HK1245616B - Instruments, systems and methods for improving hair transplantation - Google Patents

Description

Apparatus, system and method for improving hair transplantation

Technical Field

The present invention generally relates to instruments, systems and methods, such as hair transplant instruments, systems and methods of use thereof. In particular, the present application relates to automatic or semi-automatic instruments, systems and methods for implanting follicular units or hair grafts in a body surface (e.g., the scalp).

Background Art

With advances in technology, various medical and cosmetic procedures can now be performed using varying degrees of automation, often at high speeds. Some of these procedures are performed using handheld tools, while in other cases, automated systems, such as robotic arms, are utilized. These procedures include, but are not limited to, hair transplantation procedures (hair harvesting and/or hair implantation), skin implants, skin grafts, or tattooing.

During such manual, semi-automatic, or robotic-assisted procedures, there is often a need to collect and store biological units, such as for future inspection or processing, implantation, or reuse. Generally, the medium to be implanted, whether decorative jewelry or biological units (e.g., hair follicle units), is obtained from some storage device prior to its implantation. Typically, these storage devices consist of containers for bulk implants, from which a technician pulls individual implants for implantation. While various storage devices or cartridges have been proposed in the past, further improvements are needed in such storage devices that can be used in manual, partially or fully automated, or robotic-assisted systems and procedures, particularly when large quantities of biological units or other items must be stored and processed.

Summary of the Invention

According to one aspect of the present invention, an apparatus is provided. The apparatus includes a housing configured to accommodate one or more cartridges, wherein each of the one or more cartridges includes at least one indexing feature and a plurality of containers sized and configured to hold biological units. The apparatus also includes: an advancement mechanism operable to load biological units into or eject biological units from one of the plurality of containers while being substantially aligned with the container; and an indexing mechanism including at least one corresponding indexing feature configured to engage with the at least one indexing feature and move a cartridge of the one or more cartridges to align a container of the plurality of containers with the advancement mechanism. The apparatus is further configured to simultaneously accommodate at least a first and a second cartridge of the one or more cartridges, and the advancement mechanism is configured to move into alignment with a first container of the second cartridge without disconnecting the first cartridge from the apparatus.

According to another aspect, an apparatus, such as a hair transplant apparatus, is provided that includes: a first cartridge having at least one first indexing feature and comprising a first plurality of containers, each container being sized and configured to hold a biological unit or object, such as a follicular unit; a second cartridge having at least one second indexing feature and comprising a second plurality of containers, each container being sized and configured to hold a biological unit or object, such as a follicular unit; a housing configured to receive one or more cartridges; an advancement mechanism operable to load or eject the follicular unit into or from one of the first plurality of containers of the first cartridge or one of the second plurality of containers of the second cartridge when substantially aligned with the container; and an indexing mechanism including at least one corresponding indexing feature configured to engage the at least one first indexing feature of the first cartridge and/or the at least one second indexing feature of the second cartridge and to move the first and/or second cartridges to align a container of the first or second plurality with the advancement mechanism. The apparatus may be configured to operably couple the first and second cartridges to the housing or to each other such that a distance between a last container of the first cartridge and a first container of the second cartridge is equal to a predetermined spacing, and wherein the propulsion mechanism is configured to move into alignment with the first container of the second cartridge while the first cartridge remains operably connected to the apparatus, in other words, without removing or disconnecting the first cartridge from the apparatus.

In some embodiments, the apparatus may include an indicator configured to indicate when the last container of the first cartridge has been emptied or filled, or when the last container of the first cartridge is about to be emptied or filled. In other embodiments, at least one of the first cartridge or the second cartridge may include one or more identifiers configured to indicate: 1) the type of object (e.g., biological unit or follicular unit) contained therein, and/or 2) whether the end of the cartridge has been reached. Such an identifier may be, for example, a reference. The apparatus may be configured to automatically disconnect the first cartridge once the advancement mechanism has been moved into alignment with the first container of the second cartridge or substantially upon or after at least one biological unit (e.g., follicular unit) has been discharged from or loaded into the first container of the second cartridge.

The propulsion mechanism can include various structures, configurations, or mechanisms. In certain embodiments, the propulsion mechanism can include a pressure differential. In other embodiments, the propulsion mechanism can include an airtight structure sized and configured to pass through a selected container of the first or second barrel. Retraction of the airtight structure from the selected container can cause the first and/or second barrel to index. The airtight structure can include a recess at a distal end of the airtight structure, which can be configured to accommodate at least a portion of a hair graft, such as a follicular unit. The recess can be positioned around at least a portion of the circumference of the airtight structure, or in some embodiments, around the entire circumference of the airtight structure.

According to another aspect of the present invention, there is provided an apparatus that is removably received in a robotic hair transplantation system, the robotic hair transplantation system comprising a robotic arm, a control mechanism, and an implantation tool, the implantation tool having a lumen therethrough and being connected to and manipulated by the robotic arm. The control mechanism can be adapted to automatically align the selected cartridge container with the lumen of the implantation tool and to advance the follicular unit from the selected container through the lumen of the implantation tool into the body surface. In other embodiments, the apparatus may comprise a follicular unit removal tool having a lumen therethrough, the removal tool being connectable to and manipulated by the robotic arm to position the removal tool over the follicular unit located on the body surface. The control mechanism can be adapted to align the lumen of the removal tool with the selected cartridge container and to advance the follicular unit through the removal tool into the selected cartridge container.

According to another aspect of the present invention, a method for continuously feeding a cartridge into a hair transplantation device or system is provided. In some embodiments, the method includes the steps of aligning an advancement mechanism with a container of a first plurality of containers of a first cartridge, each container of the first plurality of containers being sized and configured to hold a follicular unit; activating the advancement mechanism to push the follicular unit out of or into the container of the plurality of containers; repeating the alignment and activation steps for several containers of the first plurality of containers of the first cartridge; coupling or allowing a second cartridge comprising a second plurality of containers to be coupled to the hair transplantation device or system, each container of the second plurality of containers being sized and configured to hold a follicular unit; and aligning the advancement mechanism with the first container of the second cartridge without first removing the first cartridge from the hair transplantation system or disconnecting the first cartridge from the hair transplantation system. The method may include using the first cartridge that is already preloaded or coupled to the hair transplantation system, or allowing the first cartridge to be manually or automatically coupled to the hair transplantation system. In some embodiments, the method further includes activating the advancement mechanism to push the hair graft out of or into the container of the first plurality of containers. In some embodiments, the method may include manually or automatically disconnecting (or allowing or directing such disconnection) the first cartridge once the advancement mechanism has been moved into alignment with the first container of the second cartridge or substantially when or after at least one follicular unit is discharged from or loaded into the first container of the second cartridge.

In yet another aspect of the present invention, a method for continuously feeding cartridges into an apparatus is provided, the method comprising the steps of aligning an advancement mechanism with a container of a first plurality of containers of a first cartridge, each container of the first plurality of containers being sized and configured to hold a biological unit; activating the advancement mechanism to push the biological unit out of or into the container of the first plurality of containers; allowing a second cartridge comprising a second plurality of containers to be coupled to the apparatus or coupling a second cartridge comprising a second plurality of containers to the apparatus, each container of the second plurality of containers being sized and configured to hold a biological unit; and aligning the advancement mechanism with a first container of the second cartridge while the first cartridge remains coupled to the apparatus. In some embodiments, the method further comprises activating the advancement mechanism to push the biological unit out of or into the container of the first plurality of containers.

According to yet another aspect of the present invention, a propulsion mechanism for expelling biological units (e.g., follicular units) from a storage cartridge container is provided, the propulsion mechanism comprising an elongated body having a distal end including a distal tip. In some embodiments, the propulsion mechanism (e.g., an airtight structure) may include a recess disposed on a first side along the distal end of the elongated body, the recess disposed at the distal tip and having a length for accommodating only the tip portion of the biological (e.g., follicular) units to be stored in the storage cartridge container. The recess may comprise a depth, for example, in the range of from about 0.15 mm to 0.25 mm, or in the range of from about 10% to about 30% of the cross-sectional dimension of the elongated body of the propulsion mechanism. In some embodiments, the recess may be disposed around the entire circumference of the propulsion mechanism, or a substantial portion thereof, for example, 75% to 95% of the circumference of the propulsion mechanism. When the advancement mechanism is successively aligned with the follicular unit so that the proximal end of the tissue portion of the follicular unit is adjacent to the distal tip of the slender body of the advancement mechanism, the tip portion of the follicular unit is completely accommodated by the length of the recess of the slender body and extends along the length of the recess of the slender body.

In certain embodiments, the propulsion mechanism may include a cut-off portion at the distal end of the elongated body, the cut-off portion being positioned at and angled relative to the distal tip. The angle of the cut-off portion may be, for example, between 40 and 50 degrees. The cut-off portion may extend, for example, from approximately 25% to approximately 60% of the cross-sectional dimension of the elongated body of the propulsion mechanism. The angle of the cut-off portion may be based on a desired angle or range of angles at which the propulsion mechanism is aligned with the body surface during operation such that the surface of the cut-off portion is substantially flush with the surface of the body surface. In further embodiments, the propulsion mechanism may include both a recess and a cut-off portion, for example, on opposite sides of the distal end of the propulsion mechanism.

