Patent Description:
Presently, this procedure is generally 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 implanting a single hair follicle at a time. A single hair transplant session may implant anywhere from <NUM>,<NUM> to <NUM>,<NUM> hair follicles. With each hair follicle taking as long as twenty seconds to transplant, each session is very labor intensive and can last as long as eight to ten hours. As such, the current process for hair transplantation is tedious, time-consuming, and costly.

<CIT> discloses a hair transplant device which comprises a cylindrical first cutting member having a bent blade, a cylindrical second cutting member moving forward/backward along the interior of the first cutting member, an extrusion member moving forward/backward along the interior of the second cutting member, and a housing providing a induction road for the second cutting member and the extrusion member. <CIT> relates to the implantation of hair follicles and teaches that the distal tip of an obturator exits the distal end of an implanting cannula in order to insert a hair follicle into an implantation site. The obturator maintains the follicular unit in the implantation cavity as the implanting cannula is withdrawn from the body surface by translational movement relative to the obturator. Once the implanting cannula is withdrawn, the obturator is also withdrawn, with the follicular unit implanted in the body surface.

The present disclosure overcomes the above and other drawbacks by providing systems for hair transplants using a hair transplant device that can extract a hair follicle from a donor site, create an opening in a recipient site, and implant the hair follicle within the opening in the recipient site. The systems of the present disclosure are capable of extracting multiple hair follicles from the donor site simultaneously, creating multiple openings in the recipient site simultaneously, and implanting multiple hair follicles within the multiple openings in the recipient site. This process may be done, in some implementations, simultaneously. As such, systems are provided for improved hair transplant procedures that increase extraction speed, opening speed, and implantation speed, thereby increasing efficacy and reducing cost.

The foregoing and other advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings that form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention.

Referring to <FIG>, a hair transplant device <NUM> 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. As can be seen in the illustration of <FIG>, the hair transplant device <NUM> includes a housing <NUM> containing a coring element <NUM>, a splitting element <NUM>, and a user interface <NUM>.

The housing <NUM> extends between a proximal end <NUM> and a distal end <NUM>. The housing <NUM> includes an opening <NUM> in the distal end <NUM>. In some instances, the housing <NUM> may taper toward the distal end <NUM>, as illustrated in <FIG>. In other instances, the housing <NUM> may alternatively have a distal end <NUM> that is round, flat, or any other suitable shape.

As will be further described, the housing <NUM> may be configured for connection with an automated system, such as, for example a computer-aided manufacturing (CAM) system, for automated use of the hair transplant device <NUM>. As will also be described, the housing <NUM> may additionally be configured for connection with several other similar hair transplant devices, such that an array of hair transplant devices similar to the hair transplant device <NUM> is provided to allow for automated extraction and/or implantation of multiple hair follicles in series or simultaneously. In some instances, the housing <NUM> may additionally or alternatively be configured for manual manipulation (e.g., can include a handle).

The coring element <NUM> is disposed within the housing <NUM> proximate the distal end <NUM>. The coring element <NUM> includes a central lumen <NUM> extending axially through both a coring element flange <NUM> and a coring needle <NUM>. The central lumen <NUM> is centrally disposed within and may extend through the coring element <NUM>, from a proximal surface of the coring element flange <NUM> through a distal end of the coring needle <NUM>. The coring element flange <NUM> extends radially outward at a proximal end of the coring element <NUM>, terminating at an outer surface <NUM>. The outer surface <NUM> of the coring element flange <NUM> slidably engages an inner surface <NUM> of the housing <NUM>.

The coring needle <NUM> extends distally from a distal surface of the coring element flange <NUM>, beyond the opening <NUM> in the distal end <NUM> of the housing <NUM>. As best illustrated in <FIG>, the coring needle <NUM> may be formed as a hollow needle, with the central lumen <NUM> extending therethrough. Further, the coring needle <NUM> may include a distal cutting portion <NUM>. The distal cutting portion <NUM> may be disposed completely outside of the housing <NUM> and include a pair of angled surfaces <NUM> that angle toward each other, intersecting at the distal end of the coring needle <NUM>. Accordingly, the pair of angled surfaces <NUM> form a pair of cutting edges <NUM> disposed on opposite sides of the central lumen <NUM>. The pair of cutting edges <NUM> are effectively aligned across the coring needle <NUM>, such that they both extend radially from an inner surface of the coring needle <NUM> to an outer surface of the coring needle <NUM>. As such, the coring needle <NUM> is configured to cut into tissue by driving the coring needle <NUM> into the tissue, without needing to rotate the coring needle <NUM>.

The coring element <NUM> is movable between a retracted position (shown in <FIG>) and an extended position (shown in <FIG> and <FIG>) and may be controlled, for example, through the user interface <NUM> or an automated control system, as will be described. In the extended position, the coring element <NUM> is moved distally relative to the housing <NUM> to allow for extraction of a hair follicle, as will be described below. In the retracted position, the coring element <NUM> is moved proximally, such that a smaller portion of the coring needle <NUM> extends out of the opening <NUM> in the distal end <NUM> of the housing <NUM>.

Referring again to <FIG>, the splitting element <NUM> is also disposed within the housing <NUM> proximate the distal end <NUM>, partially enveloping the coring needle <NUM> of the coring element <NUM>. The splitting element <NUM> similarly includes a central lumen <NUM> extending axially through a splitting element flange <NUM> and a splitting needle <NUM>. The central lumen <NUM> is centrally disposed within and extends all the way through the splitting element <NUM>, from a proximal surface of the splitting element flange <NUM> through a distal end of the splitting needle <NUM>. The central lumen <NUM> of the splitting element <NUM> further has an inner diameter that is slightly larger than the outer diameter of the coring needle <NUM> of the coring element <NUM>, such that coring needle <NUM> can be inserted therethrough, and the splitting element <NUM> can slide relative to the coring element <NUM> on the coring needle <NUM>, as will be described below.

