Hair transplantation procedure with on-demand graft treatment of hair follicle units

Abstract

Hair is collected for a hair transplantation process, and a hair graft is immediately placed in a bald area. The collection tool can be controlled by the robot. The tool utilizes vacuum to facilitate complete resection. The resected graft is aspirated through a conduit and delivered almost instantaneously into an implant (two-channel implant) held by the surgeon or robot. The on-demand graft system is controlled by a surgeon to acquire one, two, three or more hair grafts by sending a series of instructions to the handpiece of the implant. In another embodiment, the computer partially or integrally plans the location of each graft within the surgical field of view and selects these hair follicles to minimize the pitch left after each resection while obtaining the number of grafts selected by the surgeon.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 516264 (Agent No. 154945.581741.PV), filed July 28, 2023, and U.S. Non-Provisional Application No. 18 / 659969 (Agent No. 154945.581741), filed May 9, 2024, the contents of which are incorporated herein by reference as fully set forth herein. Background Technology 1. Technical Field

[0004] This field typically involves hair transplant surgery, which involves harvesting hair follicle units from a donor area, usually the patient's scalp, and implanting these hair follicle units into a recipient area of ​​the scalp.

[0005] 2. Discussion of related technologies

[0006] Under normal circumstances, hair transplant surgery is a long, complicated and labor-intensive process, which generally involves the following steps: collecting individual hair grafts, trimming hair grafts, sorting grafts, storing grafts, preparing grafts for implantation, recording the number of hairs for each graft, counting damaged hair grafts and deciding how to deal with them, and actually implanting grafts into the recipient area of ​​the scalp.

[0007] In conventional hair transplant surgery, to collect the graft, a surgeon or robotic device retrieves an individual hair graft from the donor area of ​​the scalp. Graft retrieval can be performed robotically, for example, in U.S. Patent No. 9,913,610 to Restoration Robotics, "Systems and methods for selecting a desired quantity of follicular units." Follicular units (grafts) are typically retrieved using a process called follicular unit extraction (FUE), in which individual follicular units are trephinated from the donor area and transported to a moisturizing bath.

[0008] In a standard hair transplant procedure, to prepare grafts for implantation, a technician (usually a skilled surgical assistant) sorts the grafts according to the number of hairs included in each follicular unit (most commonly one, two, or three hairs, although sometimes more are seen). The technician discards completely damaged or broken grafts, trims damaged grafts, and then places the grafts in a storage medium. Hair grafts are stored in an organized manner for easy access based on the required number of hairs in the graft and to maintain their viability while awaiting implantation. If necessary, the technician loads the graft into an implantation handpiece, ready for direct percutaneous implantation by the surgeon using a sharp implanter, or if the surgeon has prepared a pre-made site, the implantation can be performed by the technician using a blunt implanter.

[0009] In a routine hair transplant surgery, graft preparation specifically involves: sorting the number of hairs in each obtained graft, discarding broken hair grafts, trimming damaged hair grafts, placing these hair grafts in a solution to store them in an organized manner for easy access and to maintain the viability of the grafts while awaiting transplantation, and loading the grafts into an implantation handpiece for use in implantation.

[0010] In actual implantation, for each area of ​​the scalp recipient region, the surgeon determines the nature and characteristics of the desired graft (e.g., the amount of hair required for that particular location), makes (or pre-fabricates) an incision in the scalp, and (using a pre-loaded implantation handpiece) implants the appropriate graft into the recipient region. If a pre-fabrication has already been made at the recipient site, the same implantation procedure can be performed by a technician using jewelry forceps instead of an implantation handpiece.

[0011] Modern commercial implantation procedures are typically performed by a team of surgeons and technicians. Alternatively, a surgical assistant may use jewelry forceps to handle and potentially place the graft. It is not uncommon for grafts to be handled by multiple people, and damage to the hair within the graft can be fatal to individual hairs or all hairs in the graft. Rough handling of the graft or exposing it to air for more than 20 seconds to dry it can cause damage. Modern FUE requires highly skilled technicians who understand quality control when handling hundreds to thousands of grafts. For larger-scale FUE hair transplant procedures, it is not uncommon to have 5 to 8 technicians dedicated to handling grafts from the donor site through a sorting process, moving them to storage media, and finally transporting them to the recipient area for implantation.

[0012] Given that a typical procedure involves 1,000 to 5,000 individual grafts, a typical surgery can take 6 to 12 hours to complete. As more grafts are harvested, more technicians are typically required. Summary of the Invention

[0013] In the routine procedure, the first two steps—graft collection and preparation—are repetitive. Although time-consuming, these repetitive steps are tedious and prone to human factors issues at the technical level, such as hand or eye fatigue, which often affect graft quality. Furthermore, the long-term consequences of FUE collection can lead to various hand and eye dysfunctions in healthcare professionals and surgeons.

[0014] It is the third step in these steps—implantation—that distinguishes a skilled and competent surgeon from one who also possesses artistic talent. This analogy is easy to over-exaggerate, but in a sense, in the case of hair transplantation, the recipient area of ​​the scalp is the surgeon's canvas, and the implantation tool is their brush. The surgeon, acting as the "artist," envisions the overall effect after the surgery and then brings that vision to life through meticulous steps. This involves selecting specific implantation sites, choosing hair follicle units with the required number of hairs for implantation at the chosen sites, and implanting them at the desired depth, width, and angle—factors that determine the distribution and growth direction of the hairs in each graft.

[0015] As an "artist," the surgeon must also consider graft consumption in the donor area during graft collection. The surgeon estimates the number of grafts he / she needs to fill the recipient area of ​​the patient. The surgeon then collects that number of grafts he / she determines will meet the patient's recipient area requirements. The donor area, collected using FUE (Follicular Unit Extraction) technology, occupies 20% to 25% of the total scalp surface area, located in a 3-inch high band of scalp around the sides and back of the head, and contains a limited number of grafts within this area. Normally, the distance between grafts is approximately 1 mm per graft, presenting an irregular pattern. Typically, an average male has 10,000 to 12,000 follicular units in the 20% to 25% area around the sides and back of the head (donor area). Based on the individual hair content, the surgeon classifies the hair as fine (25 to 40 microns), medium (40 to 60 microns), or coarse (greater than 60 microns). Although the hair shaft thickness in the donor area can be measured, overlap is still evident. Individuals with coarse hair may have more than six times the number of hairs per hair strand compared to individuals with very fine hair. Furthermore, each graft typically contains one to three hairs. Surgeons must understand all these quantitative elements when determining how many grafts to remove. In this respect, donor hair depletion begins immediately after the initial FUE (not significant during the first set of excisions) when hair grafts are removed from the donor area. The more grafts removed, the greater the depletion of the donor hair supply. At some point, too many grafts may be removed, resulting in a "scalp-through" appearance in the donor area, or even significant baldness in that area. There are limits to how many grafts can be safely removed for each individual. Individuals with a higher number of hairs per graft, containing coarser hairs larger than 60 microns (possibly 80 microns), and / or with hair colors closer to their skin tone (e.g., white hair with white skin) can have the most grafts removed using FUE. Individuals with extremely fine, silky hair, a small number of hairs per graft, and high contrast between hair color and skin tone (e.g., fair skin with black hair) will face significant limitations in donor availability. The safe harvestable amount from this donor area can be calculated using standard, known formulas involving the original hair density, remaining hair density, total donor hair volume, and remaining donor hair volume. Furthermore, although the grafts are randomly located within the scalp, there is an average of one graft per square millimeter across the entire donor area. When these grafts are removed, gaps are created reflecting the removal, causing the previously uniform randomness of the unharvested donor area to be replaced by a mottled distribution of remaining grafts after FUE. The surgeon must visually monitor the degree of this new mottled distribution to ensure it is not noticeable on the patient after the procedure.

[0016] Regarding the donor area, it should be understood that it is not limited to the patient's scalp. This article focuses on the scalp because most hair transplants are performed there; however, increasingly, beard hair is being used as a donor area because beard hair is coarser and grows to almost the same length as scalp hair. Pubic hair has also been used due to its coarser texture. Surgeons now obtain hair from various parts of the body. Therefore, while this article focuses on scalp hair as a donor area, it should be understood that the scalp is not the only donor area on the human body.

[0017] Surgeons’ progress during surgery is often hampered and delayed by the time required for graft collection and preparation, which slows down the realization of the overall effect of the harvested donor area as envisioned by the surgeon.

[0018] This disclosure relates to an "on-demand graft system" in which grafts are robotically acquired based on the surgeon's immediate needs and delivered directly to the implantation handpiece, thereby virtually eliminating the need for graft handling, intermediate storage, graft preparation, and implantation. According to this aspect, the system uses machine vision to survey donor areas of the scalp, beard, or other body parts to map the location of each candidate hair follicle unit, including the number of hairs in each candidate unit. During the procedure, the surgeon instructs the controller to request a graft containing a specific number of hairs and / or other specific characteristics to meet the surgeon's implantation needs at their chosen implantation site. Using robotic technology and referencing the mapping of the donor area, the system trephines suitable hair follicle units that meet the surgeon's requirements and delivers them directly to the implantation handpiece via tubing, bypassing traditional humidification baths, all manual handling, and other preparation steps. As the graft moves through the tubing from the excision point to the implantation point, it is passed through an optical detector to identify and record any damage the graft has sustained from the excision point. If the graft is removed for any reason and contains a large amount of cut hair, the surgeon will be immediately notified of the graft's status and may choose to remove it before implantation. The surgeon then implants the graft into the recipient area using either a very sharp needle through intact scalp skin (percutaneous implantation) or a blunt needle through a pre-made incision. The expected time from request to implantation should be between 1 and 2 seconds, significantly reducing the overall procedure time, potentially to approximately 1 to 2 hours or 2 to 3 hours. Using multiple robotic arms can further increase the acquisition speed, proportionally reducing the procedure time.

[0019] In some implementations, the robot will have the ability to rotate, moving along 360-degree arcs. This flexibility is intended to allow it to reach other body donor areas, such as the beard below the chin, arms, legs, chest, abdomen, and genitals.

[0020] A specialized trephine, used in conjunction with aspiration through it, can completely remove the graft from the patient's donor site and allow the graft to be immediately delivered to a handheld implanter held by the surgeon. As an example, a trumpet-shaped trephine with an eccentric, sharp cutting edge connected to aspiration induces slight lateral vibrations during graft removal and tends to completely remove the graft without damage in over 90% of cases, allowing the graft to be easily aspirated to the implanter handpiece. In the remaining 10% of cases, the graft is easily detached from its base by continuous aspiration applied close to the harvester.

[0021] Instructions for collecting hair follicle units with specified characteristics (such as hair count) can be issued in a variety of ways, such as through voice commands, foot pedal operation, one or more buttons on the implanted handpiece, etc., or a combination of the above methods.

[0022] The beneficial effects of the implementation scheme described in this article include a significant reduction in the time required for transplantation surgery, enabling surgeons, acting as "artists," to smoothly achieve the overall surgical outcome envisioned after the procedure without the hindrance of traditional graft collection and preparation. Furthermore, the handling of the graft, a major source of graft damage, is essentially eliminated, as is the time during which the graft is prone to degeneration or necrosis after detachment.

