the pixel distance on the display corresponding to a physical metric in the ultrasound image (e.g., centimeters) at any given imaging depth. Then, the computing device can determine where the trajectory of the instrument should lie on the ultrasound image in real-time.
  • the generated image can then be displayed on a screen of the computing device, for example, as a graphical user interface (GUI).
  • GUI graphical user interface
  • the ultrasound device can receive the position data from the instrument guide device and can generate the image overlay in a manner similar or identical to that disclosed above in reference to the computing device.
  • the first sensor can be included in the instrument guide device rather than in the ultrasound probe bracket.
  • the ultrasound probe cover can include sealed, electrical ports, or contacts to enable electrical connection between the first sensor in the instrument guide device and the processor and/or transceiver in the ultrasound probe bracket, while maintaining a sterile barrier.
  • the instrument guide device can be permanently coupled to the ultrasound probe cover, through methods such as adhesive or thermal bonding, such that attachment of the ultrasound probe cover and instrument guide device over/onto the ultrasound probe bracket can occur simultaneously.
  • an instrument guidance device comprising: A) an instrument guide device comprising: 1) an instrument guide comprising a first aperture, a magnet, and one or more protrusions, wherein the instrument guide is configured to secure at least one instrument, and 2) an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings; and B) a transducer system comprising: 1) an ultrasound probe bracket comprising: i) a first sensor configured to determine a position of the instrument guide device by wirelessly tracking the magnet and configured to transmit the position of the instrument guide device, and ii) a transceiver configured to receive the position of the instrument guide device from the first sensor and output the position to an external device, 2) a processor configured to generate position data based on the position of the instrument guide device, 3) the ultrasound probe
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein: A) the instrument guide further comprises an instrument guide insert that is sized to fit within the first aperture, B) the instrument guide insert is sized to accommodate a first instrument having a specific instrument size in a second aperture created between the instrument guide insert and the instrument guide, and C) the instrument guide insert is configured to turn between an open position and closed position such that the instrument guidance device is removable from the first instrument while the first instrument is inserted in a portion of a body.
  • the instrument guidance device, system, or method of the first aspect or any other aspect further comprising a plurality of instrument guide inserts, wherein each of the plurality of instrument guide inserts can accommodate a different instrument size.
  • the instrument guidance device, system, or method of the first aspect or any other aspect further comprising an instrument guide insert, wherein: A) the instrument guide insert has a plurality of faces, B) when the instrument guide insert is rotated, each of the plurality of faces aligns with an open channel in the instrument guide to create a closed channel that is sized to accommodate a specific instrument size, and C) each of the plurality of faces of the instrument guide insert corresponds to a different instrument size, such that the instrument guide insert can be rotated to select from a set of apertures depending on a desired instrument size.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein a first insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket such that the first insert intersects with a portion of the instrument guide to lock and/or induce friction on rotation of the instrument guide.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein a first insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket such that when the first insert is tightened it deforms the instrument guide bracket and reduces the size of a cutout in the instrument guide bracket within which at least one protrusion of the one or more protrusions rotates.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein a second insert is insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein the ultrasound probe bracket is adaptable to fit a plurality of geometries.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein in response to movement of the instrument guidance device, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein the instrument guide further comprises a rotation lock configured to allow and prevent rotation of the instrument guide.
  • the instrument guidance device, system, or method of the first aspect or any other aspect wherein: A) the processor is further configured to determine whether the instrument guide is attached to the instrument guidance device; and B) the instrument guidance device further comprises: 1) a second sensor configured to: i) provide power to the instrument guidance device when the instrument guide is attached, and ii) disengage power to the instrument guidance device when the instrument guide is detached.
  • a system for instrument guidance comprising: A) a computing device comprising a first processor, a first transceiver, and a screen; B) an instrument guidance device comprising an instrument guide device and a transducer system, the instrument guidance device configured to: 1) determine, by a first sensor of the transducer system, a position of the instrument guide device by wirelessly tracking a magnet located in the instrument guide device; 2) receive, by a second transceiver of the transducer system, the position of the instrument guide device from the first sensor; 3) generate, by a second processor of the transducer system, position data based on the position of the instrument guide device, the position data indicating a position with respect to a surface of an attached ultrasound transducer of an instrument attached to the instrument guidance device; and 4) send, by the second transceiver, the position data to a computing device; C) an ultrasound device configured to: 1) generate imaging data representative of a portion of a human body; and 2) send
  • the system, device, or method of the twelfth aspect or any other aspect wherein the instrument guide device comprises: A) an instrument guide comprising an aperture, a magnet, and one or more protrusions, B) wherein the instrument guide is configured to secure at least one instrument; and C) an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings.
