WO2014164539A1 - Procédés et systèmes pour diriger un mouvement d'un outil pendant des interventions de transplantation de cheveux - Google Patents

Procédés et systèmes pour diriger un mouvement d'un outil pendant des interventions de transplantation de cheveux Download PDF

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Publication number
WO2014164539A1
WO2014164539A1 PCT/US2014/022739 US2014022739W WO2014164539A1 WO 2014164539 A1 WO2014164539 A1 WO 2014164539A1 US 2014022739 W US2014022739 W US 2014022739W WO 2014164539 A1 WO2014164539 A1 WO 2014164539A1
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WO
WIPO (PCT)
Prior art keywords
procedure
site
priority
overlap
harvesting
Prior art date
Application number
PCT/US2014/022739
Other languages
English (en)
Inventor
Hui Zhang
Mohan BODDULURI (a.k.a. Radhika Mohan)
Original Assignee
Restoration Robotics, 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 US13/796,159 external-priority patent/US9498289B2/en
Application filed by Restoration Robotics, Inc. filed Critical Restoration Robotics, Inc.
Publication of WO2014164539A1 publication Critical patent/WO2014164539A1/fr

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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
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • 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
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A61B2017/00752—Hair removal or transplantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00747—Dermatology
    • A61B2017/00769—Tattoo removal
    • 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
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/107—Visualisation of planned trajectories or target regions
    • 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
    • A61B2090/363—Use of fiducial points
    • 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
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3983—Reference marker arrangements for use with image guided surgery
    • 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/10—Hair or skin implants

Definitions

  • the present application relates generally to hair transplantation procedures and more particularly to methods and systems used for operating a tool to harvest or implant follicular units from or into a body surface using imaging and processing techniques.
  • interruptions may be mechanical, electrical, hardware, software, or medical in nature, or caused by some other means. For example, it may be desirable or simply unavoidable that the patient alters his/her position during the procedure, or that the patient and/or physician temporarily leave the place in which the operation is being carried out before returning.
  • a donor area e.g., on the patient's scalp
  • follicular units implanted into a recipient area e.g., a bald area on the patient's scalp.
  • These procedures typically take several or more hours to perform.
  • the patient may remain in the operation chair but need to alter their position due to discomfort and/or fatigue, or simply moves due to breathing or other natural movements.
  • the patient may need to interrupt the procedure to temporarily leave the chair.
  • the present application discloses systems and methods for directing movement and operation of a tool in medical procedures which are at least partially automated.
  • a method of operating a tool to perform a medical procedure is provided.
  • the method may comprise recording first locations of a plurality of fiducials appearing in one or more images; updating and recording the updated locations of at least some of the plurality of the fiducials in an updated one or more images; determining an offset of the updated locations of the at least some of the plurality of the fiducials relative to their first locations; selecting a site on which to perform the medical procedure based at least in part on the determined offset.
  • the method may further comprise instructing the tool to perform the procedure at the selected procedure site (for example, a tattoo placement or tattoo removal procedure, or a cosmetic injection procedure, ablation procedure, eye treatment procedure, or any other procedure that could benefit from the inventions described herein); and may also comprise recording a location of the performed medical procedure.
  • a tattoo placement or tattoo removal procedure for example, a tattoo placement or tattoo removal procedure, or a cosmetic injection procedure, ablation procedure, eye treatment procedure, or any other procedure that could benefit from the inventions described herein
  • recording a location of the performed medical procedure for example, a tattoo placement or tattoo removal procedure, or a cosmetic injection procedure, ablation procedure, eye treatment procedure, or any other procedure that could benefit from the inventions described herein.
  • the method may further comprise determining a boundary of an area on a body surface where a procedure is performed, for example, an area from which follicular units are to be harvested, or into which follicular units are to be implanted, and instructing a tool to perform an operation, such as in the example of hair transplantation to harvest from a selected harvesting site or implant into a selected implant site, for example, within or outside the determined boundary.
  • the boundary may be determined based on a reference, for example, a plurality of fiducials, which may comprise a set of distinctive fiducials.
  • the selection of follicular unit harvesting or implanting sites may take into account limitations of the tool.
  • such boundary may be adjusted to eliminate portions, for example, where a tool used in the procedure has limited or insufficient access for proper operation, or to take into account one or more parameters of a skin tensioning device, if such device is used, and/or the tool.
  • the tool may be operated to harvest or implant follicular units by substantially automatically changing a direction of travel of the tool based on the locations of the reference points or fiducials.
  • Harvesting and implant sites may be selected based on one or more criteria, one of which may be to minimize interference from fluids on the body surface. Another such criteria may be selecting locations which do not comprise locations of previously harvested or implanted follicular units.
  • One embodiment of the method may comprise recording first locations of a plurality of fiducials, and updating and recording updated locations of at least one or more of the plurality of fiducials, for example, to account for movement, whether that be due to interruptions or merely patient movement.
  • the method may further comprise determining an offset of the updated locations of at least some of the plurality of fiducials relative to the first locations and selecting a procedure site, such as a follicular unit harvesting or implanting site, based at least in part on the determined offset.
  • a procedure site such as a follicular unit harvesting or implanting site
  • a system may include a processor comprising a set of instructions for executing operations for moving a tool to perform a procedure, for example, moving a tool to a site where a procedure is to be performed.
  • a set of instructions may comprise instructions for selecting a procedure site from where follicular units are to be harvested (or where follicular units are to be implanted) based on first locations of the plurality of fiducials appearing in one or more images of the body surface; and updating and recording updated locations of at least one or more of the plurality of fiducials.
  • the instructions may further provide for a boundary of an area on a body surface to be determined, the area from which follicular units can be harvested from or implanted into.
  • the instructions may also provide for determining an offset of the updated locations from the first locations and selecting a procedure site, such as a follicular unit harvesting or implanting site based at least in part on the determined offset.
  • the instructions may further comprise instructing a tool to move to the site and/or perform the procedure, such as harvest from a selected harvesting site or implant into a selected implant site, optionally, outside or within the determined boundary.
  • the system may comprise an image acquisition device to provide image data containing one or more images of the body surface with fiducials thereon and an interface adapted to receive an image data containing images of a body surface.
  • the system may further comprise a processor configured to create a virtual representation of the site where the procedure has been performed, a representation for example of any harvested or implanted follicular units, and a monitor configured to display the same.
  • the system and method of the present invention is especially useful when implemented on, or integrated with, an automated system, for example, a robotic system comprising a robotic arm.
  • a system and a method for controlling a direction of travel of a tool relative to a body surface in which the tool is caused to move or travel in an identified direction and operated to perform an action or procedure, for example, to harvest or implant follicular units in the direction of travel.
  • the direction of travel or, in some embodiments also a boundary may be determined, for example, based on a plurality of fiducials, which may comprise a set of distinctive fiducials.
  • the tool is operated to travel in a direction other than the direction of travel when another fiducial is within a predetermined distance from the tool.
  • the direction other than the direction of travel may be substantially opposite the direction of travel or may be substantially orthogonal to the direction of travel.
  • a change of direction of travel may be substantially automated based, for example, at least in part on the location of the fiducials.
  • a system and method of operating a tool to harvest or implant hair grafts in which at least one image of a body surface is processed to divide the image into multiple rows and a tool may be operated to harvest or implant at least one follicular unit in a first row.
  • a determination may be made whether a number of harvested or implanted follicular units in the first row is within a range of a desired number of harvested or implanted follicular units for the first row. If the number of harvested or implanted follicular units in the first row is within the range of the desired number of harvested or implanted follicular units for the first row, the tool may be moved to a subsequent row.
  • the number of harvested or implanted follicular units in the first row is less than a lower threshold value of the range of the desired number of harvested or implanted follicular units for the first row, harvesting or implanting the at least one additional follicular unit in the first row may be continued.
  • the system comprises at least one non-transitory storage medium storing instructions, and at least one processor that executes the instructions to: process at least one image of a body surface to divide the at least one image into multiple rows; operate a tool to perform at least one procedure in a first row; and determine whether a number of performed procedures in the first row is within a range of a desired number of procedures for the first row.
  • the at least one processor may execute instructions to move the tool to a subsequent row; and if the number of the performed procedures in the first row is below a lower threshold of the range of the desired number of procedures for the first row, the at least one processor may instruct to operate the tool to perform at least one additional procedure in the first row.
  • the at least one procedure may be a tattoo placement or removal procedure, an injection of cosmetic or medicinal substance, an ablation, an eye treatment, a biopsy, or other cosmetic or dermatological procedure.
  • a system and method of operating a tool to harvest or implant hair grafts in which one or more images of a body surface are processed to determine locations of a plurality of distinctive fiducials appearing in the one or more images.
  • the one or more images may be divided into multiple rows and a tool may be operated to harvest or implant at least one follicular unit in a first row at a first location.
  • a direction of travel of the tool relative to a body surface may be identified based on the first location and the locations of at least some of the plurality of distinctive fiducials.
  • the tool may be caused to travel in the identified direction of travel.
  • a processor comprising a set of instructions for executing operations, the set of instructions including instructions for processing one or more images of a body surface to determine locations of a plurality of distinctive references appearing in the one or more images; operating a tool to perform a procedure or operation, for example, to harvest or implant a first follicular unit, at a first location; identifying a direction of travel of the tool relative to a body surface based on the first location and on the locations of at least one of the plurality of the distinctive references; causing the tool to travel in the identified direction of travel; and operating the tool to perform an action or operation, for example, to harvest or implant a second follicular unit, at a second location on the body surface in the direction of travel.
  • the instructions may further comprise utilizing at least one of the plurality of distinctive references to define a boundary, and operating the tool to perform the procedure or operation within the boundary.
  • a method for defining a region of operation of a tool during a procedure or operation, for example hair transplantation may comprise selecting a fiducial in an image of the body surface and moving, for example, an image acquisition device such that the fiducial is substantially at a reference point in the field of view of the camera.
  • a location of the fiducial is determined in a frame of reference of the body surface.
  • a subsequent fiducial may be selected, the subsequent fiducial being a closest to the fiducial for which the location has been identified.
  • the method further comprises moving the image acquisition device such that the subsequent fiducial is substantially at the reference point in the field of view of the camera and determining a location of the subsequent fiducial with respect to the initial fiducial.
  • the steps of selecting the subsequent fiducial and determining the location of the subsequent fiducial may be substantially automatically repeated for a set of fiducials that define a boundary of an area for performing a procedure or operation, for example for harvesting or implanting follicular unit.
  • a system and method for defining an exclusion region or zone is provided and information about the exclusion region is used in determining the next procedure or operation location, for example, for determining the next harvesting or implantation location.
  • the exclusion region is the region within which is not desirable to perform a procedure or operation, for example, the region from which harvesting follicular units or into which implantation of the follicular units is not desirable.
  • the exclusion zone may be defined as a closed polygon, for example, a polygon of substantially tear-drop shape on a surface of the body, or for example a donor area, such as scalp.
  • systems and methods may be provided that further enhance a selection of follicular unit harvesting or implanting sites.
  • selection may be made using, for example, a lowest and closest method, overlap-based methods, position-based methods, pattern-based methods (for example, a triangular pattern based method), and/or a combination of these methods.
  • the output selection from one of the methods may be used as an input for one of the other methods to select one of the best candidate sites.
  • systems and methods are provided to implement the above methodology in various medical and cosmetic procedures.