According to yet another aspect of the present invention, a storage cartridge having an improved design is provided. The cartridge includes a plurality of containers for holding, for example, follicular units, hair grafts, or other biological units or body jewelry, to name a few. The cartridge may include a top surface, a bottom surface, a first (or front) face, and a second (or back) face. Each of the containers extends through the body of the cartridge from the first face to the second face and includes a slot extending along at least a portion of the length of the container and an opening on the top surface of the cartridge.

Also provided are methods of ejecting biological units from a storage cartridge using the advancement mechanism of the present invention and methods of loading biological units into the cartridge of the present invention.

The apparatus, systems and methods of the present invention may be implemented to incorporate handheld, manual, partially automated and fully automated, including robotic, system and program uses, for example, for implanting biological units (including follicular units). Other and further objects and advantages of the present invention will become apparent from the following detailed description when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It should be noted that the drawings are not to scale and are intended to serve only as an aid in conjunction with the explanation in the following detailed description. In the drawings, like reference numbers identify similar elements or actions. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes and angles of various elements are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve the legibility of the drawings. Furthermore, the specific shapes of elements as drawn are not intended to be limiting. The features and advantages of the embodiments described herein will become better understood with reference to the specification, claims, and drawings.

1 is a schematic perspective view of an example of a robotic system that may be utilized in conjunction with the apparatus and methods of the present invention;

FIG2 is a schematic perspective view of an example of a hair follicle implant system having one follicular unit cartridge;

FIG3 is a schematic perspective view of an example of a hair follicle implant system having two barrels;

FIG4 is a view of two cartridges positioned adjacent to each other in an example of the system of the present invention;

FIG5 is a bottom view of the two cylinders of FIG4;

6a to 6c illustrate an example of an indexing mechanism according to the present invention;

FIG7 illustrates an example of an upper portion of an indexing mechanism including corresponding indexing features according to the present invention;

FIG8 illustrates an example of the underside of an indexing mechanism including a cam surface that may be implemented in various embodiments of the present invention;

FIG9 shows a flow chart of an example of a methodology according to aspects of the present invention;

FIG10 illustrates an example of a prior art linear follicular unit cylinder;

FIG11 illustrates a linear follicular unit cylinder according to various embodiments of the present invention;

Figure 12 illustrates the follicular unit;

FIG13 shows follicular units loaded into a linear cartridge (such as the cartridge of the example of FIG11 );

FIG14 shows follicular units being expelled from a linear cylinder, such as the cylinder of the example of FIG11 ;

FIG15 shows a schematic representation of an example of an air-sealing structure according to the present invention and its use in conjunction with the cartridge of the present invention;

Figures 16a-b show schematic representations of the airtight structures of Figures 14 and 15;

Figures 17a-b show follicular units being expelled from the tool;

FIG17 c shows a schematic representation of another embodiment of an air-tight structure;

FIG17d shows an example of the air-tight structure of FIG17c disposed inside a tool;

18 is an example of a handheld device for hair transplantation that may be used in conjunction with the devices, systems, and methodologies of the present invention.

DETAILED DESCRIPTION

In the following detailed description, reference is made to the accompanying drawings, which illustrate specific embodiments in which the present invention may be practiced. In this regard, directional terms such as "top," "bottom," "up," "down," "front," "back," "far," "near," and the like are used with reference to the orientation of the figures being described. Because components or embodiments of the present invention can be positioned in several different orientations, directional terms are used for illustrative purposes and are in no way limiting. It should be understood that other embodiments may be utilized, and structural or logical changes may be made without departing from the scope of the present invention. Therefore, the following detailed description should not be viewed in a limiting sense, and the scope of the present invention is defined by the appended claims.

The adjective "automatic" in reference to a system or process as a whole means that some or all of the steps in the particular system or process involve autonomous mechanisms or functions, i.e., the mechanisms or functions do not require manual actuation. Ultimately, one or more steps in a procedure may be automatic or autonomous, with some portions requiring manual input.

As used herein, the term "tool" refers to any number of tools or end effectors capable of performing an action, procedure, or operation in various cosmetic, medical procedures, or applications. For example, the tool may be a needle or cannula adapted for various dermatological applications, tissue transplantation, injection of fat cells (e.g., into the subcutaneous fat layer for facial or body "facelifts"), collagen implantation, injection of hyaluronic acid products and/or myostatin (e.g., ), procedures for facial or body restoration or reconstruction, such as those involving the injection of numerous minute amounts of substances into target intradermal and subcutaneous tissue, or the administration of medications. As used in reference to a hair transplant procedure, a "tool" or "implantation tool" refers to any number of tools or end effectors capable of implanting/inserting follicular units ("FUs") into the body surface. Such tools may have many different forms and configurations. In some embodiments, the tool comprises a hollow tubular shaft. The distal end of the tool (e.g., a punch, a coring device, a cutting and/or trimming device, a needle) is typically sharpened for cutting tissue. The implantation tool can also be sharpened so that the puncture and delivery of FU can be performed in one operation. However, the puncture can be formed by another tool, using an implantation tool that is relatively blunt and used only for delivering follicular units.

As used herein, the terms "operably connected," "coupled," "mounted," or "attached" mean coupled, mounted, or attached, directly or indirectly, through one or more intervening components. Embodiments of the methods of the present invention may be implemented using computer software, firmware, or hardware. Various programming languages and operating systems may be used to implement the present invention.

Continuous feeding of objects into the tool and use of multiple storage devices

According to one aspect of the present invention, systems and methods are provided that allow for the continuous feeding of objects into a tool, for example, which can then be implanted into a body surface. While the various examples and embodiments described herein will utilize the implantation of follicular units (naturally occurring aggregates of 1 to 4 hair follicles) or hair grafts for purposes of describing various aspects of the present invention, it should be understood that the general understanding of the various concepts discussed can be more broadly applied to other appropriate applications. Various applications and procedures where it is beneficial to store objects for use in procedures involving a large number of objects that can be stored in multiple cartridges, or where it is important to avoid damaging the objects being stored, can benefit from the systems, devices, and methods of the present invention. It should be understood that the devices, systems, and methods described herein can be used, for example, for drug delivery, various dermatological procedures, or treatment of various dermatological conditions. Similarly, the present invention can be applied to other objects that can be implanted into a body surface, for example, fat cells, drugs, or skin implants such as body jewelry, which can take the form of subcutaneous, transdermal, or microdermal implants, tattoos, or various biological units, including skin, tissue, or hair. The present invention is particularly beneficial in semi-automatic, automatic or robotic procedures, such as robotic hair transplantation procedures.

For the purposes of this description, with reference to hair transplantation, handheld instruments exist that enable a user to manually create an incision in a body surface and simultaneously or subsequently move follicular units previously loaded into the handheld instrument into the body surface. According to some known devices, follicular units are loaded into a cartridge associated with the handheld instrument, as described, for example, in Rassman's U.S. Patent 5,817,120. However, such devices have limited capabilities. For example, the device of U.S. Patent 5,817,120 has a single cartridge containing a limited number of hair grafts. Once all hair grafts from this cartridge have been implanted, the procedure must be interrupted or stopped to reload new grafts into the cartridge, or alternatively, the empty cartridge must be removed and a new cartridge must be installed to continue the procedure. Commonly assigned U.S. Patent No. 8,211,134 describes systems and methods for harvesting, storing, and implanting biological units, including examples of cartridges, systems, and shuttle subsystems that can form part of manual, partially automated, or robotic hair transplantation equipment.

A problem that cannot be fully solved by known cartridges (including cartridges used in manual or automatic procedures) is the need to effectively replace or reload an empty cartridge with a new cartridge (for example, once all follicular units in the cartridge have been unloaded from the cartridge and implanted into the patient). Generally speaking, it is necessary to stop or terminate the program so that the user can discard the disposable hair implantation instrument and obtain another disposable hair implantation instrument, or remove the empty cartridge from the automatic system so that another cartridge can be inserted into this automatic system. Regardless of the reason, the program usually needs to be terminated, and delays in being able to seamlessly continue the program can cause the loss of valuable time. With regard to robotic procedures, the removal and subsequent replacement of the cartridge may additionally require recalibration of the robotic device, thereby causing further extension of the hair transplantation program. In short, existing devices do not allow for the convenient and effective replacement and loading of multiple cartridges, particularly with minimal interruption to the program. The present invention provides devices, systems, and methods for addressing this problem.

According to one aspect of the invention, a continuous feed of objects (e.g., follicular units) is maintained to the hair unit implantation tool, whether the tool is attached to a manual procedure or an at least partially automated procedure, so as to minimize the need for the user to stop the procedure in order to insert another loaded cartridge into his manual or at least partially automated device.

FIG1 is a schematic perspective view of an example of a robotic system or apparatus 100 that can be used, for example, to harvest follicular units and/or implant them into a body surface (e.g., the scalp). System 100 includes a robotic arm 105 to which is coupled a tool 110 (e.g., a harvesting or implanting tool). Various motors and other motion devices may be incorporated to enable fine movement of the operating tip of tool 110 in multiple directions. Robotic system 100 further includes at least one or more (and preferably, for stereoscopic vision, two) image acquisition devices 115, which can be mounted in a fixed position or coupled (directly or indirectly) to robotic arm 105 or other controllable motion devices. Image acquisition device 115 may include a device that captures still images, may also include a device capable of real-time imaging (e.g., a webcam with the ability to continuously stream real-time information), and/or may also have video recording capabilities (e.g., a camcorder). The image acquisition device may be coupled to one or more processors or processing/computing systems 125, which in the example of FIG1 incorporates an image processor 130 to control imaging operations and process image data. The operative tip of tool 110 is shown positioned over a body surface 120 (in this case, a portion of a patient's scalp having hair follicles thereon).

