Abstract:
A method for extraction of a follicular unit from a donor area may be provided. The method may include the steps of positioning a patient in a prone position, injecting a fluid into the dermal layer of skin, evaluating a hair shaft diameter, locating the sebaceous gland, selecting a punch diameter, selecting a punch penetration depth, and extracting the follicular unit from the donor area.

Description:
BACKGROUND 
       [0001]    There are various medical and cosmetic procedures that are performed now using handheld and automated tools for hair transplantation as disclosed below for reference. 
         [0002]    Hair transplantation by strip method is widely performed. Typically, it involves removing a strip of graft of scalp from a donor region of the patient, which extends from ear to ear located in the occipital region at the back of the head. The strip of graft taken from the donor area is dissected under microscope, where a person can separate about 300 grafts per hour. However, some hair follicles may be damaged during microscopic dissection and harvesting. It is laborious and time consuming. 
         [0003]    The long incision made at the back of the patient for removing strip of graft from the donor area located from ear to ear. The graft area of the patient is stitched together, and normally leaves a visible scar. The hair that grows around the scar cannot be shortened or combed and causes significant cosmetic deformity. Sometimes, the process of skin grafting may result in complications resulting in injuries to the arteries which supply the blood to the scar and thus create pain, numbness, paresthesia and ischemia to the scar tissue. It may require more surgery to correct the problem and would result in creating more scars. 
         [0004]    Another technique, called follicular unit extraction (FUE), uses a 1 mm punch for coring through the dermis and epidermis and then extracting a follicular unit by forceps from the donor area. This method results in high transaction rate due to lack of control of angle of entry and depth of the punch and sometime makes visible scars. 
         [0005]    A machine, called a PCID (programmable Cole isolation device), and a sharp, programmable punch, called a PID (Cole isolation device), that limits the depth to just below the attachment of the arrector pili muscle for hair transplants. This punch is programmed to drill a graft at a specific angle by oscillation and rotation and reverse action. 
         [0006]    Still another known process utilizes a sharp punch to score the skin and separate follicular unit from the scalp. In order to avoid transaction, the sharp punch of about 1 mm diameter is inserted to a limited depth of about 0.3 mm to 1.5 mm, then a 1 mm diameter blunt punch is used about 4 mm to 6 mm deep enough to loosen the graft and removes the follicular unit with forceps. 
         [0007]    Another known system, called the ARTAS SYSTEM, discloses a “RESTORATION RONOTICS” which includes a punch of 1.65 mm diameter and capable of extraction of 600 grafts per hour. This system also uses a dull punch, and this system is limited to a square area. 
         [0008]    As noted above, the instruments, devices and machines are complex, expensive, and time consuming. Thus, there is a need for a new method and apparatus which is simpler, cheaper and more efficient. 
       SUMMARY 
       [0009]    A new method and apparatus for dissecting and extraction of follicular units from a donor area may be disclosed. The method and apparatus may provide advantages such as being simpler, cheaper and more efficient. 
         [0010]    Accordingly, the method of extraction of follicular units from a donor area may include injecting a fluid into the dermal layer of skin. A fluid may first be injected superficially into papillary dermis, may flow deep into reticular dermis and may make the dermal skin hard and fixed for easily drilling and may also compress the follicular units. The fluid may be prevented from entering follicles units as the follicles may be enclosed by a fibrous capsule which acts as a barrier. 
         [0011]    A user may select the diameter and length of the punch depending on the size of a hair. Generally, it is noted that a thick hair may have large sebaceous glands compared to thin hair which may have smaller sebaceous glands. In some rare cases a thick hair could have small sebaceous gland and vice versa. In general, sebaceous gland depth is between 2-4 mm and rarely reaches 5 mm, however a thick hair may have a large sebaceous gland. It is also possible in some patients that a variable sebaceous gland could occur. The drill may traverse only the sebaceous gland without insertion of arrector pili muscle. Therefore, there may be no need to exceed the depth more than 4 mm, thus reducing the chance of transecting follicular unit. This limited length punch which traverses a limited depth may provide a more free manipulation for the operator. At the beginning of the operation, one can have an idea about the size of the sebaceous gland and select a suitable punch length. One can have an idea of the sebaceous gland and decide a suitable punch length in ranges of 3, 4 or 5 mm. Regarding the selection of a suitable punch diameter, a suitable punch diameter may depend on a hair shaft diameter. 