The splitting element flange <NUM> extends radially outward at a proximal end of the splitting element <NUM>, terminating at an outer surface <NUM>. The outer surface <NUM> of the splitting element flange <NUM> slidably engages the inner surface <NUM> of the housing <NUM>. The splitting element flange <NUM> is further disposed more proximate the distal end <NUM> of the housing <NUM> than the coring element flange <NUM>.

The splitting needle <NUM> is coaxially disposed around the coring needle <NUM> and extends distally from the splitting element flange <NUM>. As best illustrated in <FIG>, the splitting needle <NUM> is a hollow needle, with the central lumen <NUM> extending therethrough. Further, the splitting needle <NUM> includes a distal cutting edge <NUM> that is angled relative to a central axis of the splitting needle <NUM>. The distal cutting edge <NUM> has a specific cutting geometry (e.g., the angle of the distal cutting edge <NUM>) that controls against tissue from entering the splitting needle <NUM> while the splitting needle <NUM> cuts into skin by piercing the skin and gradually pushing the tissue apart, similar to the function of a hypodermic needle.

The splitting element <NUM> is movable between a retracted position (shown in <FIG> and <FIG>) and an extended position (shown in <FIG>) and may be controlled, for example, through the user interface <NUM> or an automated control system, as will be described. In the retracted position, the splitting element <NUM> is advance proximally such that the distal end of the splitting needle <NUM> is disposed within the housing <NUM>, more proximal than the distal end of the coring needle <NUM>. Further, in the retracted position, the proximal surface of the splitting element flange <NUM> may contact the distal surface of the coring element flange <NUM>. In the extended position, the splitting element <NUM> is moved distally, such that a portion of the splitting needle <NUM> extends out of the opening <NUM> in the distal end <NUM> of the housing <NUM>, past the distal end of the coring needle <NUM>.

Referring again to <FIG>, the user interface <NUM> is disposed to extend from the housing <NUM>, near the proximal end <NUM>, and is partially enveloped by the coring element <NUM>. The user interface <NUM> may include a pin <NUM>, a head <NUM>, and a spring <NUM>. The pin <NUM> extends distally from the head <NUM>, and is disposed partially within the central lumen <NUM> of the coring element <NUM>. The illustrated pin <NUM> includes a distal tip surface <NUM> that is flat. However, in some instances, the distal tip surface <NUM> could alternatively be round, pointed, or any other suitable shape. The head <NUM> extends radially outward at a proximal end of the user interface <NUM>, past an outer diameter of the pin <NUM> to present a surface upon which a force or pressure can be exerted by a user to control actuation of the system. In some instances, the head <NUM> may be configured for connection with the automated system, such that the user interface <NUM> can be moved automatically. For example, in some instances, the user interface <NUM> can be actuated using a solenoid actuator to push the coring element <NUM> or the splitting element <NUM> through the scalp. The solinoid actuator may have enough force to drive a single or multiple elements or needles into the tissue. In other instances, the head <NUM> may additionally or alternatively be configured for other kinds of automated or manual manipulation.

The spring <NUM> is disposed around the pin <NUM>, between a distal surface of the head <NUM> and the proximal surface of the coring element flange <NUM> of the coring element <NUM>. The spring <NUM> is configured to compress when the user interface <NUM> is advanced distally, thereby providing a resistive force preventing the user interface <NUM> from entering the central lumen <NUM> of the coring element <NUM>.

The user interface <NUM> is movable between a retracted position (shown in <FIG> and <FIG>) and an inserted position (shown in <FIG>). In the retracted position, the user interface <NUM> is moved proximally, such that only a small portion of the pin <NUM> is disposed within the central lumen <NUM> of the coring element <NUM>. In the inserted position, the user interface <NUM> is moved distally a predetermined amount, such that a majority of the pin <NUM> is disposed within the central lumen <NUM>, and the distal tip surface <NUM> of the pin <NUM> is disposed proximate the distal end of the coring needle <NUM>.

In some instances, the user interface <NUM> may further include a central lumen <NUM> extending axially from a proximal surface of the head <NUM> through the distal tip surface <NUM> of the pin <NUM>. The central lumen <NUM> may be included to allow for flow of a gas or a liquid through the user interface <NUM>. In these cases, the head <NUM> may be coupled to a fluid delivery system and/or a fluid aspiration system to provide gas or liquid through the user interface <NUM> and/or to suction gas or liquid through the user interface <NUM>.

Now that the general structure of the hair transplant device <NUM> has been described above, exemplary methods of use will be described below. It should be noted that the methods of use described below are not encompassed by the wording of the claims.

The hair transplant device <NUM> can be used to perform multiple different procedures to complete a hair transplant operation on a patient. For example, the device <NUM> is designed to perform an extraction procedure (shown in <FIG>); an opening procedure (shown in <FIG>); and an implantation procedure (shown in <FIG>). Although any one of these three procedures can be performed individually by the hair transplant device <NUM>, the hair transplant device <NUM> allows for the three procedures to be done sequentially and repetitively. That is, the hair transplant device <NUM> can first be used to extract a hair follicle from a donor site of a donor during an extraction procedure. The hair transplant device <NUM> can then, while still containing the hair follicle from the donor site, be used to create an opening that is configured to receive the hair follicle in a recipient site of the patient. Then, the hair transplant device <NUM> can be used to implant the hair follicle from the donor site into the recipient site. Finally, once the hair follicle has been implanted into the recipient site, the hair transplant device <NUM> can be used to repeat this process again and again to complete the hair transplant operation. This process may be repeated, for example, tens, hundreds, or even thousands of times.