[0023] According to other aspects described herein, during the procedure, the system monitors the consumption of the donor site and provides real-time feedback to the surgeon, enabling the surgeon to avoid excessive consumption of the donor site. Appropriate computer algorithms will determine all mathematical variables at the start of the procedure and monitor changes in hair volume and uneven graft distribution in real time. During the procedure, the surgeon can make judgments during graft removal based on the real-time information provided to him / her. In another embodiment, computer software and / or artificial intelligence can be used to balance a more uniform spacing of remaining grafts in the donor area.

[0024] According to other aspects described herein, the acquired grafts are transported through an inspection station between the extraction device and the implantation handpiece. For this purpose, an inspection camera is installed at this inspection station, and the conduit used to transport the acquired grafts to the implantation handpiece by suction is transparent or partially removed at this inspection station. The acquired grafts are imaged as they are aspirated through the inspection station, and machine vision is used to distinguish between acceptable high-quality grafts and poor-quality grafts, allowing low-quality grafts to be removed without implantation into the recipient area.

[0025] According to other aspects described herein, a tension band can be applied near the donor area of ​​the scalp to stabilize the patient's head on a headrest. This tension band can be further configured to facilitate mapping of the donor area and graft excision. In this aspect, the tension band has fine teeth on its underside corresponding to the length of the donor area and has an elastic attachment comprising hook-shaped needles suspended from the underside of the tension band, which generates traction on the scalp below it, thereby reducing scalp laxity below the tension band and facilitating FUE. Reference marks can be set on the traction band to allow for precise mapping of the donor area along a marked line drawn by the surgeon on the scalp with an indelible pen before the application of the tension band. Reduced scalp laxity improves the harvesting of follicular units (grafts). This same band can be used to stabilize the head as part of additional hardware designed to minimize head movement during the procedure.

[0026] According to other aspects described herein, a head stabilization device may be provided for fixing the position of a patient's head during a transplant procedure. In this aspect, the head stabilization device includes a chest support and a semi-circular headrest supported by a pair of arms extending upward from the chest support. The length of the arms is adjustable, such as by locking telescopic arms. Fixation straps are adjustablely attached to opposite ends of the headrest for securing the patient's head to the headrest, wherein the fixation straps are attached to the headrest using a quick-release mechanism (such as Velcro).

[0027] According to other aspects described herein, a thumbtack-type reference locator can be provided for attachment to the skin at a donor site of a patient. In this aspect, the reference locator includes a plate having an upper surface and a lower surface, and a pair of needle-like legs extending downward from the lower surface of the plate. The needle-like legs are biased outwards such that they open outwards when the reference locator is inserted into the skin. A slidable retaining ring surrounds the legs and is slidably positioned in a first position before the reference locator is inserted into the skin, wherein the legs are held vertically relative to the outward bias, and in a second position when the reference locator is inserted into the skin, wherein the retaining ring slides upwards to allow the legs to extend outwards below the surface of the skin. Another embodiment of the thumbtack-type reference locator can be a spring-loaded, hook-type retractable structure. A reference mark is formed on the upper surface of the plate. In some embodiments, the plate includes a disc with a diameter of approximately 5 mm, and the reference positioning element may be provided as part of a sterilizable kit, which includes multiple reference positioning elements in the reference positioning element and the fixing strap for a head stabilization mechanism.

[0028] According to other aspects described herein, an apparatus for harvesting hair grafts from a donor region includes: a controller configured with machine vision to map follicular units at the donor region; one or more robotic arms controllable by the controller in angular and translational movements relative to the donor region in x / y / z directions; and a trephine harvester mounted on the one or more robotic arms, wherein the trephine harvester is configured to harvest follicular units from the donor region by movement of the robotic arms and under the control of the controller. The controller is further configured to receive instructions to harvest follicular units having specified characteristics (such as hair quantity) and to operate the robotic arms and the trephine harvester to harvest such follicular units by referring to the map of the follicular units. The harvested follicular units are delivered via aspiration through tubing to an implant handpiece.

[0029] The controller may be further configured to monitor the consumption of hair grafts from the donor area, and further includes a graphic display to display a visual and / or statistical depiction of the consumption of hair grafts from the donor area in real time.

[0030] The controller can be further configured to monitor the spacing of graft removal in the donor region, and further includes a graphic display to display in real time a visual and / or statistical depiction of the ideal spacing between grafts obtained by removing hair from the donor region.

[0031] A source of saline solution (or similar biofluid) may be provided for introducing the saline solution into the conduit near the trephine harvester to enhance aspiration and / or facilitate delivery of the harvested hair follicle units to the implant handpiece.

[0032] According to other aspects described herein, saline solution is introduced into the delivery system at key points to transport the harvested graft from the donor region to the implant handpiece. By introducing the saline solution at these key points, the graft is lubricated during its journey through the delivery system, thereby helping to reduce resistance to the graft and the likelihood of the graft clogging the conduit, while also improving the effectiveness of vacuum for complete removal of the graft from the donor region and improving the effectiveness of aspirating the graft into the implant handpiece.

[0033] According to other aspects described herein, a movable tension pad can be provided for coordinated movement with the movement of a collector to tension the scalp near the donor area while collecting hair follicle units. The tension pad can be mounted on an auxiliary robotic arm for coordinated movement. In other embodiments, the tension pad can be mounted via a flexible arm attached to the collector or the robotic arm for coordinated movement with the robotic arm and the collector.

[0034] According to other aspects described herein, the implant handheld device includes: a generally cylindrical body for gripping by a user of the implant handheld device; a first channel and a second channel located on the cylindrical body, wherein the first channel is connectable to a vacuum source and the second channel is connectable to a source of collected hair follicle units; and a central rod and a hollow needle, wherein the central rod and the hollow needle are positioned to allow slidable and relative movement of the rod within the needle. In the retracted position of the rod relative to the needle, collected hair follicle units are transported from the second channel to the interior of the hollow needle under vacuum, the vacuum being applied in front of the central rod in the first channel. In the implantation position, the slidable movement of the central rod relative to the hollow needle drives the hair follicle unit from the hollow needle to the implantation site.

[0035] A third channel may be provided for controllably introducing pressure under the user's control, wherein the pressure introduced from the third channel drives the central rod from the retracted position to the implantation position.

[0036] A third channel can be provided for the controlled introduction of a vacuum diverted from the source to drive the hair follicle unit from the hollow needle to the implantation site.

[0037] In some implementations, in the retracted position, the central rod loosely engages inside the hollow needle, the first channel is located behind the front end of the central rod and the second channel is located in front of the front end of the central rod, and the engagement of the central rod in the hollow needle is loose enough to allow a vacuum applied from the first channel to reach the side of the central rod and to aspirate the collected hair follicle units from the second channel.

[0038] Similarly, in some implementations, the user manually enables the sliding movement of the center rod relative to the hollow needle.

[0039] According to other aspects described herein, a tension band for application to a scalp donor area comprises an elastic band of suitable length for wrapping around the patient's head, extending from a forward position slightly above the patient's eyebrows to a backward position located at the lowest region of the top of the patient's scalp. Multiple reference markers can be fixed to the band, through which specific hair follicle units in the donor area can be repeatedly positioned, and multiple fine teeth extend from the underside of the band for anchoring to the upper region of the scalp above the top of the head. Multiple elastic cords can extend from the band, each ending in a hook configured to penetrate the high part of the scalp below the band and above the donor area to generate traction and reduce scalp laxity in the donor area of ​​the scalp.

[0040] According to other aspects described herein, by imaging the donor region of the scalp, such as via a vision system, monitoring hair graft consumption from the donor region of the patient's scalp during transplantation surgery, wherein the donor region is divided into multiple partitions, and by storing initial statistics of candidate grafts in each of the multiple partitions, wherein the initial statistics are automatically acquired before the start of transplantation surgery, and include candidate density and hair volume measurements in each such partition. Current statistics of candidate grafts in each of the multiple partitions are collected, wherein the current statistics are automatically acquired during graft collection from the donor region during transplantation surgery, and include current candidate density and hair volume in each such partition. A visual depiction is displayed to the surgeon for real-time comparison of the initial and current statistics of one partition of the multiple partitions of the donor region during transplantation surgery.

[0041] In one implementation, during the initial photographic recording of the patient's acquisition area, a marker of known width is placed on the acquisition area. This marker will be a small rectangle, measuring 1000 micrometers by 50 micrometers. The camera will reference this marker to determine the hair axis thickness of the entire donor area, a crucial measurement for determining the amount of multiple individual hairs within the graft and the amount of remaining hair in the donor area, as hair loss occurs in real time.

[0042] In some aspects, the marker can form a reference positioning element configured for fixation to the skin of a patient's donor area, wherein the reference positioning element includes: a plate having an upper surface and a lower surface; an attachment extending downward from the lower surface of the plate, wherein the attachment includes an insertable segment configured for insertion into the skin; an anchoring device positioned along the insertable segment of the attachment for anchoring the attachment in the skin; a reference mark formed on the upper surface of the plate; and a release mechanism that allows the reference positioning element to be easily removed from its position embedded in the scalp. The insertable segment of the attachment has a length such that it extends approximately 1.5 mm below the skin when the reference positioning element is fixed to the skin. The plate has an area of ​​approximately 20 square millimeters, such as a disc with a diameter of approximately 5 mm.

[0043] In some embodiments, the accessory may take the form of a pair of needle-like legs extending downward from the lower surface of the plate, wherein the needle-like legs are biased outward so that they open outward when the reference locator is inserted into the skin, and a slidable retaining ring surrounding the legs and slidably positioned at a first position before the reference locator is inserted into the skin, wherein the legs are held vertically relative to the outward bias of the legs, and slidably positioned at a second position when the reference locator is inserted into the skin, wherein the retaining ring slides upward so that the legs extend outward below the surface of the skin. Anchoring of the accessory is accomplished by the outwardly extending legs below the skin surface.

[0044] In other embodiments, the accessory may include a compression spring positioned below the lower surface of the plate and configured to abut against the surface of the skin, and the anchoring device may be formed by a hook positioned below the compression spring along the insertable segment.

[0045] In some embodiments, the display may further include displaying a current image of a partition of the donor region compared to an initial image of the partition. Furthermore, the display may overlay information specifying characteristics of each candidate object onto the image of the partition of the donor region, the characteristic information including at least the number of hairs or hair follicle units of each candidate object.

[0046] The implementation schemes envisioned herein include any and all of the methods, systems, devices, tangible computer-readable media, etc., that are relevant to the descriptions provided herein.

[0047] Further objectives and advantages will become apparent upon consideration of the specification, drawings, and embodiments. Attached Figure Description

[0048] FIG. 1A The diagram depicts various aspects of an on-demand acquisition system according to this disclosure, in which a surgeon manually operates an implanted handheld device.

