Abstract: Systems for hair transplantation using at least one graft extraction module, at least one graft storage module and at least one graft implantation module capable of extracting grafts with at least one hair graft from the donor site atraumatically, storing the extracted grafts, and implanting the grafts back into the recipient site atraumatically without using forceps, tweezers or any other similar tools that can damage the cells are described. The graft extraction module can have at least one rotating tubular cutting member that trims the tissue around the hair shaft(s) and suction through the tubular cutting member pulls the graft into the storage module. The implantation module has at least one transfer tube where the graft gets loaded with suction and the tip of the transfer tube makes slits at the recipient site into which the graft gets gently ejected by a pusher. The system allows simultaneous extraction and implantation. The hair transplantation system also allows the user to control various parameters through a computer interface and/or a remote control.
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority from Indian Patent Application Serial Number 1852/MUM/2014 entitled "Follicular Extraction and implantation system", filed June 5, 2014; 2611/MUM/2014 entitled " Implantation Device for Hair Transplant", filed August 13; 2014, 2612/MUM/2014 entitled " Biomedical device for improving desiccation tolerance of hair follicles", filed August 13, 2014; 2987/MUM/2014 entitled Harvesting Device for Hair Transplant" filed September 18, 2014; 4011/MUM/2014 entitled " Follicle Holding Tray for Hair Transplant" filed December 15, 2014, 4012/MUM/2014 entitled " Punch for Hair Transplant" filed Dec 15, 2014, and 4161/MUM/2014 entitled "Implantation of Follicular Grafts" filed December 26 2014, the contents of which are incorporated by reference herein in their entirety.
FIELD OF THE INVENTION
[0002] The present technology relates, in general, to hair transplant systems used for extraction, storage, and implantation of hair grafts.
BACKGROUND
[0003] Unless otherwise indicated herein, the materials described in this section are not prior art to the claims in this application and are not admitted to be prior art by inclusion in this section.
[0004] A graft in hair transplantation context is an elongated tissue surgically extracted from the donor site with the help of a punch with at least one hair within it placed almost parallel to the axis of the graft. The tissue of the graft consists of a layer of skin on top followed by dermal tissue and loose fatty tissue. In some cases it may also contain a layer of cutaneous tissue.
[0005] The known extraction techniques is scoring the graft peripheral to the hair shaft by means of a cutting tool and then plucking out the graft by holding the tissue between the jaws of a tweezer or forceps. This action causes lot of tissue damage and hampers the viability of the tissue outside the human body. It also has a tendency to remove the protective soft tissue around the bulb of the hair follicles at the roots.
[0006] Various extractors have been described in various patents, such as in U.S. Patent No. 5,827,297 (issued October 27, 1998), U.S. Patent No. 6,027,512 (issued February 22, 2000), and U.S. Patent Publication No. US 2012/0215231 Al (published August 23, 2012).
[0007] However in these kinds of devices, the storage of grafts plays a major role and hence the storage is combined with the extraction tool. A number of problems exist in the available extraction and storage technique. Being suction based system, the grafts gets de-hydrated very soon. Secondly during its travel from the cutting tool to the storage canister, the follicles faces lot of friction from the inside wall of the tubing that connects from punch to the storage canister. Further the grafts after taking out of the storage canister is exposed to ice packs which are at 4 degrees C. Thus the graft after being extracted from the body remains at 37deg C and suddenly it gets exposed to 4 degrees C. This gives a thermal shock to the grafts that is harmful for the stem cells of the grafts thereby reducing the viability of the graft or graft survival leading to poor or delayed hair growth. Controlling the depth of scoring is another difficulty faced by the surgeon in the available tools and techniques. Further there exists a considerable time gap between extraction and implantation which can hamper graft viability.
[0008] Further during implantation, almost all available techniques use a slitting tool for making slits at the recipient site and a combination of needle and forceps for placing the grafts into those slits. This technique has a major drawback. The graft while being placed into the slit has to be held at multiple places and then pushed into the slit multiple times by the forceps. This traumatizes the hair follicles to a great extent and hence reducing the viability of the graft and thereby leading to poor or delayed hair growth.
[0009] Various implanters have been described in various patents, such as in U.S. Patent No. 6,059,807 (issued May 9, 2000), U.S. Patent No. 4,762,515 (issued August 9, 1988), U.S. Patent No. 5,611,811 (issued March 18, 1997), and U.S. Patent No. 7,452,367 (issued November 18,2008).
[0010] In currently available pneumatic implanters, there is a major drawback where in, the grafts get buried as there is no control on the depth to which the follicular units or grafts are supposed to be inserted. Many grafts get buried that causes ingrowth of hair within the skin and causes infection and other clinical complications. Currently available implanters do not have a provision for slitting which consumes a considerable amount of time during the procedure. Further being pneumatic air pressure, there is a potential chance of infection if the air used is contaminated.
[0011] As a system, the currently available systems ask for complicated co-ordination of controls and do not offer the flexibility to do extraction and implantation simultaneously or do not offer the flexibility to connect multiple tools. Furthermore, available solutions do not reduce the overall procedure time significantly.
[0012] Currently available systems are not designed to facilitate simultaneous working of extraction and implantation. Simultaneous extraction and implantation reduces the storage period of the graft outside human body thereby increases the viability of the tissue.
SUMMARY
[0013] The present technology can reduce or eliminate the present drawbacks mentioned hereinabove by providing a system with various tools and accessories and a method preferable to those known in order to (i) address various factors affecting the quality of graft during various stages of the hair transplantation procedure namely, extraction, storage and implantation and so on; (ii) reduce surgical time sometimes significantly, (iii) allow the surgeon to learn and implement the new tools and techniques easily and effectively without creating any risk for the patient for better clinical outcome.
[0014] For this purpose, the technology provides a modular system comprising at least one of: of at least one graft extraction module, at least one graft storage module, at least one graft implantation module, and a user interface control panel for controlling various parameters while driving the tools. The system allows the graft extraction module and graft implantation module to work either independently or in conjunction.
[0015] The graft extraction module comprises of a detachable electrical drive motor that couples mechanically with a rotor head. The rotor head comprises of a transmission shaft with a gear connected to a corresponding gear mounted on a hollow collet shaft. One end of the collet shaft has a collet with split ends to accept rotating cutting member to pass through the shaft extending to the other end of the shaft through at least one dynamic seal system housed within a cap connector. A nut collapses the split ends against the rotating cutting member firmly and thread lock itself over corresponding threading on the collet shaft. This allows the step less adjustment of length of the rotary cutting member.
[0016] In an embodiment, the drive motor is housed within the main unit while a flexible shaft connects to the rotor head.
[0017] In an embodiment, the drive motor is replaced by a pneumatic micro-turbine system directly driving the rotary cutting member.
[0018] The graft storage module is attached close to the rotary cutting member of the graft extraction module through a flexible internally lubricated tube to reduce or minimize friction between the internal wall of the tube and the tissue surface of the grafts. The storage module has a body that is connected to the vacuum line through a flexible hose and a cap that has an internally lubricated tube having slightly more diameter than the diameter of the extracted graft and one end of which is connected to the cap while the other end is removably connected to the rotor head of the extraction module. The body of the graft storage module has an inbuilt feature with micro slits or perforations to contain the grafts while allowing excess fluid to pass through to a collection chamber. The cap and the body are sealed at the interface and at all joints to prevent leakage of vacuum.
[0019] In another embodiment, the graft storage system has a body with integrated clamps.
[0020] In another embodiment, the graft storage system is directly connected to the rotary cutting member of the extraction module with at least one dynamic seal system in between.
[0021] The graft implantation module connects to a vacuum line at one end while having a transfer tube at the tip both ends being connected though a pusher mechanism. The transfer tube has an in-built hollow sharp tip for making slits. Loading of the grafts is achieved through just suction which is activated by the remote control of the main module. The ejection takes place by activating a pusher manually by means of a pusher knob that pushes the grafts gently and axially through the lumen of the transfer tube to a depth as desired by the surgeon. After implantation surgeon withdraws the implantation module.
[0022] In one embodiment, the implantation module work synchronously thereby withdrawal of the device happens simultaneously as the ejection of graft takes place thus reducing an additional step for the surgeon to achieve consistent depth of the grafts.
[0023] In another embodiment, the tip of the transfer tube is blunt with a bevelled edged having an angle of about 10 degrees to about 90 degrees with respect to the axis of the transfer tube.
[0024] In another embodiment, the implantation module has an in-built feature to bleed vacuum when the graft is being pushed to release the holding force on the graft.
Following description along with the drawings will highlight the advantages and characteristics of the present technology.