  • the system, device, or method of the thirteenth aspect or any other aspect wherein the instrument guide further comprises an instrument guide insert that is sized to fit within the aperture, and wherein the at least one instrument is secured to the instrument guide insert.
  • the system, device, or method of the fourteenth aspect or any other aspect wherein the instrument guide insert is adaptable to accommodate instruments of different sizes.
  • the system, device, or method of the thirteenth aspect or any other aspect wherein an insert is insertable into a second opening of the instrument guide bracket from an exterior surface of the instrument guide bracket and the insert is further insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
  • the system, device, or method of the thirteenth aspect or any other aspect wherein in response to movement of the instrument guidance system, the instrument guide remains positioned in the same orientation as a first instrument secured by the instrument guide.
  • the transducer system further comprises: A) an ultrasound probe bracket, wherein the first sensor, the second transceiver, and the second processor are position with the ultrasound probe bracket; B) a cut-out space configured to allow the instrument guide device to removably attach to the ultrasound probe bracket; and C) an ultrasound probe sized to fit within the ultrasound probe bracket, wherein the ultrasound probe is removably attachable to the ultrasound probe bracket.
  • the second processor is configured to determine whether the instrument guide is attached to the instrument guidance system
  • the ultrasound probe bracket further comprises: A) a second sensor configured to: 1) provide power to the instrument guidance device when the instrument guide is attached, and 2) disengage power to the instrument guidance device when the instrument guide is detached.
  • a method for real-time instrument guidance placement comprising: A) receiving, by a transceiver of a computing device, imaging data from an ultrasound probe, the imaging data representative of a portion of a human body; B) receiving, by the transceiver, position data from an instrument guide device, the position data indicating a position with respect to a surface of an attached ultrasound probe of an instrument attached to the instrument guide device; C) determining, by a processor of the computing device, pixel distance of the imaging data at a predetermined imaging depth; D) mapping, by the processor, a physical space in the imaging data onto a virtual display based on the pixel distance; E) generating, by the processor, an image overlay that projects the position data onto the imaging data, wherein an instrument trajectory is shown in relation to the imaging data; and F) displaying, by a screen of the computing device, the image overlay.
  • an instrument guidance device comprising: A) an instrument guide device; and B) a transducer system; C) wherein the instrument guide device comprises an instrument guide comprising a sensing element and configured to secure at least one instrument; and D) wherein the transducer system comprises: 1) a first sensor configured to: i) sense positional data of the instrument guide device by wirelessly tracking the sensing element; and ii) transmit the positional data of the instrument guide device; 2) a first transceiver configured to: i) receive the positional data of the instrument guide device from the first sensor; and ii) output instrument position data; and 3) a first processor configured to generate the instrument position data based on the positional data of the instrument guide device.
  • the instrument guidance device, system, or method of the twenty-first aspect or any other aspect wherein the instrument guide further comprises: A) a first aperture; B) one or more protrusions; C) an instrument guide bracket comprising openings located at one or more side surfaces; and D) a first instrument guide insert that is sized to fit within the first aperture; E) wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion of the one or more protrusions engages with at least a first opening of the openings; F) wherein the first instrument guide insert is further sized to accommodate a first instrument having a first instrument size in a second aperture created between the first instrument guide insert and the instrument guide; and G) wherein the first instrument guide insert is configured to turn between an open position and closed position such that the instrument guidance device is removable from the first instrument while the first instrument is inserted in a portion of a body.
  • the instrument guidance device, system, or method of the twenty- second aspect or any other aspect wherein the instrument guide further comprises a second instrument guide insert that can accommodate a second instrument size different than the first instrument size.