<FIG> illustrate the hair transplant device <NUM> being used during an extraction procedure. As illustrated, the hair transplant device <NUM> can first be placed above a donor site <NUM> of a donor in an extraction position, as shown in <FIG>. In the extraction position, both the splitting element <NUM> and the user interface <NUM> are in the corresponding retracted positions. As such, the coring needle <NUM> is exposed outside of the distal end <NUM> of the housing <NUM>. With the hair transplant device <NUM> in the extraction position, the coring needle <NUM> can then be inserted into the donor site <NUM> around a skin core <NUM>, with the pair of cutting edges <NUM> cutting through the surrounding donor tissue <NUM>, as illustrated in <FIG>. The central lumen <NUM> of the coring needle <NUM> may define an inner diameter that is larger than the average distance between hair follicles within the donor site <NUM> (i.e., approximately <NUM>). As such that the hair transplant device <NUM> should always extract skin cores <NUM> containing, along with other skin components (e.g., epidermis, collagen, elastin, blood vessels, etc.), at least one hair follicle having at least one hair <NUM> during the extraction procedure.

As described below, the coring needle <NUM> can be inserted at varying angles to extract the skin core <NUM> having the hair follicle in a desired orientation. This variation of the angle of insertion can be controlled using the automated system described above. After insertion, the coring needle <NUM> can then be removed from the donor site <NUM>, still containing the skin core <NUM> within the coring needle <NUM>, thereby leaving a small opening <NUM> in the donor site <NUM>.

It should be noted that, during the extraction procedure, in the instances where the user interface <NUM> includes the central lumen <NUM> (as shown in <FIG>), suction or negative pressure may be provided through the user interface <NUM> into the coring needle <NUM> by the fluid aspiration system when removing the coring needle <NUM> to provide additional control and force for removing the skin core <NUM> from the donor site <NUM>. In these instances, a porous stop <NUM> (shown in <FIG>) may be incorporated into the needle bore to prevent the skin core <NUM> from being drawn too far into the coring needle <NUM>. Said differently, the porous stop <NUM> is configured to prevent the skin core <NUM>, potentially containing a hair follicle, from being drawn past a predetermined position within the coring needle <NUM>.

<FIG> illustrate the hair transplant device <NUM> being used during an opening procedure. As illustrated, the hair transplant device <NUM> can first be placed above a recipient site <NUM> of a recipient in an opening position, as shown in <FIG>. In the opening position, the user interface <NUM> remains in the retracted position, but the splitting element <NUM> is moved into the extended position. As such, the distal end of the splitting needle <NUM> is extended slightly past the distal end of the coring needle <NUM>. With the hair transplant device <NUM> in the opening position, the splitting needle <NUM> (and also the coring needle <NUM>) can be inserted into the recipient site <NUM>, with the distal cutting edge <NUM> forming an opening in the tissue <NUM>, thereby creating a small opening <NUM> in the recipient site <NUM>. Notably, though illustrated as creating this small opening <NUM> at an angle that is normal to a surface of the recipient site <NUM>, the small opening <NUM> may be formed at an angle that is non-normal. Such non-normal angles may be facilitated by angling surfaces of the splitting needle <NUM> and/or orienting the splitting needle <NUM> to engage the recipient site <NUM> at a non-normal angle, as described below.

<FIG> illustrate the hair transplant device <NUM> being used during an implantation procedure. As illustrated, with the distal ends of both the splitting needle <NUM> and the coring needle <NUM> inserted into the small opening <NUM> created during the opening procedure, and the skin core <NUM> disposed within the coring needle <NUM>, the hair transplant device <NUM> can be moved into the implantation position. In the implantation position, the splitting element <NUM> can remain in the extended position, and the user interface <NUM> can be moved into the inserted position. While the user interface <NUM> is moved into the inserted position, the pin <NUM> eventually comes into contact with the skin core <NUM>, thereby pushing the skin core <NUM> out of the coring needle <NUM>, into the small opening <NUM>. As such, the depth of the implantation of the skin core <NUM> into the small opening <NUM> can be controlled by the predetermined amount that the user interface <NUM> is moved distally. After the skin core <NUM> has been pushed out of the coring needle <NUM>, into the small opening <NUM>, the splitting needle <NUM> and the coring needle <NUM> can be removed from the small opening <NUM>, leaving the skin core <NUM> having the hair follicle implanted therein.

In some instances, the user interface <NUM> may be configured to remain in contact with the skin core <NUM> while the coring needle <NUM> and the splitting needle <NUM> are withdrawn from the recipient site <NUM>. Specifically, in instances not according to the claimed invention, the user interface <NUM> may be long enough to protrude distally out of both the coring needle <NUM> and the splitting needle <NUM> when they are moved into their corresponding retracted positions within the hair transplant device <NUM>. As such, the user interface <NUM> can provide pressure to the skin core <NUM> to keep the skin core <NUM> within the opening <NUM> while the coring needle <NUM> and the splitting needle <NUM> are withdrawn. In some cases, the pressure from the user interface <NUM> can be maintained for an extended period of time (e.g., one to two minutes) to aid in the reduction of bleeding from the recipient site <NUM>.

Similar to the extraction procedure above, the skin core <NUM> can be implanted at various angles to create a more natural hair appearance in the recipient site by implanting the skin core <NUM> having the hair follicle in a desired orientation, as described below.