DESCRIPTION OF THE DRAWINGS
[0025] FIG.l is an illustration of the hair transplant system of the present technology.
[0026] FIG.l A illustrates a graph of time versus torque of hair transplant system of the present technology.
[0027] FIG IB to ID illustrate example of hair transplant system along with the positions of the modules with the main drive unit.
[0028] FIGS. 2 to 6 illustrate the graft extraction module of the hair transplant system.
[0029] FIGS. 7 to 14 illustrate various embodiments of the graft extraction module of the hair transplant system.
[0030] FIGS. 14 to 17 illustrate various embodiments of the depth control mechanism of graft extraction module of the hair transplant system.
[0031] FIGS. 18 to 25 illustrate the graft storage module of the hair transplant system.
[0032] FIGS. 26 to 30 illustrate various embodiments of the graft storage module of the hair transplant system.
[0033] FIGS. 31 to 32 illustrate various embodiments of the latch for graft storage module of the hair transplant system.
[0034] FIGS. 33 to 39 illustrate various embodiments of the rotary cutting member.
[0035] FIGS. 40 to 49 illustrate the graft implantation module of the hair transplant system.
[0036] FIGS. 50 to 54 illustrate synchronous graft implantation module of the hair transplant system.
[0037] FIGS. 55 to 62 illustrate replaceable tip graft implantation module of the hair transplant system.
[0038] FIGS. 63 to 66 illustrate the graft tray for the placement of grafts after extraction.
[0039] FIG. 67 illustrates a tool holder.
DETAILED DESCRIPTION
[0040] The present technology relates to, among other things, systems and methods for atraumatically extracting hair grafts from the donor area, storing them with vital nutrients at suitable temperature, and atraumatically implanting the extracted grafts at the recipient site of a bald person. The application of the present technology is not limited to hair transplantation. There are other medical applications where this system or technique can also be used effectively.
Hair transplant systems
[0041] One example of the present technology provides a hair transplant system as shown in FIG.l wherein the system comprises of different modules such as a main drive unit (1); at least one graft extraction module (2); at least one graft storage module (3); and at least one graft implantation module (4). A module is defined as each of a set of standardized parts or independent units that can be used to construct a more complex structure or system.
[0042] In some embodiments, the hair transplant system can have at least one of: at least one graft extraction module; at least one graft storage module; and at least one graft implantation module; wherein: the graft extraction module is configured to atraumatically extract at least one graft from a donor site to provide an extracted graft; the graft storage module is configured to receive and store the at least one extracted graft from the graft extraction module to provide a stored graft; and the graft implantation module is configured to atraumatically implant the at least one stored graft onto a recipient site. In some embodiments, the hair transplant system can have at least two of: at least one graft extraction module; at least one graft storage module; and at least one graft implantation module. In other embodiments, the hair transplant system can have at least one graft extraction module; at least one graft storage module; and at least one graft implantation module. The hair transplant system can further comprise at least one main drive unit. The hair transplant system can further comprise at least one tool holder configured to hold the at least one graft extraction module, the at least one graft storage module, and the at least one graft implantation module.
[0043] A graft in hair transplantation context is an elongated tissue surgically extracted from the donor site with the help a punch with at least one hair within it placed almost parallel to the axis of the graft. The tissue of the graft consists of a layer of skin on top followed by dermal tissue and loose fatty tissue. In some cases it may also contain a layer of cutaneous tissue. In
some other application such as other cosmetic surgeries a graft may or may not contain a hair follicle.
[0044] The main drive unit as shown in FIG.l comprises of at least one set of remote foot control (5); at least one vacutainer (6); a user interface control panel (7); at least one vacuum line tubing (8); at least one antimicrobial filter (9); at least one vacuum pump (10); at least one vacuum regulator (11) and at least one solenoid valve (12); at least one controller unit (13) that drives all peripheral devices; at least one power supply (14).
[0045] The main drive unit (1) has a power supply (14) which provides required electrical power to the peripheral systems through the controller unit (13). The controller unit controls the user interface control panel (7) and also communicates with the remote foot control (5) wirelessly or with wired connection to activate or deactivate the solenoid valves (12) in order to allow the vacuum to the graft extraction module (2) and graft implantation module (4). The vacuum line (8) connects to the vacutainer (6) which acts as the central vacuum reservoir cum drainage fluid collection. A vacuum pump (10) connects the vacutainer (6) through a main vacuum line passing through a vacuum regulator (11) and an anti-microbial filter (9) before it reaches the vacutainer (6).
[0046] The graft storage module (3) which latches or connects itself on the body of the graft extraction module (2) and connects to the distal end of the graft extraction module with the vacuum line (8) through its two connectors. The graft storage module (3) with its tubing that connects the distal end of the graft extraction module (2) is internally lubricated by a coating having a low coefficient of friction such as a hydrophobic or hydrophilic compound so as to prevent trauma to the grafts due to friction with the internal walls during extraction. The graft storage module (3) is designed to hold adequate volume of fluid or storage medium irrespective of its orientation or movement during use. Excess fluid from the graft storage module goes to the vacutainer (6) and can be stored.
[0047] The user interface control panel (7) allows the user to feed the information related to patient, surgeon and procedure before'the start of the procedure and allows the user to control various parameters such as vacuum, flow rate, speed and torque through easy controls on the control panel. The control information gets processed in the controller unit (13) and controller then controls the peripheral devices of the main drive unit (1) to achieve the desired parameters. The controller unit (13) also saves all the procedure data in a built in memory chip and allows the user to retrieve the digital data through a suitable interface.
[0048] The implantation module (4) is connected to the vacutainer through a parallel vacuum line (8) through at least one solenoid valve (12). There is a vacuum regulator (11) regulates the desired vacuum level and the antimicrobial filter (9) blocks any kind of microbial transmission and also fluid flow into or from the system or the tools.
[0049] The remote control (5) is connected to the main drive unit (1) either wirelessly or by wired connection for actuating drive motor of the graft extraction module (2), suction in the graft storage module (3) and suction in the graft implantation module (4). Each remote control (5) is programmed to work only with a specific drive unit (1) through a communication method between the remote control (5) and the drive unit (1) with a pairing of a unique identification code by means of a software program.
[0050] All parameters such as rotational speed and torque of the graft extraction module, suction level and suction flow rate in all modules of the system can be controlled using at least one computerized user interface control panel (7).
[0051] The rotational speed of the graft extraction module is automatically controlled by computer algorithm that detects the skin rupture and either substantially reduces the speed or stops the rotation or substantially reduces the torque as it approaches the dermal and cutaneous layer, thereby preventing damage to the graft being extracted and/or preventing damage to nerves under the graft.
[0052] The user interface may be graphical user interface, or graphical touch interface, graphical press interface, sound or voice interface, and so on.
[0053] In an embodiment, the system being modular, part or all the system can be used for graft transplantation and other cosmetic applications. The application of the system is meant for transplantation of the graft on scalp and can be applied to other body parts and other animals/ mammals as well. The application of this system is not limited to only hair transplantation. The graft extraction module provides comfortable holding by surgeon along with quick, easy and definite manipulative extraction of each graft using suction.
[0054] As shown in FIG.1A, the graft extraction module has an integrated motor drive which is controlled by the micro-controller in the hair transplant system. In the stage of graft extraction, to start scoring, the surgeon applies a little pressure to push the rotary cutting member so that the complete graft is inside the hollow of the rotary cutting member. During this process, if the graft is curved underneath the upper skin layer, there are chances that the
radial force of the rotary cutting member may partially transect the graft. A sensor system is designed in such a way that it can detect when the upper skin layer is ruptured and the rotary cutting member is now travelling downwards along the length of the graft, so that the as the cutting member reaches the bottom tip of the graft, the radial cutting force may be reduced or stopped.
[0055] This sensor system is designed in such a way that it can measure the radial force or torque experienced by the motor drive system. During the surgical procedure when the rotary cutting member starts scoring the target, the load on the motor gradually increases. The moment the upper most layer of the skin is ruptured, an intelligent algorithm in the micro-computer detects that the upper layer scoring is complete and it automatically reduces the speed of rotation or it may also stop the rotation depending on the choice of the surgeon.
[0056] All the modules or any two modules of the system can be used together or separately as per the usage and convenience by the user which can be used in alternating combinations. The system allows the graft extraction module and/or graft implantation module to work either independently or in conjunction. The graft extraction module can work either independently or in combination with the graft storage module. The graft extraction module and the graft storage module can be combined as a single module. Any one module can also be present in the system as per requirement.
[0057] FIG.1B, FIG. 1C and FIG. ID shows examples and different configurations of the hair transplant system showing different modules and their respective connections wherein the graft extraction module along with the graft storage module and the graft implantation module are mounted on a tool holder (See FIG. 67) that can be configured to hold the described modules. The system is not limited to these examples.