Typically, the processor or computing system 125 operates as a data processing device and can execute a program that can be configured to include predetermined operations and can be incorporated into a computer. Alternatively, the program may include multiple modules that perform sub-operations of the operation, or may be part of a single module of a larger program that provides the operation. The modular construction facilitates adding, deleting, updating and/or modifying the modules and/or features within the modules. The processor can access a memory in which at least one sequence of code instructions can be stored, including a program for performing the predetermined operations. The memory and program can be located within the computer or externally. The processor 125 can include a central processing unit or a parallel processor and input/output interfaces, a memory with a program, wherein all components can be connected by a bus. These components are generally known in the art, and therefore, there is no need to describe them in detail here.

The processor 125 may include an image processor 130 for processing images obtained from the image acquisition device 115. The image processor 130 may be a separate device or may be incorporated as part of the processor 125. By way of example and not limitation, a suitable image processor 130 may be a digital processing system including one or more processors or other types of devices. For example, the processor and/or image processor may be a controller or any type of personal computer ("PC"). Alternatively, the processor may include an application-specific integrated circuit (ASIC) or a field-programmable gate array (FPGA). The processor/image processor may also include memory, storage, and other components generally known in the art, and therefore, these components need not be described in detail herein.

The same or different processor 125 may also direct the various movement devices of the robotic arm 105, including the tools 110, and function, for example, through a controller 135, as schematically shown in FIG1 . The controller 135 may be operably coupled to the robotic arm and configured to control the movements of the robotic arm, including movements based on images or data acquired by an image acquisition device. Alternatively, the controller 135 may be incorporated as part of the processor 125, so that all processing and control of all movements of all tools, the robotic arm, and any other movable parts of the assembly (including processing and control based on images or data acquired by an image acquisition device) are centralized in one location. The system 100 may further include other tools, devices, and components useful in the harvesting and/or implantation of hair follicles or in hair transplant planning.

The system further includes an interface adapted to receive image data, with the various components of the system allowing an operator to monitor conditions and provide instructions as needed. The user interface may include elements such as a display device 140 and a user input device such as a keyboard 145 and a mouse 150. The interface may also include hardware ports, cables, leads, and other data transmission means, or it may include a computer program. The processor 125 may interact with the imaging device 115 via the interface. It should be understood that the user input device may optionally include a trackpad, trackball, light pen, pen, or line tool in combination with a touch-enabled device, tablet computer, or other similar device, on which a user can input commands using their finger or gestures. A magnified image of the body surface 120 may be displayed on the display device, screen, or monitor 140. In addition, the system 100 may include other tools, devices, and components useful in the harvesting and/or implantation of hair follicles or in hair treatment planning.

FIG2 illustrates various components of a follicular unit implant system 200 that can be coupled to the end of a robotic arm 105 of a robotic system 100, incorporating a follicular unit cartridge 205. The follicular unit implant system 200 includes a tool assembly housing 210 that can be configured so that it can be attached to the end of a robotic arm 105 of a robotic system (such as the robotic system shown in FIG1 ), or it can be operably connected to or form part of a handheld device (such as the handheld device shown in FIG18 ). To optimize the utilization of the robotic system for hair transplantation purposes, in some embodiments, the housing 210 is coupled to the end of the robotic arm 105 by a rotation mechanism 215 that is configured so as to allow the housing 210 to rotate about an axis that is substantially parallel to the length of the tool 110. In this manner, under appropriate command, the rotation mechanism 215 is capable of rotating the housing 210 and, therefore, the tool 110 attached thereto.

The cartridge 205 includes a plurality of containers, each 220 sized and configured to hold follicular units (or other suitable objects, biological or otherwise). Furthermore, the cartridge 205 preferably allows for storage of the follicular units in an at least partially controlled environment, for example, to keep them sterile, moist, and/or at a desired cool temperature until needed for implantation into the body surface 120. Desirably, a quantity of saline or other known preservative fluid is placed in each container of the cartridge to keep the follicles or other biological objects hydrated or at a cool temperature during storage. Alternatively or additionally, the cartridge 205 can be placed in a container, such as a petri dish containing saline or other such preservative fluid, to maintain the health of the follicular units until needed for use in conjunction with the implant system. The shape or configuration of the cartridge 205 can take various forms and can depend on the application. FIG2 illustrates a linear cartridge. Preferably, the cartridge 205 can be sterile, allowing for reuse. Alternatively, the cartridge may be manufactured to be disposable, or such that it is prevented from being reused and is therefore disposable.

A typical hair transplant procedure on a balding male requires the implantation of between 1,500 and 3,000 hair grafts. Utilizing a single cartridge 205 configured to accommodate such a large number of follicular units (or hair grafts) would be impractical for a number of reasons. Besides the fact that such a cartridge would be extremely long and difficult to load, its use would present practical problems and limitations. First, because the cartridge 205 is utilized adjacent to the patient's head or body surface 120, the length of the portion of the cartridge 205 from which the follicular units have been expelled cannot be too long as it would collide with the patient's head or body surface 120, particularly if the rotating mechanism 215 is rotated so that the end of the cartridge is directed toward the patient's head. Second, a typical hair transplant procedure requires the implantation of a specific type of hair graft (a natural aggregation of 1 to 3 (and less commonly, 4 to 5) densely packed hair follicles, or follicular units) into different areas of the patient's head. These follicular units can be categorized or "typed" based on the number of hairs in the unit, and are identified in shorthand as "F1" for a single follicular unit, "F2" for two follicular units, and follicular units with three to five hairs, and so on. It is preferred to transplant follicular units of a specific type into specific areas of the scalp. For example, a single follicular unit (F1) is typically implanted along the hairline that outlines the face. Follicular units with more than one hair (F2, F3, etc.) are typically implanted in the middle of the scalp and on the top of the head. This arrangement of follicular unit distribution is believed to produce a more natural-looking aesthetic result, along with the presence of variation in hair density, hair direction or orientation, a specific mix of follicular unit types, and/or randomness, which contributes to a more natural-looking transplanted hair appearance. Therefore, utilizing a single long cartridge loaded with random types of follicular units is less efficient and can limit the speed at which a hair transplant procedure can be performed. A user or system would need to identify the type of follicular unit in the cartridge before implanting it and then randomly move it back and forth to various areas of the patient's head to implant such follicular units.

The ability to continue a treatment plan or procedure without stopping to reload a cartridge with implant units, replace a full cartridge with an empty cartridge, or replace an empty cartridge with a full cartridge offers numerous advantages. From the physician's perspective, valuable time can be saved, resulting in less downtime and shorter procedures (which also likely improves quality). Furthermore, it can allow the physician to treat more patients during the day and, therefore, increase their potential revenue. Time can be saved at one or more stages of the hair implant procedure, including, for example, by providing a continuous supply of empty cartridges into which follicular units harvested from the patient's body surface can be stored and/or a continuous supply of cartridges filled with follicular units for implantation into the patient's body surface. From the patient's perspective, fewer interruptions potentially mean that the patient can be treated in a shorter period of time, thereby reducing the duration of any discomfort associated with the procedure. According to one aspect of the present invention, the efficiency of the procedure and associated apparatus/instrument is substantially improved by allowing multiple cartridges to be used efficiently, for example, substantially continuously, without interrupting the procedure. A cartridge length sufficient to accommodate a certain number (e.g., in the range of 20 to 30 follicular units) allows these practicalities to be addressed while still providing a large enough number to optimize procedure time. Although shown as accommodating twenty (20) follicular units, the length of the cartridge 205 will ultimately depend on the constraints dictated by the procedure being performed, the objects the cartridge will be used to store, and the equipment to which it will be coupled. Another advantage of utilizing more than one cartridge is that each cartridge can be loaded with follicular units of a specific type, for example, all of the F2s in one cartridge, or all of the F1s placed into adjacent containers in one half of the cartridge, while the other half of the cartridge has the F2s grouped together in adjacent containers.

To assist in identifying the type (classification) of follicular units contained in each cartridge, the cartridge 205 can be configured or labeled in such a manner that the user, the imaging system, or both can easily identify which type of follicular unit is contained therein. The cartridge can include one or more identifiers, including markings such as color coding, a unique color for identifying whether a follicular unit is F1, F2, F3, etc., or fiducials in the form of a 1-D barcode, a 2-D data matrix code, a known marker such as alphanumeric characters, a series of dots, a series of bars, radio frequency identification (RFID), or any other type of unique identifier or customized scheme. It will be understood that the location of the identifier or marking will depend on how it will be used and where it needs to be placed for viewing by any applicable image acquisition device.

