Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00743—Type of operation; Specification of treatment sites
  • A61B2017/00747—Dermatology
  • A61B2017/00752—Hair removal or transplantation

Definitions

• This disclosure relates to the field of hair transplantation. More specifically, this disclosure relates to systems and methods for using a split needle device for both hair extraction and hair implantation.
• Hair loss is a physical and psychological issue that affects 80 million people in the United States alone.
• the commercial market for addressing hair loss is a multibillion dollar industry, from drug therapies to hair transplantation.
• Hair transplantation is a procedure that involves implanting multiple hair follicles or follicular units, from a donor site of a donor, into a recipient site of a patient. Generally, this procedure is done by first identifying a hair follicle in the donor site, coring around the hair follicle, and removing the hair follicle from the donor site. Then, a small opening is created in the recipient site. After the small opening has been created the hair follicle is implanted within the opening, and the opening is allowed to heal around the implanted hair follicle.
• FUT Follicular Unit Transplantation
• FUE Follicular Unit Extraction
• this procedure is performed using differing tools for extraction of the hair follicle, creation of the small opening, and implantation of the hair follicle. Further, the procedure is typically done by extracting a single follicle at a time, temporarily placing each single follicle at a holding location (e.g., a petri dish) one by one, and then implanting a single hair follicle at a time.
• a single hair transplant session may implant anywhere from 1,500 to 3,000 hair follicles. With each hair follicle taking twenty seconds or longer to transplant, each session is very labor intensive and can last as long as eight to twelve hours. As such, comparative processes for hair transplantation is tedious, time-consuming, and costly. Therefore, it would be advantageous to have systems and methods to reduce the hair transplantation surgery (FUE) time and increase hair transplantation efficiency.
• FUE hair transplantation surgery
• the present disclosure overcomes these and other drawbacks by providing systems and methods for hair transplantation using a single device which includes both extraction and implantation features via a split-needle configuration.
• the systems and methods described herein eliminate intermediate stages in the hair transplantation process (e g., manipulating hair follicles such as by placing them in the holding location prior to implant). Accordingly, the present disclosure provides for systems and methods of hair transplantation which may proceed much more quickly and efficiently than comparative methods.
• the systems and methods of the present disclosure are provided for improved hair transplant procedures that increase extraction speed, opening speed, and implantation speed, thereby increasing efficacy and reducing cost.
• the systems and methods described herein reduce stress on the hair follicles, which may lead to better transplantation outcomes.
• a hair transplant system comprising a casing; an implantation unit received in the casing, the implantation unit including an implanting needle at a distal end thereof; an extraction unit received in the implantation unit, the extraction unit including an extracting needle at a distal end thereof and a first actuator portion at a proximal end thereof; and an actuation unit received in the casing and over the extraction unit, the actuation unit including a second actuator portion in cooperation with the first actuation unit and configured to selectively move the hair transplant system between a first position in which the extracting needle is at substantially the same longitudinal position as the implanting needle, and a second position in which the extracting needle is longitudinally displaced from the implanting needle in a proximal direction.
• a hair transplant method comprises providing a hair transplant system, the hair transplant system comprising a casing; an implantation unit received in the casing, the implantation unit including an implanting needle at a distal end thereof; an extraction unit received in the implantation unit, the extraction unit including an extracting needle at a distal end thereof; and a foot plate, wherein the hair transplant system is movable between a first position in which the extracting needle is at substantially the same longitudinal position as the implanting needle, and a second position in which the extracting needle is longitudinally displaced from the implanting needle in a proximal direction, and wherein in the first position, the extracting needle and the implanting needle cooperate to form a split needle; in a state of the hair transplant system being in the first position, extracting a hair follicle from a donor site with the split needle; moving the hair transplant system from the first position to the second position; locking the foot plate at a location corresponding to the second position; in
• a method of manufacturing a hair transplant system comprises providing a casing; inserting an implantation unit in the casing, the implantation unit including an implanting needle at a distal end thereof; inserting an extraction unit in the implantation unit, the extraction unit including an extracting needle at a distal end thereof and a first actuator portion at a proximal end thereof; and inserting an actuation unit in the casing and over the extraction unit, the actuation unit including a second actuator portion in cooperation with the first actuation unit and configured to selectively move the hair transplant system between a first position in which the extracting needle is at substantially the same longitudinal position as the implanting needle, and a second position in which the extracting needle is longitudinally displaced from the implanting needle in a proximal direction.