  • the instrument guidance device, system, or method of the twenty-first aspect or any other aspect wherein the instrument guide further comprises: A) a first aperture; B) one or more protrusions; C) an instrument guide bracket comprising openings located at one or more side surfaces; and D) a first instrument guide insert; E) wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion of the one or more protrusions engages with at least a first opening of the openings; F) wherein the first instrument guide insert has a plurality of faces; G) wherein when the first instrument guide insert is rotated, at least a portion of the plurality of faces align with an open channel in the instrument guide to create a closed channel that is sized to accommodate a specific instrument size; and H) herein at least a portion of the plurality of faces of the first instrument guide insert each correspond to a different instrument size, such that the first instrument guide insert can be rotated to select from a set
  • the instrument guidance device, system, or method of the twenty-second aspect or any other aspect further comprising a first insert insertable into a second opening of the openings of the instrument guide bracket from an exterior surface of the instrument guide bracket such that the first insert intersects with a portion of the instrument guide to lock and/or induce friction on rotation of the instrument guide.
  • the instrument guidance device, system, or method of the twenty-second aspect or any other aspect further comprising a first insert insertable into a second opening of the openings of the instrument guide bracket from an exterior surface of the instrument guide bracket such that when the first insert is tightened, it deforms the instrument guide bracket and reduces the size of a cutout in the instrument guide bracket within which at least one protrusion of the one or more protrusions rotates.
  • the instrument guidance device, system, or method of the twenty-second aspect or any other aspect further comprising a second insert insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
  • the instrument guidance device, system, or method of the twenty-first aspect or any other aspect wherein the transducer system further comprises: A) an ultrasound probe bracket; and B) an ultrasound probe; C) wherein the ultrasound probe bracket is adaptable to fit a plurality of geometries of the ultrasound probe; and D) wherein the ultrasound probe bracket is removably attachable to the ultrasound probe.
  • the instrument guidance device, system, or method of the twenty- second aspect or any other aspect wherein in response to movement of the instrument guidance device, the instrument guide remains positioned in the same orientation as the first instrument secured by the instrument guide.
  • the instrument guidance device, system, or method of the twenty-second aspect or any other aspect wherein the instrument guide further comprises a rotation lock configured to allow and prevent rotation of the instrument guide.
  • the instrument guidance device, system, or method of the twenty-eighth aspect or any other aspect wherein the ultrasound probe bracket comprises a second sensor; A) wherein the first processor is further configured to determine whether the instrument guide is attached to the instrument guidance device; and B) wherein the second sensor is configured to: 1) provide power to the instrument guidance device when the instrument guide is attached; and 2) disengage power to the instrument guidance device when the instrument guide is detached.
  • an instrument guidance system comprising: A) a computing device; B) the instrument guidance device of the twenty-first aspect or any other aspect; and C) an ultrasound device configured to: 1) generate imaging data representative of a portion of a human body; and 2) send the imaging data to the computing device; D) wherein the computing device is configured to: 1) receive, by a second transceiver of the computing device, the imaging data from the ultrasound device; 2) receive, by the second transceiver, the instrument position data from the first transceiver of the transducer system of the instrument guidance device; 3) determine, by a second processor of the computing device, how physical space in the imaging data is mapped on a virtual display; 4) generate, by the second processor, an image overlay that projects the instrument position data onto the imaging data, wherein an instrument trajectory is shown in relation to the imaging data; and 5) display, by a screen of the computing device, the image overlay.
  • the instrument guide further comprises: A) a first aperture; B) one or more protrusions; C) an instrument guide bracket comprising openings located at one or more side surfaces; D) wherein the instrument guide is configured to secure at least one instrument; and E) wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion of the one or more protrusions engages with at least a first opening of the openings.
  • the system, device, or method of the thirty-third aspect or any other aspect wherein the instrument guide further comprises an instrument guide insert that is sized to fit within the first aperture; and wherein the at least one instrument is secured to the instrument guide insert.
  • the system, device, or method of the thirty-fourth aspect or any other aspect wherein the instrument guide insert is adaptable to accommodate instruments of different sizes.
  • the system, device, or method of the thirty-third aspect or any other aspect further comprising an insert insertable into a second opening of the openings of the instrument guide bracket from an exterior surface of the instrument guide bracket; and wherein the insert is further insertable into the instrument guide along a central axis such that the instrument guide is rotatable along the central axis.