[0058] The graft extraction module (2) as shown in FIG. 2, has a drive motor (21) which is detachably or irremovably connected to a to the rotor head (22) to transmit mechanical power in order to rotate the rotary cutting member (23) in clockwise or anti-clockwise or oscillating mode along its axis by means of a mechanism housed within the rotor head (22). The type of rotation is controlled by the main drive unit (1) through various programs. One end of the rotor head has a cap connector (24) which is connected to the graft collection tube (33) of the graft storage module (3). As shown in FIG. 4, the rotary cutting member (23) extends at least partially into the graft collection tube (33) passing through at least one dynamic seal (25) that provides a vacuum sealing between the rotary cutting member (23) and the cap connector (24)
even when the rotary cutting member (23) is in rotation thus providing a leak proof channel from the distal end of the rotary cutting member (23) to the graft collection tube (33) leading to the graft storage module (3) as shown in FIG. 1 and FIG. 18. The graft extraction module thus is driven by an indirect drive.
[0059] As shown in FIG. 3 to FIG. 6; the rotor head (22) comprises of a housing (29) within which the collet assembly (26) is assembled precisely supported by its bearings (264). The collet assembly (26) is retained securely within the housing (29) by a retainer ring (27). The adjusting nut (30) mounts onto the threading on collet (261) so that the tapered internal surface (2661) of the adjusting nut (30) presses the corresponding tapered surface (2611) of the distal split jaws (2610) of the collet (261) so that, the split jaws grip the rotary cutting member (23). The rotor head (22) is connected to the cap connector (24) with another dynamic seal (25) in between and axially aligned with the vacuum channel on it. The depth of cut is determined by the length of the exposed length of the rotary cutting member (23) and the required depth of cut can be steplessly adjusted by loosening the adjusting nut (30) to set the required length and tightening the adjusting nut (30). The depth of cut can be adjusted from 1mm to 10 mm however more length can also be achieved if needed. The adjusting nut (30) can be loosened or tightened by rotating it anti clock wise or clockwise respectively while holding the collet (261). The collet assembly (26) allows step-less or stepped depth adjustment of the rotary cutting member (23) with graduated markings on the external surface of the rotary cutting member (23). The collet assembly (26) accommodates the rotary cutting member in such a way that the graft does not come in contact with any component of the graft extraction module (2).
[0060] FIG. 5 and FIG. 6 shows the collet assembly (26) wherein a bearing (264) is mounted at the distal end of the gear (262). The gear (262) is mounted on the collet (261). A lock washer (263) is mounted at the proximal end of the collet over which another bearing (265) is mounted.
[0061] In one embodiment as shown in FIG. 7, FIG. 8 and FIG. 9, the graft extraction module (2) is a straight hand held instrument that can have a rotor head (22) which is driven by a flexible transmission shaft (211) so that the surgeon do not have to hold the motor in hand. The flexible transmission shaft (211) connects to a gear train (213 and 262) that drives the collet assembly. The gear train is being supported by a pair of bearings (214 and 215).
[0062] In another embodiment as shown in FIG. 8, the flexible shaft can be replaced with an inbuilt motor on the same rotor head (22).
[0063] In another embodiment as shown in FIG. 10, FIG. 11, FIG. 12 where the graft extraction module (2) uses pressurised air through a channel (271) on the cap connector (24) to drive a hollow micro-turbine (267) to rotate on its axis thereby rotating the rotary cutting member (23). The rotary cutting member (23) is removably attached to the distal end of the micro turbine (267) with a dynamic seal (276) in between to prevent leakage of vacuum. The proximal end of the micro turbine (267) is connected to the cap connector (24) with another dynamic seal (25) in between and axially aligned with the vacuum channel on it. The vacuum channel can then be connected to a graft collection tube (33). The pressurised air is forced onto the turbine vanes through a nozzle on the retainer ring (27). The pressurised air hose (270) is connected to the cap connector (24) through a nozzle (269). There is a hand control knob (273) place on the rotor head (29) to manually control the air flow of the pressurized air in order to control the speed of rotation of the micro turbine (267). This control facilitates better usability for the surgeon as the speed control is provided on the device. Being a pen type device, the graft extraction module (2) becomes easy to maneuver and handle especially at narrow accessible areas. FIG. 13 shows the direction of flow of pressurized air and its effect on the micro turbine. When the knob is pressed, it blocks the air path thereby stopping the rotational motion of the micro turbine (267) and when it is released, depending on the gap, the rotational speed can be adjusted. The knob can be made to any design that can control the flow rate of the pressurized air. The exploded view of the pneumatic driven graft extraction module (2) is shown in FIG. 14. The hand control knob (273) is mounted axially at the air inlet port (272) with a seal (274) and a spring (275) in between.
[0064] Depth of cut during extraction may vary from person to person depending on the anatomy of the donor site and thus control of depth of cut is very desirable to protect the sub-cutaneous vessels and other significant anatomical features. Secondly it also depends on the positon of the follicular bulb within the tissue at the donor site. As shown in FIG. 15, the adjusting nut (266) can be loosened or tightened by rotating it anti clock wise or clockwise respectively while holding the collet (261) at its flat anti rotation feature (2611) on its body with the help of a collet latch (268). FIG. 4 and FIG. 8 can be referred for better understanding.
[0065] In one embodiment, as shown in FIG. 16 the depth can also be adjusted by providing a soft light weight tubular sleeve (230) of a particular length over the rotary cutting member (23).
[0066] The depth of cut = (Exposed length of the rotary cutting member outside collet) - (the length of the spacer).
[0067] In another embodiment, as shown in FIG. 17 the depth control can be achieved by an external transparent depth adjuster (231) mounted on the body of the rotor head (29). The depth adjuster (231) has two parts slidably assembled with each other and having a locking system for fixing the set depth value as needed. The distal part has a substantially U-shaped geometry which accommodates the rotary cutting member (23) and has a low profiled surface to rest on the scalp that acts as a stopper feature when the rotary cutting member gets inserted into the preset value for the depth of cut. The depth adjuster (231) is made of a transparent material in order to allow good visibility of surgical site. The proximal part has a latch (2311) which gets removably clamped onto the housing of the rotor head to provide stability. The depth adjuster (231) can be rotated to any orientation around the axis of the rotary cutting member (23) as per the comfort of the surgeon.
[0068] As shown in FIG. 18 and FIG. 22; describes the graft storage module (3) which comprises of a preferably transparent storage chamber (31) detachably coupled with a preferably transparent cap (32) with at least one seal (35) in between them mounted on the groove (313) to prevent vacuum leakage from the joining interface. The cap is connected to a graft collection tube (33) while the connector (315) of the storage chamber (31) is connected to a flexible vacuum hose (34) coming from the vacutainer (6) as shown in FIG. 1. The feature (314) is just a cosmetic detail and can serve as a stopper feature for the cap positioning.
[0069] The graft storage module (3) can be clamped onto the body of the graft extraction module (2) for ease of operation by a detachable X-shaped latch (312) as shown in FIG. 20. The X shaped latch (312) as shown in FIG. 19 can be molded or machined out of plastic or metal that can provide an optimum stiffness to its jaws for secure holding of the graft storage module onto the graft extraction module (2). The latch provides flexibility to the surgeon to adjust the position of the graft storage module (3) along the length of the graft extraction module (2). The graft storage module allows only one-way travelling of extracted graft coming from the graft extraction module (2) through a graft collection tube (33). The technology has been so designed to hold multiple grafts and increasing their tolerance to desiccation throughout the surgical procedure.
[0070] In one embodiment, as shown in FIG. 21, wherein the storage chamber has an inbuilt latch feature (311) on its body. This reduces the need of an extra part in the graft storage module (3). The cap has at least one port wherein first port (321) is connected to the rotor head through the graft collection tube (33) as shown in FIG. 20.