[0049] FIG. 1A -1 is FIG. 1A An enlarged view of the inspection station shows an incision view of the catheter through which the collected graft is transported from the donor area to the implant handpiece via aspiration.

[0050] FIG. 1B The diagram depicts various aspects of an on-demand acquisition system according to this disclosure, in which a surgeon remotely operates an implanted handheld device via robot control.

[0051] FIG. 1B -1 is FIG. 1B An enlarged view of the inspection station shows an incision view of the catheter through which the collected graft is transported from the donor area to the implant handpiece via aspiration.

[0052] FIG. 2 It is a flowchart depicting typical steps in the on-demand hair transplant process.

[0053] FIG. 3 A first implementation scheme for implanting a handheld device is described.

[0054] FIG. 4A The appearance of a second embodiment of the implanted handheld device is depicted. FIG. 4B Its cross-sectional view is depicted.

[0055] FIG. 4C A manual dual-channel handheld device is described for use with FIG. 4A and FIG. 4B A comparison was made with the modified Cui-style handheld device.

[0056] FIG. 5 A third implementation scheme for implanting a handheld device is described.

[0057] FIG. 6 An example is shown where saline solution is injected to facilitate the delivery of the collected hair follicle units to the implant handpiece.

[0058] FIG. 7AAn example is illustrated of a tension band applied to the donor area of ​​the scalp to stabilize the patient's head on a headrest, and in this embodiment, hooks are also constructed to generate traction in the donor area of ​​the scalp and reduce scalp laxity.

[0059] FIG. 7B-1 to FIG. 7B-5 An example is shown of a scalp tensioning pad mounted on a tensioning robotic arm, so that the scalp tensioning pad moves independently and in coordination with the movement of the robotic arm used for the collector.

[0060] FIG. 7C-1 to FIG. 7C-6 An example is shown of a scalp tension pad mounted from a flexible arm to a robotic arm used for a data collector, so that the scalp tension pad moves in coordination with the movement of the robotic arm.

[0061] FIG. 7D It is a view depicting the mechanisms used to stabilize the patient's head during the transplant procedure.

[0062] FIG. 8A and FIG. 8B A representative display of consumption monitoring in the donor area is shown.

[0063] FIG. 9 A thumbtack-type reference positioning element configured for fixing to the donor area is described to facilitate accurate and repeatable repositioning of the data acquisition device using machine vision.

[0064] FIG. 10 Another embodiment of a thumbtack-type reference positioning element using a fishhook-shaped structure with a loading spring is described. Detailed Implementation

[0065] The embodiments covered by this disclosure include aspects relating to: a system for collecting hair follicle units on demand and delivering the collected hair follicle units to an implantation handpiece; optical inspection of the quality of the extracted grafts; an implantation handpiece adapted to receive the collected hair follicle units; a tension band for stabilizing the patient's head to, for example, a headrest and / or for generating traction and reducing scalp laxity in the donor area of ​​the scalp; using a tension pad adjacent to the extraction device to generate locally increased tension on the scalp; consumption monitoring of the donor area of ​​the scalp; injection of saline solution into a delivery conduit to improve the aspiration of the collected hair follicle units into the implantation handpiece, etc.

[0066] On-demand harvesting system

[0067] FIG. 1A The diagram depicts various aspects of an on-demand acquisition system according to this disclosure, in which a surgeon manually operates an implanted handheld device.

[0068] Simply put, such as FIG. 1AAs shown, an apparatus for harvesting hair grafts from a donor region includes: a controller configured with machine vision to map follicular units at the donor region; one or more robotic arms controllable by the controller in angular and translational movements relative to the donor region in x / y / z directions; and a trephine harvester mounted on each robotic arm, wherein the trephine harvester is configured to harvest follicular units from the donor region by movement of the robotic arms and under the control of the controller. The controller is further configured to receive instructions to harvest follicular units having specified characteristics (such as hair quantity), and to operate the robotic arms and the trephine harvester to harvest such follicular units by referring to the map of the follicular units. The harvested follicular units are delivered via aspiration through tubing to an implant handpiece.

[0069] The controller is further configured to monitor the consumption of hair grafts from the donor area, and further includes a display to show a visual depiction of the consumption of hair grafts from the donor area in real time.

[0070] A source of saline solution may be provided for introducing saline solution into the conduit near the trephine harvester to enhance aspiration, such as improving graft detachment from the skin and / or facilitating delivery of the harvested hair follicle units to the implant handpiece.

[0071] More specifically, the patient, whose scalp includes both the donor and recipient areas, remains seated and with their head immobilized during the transplant procedure. Preferably, the patient may be sedated or distracted / entertained during the procedure using methods such as virtual reality glasses.

[0072] A multi-axis robotic arm is positioned near the donor area and configured to perform translational and angular movements in the x / y / z directions. A trephine harvester is mounted on the arm and connected to a vacuum source, allowing the graft to immediately pass through the trephine and directly into the implanter when it is excised. Suction is also used to facilitate graft removal. Preferably, the end of the trephine harvester is equipped with an excision needle for the hair graft, which may have a "trumpet"-shaped trephine aligned along the hair direction by an optical sensor, wherein the cutting face of the trephine faces an axis offset from the center of the excision needle. In some embodiments, the harvester rotates, vibrates, or oscillates the trephine, or otherwise moves it, to improve the trephine's ability to penetrate the tough outer dermis and then descend through the subcutaneous layer to the desired excision depth, while reducing the chance of graft damage (e.g., damage caused by transverse cutting of the graft). A more standardized drill bit can be used instead of the trumpet-shaped design. One or more small cameras may be mounted on the robotic arm to guide the trephine to the appropriate location for graft retrieval. The camera can be installed either close to or far from the trephine drill to provide triangulation diagrams to guide the trephine drill to the precise location and ideal angle for removing the graft.

[0073] The data acquisition unit and robotic arm operate under the control of a controller. A camera is positioned to image the donor region during preoperative mapping and measurement phases, as well as during the surgical procedure.

[0074] More specifically, during the preoperative mapping and measurement phase, the controller acquires images from a camera, which it uses to create a map of the donor region. The map of the donor region includes information about the selected grafts used for follicular unit collection, including the distribution of candidate grafts within the donor region, the location of each candidate, and characteristics of the candidates, such as the number of hairs per candidate. The controller uses machine vision technology to create the map, which may also involve trained neural networks or other forms of artificial intelligence to establish a pattern recognition imprint of the donor region map. Reference locators can be placed directly on or within the scalp at different locations as a reference; similarly, reference locators can also be combined as described below. FIG. 7A It is positioned on the tensioner as described.

[0075] During the procedure, the controller references a drawing to reposition the collector on a candidate subject that meets the surgeon's requirements, such as the number of hairs. The controller then activates the collector to acquire hair follicle units, which are delivered directly via tubing to the implant handpiece for insertion into the recipient area of ​​the scalp by the surgeon.

[0076] While this implementation includes a preoperative mapping and measurement phase, the location and other information of the candidate graft for excision can also be obtained during the actual surgery, which tends to compensate for and allow for patient head movement during the procedure. Pattern recognition technology or the use of reference positioning devices will help ensure, in this process, that the intended location of the selected graft for excision matches the actual location of the selected graft, regardless of any movement or repositioning of the donor area.

[0077] A surgeon must have a plan when he / she begins a hair transplant. The required number of grafts is a crucial part of the plan, and it can be input into the system's software. By mapping the entire donor area, the system's computer can calculate the projected distribution of the FUE grafts, ensuring that the extractions are evenly distributed throughout the donor area, maintaining a uniform hair volume in its appearance. At the start, the controller displays the total number of one, two, and three hair grafts in the donor area, allowing the surgeon to determine the desired graft quantity throughout the procedure. For example, more extractions will be performed in donor areas with higher hair volume because these areas can withstand greater hair reduction than other areas with lower hair volume. This hair volume-based extraction distribution avoids uneven graft consumption in any part of the donor area.

[0078] like FIG. 1A As further described, a pressure source and / or a vacuum source are provided, and all the collectors, implantation handpieces, and pressure and / or vacuum sources (if applicable) are interconnected via conduits to enable the direct delivery of the collected hair follicle units to the implantation handpiece upon request by the surgeon, without any significant intermediate storage or other preparation prior to implantation.

[0079] During the procedure, the controller also monitors hair loss in different defined donor areas and the amount of remaining hair in these defined donor areas. FIG. 1A The described monitor provides surgeons with a real-time display of consumption, as illustrated below. FIG. 8A To explain in more detail.

[0080] During the procedure, hair grafts are extracted from the donor area by a hair excision device, controlled and positioned to remove follicular units (grafts) containing one to three or more hairs, as requested by the surgeon. One or more cameras are mounted at the end of a robotic arm or at a designated distance from the donor excision area to align the hair excision device with the direction of the hair in the graft (adjusted according to the curvature angle of the hair at the selected exit point for excision, as illustrated in U.S. Patent No. 6,572,625, "Hair transplant harvesting device and method for its use"). These grafts are moved directly from the excision device to the implanter via suction and tubing through an optical inspection station, allowing the surgeon to quickly place the grafts into the bald area with minimal time spent outside the graft.

[0081] According to various aspects of this disclosure, hollow instruments with cutting edges, such as hollow drills or “trumpet-shaped” trephines with a diameter of 0.7 mm to 1.1 mm (roughly equivalent to the width of a hair follicle unit), are used to cut into the scalp. The selection of which grafts to remove depends on: (1) the surgeon’s determination to meet the needs of the recipient region; (2) the impact of graft removal based on minimizing the voids and uneven distribution of residual grafts left after each excision; (3) the impact of significant depletion of donor hair and / or hair volume as FUE progresses during the procedure; (4) an automated algorithm driven by formulas that ensures graft removal is uniformly distributed throughout the donor region in proportion to the density and spacing of candidate grafts in each partition of the donor region; and (5) the use of imaging systems and depletion monitoring, enabling healthcare professionals to cover automated selection of grafts. Grafts are delivered via tubing by aspiration, pass through optical inspection for automated graft quality checks, and then enter a handheld implanter, allowing the surgeon to easily implant the grafts into the recipient region. Because the wound is very small, it heals relatively quickly with minimal bleeding and leaves almost no visible scar or only very slight scarring after healing.

[0082] In some implementations, the collected graft is transported through an examination station between the extraction device and the implantation handpiece. For this purpose, an examination camera is installed at this station, and the tubing carrying the collected graft is either transparent or partially removed at this station. This examination station... FIG. 1A It is shown in more detail in -1.

[0083] FIG. 1A -1 is FIG. 1AAn enlarged view of the examination station shows an incision view of the catheter used to transport the harvested graft from the donor area to the implantation handpiece via aspiration. As the harvested graft is aspirated through the examination station, the controller images it to determine whether the graft has good viability or if there are serious problems that could affect its viability. Such problems include severe transverse cutting of the graft or partial or complete transection of hair within the graft. When a poor-quality graft is detected, the controller provides notification to the surgeon, such as an audible alert, to avoid implanting the graft. The surgeon, holding the handpiece, can selectively expel the poor-quality graft to prevent it from entering the recipient area.