• FIG. 1 A illustrates a perspective view of an example of a hair transplant device in accordance with various aspects of the present disclosure.
• FIG. IB illustrates an exploded view of the hair transplant device of FIG. 1A.
• FIG. 2 illustrates a perspective view of an example of the extraction unit of FIGS. 1A-1B.
• FIG. 3 illustrates a perspective view of an example of the implantation unit of FIGS. 1A-1B.
• FIG. 4 illustrates a perspective view of an example of the actuation unit of FIGS.
• FIG. 5 illustrates a perspective view of an example of the foot plate of FIGS. 1A-1B.
• FIG. 6A illustrates a perspective view of an example position configuration of the hair transplant device of FIGS. 1A-1B.
• FIG. 6B illustrates perspective view of another example position configuration of the hair transplant device of FIGS. 1 A-1B.
• FIG. 7 illustrates an example of a hair transplant method in accordance with various aspects of the present disclosure.
• FIG. 8 illustrates an example state of a hair transplant device during operations of FIG. 7.
• FIG. 9 illustrates an example state of a hair transplant device during operations of FIG. 7.
• FIG. 10 illustrates an example state of a hair transplant device during operations of FIG. 7.
• FIG. 11 illustrates an example state of a hair transplant device during operations of FIG. 7.
• FIG. 12 illustrates an example a hair transplant system in accordance with various aspects of the present disclosure.
• FIG. 13 illustrates an example of a method of manufacturing a hair transplant device in accordance with various aspects of the present disclosure.
• any reference to an element herein using a designation such as “first,’ 7 “second,” and so forth does not limit the quantity or order of those elements, unless such limitation is explicitly stated. Rather, these designations may be used herein as a convenient method of distinguishing between two or more elements or instances of an element. Thus, a reference to first and second elements does not mean that only two elements may be employed there or that the first element must precede the second element in some manner. Also, unless stated otherwise a set of elements may comprise one or more elements.
• the term “or” as used herein is intended to indicate exclusive alternatives only when preceded by terms of exclusivity, such as ‘'only one of,” or “exactly one of.”
• a list of “only one of A, B, or C” indicates options of: A, but not B and C; B, but not A and C; and C, but not A and B.
• a list preceded by “one or more” (and variations thereon) and including “or” to separate listed elements indicates options of one or more of any or all of the listed elements.
• the phrases “one or more of A, B, or C” and “at least one of A, B, or C” indicate options of: one or more A; one or more B; one or more C; one or more A and one or more B; one or more B and one or more C; one or more A and one or more C; and one or more A, one or more B, and one or more C.
• a list preceded by “a plurality of’ (and variations thereon) and including “or” to separate listed elements indicates options of one or more of each of multiple of the listed elements.
• phrases “a plurality of A, B, or C” and “two or more of A, B, or C” indicate options of: one or more A and one or more B; one or more B and one or more C; one or more A and one or more C; and one or more A, one or more B, and one or more C.
• the present disclosure provides systems and methods for transplanting hair follicles from a donor site to a recipient site using a hair transplant system and method.
• the hair transplant device described herein includes two needles which cooperate to form a split needle.
• a split needle is a single hypodermic needle with multiple tips split into two halves.
• One half of the split needle is attached to the extraction unit and configured to extract at least one hair follicle from a donor site and a second half of the split needle is attached to an implantation unit configured to form an opening into a recipient site.
• a hair transplant device 100 for extracting hair follicles from a donor site of a donor and implanting them into a recipient site of a patient is illustrated.
• These hair follicles, or follicular units can contain a single hair or multiple hairs grouped together.