         [0012]    A single occipital hair shaft may be measured in micrometers. Therefore, sizing of the diameter may be done using the following criteria: 
         [0013]    For a hair shaft diameter of 40-50 micron a punch of 0.75 mm may be appropriate. Similarly, for 45-55 micron a 0.80 mm punch; 50-60 micron a 0.85 mm and for greater than 60 micron a 0.90 mm punch diameter may be appropriate. 
         [0014]    An angle of entry of the punch may be aligned with an angle of emergence of a hair follicle. Normally, hair emerges at specific angle. A punch may fixedly form an angle in alignment with the inclination of hair emergence before dissecting through the skin without any chance of transecting follicular unit. The punch in the new invention may be shorter in length and may have an opening at its head where any skin tissue residue exits preventing occlusion. 
         [0015]    An optimized forceps may be provided which creates a pressure around the hair follicle to grasp deeper and more firmly and extracting several hair each time which is more productive and faster than the old procedure. 
         [0016]    Advantages of disclosed methods and apparatuses may be numerous. For example, they may provide fast healing, non-invasive procedure, no visible scaring, no post operative pain, decrease in follicular units transaction, scalp is ready for another session, operation is not dependent on skin laxity, less staff is required, does not need microscope, less time spent on grafting, easy and friendly procedure, cheaper, no complications such as, necrosis, numbness on the back of the head, requires no prior estimation as a follicular unit extracted from the donor and planted in the balding region, white hair can benefit from this procedure, less staff is needed and provides more dense packing. 
         [0017]    These and other benefits of the present invention may become readily apparent upon further review of the following specification and drawings. 
         [0018]    Before starting a drilling procedure, a patient can be positioned in a prone position, which is considered a simple and safe method to improve oxygenation and comfortable position, and then a tumescent solution can be injected into the papillary dermis. The injected tumescent solution may flow further into the reticular dermis, but may not penetrate the hair follicle. For example, penetration of the hair follicle may be avoided because of a sheath around the follicle. However the tumescent solution can compress the hair follicle circumferentially. This procedure can stretch and harden the patient&#39;s skin, including a fatty layer  30 , a dermis layer  31 , and an epidermis layer  32  at a top portion, and can compress around a hair follicular unit which includes about two hair follicles. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]    The present embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements and in which: 
           [0020]      FIG. 1A  illustrates a typical cross-section through hair follicles, a technique of extraction of hair follicles according to a prior art. 
           [0021]      FIG. 1B  illustrates a positioning of a punch, a technique of extraction of hair follicles according to a prior art. 
           [0022]      FIG. 1C  illustrates a depth of penetration of a punch, a technique of extraction of hair follicles according to a prior art. 
           [0023]      FIG. 1D  illustrates schematically a first forceps holding several hair follicles according to a prior art. 
           [0024]      FIG. 1E  illustrates schematically two forceps one for holding and other for pulling several hair follicles according to a prior art. 
           [0025]      FIG. 1F  illustrates schematically a remaining forceps for pulling several hair follicles according to a prior art. 
           [0026]      FIG. 2A  a typical cross-section through hair follicles, a technique of extraction of hair follicles according to other prior art. 
           [0027]      FIG. 2B  illustrates a positioning of a punch, a technique of extraction of hair follicles according to other prior art. 
           [0028]      FIG. 2C  illustrates a depth of penetration of a punch, a technique of extraction of hair follicles according to other prior art. 
           [0029]      FIG. 2D  illustrates schematically a first forceps holding several hair follicles according to other prior art. 
           [0030]      FIG. 2E  illustrates schematically two forceps one for holding and other for pulling several hair follicles according to other prior art. 
           [0031]      FIG. 2F  illustrates schematically a remaining forceps for pulling several hair follicles according to other prior art. 
           [0032]      FIG. 3A  illustrates an exemplary positioning and insertion of new innovated punch. 
           [0033]      FIG. 3B  illustrates an exemplary view of the bulging portion of new innovated punch. 
           [0034]      FIG. 3C  illustrates an exemplary schematic view through a drilled hair follicles of new invention. 
           [0035]      FIG. 4A  illustrates an exemplary view of angle of emergence of hair of several drilled follicular units of a new invention. 
           [0036]      FIG. 4B  illustrates an exemplary view of swiping a sterile gauze against the angle of emergence of hair of several drilled follicular units of a new innovated technique. 