FIG3 shows the follicular unit implant system 200 after follicular units have been expelled from the first follicular unit cartridge 305a and illustrates the second follicular unit cartridge 305b being loaded into the tool assembly housing 210. In some embodiments, the system 200 can accommodate more than two cartridges. In the example of FIG3 , the follicular unit implant system 200 includes the follicular unit implant tool 110, the distal end of which can be seen protruding from the presser foot 650. A drive mechanism (not shown) is configured to move or drive an air-blocking structure (also not shown) through the container 220 of the cartridge 305a and into the proximal end of the lumen of the implant tool 110, with which it is substantially aligned. The length of the air-blocking structure is desirably such that its distal end can be substantially aligned with the distal end of the tool 110 as the air-blocking structure is moved in a distal direction toward the body surface through the container and into the lumen of the implant tool 110. For the purpose described, the length of the air-sealing structure may be at least the length of the implantation tool plus the width of the barrel 305a or 305b, and in certain embodiments is preferably slightly longer. The drive mechanism may include, for example, various motors and other movement devices, and/or may be part of a control mechanism that can be managed or directed by the processor 125 or controller 135 shown by example in FIG1 . Movement of the air-sealing structure in the distal direction pushes the follicular units disposed in the container 220 out of the container 220 and into the lumen of the implantation tool 110. The drive mechanism is configured to further drive the air-sealing structure toward the body surface through the implantation tool 110, ultimately driving it out of its distal end and into the body surface 120. Some embodiments (such as the embodiments shown in FIG2-3 ) may contain a presser foot 650 that is operably coupled to the air-sealing structure and includes a distal end 670. As the airtight structure is withdrawn from the body surface 120, the distal end 670 of the pressure foot 650 depresses the body surface 120 without penetrating it, thereby providing downward pressure around the airtight structure, thereby enabling easier removal of the airtight structure from the body surface and further minimizing the potential expulsion of nearby previously implanted follicular units, i.e., providing an explosion-proof mechanism. In this particular configuration, when the barrels 305a and 305b are positioned end-to-end, the adjacent end surfaces are substantially parallel to each other. The indexing mechanism 310 is configured such that the first and second indexing features 225 on the bottom sides 240 of the respective first and second barrels 305a, 305b engage with corresponding at least one or more indexing features 320 (shown in Figures 6a-c and 7) on the upper portion of the indexing mechanism 310. The indexing features 225 and corresponding indexing features 320 are shaped and configured so that when the barrels 305a and 305b are placed end to end (see Figures 4 and 5) and the indexing features 225, 320 are engaged, the spacing between the last container 410 of the first barrel 305a and the first container 420 of the second barrel 305b is a predetermined value 430. The desired distance value between the two containers 410 and 420 is such that there is a predetermined spacing 430 between adjacent containers, regardless of whether the containers are on the same barrel or on adjacent barrels. Maintaining the distance between the containers is substantially constant between all containers, regardless of whether they are on the same barrel or on adjacent barrels, allows the operation of the airtight structure (described below) to continue without interruption and allows the automation of the implant system 200 to be optimized. Optimization is facilitated by, among other things, allowing the airtight structure to continue advancing follicular units from the cartridge at a substantially constant and undisturbed rate; even after all follicular units have been expelled from a particular cartridge. The implantation system 200 is configured so that it provides a seamless, continuous supply of containers 220, thereby enabling continued implantation of follicular units for as long as a supply of cartridges loaded with follicular units is available.

In another aspect of the invention, the ends of the barrels may include locking features, such as tabs, dovetails, a combination of protrusions and recesses, or other such fastening means, which enable one barrel to be attached end-to-end to another barrel. Use of this arrangement enables two or more barrels to be temporarily attached to each other before contacting the indexing mechanism 310.

After one graft from a container has been implanted, the follicular unit barrel 205 is indexed so that another container (typically an adjacent container) is aligned with the airtight structure and/or implantation tool 110 so that a subsequent follicular unit can be implanted. This indexing can be at least partially automated, for example, under a control mechanism (e.g., controller 135) and/or by other such means (e.g., mechanical configuration, gear arrangement, electromechanical, electronic, pneumatic, hydraulic, magnetic) using a motor with a programmable control, or a combination thereof, to effect controlled indexing of the barrel to preferably align the next container of the barrel with the airtight structure. To facilitate indexing, at least one or more indexing features 225 are provided on the lower surface 240 of the barrel 205 that engage (interlock or mesh with) corresponding at least one or more indexing features 320 (as seen in Figures 6a to c) of the indexing mechanism 310 associated with the implant system 200. The indexing features 225 and corresponding indexing features 320 can, for example, include a series of teeth, ramps, or leading and trailing edges. Examples of configurations implementing indexing will be described in more detail below, although it will be appreciated that there are many ways of accomplishing this known to those skilled in the art.

6a-6c illustrate an example of an indexing mechanism 310 that can be implemented using various embodiments according to another aspect of the present invention. The indexing mechanism 310 includes not only corresponding indexing features 320 (which engage with indexing features 225 on the bottom side 240 of the barrel 205), but also a cam surface 330 configured to operate in association with an indexing cam 610. In the depicted configuration, the corresponding indexing features 320 are disposed on the upper surface of the indexing mechanism 310, which is closer to the loaded follicular units, and the cam surface 330 is disposed on the lower surface of the indexing mechanism 310, which is farthest from the loaded follicular units. The air-blocking structure 550 is slidably positioned with its proximal end coupled to a drive mechanism (not shown) driven by a drive assembly (also not shown) via the indexing cam 610 to provide a distally directed propulsion force on the air-blocking structure 550. In initial operation, as illustrated by FIG6 a, the barrel 205 is engaged with the indexing mechanism 310, and the drive mechanism is activated to retract the indexing cam 610 as shown, substantially simultaneously causing the air-tight structure 550 to retract. In this retracted position, the protrusion 615 of the indexing cam 610 is disposed at the proximal end 630 of the slot 640, further causing the pressure foot 650 to retract, and thereby retracting the distal end 670 of the pressure foot 650 away from the body surface 120. For the purposes of describing FIG6 a-c, the "distal" direction is a direction closer to the body surface 120, and the "proximal" direction is away from the body surface 120. When the air-tight structure 550 is retracted, the indexing mechanism 310 is in its biased position, biased in directions 710 and 720 by means of a spring or other such biasing member (not shown), as shown in FIG6 a. It should be understood that various modifications, substitutions, and variations in the form and details of the described configurations and in the operation of the described instruments and systems may be made without departing from the spirit of the invention. For example, in alternative embodiments, the indexing features 225 of the barrel and the indexing features 320 of the indexing mechanism 310 may be disposed in other locations (e.g., on the other side of the respective devices), and the initial bias may be in a direction other than that indicated above, and/or movement of the air-blocking structure may cause the indexing mechanism and/or barrel to move in a direction other than that described (e.g., in the opposite direction). Subsequently, the drive mechanism provides distal guide motion, causing the indexing cam 610 to move toward the barrel 205 and causing the distal end of the air-blocking structure 550 to move through the container 220 in the barrel 205 to which the air-blocking structure 550 has been substantially aligned. The indexing cam 610 is configured so that when the protrusion 615 reaches the distal end 660 of the slot 640, the distal end of the air-blocking structure 550 is substantially aligned with the distal end 670 of the presser foot 650 (FIG. 6b).

As the drive mechanism continues to move the indexing cam 610 toward the barrel 205, the disposition of the protrusion 615 in the slot 640 causes the protrusion 615 to move the pressure foot 650 and the air-blocking structure 550 in the distal direction toward the body surface 120. The cam surface 620 of the indexing cam 610 engages the cam surface 330 disposed on the lower surface of the indexing mechanism 310 and urges the indexing mechanism 310 to its cocked position, thereby urging it to move in the direction 700 shown in FIG6 c. However, because the air-blocking structure 550 is in the receptacle 220 of the barrel 205, the indexing mechanism 310 is limited in how far it can move in the direction it is urged. 8 , where it can be seen that as the cam surface 620 of the indexing cam 610 moves toward the body surface 120 and slides across the cam surface 330 of the indexing mechanism 310, the indexing mechanism 310 is advanced in direction 700, and also advanced in a distal direction 730, toward the body surface 120. The system is configured such that, due to the positioning of the airtight structure 550, the cam arrangement, the geometry and biasing of the indexing features, the indexing mechanism 310 moves a distance sufficient to increment the corresponding indexing feature 320 on the indexing mechanism 310 to the adjacent indexing feature 225 on the barrel 205. The geometry of the indexing features 225 helps ensure that once the distance sufficient to effect indexing has been moved, the corresponding indexing feature 320 of the indexing mechanism 310 falls or drops into position relative to the indexing feature 225 of the barrel 205 before the indexing mechanism 310 moves back toward its biased position, thereby ensuring that indexing occurs. During this time, the drive mechanism is controlled in such a manner as to cause the air-blocking structure 550 to push the follicular unit from the container 220 of the barrel 205 into the lumen of the implantation tool 110, out of the distal end of the implantation tool 110, and into the body surface 120. By controlling the distal end 670 of the presser foot 650 to reach the surface of the body surface 120 without penetrating it, and by substantially aligning the distal end of the air-blocking structure 550 with the distal end 670 of the presser foot 650, a desired implantation depth can be achieved and controlled. In this embodiment, neither the distal end 670 of the presser foot nor the distal end of the air-blocking structure 550 penetrates the body surface 120.