• the donor and patient may be the same or different persons.
• the donor site is a portion of the scalp located on the rear of a patient's head
• the recipient site is a portion of the scalp located on the top and/or sides of the same patient’s head.
• the hair transplant device 100 includes a casing 110, an implantation unit 120, an extraction unit 130 (shown in FIG. IB), and an actuation unit 140.
• the implantation unit 120 is configured to form an opening into a recipient site.
• FIG. 1 A illustrates the hair transplant device 100 in an assembled view
• FIG. IB illustrates the hair transplant device 100 in an exploded view.
• the casing 110 is configured to receive an implantation unit 120 and an extraction unit 130 therein. Both the implantation unit 120 and the extraction unit 130 include a needle at a distal end thereof.
• the terms ‘'proximal” and “distal” refer to the position along a longitudinal axis of the hair transplant device 100, from the perspective of an operator of the hair transplant system. Thus, in use, the proximal end portion is located nearer to the operator, and the distal end portion is located nearer to the patient.
• the proximal end portion of the casing is configured to receive a pin 160.
• a first resilient element 182 is coupled to the extraction unit 130 and a second resilient element 184 is coupled to the implantation unit 120 and footplate 150.
• the pin 160 extends through a center of the casing 110.
• the pin 160 is configured to cause the extracting needle 120 to selectively take in or eject a hair follicle.
• the pin 160 includes a distal end and a proximal end.
• the distal end of the pin 160 is covered with a mesh (not shown), and the proximal end of the pin 160 may have a port to allow a connection to a vacuum source.
• the mesh can be configured to prevent a core extracted from the donor site from being pulled into a central lumen of the pin 160.
• the mesh can provide a surface that allows suction therethrough, but does not allow the passage of objects such as the extracted core.
• the mesh can define a porous surface including a plurality of holes. The proximal end of the pin 160 is inserted into the actuation unit 140.
• the first resilient element 182 and second resilient element 184 are a spring. However, in other implementations the first resilient element 182 and second resilient element 184 may be another device that exerts a biasing force. Several of the components of the hair transplant system 100 are illustrated in more detail in FIGS. 2-5.
• the extraction unit 130 includes an extracting needle 132, an extracting needle mount 134, and an extracting needle carrier 136 including a first actuator portion 138 formed on a proximal end portion thereof.
• the first actuator portion 138 is configured to be received by the actuation unit 140 (FIG. IB).
• the extracting needle 132 may be fixedly mounted on the extracting needle mount 134, for example via an adhesive, a weld. etc.
• the extracting needle mount 134 is shown as including a threaded component which may be received into the extracting needle carrier 136, thereby to permit the extracting needle mount 134 and extracting needle 132 to be removed and disposed if necessary.
• the extracting needle mount 134 may be fixed within the extracting needle carrier 136, such as via an adhesive.
• FIG. 3 illustrates a perspective view of an example of the implantation unit of FIGS. 1A-1B.
• the distal end of the implantation unit 120 includes an implanting needle 122.
• the proximal end of the implantation unit 120 is in the form of an implanting needle carrier 124.
• Each of the extracting needle 132 and the implanting needle 122 may be in the shape as one-half of a coring needle, which is effectively formed in cooperation with the implanting needle 122 as a hollow needle with a coring needle lumen extending therethrough.
• the coring needle may include a first distal cutting end. The distal cutting end is configured to cut into the donor site to form a core in order to extract a hair follicle within the core.
• Each distal cutting end may include a pair of angled surfaces that angle toward each other, intersecting at the distal end of the coring needle. Accordingly, the pair of angled surfaces form a pair of cutting edges disposed on opposite sides of the coring needle lumen.
• each of the extracting needle 132 and the implanting needle 122 may include one angled surface forming one cutting edge. When placed in opposition to one another (i.e., at the same longitudinal position), the needles cooperate to form a split coring needle.
• the actuation unit 140 (FIGS. 1 A-1B) includes a second actuator portion 142. a knurl 144, and a set screw 146.