[0071] FIG. 23 shows the section view of the assembly of the storage chamber (31) with the cap (32) having at least one seal (35) in between them. The cap (32) has a hollow tube feature (322) substantially located at the central axis of the cap (32) whose internal diameter is substantially larger than the internal diameter of the graft collection tube (33). The diameter may change as per requirement and the internal diameter of hollow tube feature (322) may even be substantially lesser than the internal diameter of the graft collection tube (33). The internal diameter of the graft collection tube is preferably more or substantially equal than the outside diameter of the rotary cutting member (23), though it may be smaller as per requirement. The storage chamber (31) has an integrated tubular retaining filter (316) at its tip having slits or openings with size smaller than the size of the graft. The lumen of the tubular filter (316) extends outside of the storage chamber (31) to accept the vacuum line (34) coming from the vacutainer (6) as shown in FIG. 1. As shown in FIG. 24, the size of the slits or openings of the retaining filter (316) is preferably smaller than the diameter of the graft thus it retains the extracted grafts and gets deposited inside the storage chamber. The fluid can be generally any storage medium such as saline. The storage capacity is in proportion to the available volume of the storage chamber (31). Any excess fluid from the storage chamber (31) escapes through the tubular retaining filter (316) into the vacutainer (6) through the vacuum line (34). As shown in FIG. 25, the graft storage module is designed to hold the storage fluid irrespective of any orientation thus providing a wet bath to the extracted grafts thereby preventing any potential damage of graft due to desiccation by suction.
[0072] After the storage chamber (31) is substantially filled or filled to the desired level or number of grafts, the grafts are then transferred for implantation at the recipient site.
[0073] In one embodiment, the graft storage module is a vertically placed in-line storage module as shown in FIG. 26, the section view of which is shown in FIG. 27. The cap may have at least two ports as shown in FIG. 27 and FIG. 28 wherein first port (321) is connected to the rotor head (22) as shown in FIG.3 through the graft collection tube (33) while the second port (322) is connected to the vacutainer (6) through a vacuum line (34). The graft collection tube (33) passes through the first port (312) in such a way that a portion of the tube extends into the storage chamber (31) to a length substantially close to the base of the storage chamber (31). There is a micro filter (323) at the mouth of the second port (322) to prevent accidental escape of grafts into the vacutainer (6) as shown in FIG. 29. A spatula filter (36) is placed inside the storage chamber as shown in FIG. 27. An exploded view of the vertical graft storage module is shown in FIG. 30.
[0074] As shown in FIG. 30, a spatula (36) having a perforated disc is attached to a handle grip which is also provided to easily take out the grafts from the storage chamber (31) with ease. The perforation on the spatula is to allow the fluid to sip through leaving the grafts. The graft storage module (3) can be mounted in a substantially vertical position always to avoid fluid going into the vacuum line (34) and ultimately into the vacuum pump (10). There is at least one seal (35) shown which seals the cap portion (32) with the body portion (31). The size of the perforation in micro filter (323) and on the spatula filter (36) can be smaller than the size of the graft.
[0075] The X-shaped latch comprises of four arms with one pair of arms forms a contour for securely clamping on to the body of the graft extraction module with corresponding contour on it while the other pair conforms to the contour of the graft storage module. Both pair of arms has some stiffness to act as a spring for easy clamping and de-clamping of the modules during the procedure. The latch may be further of any shape.
[0076] In one embodiment the X-shaped latch can be made as a single piece in plastic or metal or a composite as shown in FIG. 31.
[0077] In another embodiment, the X-shaped latch can be made in of at least two strips formed into contours as shown in FIG 32 wherein, the two strips are identical in shape thus eliminating the requirement of molding or fabrication of two different parts. The strips can be made of plastic or metal or composite joined together by welding, adhesive, rivets, screws and so on, as shown in FIG. 32.
[0078] The rotary cutting member (23) as shown in FIG.33 has an elongated straight tubular part having a very thin wall structure with a sharp cutting edge at the distal end and a blunt edge at the other end. As shown in FIG. 34, the body of the rotary cutting member has two portions; the distal portion (234) is of variable diameter while the proximal portion (236) has a standard fixed outer diameter. The proximal portion (236) and distal portion (234) has an intermediate connecting portion (235) where the shape or taper angle may vary depending on the size of the distal portion (234) and the proximal portion (236). The wall thickness (237) remains substantially same throughout the length. The length of the rotary cutting member is sufficient enough to pass through the dynamic seal (25) of the graft extraction module (2) at the proximal end. The length is also sufficient enough to get a good grip by the collet (261) when the adjusting nut (266) is tightened as shown in FIG. 15. The distal portion stays out of the collet while the proximal portion stays inside the collet and precisely aligned with the collet
axis. FIG. 35 shows the enlarged view of the distal end wherein the distal tip has an inner bevel
(232) and an outer bevel (233) forming a cutting edge. The inner bevel (232) and outer bevel
(233) form sharp edge (231) at the distal end of the rotary cutting member (23). The internal diameter of the distal portion cutting edge is same or greater as the diameter of the graft that is required to be extracted which is grossly decided by the surgeon. The dual bevel tip helps in providing a durable cutting edge wherein the cutting edge is further toughened by coating the tip with a hard substance such as titanium nitride (TiN) coating which enhances the life of the edge. The rotary cutting member is a tubular structure having both the first end and second end open with same or different end diameters and having at least one cutting edge at one of its end. The internal diameter of the proximal portion remains slightly more than that of the distal portion to allow a free passage for the extracted graft just after getting timed. This helps in reducing the trauma on the graft due to friction and thereby trauma. The diameter of the cutting member may vary from about 0.5mm to about 5 mm however it can be changed depending on the size of the hair and number of hairs in the graft required by the surgeon. The rotary cutting member has a quick fit removable locking feature along with a seal.
[0079] In one of the embodiments, the rotary cutting member (23) has a tapered body (238) as shown in FIG. 36 wherein, the graft as soon as it gets cut gets a free passage and the amount of suction force that is required to pull the graft reduces as the surface area is increased on which the suction forces act.
[0080] In another embodiment, the rotary cutting member (23) has an internal helical fluted lumen (239) as shown in the enlarged view of the distal end in FIG. 37 or internal spiral that creates an additional drag force on the graft so as to pull the graft with bare minimum force. The suction force also helps in pulling the graft simultaneously.
[0081] In another embodiment as shown in FIG. 38, the rotary cutting member (23) has a quick-fit removable locking feature (2341) at its proximal portion that gets securely, co-axially and precisely connected with the collet assembly having a corresponding locking detail. At its distal portion it has a sharp end which is graduated marking lines (2311) having approximately at lmm gap in order to indicate the depth during graft extraction.
[0082] In another embodiment as shown in FIG.39, the rotary cutting member (23) is a straight tubular body with the proximal and distal portions have the same external and internal diameter.
[0083] In another embodiment, the cutting edge at the distal portion can have a single bevel either inside bevel or outside bevel. The graft implantation module (4) as shown in FIG. 40 is a handheld tool to facilitate atraumatic implantation of hair grafts at the recipient site without the use of forceps or tweezers or any other grasping tool that may squeeze and damage the hair graft. Being atraumatic, the cells of the graft remain free from any kind of trauma and hence helping in better cell viability leading to better and faster hair growth. In addition the graft implantation module also helps in creating slits simultaneously just before implantation of each graft thus reducing surgical time significantly. The graft implantation module also allows the user to control the implantation depth of the grafts during the procedure.
[0084] FIG. 41 shows the exploded view of the components wherein the graft implantation module (4) comprises of a left half of housing (41), a right half of housing (42) which houses various components of the graft implantation module (4) such as a knob assembly (43), a stationary transfer tube assembly (44), a pusher assembly (45), a nozzle assembly (46).
[0085] FIG. 42 shows the cross sectional view of the graft implantation module (4) to understand the arrangement of the components within the housing when the graft implantation module is in idle condition.
[0086] FIG. 41 in conjunction with FIG.42 shows the knob assembly (43) comprises of knob (430), a pivot pin (431) that passes through the pivot hole (434) on the knob (430) and gets mounted within the two halves of the housing (41 and 42). A cam roller (433) is mounted over a roller pin (432) that gets fitted on to the knob (430) in such a way that the two arms of the knob rides over the pusher body (450) and the cam roller (433) engages on the cam surface (454) of the pusher body (450) as shown in FIG. 42. The knob (430) has a grip surface to provide adequate grip force for pushing the knob. Transfer tube (441) is attached to transfer tube holder (440). The roller pin (432) is mounted inside the roller pin hole (435).
[0087] In some embodiments, the pusher assembly is configured to retract with respect to the transfer tube assembly when the knob assembly is actuated in a first direction to form a cavity (for example, graft loading position) within the transfer tube assembly to accommodate the graft; and the graft is ejected from the transfer tube assembly when the knob assembly is actuated in a second direction (for example, graft ejection position). FIG.42 and Fig. 43 shows the graft implantation module (4) in graft loading position and graft ejection position respectively. As shown in FIG. 42 when the Knob (430) is not pressed and the vacuum flow is activated to the graft implantation module, there is a vacuum created in the open cavity within
the transfer tube (441). Hair graft with its hair facing towards the mouth of the transfer tube gets sucked stays within this cavity. During Implantation, the knob (430) is pressed and vacuum is deactivated, the pusher (452) gently ejects to a depth proportional to the actuation of the knob by the surgeon thereby allowing the user to control the depth of implantation.