Once the follicular unit is implanted, the drive mechanism (or control mechanism) causes the indexing cam 610 to retract along with the air-sealing structure 550, thereby moving both in a proximal direction away from the body surface 120. In some embodiments, the drive mechanism can be actuated by one of the processors (e.g., those described with reference to the one or more processors 125 in FIG. 1 ). Initially, the retraction causes the presser foot 650 to remain stationary, and only the air-sealing structure 550 is retracted in the proximal direction. However, once fully retracted, the protrusion 615 of the indexing cam 610 reaches the proximal end 630 of the slot 640, and the presser foot 650 retracts along with the air-sealing structure 550. Maintaining initial contact between the distal end 670 of the presser foot 650 and the body surface 120 as the air-sealing structure 550 is retracted from the body surface 120 can be used to optimize implantation of the follicular unit. Finally, the airtight structure 550 is retracted from the container 220 of the barrel 205, thereby allowing the indexing mechanism 310 to be released back to its biased position, i.e., in direction 720 (see FIG. 6 a) (opposite to direction 700). Additionally, because the airtight structure 550 has been retracted from the barrel 220, the indexing mechanism 310 is also able to return to its biased position, which is in a proximal direction 710 away from the body surface 120 ( FIG. 6 a), and the barrel 220 is indexed so that the adjacent container is substantially aligned with the airtight structure 550, and the process is ready to begin again. The indexing mechanism 310 further includes a stop 340 that limits the movement of the indexing mechanism 310 as the indexing mechanism 310 returns to its biased position, which in turn ensures that indexing is limited to increments to adjacent containers. As illustrated in FIG. 8 , the stop 340 may comprise an end of the indexing mechanism 310, wherein a recess in the tool assembly housing 210 provides a stop boundary 680. In this manner, the ability to move the indexing mechanism 310 is limited to directions 700 and 720 .

As previously mentioned, utilizing the pressure foot 650 to simultaneously withdraw the air-blocking structure from the body surface 120 allows for easy removal of the air-blocking structure from the body surface and further minimizes the potential expulsion of nearby previously implanted follicular units, thereby providing a burst-proof mechanism. The distal end 670 of the pressure foot 650 depresses the body surface 120 without penetrating the body surface, thereby providing downward pressure around the air-blocking structure and effectively stabilizing the surrounding body surface. Consequently, when the air-blocking structure is removed, there is less disturbance in the area surrounding the air-blocking structure, thereby minimizing the potential expulsion of nearby previously implanted follicular units.

Utilizing a pressure foot 650 in combination with the airtight structure 550 can be particularly useful for handheld devices where the user may not readily understand the axial position of the airtight structure because it may be hidden within the lumen of the needle. The pressure foot 650 can provide a visual indicator by which the user can judge how deeply the needle has penetrated into the body surface and can also serve as a stopper for the airtight structure.

However, it should be understood that in some embodiments, the use of a presser foot is optional. For example, in some embodiments, the system's processor or controller can control the distance the airtight structure moves without using a presser foot. The image acquisition device 115 can acquire data about the distance of the implant tool and/or airtight structure relative to the body surface, and the system's processor and/or controller can control the distance the implant tool and/or airtight structure moves, including preventing the airtight structure from penetrating the body surface when desired.

FIG9 is a flow chart illustrating an example of a methodology for continuously feeding containers using the system and apparatus of the present invention. In preliminary step 810, a first cartridge 220 comprising a plurality of containers may be loaded into or coupled to the system, with adjacent containers within the plurality of containers separated by a predetermined distance. This coupling of the first cartridge may be accomplished automatically by the system or with the assistance of a user or operator (e.g., a physician or physician's assistant). In some embodiments, the system may be configured to allow a user to manually couple the cartridge to the system. The system may be programmed, configured, or operated to load objects or units into or remove objects or units from the containers of the first cartridge. Loading or removal may include operating an airtight mechanism (or other similar mechanism) to move into or into the container, thereby pushing the object or unit (e.g., a hair graft) into or out of the container, depending on the application. In other embodiments, loading or removal may be accomplished by using a pressure differential to push the object or unit out of each container and into the pushing tool 110, as further described below. In yet other embodiments, for example, a combination of mechanical propulsion and pressure differential may be used to remove the follicular units from the cartridge.

The movement of the airtight structure or similar mechanism can be controlled by one or more processors 125. At some point during the procedure, in step 820, the second barrel is operably coupled to the system, for example, by locking the second barrel to the first barrel. In some embodiments, to keep the overall size of the system to a minimum during most of its operation, the second barrel can be coupled shortly before all or nearly all of the containers of the first barrel are emptied (reference implantation procedure) or filled with objects (reference loading the barrel with objects). For example, the second barrel can be coupled when the system is about to discharge follicular units from the last container of the first (or previous) barrel. In those embodiments, the time during which both the first and second barrels are loaded into the system is minimized. However, in other embodiments, the second barrel can be coupled at any other desired or appropriate time. It should be understood that the "last" container in the first cartridge may not be the actual physical last container, but may be the last one instructed by the system to be loaded or discharged, from which it is desired to discharge the objects or units in the first (or previous) cartridge or the last container into which the objects or units in the first (or previous) cartridge are loaded before starting to operate on the second (or subsequent) cartridge. In step 830, the system is operable to load the objects or units into the first container of the second cartridge or discharge the objects or units from the first container. According to the methodology of the present invention, objects or units can be loaded into the first container of the second cartridge or discharged from the first container without losing any time by interrupting the program to remove the previous cartridge and replace it with the subsequent one. In some embodiments, step 830 can be performed while the first (previous) cartridge remains operably attached to the system, and in step 840, the first cartridge can be removed at any time after the objects (e.g., follicular units) are discharged from the first container of the second cartridge. In certain embodiments, in step 840, for example, once propulsion mechanism is moved into and aligns with the first container of the second barrel, the first barrel just can disconnect or remove.If wish, in some embodiments, some or some containers of the second (or follow-up) barrel can be emptied before the first barrel disconnects or removes from the system.In other embodiments, steps 830 and 840 can be performed substantially simultaneously, make and can remove from the system or disconnect and occur substantially simultaneously with the first barrel and load object into the first container of the second barrel or discharge object from the first container of the second barrel.In either case, removing the first barrel from the system can not affect the efficiency of loading/discharging, because it can not prevent program from continuing to allow object or unit with same speed and without interruption to be loaded into the container of follow-up barrel or discharge from the container of follow-up barrel.

In addition, in some embodiments of the present invention, system can be configured to identify and/or indicate when the work of previous barrel is completed or will be completed and when directly coupled subsequent barrel.One or more indicators (for example, datum point) can be through the end of placing adjacent first barrel and be used for the last container of the first barrel to be emptied or fill up or near the indication that is emptied or fill up and provide user or system.This information for example can be presented on display device 140, indicates that the user should remove the first barrel at once, or can be used by system to provide the automatic removal/disconnection of the first barrel.In an alternative embodiment, the length of indexing mechanism 310 can promote the automatic disconnection of the first barrel.As illustrated in Figure 7, visible indexing mechanism 310 comprises the limited length with a limited number of indexing features 320.Therefore, once the first barrel 305a has indexed in a stepwise manner, the first indexing features 225 of final first barrel 305a will no longer engage with the corresponding indexing features 320 of indexing mechanism 310. Thus, as the second barrel 305b also indexes, there will be a point in time where only the second barrel 305b engages the corresponding indexing feature 320 of the indexing mechanism 310 and the first barrel 305a will automatically disconnect therefrom. It will be appreciated that the selection of a particular length of the indexing mechanism 310 will determine the disconnection time.

Cartridges for use with the systems and methods of the present invention

According to another aspect of the present invention, the design of barrel itself and the improvement of configuration are provided.Can utilize described barrel configuration in automatic or semi-automatic program, comprise robot system.In addition, can use such as handheld device to utilize this type of barrel configuration, although this device or program can be automated to varying degrees.As explained above, barrel can have multiple containers, and it is used for containing various biological units (such as hair transplant or tissue transplant) that must be stored and removed from such container and does not damage such transplant so that it can such as be implanted or reused.Figure 10 illustrates barrel 900, and it is similar to the barrel disclosed in No. 8,211,134 United States Patent (USP) of common assignment, for example, in Figure 18, wherein container 920 is through being placed in the main body of barrel 900 spaced apart from the top surface of barrel 945.In other words, the opening or borehole 930 of container 920 extends from first or front 940 to second or back 950 (not shown), and it is substantially parallel to front 940, and wherein the part of the length of container is not exposed to top surface 945. In this particular configuration, follicular units can be loaded into the cartridge by pushing one graft (eg, follicular unit) into each opening 930 of the container 920 , with no portion of the follicular unit exposed on the surface of the cartridge 900 .