• the knurl 144 may be replaced with a lever, a push button, or an electronically driven actuator.
• the actuator 140 may be operated manually, electrically, pneumatically, or hydraulically.
• the second actuator portion 142 may be formed as a thread on an interior surface of the actuation unit 140, corresponding to a shape of the thread of the first actuator portion 138 of the extraction unit 130.
• the knurl 144 is configured to permit an operator to rotate the actuation unit 140 while the actuation unit is disposed in the casing 1 10 (e.g., through a window or slot in the casing 110). Rotation of the actuation unit 140 may cause it to advance along the extraction unit 130, thereby to cause advancement of the implantation unit 120.
• the set screw 146 is configured for locking to the implanting needle carrier 124. According to some examples, there may be a plurality of set screws 146.
• the foot plate 150 (FIGS. 1A-1B) includes a slot 152 on a proximal portion.
• the foot plate 150 is coupled to the casing 110 and, if the foot plate 150 is advanced to a certain longitudinal position, the slot 152 is configured to engage the locking mechanism 170.
• the slot 152 may be rectangular.
• the locking mechanism 170 may be a spring activated lock including a lever which is pivotable to selectively engage or disengage the slot 152.
• FIGS. 6A-6B 6 A illustrates a home or initial configuration of the hair transplant device 100 (FIGS. 1 A-1B), with certain components (e.g., the actuation unit 140 and the pin 160) omitted for clarity 7 .
• both the extracting needle and implanting needle are at the same height and the foot plate is 150 is inside of the casing 110.
• the extracting and implanting needles cooperate to form the split coring needle.
• the locking mechanism 170 is in an unlocked state. From this position the actuation unit 140 may advance the footplate 150 and implanting unit 120 forward.
• FIG. 6B illustrates a footplate 150 and implanting needle 122 extended outward toward the patient.
• the implanting needle 122 is longitudinally displaced from the extracting needle 132 in a distal direction and the extracting needle 132 is thus displaced from the implanting needle 122 in a proximal direction, so that it is not exposed.
• the implanting needle 122 acts as a splitting needle.
• the footplate 150 is locked to the casing 100 via the locking mechanism 170.
• the locking mechanism 170 is in a locked state.
• FIG. 7 depicts a method of operation 700 of a hair transplant device. Solely for purposes of explanation, the method 700 will be described as being performed by the hair transplant device 100 of FIGS. 1A-6B. Various states of the hair transplant device 100 are shown in detail in FIGS. 8-11.
• the method 700 begins with providing the hair transplant device 100, which may comprise an implantation unit (e.g., 120, FIG. IB) and an extraction unit (e.g., 130, FIG. IB).
• the operation of the hair transplant device 100 is performed with the hair transplant device 100 in an unlocked position, for example as illustrated in FIG. 8.
• Operation 702 includes setting the hair transplant device 100 to a first position.
• the implanting needle e.g., 122, FIG.
• Operation 704 includes extracting a follicle of the hair by piercing a donor site with the extracting needle.
• a core may be extracted by removing the hair transplant system 100 from the donor site.
• the hair transplant system 100 may then be prepared for implantation.
• the hair transplant device 100 is set to a second position, such as that illustrated in FIG. 9.
• the actuation unit (e.g., 140, FIG. IB) is turned to advance the implanting unit and foot plate.
• the foot plate is locked.
• the footplate is locked to the casing with a locking mechanism (e g., 170, FIG. 1A).
• the implanting needle and the extracting needle are no longer at the same longitudinal position.
• Operation 712 may be performed by turning the actuation unit in the opposite direction compared to operation 706. Because the lock mechanism is engaging the foot plate, the foot plate remains extended.
• the foot plate is unlocked (e.g., by actuating a lever of the locking mechanism) as illustrated in FIG. 11.
• the method 700 may be repeated any number of times until a hair transplant procedure is completed.
• operation 714 may inherently cause the hair transplant device to return to the first position, so it may not be necessary to perform operation 702 on subsequent iterations of the method 700.