           [0037]      FIG. 4C  illustrates an exemplary view of the angle of emergence of hair follicles after swiping with a sterile gauge of drilled follicular units of a new invention. 
           [0038]      FIG. 4D  illustrates an exemplary view of a new innovated forceps grabbing and pulling out the drilled follicular units. 
           [0039]      FIG. 5  illustrates an exemplary a front view of the punch. 
           [0040]      FIG. 6  illustrates an exemplary front view of the extraction forceps. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0041]    Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description, a discussion of several terms used herein follows. 
         [0042]    As used herein, the word “exemplary” means “serving as an example, instance or illustration.” The embodiments described herein are not limiting, but rather are exemplary only. It should be understood that the described embodiments are not necessarily to be construed as preferred or advantageous over other embodiments. Moreover, the terms “embodiments of the invention”, “embodiments” or “invention” do not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. 
         [0043]    Generally referring to a prior art in  FIGS. 1A-1C , wherein  FIG. 1A  shows a cross-section of a patient&#39;s skin in a donor area through a follicular unit  14  that has hair follicles a, b, c, d extending through a fatty layer  10 , a dermis layer  11 , and a epidermis layer  12 , having bulbs anchored into the fatty layer  10 , a sebaceous gland  13 , and an arrector pili muscle  15 . A follicular unit may include more or less than two hair follicles.  FIG. 1B  show a punch  16  inserted downward through epidermis layer  12 , dermis layer  11  and cutting sebaceous gland  13  to the level just deeper to insertion of arrector pili muscle attachment  15  and may transect hair follicular unit  14  as shown in  FIG. 1C . 
         [0044]    With reference to the prior art in  FIGS. 1D-1F , wherein  FIG. 1D  shows a drilled follicular unit  14  before extraction and a forceps  17  is used for grasping a superior end of a follicular unit. The follicular unit is then pulled out a few millimeters so as to be able to grasp the follicular unit hair below forceps  17  by a second forceps  18 , as shown in  FIG. 1E , which assists the extraction of the drilled follicular unit. The first forceps  17  is then released and the second forceps  18  is used to pull out the remaining hair follicles of the follicular unit hair  14 , as shown in  FIG. 1D . 
         [0045]    With reference to other prior art in  FIGS. 2A-2C , wherein  FIG. 2A  shows a cross-section of a patient&#39;s skin of a donor area through a follicular unit  24  that has hair follicles a, b, c, d extending through a fatty layer  10 , a dermis layer  11  and an epidermis layer  12 , having bulbs anchored into the fatty layer  10  a sebaceous gland  13  and an arrector pili muscle  23 . A follicular unit may include more or less than two hair follicles. In  FIG. 2B  a punch  26  is inserted downward through epidermis layer  12 , dermis layer  11  and into fatty layer  10 . It is noted that while pushing punch  26  into the skin, there would be side to side movement of the punch as indicated by arrows  25  on entry, and  27  at the bottom around the drilled follicular unit  24 . Instability of the punch  26  for lack of support to the operator&#39;s hand may result in transecting hair follicle a, b, c or d as shown in  FIG. 2C . 
         [0046]    With reference to the other prior art in  FIGS. 2D-2F , wherein  FIG. 2D  shows extraction of a follicular unit  24  using a forceps  28  for grasping a superior end of a follicular unit and pulling the follicular unit out by few millimeters. This allows for the grasping of the follicular unit hair below forceps  28  by a second forceps  29 , which further assists assist the extraction, as shown in  FIG. 2E . Next, the first forceps  28  can be released, and only using forceps  29 , the whole follicular unit hair  24  is pulled out, as illustrated in  FIG. 2D . Using the second forceps  29 , the operator would be able to extract one hair each time as shown in  FIG. 2F . 
         [0047]    Exemplary  FIG. 3A  is a schematic view showing the orientation and the depth of penetration of a punch, through a patient&#39;s skin of a donor area for extraction of a follicular unit. The depth of drilling is limited to the depth of a sebaceous gland and does not traverse to an arrestor pile muscle located below. The orientation of drilling follows the inclination of the angle of emergence of hair in order to avoid any hair follicle being transected. Exemplary  FIG. 3B  shows a punch  35  having a bulging body with a 45 degrees sloping shoulder  36  which when resting on the skin surface limits the drilling depth. Exemplary  FIG. 3C  shows as how the sloping shoulder of the punch when supported on the skin surface automatically assumes an angle  33  which is close to the angle of hair protrusion from the skin surface. Exemplary  FIGS. 3A-3C  exhibit as to how a depth and orientation of drilling is attained automatically without guessing and manipulation which expedites the process and saves time. 