  • the system, device, or method of the thirty-third aspect or any other aspect wherein in response to movement of the instrument guidance device, the instrument guide remains positioned in the same orientation as a first instrument of the at least one instrument secured by the instrument guide.
  • the transducer system further comprises: A) an ultrasound probe bracket; B) a cut-out space configured to allow the instrument guide device to removably attach to the ultrasound probe bracket; and C) an ultrasound probe sized to fit within the ultrasound probe bracket; D) wherein the ultrasound probe is removably attachable to the ultrasound probe bracket.
  • the ultrasound probe bracket comprises a second sensor configured to: A) provide power to the instrument guidance device when the instrument guide is attached; and B) disengage power to the instrument guidance device when the instrument guide is detached; C) wherein the first sensor, the second transceiver, and the second processor are positioned within the ultrasound probe bracket; and D) wherein the second processor is further configured to determine whether the instrument guide is attached to the instrument guidance device.
  • a method for instrument guidance using the instrument guidance system of the thirty-second aspect or any other aspect A) receiving, by the second transceiver of the computing device, the imaging data representative of the portion of the human body; B) receiving, by the second transceiver, the instrument position data from the first transceiver of the transducer system of the instrument guidance device; C) determining, by the second processor of the computing device, pixel distance of the imaging data at a predetermined imaging depth; D) mapping, by the second processor, a physical space in the imaging data onto the virtual display based on the pixel distance; E) generating, by the second processor, the image overlay that projects the instrument position data onto the imaging data, wherein the instrument trajectory is shown in relation to the imaging data; and F) displaying, by the screen of the computing device, the image overlay.
  • an instrument guidance device comprising: A) an instrument guide device comprising: 1) an instrument guide comprising a first aperture, a magnet, and one or more protrusions, wherein an insert is insertable into the first aperture and creates a second aperture between the instrument guide and the insert to secure at least one instrument; and 2) an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings; and B) a transducer system comprising: 1) an ultrasound probe bracket comprising: i) a first sensor configured to determine a position of the instrument guide device by wirelessly tracking the magnet, wherein the first sensor is configured to transmit the position of the instrument guide device; and ii) a second sensor that monitors a proximity of the magnet, wherein the second sensor is configured to: a) provide power
  • a system for instrument guidance comprising: A) an instrument guidance device, comprising: 1) an instrument guide comprising a first aperture, a magnet, and one or more protrusions, wherein an insert is insertable into the first aperture and creates a second aperture between the instrument guide and the insert to secure at least one instrument; and 2) an instrument guide bracket comprising a plurality of openings located at one or more side surfaces, wherein the instrument guide bracket is removably attachable to the instrument guide when at least a first protrusion from the one or more protrusions engages with at least a first opening from the plurality of openings; and 3) a transducer system, wherein the instrument guidance device is configured to: i) determine, by a first sensor of the transducer system, a position of the instrument guide device by wirelessly tracking a magnet located in the instrument guide device; ii) receive, by a transceiver of the transducer system, the position of the instrument guide device from the first
  • the system, device, or method of the forty-second aspect or any other aspect wherein the processor calculates an instrument guide orientation.
  • the system, device, or method of the forty-second aspect or any other aspect wherein the position data comprises an instrument guide orientation.
  • the system, device, or method of the forty-fourth aspect or any other aspect wherein the instrument guide orientation includes an angle of an instrument attached to the instrument guide.
  • the system, device, or method of the forty-second aspect or any other aspect wherein the transducer system generates, by the processor of the transducer system, position data based on the position of the instrument guide device and based on calculating an instrument guide orientation.
  • FIG. 1 is an example system for instrument guidance, in accordance with some examples of the present disclosure
  • FIG. 2A is an isometric view of an instrument guidance device, in accordance with some examples of the present disclosure.
  • FIG. 2B is a top view of an instrument guidance device, in accordance with some examples of the present disclosure.
  • FIG. 2C is a top view of an instrument guide device, in accordance with some examples of the present disclosure.
  • FIG. 3A is an isometric view of an ultrasound probe bracket and an attached instrument guide device, in accordance with some examples of the present disclosure;
  • FIG. 3B is an exploded view of an ultrasound probe bracket, in accordance with some examples of the present disclosure.