[0088] The skin layer of the graft has a thickness of which can vary from about 0.1 mm to about 1 mm, and it is preferred that it stay above the scalp surface at the recipient site after implantation. To achieve this, the tip of the pusher (452) can be positioned approximately 1 mm from the tip of the transfer tube (441) (see FIG. 43)
[0089] As shown in FIG. 44 and FIG.45 which is a cross sectional view of the transfer tube assembly wherein the transfer tube assembly (44) has a transfer tube (441) attached to a transfer tube holder (440). The transfer tube (441) has a sharp needle tip (4411) at its distal end and the proximal end of the transfer tube (441) is attached to the distal end of the transfer tube holder (440). The lumen of the transfer tube holder (4401) has a bigger cross sectional size than the internal diameter of the transfer tube (441). A dynamic seal (443) as shown in FIG. 42 and FIG. 43 is mounted within the groove (4422) at the proximal end of the transfer tube holder (440) to create a seal between the transfer tube assembly (44) and the pusher assembly (45). There is an anti-rotation feature (4423) at the distal end of the transfer tube holder (440). The transfer tube tip may be sharp or blunt and may have a bevel tip with angle ranging from 0 degrees to 45 degrees.
[0090] As shown in FIG. 46 and FIG. 47, the pusher assembly (45) comprises of a pusher body (450) with a hollow lumen (457) having a pusher (452) mounted coaxially within the lumen (457) at its distal end in such a way that there exists an open channel for the air flow throughout the length of the lumen (457). There is a stopper feature (456) for limiting the co-axial movement of the pusher assembly (45) towards the proximal end. The lumen (457) accommodates the transfer tube holder (440) of the transfer tube assembly that can move slidably coaxially within the lumen with at least one seal (443) in between them to prevent leakage of air flow or vacuum. A compression spring (453) is housed within the lumen over the pusher (452) and in between the transfer tube assembly (44) and the pusher assembly (45). The pusher body (450) has a cam surface (454) that controls the to and fro movement of the pusher assembly (45). When the knob is pushed down, the roller over the cam surface forces the pusher assembly to move towards the distal end. When the knob (430) is released, the pusher assembly (45) comes back to the original position. The hollow lumen (457) on the
pusher assembly (45) is wider at its distal end (451) to accommodate a nozzle assembly (46) and are slidably assembled in such a way that the lumen of the nozzle assembly (46) is co-axial to the lumen of the pusher assembly (45) so that the flow rate of vacuum at the nozzle assembly (46) is at least equal or more than the flow rate of vacuum at the distal end of the pusher assembly (45).
[0091] As shown in FIG. 48 and FIG. 49, the nozzle assembly (46) has a hollow lumen (462) and has a nozzle (463) at its proximal end to receive a flexible vacuum hose (8). There is at least one dynamic seal (461) mounted within the groove (466) on the nozzle body (460) to prevent leakage between the pusher assembly (45) and the nozzle assembly (46) even when the pusher assembly (45).moves co-axially over the nozzle assembly (46). The nozzle body is stationary member of the graft implantation device (4). It has an anti-rotation feature (464) to prevent unwanted rotation of the nozzle with respect to the housing (41 & 42). It also has a positioning feature (465) to locate the nozzle assembly precisely with respect to the housing (41 & 42). FIG 49 shows the cross sectional view of the nozzle body (460).
[0092] In one embodiment, as shown in FIG. 50, the graft implantation module (4) is modified into a synchronous graft implantation module (5) that has a mechanism for a synchronously retracting the device while the graft is being ejected into the recipient site. The graft implantation module (5) can replace a graft implantation module (4). FIG. 51 shows the exploded view of the graft implantation module (5) which comprises of a left half housing (51) and a right half housing (52), a retractor assembly (53), a nozzle assembly (54), a knob assembly (55) and a spring (56).
[0093] FIG. 51 in conjunction with FIG. 52 shows the nozzle assembly (54) wherein it comprises of a nozzle body (541) coaxially attached to a long transfer tube (542) at its distal end. The nozzle has a U-slot opening (545) at its distal end. The distal end of the pusher (543) passes through the lumen of the transfer tube (542) while the proximal end is free to move in the gap created between the transfer tube (542) and nozzle body (541). The nozzle body (541) has a nozzle at its proximal end to accept the vacuum line (8) from the vacutainer (6). A seal (547) is mounted on the groove feature (546) to prevent leakage between the retractor assembly (53) and the nozzle assembly (54). The transfer tube (542) has a chamfered tip at its distal end that helps in smooth guidance in entering the slits at the recipient site. There is another dynamic seal (58) which is contained within the cavity of the proximal end of the retractor assembly through which passes the transfer tube (542) of the nozzle assembly (54). Because of the
dynamic seal (58), vacuum channel is created through the gap between the transfer tube and pusher. There is a spring mounted between the retractor assembly and the housing that always keep the retractor assembly (53) in forward direction when the knob (55) is not actuated. The knob body (550) is pivoted on a pivot hole (552) by a pivot pin (551) which is locked between the housing (51 and 52). There is an anti-rotation feature (544) at the proximal end of the nozzle body (541) which positions the tip profile (5421) in correct orientation and also prevents it from rotating.
[0094] FIG. 53 shows the arrangement of components within the right half housing 51 when the device is in idle condition. In this position, the cam feature of the knob (552) rests on the corresponding cam feature (531) of the pusher assembly while the distal end of the retractor (53) completely houses the transfer tube (542).
[0095] When the knob is actuated or pressed down as shown in FIG. 54, the knob cam feature (552) pushes the corresponding cam surface (531) of the retractor assembly (53) in a first direction along with the pusher (543) back thereby exposing the transfer tube (542) and simultaneously creating an open cavity within the transfer tube (542) at the distal end. At this position in order to load the graft, vacuum channel is opened to get sufficient vacuum and flow rate to suck the graft into the open cavity.
[0096] The synchronous graft implantation module (5) is then approximated and oriented at the recipient site and slit is created using the sharp tip of the transfer tube (542) and knob is released slowly. When the knob is released, the retractor assembly (53) moves in a second direction along with the pusher (543) tries to come back to its original no load condition with respect to the transfer tube as shown in FIG. 53. But since the tip of the retractor assembly is placed gently on the surface of the recipient site, the transfer tube (542) thus relatively gets ejected out of the slit placing the graft in the slit. Thus the synchronous graft implantation module automatically gets retracted and ready for the next implantation cycle thereby reducing the learning curve for the surgeon to achieve consistent and repeatable implantation of the grafts.
[0097] In another embodiment as shown in FIGS. 55- FIG. 62, the graft implantation module has a replaceable transfer tube assembly (67) in order to allow the surgeon easy replacement of the transfer tube if the sharpness gets blunt or to change to a different size of the transfer tube.
[0098] As shown in FIG. 56, the replaceable tip graft implantation module (6) with replaceable transfer tube assembly (67) comprises of a left half housing (61) and a right half housing (62) within which contains the moving components such as a cam shaft actuator assembly (63), a nozzle tube assembly (64), a knob assembly (65), a nose (66), and a replaceable transfer tube assembly (67).
[0099] The cam shaft actuator assembly (63) comprises of a pusher rod (631) cbaxially mounted in such a way that there exists a free pathway for vacuum line or air passage throughout the channel between the distal and proximal end of the cam shaft actuator body (630). As shown in the cross sectional view in FIG. 59, at least one dynamic seal (632) is mounted at the distal end while a spring (633) is mounted at the distal end of the cam shaft actuator assembly (63). The proximal end has a larger lumen to accommodate the distal end of the nozzle tube and has an inclined surface substantially parallel to provide a sealing surface for at least one O-ring (641) of the nozzle tube assembly (64).
[0100] The nozzle tube assembly (64) as shown in FIG. 59 comprises of a nozzle tube body (640) which has a hollow lumen for vacuum line. The proximal end of the body has a larger outer diameter while the distal end has a smaller diameter junction of which forms an inclined surface. The inclined surface has a groove for accommodating at least one O-ring on it for providing adequate sealing between the cam shaft assembly (63) and the nozzle tube assembly (64). A spring (633) is mounted over the nozzle tube body (640) placed in between the cam shaft actuator body (630) and a positioning wall of the housing (61 & 62). The spring (633) always keeps the cam shaft actuator assembly pushed towards the distal end.