  • a system is provided that comprises at least one non-transitory storage medium storing instructions
  • the at least one processor that executes the instructions to: process at least one image of a body surface to divide the at least one image into multiple rows; operate a tool to perform at least one procedure in a first row; and determine whether a number of performed procedures in the first row is within a range of a desired number of procedures for the first row. If the number of the performed procedures in the first row is within the range of the desired number of procedures for the first row, the tool is moved to a subsequent row; and if the number of the performed procedures in the first row is below a lower threshold of the range of the desired number of procedures for the first row, the tool is operated to perform at least one additional procedure in the first row.
  • the system may be a hair transplantation system and the at least one procedure may be harvesting or implanting a follicular unit.
  • the at least one procedure may be a tattoo placement or removal, an injection of cosmetic or medicinal substance, an ablation, an eye treatment, a biopsy, or a cosmetic or dermatological procedure.
  • Figure 1 is a block diagram illustrating a general methodology of an example of an embodiment according to one aspect of the invention.
  • Figure 2 is a schematic representation of an example of a robotic system that could be implemented in various embodiments of the invention.
  • Figure 3 is an example of a skin tensioner including fiducials which could be utilized in various embodiments of the invention.
  • FIGS 4(a)- (f) show various examples of implementations of the methodology according to an embodiment of the invention.
  • Figures 4(g)-(h) demonstrate an example of an embodiment according to "an exclusion zone” methodology.
  • Figures 5(a)-(g) show an example of identifying and recording fiducials as could be implemented in an example of the embodiment of the invention.
  • FIGS 6(a)-(f) show another example of implementation of the methodology according to an embodiment of the invention.
  • Figures 7(a)-(f) illustrate examples of various selection criteria according to various embodiments of the invention.
  • Figures 8(a)-(f) are schematic representations illustrating an example of the use of satellite sites in the provision of exclusion zones.
  • FIGS 9(a) and (b) illustrate the difference between using and not using the satellite exclusion zone methodology.
  • Figure 10 is an example of a schematic representation of a reserved harvesting region.
  • Figure 11 is a schematic representation of an example of a grid that may be displayed on a monitor.
  • Figures 12(a)- 12(h) illustrate a number of examples of different methods for selecting a procedure site, such as follicular unit harvesting or implantation sites, that may be used with various embodiments of the present disclosure.
  • tool refers to any number of tools or end effectors that are capable of performing an action, procedure or operation in various medical procedures or applications.
  • the tool may be a needle, a surgical scalpel, blades, various types of forceps, hemostats, surgical instruments, retractors, electro surgical tools, radio-frequency ablation tools, suturing devices, tattoo placement or removal tools, eye speculum, cannula, drills or lasers.
  • a “tool” may comprise a “harvesting tool” or an "implantation tool”, and is capable of dissecting, harvesting or implanting follicular units ("FUs") from or into a skin or body surface, for example, a scalp.
  • FUs harvesting or implanting follicular units
  • the tool comprises a hollow tubular shaft and thus may be labeled, for example, a cannula, a needle, or a punch.
  • the distal end of such tools are typically sharpened, to various degrees, to penetrate tissue and extract or implant the follicular unit.
  • the terms "operatively connected,” “coupled,” or “mounted,” or “attached” as used herein, means directly or indirectly coupled, attached, or mounted through one or more intervening components.
  • Embodiments of the methods of the present invention may be implemented using computer software, firmware or hardware. Various programming languages and operating systems may be used to implement the present invention.
  • Robotics systems such as robotic hair transplantation systems generally require accurate positioning of a tool under robotic control.
  • a semi-automated or a fully automated procedure that requires precise control of the position, such as hair transplantation, it is desirable to be able to maintain such precise control despite patient motion or temporary interruptions.
  • the present application provides methodology for negating the effects of patient's movement or procedure interruptions. For example, the described methodology avoids further delays related to repositioning of a patient relative to a robot or an automated tool, and/or need for potential recalibration or a new treatment plan to be configured.
  • a variety of methodologies and systems are provided which enable a tool to automatically proceed from where it left off prior to an interruption that the procedure may be subject to, continuing its operation and essentially providing a seamless operational procedure.
  • the systems and methods described herein enable the tool to maintain its direction of travel over the patient' s body surface that it had despite patient's movement or other interruptions, to recognize where it has previously harvested follicular units or implanted them, and continue to travel in that general direction to harvest or implant further follicular units.
  • the inventions described herein enable the system to operate in a fully- automated fashion, if desired, without requiring relocation of the base of the robotic system, relocation of the body surface, physician assistance or human intervention.
  • the present invention provides methodologies that enable a tool operated by an automated system or under computer control to be operated to change its direction of travel when required, without necessarily requiring human intervention, although a user could overwrite any automated movement if desired.
  • Fig. 1 is a block diagram illustrating an example of a general methodology employed by the present invention.
  • step 110 which may be a preliminary step and it is shown in dotted line
  • one or more images of the body surface with one or more reference points, such as a plurality of fiducials may be obtained, for example, using an image acquisition device. That may be accomplished by any technique known in the art.
  • an image acquisition device may be attached to a robotic arm, and the robotic arm with the attached image acquisition device may be positioned so that the harvesting or implantation region is in focus for the cameras.
  • the image acquisition device may be still incorporated into the automated (e.g., robotic) system but it does not have to be attached to the robotic arm.
  • the image acquisition device could be a device separate from the robotic system.
  • a fiducial is an object that may act as a reference, and may be identifiable in a field of view of an imaging device. Fiducials can take many forms, for example, a single artificial reference point that uniquely identifies both position and orientation may be used as a fiducial.
  • a set of coordinate axes printed on a surface can uniquely identify the surface position and orientation.
  • the origin, together with the directions of the X and Y axes, can uniquely identify the surface position and orientation.
  • a set of artificial reference points that each uniquely specify a position can be used as fiducials.
  • the combination of three or more such reference points can specify a unique frame of reference specifying both position and orientation.
  • An example would be spheres with different colors. One sphere uniquely specifies a position in space, but not orientation. Two more spheres can be used to specify both position and orientation.
  • natural features of a surface that have unique, recognizable patterns may be used as fiducials.
  • natural physical features or anatomical landmarks present on the skin or other body surface that have unique, recognizable patterns (e.g., follicular units or hairs, moles, scars, freckles, wrinkles, bumps or depressions on the body surface, eye balls, ear canals) may be used as fiducials.
  • these may be distinctive from one another based on their distinctive physical attributes (including but not limited to size, color, shape, number, height from the body surface etc.) or their relative distance from another distinctive feature.
  • the random dot pattern of the entry locations of hairs on the surface of the head is sufficiently unique that a group of them can be used to unambiguously identify position and/or orientation.
  • a pattern-matching algorithm can be used to recognize the hair pattern in subsequent images.
  • the fiducials may also be objects placed on or affixed to the patient's skin, sometimes called external fiducials.
  • external fiducials may be placed or affixed either directly to the skin surface in the hair donor or hair recipient area, or alternatively they may be placed on some device or instrument which is in turn affixed to the body, for example, a skin tensioner used in the hair transplantation procedures, as explained in more details in reference to the examples of Figures 3 and 4.
  • a processor or an image processor processes and records an identity and a location of each of the fiducials in a frame of reference of an image acquisition device (e.g., in a camera field of view).
  • Such initial recording of fiducials could be referred to as "fiducial registration.”
  • the fiducials could be recorded in various coordinate systems, for example, in a fixed "world” coordinate system. In the example of Figures 4(a) - 4(f), the fiducials are described as recorded in a coordinate system fixed to the camera.
  • step 120 provides for acquiring additional images as needed, for example, including other subsets of the fiducials, until all fiducials have been identified. (This aspect will be described in greater detail with respect to Figure 5).
  • step 125 based on the location of the each of the plurality of fiducials, a boundary of an area, such an area within which hair grafts or follicular units are intended to be harvested from or implanted into, may be determined. The boundaries may be determined automatically, for example, by drawing lines between various fiducials.
  • the boundaries may be also adjusted to eliminate certain portions of the bound area where harvesting or implantation is difficult, as explained and described in further detail in reference to Figure 3.
  • updated images of the body surface are acquired, the images containing an image of the plurality of fiducials or a subset thereof. Due to patient motion, or another such temporary interruption, the locations of the fiducials in these updated images may be in a revised location with respect to the frame of reference of the image acquisition device.
  • the processor in step 130 processes the revised location of each of the plurality of fiducials in the frame of reference of the image acquisition device, the revised locations of each of the plurality of fiducials which may be different from the locations previously processed. Having acquired the revised locations of the fiducials, and with the knowledge of the original locations of the fiducials, an offset for at least some or all of the fiducial locations may be determined in step 130. Based on this offset information, the processor also in step 130 may process revised locations for each of the locations of interest, such as locations from which follicular units have already been harvested (if harvesting has already started in a region of interest within the boundary) or into which follicular units have already been implanted (if such implanting has been started).
  • step 130 may also comprise determining the revised boundary, for example, of the harvesting/implanting area based on the revised locations of the fiducials.
  • determining the revised boundary for example, of the harvesting/implanting area based on the revised locations of the fiducials.
  • step 135 determine or select a location from where the next hair follicle is to be harvested such that hair follicles are not taken from an already harvested location, or determine a location into which the next hair follicle is to be implanted such that hair follicles are not implanted into locations into which hair follicles have already been implanted.
  • a processor programmed to perform the above-described step such as a processor described in reference to Figure 2.
  • a tool may be moved to the selected procedure site, and in some embodiments, the procedure may be performed at the selected procedure site: for example, a hair graft or follicular unit may be harvested from or implanted into the selected location.
  • a hair graft or follicular unit may be harvested from or implanted into the selected location.
  • the location from where it has been harvested from, or implanted into may be registered or recorded by the processor in step 145. This registration may include information on the location of the harvest or implant with respect to at least one of the plurality of fiducials, or the determined boundary.
  • the method may comprise creating and displaying a virtual representation on the image of the location from which the follicular unit has been harvested (or at least dissected from the surrounding tissue for further removal using forceps or vacuum), or the location into which a follicular unit has been implanted.
  • a virtual representation on the image of the location from which the follicular unit has been harvested (or at least dissected from the surrounding tissue for further removal using forceps or vacuum), or the location into which a follicular unit has been implanted.
  • Such visual representation for example, on a monitor (e.g. a computer screen) is especially beneficial for the user to easily and quickly identify locations where hair grafts have been dissected or harvested, and also to differentiate between the previously existing follicular units and the newly implanted ones.
  • the visual representations of step 150 may be implemented by using different colors, shapes or other appropriate differentiating features.
  • step 155 the processor determines, based on the information it has recorded with respect to the area and the locations of the follicular units that have been harvested or implanted, if follicular units have been harvested from all desired sites, or if follicular units have been implanted into all desired sites.
  • the processor may communicate this information, for example, to the image acquisition device.
  • the processor may communicate this information to the user, typically providing an indication to the user (via the monitor, voice command, or any other appropriate technique), for example, that step 110 may begin again at a new donor or recipient region.
  • the processor continues to repeat steps 130 - 155 until all desired follicular unit are harvested or implanted. For example, updated images with the updated fiducial information are processes, offsets determined, the next harvest site or implant site is selected, etc.
  • a methodology is provided to enable hair follicles to continue to be harvested from or implanted into a body surface in a continuous and automatic fashion despite potential patient movements and interruptions.