• the hair transplant system 100 may include a plurality of extracting needles and implanting needles, which cooperate in pairs to selectively form split coring needles. In such implementations, the method 700 may proceed as illustrated in FIG. 5.
• the method 700 uses two needles for harvesting and implantation; thus, follicles can spend very little time outside of the body, resulting in, for example reduced mechanical trauma and the duration that a follicle is outside the body, and thus reduced instances of shedding. Moreover, there may be no need to manipulate the follicle between extraction and implantation. These benefits may further be enhanced by, for example, decreasing metabolic demand of follicles before and after transplantation, and/or hardening hair follicles against cellular stress and apoptosis.
• a hair transplant system 1200 may include a controller 1210 having one or more inputs, processors, memories, and outputs, and may be configured to operate a single hair transplant device 1230 (e.g., the hair transplant device 100 described above) and/or a matrix of hair transplant devices to carry out steps for extracting hair follicles from a donor site and implanting the hair follicles in the recipient site.
• the system 1200 may automate some or all of the operations described above.
• the system 1200 may automate extraction and implantation operations, and a user may manually attach the implantation unit to the hair transplant device 1230 therebetween.
• the hair transplant device 1230 may be configured with devices (e g., mechanical linkages) to permit the operation of attaching the implantation unit to be automated.
• the hair transplant system 1200 may include, access, or communicate with one or more user interfaces and/or an imaging system 1220, by way of a wired or wireless connection to the inputs.
• the hair transplant system 1200 may include any computing device, apparatus or system configured for carrying out instructions and providing input/output capabilities, and may operate as part of. or in collaboration with other computing devices and sensors/detectors (local and remote).
• the hair transplant system 1200 may be a system that is designed to integrate a variety of software and hardware capabilities and functionalities, and/or may be capable of operating autonomously.
• the input may include any one or more different input elements, such as a mouse, keyboard, touchpad, touch screen, buttons, and the like, for receiving various selections and operational instructions from a user through touch, movement, speech, etc.
• the input may also include various drives and receptacles, such as flash-drives, USB drives, CD/DVD drives, and other computer-readable medium receptacles, for receiving various data and information.
• input may also include various communication ports and modules, such as Ethernet, Bluetooth, or Wi-Fi, for exchanging data and information with these, and other external computers, systems, devices, machines, mainframes, servers or networks.
• the processor 1212 may be configured to execute instructions, stored in the memory 1214 in a non- transitory computer-readable media.
• the instructions executable by the processor 1212 may correspond to various instruction for completing a hair transplant procedure (such as those previously described).
• the memory 1214 may be or include a nonvolatile medium, e.g., a magnetic media or hard disk, optical storage, or flash memory; a volatile medium, such as system memory, e.g., random access memory (RAM) such as dynamic RAM (DRAM), synchronous dynamic RAM (SDRAM), static RAM (SRAM), extended data out (EDO) DRAM, extreme data rate dynamic (XDR) RAM, double data rate (DDR) SDRAM, etc.; on-chip memory; and/or an installation medium where appropriate, such as software media, e.g., a CD-ROM, or floppy disks, on which programs may be stored and/or data communications may be buffered.
• RAM random access memory
• DRAM dynamic RAM
• SDRAM synchronous dynamic RAM
• SRAM static RAM
• EEO extended data out
• XDR extreme data rate dynamic RAM
• DDR double data rate SDRAM
• non-transitory computer-readable media can be included in the memory 1214, it may be appreciated that instructions executable by the processor 1212 may be additionally or alternatively stored in another data storage location having non-transitory computer-readable media.
• the hair transplant system 1200 may be configured to implement cloud storage.
• a “processor” may include one or more individual electronic processors, each of which may include one or more processing cores, and/or one or more programmable hardware elements.
• the processor may be or include any type of electronic processing device, including but not limited to central processing units (CPUs), graphics processing units (GPUs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), microcontrollers, digital signal processors (DSPs), or other devices capable of executing software instructions.