[0101] The knob assembly (65) is mounted over the cam shaft assembly (63) in such a way that the knob body (650) is pivoted with a pivot pin (653) that is supported between the right half housing (61) and left half housing (62) while the roller (651) mounted on a roller pin (652) passes through the cam slot (634) of the cam shaft actuator in such a way that the roller is tangentially mounted on the cam surface of the cam shaft actuator (635).
[0102] The nose (66) gets replaceably attached to the distal end of the cam shaft actuator body (630) and covers the replaceable transfer tube assembly (67). The replaceable transfer tube assembly has a transfer tube (671) attached to a transfer tube holder (672). As shown in FIG. 57 and 58, the transfer tube holder (672) has a locking feature (672) at its proximal end that gets locked with a corresponding locking feature (642) of the nozzle tube assembly (64).
[0103] This as shown in FIG. 59, the transfer tube assembly is completely and securely housed inside the nose (66) and is stationary while the nose (66) can move backward towards the proximal end thereby exposing the transfer tube (671). When the knob (650) is pressed down as shown in FIG. 62, the pusher (631) moves backward creating an open cavity at the tip of the transfer tube (671). In this position vacuum is activated and graft is sucked into this open cavity. The surgeon then, creates a slit, inserts a portion of the transfer tube to a depth when the nose touches the surface of the recipient site. During ejection process, user only needs to release the knob (650) which moves the nose (66) forward there by retracting the transfer tube (671) from the surface of the recipient site relative to the nose (66).
[0104] FIG. 60 shows the replaceable tip graft implantation module (6) with the nose (66) and the transfer tube assembly (67) opened. As shown in FIG. 61, the nose has a locking feature (661) that gets locked with a corresponding locking feature (636) on the cam shaft actuator body (630).
[0105] FIG. 63 shows the graft tray (70) for arrangement of hair grafts for assisting in implantation. It comprises of an at least one holding member (71) and a covering member (72).
[0106] The holding member (71) as shown in FIG. 64 has at least one slot (712) to hold at least one graft the slot extends to at least one first opening (711) towards the front face of the holding member (71). The first opening (711) has a tapered entry to easily guide the transfer tube of a graft implantation module. A portion of the face can be used as a grip. The opening may be of any shape. The entry may be of any shape to easily guide the transfer tube as per requirement. The holding member (71) and the covering member (72) when assembled together will form at least one graft holding chamber having both ends open with different size of openings.
[0107] The covering member (72) as shown in FIG. 65 has a cavity (722) to accommodate the holding member (71) in such a way that the holding member (71) slidably fits within the covering member (72). The rear wall of the covering member has a second opening (721) so as to allow air flow during suction of the graft into the transfer tube cavity of the graft implantation module as shown in FIG. 66. The second opening can be a vent.
[0108] The transfer tube of the graft implantation module (4) is attached into the first opening (711) such that the transfer is air sealed with the holding member (71). When the suction is started in the graft implantation module, the air is pulled from the second opening (721). The negative pressure created inside the graft tray (70) moves graft towards the cavity in the tip of
the graft implantation module and gets loaded without the use of any tweezer or forceps. If required the grafts can be stored inside the graft tray with saline or other suitable fluids.
[0109] FIG. 67 shows system with at least one tool holder (15) which comprises of different features such as clamping feature (154) for clamping the tool holder (15) onto a handle (16) of the main drive unit (1), first holding feature (151) for graft extraction module (2) along with graft storage module (3) and second holding feature for graft implantation module (4) and a third holding feature for holding excess length of vacuum line (8).
[01101 Methods of transplanting hair
In other embodiments, methods of transplanting hair are provided. For example, a method of transplanting hair may include positioning a graft extraction module over a donor site; atraumatically extracting at least one hair graft from the donor site using the graft extraction module to provide at least one extracted hair graft; storing the at least one extracted hair graft in a graft storage module to provide at least one stored hair graft; positioning a graft implantation module over a recipient site; and atraumatically implanting the at least one stored hair graft onto the recipient site using the graft implantation module.
[0111] The at least one hair graft may generally be any number of hair grafts, such as 1, 2, 3, 4, 5, 10, 20, 50, 100, 200, 300, 400, 500, 1,000, 2,000, 3,000, 4,000, 5,000, 10,000, or ranges between any two of these values (including endpoints).
[0112] The positioning a graft extraction module over the donor site step can include aligning at least one rotary cutting member of the graft extraction module coaxially over the at least one hair graft at the donor site hair along a direction of the graft.
[0113] The atraumatically extracting the at least one hair graft step can include advancing the at least one rotary cutting member into a skin layer surrounding the at least one hair graft at the donor site, wherein the rotary cutting member rotates as it advances into the skin layer; and applying suction to remove the at least one hair graft from the donor site to provide the at least one extracted hair graft.
[0114] The storing the at least one extracted hair graft in the graft storage module step can include transporting the at least one extracted hair graft from rotary cutting member to the graft storage modules wherein the at least one extracted hair graft is transported through a graft
collection tube that communicates between the rotary cutting member and the graft storage module.
[0115] The method can further include trimming the at least one hair graft at the donor site before positioning the graft extraction module over the donor site. The length of the trimmed hair above the external skin surface can generally be any length, such as about 1 mm to about 5 mm, or about 1 mm to about 3 mm. Specific examples of lengths include about 1 mm, about 2 mm, about 3 mm, about 4 mm, about 5 mm, and ranges between any two of these values (including endpoints).
[0116] The method can further include providing a tumescence fluid in a space between a dermal layer that surrounds the at least one hair graft and a sub-cutaneous layer below the dermal layer, before atraumatically extracting at least one hair graft from the donor site. Examples of tumescence fluids include saline, Lidocaine solution, epinephrine solution, adrenaline solution, and any combination thereof.
[0117] The storing the at least one extracted hair graft in the graft storage module can include providing at least one preservation fluid in the graft storage module; and providing the at least one stored hair graft in the at least one preservation fluid. Examples of preservation fluids include saline, hypothermosol FRS, Lactated Ringer's solution with lactate as buffer, human serum with bicarbonate buffer, Plasma-lyte A with acetate gluconate buffer, and any combination thereof.
[0118] The method can further include removing the at least one stored hair graft from the graft storage module and providing the at least one stored hair graft into a graft tray, before atraumatically implanting the at least one stored hair graft onto the recipient site. The method can further include aligning a transfer tube of the graft implantation module coaxially over the at least one stored hair graft on the graft tray; and applying suction to transfer the at least one stored hair graft into the transfer tube.
[0119] The atraumatically implanting the at least one stored hair graft onto the recipient site step can include advancing the transfer tube into a skin layer at the recipient site to create a cavity in the skin layer; and transferring the at least one stored hair graft from the transfer tube into the cavity, wherein during the transfer, a pusher assembly pushes the stored hair graft into the cavity while the transfer tube retracts away from the cavity.
EXAMPLES
[01201 Example 1: Preparation of hair implant system
[0121] A graft extraction module, graft storage module, and graft implantation module were connected to a main drive unit through electrical and pneumatic connections. The graft collection tube of the graft storage module was connected to the rotor head of the graft extraction module.
[0122] The main drive unit was powered on, which activates the vacuum pump to create a vacuum inside the vacutainer until a pre-set automatic cut-off level is reached. The computerized user interface control panel allows selection of vacuum level of 0% to 100%.
[0123] Example 2: Preparation of donor site and recipient site
[0124] Hair at the donor site and recipient site was trimmed to leave only a short length of the hair about 1 mm to about 3 mm above the donor site skin surface. These short hairs provided the surgeon a direction of the hair shaft thereby allowing the surgeon a sense of judgement to align the graft extraction module and graft implantation module along the same direction to cut the tissue surrounding the hair without transecting the hair follicles. After trimming, the donor site and recipient site were thoroughly cleaned with a surgical disinfectant.
[0125] Example 3: Surgical extraction procedure
[0126] The surgeon sets the speed and torque of the rotary cutting member and the level of vacuum using the computerized user interface control panel. Selections may depend on factors such as the type of donor site, level of tissue laxity, and any presence of scar tissue from previous surgery or accidents. Local anaesthesia is administered at the donor site by the surgeon.
[0127] Tumescence is created by the surgeon by injecting a premixed tumescence fluid at the donor site in a space in between the dermal layer containing the follicular root and the sub cutaneous layer containing the connecting blood vessels thereby raising the dermal layer up. It may be noted that a good tumescence is desirable to (i) prevent any damage to the blood vessels during the blind cutting of tissue wherein during cutting of tissue, (surgeon usually gets two indicative sensations, first when the erector pili muscle gets dissected and second total give away sensation with substantially no resistance when the rotary cutting member cuts through the dermal layer reaching to the loose fatty tissue); (ii) allowing the detachment of grafts with
a minimal suction force and (iii) provides better tissue tension during extraction for precise cutting and (iv) to enlarge the inter-hair space in order to allow sufficient space for extraction of graft without transecting the surrounding hair follicles.