[0084] To distinguish between acceptable, high-quality grafts and poor-quality grafts, the controller in some implementations relies on machine vision, such as a trained neural network. Images of the grafts captured by an inspection camera are fed into the input layer of a multi-layer neural network, such as a convolutional neural network. The neural network provides a classification output from the input images of the grafts, indicating whether the graft is an acceptable, high-quality graft or a poor-quality graft. This neural network is trained on labeled data using methods well-known to those skilled in the art, such as gradient descent, elastic backpropagation, conjugate gradient, quasi-Newton methods, Levonorck-Marquardt methods, anomaly detection, novelty detection, etc. The labeled data used to train the network is matched to the expected input features during operation, i.e., to a diverse population of grafts exhibiting different modalities and hair counts, where most grafts are healthy and unacceptable grafts are uncommon.

[0085] According to another embodiment, an x / y / z stabilizing gantry is used to secure the robotic arm and hollow instruments, thereby securing the imaging system. In yet another embodiment, the suction device is positioned to generate traction on the graft to facilitate the cutting of follicular units and their removal from the donor area.

[0086] With the configuration described above within the scope of this disclosure, a so-called graft robot-assisted closed-loop system is obtained. This provides a "contactless" technique in which the graft (follicular unit) is immediately delivered to an implanter after being removed from the back of the head, which is ready to place the graft into the recipient region. Advantages of such systems include:

[0087] - Avoid artificial handling of grafts (a major cause of graft injury).

[0088] - No graft storage required (which is expected to reduce stress-induced hair loss that nearly 100% of patients currently experience after hair transplantation).

[0089] - Reduce the number of personnel required for surgery, from handling thousands of grafts in current surgeries to handling very few grafts.

[0090] - Shorten surgical time by eliminating multiple steps in the current process, thereby reducing anesthesia time.

[0091] therefore, FIG. 1A The system described herein uses a trephine harvester, such as a horn-tipped instrument, and computer software capable of identifying grafts with the desired number of hairs (i.e., "on-demand grafts"), to effectively drill down to the full depth of the graft while it is still located at the back of the head. The implant handpiece has a suction function that facilitates complete removal of the graft by using suction through appropriate channels during the excision phase of the FUE procedure and delivers the graft directly to the implant handpiece. Upon the surgeon issuing requests / instructions / directives to the controller and robotic software regarding desired characteristics of the graft (such as how many hairs the surgeon needs per graft), once the graft is delivered to the implanter, the implanter in the surgeon's hand can either percutaneously implant the graft into a pre-prepared site. This advantageously allows the surgeon to simply communicate the number of hairs per graft, and the computer software can identify grafts with the desired number of hairs and provide the surgeon with the option to select that particular graft or jump to another graft. When the surgeon is satisfied with the identified graft, the trephine on the robotic arm removes the appropriate graft.

[0092] Instructions for collecting hair follicle units with specified characteristics (such as hair count) can be issued in a variety of ways, such as through voice commands, foot pedal operation, one or more buttons on the implanted handpiece, etc., or a combination of the above methods.

[0093] FIG. 1B The diagram depicts various aspects of an on-demand acquisition system according to this disclosure, in which a surgeon remotely operates an implanted handheld device via robot control.

[0094] More specifically, despite FIG. 1A The implementation schemes described in the document are largely similar, but there is one difference: FIG. 1B In the implementation scheme described herein, the surgeon remotely operates the implanted handheld device via robot control, while FIG. 1A In this implementation, the surgeon manually operates the implant handheld device. A camera at the recipient / implantation area provides the surgeon with a magnified view of the implantation area. The surgeon selects a specific implantation site and further selects implantation parameters such as implantation depth and angle. The surgeon issues instructions to collect hair follicle units with specified characteristics (such as hair count), and the controller operates the robotic arm and trephine collector to collect these hair follicle units. FIG. 1A Similar to the implementation plan, the collected grafts are transported to the implant handpiece via aspiration. And... FIG. 1AUnlike other implementation schemes, in this implementation scheme, under the control of a controller, a second set of robotic arms manipulates the implantation handpiece to implant the harvested graft into the implantation site selected by the surgeon, under conditions of implantation parameters (such as implantation depth and angle) selected by the surgeon.

[0095] exist FIG. 1B The described monitor provides surgeons with a real-time display of consumption, as illustrated below. FIG. 8B To explain in more detail.

[0096] and FIG. 1A The implementation plan is similar. FIG. 1B The implementation scheme can also provide an inspection station and inspection camera, whereby the controller uses machine vision to distinguish between acceptable high-quality grafts and poor-quality grafts.

[0097] FIG. 1B -1 is FIG. 1B The magnified view of the inspection station shows an incision view of the catheter used to transport the collected graft from the donor area to the implantation handpiece via aspiration. When a substandard graft is detected, the controller automatically ejects it once it reaches the implantation device, preventing its implantation into the recipient area. Notifications, such as audible alerts, can also be provided to the surgeon.

[0098] FIG. 2 It is a flowchart depicting typical steps in the on-demand hair transplant process.

[0099] like FIG. 2 The implantation process typically begins with the surgeon and patient jointly determining the hairline. Before the surgery, the patient and surgeon meet to discuss the surgical plan, confirming the patient's initial estimate of the number of grafts needed, where the grafts will be placed, and finally, if the planned surgery involves the hairline, drawing a hairline on the patient's forehead that reflects both the patient's desired outcome and the surgeon's assessment of what would be appropriate for the postoperative result. The donor area is shaved, and the outline of the area to be acquired is drawn with an indelible ink pen; this outline will be recognized by the system's camera. The donor area is subdivided, for example, into 10 sections, with five vertical lines equidistant from each other and a horizontal line running along the midline of the upper and lower boundaries of the donor area.

[0100] Computer / camera assessment of hair thickness, hair quantity, hair per graft, and distribution within the surgeon-defined area. A complete image of the donor area will be taken by an appropriate camera located on the robotic scaffold to determine the starting value for each of the following. The following will be measured for the total donor area and for each individual area drawn on the scalp: (1) the total number of follicular units in the total donor area, (2) the total number of follicular units in each subdivision, (3) the corresponding amount of hair in the total donor area, (4) the total amount of hair in each subdivision, (5) the initial follicular unit distribution imbalance factor before the start of surgery (this is very important for those who have undergone FUE surgery), (6) each follicular unit will be analyzed to obtain a measurement of the number of hairs it contains and the average hair thickness of each hair in the follicular unit, (7) these measurements will appear on the display screen and be fixed for the surgeon's assessment. (8) Once the surgery begins, the current measurements will be taken in real time and adjusted as each graft excision progresses. In this way, surgeons will be able to understand in real time the impact of FUE on residual donor density, remaining donor hair volume, and factors contributing to uneven distribution of follicular units. These current calculations will be performed on the total donor area and on each subset of regions defined by lines drawn on the patient's head before the start of surgery.

[0101] Local anesthesia will be administered. Circular nerve block will be applied before the tension band is placed over the patient's head.

[0102] The patient will be placed in a special chair equipped with a virtual reality system for viewing in front of their eyes to optimize: (1) patient comfort and (2) the use of a strap tensioning member, which may be a tension band (this will be discussed below). FIG. 7A (Discussion) and / or tension pads that move in coordination with the movement of the collector (as discussed below in conjunction with Figures 7B and 7C). This special seat may be equipped with a chest plate so that the patient can lean against it. The chest plate is an extension of the seat (similar to a massage bed, see...). FIG. 7D These are extension arms that extend upwards to the patient's forehead. These arms are curved so as not to interfere with the receptor areas close to the head. Tension bands are attached to these arms to stabilize the patient's head. The area in front of the face may have a viewing area, where virtual reality viewed in front of the eyes can be used to watch movies, etc., during the procedure.

[0103] A special tension band can be wrapped around the head (see below) FIG. 7A(As described in the text) to stabilize the patient's head on a headrest and maintain patient comfort. The tension band can be further configured to facilitate mapping of the donor area and to facilitate graft removal, although these are optional. The portion of the band located above the donor area on the scalp has fine teeth that can superficially penetrate the scalp (to a depth of approximately 0.7 mm to 1.2 mm) to prevent the band from slipping up and down. The patient is anesthetized at this time, so the tension band will not cause pain or damage to the vascular integrity of the scalp. Suspended from this band are elastic cords resembling "rubber bands," each containing a hook. Many such cords are suspended from the band around the donor area.

[0104] These hooks are pushed high into the scalp to create traction, thereby reducing scalp laxity. This stabilizes the scalp used for follicular unit extraction (FUE) and reduces scalp laxity.

[0105] Thumbtack-type reference teeth (TTFTs) are placed throughout the peripheral donor area for reference positioning, enabling computers and optical equipment to map the donor region. These TTFTs remain in place until all grafts have been retrieved. This allows the computer to map the precise location of each hair follicle group (graft) within the donor area before and after it has been excised. Once the patient is positioned in a special chair and a headband is attached, the surgeon places these reference positioning devices. At the end of the graft retrieval process, the surgeon can remove these TTFTs.

[0106] The following describes an exemplary implementation of a thumbtack-type reference micro-tooth. These thumbtack-type reference micro-tooths are designed to be minimally invasive while still allowing for mapping of the donor region using computer and optical equipment, thereby enabling repeatable mapping and repositioning of the automated acquisition device. For a completely non-invasive implementation that allows for repeatable mapping and repositioning of the automated acquisition device, pattern recognition technology can be employed to image the donor region and store a pattern of the candidate graft. Subsequently, the acquisition device is positioned approximately above the desired donor region, and fine positioning is achieved by matching the stored pattern with the pattern of the actual image of the current donor region. After acquisition, the stored pattern is updated to reflect graft resection, enabling future repositioning near the same donor region.

[0107] The surgeon views a large computer monitor that displays video information needed to assess and reassess the donor area as FUE progresses. Baseline measurements are fixed and displayed in one area of ​​the monitor. The surgeon divides the donor area into zones, allowing the video display to refer to either a global map of the donor supply or a map drawn by zone / zone measurements. This is a dynamic process. Algorithms suggest various FUE densities and hair volume measurements for graft removal, but the surgeon can adjust the algorithm up or down to create larger or smaller residual density or hair volume measurements in the donor area during graft removal. Furthermore, while the computer system suggests optimal spacing for extracted follicles to minimize clustering of missing follicular units, the surgeon can manually override this feature. If the number of grafts used for the entire procedure is known, a suggested graft distribution can be projected onto the computer screen to allow the surgeon to understand the consequences of the surgical resection plan.

[0108] Once anesthesia is complete, helmet positioning is achieved, and computer-aided evaluation of the donor area is finished, the surgeon shifts their focus to implanting the graft in the recipient area. The surgeon can request one graft at a time, with each graft containing one, two, three, or even more hairs. For example, if the surgeon wants to first construct the front edge of the hairline, they might request only a single hair graft.