  • the tool is able to be moved to each new harvesting or implantation location with respect to fiducials, the fiducials providing a mechanism of recognizing the location of the harvesting/implanting area on the body surface, despite movement of the patient, or the image acquisition device.
  • FIG 2 is a schematic perspective view of an example of a robotic system 200 for hair harvesting (and/or implantation).
  • the system 200 includes a robotic arm 205 to which is coupled a tool 210.
  • Various motors and other movement devices may be incorporated to enable fine movements of an operating tip of the tool 210 in multiple directions.
  • the robotic system 200 further includes at least one image acquisition device 215, which is described in more detail below.
  • the image acquisition device may be mounted in a fixed position, or it may be coupled (directly or indirectly) to a robotic arm 205 or other controllable motion device.
  • the operating tip of the tool 210 is shown positioned over a body surface 220, in this case a part of the patient scalp having hair follicles thereon.
  • an image acquisition device may be provided separately and not included in the system.
  • an interface may be provided that allows various other components or modules of the system, such as image processing component, to interact with the separate image acquisition device.
  • a processor 225 of Fig. 2 may comprise an image processor 230 for processing images obtained from the image acquisition device 215.
  • the image processor 230 may be a separate device or it may be incorporated as a part of the processor 225.
  • the processor 225 may also instruct the various movement devices of the robotic arm 205, including the tool 210 that may be operatively connected to the robotic arm.
  • the processor 225 may act, for example, through a controller 235 as schematically shown in Fig. 2.
  • the controller 235 may be operatively coupled to the robotic arm and configured to control the motion of the robotic arm, including the motion based on the images or data acquired by the image acquisition device.
  • controller 235 may be incorporated as a part of the processor 225, so that all processing and controls of all movements of all the tools, the robotic arm and any other moveable parts of the assembly, including those based on the images or data acquired by the image acquisition device, are concentrated in one place.
  • the system 200 may further comprise a monitor 240, keyboard 245, and mouse 250. A magnified image of the body surface 220 can be seen on the monitor 240.
  • the system 200 may comprise other tools, devices and components, for example, those useful in harvesting, and/or implantation of the hair follicles, or in hair treatment planning.
  • the system further comprises an interface adapted to receive an image data, various parts of the system allow an operator to monitor conditions and provide instructions, as needed.
  • the processor 225 may interact with the imaging device 215 via the interface (not shown).
  • the interface may include hardware ports, cables, leads, and other data transmission means, or it may comprise a computer program.
  • an image acquisition device 215 shown in Fig. 2 include one or more cameras, such as any commercially available cameras.
  • various image capture devices or imaging devices
  • the imaging device may be one or more cameras, such as any commercially available cameras. While stereo or multi-view imaging devices are very useful in the present invention, it is not necessary to employ such geometries or configurations, and the present invention is not so limited.
  • the image acquisition device be a digital device, it is not necessary.
  • the image acquisition device could be an analog TV camera that acquires an initial image which is then processed into a digital image (for example, via an analog-to-digital device like a commercial- off-the-shelf frame grabber) for further use in the method of the present invention.
  • the image acquisition device may be coupled to a processing system, shown incorporated in the processor 225 in Fig. 2, to control the imaging operation and process image data.
  • the processor for use in the present invention may comprise any suitable device programmed and configured to perform various methods described in detail in the present application, including methods directed to automated movement of the hair harvesting/implantation tool to maintain or change a desired direction of travel within a hair donor or hair recipient area; or methods directed in reference to Figures 4-7.
  • the processor for use in the present invention may be a processor comprising a set of instructions for executing operations, the set of instructions including instructions for processing one or more images of a body surface to determine locations of a plurality of distinctive fiducials appearing in the one or more images, (in some embodiments, the plurality of the distinctive fiducials may define a boundary); moving the tool to, and operating a tool to harvest or implant a first follicular unit at a first location; identifying a direction of travel of the tool relative to a body surface based on the first location and on the locations of at least one of the plurality of the distinctive fiducials; causing the tool to travel in the identified direction of travel; and operating the tool to harvest or implant a second follicular unit at a second location on the body surface in the direction of travel.
  • the image processor for use with the present invention is
  • image processing techniques for example, segmentation, edge detection, object recognition and selection. These techniques are generally known and do not need to be separately described here.
  • a suitable processor or image processor may be a digital processing system which includes one or more processors or other type of device.
  • a processor image processor
  • the processor may be a controller or any type of personal computer ("PC").
  • the processor image processor
  • the processor may comprise an Application Specific Integrated Circuit (ASIC) or Field Programmable Gate Array (FPGA).
  • the processor may also include memory, storage devices, and other components generally known in the art and, therefore, they do not need to be described in detail here.
  • the above-described processor could be used in conjunction with various partially automated and fully automated (including robotic) hair transplantation and treatment systems and devices, including but not limited to systems for hair harvesting, or hair transplantation.
  • Figure 3 illustrates an example in which a set of unique or distinctive (meaning that they are distinguishable or different from each other) fiducials are either formed on or affixed to a frame of a skin tensioner 300 that could be used in the hair transplant procedure to tension a skin surface from which hair follicles are harvested.
  • skin tensioner could also be used in some embodiments during hair implantation if tensioning the skin surface is desired, in other embodiments fiducials could be placed directly on the skin surface during hair graft
  • fiducials e.g., moles, scars, etc.
  • natural features e.g., moles, scars, etc.
  • this description may be adjusted and it is intended that the same principles should be applied to the fiducials placed, for example, directly on the skin or on the device other than the skin tensioner, as well as to the natural fiducials previously identified (e.g. , follicular units or other physical landmarks). Therefore, such alternative implementations are within the scope of the invention.
  • the skin tensioner 300 may comprise a flexible frame 305 that lies generally in a plane and shown to comprise a single element, typically molded material and is configured such that it may be compressed inward from a relaxed position.
  • the flexible frame 305 in the example illustrated, includes four side sections 310.
  • the four side sections 310 are shown linear and arranged substantially in a square, although they may be arcuate and otherwise arranged in various geometrical patterns.
  • Each side section 310 features a plurality of perforations 315 for receiving barbs or microbarbs (not shown), which are small elements that project from skin tensioner to the skin below to puncture or form a depression in the skin surface, serving as a primary means of ensuring good grip between the skin tensioner and the skin.
  • the illustrated fiducials 320 may comprise, for example, a set of circular fiducials 325, each circular fiducial 325 being distinguishable from any other circular fiducial, and a set of square fiducials 330, each square fiducial 330 being distinguishable from any other square fiducial.
  • the fiducials may comprise a single feature, for example a dot, and each fiducial may be distinguishable from the others by the size of the feature ( e.g., the dot).
  • the fiducials may comprise a feature (such as a dot) that may be of the same (or different) size on each fiducial, but the fiducials may be further distinguishable from the one another, for example, by the number of the features (such as dots) that it has on it.
  • each fiducial may comprise a different feature or features.
  • the fiducials 320 can be of any shape or configuration, provided the imaging system is capable of distinguishing one fiducial from another. In the illustrated embodiment the imaging recognition software could, for example, recognize whether the fiducial it had identified was a circular fiducial 325 or a square fiducial 330 by determining the ratio of the square of the perimeter of the fiducial to the area of the fiducial.
  • this ratio for a circular fiducial 325 is around 12.5, and that for a square fiducial 330 is 16.
  • the processor containing image processing software would be able to distinguish the set of 6 circular fiducials 325 from the set of 4 square fiducials 330, illustrated as an example in Figure 3.
  • a similar capability in image processing could enable the processor to determine that the ratio of the area of the single smaller dot 335 on the circular fiducial 325 to the area of the circular fiducial itself, was smaller than the ratio of a larger single dot 340 on the circular fiducial 325.
  • uniquely identifiable fiducials 320 such as those illustrated by example in Figure 3, could be used to implement the methods of the present application.
  • the fiducials 320 may be placed at a known distance away from the inner edges that form a central opening 350 of the skin tensioner.
  • this known distance is illustrated as a distance 355 and it is shown as a distance from an inner edge of the tensioner to a point 345 on a fiducial where the point 345 is the closest to the central opening 350 of the skin tensioner 320.
  • a distance 355 may be measured from the inner edge of the skin tensioner to a center of the relevant fiducial.
  • the row of fiducials is placed such that the distance 355 may range between 1mm and 10 mm (and in some embodiments may further range between 2mm and 4mm) from the inner edges of the tensioning device 300.
  • this distance 355 may have widely different ranges.
  • Fiducials may be used to bound an area, for example, for harvesting, and may need to have a known relationship to that area.
  • the processor may comprise an algorithm which detects the fiducials on each side of the skin tensioner (or on the skin or other alternative surface), fits lines to the four (in the example of Figure 3) rows of fiducials and computes a quadrilateral whose corners are formed by the intersection of the best-fit plane containing all fiducials with planes passing through each line and normal to the all-fiducial plane.
  • the processor is consequently able to identify and calculate the area or central opening 350 bounded by the four side sections of the skin tensioner, which could represent the area within which it is desired that hair follicles be harvested from (or implanted into).
  • Utilization of a skin tensioner 300 to host the fiducials 320 may require other factors be taken into consideration when identifying the actual bound area where follicular units will be harvested or implanted.
  • One such factor is that the skin tensioner itself has a depth or height associated with it, that is, it does not typically lie flush with the patient's body surface, but is raised above the body surface to a certain degree. It will also be appreciated that the angle at which the follicular units extend from the patient's body surface varies.
  • the processor may be also configured to take into consideration, for example, a depth or height of the inner edge of the tensioner, and/or an angle and dimensions of the tool/punch when it orients relative to a hair graft to harvest it (or relative to a desired orientation of the hair graft to be implanted).
  • the processor may determine, using a straightforward trigonometric calculation, a revised boundary 360.
  • This revised boundary 360 provides a predetermined distance from the fiducials that the tool may safely approach, without encountering the physical inner boundaries of the tensioning device itself, encountering issues arising from one or both of the depth/height associated with the tensioning device, encountering image processing issues arising from the shadow cast by the tensioning device on the body surface, and/or the angle of approach of the tool.
  • a calculation may be performed on each hair in the field of view in order to allow selection of only those hairs that are reachable without such interference from the tensioning device or issues arising from inadequate tool dimensions.
  • This selection may be done by a user based on user-specified criteria input via, for example, a keyboard, selected via the mouse, or selection may be provided by an automated algorithm, to harvest or implant the next follicular unit accordingly. Having considered and accounted for all these variations, the location of the fiducials can be used to calculate whether the hair harvesting or implantation tool will clear the tensioner during the transplantation procedure.
  • Additional input criteria relating to the parameters of the procedure may also be selected at this time, allowing for automation of the procedure. Similar to that described above, these parameters may be input via a keyboard or a remote input device, or selected via the mouse, or selection may be provided by drop-down menus of an automated algorithm or similar such means. In this manner, the user may select, in reference to hair harvesting or implantation, for example, that the minimum distance from any previous harvest site be at least 2.0mm, the minimum distance from a previously skipped harvest site be, for example, at least 0.5mm, similarly, tensioner offset distance from each side may be selected as well, or the type of follicular unit to be harvested (F2, F3, or F4, for example), or any other such parameter(s).
  • the appropriate parameters for such specific procedure may be selected in a similar manner.