As shown in <FIG>, any of extraction, splitting, and/or implantation may be performed at angles that are non-normal to the extraction or donor sites. Said differently, the hair transplant device <NUM> can be used to extract the skin core <NUM> with the central lumen <NUM> of the coring element <NUM> aligned with a hair follicle axis <NUM> (i.e., an axis of orientation of the hair <NUM> of the hair follicle) that is not normal to a skin surface <NUM> of the donor site <NUM> (as shown in <FIG>). The hair transplant device <NUM> can further be used to create an angled opening <NUM> that is not normal to a skin surface <NUM> of the recipient site <NUM> (as shown in <FIG>). Then, the hair transplant device <NUM> can be used to insert the skin core <NUM>, within the angled opening <NUM>, with the hair follicle axis <NUM> at an angle that is not normal to the skin surface <NUM> (as shown in <FIG>).

Once implanted, the hair <NUM> of the hair follicle will grow in the direction of the hair follicle axis <NUM>. As such, extracting the skin core <NUM> with the central lumen <NUM> of the coring element <NUM> aligned with the hair follicle axis <NUM> allows the skin core <NUM> to be implanted such that the hair <NUM> will grow at a known angle relative to the skin surface <NUM> of the recipient site <NUM>. Accordingly, the skin core <NUM> can be implanted at varying angles to produce a natural-looking hair line in the recipient site <NUM>. In some instances, the skin cores <NUM> can be extracted and/or implanted at angles of up to <NUM> degrees relative to the donor site <NUM> and/or the recipient site <NUM>.

For example, these non-normal orientations may be facilitated by the arrangement of cutting surfaces and/or arrangement of the device relative to the subject. In fully automated implementations, angle control or selection can be controlled by the automated system described above. In manual implementations, device selection from among different devices with differing geometries and/or user orientation of device during the process may control angle selection.

Further, during the implantation procedure, in the instances where the user interface <NUM> includes the central lumen <NUM> (as shown in <FIG>), positive pressure may be provided through the user interface <NUM> into the coring needle <NUM> by the fluid delivery system to provide additional control and force for pushing the skin core <NUM> out of the coring needle <NUM>. Additionally or alternatively, during the implantation procedure, various fluids can be provided through the central lumen <NUM> of the user interface <NUM> into the coring needle <NUM> by the fluid delivery system to assist in procedures, therapy, and biology related to the implantation of hair follicles. These fluids can be any of lubricants, flushing fluids, cleansing fluids, anesthesia fluids, medicinal fluids, or any other fluids desired to be applied through the coring needle <NUM>.

For example, in some instances, during an extraction procedure, the hair transplant device <NUM> can be used to inject a saline solution under the donor site <NUM> to make the hair follicles stand up more normal to the donor site <NUM>. In some other instances, the hair transplant device <NUM> can be used to apply tumescent anesthesia to the donor site <NUM>.

Further, as shown in <FIG>, the fluid delivery system can continuously push a flow (signified by arrows <NUM>) of fluid (e.g., air) through the central lumen <NUM> of the coring element <NUM> to blow any long hairs <NUM> of the donor site <NUM> away from the hair transplant device <NUM> (as shown in <FIG>). With the long hairs <NUM> blown away from the coring element <NUM>, the coring element <NUM> can be used to extract the skin core <NUM> (as shown in <FIG>), as described above with reference to <FIG>. By blowing the long hairs <NUM> away from the hair transplant device <NUM>, the hair transplant device <NUM> is capable of extracting a skin core <NUM> containing a hair follicle from the donor site <NUM>, without needing to first trim or clip the long hairs <NUM>.

Referring now to <FIG>, a hair transplant device <NUM> for extracting tens, hundreds, or thousands of hair follicles simultaneously from a donor site of a donor and then implanting the tens, hundreds, or thousands of hair follicles simultaneously into a recipient site of a patient is illustrated. As can be seen in the illustration of <FIG>, the hair transplant device <NUM> includes a body <NUM> containing a plurality of hair transplant devices <NUM>. Each of the plurality of hair transplant devices <NUM> work identically to the hair transplant device <NUM> described above.

As illustrated, there are two hair transplant device <NUM> separated from a third hair transplant device <NUM> by three sets of ellipses <NUM>. The ellipses <NUM> illustrate that the hair transplant device <NUM> can include any number of hair transplant devices <NUM> desired for a given hair transplant operation. For example, the hair transplant device <NUM> can include a two dimensional array of including tens, hundreds, or thousands of hair transplant devices <NUM> configured to allow for the simultaneous extraction of tens, hundreds, or thousands of hair follicles from a donor site, the simultaneous opening of tens, hundreds, or thousands of small openings on a recipient site, and the simultaneous implantation of tens, hundreds, or thousands of hair follicles within a recipient site.

The hair transplant device <NUM> can again be configured for use with an automated system, as will be described below. As such, the angle, distribution, and separation between the plurality of hair transplant devices <NUM> can be controlled by the automated system to effectively control the angle, distribution, and separation between simultaneous extractions, such that every one of the plurality of hair transplant devices <NUM> extracts an aligned hair follicle. Similarly, the angle, distribution, and separation between the plurality of hair transplant devices <NUM> can be controlled by the automated system to effectively control the angle, distribution, and separation between simultaneous implantations.

Referring now to <FIG>, a coring device <NUM> having a coring element <NUM>, or an array of coring elements, similar to the coring element <NUM> described above, and a user interface <NUM> (or an array of corresponding pin components), similar to the user interface <NUM> described above, may be used to extract a hair follicle.

(or multiple hair follicles). Again, the user interface <NUM> can be hollow, including a central lumen <NUM>. Then, the coring element <NUM> can be positioned behind a separate splitting device <NUM> (as shown in <FIG>) including a splitting element <NUM> (or a corresponding array of splitting elements), similar to the splitting element <NUM> described above. The splitting device <NUM> can be used to create a small opening in a recipient site, as also described above. It should be noted that either of the coring device <NUM> or the splitting device <NUM> can be configured to engage the automated system, the fluid delivery system, or the fluid aspiration system described above, for similar uses to those described above with reference to the hair transplant device <NUM>.