  • FIG. 4 is an example timing diagram for instrument guidance, in accordance with some examples of the present disclosure.
  • FIG. 5 is an example flow chart of a method for instrument guidance, in accordance with some examples of the present disclosure.
  • FIG. 1 is a schematic of an exemplary system 100 used for instrument guidance.
  • the system 100 includes a computing device 110, an instrument guidance device 120, and an ultrasound device 130.
  • the instrument guide device 125 can include a first aperture, a magnet, and one or more protrusions.
  • the instrument guide device 125 can include a sensing element (e.g., a potentiometer, a feature to engage with a potentiometer, an optical sensing element that can be used by an optical sensor, and/or a capacitive sensing element that can be used by a capacitive sensor).
  • the sensing element can be contained in an instrument guide insert that is attached to the instrument guide device 125.
  • the computing device 110 can include one or more processors 112, transceiver 114, and display 116, among other things.
  • the computing device 110 can communicate with the instrument guidance device 120 and/or the ultrasound device 130.
  • the ultrasound device 130 can emit high- frequency sound waves that, when a transducer of the ultrasound device 130 is placed against a body, reflect off body structures. The ultrasound device 130 can then receive the waves and can use the waves to create imaging data. Here, the ultrasound device 130 can send the imaging data in real-time to the computing device 110.
  • the instrument guidance device 120 can include ultrasound probe 121, ultrasound probe bracket 122, instrument guide device 125, first sensor 123A, second sensor 123B, ultrasound transceiver 124A, and ultrasound processor 124B.
  • the ultrasound transceiver 124A can be located in ultrasound probe bracket 122 and can transmit various data including position data and a unique identifier for the ultrasound probe 121.
  • the first sensor 123A and/or second sensor 123B can be a magnetoresistive sensor, Hall effect sensor, magnetic potentiometer, and/or the like that can be configured to detect a magnetic field and changes as the magnetic field is rotated and/or translated.
  • a user e.g., a physician
  • the instrument guide device 125 of the instrument guidance device 120 can hold one or more instruments of differing sizes, which can be attributed to a multi-faceted block which can rotate beside an open channel to create a closed channel of variable size (shown in FIG. 2C).
  • the instrument guide device 125 can include a plurality of disposable instrument inserts that are each designed to fit a specific instrument guide, but each has a consistent outer geometry to attach.
  • the instrument guide device 125 can include a single instrument insert that includes a plurality of faces or a single continuous face that when the instrument insert is twisted, changes the size of a second aperture created between the instrument insert and the instrument guide device 125, which can allow for different instrument sizes and/or gauges to be used.
  • the instrument guide device 125 can be a single disposable instrument guide that accepts a plurality of instrument sizes. An instrument inserted into the instrument guide device 125 can be indirectly and/or removably attached or attachable to the ultrasound probe 121.
  • the magnet can change orientation accordingly; however, the magnet can be in a fixed position in rotating element of the instrument guidance device 120, such that the magnet does not change the angle and/or position relative to the rotating element.
  • the first sensor 123A can wirelessly track the magnet, using for example magnetoresistive properties that rely on the magnetic field, to determine an orientation (e.g., angle) and/or position of the instrument guide device 125.
  • the ultrasound processor 124B can generate position data (e.g., angle and positioning values), which can be in relation to the surface of the ultrasound probe 121.
  • the first sensor 123A can send a voltage within a range (e.g., 0-3.3 volts) corresponding to the angle of the magnet to the ultrasound processor 124B.
  • the ultrasound processor 124B can convert this voltage to an integer within a range (e.g., 0-1023 for a 10-bit analog-to-digital conversion).
  • the instrument guidance device 120 can send the position data, using for example Bluetooth ® technology, to the computing device 110.
  • the second sensor 123B can provide power to the instrument guidance device 120 when the instrument guide device 125 is attached. Conversely, the second sensor 123B can disengage power to the instrument guidance device 120 when the instrument guide device 125 is detached.