  • the user may select the angle of the laser to the body surface and/or the distance of the laser with respect to the skin. If instead of a tensioner some other boundary setting device is used, various distances as described above (e.g., offset on each side, etc.) may be selected by the user.
  • the present invention utilizes of a set of identifying fiducials such as those described above, to facilitate automation of a robotic system, such as follicular unit harvesting or implanting system.
  • a robotic system such as follicular unit harvesting or implanting system.
  • one or more of the fiducials are distinguishable from others, in others, all of the fiducials are distinguishable from each other.
  • the fiducials serve as objects, or reference marks in a field of view of an image acquisition device. These identifying fiducials when viewed in an image can be recognized in the image, and may be individually recognizable from each other in subsequent images.
  • Fiducials may be physically identified by a 1-D bar code, a 2-D data matrix code, known markings such as alphanumeric characters, a series of dots, a series of bars, or any other type of unique identifier or custom scheme.
  • the perimeter-to-area ratio, the ratio of area of the internal features to the outside features, and the number of internal features may be combined to ensure that a unique identifier can be determined for each fiducial.
  • Figures 4(a) - 4(f) illustrate how the steps of Figure 1 can be implemented utilizing the system of Figure 2 and fiducials, for example, similar to those as illustrated in Figure 3.
  • a tensioning device 400 is illustrated.
  • fiducials 405 which are illustrated as a series of alphabetic characters, A to F, along the vertical side sections of the skin tensioner, and a set of numeric characters, 1 to 8, along the horizontal side sections of the skin tensioner.
  • the fiducials generally may be placed in arbitrary positions relative to a working area.
  • the fiducials are placed such that a known feature of the fiducial, for example the center of each fiducial, or a known boundary of the fiducial is at a known distance from inner bounding edge of the skin tensioner.
  • the fiducials may comprise circular shaped adhesive labels that affix to the tensioning device, the edges of the circular shaped adhesive labels being such that the size of the label is less than the size of the vertical and horizontal structures of the tensioning device to which it is attached, so that when placed on the tensioning device, the fiducials themselves may be located, for example, in the region of 2mm or so from the inner boundary of the tensioning device.
  • the system can process images acquired by the image acquisition device to detect substantial relative motion, for example motion in the region of 1mm in a field of view in the region of 50mm, that may be caused, for example, by misidentification or detachment of a fiducial (if it is an externally placed fiducial), and report such an error so that measures may be taken if necessary to compensate or correct for the error.
  • the surface on which the fiducials are located is free to move (e.g. patient moving his/her head or getting up).
  • the translation and rotation of the surface with the fiducials due to motions can be computed any time when at least three non-collinear fiducials are visible.
  • the shifted and/or rotated fiducial locations are detected (for example, by an imaging device and/or image processing software or hardware which may form a part of an imaging system), the procedure is able to continue at the next harvest site. If fewer than three non-collinear fiducials are visible, another attempt to image and register fiducials is made so that three or more fiducials become visible, as described in more detail in reference to Figures 5(a) - 5(g).
  • the location and optionally the orientation of each of the fiducials 405 may be identified, registered, and electronically saved via the image processor.
  • the user may also specify via an input device such as the keyboard or the mouse, information pertaining to the physical parameters of the tensioning device 400 (if such tensioning device is used) and the tool, information such as the height of the tensioning device 400 relative to the body surface and the diameter of the tool for example.
  • the processor may, optionally, determine the location and orientation of a revised boundary 410.
  • the fiducials 405 are recorded in the coordinate system of the image acquisition device, which as indicated above is on the robotic arm, though they may be recorded in any appropriate reference frame.
  • the image processor identifies the location and optionally the orientation, of one or more hair harvesting (or implantation) sites 415, and may register and electronically save such identified information.
  • the image processor identifies the location and possibly the orientation of one or more hair harvesting (or implantation) sites 415 within the revised boundary 410.
  • the information about location and orientation of the harvesting (or implantation) site is registered and stored with respect to the location and orientation of the fiducials 405. This enables monitoring and control, for example, of the spacing between hairs to avoid underharvesting (when harvest density is too low) and overharvesting (when harvest density is too high).
  • Optimal density can be maintained only if the system, such as the robotic system is able to maintain its knowledge of the harvest (implant) area, and use the full area available for harvesting or implanting.
  • the fiducials are used to define the boundaries, for example, of the harvest area, harvesting may be automatically performed as close as desired to that boundary.
  • the harvesting mechanism can turn automatically to start a new row when the boundary is approached, and can stop
  • FIGS 4(a) - 4(f) will be discussed, as an example, in reference to the hair harvesting, and assuming that revised boundaries 410 are utilized. However, it should be understood that this description applies and could be adjusted accordingly in reference to hair implantation, and to eliminate the determination of revised boundaries 410.
  • the harvesting tool is operated to initiate the harvesting procedure from the bottom left hand corner of the quadrilaterally shaped bound area, bounded by the revised boundary 410.
  • various fluids including for example, blood and saline will be present on the body surface.
  • the harvesting tool may be moved to the initial or first harvesting location, such as location 415 in Figure 4(a), directly or indirectly by the physician (for example, the physician may click on the image to identify the desired harvesting location), or the processor may be configured or programmed to find this location itself, for example, based on the information it has acquired on the fiducials, the processor may then provide instructions to the control unit to move the tool accordingly.
  • the physician for example, the physician may click on the image to identify the desired harvesting location
  • the processor may be configured or programmed to find this location itself, for example, based on the information it has acquired on the fiducials, the processor may then provide instructions to the control unit to move the tool accordingly.
  • the tool has been instructed to move to the location
  • the processor may create a visual representation of the location on the site at which the follicular unit has been harvested This representation may comprise a circular shape such as that illustrated, a cross, or any other such visualization.
  • the visual representation or the marking of the harvesting (or implantation) site is beneficial to the user of the system, providing a visual image of where harvests (or implantations) have occurred.
  • the tool is then controlled to move in the direction represented by arrow 420, along the row defined by virtual line C-F, substantially parallel to a horizontal side of the revised boundary 410.
  • the processor can be configured to operate the tool to harvest follicular units at predetermined locations, such as in this example, by passing over, for example, any locations in row C-F between fiducial locations 5 and 7 without harvesting a follicular unit, and making its subsequent or second harvest at the location 425 that could be defined as C7.
  • the selected harvesting location for example, on the row C-F does not have to be exactly at the level of the location of the fiducials 405 (such as fiducial 7), but rather may be anywhere and at any distance from a particular fiducial (e.g., between the level of fiducials 6 and 7).
  • the processor determines that the tool is within a predetermined distance from fiducial F and the end of this first harvesting row, or that the revised boundary 410 has been reached, the processor provides instructions to the control unit to cause the tool to move in a direction away from fiducial F to automatically increment to the next harvesting row.
  • the tool is controlled such that it moves initially in an upwardly direction 430, from F to E, and then in a direction denoted by arrow 435, away from E, away from the revised boundary 410, and along the virtual line EB.
  • the tool is controlled to move to a harvesting site 440 located at approximately B-8, and operated to harvest a follicular unit at that location before moving on.
  • the system is configured to direct a tool to move and operate, for example, at least in part based on the location of the fiducials. In this manner, the tool can be operated to turn automatically when the revised boundary is approached and start the next row of the harvesting process, and to stop automatically when the area bound by the revised boundary 410 has had all desired follicular units harvested.
  • Figure 4(d) indicates a location 445 denoted by an "X", at which it is intended that the next follicular unit be harvested.
  • X a location 445 denoted by an "X"
  • Figure 4(d) indicates a location 445 denoted by an "X”, at which it is intended that the next follicular unit be harvested.
  • the patient's body surface may have moved such that the existing follicular units can be seen to have moved both to the right, and upwardly, in the frame of view 450. If the tool was moved to harvest the next follicular unit at a location with coordinates referenced with respect to the frame of view 450, it can be seen that the follicular unit would be harvested from a location 455 marked with the "X" which is not the original desired location marked as 445 in Figure 4(d). As indicated in Figure 4(e), this location 455 is close to another follicular unit 460 that could be damaged by harvesting the location 455. This location 455 is also close to a location from which another follicular unit has already been harvested, location 465.
  • the robotic system By registering the intended harvesting site with respect to the fiducials 405, the robotic system is able to avoid some or all of these errors, and additionally is able to continue the harvesting process without necessarily requiring significant intervention of the physician to do so.
  • the robotic system is configured to determine the location and orientation of each of the fiducials 405, and compare these new or revised locations and orientations with the already saved information on each of the distinctive fiducials 405.
  • each of the fiducials 405 it will determine that the location of each of the fiducials 405 has moved a certain distance towards the right hand side of the frame of view, and a certain distance in an upwardly direction also.
  • the system is able to determine how each of the initially identified fiducials has been transformed in location and orientation, and determine the transformation that needs to be applied to the location 455, to relocate that same location 455 with respect to the fiducials 405.
  • the processor is then able, using known transformation techniques, to modify the location and orientation information of the intended implantation location 455 accordingly, applying the necessary transformation of the coordinates of the location, so that the tool can be operated to move to the correct harvesting site 470 (which correspond to the originally marked site 445), as illustrated in Figure 4(f).
  • the system is configured to operate the follicular unit harvesting tool to maintain its harvesting direction that is along the virtual row A- D, despite patient movement.
  • the system is configured to ensure that harvesting does not occur at sites where harvesting has already taken place, enabling site to site spacing and row- to-row spacing to be maintained.
  • the provision of visual image for example, in the form of circles centered about where harvesting has been performed, provides the user with a visual representation that confirms that harvesting has occurred at the site to site spacing and row-to-row spacing desired.
  • the visual circular representations not correspond with the desired outcome, the user has an opportunity, based on the recognition of the deviation from expectation, to correct for any errors that may be visualized. This correction can be implemented at any moment that deviation from expectation has been detected, and multiple corrections may be performed throughout any procedure. In this manner, the system is able to harvest follicular units despite patient movement.
  • harvesting and implantation locations could be used to define "exclusion zones" around harvesting or implantation sites.
  • arbitrarily shaped features or structures may be utilized to facilitate selection of the next harvest or implant site, which may optionally be visually represented to the user.
  • the perimeter or an outline of the arbitrarily shaped feature can be tailored to indicate an exclusion zone, that is an area within which selection of the next potential harvesting site or a potential implantation site should be avoided.
  • a simple circle (representing a simple exclusion zone) may be utilized to facilitate selection of the subsequent hair harvesting or implantation site, by creating the perimeter around a new potential harvesting/implanting site.
  • the perimeter of such circle will be larger than the potential harvesting/implanting site to provide for an exclusion zone around the harvesting/implanting site, that is an area in which the tool should avoid harvesting/implanting a subsequent follicular unit.
  • Such harvesting/implanting should be avoided if, in addition to the potential harvesting/implantation site, there is also a location of already previously harvested/implanted site within the perimeter of the circle, or perhaps within a predetermined distance from the perimeter.
  • the exclusion zone may be based on various criteria, including, for example, avoiding problems such as the potential harvest/implant site coinciding, intersecting with, or coming too close to an already existing harvest/implant site, or merely defining the minimum separation of follicular units that are to be harvested/implanted for medical or aesthetic reasons.
  • the harvesting tool enters the body surface substantially orthogonal to the body surface.