In some instances, a coring needle <NUM> of the coring element <NUM> can then be inserted through a central lumen <NUM> of the splitting element <NUM> to implant the hair follicle into the small opening created in the recipient site by the splitting element <NUM>. However, in the case that the central lumen <NUM> of the splitting element <NUM> is not large enough for the coring element <NUM> to fit through, with the coring element <NUM> positioned behind the splitting element <NUM>, the user interface <NUM> can be configured to push the hair follicle into and through the central lumen <NUM> of the splitting element <NUM>, into the small opening in the recipient site.

Referring to <FIG>, a rotating chamber container <NUM> for loading and dispensing hair follicles is illustrated. The rotating chamber container <NUM> includes a device port <NUM> and a plurality of hair follicle chambers <NUM>. As illustrated, the rotating chamber container <NUM> includes four evenly spaced hair follicle chambers <NUM>. However, as signified by ellipses <NUM> spanning between each adjacent hair follicle chamber <NUM>, the rotating chamber container <NUM> can include any number of evenly or unevenly spaced hair follicle chambers <NUM>. The device port <NUM> is rotatably coupled to the rotating chamber container <NUM> and configured to engage either of the coring device <NUM> or the splitting device <NUM> described above, thereby selectively coupling either of the coring device <NUM> or the splitting device <NUM> to the rotating chamber container <NUM>.

As such, during a hair transplant operation, the coring device <NUM> can first be attached to the rotating chamber container <NUM> using the device port <NUM>. With the coring device <NUM> attached to the rotating chamber container <NUM>, the coring element <NUM> can then be used to extract a hair follicle from a donor site, as described above. After the coring element <NUM> has extracted a hair follicle from a donor site, suction can be applied through the central lumen <NUM> of the user interface <NUM> to move the hair follicle up, through the device port <NUM>, and into one of the hair follicle chambers <NUM>, thereby loading the hair follicle chamber <NUM>. Once the hair follicle chamber <NUM> has been loaded with the hair follicle, the rotating chamber container <NUM> can be rotated to align the device port <NUM> with the next unloaded hair follicle chamber <NUM>. The coring device <NUM> can then similarly be used to load that hair follicle chamber <NUM>. This process can be repeated until a desired number (or every one) of the hair follicle chambers <NUM> of the rotating chamber container <NUM> has been loaded.

Once the desired number (or every one) of the hair follicle chambers <NUM> has been loaded, the coring device <NUM> can be detached from the rotating chamber container <NUM>, and the splitting device <NUM> can similarly be attached to the rotating chamber container <NUM> using the device port. With the splitting device <NUM> attached to the rotating chamber container <NUM>, the splitting element <NUM> can be used to create a small opening in a recipient site, as described above. Then, positive pressure can move the hair follicle from a hair follicle chamber <NUM>, through the central lumen <NUM> of the splitting element <NUM>, and into the small opening, thereby implanting the hair follicle within the recipient site. This process can repeated several times until every hair follicle within the loaded hair follicle chambers <NUM> has been implanted into the recipient site.

Referring now to <FIG>, an alternate rotating container <NUM> is illustrated. The rotating container <NUM> is similar to the rotating chamber container <NUM>, but instead of having a plurality of hair follicle chambers <NUM>, it has a plurality of hair transplant devices <NUM>. The hair transplant devices <NUM> are substantially similar to the hair transplant device <NUM> described above. As illustrated, there are four hair transplant devices <NUM>. However, again, ellipses <NUM> are shown between the hair transplant devices <NUM> to signify that there could be any number of evenly or unevenly spaced hair transplant devices <NUM> disposed around the circumference of the rotating container <NUM>.

The hair transplant devices <NUM> of the rotating container <NUM> can be used to extract a plurality of skin cores containing hair follicles from a donor site, as described above with respect to the hair transplant device <NUM>. As such, the rotating container <NUM> can first extract a first skin core having a first hair follicle with a first hair transplant device <NUM>. Then the rotating container <NUM> can be rotated, and a second skin core having a second hair follicle can be extracted using a second hair transplant device <NUM>. This can be repeated until the rotating container <NUM> is loaded (i.e., each of the hair transplant devices <NUM> contains a skin core having a hair follicle).

Once the rotating container <NUM> is loaded, the hair transplant devices <NUM> of the rotating container <NUM> can similarly be used to implant the skin cores having the hair follicles within a recipient site, as described above with respect to the hair transplant device <NUM>. As such, the rotating container <NUM> can create a first opening using the first hair transplant device <NUM>, and can subsequently implant the first skin core from the first hair transplant device <NUM> within the first opening. The rotating container <NUM> can then be rotated and used to create a second opening with the second hair transplant device <NUM>. Subsequently, the rotating container <NUM> can implant the second skin core from the second hair transplant device <NUM> within the second opening. This can be repeated until the rotating container <NUM> is unloaded (i.e., each of the skin cores within the hair transplant devices <NUM> have been implanted into the recipient site).

As such, the rotating container <NUM> can be operated in this manner (i.e., loading and unloading the rotating container <NUM>) repetitively to complete a hair transplant procedure.

Referring to <FIG>, a block diagram of an exemplary automated hair transplant system <NUM> configured to operate any of the hair transplant devices described herein is shown. In general, the hair transplant system <NUM> may include a controller <NUM> having one or more inputs <NUM>, processors <NUM>, memories <NUM>, and outputs <NUM>, and may be configured to operate a single hair transplant device <NUM> and/or a matrix <NUM> of hair transplant devices <NUM> to carry out steps for extracting hair follicles from a donor site, creating an opening in a recipient site, and implanting the hair follicles in the recipient site. The hair transplant devices <NUM>, <NUM> can include, for example, any of the hair transplant devices <NUM>, <NUM>, <NUM>, <NUM> described above.