[0109] One or more robots located at the back of the head will individually identify areas of priority for the surgeon and begin removing the requested grafts using a special trephine. After each graft removal, it is delivered directly from the donor area through a tube to a handheld dual-channel implanter. Along the delivery path, optical detectors examine the grafts to assess their integrity. This process takes less than a second. The graft is then implanted by the surgeon or via the robot. This is an iterative process, with the surgeon identifying the number of hairs / grafts individually at each step of the FUE and implantation procedure.

[0110] Surgeons can allow computers to select excision areas based on calculations of the remaining donor density and remaining hair volume measurements in the area selected by the surgeon.

[0111] Surgeons may want to control how the robot moves in the donor area; this is an option for surgeons to better control the decision-making process of the FUE components of the surgery.

[0112] At any time, surgeons can visualize the remaining donor density and amount of remaining donor hair in a digital graphical format. Surgeons can also visualize the degree of “patina” created by the FUE procedure by recording data on areas of abnormal spacing created by the extraction process. Visualization can be performed at the local or global scale.

[0113] A handheld implanter can be used (see...) FIG. 1A ) or use a second set of robotic arms (see FIG. 1B The implantation can be performed remotely. As the recipient region is filled, the donor region's donor depletion will be presented to the surgeon.

[0114] Implantation can be performed robotically, using a pre-designed plan. This plan graphically defines the locations where grafts of various sizes can be implanted.

[0115] Implantation handpiece

[0116] The following discusses representative implementations of implantable handheld devices. Generally, these handheld devices include a generally cylindrical body for gripping by a surgeon, and a first channel and a second channel positioned on the cylindrical body. The first channel is connectable to a vacuum source, and the second channel is connectable to a source of collected hair follicle units. A central rod and a hollow needle are provided, wherein the central rod and the hollow needle are positioned to allow for slidable and relative movement of the rod within the needle. In the retracted position of the rod relative to the needle, collected hair follicle units are transported from the second channel into the interior of the hollow needle under vacuum, which is applied in front of the central rod in the first channel. In the implantation position, the slidable movement of the central rod relative to the hollow needle drives the hair follicle unit from the hollow needle to the implantation site.

[0117] In the context of controlled, on-demand graft removal in the donor region, the implant handpiece typically plays a central role. For example, when a surgeon holds the implant handpiece in their hand, they effectively control the entire procedure. For instance, if a surgeon requests a graft of three hairs, the controller responds to the surgeon's instructions by moving a robotic arm that holds the extraction tool within a selected section of the donor region and at a suitable location within that section for the removal of the requested graft.

[0118] FIG. 3 A first embodiment of the implanted handheld device is described. In this document, this embodiment is referred to as "manual dual-channel," where "manual" means that the handheld device is manually operated by a surgeon using a plunger, and "dual-channel" means that the handheld device has two channels: a first (rearward) channel that can be connected to a vacuum source and a second (forward) channel that can be connected to a source of collected hair follicle units.

[0119] FIG. 3 Sections A, B, and C describe the configuration of the manual dual-channel system during the implantation cycle.

[0120] FIG. 4A The appearance of a second embodiment of the implanted handheld device is depicted. FIG. 4B Its cross-sectional view is depicted. FIG. 4A andFIG. 4B The described implementation is referred to herein as the "modified Cui-style" handpiece. The term "modified" indicates that significant modifications have been made to the Cui-style manually implanted handpiece.

[0121] In particular, FIG. 4A The modification to the Tsui manual implantation handpiece shown includes adding two channels to the handpiece: a first (rearward) channel connectable to a vacuum source, and a second (forward) channel connectable to a source of collected hair follicle units. Furthermore, the central rod is modified such that, in the retracted position, it loosely engages within the hollow needle. The first channel is located behind the front end of the central rod, and the second channel is located in front of the front end of the central rod. The engagement of the central rod within the hollow needle is loose enough to allow vacuum applied from the first channel to reach the side of the central rod, and for the collected hair follicle units to be aspirated from the second channel.

[0122] FIG. 4C A manual dual-channel handheld device is described for use with FIG. 4A and FIG. 4B A comparison was made with the modified Cui-style handheld device.

[0123] FIG. 5 A third implementation scheme for the implanted handheld device is described. In this paper, FIG. 5 The described implementation scheme is referred to herein as a "pressure-actuated dual-channel", where "pressure actuation" means relative to FIG. 3 The manual dual-channel design includes a third channel for controllable pressure introduction under the surgeon's supervision. Pressure introduced from the third channel drives the central rod from the retracted position to the implantation position, thereby completing the implantation of the hair follicle unit.

[0124] Saline injection

[0125] FIG. 6 An example is given of injecting saline (or other suitable solution) to facilitate the delivery of the collected hair follicle units to the implant handpiece.

[0126] like FIG. 6 As illustrated, a source of saline solution is introduced into the tubing near the trephine harvester in Figure 1 to improve the aspiration effectiveness of drawing the harvested graft into the implant handpiece, ensuring complete removal of the graft from the donor area, and lubricating the interior of the delivery tubing, thereby reducing the likelihood of graft damage during delivery of the harvested follicular units to the implant handpiece and reducing the likelihood of graft blockage of the tubing.

[0127] Saline solution can also be used in many other ways to facilitate the excision of the graft and its delivery to the implantation handpiece. For example, saline solution can be injected around the donor graft while making the incision with the trephine. Injecting saline solution around the donor graft helps promote deep dissection from the skin when the graft is collected by aspiration. Alternatively, a small amount of saline solution can be injected into the donor area of ​​the scalp immediately adjacent to the selected graft before the trephine actually pierces the skin at the donor site. Saline solution can be injected into the general area where the trephine is working, or targeted at the selected follicular units to be collected and excised, injected into an area 1.0 mm or smaller than the trephine excision site. Injecting saline solution into the scalp increases the swelling / firmness of the donor area, generally resulting in better trephine manipulation.

[0128] FIG. 6 The illustrated suction tube is used only when the implanter is used alone without the graft-on-demand robotic system (GODR) described herein. During normal operation of the GODR, FIG. 6 The catheters discussed herein will be made by, for example FIG. 5 The appropriate conduit shown is directly connected to the implant.

[0129] Tensioning band

[0130] FIG. 7A An example of a tension band is illustrated for application to the donor area of ​​the scalp to stabilize a patient's head on a headrest and maintain patient comfort. The tension band includes components for securing the band to the headrest, which supports the patient's head during graft retrieval from the donor area. Such components for securing the band to the headrest include a mechanism for easy release to (a) prevent patient injury, (b) allow the patient to rest or use the restroom during the procedure, and (c) facilitate the management of other medical issues.

[0131] like FIG. 7A As illustrated, the tension band is further configured with hooks to generate traction on the donor area of ​​the scalp and reduce scalp laxity, thereby facilitating graft removal, and the tension band is further configured with reference markers to facilitate mapping of the donor area. It should be understood that the use of hooks and reference markers is optional, especially when the primary purpose of the tension band is to stabilize the patient's head and / or maintain patient comfort.

[0132] Simply put, such as FIG. 7AThe described tension band comprises an elastic band of suitable length for wrapping around the patient's head, extending from a forward position slightly above the patient's eyebrows to a backward position on the top of the scalp. This band can be attached to a headrest used by the patient for support. Combining the band and headrest minimizes head movement during graft retrieval. Multiple reference markers are fixed to the band, allowing for the repositioning of specific follicular units within the donor area, and multiple fine teeth extend from the band for anchoring to the upper region of the scalp above the top of the head. Multiple elastic cords extend from the band, each ending in a hook configured to insert high on the scalp below the band and above the donor area to generate traction on the donor area of ​​the scalp and reduce scalp laxity. The hooks can be interconnected via a crossbar, making them easier to use than operating individually.

[0133] In the priority documents of this case, FIG. 7A The width of the straps in the original document has been exaggerated. In this document, the straps are correctly shown as narrower.

[0134] Tensioning shim

[0135] During manual harvesting using standard techniques, surgeons typically press their non-dominant thumb onto the scalp and remove it from the selected donor site to create and generate tension in the scalp near the donor area. This creates localized traction on the scalp near the donor follicular unit, while also helping the surgeon make an initial incision in the scalp around the follicular unit for a more successful resection.

[0136] According to this embodiment, a tensioning pad can be provided to tension the scalp near the donor area. The pad has a small contact area, approximately 1.0 to 2.0 square centimeters, and its contact side is configured to engage with and tension the scalp. To ensure sufficient engagement of the tensioning pad with the scalp for lateral traction of the scalp during collection, the surface of the contact side of the pad can be roughened or fitted with small puncture or non-puncture teeth.

[0137] FIG. 7B-1 to FIG. 7B-5 An example embodiment of a scalp tension pad is illustrated. In this embodiment, the scalp tension pad 75 is equipped with small, non-puncture teeth 76 for engaging with scalp 77 near the donor area. The tension pad 75 is mounted to an auxiliary robotic arm (tensioning robotic arm) via a rod 74 so that the scalp tension pad can move independently and in a coordinated manner with the movement of the robotic arm used for the collector. The pad 75 may be mounted on the rod 74 via a hinged bracket to allow slight angular movement of the pad 75 relative to the rod 74 to accommodate the curvature of the scalp.

[0138] These diagrams only depict the collector's trephine 71, with its end being a flared, trumpet-shaped tip 72. (See diagram below.) FIG. 1A and FIG. 1B As depicted, the trephine 71 is mounted on the chuck of a rotary collector (not shown), which in turn is mounted on its separate robotic arm.

[0139] These figures illustrate the sequence of procedures for extracting hair follicle units 78 from the patient's scalp 77. These figures are highly magnified.

[0140] In these figures, the hollow extraction trephine 71 has a flared tip 72 and is controlled by an invisible robotic arm. A rod 74 supports a pad 75 (which may be on an articulated bracket) and small teeth (or pins) 76 extending from the pad. The rod / pad assembly is also controlled by an invisible robotic arm.

[0141] The patient's scalp 77 has multiple hair follicle units 78, some of which were harvested using a trephine.

[0142] exist FIG. 7B-2 In the middle, the rod 74 extends independently of the movement of the collector and its trephine 71 by the tensioning robotic arm until the pad 75 and the fine teeth 76 contact the scalp. FIG. 7B-3 In this configuration, the rod, driven by a tensioning robotic arm, moves laterally away from the selected hair follicle unit for collection (in this illustration, the direction of movement is upwards away from the hair follicle unit). Due to the action of the fine teeth 76, the scalp under the pad 75 moves upwards along with it, resulting in tension within the stretched scalp. FIG. 7B-4 In this process, the trephine 71, which rotates and / or vibrates due to its fixed position in the chuck of the acquisition device, is repositioned and cuts into the scalp surrounding the hair follicle unit 78. FIG. 7B-5 In the middle, the trephine 71 retracts with the harvested hair follicle units. The harvested hair follicle units are then transported via a conduit to the implantation handpiece, such as... FIG. 1A and FIG. 1B The description.

[0143] FIG. 7C-1 to FIG. 7C-6 Another example embodiment of the scalp tension pad is illustrated. In this embodiment, the scalp tension pad 75 is mounted to the same robotic arm used for the collector by a flexible or non-flexible arm 82, so that the scalp tension pad moves in coordination with the movement of the robotic arm.