[0128] Saline or other suitable storage fluid is introduced into the graft storage module to provide a storage medium for the extracted grafts. Excess saline drains out to the vacutainer through the vacuum hose connecting to the graft extraction module. An anti-microbial filter in the pneumatic line between the vacutainer and the vacuum pump prevents introduction of bacteria into the system, and does not allow water to enter into the vacuum pump or other peripheral devices in the pneumatic circuit.
[0129] The rotary cutting member of the graft extraction module is aligned coaxially over the hair along the direction of the hair shaft and is approximated towards the skin to cut through the skin layer and then through the dermal layers to a depth where the graft becomes loose and the suction force pulls the graft through the lumen of the rotary cutting member into the graft storage chamber through a graft collection tube.
[0130] The extraction process is repeated multiple times until the graft storage module is substantially filled, or until a desired number of grafts are obtained. The hair transplant system maintains and displays a count of the number of extracted grafts.
[0131] The extracted grafts can either be implanted immediately after the extraction procedure, or can be stored for use at a later time.
[0132] Example 4: Surgical implantation
[0133] Extracted grafts can be separated by a technician with respect to the number of hairs in a single graft. For example, a graft may have one, two, or three hairs. The surgeon selects the implanter mode on the computerized user interface control panel, and sets the desired suction parameters.
[0134] The surgeon aligns the transfer tube of the implantation module such that the transfer tube is substantially coaxial with the graft and that the hair is pointing towards the mouth of the transfer tube. The surgeon activates the vacuum, which sucks the graft into the cavity within the transfer tube.
[0135] Next, the graft implantation tube is oriented in a direction of the desired hair direction, and the skin of the recipient site is pierced by the tip of the transfer tube. This creates a slit at
a depth selected by the surgeon. If an implantation module is used having a blunt transfer tube, the slits can be made by use of a micro blade of substantially the same size of the graft at the recipient site prior to ejection of the grafts.
[0136] After the slit is created and the transfer tube is still present within the slit, the surgeon gently presses the knob on the graft implantation tube thereby pushing the graft out of the transfer tube while the graft implantation module is being withdrawn simultaneously thus placing the graft inside the slit securely.
[0137] This process is repeated multiple times until a desired number of extracted grafts are implanted at the recipient site. The recipient's hair line and hair pattern may be used by the surgeon to select the number, density, and location of the implanted grafts. The hair transplant system maintains and displays a count of the number of implanted grafts.
I"0138] Example 5: Comparison with manual extraction
A comparison was performed comparing the morphology of grafts extracted by the hair transplant system described herein against those manually extracted using a punch and forceps. Morphology is frequently measured in "chubbiness", where a chubbier graft is found to lead to superior hair growth.
[0139] Grafts extracted by the hair transplant system were found to be about 30% chubbier than those manually extracted, conferring better protection of the follicular roots and ultimately superior hair growth.
[0140] Example 6: Setting vacuum and flow rate
[0141] Vacuum levels in the hair transplant system were varied from 200 mm Hg to 750 mm Hg. The vacuum level can be set using the computerized user interface control panel. Vacuum flow rate was found to be particularly suitable at about 0.1 LPM (liters per minute) to about 15 LPM at the point of the graft extraction module. These settings were still found to be suitable even when two or more of the graft extraction module, graft storage module, and graft implantation module were used simultaneously. The vacuum level and flow rate can be varied according to the situation, taking into account the size of the graft extracted, the tissue laxity, the frictional forces between the tissue and the tools and accessories in contact, and the adhesion of the graft with surrounding tissue at the base.
[0142] Example 7: Setting speed and torque
[0143] Speed and torque are inversely proportional and the preference for selection of speed and torque varies from surgeon to surgeon and depends on multiple factors/Typically, an option for selection range from about 0 RPM to about 3000 RPM is provided for the graft extraction module. The surgeon can choose any speed in this range. Torque depends on the gear ratio and the speed reduction can be achieved by changing the mechanical gear ratio, or by electronically, or both.
[0144] In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.
[0145] The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.
[0146] With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity.
[0147] It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," et cetera). While various compositions, methods, and devices are described in terms of "comprising" various components or steps (interpreted as meaning "including, but not limited to"), the compositions, methods, and devices can also "consist essentially of or "consist of the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups. It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an"-limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (for example, "a" and/or "an" should be interpreted to mean "at least one" or "one or more"); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to "at least one of A, B, and C, et cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example," a system having at least one of A, B, and C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). In those instances where a convention analogous to "at least one of A, B, or C, et cetera" is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, " a system having at least one of A, B, or C" would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). It will be further understood by those within
the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."
[0148] In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.
[0149] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera As will also be understood by one skilled in the art all language such as "up to," "at least," and the like include the number recited and refer to ranges which can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 cells refers to groups having 1, 2, or 3 cells. Similarly, a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.
[0150] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.
What is claimed is:
1. A hair transplant system comprising at least one of:
at least one graft extraction module;
at least one graft storage module; and
at least one graft implantation module; wherein:
the graft extraction module is configured to atraumatically extract at least one graft from a donor site to provide an extracted graft;
the graft storage module is configured to receive and store the at least one extracted graft from the graft extraction module to provide a stored graft;
and the graft implantation module is configured to atraumatically implant the at least one stored graft onto a recipient site.
2. The hair transplant system of claim 1, comprising at least two of:
at least one graft extraction module;
at least one graft storage module; and at least one graft implantation module.
3. The hair transplant system of claim 2, comprising:
at least one graft extraction module;
at least one graft storage module; and at least one graft implantation module.
4. The hair transplant system of claim 1, wherein the graft extraction module comprises at least one drive motor, at least one rotor head, at least one collet assembly, and at least one rotary cutting member.
5. The hair transplant system of claim 2, wherein:
the rotary cutting member is driven by at least one air actuated turbine; and
the rotary cutting member comprises at least one quick fit removable locking unit and at least one seal.
6. The hair transplant system of claim 2, wherein the rotor head comprises at least one seal or at least one dynamic sealing mechanism, configured to prevent leakage of vacuum between the rotary cutting member and the graft storage module.
7. The hair transplant system of claim 2, wherein:
the collet assembly is configured to allow step-less or stepped depth adjustment of the rotary cutting member; and
the rotary cutting member has an external surface with graduated markings.
8. The hair transplant system of claim 2, wherein the collet assembly is configured to accommodate, grip and drive the rotary cutting member without obstructing the passage of graft from the rotary cutting member to the graft storage module.
9. The hair transplant system of claim 2, wherein the collet assembly is configured to accommodate the rotary cutting member such that the graft does not come in contact with the graft extraction module.
10. The hair transplant system of claim 2, wherein the rotary cutting member is stepped or stepless.
11. The hair transplant system of claim 2, wherein:
the rotary cutting member is a tubular structure having a first open end and a second open end, the first open end having a first diameter and the second open end having a second diameter;
wherein the first diameter and the second diameter are the same or different; and
at least one of the first open end and second open end have a cutting edge.
12. The hair transplant system of claim 2, wherein the rotary cutting member comprises:
an internal surface coated with titanium nitride (TiN); and
an external surface coated with titanium nitride (TiN).
13. The hair transplant system of claim 2, wherein the rotary cutting member comprises:
an internal spiral lumen with a sharp cutting edge or a blunt cutting edge; or
a helical fluted lumen with a sharp cutting edge or a blunt cutting edge.
14. The hair transplant system of claim 1, wherein:
the graft storage module comprises at least one storage chamber, at least one cap, at least one graft collection tube; and at least one retaining filter;
the graft storage module is configured to work in conjunction with the graft extraction module; and
the graft storage module is configured to work independently from the graft implantation module or in conjunction with the graft implantation module.
15. The hair transplant system of claim 1, wherein the graft storage module comprises an internal surface having a coefficient of friction equal to or less than about 0.3.
16. The hair transplant system of claim 1, wherein the graft storage module comprises a hydrophilic internal surface.
17. The hair transplant system of claim 1, wherein the graft storage module comprises a hydrophobic internal surface.
18. The hair transplant system of claim 1, wherein:
the graft extraction module comprises at least one drive motor, at least one rotor head, at least one collet assembly, and at least one rotary cutting member;
the rotary cutting member has an internal diameter;
the graft collection tube has an internal diameter; and
the internal diameter of the graft collection tube is equal to or greater than the internal diameter of the rotary cutting member.
19. The hair transplant system of claim 1, wherein the graft storage module comprises at least one integrated retaining filter whose openings are smaller than the graft thereby preventing passage through the integrated retaining filter and out of the graft storage module.