The hair transplant system <NUM> may include, access, or communicate with one or more user interfaces <NUM> and/or an imaging system <NUM>, by way of a wired or wireless connection to the inputs <NUM>. In various implementations, the hair transplant system <NUM> 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). In this regard, the hair transplant system <NUM> 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. In addition, in various configurations, the components illustrated in <FIG> may be implemented using multiple separate components, and similarly, multiple illustrated components can be combined into one component.

The input <NUM> 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 <NUM> 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. To this end, input <NUM> 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.

In addition to being configured to carry out various steps for operating the hair transplant system <NUM>, the processor <NUM> may be configured to execute instructions, stored in the memory <NUM> in a non-transitory computer-readable media <NUM>. The instructions executable by the processor <NUM> may correspond to various instruction for completing a hair transplant procedure. Although the non-transitory computer-readable media <NUM> is shown in <FIG> as included in the memory <NUM>, it may be appreciated that instructions executable by the processor <NUM> may be additionally or alternatively stored in another data storage location having non-transitory computer-readable media.

In some aspects, the processor <NUM> may be configured to receive and process image data from a subject <NUM>, such as a donor or a recipient, captured by the imaging system <NUM> 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. In some aspects, the processor <NUM> may access information and data, including video signals, stored in or emitted by the imaging system <NUM> and/or the user interface <NUM>. In some aspects, the imaging system <NUM> 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 <NUM>.

The output <NUM> of the hair transplant system <NUM> is configured to effectuate the operation of the matrix <NUM> of hair transplant devices <NUM>. As such, the output <NUM> may include various robotic devices capable of manipulating and operating the hair transplant devices <NUM> 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, with reference to any of the hair transplant devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. The hair transplant devices <NUM> can be disposed between approximately <NUM> and <NUM> away from each other to provide a natural-looking hair implant disbursement.

As such, a user <NUM>, such as a doctor or other hair transplant procedure personnel, can interact with the user interface <NUM> to command the automated hair transplant system <NUM> to effectuate a hair transplant procedure on a subject <NUM> in accordance with any of the devices and methods described herein.

Referring now to <FIG>, several different possible matrices are illustrated that are capable of being operated by the hair transplant system <NUM>. As illustrated, the hair transplant system <NUM> is capable of operating matrices of varying shapes and configurations. In some instances, the hair transplant system <NUM> can operate a matrix <NUM> having a rectangular shape with evenly-spaced hair transplant devices <NUM>, as shown in <FIG>. In some other instances, the hair transplant system <NUM> can operate a matrix <NUM> having a circular shape and evenly-spaced hair transplant devices <NUM>, as shown in <FIG>. In yet some other instances, the hair transplant system <NUM> can operate a matrix <NUM> having a circular shape and unevenly-spaced hair transplant devices <NUM>, as shown in <FIG>. As such, the hair transplant system <NUM> can operate matrices of any suitable shape or size, with evenly or unevenly spaced hair transplant devices, as desired by the doctor or other hair transplant procedure personnel.

For example, in some instances, matrices can be designed to implant entire pre-designed hair line implants simultaneously. For example, if it is desired to create a natural-looking hair pattern, such as, for example, a widow's peak, a cowlick, or any other desired hair pattern, a matrix can be designed using a plurality of hair transplant devices in a desired shape, distribution, and angulation to create the desired hair pattern.

Further, each of the coring elements, splitting elements, and pins of the hair transplant devices within each of the arrays may be linked, such that the hair transplant system <NUM> can effectuate all of the coring elements, splitting elements, or pins simultaneously.

Alternatively, the hair transplant system <NUM> can be configured to rapidly effectuate the hair transplant device <NUM> to create any desired hair line and/or hair pattern in a hair-by-hair fashion.

Referring now to <FIG>, various splitting devices and elements can be used in conjunction with or in lieu of the various splitting devices and elements described above to create openings within the recipient site of a recipient. For example, in some instances, a splitting device <NUM> can be provided that includes a splitting element <NUM> that comprises a blade. The blade in these instances does not include a lumen and therefore does not have to be disposed coaxially with the coring needle. Similarly, in some instances, a splitting device <NUM> can be provided that includes a handle <NUM> and a splitting element <NUM> that comprises a sharp stylet. Again, in these instances, the splitting element <NUM> does not include a lumen and therefore does not have to be disposed coaxially with the coring needle.

Referring now to <FIG>, a hair transplant device <NUM> substantially similar to the hair transplant device <NUM> is illustrated. The hair transplant device <NUM> includes a housing <NUM> containing a coring element <NUM>, a splitting element <NUM>, and a user interface <NUM>.

The housing <NUM>, the coring element <NUM>, and the user interface <NUM> each function identically to the housing <NUM>, the coring element <NUM> and the user interface <NUM>. The splitting element <NUM>, however, has a slightly different structure and function than the splitting element <NUM>.

Specifically, the splitting element <NUM> includes a distal cutting end <NUM> having a pair of movable walls <NUM> that are movable between a closed orientation, where the pair of movable walls <NUM> form a distal cutting point <NUM>, as shown in <FIG>, and an opened orientation, where the pair of movable walls <NUM> are bent away from each other, as shown in <FIG>. The distal cutting end <NUM> may be naturally biased toward the closed orientation. In some instances, the pair of movable walls <NUM> may comprise two sharp-tipped, pointed half round metal pieces that are attached to each other at one end. The splitting element <NUM> may be disposed around the shaft of the coring element <NUM> and arranged so that cutting tips of the coring element <NUM> are offset from cutting tips of the splitting element <NUM>.