[0144] In these figures, with FIG. 7B-1 to FIG. 7B-5Similarly, the contact surface of the tensioning pad 75 is configured to engage with and tension the scalp, employing small, non-piercing teeth 75. The tensioning pad 74 is attached to the extraction handpiece, and both are moved together by the robotic arm. This attachment is achieved via a slightly curved and flexible arm 82.

[0145] FIG. 7C-6 The overall layout is shown, with particular depiction of a handheld component 80, which includes a gripper 81 for attachment to a robotic arm, and a flexible rod 82 attached to the gripper for supporting the pad-tooth assembly. FIG. 7B-1 to FIG. 7B-5 As shown, the collector is an extraction handheld device 80 with a trephine 71, the end of which is a flared, trumpet-shaped tip 72 and is mounted on the chuck of the handheld device 80. FIG. 1A Hehe FIG. 1B As depicted, a collector mounted on a robotic arm mounts a trephine 71 onto a chuck, enabling the trephine 71 to rotate and / or vibrate. A pad 75 is mounted on a rod 74 via a hinged bracket, allowing the pad 75 to move slightly angularly relative to the rod 74 to accommodate the curvature of the scalp. With this configuration, the collector and tensioning pad move together as a single unit, and the bending of the flexible arm 82 produces a scalp tensioning effect as described below.

[0146] More specifically, FIG. 7C-1 to FIG. 7C-5 The sequence of operations for extracting hair follicle units 78 from the patient's scalp 77 is shown. These figures are highly magnified. As shown in these figures, the pad 75 is initially positioned in front of the tip 72 of the extraction trephine 71.

[0147] During operation, as the robotic arm advances toward the scalp, the pad 75 initially contacts the scalp due to its forward positioning relative to the tip 72 of the trephine. This initial contact... FIG. 7C-2 As depicted in the image, the degree of bending of the flexible rod increases further as the robotic arm continues to move forward, such as... FIG. 7C-3 As shown, the pad 75 is moved upward away from the selected hair follicle unit for collection (in this illustration, the direction of movement is upward away from the hair follicle unit; however, in other parts of the body, traction may need to be performed in almost any direction). Due to the action of the teeth 76, the scalp under the pad 75 moves upward along with it, resulting in tension in the stretched scalp.

[0148] exist FIG. 7C-4 The robotic arm continues to advance until the trephine 71 contacts and penetrates the scalp. If the tension is sufficient to support multiple graft retrievals, the flexible rod can remain in this position for one or more retrievals; otherwise, both the flexible rod and the trephine can retract, at which point the harvested graft 78 is located inside the trephine. The harvested hair follicle units are then transported via tubing to the implantation handpiece using suction.FIG. 1A and FIG. 1B The description.

[0149] Head stabilization

[0150] FIG. 7D It is a view depicting the mechanisms used to stabilize the patient's head during the transplant procedure.

[0151] like FIG. 7D As shown, the patient sits in a slightly forward, upright position with their chest resting on a chest support and their head supported by a rigid or semi-rigid, semi-circular headrest. A padded headrest can be used to increase patient comfort.

[0152] Extending from the chest support are two rigid arms that support a semi-circular headrest. The length of the arms is adjustable to accommodate patients of different sizes. In this embodiment, a locking telescopic device is provided along the length of the arms to allow for adjustment.

[0153] The headrest is semi-circular, supporting the area directly above the patient's eyebrows, fully exposing the patient's forehead. A flexible securing strap extends from one side of the headrest, wrapping around the patient's head and extending to the other side. The strap is adjustable to accommodate different head circumferences and can be adjusted and secured to one or both sides of the headrest, with quick-release capability to ensure patient safety. In this embodiment, Velcro is used for quick-release securing. The securing strap wraps around the back of the patient's head to secure it to the headrest. The strap is positioned directly below the top of the head, fully exposing the occipital region.

[0154] Peg-style fiducial locator

[0155] FIG. 9 A thumbtack-type reference positioning element configured for fixing to the donor area is described to facilitate accurate and repeatable repositioning of the data acquisition device using machine vision.

[0156] exist FIG. 9 In the middle, the left view is a view showing the reference positioning element that engages with the epidermis of the donor area, and the right view is a view showing the disengagement.

[0157] More specifically, such as FIG. 9 The depicted reference positioning element comprises a small-diameter (approximately 5 mm) nail-like structure from which two needle-like legs extend downward. The nail is configured for insertion into the donor area of ​​the patient. The needle-like legs are biased outwards such that they open outwards as the nail is inserted under the skin into the donor area. A slidable retaining ring surrounds the two legs and is positioned such that the legs remain vertical before the nail is inserted into the donor area to resist their own outward bias.

[0158] As the staple is inserted into the donor area, the retaining ring slides upward, allowing the legs to extend outward beneath the surface of the donor area (scalp in this embodiment). These two legs extend superficially into the scalp to a depth of approximately 1.0 to 1.5 millimeters, penetrating the epidermis but not reaching the dermis to the point of touching sebaceous glands or causing significant bleeding. This depth is sufficient to ensure that the staple remains fixed to the scalp regardless of movement of the head (donor area), but not to cause postoperative damage or wounds.

[0159] like FIG. 10 As illustrated, other iterations of the thumbtack can use a spring-loaded fishhook-type device or a screw-type device inserted into the scalp.

[0160] A reference mark, such as a one-dimensional barcode or a two-dimensional QR code, is formed on the surface of the nail's diameter.

[0161] During acquisition, multiple thumbtack-style reference locators are applied to the donor region, each with a different code. For example, reference locators can be used to define the boundaries of each of multiple partitions within the donor region. Because the reference locators are applied directly to the skin of the donor region, machine vision facilitates accurate and repeatable repositioning of the acquirer even if the donor region has been moved. For instance, during the transplant procedure, the patient may need to take a short break, requiring release from the headrest support. Upon returning, the head will naturally deviate slightly from its pre-rest position. However, the reference locators themselves remain in the same position, allowing machine vision to accurately restore the acquisition location.

[0162] A reference positioning element can also be used in the implantation area to achieve accurate and repeatable positioning of the implanted handheld device, especially in applications such as... FIG. 1B In the described implementation, the implanted handheld device is operated remotely.

[0163] The reference positioning element can be placed in a sterilizable kit along with other components used in the process, such as a fixation strap for head stabilization.

[0164] Consumption monitoring

[0165] FIG. 8A This example illustrates a representative display of consumption monitoring in the donor area. Multiple reference positioning elements can be placed along the edge of the donor area in or on the donor area (scalp).

[0166] More specifically, the donor area of ​​scalp designated by the surgeon is typically divided into multiple partitions because each distinct partition within the donor area has different statistical characteristics in terms of the number, density, and color of candidate grafts. In one example, the donor area was divided into sixteen (16) partitions, such as as follows:

[0167]

[0168] During the procedure, the donor area is consumed as grafts are harvested. In this implementation, computerized algorithms and formulas are used to select which grafts to harvest to ensure that graft removal is evenly distributed throughout the donor area and proportional to the distribution of candidate grafts in each partition of the donor area. The surgeon can input the number of 1, 2, and 3 (or more) hair grafts he / she wishes to harvest. Therefore, calculations can be easily performed for all areas to allocate harvesting in the most harmless manner. However, for safety and patient protection purposes, and to ensure a good postoperative appearance of the donor area, the surgeon may decide on automated artificial coverage selection. The consumption monitoring described herein provides the surgeon with a tool to determine whether artificial coverage is recommended.

[0169] While the consumption monitoring described herein is well-suited to automated graft collection, it should be understood that consumption monitoring can be used in situations other than automated collection, such as when grafts are collected manually, or even independently as a diagnostic or planning tool to assist surgeons in making decisions during transplantation.

[0170] When harvesting beard hair from the chin or pubic area, the goal might be to remove all grafts from these areas. In this case, the consumption target might be 100%, but this would never happen in the case of scalp harvesting. In the case of scalp harvesting, the consumption limit directly affects the appearance of the donor area, and enough donor hair must be preserved to avoid the appearance of "through-the-scalp" or baldness in the donor area.

[0171] In short, according to the implementation described herein, hair graft consumption from the donor area of ​​the scalp during transplantation surgery is monitored by imaging the donor area of ​​the scalp, such as via a visual system. The donor area is divided into multiple partitions, and initial statistics of candidate grafts in each of these partitions are stored, automatically acquired before the start of the transplantation surgery. Candidate density is also measured in each such partition. Current statistics of candidate grafts in each of these partitions are collected, automatically acquired during graft collection from the donor area during the transplantation surgery, and include the real-time candidate density in each such partition. A visual depiction is displayed to the surgeon for real-time comparison of the initial and current statistics of one partition of the donor area during the transplantation surgery. The illustrated display is only one implementation of graft consumption monitoring.

[0172] The computer screen may further include displaying a current image of the donor region partition compared to an initial image of the donor region partition. Furthermore, on the image of the donor region partition, the display may further overlay information specifying characteristics of each candidate object, including at least the number of hairs in each candidate object.

[0173] Therefore, as FIG. 8A As shown, the display includes an upper section showing statistical information and a lower section showing an image of the donor region. In this example, the upper section displays a subset of statistical information for each of two distinct partitions out of sixteen partitions of the donor region. Here, partition 12 appears on the left and partition 9 appears on the right. The statistical information includes candidate density in the partition, average hair thickness, and the amount of donor hair in the partition shown. The statistical information is given in a subset of two regions out of the 16 partitioned regions before the start of surgery. Displaying subsets of the partitions reduces the complexity illustrated in this patent.

[0174] Statistical information may include one or more of the following statistical indicators.

[0175] Hair volume: based on the thickness of a single hair in micrometers multiplied by A=πr 2 Then multiply by the number of hairs measured within the calculated range (e.g., FIG. 8A and FIG. 8B (The 16 regions shown are a subset of the entire head).

[0176] Area hair volume: refers to the sum of all hairs in one of the 16 effective areas, where the effective FUE area = thickness in micrometers multiplied by A = πr 2 x Number of hairs / Divide by 1000 to convert to mm.

[0177] Donor hair volume: the sum of all hairs in the donor area of ​​the head designated by the surgeon, multiplied by the thickness of all hairs in micrometers, and then multiplied by A=πr. 2 x Number of hairs / Divide by 1000 to convert to mm.

[0178] Region donor density: The density in a processed region (the actual effective subset of the region, calculated by dividing the number of hairs in the field of view by the number of hair follicle units).

[0179] Overall donor density: If the entire donor area of ​​the scalp has been measured, it is calculated by dividing the number of hairs in the entire donor area by the number of follicular units in the donor area; or by extrapolating from the donor area to the entire head, by dividing the number of hairs in the field of vision by the number of follicular units. A typical Caucasian scalp has 110,000 hairs and 50,000 follicular units. The average donor density for a Caucasian is 110,000 / 50,000 = 2.2 hairs per follicular unit. A typical donor area has 12,500 follicular units or 27,500 hairs. This will be converted to 2.2 hairs per follicular unit for calculation. The figures used here are a known average for a typical Caucasian male.