  • the computing device 110 can receive the imaging data and the position data from the ultrasound device 130 and the instrument guidance device 120, respectively. The computing device 110 can then generate an image overlay using the imaging data and the position data. The image overlay can project the position data onto the imaging data. Further, the computing device 110 can display the image overlay on the display 116 of the computing device 110 or in some examples, the computing device 110 can send the image overlay to an external device and/or the ultrasound device 130 that displays the image overlay. Additionally or alternatively, the computing device 110 can project the image overlay over a screen of the ultrasound device 130, using for example lasers, or by placing a see-through screen over the screen of the ultrasound sound device 130. In other words, the position of an instrument can be mapped onto the imaging data that shows an image of the body. Thus, in real-time, for example, a healthcare professional can see the position of an instrument and a blood vessel, which can eliminate errors.
  • the instrument guidance device 120 may need to be assembled prior to use.
  • the following embodiment refers to an instrument guide insert that is used with the instrument guide device 125 in place of the multi-faceted block (discussed above).
  • the instrument guide insert can be positioned over the instrument guide device 125 and pressed into the first aperture, which may make a snapping noise when inserted.
  • the instrument guide device 125 can be attached to an instrument guide bracket that contains holes that the one or more protrusions are sized to fit in.
  • ultrasound probe bracket 122 can be attached to the ultrasound probe 121, for example, by aligning the ultrasound probe bracket 122 with the ultrasound probe 121 and pushing upwards until a clicking/snapping noise is audible and/or a tactile cue is felt.
  • the ultrasound probe 121 can be used to assemble the ultrasound probe bracket 122 in a pivoting motion. After attachment, an ultrasound probe cover can be placed over the ultrasound probe bracket 122 and the ultrasound probe 121. Then, the assembled instrument guide device 125 can be attached to the ultrasound probe bracket 122 over the ultrasound probe cover to form a sterile barrier. In some examples, the instrument guide device 125 can attach to the ultrasound probe bracket 122 via a magnetic attachment, an adhesive attachment, a hook-and-loop strips attachment, and/or the like.
  • the instrument guide insert can include the one or more protrusions and/or one or more features that align with the one or more protrusions and/or the one or more features on the instrument guide device 125 such that the instrument guide insert snaps into pre-defined rotational positions as it is rotated to select apertures (e.g., a set of apertures) for different instrument sizes.
  • apertures e.g., a set of apertures
  • the instrument guide insert can be rotated one way to close the second aperture between the instrument guide insert and the instrument guide device 125, and rotated another way to open the second aperture between the instrument guide insert and the instrument guide device 125, such that the first instrument (e.g., the needle) can be removed from the instrument guidance device 120 in a direction perpendicular to the first instrument’s central axis.
  • the instrument guide insert and/or the instrument guide device 125 can include a button and/or a lever that can be actuated to open and close the second aperture created between the instrument guide insert and instrument guide device 125.
  • the ultrasound probe bracket 122 can include top portion 122A and bottom portion 122B (shown in FIG. 3B) that can be joined together (e.g., snapped into place) to form the ultrasound probe bracket 122.
  • the ultrasound probe bracket 122 can be opened about a hinge, fit around the ultrasound probe 121, and then closed together while maintaining alignment.
  • the ultrasound probe bracket 122 can include a pin snap fit or a latch to join members of the ultrasound probe bracket 122.
  • the ultrasound probe bracket 122 may fit the geometry of various sized ultrasound probes.
  • the ultrasound probe bracket 122 can be split into a plurality of pieces (e.g., halves) and/or can be opened and/or closed around the ultrasound probe 121.
  • FIG. 4 shows a timing diagram of a method 400 for instrument guidance (e.g., using system 100).
  • the method 400 can be performed by the computing device 110, the instrument guidance device 120, and the ultrasound device 130. Further, each of the aforementioned devices may be in communication with one another to perform the method 400.
  • the ultrasound device 130 generates imaging data, i.e., an ultrasound image of a portion of a person’s body. Then, at 404, the ultrasound device 130 sends the imaging data to the computing device 110.
  • the instrument guidance device 120 using the first sensor 123A, can determine an angle of the instrument guide device 125 by tracking a magnet that is included within the instrument guide device 125. The instrument guidance device 120 then generates, at 408, position data based on the angle of the instrument guide device 125.
  • the instrument guidance device 120 sends the position data to the computing device 110.
  • the computing device can, at 412, compute the pixel distance, for example on the display 116 or the ultrasound device 130, corresponding to a physical metric in the ultrasound image (e.g., centimeters) at the present imaging depth.