During the extraction procedure, the coring element <NUM> can be pushed through the distal cutting end <NUM>, thereby forcing the pair of movable walls <NUM> apart, into the opened orientation. With the coring element <NUM> pushed through the distal cutting end <NUM>, the coring element <NUM> can be used to extract the skin core <NUM> from the donor site <NUM>. In some instances, with the coring element <NUM> inserted into the donor site <NUM>, the splitting element <NUM> may be advanced, or the coring element <NUM> may be retracted, such that the distal cutting end <NUM> can move toward the closed orientation. This closure of the distal cutting end <NUM> may aid in the extraction of the skin core <NUM> by cutting or grabbing the tissue of the skin core <NUM>.

While creating the opening in the recipient site <NUM>, the distal cutting end <NUM> is in the closed orientation. With the distal cutting end <NUM> in the closed orientation, the distal cutting point <NUM> splits the tissue of the recipient site <NUM> to create the opening. With the distal cutting end <NUM> disposed within the tissue of the recipient site <NUM>, the coring element <NUM>, which, as illustrated, can contain a skin core <NUM>, can be pushed through the distal cutting end <NUM>, thereby forcing the pair of movable walls <NUM> apart, into the opened orientation. With the coring element <NUM> pushed through the distal cutting end <NUM>, the skin core <NUM> can be implanted within the recipient site <NUM> at a desired depth within the recipient site <NUM>, thereby allowing for precise positioning of the skin core <NUM> within the scalp tissue of the recipient site <NUM>. Once the skin core <NUM> has been implanted within the recipient site <NUM>, the hair transplant device <NUM> can once again be used to extract another skin core <NUM> from the donor site <NUM>.

In some instances, the pair of movable walls <NUM> are made of a material that changes shape in response to external cues (e.g. temperature). As such, the pair of movable walls <NUM> is configured to move between the closed and opened orientations based on a heat memory of the material of the splitting element <NUM>. For example, in some instances, when the splitting element <NUM> is at room temperature, it can be configured to remain in the closed orientation. Then, when the splitting element <NUM> is inserted into the tissue, the temperature increase associated with the tissue can result in the splitting element <NUM> moving into the opened orientation, thereby providing a channel within the recipient site <NUM> for the skin core <NUM> to be implanted into. In some instances, the splitting element <NUM> can be configured to remain in the opened orientation at room temperature. Then, when the splitting element <NUM> is inserted into the tissue, the temperature increase associated with the tissue can result in the splitting element <NUM> moving into the closed orientation, thereby aiding in the removal of the skin core <NUM> from the donor site <NUM>.

Referring to <FIG>, in some instances, the splitting element <NUM> is excluded, and the coring element <NUM> includes a distal cutting end <NUM>, similar to the distal cutting end <NUM>, that is similarly made of a material that changes shape in response to external cues (e.g. temperature). Accordingly, the distal cutting end <NUM> can be open before insertion into the donor site <NUM>. Then, once the distal cutting end <NUM> is inserted into the donor site <NUM>, the distal cutting end <NUM> is configured to move into a closed orientation due to the heat memory of the material. For example, the distal cutting end <NUM> may comprise a bimetallic material or a combination of materials having differing thermal expansion coefficients to provide the natural actuation between the opened and closed orientations. In some instances, the bimetallic material may comprise steel and copper. In other instances, any other suitable materials may be used that provide the necessary thermal expansion properties.

When the distal cutting end <NUM> closes, the skin core is severed and trapped within the coring element <NUM>. With the distal cutting end <NUM> in the closed orientation, the coring element <NUM> can be used to insert the skin core <NUM> into the recipient site <NUM>. With the coring element <NUM> inserted into the recipient site <NUM>, the distal cutting end <NUM> can be opened by, for example, applying heat or cooling to the coring element <NUM>, so that the coring element <NUM> can be withdrawn, leaving behind the skin core <NUM>.

Referring to <FIG>, a coring needle <NUM> is illustrated. The coring needle <NUM> is configured for use with any of the devices, systems, and methods described herein. As shown, the coring needle <NUM> includes a plurality of cutting edges <NUM>. In the illustrated non-limiting examples, the coring needle <NUM> may include four cutting edges <NUM> (as shown in <FIG>) or three cutting edges <NUM> (as shown in <FIG>). In other examples the coring needle <NUM> may include more than four cutting edges <NUM> or less than three cutting edges <NUM>, as desired for a particular procedure.

With fewer cutting edges <NUM>, the epidermal area may end up being cut in a semi-ovoid shape during extraction. This may result in a larger skin core being extracted from the donor site <NUM>, as compared to a perfectly round skin core. In some instances, it may be beneficial to minimize the skin core size during extraction. In these cases, increasing the number of cutting edges <NUM> may allow for a more uniform diameter skin core to be extracted. The additional cutting edges <NUM> increase the force needed to push the coring needle <NUM> through the scalp tissue.

Referring now to <FIG>, in some other instances, extraction of the skin core <NUM> from the donor site <NUM> may be further aided using a flat wire <NUM>. The flat wire <NUM> can be advanced to aid in cutting, tearing, and/or separating the skin core <NUM> from the donor site <NUM>. In the illustrated non-limiting example, there is a single flat wire <NUM> arranged on the outside of the coring needle <NUM>. In other non-limiting examples, there can be two wires opposite each other that are either on the inside or outside the of the coring needle <NUM>. In these instances, when the two wires are advanced along the coring needle <NUM>, they can come toward each other and to cut or grab the skin core <NUM>, thereby aiding in removal.

Referring now to <FIG>, another coring element <NUM> is illustrated. The coring element <NUM>, or in some devices several coring elements similar to the coring element <NUM>, may be employed within a handheld or automated hair transplant device, such as any of the devices, systems, and methods described herein. The coring element <NUM> includes a coring needle <NUM> and a spring <NUM>.