  • hairs do not generally grow orthogonal to the body surface, or at least the portion of the hair beneath body surface does not grow substantially orthogonal to the body surface. Therefore, it is more likely that a harvesting tool will be approaching a scalp at an angle. Assume that this angle is an acute angle. Due to the acute angle of the approach, and the velocity of approach, the tool (such as a harvesting punch) may tend to skive the skin, sliding a little further than perhaps originally intended, and enter the body surface slightly off-center from the intended harvesting site.
  • the distal end of the harvesting tool may not only enter the body surface at a location that differs from the intended entry point (the intended harvesting site), but the distal end of the harvesting tool may also reach a location beneath the body surface that differs in the horizontal direction from the original location of entry on the body surface. It is therefore possible that on so doing, the distal end of the harvesting tool may coincide or intersect with an already harvested site, or a site that has already been implanted into.
  • an exclusion zone that is tailored to accommodate at least one or more of various factors, for example, with reference to hair transplantation, a minimum distance between harvests, a minimum distance between implants, the diameter of the tool, the angle of approach of the tool, the direction and/or velocity of approach of the tool, or the depth of penetration of the tool.
  • an exclusion zone will be tailored to the factors appropriate for such procedures.
  • Such an exclusion zone may comprise any closed polygon-shaped feature, be it oval, elliptically- shaped, tear-drop shaped, or any arbitrarily shaped feature configured to accommodate or take into consideration the examples of the factors mentioned above.
  • the parameters of the exclusion zone provide information that can be utilized by the processor in the selection of the next harvesting or implantation site, to exclude harvesting or implanting into already harvested or implanted regions, or too close to such regions, whether those regions be at the skin surface or below it. It also provides a visual indication to the user that appropriate selections of harvesting or implantation sites are being made by the automated hair
  • a method for defining an exclusion region of operation of a tool during hair transplantation may comprise providing processing instructions that can cause an exclusion zone to be created around a potential harvest/implant site, the exclusion zone may be based on at least one of or more of a minimum distance between harvests, a minimum distance between implants, the diameter of the tool, the angle of approach of the tool, the direction and/or velocity of approach of the tool, or the depth of penetration of the tool.
  • the method further comprises determining existence of any previous harvest or implant site that may lie within the exclusion zone, in addition to the proposed harvest/implant site.
  • FIGS. 4(g) and 4(h) illustrate an example of an embodiment using an exclusion region methodology. Turning first to figure 4(g), already harvested locations 472 and 474 are identified with a circular representations 476 and 478 indicating larger regions centered about the harvest locations 472 and 474.
  • the processor may select a potential harvesting location 480, which is outside the circular representations 476 and 478.
  • the processor creates an arbitrary shaped feature 482, which in this instance is shaped as a tear-drop, around the potential harvesting location 480.
  • the shape of the feature 482 can be described as a circle around the potential harvesting location 480, which has been extended, or stretched in the direction 484, which is the direction in which the tool is both travelling and angled to harvest, thus forming a tear-drop shape (or exclusion zone).
  • the processor determines whether there are any already harvested sites that fall within the exclusion zone 482 in addition to the potential harvesting site 480. In this instance, the already existing harvesting site 472 can be seen to fall within the exclusion zone of the tear-drop 482, and so the processor will determine that this potential harvesting site 480 is not a site from which a follicular unit should be harvested. Harvesting a follicular unit from this location 480, with the tool orientated at the selected angle and in the direction 484, could possibly create a harvesting path that coincides or intersects with the already existing path that was created at location 472. Therefore, the processor selects an alternative potential harvesting site, for example that indicated in Figure 4(h).
  • FIG. 4(h) once again already harvested locations 472 and 474 are identified with circular representations 476 and 478 indicating larger regions centered about the harvest locations 472 and 474, from which it is not desirable to harvest additional follicular units.
  • the processor selects a potential harvesting location 486, which is outside the circular representations 476 and 478.
  • the processor creates an arbitrary shaped feature 490 (or exclusion zone) which once again is shaped as a tear-drop, around the potential harvesting location 486.
  • the shape of the feature 490 can be described as a circle around the potential harvesting location 486, which has been extended, or stretched in the direction 488, which is the direction in which the tool is both travelling and angled to harvest, thus forming a shape that is tear-drop shaped.
  • the processor determines whether there are any already harvested sites that fall within the exclusion zone 490 in addition to the potential harvesting site 486. In this instance, while there are follicular units within the exclusion zone 490, for example, the harvesting site 492, none of them has been harvested yet. Therefore, a candidate or potential harvesting site 486 is an acceptable candidate, and the processor may determine that this potential harvesting site 486 could be harvested without intersecting with any already existing harvesting path.
  • the generation of visual representations that define exclusion zones that are centered, for example, about a harvesting site, may create an image that has numerous overlapping
  • gaps By avoiding the creation of these gaps, and in particular the relatively small gaps, a visual representation that is more pleasing to the eye can be created, a more "friendly" visual representation for the processor and/or the user, one in which gaps are fewer and easier to identify.
  • This is particularly beneficial, for example, in situations where manual follicular unit selection is desired, situations in which for example, the user can manually select follicular units to be harvested that were missed by an automatic selection algorithm or close to the skin tensioner but still harvestable in the eyes of the user.
  • the gap 835 illustrated in Figure 8(a) is by using an alternative or additional methodology which serves to fill the gaps between the exclusion zones 820, 825 and 830.
  • more than one existing follicular unit harvest site is used to create a visual representation of the exclusion zone for that particular harvested follicular unit.
  • the visual representation is generated by using not only the newly harvested follicular unit, but by using information from its neighboring or satellite sites, the sites of previously harvested follicular units that are in close proximity to the newly harvested follicular unit.
  • Figure 8(b) shows the two existing harvested follicular unit sites 805 and 810, and a site 815 which represents a site of a newly harvested follicular unit.
  • the exclusion zones 820, 825 and 830 have been omitted.
  • the processor is configured to determine whether or not the already existing follicular unit harvesting site 805 is within, for example, a predetermined distance from it. This predetermined distance may be based, for example, on a multiple of the minimum harvest distance described above, the multiple being greater than one, and ranging, for example, from 1.5 to 2.5.
  • the predetermined distance may be less than or equal to at least twice the minimum harvest distance from the newly harvested follicular unit site 815, that is a distance of, for example, 3.8mm. If it is found that the already existing follicular unit harvesting site 805, for example, is less than or equal to at least twice the minimum harvest distance away from the newly harvested follicular unit site 815, the already existing follicular unit harvesting site 805 may be considered to be a satellite site with respect to the newly harvested follicular unit site 815.
  • the already existing follicular unit harvesting site 805 may be considered not to be a satellite site with respect to the newly harvested follicular unit site 815.
  • the processor when processing the exclusion zone for the newly harvested follicular unit site 815, the processor is configured to determine whether or not the already existing follicular unit harvesting site 810 is less than or equal to at least twice the minimum harvest distance from the newly harvested follicular unit site 815, that is a distance of, for example, 3.8mm.
  • both existing harvested follicular unit sites 805 and 810 are less than or equal to at least two times the minimum harvesting distance from the newly harvested follicular unit site 815.
  • the processor creates a closed loop profile, or a supplemental exclusion zone, based on the locations of the newly harvested follicular unit site 815, and the existing harvested follicular unit sites 805 and 810, forming a triangular shape 840 as illustrated in Figure 8(b).
  • the processor combines or superimposes this closed loop triangular profile 840 (the supplemental exclusion zone) onto the three circular exclusion zones 820, 825 and 830, as illustrated in Figure 8(c) to form a visual presentation of the modified exclusion zone 845, as illustrated in Figure 8(d) that no longer incorporates the relatively small gap 835.
  • Figure 8(e) illustrates an example in which a newly harvested follicular unit site 850 is introduced, sites 805, 810 and 815 all being already existing harvested follicular unit sites. If one assumes that the existing harvested follicular unit sites 805, 810 and 815 are less than or equal to a certain minimum harvesting distance, for example, at least two times the minimum harvesting distance, from newly harvested follicular unit site 850, they will all be considered satellite sites to newly harvested follicular unit site 850.
  • a certain minimum harvesting distance for example, at least two times the minimum harvesting distance
  • the processor in this instance is configured to create a closed loop profile (supplemental exclusion zone), based on the locations of the newly harvested follicular unit site 850, and the existing harvested follicular unit sites 805, 810 and 815, forming a polygon with indices 805, 810, 815 and 850.
  • a closed loop profile supplemental exclusion zone
  • Figure 8(f) illustrates an example in which the centrally located newly harvested follicular unit site 885 has five satellite sites 860, 865, 870, 875 and 880 around it.
  • the processor having determined that each of the already existing harvested follicular unit sites 860, 865, 870, 875 and 880
  • Figure 9(a) illustrates a visual representation which only utilizes a methodology in which the exclusion zones are centered about the harvested follicular units.
  • Figure 9(a) attention is drawn to one particular gap 910.
  • Figure 9(b) illustrates the visual representation which utilizes a combined methodology in which the exclusion zones are centered about the harvested follicular units and then combined with the overlay of the supplemental exclusion zone provides by the appropriate satellite sites.
  • the location where there used to be a gap 910 is no longer there.
  • a visually more "friendly" image has been rendered.
  • a method is provided for generating a visual representation of a region where a procedure was performed.
  • the method comprising generating a visual representation of one or more procedure sites (e.g. harvest sites) where a procedure was performed. If more than one procedure site exists, the visual representation of the exclusion zones for each of the procedure sites are overlapped.
  • the method further comprises generating one or more supplemental exclusion zones for any or all procedure sites; and overlapping the exclusion zone and the supplemental exclusion zones to generate the
  • the step of generating one or more supplemental exclusion zones may be accomplished by comparing a distance between a particular procedure site and one or more previous procedure sites that surround that particular procedure site, and for those surrounding sites where the distance is within a predetermined or selected limit, such surrounding sites are identified as the satellite sites for the particular site.
  • the above-mentioned comparison may be run against every existing procedure site to identify a corresponding collection of the satellite sites for each existing procedure site.
  • each new harvested hair graft may be compared to any or all other previous harvested hair grafts and be added, as appropriate, based on the results of the comparison, to a collection of the satellite sites for each relevant previous harvest site.
  • any or all previous harvest sites may be compared to a newly harvested site and, based on the results of such comparison, be identified as the satellite sites for the newly harvested site.
  • the satellite sites may be sorted based on certain criteria, such as the tangle angle in the coordinate system, for example, with the smaller angle going first, forming a counter-clockwise sequence, or with a greater angle going first, forming a clockwise sequence. This sorting may be used to generate a continuous convex profile. Without sorting, the random sequencing of the satellite sites may miss some parts of the geometry profile.
  • the method may further comprise updating and displaying the previous procedure region.
  • Reserved harvest regions define areas from which hairs are not to be selected for harvesting.
  • These reserved harvest regions may define areas where skin conditions exist that make the area unsuitable or undesirable for harvesting from or implanting into, areas which contain previously implanted follicular units, areas containing a particular classification of follicular unit (such as Fl for example) that are not desired for the current harvest, areas where moles or scars exist, or define areas exhibiting any number of other conditions.
  • These reserved harvest regions can be illustrated, as shown, for example, in Figure 10, as a box 1010, or as a circular representation (note that if a circular representation is used, the circles representing the reserved harvest regions may be formed in a different color than the circles used to identify the exclusion regions 1020), or as any arbitrary shape, and may be created in numerous ways.