• CPUs central processing units
• GPUs graphics processing units
• ASICs application-specific integrated circuits
• FPGAs field-programmable gate arrays
• DSPs digital signal processors
• a device is referred to as “including a processor,” one or all of the individual electronic processors may be external to the device (e.g., to implement cloud or distributed computing).
• individual operations described herein may be performed by any one or more of the microprocessors or processing cores, in series or parallel, in any combination.
• the processor 1212 may be configured to receive and process image data from a subject, such as a donor or a recipient, captured by the imaging system 1220 to identify hair follicles and hair follicle orientations within a donor site of the donor and/or to determine implantation locations and necessary' implantation angles within a recipient site of the recipient.
• the processor 1212 may access information and data, including video signals, stored in or emitted by the imaging system 1220.
• the imaging system 1220 may acquire either a single image or a continuous video signal using, for example, a camera, an infrared scanning system, or any other image capturing or video recording device that can be used to periodically image and/or scan and/or continuously record the subject.
• the imaging system 1220 may be utilized to align the coring needles of the hair transplant devices 1230 along a hair shaft or a plurality of hair shafts.
• the imaging system 1220 can include a camera such as a standard complementary’ metal-oxide-semiconductor (CMOS) camera, a charge-coupled device (CCD) camera, or an optical coherence tomography (OCT) imaging device.
• CMOS complementary metal-oxide-semiconductor
• CCD charge-coupled device
• OCT optical coherence tomography
• the OCT imaging device may allow for more precise alignment of the coring needles with reference to the hair shafts due to the capability of OCT imaging to see vertically into the tissue.
• the hair transplant device 1230 under control of the automated hair transplant system 1200, may position itself over the recipient site for implantation of the hairs.
• a computer image may similarly be obtained of the recipient site that may show a natural hair line for the patient and direct where the hairs should be implanted.
• the ability of the needles to move independently may allow for better shaping and following of a natural hair line.
• the patient may be positioned in a support holder or laying down to limit movement during this process.
• the output of the hair transplant system 1200 is configured to effectuate the operation of the hair transplant devices 1230.
• the output may include various robotic devices capable of manipulating and operating the hair transplant devices 1230 and the interface features thereof, to effectuate extraction of hair follicles from a donor site, creation of openings within the recipient, and implantation of the hair follicles within the openings of the recipient, as described above.
• a user such as a doctor or other hair transplant procedure personnel, can interact with a user interface of the hair transplant system 1200 to command the automated hair transplant system 1200 to effectuate a hair transplant procedure on a subject in accordance with any of the devices and methods described herein.
• FIG. 13 depicts a method 1300 of manufacturing and assembly of a hair transplant system, which may be the hair transplant device 100 illustrated in FIG. 1A.
• the method 1300 includes a first operation 1302 of providing a casing (e.g. as shown in FIG. 1 A).
• the casing may include a locking mechanism such as a spring activated lock.
• the method 1300 includes a second operation 1304 of inserting an implantation unit (e.g., 120 of FIG. IB) into the casing.
• the implantation unit including an implanting needle and implanting needle carrier.
• the method 1300 includes a third operation 1306 of inserting the extraction unit (e.g. 130 of FIG. IB) into the implantation unit.
• the extraction unit includes an extracting needle and extracting needle carrier.
• the method includes a fourth operation 1308 of inserting an actuation unit into the casing and over the extraction unit.
• the casing may be configured to receive a foot plate on the distal end and an actuation unit on the proximal end.
• the actuation unit is configured to selectively advance the footplate and implantation unit forward concurrently the footplate gets locked into the casing with the locking mechanism.
• the hair transplantation device 100 may be manufactured in an assembled state, and thus method 1300 may be followed by inserting the implantation unit into the casing, inserting the extraction unit in the implantation unit and inserting the actuation unit into the casing and over the extraction unit. Variations on the method 1300 are also contemplated.
• the hair transplant device 100 may be manufactured by providing the various components in any order, and then assembling the components.

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• 2023
  • 2023-11-08 EP EP23889647.6A patent/EP4615347A1/de active Pending
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