FIG11 illustrates a cartridge 1000 according to the present invention. The cartridge 1000 includes a body having a first or top surface 1035, a second or bottom surface 1040, a front face 1045, and a rear face 1050 (not shown), and defining a plurality of containers 1020 extending substantially parallel from the front face 1045 to the rear face 1050. In the illustrated example, the cartridge 1000 includes twenty (20) containers 1020, each sized and configured to hold a follicular unit. However, it should be understood that this is merely an example and that a different number of containers is within the scope of the present invention. In the example of FIG11 , the length 1025 of the cartridge 1000 has been selected so that it can be easily stored in a petri dish until needed, with the length 1025 being in the range of 2 to 10 cm, with a length of 3 to 3.5 cm, and more specifically, 3.2 cm, for example, to easily accommodate the 20 containers illustrated. The container 1020 is configured so that it is positioned closer to the top surface 1035 , for example, within 0.2 mm to 0.5 mm from the top surface 1035 .

In this particular example, slots 1060 extend from the container 1020 and are open to the top surface 1035 of the cartridge 1000. These slots 1060 assist in the process of loading the follicular units into the container 1020 of the cartridge 1000. In certain embodiments, the graft or follicular unit is placed into the container using forceps. The slots 1060 allow for guidance of the forceps as the follicular unit is pulled through the first opening 1055 and into the container 1020. Additionally, the slots 1060 may taper (e.g., widen) toward the first opening 1055 of the container 1020, with the tapered portion providing additional guide features 1065 that can, for example, further accommodate the forceps as they introduce the follicular unit into the first opening 1055 without incurring any unnecessary trauma to the loading of the follicular unit. This configuration enables the user to load the cartridge with follicular units more quickly and/or more easily than in a configuration that does not include slots 1060 or additional guide features 1065. To help understand how follicular units are loaded into the cartridge, refer to Figures 12 and 13. Figure 12 depicts a follicular unit or hair graft 1100, which includes one or more hair follicles or hair grafts 1108, each extending from a corresponding hair root 1110, with the follicular unit 1110 having a distal end 1120 positioned beneath the skin. Typically, the hair root 1110 and a portion 1106 of the hair graft 1108 are surrounded by tissue 1115, with the tip portion 1105 of the hair graft 1108 distal to any tissue and representing the portion of the follicle or hair graft that emerges from the body's surface. When the hair graft is performed using a handheld instrument or during an automated (e.g., robotic) follicular unit extraction procedure, this tip portion 1105 is typically trimmed to approximately 1 mm to 2 mm (0.04 to 0.08 inches), and when a bandage hair graft procedure is performed, it is typically trimmed to approximately 3 mm to 5 mm (0.12 to 0.20 inches). The stem cells responsible for hair growth are typically located along portion 1106 of the hair follicle 1108 beneath the epidermis, penetrating the hair root 1110. As shown in FIG13, a user can use a pair of tweezers 1200 or similar device to guide the follicular unit 1100, held by the tip portion 1105, into the slot 1060 of the container 1020 (typically starting at the first opening 1055) (shown in FIG11). In some embodiments, the slot 1060 can traverse the width of the barrel 1000. In other embodiments, such as the illustrated embodiment, the slot can traverse only a portion (in some cases, a substantial portion) of the width of the barrel 1000, but end before reaching the rear face 1050. In this way, the user is able to hold the tip portion 1105 of the follicular unit 1100 with the help of tweezers (see FIG. 12 ) without squeezing and potentially damaging the portion containing the stem cells and surrounded by the tissue 1115, and pull the follicular unit 1100 through the container 1020 into the first opening 1055 until it reaches the end of the slot 1210 farthest from the first opening 1055 (as shown by the example in FIG. 14 ). At this point, the tissue portion 1115 of the hair transplant will be substantially disposed within and along the container 1020, with the distal end 1120 of the follicular unit 1100 disposed at or near the first opening 1055, and with the end of the tip portion 1105 protruding from the other end 1210 of the slot, as seen in FIG. 14 .

Another feature of the cartridges of the present invention provides convenient marking to inform a user or automated system which type of biological unit is contained or other characteristics or information about the biological unit. For example, with reference to hair transplantation, the cartridges can be marked to indicate the number of follicles in the corresponding follicular unit contained in a particular cartridge. The illustrated series of dots 1030 (see FIG. 11 ) can be used to illustrate one example of how a cartridge 1000 containing type F2 follicular units can be marked.

Once the cartridge has been loaded with follicular units, it can be inserted into or coupled with the follicular unit implantation system 200 to implant the follicular units into the patient's body surface 120. The movement of follicles from the receptacles 1020 of the cartridge 1000 to the implantation tool 110 can be accomplished using a variety of methods. For example, a mechanical device or structure (e.g., an airtight structure 550) can be used to push the follicular units 1100 from the cartridge 1000 into the implantation tool 110. An operator or system can translate the airtight structure 550 through a portion or the entire length of the receptacles 1020, thereby pushing the follicular units 1100 out of the receptacles 1020 and into the lumen of the tool 110, which is positioned to be substantially aligned with the receptacles 1020. The reader will appreciate that the transfer of follicular units from the cartridge to the implantation tool can be accomplished using several alternative methods. Another option is to use a pressure differential to push the follicular units out of each receptacle and into the implantation tool 110. In other alternative embodiments, a combination of mechanical pushing and pressure differentials may be used to expel the follicular units from the barrel.

Airtight structures used in conjunction with the systems and methods of the present invention

According to yet another aspect of the present invention, Figures 14 to 17 illustrate a new and improved design of an airtight structure 1150 that can be used in conjunction with the systems and methods of the present invention. Typically, an airtight structure for hair transplantation can have a diameter of approximately 0.8 mm to 1.1 mm (or approximately 0.03 to 0.04 inches). With reference to hair transplantation, the airtight structure 1150 is sized, shaped, and configured so that it accommodates the tip portion 1105 of one or more hair follicles 1108, which protrude from the tissue 1115 and improve the successful guidance of the hair graft or follicular unit 1100 into the tool as the airtight structure 1150 pushes the follicular unit 1100 out of the container 1020. For that purpose, the distal end of the airtight structure 1150 includes a recess 1155 disposed in a first (e.g., top) side 1180 thereof. The recess 1155 is sized and configured so that the tip portion 1105 can be located or retained within the recess 1155 so that it will not be caught or pinched when the graft is ejected from the container of the barrel into the tool 110 by the airtight structure. There is a certain tolerance between the outer diameter of the airtight structure 1150 and the inner diameter (or lumen wall) of the implant needle 110, or the inner diameter of the container 1020 of the barrel 1000. Nominally, the tolerance may be between about 0.025 mm and 0.05 mm (or between about 0.001 and 0.002 inches). Conventional tip portions 1105 of hairs have a nominal diameter of 0.1 mm or 0.004 inches, but microhairs having diameters less than 0.05 mm or 0.002 inches are not uncommon. Therefore, without recess 1155, there is a possibility that the tip portion 1105 of a hair could be caught between the inner diameter of the implant needle 110 and the outer diameter of the air-sealing structure 1150, or between the inner diameter of the container 1020 of the cartridge 1000 and the outer diameter of the air-sealing structure. There is also a possibility that the tip portion 1105 of a hair could become caught when traveling from the container 1020 of the cartridge 1000 to the implant needle 110, as it must overcome the small gap between the two. Recesses (such as recess 1155) on the top side at the distal end of the air-sealing structure 1150 provide a pocket for the hair. For example, in embodiments where the units stored in the cartridge are hair transplants, the length of recess 1155 may be approximately 1.5 to 2.5 mm (0.06 to 0.1 inches) (to accommodate a tip portion 1105 having a length of 1 to 2 mm (0.04 to 0.08 inches)). The depth of the recess 1155 can be, for example, 0.2 mm to 0.3 mm (0.008 to 0.012 inches) (which comfortably accommodates the diameter of one or more tip portions 1105 of the follicular unit 1110), or in the range of about 10% to about 30%, for example, 25%, of the cross-sectional dimension of the elongated body of the air-sealing structure. As will be understood by those skilled in the art, the dimensions of the recess 1155 described above are provided by way of example and are not limiting and can be adjusted depending on the desired embodiment and application. In this configuration, when the distal tip 1160 of the air-sealing structure 1150 is advanced into the portion of the graft surrounded by tissue 1115, the tip portion 1105 protruding from the tissue 1115 is less likely to bend, become pinched, or catch as explained above, which allows the graft to be properly aligned and smoothly transferred from the storage cartridge to the tool 110. In one embodiment of the present invention, the airtight structure 1150 is advanced through the container 1020 to which it is aligned, thereby propelling the follicular units 1100 contained therein out of the container 1020 and into the proximal end of the lumen of the implantation tool 110. The implantation tool 110 is operated to cause the distal end of the implantation tool 110 to enter the body surface 120. To achieve this, the distal end of the implantation tool 110 can be sharpened so that the tool itself penetrates the body surface, or alternatively, the tool can be introduced into a previously formed perforation or incision (formed by another instrument). It should be understood that penetration of the body surface can occur before, during, or after the time at which the follicular units are discharged from the container 1020 and into the lumen of the implantation tool 110. It should also be understood that the method by which the follicular units 1100 are caused to move from the barrel 1000 to the implantation tool 110 can be achieved by various methods other than those described above.