  • the computing device 110 can compute how the position data should be displayed at the present imaging depth given the pixel distance determined at 412.
  • the computing device 110 can generate an image overlay that projects the position data onto the imaging data, which can be displayed by the computing device 110, at 418.
  • the computing device 110 can send the image overlay to the ultrasound device 130 (as shown) and/or an external device.
  • FIG. 5 illustrates a flow chart of a method 500 for instrument guidance. The method 500 is written from the perspective of the computing device 110 that can communicate with the instrument guidance device 120, the ultrasound device 130, and/or an external device. Using the method 500 can allow the computing device 110 to provide real-time imaging of both a patient’s body and an instrument in relation to the patient’s body.
  • the computing device 110 can receive imaging data from the ultrasound device 130.
  • the computing device 110 can also receive position data from the instrument guidance device 120, at 510.
  • the computing device 110 can determine pixel distance on the display corresponding to a physical metric (e.g., centimeters) in the ultrasound image at the present imaging depth.
  • the computing device 110 can map a physical space in the imaging data onto a virtual display based on the pixel distance.
  • the computing device 110 can generate an image overlay that maps the position data (e.g., position of the needle and a trajectory of the needle) over the imaging data, such that the position of the instrument is shown in relation to the portion of the body being viewed by the ultrasound device 130.
  • the computing device 110 can display the image overlay.
  • such computer-readable media can comprise various forms of data storage devices or media such as RAM, ROM, flash memory, EEPROM, CD-ROM, DVD, or other optical disk storage, magnetic disk storage, solid state drives (SSDs) or other data storage devices, any type of removable non volatile memories such as secure digital (SD), flash memory, memory stick, etc., or any other medium which can be used to carry or store computer program code in the form of computer- executable instructions or data structures and which can be accessed by a computer.
  • data storage devices or media such as RAM, ROM, flash memory, EEPROM, CD-ROM, DVD, or other optical disk storage, magnetic disk storage, solid state drives (SSDs) or other data storage devices, any type of removable non volatile memories such as secure digital (SD), flash memory, memory stick, etc.
  • Computer-executable instructions comprise, for example, instructions and data which cause a computer to perform one specific function or a group of functions.
  • Computer-executable instructions, associated data structures and/or schemas, and program modules represent examples of the program code for executing steps of the processes disclosed herein.
  • the particular sequence of such executable instructions or associated data structures represent examples of corresponding acts for implementing the functions described in such steps.
  • An exemplary system for implementing various aspects of the described operations includes a computing device including a processing unit, a system memory, and a system bus that couples various system components including the system memory to the processing unit.
  • the computer will typically include one or more data storage devices for reading data from and writing data to.
  • the data storage devices provide nonvolatile storage of computer-executable instructions, data structures, program modules, and other data for the computer.
  • Computer program code that implements the functionality described herein typically comprises one or more program modules that may be stored on a data storage device.
  • This program code usually includes an operating system, one or more application programs, other program modules, and program data.
  • a user may enter commands and information into the computer through keyboard, touch screen, pointing device, a script containing computer program code written in a scripting language or other input devices (not shown), such as a microphone, etc.
  • input devices are often connected to the processing unit through known electrical, optical, or wireless connections.
  • the computer that effects many aspects of the described processes will typically operate in a networked environment using logical connections to one or more remote computers or data sources, which are described further below.
  • Remote computers may be another personal computer, a server, a router, a network PC, a peer device or other common network node, and typically include many or all of the elements described above relative to the main computer system in which the devices, systems, and methods are embodied.
  • the logical connections between computers include a local area network (LAN), a wide area network (WAN), virtual networks (WAN or LAN), and wireless LANs (WLAN) that are presented here by way of example and not limitation.
  • LAN local area network
  • WAN wide area network
  • WAN or LAN virtual networks
  • WLAN wireless LANs
  • a computer system When used in a LAN or WLAN networking environment, a computer system implementing aspects of the devices, systems, and methods is connected to the local network through a network interface or adapter.
  • the computer When used in a WAN or WLAN networking environment, the computer may include a modem, a wireless link, or other mechanisms for establishing communications over the wide area network, such as the Internet.