         [0048]    Before starting a drilling procedure, a patient can be positioned in a prone position, which is considered a simple and safe method to improve oxygenation and comfortable position, and then a tumescent solution can be injected into the papillary dermis. The injected tumescent solution may flow further into the reticular dermis, but may not penetrate the hair follicle. For example, penetration of the hair follicle may be avoided because of a sheath around the follicle. However the tumescent solution can compress the hair follicle circumferentially. This procedure can stretch and harden the patient&#39;s skin, including a fatty layer  30 , a dermis layer  31 , and an epidermis layer  32  at a top portion, and can compress around a hair follicular unit which includes about two hair follicles. 
         [0049]    Exemplary  FIGS. 4A-4D  shows a cross-section through a several drilled follicular units of a patient&#39;s skin in a donor area. Exemplary  FIG. 4A  shows the cross-section through several drilled follicular units ready for extraction. Exemplary  FIG. 4B  shows a piece of sterile gauze  37  is being used to swipe across a localized area of skin surface opposite to the direction of hair protrusion in order to loosen the drilled follicular units and also to straighten the hair follicles for facilitating the gripping of hair before extraction. Exemplary  FIG. 4C  shows the straightened hair follicles  38  ready for extraction. Exemplary  FIG. 4D  shows a special forceps  39  which can have a longer tip and a more rigid structure, as compared to other hair extraction forceps now being used. The forceps  39  in the present exemplary embodiment may have a longer gripping handle and firmer tip which can be pressed on the skin surface. Thus, forceps  39  can allow for grasping firmly several hair follicles  38  more deeply at the skin surface and pulling out the hair in one step, instead of using two. Thus a shorter and shorten the procedure time. 
         [0050]    Exemplary  FIG. 5  illustrates an embodiment of the punch  40  having a cylindrical portion  41  with a 45 degrees sloping conical portion  42 . The conical portion  42  further can include a hollow punch barrel  44  that may have a sharp cutting edge at an end and an elongated handle portion  46  The cylindrical portion  41  can be provided with a hole  45  of about 3.16 mm which opens into the hollow barrel  43  of the punch, although it may be appreciated that any other dimensions of the hole  45  may be utilized, as desired. The punch barrel may further have an inner diameter less than an outer diameter. 
         [0051]    The length of the elongated cylindrical tubing  44  of the punch can be variable and may be selected based on the size of a sebaceous gland, which often ranges from 3 mm to 4 mm or more in thickness. The diameter of the punch barrel can be sized based on thickness of a hair measured in micrometers which is about 0.75 μmm, about 0.80 μm, about 0.85 μm or about 0.90 μm. In some exemplary embodiments, however, the cylindrical portion  41  with a conical portion  42  can limit the entry of the punch tubing  44  into the skin. In some exemplary embodiments, selecting a 45 degree sloping conical portion  42  may be based on the angle of hair exiting from the skin. Such an angle may be detrimental in controlling the angle of the entry of the punch and also stabilizing the movement of operation when drilling through the skin. The length of the handle  46  is about 23.25 mm and the diameter is about 2.4 mm, which is the longest component of the punch  40 , although variations in size and shape may be made, as desired. 
         [0052]    Exemplary  FIG. 6 , illustrates a forceps  50  used in some embodiments described herein. The forceps  50  can be held between a thumb and two fingers of a user in operation. The forceps  50  can have a pair of elongated, separable and flexible arms that may include of a serrated handle  53  and joined at top  54 . Additionally, the arms  53  may be spring biased which may allow for quick and easily grasping the hair follicle, for example, by a bow shaped curved portion of the shaft  52 ,  53  which is joined at top  54  having a tip  51  at an end portion. The tip  51  can have a tapered shape having an inner dimension of about 6.1 mm and outer dimension about 9.2 mm, although other dimension may be utilized, as desired. The serrated portion  53  of the forceps  50  can be about 36 mm long, which may allow for comfortable holding by a thumb and two fingers. The forceps  50  may allow for exerting pressure on the skin and controlling depth and angle of the extraction of follicular unit, as shown in exemplary  FIG. 4D . 
         [0053]    The foregoing description and accompanying figures illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art. 
         [0054]    Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.