[0180] exist FIG. 8A and FIG. 8B The following assumptions were made during the preparation process.

[0181] The average Caucasian has 50,000 hair follicle units on their head, which is... FIG. 8A and FIG. 8B The calculations used.

[0182] Hair volume doesn't have units of measurement (like length or area); it's simply a way of comparing the thickness of individual hairs when adding one hair to other hairs within an effective field of view (or across the entire head in the case of a shaved head). If hair volume did have units of measurement, then incorporating the length of an individual's hair when calculating hair volume would be more realistic (though impractical), but this isn't the case from a hair transplant surgeon's perspective. These examples assume the entire head has been shaved to allow for... FIG. 8A and FIG. 8B The reference values ​​at the top are measured. Therefore, for these patients, the donor area must be shaved very short to obtain the reference values ​​in the examples. If the entire head is not shaved, calculations can be made based solely on the donor area. Furthermore, the hairs within the follicular units of the donor area are generally uniform in thickness; however, this may not always be the case. Obviously, if some hairs within a follicular unit are thinner, the amount of hair in that follicular unit will be reduced. Many small cameras can be used to view the donor area from different directions, and there will be enough cameras to image every hair in the follicular unit and to calculate the hair volume along with other calculations. As for head size, knowing the size of the donor area allows for a reasonable estimation of the head size.

[0183] As discussed above, the global hair density assumption (in the figure) was calculated before the surgery began, with the patient's head completely shaved.

[0184] exist FIG. 8AThe lower part of the example shows images of two partitions selected by the surgeon (both partitions are subsets of the partitions used for illustrative purposes). This image shows two different partitions selected by the surgeon. These reflect the initial state of the partitions before the FUE procedure begins. For illustrative purposes, the number of hairs for each graft is written to each follicular unit (graft); however, this may not be the programming method shown. Although the number of follicular units (grafts) differs between the two areas, the donor density shows a difference in density between the two areas. It is not uncommon for the area above the ear to have lower density compared to the back of the head. The surgeon can move the field of view from one area to another. In this example, an index of baseline irregularities (not shown) for both areas can be provided.

[0185] Overlaid on the image are indicators specifying the characteristics of each follicular unit candidate. In this embodiment, the indicator indicates the number of hairs and grafts in each candidate for the entire head (if the head is shaved), limited to the entire donor area (not shown), or for each of the 16 areas defined by the surgeon. The donor area is marked. In other embodiments, the characteristics of the candidate may include: the color of the candidate's hair and skin, the width of the candidate's hair shaft, the angle at which the candidate's hair emerges from the scalp, the thickness of individual hairs within the graft, and these characteristics may be statistically analyzed based on any single measurement, or based on one of the 16 sections of the donor area, the entire donor area, or even extrapolated to the entire head based on the overall size of the head and the extent of surgical resection, etc.

[0186] FIG. 8B Another representative example of consumption detection in the donor region is illustrated. Multiple reference positioning elements can be placed in or on the donor region (scalp) along the edge of the donor region, or pattern recognition can be used to properly orient the robotic arm.

[0187] like FIG. 8BAs shown, the display includes an upper section showing statistical information and a lower section showing an image of the donor area. In this example, the upper section displays statistics for a designated partition of one of sixteen partitions of the donor area selected by the surgeon as the current donor area. The statistics include candidate density, average hair thickness, and donor hair volume within the partition. The statistics are presented at two time points: the current state of the partition (left image) and the preoperative (baseline) state of the partition (right image), allowing the surgeon to compare the initial statistics with the current statistics. In this example, the system computer calculates the percentage of hair loss recorded in real time for the surgeon to review. It should also be noted that the data reported in the computer image records the amount of hair loss in the hair volume in real time. The computer estimates that 32% of the hair volume has been removed in the left image. Even with good computer advice, removing more than 20% of the hair volume, high hair loss, such as in patients with very low preoperative hair volume, can be damaging. This will produce a bald appearance in the donor area. This provides the surgeon with a tool to optimize extraction based on a plan developed jointly by the surgeon and patient.

[0188] exist FIG. 8B The lower part of the example shows an image of a designated partition (here, "Partition 1") selected by the surgeon. On the right, there is a historical initial image of this partition, and on the left, there is a current image of this partition, depicting the images that have already been acquired. The current state of this partition is illustrated in real-time in the left-hand image, showing the site of previous graft removal. Overlaid on the right-hand image of the initial (baseline) state of this partition is an indicator specifying the number of hairs in each follicular unit. This illustration shows the count of individual hairs in each follicular unit. In this embodiment, the indicator represents the number of hairs and grafts for each candidate. In other embodiments, the characteristics of the candidate may include: the color of the candidate's hair and skin, the width of the candidate hair axis (which varies within a single follicular unit), the angle at which the candidate's hair emerges from the scalp, the average thickness of individual hairs within the graft, the overall size of the head and the surgically removed area, and so on.

[0189] The embodiments illustrated and discussed in this specification are for educational purposes only, to teach those skilled in the art how to make and use the invention herein. For illustrative purposes, FIG. 8A and FIG. 8B The area shown has been deliberately reduced in size. It should be understood that features of various implementation schemes can be combined, for example, combining manual operation with robot-assisted implantation.

[0190] Automatic selection of grafts to harvest

[0191] As described above, computerized algorithms and formulas are used to select which grafts to collect to ensure that graft removal is distributed approximately evenly throughout the donor region and proportional to the distribution of candidate grafts in each partition of the donor region.

[0192] One goal in selecting grafts is to maintain the appearance of the donor area after graft collection. Some studies suggest that for donor areas in the occipital region of the scalp, individuals with an average hair thickness between 40 and 60 micrometers require a hair density of at least 100 hairs per square centimeter to maintain the appearance of the donor area post-surgery. Higher densities are often required, especially when the hair thickness is below 40 micrometers and multiple surgeries are necessary. Considering the goal of maintaining the appearance of the donor area after graft collection, measures beyond simply maintaining hair density can be applied. For example, hair color, especially color associated with the donor area, may be a factor in some cases.

[0193] One known technique for automatically selecting grafts to be harvested is completely random selection. Random selection has drawbacks. One drawback is that it cannot guarantee a roughly uniform distribution of selections within the donor area. In fact, with random selection, the harvested follicular units may inadvertently cluster in a few groups, resulting in a mottled and uneven postoperative appearance. Another drawback is that the excised graft wound may inadvertently generate visible patterns, such as visible lines, spirals, or other visual artifacts formed by the wound. Another drawback in the context of on-demand graft processing is that, in response to the randomness of selection, drastic and potentially extensive repositioning of the harvesting arm is required, thus the next randomly selected candidate may not be close to the current excision.

[0194] Therefore, automated selection of the graft to be harvested should ensure that grafts are selected approximately uniformly within the donor area, but retain sufficient irregularity to ensure that the residual wound from the excised graft forms a visible pattern. Furthermore, a potential advantage is minimizing the movement of the harvesting arm in response to selecting the next graft.

[0195] The implementation scheme for automated graft selection described herein generates a disturbed pattern of locations for candidate grafts to be excised. This pattern is approximately uniformly spaced within each partition of the donor region, thereby minimizing clustering of the harvested grafts. Furthermore, the pattern is sufficiently disturbed to prevent the formation of a visible pattern within the residual wound. Additionally, the spacing of the disturbed pattern ensures minimal movement of the harvesting arm from one excision to the next. The hair follicle unit is selected as the harvesting candidate when it is closest to the actual location of the generated pattern.

[0196] In one embodiment of generating the disturbed pattern, a partition-by-partition selection is performed to determine the number of grafts required to be collected from each partition. This number is used to define a regular pattern of lattice grid points on the partition. This regular pattern can be rectangular, hexagonal, triangular, or any other suitable regular pattern. Each lattice grid point is then disturbed horizontally and vertically by a random amount. The degree of randomness is proportional to a small fraction of the average spacing between grid points. For example, the degree of randomness can be approximately + / - 10% to + / - 40% of the average spacing between grid points, preferably 20% of that average spacing. The distribution of randomness can be uniform, such as a uniform distribution of -20% to +20% of the average spacing between grid points. For example, if the average spacing of points in a regular lattice of grid points in a partition of the donor region is approximately 8.5 mm laterally in either the horizontal or vertical direction, then the applied randomness should be between 8.5 x 0.10 = 0.85 mm and 8.5 x 40 = 3.40 mm, preferably approximately 8.5 x 0.2 = 1.7 mm, individually selected from a uniform distribution for each grid point. Other distributions, such as Gaussian distributions, can also be considered.

[0197] In use, the interference pattern of the lattice points is superimposed on the donor area by the computer, and the hair follicle unit closest to the lattice point is selected for acquisition.

[0198] Individual patterns are generated for each feature specified by the surgeon. For example, individual patterns are generated for grafts with one hair, grafts with two hairs, and grafts with three or more hairs. As mentioned above, other features may include the thickness of the hair in the graft, the color of the candidate's hair and skin, the width of the candidate's hair shaft, and the angle at which the candidate's hair emerges from the scalp.

[0199] In another embodiment of generating a disturbed pattern of candidate locations for graft excision, a regular pattern of lattice grid points is defined on each partition using the number of grafts required for partitioning. In this embodiment, since the locations of the grid points are disturbed during use, it is not necessary to randomize the locations of the lattice grid points. Of course, the grid points can also be randomized before use as described above.

[0200] In practice, the pattern of lattice points is superimposed onto the donor region by a computer, and the first hair follicle unit closest to the first lattice point is selected for acquisition. However, since hair follicle units are naturally distributed within the partitions of the donor region, candidate hair follicle units will not be accurately found at the first lattice point. This is beneficial because it ensures that the selection of candidates has sufficient irregularity, thereby ensuring that no visible pattern is found in the residual extraction wound.

[0201] After selecting the hair follicle unit closest to the lattice point, the horizontal and vertical differences between the actual position of the selected hair follicle unit and the target position of the lattice are calculated. This positional error is distributed among one or more adjacent lattice points to disrupt the lattice pattern. For example, if the acquired hair follicle unit is positioned to the left of the first lattice point, adjacent lattice points are disrupted by shifting it to the right. In this way, candidates are selected approximately uniformly within each partition of the donor area, thus avoiding a mottled appearance in the donor area postoperatively, while ensuring sufficient irregularity in the selection to prevent visible patterns from forming in the wound left by the excised graft. Furthermore, only minor repositioning of the acquisition arm is required between excisions.

[0202] Instead of distributing the position error across the next nearest candidate, it's better to use a 1D or 2D kernel function to distribute the error across two or more adjacent candidate objects. For example, the following kernel function would distribute half of the position error to the next candidate object to the right and the other half to the next candidate object below:

[0203]

[0204] The "#" symbol indicates the candidate object currently being processed. Other kernel functions can be used, such as:

[0205]

[0206] The kernel function distributes half of the position error to the next candidate object to the right, one-third to the next candidate object to the bottom, and one-sixth to the next candidate object to the bottom right.