  • program modules depicted relative to the computer, or portions thereof may be stored in a remote data storage device. It will be appreciated that the network connections described or shown are exemplary and other mechanisms of establishing communications over wide area networks or the Internet may be used.
  • steps of various processes may be shown and described as being in a preferred sequence or temporal order, the steps of any such processes are not limited to being carried out in any particular sequence or order, absent a specific indication of such to achieve a particular intended result. In most cases, the steps of such processes may be carried out in a variety of different sequences and orders, while still falling within the scope of the claimed devices, systems, and methods. In addition, some steps may be carried out simultaneously, contemporaneously, or in synchronization with other steps.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention porte sur un système de guidage d'instrument. Le système peut comprendre un dispositif de guidage d'instrument et un système de transducteur. Le dispositif de guidage d'instrument peut comprendre un guide d'instrument et un support de guide d'instrument qui comprend un aimant, et le support de guide d'instrument peut être fixé de manière amovible au guide d'instrument. Le système de transducteur peut comprendre un support de sonde à ultrasons qui peut être fixé de manière amovible à une sonde à ultrasons. En outre, le dispositif de guidage d'instrument peut se fixer de manière amovible au support de sonde à ultrasons. Le support de sonde à ultrasons peut comprendre en outre un premier bras et un second bras. Le premier capteur peut suivre sans fil une position de l'aimant pour déterminer des données de position du système de guidage d'instrument. Et le second capteur peut fournir une puissance ou un dégagement d'énergie au dispositif de guidage d'instrument lorsque le guide d'instrument est fixé ou détaché, respectivement.
PCT/US2020/039938 2019-06-26 2020-06-26 Systèmes, procédés et dispositifs pour guidage d'instrument Ceased WO2020264383A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2020304669A AU2020304669A1 (en) 2019-06-26 2020-06-26 Systems, methods, and devices for instrument guidance
CA3139694A CA3139694A1 (fr) 2019-06-26 2020-06-26 Systemes, procedes et dispositifs pour guidage d'instrument
JP2021576834A JP2022538126A (ja) 2019-06-26 2020-06-26 器具の誘導のためのシステム、方法、および装置
EP20832232.1A EP3989850A4 (fr) 2019-06-26 2020-06-26 Systèmes, procédés et dispositifs pour guidage d'instrument

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201962866950P 2019-06-26 2019-06-26
US62/866,950 2019-06-26
US16/810,569 2020-03-05
US16/810,569 US20200281561A1 (en) 2019-03-05 2020-03-05 Systems, Methods, and Devices for Instrument Guidance
US16/816,363 US11701088B2 (en) 2019-03-05 2020-03-12 Systems, methods, and devices for instrument guidance
US16/816,363 2020-03-12

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JP (1) JP2022538126A (fr)
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WO (1) WO2020264383A1 (fr)

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US20140228685A1 (en) * 2011-10-12 2014-08-14 Teleflex Medical, Inc. Needle guide and method for determining the position of a needle which is attached movably in a needle guide of this type to an imaging probe
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EP2912999B1 (fr) * 2010-05-28 2022-06-29 C. R. Bard, Inc. Appareil destiné à être utilisé avec un système de guidage d'insertion d'aiguille
EP3581129B1 (fr) * 2014-01-10 2023-02-15 Soma Research, LLC Systèmes de guidage d'aiguilles à utiliser avec des dispositifs à ultrasons
JP6923532B2 (ja) * 2016-01-08 2021-08-18 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 外科的誘導装置、システム及び方法

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US20140228685A1 (en) * 2011-10-12 2014-08-14 Teleflex Medical, Inc. Needle guide and method for determining the position of a needle which is attached movably in a needle guide of this type to an imaging probe
US20170035385A1 (en) * 2014-04-16 2017-02-09 B-K Medical Aps Multi-purpose instrument guide
US20170361032A1 (en) * 2014-12-31 2017-12-21 Amolifescience Co., Ltd. Guide device for injection needle puncture
WO2018035068A1 (fr) * 2016-08-18 2018-02-22 Shields Samuel S Guide hybride

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EP3989850A1 (fr) 2022-05-04
CA3139694A1 (fr) 2020-12-30
JP2022538126A (ja) 2022-08-31
AU2020304669A1 (en) 2022-01-06
EP3989850A4 (fr) 2023-07-05

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