Additionally, in some embodiments, the airtight structure 1150 of the present invention can be configured with a cutting portion 1170 disposed at the distal tip of the airtight structure 1150, but on a second (e.g., bottom) or opposite side 1185 of the recess 1155 (see Figures 16a-16b). The cutting portion 1170 can be configured such that, in use, when the distal end of the implant needle 110 penetrates the body surface 120 at an approach angle, designated 1174 in Figure 17b, the surface of the cutting portion 1170 of the airtight structure 1150 is positioned substantially parallel to the body surface 120. In this manner, when the distal tip 1160 of the airtight structure 1150 pushes against the proximal end 1168 of the portion of the graft surrounded by tissue 1115, the surface of the cutting portion 1170 is substantially aligned with the body surface 120, thereby preventing the airtight structure 1150 from entering beneath the body surface, as shown in Figure 17b. At the same time, the distal tip 1160 of the airtight structure 1150 is capable of exerting sufficient force to push the follicular units into the desired position, resulting in implantation. To perform a hair implantation procedure, the implantation needle 110 can be advanced at an approach angle ranging from 30 to 90 degrees relative to the body surface, although an approach angle range of 40 to 45 degrees is more typical. Therefore, to position the cutting portion 1170 of the airtight structure 1150 substantially parallel to the body surface (when the airtight structure 1150 is in use and utilizing the approach angle to penetrate the body surface), the cutting portion 1170 is configured to form an angle (designated 1176 in FIG. 16b ) ranging from 0 to 60 degrees, and typically between 45 and 50 degrees. In some embodiments, the cutting portion may extend through an entire portion or a portion of the diameter of the airtight structure. In such embodiments, the distal tip 1160 intersects the cutting portion 1170 at a line substantially spanning the diameter of the airtight structure 1150, with the cutting portion 1170 beginning approximately along or near the line extending through the diameter of the airtight structure. As previously mentioned, the diameter 1178 of the air-blocking structure 550 can be in the region of 0.8 to 1.1 mm (0.03 to 0.04 inches). In some other embodiments, the cut portion 1170 can extend from about 25% to about 60% (e.g., 50%) of the cross-sectional dimension of the air-blocking structure 1150, for example, such that only a portion of the cross-sectional area of the distal tip of the air-blocking structure, which is positioned closer to the body surface, is cut. The cut 1170 is configured and functions so that when the air-blocking structure is pressed against the body surface 120, the cut is substantially flush with the surface of the body surface, thereby enabling the distal end of the air-blocking structure to not substantially compress the body surface.

It should be understood that an airtight structure according to the present invention may include recesses having sizes, shapes, and configurations different from the recess 1155 shown by the example in FIG16a. For example, the recess 1155 shown disposed on one side of the distal end of the airtight structure 1150 may work well when using a cartridge (such as the cartridge shown by the example in FIG11) in which the slot 1060 is open to the top surface 1035. In other cartridge configurations, such as the cartridge illustrated in FIG10, the positioning of the tissue-free tip portion 1105 of the hair graft 1108 may not fully utilize a recess 1155 disposed only on one of the distal ends of the airtight structure 1150 (e.g., the top side 1150). In such cases, it may be beneficial to use a recess 1155 that extends around at least a substantial portion of the circumference of the distal end of the airtight structure, thereby providing a clearance region 1300, such as the clearance region illustrated in FIG17c-17d. The clearance area 1300 can be sized and configured so that the tip portion 1105 of the hair transplant 1108 can be located or retained in the clearance area 1300, regardless of which side of the air-sealing structure the tip portion 1105 finds itself on. This configuration will help prevent the tip portion 1105 from getting caught or pinched when the hair transplant is expelled from the container of the cartridge to the tool or from the tool to the body surface, or when the air-sealing structure 1305 and tool are removed from the body surface after the hair transplant has been implanted.

FIG17c illustrates another example of an air-sealing structure 1305 comprising a recess having a clearance region 1300 disposed around a substantial portion of the air-sealing structure's circumference. In this example, the air-sealing structure does not extend around the entire circumference of the air-sealing structure, as the geometry of the air-sealing structure 1305 can also be used in the indexing process. In the embodiment of the example of FIG17c , the recess/clearance region may extend, for example, anywhere between 50% and 95% of the air-sealing structure's circumference, and more specifically, between 75% and 95% of the circumference, or between 75% and 90% of the circumference, or within a range of 300 to 330 degrees. However, in other configurations where indexing is not required or where an indexing mechanism other than that described herein is utilized, the clearance region 1300 may be disposed around the entire circumference of the air-sealing structure. The length 1310 of the clearance region 1300 may be based on the length of the relevant object or biological unit (e.g., the length of the tissue-free tip portion 1105 of the hair graft 1108). For example, referring to the hair transplant example, the length 1310 of the gap region can be approximately in the range of 1.5 mm to 3.5 mm (0.06 to 0.13 inches) to accommodate a tip portion 1105 having a length of 1 to 3 mm (0.04 to 0.12 inches). This length 1310 is typically in the range of 1 to 4 mm, but may have an upper limit of 6 or 7 mm, for example, depending on the length of the implanted hair. The depth 1315 of the recess or gap region 1300 can be similar to the depth of the recess 1150 and is typically in the range of 0.2 mm to 0.3 mm (0.008 to 0.012 inches), which comfortably accommodates the diameter of one or more tip portions 1105 of the follicular unit 1110, or in the range of about 10% to about 30%, for example, 25%, of the cross-sectional dimension of the elongated body of the airtight structure. As will be appreciated by those skilled in the art, the dimensions of the gap region 1300 described above are provided by way of example and are not limiting and may be adjusted depending on the desired implementation and application. Furthermore, while the embodiments illustrated in Figures 17c-17d do not include a cutout portion 1170, a cutout portion may be included, similar to the cutout portion described with reference to Figures 16b and 17b.

17d , the air-sealing structure 1305 provides (among other things) a gap between the inner wall 1320 of the implantation tool 1325 and the outer wall of the distal end of the air-sealing structure 1305. The gap area 1300 is configured so that the distal tip of the implanted follicular unit protruding from the body surface will not be caught or pinched between the inner wall 1320 of the implantation tool 1325 and the outer wall of the distal end of the air-sealing structure 1305, particularly when the air-sealing structure 1305 and the implantation tool 1325 are removed from the body surface. Thus, it will not pull out the most recently implanted follicular unit/hair graft, and the variation of such implanted hair grafts remaining in the body surface is improved by the proposed design and configuration of the instrument used.

In some embodiments, the distal end of the air-sealing structure 1150, the end that physically contacts the follicular unit, may additionally include a non-traumatic surface that preferably does not damage the hair graft when it pushes against the hair graft portion 1115. On the other hand, in some alternative embodiments that do not have the recess 1155 shown in the embodiments of Figures 16-17, at least a portion of the distal end of the air-sealing structure 1150 may have a sharp cutting edge. The purpose of this cutting edge is to facilitate a smooth transition of the graft into the tool 110 by being able to cut the tip portion 1105 that can be captured between the outer diameter of the air-sealing structure and the inner diameter of the container of the barrel 1000, or between the outer diameter of the air-sealing structure and the inner diameter of the implant needle or tool 110.

Alternatively, other propulsion mechanisms or means for propelling the follicular units through the implantation tool may be utilized. For example, a pressure differential as mentioned above may be applied to the implantation tool by reducing the pressure at the distal end of the container relative to the proximal end. An example of such a pressure is the pressure caused by a very small amount of saline that has been pushed from the tip of the tubular airtight structure (for embodiments in which saline is used).

FIG18 illustrates an example of a handheld instrument 1200 for implanting hair grafts into a body surface. The hair grafts are loaded into a plurality of containers of a barrel 1210, which can be configured to be releasably connected to the body 1220 of the handheld instrument 1200, for example, via a release mechanism 1230. The release mechanism 1230 can include, for example, two outwardly directed and radially arranged biased or spring-loaded protrusions that engage inwardly directed recesses on the inner wall of the barrel 1210. Twisting or turning the barrel 1210 advances the protrusions to release the barrel 1210 from the body 1220 of the handheld instrument or to lock the barrel 1210 to the body 1220 of the handheld instrument. Other mechanisms for selectively locking and releasing a barrel from a body are known to those skilled in the art and will therefore not be described further. In use, the piston 1240 can be activated (e.g., by the user or automatically), which operates an airtight structure or other advancement mechanism (not shown) to advance the follicular units from the barrel 1210 into the implantation tool 1250 and out its distal end. The piston 1240 can also activate the pressure foot. When the airtight structure is retracted (or, for example, the pressure differential is released), the barrel is indexed and adjacent follicular units in the barrel are aligned for implantation. Although described using a circular barrel, the handheld barrel can include a linear barrel that includes one or more of the novel features described above.

The various embodiments described above are provided by way of illustration only and should not be construed as limiting the claimed disclosure. These embodiments are susceptible to various modifications and alternative forms, and it should be understood that, in general, the present invention and the specific embodiments described herein cover all modifications, equivalents, and alternatives falling within the scope of the appended claims. By way of non-limiting example, one skilled in the art will appreciate that a particular feature or characteristic described with reference to one figure or embodiment may be combined with a feature or characteristic described in another figure or embodiment, as appropriate. For example, some portions of the barrel may contain one type of biological unit (e.g., follicular unit), while other portions of the barrel may contain another type of biological unit. Thus, a fiducial or other marker/identifier may be used as, for example, a unique identifier for the type of biological (e.g., follicular) unit contained in a pre-assigned portion of the barrel. The unique identifier can then be recognized by an imaging acquisition device associated with the robot and implantation system, allowing an indexing mechanism to index the barrel so that the desired follicular unit type is aligned with the tool for implantation into the body surface. This particular configuration requires the indexing mechanism to be able to index the barrel both backward and forward, rather than in a single direction as described above. Furthermore, those skilled in the art will recognize that the devices, systems, and methods disclosed herein are not limited to a single field, such as hair restoration, but may be applied to any number of fields. Therefore, the description should not be taken in a limiting sense, and the scope of the present invention is defined by the appended claims. Those skilled in the art will further understand that the present invention is not limited to use with a specific system, and that automated (including robotic), semi-automated, and manual systems and devices may be used to position and actuate the corresponding tools and other devices and components disclosed herein.