[0207] The process of generating the disturbed pattern during the use of the disturbed pattern is performed independently on a segment-by-segment basis for collecting grafts with 3 hairs, 2 hairs, and 1 hair follicle unit, or for collecting based on any other characteristics (such as thickness) of the candidate object for determining the excised graft.

[0208] In describing embodiments of this disclosure, specific terminology has been used for clarity. However, this disclosure is not limited to the specific terminology chosen. Modifications or variations of the above embodiments of this disclosure can be made by those skilled in the art, inspired by the foregoing teachings, without departing from the scope of this disclosure. Therefore, it should be understood that this disclosure may be implemented in ways other than those specifically described above, within the scope of the claims and their equivalents.

Claims

1. An apparatus for harvesting hair grafts from a donor area, the apparatus comprising: a robotic arm having a trephine harvester mounted thereon, wherein the trephine harvester is configured to harvest hair follicle units from the donor area by hand-held or robotically controlled movement of the robotic arm in response to instructions to harvest hair follicle units; and a conduit for delivering harvested hair follicle units to an implantation handpiece via suction.

2. The apparatus of claim 1, further comprising one or more cameras positioned to image the donor area, wherein the instructions to harvest hair follicle units include instructions to harvest hair follicle units having specified characteristics such as number of hairs, and wherein the robotic arm is moved to candidate locations for harvesting the hair follicle units by reference to camera images of the donor area.

3. The apparatus of claim 1, further comprising an implantation robotic arm having the implantation handpiece mounted thereon, wherein the implantation handpiece is configured to implant the hair follicle units delivered to the implantation handpiece to specified implantation sites in a recipient area of the scalp by robotically controlled movement of the implantation robotic arm in response to instructions to implant the hair follicle units.

4. The apparatus of claim 1, wherein to harvest hair follicle units, the hair follicle units to be harvested are selected by reference to an algorithm that minimizes areas within the donor area that can become very sparse mottled in a manner that spaces harvested grafts on the donor area.

5. The apparatus of claim 1, wherein to harvest hair follicle units, the hair follicle units to be harvested are selected by reference to an algorithm that avoids over- depletion of grafts from each defined area of the donor area in a manner that spaces harvested grafts on the donor area.

6. The apparatus of claim 1, wherein the instructions to harvest hair follicle units having the specified characteristics such as number of hairs are issued by voice commands.

7. The apparatus of claim 1, wherein the instructions to harvest hair follicle units having the specified characteristics such as number of hairs are issued by operation of a foot pedal.

8. The apparatus of claim 1, wherein the instructions to harvest hair follicle units having the specified characteristics such as number of hairs are issued by one or more buttons on the implantation handpiece.

9. The apparatus of claim 1, further comprising a controller configured to monitor depletion of hair grafts from the donor area by number of grafts remaining or amount of hair remaining or density of identified areas, and further comprising a display controlled to display in real time a visual depiction of the depletion of hair grafts from the donor area and to display data quantifying donor density and amount of hair values.

10. The apparatus of claim 1, further comprising a source of normal saline introduced into the conduit proximate the trephine collector to enhance suction effect and / or facilitate transport of harvested follicular units to the implant handpiece.

11. The apparatus of claim 1, further comprising injection of normal saline into the donor area in the collection zone proximate the graft excision site, wherein the normal saline is injected in the general area where the trephine is performing collection, or targeted to the follicular units selected for collection and excision, such as within 1.0 mm or less of the trephine excision site.

12. The apparatus of claim 1, further comprising an optical system positioned to image the harvested grafts at an inspection station for automatic determination of graft quality during transport of the harvested grafts from the donor area to the implant handpiece.

13. The apparatus of claim 12, wherein a notification is provided in response to detection of a poor quality graft to alert against implanting the graft.

14. The apparatus of claim 13, wherein the notification is an audible alert to the surgeon to provide the surgeon with the option to discard the poor quality graft.

15. The apparatus of claim 13, wherein the notification is a signal to eject the graft once it reaches the implant device so that the graft is not implanted in the recipient area.

16. The apparatus of claim 13, wherein the notification is an image of the graft displayed on a computer monitor to confirm the number of hairs in each graft.

17. The apparatus of claim 1, further comprising a donor area tensioning pad that is movable in coordination with movement of the robotic arm to apply tension to the scalp proximate the donor area as the follicular units are collected.

18. The apparatus of claim 17, wherein the donor area tensioning pad is mounted to the robotic arm by a flexible arm to move in coordination with movement of the robotic arm.

19. The apparatus of claim 17, wherein the donor area tensioning pad is mounted to a tensioning robotic arm so that the scalp tensioning pad moves independently and in coordination with movement of the robotic arm.

20. An implant handpiece, comprising: a generally cylindrical body for gripping by a user of the implant handpiece; a first and second channel on the cylindrical body, wherein the first channel is connectable to a vacuum source and the second channel is connectable to a source of harvested follicular units; a central rod and a hollow needle, wherein the central rod and the hollow needle are positioned to enable slidable and relative movement of the rod within the needle, a first and second channel on the cylindrical body, wherein the first channel is connectable to a vacuum source and the second channel is connectable to a source of harvested follicular units; wherein in the retracted position of the rod relative to the needle, the harvested follicular units are transported from the second channel to the interior of the hollow needle under the action of vacuum applied at a position in front of the central rod of the first channel, and wherein in the implanted position, the slidable movement of the central rod relative to the hollow needle drives the follicular units from the hollow needle to the implantation site.

21. The implantation handpiece of claim 20, further comprising a third channel for controllably introducing pressure or directing vacuum under the control of the user to achieve the same function, wherein the introduction of pressure (or vacuum) from the third channel drives the central rod from the retracted position to the implanted position.

22. The implantation handpiece of claim 20, wherein in the retracted position, the central rod fits loosely inside the hollow needle, wherein the first channel is located behind the front end of the central rod and the second channel is located in front of the front end of the central rod, and wherein the fit of the central rod in the hollow needle is loose enough to enable vacuum applied from the first channel to reach alongside the central rod, and suction of the harvested follicular units from the second channel.

23. The implantation handpiece of claim 20, wherein the slidable movement of the central rod relative to the hollow needle is achieved manually by the user.

24. The implantation handpiece of claim 20, further comprising one or more manually operable control means positioned along the cylindrical body, used by the surgeon to issue instructions for excising follicular units having specified characteristics and for transporting corresponding grafts to the handpiece for implantation.

25. A strap for application to a donor area of a scalp, the strap comprising: an elastic band of suitable length for wrapping around the head of a patient, extending from an anterior position slightly above the eyebrows of the patient to a posterior position at the base of the crown of the patient's scalp; a means for securing the band to a headrest that supports the head of the patient during harvesting of grafts from the donor area; and a release mechanism for releasing the means for securing to release the band from the headrest.

26. The strap of claim 25, further comprising: a plurality of fiducial markers affixed to the band by which specific follicular units in the donor area can be repeatedly located, and a plurality of fine teeth extending from the band for anchoring in the upper region of the scalp above the crown and over the band extending along the length of the surgical area.

27. The strap of claim 25, further comprising: a plurality of elastic cords extending from the band, the end of each of the elastic cords being a hook, wherein the hooks are configured to be threaded into the scalp at a high position above the band and above the donor area to create traction on the donor area of the scalp and reduce scalp laxity. ​ 28. A head stabilization apparatus, comprising: a chest support; a semi-circular headrest supported by a pair of arms extending upwardly from the chest support, wherein the length of the arms is adjustable; and a securing strap adjustably attached to opposite ends of the headrest for securing a patient's head on the headrest, wherein the securing strap is attached to the headrest with a quick release mechanism.

29. The apparatus of claim 28, wherein the quick release mechanism comprises a Velcro® patch.

30. The apparatus of claim 28, wherein the arms comprise locking telescoping arms.

31. A fiducial locator configured for securing to the skin at a donor region of a patient, the fiducial locator comprising: a plate having an upper surface and a lower surface; an appendage extending downwardly from the lower surface of the plate, wherein the appendage comprises an embeddable segment configured for insertion into the skin; an anchoring device positioned along the embeddable segment of the appendage for anchoring the appendage in the skin; a fiducial marker formed on the upper surface of the plate; and a release mechanism enabling the fiducial locator to be easily removed from its location embedded in the scalp.

32. The fiducial locator of claim 31, wherein the appendage comprises: a pair of needle-like legs extending downwardly from the lower surface of the plate, wherein the needle-like legs are outwardly biased such that when the fiducial locator is inserted into the skin, the needle-like legs splay outwardly; and a slidable retaining ring encircling the legs and being slidably positionable at a first location before the fiducial locator is inserted into the skin, wherein the outward bias of the legs relative to the legs is maintained in a vertical orientation, and at a second location when the fiducial locator is inserted into the skin, wherein the retaining ring slides upwardly to enable the legs to extend outwardly below the surface of the skin, and wherein the anchoring device comprises the outwardly extending legs below the surface of the skin.

33. The fiducial locator of claim 31, further comprising a compression spring positioned below the lower surface of the plate and configured for abutting against the surface of the skin, wherein the anchoring device comprises a hook positioned below the compression spring along the embeddable segment.

34. The fiducial locator of claim 31, wherein the embeddable segment of the appendage has a length so as to extend about 1.5 mm below the skin when the fiducial locator is secured to the skin.

35. The fiducial locator of claim 31, wherein the plate comprises a circular disc having a diameter of about 5 mm.

36. A sterilizable kit comprising a plurality of the fiducial locators of claim 31 and a securing strap configured for adjustably attaching to opposite ends of a headrest for securing a patient's head on the headrest.

37. An apparatus for monitoring depletion of hair grafts from a donor area of a patient's scalp during a hair transplant procedure, the apparatus comprising: a vision system for imaging the donor area of the scalp, the donor area being divided into a plurality of sub-zones; a memory for storing initial statistical content of candidate grafts in each of the plurality of sub-zones, wherein the initial statistical content is automatically captured using the vision system at a time prior to the start of the hair transplant procedure and includes candidate density in each such sub-zone; a controller for collecting current statistical content of candidate grafts in each or all of the plurality of sub-zones, wherein the current statistical content is automatically captured using the vision system at a time during the hair transplant procedure during harvesting of grafts from the donor area and includes real-time candidate density and hair volume calculations in each such sub-zone at any time prior to the start of the hair transplant procedure to the end of the hair transplant procedure; a display under control of the controller for displaying a visual depiction for comparing the initial statistical content and the current statistical content of one of the plurality of sub-zones of the donor area in real-time during the hair transplant procedure.

38. The apparatus of claim 37, wherein the display further displays a current image of a sub-zone of the donor area compared to an initial image of a sub-zone of the donor area.

39. The apparatus of claim 38, wherein the display further superimposes on the image of a sub-zone of the donor area indicators designating characteristics of each candidate object, the characteristic information including at least a number of hairs of each candidate object.

40. Any and all of the methods, systems, apparatuses, tangible computer readable media, and the like related to the description provided herein.

Images