  • the user may manually define a reserved harvesting site by manually clicking a mouse at a point within the revised boundary 410, to create a reserved harvest region box of pre-defined size.
  • a reserved harvest region box may be created whose sides may be adjusted by the user, or several points may be identified by the user, and the processor may create a closed-loop arbitrary shape that encompasses all the identified points.
  • the reserved harvest regions may be automatically created by the processor once it has processed the information contained in the acquired images, and the user may be allowed to accept or reject these automatically created reserved harvest regions. It will be apparent that there are many other ways in which such reserved harvest regions may be created for or by the user.
  • the system may use the limited information initially available and ultimately create a register of the location of all the fiducials with respect to each other.
  • examples of locating and registering a plurality of fiducials are described in reference to Figures 5(a) - 5(g).
  • the robot since the field of view of the cameras (for example, 2 cameras used for stereovision) may be smaller than the area spanned by the fiducials, it may be necessary to move the robot around the boundary (e.g. perimeter of the tensioner or a region defined by a pattern of existing hairs acting as fiducials) to capture the locations of the fiducials. This motion may be performed, for example, manually by an operator's hand dragging the imaging mechanism attached to the robotic arm using "force- control", or by manipulating the robotic pendant.
  • the boundary e.g. perimeter of the tensioner or a region defined by a pattern of existing hairs acting as fiducials
  • a robotic arm with the attached image acquisition device may be moved automatically around the periphery of the skin tensioner (or around the boundary with a plurality of fiducials that defines the harvesting or implantation region).
  • the robot may be first moved manually to the initial position which brings enough fiducials into view to establish the fiducial frame of reference. Typically, it requires at least three (3) fiducials.
  • Figure 5(a) illustrates an initial frame of view 502 taken from the frame of view of the camera(s) which is mounted on a robotic arm of a follicular unit harvesting or implanting system, the frame of view having a center point of reference 504.
  • fiducials A, B, 1 and 2 are visible in the initial frame of view 502.
  • the system has to acquire the location and/or orientation of each fiducial with reference to at least one other fiducial.
  • at least three fiducials are required to be visible in the initial frame of view 502.
  • some examples of obtaining, tracking and recording information about fiducials that could be used in the present invention is described in the commonly owned co-pending patent application published as US 2010-0080415A1 on April 1, 2010, which is incorporated herein by reference.
  • the system initially moves the field of view of the camera over the body surface such that one of the fiducials that was in the initial frame of view 502, is located at the center of the frame of view, that is, that the centroid of fiducial 1 is substantially aligned with the point of reference 504, as shown in Figure 5(b).
  • This first fiducial 1 is allocated location and optionally orientation coordinates, for example it may be given the reference coordinates of (2,4).
  • the image processor subsequently identifies the next closest fiducial that has not already been centered. In the event that there are two or more closest fiducials, the system is configured to select the closest fiducial according to a predetermined selection mechanism.
  • the selection mechanism may be relatively simple, such as always selecting the one towards a particular direction, and only doing so if the reference coordinates of the fiducial in that direction have not already been acquired.
  • the selection mechanism hierarchy may comprise, for example, the order of to the right, downwards in direction, toward the left and finally upwards in direction.
  • Figure 5(c) illustrates the camera having been moved over the body surface such that the centroid of the closest fiducial 2, to the right hand side of the fiducial 1 is located at the reference location 504 of the field of view 502.
  • the movement undertaken by the camera itself is registered. For example, if the camera movement from a position where the centroid of fiducial 1 was at the point of reference 504 to a position where the centroid of fiducial 2 was at the point of reference 504, is defined by (2,0), then the coordinate for the location of the centroid of fiducial 2 would be (4, 4).
  • virtual lines 506, 508, 510 and 512 may be drawn to define an initial boundary, and after taking into account the location of the centroids of the fiducials, for example, from the inner edges of the tensioning device, the relative height of the tensioning device above the body surface (assuming an embodiment where there is one) and/or the tool diameter, a revised boundary 514 can be determined, inside of which the coordinates of follicular unit can be identified for harvesting, or the coordinates of follicular unit implantation sites can be identified for implantation.
  • an initial image and one or more successive images are taken of a skin surface containing a plurality of fiducial marks.
  • the offset of the fiducials from their positions in the initial image is recorded by computing, for example, a best-fit transformation T that minimizes the error between the original positions and the transformed value of the subsequent positions. If new fiducials are seen in subsequent images, their positions are transformed by the inverse of T so that they too can be recorded in the frame of reference of the initial image. Once their location is transformed and recorded, these new fiducials can then be used in conjunction with the original fiducials to locate an update to the best-fit transformation T.
  • This fiducial offset information is utilized in processing the location and/or orientation, for example, of a harvesting site, applying the offset to the intended harvesting location prior to carrying out the harvesting itself.
  • the fiducial offset information could be used in processing locations and/or orientations of the intended implantation sites and such offset could be applied to the intended implantation location prior to actual implanting.
  • the procedure can be carried out, using the visible fiducials as reference points.
  • the field of view is isolated from the fiducials, harvesting locations from where follicular units have already been harvested or implantation sites into which follicular units have already been implanted can be used to supply additional reference points, to which future harvesting or implantation locations can be referenced.
  • a method is provided that allows defining a region over which a tool is to be operated, for example, to harvest or implant hair grafts.
  • such method may be substantially automated (which means that at least most of the steps could be performed automatically by the robotic system itself). It does not exclude that a user may intervene and participate, for example, by giving an alternative command through a user interface, or override the automated command.
  • an operator may initiate an automatic procedure as follows. One of the fiducials that was previously identified may be arbitrarily chosen.
  • the robotic arm with a camera operatively connected to it may move automatically to center the fiducial in the field of view of the camera. As long as spacing between the fiducials is less than half of the field of view, this will assure that at least two fiducials will be visible.
  • the processor may then direct the robotic arm with the camera to choose the next closest fiducial that has not already been centered. In the same fashion, the robotic arm will continue to move automatically to the next fiducial to center the next fiducial until all fiducials have been identified. If the fiducials are located on the skin tensioner, then the robotic arm will be directed to move around the skin tensioner.
  • the boundary of the region defined by the fiducials may be automatically computed by the processor, and furthermore such boundary may be adjusted so that a tool (e.g., harvesting needle) may safely access follicular units inside the boundary.
  • the start and the initial harvest position and direction may be computed automatically by the automated system.
  • the processor may be programmed to start harvesting or implanting from the edge of the boundary with the lowest height and close to the corner.
  • the robotic arm is directed to automatically move with the attached tool to harvest or implant hair grafts within the boundary.
  • Figures 6(a)-6(f) demonstrate an embodiment according to another implementation of the invention which uses a defined virtual selection region.
  • the tool may be moved automatically within such selection region as explained below based on desired criteria.
  • the revised boundary 610 has dimensions, for example, in the region of 4cm horizontally and 3cm vertically.
  • the tool is operated (for example, automatically or semi-automatically) to initiate the harvesting procedure from the bottom left hand corner of the revised bound area.
  • the tool may be operated to move to the location that is approximately at the intersection of row C-F and column 1-5, and aligned with the follicular unit 615.
  • the processor at this time may also dictate that the tool be moved in the general direction of arrow 620, away from the location of fiducial C and towards fiducial F, in a horizontal direction substantially parallel to a horizontal side of the revised boundary 610.
  • the processor may compute virtual boundaries of a smaller virtual selection region 625 located just in front of the tool in the direction of travel 620.
  • the virtual selection region 625 may comprise a quadrilateral, such as a rectangle having, for example, dimensions of 6-8mm by 3.5-4.5mm. Other dimensions of the selection region 625 are also contemplated within the scope of this application.
  • Use of a smaller virtual selection region 625 reduces the computation required to find a subsequent follicular unit to harvest by restricting the area of consideration to an area just in front of the previous harvested follicular unit 615 and along the direction of travel 620.
  • the tool is operated to harvest the follicular unit 615 and the location of the harvested follicular unit 615 is visually identified, for example, by a circle 630, as seen in Figures 6(a).
  • the harvesting tool After harvesting the follicular unit 615 the harvesting tool is moved in the general direction of the arrow 620, and operated to harvest one or more follicular units located within the virtual selection region 625. As seen, there are several follicular units located within the region 625. However, the next selected follicular unit for harvesting may be not the follicular unit located within the shortest distance from the harvested follicular unit 615 inside the region 625 (such as follicular unit 640), but may instead be based on predetermined selection criteria, such as in this example where the tool is moved to the location of the follicular unit 635 that is the closest to the horizontal boundary 610.
  • follicular unit 720 may be to harvest every other follicular unit within the selection region except when the distance to the next available follicular unit exceeds certain predetermined distance.
  • follicular unit 725 is the next available follicular unit, it is harvested because it is located at a distance, for example greater than 1.9mm away, from the already harvested follicular unit 720.
  • Figure 7(b) once the follicular unit 715 has been harvested, a new virtual selection region 625 is created next to the harvested follicular unit in the same direction of travel.
  • follicular unit 730 once follicular unit 730 has been harvested, follicular unit 735 is left un-harvested, and although follicular unit 745 is the next available follicular unit in the horizontal direction, it too is left un-harvested.
  • the predetermined selection criteria is set such that the next follicular unit available can be selected whether it be the next available closest in the horizontal or the vertical direction, provided that it is contained within the virtual selection region 625. Consequently, follicular unit 750 is harvested, as indicated in Figure 7(f).
  • the follicular unit 640 was too far in the vertical direction from the horizontal boundary 610, and it was therefore not a desirable follicular unit to harvest at this time.
  • the system as shown in Figure 6(b) illustrates follicular unit 640 still on the patient's body surface, and follicular unit 635 being harvested.
  • the image processor On reaching the fiducial F, as illustrated in Figure 6(c), the image processor ascertains that the revised vertical boundary has been reached, and provides the control signals necessary for the robotic arm to move in the direction of arrow 650, as shown in Figure 6(d).
  • the movement of the tool in the direction of arrow 650 will allow the harvesting tool to harvest the follicular unit 640 that was previously left un-harvested.
  • the virtual selection region 625 is moved in the direction 650 along the row F-C until all desired follicular units in that row are harvested.
  • the tool is operated to move in an upwardly direction 660 and towards the right, in the direction of arrow 665, to harvest follicular units in the row B-E in a similar manner, as illustrated in Figure 6(f).
  • follicular units are harvested within the virtual selection region until no desired follicular units remain to be harvested within the desired "harvest quadrilateral" whereupon the virtual selection region is incremented to the next row, it is understood that this is an example. Other procedures are possible and contemplated without departing from the scope of the present disclosure.
  • follicular units may be collected by proceeding along a row and then automatically incrementing to the next row.
  • a harvest target of harvesting a particular percentage of follicular units within an area of skin may be established.
  • a harvest target of harvesting 50% of the follicular units within an area of skin may be established.
  • a follicular unit row target of approximately 10 follicular units may need to be harvested within each row into which the area is divided.
  • the follicular unit row target of 10 follicular units (and thereby the harvest target of 50%) may not be achieved.
  • the area may be divided into rows and follicular units within a row (such as the row located at the bottom of the area) may be harvested (such as within a virtual selection region moved along the row and/or moved back and forth along the row) until a particular target of the numbers of the follicular units for the row is reached.