20. The hair transplant system of claim 1, wherein:
the graft storage module comprises at least one cap removably mounted to a storage chamber;
the cap has an internally protruding hollow tube feature;
the storage chamber has a retaining filter; and
the hollow tube feature and the retaining filter are coaxial.
21. The hair transplant system of claim 1, wherein the graft storage module is configured to be adjustably latched onto a body of the graft extraction module by a latch.
22. The hair transplant system of claim 1, wherein the graft storage module is configured to be adjustably latched onto a body of graft extraction module by a latch integrated with the graft storage module.
23. The hair transplant system of claim 1, wherein the graft storage module is integrated with the graft extraction module.
24. The hair transplant system of claim 1, wherein the graft implantation module comprises at least one knob assembly, at least one transfer tube assembly, at least one pusher assembly, and at least one nozzle assembly.
25. The hair transplant system of claim 24, wherein the graft implantation module is configured to accept at least one graft at a time through the transfer tube assembly with suction.
26. The hair transplant system of claim 24, wherein the graft implantation module is configured to create slits at a recipient site with a sharp distal tip of the transfer tube assembly.
27. The hair transplant system of claim 24, wherein a tip of the transfer tube assembly is sharp or blunt, and has a bevel tip with angle of 0 degrees to about 45 degrees.
28. The hair transplant system of claim 24, wherein the graft implantation module is configured to provide control over the depth of implantation of the graft by actuation of the pusher assembly by the knob assembly.
29. The hair transplant system of claim 3, further comprising at least one tool holder configured to hold the at least one graft extraction module, the at least one graft storage module, and the at least one graft implantation module.
30. The hair transplant system of claim 24, wherein the transfer tube assembly is replaceable.
31. The hair transplant system of claim 1, further comprising at least one graft tray, wherein:
the graft tray comprises a holding member and a covering member;
the holding member and covering member are configured to form a graft holding chamber having a first end with a first opening and a second end with a second opening; and
the first opening is a different size than the second opening.
32. The hair transplant system of claim 31, wherein the graft tray has an opening configured to accept a transfer tube assembly of the graft implantation module during loading of graft by suction.
33. The hair transplant system of claim 1, comprising two or more graft extraction modules, two or more graft storage modules, two or more graft implantation modules, or combinations thereof; and
wherein the system is configured to operate the various modules individually or simultaneously in any combination.
34. The hair transplant system of claim 1, further comprising a computerized user interface control panel configured to control rotational speed and torque of the graft extraction module, and suction level and suction flow rate in all modules of the system.
35. The hair transplant system of claim 34, wherein the computerized user interface control panel is configured to control rotational speed and torque of the graft extraction module in response to detected skin rupture in order to reduce or prevent damage to the graft.
36. The hair transplant system of claim 34, wherein the user interface is a graphical user interface, a graphical touch interface, a graphical press interface, a sound interface, a voice interface, or any combination thereof.
37. The hair transplant system of claim 1, wherein the all the modules of the system are controlled by wireless control, wired control, or a combination thereof.
38. A method of transplanting hair, the method comprising:
positioning a graft extraction module over a donor site;
atraumatically extracting at least one hair graft from the donor site using the graft extraction module to provide at least one extracted hair graft;
storing the at least one extracted hair graft in a graft storage module to provide at least one stored hair graft;
positioning a graft implantation module over a recipient site; and
atraumatically implanting the at least one stored hair graft onto the recipient site using the graft implantation module.
39. The method of claim 38, wherein positioning the graft extraction module over the donor site
comprises:
aligning at least one rotary cutting member of the graft extraction module coaxially over the at least one hair graft at the donor site hair along a direction of the graft.
40. The method of claim 38, wherein atraumatically extracting the at least one hair graft comprises:
advancing the at least one rotary cutting member into a skin layer surrounding the at least one hair graft at the donor site, wherein the rotary cutting member rotates as it advances into the skin layer; and
applying suction to remove the at least one hair graft from the donor site to provide the at least one extracted hair graft.
41. The method of claim 38, wherein storing the at least one extracted hair graft in the graft storage
module comprises:
transporting the at least one extracted hair graft from the rotary cutting member to the graft storage module, wherein the at least one extracted hair graft is transported through a graft collection tube that communicates between the rotary cutting member and the graft storage module.
42. The method of claim 38, further comprising trimming the at least one hair graft at the donor site before positioning the graft extraction module over the donor site.
43. The method of claim 42, wherein the at least one hair graft at the donor site is trimmed to a length of about 1 mm to about 5 mm above an external skin surface.
44. The method of claim 38, further comprising providing a tumescence fluid in a space between a dermal layer that surrounds the at least one hair graft and a sub-cutaneous layer below the dermal layer, before atraumatically extracting the at least one hair graft from the donor site.
45. The method of claim 38, wherein storing the at least one extracted hair graft in the graft storage module comprises:
providing at least one preservation fluid in the graft storage module; and
providing the at least one stored hair graft in the at least one preservation fluid.
46. The method of claim 45, wherein the at least one preservation fluid comprises saline, hypothermosol FRS, Lactated Ringer's solution with lactate as buffer, human serum with bicarbonate buffer, Plasma-lyte A with acetate gluconate buffer, or any combination thereof.
47. The method of claim 38, further comprising removing the at least one stored hair graft from the graft storage module and providing the at least one stored hair graft into a graft tray, before atraumatically implanting the at least one stored hair graft onto the recipient site.
48. The method of claim 47, further comprising:
aligning a transfer tube of the graft implantation module coaxially over the at least one stored hair graft on the graft tray; and
applying suction to transfer the at least one stored hair graft into the transfer tube.
49. The method of claim 48, wherein atraumatically implanting the at least one stored hair graft onto
the recipient site comprises:
advancing the transfer tube into a skin layer at the recipient site to create a cavity in the skin layer; and
transferring the at least one stored hair graft from the transfer tube into the cavity, wherein during the transfer, a pusher assembly pushes the stored hair graft into the cavity while the transfer tube retracts away from the cavity.
| # | Name | Date |
|---|---|---|
| 1 | ABSTRACT1.jpg | 2018-08-11 |
| 2 | 1852-MUM-2014-SSI REGISTRATION(2-7-2015).pdf | 2018-08-11 |
| 3 | 1852-MUM-2014-FORM 5.pdf | 2018-08-11 |
| 4 | 1852-MUM-2014-Form 5-050615.pdf | 2018-08-11 |
| 5 | 1852-MUM-2014-FORM 3.pdf | 2018-08-11 |
| 6 | 1852-MUM-2014-Form 3-050615.pdf | 2018-08-11 |
| 7 | 1852-MUM-2014-FORM 28.pdf | 2018-08-11 |
| 8 | 1852-MUM-2014-FORM 28(2-7-2015).pdf | 2018-08-11 |
| 9 | 1852-MUM-2014-FORM 2.pdf | 2018-08-11 |
| 10 | 1852-MUM-2014-FORM 2-050615.pdf | 2018-08-11 |
| 11 | 1852-MUM-2014-FORM 2(TITLE PAGE).pdf | 2018-08-11 |
| 12 | 1852-MUM-2014-Form 2(Title Page)-050615.pdf | 2018-08-11 |
| 13 | 1852-MUM-2014-FORM 18(2-7-2015).pdf | 2018-08-11 |
| 14 | 1852-MUM-2014-FORM 1.pdf | 2018-08-11 |
| 15 | 1852-MUM-2014-DRAWING.pdf | 2018-08-11 |
| 16 | 1852-MUM-2014-Drawing-050615.pdf | 2018-08-11 |
| 17 | 1852-MUM-2014-DESCRIPTION(PROVISIONAL).pdf | 2018-08-11 |
| 18 | 1852-MUM-2014-Description(Complete)-050615.pdf | 2018-08-11 |
| 19 | 1852-MUM-2014-CORRESPONDENCE.pdf | 2018-08-11 |
| 20 | 1852-MUM-2014-CORRESPONDENCE(IPO)-(13-8-2014).pdf | 2018-08-11 |
| 21 | 1852-MUM-2014-CORRESPONDENCE(2-7-2015).pdf | 2018-08-11 |
| 22 | 1852-MUM-2014-Correspondance-050615.pdf | 2018-08-11 |
| 23 | 1852-MUM-2014-Claims-050615.pdf | 2018-08-11 |
| 24 | 1852-MUM-2014-Abstract-050615.pdf | 2018-08-11 |
| 25 | 1852-MUM-2014-FER.pdf | 2020-07-31 |
| 1 | SS_1852MUM2014E_14-07-2020.pdf |