During the extraction procedure, the coring needle <NUM> can be actuated in a spring-loaded manner, using the spring <NUM>. For example, in the illustrated non-limiting example, the spring <NUM> is coupled between a proximal surface <NUM> of the coring needle <NUM> and a surface <NUM> within the corresponding hair transplant device, such as, for example, the user interface. The spring <NUM> is initially stretched past its natural resting length, thereby spring-loading the coring needle <NUM>, as shown in <FIG>. With the coring needle <NUM> positioned and aligned over the donor site <NUM>, the spring <NUM> is quickly released from the surface <NUM>, causing a propagational force to drive the coring needle <NUM>, or, in some instances, a group of needles, into the donor site <NUM>.

In some instances, a pin <NUM>, or multiple pins, may be included within the coring element <NUM>, or the several coring elements, and the distal end of the spring <NUM> can be coupled to the pin <NUM>, such that pulling back on the spring <NUM> creates a suction within the coring element <NUM>, to aid in pulling the skin core(s) <NUM> out of the donor site <NUM>.

During the implantation procedure, the coring element(s) <NUM> and corresponding splitting elements (not shown), similar to the splitting elements described above, may be positioned on the recipient site <NUM>. The spring <NUM> may be restreched or loaded, and subsequently similarly used to drive both a splitting needle of the splitting element and the coring needle <NUM>, disposed within the splitting needle, into the tissue. In some instances, the pin <NUM> can be arranged on the inside of the spring <NUM>, and can be actuated to implant the skin core <NUM> into the recipient site <NUM>. In some other instances, the spring <NUM> may be arranged on the exterior.

Prior to the implantation procedure, key holes may be formed in the recipient site <NUM> by using a hollow spike or a series of hollow spikes. The spikes may be positioned on the recepient site <NUM> and the skin cores <NUM> within the coring needles may be deployed into the recipient site <NUM> through the spikes using the pins. In some instances, the spikes may be made of two halves, attached by a spring-loaded mechanism (e.g., similar to the mechanism in a clothes pin), such that the spikes may be opened and removed after the skin cores <NUM> have been deployed into the recipient site <NUM>.

As shown in <FIG>, in some instances, the skin core <NUM> can be embedded in a molded spike <NUM> created using a mold <NUM>. The molded spike <NUM> has a spiked shape to ease insertion into recipient site <NUM>. The molded spikes <NUM> can have ridges or flanges <NUM> to help anchor them into the recipient site <NUM>. The molded spikes <NUM> can be made of a biomaterial/polymer material having a freezing temperature lower than skin temperature, but not so low as to damage the skin (e.g., room temperature). Accordingly, the molded spikes <NUM> can be formed around the skin core <NUM> and subsequently forced into the recipient site <NUM>. In some instances, the molded spikes <NUM> can be forced into the recipient site using ballistic or pneumatic mechanisms. These mechanisms may function similar to a staple or nail gun.

In some instances, the devices, systems, and methods disclosed herein may be automated, for example, using a robotic system. For example, a robotic arm made for medical uses may be utilized to increase precision of the processes disclosed herein. For example, a series of coring needles may be loaded onto the end of the robotic arm. The coring needles may be configured so that each coring needle may be positoned anglularly or moved closer or further apart from each other. The robotic arm may be controlled by computer vision (i.e., a camera may be utilized to align the robotic arm along a hair shaft or a plurality of hair shalves).

In some non-limiting examples, the camera could be a standard Cmos camera or an OCT imaging device. The OCT imaging device may allow for more precise alignment of the robotic arm with reference to the hair shalves due to the capability of OCT imaging to see vertically into the tissue. Once the skin cores have been extracted, the robotic arm may position itself over the recepient 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 ablitiy of the needles to move independently may allow for better shaping and following of a natural hair line. In some instances, the patient may be positioned in a support holder or laying down to limit movement during this process.

As such, the devices, systems, and methods described herein allow for a user to extract at least one hair follicle from a donor site, create at least one opening in a recipient site, and implant the at least one hair follicle in the at least one opening repetitively using a single device without the need for any physical manipulation of the at least one hair follicle. Accordingly, these devices, systems, and methods allow for more efficient, reliable, and predictable hair transplant procedures than compared to traditional devices, systems, and methods.

Claim 1:
A hair transplant device (<NUM>; <NUM>; <NUM>; <NUM>, <NUM>; <NUM>; <NUM>; <NUM>; <NUM>) comprising:
a coring needle (<NUM>; <NUM>; <NUM>; <NUM>) forming a coring lumen (<NUM>) configured to extract a hair follicle from a donor site (<NUM>), the coring needle including a flange;
a splitting needle (<NUM>) configured to create an opening (<NUM>, <NUM>) in a recipient site (<NUM>);
a housing (<NUM>; <NUM>) at least partially surrounding one of the coring needle and the splitting needle; and
a user interface (<NUM>; <NUM>; <NUM>) extending from the housing and movable relative to the coring needle to push the hair follicle from the coring lumen into the opening in the recipient site formed by the splitting needle;
wherein the coring needle (<NUM>; <NUM>; <NUM>; <NUM>) and the splitting needle (<NUM>) are coaxially disposed within the housing (<NUM>; <NUM>), and are movable relative to the housing, such that the coring needle (<NUM>; <NUM>; <NUM>; <NUM>) and the splitting needle (<NUM>) can be selectively and individually deployed, and
wherein the user interface is movable between a retracted position and an inserted position, and a distal tip (<NUM>) of the user interface is prevented from extending distally past the coring needle via a head of the user interface contacting the flange, the head opposite the distal tip of the user interface.