  • the determination as to whether or not the follicular unit row target (such as 10 follicular units) for the row is reached may be made at the end of the row. In other cases, the determination may be made at other times, such as subsequent to each time a follicular unit is harvested. Regardless, if the follicular unit row target has not been reached, harvesting continues within the row.
  • harvesting may continue at the next row.
  • this example describes incrementing the row from which follicular units are to be harvested only if the follicular unit row target for the row has been precisely met, it is understood that this is for the purposes of example. In other implementations other procedures are possible and contemplated without departing from the scope of the present disclosure. For instance, in some cases, a certain number that is less than the follicular unit row target may be harvested from one or more rows of the area while still achieving the overall desired target number for the area. In such cases, the row may be incremented if the number of follicular units that have been harvested is within a range of the follicular unit row target for the row, or a desired percentage of an area of skin.
  • a harvest target of 75% may be set for an area of skin.
  • an average of 15 follicular units may need to be harvested from each row into which the area has been divided, some rows providing more than average 15 and some less than average 15 follicular units, as long as the actual number of follicular units harvested in the relevant area averages 15 follicular units per row.
  • a comparison may be made between the number of follicular units that have been harvested and the follicular unit row target of 15.
  • a threshold range above and below the target number may be established in certain embodiments. If the number is above a lower threshold value (such as within three follicular units of the target 15, or at least 12), the row may be incremented.
  • harvesting may continue within the current row.
  • the row may be incremented when the upper threshold value of the range of the desired target number is achieved.
  • incrementing rows is discussed within the context of harvesting follicular units. However, it is understood that this is for the purposes of example and such row incrementing is not limited to harvesting of follicular units.
  • such techniques may be used in the context of transplanting follicular units, other medical procedures, and so on without departing from the scope of the present disclosure.
  • a method of operating a tool is provided.
  • the method comprising: processing at least one image of a body surface, using at least one processing unit, to divide the image into multiple rows; operating a tool to perform at least one procedure in a first row; determining, using the at least one processing unit or at least one different processing unit, whether a number of the performed procedures in the first row is within a range of a desired number of the procedures for the first row. If the number of the performed procedures in the first row is within the range of the desired number of the procedures for the first row, moving the tool to a subsequent row; and if the number of the performed procedures in the first row is less than a lower threshold value of the range of the desired number of the procedures for the first row, continue performing at least one additional procedure in the first row.
  • the at least one procedure may be a tattoo placement or removal procedure, an injection of cosmetic or medicinal substance, an ablation, an eye treatment, a biopsy, or other cosmetic or dermatological procedure.
  • the systems and processors configured to implement the above-mentioned methods are also provided.
  • a 'row' may be any portion of a selection region of some width and follicular units may be positioned within such row in a way that is not uniform (i.e., follicular units may be positioned slightly higher than others, slightly lower than others, at various distances from each other, and so on).
  • FIGS 6(a)-6(f) and FIGS. 7(a)-7(e) illustrate a number of criteria for selecting follicular unit harvesting or implantation sites.
  • these criteria are provided for the sake of example and are not intended to be limiting.
  • Follicular unit harvesting or implantation sites may be selected according to a number of different methods without departing from the scope of the present disclosure.
  • FIGS. 12(a)- 12(h) illustrate a number of different methods for selecting follicular unit harvesting or implantation sites in order to closely pack such follicular unit harvesting or implanting sites in accordance with various embodiments of the present disclosure.
  • FIGS. 12(a)- 12(h) are illustrated and described below as involving harvesting of follicular units. However, it is understood that this is for the purposes of example and the techniques disclosed may be utilized in the context of implanting follicular units and/or other medical procedures.
  • FIG. 12(a) illustrates follicular units 1250 on the skin of a patient within a boundary 1210.
  • Circles 1260, 1201, 1202, and 1203 illustrate sites where follicular units have already been harvested.
  • follicular units for harvesting may be made from within a virtual selection region 1225 which may be moved, for example, from left to right across rows beginning at the bottom left and proceeding to the top right of the boundary 1210.
  • a number of follicular units are within the virtual selection region 1225 and are therefore candidates for harvesting.
  • follicular units may be selected using a 'lowest and closest' method.
  • the lowest and closest method may select follicular units that are the lowest in the virtual selection region 1225 and closest to the current position of the harvesting tool in order to minimize harvesting tool movement in order to harvest follicular units.
  • the harvesting tool may be aligned with the bottom left of the virtual selection region 1225.
  • the follicular unit 1232 may be the lowest and closest follicular unit to the bottom left of the virtual selection region 1225 (i.e., the current position of the harvesting tool). As such, the follicular unit 1232 may be selected and harvested (as is illustrated by the circle 1240 in FIG. 12(b)).
  • follicular units may be selected using various enhancements, including without limitation an Overlap priority' method, a 'position priority' method, a pattern-based method, such as 'triangular pattern priority' method, and/or a combination of these methods. It is understood that any of these methods and/or combination of these methods may also use the lowest and closest method to select between multiple candidates identified by the respective method or combination of the methods. Such methods may result in a closer packing of harvesting sites than selection utilizing the lowest and closest method.
  • exclusion zones may be identified around previous harvest sites inside which follicular units will not be selected. Potential exclusion zones for follicular unit harvesting candidates may also be identified. Overlap between the existing exclusion zones for already harvested follicular units and the potential exclusion zones for the future candidates follicular units may then be analyzed to select or eliminate certain follicular unit harvesting candidates.
  • FIG. 12(c) illustrates exclusion zones 1271, 1272, and 1273 around previous harvest sites 1201, 1202, and 1203, respectively.
  • FIG. 12(c) also illustrates potential exclusion zone 1274a around harvesting candidate 1233, potential exclusion zone 1274b around harvesting candidate 1232, and potential exclusion zone 1274c around harvesting candidate 1231.
  • FIG. 12(c) shows, only potential exclusion zone 1274a overlaps in any way with any of the exclusion zones 1271, 1272, or 1273, while the harvesting candidate 1233 itself is not within any of the exclusion zones 1271, 1272 or 1273.
  • the follicular unit harvesting candidate 1233 is selected for harvesting (as is shown in FIG. 12(d)).
  • the candidate follicular unit that does not fall within the exclusion zone of a harvest site, and has the most overlap between the potential exclusion zone and the existing exclusion zone may be selected for harvesting.
  • the following example formula may be used in some implementations to determine whether or not the exclusion zone of a harvesting candidate has overlap with an exclusion zone from a revious harvest site: %-minBistmwe— distrnize ⁇ i))
  • minDistance may be a pre-set value (such as 1.6-2.0mm) to define, for example as shown in Fig. 12(c), the radius of a circle, for example, from a center of the previous harvest site. If the distance(i) between a candidate harvesting site and the previous harvest site is less than 2 times minDistance, the two circles (each centered on the respective follicular unit, or location of previously harvested follicular unit, with radius of minDistance) have overlap. The formula determines how much the overlap is. If distance is small, this determined overlap will be higher. If distance is large, for example, 2 times minDistance, the value will be 0, which means no overlap. As stated above in the formula, as long as distance (i) is less than 2 times minDistance, the formula is useful to determine how much overlap exists and if there are hairs that meet this condition.
  • a pre-set value such as 1.6-2.0mm
  • a follicular unit harvesting candidate may be selected utilizing the lowest and closest method.
  • a number of potential exclusion zones may overlap with one or more existing exclusion zones.
  • selection among follicular unit harvesting candidates corresponding to the overlapping potential exclusion zones may be performed utilizing various criteria.
  • a follicular unit harvesting candidate may be selected utilizing the lowest and closest method.
  • the follicular unit harvesting candidate that corresponds to an
  • overlapping potential exclusion zone may be selected if that follicular unit harvesting candidate is the lowest in the virtual selection region 1225 and closest to the current position of the harvesting tool out of all the follicular unit harvesting candidates corresponding to the overlapping potential exclusion zones.
  • This extension/modification of the overlap method may be referred to as the Overlap-based lowest and closest' or Overlap priority lowest and closest' method.
  • the follicular unit harvesting candidate that corresponds to an overlapping potential exclusion zone may be selected if the potential exclusion zone
  • This extension to the overlap method may be referred to as the 'max overlap priority' method.
  • a proximity band may be identified around previous harvesting sites. For example, in reference to FIG. 12E, if circular areas corresponding to the exclusion zone for previous harvesting sites have a 2 millimeter diameter, the proximity band may extend, for example, 1 millimeter beyond the exclusion zone corresponding to the respective previous harvesting site. Follicular unit harvesting candidates may then be selected if they are within a proximity band.
  • exclusion zones may be shaped other than circles (including the shapes described and shown in reference to other Figures and embodiments) and proximity bands may extend an area outside various shaped exclusion zones accordingly.
  • FIG. 12(e) illustrates proximity bands 1275, 1276, and 1277 around exclusion zones 1201a, 1202a, and 1203a of harvest sites 1201, 1202, and 1203, respectively.
  • FIG. 12(e) shows, only follicular unit harvesting candidate 1231 is located within any of the proximity bands (specifically, proximity band 1275). As such, the follicular unit harvesting candidate 1231 is selected for harvesting (as is shown in FIG. 12(f)).
  • no follicular unit harvesting candidates may be located within a proximity band.
  • a follicular unit harvesting candidate may be selected utilizing the lowest and closest method.
  • a number of follicular unit harvesting candidates may be located within proximity bands. In such instances, selection among follicular unit harvesting candidates located within one or more proximity bands may be performed utilizing various criteria. In some cases where a number of follicular unit harvesting candidates are located within proximity bands, a follicular unit harvesting candidate may be selected utilizing the lowest and closest method. In another case, exclusion zones may be identified around previous harvest sites inside which follicular units will not be selected and potential exclusion zones for follicular unit harvesting candidates that are located in one or more proximity bands may also be identified.
  • Overlap between the existing exclusion zones and the potential exclusion zones may then be analyzed to select follicular unit harvesting candidates within one or more proximity bands for selection (such as by the overlap priority method, the overlap priority lowest and closest method, the max overlap priority method, and so on).
  • This extension to the position priority method may be referred to as the 'position-based overlap' or 'position priority overlap' method.
  • the position priority overlap method first determines follicular unit harvesting candidates that are located within proximity bands and then determines which of these have potential exclusion zones that overlap with existing exclusion zones, it is understood that this is for the purposes of example and is not intending to be limiting.
  • follicular unit harvesting candidates that have potential exclusion zones that overlap with existing exclusion zones may first be determines and then which of these are located within proximity bands may be determined.
  • X and Y may be the relative distance in X and Y to a candidate follicular harvesting site.
  • Ratio may be a factor defined to assign more weight in the formula to the X axis or the Y axis.
  • W may be a weight to select between overlap priority or position priority methods.
  • [ - w * (ratio * Y + X)] of the formula if a candidate follicular harvesting site is closer to a previous harvest site (smaller Y and X), this value will be large. However, if a candidate hair is further away (larger Y and X), this value will be small (possibly negative).
  • the formula is useful when distance (i) is less than 2 times minDistance.
  • one such pattern-based method may be a 'triangular pattern-based' method or 'triangular pattern priority' method.
  • an equilateral triangle may be formed with a base of a triangle being a distance between two previous harvesting sites (e.g., distance "x").
  • An equilateral triangle is a triangle that includes sides of all the same length. Once a third point or apex of the equilateral triangle (other than two previous harvest sites) is determined, any hair that is positioned within a predetermined small distance (such as, for example, one half of "x”) may be selected for harvesting.