Claims (32)

1. A hair transplantation device comprising: a housing configured to receive two or more cartridges, wherein each of the two or more cartridges comprises at least one indexing feature and a plurality of containers sized and configured to hold biological units; an advancement mechanism operable, when substantially aligned with one of the plurality of containers, to load the biological unit into or eject the biological unit from the container; and an indexing mechanism including indexing features configured to simultaneously engage at least one indexing feature of a first barrel and at least one indexing feature of a second barrel of the two or more barrels when the first barrel and the second barrel are placed end to end, and to simultaneously move the two or more barrels in the same direction to align a container of the plurality of containers with the advancement mechanism; wherein the apparatus is configured to simultaneously accommodate the first and second cartridges of the two or more cartridges, and wherein the advancement mechanism is configured to move into alignment with the first receptacle of the second cartridge without disconnecting the first cartridge from the apparatus. 2. The apparatus of claim 1 , wherein the apparatus is configured to automatically disconnect the first cartridge once the advancement mechanism is moved into alignment with the first container of the second cartridge or substantially upon or after at least one biological unit is discharged from or loaded into the first container of the second cartridge. 3. The apparatus of any one of claims 1-2, wherein the propulsion mechanism comprises an air-locking structure sized and configured to pass through a selected container in the first barrel or the second barrel. 4. The apparatus of claim 3, wherein the air-closing structure comprises a recess at a distal end of the air-closing structure surrounding at least a portion of a circumference of the air-closing structure. 5. The apparatus of claim 3, wherein the apparatus is configured such that retraction of the airtight structure from the selected container causes indexing of the first and/or second barrel. 6. The apparatus of claim 1 or claim 2, wherein the at least one indexing feature of the two or more barrels and/or the indexing feature of the indexing mechanism comprises one or more teeth. 7. An apparatus according to claim 1 or claim 2, wherein the first barrel includes a first plurality of containers with predetermined spacing therebetween, and wherein the apparatus is configured to accommodate the first barrel and the second barrel in the housing such that the distance between the last container of the first barrel and the first container of the second barrel is equal to the predetermined spacing. 8. The apparatus of claim 7, comprising an indicator configured to notify when the last container of the first cartridge has been emptied or filled or when the last container of the first cartridge will be emptied or filled. 9. The apparatus of claim 1 or claim 2, wherein the first and second barrels each comprise a substantially elongated linear body, and the apparatus is configured to couple the first and second barrels to each other or to the housing when placed end-to-end. 10. The apparatus of claim 1 or claim 2, wherein at least one of the plurality of containers contains a biological unit protection solution. 11. The device of claim 1 or claim 2, wherein the device is a hair transplant device, the biological units are follicular units, and wherein at least one of the first barrel or the second barrel includes one or more indicators indicating: 1) the type of follicular unit contained therein, and/or 2) whether the end of the barrel has been reached. 12. The apparatus of claim 1 or claim 2, wherein the first and second cartridges are configured to be removably received in a handheld or at least partially automated system. 13. An apparatus according to claim 1 or claim 2, wherein the apparatus is configured to be removably received in a robotic hair transplantation system, the robotic hair transplantation system comprising a robotic arm, a control mechanism and an implantation tool, the implantation tool having an inner cavity therethrough and being connected to and manipulated by the robotic arm; and wherein the control mechanism is adapted to automatically align a selected cartridge container with the inner cavity of the implantation tool and to advance the biological unit from the selected container through the inner cavity of the implantation tool into the body surface. 14. The apparatus of claim 1 or claim 2, further comprising an explosion-proof feature configured to minimize potential expulsion of the biological unit from a body surface. 15. The apparatus of claim 13, wherein the robotic hair transplantation system further comprises a pressure differential across the selected cartridge container, and wherein the control mechanism activates the pressure differential through the selected cartridge container to advance the biological unit from the selected container. 16. The apparatus of claim 13 , further comprising a removal tool having a lumen therethrough, the removal tool being connected to the robotic arm and being manipulated by the robotic arm to position the removal tool over a biological unit located on a body surface; and wherein the control mechanism is adapted to align the lumen of the removal tool with a selected cartridge container and to advance the biological unit through the removal tool into the selected cartridge container. 17. The apparatus of claim 13, further comprising a presser foot operably coupled to the control mechanism and configured to depress the body surface without penetrating the body surface when expelling the biological unit through the lumen of the implant tool into the body surface. 18. The apparatus of claim 3, wherein the air-blocking structure comprises a cutting portion disposed at and at an angle to a distal tip of the air-blocking structure. 19. A method for continuously feeding a cartridge into an apparatus, the method comprising the steps of: aligning an advancement mechanism with a container of a first plurality of containers of a first cartridge, each container of the first plurality of containers being sized and configured to hold a biological unit; activating the advancement mechanism to push the biological unit out of or into the container of the first plurality of containers; allowing coupling to the apparatus of a second cartridge comprising a second plurality of containers, or coupling to the apparatus of a second cartridge comprising a second plurality of containers, each of the second plurality of containers being sized and configured to hold a biological unit; and aligning the advancement mechanism with the first receptacle of the second cartridge while the first cartridge remains coupled to the apparatus; The method further includes simultaneously engaging an indexing feature of an indexing mechanism with at least one first indexing feature of the first barrel and at least one second indexing feature of the second barrel when the first barrel and the second barrel are placed end to end, and wherein aligning the advancement mechanism includes simultaneously moving the first barrel and the second barrel in the same direction. 20. The method of claim 19, further comprising indexing the first and second cartridges once the first container of the second cartridge is loaded or emptied using the advancement mechanism. 21. The method of any one of claims 19-20, wherein the steps of aligning and activating the propulsion mechanism are performed automatically by the apparatus. 22. The method of claim 19 or claim 20, further comprising allowing a first cartridge to be coupled to the device, or coupling a first cartridge to the device. 23. The method of claim 19 or claim 20, comprising automatically disconnecting the first cartridge once the advancement mechanism has been moved into alignment with the first container of the second cartridge or substantially upon or after at least one biological unit is discharged from or loaded into the first container of the second cartridge. 24. A method according to claim 19 or claim 20, wherein the propulsion mechanism includes an air-tight structure, which is positioned to pass through a selected container of the first barrel or the second barrel, and the method includes retracting the air-tight structure from the selected container to index the first barrel and/or the second barrel. 25. A method according to claim 19 or claim 20, wherein the advancement mechanism comprises a pressure differential across a selected container of the first or second barrel, the method comprising activating the pressure differential to index the first and/or second barrel. 26. A method according to claim 19 or claim 20, comprising automatically notifying when the last container of the first cartridge has been emptied or filled or when the last container of the first cartridge is about to be emptied or filled. 27. A method according to claim 19 or claim 20 comprising providing an indication of the contents of the container of the first cartridge and/or the second cartridge. 28. A method according to claim 19 or claim 20, comprising using a length or feature of the indexing mechanism to automatically break the first barrel. 29. A method according to claim 19 or claim 20, comprising using a presser foot of the apparatus as an explosion proof mechanism. 30. The method of claim 19 or claim 20, wherein the device is a hair transplantation system, the biological unit is a hair graft, and the method comprises advancing the hair graft from the container of the first plurality of containers into an implantation tool. 31. A hair transplantation device comprising: a first barrel having at least one first indexing feature and comprising a first plurality of containers, each container being sized and configured to hold a follicular unit; a second barrel having at least one second indexing feature and comprising a second plurality of containers, each container being sized and configured to hold a follicular unit; a housing configured to receive one or more cartridges; an advancement mechanism operable to load or eject the follicular unit into or from one of the first plurality of containers of the first cartridge or one of the second plurality of containers of the second cartridge while substantially aligned with the container; and an indexing mechanism including indexing features configured to simultaneously engage the at least one first indexing feature in the first barrel and the at least one second indexing feature in the second barrel when the first barrel and the second barrel are placed end to end, and to simultaneously move the first barrel and the second barrel in the same direction to align a container of the first plurality of containers or the second plurality of containers with the advancement mechanism; wherein the apparatus is configured to simultaneously accommodate the first cartridge and the second cartridge, and wherein the advancement mechanism is configured to move into alignment with the first receptacle of the second cartridge without disconnecting the first cartridge from the apparatus. 32. An apparatus according to claim 31, wherein the first plurality of containers have predetermined spacing between the containers, and wherein the apparatus is configured to accommodate the first barrel and the second barrel in the housing such that the distance between the last container of the first barrel and the first container of the second barrel is equal to the predetermined spacing.