  • several triangles may be formed between two previous harvesting sites and available candidate follicular units.
  • One triangle may be closer to an equilateral triangle than another triangle, even if neither has sides of all the same length, if the differences between the sides of the first triangle is smaller than the differences between the sides of the second triangle.
  • a first triangle with sides 5-6-7 is closer to an equilateral triangle than a second triangle with sides 5-14-22.
  • available candidates one would give priority to the candidate follicular units which forms triangle that is closest to the equilateral triangle than triangles formed by other candidates and previous harvesting sites.
  • FIG. 12(g) illustrates equilateral triangles 1282 and 1283 respectively formed based on previous harvest sites.
  • triangle 1283 is formed based on the distance between two previous harvesting sites, as shown.
  • Any candidate follicular unit that is positioned, for example, within a certain small distance (which could be pre-determined, or selected by the user, and in some embodiments, may be a percentage of the distance between the two previous harvesting sites that formed the basis for the triangle) from an apex of such triangle may be selected for harvesting.
  • candidate follicular unit 1232 is not within a predetermined distance from the apex of the triangle (shown as shaded area), and therefore is not selected for harvesting.
  • FIG. 12(g) illustrates equilateral triangles 1282 and 1283 respectively formed based on previous harvest sites.
  • triangle 1283 is formed based on the distance between two previous harvesting sites, as shown.
  • Any candidate follicular unit that is positioned, for example, within a certain small distance which could be
  • follicular unit candidate 1233 is positioned close to or within a small distance from the apex of the equilateral triangle 1282 . As such, follicular unit harvesting candidate 1233 is selected for harvesting (as is shown in FIG. 12(h)).
  • distanceA (which may correspond to a line defined as a point C to a point A of a triangle) and distanceB (which may correspond to a line defined as point C to a point B) may be the two shortest distances from a candidate follicular harvesting site (corresponding to the point C) to previous harvest sites (corresponding to points B and A). If points A, B and C form a triangle with equal edge distances, minDistance may be close to both distanceA and distanceB.
  • follicular unit harvesting candidates may be selected utilizing the lowest and closest method.
  • more than one follicular unit harvesting candidates may be positioned within a predetermined distance from the equilateral triangles, or correspond to triangles that are approximately equilateral triangles. In such instances, selection among follicular unit harvesting candidates that meet the above condition may be performed utilizing various criteria. In some cases a particular follicular unit harvesting candidate out of several follicular unit harvesting candidates that meet the above condition may be selected utilizing the lowest and closest method.
  • exclusion zones around previous harvest sites and potential exclusion zones for follicular unit harvesting candidates that correspond to triangles that are identically close to equilateral triangles may be identified. Overlap between the existing exclusion zones and the potential exclusion zones may then be analyzed to select follicular unit harvesting candidates that correspond to such triangles (such as by the overlap priority method, the overlap priority lowest and closest method, the max overlap priority method, and so on).
  • This extension to the triangular pattern priority method may be referred to as the 'triangular pattern priority overlap' method.
  • proximity bands may be identified around previous harvest sites and follicular unit harvesting candidates that correspond to triangles that are identically close to equilateral triangles may be selected if they are within a proximity band.
  • This extension to the triangular pattern priority method may be referred to as the 'triangular pattern priority position' method.
  • exclusion zones around previous harvest sites and potential exclusion zones for follicular unit harvesting candidates that correspond to triangles that are identically close to equilateral triangles may be identified. Overlap between the existing exclusion zones and the potential exclusion zones may then be analyzed to select follicular unit harvesting candidates that correspond to such triangles (such as by the overlap priority method, the overlap priority lowest and closest method, the max overlap priority method, and so on). If multiple potential exclusion zones overlap existing exclusion zones, proximity bands may be identified around previous harvest sites and follicular unit harvesting candidates that correspond to the overlapping potential exclusion zones may be selected if they are within a proximity band. This extension to the triangular pattern priority method may be referred to as the 'triangular pattern priority overlap position' method.
  • proximity bands may be identified around previous harvest sites and follicular unit harvesting candidates that correspond to triangles that are identically close to equilateral triangles may be selected if they are within a proximity band. If multiple follicular unit harvesting candidates are located within a proximity band, exclusion zones for previous harvest sites and potential exclusion zones for follicular unit harvesting candidates within a proximity band may be identified. If multiple follicular unit harvesting candidates are within a proximity band, exclusion zones around previous harvest sites and potential exclusion zones for follicular unit harvesting candidates within a proximity band may be identified.
  • Overlap between the existing exclusion zones and the potential exclusion zones may then be analyzed to select follicular unit harvesting candidates that correspond to triangles and are within proximity bands (such as by the overlap priority method, the overlap priority lowest and closest method, the max overlap priority method, and so on).
  • This extension to the triangular pattern priority method may be referred to as the 'triangular pattern priority position overlap' method.
  • any of the above methods and/or any combination thereof may use the lowest and closest method when the respective method does not select any follicular unit harvesting candidates and/or when the respective method identifies multiple follicular unit harvesting candidates for selection.
  • FIGS. 12(a)- 12(h) are illustrated and described above in the context of harvesting of follicular units, it is understood that this is for the purposes of example.
  • the methods discussed herein may be utilized in the context of implanting follicular units and/or any other medical procedure.
  • a method of operating a tool comprising selecting, using at least one processing unit, a procedure site using at least one of an overlap priority method, a position priority method, a pattern priority method, a lowest and closest method, or a combination thereof in order to closely pack procedure sites; and instructing the tool, using the at least one processing unit or at least one different processing unit, to perform the procedure at the selected procedure site.
  • the procedure site may be a follicular unit harvesting site, follicular unit implanting site, a site of a tattoo placement or removal, an injection site, an ablation site, a biopsy site, an eye or spine treatment site, or a cosmetic or dermatological procedure site.
  • the methods of the present invention may be embodied, at least in part, in software and carried out in a computer system or other data processing system. Therefore, in some exemplary embodiments hardware may be used in combination with software instructions to implement the present invention.
  • a machine -readable medium may be used to store software and data which causes the system to perform methods of the present invention.
  • the above-mentioned machine-readable medium may include any suitable medium capable of storing and transmitting information in a form accessible by processing device, for example, one or more computers.
  • Some examples of the machine-readable medium include, but not limited to, magnetic disc storage, flash memory device, optical storage, random access memory, etc.
  • Certain procedures may require performing the same or similar operation on different areas or portions of the body surface.
  • an area of the body surface may be divided into several sections and a procedure performed on one or more sections at time, until the entire area has been covered.
  • a skin tensioner may be positioned in a series of positions on the patient's head, and the hair transplantation procedure performed in each of the series of positions.
  • this series of positions may be configured to best suit the hair transplantation case in question, but may for example take the form of a grid with two rows and eight columns (four positions on each side of the head), as illustrated in Figure 11.
  • the user may place a skin tensioner on the patient's head, beginning at the left-hand low corner, move the grid across the patient's head in a series of moves, for example, 8 moves as shown in the example of Figure 11, until the right-hand lower corner is reached, and then move up to a second row on the patient's head, but once again move from left to right, until all sixteen sections have been completed.
  • the advantage of moving from left to right in this manner is that while follicular units are being harvested from grid 1115, the dissected follicular units can be removed from grid 1110, thereby increasing efficiency of the procedure.
  • the monitor 240 can schematically display the regions to the user.
  • the user may be required to provide some sort of action to enable the system to correlate the grid locations, in the present example, on the patient's head to the grid locations on the computer monitor.
  • One way in which the user can provide the identity of the grid location is by selecting the appropriate grid, for example 1110, on the display that corresponds to the location on the patient's head. Such selection may be provided by clicking of a mouse button, touching the monitor, or by using the up-, down-, left- and right-arrow keys of a keyboard, for example, or in any number of ways known to those skilled in the art.
  • the system is able to associate the placing of the skin tensioner in a particular location with a designated grid on the display.
  • the system may also increment a grid number indicator 1105 on the monitor. For example, when selecting grid 1110, the grid number indicator may indicate that grid 8 has been chosen.
  • the system may then be operated to identify the location of each of the fiducials on the skin tensioner, and to select a location from where the next hair follicle is to be harvested from, or determine a location into which the next hair follicle is to be implanted.
  • the user may move the skin tensioner to the next grid location, for example 1115, on the patient's head, (having first moved the robot to a safe location so the user can safely access the skin tensioner). Having done so, the user may once again identify to the system the new grid location 1115 on the display. The system will associate the positioning of the skin tensioner with grid 1115 on the display, and increments the grid number accordingly, in this case such that indicates grid 9 has been selected.
  • grid numbers in this case 8 and 9 can be used in a treatment report, and allow the physician to correlate dissection results to skin tensioner location on the patient's scalp. Knowing which parameters were used for any one grid location, the user can perhaps try and optimize the parameters used to provide for optimal harvesting results. In addition, this also allows the user to select certain parameters that may have been used to one particular grid, and apply them to another. For example, the user may set the system such that only every other hair that is visualized by the imaging system is harvested from grid location 8, and call that particular selection, harvest program 1. Rather than having to go through setting all the parameters again when the skin tensioner is moved to grid 9, the user may simply select the same harvesting program that was applied to grid 8, that is harvest program 1, and only every other hair that is visualized by the imaging system will be harvested from grid location 9.

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Abstract

L'invention concerne des procédés et des systèmes utiles dans diverses interventions, comprenant la collecte et l'implantation de cheveux, et comprenant en outre la transplantation de cheveux exécutée par ordinateur et/ou robotique. Des méthodologies sont décrites, lesquelles permettent la sélection de sites de collecte ou d'implantation d'unité folliculaire. Dans divers cas, une telle sélection peut être réalisée à l'aide d'un procédé le plus bas et le plus proche, de procédés basés sur un chevauchement, de procédés basés sur une position, de procédés basés sur un modèle et/ou d'une combinaison de ces procédés. Dans diverses combinaisons des procédés, la sélection de sortie parmi l'un des procédés peut être utilisée comme entrée pour l'un des autres procédés.
PCT/US2014/022739 2013-03-12 2014-03-10 Procédés et systèmes pour diriger un mouvement d'un outil pendant des interventions de transplantation de cheveux WO2014164539A1 (fr)

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US13/796,159 US9498289B2 (en) 2010-12-21 2013-03-12 Methods and systems for directing movement of a tool in hair transplantation procedures

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CN114694141A (zh) * 2020-12-25 2022-07-01 上海微创卜算子医疗科技有限公司 毛囊点识别方法、系统、装置和存储介质

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US20120158019A1 (en) * 2010-12-21 2012-06-21 Tenney John A Methods and systems for directing movement of a tool in hair transplantation procedures

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US20050096515A1 (en) * 2003-10-23 2005-05-05 Geng Z. J. Three-dimensional surface image guided adaptive therapy system
US20070150247A1 (en) * 2005-12-22 2007-06-28 Restoration Robotics, Inc. Follicular unit transplantation planner and methods of its use
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019016089A1 (fr) * 2017-07-17 2019-01-24 Kuka Industries Gmbh Robot et procédé de traitement de surfaces
CN114694141A (zh) * 2020-12-25 2022-07-01 上海微创卜算子医疗科技有限公司 毛囊点识别方法、系统、装置和存储介质

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